Treatment and treatment related impairment of health-related quality of life ( HRQoL ) may affect survival .


When these effects are analyzed separately , bias may arise .


Therefore , we investigated the combined effect of treatment and longitudinally measured HRQoL on survival .


Patients with anaplastic oligodendrogliomas ( n = 288 ) who were randomized ( EORTC 26951 ) to radiotherapy ( RT ) alone or RT plus procarbazine , lomustine , and vincristine ( PCV ) chemotherapy were analyzed .


HRQoL [ appetite loss ( AP ) ] was assessed with the EORTC QLQ-C30 .


We compared survival results from different analysis strategies : Cox model with treatment only [ model 1 ( M1 ) ] or with treatment and time-dependent AP score [ model 2 ( M2 ) ] and the joint model combining longitudinal AP score and survival [ model 3 ( M3 ) ] .


The estimated hazard ratio ( HR ) for RT plus PCV was 0.76 ( 95 % CI 0.58-1 .00 ) for M1 , 0.72 ( 0.55-0 .96 ) for M2 , and 0.69 ( 0.52-0 .92 ) for M3 .


This corresponds to a lower risk of death of 24 % in M1 , 28 % in M2 , and 31 % in M3 , for patients treated with RT plus PCV chemotherapy .


AP resulted in an increased risk of death , with estimated HR of 1.06 ( 1.01-1 .12 ) for M2 and 1.13 ( 1.03-1 .23 ) for M3 : Every 10-point increase of AP resulted in a 13 % increased risk of death in M3 as compared to 6 % in M2 .


Part of the survival benefit of treatment with RT plus PCV chemotherapy can be masked by the negative effect that this treatment has on patients ' HRQoL .


In our study , up to 7 % of the theoretical treatment efficacy was lost when AP was not adjusted through joint modeling .


Diabetes mellitus is a global epidemic affecting 346 million people in the world .


The glycemic control is the key for diabetes prevention and management .


Some proteins can stimulate insulin release and modulate glycemic response .


To assess the effect of the consumption of different types of protein ( whey protein , soy protein and egg white ) on a second meal postprandial glycaemia in normal weight and normoglycemic subjects .


Randomized crossover clinical trial .


After an overnight fast of 12-hours , ten subjects attended the laboratory to drink one of the protein shakes ( whey , soy or egg white ) or the control drink .


Thirty minutes later , the subjects consumed a glucose solution ( 25 g glucose ) .


Glycemic response was monitored at times 0 ( before glucose solution ) and 15 , 30 , 45 , 60 , 90 and 120 min ( after glucose solution consumption ) .


Incremental area under the glycemic curve ( iAUC ) was calculated by the trapezoidal method .


Furthermore , glycemic response was assessed by a new method using iG equation .


Compared with control , whey and soy protein drinks reduced postprandial iAUC in 56.5 % ( p = 0.004 ) and 44.4 % ( p = 0.029 ) , respectively .


Whey protein was the only protein capable of avoiding great fluctuations and a peak in postprandial glycemia .


The assessment of glycemic response by iG equation showed positive correlation with iAUC ( Pearson 0.985 , p < 0.05 ) .


The consumption of whey and soy protein 30 minutes before a glucose load resulted in lower iAUC compared with control drink .


Whey protein maintained postprandial glycemia more stable .


To evaluate the efficacy and safety of Yigan Fupi Decoction ( YFD ) in the treatment of irritable bowel syndrome with diarrhea ( IBS-D ) patients .


A randomized controlled clinical trail was carried out in patients with IBS-D .


All patients were randomly assigned to the treatment group ( 58 cases , treated with YFD ) and the control group ( 58 cases , treated with Pinaverium Bromide Tablet ) .


The treatment course was 4 weeks for all patients .


The total effective rate , the stool property and state , the quality of life ( QOL ) , and TCM syndrome efficacy were assessed by IBS bowel symptom severity scale ( IBS-BSS ) , IBS defecation state questionnaire ( IBS-DSQ ) , IBS quality of life questionnaire ( IBS-QOL ) , and traditional Chinese medicine pattern curative effect scoring system ( TCM-PES ) before and after treatment .


There was no statistical difference in the total effective rate between the two groups ( 82.76 % vs. 77.59 % , P > 0.05 ) .


The treatment group was superior in the total IBS-BSS integral to the control group ( P < 0.05 ) .


The total effective rate of improving the stool property was better in the treatment group than in the control group ( 81.03 % vs. 72.41 % , P < 0.05 ) .


Besides , the number of days for emergent defecation among 10 days was less in the treatment group than in the control group ( P < 0.05 ) .


The improvement of the total IBS-QOL integral and the total integral of TCM syndrome were better in the treatment group than in the control group ( P < 0.01 ) .


The total effective rate of TCM-PES was better in the treatment group than in the control group ( 84.48 % vs. 70.69 % , P < 0.05 ) .


YFD was effective in the treatment of IBS-D patients of Gan-qi invading Pi syndrome , and could effectively relieve bowel symptoms , improve the stool property and the defecation frequency , elevate their QOL , and attenuate Gan-qi invading Pi syndrome with favorable safety and compliance .


To compare same-day whole-dose vs split-dose of 2-litre polyethylene glycol electrolyte lavage solution ( PEG-ELS ) plus bisacodyl for colon cleansing for morning colonoscopy .


Consecutive adult patients undergoing morning colonoscopy were allocated into two groups i.e. , same-day whole-dose or split-dose of 2-litre PEG-ELS .


Investigators and endoscopists were blinded to the allocation .


All patients completed a questionnaire that was designed by Aronchick and colleagues to assess the tolerability of the bowel preparation regime used .


In addition , patients answered an ordinal five-value Likert scale question on comfort level during bowel preparation .


Endoscopists graded the quality of bowel preparation using the Boston bowel preparation scale ( BBPS ) .


In addition , endoscopists gave an overall grading of the quality of bowel preparation .


Cecal intubation time , withdrawal time , total colonoscopy time , adenoma detection rate and number of adenomas detected for each patient were recorded .


Sample size was calculated using an online calculator for binary outcome non-inferiority trial .


Analyses was based upon intent-to-treat .


Significance was assumed at P-value < 0.05 .


Data for 295 patients were analysed .


Mean age was 62.0 14.4 years old and consisted of 50.2 % male .


There were 143 and 152 patients in the split-dose and whole-dose group , respectively .


Split-dose was as good as whole-dose for quality of bowel preparation .


The total BBPS score was as good in the split-dose group compared to the whole-dose group [ 6 ( 6-8 ) vs 6 ( 6-7 ) , P = 0.038 ] .


There was no difference in cecal intubation rate , cecal intubation time , withdrawal time , total colonoscopy time and adenoma detection rate .


Median number of adenoma detected was marginally higher in the split-dose group [ 2 ( 1-3 ) vs 1 ( 1-2 ) , P = 0.010 ] .


Patients in the whole-dose group had more nausea ( 37.5 % vs 25.2 % , P = 0.023 ) and vomiting ( 16.4 % vs 8.4 % , P = 0.037 ) , and were less likely to complete the bowel preparation ( 94.1 % vs 99.3 % , P = 0.020 ) .


Patients in the split-dose group were less likely to refuse the same bowel preparation regime ( 6.3 % vs 13.8 % , P = 0.033 ) and less likely to want to try another bowel preparation regime ( 53.8 % vs 78.9 % , P < 0.001 ) .


Splitting reduced-volume PEG-ELS for morning colonoscopy is as effective as taking the whole dose on the same morning but is better tolerated and preferred by patients .


The probability of developing osteoporosis decreases with an adequate supply of vitamin D , a balanced diet , and increased physical activity .


In this study , we evaluated whether an educational intervention improves osteoporosis-related behavior in perimenopausal women from rural areas .


A randomized experimental evaluation was performed of an educational intervention .


The variables were physical activity , calcium intake and sun exposure in women from rural areas aged 45-54 years ( n = 216 ) at time 0 and 12 months after the educational intervention .


In the control group ( n = 106 ) , the information was sent by surface mail ( month 0 ) .


In the intervention group ( n = 110 ) , two interactive workshops were given ( month 0 ) .


The topic of the workshops and the information sent by surface mail was healthy habits for osteoporosis prevention .


After 12 months , the intervention group , but not the control group , had increased their physical activity ( p = 0.006 ) , sun exposure ( p = 0.029 ) , and calcium intake ( 53 % to 64 % ) .


A simple educational intervention in perimenopausal women from rural areas improved healthy habits for osteoporosis prevention .


To investigate the impact of antiangiogenic monotherapy and photodynamic therapy ( PDT ) as add-on strategy on retinal morphology , and to analyse prognostic biomarkers for visual outcome and retreatment frequency in neovascular age-related macular degeneration ( nAMD ) .


255 patients participating in the MONT BLANC study were evaluated .


Patients were randomised to receive as-needed ranibizumab monotherapy or combination therapy ( verteporfin PDT and ranibizumab ) .


Outcome measures included visual acuity ( VA ) , retinal morphology assessed by optical coherence tomography and retreatment frequency .


The proportion of scans showing intraretinal cysts ( IRC ) or subretinal fluid ( SRF ) decreased more intensively in the combination than in the monotherapy group .


Pigment epithelial detachments ( PED ) decreased significantly only in the combination group .


Patients with IRC presented the lowest initial VA , and IRC had the strongest negative predictive value for functional improvement in both groups .


SRF showed a predictive value for a higher number of ranibizumab injections ( combination , +0.9 ; monotherapy , +0.8 ) and a higher number of PDT treatments in the combination group ( +0.3 ) .


PED was associated with a higher number of ranibizumab injections only in the monotherapy group ( +1.2 ) .


Combination and monotherapy showed a distinct response pattern for morphological parameters in nAMD .


IRC was the only relevant prognostic parameter for functional outcome .


NCT00433017 .


Thyroid hormones are required for normal brain maturation , and neonatal plasma thyroid hormone concentrations are low in infants less than 28 weeks gestation .


It is not known whether treatment of such infants with thyroid hormone improves neurodevelopmental outcome .


At three years corrected age , mental , motor , and neurological development was assessed in infants born at less than 28 weeks gestational age who had participated in a phase 1 trial of differing doses and modes of administration of thyroid hormone .


The trial 's endpoints were thyroid hormone ( thyroxine , T4 ) and thyotropin plasma concentrations in eight study arms : six treated with T4 [ 4 , 8 , and 16 g / ( kg day ) ] , bolus or continuous ] , one treated with iodine only , and one treated with placebo .


Follow-up at three years was not part of the original study goals .


Developmental index scores , rates of cerebral palsy ( CP ) , and rates of adverse outcome ( death or moderate to severe delay in development and/or disabling CP ) were compared between the eight study groups and between groups combined by dosage level , and between infants with and without T4 supplementation .


Of 166 randomized infants , 32 ( 19 % ) died in the neonatal period .


Of the 134 survivors , follow-up results were available for 89 children ( 66 % ) .


Mental and motor development and rates of cerebral palsy did not differ in any of the comparisons made .


In this study , no differences in neurodevelopment were found in relation to thyroid hormone treatment , but power was insufficient to detect any but very large differences .


To compare the effect of intravenous 20 % mannitol or dexamethasone ( DM ) on low back and leg pain after minimally invasive transforaminal lumbar interbody fusion ( MI-TLIF ) .


Between October 2012 and September 2013 , 100 patients with degenerative lumbar diseases underwent MI-TLIF and percutaneous pedicle screw fixation .


All patients were randomly divided into 3 groups : 34 patients received intravenous 20 % mannitol after operation ( mannitol group ) ; 32 patients received intravenous DM after operation ( DM group ) ; and 34 patients received neither dehydrating agent nor steroid after operation ( control group ) .


There was no significant difference in gender , age , disease duration , clinical symptoms , lesion types , and lesion segments between groups ( P > 0.05 ) .


The serum levels of inflammatory factors [ tumor necrosis factor a ( TNF-alpha ) , interleukin 1beta ( IL-1beta ) , and IL-6 ] were measured by ELISA at pre-operation and 3 , 24 , 48 , 72 , and 96 hours after operation .


Low back and leg pain was determined by using visual analogue scale ( VAS ) score after operation .


All procedures were smoothly performed without major complications of nerve root injury , hematoma , or infection .


There was no significant difference in operation time and intraoperative blood loss between groups ( P > 0.05 ) .


The VAS score of low back pain showed no significant difference between groups at all time points after operation ( P > 0.05 ) ; the VAS score of leg pain in the DM group was significantly lower than that in the control group at all time points ( P < 0.05 ) , and than those in the mannitol group at 3 , 24 , 48 , and 96 hours after operation ( P < 0.05 ) .


The serum level of TNF-a in the DM group was significantly lower than that in the control group at all time points ( P < 0.05 ) , and than that in the mannitol group at 3 , 48 , 72 , and 96 hours after operation ( P < 0.05 ) .


The serum level of IL-1beta in the DM group was significantly lower than that in the control group at 3 , 24 , 48 , and 72 hours after operation ( P < 0.05 ) , and than that in the mannitol group at all time points after operation ( P < 0.05 ) .


The serum level of IL-6 in the DM group was significantly lower than that in the control group at 3 and 24 hours after operation ( P < 0.05 ) , and than that in the mannitol group at 3 , 24 , and 48 hours after operation ( P < 0.05 ) .


Intravenous 20 % mannitol may has no effect on postoperative low back and leg pain , while DM can markedly relieve leg pain after MI-TLIF .


To assess the efficacy of a second-line regimen of oxaliplatin and folinic acid-modulated fluorouracil in patients with advanced pancreatic cancer who have experienced progression while receiving gemcitabine monotherapy .


A randomized , open-label , phase III study was conducted in 16 institutions throughout Germany .


Recruitment ran from January 2004 until May 2007 , and the last follow-up concluded in December 2012 .


Overall , 168 patients age 18 years or older who experienced disease progression during first-line gemcitabine therapy were randomly assigned to folinic acid and fluorouracil ( FF ) or oxaliplatin and FF ( OFF ) .


Patients were stratified according to the presence of metastases , duration of first-line therapy , and Karnofsky performance status .


Median follow-up was 54.1 months , and 160 patients were eligible for the primary analysis .


The median overall survival in the OFF group ( 5.9 months ; 95 % CI , 4.1 to 7.4 ) versus the FF group ( 3.3 months ; 95 % CI , 2.7 to 4.0 ) was significantly improved ( hazard ratio [ HR ] , 0.66 ; 95 % CI , 0.48 to 0.91 ; log-rank P = .010 ) .


Time to progression with OFF ( 2.9 months ; 95 % CI , 2.4 to 3.2 ) versus FF ( 2.0 months ; 95 % CI , 1.6 to 2.3 ) was significantly extended also ( HR , 0.68 ; 95 % CI , 0.50 to 0.94 ; log-rank P = .019 ) .


Rates of adverse events were similar between treatment arms , with the exception of grades 1 to 2 neurotoxicity , which were reported in 29 patients ( 38.2 % ) and six patients ( 7.1 % ) in the OFF and FF groups , respectively ( P < .001 ) .


Second-line OFF significantly extended the duration of overall survival when compared with FF alone in patients with advanced gemcitabine-refractory pancreatic cancer .


Patients receiving hemodialysis often perceive their caregivers are overburdened .


We hypothesize that increasing hemodialysis frequency would result in higher patient perceptions of burden on their unpaid caregivers .


In two separate trials , 245 patients were randomized to receive in-center daily hemodialysis ( 6 days/week ) or conventional hemodialysis ( 3 days/week ) while 87 patients were randomized to receive home nocturnal hemodialysis ( 6 nights/week ) or home conventional hemodialysis for 12 months .


Changes in overall mean scores over time in the 10-question Cousineau perceived burden scale were compared .


In total , 173 of 245 ( 70 % ) and 80 of 87 ( 92 % ) randomized patients in the Daily and Nocturnal Trials , respectively , reported having an unpaid caregiver at baseline or during follow-up .


Relative to in-center conventional dialysis , the 12-month change in mean perceived burden score with in-center daily hemodialysis was -2.1 ( 95 % confidence interval , -9.4 to +5.3 ; P = 0.58 ) .


Relative to home conventional dialysis , the 12-month change in mean perceived burden score with home nocturnal dialysis was +6.1 ( 95 % confidence interval , -0.8 to +13.1 ; P = 0.08 ) .


After multiple imputation for missing data in the Nocturnal Trial , the relative difference between home nocturnal and home conventional hemodialysis was +9.4 ( 95 % confidence interval , +0.55 to +18.3 ; P = 0.04 ) .


In the Nocturnal Trial , changes in perceived burden were inversely correlated with adherence to dialysis treatments ( Pearson r = -0.35 ; P = 0.02 ) .


Relative to conventional hemodialysis , in-center daily hemodialysis did not result in higher perceptions of caregiver burden .


There was a trend to higher perceived caregiver burden among patients randomized to home nocturnal hemodialysis .


These findings may have implications for the adoption of and adherence to frequent nocturnal hemodialysis .


The first in class angiotensin receptor neprilysin inhibitor , LCZ696 has been shown to reduce levels of N-terminal pro-brain natriuretic peptide ( NT-proBNP ) , reduce left atrial size and improve New York Heart Association ( NYHA ) class in patients with heart failure with preserved ejection fraction ( HFpEF ) .


We examined whether the effects of LCZ696 were independent of systolic blood pressure ( SBP ) lowering .


In the Prospective comparison of ARNi ( angiotensin receptor neprilysin inhibitor ) with ARB ( angiotensin receptor blocker ) on Management Of heart failUre with preserved ejectioN fracTion ( PARAMOUNT ) trial 301 patients were randomly assigned to LCZ696 or valsartan .


We examined the relationship between SBP lowering and LCZ696 on NT-proBNP level , left atrial size , NYHA class and estimated glomerular filtration rate ( eGFR ) .


By 12weeks blood pressure was reduced by 9mmHg ( SD 15 ) / 5mmHg ( SD 11 ) in patients receiving LCZ696 in comparison with 3mmHg ( SD 17 ) / 2mmHg ( SD 12 ) in those receiving valsartan .


The change in NT-proBNP was poorly correlated with change in SBP ( LCZ696 , r = 0.17 , P = 0.06 ; valsartan , r = 0.05 , P = 0.58 ) After adjustment for change in SBP , the ratio of change in NT-proBNP at 12weeks for LCZ696 vs. valsartan was 0.76 ( 95 % CI 0.63-0 .93 , P = 0.008 ) , and similar to the ratio not adjusting for SBP ( 0.76 , 95 % CI 0.63-0 .92 , P = 0.006 ) ; P for interaction was 0.38 ) .


Similarly , reduction in left atrial volume index at 36weeks , improvement in NYHA class and eGFR were all independent of the change in SBP .


In patients with HFpEF , the effect of the angiotensin receptor neprilysin inhibitor LCZ696 on NT-proBNP , left atrial volume , functional class , and eGFR was independent of reduction in SBP .


Helping patients control obesity remains a clinical challenge for internists , and African Americans experience obesity rates higher than other racial/ethnic groups .


To investigate whether a behavioral theory-based mobile health intervention would enhance weight loss when added to standard care among overweight/obese African American adults .


A randomized controlled trial of 124 adults recruited from Baltimore-area African American churches .


Participant follow-up ended March 2013 .


Participants were randomized to standard care ( included one-on-one counseling sessions with a dietitian and a physician ) or standard care plus daily tailored text messages for 6 months .


Text messages were delivered in phases : preparation , reinforcement of participant-selected diet and exercise goals , reflection , goal integration , weight loss methods , and maintenance .


There were follow-up visits at 3 , 6 , and 12 months .


Primary outcome was weight change from baseline to end-intervention at 6 months .


Secondary outcomes included weight change at 3 months , engagement , and satisfaction with the intervention .


Sixty-three participants were randomized to the mobile health intervention and 61 to standard-care control .


Weights were collected in-window for 45 ( 36.3 % ) at 3 months and 51 ( 41.1 % ) at 6 months .


Mean weight loss at 3 months was 2.5 kg greater in the intervention group compared with standard care ( 95 % confidence interval [ CI ] , -4.3 to-0 .6 ; P < .001 ) , and 3.4 kg greater ( 95 % CI,-5 .2 to-1 .7 ; P = .001 ) at 6 months .


Degree of engagement with messages was correlated with weight loss .


While attrition was high , this study supports a tailored , interactive text-message intervention to enhance weight loss among obese African-American adults .


Severe immobility due to lesions of the brain necessitates therapeutic positioning over the long term .


There is little scientific evidence concerning the efficacy of different positioning methods .


This clinical trial compares the effects of conventional positioning ( CON ) with those of positioning in neutral ( LiN ) .


A prospective , multicenter , investigator-blinded , randomized , controlled trial was performed on a total of 218 non-ambulatory patients ( underlying disease : stroke , 141 patients ; hypoxic brain damage , 28 ; traumatic brain injury , 20 ; other , 29 ) .


The subjects were randomly assigned to either LiN ( 105 patients ) or CON ( 113 patients ) and stratified within each of these two positioning concepts to five different positions .


They remained in the assigned positions for two hours .


The primary endpoint was change in the passive range of motion ( PROM ) of the hip joints .


Secondary endpoints were change in the PROM of the shoulder joints and patient comfort .


Patients in the LiN group had a significantly better PROM of the hips after positioning than those in the CON group ( difference , 12.84 ; p < 0.001 ; 95 % confidence interval [ CI ] , 5.72-19 .96 ) .


The same was true for PROM of shoulder flexion ( 11.85 ; p < 0.001 ; 95 % CI , 4.50-19 .19 ) and external rotation ( 7.08 ; p < 0.001 ; 95 % CI : 2.70-11 .47 ) .


81 % of patients in the LiN group reported their comfort level as good , compared to only 38 % in the CON group ( p < 0.001 ) .


Positioning severely immobilized patients in LiN for two hours improved passive hip and shoulder mobility and patient comfort compared to conventional positioning .


Further studies are needed to determine whether prolonged LiN positioning might improve rehabilitation and quality of life , prevent pressure sores , or ease nursing care .


To compare the effects of right unilateral ( RUL ) electroconvulsive therapy ( ECT ) and algorithm-based pharmacologic treatment ( APT ) on neurocognitive function in treatment-resistant bipolar disorder depression .


Inpatients with DSM-IV-TR-diagnosed , treatment-resistant bipolar depression , who were acutely admitted to 1 of the 7 clinical study centers in Norway , were recruited from May 2008 to April 2011 into a prospective , randomized controlled , 6-week acute treatment trial .


General neurocognitive function was assessed with the MATRICS Consensus Cognitive Battery ( MCCB ) , and retrograde memory for autobiographical events was assessed with the Autobiographical Memory Interview-Short Form ( AMI-SF ) before and shortly after ( mean = 23.5 days ) a trial with either RUL brief-pulse ECT ( mean dose = 233.3 mC ) or APT .


Seventy-three patients entered , and 39 ( nECT = 19 , nAPT = 20 ) completed .


Both groups showed improvements in all MCCB domain scores , with no significant differences between the study groups ( no interaction effect : F , = 1.52 , P = NS ) .


Improvements in neurocognitive performance were significantly correlated with reductions in depression ratings posttreatment .


The AMI-SF score was significantly lower ( based on consistent answers from pre - to posttreatment ) in the ECT group ( 72.9 % ) than in the APT group ( 80.8 % , P = .025 ) , indicating reduced consistency in autobiographical memory after ECT .


General neurocognitive function was unaffected by RUL brief-pulse ECT treatment and positively related to improved mood in bipolar depression .


Autobiographical memory consistency was reduced in patients treated with ECT .


The results suggest that ECT can be used in treatment-resistant bipolar depression without compromising general neurocognitive function .


The clinical relevance of reduced autobiographical memory consistency in the ECT group requires further investigation .


ClinicalTrials.gov identifier : NCT00664976 .


The purpose of this study was to evaluate the effectiveness of the application of analyzing treadmill , muscle strengthening , and balance training compared with a standard care intervention in patients with diabetic neuropathy .


Twenty-seven patients , 63 % female ( mean standard deviations age , 72 9 years ) , with diabetic neuropathy randomly assigned to receive a multimodal manual treatment approach including analyzing treadmill with feedback focused , isokinetic dynamometric muscle strengthening , and balance retraining on dynamic balance platform or a standard care intervention for activities targeted to improve endurance , manual exercises of muscle strengthening , stretching exercises , gait , and balance exercises ( 5 weekly over 4 weeks ) .


This study was designed as a double-blind , randomized clinical trial .


Measures were assessed at pretreatment , 4 weeks posttreatment , and 2-month follow-up .


No important baseline differences were observed between groups .


At the end of the treatment period , the experimental group showed a significant increase in gait endurance in a 6-minute walk test , 65.6 m ( F [ 2.0 ] = 9.636 ; P = .001 ) .


In addition , the 6-minute walk test increased after the intervention , and an even greater difference was found at follow-up ( P = .005 ) for the standard care group .


The Functional Independence Measure in both groups increased ( P < .01 ) and continued until the follow-up in the standard care group ( P = .003 ) .


The results suggest that the experimental rehabilitation program showed positive effects on the gait endurance after 4 weeks of treatment , whereas it did not produce significant improvements of the gait speed .


Both the treatments produced significant improvement of functionalities of the patient .


Median sternotomy is the preferred approach for open heart surgeries .


The sternotomy incision is predominantly closed with either steel wire or polyester suture .


The type of material used is primarily based on the surgeon 's choice , and both materials achieve a good result .


No prospective clinical study has been undertaken to evaluate differences in the incidence of wound infection and the degree of pain associated with both techniques .


Our randomized controlled double-blind study included 200 adults undergoing single-valve replacement .


The technique of surgery , apart from the material used for sternal closure , was the same in both groups .


Postoperatively , patients were analyzed for wound infection and wound pain based on the ASEPSIS score and Numeric Pain Rating Score , respectively .


The polyester suture group had a significantly higher mean ASEPSIS score , indicating a higher incidence of wound infection , and more late wound complications .


The polyester suture group also had a significantly higher mean pain score .


The steel wire group had significantly higher mediastinal drain output in the first 48 h after surgery .


The use of polyester suture for sternal closure in adult patients results in increased wound infection , wound pain , and late wound complications , but lower mediastinal drain output .


To compare surgeons ' intraoperative surgeon acceptability or assessment of the operative field regarding bowel contents and patients ' satisfaction with or without a mechanical bowel preparation before reconstructive vaginal prolapse surgery .


In this single-blind , randomized trial , women scheduled to undergo vaginal prolapse surgery with a planned apical suspension and posterior colporrhaphy were allocated using block randomization to an intervention or control group .


Surgeons were blinded to patient allocation .


One day before surgery , mechanical bowel preparation instructions consisted of a clear liquid diet and two self-administered saline enemas ; the participants in the control group sustained a regular diet and nothing by mouth after midnight .


The primary outcome was surgeons ' intraoperative assessment of the surgical field regarding bowel content as measured on a 4-point Likert scale ( 1 , excellent ; 4 , poor ) .


Secondary outcomes included participant satisfaction and bowel symptoms .


The primary outcome was determined by intention-to-treat analysis and other analyses were per protocol .


Of the 150 women randomized ( 75 women to intervention and control group ) , 145 completed the study .


No differences existed in the demographic , clinical , and intraoperative characteristics between groups ( P > .05 ) .


Surgeons ' intraoperative assessment rating was 85 % `` excellent or good '' with bowel preparation compared with 90 % for participants in the control group ( odds ratio [ OR ] 0.59 , 95 % confidence interval [ CI ] 0.21-1 .61 ; P = .30 ) .


The bowel preparation group was less likely to report `` complete '' satisfaction compared with the participants in the control group ( OR 0.11 , 95 % CI 0.04-0 .35 ; P < .001 ) .


Abdominal fullness and cramping , fatigue , anal irritation , and hunger pains were greater in the bowel preparation group ( all P < .01 ) .


Before reconstructive vaginal surgery , mechanical bowel preparation conferred no benefit regarding surgeons ' intraoperative assessment of the operative field , reflected decreased patient satisfaction , and had increased abdominal symptoms .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01431040 .


I.


To observe clinical effect , feasibility and security of preconditioning of thermopaste application at Shenque ( CV 8 ) for relieving stretch reflex induced by procedure for prolapse and hemorrhoids ( PPH ) .


A total of 100 cases of mixed hemorrhoids ( stage III and IV ) patients were randomized into 1.0 h , 0.5 h , 0 h and control ( no application ) groups ( n = 25 in each group ) according to a random number table .


Thermopaste was applied to Shenque ( CV 8 ) 1.0 h and 0.5 h before PPH or conducted simultaneously with PPH .


The mean arterial pressure , heart rate , blood oxygen saturation of patients before and after anastomose operation , and the incidence of adverse reactions within 24 hours after the procedure were monitored and recorded .


The patient 's pain degree was assessed by using visual analogue scale .


After the preconditioning , of the 25 patients in the 0.5 h group ( 0.5 h G ) , 14 experienced marked improvement ( in the stretch reflex during PPH ) , 10 had an improvement , and 1 was invalid , respectively .


The markedly effective rate and the total effective rate were 56 % and 96 % , respectively .


The therapeutic effects for inhibiting stretch reflect being from the better to the poorer were 0.5 h G > 1.0 h G > 0 h G > NG .


The heart rate and blood pressure from more stable to lesser stable were 0.5 h G > 1.0 h G > 0 h G > NG .


The patients ' pain reaction during operation and their adverse effects of nausea , vomiting , abdominal distention and abdominal pain , etc. occurred during operation also presented the same tendency in the 4 groups .


Thermopaste application to Shenque ( CV 8 ) can effectively prevent and control visceral reflex in patients undergoing PPH , which effect is significantly better when conducted 0.5 hour before the operation .


This study aims to investigate the safety and efficacy of hepatic arterial infusion chemotherapy ( HAIC ) on liver metastases from pancreatic cancer after pancreatectomy .


We randomly assigned 106 patients with pancreatic cancer after pancreatectomy between 2005 and 2010 to receive 2 cycles of HAIC plus 4 cycles of systemic chemotherapy ( Combined Therapy ) or 6 cycles of systemic chemotherapy alone ( Monotherapy ) .


Both the HAIC and systemic chemotherapy regimen consisted of a 5-hour infusion of 5-fluorouracil 1000 mg/m2 on day 1 followed by gemcitabine 800 mg/m2 as an over 30-min infusion on day 1 and day 8 .


The treatment was started on an average of 21.2 days after surgery and repeated every 4 weeks .


The disease-free survival , overall survival and liver metastases-free survival were compared .


There was no significant difference in adverse effects between two groups .


Significant differences were found in 3-year overall survival ( Combined Therapy , 23.08 % ; Monotherapy , 14.81 % ; P = 0.0473 ) and liver metastases-free survival ( Combined Therapy , 80.77 % ; Monotherapy , 55.56 % ; P = 0.0014 ) .


HAIC effectively and safely prevents liver metastases and improves the prognosis of patients with pancreatic cancer after pancreatectomy .


This study evaluated the performance and acceptability of the Enlite ( ) glucose sensor ( Medtronic MiniMed , Inc. , Northridge , CA ) .


Ninety adults with type 1 or type 2 diabetes wore two Enlite sensors on the abdomen and/or buttock for 6 days and calibrated them at different frequencies .


On Days 1 , 3 , and 6 , accuracy was evaluated by comparison of sensor glucose values with frequently sampled plasma glucose values collected over a 12-h period .


Accuracy was assessed at different reference glucose concentrations and during times when absolute glucose concentration rates of change were < 1 , 1-2 , and > 2 mg/dL/min .


The sensor 's ability to detect hypoglycemia or hyperglycemia was evaluated with simulated alerts .


Subject satisfaction was evaluated with a 7-point Likert-type questionnaire , with a score of 7 indicating strong agreement .


With abdomen sensors under actual-use calibration ( mean , 2.8 0.9 times/day ) , the overall mean ( median ) absolute relative difference ( ARD ) values between sensor and reference values were 13.6 % ( 10.1 % ) ; the corresponding buttock sensor ARD values were 15.5 % ( 10.5 % ) .


With abdomen sensors under minimal calibration ( mean , 1.2 0.9 times/day ) , the mean ( median ) ARD values were 14.7 % ( 10.8 % ) .


Mean ARD values of abdomen sensors at rates of change of < 1 , 1-2 , and > 2 mg/dL/min were 13.6 % , 12.9 % , and 16.3 % , respectively .


With abdomen sensors , 79.5 % and 94.1 % of hypoglycemic and hyperglycemic events , respectively , were correctly detected ; 81.9 % and 94.9 % of hypoglycemic and hyperglycemic alerts , respectively , were confirmed .


The failure rates for abdomen and buttock sensors were 19.7 % and 13.9 % , respectively .


Mean responses to survey questions for all subjects related to comfort and ease of use were favorable .


The Enlite sensor provided accurate data at different glucose concentrations and rates of change .


Subjects found the sensor comfortable and easy to use .


Human autoimmune myocarditis is characterized by an increased frequency of serum organ and disease-specific anti-heart autoantibodies ( AHA ) in affected patients .


To assess whether AHA are directly pathogenic , we used the passive transfer technique of AHA from patients to normal Balb/c mice to induce an experimental myocarditis .


In keeping with a classical passive transfer experiment , sera from 5 AHA positive myocarditis patients ( 3 male , mean age 30 11 years , 3 with giant cell and 2 with lymphocytic myocarditis ) were affinity purified and injected into 25 Balb/c mice .


As controls , affinity purified sera from 5 healthy donors were passively transferred to 25 Balb/c mice .


Further 15 control mice were injected with phosphate-buffered saline and 9 mice did not receive any injection .


In all patients cardiac-specific AHA of IgG class had been previously detected by an indirect immunofluorescence ( IFL ) technique on cryostat sections of O blood group human heart .


The animals were sacrificed after 4 weeks and the hearts were blindly examined for histological evidence of myocarditis by an expert cardiac pathologist .


Myocarditis was present in 13/25 ( 52 % ) of the mice which received affinity-purified IgG from patients .


The findings of severe , moderate or mild myocarditis were more common in the mice which received affinity-purified IgG from patients ( 20 % ; 20 % and 12 % ) than in control animals ( 2 % , p = 0.01 ; 0 % , p = 0.003 ; and 0 % , p = 0.04 respectively ) .


These findings provide a new evidence for AHA-mediated pathogenicity in human myocarditis , according to Rose-Witebsky criteria .


Traumatic brain injury ( TBI ) is a leading cause of death and disability worldwide .


Prophylactic hypothermia is effective in laboratory models , but clinical studies to date have been inconclusive , partly because of methodological limitations .


Our Prophylactic Hypothermia Trial to Lessen Traumatic Brain Injury ( POLAR ) randomised controlled trial is currently underway comparing early , sustained hypothermia versus standard care in patients with severe TBI .


We describe our study protocol and the challenges in conducting prophylactic hypothermia research in TBI .


We aim to randomise 500 patients to either prophylactic 33C hypothermia initiated within 3 hours of injury and continued for at least 72 hours , or standard normothermic management .


Patients will be enrolled by paramedic services in the prehospital setting , or by emergency department staff at participating sites in Australia , New Zealand and Europe .


The primary outcome will be the eight-level extended Glasgow outcome scale ( GOSE ) , dichotomised to favourable and unfavourable outcomes at 6 months after injury .


Secondary outcomes will include mortality at hospital discharge and at 6 months , ordinal analyses of 6-month GOSE outcomes , quality of life with health economic evaluations and the differential proportion of adverse events .


We will predefine subgroup and interaction analyses .


After a run-in phase , recruitment for our main study began in December 2010 .


When the study is completed , we aim to provide evidence on the efficacy of prophylactic hypothermia in TBI to guide clinicians in their management of this devastating condition .


To assess the efficacy and safety of fluvastatin sodium extended-release tablets ( fluvastatin XL ) 80 mg once daily compared to fluvastatin sodium immediate-release capsules ( fluvastatin IR ) 40 mg twice daily in Chinese hyperlipidemic patients with moderate or high cardiovascular risk .


In this multi-center , randomized , double-blind , double-dummy , active-controlled , parallel-group study , after 6-week open-label treatment with fluvastatin IR 40 mg once daily , patients who did not reach their lipid goals were randomized to 12-week double-blind treatment with fluvastatin XL 80 mg once daily or fluvastatin IR 40 mg twice daily .


( 1 ) There were 218 patients enrolled in each group .


At the study endpoint , no statistical difference was found in the mean percent change from baseline for LDL-C with -8.69 % [ from ( 3.504 0.060 ) mmol/L to ( 3.153 0.065 ) mmol/L ] in the fluvastatin XL group and -7.89 % [ from ( 3.491 0.050 ) mmol/L to ( 3.181 0.060 ) mmol/L ] in the fluvastatin IR group ( P > 0.05 ) .


The 95 % CI for difference between the two groups in adjusted mean percent change from baseline was ( -4.70 % -3.09 % ) , which was within the pre-specified non-inferiority margin .


In the fluvastatin XL group , the proportion of patients with moderate cardiovascular ( CV ) risk and high CV risk achieving their LDL-C treatment goals at endpoint was 50.0 % and 31.5 % respectively , while the proportion was 42.5 % and 24.5 % respectively in the fluvastatin IR group .


No significant difference was found between the two groups in the proportion of patients who reached their lipid goals and the changes from baseline with other lipid parameters .


( 2 ) Similar safety profiles were observed in the two treatment groups , with 21.1 % adverse event ( AE ) ( 8.3 % study-drug related AE ) in the fluvastatin XL group and 17.0 % AE ( 6.3 % study-drug related AE ) in the fluvastatin IR group .


The efficacy of fluvastatin XL 80 mg once daily is comparable to fluvastatin IR 40 mg twice daily in Chinese hyperlipidemic patients with moderate or high cardiovascular risk and both treatments are safe and well-tolerated .


The purpose of this study was to evaluate the short-term effects of classic massage ( CM ) and connective tissue massage ( CTM ) on pressure pain threshold and muscle relaxation response in women with chronic neck pain .


Participants included 45 female volunteers ( ages between 25 and 45 years ) presenting to the Kroglu State Hospital Neurosurgery Polyclinic who had experienced neck pain for 3 to 6 months .


The volunteers were randomly assigned to 2 groups ( CM or CTM to the thoracic spine and the neck ) .


Each treatment was carried out for 1 session .


Outcome measures were obtained before and after treatment , which included pressure pain threshold that was measured with an algometer and muscle relaxation response that was evaluated with electromyography biofeedback ( EMG-BF ) .


Pressure pain threshold of the sternocleidomastoid muscle was significantly different for the CM ( P < .05 ) group .


The EMG-BF values were significantly different for the CTM group ( P < .05 ) .


Comparing the results of CM and CTM , EMG-BF averages favored the CTM group ( P < .05 ) .


For the group of women with chronic neck pain that were included in this study , 1 treatment of CTM demonstrated relaxation responses and 1 treatment of CM demonstrated pain reduction .


It is unclear whether advising a prudent breakfast alone is sufficient to improve blood lipids and cardiometabolic risk factors in overweight hypercholesterolemic subjects .


The aim of this study was to investigate whether a prudent low-fat breakfast ( PB ) rich in dietary fiber lowers low-density lipoprotein cholesterol ( LDL-C ) and other cardiometabolic risk factors in subjects with elevated LDL-cholesterol levels .


In a parallel , controlled , 12-week study , 79 healthy overweight subjects ( all regular breakfast eaters ) were randomly allocated to a group that received a PB based on Nordic foods provided ad libitum or a control group that consumed their usual breakfast .


The primary outcome was plasma LDL-C .


Secondary outcomes were other blood lipids , body weight , sagittal abdominal diameter ( SAD ) , glucose tolerance , insulin sensitivity and inflammation markers ( C-reactive protein [ CRP ] and tumor necrosis factor receptor-2 [ TNF-R2 ] ) , and blood pressure .


The PB was in accordance with national and Nordic nutrition recommendations and included oat bran porridge with low-fat milk or yogurt , bilberry or lingonberry jam , whole grain bread , low-fat spread , poultry or fatty fish , and fruit .


No differences were found in LDL-C , other blood lipids , body weight , or glucose metabolism , but SAD , plasma CRP , and TNF-R2 decreased more during PB compared with controls ( p < 0.05 ) .


In the overall diet , PB increased dietary fiber and - glucan compared with controls ( p < 0.05 ) .


Advising a prudent breakfast for 3 months did not influence blood lipids , body weight , or glucose metabolism but reduced markers of visceral fat and inflammation .


The trial was registered in the Current Controlled Trials database ( http://www.controlled-trials.com ) ; International Standard Randomized Controlled Trial Number ( ISRCTN ) : 84550872 .


Varicose veins are treated under local infiltration anesthesia .


Literature shows that adding sodium bicarbonate reduces the pain associated with local infiltration anesthesia .


Nonetheless , sodium bicarbonate is underused .


We sought to assess if the use of a solution of mepivacaine 2 % plus adrenaline with sodium bicarbonate 1.4 % results in less pain associated with local infiltration anesthesia preceding ambulatory phlebectomies , compared with standard preparation diluted with normal saline .


In all , 100 adult patients undergoing scheduled ambulatory phlebectomy were randomized to receive either a solution of mepivacaine chlorhydrate 2 % plus adrenaline in sodium bicarbonate 1.4 % or a similar solution diluted in normal saline 0.9 % .


Median pain scores associated with local infiltration anesthesia reported in the intervention and control groups were 2 ( SD = 1.6 ) and 5 ( SD = 2.0 ) ( P < .0001 ) , respectively .


A general linear model with bootstrapped confidence intervals showed that using the alkalinized solution would lead to a reduction in pain rating of about 3 points .


Patients were not asked to distinguish the pain of the needle stick from the pain of the infiltration .


Moreover , a complete clinical study of sensitivity on the infiltrated area was not conducted .


Data obtained from this study may contribute to improve local infiltration anesthesia in ambulatory phlebectomy and other phlebologic procedures .


We hypothesized that the time to successful fibreoptic tracheal intubation through the nasal route would be faster than the oral route for both experts and trainees in children < 2 yr of age .


One hundred children , 24 months and under in age , were randomized to an operator ( expert or trainee ) , and route ( nasal or oral ) for fibreoptic tracheal intubation .


Three separate times were then measured : ( i ) time to first glottic view , ( ii ) time to carinal view , and ( iii ) total time to successful tracheal intubation .


The number of attempts made , manoeuvres needed to obtain an adequate laryngeal view , and manoeuvres for tracheal tube passage were also recorded .


Time to successful tracheal intubation was significantly faster for experts than trainees .


There was no difference in the time to tracheal intubation between the nasal and oral routes for experts .


In trainees , intubation times were shorter for the nasal route-median ( inter-quartile range ) time ( s ) to carinal view was 35 ( 27-63 ) for the nasal route vs 59 ( 38-94 ) for the oral route ( P = 0.03 ) , and the median time to successful tracheal intubation were 62 ( 49-122 ) vs 117 ( 61-224 ) , P = 0.05 , for the nasal and oral routes , respectively .


For trainees , the oral route required a greater number of airway manoeuvres for adequate laryngeal views and passage of the tracheal tube compared with the nasal route .


For clinicians with less experience in using paediatric bronchoscopes , fibreoptic tracheal intubation through the nasal route may be a more straightforward process than the oral route in children < 2 yr of age .


NCT02029300 ( www.clinicaltrials.gov ) .


Adverse events ( AEs ) , defined as unintended patient harm related to healthcare provided rather than an underlying medical condition , represent a significant threat to patient safety and public health .


The emergency department ( ED ) is a high-risk patient safety setting for many reasons including presentation ` outside of regular hours ' , high patient volumes , and a chaotic work environment .


Children have also been identified as particularly vulnerable to AEs .


Despite the identification of the ED as a high-risk setting and the vulnerability of the paediatric population , little research has been conducted regarding paediatric patient safety in the ED .


The study objective is to generate an estimate of the risk and type of AEs , as well as their preventability and severity , for children seen in Canadian paediatric EDs .


This multicentre , prospective cohort study will enrol patients under 18 years of age from nine paediatric EDs across Canada .


A stratified cluster random sampling scheme will be used to ensure patients recruited are representative of the overall ED population .


A rigorous , standardised two-stage process will be used for AE identification .


The primary outcome will be the proportion of children with AEs associated with ED care in the 3 weeks following the ED visit .


Secondary outcomes will include the proportion of children with preventable AEs and the types and severity of AEs .


We will aim to recruit 5632 patients over 1 year and this will allow us to detect a proportion of patients with an AE of 5 % ( to within an absolute margin of error of 0.6 % ) .


Ethics approval has been obtained from participating sites .


Results will be disseminated through presentations , peer review publications , linkages with emergency research network and a webinars for key knowledge user groups .


This study is registered at Clinicaltrials.gov ( NCT02162147 ; https://clinicaltrials.gov/ct2/show/NCT02162147 ) .


To investigate whether Wii Sports Resort training is effective and if any benefits are maintained .


Randomized , single-blind trial .


Sixty-two hemiplegic children with cerebral palsy ( 6-13 years ) .


Experimental group undertook six weeks of home-based Wii Sports Resort training plus usual therapy , while the control group received usual therapy .


Outcomes were coordination , strength , hand function , and carers ' perception of hand function , measured at baseline , six , and 12 weeks by a blinded assessor .


There was a trend of mean difference ( MD ) for the experimental group to have more grip strength by six ( MD 4.0 N , 95 % confidence interval ( CI ) -0.8 to 8.8 , p = 0.10 ) and 12 ( MD 4.1 N , 95 % CI -2.1 to 10.3 , p = 0.19 ) weeks , and to have a higher quantity of hand function according to carers ' perception by six ( MD 4.5 N , 95 % CI -0.7 to 9.7 , p = 0.09 ) and strengthened by 12 ( MD 6.4 , 95 % CI 0.6 to 12.3 , p = 0.03 ) weeks than the control group .


There was no difference between groups in coordination and hand function by six or 12 weeks .


Wii training did not improve coordination , strength , or hand function .


Beyond the intervention , carers perceived that the children used their hands more .


Sickle cell disease ( SCD ) is a genetic disorder common in malaria endemic areas .


In endemic areas , malaria is a major cause of morbidity and mortality among SCD patients .


This suggests the need for prompt initiation of efficacious anti-malarial therapy in SCD patients with acute malaria .


However , there is no information to date , on the efficacy or safety of artemisinin combination therapy when used for malaria treatment in SCD patients .


Children with SCD and acute uncomplicated malaria ( n = 60 ) were randomized to treatment with artesunate-amodiaquine ( AA ) , or artemether-lumefantrine ( AL ) .


A comparison group of non-SCD children ( HbAA genotype ; n = 59 ) with uncomplicated malaria were also randomized to treatment with AA or AL. .


Recruited children were followed up and selected investigations were done on days 1 , 2 , 3 , 7 , 14 , 28 , 35 , and 42 .


Selected clinical and laboratory parameters of the SCD patients were also compared with a group of malaria-negative SCD children ( n = 82 ) in steady state .


The parasite densities on admission were significantly lower in the SCD group , compared with the non-SCD group ( p = 0.0006 ) .


The parasite reduction ratio ( PRR ) was lower , clearance was slower ( p < 0.0001 ) , and time for initial parasitaemia to decline by 50 and 90 % were longer for the SCD group .


Adequate clinical and parasitological response ( ACPR ) on day 28 was 98.3 % ( 58/59 ) in the SCD group and 100 % ( 57/57 ) in the non-SCD group .


Corresponding ACPR rates on day 42 were 96.5 % ( 55/57 ) in the SCD group and 96.4 % ( 53/55 ) in the non-SCD group .


The fractional changes in haemoglobin , platelets and white blood cell counts between baseline ( day 0 ) and endpoint ( day 42 ) were 16.9 , 40.6 and 92.3 % , respectively , for the SCD group , and , 12.3 , 48.8 and 7.5 % , respectively , for the non-SCD group .


There were no differences in these indices between AA - and AL-treated subjects .


The parasite clearance of SCD children with uncomplicated malaria was slower compared with non-SCD children .


AA and AL showed similar clinical and parasitological effects in the SCD and non-SCD groups .


The alterations in WBC and platelet counts may have implications for SCD severity .


Current controlled trials ISRCTN96891086 .


To investigate the pharmacokinetics of enteric-coated mycophenolate sodium ( EC-MPS ) and the clinical outcome in kidney transplant recipients in the early post-transplantation phase .


Then explain which regimen is more suitable for Chinese renal transplant recipients .


In total , 60 de novo kidney transplant recipients treated with tacrolimus and steroids were randomised to receive EC-MPS at standard dose ( SD ; 1440mg/day ; n = 28 ) or low dose ( LD ; 1080mg/day ; n = 32 ) .


Efficacy parameters , safety and tolerability were assessed over a 6-month study period .


Full mycophenolic acid ( MPA ) areas under the curve ( AUCs ) were completed on days 3 and 5 , whereas a three-point limited sampling strategy ( LSS ) was utilised for MPA AUC assessments at 2weeks and months 1 , 3 and 6 ( the LSS for three-time-point MPA AUC 0-12h ( mgh/l ) = 15.99 +0.87 C1h +0.68 C2h +7.85 C4h ; r ( 2 ) = 0.8670 .


The mean AUC levels at day 3 and day 5 in the SD group were significantly higher than in the LD group ( 57.4 mgh/l vs. 38.2 mgh/l and 59.3 mgh/l vs. 44.8 mgh/l , respectively , p < 0.01 ) .


There was a trend for fewer clinically diagnosed acute rejections in the SD group vs. the LD group at 6months ( 7.1 % vs. 12.5 % ) .


This trend was also present when acute rejection was analysed as biopsy-proven cases .


There were significantly more acute rejections ( all definitions ) in patients with MPA AUC levels < 30mgh/l compared with those with MPA AUC levels 30mgh/l within 6months ( p < 0.05 ) .


Renal function , incidence of infection and haematological disorders were not significantly different in either study group .


Early adequate MPA exposure in renal transplant recipients can be achieved with a higher starting dose .


In addition , a SD regimen was as well-tolerated as a LD regimen .


Furthermore , early adequate MPA exposure significantly lowered the rate of acute rejection without compromising safety and tolerability .


Blunt head trauma is a common cause of death and disability in children worldwide .


Cranial computed tomography ( CT ) , the reference standard for the diagnosis of traumatic brain injury ( TBI ) , exposes children to ionizing radiation which has been linked to the development of brain tumors , leukemia , and other cancers .


We describe the methods used to develop and test the effectiveness of a decision aid to facilitate shared decision-making with parents regarding whether to obtain a head CT scan or to further observe their child at home .


This is a protocol for a multicenter clinician-level parallel randomized trial to compare an intervention group receiving a decision aid , ` Head CT Choice ' , to a control group receiving usual care .


The trial will be conducted at five diverse emergency departments ( EDs ) in Minnesota and California .


Clinicians will be randomized to decision aid or usual care .


Parents visiting the ED with children who are less than 18-years-old , have experienced blunt head trauma within 24 hours , and have one or two risk factors for clinically-important TBI ( ciTBI ) from the Pediatric Emergency Care Applied Research Network head injury clinical prediction rules will be eligible for enrollment .


We will measure the effect of Head CT Choice on : ( 1 ) parent knowledge regarding their child 's risk of ciTBI , the available diagnostic options , and the risks of radiation exposure associated with a cranial CT scan ( primary outcome ) ; ( 2 ) parent engagement in the decision-making process ; ( 3 ) the degree of conflict parents experience related to feeling uninformed ; ( 4 ) patient and clinician satisfaction with the decision made ; ( 5 ) the rate of ciTBI at seven days ; ( 6 ) the proportion of patients in whom a cranial CT scan is obtained ; and ( 7 ) seven-day healthcare utilization .


To capture these outcomes , we will administer parent and clinician surveys immediately after each clinical encounter , obtain video recordings of parent-clinician discussions , administer parent healthcare utilization diaries , analyze hospital billing records , review the electronic medical record , and conduct telephone follow-up .


This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes , safety , and healthcare utilization in parents of children with minor head trauma in five diverse EDs .


ClinicalTrials.gov registration number : NCT02063087 .


Registration date February 13 , 2014 .


The aim of the study was to evaluate whether dietary intervention could reduce maternal and perinatal morbidity in pregnancies with one elevated 100 g oral glucose tolerance test ( OGTT ) value .


The study was conducted among patients with positive 50 g glucose challenge test ( GCT ) and one elevated 100 g OGTT value .


Plasma glucose value of 140 mg/dL was used as the threshold to define an abnormal GCT result .


Carpenter and Coustan criteria were used to evaluate the OGTT results .


Seventy-four women with normal GCT values comprised group I. Ninety-nine women with one elevated 100 g OGTT value who were given a caloric diet and 102 women with one elevated OGTT value in group III who received antenatal care with no special diet were randomly assigned to groups II and III , respectively .


All women were followed up until the end of pregnancy .


Poor maternal outcome was defined as : cesarean delivery performed due to cephalopelvic disproportion , failure to progress or fetal distress , preeclampsia , and/or preterm labor .


Poor perinatal outcome was defined as : small for gestational age , large for gestational age or admission to a neonatal intensive care unit .


The groups were compared in terms of maternal and perinatal outcomes .


The rates of macrosomia and large for gestational age incidence were significantly higher in group III as compared to groups I and II .


When we examined the multivariate effects of the risk factors considered to be predictive of poor maternal outcomes , group III was the only statistically significant risk factor ( OR = 3.90 , 95 % CI :1.95 - 7.84 ; p = < 0.001 ) .


In terms of poor perinatal outcome , one elevated OGTT value ( group III ) was the only significant risk factor ( OR = 2.92 , 95 % CI :1.56 -5.46 ; p = < 0.001 ) .


Women with one elevated OGTT value benefit from a structured program of diet therapy aimed to reduce adverse maternal and perinatal outcomes .


Solar ultraviolet ( UV ) radiation has deleterious effects on the skin , including sunburn , photoaging and cancer .


Chocolate flavanols are naturally-occurring antioxidant and anti-inflammatory molecules that could play a role in preventing cutaneous UV damage .


We investigated the influence of 12-week high-flavanol chocolate ( HFC ) consumption on skin sensitivity to UV radiation , measured by minimal erythema dose ( MED ) .


We also evaluated skin elasticity and hydration .


In this 2-group , parallel , double-blind , randomized controlled trial , 74 women aged 20-65 years and Fitzpatrick skin phototypes I or II were recruited from the general community in Quebec City , for randomization to either HFC ( n = 33 ) or low-flavanol chocolate ( LFC ) ( n = 41 ) .


A blocked randomisation ( 4 ) , considering date of entry , skin type and age as factors , generated a sequentially-numbered allocation list .


Study participants and research assistants were blinded .


Totally , 30g of chocolate were consumed daily for 12weeks , followed by a 3-week washout period .


MED was assessed at baseline and at 6 , 9 , 12 and 15weeks .


Main outcome was changes in MED at week 12 .


33 participants in the HFC group and 41 in the LFC group were analyzed with 15weeks of follow-up .


Both groups showed similarly-increased MED at 12weeks ( HFC : 0.02520.1099 J/cm2 [ meanstandard deviation ( SD ) ] ; LFC : 0.01510.1118 ; mean difference ( MD ) : 0.0100 J/cm2 ; 95 % confidence interval ( CI ) : -0.0417 to 0.0618 ) .


However , after 3-week washout , the HFC group presented decreased MED ( -0.02480.1145 ) whereas no effect was seen in the LFC group ( 0.01680.1698 ) ( MD : -0.0417 ; 95 % CI : -0.1106 to 0.0272 ) .


Net temple elasticity increased slightly but significantly by 0.090.12 mm in the HFC group at 12weeks compared to 0.020.12 mm in the LFC group ( MD : 0.06 ; 95 % CI : 0.01 to 0.12 ) .


No significant adverse events were reported .


Our study failed to demonstrate a statistically-significant protective effect of HFC vs. LFC consumption on skin sensitivity to UV radiation as measured by MED .


ClinicalTrials.gov identifier : NCT01444625 .


Timely and efficient upper esophageal sphincter ( UES ) opening may be critical to safe transport of food or liquid to the stomach and to prevent aspiration during the swallow .


The purpose of this study was to examine the temporal and biomechanical characteristics of the UES opening in stroke survivors .


Maximum duration and width of the UES opening were obtained from 15 stroke survivors with aspiration and 15 stroke survivors with no aspiration .


The control group was composed of 15 normal subjects undergoing videofluoroscopic swallowing examinations .


The videofluoroscopic swallowing examination protocol was as follows : two swallows of 5 ml thin liquid and two swallows of 10 ml thin liquid .


Statistical comparisons were made by repeated measurements of analysis of variance , and the significance level was set at P < 0.025 .


The stroke survivors with aspiration , the stroke survivors without aspiration , and the control group differed significantly for duration of UES opening ( P < 0.01 ) but not maximum width of UES opening .


Prolonged UES opening may be related to prolonged pharyngeal transition of the bolus and slower UES muscle contraction and hyolaryngeal excursion after stroke .


Ceftobiprole , the active moiety of ceftobiprole medocaril , is a novel broad-spectrum cephalosporin , with bactericidal activity against a wide range of gram-positive bacteria , including Staphylococcus aureus ( including methicillin-resistant strains ) and penicillin - and ceftriaxone-resistant pneumococci , and gram-negative bacteria , including Enterobacteriaceae and Pseudomonas aeruginosa .


This was a double-blind , randomized , multicenter study of 781 patients with hospital-acquired pneumonia ( HAP ) , including 210 with ventilator-associated pneumonia ( VAP ) .


Treatment was intravenous ceftobiprole 500 mg every 8 hours , or ceftazidime 2 g every 8 hours plus linezolid 600 mg every 12 hours ; primary outcome was clinical cure at the test-of-cure visit .


Overall cure rates for ceftobiprole vs ceftazidime/linezolid were 49.9 % vs 52.8 % ( intent-to-treat [ ITT ] , 95 % confidence interval [ CI ] for the difference , -10.0 to 4.1 ) and 69.3 % vs 71.3 % ( clinically evaluable [ CE ] , 95 % CI , -10.0 to 6.1 ) .


Cure rates in HAP ( excluding VAP ) patients were 59.6 % vs 58.8 % ( ITT , 95 % CI , -7.3 to 8.8 ) , and 77.8 % vs 76.2 % ( CE , 95 % CI , -6.9 to 10.0 ) .


Cure rates in VAP patients were 23.1 % vs 36.8 % ( ITT , 95 % CI , -26.0 to -1.5 ) and 37.7 % vs 55.9 % ( CE , 95 % CI , -36.4 to 0 ) .


Microbiological eradication rates in HAP ( excluding VAP ) patients were , respectively , 62.9 % vs 67.5 % ( microbiologically evaluable [ ME ] , 95 % CI , -16.7 to 7.6 ) , and in VAP patients 30.4 % vs 50.0 % ( ME , 95 % CI , -38.8 to -0.4 ) .


Treatment-related adverse events were comparable for ceftobiprole ( 24.9 % ) and ceftazidime/linezolid ( 25.4 % ) .


Ceftobiprole is a safe and effective bactericidal antibiotic for the empiric treatment of HAP ( excluding VAP ) .


Further investigations are needed before recommending the use of ceftobiprole in VAP patients .


Clinical Trials Registration .


NCT00210964 , NCT00229008 .


The efficacy of nebulized sodium nitrite ( AIR001 ) has been demonstrated in animal models of pulmonary arterial hypertension ( PAH ) , but it was not known if inhaled nitrite would be well tolerated in human subjects at exposure levels associated with efficacy in these models .


Inhaled nebulized sodium nitrite was assessed in three independent studies in a total of 82 healthy male and female subjects .


Study objectives included determination of the maximum tolerated dose ( MTD ) and dose-limiting toxicity ( DLT ) under normal and mildly hypoxic conditions , and following co-administration with steady-state sildenafil , assessment of nitrite pharmacokinetics , and evaluation of the fraction exhaled nitric oxide ( FENO ) and concentrations of iron-nitrosyl hemoglobin ( Hb ( Fe ) - NO ) and S-nitrosothiols ( R-SNO ) as biomarkers of local and systemic NO exposure , respectively .


Nebulized sodium nitrite was well tolerated following 6days of every 8 h administration up to 90mg , producing significant increases in circulating Hb ( Fe ) - NO , R-SNO , and FENO .


Pulmonary absorption of nitrite was rapid and complete , and plasma exposure dose was proportional through the MTD dosage level of 90mg , without accumulation following repeated inhalation .


At higher dosage levels , DLTs were orthostasis ( observed at 120mg ) and hypotension with tachycardia ( at 176mg ) , but venous methemoglobin did not exceed 3.0 % at any time in any subject .


Neither the tolerability nor pharmacokinetics of nitrite was impacted by conditions of mild hypoxia , or co-administration with sildenafil , supporting the safe use of inhaled nitrite in the clinical setting of PAH .


On the basis of these results , nebulized sodium nitrite ( AIR001 ) has been advanced into randomized trials in PAH patients .


To determine if temperature regulation is improved during neonatal transport using a servo-regulated cooling device when compared with standard practice .


We performed a multicenter , randomized , nonmasked clinical trial in newborns with neonatal encephalopathy cooled during transport to 9 neonatal intensive care units in California .


Newborns who met institutional criteria for therapeutic hypothermia were randomly assigned to receive cooling according to usual center practices vs device servo-regulated cooling .


The primary outcome was the percentage of temperatures in target range ( 33-34C ) during transport .


Secondary outcomes included percentage of newborns reaching target temperature any time during transport , time to target temperature , and percentage of newborns in target range 1 hour after cooling initiation .


One hundred newborns were enrolled : 49 to control arm and 51 to device arm .


Baseline demographics did not differ with the exception of cord pH. For each subject , the percentage of temperatures in the target range was calculated .


Infants cooled using the device had a higher percentage of temperatures in target range compared with control infants ( median 73 % [ IQR 17-88 ] vs 0 % [ IQR 0-52 ] , P < .001 ) .


More subjects reached target temperature during transport using the servo-regulated device ( 80 % vs 49 % , P < .001 ) , and in a shorter time period ( 44 31 minutes vs 63 37 minutes , P = .04 ) .


Device-cooled infants reached target temperature by 1 hour with greater frequency than control infants ( 71 % vs 20 % , P < .001 ) .


Cooling using a servo-regulated device provides more predictable temperature management during neonatal transport than does usual care for outborn newborns with neonatal encephalopathy .


Analysis of the patient-therapist relationship ( relationship work ) is considered a core active ingredient in dynamic psychotherapy .


However , there are contradictory findings as for whom and under what circumstances these interventions are beneficial .


This study investigates long-term effects of relationship work in the context of patients ' level of personality pathology and therapists ' self-reported parental feelings .


One hundred outpatients seeking psychotherapy for depression , anxiety , and personality disorders were randomly assigned to weekly dynamic psychotherapy , either with or without relationship work , for 1 year .


Personality pathology was evaluated before treatment as the sum of fulfilled personality disorder criteria items on the Structured Clinical Interview for DSM-III-R Personality Disorders .


Therapist feelings were assessed using the Feeling Word Checklist-58 .


The outcome variables were the Psychodynamic Functioning Scales and Inventory of Interpersonal Problems , measured at pretreatment , midtreatment , posttreatment , 1 year , and 3 years after treatment termination .


A significant interaction of treatment group ( relationship work vs. no relationship work ) by personality pathology by parental therapist feelings was present , indicating that parental feelings were differentially associated with long-term effects of relationship work , depending on the level of personality pathology .


In the context of low parental feelings , relationship work was positive for all patients .


However , when parental feelings were stronger , the specific effects of such interventions were even more positive for patients with high levels of personality pathology , but negative for patients with low levels of personality pathology .


The interaction of parental therapist feelings and patients ' personality pathology was strongly associated with the long-term specific effects of analysis of the patient-therapist relationship .


A number of effective strategies have been developed to improve the quality of life in patients with COPD .


However , few have been implemented in patients with COPD at all stages in a community setting .


This study evaluated the efficacy of a complex COPD health management intervention in rural communities in China .


A randomized controlled trial including 8,217 subjects with COPD was implemented from May 2008 to May 2012 in 14 community health-care centers .


The control group of subjects received usual care , whereas the management group of subjects participated in a health management program that included assessing the subjects ' health status , giving regular health lectures , smoking cessation counseling , encouraging regular exercise , providing rehabilitative training and psychological counseling , and regular follow-up .


As a primary outcome , we examined the changes in the BODE index .


Secondary outcomes included depression and anxiety rates , current smoking rate , awareness of COPD , mortality , risk factors , respiratory medication use , hospital admissions , and emergency department visits .


After 4 y , the mean cumulative value of the BODE index increased by 0.7 per subject in the control group and decreased by 0.4 per subject in the health management group ( difference of 1.1 , 95 % CI 0.2-2 .0 , P < .001 ) .


Health management reduced anxiety symptoms by 4.8 % , depression symptoms by 6.6 % , current smoking by 14.3 % , mortality due to all causes by 9.0 % , hospitalizations due to all causes by 16.1 % , and emergency department visits due to all causes by 18.1 % ( P < .05 for all ) .


However , it increased immunomodulator use by 58.9 % , respiratory medication use by 14.1-21 .9 % , and awareness scores for COPD by 57.2 % ( P < .05 for all ) .


The health management program is an effective community-based strategy for the prevention and management of COPD in China , increasing awareness and knowledge among patients and practitioners and improving management within the limitations of access to pharmacotherapy .


Telomeres are repetitive nucleoproteins that help maintain chromosomal stability by inhibiting exonucleolytic degradation , prohibiting inappropriate homologous recombination , and preventing chromosomal fusions by suppressing double-strand break signals .


We recently observed that men treated for clinically localized prostate cancer with shorter telomeres in their cancer-associated stromal cells , in combination with greater variation in cancer cell telomere lengths , were significantly more likely to progress to distant metastases , and die from their disease .


Here , we hypothesized that shorter stromal cell telomere length would be associated with prostate cancer risk at time of biopsy .


Telomere-specific fluorescence in situ hybridization ( FISH ) analysis was performed in normal-appearing stromal , basal epithelial , and luminal epithelial cells in biopsies from men randomized to the placebo arm of the Prostate Cancer Prevention Trial .


Prostate cancer cases ( N = 32 ) were either detected on a biopsy performed for cause or at the end of the study per trial protocol , and controls ( N = 50 ) , defined as negative for cancer on an end-of-study biopsy performed per trial protocol ( e.g. , irrespective of indication ) , were sampled .


Logistic regression was used to estimate the association between mean telomere length of the particular cell populations , cell-to-cell telomere length variability , and risk of prostate cancer .


Men with short stromal cell telomere lengths ( below median ) had 2.66 ( 95 % CI 1.04-3 .06 ; P = 0.04 ) times the odds of prostate cancer compared with men who had longer lengths ( at or above median ) .


Conversely , we did not observe statistically significant associations for short telomere lengths in normal-appearing basal ( OR = 2.15 , 95 % CI 0.86-5 .39 ; P = 0.10 ) or luminal ( OR = 1.15 , 95 % CI 0.47-2 .80 ; P = 0.77 ) cells .


These findings suggest that telomere shortening in normal stromal cells is associated with prostate cancer risk .


It is essential to extend and validate these findings , while also identifying the cellular milieu that comprises the subset of cells with short telomeres within the prostate tumor microenvironment .


Exposure to particulate air pollution increases respiratory and cardiovascular morbidity and mortality , especially in elderly , possibly through inflammation and vascular dysfunction .


We examined potential beneficial effects of indoor air filtration in the homes of elderly , including people taking vasoactive drugs.Forty-eight nonsmoking subjects ( 51 to 81 years ) in 27 homes were included in this randomized , double-blind , crossover intervention study with consecutive two-week periods with or without the inclusion of a high-efficiency particle air filter in re-circulating custom built units in their living room and bedroom .


We measured blood pressure , microvascular and lung function and collected blood samples for hematological , inflammation , monocyte surface and lung cell damage markers before and at day 2 , 7 and 14 during each exposure scenario .


The particle filters reduced the median concentration of PM2 .5 from approximately 8 to 4 g/m3 and the particle number concentration from 7669 to 5352 particles/cm3 .


No statistically significant effects of filtration as category were observed on microvascular and lung function or the biomarkers of systemic inflammation among all subjects , or in the subgroups taking ( n = 11 ) or not taking vasoactive drugs ( n = 37 ) .


However , the filtration efficacy was variable and microvascular function was within 2 days significantly increased with the actual PM2 .5 decrease in the bedroom , especially among 25 subjects not taking any drugs .


Substantial exposure contrasts in the bedroom and no confounding by drugs appear required for improved microvascular function by air filtration , whereas no other beneficial effect was found in this elderly population .


Postmenopausal women have a high prevalence of hypertension and often develop arterial stiffness thereby increasing cardiovascular disease risk .


Although antihypertensive drug therapies exist , increasing numbers of people prefer natural therapies .


In vivo studies and a limited number of clinical studies have demonstrated the antihypertensive and vascular-protective effects of blueberries .


To examine the effects of daily blueberry consumption for 8 weeks on blood pressure and arterial stiffness in postmenopausal women with pre - and stage 1-hypertension .


This was an 8-week , randomized , double-blind , placebo-controlled clinical trial .


Forty-eight postmenopausal women with pre - and stage 1-hypertension recruited from the greater Tallahassee , FL , area participated .


Participants were randomly assigned to receive either 22 g freeze-dried blueberry powder or 22 g control powder .


Resting brachial systolic and diastolic blood pressures were evaluated and arterial stiffness was assessed using carotid-femoral pulse wave velocity and brachial-ankle pulse wave velocity .


C-reactive protein , nitric oxide , and superoxide dismutase were measured at baseline , 4 weeks , and 8 weeks .


Statistical analysis was performed using a split plot model of repeated measures analysis of variance .


After 8 weeks , systolic blood pressure and diastolic blood pressure ( 13117 mm Hg [ P < 0.05 ] and 759 mm Hg [ P < 0.01 ] , respectively ) and brachial-ankle pulse wave velocity ( 1,401122 cm/second ; P < 0.01 ) were significantly lower than baseline levels ( 13814 mm Hg , 807 mm Hg , and 1,498179 cm/second , respectively ) , with significant ( P < 0.05 ) grouptime interactions in the blueberry powder group , whereas there were no changes in the group receiving the control powder .


Nitric oxide levels were greater ( 15.3511.16 mol/L ; P < 0.01 ) in the blueberry powder group at 8 weeks compared with baseline values ( 9.117.95 mol/L ) , whereas there were no changes in the control group .


Daily blueberry consumption may reduce blood pressure and arterial stiffness , which may be due , in part , to increased nitric oxide production .


To evaluate and compare the 1-year postoperative levels of posterior capsule opacification ( PCO ) as well as the level of anterior capsule retraction and opacification ( ACO ) after implantation of two single-piece hydrophobic acrylic intraocular lens ( IOL ) models .


Randomised , controlled , prospective and double-blind study including 148 eyes of 74 patients ( age range , 61-80 years ) with bilateral senile cataract .


Each patient underwent surgery with implantation of an AcrySof SA60AT ( Group A ) in one eye and Tecnis ZCB00 ( Group B ) in the fellow eye by the same experienced surgeon .


Lens allocation to the first or second operated eye followed a randomisation process .


At 12 months postoperatively , the PCO level was evaluated with the Evaluation of Posterior Capsule Opacification software , whereas the level of ACO and capsule retraction was evaluated and graded subjectively .


All surgeries were uneventful .


The mean PCO scores were 0.10 0.17 and 0.21 0.89 in Groups A and B , respectively , with no statistically significant differences between the groups ( p = 0.47 ) .


No significant correlation was found between the PCO scores in Groups A and B ( r = 0.16 , p = 0.17 ) .


Regarding ACO , it was present in 15 eyes ( 20.3 % ) and two eyes ( 2.7 % ) in Groups A and B , respectively ( p = 0.37 ) .


Capsular phimosis ( 13 eyes , 17.6 % ) was only observed in Group A.


Both IOLs had a similar low rate of PCO 1 year after surgery .


However , there seems to be a difference in the anterior capsule behaviour between both IOL models .


Subjective symptoms represent significant criteria of a patient 's health condition ; therefore , we focused on the long-term prevalence of heart failure symptoms and angina pectoris after myocardial infarction between two groups of patients in which two different therapeutic strategies were used during the acute phase of ST-elevation myocardial infarction ( STEMI ) .


The PRAGUE-2 study enrolled 850 patients with STEMI .


The patients were randomized into two groups - transport to a primary percutaneous coronary intervention ( PCI ) centre ( n = 429 ) vs. fibrinolysis in community hospitals ( n = 421 ) .


The data were collected from either primary hospitals or PCI centres , as well as via questionnaires .


The mean follow-up was 58 months .


At 5 years , 45.4 % of patients were in New York Heart Association class I following primary PCI vs. 31.8 % of those treated with fibrinolysis ( OR 2.02 , 95 % CI 1.37-2 .97 , p < 0.002 ) .


At 5 years , 83.6 % of patients had no symptoms of angina pectoris following invasive therapy vs. 58 % of patients treated with fibrinolysis ( OR 4.47 , 95 % CI 2.79-7 .18 , p < 0.001 ) .


The symptoms of angina pectoris and heart failure were significantly lower in patients assigned to primary PCI in the acute stage of myocardial infarction compared with patients treated with fibrinolysis at the 5-year follow up .


Allergic rhinitis ( AR ) presents as the main and most invasive symptom in the blocking of the nose .


This condition is almost always related to hypertrophy of the inferior turbinates .


When the medical treatments are found to be insufficient to solve the obstructive symptom of the patient , the quality of life is considerably impaired and it is often necessary to submit the patient to a surgical approach .


In the present study we aimed to establish the efficacy and safety of a new technique recently introduced for the shrinkage of hypertrophic turbinates using a specific device , based on a new radiofrequency energy that does not produce thermal mucosal damage , viz. , quantic molecular resonance ( QMR ) in a group of patients with persistent moderate-severe allergic rhinitis , in addition to standard medical treatment ( nasal steroid and oral antihistamine ) .


All patients were randomly assigned to two homogeneous groups ( group A , control subjects ; group B , treated patients ) ; each group included 145 individuals .


During the study , both groups received standard medications ( ebastine , 10-mg tablet , and budesonide nasal spray at 100 micrograms/nostril per day ) for 90 days .


Before the medical treatment , patients in group B underwent inferior endoscopic turbinoplasty using QMR .


All of the patients enrolled in this study were submitted to a complete otorhinolaryngologic evaluation with objective clinical examination ( basal rhinomanometry , nasal provocation test rhinomanometry , and mucociliary transport time ) , endoscopy , and questionnaires ( 22-item Sino-Nasal Outcome Test and visual analog scale for nasal symptoms ) .


Greater efficacy has been achieved using a combined approach with the association of medical and QMR treatment , compared with medical treatment alone , in the control of AR associated with hypertrophy of the inferior turbinates , in particular in the reduction of turbinate volume at rhinoendoscopy .


QMR inferior turbinoplasty , in conjunction with medical therapy , improves the nasal flow , without any thermal mucosal damage , more effectively when compared with medical treatment alone in persistent moderate-to-severe AR .


In particular , local reactivity , as measured with nasal provocation test , was noticeably reduced .


To assess whether immunization attenuates nicotinic stimulation of the brain and elucidate brain and behavioural responses during exposure to smoking cues and a working memory task .


Randomized , placebo-controlled parallel-group , repeated-measures design .


Maastricht University , the Netherlands .


Forty-eight male smokers were randomized to receive five injections with either 400g/ml of the 3 ' - aminomethylnicotine Pseudomonasaeruginosa r-Exoprotein-conjugated vaccine or placebo .


Subjects were tested on two occasions , once after a nicotine challenge and once after a placebo challenge , and were asked to refrain from smoking 10 hours before testing .


Reaction-times and accuracies were recorded during an n-back task .


Moreover , regional blood oxygenated level-dependent ( BOLD ) response was measured during this task and during smoking cue exposure .


Greater activation was found in response to smoking cues compared to neutral cues in bilateral trans-occipital sulcus ( P < 0.005 ) ; however , this effect did not survive correction for multiple comparisons .


There was no difference in brain activity to smoking cues between the treatment groups and no effects of acute nicotine challenge were established .


For the n-back task we found working memory load-sensitive increases in brain activity in several frontal and parietal areas ( P < 0.0025 ) .


However , no effects of immunization or nicotine challenge were observed .


No significant effects of immunization on brain activity in response to a nicotine challenge were established .


Therefore this vaccine is not likely to be an effective aid in smoking cessation .


The aim of the present study was to evaluate three mouth rinse solutions ' ( Plax , Listerine and Periogard ) influence on the microhardness and color stability of a composite resin ( Esthet.X , Dentsply ) .


For this purpose , forty specimens were prepared , being 10 specimens for each solution and 10 for artificial saliva ( control group ) .


Initially , specimens were polished and immersed in artificial saliva and following the initial color , an evaluation was made .


For 30 days , specimens were immersed in the solutions three times a day for 1 min .


After this cycling period , color change was analyzed and Knoop microhardness measures were carried out .


A new color measurement was performed after repolishing the specimens .


The microhardness and color stability results showed no statistically significant difference among the studied solutions .


However , samples immersed in Periogard showed a significant alteration in the composite resin brightness test .


It can be concluded that mouth rinse can influence the luminosity of composite resin .


To evaluate short-term perineal pain among primiparous women after mediolateral episiotomy ( MLE ) and lateral episiotomy ( LE ) .


The prospective randomized study was conducted in the Czech Republic during 2010-2012 .


Consecutive primiparous women who gave birth at or after 37 weeks of pregnancy and had indications for an episiotomy were enrolled and randomly assigned to undergo MLE or LE .


Patients were unaware of the episiotomy type performed .


The primary outcomes were pain at 24 hours , 72 hours , and 10 days post partum , measured by a visual analog scale , verbal rating scale , interference with activities of daily living , and amount of analgesic use .


The analysis included 266 women who underwent MLE and 297 women who underwent LE .


Complete relief of pain was observed in 6 ( 2.3 % ) of 266 women after 24 hours , 21 ( 8.0 % ) of 264 after 72 hours , and 77 ( 29.1 % ) of 265 after 10 days in the MLE group , and in 11 ( 3.9 % ) of 285 , 23 ( 7.7 % ) of 297 , and 78 ( 26.4 % ) of 295 in the LE group , respectively ( P = 0.36 ) .


There were no significant differences in overall pain scores from any rating system or in the amount of analgesics used .


Incidence and extent of pain in the first 10 days after LE correspond to those after adequately performed MLE .


Preterm birth is the most important single determinant of adverse outcome in the United Kingdom ; one in every 70 babies ( 1.4 % ) is born before 32weeks ( very preterm ) , yet these births account for over half of infant deaths.Deferring cord clamping allows blood flow between baby and placenta to continue for a short time .


This often leads to increased neonatal blood volume at birth and may allow longer for transition to the neonatal circulation .


Optimal timing for clamping the cord remains uncertain , however .


The Cochrane Review suggests that deferring umbilical cord clamping for preterm births may improve outcome , but larger studies reporting substantive outcomes and with long-term follow-up are needed .


Studies of the physiology of placental transfusion suggest that flow in the umbilical cord at very preterm birth may continue for several minutes .


This pilot trial aims to assess the feasibility of conducting a large randomised trial comparing immediate and deferred cord clamping in the UK .


Women are eligible for the trial if they are expected to have a live birth before 32weeks gestation .


Exclusion criteria are known monochorionic twins or clinical evidence of twin-twin transfusion syndrome , triplet or higher order multiple pregnancy , and known major congenital malformation .


The interventions will be cord clamping within 20seconds compared with cord clamping after at least two minutes .


For births with cord clamping after at least two minutes , initial neonatal care is at the bedside .


For the pilot trial , outcomes include measures of recruitment , compliance with the intervention , retention of participants and data quality for the clinical outcomes.Information about the trial is available to women during their antenatal care .


Women considered likely to have a very preterm birth are approached for informed consent .


Randomisation is close to the time of birth .


Follow-up for the women is for one year , and for the children to two years of age ( corrected for gestation at birth ) .


The target sample size is 100 to 110 mother-infant pairs recruited over 12months at eight sites .


ISRCTN21456601 , registered on 28 February 2013 .


Exercises aiming to strengthen the upper extremities are recommended to increase activities of daily living ( ADLs ) in patients with spinal cord injury ( SCI ) .


The aim of this study was to compare the effects of upper extremity progressive resistance exercises ( PRE ) and endurance exercises ( EE ) performed with an arm ergometer in patients with paraplegia due to SCI .


A total of 19 SCI patients were included in the study , and randomly divided into two groups .


The first group performed PRE while the second group performed arm EE .


The functional independence measurement ( FIM ) was used on each patient at the beginning and at the end of the study .


The elbow flexion and extension muscle strengths of each patient were determined with the computerized isokinetic dynamometer at the beginning and end of the study .


Post-training increased the FIM scores in both PRE ( p = 0.005 ) and EE groups ( p = 0.008 ) .


There were increases in the extension peak torque ( PT ) and total work ( TW ) at 180/sec and 60/sec angular velocity in the PRE group compared to the EE group ( all p < 0.05 ) .


There were improvement in post-training muscle strength values in both the PRE ( found to be more effective ) and EE groups .


Randomized trial ( Level I ) .


In the TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet inhibitioN with prasugrel Thrombolysis In Myocardial Infarction 38 ( TRITON-TIMI 38 ) , prasugrel reduced the primary ischaemic endpoint as compared with clopidogrel in acute coronary syndrome ( ACS ) patients planned to undergo percutaneous coronary interventions , but increased the risk of bleeding .


The present analysis shows the efficacy and safety data for the 10,074 non-ST segment elevation ( NSTE ) - ACS patients included in that trial .


The primary endpoint was significantly reduced by prasugrel in the overall NSTE-ACS population ( hazard ratio ( HR ) 0.82 , 95 % confidence interval ( CI ) 0.73-0 .93 , p = 0.002 ) as well as in unstable angina ( UA ) and in non-ST elevation myocardial infarction ( NSTEMI ) patient subgroups ( interaction p value = 0.39 ) .


Although non-coronary artery bypass graft ( CABG ) TIMI major bleeding was increased with prasugrel as compared with clopidogrel ( HR 1.40 , 95 % CI 1.05-1 .88 , p = 0.02 ) , there was a net clinical benefit in patients assigned to prasugrel ( HR 0.89 , 95 % CI 0.80-1 .00 , p = 0.043 ) , which was consistent for UA and NSTEMI subgroups ( interaction p value = 0.84 and 0.72 ) .


In patients who met the criteria for prasugrel use recommended by the European Medicines Agency , thus excluding from the analysis patients with prior transient ischemic attack ( TIA ) / stroke , with weight < 60 kg or age 75 years , and censoring follow-up at 365 days , ( European Union ( EU ) - label cohort ) prasugrel showed superiority over clopidogrel with regard to the primary endpoint ( HR 0.73 , 95 % CI 0.63-0 .85 , p < 0.0001 ) for the entire NSTE-ACS population , as well as for UA patients and NSTEMI patients without significant differences in non-CABG TIMI major bleeding .


Prasugrel , as compared with clopidogrel , significantly reduced the primary endpoint of the TRITON-TIMI 38 trial in NSTE-ACS patients , as well as in the UA and NSTEMI groups .


A significant reduction in the primary endpoint without increased bleeding was observed in the EU-label cohort .


ANTHEM-HF evaluated a novel autonomic regulation therapy ( ART ) via either left or right vagus nerve stimulation ( VNS ) in patients with heart failure ( HF ) and reduced ejection fraction ( HFrEF ) .


Sixty subjects ( New York Heart Association [ NYHA ] functional class II-III , left ventricular ejection fraction ( LVEF ) 40 % , left ventricular end-diastolic diameter 50 mm to < 80 mm ) receiving optimal pharmacologic therapy were randomized at 10 sites .


VNS systems were randomly implanted on the left ( n = 31 ) or right ( n = 29 ) side .


All patients were successfully implanted and 59 were titrated over 10 weeks to a well tolerated stimulation intensity .


One patient died 3 days after an embolic stroke that occurred during implantation .


Common device-related adverse events after VNS titration were transient mild dysphonia , cough , and oropharyngeal pain , which were similar for left - and right-side VNS .


After 6 months of ART , the adjusted left-right differences in LVEF , left ventricular end-systolic volume ( LVESV ) , and left ventricular end-systolic diameter ( LVESD ) were 0.2 % ( 95 % CI -4.4 to 4.7 ) , 3.7 mL ( 95 % CI -7.0 to 14.4 ) , and 1.3 mm ( 95 % CI -0.9 to 3.6 ) , respectively .


In the combined population , absolute LVEF improved by 4.5 % ( 95 % CI 2.4-6 .6 ) , LVESV improved by -4.1 mL ( 95 % CI -9.0 to 0.8 ) , and LVESD improved by -1.7 mm ( 95 % CI -2.8 to -0.7 ) .


Heart rate variability improved by 17 ms ( 95 % CI 6.5-28 ) with minimal left-right difference .


Six-minute walk distance improved an average of 56 m ( 95 % CI 37-75 ) ; however , improvement was greater for right-side ART ( 77 m [ 95 % CI 49-105 ] ) .


NYHA functional class improved in 77 % of patients ( baseline to 6 months ) .


Chronic open-loop ART via left - or right-side VNS is feasible and well tolerated in HFrEF patients .


Safety and efficacy measures are encouraging and warrant further study .


Moderate alcohol consumption exerts a cardioprotective effect , but no studies have evaluated the alcohol-independent cardiovascular effects of the non-alcoholic components of beer .


We aimed to evaluate the effects of ethanol and the phenolic compounds of beer on classical and novel cardiovascular risk factors .


Thirty-three high risk male volunteers were included in a randomized , crossover feeding trial .


After a washout period , all subjects received beer ( 30 g alcohol/d , 660 mL ) , the equivalent amount of polyphenols as non-alcoholic beer ( 990 mL ) , and gin ( 30 g alcohol/d , 100 mL ) for 4 weeks .


All outcomes were evaluated before and after each intervention period .


Moderate alcohol consumption increased serum HDL-cholesterol ( 5 % ) , ApoA-I ( 6 % ) , ApoA-II ( 7 % ) and adiponectin ( 7 % ) , and decreased serum fibrinogen ( 8 % ) , and interleukin ( IL ) -5 ( 14 % ) concentrations , whereas the non-alcoholic fraction of beer ( mainly polyphenols ) increased the receptor antagonist of IL-1 ( 24 % ) , and decreased lymphocyte expression of lymphocyte function-associated antigen-1 ( 11 % ) , lymphocyte and monocyte expression of Sialil-Lewis X ( 16 % ) and monocyte expression of CCR2 ( 31 % ) , and tumor necrosis factor ( TNF ) - ( 14 % ) and IL-15 ( 22 % ) plasma concentrations .


No changes were observed in glucose metabolism parameters or in body weight and adiposity parameters .


The phenolic content of beer reduces leukocyte adhesion molecules and inflammatory biomarkers , whereas alcohol mainly improves the lipid profile and reduces some plasma inflammatory biomarkers related to atherosclerosis .


Defaecatory function is often poor after anterior resection .


Denervation of the neorectum following high ligation of the inferior mesenteric artery ( IMA ) is a possible cause of impaired defaecatory function .


The purpose of this randomized clinical trial was to clarify whether the level of ligation of the IMA in patients with rectal cancer affects defaecatory function .


Between 2008 and 2011 , patients who underwent anterior resection for rectal cancer were randomized to receive either high or low ligation of the IMA .


The primary endpoint was to demonstrate the superiority of low ligation in terms of defaecatory function .


One hundred patients were enrolled in the study ; 51 were randomized to high ligation of the IMA and 49 to low ligation .


There were no differences between the groups in terms of clinical data , except tumour stage , which was more advanced in the high-ligation group ( P = 0046 ) .


Nor were there any differences in defaecatory function , self-assessment of defaecation , Faecal Incontinence Quality of Life scale or continence score between groups at 3months and 1year .


The number of harvested lymph nodes was similar .


The rate of symptomatic anastomotic leakage was 16 per cent in the high-ligation group and 10 per cent in the low-ligation group ( P = 0415 ) .


The level of ligation of the IMA in patients with rectal cancer did not affect defaecatory function or the incidence of postoperative complications .


NCT00701012 ( http://www.clinicaltrials.gov ) .


A high percentage of biventricular pacing is required for optimal outcome in patients treated with cardiac resynchronization therapy ( CRT ) , but the influence of ectopic beats on the success of biventricular pacing has not been well established .


This study sought to determine if increased ectopic beats reduce the chance of high biventricular pacing percentage and are associated with subsequent adverse outcomes .