In a low-risk population , the noninferiority hypothesis of 6 vs. 12 months DAPT following second-generation DES implantation appears accepted for the incidence of cardiac death , MI , stroke , definite/probable stentthrombosis , and BARC type 3 or 5 bleeding at 12 months .


( Second Generation Drug-Eluting Stent Implantation Followed by Six - Versus Twelve-Month Dual Antiplatelet Therapy ; NCT00944333 ) .


Lafutidine is a new H2-blocker in India claimed to be more potent and effective than existing H2-blockers .


Proton pump inhibitors ( PPIs ) , by virtue of their mechanism of action , have greater efficacy than H2-blockers in gastric acid suppression .


However , clinical trials comparing H2-blockers directly with PPIs are limited .


We carried out a head-to-head comparison of the effectiveness of lafutidine versus the PPI pantoprazole in uninvestigated dyspepsia [ CTRI/2013/12 / 004261 ] .


A prospective , open label , randomized , controlled trial was conducted in a tertiary care hospital .


Ambulatory adult patients with dyspepsia , not yet subjected to endoscopy , were recruited if they had at least moderately severe symptoms , defined as a score of 4 on a 7-point Global Overall Symptom ( GOS ) Scale .


Those with alarm features or significant comorbidity were excluded .


Subjects received either once daily lafutidine 10 mg or pantoprazole 40 mg , orally , for 8 weeks .


Reflux , dysmotility and pain scores were assessed by Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease ( mFSSGERD ) , and quality of life ( QoL ) by SF-8 scale .


The latter had physical and mental components summarized by physical component summary score ( PCS ) and a mental component summary score ( MCS ) .


Of 122 patients enrolled , data of 57 on lafutidine and 60 on pantoprazole were analyzed .


At 4 weeks , proportion of subjects responding ( GOS score 2 ) in the two arms ( lafutidine 45.61 % vs. pantoprazole 48.33 % , P = 0.854 ) or showing symptom resolution ( GOS score 1 ) ( lafutidine 12.28 % vs. pantoprazole 5.00 % ; P = 0.197 ) were comparable .


Similarly at 8 weeks , both responder ( lafutidine 52.63 % vs. pantoprazole 56.67 % ; P = 0.712 ) and symptom resolution proportions ( lafutidine 33.33 % vs. pantoprazole 30 % ; P = 0.843 ) were comparable .


Total score on mFSSGERD scale , as well as all its three component scores , and PCS and MCS scores on QoL SF-8 scale showed improvement but no statistically significant difference between the two arms .


Tolerability of both drugs was excellent .


Lafutidine is well-tolerated and there is no clinically worthwhile difference between the two drugs in the empirical treatment of uninvestigated dyspepsia .


An increasing number of patients with heart failure receive implantable cardioverter-defibrillators ( ICDs ) or cardiac resynchronisation defibrillators ( CRT-Ds ) with telemonitoring function .


Early detection of worsening heart failure , or upstream factors predisposing to worsening heart failure , by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes , but the evidence is weak .


We investigated this possibility in IN-TIME , a clinical trial .


We did this randomised , controlled trial at 36 tertiary clinical centres and hospitals in Australia , Europe , and Israel .


We enrolled patients with chronic heart failure , NYHA class II-III symptoms , ejection fraction of no more than 35 % , optimal drug treatment , no permanent atrial fibrillation , and a recent dual-chamber ICD or CRT-D implantation .


After a 1 month run-in phase , patients were randomly assigned ( 1:1 ) to either automatic , daily , implant-based , multiparameter telemonitoring in addition to standard care or standard care without telemonitoring .


Investigators were not masked to treatment allocation .


Patients were masked to allocation unless they were contacted because of telemonitoring findings .


Follow-up was 1 year .


The primary outcome measure was a composite clinical score combining all-cause death , overnight hospital admission for heart failure , change in NYHA class , and change in patient global self-assessment , for the intention-to-treat population .


The trial is registered with ClinicalTrials.gov , number NCT00538356 .


We enrolled 716 patients , of whom 664 were randomly assigned ( 333 to telemonitoring , 331 to control ) .


Mean age was 655 years and mean ejection fraction was 26 % .


285 ( 43 % ) of patients had NYHA functional class II and 378 ( 57 % ) had NYHA class III .


Most patients received CRT-Ds ( 390 ; 587 % ) .


At 1 year , 63 ( 189 % ) of 333 patients in the telemonitoring group versus 90 ( 272 % ) of 331 in the control group ( p = 0013 ) had worsened composite score ( odds ratio 063 , 95 % CI 043-090 ) .


Ten versus 27 patients died during follow-up .


Automatic , daily , implant-based , multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure .


Such telemonitoring is feasible and should be used in clinical practice .


Biotronik SE & Co. .


KG .


The aim of this prospective randomized trial was to compare operative factors , postoperative outcomes , and surgical complications of neck dissection ( ND ) when using the harmonic scalpel ( HS ) versus conventional haemostasis ( CH ) ( classic technique of tying and knots , resorbable ligature , and bipolar diathermy ) .


Sixty-one patients who underwent ND with primary head and neck cancer ( HNSCC ) resection were enrolled in this study and were randomized into two homogeneous groups : CH ( conventional haemostasis with classic technique of tying and knots , resorbable ligature , and bipolar diathermy ) and HS ( haemostasis with harmonic scalpel ) .


Outcomes of the study included operative time , intraoperative blood loss , drainage volume , postoperative pain , hospital stay , and incidence of intraoperative and postoperative complications .


The use of the HS reduced significantly the operating time , the intraoperative blood loss , the postoperative pain , and the volume of drainage .


No significant difference was observed in mean hospital stay and perioperative , and postoperative complications .


The HS is a reliable and safe tool for reducing intraoperative blood loss , operative time , volume of drainage and postoperative pain in patients undergoing ND for HNSCC .


Multicenter randomized studies need to be done to confirm the advantages of this technique and to evaluate the cost-benefit ratio .


Pregnancy and lactation in adolescents with low calcium intake may impair fetal growth and infant bone mass .


We investigated the effects of calcium plus vitamin D supplementation during pregnancy in Brazilian adolescent mothers consuming low calcium diets ( 600 mg/d ) on fetal biometry and infant bone mass , and the relation between infant and maternal bone mass during early lactation .


Infants of mothers who received calcium ( 600 mg/d ) plus cholecalciferol ( 200 IU/d ) supplementation ( n = 30 ) or placebo ( n = 26 ) from 26 wk of gestation until parturition were studied .


Fetal biometric measurements at 23 and 36 wk of gestation were obtained from medical records .


Infant anthropometric and total body bone measurements [ bone mineral content ( BMC ) , bone area ( BA ) , and bone mineral density ( BMD ) ] at 5 wk postpartum were assessed by dual-energy X-ray absorptiometry .


Maternal BMD z scores for total body , lumbar spine , total hip , and femoral neck at 5 wk postpartum were obtained .


Group comparisons were adjusted for significant covariates .


Maternal mean serum 25-hydroxyvitamin D was 59 nmol/L at baseline in both groups .


No differences in fetal measurements at 36 wk of gestation were observed between the groups , except for body weight and its increment from 23 to 36 wk , which were higher in the supplemented group ( 6.8 % , P = 0.014 and 10.5 % , P = 0.07 , respectively ) .


Infant BMC ( 61.1 21.7 g ) , BA ( 167 79 cm ( 2 ) ) , and BMD ( 0.385 0.069 g/cm ( 2 ) ) did not significantly differ between the groups .


In the placebo group , infant BMC and BA were negatively correlated with maternal BMD z scores for total body ( r = -0.40 and r = -0.47 ; P < 0.05 ) and hip ( r = -0.41 and r = -0.46 ; P < 0.05 ) .


In contrast , no correlations were observed in the supplemented group .


Calcium and vitamin D supplementation of the adolescents studied resulted in higher fetal body weight at 36 wk of gestation and had no effect on infant bone mass at 5 wk postpartum .


Because correlations between maternal and infant bone mass were evident only in the placebo group , infant bone mass appeared to be more dependent on maternal skeletal mass when calcium intake was low .


This trial was registered at clinicaltrials.gov as NCT01732328 .


Skill readiness remains a challenge for all health care professionals who are involved in direct patient care .


Researchers suggest that skill retention may decrease within 6 months of an educational session .


The purpose of this study was to explore competency retention for high-risk , low-frequency procedures , specifically , managing a difficult airway and placing a laryngeal mask airway , using a web-based content refresher .


The pilot study was conducted in two sessions .


Session one established clinical skill competency .


Six months later , the advanced practice RNs were randomized into two groups .


Group 1 reviewed didactic content and participated in a complex airway management simulation .


Group 2 participated only in a complex airway management simulation .


This study showed a positive trend in maintaining competency for a low-frequency procedure for which complex airway management was given , using web-based content review .


It is feasible to maintain competency for low-frequency procedures using web-based content refreshers .


This pilot study benefited advanced practice nurses by providing them with the potential to maintain competency in this high-risk , low-frequency procedure .


Continuing education is an important consideration for health care organizations .


Breast cancer accounts for almost 30 % of all cancers and is the second leading cause of cancer deaths in women in Scotland .


Screening is key to early detection .


The Scottish Breast Screening Programme is a nationwide , free at point of delivery screening service , to which all women aged between 50 and 70 years are invited to attend every 3 years .


Currently over three-quarters of invited women regularly attend screening .


However , women from more deprived areas are much less likely to attend : for example in the 3 years from 2010-2012 only 63 % of women in the most deprived area attended the East of Scotland Breast Screening programme versus 81 % in the least deprived .


Research has suggested that reminders ( telephone or letter ) and brief , personalised interventions addressing barriers to attendance may be helpful in increasing uptake in low-income women .


We will employ a brief telephone reminder and support intervention , whose purpose is to elicit and address any mistaken beliefs women have about breast screening , with the aim that the perceived benefits of screening come to outweigh any perceived barriers for individuals .


We will test whether this intervention , plus a simple anticipated regret manipulation , will lead to an increase in the uptake of breast cancer screening amongst low-income women who have failed to attend a first appointment , in a randomised controlled trial with 600 women .


Participants will be randomly allocated to one of four treatment arms i.e. 1 ) Letter reminder ( i.e. Treatment as usual : CONTROL ) ; 2 ) Telephone reminder ( TEL ) , 3 ) Telephone reminder plus telephone support ( TEL-SUPP ) and 4 ) Telephone reminder plus support plus AR ( TEL-SUPP-AR ) .


The primary outcome will be attendance at breast screening within 3 months of the reminder letter .


If this simple telephone support intervention ( with or without AR intervention ) leads to a significant increase in breast screening attendance , this would represent a rare example of a theoretically-driven , relatively simple psychological intervention that could result in earlier detection of breast cancer amongst an under-served group of lower socio-economic women .


Current Controlled trials : ISRCTN06039270 .


Registered 16th January 2014 .


Brief physician counselling has been shown to be effective in improving smokers ' behaviour .


If the counselling sessions can be given at the workplace , this would benefit a larger number of smokers .


This study aimed to determine the effectiveness of a ten-minute physician counseling session at the workplace in improving smoking behaviour .


This prospective randomised control trial was conducted on smokers in a factory .


A total of 163 participants were recruited and randomised into control and intervention groups using a table of random numbers .


The intervention group received a ten-minute brief physician counselling session to quit smoking .


Stages of smoking behaviour were measured in both groups using a translated and validated questionnaire at baseline , one month and three months post intervention .


There was a significant improvement in smoking behaviour at one-month post intervention ( p = 0.024 , intention to treat analysis ; OR = 2.525 ; CI = 1.109-5 .747 ) .


This was not significant at three-month post intervention ( p = 0.946 , intention to treat analysis ; OR = 1.026 ; 95 % CI = 0.486-2 .168 ) .


A session of brief physician counselling was effective in improving smokers ' behaviour at workplace , but the effect was not sustained .


Chronic tinnitus negatively affects the quality of life for millions of people .


This clinical trial assesses a potential treatment for tinnitus .


To determine if repetitive transcranial magnetic stimulation ( rTMS ) can reduce the perception or severity of tinnitus and to test the hypothesis that rTMS will result in a statistically significantly greater percentage of responders to treatment in an active rTMS group compared with a placebo rTMS group .


A randomized , participant and clinician or observer-blinded , placebo-controlled clinical trial of rTMS involving individuals who experience chronic tinnitus .


Follow-up assessments were conducted at 1 , 2 , 4 , 13 , and 26 weeks after the last treatment session .


The trial was conducted between April 2011 and December 2014 at Portland Veterans Affairs Medical Center among 348 individuals with chronic tinnitus who were initially screened for participation .


Of those , 92 provided informed consent and underwent more detailed assessments .


Seventy individuals met criteria for inclusion and were randomized to receive active or placebo rTMS .


Sixty-four participants ( 51 men and 13 women , with a mean [ SD ] age of 60.6 [ 8.9 ] years ) were included in the data analyses .


No participants withdrew because of adverse effects of rTMS .


Participants received 2000 pulses per session of active or placebo rTMS at a rate of 1-Hz rTMS daily on 10 consecutive workdays .


The Tinnitus Functional Index ( TFI ) was the main study outcome .


Our hypothesis was tested by comparing baseline and posttreatment TFIs for each participant and group .


Overall , 18 of 32 participants ( 56 % ) in the active rTMS group and 7 of 32 participants ( 22 % ) in the placebo rTMS group were responders to rTMS treatment .


The difference in the percentage of responders to treatment in each group was statistically significant ( ( 1 ) ( 2 ) = 7.94 , P < .005 ) .


Application of 1-Hz rTMS daily for 10 consecutive workdays resulted in a statistically significantly greater percentage of responders to treatment in the active rTMS group compared with the placebo rTMS group .


Improvements in tinnitus severity experienced by responders were sustained during the 26-week follow-up period .


Before this procedure can be implemented clinically , larger studies should be conducted to refine treatment protocols .


clinicaltrials.gov Identifier : NCT01104207 .


The aim of the current study was to compare block of the sciatic nerve through the anterior approach by two methods , namely , the nerve-stimulator guided and ultrasound-guided , with or without nerve stimulation , with regard to the ease of performance , reliability and safety of this approach .


36 adult patients were randomly allocated equally into one of 2 main groups : `` Nerve Stimulator-Guided Group ( NSG ) '' where the nerve was located by nerve stimulator only and `` Ultrasound guided group ( USG ) '' where the sciatic nerves were blocked by a stimulated needle under guidance of the ultrasound .


Assessment of performing each technique , sensory and motor blockades , occurrence of acute systemic toxicity and haematoma formation were compared .


Only one-third of the sciatic nerves could be visualized by US .


This did not affect the block execution time but caused less number of needle passes in a statistically significant value .


Sensory and motor block showed significant differences between the 2 groups .


Criteria of acute systemic toxicity and occurrence of hematoma were not reported in both groups .


Results of the current study showed that the addition of ultrasound to nerve stimulator in the anterior approach to the sciatic nerve block added only little to the ease of performance , reliability and safety .


This was because only one-third of the nerves could be seen .


More practice , better machines and new blocking techniques may be needed to overcome the problem of anisotropy of the nerve .


To investigate how radiotherapy ( XRT ) adds to tumor control using a standardized surgical technique with meticulous control of surgical margins in a randomized trial with 20 years of follow-up .


Three hundred eighty-one women with pT1N0 breast cancer were randomly assigned to sector resection with ( XRT group ) or without ( non-XRT group ) postoperative radiotherapy to the breast .


With follow-up through 2010 , we estimated cumulative proportion of recurrence , breast cancer death , and all-cause mortality .


The cumulative probability of a first breast cancer event of any type after 20 years was 30.9 % in the XRT group and 45.1 % in the non-XRT group ( hazard ratio [ HR ] , 0.58 ; 95 % CI , 0.41 to 0.82 ) .


The benefit of radiotherapy was achieved within the first 5 years .


After 20 years , 50.4 % of the women in the XRT group died compared with 54.0 % in the non-XRT group ( HR , 0.92 ; 95 % CI , 0.71 to 1.19 ) .


The cumulative probability of contralateral cancer or death as a result of cancer other than breast cancer was 27.1 % in the XRT group and 24.9 % in the non-XRT group ( HR , 1.17 ; 95 % CI , 0.77 to 1.77 ) .


In an anticipated low-risk group , the cumulative incidence of first breast cancer of any type was 24.8 % in the XRT group and 36.1 % in the non-XRT group ( HR , 0.61 ; 95 % CI , 0.35 to 1.07 ) .


Radiotherapy protects against recurrences during the first 5 years of follow-up , indicating that XRT mainly eradicates undetected cancer foci present at primary treatment .


The similar rate of recurrences beyond 5 years in the two groups indicates that late recurrences are new tumors .


There are subgroups with clinically relevant differences in risk .


Patients undergoing cardiac surgery presenting with chronic obstructive pulmonary disease ( COPD ) have a higher 30-day mortality risk .


In these patients , pulmonary dysfunction linked to an inflammatory response is frequent after cardiac operations using cardiopulmonary bypass ( CPB ) , which causes pulmonary hypoperfusion .


We hypothesize that selective pulmonary perfusion ( sPP ) of the lungs leads to a reduction of pulmonary inflammation and a better clinical outcome .


Fifty-nine COPD patients ( forced expiratory volume in 1 s/vital capacity < 70 % ) undergoing cardiac surgery procedures ( coronary artery bypass grafting 64 % , valve 14 % ) were block-randomized to sPP ( venous blood , temperature 2C , 4 l ) or standard CPB ( 28/28 ) .


The primary end-point of the study was to evaluate the effect of pulmonary perfusion on gas exchange by measuring alveolar-arterial oxygen gradient .


The surrogate end-points were inflammatory response , intensive care unit ( ICU ) stay , time on respirator ( TOR ) and major adverse cardiac and cerebrovascular events .


A cytokine assay for interleukin-1 , IL-6 , IL-10 , tumour necrosis factor - ( TNF - ) and polymorphonuclear elastase was performed with peripheral blood at different time-points [ ( t1 ) pre-CPB , ( t2 ) end of CPB , ( t3 ) 3 h , ( t4 ) 24 h , ( t5 ) 48 h postoperatively ] .


Repeated-measure analysis of variance and non-parametric statistics were used to assess the between-group and during time differences .


The two groups proved comparable for perioperative variables .


Serum cytokines were not different in the two groups throughout the study ( P > 0.05 at single time-points ) , but as a function of time , the markers of the inflammatory response increased after CBP ( P < 0.05 pre-CPB to 24 h ) .


Clinical end-points were statistically comparable in both groups , but with a trend towards a shorter TOR ( 72 159 h/106 193 h ) and ICU stay ( 3.9 7.2 days/5 .5 9.2 days ) in the sPP group despite a slightly longer time on extracorporeal circulation ( 120 vs 158 min ) .


These results indicate a non-significant trend that repeated hypothermic lung perfusion with venous blood during CPB may have a protective effect on the lungs .


A multicentre study design and larger cohort seem necessary to demonstrate the benefits of sPP more clearly .


This study compared efficacy and safety of the selective relaxant binding agent sugammadex ( 2mg/kg ) with neostigmine ( 50g/kg ) for neuromuscular blockade ( NMB ) reversal in Chinese and Caucasian subjects .


This was a randomized , active-controlled , multicenter , safety-assessor-blinded study ( NCT00825812 ) in American Society of Anesthesiologists Class 1-3 subjects undergoing surgery with propofol anesthesia .


Rocuronium 0.6 mg/kg was administered for endotracheal intubation , with 0.1-0 .2 mg/kg maintenance doses given as required .


NMB was monitored using TOF-Watch ( ) SX .


At second twitch reappearance , after last rocuronium dose , subjects received sugammadex 2mg/kg or neostigmine 50g/kg plus atropine 10-20g / kg , according to randomization .


Primary efficacy variable was time from sugammadex/neostigmine to recovery of the train-of-four ( TOF ) ratio to 0.9 .


Overall , 230 Chinese subjects ( sugammadex , n = 119 , neostigmine , n = 111 ) ; and 59 Caucasian subjects ( sugammadex , n = 29 , neostigmine , n = 30 ) had evaluable data .


Geometric mean ( 95 % CI ) time to recovery to TOF ratio 0.9 was 1.6 ( 1.5-1 .7 ) min with sugammadex vs 9.1 ( 8.0-10 .3 ) min with neostigmine in Chinese subjects .


Corresponding times for Caucasian subjects were 1.4 ( 1.3-1 .5 ) min and 6.7 ( 5.5-8 .0 ) min , respectively .


Sugammadex 2mg/kg was generally well tolerated , with no serious adverse events reported .


There was no residual NMB or recurrence of NMB .


Both Chinese and Caucasian subjects recovered from NMB significantly faster after sugammadex 2mg/kg vs neostigmine 50g/kg , with a ~ 5.7 times ( p < 0.0001 ) faster recovery with sugammadex vs neostigmine in Chinese subjects .


Sugammadex was generally well tolerated .


ClinicalTrials.gov Identifier : NCT00825812 .


Little is known about the factors that predict for gastrointestinal stromal tumor ( GIST ) recurrence in patients treated with adjuvant imatinib .


Risk factors for GIST recurrence were identified , and 2 risk stratification scores were developed using the database of the Scandinavian Sarcoma Group ( SSG ) XVIII trial , where 358 patients with high-risk GIST with no overt metastases were randomly assigned to adjuvant imatinib 400 mg/day either for 12 or 36 months after surgery .


The findings were validated in the imatinib arm of the American College of Surgeons Oncology Group Z9001 trial , where 359 patients with GIST were randomized to receive imatinib and 354 were to receive placebo for 12 months .


Five factors ( high tumor mitotic count , nongastric location , large size , rupture , and adjuvant imatinib for 12 months ) were independently associated with unfavorable recurrence-free survival ( RFS ) in a multivariable analysis in the SSGXVIII cohort .


A risk score based on these 5 factors had a concordance index with GIST recurrence of 78.9 % .


When a simpler score consisting of the 2 strongest predictive factors ( mitotic count and tumor site ) was devised , the groups with the lowest , intermediate high , and the highest risk had 5-year RFS of 76.7 % , 47.5 % , and 8.4 % , respectively .


Both scores were strongly associated with RFS in the validation cohort ( P < .001 for each comparison ) .


The scores generated were effective in stratifying the risk of GIST recurrence in patient populations treated with adjuvant imatinib .


Patients with nongastric GIST with a high mitotic count are at a particularly high risk for recurrence .


To evaluate both the short - and long-term effectiveness of a lifestyle intervention on physical fitness in adolescents and young adults with cerebral palsy ( CP ) .


Single-blind , randomized controlled trial .


University hospitals and rehabilitation clinics .


Adolescents and young adults ( N = 57 ) with spastic CP classified in Gross Motor Function Classification System levels I through IV ; of these , 42 completed the study .


A 6-month lifestyle intervention consisting of physical fitness training combined with counseling sessions focused on physical behavior and sports participation .


Physical fitness , including measures of cardiopulmonary fitness , muscle strength , and body composition .


Favorable short - and medium-term effects were found for peak oxygen consumption , oxygen consumption , and load on the anaerobic threshold and waist circumference .


Favorable long-term effects were found for sum of skinfolds , systolic blood pressure , and total cholesterol .


This exploratory study showed that the lifestyle intervention was effective in improving cardiopulmonary fitness and body composition .


Effects of body composition were maintained in the long term .


However , the intervention needs to be optimized to increase muscle strength and for long-term retention of effects on aerobic capacity .


Arterial and thromboembolic pulmonary hypertension ( PH ) lead to arterial hypoxaemia .


To investigate whether cerebral tissue oxygenation ( CTO ) in patients with PH is reduced and whether this is associated with reduced exercise tolerance .


16 patients with PH ( mean pulmonary arterial pressure 25 mmHg , 14 arterial , 2 chronic thromboembolic ) and 15 controls underwent right heart catheterisation with monitoring of CTO at rest , during maximal bicycle exercise and during inhalation of oxygen and NO .


The 6 min walk distance ( 6MWD ) was measured .


Median CTO in PH-patients at rest was 62 % ( quartiles 53 ; 71 ) , during exercise 60 % ( 53 ; 65 ) ; corresponding values in controls were 65 % ( 73 ; 73 ) ( P = NS ) and 68 % ( 66 ; 70 ) ( p = .013 vs. PH ) .


Inhalation of NO and oxygen improved CTO in PH. In multivariate regression analysis CTO at maximal exercise predicted the work load achieved when controlled for age , pulmonary vascular resistance and mixed venous oxygen saturation ( R ( 2 ) = .419 , p < .000 ) ; in addition , the 6MWD was predicted by CTO ( adjusted R ( 2 ) = .511 , p < .000 ) .


In PH-patients but not in controls CTO decreased during exercise .


Since CTO was an independent predictor of the work load achieved and the 6MWD cerebral hypoxia may contribute to exercise limitation in PH. Clinicaltrials.gov : NCT01463514 .


A lipid emulsion composed of soybean oil ( long-chain triglycerides , LCT ) , medium-chain triglycerides ( MCT ) and n-3 poly-unsaturated fatty acids ( PUFAs ) was evaluated for immune-modulation efficacy , safety , and tolerance in patients undergoing major surgery for gastric and colorectal cancer .


In a prospective , randomized , double-blind study , 99 patients with gastric and colorectal cancer receiving elective surgery were recruited and randomly assigned to either the study group , receiving the n-3 PUFAs enriched intravenous fat emulsion ( IVFE ) , or the control group , receiving a lipid emulsion comprised of soybean oil and MCTs ( 0.8 - 1.5gkg-1day-1 ) as part of total parenteral nutrition ( TPN ) regimen from surgery ( day -1 ) up to post-operative day 7 .


Safety and efficacy parameters were assessed on day -1 and post-operative visits on day 1 , 3 , and 7 .


Adverse events were documented daily and compared between the groups .


Pro-inflammatory markers , laboratory parameters , and adverse events did not differ prominently between the 2 groups , with the exception of net changes ( day 7 minus day -1 ) of free fatty acids ( FFAs ) , triglyceride , and high-density lipoprotein ( HDL ) .


Net decrease of FFAs was remarkably higher in the study group , while the net increase of triglyceride and decrease of HDL was significantly lower .


The n-3 PUFA-enriched IVFE showed improvements in lipid metabolism .


In respect of efficacy , safety and tolerance both IVFE were comparable .


In patients with severe stress , there is an inflammation-attenuating effect of n-3 PUFAs .


Further , adequately powered clinical trials will be necessary to address this question in postsurgical GI cancer patients .


US ClinicalTrials.gov NCT00798447 .


Butter is rich in saturated fat [ saturated fatty acids ( SFAs ) ] and can increase plasma low density lipoprotein ( LDL ) cholesterol , which is a major risk factor for cardiovascular disease .


However , compared with other dairy foods , butter is low in milk fat globule membrane ( MFGM ) content , which encloses the fat .


We hypothesized that different dairy foods may have distinct effects on plasma lipids because of a varying content of MFGM .


We aimed to investigate whether the effects of milk fat on plasma lipids and cardiometabolic risk markers are modulated by the MFGM content .


The study was an 8-wk , single-blind , randomized , controlled isocaloric trial with 2 parallel groups including overweight men and women ( n = 57 randomly assigned ) .


For the intervention , subjects consumed 40 g milk fat/d as either whipping cream ( MFGM diet ) or butter oil ( control diet ) .


Intervention foods were matched for total fat , protein , carbohydrates , and calcium .


Subjects were discouraged from consuming any other dairy products during the study .


Plasma markers of cholesterol absorption and hepatic cholesterol metabolism were assessed together with global gene-expression analyses in peripheral blood mononuclear cells .


As expected , the control diet increased plasma lipids , whereas the MFGM diet did not [ total cholesterol ( SD ) : +0.30 0.49 compared with -0.04 0.49 mmol/L , respectively ( P = 0.024 ) ; LDL cholesterol : +0.36 0.50 compared with +0.04 0.36 mmol/L , respectively ( P = 0.024 ) ; apolipoprotein B : apolipoprotein A-I ratio : +0.03 0.09 compared with -0.05 0.10 mmol/L , respectively ( P = 0.007 ) ; and non-HDL cholesterol : +0.24 0.49 compared with -0.14 0.51 mmol/L , respectively ( P = 0.013 ) ] .


HDL-cholesterol , triglyceride , sitosterol , lathosterol , campesterol , and proprotein convertase subtilisin/kexin type 9 plasma concentrations and fatty acid compositions did not differ between groups .


Nineteen genes were differentially regulated between groups , and these genes were mostly correlated with lipid changes .


In contrast to milk fat without MFGM , milk fat enclosed by MFGM does not impair the lipoprotein profile .


The mechanism is not clear although suppressed gene expression by MFGM correlated inversely with plasma lipids .


The food matrix should be considered when evaluating cardiovascular aspects of different dairy foods .


This trial was registered at clinicaltrials.gov as NCT01767077 .


To observe differences of therapeutic effect between acupuncture combined with bloodletting and regular western medication on chronic urticarial .


One hundred and sixty patients were randomly divided into an acupuncture bloodletting group and a loratadine group , 80 cases in each group .


In the acupuncture bloodletting group , Quchi ( LI 11 ) , Neiguan ( PC 6 ) , Xuehai ( SP 10 ) and Sanyinjiao ( SP 6 ) were selected and manipulated with reducing method , and pricking bloodletting with three-edge needle and cupping were given at Feishu ( BL 13 ) and Geshu ( BL 17 ) , once every other day .


The oral administration of 10 mg loratadine was applied in the loratadine group , once a day .


The therapeutic effect in two groups was observed and compared after four weeks .


The cured and markedly effective rate was 91.3 % ( 73/80 ) in the acupuncture bloodletting group , which was similar to 81.3 % ( 65/80 ) in the loratadine group ( P > 0.05 ) .


The scores of symptom-sign in the two groups were reduced after treatment ( 10.14 + / - 1.95 vs 2.12 + / - 40.32 , 10.30 + / - 1.82 vs 3.21 + / - 0.28 , both P < 0.01 ) , but there was no statistically significant difference between two groups after treatment ( P > 0.05 ) .


There was no obvious adverse effect in the acupuncture bloodletting group while 3 cases of mild somnolence were reported in the loratadine group .


The acupuncture bloodletting is an effective method for chronic urticarial , which has similar effect to loratadine without adverse effect .


Reducing the wound healing time is crucial in wound as it lowers the chance of infection and decreases complications and cost .


Grape seed extract has the ability to release endothelial growth factor and its topical application results in contraction and closure of the skin wound .


Furthermore , it possesses antioxidant and antibacterial properties .


In several studies it has been proved effective in animals .


Therefore , due to low side effects and recognition of herbal medicine , we decided to evaluate the effect of grape seed extract 2 % herbal cream on human skin lesions .


This study is a double blind clinical trial conducted on two groups of treatment and placebo .


Surgery was performed on skin lesions such as skin tags and moles which were found on the neck , trunk and limbs ( except for face ) .


After enrollment and obtaining informed consent from participants , they were randomized into two groups of treatment and placebo .


Excision of the lesions was done by surgical scissors .


The lesions got restored by secondary intention method .


After the first day of treatment , the patients were visited on the 3rd , 7th , 10th , 14th , and 21st day .


Grape seed extract cream 2 % was produced and coded by the Faculty of Pharmacy , Ahvaz University of Medical Sciences .


In order to compare the two groups , T-test was used .


For time assessing , analysis of variance with repeated measures was employed .


The results showed complete repair of wounds averagely on day 8 for the treatment group and on day 14 for the placebo group , which was clearly significant in terms of statistical difference ( p = 0.00 ) .


Proanthocyanidins in grape seed extract trigger the release of vascular endothelial growth factor and its topical application causes wound contraction and closure .


Curing skin lesions with grape seed extract caused proliferation areas with protected boundaries in epithelium , increased cell density and increased deposition of connective tissue at the wound site which in general improves cellular structure in wound .


In addition , its anti-inflammatory and anti-microbial properties are effective in wound healing .


We tested if an increase in immune activation and a decrease in CD4 T cells induced by different antigenic stimuli could be associated with changes in the thymic function and the interleukin ( IL ) -7 / CD127 system .


Twenty-six HIV-infected patients under combined antiretroviral therapy ( cART ) were randomized to receive , during 12 months , a complete immunization schedule ( 7 vaccines and 15 doses ) or placebo .


Thereafter , cART was interrupted during 6 months .


Changes in the thymic function and the IL-7 / CD127 system after 3 different antigenic stimuli ( vaccines , episodes of low-level intermittent viremia before cART interruption , or viral load rebound after cART interruption ) were assessed .


During the period on cART , neither vaccines nor low-level viremia influenced thymic function or IL-7 / CD127 system parameters .


By analyzing the cohort as a whole while on cART , a significant improvement was observed in the thymic function as measured by an increase in the thymic volume ( P = 0.024 ) , T-cell receptor excision circle-bearing cells ( P = 0.012 ) , and naive CD4 and CD8 T cells ( P = 0.069 both ) .


No significant changes were observed in the IL-7 / CD127 system .


After cART interruption , a decrease in T-cell receptor excision circles ( P < 0.001 ) and naive CD8 T cells ( P < 0.001 ) , an increase in IL-7 and expression of CD127 on naive and memory CD4 T cells ( P = 0.028 , P = 0.088 , and P = 0.04 , respectively ) , and a significant decrease in CD127 on naive and memory CD8 T cells ( P = 0.01 , P = 0.006 , respectively ) were observed .


Low-level transient antigenic stimuli during cART were not associated with changes in the thymic function or the IL-7 / CD127 system .


Conversely , viral load rebound very early after cART interruption influenced the thymic function and the IL-7 / CD127 system .


Clinical Trials.gov number NCT00329251 .


We have previously shown that the PAM50-based risk of recurrence ( ROR ) score is significantly correlated with distant recurrence in both the translational research cohort within the Arimidex , Tamoxifen Alone or in Combination ( ATAC ) trial ( TransATAC ) and Austrian Breast and Colorectal Cancer Study Group 8 ( ABCSG 8 ) randomized trials .


Here , we focus on the ROR score for predicting distant recurrence after 5 years of follow-up in a combined analysis of these two randomized trials .


Long-term follow-up data and tissue samples were obtained from 2,137 postmenopausal women with hormone receptor-positive early-stage breast cancer from the ABCSG 8 and TransATAC trials .


We used Cox proportional hazard regression models to determine the prognostic value of ROR for distant recurrence beyond 5 years in the combined data set .


A total of 2,137 women who did not have a recurrence 5 years after diagnosis were included in the combined analyses .


The Clinical Treatment Score ( CTS ) was the strongest prognostic factor 5 years after diagnosis ( univariable : likelihood ratio [ LR ] ( 2 ) = 94.12 , bivariable : LR ( 2 ) = 61.43 ) .


The ROR score was significantly prognostic by itself in years 5 to 10 .


In the node-negative/human epidermal growth factor receptor 2-negative subgroup , more prognostic value for late distant recurrence was added by the ROR score compared with the CTS .


The ROR score added clinically meaningful prognostic information to the CTS in all patients and all subgroups in the late follow-up period .


These results suggest that the ROR score may be helpful for separating patients into risk groups who could be spared or potentially benefit from extended hormonal therapy beyond 5 years of treatment .


This study measured the effects of dietary supplementation with lipid-based nutrient supplements ( LNSs ) on 18-month-old children 's physical activity .


In a randomised , controlled , outcome-assessor blinded trial 1932 six-month-old children from Malawi received one of five interventions daily from 6-18 months of age : 10-g milk-LNS , 20-g milk-LNS , 20-g non-milk-LNS , 40-g milk-LNS or 40-g non-milk-LNS , or received no intervention in the same period ( control ) .


The control group received delayed intervention with corn-soy blend from 18-30 months .


Physical activity was measured over 1 week by ActiGraph GT3X + accelerometer at 18 months .


Main outcome was mean vector magnitude accelerometer counts/15s .


Analyses were restricted to children with valid accelerometer data on at least 4 days with minimum 6h of wearing time per day .


Of the 1435 children recruited to this substudy , 1053 provided sufficient data for analysis .


The mean ( s.d. ) vector magnitude accelerometer counts in the total sample were 307 ( 64 ) .


The difference ( 95 % CI ) in mean accelerometer counts , compared with the control group , was 8 ( -6 to 21 , P = 0.258 ) in 10-g milk-LNS , 3 ( -11 to 17 , P = 0.715 ) in 20-g milk-LNS , 5 ( -8 to 19 , P = 0.445 ) in 20-g non-milk-LNS , 10 ( -3 to 23 , P = 0.148 ) in 40-g milk-LNS and 2 ( -12 to 16 , P = 0.760 ) in 40-g non-milk-LNS groups .


Provision of 10-40g doses of LNS daily for 12 months did not increase physical activity of Malawian toddlers .


To present the impact of treatments on health-related quality of life ( HRQoL ) from the double-blind , randomised phase III COMBI-d study that investigated the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600E/K-mutant metastatic melanoma .


COMBI-d showed significantly prolonged progression-free survival for the combination .


HRQoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 , a generic cancer questionnaire ( completed at baseline , during study treatment , at progression and post progression ) assessing various dimensions ( global health/QoL , functional status , and symptom impact ) .


A mixed-model , repeated-measures analyses of covariance evaluated differences between arms .


Questionnaire completion rates were > 95 % at baseline , > 85 % to week 40 and > 70 % at disease progression .


Baseline scores across both arms were comparable for all dimensions .


Global health dimension scores were significantly better at weeks 8 , 16 and 24 for patients receiving the combination during treatment and at progression .


The majority of functional dimension scores ( physical , social , role , emotional and cognitive functioning ) trended in favour of the combination .


Pain scores were significantly improved and clinically meaningful ( 6-13 point difference ) for patients receiving the combination for all follow-up assessments versus those receiving dabrafenib monotherapy .


For other symptom dimensions ( nausea and vomiting , diarrhoea , dyspnoea , and constipation ) , scores trended in favour of dabrafenib monotherapy .


This analysis demonstrates that the combination of dabrafenib and trametinib provides better preservation of HRQoL and pain improvements versus dabrafenib monotherapy while also delaying progression .


( Clinicaltrials.gov registration number : NCT01584648 ) .


The treatment of large ( 10-25mm ) or giant ( 25mm ) cerebral aneurysms remains technically challenging , with a much higher complication and recanalization rate than that is observed for smaller aneurysms .


The use of a flow diverter seems to facilitate the treatment of this special entity .


In a previous single-center prospective study approved by the Ethics Committee and China Food and Drug Administration ( CFDA ) , we obtained promising results , showing remarkable safety and effectiveness for the Tubridge flow diverter .


Nevertheless , the previous study may have been limited by biases due to its single-center design and limited number of subjects .


Furthermore , although various articles have reported durable results from treating aneurysms using flow diverters , increasing questions have arisen about this form of treatment .


Thus , prospective , multiple-center , randomized trials containing more subjects are needed .


This study is a multicenter , randomized , controlled clinical trial comparing clinical outcomes for patients with unruptured large/giant intracranial aneurysms treated with either conventional stent-assisted coiling or flow diverter implantation .


A total of 124 patients who fulfill the inclusion and exclusion criteria will be randomized into either a treatment group or a control group in the ratio of 1:1 .


The treatment group will receive Tubridge implantation alone or combined with bared coils , and the control group will be treated with stent-assisted coiling ( bare coils ) .


The primary endpoint will be the complete occlusion rate at 6-month follow-up .


Secondary endpoints include the immediate technique success rate , overall mortality , adverse events ( ischemic stroke or intracranial bleeding ) within 30days , 90days and 1year post-operation , and the rate of intra-stent stenosis and thrombosis 6months post-operation .


This prospective trial may provide more information on the safety and efficacy of the Tubridge flow diverter and may potentially change the strategy for treatment of large or giant aneurysms .


The trial is registered on the Chinese Clinical Trial Registry : ChiCTR-TRC-13003127 .


The prevalence of obesity in men in the UK is amongst the highest in Europe but men are less likely than women to use existing weight loss programmes .


Developing weight management programmes which are appealing and acceptable to men is a public health priority .


Football Fans in Training ( FFIT ) , a men-only weight management programme delivered to groups of men at top professional football clubs , encourages men to lose weight by working with , not against , cultural ideals of masculinity .


To inform further development of interventions in football club settings , the current study explored who is attracted to FFIT and why overweight/obese men choose to take part .


A mixed-methods study analysing baseline data on 747 men aged 35-65years with BMI28kg/m2 who were participants in a randomised controlled trial of FFIT , and data from 13 focus group discussions with 63 men who had attended the programme .


Objectively-measured mean body mass index was 35.3 kg/m2 ( sd 4.9 ) .


Overall over 90 % of participants were at very high or extremely high risk of future ill-health .


Around three-quarters of participants in all age groups were at ` very high ' risk of type 2 diabetes , hypertension and cardiovascular disease ( 72 % , 73 % and 80 % of men aged 35-44 , 45-54 and 55-64years respectively ) .


A further 21 % , 16 % and 13 % were at ` extremely high ' risk .


Qualitative data revealed that the powerful ` draw ' of the football club attracted men otherwise reluctant to attend existing weight management programmes .


The location and style of delivery of early FFIT sessions fostered team spirit ; men appreciated being with others ` like them ' and the opportunity to undertake weight management in circumstances that enhanced physical and symbolic proximity to something they valued highly , the football club .


The delivery of a weight management intervention via professional football clubs attracted men at high risk of ill-health .


The setting enabled men to join a weight management programme in circumstances that felt ` right ' rather than threatening to themselves as men .


FFIT is an example of how to facilitate health promotion activities in a way that is consistent with , rather than challenging to , common ideals of masculinity .


To evaluate the efficacy of sequential enteral nutrition support in patients with severe cerebral stroke .


Forty-nine patients with severe cerebral stroke met the inclusion criteria were randomly divided into sequential enteral nutrition group ( Group A , n = 24 ) and conventional enteral nutrition group ( Group B , n = 25 ) .


Patients in Group A received short-peptide-based enteral nutrition support first , then gradually transferred to intact protein enteral nutrition .


Meanwhile , patients in Group B constantly received intact protein enteral nutrition support .


The nutritional indexes and the rate of complications were compared between two groups .


The nutritional indexes were decreased in both groups within 4 weeks after admission , but the decreasing levels of hemoglobin and albumin in Group A were significantly lower than those in Group B ( P < 0.05 ) , and the incidence of infections and gastrointestinal hemorrhage in Group A was also lower than that in Group B ( P < 0.05 ) .


However , there were no significant differences in body weight , BMI , triceps skinfold thickness , biceps circumference , arm muscle circumference between two groups ( P > 0.05 ) .


Sequential enteral nutritional support can improve the nutritional status and decrease the incidence of complications in critical patients with cerebral stroke .


There are no effective and safe treatments for chronic hepatitis C virus ( HCV ) infection of patients who have advanced liver disease .


In this phase 2 , open-label study , we assessed treatment with the NS5A inhibitor ledipasvir , the nucleotide polymerase inhibitor sofosbuvir , and ribavirin in patients infected with HCV genotypes 1 or 4 .


Cohort A enrolled patients with cirrhosis and moderate or severe hepatic impairment who had not undergone liver transplantation .


Cohort B enrolled patients who had undergone liver transplantation : those without cirrhosis ; those with cirrhosis and mild , moderate , or severe hepatic impairment ; and those with fibrosing cholestatic hepatitis .


Patients were assigned randomly ( 1:1 ) to receive 12 or 24 weeks of a fixed-dose combination tablet containing ledipasvir and sofosbuvir , once daily , plus ribavirin .


The primary end point was sustained virologic response at 12 weeks after the end of treatment ( SVR12 ) .


We enrolled 337 patients , 332 ( 99 % ) with HCV genotype 1 infection and 5 ( 1 % ) with HCV genotype 4 infection .


In cohort A ( nontransplant ) , SVR12 was achieved by 86 % -89 % of patients .


In cohort B ( transplant recipients ) , SVR12 was achieved by 96 % -98 % of patients without cirrhosis or with compensated cirrhosis , by 85 % -88 % of patients with moderate hepatic impairment , by 60 % -75 % of patients with severe hepatic impairment , and by all 6 patients with fibrosing cholestatic hepatitis .


Response rates in the 12-and 24-week groups were similar .


Thirteen patients ( 4 % ) discontinued the ledipasvir and sofosbuvir combination prematurely because of adverse events ; 10 patients died , mainly from complications related to hepatic decompensation .


The combination of ledipasvir , sofosbuvir , andribavirin for 12 weeks produced high rates of SVR12 in patients with advanced liver disease , including those with decompensated cirrhosis before and after liver transplantation .


ClinTrials.gov : NCT01938430 .


Secondary peritonitis is an advanced form of complicated intra-abdominal infection ( cIAI ) requiring hospitalization , surgical source control , and empiric antibiotic therapy against causative aerobic and anaerobic bacteria .


This pooled analysis of four prospective , active-controlled randomized clinical trials compared the efficacy and safety of moxifloxacin with that of comparator antibiotics in patients with confirmed secondary peritonitis .


The primary efficacy endpoint was clinical success rate at test-of-cure ( TOC ) between day 10 and 45 post-therapy in the per-protocol ( PP ) population .


Safety and clinical efficacy were assessed also in the intent-to-treat population ( ITT ) .


Bacteriological success was assessed at TOC in the microbiologically-valid population as a secondary efficacy endpoint .


Overall clinical success rates at TOC were 85.3 % ( 431 of 505 patients ) in the moxifloxacin and 88.4 % ( 459 of 519 patients ) in the comparator treatment groups ( PP population , point estimate for the difference in success rates : -3.0 % ; 95 % CI -7.06 % , 1.05 % ) , respectively .


Similar clinical success rates between moxifloxacin and comparators were observed by anatomical site of infection , and ranged from 80.6 % to 100 % for moxifloxacin and from 71.4 % to 96.6 % for comparators , respectively .


Bacteriologic success rates were similar with moxifloxacin ( 82.4 % ) and comparators ( 86.8 % ) , respectively .


The proportion of patients experiencing any treatment-emergent adverse events was slightly higher with moxifloxacin ( 67.3 % ) versus comparators ( 59.8 % ) .


Rates of drug-related adverse events ( 20.9 % versus 20.0 % ) and deaths ( 4.3 % versus 3.4 % ) were similar in moxifloxacin and comparator groups ; none of the deaths were drug-related .


The data suggests that once-daily IV ( or IV/PO ) moxifloxacin has a comparable efficacy and safety profile to antibiotic regimens approved previously in the subgroup of patients with secondary peritonitis of mild-to-moderate severity .


International geographic differences in outcomes may exist for clinical trials of heart failure and reduced ejection fraction ( HF-REF ) , but there are few data for those with preserved ejection fraction ( HF-PEF ) .


We analyzed outcomes by international geographic region in the Irbesartan in Heart Failure with Preserved systolic function trial ( I-Preserve ) , the Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity ( CHARM ) - Preserved trial , the CHARM-Alternative and CHARM-Added HF-REF trials , and the Controlled Rosuvastatin Multinational Trial in HF-REF ( CORONA ) .


Crude rates of heart failure hospitalization varied by geographic region , and more so for HF-PEF than for HF-REF .


Rates in patients with HF-PEF were highest in the United States/Canada ( HF hospitalization rate 7.6 per 100 patient-years in I-Preserve ; 8.8 in CHARM-Preserved ) , intermediate in Western Europe ( 4.8 / 100 and 4.7 / 100 ) , and lowest in Eastern Europe/Russia ( 3.3 / 100 and 2.8 / 100 ) .


The difference between the United States/Canada versus Eastern Europe/Russia persisted after adjustment for key prognostic variables : adjusted hazard ratios 1.34 ( 95 % confidence interval , 1.01-1 .74 ; P = 0.04 ) in I-Preserve and 1.85 ( 95 % confidence interval , 1.17-2 .91 ; P = 0.01 ) in CHARM-Preserved .


In HF-REF , rates of HF hospitalization were slightly lower in Western Europe compared with other regions .


For both HF-REF and HF-PEF , there were few regional differences in rates of all-cause or cardiovascular mortality .


The differences in event rates observed suggest there is international geographic variation in 1 or more of the definition and diagnosis of HF-PEF , the risk profile of patients enrolled , and the threshold for hospitalization , which has implications for the conduct of future global trials .


To compare immediately loaded post-extractive single implants using a definitive abutment versus provisional abutment later replaced by custom-made abutment .


In two private clinics , 28 patients in need of one single post-extractive implant in the maxilla or mandible from the left second premolar to the right second premolar area were randomised shortly before tooth extraction to provisional abutment ( PA ) and definitive abutment ( DA ) groups .


Three patients had to be excluded for buccal wall fracture after tooth extraction .


In the PA group , implants were immediately restored using a platform-switched provisional titanium abutment and definitive platform-switched titanium abutments were used in the DA group .


In both groups , a non-occluding provisional single crown was provided .


Implants were definitively restored after 4 months .


In the PA group , the abutment was removed and the impression was made directly on the implant platform .


In the DA group an impression of the abutment was made using a retraction cord .


Outcome measures were : implant failures ; complications ; and marginal peri-implant bone level changes .


Patients were followed up to 1 year after loading .


Twelve patients were randomised to the DA group and 13 patients to the PA group .


At the 12-month follow-up , no implant failed .


One biological complication occurred in the DA group and one mechanical complication occurred in the PA group .


All complications were successfully treated .


One year after loading , implants in the DA group lost an average of 0.11 mm ( SD : 0.06 ) of periimplant bone and implants in PA group about 0.58 mm ( SD : 0.11 ) .


At the 12-month follow-up , there was a statistically significant difference in bone level change between groups ( mean difference : 0.48 mm , CI 95 % 0.40 ; 0.55 , P < 0.0001 ) .


Within the limits of this study , the non-removal of abutments placed at the time of surgery resulted in the maintenance of 0.5 mm more bone levels around immediately restored postextractive single implants than repeated abutment removal , although this amount of bone maintenance may not have a clinical impact .


Conflicts of interest notification : Dr Tommaso Grandi and Dr Paolo Guazzi serve as consultants for JDentalCare .


This study was completely self-financed and no funding was sought or obtained , not even in the form of free materials .


To compare clinical profiles of Shang Ring versus conventional circumcisions .


Parallel group open-label randomized controlled trial with one-to-one allocations in 2 sites .


We enrolled HIV-negative men aged 18-54 years in Homa Bay , Kenya , and Lusaka , Zambia and followed them at 2 , 7 , 14 , 21 , 28 , 42 , and 60 days after Shang Ring versus conventional circumcision .


We compared the duration of surgery , postoperative pain using a visual analog scale , adverse events rates , time to complete wound healing by clinical assessment , participant acceptability , and provider preferences between circumcision groups .


We randomized 200 men to each group ; 197 and 201 contributed to the Shang Ring and conventional surgery analyses , respectively .


Adverse event rates were similar between groups .


Pain scores at most time points were similar , however , the Shang Ring group reported higher scores for worst pain during erections ( 3.5 1.9 vs. 2.3 1.7 ; P < 0.001 ) .


Significantly more men were satisfied with the cosmetic appearance following Shang Ring male circumcision ( MC ) , 95.7 % versus 85.9 % ( P = 0.02 ) in Kenya , and 96.8 % versus 71.3 % ( P < 0.01 ) in Zambia .


Although median time to complete wound healing was 43 days in both groups , conventional circumcisions healed on average 5.2 days sooner ( P < 0.001 ) .


Shang Ring procedures took one-third the time of conventional MC , 7 versus 20 minutes .


All circumcision providers preferred the Shang Ring .


Safety profiles of the 2 techniques were similar , all MC providers preferred the Shang Ring technique , and study participants preferred the Shang Ring 's cosmetic results .


The Shang Ring should be considered for adult MC as programs scale-up .


In spite of widespread use of nasal CPAP there are comparatively few studies to guide the choice of nasal prongs .


To determine whether the Fisher & Paykel Healthcare ( FPH ) neonatal continuous positive airway pressure ( CPAP ) interface was effective in providing bubble CPAP when compared to the Hudson prong interface .


The study was a randomized cross-over study of twenty newborn infants 500 g or more requiring CPAP for respiratory support at birth .


Infants were randomized to either the Fisher & Paykel Healthcare or Hudson CPAP interface for twenty four hours .


Crossover between interfaces occurred after subsequent twenty four hour periods .


The primary outcome was the provision of desired CPAP pressures , defined as provision of CPAP within one cm H2O of set pressure .


The percentage time CPAP was within one cm H2O of set pressure was 66.5 % for the Hudson and 71.8 % for the FPH interface ( p = 0.66 ) .


Oxygen saturations for the Hudson interface were in target range for a median of 97.8 % of the time , and , with the FPH interface , for a median of 98.2 % of the time ( p = 0.76 ) .


Clinically significant differences in primary or secondary outcomes between the two groups were not detected .


The nasal CPAP interfaces studied were equally effective in achieving desired bubble CPAP pressures and target saturations .


To determine the impact of music intervention on endothelial function , hemodynamics , and patient anxiety before , during , and after cardiac catheterization .


The effect of music therapy during cardiac catheterization on endothelial function and patient satisfaction has received limited study .


Seventy patients undergoing elective cardiac catheterization were randomized to music therapy ( n = 36 ) or no music therapy ( n = 34 ) .


Peripheral arterial tonometry was performed before and after catheterization .


A 6 item ( 24-point scale ) questionnaire evaluating patient anxiety and discomfort levels was also administered after the procedure .


Both study groups had similar baseline characteristics , fluoroscopy time , and contrast administration .


Reactive hyperemia index ( RHI ) change was 0.14 0.72 in the music group and 0.30 0.58 in the control group ( P = .35 ) .


Systolic and diastolic blood pressure ( BP ) changes did not significantly differ between the two groups ( systolic BP change -3.3 17.3 mm Hg vs -2.3 19.4 mm Hg ; P = .83 and diastolic BP change -1.9 12.2 mm Hg vs. 2.0 13.4 mm Hg ; P = .23 ) .


Heart rate changes were also comparable between the two groups ( -1 6 beats / min vs -1 7 beats/min ; P = .22 ) .


Patient satisfaction questionnaire measurements were found to be similar in patients with and without music therapy ( 8 [ 7-11 ] vs 9 [ 8-12 ] ; P = .36 ) .


In this study , music intervention did not elicit a vasodilator response , did not lower blood pressure or heart rate , and did not relieve anxiety or stress discomfort in patients who underwent coronary angiography .


The perineal wound is a major source of morbidity after abdominoperineal resection ( APR ) for rectal cancer , particularly after preoperative irradiation .


Myocutaneous flap reconstruction is a viable alternative to primary perineal wound repair providing well-vascularized non-irradiated tissue to fill the dead space , and improve wound healing .


Sixty patients with low rectal cancer receiving neoadjuvant radiotherapy were prospectively randomized to either primary perineal wound closure ( Group B ) or VRAM perineal reconstruction ( Group A ) .


The study was carried out in the surgical department , National Cancer Institute ( NCI ) , Cairo University over a period of 4 years from August 2008 to July 2012 .


All patients were evaluated as regards incidence of perineal wound complications , abdominal wall complications , and added co-morbidity .


Perineal wound complications were observed in 5 patients in group A ( 17.2 % ) and in 14 patients in group B ( 46.4 % ) ( P = 0.015 ) .


There was no significant difference in the incidence of abdominal wound morbidity between both groups .


Operative blood loss and time were lower in group B.


The vertical rectus myocutaneous flap ( VRAM ) is a relatively simple and reliable technique for perineal wound reconstruction after abdominoperineal resection .


Quantifying pediatric immunologic recovery by highly active antiretroviral therapy ( HAART ) initiation at different CD4 percentage ( CD4 % ) and age thresholds may inform decisions about timing of treatment initiation .


HIV-1-infected , HAART-naive children in Europe and the Americas were followed from 2002 through 2009 in PENPACT-1 .


Data from 162 vertically infected children , with at least World Health Organization `` mild '' immunosuppression and CD4 % < 10th percentile , were analyzed for improvement to a normal CD4 % ( 10th percentile ) within 4 years after HAART initiation .


Data from 209 vertically infected children , regardless of immune status , were analyzed for CD4 % outcomes at 4 years and viral failure within 4 years .


Seventy-two percent of baseline immunosuppressed children recovered to normal within 4 years .


Compared with `` severe '' immunosuppression , more children with `` mild '' immunosuppression ( difference 36 % , 95 % confidence interval [ CI ] : 22 % to 49 % ) or `` advanced '' immunosuppression ( difference 20.8 % , 95 % CI : 5.8 % to 35.9 % ) recovered a normal CD4 % .


For each 5-year increase in baseline age , the proportion of children achieving a normal CD4 % declined by 19 % ( 95 % CI : 11 % to 27 % ) .


Combining baseline CD4 % and age effects resulted in > 90 % recovery when initiating HAART with `` mild '' immunosuppression at any age or `` advanced '' immunosuppression at age < 3 years .


Baseline CD4 % effects became greater with increasing age ( P = .02 ) .


At 4 years , most immunologic benefits were still significant but diminished .


Viral failure was highest in infancy ( 56 % ) and adolescence ( 63 % ) .


Initiating HAART at higher CD4 % and younger ages maximizes potential for immunologic recovery .


Guidelines should weigh immunologic benefits against long-term risks .


To evaluate and compare the visual , refractive , contrast sensitivity , and aberrometric outcomes with a diffractive bifocal and trifocal intraocular lens ( IOL ) of the same material and haptic design .


Sixty eyes of 30 patients undergoing bilateral cataract surgery were enrolled and randomly assigned to one of two groups : the bifocal group , including 30 eyes implanted with the bifocal diffractive IOL AT LISA 801 ( Carl Zeiss Meditec , Jena , Germany ) , and the trifocal group , including eyes implanted with the trifocal diffractive IOL AT LISA tri 839 MP ( Carl Zeiss Meditec ) .


Analysis of visual and refractive outcomes , contrast sensitivity , ocular aberrations ( OPD-Scan III ; Nidek , Inc. , Gagamori , Japan ) , and defocus curve were performed during a 3-month follow-up period .


No statistically significant differences between groups were found in 3-month postoperative uncorrected and corrected distance visual acuity ( P .21 ) .


However , uncorrected , corrected , and distance-corrected near and intermediate visual acuities were significantly better in the trifocal group ( P < .01 ) .


No significant differences between groups were found in postoperative spherical equivalent ( P = .22 ) .


In the binocular defocus curve , the visual acuity was significantly better for defocus of -0.50 to -1.50 diopters in the trifocal group ( P .04 ) and -3.50 to -4.00 diopters in the bifocal group ( P .03 ) .


No statistically significant differences were found between groups in most of the postoperative corneal , internal , and ocular aberrations ( P .31 ) , and in contrast sensitivity for most frequencies analyzed ( P .15 ) .


Trifocal diffractive IOLs provide significantly better intermediate vision over bifocal IOLs , with equivalent postoperative levels of visual and ocular optical quality .


Higher heart rate is associated with poorer outcomes in patients with heart failure and reduced ejection fraction ( HF-REF ) .


Less is known about the association between heart rate and outcomes in patients with heart failure and preserved ejection fraction ( HF-PEF ) .


Therefore , we examined the relationship between heart rate and outcomes in the irbesartan in patients with heart failure and preserved systolic function trial ( I-Preserve ) in patients with an ejection fraction > 45 % aged > 60 years .


Heart rate was analysed as both a categorical ( tertiles ) and continuous variable .


Patients in sinus rhythm ( n = 3271 ) and atrial fibrillation ( n = 696 ) were analysed separately .


The outcomes examined were the primary endpoint of the trial ( all-cause death or cardiovascular hospitalization ) , the composite of cardiovascular death or heart failure hospitalization ( and its components ) and all-cause death alone .


Higher heart rate was associated with a significantly higher risk of all outcomes studied for patients in sinus rhythm , even after adjustment for other prognostic variables , including N-terminal pro-B-type natriuretic peptide .


Each standard deviation ( 12.4 bpm ) increase in heart rate was associated with an increase in risk of 13 % for cardiovascular death or heart failure hospitalization ( P = 0.002 ) .


No relationship between heart rate and outcomes was observed for patients in atrial fibrillation .


Beta-blocker treatment did not reduce the heart rate-risk relationship .


In patients with heart failure and preserved ejection fraction , heart rate is in sinus rhythm an independent predictor of adverse clinical outcomes and might be a therapeutic target in this syndrome .


Clinical Trial Registration - URL http://www.clinicaltrials.gov .


Unique identifier : NCT 0095238 .


To observe the effect of warm-reinforcing needling combined with modern rehabilitation training on motor function of cerebral palsy ( CP ) children .


Sixty cases of CP children were randomly divided into acupuncture combined with rehabilitation ( Acu + Rehab , n = 30 ) group and Rehab ( n = 30 ) group .


Patients of the Acu + Rehab group were treated by warm-reinforcing needling stimulation of Jiaji ( EX-B 2 ) , Jianyu ( LI 15 ) , Quchi ( LI 11 ) , Hegu ( LI 4 ) , Zusanli ( ST 36 ) , Yinlingquan ( GB 34 ) , Sanyinjiao ( SP 6 ) , Juegu ( GB 39 ) , Yanglingquan ( GB 34 ) , etc. , combined with Bobath rehabilitation therapy , and those of the Rehab group treated by Bobath rehabilitation ( stimulating key control points in the body , triggering reflexes that provide head and body control ) .


The treatment was conducted every day , with three months being a therapeutic course , two courses in all .


The Peabody Developmental Motor Scales 2 ( PDMS-2 ) was used to evaluate the CP children 's motor function [ 1 ) gross motor : posture ( straightness ratio ) , locomotion and object manipulation ; 2 ) fine motor : grasping and visual-Motor integration ] .


After the treatment , of the 30 and 30 cases in the Acu + Rehab and Rehab groups , 1 ( 3.33 % ) and 0 ( 0 % ) were cured , 20 ( 66.67 % ) and 18 ( 60.00 % ) experienced marked improvement , 9 ( 30.00 % ) and 12 ( 40.00 % ) were invalid , with the effective rates being 70.00 % and 60.00 % respectively .


The therapeutic effect of the Acu + Rehab group was markedly superior to that of the Rehab group ( P < 0.05 ) .


After 6 months ' treatment , the scores of posture , locomotor , object manipulation and grasping , and visual-movement integration were significantly increased in comparison with pre-treatment in the same one group ( P < 0.05 ) , and the effects of the Acu + Rehab group were obviously superior to those of Rehab group in increasing the scores of posture , locomotor , object manipulation and grasping after 6 months ' treatment ( P < 0.05 ) .


Warm-reinforcing needling combined with Bobath rehabilitation has a better therapeutic effect in improving gross motor and fine motor functions of CP children .


Data were obtained through a multisite clinical trial in which different types of genetic risk-related information were disclosed to individuals ( n = 246 ) seeking a risk assessment for Alzheimer 's disease .


Six weeks after disclosure , 83 % of participants correctly recalled the number of risk-increasing APOE alleles they possessed , and 74 % correctly recalled their APOE genotype .


While 84 % of participants recalled their lifetime risk estimate to within 5 percentage points , only 51 % correctly recalled their lifetime risk estimate exactly .


Correct recall of the number of APOE risk-increasing alleles was independently associated with higher education ( p < 0.001 ) , greater numeracy ( p < 0.05 ) and stronger family history of Alzheimer 's disease ( p < 0.05 ) .


Before adjustments for confounding , correct recall of APOE genotype was also associated with higher education , greater numeracy and stronger family history of Alzheimer 's disease , as well as with higher comfort with numbers and European American ethnicity ( all p < 0.05 ) .


Correct recall of the lifetime risk estimate was independently associated only with younger age ( p < 0.05 ) .


Recall of genotype-specific information is high , but recall of exact risk estimates is lower .


Incorrect recall of numeric risk may lead to distortions in understanding risk .


Further research is needed to determine how best to communicate different types of genetic risk information to patients , particularly to those with lower educational levels and lower numeracy .


Health-care professionals should be aware that each type of genetic risk information may be differentially interpreted and retained by patients and that some patient subgroups may have more problems with recall than others .


Selexipag is a novel , oral , selective prostacyclin ( PGI2 ) receptor agonist in clinical development for the treatment of pulmonary arterial hypertension .


Film-coated tablets with strength between 200 and 1,600 g were used .


Bioequivalence between 8 x 200 g and a new 1,600 g tablet was evaluated at steady state in healthy male subjects .


This was an open-label , 2-treatment , 2-period , crossover , up-titration , phase 1 study .


The treatments were selexipag at 1,600 g b.i.d. for 4.5 days either as 8 x 200 g tablets ( reference : A ) or 1 x 1,600 g tablet ( test : B ) , both preceded by an up-titration phase starting from 400 g b.i.d. doses , in 200-g steps every 4th day .


Subjects were randomized 1 : 1 to the A-B or B-A sequence .


The pharmacokinetics and tolerability of selexipag and its active metabolite , ACT-333679 , were investigated .


80 subjects were enrolled in the study : 65 subjects completed the study according to protocol , and 15 subjects withdrew from the study .


The most frequent adverse events ( AEs ) were headache ( 86 % ) , myalgia ( 73 % ) , and jaw pain ( 73 % ) .


There was no difference in nature and overall frequency of AEs between the two treatments .


Steady state was attained within 3 days of the selexipag 1,600 g b.i.d.


The 90 % confidence intervals ( CIs ) of the geometric mean ratio ( B/A ) at steady state for AUC and Cmax , ss were within ( 0.80 , 1.25 ) bioequivalence interval : ( 0.92 , 1.06 ) and ( 0.95 , 1.14 ) , respectively , for selexipag and ( 0.95 , 1.06 ) and ( 0.94 , 1.07 ) , respectively , for the active metabolite , ACT-333679 .


Bioequivalence was demonstrated between 8 x 200 g and 1 x 1,600 g selexipag at steady state .


The PASI score , the most common outcome measure in clinical trials of psoriasis treatment , is a non-linear scale that does not allow reliable assessment of subtle variations of its components ( erythema , induration , and desquamation ) .


Highlight treatment response patterns potentially hidden by PASI score 's compounded weighted-average calculation .


Patients with moderate-to-severe psoriasis enrolled in the phase-3 , 16-week , randomized CHAMPION study , and received adalimumab , methotrexate , or placebo .


PASI scores were assessed post hoc for improvement , by body region and component .


At Week 16 , a significantly greater percentage of adalimumab-treated patients vs methotrexate - and placebo-treated patients , achieved PASI 75 , PASI 90 and PASI 100 response in each body region and component .


55.7 % of adalimumab-treated patients reached PASI 100 response in the head and neck region vs 16.7 % overall .


Two key components of PASI , induration and desquamation , were affected by treatment more than erythema , the third component .


Adalimumab was particularly effective in complete resolution of induration ( 44.9 % of patients ) vs methotrexate ( 10.9 % ) .


For all PASI body regions and components , mean percent improvement in score at Weeks 2 , 4 , 8 , 12 , and 16 was significantly greater ( P < 0.05 ) for adalimumab treatment vs methotrexate or placebo .


Adalimumab therapy resulted in complete resolution of individual body regions in at least 30.6 % up to 55.7 % of patients in CHAMPION .


This was more than twice that of methotrexate and placebo .


PASI improvement by body region is a novel and an important patient-relevant outcome worthy of reporting in future studies .


Progression of Parkinson 's disease ( PD ) is frequently characterized by the occurrence of freezing of gait ( FOG ) representing a disabling motor complication .


We aim to investigate safety and efficacy of transcranial direct current stimulation of the primary motor cortex of PD patients with FOG .


In this cross-over , double-blind , sham-controlled study , 10 PD patients with FOG persisting in `` on '' state underwent anodal and sham direct current stimulation for 5 consecutive days .


Clinical assessment over a 1-month period was performed .


A significant improvement of gait , as assessed by the Stand Walk Sit test , with reduction in number and duration of FOG episodes , along with a significant reduction in the Unified Parkinson 's Disease Rating Scale score , were observed after anodal stimulation .


Beneficial effects were more evident after the entire 5-day stimulation session , and persisted until the end of the observation period .


Anodal transcranial direct current stimulation of the motor cortex is safe and has therapeutic potential in PD patients with FOG .


Many patients who are candidates for implantable cardioverter defibrillators ( ICDs ) are not referred for potential implantation .


We sought to determine if a simple provider reminder would increase referrals .


We identified consecutive patients from January 2007 through July 2010 in the VA Palo Alto Health Care System with a left ventricular ejection fraction < 35 % on echocardiography .


Patients were excluded using available administrative data only ( no chart review ) if they were known to have an ICD , if they were 80 years old , or if they did not have a current primary care or cardiology provider within the system .


We randomized patients to no intervention or a clinical note to the provider in the medical record .


The outcomes were referral for consideration of defibrillator implantation ( primary ) and documented discussion ( secondary ) .


Of 330 patients with left ventricular ejection fraction35 % , 128 were known to have an ICD , 85 were no longer followed in the healthcare system , and 28 were 80 years old , leaving 89 patients to be randomized .


Forty-six patients were randomized to intervention and 43 to control .


Eleven of 46 ( 24 % ) intervention patients were referred for consideration of ICD implantation during the following 6 months versus 1 of 43 ( 2 % ) control patients ( P = 0.004 ) .


Overall , 31 of 46 ( 67 % ) intervention patients versus 19 of 43 ( 44 % ) control patients had documentation discussing potential candidacy for defibrillators ( P = 0.05 ) .


In patients with low left ventricular ejection fraction , a simple electronic medical record-based intervention directed to their providers improved the rates of referral for ICD implantation .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT01217827 .


The existing research findings regarding the effects of lemongrass ( Cymbopogon citratus ) tea on renal function indices are conflicting and inconclusive .


In the present study , we investigated the effects of infusions prepared from C citratus leaves on creatinine clearance rate ( CCr ) and estimated glomerular filtration rate ( eGFR ) in humans .


One hundred five subjects ( 55 men and 50 women ) aged 18 to 35years were randomly assigned to groups set to orally receive infusions prepared from 2 , 4 , or 8g of C citratus leaf powder once daily , for 30days .


Serum and urinary levels of urea , creatinine , pH , specific gravity , uric acid , electrolytes , diuretic indices , and eGFR were assessed at days 0 , 10 , and 30 after the initiation of treatment .


Results obtained on days10 and 30 were compared with baseline values .


CCr and eGFR decreased significantly at day 30 in both male and female subjects in all the groups and in females treated with infusion prepared from 8g of C citratus leaf powder for 10days .


At day 10 , CCr and eGFR were unchanged in those treated with infusions prepared from 2 or 4g of the leaf powder , whereas diuretic indices ( urine volume , urination frequency , diuretic action , and saliuretic indices ) increased above the baseline levels .


Serum and urinary creatinine levels significantly increased ( P < .05 ) in both male and female subjects in all the groups .


Serum urea significantly increased in the groups treated with infusions prepared from 4 or 8g of the leaf powder ( P < .05 ) for 30days .


Serum electrolytes remained unchanged , but their urinary levels increased .


We observed dose - and time-dependent adverse effects of C citratus on CCr and eGFR .


At a high dose or with prolonged treatment with a low dose , eGFR decrease may be followed by a decline in the other renal function indices .


Treatment of complex fractures of the distal femur utilizing monoaxial locking plates ( e.g. Less Invasive Stabilisation System , LISS , Synthes ) is considered to be superior to conventional plating systems .


Due to the limitation that the thread forces the screw into pre-determined positions , modifications have been made to allow screw positioning within a range of 30 ( Non Contact Bridging , NCB-DF , Zimmer ) .


For the first time , this multicenter prospective randomized clinical trial ( RCT ) investigates the outcome of LISS vs. NCB-DF treatment following complex fractures of the distal femur .


Since June 2008 , 27 patients with a fracture of the distal femur ( AO ASIF 33-A-C and periprosthetic fractures ) were enrolled in this study by four university trauma centres in southern Germany .


Clinical ( e.g. range of motion , Oxford knee score , Tegner score ) and radiological ( e.g. axis deviation , secondary loss of realignment ) follow-ups were conducted one and six weeks , as well as three , six , and 12 months after the operation .


This study comprises data of 27 patients ( 8 male , 19 female ; 15 NCB-DF , 12 LISS ) .


Polyaxial osteosynthesis using the NCB system tended to result in better functional knee scores and a higher range of motion .


Interestingly , fracture union tended to be more rapid using the polyaxial plating system .


We present the analysis of a multicenter prospective RCT to compare the monoaxial LISS vs. the polyaxial NCB-DF treatment following complex fractures of the distal femur .


NCB-DF treatment tended to result in better functional and radiological outcomes than LISS treatment .


Level I.


Hemodynamic stability is one of the most critical concerns during induction of anesthesia .


Whether the pharmacokinetic model by Marsh or the one by Schnider will produce better hemodynamic stability remains unclear .


This study compared hemodynamic changes during induction between the two models .


60 patients who underwent elective surgery were randomly assigned to plasma target-controlled infusion by Marsh 's ( n = 30 ) or Schnider 's ( n = 30 ) model with an initial target concentration of 4 gmL-1 .


The target was then reset and gradually titrated to a sedation level with a narcotrend index ( NI ) below 64 .


Stroke volume , cardiac output , systemic vascular resistance , arterial pressure , target , and effect site concentration , and dose of propofol infused were recorded every minute during the first 25 minutes of infusion .


Throughout the first 25 minutes , stroke volume index and cardiac index were decreased significantly in both Marsh and Schnider groups , but no statistical difference was detected between the groups ( p > 0.05 ) .


Central venous pressure ( CVP ) , systemic vascular resistance index ( SVRI ) , and heart rate ( HR ) did not significantly change during induction ( p > 0.05 ) .


Time to loss of responsiveness ( LOR ) , and time for NI to decrease to 64 was faster in Marsh than in Schnider ( 1.51 0.8 minutes vs. 2.8 1.2 min , p < 0.001 ; 3.3 2.0 minutes vs. 5.2 2.3 minutes , p < 0.01 , respectively ) .


When target concentrations are titrated according to NI during induction of anesthesia , Marsh 's model could induce sedation faster than Schnider 's .


Meanwhile , hemodynamic changes were not observed to be statistically different between the two models .


Hypotension induced by plasma target-controlled infusion of propofol could mainly be attributed to decreased stroke volume instead of vascular dilation .


The effects of box shape -- specifically width and height -- on the perception of heaviness were evaluated during individual and team lifting .


Large objects are perceived to be as much as 50 % lighter than smaller objects with the same mass .


This size-weight illusion presents an obvious risk when lifting large and heavy boxes .


Recent research has shown that shape influences this illusion .


Specifically , increases in length and width do not produce identical decreases in perceived heaviness .


However , this effect has been documented only in individual lifting , mostly with small objects .


Individuals and teams lifted large boxes and reported their perceptions of heaviness .


The mass , height , and width of the boxes were varied independently to determine their unique effects on perceived heaviness .


For both types of lift , increasing width produced a greater mean illusory drop ( expressed as a percentage decrease with 95 % confidence intervals ) in perceived heaviness ( 24 + / - 7 % during individual lifting and 41 + / - 8 % during team lifting ) than increasing height ( 15 + / - 7 % during individual lifting and 18 + / - 8 % during team lifting ) .


Size and shape are important factors in perceiving the heaviness of boxes during both individual and team lifting .


To avoid misperceiving weight and risking injury , lifters should be careful when approaching larger ( especially wider ) boxes .


Primary hyperparathyroidism ( PHPT ) is diagnosed by the presence of hypercalcemia and elevated or nonsuppressed parathyroid hormone ( PTH ) levels .


Although surgery is usually curative , some individuals fail or are unable or unwilling to undergo parathyroidectomy .


In such individuals , targeted medical therapy may be of value .


Cinacalcet normalized calcium level and lowered PTH in patients with PHPT in several phase 2 and open-label studies .


We compared cinacalcet and placebo in subjects with PHPT unable to undergo parathyroidectomy .


Phase 3 , double-blind , multi centere , randomized , placebo-controlled study .


Sixty-seven subjects ( 78 % women ) with moderate PHPT were randomized ( 1:1 ) to cinacalcet or placebo for 28 weeks .


Achievement of a normal mean corrected total serum calcium concentration of 10.3 mg/dl ( 2.575 mmol/l ) .


Baseline median ( quartile 1 ( Q1 ) , Q3 ) serum PTH was 164.0 ( 131.0 , 211.0 ) pg/ml and mean ( s.d. ) serum Ca was 11.77 ( 0.46 ) mg/dl .


Serum Ca normalized ( 10.3 mg/dl ) in 75.8 % of cinacalcet - vs 0 % of placebo-treated subjects ( P < 0.001 ) .


Corrected serum Ca decreased by 1.0 mg/dl from baseline in 84.8 % of cinacalcet - vs 5.9 % of placebo-treated subjects ( P < 0.001 ) .


Least squares mean ( s.e.m. ) plasma PTH change from baseline was -23.80 % ( 4.18 % ) ( cinacalcet ) vs -1.01 % ( 4.05 % ) ( placebo ) ( P < 0.001 ) .


Similar numbers of subjects in the cinacalcet and placebo groups reported adverse events ( AEs ) ( 27 vs 20 ) and serious AEs ( three vs four ) .


Most commonly reported AEs were nausea and muscle spasms .


These results demonstrate that cinacalcet normalizes serum calcium in this PHPT population and appears to be well tolerated .


This randomized phase III trial compared pathologic complete response ( pCR ) rates of early breast cancer ( EBC ) following neoadjuvant epirubicin-docetaxel ( ED ) capecitabine ( C ) , and evaluated the addition of trastuzumab in HER2-positive tumors .


Patients with invasive breast cancer ( except T4d ) were randomly assigned to receive six 3-weekly cycles of ED ( both 75 mg/m2 ) C ( 1000 mg/m2 , twice daily , days 1-14 ) .


Patients with HER2-positive disease were further randomized to receive trastuzumab ( 8 mg/kg , then 6 mg/kg every 3 weeks ) or not .


Primary end point : pCR rate at the time of surgery .


Five hundred thirty-six patients were randomized to ED ( n = 266 ) or EDC ( n = 270 ) ; 93 patients were further randomized to trastuzumab ( n = 44 ) or not ( n = 49 ) .


pCR rate was significantly increased with EDC ( 23.0 % versus 15.4 % ED , P = 0.027 ) , and nonsignificantly further increased with trastuzumab ( 38.6 % EDC versus 26.5 % ED , P = 0.212 ) .


Rates of axillary node involvement at surgery and breast conservation were improved with EDC versus ED , but not significantly ; the addition of trastuzumab had no further impact .


Hormone receptor status , tumor size , grade , and C ( all P0 .035 ) were independent prognostic factors for pCR .


Trastuzumab added to EDC significantly increased the number of serious adverse events ( 35 versus 18 ; P = 0.020 ) , mainly due to infusion-related reactions .


These findings show that the integration of C into a neoadjuvant taxane - / anthracycline-based regimen is a feasible , safe , and effective treatment option , with incorporation of trastuzumab in HER2-positive disease .


NCT00309556 , www.clinicaltrials.gov .


This study explored the safety and efficacy of recombinant type I pancreatic elastase ( PRT-201 ) topically applied once to the external surface of an arteriovenous fistula .


This was a randomized , double-blind , placebo-controlled trial .


Adults with kidney disease undergoing creation of a radiocephalic fistula ( RCF ) or brachiocephalic fistula were randomized to treatment with placebo ( n = 51 ) , PRT-201 at 10 g ( n = 51 ) , or PRT-201 at 30 g ( n = 49 ) .


The primary efficacy measure was unassisted primary patency ( PP ) over 1 year .


Secondary efficacy measures were secondary patency ( SP ) , unassisted maturation by ultrasound interrogation , use for hemodialysis , and hemodynamically significant lumen stenosis .


Median PP was 224 days for placebo and > 365 days for the PRT-201 groups .


At 1 year , 45 % , 54 % , and 53 % of placebo , 10-g , and 30-g patients retained PP .


The risk of PP loss was nonsignificantly reduced for 10 g ( hazard ratio [ HR ] , 0.69 ; P = .19 ) and 30 g ( HR , 0.67 ; P = .17 ) vs placebo .


In the subset ( 44 % of patients ) with a RCF , the median PP was 125 days for placebo and > 365 days for the PRT-201 groups .


At 1 year , 31 % , 50 % , and 63 % of placebo , 10-g , and 30-g RCFs retained PP .


The risk of RCF PP loss was nonsignificantly reduced by 10 g ( HR , 0.59 ; P = .18 ) and significantly reduced by 30 g ( HR , 0.37 ; P = .02 ) vs placebo .


At 1 year , 77 % , 81 % , and 83 % of placebo , 10-g , and 30-g patients retained SP .


The risk of SP loss was nonsignificantly reduced for 10 g ( HR , 0.79 ; P = .61 ) and 30 g ( HR , 0.76 ; P = .55 ) vs placebo .


In the subset with RCFs , 65 % , 82 % , and 90 % of placebo , 10-g , and 30-g patients retained SP at 1 year .


The risk of RCF SP loss was nonsignificantly reduced for 10 g ( HR , 0.45 ; P = .19 ) and 30 g ( HR , 0.27 ; P = .08 ) vs placebo .


At month 3 , 67 % , 87 % ( P = .03 ) , and 92 % ( P < .01 ) of the placebo , 10-g , and 30-g group fistulas had unassisted maturation by ultrasound interrogation .


At month 3 in the subset with an RCF , 47 % , 74 % ( P = .17 ) , and 93 % ( P < .01 ) of placebo , 10-g , and 30-g group fistulas had unassisted maturation by ultrasound interrogation .


Adverse event reports were not meaningfully different between groups .


PRT-201 appeared safe .


The primary efficacy end point was not met .


However , both PRT-201 doses were associated with improved unassisted maturation .


The 30-g dose was associated with increased PP in the subset with RCF .


Ingestion of polyunsaturated fatty acids ( PUFAs ) has been proposed to influence several chronic diseases including coronary heart disease ( CHD ) and type-2 diabetes ( T2D ) .


There is strong evidence that omega-3 ( n-3 ) PUFAs provide protection against CHD and biomarkers of atherosclerosis .


In contrast , there is more limited and inconsistent data for T2D .


Few studies have examined the impact of n-3 PUFA-containing botanical oils on T2D .


Fifty-nine subjects with early-stageT2D or metabolic syndrome participated in an 8-week , randomized , single-blind , parallel intervention study and were provided PUFA-containing oils .


Individuals received either corn oil ( CO ) , a botanical oil ( BO ) combination ( borage [ Borago officinalis L. ] / echium oil [ Echium plantagineum L. ] ) or fish oil ( FO ) .


The BO combination was enriched in alpha-linolenic , gamma-linolenic , and stearidonic acids and the FO in eicosapentaenoic and docosahexaenoic acids .


Serum fatty acids and other serum lipids ( triglycerides and total , HDL and LDL cholesterol ) , as well as markers of inflammation ( leptin , and C-reactive protein ) and glucose regulation ( glucose and hemoglobin A1c ) were assessed from fasting participants at baseline and after the intervention .


Compliance was verified by expected increases in specific PUFAs in each of the three oil arms .


Participants in the CO group showed no differences in serum lipids , markers of inflammation or glucose regulation between pre - and post-treatment measures .


Supplementation with BO significantly lowered total and LDL cholesterol levels and FO reduced serum triglycerides , hemoglobin A1c and increased HDL-cholesterol .


Short-term dietary supplementation with BO and FO improved biomarkers associated with T2D/metabolic syndrome .


Clinicaltrial.gov NCT01145066 .


The role of secondary cytoreductive surgery ( SCR ) in platinum-sensitive recurrent ovarian cancer ( ROC ) remains controversial .


The overall survival ( OS ) benefits for surgery reported in observational studies may be due to the selection of patients with better prognosis .


Using data from the CALYPSO trial , OS of patients who had SCR was compared to those treated with chemotherapy alone .


Multivariate analyses were performed to adjust for prognostic factors .


We also tested for an interaction between baseline prognostic groupings and the benefit of surgery .


Of the 975 patients randomised in CALYPSO , 19 % had SCR and 80 % had chemotherapy alone .


OS was longer for the SCR group than for chemotherapy alone ( median , 49.9 vs. 29.7 months ; adjusted hazard ratio ( HR ) , 0.68 ; P = 0.004 ) .


For patients with SCR , the 3-year OS was 72 % for those with no measurable disease , and 28 % if residual tumour was larger than 5 cm .


Patients with good prognostic features benefited the most from SCR ( HR 0.43 ; P < 0.001 ) .


The benefit of SCR was less in patients with poorer prognostic features ( test of trend P < 0.001 ) .


SCR was associated with improved OS in platinum-sensitive ROC , particularly in patients with favourable prognostic characteristics .


However , these findings may be due to selection bias , and hence randomised trials are still essential .


To evaluate the verbal and written preoperative information in patients undergoing surgery for malignant gynaecologic disease , in terms of satisfaction about preoperative received informations , hospitalization days , postoperative pain experienced using visual analogue scale ( VAS ) and number of pain drugs used daily .


From January 2008 to December 2012 , consecutive patients with diagnosis of endometrial cancer , referred to the Division of Gynecology of University Campus Bio-Medico of Rome , were enrolled .


Eligible subjects were randomized into two groups : Group V ( Verbal information ward ) consisted of patients who had verbal preoperative information about surgical procedure and postoperative management and Group W ( Written Information ward ) consisted of patients who had written preoperative information .


All preoperative and postoperative data were recorded .


Concerning satisfaction about preoperative received informations , patients were asked to complete the QLQ-C30 and the EORTC INFO25 .


190 patients were considered in this study .


Group W ( n = 92 ) has a better info satisfaction ( p = 0.0008 , statistically significant ) , a mean VAS value lower ( p = 0.02 , statistically significant ) and also a lower number of hospitalization days ( p = 0.0265 , statistically significant ) and pain medications used daily , ( p = 0.0120 , statistically significant ) , comparing with group V ( n = 98 ) .


We support the use of preoperative information leaflet to better prepare patients for a surgical procedure , showing a faster recovery , low medications use and a better quality of life outcome .


In most Asian countries , 50 - 90 % of pharmaceutical sales are made in private drug outlets , by personnel with some training in drugs but not for the treatment of common health problems .


The objective of the study was to determine effects of focused training for private drug sellers to improve practices in treating acute respiratory infections and diarrhoea in children , and anaemia in pregnancy in Nepal .


Randomized controlled , four way nested design study incorporating four interventions for drug retailers in both hill and terai districts .


One group received mailed printed educational materials followed by mailed feedback ; a second received small group training followed by feedback ; a third received small group training only ; and a fourth , the control group , received no intervention .


Surrogate customer method was used to assess practices .


Outcomes were measured using multivariate linear regression .


A significant increase in the asking of key history questions , recommendation ( prescribing by drug retailers ) of cotrimoxazole , and advice-giving for pneumonia ; a significant increase in ORS recommendation , and advice giving for diarrhoea including the avoidance of antidiarrhoeals ; and a significant increase in asking key history questions and recommending appropriate products in pregnancy cases .


Training intervention as well as training followed by practice feedback was effective in improving the management of common illnesses and pregnancy by private drug sellers .


A post hoc analysis to determine the diagnostic yield of random biopsy in detecting high-grade cervical disease in women with negative colposcopy .


The ATHENA ( Addressing the Need for Advanced HPV Diagnostics ) trial screened more than 47,000 women with cytology and high-risk human papillomavirus ( HPV ) DNA genotyping .


Colposcopy was performed in all women with abnormal cytology or positive HPV results .


A single random biopsy was taken at the squamocolumnar junction if colposcopy was adequate and no lesions were identified .


The random biopsy diagnosed 20.9 % ( 81/388 , 95 % confidence interval [ CI ] 16.9-25 .3 % ) and 18.9 % ( 45/238 , 95 % CI 14.1-24 .5 % ) of the total cervical intraepithelial neoplasia ( CIN ) grade 2 or worse and grade 3 or worse , respectively .


This additional disease was detected in both HPV 16 or 18 + and for 12 other high-risk HPV + women .


For HPV 16 or 18 , the absolute risk for detection of CIN 2 or worse on random biopsy in the overall population was 13.1 % ( 40/305 , 95 % CI 9.8-17 .4 % ) and 8.2 % ( 25/305 , 95 % CI 5.6-11 .8 % ) for CIN 3 or worse .


By contrast , the absolute risk for 12 other high-risk HPV + women was 3.5 % ( 29/820 , 95 % CI 2.5-5 % ) and 1.7 % ( 14/820 , 95 % CI 1.0-2 .8 % ) for CIN 2 or worse and CIN 3 or worse , respectively .