Most patients had a cavity with localized granulation .


After treatment , inflammation score decreased in both groups ( p < 0.05 ) , with more pronounced inflammation-free cavities in the honey group .


Honey treatment resulted in less discomfort ( p < 0.001 ) and otorrhea ( p < 0.001 ) , even after correction for additional medication use ( p < 0.05 , p < 0.01 ) .


This decrease was not seen in the control group .


Pain and itching did not change on treatment .


Most cavities were infected with Pseudomonas species and Staphylococcus aureus .


After treatment , a 23 % increase of negative culture was seen with honey compared with 30 % in the control group ( nonsignificant ) .


No serious adverse reactions were found .


Medical honey gel is a safe alternative treatment option for patients with a chronically discharging open mastoid cavity and beneficial in reducing discomfort , otorrhea , and inflammation with a bactericidal effect .


Obesity is a chronic condition related to serious morbidity and mortality of increasing incidence and prevalence .


Several studies show a significantly higher weight loss with acupuncture treatment .


This is the first prospective , randomized , double-blinded study , testing the effects of auricular electroacupuncture on weight loss in obese female patients .


56 female obese patients ( age > 18 , Body Mass Index , BMI > 25 ) were randomized to receive either auricular acupuncture with electrical stimulation with a P-Stim device ( verum group , n = 28 ) or placebo treatment with a P-Stim dummy ( n = 28 ) for four days .


Three auricular acupuncture points were chosen ( hunger 18 , stomach 87 and colon 91 ) .


The treatment was performed once a week for a period of six weeks .


A follow-up visit was performed after 4 weeks .


At each visit body weight , BMI ( Body Mass Index ) and body fat were measured .


Relative reduction of body weight was significantly greater in the verum group ( -3.73 % ; CI = -4.70 to -2.76 ) than in the placebo group ( -0.70 % ; CI = -1.57 to +0.16 ; p < 0.001 ) In addition we also observed a significant reduction of BMI ( p < 0.001 ) in the verum group ( -3.62 % ; CI = -4.39 to -2.84 ) compared to placebo ( -0.82 % ; CI = -1.55 to -0.10 ; p < 0.001 ) .


No patient reported side effects related to acupuncture .


In conclusion electrical auricular acupuncture could be a safe , additive , non-pharmacological treatment in obese patients .


In behavioral studies of weight loss programs , participants typically receive interventions free of charge .


Understanding an individual 's willingness to pay ( WTP ) for weight loss programs could be helpful when evaluating potential funding models .


This study assessed WTP for the continuation of a weight loss program at the end of a weight loss study .


WTP was assessed with monthly coaching contacts at the end of the two-year Hopkins POWER trial .


Interview-administered questionnaires determined the amount participants were willing to pay for continued intervention .


Estimated maximum payment was calculated among those willing to pay and was based on quantile regression adjusted for age , body mass index , race , sex , household income , treatment condition , and weight change at 24 months .


Among the participants ( N = 234 ) , 95 % were willing to pay for continued weight loss intervention ; the adjusted median payment was $ 45 per month .


Blacks had a higher adjusted median WTP ( $ 65/month ) compared to Non-Blacks ( $ 45/month ) , P = 0.021 .


A majority of participants were willing to pay for a continued weight loss intervention with a median monthly amount that was similar to the cost of commercial weight loss programs .


Optimal physical behaviour is important , as physical inactivity contributes to functional deterioration and reduced social participation .


Nevertheless , research showed that persons with cerebral palsy ( CP ) have low physical activity levels .


The objective of this study is to evaluate the effectiveness of a lifestyle intervention programme on physical behaviour .


Fifty-seven persons ( 36 completed the total study ) with spastic CP ( age range 16 to 25y ; 27 males , 30 females ) , classified as Gross Motor Function Classification System levels I-IV were included in this randomized controlled trial .


Twenty-nine participants had a unilateral CP and 27 had a bilateral CP .


A 6-month lifestyle intervention consisting of fitness training and counselling on physical behaviour and sports participation was evaluated .


Physical behaviour was objectively measured using ambulatory activity monitors .


Self-reported physical activity was determined using the Physical Activity Scale for Individuals with Physical Disabilities .


The intervention did not affect the objectively measured physical activity during the intervention ( beta = 0.34 , CI = -1.70 to 2.37 ) or at follow-up ( beta = 0.30 , CI = -1.99 to 2.59 ) .


Self-reported physical activity was positively affected during the intervention period ( beta = 7.61 , CI = 0.17-15 .05 ) ; however , this effect was not present at follow-up ( beta = 3.65 , CI = -3.05 to 10.36 ) .


The lifestyle intervention was ineffective in eliciting a behavioural change towards more favourable physical behaviour in adolescents and young adults with spastic CP .


Animal models and retrospective clinical data suggest that certain anaesthetic techniques can attenuate immunosuppression and minimize metastasis after cancer surgery .


Natural killer ( NK ) T cells are a critical component of the anti-tumour immune response .


We investigated the effect of serum from women undergoing primary breast cancer surgery , randomized to propofol-paravertebral block ( PPA ) or sevoflurane-opioid ( GA ) anaesthetic techniques , on healthy human donor NK cell function and cytotoxicity against oestrogen and progesterone receptor-positive breast cancer cells ( HCC1500 ) .


Ten subjects who donated serum before operation and 24 h after operation in an ongoing randomized prospective trial ( NCT 00418457 ) were randomly selected .


Serum from PPA ( n = 5 ) and GA ( n = 5 ) subjects was co-cultured with HCC1500 and healthy primary NK cells .


NK cell activating receptors ( NKp30 , NKp44 , NKp46 , 2b4 , CD16 , NKG2D ) , cytokine production , NK CD107a expression , and cytotoxicity towards HCC1500 were examined .


Serum from PPA subjects did not alter normal NK marker expression or secretion of cytokines .


Serum from GA subjects reduced NK cell activating receptor CD16 [ from mean ( sem ) , 82 ( 2 ) % to 50 ( 4 ) % , P = 0.001 ] , IL-10 [ from 1700 ( 80 ) to 1200 ( 92 ) pg ml ( -1 ) , P = 0.001 ] , and IL-1 [ from 68 ( 12 ) to 19 ( 4 ) pg ml ( -1 ) , P = 0.01 ] .


An increase in NK cell CD107a [ 23 ( 2 ) % to 37 ( 3 ) % , P = 0.007 ] and apoptosis of HCC1500 [ 11 ( 1 ) % to 21 ( 2 ) % , P = 0.0001 ] was observed with PPA serum , but not GA serum , treated NK cells .


Serum from women with breast cancer undergoing surgical excision who were randomized to receive a PPA anaesthetic technique led to greater human donor NK cell cytotoxicity in vitro compared with serum from women who received GA. .


NCT 041857 .


In Korean medicine , the steamed root of Panax ginseng C.A. Meyer , known as Korean red ginseng ( KRG ) , is used to invigorate the body , enhance qi , and improve blood flow .


It is a potential treatment for cold hypersensitivity in the hands and feet ( CHHF ) , a common complaint among Asians , especially women .


However , few studies of its efficacy and safety for CHHF have been conducted .


This randomized , double-blind , placebo-controlled trial included 80 female patients with CHHF at Kyung Hee University Hospital at Gangdong , Seoul , Korea .


The participants took six capsules of 500-mg KRG powder or placebo twice daily for 8 weeks and were followed up for 4 weeks .


The primary outcome measure was change in skin temperature of the hands .


The secondary outcome measures included change in skin temperature of the feet , visual analog scale ( VAS ) scores of CHHF severity , recovered temperature ( RT ) of the hands after cold stress test , distal-dorsal difference ( DDD ) in temperature of the hands , power variables of heart rate variability ( HRV ) , and 36-item Short-Form Health Survey ( SF-36 ) scores .


The KRG group had significantly higher skin temperature of the hands and feet , lower VAS scores , higher RT of the right 5th finger , and less parasympathetic activity than the placebo group at 8 weeks .


No significant differences were noted in DDD of the hands and SF-36 scores .


No serious adverse events were reported during the study .


Peripheral vasodilation by KRG may alleviate CHHF .


Further controlled studies are required to elucidate the effects of KRG on the autonomic nervous system .


This work provides a reference for future papers originating from this study by providing basic results on body mass , urine volume , and hemodynamic changes to 5 days of bed rest ( BR ) and by describing acute cardio-respiratory/mechanographic responses to a short versatile upright exercise battery .


Ten male subjects ( mean SEM age : 29.4 1.5 years ; height : 178.8 1.5 cm ; body mass : 77.7 1.5 kg ) performed , in random order , 5 days of 6 head-down tilt ( HDT ) BR with no exercise ( CON ) , or BR with daily 25 minutes of quiet upright standing ( STA ) or upright locomotion replacement training ( LRT ) .


Plasma volume , exercise capacity and orthostatic tolerance decreased similarly between interventions following 5 days of BR .


Upright heart rate during LRT and STA increased throughout BR ; from 137 4 bpm to 146 4 bpm for LRT ( P < 0.01 ) ; and from 90 3 bpm to 102 6 bpm ( P < 0.001 ) for STA .


the overall similarity in the response to BR , and increase in upright heart rate during the LRT sessions suggest early and advancing cardiovascular deconditioning during 5 days of BR bed rest , which was not prevented by the versatile exercise regime .


The objective of the study was to determine whether transversus abdominis plane ( TAP ) block reduces postoperative pain when compared with trocar site infiltration of bupivacaine in gynecological laparoscopy .


This was a prospective , randomized , double-blinded clinical trial using patients as their own controls .


Women undergoing gynecologic laparoscopy using a 4-port symmetrical technique were randomly assigned to right - or left-sided TAP block using 30 mL of 0.25 % bupivacaine with epinephrine .


Two cohorts of patients were studied .


Cohort 1 consisted of anesthesiologist-administered ultrasound-guided TAP block .


Cohort 2 consisted of surgeon-administered laparoscopic-guided TAP block .


In both cohorts , contralateral port sites were infiltrated with an equal amount of bupivacaine in divided doses .


All patients received intraoperative acetaminophen and ketorolac .


Postoperative abdominal pain was assessed at 1 , 2 , 4 , 6 , 8 , 12 , 18 , 24 , and 48 hours on the block and contralateral sides , before and after palpation , using the 10 point visual analog scale .


A 2 point difference in the reported pain scores was considered clinically meaningful .


Eighty-eight patients were eligible for statistical analysis : 45 and 43 patients in cohorts 1 and 2 , respectively .


In both cohorts , most patients reported equal pain on the block side and local side .


In cohort 1 , there was a statistically significant difference in mean reported pain scores at 2 hours and across time favoring the ultrasound-guided block ; however , this did not reach clinical significance .


There was no statistically significant difference found at all other time points or when pain scores were objectively assessed after palpation of the incisions .


When comparing laparoscopic-guided block with local infiltration , there was no statistically significant difference in reported mean pain scores at all time points or after palpation .


As part of this multimodal analgesic regimen , neither block method provided a significant clinical benefit compared with trocar site bupivacaine infiltration .


The goal of this trial was to study the long-term effects of intravenous ( IV ) metoprolol administration before reperfusion on left ventricular ( LV ) function and clinical events .


Early IV metoprolol during ST-segment elevation myocardial infarction ( STEMI ) has been shown to reduce infarct size when used in conjunction with primary percutaneous coronary intervention ( pPCI ) .


The METOCARD-CNIC ( Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction ) trial recruited 270 patients with Killip class II anterior STEMI presenting early after symptom onset ( < 6 h ) and randomized them to pre-reperfusion IV metoprolol or control group .


Long-term magnetic resonance imaging ( MRI ) was performed on 202 patients ( 101 per group ) 6 months after STEMI .


Patients had a minimal 12-month clinical follow-up .


Left ventricular ejection fraction ( LVEF ) at the 6 months MRI was higher after IV metoprolol ( 48.7 9.9 % vs. 45.0 11.7 % in control subjects ; adjusted treatment effect 3.49 % ; 95 % confidence interval [ CI ] : 0.44 % to 6.55 % ; p = 0.025 ) .


The occurrence of severely depressed LVEF ( 35 % ) at 6 months was significantly lower in patients treated with IV metoprolol ( 11 % vs. 27 % , p = 0.006 ) .


The proportion of patients fulfilling Class I indications for an implantable cardioverter-defibrillator ( ICD ) was significantly lower in the IV metoprolol group ( 7 % vs. 20 % , p = 0.012 ) .


At a median follow-up of 2 years , occurrence of the pre-specified composite of death , heart failure admission , reinfarction , and malignant arrhythmias was 10.8 % in the IV metoprolol group versus 18.3 % in the control group , adjusted hazard ratio ( HR ) : 0.55 ; 95 % CI : 0.26 to 1.04 ; p = 0.065 .


Heart failure admission was significantly lower in the IV metoprolol group ( HR : 0.32 ; 95 % CI : 0.015 to 0.95 ; p = 0.046 ) .


In patients with anterior Killip class II STEMI undergoing pPCI , early IV metoprolol before reperfusion resulted in higher long-term LVEF , reduced incidence of severe LV systolic dysfunction and ICD indications , and fewer heart failure admissions .


( Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion .


The METOCARD-CNIC Trial ; NCT01311700 ) .


Few studies have examined consumer acceptability or comprehension of cholesterol-lowering claims on food labels .


Our objective was to assess consumer attitudes and understanding of cholesterol-lowering claims regarding plant sterols ( PS ) and oat fibre ( OF ) .


We conducted two studies on : ( 1 ) PS claims and ( 2 ) OF claims .


Both studies involved a randomized mock-packaged experiment within an online survey administered to Canadian consumers .


In the PS study ( n = 721 ) , we tested three PS-related claims ( disease risk reduction claim , function claim and nutrient content claim ) and a ` tastes great ' claim ( control ) on identical margarine containers .


Similarly , in the OF study ( n = 710 ) , we tested three claims related to OF and a ` taste great ' claim on identical cereal boxes .


In both studies , participants answered the same set of questions on attitudes and understanding of claims after seeing each mock package .


All claims that mentioned either PS or OF resulted in more positive attitudes than the taste control claim ( P < 0.0001 ) , despite all products within each study having the same nutrition profile .


How consumers responded to the nutrition claims between the two studies was influenced by contextual factors such as familiarity with the functional food/component and the food product that carried the claim .


Permitted nutrition claims are approved based on physiological evidence and are allowed on any food product as long as it meets the associated nutrient criteria .


However , it is difficult to generalize attitudes and understanding of claims when they are so highly dependent on contextual factors .


This randomised clinical trial ( RCT ) compared the clinical outcomes of three aesthetic full-coronal restorations ( composite strip crowns , pre-veneered stainless steel crowns ( SSCs ) and pre-fabricated primary zirconia crowns ) in carious and traumatised primary maxillary incisors .


One hundred and twenty nine teeth in 39 children aged between 3 to 5 years were included .


Children were randomly assigned to one of three treatment groups using a permuted block randomisation technique with a total of 43 teeth in each group .


After trainee calibration , restorations were placed and evaluated after 6 months .


Outcomes evaluated were restoration failure , tooth wear of opposing teeth and gingival health .


The retention rate was highest for zirconia crowns ( 100 % ) followed by pre-veneered SSCs ( 95 % ) .


Strip crowns were the least retentive ( 78 % ) .


Zirconia crowns showed low grade abrasion in four opposing teeth .


Teeth restored with resin composite and pre-veneered SSC showed an increase in mean gingival index score , while corresponding values decreased in zirconia crowns .


Resin composite strip crown is a highly sensitive technique leading to lower retention rate .


Pre-veneered stainless steel crowns showed increased incidence of facial veneer fracture .


Zirconia crowns are highly retentive and biocompatible but cause low grade of abrasion of their opposing natural dentition at the 6-month follow-up .


To evaluate the clinical , microbiological and immunological effects of systemic doxycycline as an adjunct to scaling and root planing ( SRP ) in chronic periodontitis patients with well-controlled type 2 diabetes .


Sixty-six patients compliant to oral hygiene ( Hygiene Index < 20 % ) allocated to either a test ( systemic doxycycline for 21 days ) or a control ( placebo ) group participated in the present randomized controlled trial ( RCT ) .


Clinical assessments were recorded at baseline , 3 and 6 months after therapy and included clinical attachment level ( CAL ) , set as the primary outcome of the study , probing pocket depth ( PPD ) , recession ( RE ) and bleeding on probing ( BOP ) .


At the same time points , counts of 15 subgingival species were evaluated by `` checkerboard '' DNA-DNA hybridization , gingival crevicular fluid samples were analysed for matrix metalloproteinase-8 ( MMP-8 ) by ELISA and HbA1c levels were determined .


Comparisons between and within groups were performed by non-parametric tests ( Mann-Whitney , Wilcoxon signed-ranks and z-test for proportions with Bonferroni corrections ) at the 0.05 level .


No major differences were noticed in clinical and microbiological parameters of periodontal disease or levels of MMP-8 between the two groups .


Adjunctive systemic doxycycline does not seem to significantly enhance the effects of SRP in well-controlled diabetes type 2 patients .


Disproportionally low retention of minority populations can adversely affect the generalizability of clinical research trials .


We determine the overall retention rates for White and Black participants from the Selenium and Vitamin E Cancer Prevention Trial ( SELECT ) and explore participant and site characteristics associated with retention failure ( study disengagement ) for these groups .


A secondary analysis of 28,118 White ( age 55 ) , and 4,322 Black ( age 50 ) SELECT participants used multivariate Cox regression to estimate overall retention rates and to calculate HRs and 95 % confidence intervals ( CI ) .


Blacks had higher age-adjusted risk of disengagement than Whites ( HR , 1.92 ; 95 % CI , 1.77-2 .08 ) .


Among Black participants , those ages 50 to 54 were at three times the risk of disengagement than those 65 years of age ( HR , 3.61 ; 95 % CI , 2.41-5 .41 ) .


Blacks age 65 had 1.6 times the risk of disengagement than Whites age 65 ( HR , 1.60 ; 95 % CI , 1.38-1 .87 ) .


By 6 years after randomization , 84 % of Whites and 69 % of Blacks remained engaged in the study .


Current smoking status was an independent risk factor for study disengagement for both White and Black participants .


For both groups , sites whose staffs missed SELECT training sessions or who received SELECT Retention and Adherence grants were associated with increased and decreased disengagement risks , respectively .


SELECT retention was disproportionately lower for Blacks than for Whites .


The observed difference in retention rates for Blacks and Whites and factors identified by race for study disengagement in SELECT may inform retention efforts for future long-term , cancer prevention trials .


New oral anticoagulants for stroke prevention in atrial fibrillation were developed to be given in fixed doses without the need for the routine monitoring that has hindered usage and acceptance of vitamin K antagonists .


A concern has emerged , however , that measurement of drug concentration or anticoagulant activity might be needed to prevent excess drug concentrations , which significantly increase bleeding risk .


In the ENGAGE AF-TIMI 48 trial , higher-dose and lower-dose edoxaban were compared with warfarin in patients with atrial fibrillation .


Each regimen incorporated a 50 % dose reduction in patients with clinical features known to increase edoxaban drug exposure .


We aim to assess whether adjustment of edoxaban dose in this trial prevented excess drug concentration and the risk of bleeding events .


We analysed data from the randomised , double-blind ENGAGE AF-TIMI 48 trial .


We correlated edoxaban dose , plasma concentration , and anti-Factor Xa ( FXa ) activity and compared efficacy and safety outcomes with warfarin stratified by dose reduction status .


Patients with atrial fibrillation and at moderate to high risk of stroke were randomly assigned in a 1:1:1 ratio to receive warfarin , dose adjusted to an international normalised ratio of 20-30 , higher-dose edoxaban ( 60 mg once daily ) , or lower-dose edoxaban ( 30 mg once daily ) .


Randomisation was done with use of a central , 24 h , interactive , computerised response system .


International normalised ratio was measured using an encrypted point-of-care device .


To maintain masking , sham international normalised ratio values were generated for patients assigned to edoxaban .


Edoxaban ( or placebo-edoxaban in warfarin group ) doses were halved at randomisation or during the trial if patients had creatinine clearance 30-50 mL/min , bodyweight 60 kg or less , or concomitant medication with potent P-glycoprotein interaction .


Efficacy outcomes included the primary endpoint of all-cause stroke or systemic embolism , ischaemic stroke , and all-cause mortality .


Safety outcomes included the primary safety endpoint of major bleeding , fatal bleeding , intracranial haemorrhage , and gastrointestinal bleeding .


This trial is registered with ClinicalTrials.gov , number NCT00781391 .


Between Nov 19 , 2008 and Nov 22 , 2010 , 21105 patients were recruited .


Patients who met clinical criteria for dose reduction at randomisation ( n = 5356 ) had higher rates of stroke , bleeding , and death compared with those who did not have a dose reduction ( n = 15749 ) .


Edoxaban dose ranged from 15 mg to 60 mg , resulting in a two-fold to three fold gradient of mean trough drug exposure ( 160-485 ng/mL in 6780 patients with data available ) and mean trough anti-FXa activity ( 035-085 IU/mL in 2865 patients ) .


Dose reduction decreased mean exposure by 29 % ( from 485 ng/mL [ SD 458 ] to 346 ng/mL [ 309 ] ) and 35 % ( from 245 ng/mL [ 227 ] to 160 ng/mL [ 145 ] ) and mean anti-FXa activity by 25 % ( from 085 IU/mL [ 076 ] to 064 IU/mL [ 054 ] ) and 20 % ( from 044 IU/mL [ 037 ] to 035 IU/mL [ 028 ] ) in the higher-dose and lower-dose regimens , respectively .


Despite the lower anti-FXa activity , dose reduction preserved the efficacy of edoxaban compared with warfarin ( stroke or systemic embolic event : higher dose pinteraction = 085 , lower dose pinteraction = 099 ) and provided even greater safety ( major bleeding : higher dose pinteraction 002 , lower dose pinteraction = 0002 ) .


These findings validate the strategy that tailoring of the dose of edoxaban on the basis of clinical factors alone achieves the dual goal of preventing excess drug concentrations and helps to optimise an individual patient 's risk of ischaemic and bleeding events and show that the therapeutic window for edoxaban is narrower for major bleeding than thromboembolism .


Daiichi-Sankyo Pharma Development .


Financial incentives promote many health behaviors , but effective ways to deliver health incentives remain uncertain .


We randomly assigned CVS Caremark employees and their relatives and friends to one of four incentive programs or to usual care for smoking cessation .


Two of the incentive programs targeted individuals , and two targeted groups of six participants .


One of the individual-oriented programs and one of the group-oriented programs entailed rewards of approximately $ 800 for smoking cessation ; the others entailed refundable deposits of $ 150 plus $ 650 in reward payments for successful participants .


Usual care included informational resources and free smoking-cessation aids .


Overall , 2538 participants were enrolled .


Of those assigned to reward-based programs , 90.0 % accepted the assignment , as compared with 13.7 % of those assigned to deposit-based programs ( P < 0.001 ) .


In intention-to-treat analyses , rates of sustained abstinence from smoking through 6 months were higher with each of the four incentive programs ( range , 9.4 to 16.0 % ) than with usual care ( 6.0 % ) ( P < 0.05 for all comparisons ) ; the superiority of reward-based programs was sustained through 12 months .


Group-oriented and individual-oriented programs were associated with similar 6-month abstinence rates ( 13.7 % and 12.1 % , respectively ; P = 0.29 ) .


Reward-based programs were associated with higher abstinence rates than deposit-based programs ( 15.7 % vs. 10.2 % , P < 0.001 ) .


However , in instrumental-variable analyses that accounted for differential acceptance , the rate of abstinence at 6 months was 13.2 percentage points ( 95 % confidence interval , 3.1 to 22.8 ) higher in the deposit-based programs than in the reward-based programs among the estimated 13.7 % of the participants who would accept participation in either type of program .


Reward-based programs were much more commonly accepted than deposit-based programs , leading to higher rates of sustained abstinence from smoking .


Group-oriented incentive programs were no more effective than individual-oriented programs .


( Funded by the National Institutes of Health and CVS Caremark ; ClinicalTrials.gov number , NCT01526265 . )


Time-dependent variability of electrocardiogram ( ECG ) in patients with Brugada syndrome could affect the interpretation of provocative testing .


The aim of this study was to characterize ECG changes during and after flecainide infusion .


We studied 59 consecutive patients .


The ECG was continuously analyzed during the first 30 minutes of provocative testing , and a single ECG was recorded 60 minutes later .


We analyzed CYP2D6 and CYP3A5 variants affecting flecainide metabolism and performed blinded measurements at lead II .


At baseline , ECG patterns were classified as follows : type II in 31 patients ( 53 % ) , type III in 15 ( 25 % ) , and normal ECG in 13 ( 22 % ) .


Because of induction of type I ECG , the percentage of responders progressively increased with longer recording time periods ( 6.8 % in 10 minutes vs 11.9 % in 20-30 minutes vs 18.6 % in 90 minutes ; P < .01 ) .


Four patients displayed a late response , which was evidenced 90 minutes after the initiation of provocative testing .


QRS width differentially increased between responders and nonresponders ( P < .01 ) , with a maximum QRS width of 110 ms during the first 30 minutes being effective for identifying possible late responders ( sensitivity 100 % ; specificity 85.6 % ; positive predictive value 88 % ; negative predictive value 100 % ) .


The incidence of CYP2D6 variants was lower in late responders than in early or delayed responders ( 0 % vs 75 % vs 100 % ; P = .04 ) , while a homogeneous distribution of CYP3A5 * 3 / * 3 was observed in our population .


Response to flecainide exhibits time-dependent variability of ECG patterns and intervals .


Longer periods of ECG recording increase the recognition probability of type I ECG .


Ovarian failure is a common toxic effect of chemotherapy .


Studies of the use of gonadotropin-releasing hormone ( GnRH ) agonists to protect ovarian function have shown mixed results and lack data on pregnancy outcomes .


We randomly assigned 257 premenopausal women with operable hormone-receptor-negative breast cancer to receive standard chemotherapy with the GnRH agonist goserelin ( goserelin group ) or standard chemotherapy without goserelin ( chemotherapy-alone group ) .


The primary study end point was the rate of ovarian failure at 2 years , with ovarian failure defined as the absence of menses in the preceding 6 months and levels of follicle-stimulating hormone ( FSH ) in the postmenopausal range .


Rates were compared with the use of conditional logistic regression .


Secondary end points included pregnancy outcomes and disease-free and overall survival .


At baseline , 218 patients were eligible and could be evaluated .


Among 135 with complete primary end-point data , the ovarian failure rate was 8 % in the goserelin group and 22 % in the chemotherapy-alone group ( odds ratio , 0.30 ; 95 % confidence interval [ CI ] , 0.09 to 0.97 ; two-sided P = 0.04 ) .


Owing to missing primary end-point data , sensitivity analyses were performed , and the results were consistent with the main findings .


Missing data did not differ according to treatment group or according to the stratification factors of age and planned chemotherapy regimen .


Among the 218 patients who could be evaluated , pregnancy occurred in more women in the goserelin group than in the chemotherapy-alone group ( 21 % vs. 11 % , P = 0.03 ) ; women in the goserelin group also had improved disease-free survival ( P = 0.04 ) and overall survival ( P = 0.05 ) .


Although missing data weaken interpretation of the findings , administration of goserelin with chemotherapy appeared to protect against ovarian failure , reducing the risk of early menopause and improving prospects for fertility .


( Funded by the National Cancer Institute and others ; POEMS/S0230 ClinicalTrials.gov number , NCT00068601 . )


Statins exert pleiotropic effects that result in cardioprotective and antiinflammatory properties .


There is a lack of information about the effect of preoperative reloading statin administration in surgical coronary patients regarding myocardial protection , systemic inflammatory response ( SIR ) attenuation and nitric oxide ( NO ) metabolism .


Thirty consecutive dyslipidemic patients under chronic treatment with statins were randomized to orally receive pravastatin 80 mg ( N. = 10 ) , 40 mg ( N. = 10 ) or placebo ( N. = 10 ) two hours before anesthetic induction for non-emergent on-pump coronary artery bypass grafting ( CABG ) procedures .


Perioperative peripheral venous and intraoperative CS blood samples were collected for determination of drug-related adverse effects , NO metabolism and both myocardial damage and SIR biomarkers .


Pravastatin reloading resulted in a significant and dose-related intense attenuation of SIR , but no differences in cardiac damage biomarker levels were demonstrated .


NO release and inducible nitric oxide synthase expression was significantly reduced in both treatment groups .


Highest pravastatin doses significantly increased systemic creatine phosphokinase ( CPK ) concentration compared with intermediate doses but no other adverse effects were observed .


Oral pravastatin reloading before non-emergent CABG significantly attenuates postoperative SIR and systemic NO/iNOS concentrations with no effect in perioperative myocardial damage .


Highest pravastatin doses increase CPK levels and must be avoided in susceptible patients .


Hernioplasty is one of the most frequent surgeries in the UK .


Light-weight mesh ( LWM ) has the potential to reduce chronic groin pain but its cost-effectiveness compared with heavy-weight mesh ( HWM ) is unknown .


Our objective was to conduct a cost-utility analysis between laparoscopic hernioplasty with HWM and LWM for unilateral inguinal hernias .


A Markov model simulated costs and health outcomes over a period of 1year ( 2012 ) from the societal and National Health Service ( NHS ) perspective ( England ) .


The main outcome was cost per quality-adjusted life-year ( QALY ) gained .


Surgery results were gleaned from the randomized control trial by Bittner et al. .


Other input parameters were drawn from the literature and public sources of the NHS .


From the societal perspective , LWM induces lower incremental costs ( -88.85 ) than HWM but yields a slightly smaller incremental effect ( -0.00094 QALYs ) .


The deterministic incremental cost-effectiveness ratio ( ICER ) for HWM compared with LWM amounts to 94,899 per QALY , while the probabilistic ICER is 118,750 ( 95 % confidence interval [ CI ] 57,603-180 ,920 ) .


Owing to the withdrawal of productivity losses from the NHS perspective , LWM causes higher incremental costs ( 13.09 ) and an inferior incremental effect ( -0.00093 ) , resulting in a dominance of HWM over LWM ( ICER 95 % CI -12,382 to -21,590 ) .


There is no support for the adoption of LWM as standard treatment from an NHS perspective .


However , given the small differences between HWM and LWM , LWM has at least the potential of improving patient outcomes and reducing expenditure from the societal perspective .


With functional magnetic resonance imaging ( fMRI ) , cerebral function imaging of acupuncture and sham acupuncture at Taichong ( LR 3 ) in patients with essential hypertension ( EH ) was observed to analyze central mechanism of Taichong ( LR 3 ) to treat EH .


Eighteen EH patients were divided into a twisting acupuncture group ( 10 cases ) and a sham acupuncture group ( 8 cases ) , which were treated with twisting manipulation and sham acu - puncture at right Taichong ( LR 3 ) , respectively .


The treatments were both given with 30-second manipulation and 30 - second interval for totally 5 min .


During the acupuncture , fMRI was adopted to scan the cerebral function imaging of EH patients on resting state , and the acquired data were analyzed with SPM2 module in Matlab software .


Acupunc - ture at Taichong ( LR 3 ) in EH patients mainly increased opposite-side oxygen consumption , which generally activated left anterior cingulated gyrus ( BA 32 ) , left inferior parietal lobule ( BA 40 ) , left inferior temporal gyrus ( BA 19 ) , left middle temporal gyrus ( BA 37 ) and right anterior central gyrus ( BA 6 ) .


The activated areas were related to motor , vision and cognition of emotion .


Stimulation region of sham acupuncture mainly included right anterior cingulated gyrus ( BA 24 ) , left inferior parietal lobule ( BA 40 ) and left inferior frontal gyrus ( BA 7 ) .


The central mechanism of Tai - chong ( LR 3 ) on antihypertensive effect and symptom improvement is not in thalamus and medulla that are traditionally believed to control blood pressure .


Taichong ( LR 3 ) could activate anterior cingulated gyrus to regulate parasympathetic nerve and lower blood pressure , and through anterior cingulated gyrus , the connection with the surrounding areas is strengthened to improve the cognitive impairment caused by long-term hypertension .


The aim of the study was to objectively determine whether the Nutrition and Physical Activity Self-Assessment for Child Care ( NAP SACC ) program improved physical activity levels during the school day .


The study compared the physical activity levels of subjects from 26 daycare centers , randomized into treatment ( N = 13 ) and control ( N = 13 ) groups .


The subjects were 3 to 5 year olds ( N = 209 , 104 males and 105 females ; age [ years ] = 3.850.8 [ meanstandard deviation ] ) , and accelerometry was used to determine the subjects ' physical activity levels .


Accelerometers were attached to each subject for 2 days before and immediately after a 6-month intervention .


Height , mass , and waist were also measured .


Regression analyses indicated that the treatment group demonstrated significant increases in moderate and vigorous physical activity , as compared to the control group ( F ( 1 , 207 ) = 6.3 , p < 0.05 , Cohen 's d = 0.30 ; F ( 1 , 207 ) = 4.7 , p < 0.05 , Cohen 's d = 0.25 , respectively ) .


The treatment group also showed significant increases in total physical activity ( F ( 1 , 218 ) = 12.4 ; p < 0.05 ) from pre - to post-test with significant increases in moderate and vigorous intensity physical activity ( F ( 1 , 218 ) = 18.6 , p < 0.05 ; F ( 1 , 218 ) = 23.3 , p < 0.05 , respectively ) .


Regression analyses revealed significant increases in height for both groups from pre - to post-tests , but no differences were noted between groups .


Implementation of the NAP SACC program in treatment daycare facilities resulted in significant increases in objectively measured physical activity levels , compared to the control group , demonstrating physical activity improvement in the treatment daycare centers .


Previous validation studies assessing the use of administrative data to identify patients with epilepsy have used targeted sampling or have used a reference standard of patients in the neurologist , hospital , or emergency room setting .


Therefore , the validity of using administrative data to identify patients with epilepsy in the general population has not been previously assessed .


The purpose of this study was to determine the validity of using administrative data to identify patients with epilepsy in the general population .


A retrospective chart abstraction study was performed using primary care physician records from 83 physicians distributed throughout Ontario and contributing data to the Electronic Medical Record Administrative data Linked Database ( EMRALD ) A random sample of 7,500 adult patients , from a possible 73,014 eligible , was manually chart abstracted to identify patients who had ever had epilepsy .


These patients were used as a reference standard to test a variety of administrative data algorithms .


An algorithm of three physician billing codes ( separated by at least 30days ) in 2years or one hospitalization had a sensitivity of 73.7 % ( 95 % confidence interval [ CI ] 64.8-82 .5 % ) , specificity of 99.8 % ( 95 % CI 99.6-99 .9 % ) , positive predictive value ( PPV ) of 79.5 % ( 95 % CI71.1-88 .0 % ) , and negative predictive value ( NPV ) of 99.7 % ( 95 % CI99.5-99 .8 % ) for identifying patients who had ever had epilepsy .


The results of our study showed that administrative data can reasonably accurately identify patients who have ever had epilepsy , allowing for a `` lifetime '' population prevalence determination of epilepsy in Ontario and the rest of Canada with similar administrative databases .


This will facilitate future studies on population level patterns and outcomes of care for patients living with epilepsy .


The application of - adrenoceptor agonists can improve faecal incontinence symptoms .


The aim of this study was to investigate the pharmacokinetic and systemic effects of NRL001 administered as different strengths in 1 or 2 g suppositories .


This randomised , double-blind , placebo controlled study included 48 healthy subjects .


Group 1 consisted of two cohorts of 12 subjects administered either four single doses of 1 or 2 g rectal suppository with either 5 , 7.5 or 10 mg NRL001 , or matching placebo .


Group 2 consisted of two cohorts of 12 subjects administered either four single doses of 1 or 2 g rectal suppository with either 10 , 12.5 or 15 mg NRL001 , or matching placebo .


Doses were given in an escalating manner with placebo at a random position within the sequence .


Tmax was at ~ 4.5 h post-dose for all NRL001 doses .


Median AUC0-tz , AUC0 - and Cmax increased with increasing dose for both suppository sizes .


The estimate of ratios of geometric means comparing 2 g with 1 g suppository , and regression analysis for dose proportionality , was close to 1 for the variables AUC0-tz , AUC0 - and Cmax ( P > 0.05 ) .


For both suppository sizes , 20-min mean pulse rate was significantly decreased compared with placebo with all doses ( P < 0.05 ) .


Blood pressure decreased overall .


There were 144 adverse events ( AEs ) and no serious AEs reported during the study .


All AEs were mild in severity .


The regression analysis concluded that the doses were dose proportional .


Results of regular drug-eluting stents ( rDESs ) in bifurcation treatment are not optimal .


The aim of the Polish Bifurcation Optimal Stenting I ( POLBOS I ) trial was to compare bifurcation treatment with any rDES vs the dedicated bifurcation paclitaxel-eluting stent BiOSS Expert ( Balton , Poland ) .


The second aim was to study the effect of final kissing balloon ( FKB ) inflation on clinical outcomes .


Between October 2010 and January 2013 patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome were assigned 1:1 to 1 of 2 treatment strategies : BiOSS Expert stent or rDES implantation .


Coronary angiography was performed at 12 months .


The primary end point was a composite of cardiac-related death , myocardial infarction ( MI ) , and target lesion revascularization ( TLR ) at 12 months .


The BiOSS Expert was implanted in 120 patients ( 49.4 % ) , and an rDES was implanted in 123 patients .


The target vessel was the left anterior descending ( LAD ) artery ( 52 % vs 70 % ) followed by the left main stem ( LMS ) coronary artery ( 22 % vs 15 % ) .


In the rDES group , 38.2 % received paclitaxel-eluting stents .


There were 3 stent implantation failures ( 2 in the rDES group and 1 in the BiOSS Expert group ) .


Side branch treatment with an rDES was required in 10 % of cases in both groups .


At 12 months , the incidence of cumulative major adverse cardiovascular events ( MACE ) was similar in both groups : 13.3 % vs 12.2 % ( P = 0.7 ) .


The TLR rate was significantly higher in the BiOSS Expert group compared with the rDES group ( 11.5 % vs 7.3 % ; P = 0.02 ) .


Significantly lower rates of restenosis were observed in FKB subgroups of both the BiOSS Expert ( 8.1 % vs 13.2 % ; P < 0.05 ) and rDES groups ( 4.9 % vs 9.5 % ; P < 0.05 ) .


MACE rates were comparable between the 2 groups ; however , the TLR rate was higher in the BiOSS Expert group .


A more aggressive protocol yielded better angiographic and clinical outcomes .


A hybrid knife was recently developed to allow waterjet-assisted endoscopic submucosal dissection , which aims to speed up and simplify the procedure .


This technique has been shown to be effective and safe for the treatment of early gastric cancer ( EGC ) but it has not yet been compared with conventional ESD .


In this two-center study , patients with an endoscopic and histopathological diagnosis of gastric adenoma or early gastric adenocarcinoma ( meeting the extended Japanese criteria for local resection ) were randomized to either conventional or waterjet-assisted ESD .


The choice of knife was left to the endoscopist in the conventional group whereas the hybrid knife was used in the waterjet group.The primary end point was procedure time , and secondary outcomes included rates of en bloc resection , R0 resection , and complications .


A total of 117 patients ( mean age 63.0 10.6 years , 76 men ) were randomized to either conventional ESD ( n = 59 ; control group ) or waterjet-assisted ESD ( n = 58 ) .


There were no significant differences in patient demographics or lesion features between the groups .


The mean procedure time was significantly shorter in the waterjet group compared with the conventional group ( 27.5 30.6 vs. 35.0 22.5 minutes ; P = 0.0008 ) , and a change of accessories was less frequently required ( mean number of changes 1.4 2.0 vs. 23.0 15.4 ; P < 0.0001 ) .


There was no significant difference between the groups in the size of resected specimen , R0 resection rates , number of perforations , major delayed bleedings , or rates of complete remission of neoplasia after 3 months .


Waterjet-assisted ESD and conventional ESD are comparably effective and safe techniques for the local treatment of EGC .


The waterjet-assisted technique is a faster and simpler procedure and requires fewer accessory changes compared with conventional ESD .


To verify the clinical efficacy on post-stroke dysphagia treated with acupuncture at Lianquan ( CV 23 ) .


One hundred and eighty patients were randomized into an acupuncture A group , an acupuncture B group and a rehabilitation group , 60 cases in each one .


On the basis of the conventional medication , in the acupuncture A group , acupuncture was applied at Lianquan ( CV 23 ) ; in the acupuncture B group , acupuncture was applied at Hegu ( LI 4 ) and Neiguan ( PC 6 ) and in the rehabilitation group , the swallowing rehabilitation training was adopted .


The treatment was given once a day , 5 times a week , and the 4 weeks of treatment was required in all of the groups .


The national institute of health stroke scale ( NIHSS ) and TV X-ray fluoroscope swallowing scale ( VFSS ) were used to evaluate neurologic deficit and swallowing function before and after treatment in the patients of each group .


The morbidity of pneumonia and clinical efficacy were compared among the groups .


The scores of NIHSS and VFSS were improved apparently after treatment in the patients of the three groups ( all P < 0.05 ) and the results in the acupuncture A group were superior to those in the other two groups ( all P < 0.05 ) .


The morbidity of pneumonia in the acupuncture A group was lower than that in the acupuncture B group and the rehabilitation group [ 3.3 % ( 2/60 ) vs 6.7 % ( 4/60 ) , 8.3 % ( 5/60 ) , both P < 0.05 ] .


The effective rate in the acupuncture A group was better than that in either of the other two groups [ 95.0 % ( 57/60 ) vs 81.7 % ( 49 / 60 ) , 75.0 % ( 45/60 ) , both P < 0.05 ] .


On the basis of the conventional medication , acupuncture at Lianquan ( CV 23 ) effectively improves the swallowing function , relieves neurological deficit and reduces the morbidity of pneumonia in the patients of post-stroke dysphagia .


Little evidence exists on the effect of an energy-unrestricted healthy diet on metabolic syndrome .


We evaluated the long-term effect of Mediterranean diets ad libitum on the incidence or reversion of metabolic syndrome .


We performed a secondary analysis of the PREDIMED trial -- a multicentre , randomized trial done between October 2003 and December 2010 that involved men and women ( age 55-80 yr ) at high risk for cardiovascular disease .


Participants were randomly assigned to 1 of 3 dietary interventions : a Mediterranean diet supplemented with extra-virgin olive oil , a Mediterranean diet supplemented with nuts or advice on following a low-fat diet ( the control group ) .


The interventions did not include increased physical activity or weight loss as a goal .


We analyzed available data from 5801 participants .


We determined the effect of diet on incidence and reversion of metabolic syndrome using Cox regression analysis to calculate hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) .


Over 4.8 years of follow-up , metabolic syndrome developed in 960 ( 50.0 % ) of the 1919 participants who did not have the condition at baseline .


The risk of developing metabolic syndrome did not differ between participants assigned to the control diet and those assigned to either of the Mediterranean diets ( control v. olive oil HR 1.10 , 95 % CI 0.94-1 .30 , p = 0.231 ; control v. nuts HR 1.08 , 95 % CI 0.92-1 .27 , p = 0.3 ) .


Reversion occurred in 958 ( 28.2 % ) of the 3392 participants who had metabolic syndrome at baseline .


Compared with the control group , participants on either Mediterranean diet were more likely to undergo reversion ( control v. olive oil HR 1.35 , 95 % CI 1.15-1 .58 , p < 0.001 ; control v. nuts HR 1.28 , 95 % CI 1.08-1 .51 , p < 0.001 ) .


Participants in the group receiving olive oil supplementation showed significant decreases in both central obesity and high fasting glucose ( p = 0.02 ) ; participants in the group supplemented with nuts showed a significant decrease in central obesity .


A Mediterranean diet supplemented with either extra virgin olive oil or nuts is not associated with the onset of metabolic syndrome , but such diets are more likely to cause reversion of the condition .


An energy-unrestricted Mediterranean diet may be useful in reducing the risks of central obesity and hyperglycemia in people at high risk of cardiovascular disease .


ClinicalTrials.gov , no .


ISRCTN35739639 .


Topical corticosteroids are the current first-line therapy for vulvar lichen sclerosus ( VLS ) .


UV-A1 phototherapy may be a promising alternative treatment option , but controlled studies are lacking .


To compare the efficacy of high-potent topical corticosteroids with UV-A1 phototherapy in the treatment of VLS .


A 2-arm randomized clinical trial was conducted at a university hospital dermatology department according to the intention-to-treat principle with last observation carried forward .


The study population comprised 30 female patients with VLS .


Treatment of VLS with clobetasol propionate , 0.05 % , ointment applied once daily for 3 months or medium-dose UV-A1 ( 50 J/cm ) home-based phototherapy , performed 4 times weekly for 3 months .


Mean relative reduction of the total clinician 's score ( TCS ) was considered the primary outcome measure .


Secondary outcome measures included the reduction of pruritus and burning and/or pain according to a visual analog scale ( VAS ) , a health-related quality of life score ( Skindex-29 ) , 20-MHz ultrasonography , and histopathological analysis before and after 3 months of therapy .


Fifteen patients were randomized in each treatment arm , and 2 patients dropped out in both treatment arms .


After therapy , both therapies resulted in a significant decrease in mean TCS ( 51.4 % [ 95 % CI , 39.7 % to 63.0 % ] for clobetasol ointment [ P < .001 ] and 35.6 % [ 95 % CI , 18.2 % to 53.1 % ] for UV-A1 phototherapy [ P = .006 ] ) .


No significant difference was found between both treatments ( P > .05 ) .


The Skindex-29 ( mean difference [ MD ] , 29.6 [ 95 % CI , 7.9 to 51.2 ] [ P = .009 ] ) and the VAS score for pruritus ( MD , 4.6 [ 95 % CI , 1.5 to 7.7 ] [ P = .005 ] ) and burning and/or pain ( MD , 4.2 [ 95 % CI , 1.9 to 6.6 ] [ P = .001 ] ) significantly decreased after clobetasol treatment .


After UV-A1 phototherapy , the VAS score for burning and/or pain ( MD , 3.2 [ 95 % CI , 0.7 to 5.7 ] [ P = .01 ] ) was also significantly reduced ; however , there was no significant reduction in pruritus ( MD , 2.1 [ 95 % CI , 0.5 to 3.7 ] [ P = .16 ] ) and in the Skindex-29 score ( MD , 4.9 [ 95 % CI , -12.6 to 22.4 ] [ P > .99 ] ) .


A significant reduction of the corium thickness and a significant increase in dermal density in 20-MHz ultrasonography as well as significant histopathological reduction of the inflammatory infiltrate was observed after clobetasol treatment but not after UV-A1 phototherapy .


Although resulting in a significant clinical improvement , UV-A1 phototherapy was inferior to the current gold standard treatment with topical high-potent corticosteroids with respect to practicability , relief of itch , and improvement in quality of life .


UV-A1 phototherapy may be considered a potential second-line treatment for VLS .


clinicaltrials.gov Identifier : NCT01400022 .


Compulsory admission to psychiatric hospitals may be distressing , disruptive to patients and families , and associated with considerable cost to the health service .


Improved patient experience and cost reductions could be realised by providing cost-effective crisis planning services .


Economic evaluation within a multi-centre randomised controlled trial comparing Joint Crisis Plans ( JCP ) plus treatment as usual ( TAU ) to TAU alone for patients aged over 16 , with at least one psychiatric hospital admission in the previous two years and on the Enhanced Care Programme Approach register .


JCPs , containing the patient 's treatment preferences for any future psychiatric emergency , are a form of crisis intervention that aim to mitigate the negative consequences of relapse , including hospital admission and use of coercion .


Data were collected at baseline and 18-months after randomisation .


The primary outcome was admission to hospital under the Mental Health Act .


The economic evaluation took a service perspective ( health , social care and criminal justice services ) and a societal perspective ( additionally including criminal activity and productivity losses ) .


The addition of JCPs to TAU had no significant effect on compulsory admissions or total societal cost per participant over 18-months follow-up .


From the service cost perspective , however , evidence suggests a higher probability ( 80 % ) of JCPs being the more cost-effective option .


Exploration by ethnic group highlights distinct patterns of costs and effects .


Whilst the evidence does not support the cost-effectiveness of JCPs for White or Asian ethnic groups , there is at least a 90 % probability of the JCP intervention being the more cost-effective option in the Black ethnic group .


The results by ethnic group are sufficiently striking to warrant further investigation into the potential for patient gain from JCPs among black patient groups .


Current Controlled Trials ISRCTN11501328 .


To determine whether the additional benefits of improved prostate cancer detection associated with 5-reductase inhibitors are sufficient to warrant chemoprevention in the case where the degree of prostate cancer risk reduction is deemed inadequate .


We reanalyzed data from REDUCE , a randomized trial of dutasteride for prostate cancer chemoprevention in men with prior negative biopsy .


We evaluated whether statistical models using prostate-specific antigen ( PSA ) and PSA velocity could help predict the result of repeat prostate biopsy separately for dutasteride and placebo groups .


Area under the curve was evaluated by 10-fold cross-validation .


PSA velocity improved discrimination at 4 years in the dutasteride group but not at 2 years nor in the placebo group .


At 2 years , dutasteride improved discrimination of PSA slightly ( 0.616 vs. 0.603 for any grade cancer ; 0.681 vs. 0.676 for high-grade disease ) .


Between-group differences in cancer rates at 4 years were small .


Clinicians who are willing to treat at least 23 patients with dutasteride for 2 years to avoid 1 prostate cancer diagnosis should offer dutasteride after initial negative biopsy .


Clinicians not willing to do so might consider dutasteride for its additional benefit of reducing unnecessary biopsy , although this benefit is apparent only under very restrictive conditions .


It is difficult to justify extending treatment with dutasteride for > 2 years .


The aim of this study was to compare the vacuum assisted wound closure ( VAC ) system ( negative pressure wound therapy ; NPWT ) and alginate wound dressings in terms of quality of life ( QoL ) , pain resource use and cost in patients with deep peri-vascular groin infection after vascular surgery .


Patients with deep peri-vascular groin infection ( Szilagyi grade III ) were included and randomised to NPWT or alginate therapy .


EuroQol 5D ( EQ-5D ) and brief pain inventory ( BPI ) were used to evaluate QoL and pain , respectively .


Wound healing time until complete skin epithelialisation was shorter in the NPWT ( n = 9 ) compared to the alginate group ( n = 7 ) , median 57 and 104 days , respectively ( p = 0.026 ) .


No difference was recorded in QoL and pain between the groups at study start and the second assessment .


QoL analysis within groups between time points , showed that patients in NPWT groups improved in EQ-5D domains , ` self-care ' ( p = 0.034 ) , ` usual activities ' ( p = 0.046 ) ; EQ-5D index value ( p = 0.046 ) and EQ-VAS ( p = 0.028 ) .


Patients in the NPWT group reported significantly less pain ` affecting their relations with other people ' and ` sleep ' between time points .


The NPWT group had significantly fewer dressing changes compared to the alginate group ( p < 0.001 ) .


The median frequency of wound dressing changes outside hospital was 20 ( IQR 6-29 ) in the NPWT group ( n = 9 ) , compared to 48 ( IQR 42-77 ) in the alginate group ( n = 8 ; p = 0.004 ) .


The saved personnel time for wound care in the first week for the NPWT group , compared with the alginate group , was 4.5 hours per week per nurse .


The total hospitalised care cost was 83-87 % of the total cost in both groups .


NPWT therapy in patients with deep peri-vascular groin infection can be regarded as the dominant strategy due to improved clinical outcome with equal cost and quality of life measures .


Allergen-specific immunotherapy ( SIT ) faces problems related to side effects and limited efficacy .


Direct administration of allergen extracts into lymph nodes induces increased specific IgG production and T-cell responses using significantly lower allergen doses .


In this study , mechanisms of immune regulation by MAT vaccines in vitro and in allergen-SIT of cat-allergic rhinitis patients , who received 3 inguinal intra-lymph node injections of MAT-Fel d 1 vaccine , were investigated in PBMC and cell cultures for specific T-cell proliferation , Fel d 1-tetramer-specific responses , and multiple immune regulatory molecules .


MAT-Fel d 1 vaccine was efficiently internalized by antigen-presenting cells .


This was followed by precaspase 1 cleavage to caspase 1 and secretion of IL-1 , indicating inflammasome activation .


Mat-Fel d 1 induced specific T-cell proliferation and an IL-10 - and IFN -- dominated T-cell responses with decreased Th2 cytokines at 100 times lower doses than Fel d 1 .


Induction of immune tolerance by MAT-Fel d 1-ILIT involved multiple mechanisms of immune suppression .


Early Fel d 1-specific T-cell activation was followed by full T-cell unresponsiveness to allergen after 1year in the MAT-Fel d 1 group , characterized by increased allergen-specific T regulatory cells , decreased circulating Fel d 1 tetramer-positive cells , increased IL-10 and FOXP3 expression , and change in the HR2/HR1 ratio toward HR2 .


This study demonstrates the induction of allergen tolerance after 3 intra-lymph node injections of MAT-Fel d 1 vaccine , mediated by increased cellular internalization of the allergen , activation of inflammasome , and generation of allergen-specific peripheral T-cell tolerance .


To compare the difference in the efficacy on thoracic facet joint disorder between the combined therapy of electroacupuncture and manual reduction and the simple manual reduction .


One hundred and sixty patients were randomized into an electroacupuncture and manual manipulation group ( group A ) and a simple manual manipulation group ( group B ) , 80 cases in each one .


In the group A , Ashi points and three pairs of Jiaji ( EX-B 2 ) bilateral to the painful sites were selected .


The perpendicular puncture was used at Ashi points , the oblique puncture was used at Jiaji ( EX-B 2 ) and connected with electric stimulation for 20 min , additionally , the corresponding manual reduction was adopted at the sites of facet joint disorder .


In the group B , the simple manual reduction was applied to the affected sites .


Acupuncture was given once every day , the manual reduction was applied once every 10 days .


The treatment of 10 days made one session .


The efficacy was analyzed statistically at the end of two sessions of treatment .


Before and after treatment , McGill pain scale was adopted for the value statistical analysis .


PRI score , VAS score and PPI score of patients were calculated before and after treatment and compared in the two groups .


The efficacy was compared between the two groups .


The curative rate was 56.3 % ( 45/80 ) in the group A , which was better than 18.8 % ( 15/80 ) in the group B ( P < 0.01 ) .


The total effective rate was 95.0 % ( 76/80 ) in the group A , which was better than 76.3 % ( 61/80 ) in the group B ( P < 0.01 ) .


The scores of PRI , VAS and PPI after treatment were all improved significantly in the two groups ( all P < 0.05 ) , in which , the results in the group A were better than those in the group B ( PRI : 4.00 + / - 0.97 vs 5.44 + / - 1.16 , VAS : 3.29 + / - 0.72 vs 3.87 + / - 0.81 , PPI : 1.07 + / - 0.74 vs 1.64 + / - 0.90 , all P < 0.05 ) .


The combined therapy of electroacupuncture and manual manipulation achieves the superior efficacy on thoracic facet joint disorder as compared with the simple manual manipulation .


The combined therapy relieves the symptoms of thoracic facet joint disorder and reduces the severity of disorder .


Rye bread benefits glucose metabolism .


It is unknown whether the same effect is achieved by rye bran-enriched wheat bread .


We tested whether white wheat bread enriched with bioprocessed rye bran ( BRB+WW ) and sourdough wholegrain rye bread ( WGR ) have similar effects on glucose metabolism and plasma level of short chain fatty acids ( SCFAs ) .


Twenty-one ( 12 women ) of 23 recruited subjects completed an intervention with a four-week run-in and two four-week test periods in cross-over design .


White wheat bread ( WW ; 3 % fibre ) was consumed during the run-in , and WGR and BRB+WW ( 10 % fibre ) during the test periods .


A meal test providing 51/33/11 E % from carbohydrates/fat/protein was conducted at the end of each period .


Fasting and postprandial plasma samples were analysed for glucose , insulin , and SCFA .


Glucose and insulin responses and plasma concentrations of SCFAs to the meal test were similar between the WGR and BRB+WW periods .


When compared to the WW period , postprandial insulin concentration at 120 min was lower ( p = 0.023 ) and the first-phase insulin secretion improved ( p = 0.033 ) only after the WGR period , whereas postprandial concentrations of butyrate ( p < 0.05 ) and propionate ( p = 0.009 ) at 30 min increased during both rye bread periods .


Beneficial effects of WGR over white wheat bread on glucose and SCFA production were confirmed .


The enrichment of the white wheat bread with bioprocessed rye bran ( BRB+WW ) yielded similar but not as pronounced effects than WGR when compared to WW alone .


Postprandially measured glucose metabolism and concentrations of SCFAs provided additional information along with fasting measurements .


Evidence suggests that cardiac output-guided haemodynamic therapy algorithms improve outcomes after high-risk surgery , but there is some concern that this could promote acute myocardial injury .


We evaluated the incidence of myocardial injury in a perioperative goal-directed therapy trial .


Patients undergoing major gastrointestinal surgery ( n = 723 ) were randomly assigned to cardiac output-guided haemodynamic therapy ( intervention group ) or usual care as part of the OPTIMISE trial .


At four participating sites , 288 patients were enrolled in a biomarker substudy .


Serum high-sensitivity cardiac troponin I ( TnI ) concentration and N-terminal pro-brain natriuretic peptide ( NT-proBNP ) concentration were measured before and at 24 and 72 h after surgery .


Median preoperative TnI and NT-ProBNP concentrations were 4.3 ng litre ( -1 ) and 144 pg ml ( -1 ) , respectively .


After surgery , 67 ( 46 % ) patients in the intervention group and 68 ( 48 % ) patients receiving usual care had TnI concentrations above the 99th centile upper reference limit ( P = 0.82 ) .


Peak serum TnI concentration was similar in the intervention and usual care groups ( median [ interquartile range ] : 10.0 [ 5.3-21 .5 ] vs 7.8 [ 5.0-21 .8 ] ng litre ( -1 ) ; P = 0.85 ) , and no differences were observed in serum TnI concentrations over 72 h ( repeated-measures anova , P = 0.51 ) .


Likewise , there were no differences in peak NT-proBNP concentration between intervention and usual care groups ( 645 [ 362-1169 ] vs 659 [ 381-1028 ] pg ml ( -1 ) ; P = 0.86 ) or in serial NT-proBNP concentrations over 72 h ( P = 0.20 ) .


Myocardial injury is common among patients undergoing major gastrointestinal surgery .


In this study , the frequency was not affected by cardiac output-guided fluid and low-dose inotropic therapy .


Lactoferrin ( LF ) is effective in the prevention of sepsis in very low birth weight ( VLBW ) neonates .


T-regulatory cells ( Tregs ) are important subsets of T lymphocytes that control pathogen-specific immune responses and are essential for intestinal immune homoeostasis .


The aim of the present study is to determine whether oral LF at a dosage of 200 mg/d reduces nosocomial sepsis episodes and necrotizing enterocolitis ( NEC ) in premature infants and to evaluate the possible effects of LF on Treg levels .


In this prospective , placebo-controlled , double-blind , randomized trial , infants either VLBW or born before 32 weeks were assigned to receive either placebo ( n = 25 ) , or 200 mg LF ( n = 25 ) daily throughout hospitalization .


Episodes of culture proven nosocomial sepsis and NEC were recorded .


The level of FOXP3 + CD4 + CD25hi lymphocytes was studied by flow cytometry at birth and discharge .


A third comparison was made with healthy term neonates ( n = 16 ) .


Fewer sepsis episodes were observed in LF-treated infants ( 4.4 vs. 17.3 / 1,000 patient days , p = 0.007 ) with none developing NEC , without statistical significance .


Treg levels at birth and discharge were similar , while preterm infants showed significantly lower levels than term controls .


However , individual increases in Treg levels were higher in the LF group .


LF prophylaxis reduced nosocomial sepsis episodes .


Treg levels in preterm infants were lower than in term infants and an increase of Treg levels under LF prophylaxis was observed .


Increase in Treg levels can be the mechanism for protective effects of LF on nosocomial sepsis .


Among people with diabetes , 10-25 % will experience a foot ulcer .


Research has shown that supplementation with arginine , glutamine and - hydroxy -- methylbutyrate may improve wound repair .


This study tested whether such supplementation would improve healing of foot ulcers in persons with diabetes .


Along with standard of care , 270 subjects received , in a double-blinded fashion , ( twice per day ) either arginine , glutamine and - hydroxy -- methylbutyrate or a control drink for 16 weeks .


The proportion of subjects with total wound closure and time to complete healing was assessed .


In a post-hoc analysis , the interaction of serum albumin or limb perfusion , as measured by ankle-brachial index , and supplementation on healing was investigated .


Overall , there were no group differences in wound closure or time to wound healing at week 16 .


However , in subjects with an albumin level of 40 g/l and/or an ankle-brachial index of < 1.0 , a significantly greater proportion of subjects in the arginine , glutamine and - hydroxy -- methylbutyrate group healed at week 16 compared with control subjects ( P = 0.03 and 0.008 , respectively ) .


Those with low albumin or decreased limb perfusion in the supplementation group were 1.70 ( 95 % CI 1.04-2 .79 ) and 1.66 ( 95 % CI 1.15-2 .38 ) times more likely to heal .


While no differences in healing were identified with supplementation in non-ischaemic patients or those with normal albumin , addition of arginine , glutamine and - hydroxy -- methylbutyrate as an adjunct to standard of care may improve healing of diabetic foot ulcers in patients with risk of poor limb perfusion and/or low albumin levels .


Further investigation involving arginine , glutamine and - hydroxy -- methylbutyrate in these high-risk subgroups might prove clinically valuable .


To study the clinical effects of `` Reinforcing Qi and Activating Blood '' in the treatment of stable chronic obstructive pulmonary disease ( Qi Deficiency and Blood Stasis Syndrome ) .


This study recruit 50 outpatients with stabe chronic obstructive pulmonary disease ( Qi Deficiency and Blood Stasis Syndrome ) , who were randomly divided into 2 groups , control group and treatment of `` Reinforcing Qi and Activating Blood '' group .


The patients in control group were given conventional treatment , while the patients in treatment group not only received conventional treatment but also the treatment of Yu-Ping-Feng capsules and Fu-Fang-Dan-Shen tablets for 3 months .


The duration of follow up was 12 months , and chinese medicine ( CM ) symptoms , cellular immunity indexes and haemodynamics indexes were assessed every 3 months .


The total effective rate in treatment group at 3 months treatment and 3 months follow-up were higher than that in control group ( P < 0.05 ) .


The CM symptoms in treatment group were improved significantly ( P < 0.05 ) .


In treatment group , the level of CD4 and the ratio of CD4/CD8 after therapy were higher than those before ( P < 0.05 ) , and the level of CD8 was lower than that before ( P < 0.05 ) .


The level of NO was no significant difference ( P > 0.05 ) , while the level of endothelin ( ET ) was significantly different ( P < 0.05 ) .


The frequency of suffering from cold , the admission due to acute exacerbation and hospital stay in treatment group were all lower than those in control group ( P < 0.05 ) .


The `` Reinforcing Qi and Activating Blood '' therapy can improve the symptoms and clinical curative effect of TCM in the treatment of stable COPD ( Qi Deficiency and Blood Stasis Syndrome ) , with the improvement of their cellular immunological function and vasomotor function .


Clonidine is often used as a sedative in critically ill children , but its effectiveness has not been evaluated in a large , rigorous randomized controlled trial .


Our objectives in this pilot trial were to assess the feasibility of a larger trial with respect to ( 1 ) effective screening , ( 2 ) recruitment , ( 3 ) timely drug administration , and ( 4 ) protocol adherence .


This is a randomized , blinded , placebo-controlled pilot trial .


Mechanically ventilated children received enteral clonidine 5 g/kg or placebo every 6 hours ; additional sedatives were at the discretion of attending physicians .


We enrolled 50 children .


The median interquartile range ( IQR ) age was 2.5 ( 0.7-5 .2 ) years , and Pediatric Risk of Mortality score on pediatric intensive care unit admission was 12 ( 8-15 ) .


In terms of feasibility outcomes , 90 ( 87 % ) of 104 eligible patients were approached for consent , and on average , 1.7 children were enrolled per month .


Thirty-five ( 70 % ) were enrolled within 1 day of becoming eligible ( mean , 1.2 days ) .


Thereafter , 94 % of doses were administered by protocol .


Clinical outcomes and adverse effects were not significantly different between the groups .


This pilot trial demonstrated feasibility of a larger randomized controlled trial .


Some important challenges emerged , allowing refinement of the study protocol and enrolment estimates .


We recommend that future trials capitalize on the experience gained and use these results to design a larger trial focusing on clinically important outcomes .


To evaluate the impact of ` Resident Antimicrobial Management Plan ' ( RAMP ) , a novel antimicrobial stewardship tool on systemic antibiotic use for treatment of infection in nursing homes ( NHs ) .


A pilot cluster randomized control study was conducted in 30 NHs in London .


Pre-intervention , we collected point prevalence data on antimicrobial use on three occasions and total antimicrobial consumption for a 12 week period .


Post-intervention data were collected in the same manner and included assessment of compliance with RAMP in the intervention group ( IG ) .


The number of residents included was 1628 pre-intervention [ 825 IG/803 control group ( CG ) ] and 1610 post-intervention ( 838 IG/772 CG ) .


The corresponding pre - and post-intervention point prevalence of systemic antibiotic prescribing for treatment of infection was 6.46 % and 6.52 % in the IG [ estimated prevalence ratio : 1.01 ( 95 % CI : 0.81-1 .25 ) , P = 0.94 ] compared with 5.27 % and 5.83 % , respectively , in the CG [ estimated prevalence ratio : 1.11 ( 95 % CI : 0.87-1 .41 ) , P = 0.4 ] .


Total antibiotic consumption was 69.78 defined daily doses/1000 residents/day ( DRD ) pre-intervention and 66.53 DRD post-intervention in the IG compared with 49.68 and 51.92 DRD , respectively , in the CG .


There was a significant decrease of 4.9 % ( 3.25 DRD ) in the IG ( 95 % CI : 1.0 % -8.6 % ) ( P = 0.02 ) compared with a significant increase of 5.1 % ( 2.24 DRD ) in the CG ( 95 % CI : 0.2 % -10.2 % ) ( P = 0.04 ) .


Main indications for antibiotics were lower respiratory tract infections ( 34.1 % ) , urinary tract infections ( 28.5 % ) and skin/soft tissue infections ( 25.1 % ) .


This pilot study demonstrated that use of RAMP was associated with a statistically significant decrease in total antibiotic consumption and has the potential to be an important antimicrobial stewardship tool for NHs .


Cleft lip and cleft palate are the most common craniofacial anomalies affecting approximately 2.49 of every 1,000 children born in North-east of Thailand .


Srinagarind Hospital has 100-150 cases of cleft lip each year .


Children with cleft lip and palate need surgical procedures as soon as possible .


After lip repair the normal recommendation is not using bottle or breast feeding for 2 weeks to avoid tension at the sutured area during sucking and possible cause of wound dehiscence .


So this is quite complicated for the parents , and patients feel frustrated , cry , and move their head around , because of hunger which can not easily be satisfied .


Previous research found that sucking does not cause wound dehiscence , but mentioned no detail about severity of cleft .


Primary objective is to compare surgical wound dehiscence between breast feeding/bottle and spoon/syringe feeding after lip repair .


This is an experimental study : non-inferiority trials study .


The population is the patients with cleft lip who underwent lip repair in Inpatient Department 3C , Srinagarind Hospital , Faculty of Medicine , Khon Kaen University .


The study period is during May 2010-February 2013 .


The total sample size in the present study is 192 participants , 96 cases breast/bottle feeding , 96 cases spoon/syringe feeding .


The wound dehiscence rate was analyzed by Z-test .


Parents ` satisfaction is a qualitative data and was analyzed through content analysis .


No statistical significant diference between breast/bottle and spoon/syringe groups ( p-value = 0.320 , 95 % confidence interval -0.031 -0.010 ) .


Parents were more satisfied to feed children by breast/bottle and patients were more relaxed with breast/bottle feeding .


Breast/bottle feeding and syringe/spoon feeding have the same result on the surgical wound .


Breast/bottle feeding are not causes of wound dehiscence .


The benefit of protein supplementation on the adaptive response of muscle to exercise training in older people is controversial .


To investigate the independent and combined effects of a multicomponent exercise program with and without a milk-based nutritional supplement on muscle strength and mass , lower-extremity fatigue , and metabolic markers .


A sample of 48 healthy sedentary men aged 60.8 0.4 years were randomly assigned to a 16-week multicomponent exercise training program with a milk-based supplement containing , besides proteins [ total milk proteins 4 or 10 g/day or soluble milk proteins rich in leucine ( PRO ) 10 g/day ] , carbohydrates and fat .


Body composition , muscle mass and strength , and time to task failure , an index of muscle fatigue , were measured .


Blood lipid , fibrinogen , creatine phosphokinase , glucose , insulin , C-reactive protein , interleukin-6 , tumor necrosis factor - soluble receptors , and endothelial markers were assessed .


Body fat mass was reduced after the 4-month training program in groups receiving 10 g/day of protein supplementation ( P < .01 ) .


The training program sustained with the daily 10 g/day PRO was associated with a significant increase in dominant fat free mass ( +5.4 % , P < .01 ) and in appendicular muscle mass ( +4.5 % , P < .01 ) .


Blood cholesterol was decreased in the trained group receiving 10 g/day PRO .


The index of insulin resistance ( homeostasis model assessment-insulin resistance ) and blood creatine phosphokinase were reduced in the groups receiving 10 g/day PRO , irrespective of exercise .


The inflammatory and endothelial markers were not different between the groups .


Training caused a significant improvement ( +10.6 % to 19.4 % , P < .01 ) in the maximal oxygen uptake .


Increased maximum voluntary contraction force was seen in the trained groups receiving 10 g/day of proteins ( about 3 % , P < .05 ) .


Time to task failure was improved in the trained participants receiving a 10 g/day supplementation with PRO ( P < .01 ) .


Soluble milk proteins rich in leucine improved time to muscle failure and increase in skeletal muscle mass and strength after prolonged multicomponent exercise training in healthy older men .


To compare the effects of piglitazone and metformin on retinol-binding protein-4 ( RBP-4 ) and adiponcetin ( APN ) in patients with type 2 diabetes mellitus ( T2DM ) complicated with Non alcohol fatty acid liver disease ( NAFLD ) .


Totally 60 T2DM patients complicated with NAFLD were equally and randomly divided into pioglitazone group and metform group .


The levels of biochemical indicators including body mass index ( BMI ) , glucose hemoglobin A1C ( GHbA1C ) , insulin resistance ( HOMA-IR ) , fasting blood glucose ( FBG ) , fasting insulin ( FIns ) , and serum triglycerides ( TG ) as well as serum RBP-4 and APN level were measured pre-treatment and 12 weeks after treatments .


After 12 weeks of treaments , BMI , FBG , HOMA-IR , GHbA1C , FIns , and TG decreased ( all P < 0.05 ) in both piglitazone group and metform group .


APN increased ( all P < 0.05 ) in both groups .


RBP-4 decreased ( P < 0.05 ) in piglitazone group .


Compare with the metform group , the levels of RBP-4 , FIns , and HOMA-IR decreased and BMI increased in piglitazone group ( P < 0.05 ) .


Piglitazone is superior to metoform in decreasing RBP-4 level and HOMA-IR in patients with T2DM complicated with NAFLD .


Angiotensin-converting enzyme inhibitor-induced angioedema ( ACEI-AE ) is mediated by bradykinin .


There remains an unmet treatment need because these patients , when presenting to the emergency department ( ED ) , do not respond to conventional therapies , such as antihistamines and corticosteroids .


To estimate the treatment effect of ecallantide , a recombinant plasma kallikrein inhibitor , in ED patients with ACEI-AE in whom conventional therapy fails .


This was a triple-blind ( patient , physician , and statistician ) , randomized , controlled , phase 2 study to estimate the magnitude of safety and efficacy signals for designing a definitive phase 3 trial comparing conventional therapy with ecallantide to conventional therapy with placebo .


Patients were enrolled from April 1 , 2010 , through January 31 , 2013 .


The primary efficacy study end point was achieving discharge criteria from the ED within 4 hours after initiating study-related treatment .


Discharge criteria from the ED was met in 4 hours or less for 8 ( 31 % ) of 26 patients receiving ecallantide vs 5 of ( 21 % ) 24 patients receiving placebo ( difference in proportions , 10 % ; 95 % confidence interval,-14 % to 34 % ) .


Ecallantide was well tolerated in both groups .


The results from this preliminary study reveal that ecallantide is safe to use and may increase the proportion of patients who meet early discharge criteria by approximately10 % .


A larger phase 3 study is necessary to confirm the efficacy and evaluate the cost-effectiveness of ecallantide use for ACEI-AE in the ED setting .


clinicaltrials.gov Identifier : NCT01036659 .


Vitamin A supplementation significantly reduces all-cause mortality when given between 6-59 months of age , but has a null or detrimental effect when given between 1-5 months .


Studies of neonatal vitamin A supplementation conducted across Africa and South Asia have produced conflicting findings .


These age-pattern variations might result from immunological interactions between vitamin A supplementation and vaccines .


Knowledge on the potential immunological sequelae of human neonatal vitamin A supplementation is so scarce that the foremost aim of this study is to seek indicative data on aspects of immunity likely to be affected by neonatal vitamin A supplementation .


The objective of this trial is to test whether human neonatal vitamin A supplementation modulates immune function including improved thymic maturation in infancy and improved systemic immune responses to routine immunization .


In an area of moderate vitamin A deficiency in a peri-urban area of The Gambia , 200 mother-infant pairs were enrolled in a double-blind randomised controlled trial .


Within 48 hours of birth , neonates were randomised with stratification by birth weight and sex to receive either an oral dose of 50,000 IU vitamin A or placebo .


Expanded Programme of Immunisation birth vaccinations were administered after supplementation , with subsequent vaccinations administered at 8 , 12 and 16 weeks of age .


A range of immunological outcomes were examined up to 17 weeks of age , with additional morbidity and anthropometry follow-up carried out throughout the first year of life .


The primary endpoint of this trial is the frequency of circulating T regulatory ( Treg ) cells expressing gut homing receptors in infants at 17 week post-supplementation , with secondary outcomes including thymus maturation and B cell immune responses .


Indicative immunological data from this trial ( and its Bangladeshi counterpart ) , will complement the larger randomised controlled trials ( conducted in India , Tanzania and Ghana ) , on the effectiveness and safety of neonatal vitamin A supplementation in improving infant survival .


Combined these trials , in addition to the existing trials , will inform policy .


clinicaltrials.gov NCT01476358 .


Everolimus is an agent frequently associated with specific toxicities .


Predictive markers of efficacy are needed to help define which patients could benefit from it .


The goal of this exploratory study was to identify potential predictive biomarkers in the mammalian target of rapamycin ( mTOR ) complex 1 ( mTORC1 ) activation pathway using primary tumor samples collected during the phase II tamoxifen plus everolimus ( TAMRAD ) trial .


Tumor tissues were collected retrospectively from the TAMRAD trial .


Immunohistochemistry was carried out using specific antibodies directed toward proteins that result in mTORC1 activation [ canonical phosphatidylinositol 3-kinase ( PI3K ) / protein kinase B ( Akt ) / mTOR or alternative pathways ] .


DNA was extracted from the tumor tissue ; mutation screening in the PIK3CA gene ( exons 9 and 20 ) and the KRAS gene ( exons 2 and 3 ) was first carried out using Sanger direct sequencing , and then completed by next-generation sequencing for PIK3CA .


An exploratory analysis of everolimus efficacy in terms of a time-to-progression ( TTP ) increase was carried out in each biomarker subgroup ( high versus low expression referring to the median percentage of marked cells ) .


A total of 55 primary tumor samples from the TAMRAD trial25 from the tamoxifen-alone group and 30 from the tamoxifen/everolimus groupwere evaluated for biomarkers .


The subgroups most likely to have an improvement in TTP with tamoxifen/everolimus therapy , compared with tamoxifen alone , were patients with high p4EBP1 , low 4EBP1 , low liver kinase B1 , low pAkt , and low PI3K .


Among the 45 samples screened for mutation status , nine samples ( 20 % ; 95 % CI 9.6-34 .6 ) had a PIK3CA mutation .


KRAS mutation was observed in one patient .


A positive correlation between late effectors of mTORC1 activation , a positive correlation between Akt-independent mTORC1 activation , and an inverse correlation between canonical PI3K/Akt/mTOR pathway and everolimus efficacy were observed in this exploratory analysis .


However , these correlations need to be validated in larger studies before applying the findings to routine clinical practice .


Observational studies have documented an off-pump over on-pump advantage for high-risk patients , including diabetic patients .


Randomized trials have not confirmed this advantage .


The VA Randomization On Versus Off Bypass ( ROOBY ) trial randomly assigned 2,203 coronary artery bypass graft surgery ( CABG ) patients at 18 sites to either on-pump ( n = 1,099 ) or off-pump ( n = 1,104 ) procedures .


An a priori ROOBY aim was to evaluate treatment impact on diabetic patients .


Actively treated diabetic patients ( n = 835 , receiving oral hypoglycemic or insulin medications ) received off-pump CABG ( n = 402 ) or on-pump CABG ( n = 433 ) .


The primary ROOBY trial endpoints were a short-term composite ( 30-day operative death or major complications ) and a 1-year composite ( death , nonfatal acute myocardial infarction , or repeat revascularization ) .


Secondary ROOBY endpoints included 1-year all-cause death , 1-year graft patency , 1-year changes from baseline in neurocognitive status and health-related quality of life , and costs .


Diabetic patients ' risk factors at baseline were balanced across treatments .


For diabetic patients , the primary short-term composite outcome rate showed a worse trend for off-pump ( 8.0 % ) than on-pump ( 3.9 % , p = 0.013 ) , with no difference in the 1-year primary composite outcome or 1-year death rate .


One-year patency was 83.1 % off-pump versus 88.4 % on-pump ( p = 0.004 ) .


No differences were found in neurocognitive , health-related quality of life , discharge cost , and 1-year cumulative cost .


Concordant with the ROOBY trial 's overall findings , off-pump CABG yielded no advantage over on-pump CABG for actively treated diabetic patients .


The 1-year graft patency was lower and the short-term composite trended higher for off-pump CABG , with no other significant outcome or cost differences .


Closure of the hernia gap in laparoscopic ventral hernia repair before mesh reinforcement has gained increasing acceptance among surgeons despite creating a tension-based repair .


Beneficial effects of this technique have been reported sporadically , but no evidence is available from randomised controlled trials .


The primary purpose of this paper is to compare early post-operative activity-related pain in patients undergoing laparoscopic ventral hernia repair with closure of the gap with patients undergoing standard laparoscopic ventral hernia repair ( non-closure of the gap ) .


Secondary outcomes are patient-rated cosmesis and hernia-specific quality of life .


A randomised , controlled , double-blinded study is planned .


Based on power calculation , we will include 40 patients in each arm .


Patients undergoing elective laparoscopic umbilical , epigastric or umbilical trocar-site hernia repair at Hvidovre Hospital and Herlev Hospital , Denmark , are invited to participate .


The gap closure technique may induce more post-operative pain than the non-closure repair , but it may also be superior with regard to other important surgical outcomes .


No studies have previously investigated closure of the gap in the setting of a randomised controlled trial .


The study is funded by The University of Copenhagen and private foundations .


NCT01962480 ( clinicaltrials.gov ) .


Most people referred to rapid access chest pain clinics have non-cardiac chest pain , and in those diagnosed with stable coronary heart disease , guidance recommends that first-line treatment is usually medication rather than revascularisation .


Consequently , many patients are not reassured they have the correct diagnosis or treatment .


A previous trial reported that , in people with non-cardiac chest pain , a brief discussion with a health psychologist before the tests about the meaning of potential results led to people being significantly more reassured .


The aim of this pilot was to test study procedures and inform sample size for a future multi-centre trial and to gain initial estimates of effectiveness of the discussion intervention .


This was a two-arm pilot randomised controlled trial in outpatient rapid access chest pain clinic in 120 people undergoing investigation for new onset , non-urgent chest pain .


Eligible participants were randomised to receive either : a discussion about the meaning and implication of test results , delivered by a nurse before tests in clinic , plus a pre-test pamphlet covering the same information ( Discussion arm ) or the pre-test pamphlet alone ( Pamphlet arm ) .


Main outcome measures were recruitment rate and feasibility for a future multi-centre trial , with an estimate of reassurance in the groups at month 1 and 6 using a 5-item patient-reported scale .


Two hundred and seventy people attended rapid access chest pain clinic during recruitment and 120/270 participants ( 44 % ) were randomised , 60 to each arm .


There was no evidence of a difference between the Discussion and Pamphlet arms in the mean reassurance score at month 1 ( 34.2 vs 33.7 ) or at month 6 ( 35.3 vs 35.9 ) .


Patient-reported chest pain and use of heart medications were also similar between the two arms .


A larger trial of the discussion intervention in the UK would not be warranted .


Patients reported high levels of reassurance which were similar in patients receiving the discussion with a nurse and in those receiving a pamphlet alone .


Current Controlled Trials ISRCTN60618114 ( assigned 27.05.2011 ) .


To compare the outcomes of bipolar transurethral vaporization of the prostate ( TUVP ) with bipolar transurethral resection of the prostate ( TURP ) .


In a prospective randomized trial , 88 patients with moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia ( BPH ) underwent bipolar TUVP ( N = 39 ) or bipolar TURP ( N = 49 ) from October 2010 to November 2011 .


The inclusion criteria were age > 50 years , prostate volume of 30-80 mL , serum PSA < 4 ng/mL , IPSS 20 , Qmax 10 mL/s and failed medical therapy .


The perioperative and postoperative outcomes were evaluated and the IPSS and Qmax were assessed preoperatively and 3 months after procedure in all cases .


Both groups were similar in patient age , prostate volume , preoperative IPSS and Qmax .


The TUVP group had significantly lower mean values of operative time , hospital stay , catheterization period , irrigation fluid volume and serum hemoglobin , creatinine , sodium and potassium changes compared with TURP group .


No significant differences were seen between two groups regarding complications ( TUVP = 10.3 % ; TURP = 12.2 % ) and modified Clavien classification of complications .


No TUR syndrome , obturator reflex or epididymitis occurred in both groups .


Re-hospitalization and transfusion due to clot retention ( N = 2 ) and urethral stricture ( N = 1 ) were reported only in the TURP group .


Three patients experienced urinary retention after catheter removal in the TUVP group .


Two patients were re-catheterized temporarily and one patient required repeat bipolar TUVP .


Three months after surgery , two groups had significant improvement in IPSS and Qmax .


But the TUVP group had significantly lower IPSS and higher Qmax than TURP group .


Bipolar TUVP is a safe , effective and low cost procedure among minimally invasive surgeries of BPH .


Compared with bipolar TURP , the bipolar TUVP had similar complications , better perioperative and postoperative outcomes , superior hemostasis and higher efficacy .


Resveratrol , a polyphenol found in grapes , red wine , chocolate , and certain berries and roots , is considered to have antioxidant , anti-inflammatory , and anticancer effects in humans and is related to longevity in some lower organisms .


To determine whether resveratrol levels achieved with diet are associated with inflammation , cancer , cardiovascular disease , and mortality in humans .


Prospective cohort study , the Invecchiare in Chianti ( InCHIANTI ) Study ( `` Aging in the Chianti Region '' ) , 1998 to 2009 conducted in 2 villages in the Chianti area in a population-based sample of 783 community-dwelling men and women 65 years or older .


Twenty-four-hour urinary resveratrol metabolites .


Primary outcome measure was all-cause mortality .


Secondary outcomes were markers of inflammation ( serum C-reactive protein [ CRP ] , interleukin [ IL ] -6 , IL-1 , and tumor necrosis factor [ TNF ] ) and prevalent and incident cancer and cardiovascular disease .


Mean ( 95 % CI ) log total urinary resveratrol metabolite concentrations were 7.08 ( 6.69-7 .48 ) nmol/g of creatinine .


During 9 years of follow-up , 268 ( 34.3 % ) of the participants died .


From the lowest to the highest quartile of baseline total urinary resveratrol metabolites , the proportion of participants who died from all causes was 34.4 % , 31.6 % , 33.5 % , and 37.4 % , respectively ( P = .67 ) .


Participants in the lowest quartile had a hazards ratio for mortality of 0.80 ( 95 % CI , 0.54-1 .17 ) compared with those in the highest quartile of total urinary resveratrol in a multivariable Cox proportional hazards model that adjusted for potential confounders .


Resveratrol levels were not significantly associated with serum CRP , IL-6 , IL-1 , TNF , prevalent or incident cardiovascular disease , or cancer .


In older community-dwelling adults , total urinary resveratrol metabolite concentration was not associated with inflammatory markers , cardiovascular disease , or cancer or predictive of all-cause mortality .


Resveratrol levels achieved with a Western diet did not have a substantial influence on health status and mortality risk of the population in this study .


To compare antimllerian hormone ( AMH ) and antral follicle count ( AFC ) as predictors of ovarian response to controlled ovarian stimulation at individual fertility clinics .


Retrospective analysis of individual study center data in two multicenter trials .


Centers that provided > 10 patients were included in the analysis .


A total of 19 ( n = 519 patients ) and 18 study centers ( n = 686 patients ) participating in a long GnRH agonist trial ( MERIT ) and a GnRH antagonist trial ( MEGASET ) , respectively .


Infertile women of good prognosis .


Long GnRH agonist or GnRH antagonist cycles .


Correlation between AMH and AFC , and oocyte yield by each study center for each trial .


Antimllerian hormone was more strongly correlated with oocyte yield than AFC : r = 0.56 vs. r = 0.28 in the GnRH agonist cohort , and r = 0.55 vs. r = 0.33 in the GnRH antagonist cohort .


The correlation was numerically higher for AMH than for AFC at a significantly higher proportion of study centers : 17 ( 89 % ) and 15 ( 83 % ) centers in the long GnRH agonist and GnRH antagonist trial , respectively .


Assessment of the relative capacity of AMH and AFC for predicting oocyte yield demonstrated that AMH dominated the model : AMH , R ( 2 ) = 0.29 and 0.23 ; AFC : R ( 2 ) = 0.07 and 0.07 ; AMH + AFC : R ( 2 ) = 0.30 and 0.23 for long GnRH agonist and GnRH antagonist trials , respectively .


Antimllerian hormone was a stronger predictor of ovarian response to gonadotropin therapy than AFC at the study center level in both randomized trials utilizing GnRH agonist and GnRH antagonist protocols .


Antral follicle count provided no added predictive value beyond AMH .


Hispanics are at increased risk of developing type 2 diabetes .


Lifestyle interventions are effective in preventing diabetes and restoring glucose regulation .


We recruited Hispanic men and women ( N = 320 ) who were residents of the Lower Yakima Valley , Washington , aged 18 years or older with hemoglobin A1c ( HbA1c ) levels higher than 6 % to a parallel 2-arm randomized-controlled trial conducted from 2008 through 2012 .


The trial compared participants in the intervention arm , who received an immediate educational curriculum ( n = 166 ) , to participants in the control arm , who received a delayed educational curriculum ( n = 154 ) .


The home-based curriculum consisted of 5 sessions led by community health workers and was designed to inform participants about diabetes , diabetes treatment , and healthy dietary and physical activity behaviors .


Participants were randomly assigned to the intervention and control arms , and analysts were blinded as to participant arm .


We evaluated intervention effects on HbA1c levels ; frequency ( times per week ) of fruit and vegetable consumption ; and frequency ( times per week ) of mild , moderate , and strenuous leisure-time physical activity .


At baseline , 3 months , and 6 months after randomization , participants completed a questionnaire and provided a blood sample .


Analysts were blinded to intervention arm .


The immediate intervention group ( -0.64 % [ standard error ( SE ) 0.10 ] ) showed a significant improvement in HbA1c scores ( -37.5 % , P = .04 ) compared with the delayed intervention group ( -0.44 % , P = .14 ) .


No significant changes were seen for dietary end points or changes in physical activity .


We did observe a trend of greater increases in frequency of moderate and vigorous physical activity and a smaller increase in mild physical activity in the immediate intervention group than in the delayed intervention group .


This home-based intervention delivered by CHWs was associated with a clinically and statistically significant reduction in HbA1c levels in Hispanic adults with HbA1c levels higher than 6 % .


To evaluate the impact of a clinical pharmacy program on health outcomes in patients with type 2 diabetes undergoing insulin therapy at a teaching hospital in Brazil .


A randomized controlled trial with a 6-month follow-up period was performed in 70 adults , aged 45 years or older , with type 2 diabetes who were taking insulin and who had an HbA1c level 8 % .


Patients in the control group ( CG ) ( n = 36 ) received standard care , patients in the intervention group ( IG ) ( n = 34 ) received an individualized pharmacotherapeutic care plan and diabetes education .


The primary outcome measure was change in HbA1c .


Secondary outcomes included diabetes and medication knowledge , adherence to medication , insulin injection and home blood glucose monitoring techniques and diabetes-related quality of life .