Fibroblast growth factor 19 ( FGF19 ) improves glycemic control in diabetic animals and is secreted from the gastrointestinal tract after meals in response to bile acid stimulation .


We sought to understand how ingestion of carbohydrates , protein or lipids affect both FGF19 and bile acid concentrations in human plasma , with the hypothesis that variation in the bile acid response to different macronutrients would predict differences in plasma FGF19 levels .


This was a randomized , within-subjects crossover study .


The study was conducted at a university clinical research center .


There were 16 healthy human subjects included in the study .


Isocaloric , isovolemic beverages composed primarily of carbohydrates , proteins , or lipids were provided to each participant on 3 separate occasions .


The magnitudes of postprandial rises of plasma FGF19 and total bile acid levels were determined .


All beverages induced an initial transient decline of plasma FGF19 levels during the first 60 minutes after consumption .


For FGF19 , the ingestion of carbohydrate was associated with the fastest and highest increase of plasma levels , returning to baseline at 5 hours .


By comparison , the protein beverage induced a modest but significant elevation of FGF19 levels that peaked at the end of the 6-hour sampling interval , whereas a lipid beverage was without effect .


In contrast , total bile acid levels increased in plasma only in response to a high-lipid beverage , demonstrating a marked divergence between the FGF19 and bile acid response to lipid vs carbohydrate .


A bile acid-independent mechanism is implicated in the effect of meals to raise plasma FGF19 concentrations .


In this clinical trial , we aimed to compare three means of performing chronic hemodialysis in patients with contra-indication to systemic heparinization .


This open-label monocentric randomized n-of-one trial , conducted in a single tertiary care center , recruited chronic hemodialysis patients with a contra-indication to systemic heparinization for at least 3 consecutive sessions .


All patients underwent hemodialysis with an AN69ST dialyzer , and were administered three alternative dialysis procedures in a random sequence : intermittent saline flushes , constant saline infusion , or pre-dialysis heparin coating of the membrane .


The primary outcome was the need to interrupt the dialysis session because of clotting events due to either ( i ) a complete coagulation of the circuit ; ( ii ) a partial coagulation of the circuit ; ( iii ) a > 50 % rise over baseline in the venous pressure .


At the end of the inclusion period ( May , 2007 to December , 2008 ) , the number of patients to include ( n = 75 ) was not reached : only 46 patients were included and underwent randomization .


The study was terminated , and statistical analysis took into account 224 hemodialysis sessions performed in 44 patients with analyzable data .


Heparin adsorption was associated with a significant reduction of the need to interrupt the dialysis session because of clotting events : odds ratio 0.3 ( CI 95 % 0.2 to 0.6 ; p < 0.001 , versus intermittent saline flushes ) .


Heparin adsorption was also associated with higher odds for performing > 3 h dialysis sessions and for having complete blood restitution .


There were no significant effects of the dialysis procedure on weight loss , online ionic dialysance , and adverse events .


Heparin-coated AN69ST dialysis membrane is a safe and effective method to avoid or delay per-dialytic clotting events in patients with contra-indication to systemic anticoagulation .


However , results are not generalizable safely to patients with active bleeding , since weak heparinemia , not assessed in this study , may occur .


ClinicalTrials.gov NCT00473109 .


To examine the effects of galantamine and risperidone on agitation in patients with dementia .


A total of 100 patients with dementia and neuropsychiatric symptoms ( mean age SD : 78.6 7.5 years ; 67 % female ) were included in this 12-week , randomized , parallel-group , controlled , single-center trial .


The participants received galantamine ( n = 50 ; target dose : 24 mg ) or risperidone ( n = 50 ; target dose : 1.5 mg ) for 12 weeks .


Both galantamine and risperidone treatment resulted in reduced agitation .


However , risperidone showed a significant advantage over galantamine both at week 3 ( mean difference in total Cohen-Mansfield Agitation Inventory score : 3.7 points ; p = 0.03 ) and at week 12 ( 4.3 points ; p = 0.01 ) .


Agitation improved in both groups , even if the treatment effects were more pronounced in the risperidone group ; however , the effects on cognition and other aspects of tolerability were stronger with galantamine .


To determine the reliability of patient reports of pain intensity during the application of physical tests .


A single examiner required participants to use the numeric pain rating scale ( NPRS ) to report the intensity of pain provoked during physical testing of the hip .


Standardized versions of 14 physical tests were used on 18 people with hip pain .


Tests were repeated at 1 hour and 2-7 days later .


Within - and between-session reliability of reports of pain intensity was calculated using intraclass correlation coefficients ( ICCs ) and Lin 's concordance correlation coefficients ( CCCs ) .


Standard errors of measurement ( SEMs ) were calculated .


ICC/CCC values for within-session reports of pain intensity ranged from 0.34 ( 95 % confidence interval [ 95 % CI ] -0.08 , 0.66 ) to 0.88 ( 95 % CI 0.73 , 0.95 ) .


Patients demonstrated `` substantial '' or `` almost perfect '' reliability in reporting pain intensity with 9 of 14 tests and `` moderate '' reliability with 3 tests .


Two tests were unreliable ( ICC 0.35 and 0.34 ) .


ICC/CCC values for between-session reports of pain intensity ranged from -0.05 ( 95 % CI -0.42 , 0.34 ) to 0.84 ( 95 % CI 0.44 , 0.95 ) .


Patients demonstrated substantial or almost perfect reliability in reporting pain intensity with 11 of 14 tests .


Two tests were unreliable ( ICC 0.26 and -0.05 ) .


The average SEM value of 0.9 points on the NPRS was the same for both within - and between-session testing ( range 0.6-1 .6 ) .


Patient reports of the intensity of pain provoked by physical tests are sufficiently reliable to be clinically useful .


However , the SEM of 0.9 points should be considered when precise calculations of changes in pain intensity are important .


Mechanisms , acute management , and outcomes for patients who experience intracerebral hemorrhage may differ from patients with ischemic stroke .


Studies of very early rehabilitation have been mainly undertaken in patients with ischemic stroke , and it is unknown if benefits apply to those with intracerebral hemorrhage .


We hypothesized that early rehabilitation , within 48 hours of stroke , would improve survival and functional outcomes in patients with intracerebral hemorrhage .


This was a multicenter , randomized controlled study , with blinded assessment of outcome at 3 and 6 months .


Eligible patients were randomized to receive standard care or standard care plus early rehabilitation .


Primary outcome includes survival .


Secondary outcomes includes health-related quality of life using the 36-item Short Form Questionnaire , function measured with the modified Barthel Index , and anxiety measured with the Zung Self-Rated Anxiety Scale .


Two hundred forty-three of 326 patients were randomized ( mean age , 59 years ; 56 % men ) .


At 6 months , patients receiving standard care were more likely to have died ( adjusted hazard ratio , 4.44 ; 95 % confidence interval [ CI ] , 1.24-15 .87 ) ; for morbidity outcomes , a 6-point difference in the Physical Component Summary score of the 36-item Short Form Questionnaire ( 95 % CI , 4.2-8 .7 ) , a 7-point difference for the Mental Component Summary score ( 95 % CI , 4.5-9 .5 ) , a 13-point difference in Modified Barthel Index scores ( 95 % CI , 6.8-18 .3 ) , and a 6-point difference in Self-Rating Anxiety Scale scores ( 95 % CI , 4.4-8 .3 ) was reported in favor of the intervention groups .


For the first time , we have shown that commencing rehabilitation within 48 hours of intracerebral hemorrhage improves survival and functional outcomes at 6 months after stroke in hospitalized patients in China .


http://www.chictr.org/en .


Unique identifier : ChiCTR-TRC-13004039 .


This study sought to evaluate the outcomes of endovascular treatment with covered versus bare Cheatham-platinum stents ( NuMed , Hopkinton , New York ) in coarctation of aorta ( CoA ) patients .


Covered stenting has been newly recognized as a useful therapeutic method for patients with native CoA , but there has been no study comparing the use of covered stents with bare stents for treating CoA .


In this randomized clinical trial , 120 patients with a mean age of 23.60 10.99 years ( range 12 to 58 years , 79 men ) , with post-ductal , short-segment , severe native CoA underwent implantation of bare Cheatham-Platinum ( bCP ) ( n = 60 ) or covered Cheatham-Platinum ( cCP ) ( n = 60 ) stents .


Patients were followed clinically at 1 , 3 , 6 , and 12 months after the stenting and yearly thereafter .


During follow-up , multislice computed tomography ( 64 slices ) was scheduled to assess any complications .


The procedural success rate was 100 % in both groups .


Patients were followed for 31.1 19.2 months .


Although recoarctation was seen only in the bCP group during follow-up , the difference betweengroups did not reach statistical significance ( 6.7 % vs. 0 % ; p = NS ) .


Two cases of pseudoaneurysm ( 3.3 % ) occurred in the cCP group , but none was observed in the bCP group ( p = NS ) .


Normotensive statussignificantly increased during follow-up in both groups ( from 15 % to 73.3 % in the bCP group and16 .7 % to78 .3 % in the cCP group , p < 0.001 for each group and not significant between groups ) .


Implanting bCP and cCP stents have very high success rates with remarkable hemodynamic effects in severe native CoA patients .


Patients undergoing cCP stent implantation experienced a nonsignificantly lower recoarctation rate and a higher occurrence of pseudoaneurysm formation with respect to bCP stenting during follow-up .


These findings indicate that CoA stenting isasafe procedure .


( Endovascular Stenting With Covered CP Stent Compared With Bare CP Stent forAdultPatients With Coarctation : The Initial and Intermediate-Term Follow-Up Results ; IRCT201012045311N1 ) .


To observe the clinical effect of low-dose once-daily tadalafil combined with Shuganyiyang Capsules in the treatment of mild-to-moderate erectile dysfunction ( ED ) .


Ninety patients with mild-to-moderate ED were equally randomized to groups A , B and C to receive Shuganyiyang Capsules , tadalafil , and tadalafil + Shuganyiyang Capsules , respectively .


The scores of the patients on IIEF-5 and SF-PAIRS ( 15-Item Short Form of Psychological Interpersonal Relationship Scales ) were recorded before and at 1 and 3 months after treatment .


The IIEF-5 scores of groups A , B and C were 10.13 + / - 1.55 , 11.00 + 1.60 and 10.73 + / - 1.91 before treatment , and 13.77 + / - 2.11 , 17.77 + / - 2.13 and 17.17 + / - 3.84 at 1 month after treatment , significantly higher in B and C than in A ( P < 0.001 ) , but with no remarkable difference between B and C ( P = 0.411 ) .


At 3 months after treatment , the IIEF-5 scores were 15.77 + / - 2.05 , 18.07 + / - 2.24 and 19.37 + / - 3.76 in the three groups , dramatically higher in B and C than in A ( P < 0.001 ) as well as in C than in B ( P < 0.05 ) .


The scores on sexual self-confidence , sexual spontaneity and time concerns in SF-PAIRS were 3.90 + / -0.80 , 8.67 + / - 1.94 and 14.43 + / - 1.92 before medication , 5.83 + / - 1.02 , 9.90 + / - 1.75 and 11.17 + / - 1.68 at 1 month and 6.73 + / - 0.98 , 11.07 + / - 2.08 and 10.67 + / -1.60 at 3 months after medication in group A ; 4.17 + / - 0.87 , 9.37 + / -1.43 and 14.47 + / -1.57 before medication , 6.47 + / -0.78 , 10.83 + / - 2.18 and 10.20 + / -1.56 at 1 month and 6.83 + / -0.91 , 11.30 + / - 1.88 and 9.47 + / - 1.57 at 3 months in group B ; and 4.23 + / -0.94 , 9.50 + / - 1.89 and 14.67 + / - 2.91 before medication , 8.03 + / - 1.67 , 13.43 + / -1.10 and 9.70 + / -1.21 at 1 month and 8.93 + / - 1.78 , 14.70 + / - 1.26 and 8.87 + / - 0.97 at 3 months in group C. Compared with the baseline , the SF-PAIRS scores of the three groups were all significantly improved after treatment ( P < 0.05 ) , and markedly higher in C than in the other two groups ( P < 0.05 ) .


Low-dose once-daily tadalafil combined with Shuganyiyang Capsules is obviously effective in the treatment of mild-to-moderate ED , which not only improves the patients ` erectile function , sexual self-confidence and sexual spontaneity , but also reduces their time concerns .


Milligan-Morgan hemorrhoidectomy ( MM ) is still the most common treatment for grades III and IV hemorrhoids despite prolonged post-operative anal pain and wound healing .


This multicenter , double blind , randomized , controlled trial was designed to assess the safety and the efficacy of anal wound cleansing with Triclosan ( Proctocid ) in the control of symptoms and healing time after MM .


A total of 113 patients with grades III and IV hemorrhoids , undergoing open hemorroidectomy by diathermy or Ligasure vessel sealing device , were randomly assigned to Triclosan or sodium hypochlorite solution .


All patients received analgesics and a fiber-rich diet after hemorrhoidectomy .


Postoperative anal pain , bleeding and/or secretion and itch were assessed 7 , 14 and 21 days after hemorrhoidectomy by a Visual Analogue Scale ( VAS ) and the day of complete re-epithelialization of anal wounds was recorded .


Fifty-five patients were randomized for Triclosan treatment and 58 for the control drug .


The two groups were comparable for demographics , severity of hemorrhoids and technique used for the hemorrhoidectomy .


The comparison of days to get complete anal wound healing shows a trend of significance ( P = 0.05 ) for the Triclosan group .


Bleeding and/or secretion , anal pain and itch were significantly better ( P = 0.003 ; P < 0.0001 and P = 0.01 , respectively ) .


Triclosan solution for the treatment of post-hemorrhoidectomy wounds is safe and improves the control of post-operative symptoms and wound healing time compared to sodium hypochlorite .


To determine if transversus abdominis plane anesthetic blockage ( TAP block ) diminishes early postoperative pain scores and facilitates ambulatory management following total laparoscopic hysterectomy .


Randomized triple blind trial .


Gynecological endoscopy unit at a referral center for laparoscopic surgery .


A total of 197 patients .


Comparison of a treatment group receiving TAP block with bupivacaine 0.25 % and placebo group with comparably placed bilateral injection of sterile saline solution .


Pain scores at discharge 24 , 48 and 72h after surgery , opioid requirement after procedure .


Patients who had TAP block had a significant reduction in their pain score at discharge compared with the placebo group ( p = 0.017 ) .


There were no significant differences in the pain scores between groups at 24h ( 95 % CI 1.36-0 .133 , p = 0.237 ) , 48h ( 95 % CI 0.689-0 .465 , p = 0.702 ) and 72h ( 95 % CI -0.631 to 0.223 , p = 0.347 ) .


No differences were found between the groups regarding opioid requirements following the procedure ( ( 2 ) = 3.62 , p = 0.46 ) .


Although TAP block after a total laparoscopic hysterectomy reduced the pain score at discharge compared with placebo , its role in this setting is debatable due to the possible lack of clinical significance of the small difference found .


Studies done in Asia have shown that a regimen of S-1 plus oxaliplatin ( SOX ) has promising efficacy and safety in patients with metastatic colorectal cancer .


We aimed to establish whether SOX plus bevacizumab is non-inferior to mFOLFOX6 ( modified regimen of leucovorin , fluorouracil , and oxaliplatin ) plus bevacizumab as first-line chemotherapy for metastatic colorectal cancer .


We undertook an open-label , non-inferiority , randomised phase 3 trial in 82 sites in Japan .


We enrolled individuals aged 20-80 years who had metastatic colorectal cancer , had an Eastern Cooperative Oncology Group performance status of 0 or 1 , had assessable lesions , had received no previous chemotherapy or radiotherapy , could take drugs orally , and had adequate organ function .


Eligible patients were randomly assigned ( 1:1 ) to receive either mFOLFOX6 plus bevacizumab ( on day 1 of each 2-week cycle , 5 mg/kg intravenous infusion of bevacizumab and a simultaneous intravenous infusion of 85 mg/m ( 2 ) oxaliplatin , 200 mg/m ( 2 ) l-leucovorin , 400 mg/m ( 2 ) bolus fluorouracil , and 2400 mg/m ( 2 ) infusional fluorouracil ) or SOX plus bevacizumab ( on day 1 of each 3-week cycle , 75 mg/kg intravenous infusion of bevacizumab and 130 mg/m ( 2 ) intravenous infusion of oxaliplatin ; assigned dose of S-1 twice a day from after dinner on day 1 to after breakfast on day 15 , followed by 7-day break ) .


Randomisation was done centrally with the minimisation method , with stratification by institution and whether postoperative adjuvant chemotherapy had been given .


Participants , investigators , and data analysts were not masked to treatment assignment .


The primary endpoint was progression-free survival ( PFS ) , which was defined as the interval between enrolment and progressive disease ( 20 % increase in sum of longest dimensions of target lesions from baseline , or appearance of new lesions ) or death , whichever came first .


The primary analysis was done by modified intention to treat .


This trial is registered with the Japan Pharmaceutical Information Center , number JapicCTI-090699 .


Between Feb 1 , 2009 , and March 31 , 2011 , 512 patients underwent randomisation .


256 patients assigned to receive SOX plus bevacizumab and 255 assigned to receive mFOLFOX6 plus bevacizumab were included in the primary analysis .


Median PFS was 115 months ( 95 % CI 107-132 ) in the group assigned to mFOLFOX6 plus bevacizumab and 117 months ( 107-129 ) in the group assigned to SOX plus bevacizumab ( HR 104 , 95 % CI 086-127 ; less than non-inferiority margin of 133 , pnon-inferiority = 0014 ) .


The most common haematological adverse events of grade 3 or higher were leucopenia ( 21 [ 8 % ] of 249 patients given mFOLFOX6 plus bevacizumab included in safety analysis vs six [ 2 % ] of 250 given SOX plus bevacizumab ; p = 00029 ) and neutropenia ( 84 [ 34 % ] vs 22 [ 9 % ] ; p < 00001 ) .


Grade 3 or higher anorexia ( 13 [ 5 % ] vs three [ 1 % ] ; p = 0019 ) and diarrhoea ( 23 [ 9 % ] vs seven [ 3 % ] ; p = 00040 ) were significantly more common in patients given SOX plus bevacizumab than in those given mFOLFOX6 plus bevacizumab .


We recorded seven treatment-related deaths ( three in the group given mFOLFOX6 plus bevacizumab ; four in that given SOX plus bevacizumab ) .


SOX plus bevacizumab is non-inferior to mFOLFOX6 plus bevacizumab with respect to PFS as first-line treatment for metastatic colorectal cancer , and could become standard treatment in Asian populations .


Taiho .


The use of 1-hydroxylated vitamin D therapy to control secondary hyperparathyroidism in renal failure patients has been a success story , culminating with the demonstration of increased life expectancy in patients treated with these compounds .


However , hypercalcemic episodes have been a recurrent problem with these therapies and have resulted in the added use of calcium mimetics .


Clearly there is good reason to search for improved vitamin D therapy .


In our inventory of vitamin D compounds , 2-methylene-19-nor - ( 20S ) -1,25 - dihydroxyvitamin D3 ( 2MD ) surfaced as a potential candidate .


This was based on its preferential localization in the parathyroid gland and a clear suppression of serum parathyroid hormone ( PTH ) levels without a change in serum calcium in a clinical trial in postmenopausal women .


2MD has now been tested in the rat 5/6-nephrectomy model of renal failure , and in postmenopausal women to determine if it can suppress serum PTH at doses that do not elevate serum calcium and serum phosphorus concentrations .


Daily oral treatment of uremic rats on 2.5 ng/bw/day of 2MD dramatically suppressed PTH without a change in serum calcium or serum phosphorus .


Further , PTH was suppressed in postmenopausal women after only 3 daily oral doses of 2MD that continued for 4 weeks with no change in serum calcium or serum phosphorus .


These results coupled with a pharmacokinetic half-life of ~ 24 h suggest that 2MD given either daily or at the time of dialysis may be a superior therapy for secondary hyperparathyroidism in chronic renal failure patients .


Our aim was to investigate the relationship between mutant p53 and the prognosis of malignant glioma treated with temozolomide , and the regulation of mutant TP53 induced drug resistance , by molecular experimentation and a clinical trial .


Adult patients with newly surgical diagnosed glioblastoma were randomly assigned to receive either temozolomide or semustine after radiation treatment .


The statuses of TP53 and expression of TP53 and O ( 6 ) - methylguanine DNA-methyltransferase ( MGMT ) were determined retrospectively in tumor tissue from enrolled patients .


The primary end point was overall survival .


Synthetic small interfering RNA was used to knock down mutant TP53 in T98G and U138 cells , which are human glioblastoma cells with a P53 mutation , by screening of exons 4-8 .


Viable cell survival was measured when these cells were exposed to temozolomide or semustine .


Expression of MGMT at the messenger RNA level was also determined .


The overall survival was 34.3 % at 2 years , 22.9 % at 3 years , 11.4 % at 4 years , and 8.6 % at 5 years with temozolomide , versus 18.2 , 12.1 , 3.0 , and 0 % , respectively , with semustine .


TP53 mutation and expression of mutant TP53 and MGMT showed significant inverse correlations with overall survival .


Knockdown of mutant TP53 led to a fivefold increase in chemosensitivity to temozolomide but not semustine .


Mutant TP53 knockdown induced down-regulation of MGMT expression .


Mutant TP53 is strongly associated with a poor prognosis for overall survival in patients with glioblastoma .


Also , TP53 mutation may decrease the chemosensitivity of glioblastoma to temozolomide by increasing MGMT expression .


Coronary bifurcation lesions can be approached using a simple or a complex strategy .


In clinical trials with first-generation drug-eluting stents , the complex strategy was not superior to the simple approach .


However , to date , the best strategy when using second-generation drug-eluting stents has not been defined .


We performed a prospective randomized study comparing a simple vs a complex strategy involving T-stenting for the percutaneous revascularization of bifurcation lesions using the everolimus-eluting stent .


Angiographic and clinical follow-up were performed at 9 months .


We included 70 lesions in 69 patients , who were randomized to the simple ( 34 lesions , 33 patients ) or complex strategy ( 36 lesions and patients ) .


In all , 85.6 % of the lesions included were true bifurcations .


The crossover rate was 17.1 % .


The binary restenosis rate was 12.1 % , with no differences between the groups .


Side branch restenosis tended to be higher with the simple strategy in the intention to treat analysis ( 10.7 % vs 0 % ) but not in the per protocol analysis ( 5.9 % vs 4.2 % ) .


The incidence of major adverse cardiac events ( cardiac death , myocardial infarction , and target vessel revascularization ) was 9.2 % , with no differences between groups .


There were no cases of stent thrombosis .


According to the clinical and angiographic findings , the complex strategy was not significantly superior to the simple approach in the revascularization of bifurcation lesions with second-generation everolimus-drug eluting stents .


Current literature supports the thought that anesthesia and analgesia administered perioperatively for an anterior cruciate ligament ( ACL ) reconstruction have a great influence on time to effective rehabilitation during the first week after hospital discharge .


The aim of this study is to answer the research question is there a difference in clinical outcomes between the use of a femoral nerve block with spinal anesthesia versus spinal analgesia alone for people undergoing ACL reconstruction ?


ACL reconstruction with spinal anesthesia and patient sedation ( Group one ) ; and spinal anesthesia with patient sedation and an additional femoral nerve block ( Group two ) .


Patients were re-evaluated for pain , range of motion ( ROM ) , active contraction of the quadriceps , and a Functional Independence Measure ( FIM ) scoring scale .


Spinal anesthesia with a femoral nerve block demonstrates pain relief 6h after surgery ( VAS 0.37 ; p = 0.007 ) .


From the third ( VAS = 4.56 ; p = 0.028 ) to the seventh ( VAS = 2.87 ; p = 0.05 ) days after surgery , this same nerve blockage delivered higher pain scores .


Patients had a similar progressive improvement on knee joint range of motion with or without femoral nerve block ( p < 0.002 ) .


Group one and two had 23.75 and 24.29 6h after surgery and 87.81 and 85.36 of knee flexion after 48h post op .


Spinal anesthesia associated with a femoral nerve block had no additional benefits on pain control after the third postoperative day .


There were no differences between groups concerning ability for knee flexion and to complete daily activities during postoperative period .


Randomized Clinical Trial Level I.


Tasquinimod ( Active Biotech ) is an oral immunomodulatory , anti-angiogenic , and anti-metastatic agent that delayed metastatic disease progression in a randomized placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer ( mCRPC ) .


Here , we report long-term survival with biomarker correlates from this trial .


Two hundred and one ( 134 tasquinimod and 67 placebo ) men with mCRPC were evaluated .


Forty-one men randomized to placebo crossed over to tasquinimod .


Survival data were collected with a median follow-up time of 37 months .


Exploratory biomarker studies at baseline and over time were collected to evaluate potential mechanism-based correlates with tasquinimod efficacy including progression-free survival ( PFS ) and overall survival ( OS ) .


With 111 mortality events , median OS was 33.4 months for tasquinimod versus 30.4 months for placebo overall , and 34.2 versus 27.1 months in men with bone metastases ( n = 136 ) , respectively .


Multivariable analysis demonstrated an adjusted HR of 0.52 [ 95 % confidence interval ( CI ) , 0.35-0 .78 ; P = 0.001 ] for PFS and 0.64 ( 95 % CI , 0.42-0 .97 ; P = 0.034 ) for OS , favoring tasquinimod .


Time-to-symptomatic progression was improved with tasquinimod ( P = 0.039 , HR = 0.42 ) .


Toxicities tended to be mild in nature and improved over time .


Biomarker analyses suggested a favorable impact on bone alkaline phosphatase and lactate dehydrogenase ( LDH ) over time and a transient induction of inflammatory biomarkers , VEGF-A , and thrombospondin-1 levels with tasquinimod .


Baseline levels of thrombospondin-1 less than the median were predictive of treatment benefit .


The survival observed in this trial of men with minimally symptomatic mCRPC suggests that the prolongation in PFS with tasquinimod may lead to a survival advantage in this setting , particularly among men with skeletal metastases , and has a favorable risk : benefit ratio .


The efficacy of clipping for preventing the delayed bleeding after the removal of colon polyps is still controversial .


In order to clarify this efficacy , a randomized controlled study was performed .


One hundred and fifty-six patients with colon neoplasms ( 288 lesions ) were enrolled in the study .


The patients were randomly divided into two groups : clipping or nonclipping groups using a sealed envelope method before the endoscopic resections .


Eight specialists and nine residents were invited to perform this procedure .


The risk factors and the rates of delayed bleeding after the endoscopic resections in each group were investigated .


There were no significant differences in the bleeding rate between the clipping and nonclipping groups , while the length of the procedure was significantly longer and the cost was higher in the clipping group than in the nonclipping group .


The rate of bleeding was significantly higher in cases with polyps 2 cm or larger and with a longer procedure time , while none of the other factors affected the bleeding rate .


This randomized controlled study revealed no significant effect of prophylactic clipping for preventing delayed bleeding after the endoscopic resection of colon polyps .


The CLASSIC trial was done to compare adjuvant capecitabine plus oxaliplatin versus observation after D2 gastrectomy for patients with stage II or III gastric cancer .


The planned interim analysis of CLASSIC ( median follow-up 34 months ) showed that adjuvant capecitabine plus oxaliplatin significantly improved disease-free survival , the primary endpoint , compared with observation after D2 gastrectomy .


We report the 5-year follow-up data from the trial .


CLASSIC was a phase 3 , randomised , open-label study done at 35 cancer centres , medical centres , and hospitals in China , South Korea , and Taiwan .


Patients with stage II-IIIB gastric cancer who underwent curative D2 gastrectomy were randomly assigned ( 1:1 ) after surgery to receive adjuvant chemotherapy with capecitabine and oxaliplatin ( eight 3-week cycles of oral capecitabine 1000 mg/m ( 2 ) twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m ( 2 ) on day 1 ) for 6 months or observation alone .


Randomisation was stratified by country and disease stage with a permuted block ( size four ) design .


Neither patients nor investigators were masked to treatment assignment .


The primary outcome was 3-year disease-free survival in the intention-to-treat population .


This analysis presents the final preplanned assessment of outcomes after 5 years .


The study is registered with ClinicalTrials.gov , NCT00411229 .


We enrolled 1035 patients : 520 were randomly assigned to adjuvant capecitabine and oxaliplatin , and 515 to observation .


Median follow-up for this analysis in the intention-to-treat population was 624 months ( IQR 54-70 ) .


139 ( 27 % ) patients had disease-free survival events in the adjuvant capecitabine and oxaliplatin group versus 203 ( 39 % ) patients in the observation group ( stratified hazard ratio [ HR ] 058 , 95 % CI 047-072 ; p < 00001 ) .


Estimated 5-year disease-free survival was 68 % ( 95 % CI 63-73 ) in the adjuvant capecitabine and oxaliplatin group versus 53 % ( 47-58 ) in the observation alone group .


By the clinical cutoff date , 103 patients ( 20 % ) had died in the adjuvant capecitabine and oxaliplatin group versus 141 patients ( 27 % ) in the observation group ( stratified HR 066 , 95 % CI 051-085 ; p = 00015 ) .


Estimated 5-year overall survival was 78 % ( 95 % CI 74-82 ) in the adjuvant capecitabine and oxaliplatin group versus 69 % ( 64-73 ) in the observation group .


Adverse event data were not collected after the primary analysis .


Adjuvant treatment with capecitabine plus oxaliplatin after D2 gastrectomy should be considered for patients with operable stage II or III gastric cancer .


F Hoffmann La-Roche and Sanofi .


The financial costs associated with asthma care continue to increase while care remains suboptimal .


Promoting optimal self-management , including the use of asthma action plans , along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally .


Despite evidence of benefit , guided self-management remains underused , however the potential for online resources to promote self-management behaviors is gaining increasing recognition .


The aim of this paper is to describe the protocol for a pilot evaluation of a website ` Living well with asthma ' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes .


The study is a parallel randomized controlled trial , where adults with asthma are randomly assigned to either access to the website for 12 weeks , or usual asthma care for 12 weeks ( followed by access to the website if desired ) .


Individuals are included if they are over 16-years-old , have a diagnosis of asthma with an Asthma Control Questionnaire ( ACQ ) score of greater than , or equal to 1 , and have access to the internet .


Primary outcomes for this evaluation include recruitment and retention rates , changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire ( AQLQ ) scores , and quantitative data describing website usage ( number of times logged on , length of time logged on , number of times individual pages looked at , and for how long ) .


Secondary outcomes include clinical outcomes ( medication use , health services use , lung function ) and patient reported outcomes ( including adherence , patient activation measures , and health status ) .


Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes .


Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the ` Living well with asthma ' website .


This trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13 .


Arformoterol tartrate ( arformoterol , 15 g bid ) is a nebulized long-acting 2-agonist approved for maintenance treatment of COPD .


This was a multicenter , double-blind , randomized , placebo-controlled study .


Patients ( aged 40 years with baseline FEV1 65 % predicted , FEV1 > 0.50 L , FEV1/FVC 70 % , and 15 pack-year smoking history ) received arformoterol ( n = 420 ) or placebo ( n = 421 ) for 1 year .


The primary assessment was time from randomization to respiratory death or first COPD exacerbation-related hospitalization .


Among 841 patients randomized , 103 had 1 primary event ( 9.5 % vs 15.0 % , for arformoterol vs placebo , respectively ) .


Patients who discontinued treatment for any reason ( 39.3 % vs 49.9 % , for arformoterol vs placebo , respectively ) were followed for up to 1 year postrandomization to assess for primary events .


Fewer patients receiving arformoterol than placebo experienced COPD exacerbation-related hospitalizations ( 9.0 % vs 14.3 % , respectively ) .


Twelve patients ( 2.9 % ) receiving arformoterol and 10 patients ( 2.4 % ) receiving placebo died during the study .


Risk for first respiratory serious adverse event was 50 % lower with arformoterol than placebo ( P = .003 ) .


Numerically more patients on arformoterol ( 13 ; 3.1 % ) than placebo ( 10 ; 2.4 % ) experienced cardiac serious adverse events ; however , time-to-first cardiac serious adverse event was not significantly different .


Improvements in trough FEV1 and FVC were greater with arformoterol ( least-squares mean change from baseline vs placebo : 0.051 L , P = .030 and 0.075 L , P = .018 , respectively ) .


Significant improvements in quality of life ( overall St. George 's Hospital Respiratory Questionnaire and Clinical COPD Questionnaire ) were observed with arformoterol vs placebo ( P < .05 ) .


Arformoterol demonstrated an approximately 40 % lower risk of respiratory death or COPD exacerbation-related hospitalization over 1 year vs placebo .


Arformoterol was well-tolerated and improved lung function vs placebo .


ClinicalTrials.gov ; No. : NCT00909779 ; URL : www.clinicaltrials.gov .


Postexercise protein or amino acid ingestion restores muscle protein synthesis in older adults and represents an important therapeutic strategy for aging muscle .


However , the precise nutritional factors involved are unknown .


The purpose of this study was to determine the role of increased postexercise Leu ingestion on skeletal muscle myofibrillar protein synthesis ( MyoPS ) , mammalian/mechanistic target of rapamycin complex 1 signaling , and amino acid transporter ( AAT ) mRNA expression in older men over a 24-h post-resistance exercise ( RE ) time course .


During a stable isotope infusion trial ( l - [ ring - ( 13 ) C6 ] Phe ; l - [ 1 - ( 13 ) C ] Leu ) , older men performed RE and , at 1 h after exercise , ingested 10 g of essential amino acids ( EAAs ) containing either a Leu content similar to quality protein ( control , 1.85 g of Leu , n = 7 ) or enriched Leu ( LEU ; 3.5 g of Leu , n = 8 ) .


Muscle biopsies ( vastus lateralis ) were obtained at rest and 2 , 5 , and 24 h after exercise .


p70 S6 kinase 1 phosphorylation was increased in each group at 2 h ( P < 0.05 ) , whereas 4E binding protein 1 phosphorylation increased only in the LEU group ( P < 0.05 ) .


MyoPS was similarly increased ( 90 % ) above basal in each group at 5 h ( P < 0.05 ) and remained elevated ( 90 % ) at 24 h only in the LEU group ( P < 0.05 ) .


The mRNA expression of select AATs was increased at 2 and 5 h in each group ( P < 0.05 ) , but AAT expression was increased at 24 h only in the LEU group ( P < 0.05 ) .


Leu-enriched EAA ingestion after RE may prolong the anabolic response and sensitivity of skeletal muscle to amino acids in older adults .


These data emphasize the potential importance of adequate postexercise Leu ingestion to enhance the response of aging muscle to preventive or therapeutic exercise-based rehabilitation programs .


This trial was registered at clinicaltrials.gov as NCT00891696 .


Antibiotics are of limited overall clinical benefit for uncomplicated lower respiratory tract infection ( LRTI ) but there is uncertainty about their effectiveness for patients with features associated with higher levels of antibiotic prescribing .


To estimate the benefits and harms of antibiotics for acute LRTI among those producing coloured sputum , smokers , those with fever or prior comorbidities , and longer duration of prior illness .


Secondary analysis of a randomised controlled trial of antibiotic placebo for acute LRTI in primary care .


Two thousand and sixty-one adults with acute LRTI , where pneumonia was not suspected clinically , were given amoxicillin or matching placebo .


The duration of symptoms , rated moderately bad or worse ( primary outcome ) , symptom severity on days 2-4 ( 0-6 scale ) , and the development of new or worsening symptoms were analysed in pre-specified subgroups of interest .


Evidence of differential treatment effectiveness was assessed in prespecified subgroups by interaction terms .


No subgroups were identified that were significantly more likely to benefit from antibiotics in terms of symptom duration or the development of new or worsening symptoms .


Those with a history of significant comorbidities experienced a significantly greater reduction in symptom severity between days 2 and 4 ( interaction term -0.28 , P = 0.003 ; estimated effect of antibiotics among those with a past history -0.28 [ 95 % confidence interval = -0.44 to -0.11 ] , P = 0.001 ) , equivalent to three people in 10 rating symptoms as a slight rather than a moderately bad problem .


For subgroups not specified in advance antibiotics provided a modest reduction in symptom severity for non-smokers and for those with short prior illness duration ( < 7 days ) , and a modest reduction in symptom duration for those with short prior illness duration .


There is no clear evidence of clinically meaningful benefit from antibiotics in the studied high-risk groups of patients presenting in general practice with uncomplicated LRTIs where prescribing is highest .


Any possible benefit must be balanced against the side-effects and longer-term effects on antibiotic resistance .


Postural tachycardia syndrome ( POTS ) induces disabling chronic orthostatic intolerance with an excessive increase in heart rate ( HR ) upon standing , and many POTS patients have a hyperadrenergic state .


Medications that restrain HR are a promising approach to this problem .


We tested the hypothesis that melatonin will attenuate the tachycardia and improve symptom burden in patients with POTS .


Patients with POTS ( n = 78 ) underwent acute drug trials with melatonin 3 mg orally and placebo , on separate mornings , in a randomized crossover design .


Blood pressure , HR , and symptoms were assessed while seated and after standing for up to 10 min prior to , and hourly for 4 h following study drug administration .


The reduction in standing HR was significantly greater 2 h after melatonin compared with placebo ( P = 0.017 ) .


There was no significant difference in the reduction of systolic blood pressure between melatonin and placebo , either with standing or while seated .


The symptom burden was not improved with melatonin compared with placebo .


Oral melatonin produced a modest decrease in standing tachycardia in POTS .


Further research is needed to determine the effects of regular night-time use of this medication in POTS .


Management of AO type B and C fractures of the distal radius is controversial .


This study compares outcomes and complications of AO type B and C fractures of the distal radius treated with volar locked plating and nonoperative methods .


Sixty-four patients with fractures of the distal radius ( AO type B and C ) were included in this study , according to inclusion criteria , and were allocated to the volar plating group or nonoperative group by alternate randomization : 32 patients with odd numbers went into the nonoperative group and the other 32 with even numbers went into the volar plating group .


Patients in the nonoperative group were managed with closed reduction of the fracture and plaster cast application under an image intensifier .


Those in the volar plating group were managed by open reduction and fixation with a volar locked plate .


Preoperative and postoperative serial clinico-radiological follow-up was done .


The range of movement , grip strength , functional outcome scores and radiological parameters were compared .


Student 's t-test was used for statistical analysis with significance at p < 0.05 .


Range of movement and functional scores were significantly ( p < 0.001 ) better in the volar plating group , but the difference in ulnar variance and radial and ulnar deviation was insignificant as compared to the nonoperative group .


At 24 months follow-up , the nonoperative group had significantly more cases with malunion , articular incongruity and osteoarthritis .


In cases of AO type B or C fractures of the distal radius , volar locked plating provides anatomical stable fixation and early mobilization with better clinico-radiological outcome as compared to conservative treatment .


Ingrown toe nail is common problem presenting to the surgeon .


Partial Nail avulsion only results in recurrence of the ingrown toe nail .


The aim of this study was too see the effect of phenolization in preventing recurrence after partial nail avulsion .


This was a randomized controlled trial carried out at Department of Surgery , Pakistan Institute of Medical Sciences , Islamabad .


This study included 100 patients ( 50 in each group ) with ingrown toe nail presented from November 2009 to October 2010 .


This study compared the application of phenol after partial avulsion with partial avulsion alone in the treatment of ingrown toe nail .


Sixty-nine percent of the patients were males and 31 % were female .


The mean age in both groups was 18 years .


Patient in the partial nail avulsion with application of phenol group had less pain as compared to patient with partial nail avulsion group only .


Our study has shown that patient in phenol group had less post operative infection , spike formation and recurrence as compared to wedge resection group only .


Partial nail avulsion with phenolization is better than nartial nail avulsion only for the management of the in-growing toe nail .


A post-hoc analysis was performed to determine the relationship between the timing and magnitude of DAS28 ( ESR ) response and long term outcomes in Japanese patients after 1 year of CZP treatment .


Our analysis included 82 J-RAPID trial patients treated with CZP 200 mg and methotrexate , and 116 HIKARI trial patients treated with CZP 200 mg alone or with disease-modifying agents other than methotrexate .


Remission rates and changes in mTSS at year 1 were compared to the DAS28 ( ESR ) response at week 12 of CZP treatment .


After 1 year of treatment , remission was achieved in 41.3 % of the J-RAPID and 34.9 % of the HIKARI patients with a week 12 DAS28 ( ESR ) response of 1.2 .


In comparison , patients with a DAS28 ( ESR ) response of < 1.2 at week 12 only had a < 7 % probability of achieving remission and displayed higher change in mTSS after 1-year treatment .


The likelihood of remission and extent of radiographic progression after 1 year was associated with the week 12 DAS28 ( ESR ) response .


The DAS28 ( ESR ) response at 12 weeks could be beneficial for identifying patients that are unlikely to respond to prolonged CZP treatment .


The likelihood of an adolescent taking up smoking may be influenced by his or her society , school and family .


Thus , changes in the immediate environment may alter a young person 's perception of smoking .


The proposed multi-center , cluster-randomized controlled trial will be stratified by the baseline prevalence of smoking in schools .


Municipalities with fewer than 100,000 inhabitants will be randomly assigned to a control or intervention group .


One secondary school will be randomly selected from each municipality .


These schools will be randomized to two groups : the students of one will receive any existing educational course regarding smoking , while those of the other school will receive a four-year , class-based curriculum intervention ( 22 classroom lessons ) aimed at reinforcing a smoke-free school policy and encouraging smoking cessation in parents , pupils , and teachers .


The intervention will also include annual meetings with parents and efforts to empower adolescents to change the smoking-related attitudes and behaviors in their homes , classrooms and communities.We will enroll children aged 12-13 years as they enter secondary school during two consecutive school years ( to obtain sufficient enrolled subjects ) .


We will follow them for five years , until two years after they leave secondary school .


All external evaluators and analysts will be blinded to school allocation.The aim of this study is to analyze the effectiveness of a complex intervention in reducing the prevalence of smoking in the third year of compulsory secondary education ( ESO ) and two years after secondary school , when the participants are 14-15 and 17-18 years old , respectively .


Most interventions aimed at preventing smoking among adolescents yield little to no positive long-term effects .


This clinical trial will analyze the effectiveness of a complex intervention aimed at reducing the incidence and prevalence of smoking in this vulnerable age group .


Current Controlled Trials : NCT01602796 .


Although evidence exists for the effectiveness of web-based smoking cessation interventions , information about the cost-effectiveness of these interventions is limited .


The study investigated the cost-effectiveness and cost-utility of two web-based computer-tailored ( CT ) smoking cessation interventions ( video - vs. text-based CT ) compared to a control condition that received general text-based advice .


In a randomized controlled trial , respondents were allocated to the video-based condition ( N = 670 ) , the text-based condition ( N = 708 ) or the control condition ( N = 721 ) .


Societal costs , smoking status , and quality-adjusted life years ( QALYs ; EQ-5D-3L ) were assessed at baseline , six-and twelve-month follow-up .


The incremental costs per abstinent respondent and per QALYs gained were calculated .


To account for uncertainty , bootstrapping techniques and sensitivity analyses were carried out .


No significant differences were found in the three conditions regarding demographics , baseline values of outcomes and societal costs over the three months prior to baseline .


Analyses using prolonged abstinence as outcome measure indicated that from a willingness to pay of 1,500 , the video-based intervention was likely to be the most cost-effective treatment , whereas from a willingness to pay of 50,400 , the text-based intervention was likely to be the most cost-effective .


With regard to cost-utilities , when quality of life was used as outcome measure , the control condition had the highest probability of being the most preferable treatment .


Sensitivity analyses yielded comparable results .


The video-based CT smoking cessation intervention was the most cost-effective treatment for smoking abstinence after twelve months , varying the willingness to pay per abstinent respondent from 0 up to 80,000 .


With regard to cost-utility , the control condition seemed to be the most preferable treatment .


Probably , more time will be required to assess changes in quality of life .


Future studies with longer follow-up periods are needed to investigate whether cost-utility results regarding quality of life may change in the long run .


Nederlands Trial Register NTR3102 .


To compare the effects of two maternal feeding policies-early versus conventional oral feeding-after cesarean delivery .


This prospective multicenter randomized comparative trial was conducted at tertiary care hospitals in Sindh , Pakistan , from 2010 to 2012 .


Women with an uncomplicated cesarean delivery under spinal anesthesia were allocated to an intervention of early ( after 2 hours ) or conventional ( after 18 hours ) initiation of oral feeding .


Outcomes included maternal ambulation , maternal satisfaction , gastrointestinal functions , and length of hospital stay .


In total , 1174 women ( n = 587 per group ) were included in the final analysis .


Gastrointestinal complications were not significantly different between the two groups .


Lower intensities of thirst and hunger and a higher rate of maternal satisfaction were observed in the early feeding group ( P < 0.05 ) , and 53.8 % of women in this group were able to ambulate within 15 hours of surgery , compared with 27.9 % of women in the conventional feeding group .


The frequencies of readmission , febrile morbidity , and wound infection were insignificant .


Early oral dietary initiation after cesarean delivery resulted in early ambulation , greater maternal satisfaction , and reduced length of hospital stay , with no detrimental outcomes , making this practice cost-effective .


Hence , day-care cesarean delivery might be an option in resource-constrained settings .


ChiCTR-TRC-13003651 , http://www.chictr.org .


There is lack of well-designed trials evaluating structural benefits of non-pharmacologic therapies in knee osteoarthritis ( OA ) .


In this parallel-group randomized controlled trial , we aim to compare the possible advantages of lateral wedge insole and acupuncture in patients with medial knee OA .


Patients with grade two or three of medial knee OA were randomly allocated to group one who received an in shoe lateral wedge and group two who underwent acupuncture .


We assessed patients ' pain , function and knee joint cartilage thickness before and after intervention .


Paired t-test and independent samples t-test were used for in group and between group analyses .


2 . )


Twenty patients in each group were recruited in the study .


Pain significantly decreased after therapy in both groups one and two ( paired t test , P < 0.001 , 95 % CI : 1.62-3 .25 and 1.58-3 .20 respectively ) .


Function improved in each group ( paired t test , P = 0.001 , 95 % CI of 0.94-2 .38 in group one and 0.97-2 .43 in group two ) .


A non-clinically statistically significant difference regarding the femoral and tibial cartilage thickness was obtained in both groups one ( P = 0.005 , CI : -0.43 -0.82 and P = 0.037 , CI : -0.44 -0.80 respectively ) and two ( P = 0.025 , CI : -0.45 -0.79 and P = 0.035 , CI : -0.29 -0.96 respectively ) .


Between groups analysis showed no significant difference regarding abovementioned measures .


Both lateral wedge insole and acupuncture can be effective in the treatment of medial knee osteoarthritis without any superiority of one over the other .


Iranian Registry of Clinical Trials : IRCT201201108235N1 .


URL : http://irct.ir/searchen.php .


Glucose-insulin-potassium ( GIK ) administration during cardiac surgery inconsistently improves myocardial function , perhaps because hyperglycemia negates the beneficial effects of GIK .


The hyperinsulinemic normoglycemic clamp ( HNC ) technique may better enhance the myocardial benefits of GIK .


The authors extended previous GIK investigations by ( 1 ) targeting normoglycemia while administering a GIK infusion ( HNC ) ; ( 2 ) using improved echocardiographic measures of myocardial deformation , specifically myocardial longitudinal strain and strain rate ; and ( 3 ) assessing the activation of glucose metabolic pathways .


A total of 100 patients having aortic valve replacement for aortic stenosis were randomly assigned to HNC ( high-dose insulin with concomitant glucose infusion titrated to normoglycemia ) versus standard therapy ( insulin treatment if glucose > 150mg/dl ) .


The primary outcomes were left ventricular longitudinal strain and strain rate , assessed using speckle-tracking echocardiography .


Right atrial tissue was analyzed for activation of glycolysis/pyruvate oxidation and alternative metabolic pathways .


Time-weighted mean glucose concentrations were lower with HNC ( 12719mg/dl ) than standard care ( 17741mg/dl ; P < 0.001 ) .


Echocardiographic data were adequate in 72 patients for strain analysis and 67 patients for strain rate analysis .


HNC did not improve myocardial strain , with an HNC minus standard therapy difference of -1.2 % ( 97.5 % CI , -2.9 to 0.5 % ; P = 0.11 ) .


Strain rate was significantly better , but by a clinically unimportant amount : -0.16 s ( -0.30 to -0.03 s ; P = 0.007 ) .


There was no evidence of increased glycolytic , pyruvate oxidation , or hexosamine biosynthetic pathway activation in right atrial samples ( HNC , n = 20 ; standard therapy , 22 ) .


Administration of glucose and insulin while targeting normoglycemia during aortic valve replacement did not meaningfully improve myocardial function .


Infectious illnesses such as influenza and diarrhea are leading causes of absenteeism among Danish school children .


Interventions in school settings addressing hand hygiene have shown to reduce the number of infectious illnesses .


However , most of these studies include small populations and almost none of them are conducted as randomized controlled trials .


The overall aim of the Hi Five study was to develop , implement and evaluate a multi-component school-based intervention to improve hand hygiene and well-being and to reduce the prevalence of infections among school children in intervention schools by 20 % compared to control schools .


This paper describes the development and the evaluation design of Hi Five .


The Hi Five study was designed as a tree-armed cluster-randomized controlled trial .


A national random sample of schools ( n = 44 ) was randomized to one of two intervention groups ( n = 29 ) or to a control group with no intervention ( n = 15 ) .


A total of 8,438 six to fifteen-year-old school children were enrolled in the study .


The Hi Five intervention consisted of three components : 1 ) a curriculum component 2 ) mandatory daily hand washing before lunch 3 ) extra cleaning of school toilets during the school day .


Baseline data was collected from December 2011 to April 2012 .


The intervention period was August 2012 to June 2013 .


The follow-up data was collected from December 2012 to April 2013 .


The Hi Five study fills a gap in international research .


This large randomized multi-component school-based hand hygiene intervention is the first to include education on healthy and appropriate toilet behavior as part of the curriculum .


No previous studies have involved supplementary cleaning at the school toilets as an intervention component .


The study will have the added value of providing new knowledge about usability of short message service ( SMS , text message ) for collecting data on infectious illness and absenteeism in large study populations .


Current Controlled Trials ISRCTN19287682 , 21 December 2012 .


Bacterial screening offers the possibility of extending platelet ( PLT ) storage to Day 7 .


We conducted a noninferiority , crossover trial comparing PLTs stored for 6 or 7 days versus 2 to 5 days .


Stable hematology patients were allocated to receive blocks of 2 - to 5 - and 6 - or 7-day PLTs in random order .


The primary outcome was the proportion of successful transfusions during the first block , defined as a corrected count increment ( CCI ) of more than 4.5 at 8 to 24 hours posttransfusion .


Of 122 patients with an evaluable first block , 87 ( 71 % ) and 84 ( 69 % ) had successful transfusions after 2 - to 5 - and 6 - or 7-day PLTs of mean ( SD ) ages of 3.8 ( 1.0 ) and 6.4 ( 0.5 ) days , respectively .


Six - or 7-day PLTs were declared noninferior to 2 - to 5-day PLTs since the upper confidence interval ( CI ) limit was less than the predefined noninferiority margin of 10 % ( 95 % CI , -14.0 % to 9.1 % ; p = 0.766 ) .


Logistic regression analysis gave an adjusted odds ratio of 0.86 ( 95 % CI , 0.47-1 .58 ; p = 0.625 ) .


Mean ( SD ) 8 - to 24-hour CCIs were 9.4 ( 7.9 ) and 7.7 ( 7.1 ) after transfusion with 2 - to 5 - or 6 - or 7-day PLTs ( 95 % CI , -3.31 to 0.03 ; p = 0.054 ) .


The proportions of days with bleeding scores of WHO Grade 2 or higher were 13 % ( 38/297 days ) and 11 % ( 32/296 days ; 95 % CI , -3.2 to 7.2 ; p = 0.454 ) .


Median interval to next PLT transfusion ( 2 days ) was unaffected ( 95 % CI , -10.5 to 5.4 ; p = 0.531 ) .


In hematology patients , there was no evidence that 6 - or 7-day PLTs were inferior to 2 - to 5-day PLTs , as measured by proportion of patients with successful transfusions , bleeding events , or interval to next transfusion .


To evaluate the effect of the resin cement thickness ( RCT ) on bond strength ( BS ) and gap formation ( GF ) of fiber posts bonded to root dentin .


The roots of 24 extracted human mandibular premolars were treated endodontically and the post spaces were prepared using drills with different diameters according to the following groups ( n = 8 ) : well adapted ( WA ) , moderately well adapted ( MA ) and poorly adapted ( PA ) .


The fiber glass posts were cemented ( Excite DSC and Variolink II ) in accordance with the manufacturer 's instructions .


After 1 week , the roots were transversely sectioned into six 1-mm-thick disks and photographed using an optical microscope to determine the RCT .


After this , epoxy resin replicas of each sample were observed using SEM , and the mean length and width of the gaps formed in the cement/dentin/post interface were measured .


Finally , each sample was subjected to the push-out test ( 0.5 mm/min ) , and the data were statistically analyzed using one-way ANOVA and Tukey 's tests at the 5 % level of significance .


The lowest RCT ( m ) was observed for WA and the highest for PA. .


The group MA showed an intermediate value .


Significantly higher push-out BS values were observed for WA compared to the other groups .


The MA and PA groups were statistically similar .


The highest mean gap length ( % ) and width ( m ) were observed for PA. .


The groups MA and WA were statistically similar .


Lower resin cement thickness resulted in better fiber post adhesion , that is , in higher bond strength and less gap formation .


We assessed the effects of reduction and withdrawal of treatment in patients with rheumatoid arthritis who had a remission while receiving etanercept-plus-methotrexate therapy .


Patients with early active disease who had not previously received methotrexate or biologic therapy received 50 mg of etanercept plus methotrexate weekly for 52 weeks ( open-label phase ) .


We then randomly assigned patients who had qualifying responses at weeks 39 and 52 to receive 25 mg of etanercept plus methotrexate ( combination-therapy group ) , methotrexate alone , or placebo for 39 weeks ( double-blind phase ) .


Patients who had qualifying responses at week 39 of the double-blind phase had all treatment withdrawn at that time and were followed to week 65 ( treatment-withdrawal phase ) .


The primary end point was the proportion of patients with sustained remission in the double-blind phase .


Of 306 patients enrolled , 193 underwent randomization in the double-blind phase ; 131 qualified for the treatment-withdrawal phase .


More patients in the combination-therapy group than in the methotrexate-alone group or the placebo group met the criterion for the primary end point ( 40 of 63 [ 63 % ] vs. 26 of 65 [ 40 % ] and 15 of 65 [ 23 % ] , respectively ; P = 0.009 for combination therapy vs. methotrexate alone ; P < 0.001 for combination therapy vs. placebo ) .


At 65 weeks , 28 patients ( 44 % ) who had received combination therapy , 19 ( 29 % ) who had received methotrexate alone , and 15 ( 23 % ) who had received placebo were in remission ( P = 0.10 for combination therapy vs. methotrexate alone ; P = 0.02 for combination therapy vs. placebo ; P = 0.55 for methotrexate alone vs. placebo ) .


No significant between-group differences were observed in radiographic progression of disease .


Serious adverse events were reported in 3 patients ( 5 % ) in the combination-therapy group , 2 ( 3 % ) in the methotrexate-alone group , and 2 ( 3 % ) in the placebo group .


In patients with early rheumatoid arthritis who had a remission while receiving full-dose etanercept-plus-methotrexate therapy , continuing combination therapy at a reduced dose resulted in better disease control than switching to methotrexate alone or placebo , but no significant difference was observed in radiographic progression .


( Funded by Pfizer ; ClinicalTrials.gov number , NCT00913458 . )


Heart failure with reduced ejection fraction and obstructive sleep apnea ( OSA ) , 2 states of increased metabolic demand and sympathetic nervous system activation , often coexist .


Continuous positive airway pressure ( CPAP ) , which alleviates OSA , can improve ventricular function .


It is unknown whether this is due to altered oxidative metabolism or presynaptic sympathetic nerve function .


We hypothesized that short-term ( 6-8 weeks ) CPAP in patients with OSA and heart failure with reduced ejection fraction would improve myocardial sympathetic nerve function and energetics .


Forty-five patients with OSA and heart failure with reduced ejection fraction ( left ventricular ejection fraction 35.89.7 % [ meanSD ] ) were evaluated with the use of echocardiography and 11C-acetate and 11C-hydroxyephedrine positron emission tomography before and 6 to 8 weeks after randomization to receive short-term CPAP ( n = 22 ) or no CPAP ( n = 23 ) .


Work metabolic index , an estimate of myocardial efficiency , was calculated as follows : ( stroke volume indexheart ratesystolic blood pressureKmono ) , where Kmono is the monoexponential function fit to the myocardial 11C-acetate time-activity data , reflecting oxidative metabolism .


Presynaptic sympathetic nerve function was measured with the use of the 11C-hydroxyephedrine retention index .


CPAP significantly increased hydroxyephedrine retention versus no CPAP ( retention : +0.012 [ 0.002 , 0.021 ] versus -0.006 [ -0.013 , 0.005 ] min ( -1 ) ; P = 0.003 ) .


There was no significant change in work metabolic index between groups .


However , in those with more severe OSA ( apnea-hypopnea index > 20 events per hour ) , CPAP significantly increased both work metabolic index and systolic blood pressure ( P < 0.05 ) .


In patients with heart failure with reduced ejection fraction and OSA , short-term CPAP increased hydroxyephedrine retention , indicating improved myocardial sympathetic nerve function , but overall did not affect energetics .


In those with more severe OSA , CPAP may improve cardiac efficiency .


Further outcome-based investigation of the consequences of CPAP is warranted .


http://www.clinicaltrials.gov .


Unique identifier : NCT00756366 .


We performed a pilot study examining the safety and tolerability of valacyclovir in veterans with herpes simplex virus type 2 and hepatitis C virus ( HCV ) coinfection .


We performed a randomized double-blind , placebo-controlled , crossover clinical trial in U.S. veterans with genotype 1 HCV/herpes simplex virus type 2 coinfection .


Patients were randomized 1:1 in blocks of 10 to receive either 1 g twice-daily valacyclovir or matching placebo for 8 weeks followed by a 2-week washout phase with daily placebo .


The alternate therapy ( valacyclovir or placebo ) was given for an additional 8-week period .


Safety assessments were performed every 2 weeks .


Changes in HCV RNA and alanine aminotransferase ( ALT ) were estimated using linear mixed models ( SAS Proc Mixed ) .


Thirty patients were enrolled .


Valacyclovir was not associated with toxicity or adverse events .


ALT levels declined 6 % to 10 % ; mean HCV RNA levels were reduced 24 % ( 1.3 million IU/mL [ 0.21 log10 IU/mL ] ) during the valacyclovir phase ( P = 0.08 ) with no carryover effect observed ( P = 0.21 ) .


Valacyclovir 1 g twice daily showed no evidence of hepatotoxicity in U.S. veterans with hepatitis C.


A modest reduction in serum levels of ALT and plasma levels of HCV RNA was observed .


Leucovorin is commonly used as folate supplement in 5-fluorouracil-based chemotherapy , but needs to be converted to active 5,10-methylenetetrahydrofolate ( methyleneTHF ) intracellularly .


This provides for interindividual differences .


MethyleneTHF has recently been developed into the stable , distributable drug , Modufolin .


The aim was to compare the concentration of folate metabolites in tumor , mucosa , and plasma of patients with colon cancer after administration of Modufolin or Isovorin ( levo-leucovorin ) .


Thirty-two patients scheduled for colon resection were randomized to receive Modufolin or Isovorin at dosage of 60 or 200 mg/m .


The study drug was given as one i.v. bolus injection after anesthesia .


Plasma was collected for pharmacokinetic ( PK ) analysis before , during , and after surgery .


Tissue biopsies were collected at surgery .


Folate metabolites were analyzed by LC-MS/MS .


MethyleneTHF and THF concentrations were significantly higher in mucosa ( p < 0.01 , both dosages ) and tumors ( p < 0.01 , 200 mg/m ) after Modufolin as compared to Isovorin administration .


The results correlated with PK observations .


The Modufolin to Isovorin C ( max ) ratio for methyleneTHF was 113 at 200 mg/m and 52 at 60 mg/m ; the AUC ( last ) ratios were 17 and 9 , respectively .


The THF plasma concentrations were also higher after Modufolin administration ( C ( max ) ratio 23 , AUC ( last ) ratio 13 at 200 mg/m ; C ( max ) ratio 15 , AUC ( last ) ratio 11 at 60 mg/m ) .


Modufolin administration resulted in significantly higher methyleneTHF levels than Isovorin and may potentially increase the efficacy of 5-fluorouracil-based chemotherapy .


The results encourage further evaluation of Modufolin as a substitute to Isovorin including the potential clinical benefits .


Therapy guided by N-terminal-pro-B-type natriuretic peptide ( NT-proBNP ) levels may improve outcomes in patients with chronic heart failure ( HF ) , especially in younger patients with reduced left ventricular ejection fraction .


It remains unclear whether treatment effects persist after discontinuation of the NT-proBNP-guided treatment strategy .


Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure randomized 499 patients with HF aged60 years with left ventricular ejection fraction45 % to intensified , NT-proBNP-guided versus standard , symptom-guided therapy into prespecified age groups ( 60-74 and 75 years ) during 18 months .


A total of 329 patients ( 92 % ) alive at 18 months agreed to long-term follow-up .


HF medication was intensified to a larger extent in the NT-proBNP-guided group .


During long-term , NT-proBNP-guided therapy did not improve hospital-free ( primary end point : hazard ratio , 0.87 ; 95 % confidence interval , 0.71-1 .06 ; P = 0.16 ) or overall survival ( hazard ratio , 0.85 ; 95 % confidence interval , 0.64-1 .13 ; P = 0.25 ) but did improve HF hospitalization-free survival ( hazard ratio , 0.70 ; 95 % confidence interval , 0.55-0 .90 ; P = 0.005 ) .


Patients aged 60 to 74 years had benefit from NT-proBNP-guided therapy on the primary end point and HF hospitalization-free survival , whereas patients aged75 years did not ( P < 0.10 for interaction ) .


In landmark analysis , there was no regression to the mean after cessation of the NT-proBNP-guided strategy .


More intensified HF medication at month 12 was associated with better long-term HF hospitalization-free and overall survival .


Intensified , NT-proBNP-guided therapy did not improve the primary end point compared with symptom-guided therapy but did improve HF hospitalization-free survival .


Within the subgroup of patients aged 60 to 74 years , it improved clinical outcome including the primary end point .


These effects did not disappear after cessation of the NT-proBNP-guided strategy on the long-term .


This is possibly attributable to a more intensified HF medical therapy in the NT-proBNP-guided group .


URL : http://www.isrctn.org .


Unique identifier : ISRCTN43596477 .


Probiotics can modulate the immune system in healthy individuals and may help reduce symptoms related to respiratory infections .


The objective of the study was to investigate the effect of the probiotic strain Lactobacillus paracasei subsp .


paracasei , L. casei 431 ( Chr .


Hansen A/S ) ( hereafter , L. casei 431 ) on immune response to influenza vaccination and respiratory symptoms in healthy adults .


A randomized double-blind , placebo-controlled trial was conducted in 1104 healthy subjects aged 18-60 y at 2 centers in Germany and Denmark .


Subjects were randomly assigned to receive an acidified milk drink containing 10 ( 9 ) colony-forming units of L. casei 431 ( n = 553 ) or placebo ( n = 551 ) for 42 d.


After 21 d , subjects received the seasonal influenza vaccination .


The primary outcome was seroprotection rate ( anti-influenza antibody titers by hemagglutination inhibition ) 21 d after vaccination .


Other outcomes were seroconversion rate and mean titers , influenza A-specific antibodies and incidence , and duration and severity of upper respiratory symptoms .


Antibiotic use and use of health care resources were recorded .


There was no effect of L. casei 431 on immune responses to influenza vaccination .


Generalized linear mixed modeling showed a shorter duration of upper respiratory symptoms in the probiotic group than in the placebo group ( mean SD : 6.4 6.1 vs. 7.3 9.7 d , P = 0.0059 ) in the last 3 wk of the intervention period .


No statistically significant differences were found for incidence or severity .


Daily consumption of L. casei 431 resulted in no observable effect on the components of the immune response to influenza vaccination but reduced the duration of upper respiratory symptoms .


The trial was registered at www.isrctn.com as ISRCTN08280229 .


Influenza vaccination is recommended for inflammatory bowel disease ( IBD ) patients on immunosuppressive therapy .


The objective was to evaluate the antibody and cell-mediated immune response to the split and whole virion influenza vaccine in patients with IBD treated with anti-TNF - and immunosuppressive therapy .


One hundred and fifty-six immunocompromised IBD patients were vaccinated .


Fifty-three patients ( control group ) refused vaccination .


Split virion vaccine and whole virion vaccine were used .


Serum samples were obtained for pre - and postimmunization antibody titers to influenza vaccine ( A/California/7 / 2009 [ H1N1 ] , A/Victoria/361 / 2011 [ H3N2 ] , B/Wisconsin/1 / 2010-like B/Hubei-Wujiagang/158 / 2009 ) .


Cell-mediated response was evaluated using an interferon ( INF ) - , interleukine ( IL ) -2 and tumor necrosis factor ( TNF ) - ELISA .


Postimmunization titers of both influenza subtypes increased significantly after the administration of split virion vaccines compared to the controls and to those who received whole virion vaccine .


The antibody titers of Influenza B also increased significantly in patients immunized with split vaccine and treated with anti-TNF - therapy .


After influenza vaccination , the level of serum IL-2 significantly decreased .


No serious side effects developed occurred after influenza vaccination , and the influenza-like symptoms did not differ significantly between vaccinated versus control patients .


The relapse of the disease was observed in only 10 % of the patients and was more common in vaccinated than in control subjects .


Split virion vaccines seem to be more effective than whole virion vaccines .


Measuring the antibody responses is worthwhile in patients treated with immunosuppressants to determine the efficacy of influenza vaccination .


Bevacizumab improves outcome for patients with advanced colorectal cancer ( CRC ) when added to chemotherapy .


The HORIZON I trial resulted in similar outcome with bevacizumab or cediranib , a small-molecule tyrosine kinase inhibitor of vascular endothelial growth factor ( VEGF ) receptor , as treatment of advanced CRC .


The spectrum of lactate dehydrogenase ( LDH ) isoenzyme expression was examined in serum samples of HORIZON I participants to identify biomarkers predictive of efficacy of VEGF pathway inhibitors .


Total LDH levels , as well as LDH isoenzyme levels in frozen baseline serum samples , were retrospectively evaluated .


Total LDH serum levels measured during the study , progression-free survival ( PFS ) , and overall survival ( OS ) were available from the HORIZON I study data .


Total LDH levels measured in the frozen serum samples correlated with those measured in fresh samples .


The expected reciprocal correlation was found between hypoxic and oxic LDH isoenzymes .


High total LDH correlated with shorter PFS , and high hypoxia-related LDH isoenzymes correlated with shorter PFS and OS .


The difference in outcome of the cediranib-treated patients vs. those treated with bevacizumab was not substantially different in the various LDH isoform expression subgroups .


In patients with a hypoxic LDH pattern of expression , there was a nonsignificant trend of better outcome in cediranib-treated patients .


Evaluation of total LDH and its isoforms in frozen serum samples is feasible .


High total LDH and high hypoxic LDH isoenzymes were associated with poor prognosis .


Further studies are needed to evaluate the predictive value of LDH isoenzyme expression pattern for VEGF-pathway inhibition efficacy .


The aim of this study was to evaluate the clinical outcomes of intrastromal MyoRing ( Dioptex , GmbH , Linz , Austria ) implantation at 2 different depths of 250 and 300 m.


This was a prospective interventional randomized controlled trial , a pilot study .


Keratoconic patients with keratometry values between 48 and 52 diopters were randomly divided into 2 groups .


A continuous intrastromal corneal ring of the same size was implanted at 2 different stromal depths of 250 m ( group 1 ) and 300 m ( group 2 ) using femtosecond laser technology for both groups .


Visual and refractive outcomes , keratometry , corneal biomechanical characteristics , and higher order aberrations were compared at the 1-year postoperative follow-up .


In both groups , uncorrected distance visual acuity significantly improved after MyoRing implantation , whereas neither of these showed any improvement in the corrected distance visual acuity .


In addition , the mean central keratometry and spherical and cylindrical refraction reduced significantly in both groups , and spherical aberration increased significantly in both groups .


On one hand , coma was reduced almost significantly in both groups , and on the other hand , corneal hysteresis and corneal resistance factor did not change significantly after the operation .


None of the patients in both groups had intraoperative or postoperative complications .


There were no differences observed in any of the measured variables of the 2 study groups .


An implantation depth of 250 m has comparable outcomes with the previously applied 300-m implantation depth .


It may be appropriate for selected cases of keratoconus with lower pachymetry .


Taxane-based adjuvant chemotherapy is standard in node-positive ( N + ) early breast cancer ( BC ) .


The magnitude of benefit in intermediate-risk N + early BC is still unclear .


WSG-AGO epiribicine and cyclophosphamide ( EC ) - Doc is a large trial evaluating modern taxane-based chemotherapy in patients with 1-3 positive lymph nodes ( LNs ) only .


A total of 2011 BC patients ( 18-65 years , pN1 ) were entered into a randomized phase III trial comparing 4 E90C600 q3w followed by 4 docetaxel 100 q3w ( n = 1008 ) with the current standard : 6 F500E100C500 q3w ( n = 828 ) or C600M40F600 d1 , 8 q4w ( n = 175 ) .


Primary end point was event-free survival ( EFS ) ; secondary end points were overall survival ( OS ) , toxicity , translational research , and quality of life .


Central tumor bank samples were evaluable in a representative collective ( n = 772 ; 40 % ) .


Ki-67 was assessed centrally in hormone receptor-positive disease as a surrogate marker for the distinction of luminal A/B-like tumors .


Baseline characteristics were well balanced between study arms in both main study and central tumor bank subset .


At 59-month median follow-up , superior efficacy of EC-Doc [ versus FEC ( a combination of 5-fluorouracil , epirubicin , and cyclophosphamide ) ] was seen in EFS and OS : 5-year EFS : 89.8 % versus 87.3 % ( P = 0.038 ) ; 5-year OS : 94.5 % versus 92.8 % ( P = 0.034 ) ; both tests one-tailed .


EC-Doc caused more toxicity .


In hormone receptor-positive ( HR ) + disease , only high-Ki-67 tumors ( 20 % ) derived significant benefit from taxane-based therapy : hazard ratio = 0.39 ( 95 % CI 0.18-0 .82 ) for EC-Doc versus FEC ( test for interaction ; P = 0.01 ) .


EC-Doc significantly improved EFS and OS versus FEC in intermediate-risk BC ( 1-3 LNs ) within all subgroups as defined by local pathology .


In HR + disease , patients with luminal A-like tumors may be potentially over-treated by taxane-based chemotherapy .


ClinicalTrials.gov , NCT02115204 .


To clarify whether the results of repair of a complex mitral lesion ( Barlow valve ) at the intermediate-term follow-up are independent of the mode of surgical access [ minithoracotomy vs. median sternotomy ( MS ) ] .


In a prospective randomized study of mitral repair for Barlow disease using either a minimally invasive ( MI ) approach or MS , we achieved an average follow-up of 3 years ( echocardiography , physical examination and quality of life ) .


Mitral repair was achieved with polytetrafluoroethylene chordal implantation for both leaflets .


Both groups included 80 patients .


Mechanical ventilation time and intensive care unit and hospital stay were shorter in the MI group ( p = 0.01 , p = 0.013 and p = 0.02 , respectively ) .


During the follow-up , 5 patients in each group ( 6.25 % ) displayed mild mitral regurgitation , while 2 patients in each group ( 2.5 % ) developed recurrent regurgitation graded as at least moderate/severe .


The rate of mitral reoperation was 2.5 % in the MI group and 1.25 % in the MS group ( p = 0.9 ) .


The overall follow-up mortality was 3.75 % in both the MI and the MS groups .


The 3-year results of repair of Barlow valves were satisfactory irrespective of the approach used to repair the valve .


The advantages of MI surgery can be achieved in patients with mitral Barlow disease without concerns over the durability of repair .


To study the clinical value of the preeclampsia risk assessment system , and to explore the preventive effect of Qiju Dihuang Oral Liquid ( QDOL ) on preeclampsia patients .


Totally 2 000 pregnant women in the gestational week 16 -20 were equally assigned to Group A and Group B by randomized sampling .


Their preeclampsia incidence was respectively assessed by preeclampsia risk assessment system and mean arterial pressure method .


Of them , 200 pregnant women at predicted high risk of preeclampsia were assigned to the control group and the treatment group , 100 in each group .


All received routine treatment .


Patients in the treatment group additionally took QDOL , 10 mL each time , twice daily ; 2 consecutive weeks per month for totally 2 weeks ; lasting for six consecutive courses or ending according to the therapeutic course .


The incidence was observed and compared between the two groups .


The predicted coincidence rate of the risk assessment system was 72.3 % , higher than that of mean arterial pressure method ( 50.5 % , P < 0.05 ) .


The incidence rate of the treatment group was 32.0 % , lower than that of the control group ( 46.0 % , P < 0.05 ) .


The preeclampsia risk assessment system was more accurate .


QDOL could lower the incidence of preeclampsia as intervention .


To compare the efficacy of two modes of delivery of information for patients undergoing functional endoscopic sinus surgery : website and printed leaflet .


A two-centre , prospective , single-blinded , randomised , controlled trial was conducted , comparing mode of information delivery .


Adult patients were randomly allocated to receive pre-operative information regarding functional endoscopic sinus surgery , either via a website or a printed leaflet .


Primary outcomes , measured by questionnaire , were : readability , usability and recall of complications .


Fifty-eight patients were recruited .


Fifty met the inclusion criteria , of which 40 were analysed in the study ( 20 patients per group ) , meeting the power criteria set .


There were 18 male and 22 female patients , ranging in age from 21 to 76 years ( mean , 47 years ) .


Patients found both the printed leaflet and the website readable , and were satisfied with the usability of both modes .


There were similar rates for recall of complications in both study arms .


Patient information on functional endoscopic sinus surgery can be provided either as a printed leaflet or a website , with similar rates for usability , readability and recall of complications .


These findings could help tailor the provision of pre-operative information for patients undergoing functional endoscopic sinus surgery , based on patient preference .


Phenolization is often used to treat ingrown toenails .


Alcohol lavage with or without supplemental chlorhexidine may be used to remove residual phenol , which can contribute to side effects such as persistent oozing or drainage .


We sought to compare the effectiveness in removing residual phenol of lavage with alcohol plus chlorhexidine versus alcohol alone .


We studied 80 patients who underwent unilateral phenol matricectomy : 40 who received irrigation with alcohol alone and 40 who received irrigation with alcohol plus chlorhexidine .


Phenol levels were measured after each of 5 rounds of 3-mL irrigations .


After the first irrigation , an average of 44.92 % and 38.35 % of the phenol remained in the nailfold in the alcohol and the alcohol/chlorhexidine groups , respectively ( P < .05 ) .


After all 5 irrigations , no difference in efficacy between the 2 solutions was found ( P > .005 ) .


It was not possible to calculate the quantity of phenol initially introduced into the nail bed .


The percentage remaining was calculated from the total amount of phenol recovered .


When a single irrigation step is performed after phenolization , alcohol plus chlorhexidine is more effective than alcohol alone for removing residual phenol .


When multiple irrigations are performed , the 2 solutions are equally effective .


This study aimed to investigate the clinical significance of 3-dimensional ( 3D ) reconstruction of peripancreatic vessels for patients with suspected pancreatic cancer ( PC ) .


A total of 89 patients with PC were included ; 60 patients randomly underwent computed tomographic angiography .


Based on the findings of 3D reconstruction of peripancreatic vessels , the appropriate method for individualized tumor resection was determined .


These patients were compared with 29 conventionally treated patients with PC .


The rate of visualization was 100 % for great vessels around the pancreas .


The detection rates for anterior superior pancreaticoduodenal artery , posterior superior pancreaticoduodenal artery , anterior inferior pancreaticoduodenal artery , posterior inferior pancreaticoduodenal artery , dorsal pancreatic artery , superior marginal arterial branch of the pancreatic head , anterior superior pancreaticoduodenal vein , posterior superior pancreaticoduodenal vein , anterior inferior pancreaticoduodenal vein , and posterior inferior pancreaticoduodenal vein were 86.6 % , 85.0 % , 76.6 % , 71.6 % , 91.6 % , 53.3 % , 61.6 % , 55.0 % , 43.3 % , and 51.6 % , respectively .


Forty-three patients who had undergone 3D reconstruction underwent surgery .


Of the 29 conventionally treated patients , 19 underwent surgery .


The operative time , blood loss , length of hospital stay , and complication incidence of the 43 patients were superior to that of the 19 patients .


A peripancreatic vascular reconstruction can reveal the vascular anatomy , variations of peripancreatic vascular , and tumor-induced vascular changes ; the application of the simulation surgery platform could reduce surgical trauma and decrease operative time .


This study aims to evaluate the efficacy and safety of - lipoic acid in the treatment of aged type 2 diabetes mellitus ( T2DM ) complicated with acute cerebral infarction .


90 patients were randomly divided into two groups , on the basis of conventional treatment .


The experiment group was administrated with - lipoic acid , while only Vitamin C for the control group , for 3 consecutive weeks .


Before and after the experiment , superoxide dismutase ( SOD ) , glutathione peroxidase ( GSH-Px ) and malondialdehyde ( MDA ) levels were measured and scored with the NIHSS ( National Institutes of Health Stroke Scale ) , and the changes of blood glucose , insulin function and other indicators were observed .


After the treatment , the plasma SOD and GSH-Px levels increased , while MDA decreased ( p < 0.05 ) , with statistical significance when compared with the control group ( p < 0.01 ) .


NIHSS score , blood glucose , blood lipids and HOMA-IA of the experiment group decreased significantly ( p < 0.01 ) ; and no significant adverse reactions were found in both groups .


- lipoic acid was safe and effective in the treatment of aged T2DM complicated with acute cerebral infarction , significantly reducing the patient 's oxidative stress , blood glucose and lipid levels and being able to improve islet function .


Several provincial and federal bills have recommended various forms of menu labelling that would require information beyond just calories ; however , the additional benefit of including sodium information is unknown .


The objective of this study was to determine whether sodium information on menus helps consumers make lower-sodium choices and to understand what other factors influence the effect of menu labelling on consumers ' meal choices .


A total of 3,080 Canadian consumers completed an online survey that included a repeated measures experiment in which consumers were asked to select what they would typically order from four mock-restaurant menus .


Subsequently , consumers were randomly allocated to see one of three menu-labelling treatments ( calories ; calories and sodium ; or calories , sodium and serving size ) and were given the option to change their order .


There was a significant difference in the proportion of consumers who changed their order , varying from 17 % to 30 % , depending on the restaurant type .


After participants had seen menu labelling , sodium levels decreased in all treatments ( p < 0.0001 ) .


However , in three of the four restaurant types , consumers who saw calorie and sodium information ordered meals with significantly less sodium than consumers who saw only calorie information ( p < 0.01 ) .


Consumers who saw sodium labelling decreased the sodium level of their meal by an average of 171-384 mg , depending on the restaurant .


In the subset of consumers who saw sodium information and chose to change their order , sodium levels decreased by an average of 681-1 ,360 mg , depending on the restaurant .


Sex , intent to lose weight and the amount of calories ordered at baseline were the most important predictors of who used menu labelling .


Eighty percent of survey panelists wanted to see nutrition information when dining out .


Including sodium information alongside calorie information may result in a larger decrease in the amount of sodium ordered by restaurant-goers .


A widened electrocardiographic spatial QRS-T angle has been shown to be predictive of cardiovascular disease in HIV-infected individuals .


However , determinants and risk factors of developing widened QRS-T angle over time in this population remain unknown .


Spatial QRS-T angle was automatically measured from standard electrocardiogram of 1444 HIV-infected individuals without baseline widened spatial QRS-T angle from the Strategies for Management of Antiretroviral Therapy [ SMART ] , a clinical trial comparing two antiretroviral treatment strategies [ Drug Conservation ( DC ) vs. Viral Suppression ( VS ) ] .


Conditional logistic regression analysis was used to examine the association between baseline characteristics and incident widened spatial QRS-T angle ( a new angle > 93 in males and > 74 in females ) .


During 2544 person-years of follow-up , 199 participants developed widened angle at a rate of 7.8 per 100 person-years .


In unadjusted models , female sex , black race ( vs. white ) , DC treatment strategy , current and past smokers ( vs. never ) , history of alcohol abuse , greater body mass index , history of diabetes and higher levels of hs-C-reactive protein were associated with incident widened spatial QRS-T angle .


When these variables were entered together in the same model with adjustment for demographics and treatment strategy , DC treatment strategy [ OR ( 95 % CI ) : 1.50 ( 1.09 , 2.07 ) ] , female gender [ 1.69 ( 1.17 , 2.45 ) ] , current and past smoking ( vs. never ) [ 2.49 ( 1.63 , 3.81 ) and 1.93 ( 1.21 , 3.09 ) , respectively ] , and diabetes [ 2.28 ( 1.33 , 3.91 ) ] predicted incident widened spatial QRS-T angle .


Drug conservation treatment strategy , female gender , smoking , and diabetes are independently predictive of incident widened spatial QRS-T angle in HIV-infected individuals .


Empagliflozin is a potent , oral , selective inhibitor of sodium glucose cotransporter 2 in development for the treatment of type 2 diabetes mellitus .


The goal of these studies was to investigate potential drug-drug interactions between empagliflozin and gemfibrozil ( an organic anion-transporting polypeptide 1B1 [ OATP1B1 ] / 1B3 and organic anion transporter 3 [ OAT3 ] inhibitor ) , rifampicin ( an OATP1B1/1B3 inhibitor ) , or probenecid ( an OAT3 and uridine diphosphate glucuronosyltransferase inhibitor ) .


Two open-label , randomized , crossover studies were undertaken in healthy subjects .


In the first study , 18 subjects received the following in 1 of 2 randomized treatment sequences : a single dose of empagliflozin 25 mg alone and gemfibrozil 600 mg BID for 5 days with a single dose of empagliflozin 25 mg on the third day .


In the second study , 18 subjects received a single dose of empagliflozin 10 mg , a single dose of empagliflozin 10 mg coadministered with a single dose of rifampicin 600 mg , and probenecid 500 mg BID for 4 days with a single dose of empagliflozin 10 mg on the second day in 1 of 6 randomized treatment sequences .


In the gemfibrozil study , 11 subjects were male , mean age was 35.1 years and mean body mass index ( BMI ) was 23.47 kg/m ( 2 ) .


In the rifampicin/probenecid study , 10 subjects were male , mean age was 32.7 years and mean BMI was 23.03 kg/m ( 2 ) .


Exposure to empagliflozin was increased by coadministration with gemfibrozil ( AUC0 - : geometric mean ratio [ GMR ] , 158.50 % [ 90 % CI , 151.77-165 .53 ] ; Cmax : GMR , 115.00 % [ 90 % CI , 106.15-124 .59 ] ) , rifampicin ( AUC0 - : GMR , 135.20 % [ 90 % CI , 129.58-141 .06 ] ; Cmax : GMR , 175.14 % [ 90 % CI , 160.14-191 .56 ] ) , and probenecid ( AUC0 - : GMR , 153.47 % [ 90 % CI , 146.41-160 .88 ] ; Cmax : GMR , 125.60 % [ 90 % CI , 113.67-138 .78 ] ) .


All treatments were well tolerated .


Increases in empagliflozin exposure were < 2-fold , indicating that the inhibition of the OATP1B1/1B3 , OAT3 transporter , and uridine diphosphate glucuronosyltransferases did not have a clinically relevant effect on empagliflozin exposure .


No dose adjustments of empagliflozin were necessary when it was coadministered with gemfibrozil , rifampicin , or probenecid .


ClinicalTrials.gov identifiers : NCT01301742 and NCT01634100 .


Prostaglandins that constrict and relax airways are synthesized in reactions catalyzed by either COX-1 or COX-2 .


It is not known whether selective inhibition of COX-2 makes asthmatic responses better or worse .


To determine the effects of the selective COX-2 inhibitor , etoricoxib , on allergen-induced bronchoconstriction in asthmatic subjects .


Sixteen subjects with mild atopic asthma underwent rising dose inhalation challenges with allergen or methacholine to determine PD20 FEV1 during a control study period or after 10 to 13 days of treatment with etoricoxib ( 90 mg once daily ) .


The order of study periods was randomized with at least 2-week washout periods .


Induced sputum cells and fractional exhaled nitric oxide levels were used to assess airway inflammation and blood assays for COX-1 and COX-2 activity to assess enzyme inhibition .


Urinary excretion of lipids was used to assess prostaglandin biosynthesis .


Etoricoxib did not change baseline lung function , nor airway responsiveness to allergen or to methacholine .


Neither were the allergen-induced increase in sputum eosinophils and fractional exhaled nitric oxide levels affected by treatment .


The biochemical effectiveness of the treatment was established both in the blood assays and by the distinct inhibitory effect of etoricoxib on urinary excretion of tetranor-prostaglandin E2 ( P < .001 ) .


This first study of COX-2 inhibition in provoked asthma found no negative effects of etoricoxib on allergen-induced airflow obstruction and sputum eosinophils , basal lung function , or methacholine responsiveness .


The study suggests that short-term use of COX-2 inhibitors is safe in subjects with asthma .


Higher body mass index is linked to lower prostate specific antigen .


This has given rise to concerns that prostate specific antigen may be less reliable for predicting prostate cancer among obese men .


We tested the accuracy of prebiopsy prostate specific antigen for predicting prostate cancer across body mass index categories .


We used the REDUCE study , which tested dutasteride for prostate cancer risk reduction in men with a prostate specific antigen of 2.5 to 10.0 ng/ml and a negative pre-study biopsy .


All men were required to have a biopsy at 2 and 4 years independent of prostate specific antigen .


We assessed the performance of prebiopsy prostate specific antigen to predict overall and high grade prostate cancer ( Gleason sum 7 or greater ) in each body mass index group using AUC .


Of 6,103 men who had a 2-year biopsy 1,646 ( 27 % ) were normal weight , 3,209 ( 53 % ) were overweight and 1,248 ( 20 % ) were obese .


Mean adjusted prostate specific antigen for normal weight , overweight and obese subjects on placebo was 7.73 , 7.17 and 6.79 ng/ml ( p-trend = 0.192 ) , and on dutasteride 3.16 , 2.93 and 2.62 ng/ml ( p = 0.008 ) .


AUC analysis using raw prostate specific antigen data for predicting prostate cancer ranged from 0.60 to 0.64 in the placebo arm and 0.58 to 0.66 in the dutasteride arm with no difference across body mass index categories ( p-interactions 0.212 ) .


Similar results were found for high grade prostate cancer with AUC ranging from 0.69 to 0.70 in the placebo arm and 0.65 to 0.75 in the dutasteride arm but no differences across body mass index categories ( p-interactions 0.157 ) .


Among men with a previous negative biopsy the accuracy of prebiopsy prostate specific antigen to predict overall and high grade prostate cancer was independent of body mass index .


To observe the clinical effect of acupoint heat-sensitive moxibustion for acut knee arthralgia and to analyze its effect on serum osteopontin ( OPN ) and matrix metalloproteinase-3 ( MMP-3 ) contents in patients with knee osteoarthritis so as to study its mechanism underlying improving arthralgia .


One hundred and forty-four patients with acute knee knee osteoarthritis were randomly allocated to acupoint heat-sensitive moxibustion ( moxibustion ) , electroacupuncture ( EA ) and medication groups .


Patients of the moxibustion group were treated by suspended moxibustion over bilateral Weizhong ( BL 40 ) for 40 min each point , once daily for 15 days .


Patients of the EA group were treated by EA stimulation of Neixiyan ( EX-LE 4 ) , Dubi ( ST 35 ) , Xuehai ( SP 10 ) and Liangqiu ( ST 34 ) for 30 min , once daily for 15 days ; and those of the medication group treated by oral administration of Sanqi Tongshu capsules ( Panax Notoginseng , etc. used for promoting blood circulation and removing blood stasis ) , 3 times daily for 15 days .


Serum OPN and MMP-3 levels were detected with ELISA .


Following the treatment , of the 50 , 50 and 44 cases in the moxibustion , EA and medication groups , 24 , 20 and 14 were excellent , 18 , 16 and 13 were good in therapeutic effect , 7 , 4 , and 3 were effective , and 1 , 10 , and 14 invalid , with the excellent and good rates being 84 % , 72.0 % and 61.4 % , respectively .