Efficacy measures ( time to prostate-specific antigen [ PSA ] progression and time to clinical progression ) were gathered to guide treatment decisions .


We included in our analysis all patients who received at least one dose of abiraterone acetate .


This study is registered with ClinicalTrials.gov , number NCT01217697 .


Between Nov 17 , 2010 , and Sept 30 , 2013 , 2314 patients were enrolled into the early-access protocol trial .


Median follow-up was 57 months ( IQR 35-106 ) .


952 ( 41 % ) patients had a grade 3 or 4 treatment-related adverse event , and grade 3 or 4 serious adverse events were recorded in 585 ( 25 % ) people .


The most common grade 3 and 4 adverse events were hepatotoxicity ( 188 [ 8 % ] ) , hypertension ( 99 [ 4 % ] ) , cardiac disorders ( 52 [ 2 % ] ) , osteoporosis ( 31 [ 1 % ] ) , hypokalaemia ( 28 [ 1 % ] ) , and fluid retention or oedema ( 23 [ 1 % ] ) .


172 ( 7 % ) patients discontinued the study because of adverse events ( 64 [ 3 % ] were drug-related ) , as assessed by the investigator , and 171 ( 7 % ) people died .


The funder assessed causes of death , which were due to disease progression ( 85 [ 4 % ] ) , an unrelated adverse experience ( 72 [ 3 % ] ) , and unknown reasons ( 14 [ 1 % ] ) .


Of the 86 deaths not attributable to disease progression , 18 ( < 1 % ) were caused by a drug-related adverse event , as assessed by the investigator .


Median time to PSA progression was 85 months ( 95 % CI 83-97 ) and median time to clinical progression was 127 months ( 118-138 ) .


No new safety signals or unexpected adverse events were found in this early-access protocol trial to assess abiraterone acetate for patients with metastatic castration-resistant prostate cancer who progressed after chemotherapy .


Future work is needed to ascertain the most effective regimen of abiraterone acetate to optimise patients ' outcomes .


Janssen Research & Development .


In the last years there has been a progressive reduction of the average duration of sleep and an increase in the incidence of sleep disturbances .


At the same time , an increase of the incidence of the metabolic syndrome has been described , partly attributable to the progressive worsening of dietary habits and the increase in sedentary lifestyle .


Recent studies suggest that adequate sleep is essential to maintain good glucose metabolism and sleep disturbances may contribute to the manifestation of the metabolic syndrome .


Benzodiazepines ( BZ ) , such as brotizolam , and imidazopyridines , such as zolpidem , are frequently used as hypnotics but their potential impact on glucose metabolism has never been evaluated so far .


In 12 healthy volunteers [ age ( mean SEM ) 38.3 8.1 years ; body mass index ( BMI ) 21.9 0.8 kg/m ] we studied glucose and insulin responses to oral glucose tolerance test ( OGTT , 75 g ) before and after 15 days treatment with brotizolam 0.25 mg/day or zolpidem 10 mg/day .


Brotizolam increased glucose delta area under curve response to the OGTT by 122 % ( p < 0.01 ) and zolpidem by 86 % ( p < 0.01 ) without significant variations of insulin levels , suggesting an impact on insulin sensitivity and/or insulin secretion .


This study suggests that BZ and imidazopyridines have a rapid glucometabolic effect that is detectable as early as after 15 days treatment .


To compare the therapeutic and side effects of using Californium252 ( 252Cf ) neutron brachytherapy with neoadjuvant intra-arterial embolism chemotherapy in combination with surgery for treating Stage Ib2-IIb cervical cancers ( CCs ) .


Thirty-two Stage Ib2-IIb CC patients were enrolled and randomly divided into two groups from January 2007 to April 2010 in the present Hospital .


Prior to surgery within four weeks , a total of 17 cases were treated with 252Cf neutron brachytherapy ( 700-800 cGy doses at point A ) once a week ( Group A ) , and 15 cases were treated by neoadjuvant intra-arterial embolism chemotherapy using a combination of bleomycin , carboplatin , and cyclophosphamide twice ( Group B ) .


The clinical symptoms and signs , side effects , and relapse condition follow up until July 2013 were compared between the two groups for the perioperation .


Reductions in tumor mass and CR+PR were not significantly different between the groups before the surgery ( p > 0.05 ) .


Abdominal pain and pelvic adhesions were significantly more severe in Group B ( p < 0.05 ) .


There were no significant differences in surgical time , blood loss or the other side effects between Groups A and B ( p > 0.05 ) .


The percentage of pelvic tumor recurrences in Group A was lower than that of the patients in Group B ( 11.8 % vs 20.0 % ) although with no significant difference at present .


No distant metastasis has been found in both two groups .


Except for less abdominal pain and pelvic adhesions , 252Cf neutron brachytherapy has perioperative effects similar to those of neoadjuvant intra-arterial embolism chemotherapy .


New-onset postoperative atrial fibrillation ( POAF ) after coronary artery bypass graft surgery ( CABG ) is associated with worse in-hospital morbidity and mortality , extended hospital stays , and higher costs .


Beyond the initial hospital discharge , the cost and outcomes of POAF have not been well studied .


For CABG patients with and without new-onset POAF , a retrospective propensity-matched , multivariable regression analysis was performed to compare 1-year outcomes ( including health-related quality of life [ HRQoL ] scores and mortality rates ) and costs ( standardized to 2010 dollars ) .


Regression models controlled for site and patient factors , with propensity matching used to adjust for differences in POAF versus no-POAF patients ' risk profiles .


Using the existing CABG trial database , 2,096 patient records were analyzed , including POAF patients ( n = 549 ) versus no-POAF patients ( n = 1,547 ) .


For the index CABG hospitalization , POAF patients had longer postoperative length of stay ( +3.9 days ) and higher discharge costs ( + $ 13,993 ) than no-POAF patients .


At 1 year , POAF patients had more than twice the adjusted odds of dying ( p < 0.01 ) , with higher 1-year total cumulative costs .


This 1-year cost difference ( + $ 15,593 ) was largely attributable to hospital-based costs during the index surgery hospitalization .


There was no difference in 1-year HRQoL scores ( or HRQoL score changes ) between POAF patients and no-POAF patients .


Compared with no-POAF patients , POAF patients had higher discharge and 1-year costs along with higher 1-year mortality rates , but no differences were observed in 1-year HRQoL scores .


Additional research appears warranted to improve the longer-term survival rates for POAF CABG patients , targeting future POAF-specific postdischarge interventions .


Deficiency of vitamin D is an environmental risk factor for MS. Vitamin D has immunomodulatory effects , including promotion of T-cell differentiation into T-regulatory cells , which produces regulatory cytokines including TGF - .


Increasing serum vitamin D levels have been associated with decreased disease activity in MS patients , but there are only few studies concerning the immunological effects of vitamin D supplementation in MS. In this study we investigated the effect of weekly supplementation of vitamin D3 or placebo on serum levels of multiple cytokines in patients with relapsing remitting MS.


The study was conducted on the patient cohort of the Finnish Vitamin D study .


All patients were using IFN-beta-1b and were randomized to add-on treatment with either cholecalciferol 20,000 IU/week or placebo .


Concentrations of LAP ( TGF - ) , INF - , IL-17A , IL-2 , IL-10 , IL-9 , IL-22 , IL-6 , IL-13 , IL-4 , IL-5 , IL-1 and TNF - were determined at screening and at 12 months using commercial fluorescent bead immunoassay kits .


LAP ( TGF - ) levels increased significantly in the vitamin D treated group from a mean of 47 ( SE 11 ) pg/ml to 55 ( SE 14 ) pg/ml in 12 months ( p-value = 0.0249 ) .


Placebo treatment had no significant effect on LAP levels .


The levels of the other cytokines did not change significantly in either group .


We showed increased serum latency activated peptide ( LAP ) of TGF - levels in MS patients treated with vitamin D3 .


The immune regulatory effects of TGF-beta may play a role in the improved MRI outcomes that we observed earlier in the vitamin D treated group of patients .


Many patients with suspected non-ST-segment elevation acute coronary syndrome ( NSTE-ACS ) do not have significant coronary artery disease .


The current diagnostic approach of repeated electrocardiography and cardiac biomarker assessment requires observation for > 6 to 12 hours .


This strategy places a heavy burden on hospital facilities .


The objective of this study was to investigate whether myocardial strain assessment by echocardiography could exclude significant coronary artery stenosis in patients presenting with suspected NSTE-ACS .


Sixty-four patients presenting to the emergency department with suspected NSTE-ACS without known coronary artery disease , inconclusive electrocardiographic findings , and normal cardiac biomarkers at arrival were enrolled .


Twelve-lead electrocardiography , troponin T assay , and echocardiography were performed at arrival , and all patients underwent coronary angiography .


Significant coronary stenosis was defined as > 50 % luminal narrowing .


Global myocardial peak systolic longitudinal strain was measured using speckle-tracking echocardiography .


Left ventricular ejection fraction and wall motion score index were calculated .


No significant stenosis in any coronary artery was found in 35 patients ( 55 % ) .


Global peak systolic longitudinal strain was superior to conventional echocardiographic parameters in distinguishing patients with and without significant coronary artery stenosis ( area under the curve , 0.87 ) .


Sensitivity and specificity were calculated as 0.93 and 0.78 , respectively , and positive predictive value and negative predictive value as 0.74 and 0.92 , respectively .


Feasibility of the strain measurements was excellent , with 97 % of segments analyzed .


Myocardial strain by echocardiography may facilitate the exclusion of significant coronary artery stenosis among patients presenting with suspected NSTE-ACS with inconclusive electrocardiographic findings and normal cardiac biomarkers .


Evidence-based treatments that achieve optimal energy intake and improve growth in preschool-aged children with cystic fibrosis ( CF ) are a critical need .


To test whether behavioral and nutritional treatment ( intervention ) was superior to an education and attention control treatment in increasing energy intake , weight z ( WAZ ) score , and height z ( HAZ ) score .


This randomized clinical trial included 78 children aged 2 to 6 years ( mean age , 3.8 years ) with CF and pancreatic insufficiency ( intervention , n = 36 and control , n = 42 ) .


The study was conducted at 7 CF centers between January 2006 and November 2012 ; all 78 participants who met intent-to-treat criteria completed through follow-up .


Behavioral intervention combined individualized nutritional counseling targeting increased energy intake and training in behavioral child management skills .


The control arm provided education and served as a behavioral placebo controlling for attention and contact frequency .


Both treatments were delivered in person or telehealth ( via telephone ) .


Sessions occurred weekly for 8 weeks then monthly for 4 months ( 6 months ) .


Participants then returned to standard care for 1 year , with 12-month follow-up thereafter .


Changes in energy intake and WAZ score were examined from pretreatment to posttreatment ( 6 months ) and change in HAZ score was assessed pretreatment to follow-up ( 18 months ) .


Covariates included sex , Pseudomonas aeruginosa status at baseline , and treatment modality ( in person vs telehealth ) .


At baseline , mean ( SD ) energy intake was 1462 ( 329 ) kcals/d , WAZ score was -0.44 ( 0.81 ) , and HAZ score was -0.55 ( 0.84 ) .


From pretreatment to posttreatment , the intervention increased daily energy intake by 485 calories vs 58 calories for the control group ( adjusted difference , 431 calories ; 95 % CI , 282 to 581 ; P < .001 ) and increased the WAZ score by 0.12 units vs 0.06 for the control ( adjusted difference , 0.09 ; 95 % CI , -0.06 to 0.24 ; P = .25 ) .


From pretreatment to follow-up , the intervention increased the HAZ score by 0.09 units vs -0.02 for the control ( adjusted difference , 0.14 units ; 95 % CI , 0.001 to 0.27 ; P = .049 ) .


Measured treatment integrity and credibility were high for both groups .


Behavioral and nutritional intervention improved energy intake and HAZ score outcomes but not WAZ score outcomes .


Our results provide evidence that behavioral and nutritional treatment may be efficacious as a nutritional intervention for preschoolers aged 2 to 6 years with CF and pancreatic insufficiency .


clinicaltrials.gov Identifier : NCT00241969 .


This study describes the lifetime prevalence of teen dating violence ( TDV ) perpetration in a sample of middle school students from high-risk urban communities and examines the relation between TDV and related cognitive and behavioral risk factors .


Surveys were administered to 2,895 middle school students in four U.S. cities ; 1,673 students ( 58 % ) reported having dated and were included in analyses .


The sample was 52.3 % female , 48.2 % non-Hispanic black/African-American , 38.2 % Hispanic , 4.8 % non-Hispanic white , and 7.6 % other race .


Six types of TDV perpetration were assessed : threatening behaviors , verbal/emotional abuse , relational abuse , physical abuse , sexual abuse , and stalking .


Of the students who had dated , 77 % reported perpetrating verbal/emotional abuse , 32 % reported perpetrating physical abuse , 20 % reported threatening a partner , 15 % reported perpetrating sexual abuse , 13 % reported perpetrating relational abuse , and 6 % reported stalking .


Girls were more likely than boys to report perpetrating threatening behaviors , verbal/emotional abuse , and physical abuse , and boys were more likely to report perpetrating sexual abuse .


Involvement in bullying positively predicted perpetration of TDV , albeit , in different ways for boys and girls .


Other risk factors differed by sex .


For instance , alcohol use and sex initiation predicted multiple forms of TDV perpetration for boys , whereas weapon carrying and emotional symptoms predicted several forms of TDV perpetration for girls .


The prevalence of TDV was high in our sample .


Important sex differences in rates of perpetration and risk factors emerged .


Comprehensive prevention programs that target TDV and related risk factors , such as bullying and other risk factors , seem warranted .


The aim of the research was to indicate whether there are differences between locus of control ( LOC ) in girls with anorexia readiness syndrome ( ARS ) and without this syndrome .


There was also a question about the relationship between LOC and the tendency to respond in incorrect attitudes towards food , eating and their bodies under stress .


The sample consisted of girls aged 13-18 years randomly selected from five public Polish middle and high schools .


Tools : 1 ) Eating Attitudes Questionnaire ( EAQ ) by B. Zikowska ; 2 ) Locus of Control Questionnaire ( LOCQ ) by G. Krasowicz , A. Kurzyp-Wojnarska , to assess LOC of the subjects .


The criterion group ( N = 23 ) was formed by girls who received high score in EAQ ( signs of ARS ) in the first stage of research ( N = 189 ) .


The control group ( N = 23 ) were girls who received a low score in EAQ ( no signs of ARS ) .


Subjects with ARS were characterized by more external LOC than girls without any signs of this syndrome ( t = -2.898 ; p < 0.01 ) .


The results did not confirm the hypothesis about the relationship between LOC and the tendency to respond by abnormal attitude to eating and own body in difficult situations in both groups .


In pathogenesis of ARS where anorexic behaviors can become a way to a regain lost control , LOC may play a role as a mediating variable rather than a direct determinant of this syndrome .


Adults with osteogenesis imperfecta ( OI ) have a high risk of fracture .


Currently , few treatment options are available , and bone anabolic therapies have not been tested in clinical trials for OI treatment .


79 adults with OI were randomized to receive 20 g recombinant human parathyroid hormone ( teriparatide ) or placebo for 18 months in a double-blind , placebo-controlled trial .


The primary endpoint was the percent change in areal bone mineral density ( aBMD ) of the lumbar spine ( LS ) , as determined by dual-energy X-ray absorptiometry .


Secondary endpoints included percent change in bone remodeling markers and vertebral volumetric BMD ( vBMD ) by quantitative computed tomography , estimated vertebral strength by finite element analysis , and self-reported fractures .


Compared with the placebo group , the teriparatide group showed increased LS aBMD ( 6.1 % 1.0 % vs. 2.8 % 1.0 % change from baseline ; P < 0.05 ) and total hip aBMD ( 2.6 % 1.0 % vs. -2.4 % 1.0 % change ; P < 0.001 ) .


Vertebral vBMD and strength improved with teriparatide therapy ( 18 % 6 % and 15 % 3 % change , respectively ) , but declined with placebo ( -5.0 % 6 % and -2.0 % 3 % change ; P < 0.05 for both comparisons ) .


Serum procollagen type 1 N-terminal propeptide ( P1NP ) and urine collagen N-telopeptide ( NTx ) levels increased with teriparatide therapy ( 135 % 14 % and 64 % 10 % change , respectively ) .


Teriparatide-induced elevation of P1NP levels was less pronounced in severe forms of OI ( type III/IV ) compared with the milder form ( type I ) .


Type I OI patients exhibited robust BMD increases with teriparatide ; however , there was no observed benefit for those with type III/IV OI .


There was no difference in self-reported fractures between the 2 groups .


Adults with OI , particularly those with less severe disease ( type I ) , displayed a teriparatide-induced anabolic response , as well as increased hip and spine aBMD , vertebral vBMD , and estimated vertebral strength .


Trial registration .


Clinicaltrials.gov NCT00131469 .


Funding .


The Osteoporosis Imperfecta Foundation , Eli Lilly and Co. , the National Center for Advancing Translational Science ( NCATS ) at the NIH ( grant no .


UL1RR024140 ) , and the Baylor College of Medicine General Clinical Research Center ( grant no .


RR00188 ) .


To evaluate the effects of remote ischemic preconditioning ( RIPC ) on the perioperative period in elective aortic valve replacement ( AVR ) along different anaesthesia techniques .


48 patients aged 50 to 75 years ( 64 ( 56 ; 69 ) ) which were scheduled for AVR due to aortic valve stenosis were included into the prospective , randomized study .


Four groups were formed after randomization : 1 ) RIPC applied during propofol anesthesia ( RIPCprop , n = 12 ) , 2 ) RIPC applied during sevoflurane anesthesia ( RIPCsevo , n = 12 ) , 3 ) propofol anesthesia without RIPC ( CONTROLprop , n = 12 ) , 4 ) sevoflurane anesthesia without RIPC ( CONTROLsevo , n = 12 ) .


Groups were similar in baseline data of patients .


RIPC protocol : three five-minutes episodes of simultaneous both lower limbs ischemia with five-minutes reperfusion intervals .


Troponin I ( cTrI ) , interleukin-6 ( IL-6 ) , Interleukin-8 ( IL-8 ) and C-reactive protein ( CRP ) levels were assessed prior to induction of anesthesia , at 30 min , 6 , 12 , 24 and 48 hours after the cessation of CPB .


Significant differences were assessed by the nonparametric Mann-Whitney and Fisher 's exact tests .


Data are presented as : median ( 25th percentile , 75th percentile ) .


Significant differences in cTnI were found between RIPCsevo and CONTROLsevo groups at 6 , 12 and 24 hours : 1.68 ( 1.28 , 2.09 ) ng/ml vs 3.66 ( 2.07 , 4.49 ) ng/ml , respectively at 6 hours ( p = 0.04 ) ; 1.89 ( 1.59 , 2.36 ) ng/ml vs 3.66 ( 2.91 , 5.64 ) ng/ml , respectively at 12 hours ( p = 0.001 ) ; 1.68 ( 1.55 ; 2.23 ) ng/ml vs 3.32 ( 2.10 ; 5.46 ) ng/ml , respectively at 24 hours ( p = 0.01 ) .


There were no differences found in cTnI between RIPCprop and CONTROLprop groups during the whole study .


There were no significant differences found in the levels of IL-6 and CRP between RIPC and control groups during the whole study Unexpectedly significant excess concentrations of IL-8 at 24 h were found when RIPC applied during sevoflurane anesthesia : 12.3 ( 10.6 , 14.4 ) pg/mL in RIPCsevo group vs 6.2 ( 4.8 , 11.1 ) pg/ml in CONTROLsevo group ( p = 0.02 ) .


There was no paroxysmal atrial fibrillation ( AF ) after RIPC , and 5 cases were registered in the control groups ( p = 0.02 ) .


No other significant differences in the clinical course of the postoperative period were found .


Cardioprotective effect of RIPC and its effect on systemic inflammatory response should be assessed in the selected anesthesia groups .


RIPC on the background of sevoflurane anesthesia reduces myocardial injury during AVR .


RIPC does not reduce the severity of the systemic inflammatory response after AVR .


RIPC reduces the risk of AF after AVR .


The purpose of this study is to investigate potential associations between sympathoadrenal activation and/or vasopressor/inotropic therapy and endothelial activation , damage , and coagulopathy in septic patients .


Septic patients included in the Scandinavian Starch for Severe Sepsis/Septic Shock trial who were expected not to receive catecholamines at screening preintervention ( baseline ) and had baseline blood sampled .


Clinical , outcome data , and measurements of plasma concentration ( p - ) biomarkers reflecting sympathoadrenal activation , endothelial activation and damage , natural anticoagulation , fibrinolysis , cell damage , and platelet activation .


Sixty-seven patients were included , of whom 14 turned out to receive noradrenaline infusion at blood sampling .


These 14 patients had p-noradrenaline 5-fold higher than patients not receiving catecholamines ( n = 53 ) , whereas no other baseline preintervention biomarkers differed .


In the 53 patients not receiving catecholamines at blood sampling , endogenous p-noradrenaline correlated positively with adrenaline , syndecan 1 , soluble vascular endothelial growth factor receptor 1 , soluble CD40 ligand , tissue-type plasminogen activator , and plasminogen activator inhibitor 1 ( PAI-1 ) and negatively with PAI-1 / tissue-type plasminogen activator ratio ( all P < .05 ) and was independently associated with syndecan 1 , soluble vascular endothelial growth factor receptor 1 , and PAI-1 ( all P < .05 ) , and 28 - and 90-day mortality ( P < .05 ) .


In septic patients , endogenous noradrenaline was independently associated with biomarkers of endothelial activation , damage , fibrinolysis and mortality , comparable with findings in trauma and myocardial infarction patients .


The catecholamine surge in critical illness may contribute to balance endothelial damage and procoagulation with hypocoagulability and hyperfibrinolysis in the circulating blood .


The objective was to determine the effects of omega-3 supplementation on nutritional state and inflammatory markers of hemodialysis patients .


This was a randomized , placebo-controlled trial .


Adult patients undergoing maintenance hemodialysis were included .


Patients with malignancy , pregnancy , concurrent inflammatory or infectious diseases , or concomitant use of any medication affecting inflammation status were excluded .


The omega-3 group received 6 soft-gel capsules of fish oil ( 180mg eicosapentaenoic acid and 120mg docosahexaenoic acid in each ) daily for 4months , and the placebo group received corresponding paraffin oil capsules.Nutrition indices including body mass index ; mid-arm muscle circumference ; serum concentrations of albumin , prealbumin , and transferrin ; and serum levels of inflammatory/anti-inflammatory markers including interleukin ( IL ) -6 , IL-10 , tumor necrosis factor ( TNF ) - , C-reactive protein , ferritin , parathyroid hormone , and ratios of IL-10 to TNF - and IL-10 to IL-6 were measured before and after 4months of intervention .


Twenty patients in the placebo and 25 patients in the omega-3 group completed the study .


There were no significant changes in nutritional markers between the omega-3 and placebo groups after 4months of intervention .


Regression analysis adjusting post-treatment values of nutrition markers for baseline values , omega-3 treatment , and patients ' baseline demographic and clinical data revealed that omega-3 treatment was a significant independent predictor of increased serum prealbumin level ( 182.53 ; 95 % confidence interval 21.14 , 511.18 ; P = .11 ) .


Although slight reduction of inflammatory state was observed in the omega-3 group , no significant differences were evident in the mean changes of inflammatory and anti-inflammatory markers between the 2 groups with the exception of serum ferritin level and the IL-10 to IL-6 ratio , which significantly changed in favor of omega-3 supplementation ( P < .001 and P = .003 , respectively ) .


Omega-3 supplementation in hemodialysis patients produced a slight attenuation in systemic inflammation without any remarkable effects on nutritional markers .


To improve gait and balance in patients with Parkinson 's disease by combining anodal transcranial direct current stimulation with physical training .


In a double-blind design , one group ( physical training ; n = 8 ) underwent gait and balance training during transcranial direct current stimulation ( tDCS ; real/sham ) .


Real stimulation consisted of 15 minutes of 2 mA transcranial direct current stimulation over primary motor and premotor cortex .


For sham , the current was switched off after 30 seconds .


Patients received the opposite stimulation ( sham/real ) with physical training one week later ; the second group ( No physical training ; n = 8 ) received stimulation ( real/sham ) but no training , and also repeated a sequential transcranial direct current stimulation session one week later ( sham/real ) .


Hospital Srio Libanes , Buenos Aires , Argentina .


Sixteen community-dwelling patients with Parkinson 's disease .


Transcranial direct current stimulation with and without concomitant physical training .


Gait velocity ( primary gait outcome ) , stride length , timed 6-minute walk test , Timed Up and Go Test ( secondary outcomes ) , and performance on the pull test ( primary balance outcome ) .


Transcranial direct current stimulation with physical training increased gait velocity ( mean = 29.5 % , SD = 13 ; p < 0.01 ) and improved balance ( pull test : mean = 50.9 % , SD = 37 ; p = 0.01 ) compared with transcranial direct current stimulation alone .


There was no isolated benefit of transcranial direct current stimulation alone .


Although physical training improved gait velocity ( mean = 15.5 % , SD = 12.3 ; p = 0.03 ) , these effects were comparatively less than with combined tDCS + physical therapy ( p < 0.025 ) .


Greater stimulation-related improvements were seen in patients with more advanced disease .


Anodal transcranial direct current stimulation during physical training improves gait and balance in patients with Parkinson 's disease .


Power calculations revealed that 14 patients per treatment arm ( = 0.05 ; power = 0.8 ) are required for a definitive trial .


The purpose of the study is to investigate the efficacy of an alpha-1 adrenergic receptor antagonist ( silodosin ) for the treatment of lower urinary tract symptoms ( LUTS ) associated with interstitial ( 125 ) I implantation for prostate cancer .


This randomized single-center study involved 105 patients ( 53 with and 52 without silodosin ) .


Silodosin was postoperatively administered , daily , for 6 months ( 8 mg/day ) .


Urinary symptoms and pressure flow were evaluated preoperatively and postoperatively at 1 , 3 , 6 , and 12 months .


At 12 months , interstitial ( 125 ) I implantation had induced a significant decrease in prostate volume ( 28.3 11.1-20 .5 8.1 g in the silodosin group and 26.1 9.7-17 .7 4.9 g in the controls ) and the prostate-specific antigen level ( 7.1 3.6-1 .4 1.7 ng/mL in the silodosin group and 8.1 4.3-1 .3 1.2 ng/mL in the controls ) .


Significant improvements in the international prostate symptom voiding subscores at 6 months and quality of life at 3 months were observed in those receiving silodosin .


The pressure flow studies demonstrated that silodosin had significantly enlarged the bladder capacity when the first non-voiding contraction was seen at 3 and 12 months ( 3M : 127.1 74.8 vs. 118.2 83.9 mL , p = 0.001 ; 12M : 123.7 79.3 vs. 100.3 73.4 mL , p = 0.01 ) ; however , there were no improvements in the bladder outlet obstruction index ( BOOI ) or urinary flow .


Silodosin temporarily improved LUTS , but did not improve the BOOI after ( 125 ) I implantation in the prostate .


The purpose of this prospective and randomized clinical study was to assess differences in patient morbidity between minimally invasive lateral sinus elevation ( study group , n = 14 ) and conventional one-stage lateral sinus elevation ( control group , n = 12 ) .


It was hypothesized that trauma to soft tissue was reduced in the study group .


Optical 3-D imaging was assessed blinded on days 1 and 7 after surgery to determine the visible soft tissue swelling of the upper lip and cheeks .


Postoperative pain and discomfort were evaluated by a visual analogue scale ( VAS ; scale 0-10 ) .


Immediately and on day 1 after surgery , the study group patients rated pain and discomfort as 2.4 [ SD 1.7 ] and 3.1 [ SD 2.1 ] , respectively , on the VAS ; while , the controls rated 4 [ SD 1.6 ] and 5.6 [ SD 1.7 ] , respectively .


The mean facial soft tissue volume change , assessed on day 1 after surgery , was 5.0 cm ( 3 ) [ range : 0.2-9 .2 ] for the study group and 15.5 cm ( 3 ) ( 9.3-21 .55 ) for the controls ( p = 0.00 ) .


Despite the small number of patients in this prospective study , 3-D based minimally invasive one-stage lateral sinus elevation resulted in favourable patient morbidity with less postoperative visible facial soft tissue volume changes .


The purpose of this study was to investigate if differences in spinal height changes in healthy individuals were observed after a period of spinal unloading using repetitive as compared with sustained lumbar extension exercises .


This study used a pretest , posttest , crossover design .


Asymptomatic participants were recruited using convenience sampling .


Thirty-two participants ( 15 male ; 17 female ) without back pain were included in the data analysis ( mean , 24.4 years ; range , 20-41 years ) .


Participants performed sustained or repetitive prone lumbar extension exercises after 1 hour of sustained spinal unloading .


Spinal height was measured using a stadiometer before and after the repetitive and sustained prone lumbar extension exercises .


Paired t tests revealed no significant difference in spine height after repetitive ( P = .774 ) or sustained ( P = .545 ) prone lumbar extension after a period of spinal unloading .


No significant difference between spinal height changes occurred between sustained ( mean [ SD ] , -0.28 [ 2.59 ] mm ) and repetitive ( mean [ SD ] , -0.12 [ 2.42 ] mm ) lumbar extension ( P = .756 ) .


In this group of asymptomatic individuals , sustained and repetitive lumbar extension exercises did not appear to affect spinal height after a period of spinal unloading .


Skills in single-incision laparoscopic surgery ( SILS ) are difficult to acquire .


Simulation training leads to skill acquisition but circumstances about skill deterioration are unclear .


The aim of this study was to evaluate skill acquisition and retention after single-incision laparoscopic simulation training .


From October 2013 to January 2014 , 30 surgically naive participants underwent a SILS training curriculum and completed two validated tasks ( peg transfer , precision cutting ) with subsequent testing to assess acquisition of skills ( baseline testing , BT ) .


The participants were randomized into two groups and skill retention testing ( RT ) was measured after 4 weeks ( group A ) or 12 weeks ( group B ) .


Task completion was measured in time with penalties for inaccurate performance .


A SILS training curriculum was established .


90 % of the participants completed the training successfully and reached the required levels of proficiency .


Comparison of BT and RT revealed significantly better RT performances for peg transfer and precision cutting in group A ( P < 0.05 ) .


These effects were not seen for RT in group B. Evaluating the RT performance of both groups , group A showed a non-significant trend for improved peg transfer and precision cutting compared to group B.


A proficiency-based training curriculum for acquisition of basic SILS skills was successfully established in our department .


The results of this study indicate that acquired SILS skills are well retained for a short period without training ( 4 weeks ) but a longer non-training period ( 12 weeks ) resulted in a significant loss of acquired skills .


For enhancement of surgical skills , specialised SILS training curricula could be developed for novices and inexperienced surgeons ; however , continuous training is essential to maintain these acquired skills .


To reduce radiation exposure of frequently performed radiographs of the knee in follow-up of total-knee arthroplasty ensuring accurate assessment by using objective quality control criteria .


In this prospective randomized study 278 radiographs of the knee in follow-up of total-knee arthroplasty were performed with standard and 37 % reduced radiation dose .


The evaluation of the plain-radiographs was conducted using the following criteria : bone-implant interface , implant-surface character , implant-implant discrimination and periarticular heterotopic ossification .


Two radiologists evaluated these criteria using a score ranging from 1 ( definitely assessable ) to 4 ( not assessable ) .


If a single criterion had been evaluated with a score 3 or more than 2 criteria with 2 points , the radiograph was score das `` not assessable '' .


The study was designed as non-inferiority-trial .


100 % of examined radiographs were scored as assessable , hence no statistical inferiority between the examinations with standard and reduced dose could be observed .


Singular assessment of the defined criteria was likewise dose-independent .


Plain-radiography of the knee following total-knee arthroplasty can be performed with 63 % of standard dose without loss of diagnostic validity .


Due to the non-inferiority of digital radiographs of the knee joint after total-knee arthroplasty done with 37 % reduced image receiver dose we recommend the tested speed class of SC 800 as a new reference value for digital radiographs with this indication .


The present study was conducted to investigate the influence of different operating table heights on the quality of laryngeal view and the discomfort of the anaesthetist during enodotracheal intubation .


Eight anaesthetists participated , to each of whom 20 patients were allocated .


Before induction of anaesthesia , the height of the operating table was adjusted to place the patient 's forehead at one of four landmarks on the anaesthetist 's body ( the order being determined by block randomization with eight blocks ) : umbilicus ( Group U ) , lowest rib margin ( Group R ) , xiphoid process ( Group X ) , and nipple ( Group N ) .


Next , the anaesthetist began the laryngoscopy and evaluated the grade of laryngeal view .


For this ` initial posture ' , the anaesthetist was not allowed to adjust his or her posture ( flexion or extension of the neck , lower back , knee , and ankle ) .


This laryngeal view was then re-graded after these constraints were relaxed .


At each posture , the anaesthetist 's joint movements and discomfort during mask ventilation or intubation were evaluated .


The laryngeal view before postural changes was better in Group N than in Group U ( P = 0.003 ) .


The objective and subjective measurements of neck or lower back flexion during intubation were higher in Group U than in Groups X and N ( P < 0.01 for each ) .


The improvement of laryngeal view resulting from postural changes correlated with the anaesthetist 's discomfort score before the postural change ( P < 0.01 ) .


Higher operating tables ( at the xiphoid process and nipple level of the anaesthetist ) can provide better laryngeal views with less discomfort during tracheal intubation .


TRIAL REGISTRY NUMBER : NCT01649973 ( clinicaltrials.gov ) .


This study examines the efficacy of an online screening decision aid ( DA ) for men with a family history of prostate cancer .


Unaffected Australian men ( 40-79 years ) with at least one affected relative completed the first online questionnaire , were randomized to read either the tailored DA ( intervention ) or nontailored information about prostate cancer screening ( control ) , then completed a questionnaire postreading and 12 months later .


The primary outcome was decisional conflict regarding prostate specific antigen ( PSA ) testing .


The impact of the DA on longitudinal outcomes was analyzed by using random intercept mixed effects models .


Logistic and linear regressions were used to analyze the impact of the DA on screening behavior and decision regret .


Stage of decision-making was tested as a moderator for decisional conflict and decision regret .


The frequency of online material access was recorded .


The DA had no effect on decisional conflict , knowledge , inclination toward PSA testing , accuracy of perceived risk , or screening behavior .


However , among men considering PSA testing , those who read the DA had lower decision regret compared with men who read the control materials , = 0.34 , p < .001 , 95 % confidence interval ( CI ) = [ .22 , .53 ] .


This is the first study to our knowledge to evaluate the uptake and efficacy of an online screening DA among men with a family history of prostate cancer .


Men who were undecided about screening at baseline benefitted from the DA , experiencing less regret 12 months later .


In relation to decisional conflict , the control materials may have operated as a less complex and equally informative DA .


Despite decades of nutrition education , the prevalence of unhealthy dietary patterns is still high and inequalities in intake between high and low socioeconomic groups still exist .


Therefore , it is important to innovate and improve existing nutrition education interventions .


This paper describes the development , design and evaluation protocol of a web-based computer-tailored nutrition education intervention for adults targeting fruit , vegetable , high-energy snack and fat intake .


This intervention innovates existing computer-tailored interventions by not only targeting motivational factors , but also volitional and self-regulation processes and environmental-level factors .


The intervention development was guided by the Intervention Mapping protocol , ensuring a theory-informed and evidence-based intervention .


Two versions of the intervention were developed : a basic version targeting knowledge , awareness , attitude , self-efficacy and volitional and self-regulation processes , and a plus version additionally addressing the home environment arrangement and the availability and price of healthy food products in supermarkets .


Both versions consist of four modules : one for each dietary behavior , i.e. fruit , vegetables , high-energy snacks and fat .


Based on the self-regulation phases , each module is divided into three sessions .


In the first session , feedback on dietary behavior is provided to increase awareness , feedback on attitude and self-efficacy is provided and goals and action plans are stated .


In the second session goal achievement is evaluated , reasons for failure are explored , coping plans are stated and goals can be adapted .


In the third session , participants can again evaluate their behavioral change and tips for maintenance are provided .


Both versions will be evaluated in a three-group randomized controlled trial with measurements at baseline , 1-month , 4-months and 9-months post-intervention , using online questionnaires .


Both versions will be compared with a generic nutrition information control condition .


The primary outcomes are fruit , vegetable , high-energy snack and fat intake .


The evaluation study will provide insight into the short - and long-term efficacy of both intervention versions in adults .


Additionally , differences in the efficacy among high - and low-educated people will be examined .


If these interventions are effective , two well-developed interventions will become available for the implementation and promotion of healthy dietary patterns among both high - and low-educated adults in the Netherlands .


Dutch Trial Registry NTR3396 .


Lymphoceles are a common complication after pelvic lymphadenectomy in women with gynecologic malignancies .


Although typically asymptomatic , lymphoceles can superinfect requiring medical or surgical intervention .


A single center randomized controlled trial provided first evidence , that a collagen-fibrin patch ( Tachosil ) is effective in the prevention of symptomatic lymphoceles after pelvic lymphadenectomy .


We will perform a multicentre , blinded , randomized , controlled trial comprising 140 women with gynecologic malignancies undergoing pelvic lymphadenectomy .


Women will be randomly allocated to Tachosil application or no application .


Primary outcome is efficacy , defined as lymphocele CTCAE 4.03 grade 2 within four weeks after surgery .


Secondary outcomes are asymptomatic lymphocele verified by ultrasound , medical or surgical intervention .


Assuming a two-sided 5 % significance level , a power of 80 % , and a drop out rate of 10 % , a sample size of 68 patients per group was calculated to detect a 66 % absolute decrease in symptomatic lymphoceles .


We aim to provide further evidence for the efficacy of a collagen-fibrin patch in the prevention of symptomatic lymphoceles in women with gynecological malignancies undergoing pelvic lymphadenectomy .


This study is registered at ClinicalTrials.gov ( NCT01470677 , protocol ID : TACHO-1 ) .


This study is registered at the EudraCT database ( EudraCT number : 2011-003115-34 ) .


South African alcohol-serving establishments ( i.e. , shebeens ) offer unique opportunities to reduce HIV risks among men who drink .


To test an individual - and a social structural-level HIV prevention intervention for men who drink in shebeens .


Twelve matched pairs of township neighbourhoods were randomized to receive either ( i ) an HIV prevention intervention ( guided by Social Action Theory ) to reduce sexual risk and increase risk reduction communication in social networks , or ( ii ) an attention-matched control intervention that focused on the prevention of relationship violence .


At the individual level , the interventions delivered skills building workshops focused on sexual risk reduction .


At the social structural level , the intervention aimed to increase conversations about safer sex among men in the shebeens , distributed small media and implemented community educational events .


Individual-level outcomes were assessed by following the workshop cohorts for 1 year ( N = 984 ) , and community-level outcomes were examined through cross-sectional community surveys conducted for 1 year in the shebeens ( N = 9,678 ) .


Men in the HIV prevention workshops demonstrated greater condom use , more HIV prevention-oriented conversations and greater perceptions of safer sex norms than men in the comparison workshops .


Changes at the community level demonstrated significant differences in condom use , although the pattern was not consistent over time .


Multi-level interventions that target men who drink in South African shebeens may help reduce risks for HIV and other sexually transmitted infections .


There is no standardized method for cold pressor pain tasks across experiments .


Temperature , apparatus and aspects of experimenters vary widely among studies .


It is well known that experimental pain tolerance is influenced by setting as well as the sex of the experimenter .


It is not known whether other contextual factors influence experimental pain reporting .


The present two-part experiment examines whether minimizing and standardizing interactions with laboratory personnel ( eg , limiting interaction with participants to consenting and questions and not during the actual pain task ) eliminates the influence of examiner characteristics on subjective pain reports and whether using different cold pain apparatus ( cooler versus machine ) influences reports .


The present experiment manipulated the gender of the experimenter ( male , female and transgender ) and the type of cold pressor task ( CPT ) apparatus ( ice cooler versus refrigerated bath circulator ) .


Participants conducted the CPT at one of two pain levels ( 5C or 16C ) without an experimenter present .


Men and women showed lower pain sensitivity when they were processed by biological male personnel than by biological female personnel before the CPT .


Women who interacted with a transgendered researcher likewise reported higher pain sensitivity than women processed by biological male or female researchers .


The type of CPT apparatus , despite operating at equivalent temperatures , also influenced subjective pain reports .


The findings show that even minimal interactions with laboratory personnel who differ in gender , and differences in laboratory materials impact the reliable measurement of pain .


More standardized protocols for measuring pain across varying research and clinical settings should be developed .


Alteplase is the only approved thrombolytic agent for acute ischaemic stroke .


The overall benefit from alteplase is substantial , but some evidence indicates that alteplase also has negative effects on the ischaemic brain .


Tenecteplase may be more effective and less harmfull than alteplase , but large randomised controlled phase 3 trials are lacking .


The Norwegian Tenecteplase Stroke Trial ( NOR-TEST ) aims to compare efficacy and safety of tenecteplase vs. alteplase .


NOR-TEST is a multi-centre PROBE ( prospective randomised , open-label , blinded endpoint ) trial designed to establish superiority of tenecteplase 0.4 mg/kg ( single bolus ) as compared with alteplase 0.9 mg/kg ( 10 % bolus +90 % infusion/60minutes ) for consecutively admitted patients with acute ischaemic stroke eligible for thrombolytic therapy , i.e. patients a ) admitted < 4hours after symptoms onset ; b ) admitted < 4hours after awakening with stroke symptoms c ) receiving bridging therapy before embolectomy.Randomisation tenecteplase : alteplase is 1:1 .


The primary study endpoint is favourable functional outcome defined as modified Rankin Scale 0-1 at 90days .


Secondary study endpoints are : 1 ) haemorrhagic transformation ( haemorrhagic infarct/haematoma ) ; 2 ) symptomatic cerebral haemorrhage on CT 24-48 hours ; 3 ) major neurological improvement at 24hours ; 4 ) recanalisation at 24-36 hours ; 5 ) death .


NOR-TEST may establish a novel approach to acute ischaemic stroke treatment .


A positive result will lead to a more effective , safer and easier treatment for all acute ischaemic stroke pasients.NOR-TEST is reviewed and approved by the Regional Committee for Medical and Health Research Ethics ( 2011/2435 ) , and The Norwegian Medicines Agency ( 12/01402 ) .


NOR-TEST is registered with EudraCT No 2011-005793-33 and in ClinicalTrials.gov ( NCT01949948 ) .


The intensity of pain after cardiac surgery is often underestimated , and inadequate pain control may be associated with poorer quality of recovery .


The aim of this investigation was to examine the effect of intraoperative methadone on postoperative analgesic requirements , pain scores , patient satisfaction , and clinical recovery .


Patients undergoing cardiac surgery with cardiopulmonary bypass ( n = 156 ) were randomized to receive methadone ( 0.3 mg/kg ) or fentanyl ( 12 g/kg ) intraoperatively .


Postoperative analgesic requirements were recorded .


Patients were assessed for pain at rest and with coughing 15min and 2 , 4 , 8 , 12 , 24 , 48 , and 72h after tracheal extubation .


Patients were also evaluated for level of sedation , nausea , vomiting , itching , hypoventilation , and hypoxia at these times .


Postoperative morphine requirements during the first 24h were reduced from a median of 10mg in the fentanyl group to 6mg in the methadone group ( median difference [ 99 % CI ] , -4 [ -8 to -2 ] mg ; P < 0.001 ) .


Reductions in pain scores with coughing were observed during the first 24h after extubation ; the level of pain with coughing at 12h was reduced from a median of 6 in the fentanyl group to 4 in the methadone group ( -2 [ -3 to -1 ] ; P < 0.001 ) .


Improvements in patient-perceived quality of pain management were described in the methadone group .


The incidence of opioid-related adverse events was not increased in patients administered methadone .


Intraoperative methadone administration resulted in reduced postoperative morphine requirements , improved pain scores , and enhanced patient-perceived quality of pain management .


Involving family as part of the patient 's rehabilitation plan of care might enhance the management of COPD .


The primary aim of this study was to investigate the impact of a family-based pulmonary rehabilitation ( PR ) program on patients and family members ' coping strategies to manage COPD .


Family dyads ( patient and family member ) were randomly assigned to family-based ( experimental ) or conventional ( control ) PR .


Patients from both groups underwent exercise training three times a week and psychosocial support and education once a week , during 12 weeks .


Family members of the family-based PR attended the psychosocial support and education sessions together with patients .


In the conventional PR , family members did not participate .


Family coping and psychosocial adjustment to illness were assessed in patients and family members of both groups .


Patients ' exercise tolerance , functional balance , muscle strength , and health-related quality of life were also measured .


All measures were collected pre/post-program .


Forty-two dyads participated ( patients : FEV1 , 70.4 % 22.1 % predicted ) .


Patients ( P = .048 ) and family members ( P = .004 ) in the family-based PR had significantly greater improvements in family coping than the control group .


Family members of the family-based PR had significantly greater changes in sexual relationships ( P = .026 ) and in psychologic distress ( P = .033 ) compared with the control group .


Patients from both groups experienced significant improvements in exercise tolerance , functional balance , knee extensors strength , and health-related quality of life after intervention ( P < .001 ) .


This research supports family-based PR programs to enhance coping and psychosocial adjustment to illness of the family system .


ClinicalTrials.gov ; No. : NCT02048306 ; URL : www.clinicaltrials.gov .


The Italian Association of Medical Physics ( AIFM ) started a working group dedicated to stereotactic body radiotherapy ( SBRT ) treatment .


In this work , we performed a multicenter planning study on patients who were candidates for SBRT in the treatment of prostate cancer with the aim of evaluating the dosimetric consistency among the different hospitals .


Fourteen centers were provided the contours of 5 patients .


Plans were performed following the dose prescription and constraints for organs at risk ( OARs ) of a reference paper .


The dose prescription was 35 Gy in five fractions for the planning target volume ( PTV ) .


Different techniques were used ( 3D-CRT , fixed-Field IMRT , VMAT , CyberKnife ) .


Plans were compared in terms of dose-volume histogram ( DVH ) parameters .


Furthermore , the median DVH was calculated and one patient was re-planned .


A total of 70 plans were compared .


The maximum dose to the body was 107.94.5 % ( range 101.5-116 .3 % ) .


Dose at 98 % ( D98 % ) and mean dose to the clinical target volume ( CTV ) were 102.00.9 % ( global range 101.1-102 .9 % ) and 105.10.6 % ( range 98.6-124 .6 % ) .


Similar trends were found for D95 % and mean dose to the PTV .


Important differences were found in terms of the homogeneity index .


Doses to OARs were heterogeneous .


The subgroups with the same treatment planning system showed differences comparable to the differences of the whole group .


In the re-optimized plans , DVH differences among institutes were reduced and OAR sparing improved .


Important dosimetric differences with possible clinical implications , in particular related to OARs , were found .


Replanning allowed a reduction in the OAR dose and decreased standard deviations .


Multicenter clinical trials on SBRT should require a preplanning study to standardize the optimization procedure .


Delayed gastric emptying symptoms interfere with the absorption of oral medications .


Intranasal metoclopramide is being developed as an alternative to oral metoclopramide for patients with diabetic gastroparesis .


To compare the efficacy and safety of metoclopramide nasal spray to oral tablets in diabetic patients with symptoms of gastroparesis , this randomized , open-label , parallel design study randomized subjects to 10 or 20 mg nasal spray or 10 mg tablet four times a day for 6 weeks .


Efficacy was evaluated using a total symptom score ( TSS ) .


Eighty-nine subjects were enrolled .


For the intention to treat population , both nasal dose groups ( 10 and 20 mg ) had lower TSS with treatment compared to the oral 10 mg group .


The change from baseline in TSS for nasal 20 mg was greater than the oral 10 mg at Week 6 ( p = 0.026 ) .


For the per-protocol population , there was a significant difference in the TSS between baseline and Week 6 for both the nasal 10 mg ( p = 0.026 ) and the nasal 20 mg ( p = 0.008 ) cohorts compared to the oral 10 mg group .


Based on the definition of a responder , 88.9 % of subjects who received oral 10 mg , 91.2 % who received nasal 10 mg , and 97.1 % who received nasal 20 metoclopramide were classified as responders .


The side-effect profile of the metoclopramide nasal spray was favorable .


More side effects , especially nausea , occurred with the oral tablets .


Metoclopramide nasal spray offers better symptom control than metoclopramide oral tablet in diabetic patients with symptoms of gastroparesis .


A previous randomized study showed that clarithromycin decreases the risk of death due to ventilator-associated pneumonia and shortens the time until infection resolution .


The efficacy of clarithromycin was tested in a larger population with sepsis .


Six hundred patients with systemic inflammatory response syndrome due to acute pyelonephritis , acute intra-abdominal infections or primary Gram-negative bacteraemia were enrolled in a double-blind , randomized , multicentre trial .


Clarithromycin ( 1 g ) was administered intravenously once daily for 4 days consecutively in 302 patients ; another 298 patients were treated with placebo .


Mortality was the primary outcome ; resolution of infection and hospitalization costs were the secondary outcomes .


The groups were well matched for demographics , disease severity , microbiology and appropriateness of the administered antimicrobials .


Overall 28 day mortality was 17.1 % ( 51 deaths ) in the placebo arm and 18.5 % ( 56 deaths ) in the clarithromycin arm ( P = 0.671 ) .


Nineteen out of 26 placebo-treated patients with septic shock and multiple organ dysfunctions died ( 73.1 % ) compared with 15 out of 28 clarithromycin-treated patients ( 53.6 % , P = 0.020 ) .


The median time until resolution of infection was 5 days in both arms .


In the subgroup with severe sepsis/shock , this was 10 days in the placebo arm and 6 days in the clarithromycin arm ( P = 0.037 ) .


The cost of hospitalization was lower after treatment with clarithromycin ( P = 0.044 ) .


Serious adverse events were observed in 1.3 % and 0.7 % of placebo - and clarithromycin-treated patients , respectively ( P = 0.502 ) .


Intravenous clarithromycin did not affect overall mortality ; however , administration shortened the time to resolution of infection and decreased the hospitalization costs .


The rate and effect of coronary interventions and induced hypothermia after out-of-hospital cardiac arrest ( OHCA ) are unknown .


We measured the association of early ( 24h after arrival ) coronary angiography , reperfusion , and induced hypothermia with favorable outcome after OHCA .


We performed a secondary analysis of a multicenter clinical trial ( NCT00394706 ) conducted between 2007 and 2009 in 10 North American regions .


Subjects were adults ( 18 years ) hospitalized after OHCA with pulses sustained 60min .


We measured the association of early coronary catheterization , percutaneous coronary intervention , fibrinolysis , and induced hypothermia with survival to hospital discharge with favorable functional status ( modified Rankin Score3 ) .


From 16,875 OHCA subjects , 3981 ( 23.6 % ) arrived at 151 hospitals with sustained pulses .


1317 ( 33.1 % ) survived to hospital discharge , with 1006 ( 25.3 % ) favorable outcomes .


Rates of early coronary catheterization ( 19.2 % ) , coronary reperfusion ( 17.7 % ) or induced hypothermia ( 39.3 % ) varied among hospitals , and were higher in hospitals treating more subjects per year .


Odds of survival and favorable outcome increased with hospital volume ( per 5 subjects/year OR 1.06 ; 95 % CI : 1.04-1 .08 and OR 1.06 ; 95 % CI : 1.04 , 1.08 , respectively ) .


Survival and favorable outcome were independently associated with early coronary angiography ( OR 1.69 ; 95 % CI 1.06-2 .70 and OR 1.87 ; 95 % CI 1.15-3 .04 ) , coronary reperfusion ( OR 1.94 ; 95 % CI 1.34-2 .82 and OR 2.14 ; 95 % CI 1.46-3 .14 ) , and induced hypothermia ( OR 1.36 ; 95 % CI 1.01-1 .83 and OR 1.42 ; 95 % CI 1.04-1 .94 ) .


Early coronary intervention and induced hypothermia are associated with favorable outcome and are more frequent in hospitals that treat higher numbers of OHCA subjects per year .


Previous studies conducted on animals linked consumption of Nigella sativa L. seeds ( NS ) to decreased anxiety and improved memory .


The present study , which was carried out at a boarding school in Bangladesh , was designed to examine probable effect of NS on mood , anxiety and cognition in adolescent human males .


Forty-eight healthy adolescent human males aged between 14 to 17 years were randomly recruited as volunteers and were randomly split into two groups : A ( n = 24 ) and B ( n = 24 ) .


The treatment procedure for group A and B were one capsule of 500 mg placebo and 500 mg NS respectively once daily for four weeks .


All the volunteers were assessed for cognition with modified California verbal learning test-II ( CVLT-II ) , mood with Bond-Lader scale and anxiety with State-Trait Anxiety Inventory ( STAI ) at the beginning and after four weeks of either NS or placebo ingestion .


No parameter showed statistically significant variation between A and B in measurements in the beginning , but after 4 weeks of one capsule of NS 500 mg intake , there was statistically significant variation of mood within group B but there was not statistically significant variation between group A and B. No significant variation was found in state anxiety within groups and between group A and B but in case of trait anxiety , significant variation was found within group B but not between group A and B.


In case of CVLT II , there was significant variation within B in immediate short-term recall at trial 4 and 5 whereas this difference was found only in case of trial 5 between group A and B. Within group B , short term-free recall , long-term free recall and long-term cued recall had statistical difference whereas between group A and B long-term free recall and long-term cued recall had statistical difference .


No parameters had significant variation within group A after placebo intake for 4 weeks .


Over the 4 weeks study period , the use of NS as a nutritional supplement been observed to - stabilize mood , decrease anxiety and modulate cognition positively .


However , long term study is suggested before using NS extensively .


Although noninvasive positive pressure ventilation ( NPPV ) has been successfully used for various kinds of acute respiratory failure , the data are limited regarding its application in postoperative respiratory failure after cardiac surgery .


Therefore , we conducted a prospective randomized control study in a university surgical intensive care unit to evaluate the efficacy and safety of NPPV in the treatment of acute respiratory failure after cardiac surgery , and explore the predicting factors of NPPV failure .


From September 2011 to November 2012 patients with acute respiratory failure after cardiac surgery who had indication for the use of NPPV were randomly divided into a NPPV treatment group ( NPPV group ) and the conventional treatment group ( control group ) .


The between-group differences in the patients ' baseline characteristics , re-intubation rate , tracheotomy rate , ventilator associated pneumonia ( VAP ) incidence , in-hospital mortality , mechanical ventilation time after enrollment ( MV time ) , intensive care unit ( ICU ) and postoperative hospital stays were compared .


The factors that predict NPPV failure were analyzed .


During the study period , a total of 139 patients who had acute respiratory failure after cardiac surgery were recorded , and 95 of them met the inclusion criteria , which included 59 males and 36 females with a mean age of ( 61.5 11.2 ) years .


Forty-three patients underwent coronary artery bypass grafting ( CABG ) , 23 underwent valve surgery , 13 underwent CABG + valve surgery , 13 underwent major vascular surgery , and three underwent other surgeries .


The NPPV group had 48 patients and the control group had 47 patients .


In the NPPV group , the re-intubation rate was 18.8 % , tracheotomy rate was 12.5 % , VAP incidence was 0 , and the in-hospital mortality was 18.8 % , significantly lower than in the control group 80.9 % , 29.8 % , 17.0 % and 38.3 % respectively , P < 0.05 or P < 0.01 .


The MV time and ICU stay ( expressed as the median ( P25 , P75 ) ) were 18.0 ( 9.2 , 35.0 ) hours and 4.0 ( 2.0 , 5.0 ) days , which were significantly shorter than in the control group , 96.0 ( 26.0 , 240.0 ) hours and 6.0 ( 4.0 , 9.0 ) days respectively , P < 0.05 or P < 0.01 .


The postoperative hospital stays of the two groups were similar .


The univariate analysis showed that the NPPV success subgroup had more patients with acute lung injury ( ALI ) ( 17 vs. 0 , P = 0.038 ) , fewer patients with pneumonia ( 2 vs. 7 , P < 0.001 ) and lower acute physiology and chronic health evaluation II ( APACHE II ) scores ( 16.1 2.8 vs. 21.8 3.2 , P < 0.001 ) .


Multivariate analysis showed that pneumonia ( P = 0.027 ) and a high APACHE II score > 20 ( P = 0.002 ) were the independent risk factors of NPPV failure .


We conclude that NPPV can be applied in selected patients with acute respiratory failure after cardiac surgery to reduce the need of re-intubation and improve clinical outcome as compared with conventional treatment .


Pneumonia and a high APACHE II score > 20 might be the independent risk factors of NPPV failure in this group of patients .


Rifaximin is a gut-selective , oral antimicrobial agent shown to reduce the recurrence of overt hepatic encephalopathy ( HE ) and HE-related hospitalizations in a 6-month , randomized , controlled trial ( RCT ) .


We performed a phase 3 , open-label maintenance study to assess the safety and rate of hospitalization with long-term rifaximin use .


We conducted a 24-month , open-label maintenance study of rifaximin ( 550 mg , twice daily ) in patients with HE who participated in the previous RCT of rifaximin or new patients enrolled from March 2007 to December 2010 .


Safety was assessed ( adverse events , clinical laboratory parameters ) for the integrated population of all patients , who were given rifaximin 550 mg twice daily ( all-rifaximin population , N = 392 ) .


Safety and hospitalization data were compared between the group given placebo in the original RCT ( n = 159 ) and those given rifaximin ( n = 140 ) .


In the all-rifaximin population , the median exposure to rifaximin was 427.0 days ( range , 2-1427 d ) , with 510.5 person-years of exposure .


The profile and rate of adverse events with long-term rifaximin treatment were similar to those of the original RCT .


There was no increase in the rate of infections , including with Clostridium difficile , or development of bacterial antibiotic resistance .


Rates of hospitalizations with long-term rifaximin administration remained low : the HE-related hospitalization rate , normalized for exposure ( 0.21 ; all-rifaximin population ) , was similar to that of the rifaximin group in the original RCT ( 0.30 ) , and lower than that for the placebo group ( 0.72 ) .


Long-term treatment ( 24 mo ) with rifaximin ( 550 mg , twice daily ) appears to provide a continued reduction in the rate of HE-related and all-cause hospitalization , without an increased rate of adverse events .


ClinicalTrials.gov number : NCT00686920 .


Physical activity levels of Australia 's ageing population are declining and coincidentally rates of overweight and obesity are increasing .


Adequate levels of physical activity and a healthy diet are recognised as important lifestyle factors for the maintenance of a healthy weight and prevention of chronic diseases .


Retirement village ( RV ) residents rarely engage in physical activity and nutrition programmes offered , with poor attendance and low use of existing facilities such as on-site fitness centres and classes and nutrition seminars .


The RV provides a unique setting to access and engage with this older target group , to test the effectiveness of strategies to increase levels of physical activity , improve nutrition and maintain a healthy weight .


This cluster-randomised controlled trial will evaluate a physical activity , nutrition and healthy weight management intervention for insufficiently active ( ` not achieving 150 min of moderate-intensity physical activity per week ' ) adults aged 60-75 residing in RV 's .


A total of 400 participants will be recruited from 20 randomly selected RV 's in Perth , Western Australia .


Villages will be assigned to either the intervention group ( n = 10 ) or the control group ( n = 10 ) each containing 200 participants .


The Retirement Village Physical Activity and Nutrition for Seniors ( RVPANS ) programme is a home-based physical activity and nutrition programme that includes educational resources , along with facilitators who will motivate and guide the participants during the 6-month intervention .


Descriptive statistics and mixed regression models will be performed to assess the intervention effects .


This trial will evaluate an intervention for the modification of health risk factors in the RV setting .


Such research conducted in RV 's has been limited .


Curtin University Human Research Ethics Committee ( approval number : HR128/2012 ) .


Dissemination of the study results will occur through publications , reports , conference presentations and community seminars .


Australia and New Zealand Clinical Trial Registry ( ACTRN12612001168842 ) .


The supplementation of fat to lactating dairy cows has long been used as a management tool to increase dietary energy density for improving cow production , reproduction and to alleviate negative energy balance .


Attempts have been made to investigate the effect of canola meal on plasma metabolites in lactating cows , but the results have been diverse and inconsistent .


To our current knowledge , there is a dearth of published information on the utilization of Crude Degummed Canola Oil ( CDCO ) in pasture-based dairy systems .


Therefore , the objective of this study was to investigate the changes in plasma metabolite profiles of pasture-based , primiparous , Holstein-Friesian cows supplemented with varying dietary levels of CDCO for eight weeks .


The study tested the hypothesis that feeding grazing primiparous Holstein-Friesian cows for eight weeks with incremental levels of CDCO supplement will decrease plasma non-esterified fatty acids ( NEFA ) and - hydroxybutyrate ( BHBA ) , but increase plasma cholesterol and glucose metabolites .


Twenty lactating primiparous Holstein-Friesian cows 40 days in milk were randomly allotted into four treatment groups that consisted of a wheat-based , pelleted basal diet with no supplemental CDCO ( control ) , basal diet with CDCO added at 25 ml/kgDM ( DM ; dry matter ) ( low ) , 35 ml/kgDM ( medium ) and 50 ml/kgDM ( high ) in an eight-week feeding trial , after two weeks of adjustment .


Treatment influenced BHBA but had no effect on plasma NEFA , cholesterol and glucose metabolite profiles ( P > 0.05 ) .


However , week of supplementation had a significant effect ( P < 0.05 ) on BHBA , NEFA and glucose concentrations .


We concluded that with the exception of BHBA , CDCO at current levels of supplementation does not alter the plasma metabolite profiles of grazing primiparous cows .


The lack of significant differences across treatments seems to indicate that higher levels of CDCO than the current levels used in this study , are probably needed .


Furthermore , the duration of supplementation with CDCO had a greater impact on plasma metabolites than the levels of supplementation .


Our findings also suggest that primiparous cows grazing high quality pastures during spring have sufficient energy intakes to prevent negative energy balance at 40 days in milk without the need for added fat supplements .


To investigate the variations in blood glucose levels , hemodynamic effects and patient anxiety scores during tooth extraction in patients with type 2 diabetes mellitus T2DM and coronary disease under local anesthesia with 2 % lidocaine with or without epinephrine .


This is a prospective randomized study of 70 patients with T2DM with coronary disease who underwent oral surgery .


The study was double blind with respect to the glycemia measurements .


Blood glucose levels were continuously monitored for 24 hours using the MiniMed Continuous Glucose Monitoring System .


Patients were randomized into two groups : 35 patients received 5.4 mL of 2 % lidocaine , and 35 patients received 5.4 mL of 2 % lidocaine with 1:100,000 epinephrine .


Hemodynamic parameters ( blood pressure and heart rate ) and anxiety levels were also evaluated .


There was no difference in blood glucose levels between the groups at each time point evaluated .


Surprisingly , both groups demonstrated a significant decrease in blood glucose levels over time .


The groups showed no significant differences in hemodynamic and anxiety status parameters .


The administration of 5.4 mL of 2 % lidocaine with epinephrine neither caused hyperglycemia nor had any significant impact on hemodynamic or anxiety parameters .


However , lower blood glucose levels were observed .


This is the first report using continuous blood glucose monitoring to show the benefits and lack of side effects of local anesthesia with epinephrine in patients with type 2 diabetes mellitus and coronary disease .


An acid-base imbalance precedes renal disease progression in patients with chronic kidney disease ( CKD ) .


Little is known about the effects of a low-salt diet ( LSD ) on net endogenous acid production ( NEAP ) levels in CKD patients using angiotensin receptor blockade .


We enrolled a total of 202 nondiabetic CKD patients who underwent an 8-week treatment with olmesartan from the original trial [ Effects of Low Sodium Intake on the Antiproteinuric Efficacy of Olmesartan in Hypertensive Patients with Albuminuria ( ESPECIAL ) trial : NCT01552954 ] .


The patients were divided into good - and poor-LSD-compliance groups .


During the interventional 8 weeks , the NEAP in the good-compliance group increased compared to the control group ( 12.9 32.0 vs. -2.0 35.0 mmol/day , p = 0.002 ) .


NEAP was positively associated with the good-LSD-compliance group in the fully adjusted analyses ( r = 0.135 , p = 0.016 ) .


The additional reduction of 2.39 g/day of protein intake with a reduction of 1 g/day of salt intake did not increase the NEAP under angiotensin II receptor blockade ( ARB ) treatment with an LSD ( r = 0.546 , p < 0.001 ) .


We found that an LSD may increase the NEAP in nondiabetic CKD patients using ARB , which suggests that additional acid producing-protein restriction should be required to prevent the NEAP from rising .


Coenzyme Q10 ( CoQ10 ) supplementation is the most popular therapy for statin myalgia among both physicians and patients despite limited and conflicting evidence of its efficacy .


This study examined the effect of coenzyme Q10 ( CoQ10 ) supplementation on simvastatin-associated muscle pain , muscle strength and aerobic performance in patients with confirmed statin myalgia .


Statin myalgia was confirmed in 120 patients with prior symptoms of statin myalgia using an 8-week randomized , double-blind crossover trial of simvastatin 20mg/d and placebo .


Forty-one subjects developed muscle pain with simvastatin but not with placebo and were randomized to simvastatin 20mg/d combined with CoQ10 ( 600mg/d ubiquinol ) or placebo for 8 weeks .


Muscle pain ( Brief Pain Inventory [ BPI ] ) , time to pain onset , arm and leg muscle strength , and maximal oxygen uptake ( VO2max ) were measured before and after each treatment .


Serum CoQ10 increased from 1.30.4 to 5.22.3 mcg/mL with simvastatin and CoQ10 , but did not increase with simvastatin and placebo ( 1.30.3 to 0.80.2 ) ( p < 0.05 ) .


BPI pain severity and interference scores increased with simvastatin therapy ( both p < 0.01 ) , irrespective of CoQ10 assignment ( p = 0.53 and 0.56 ) .


There were no changes in muscle strength or VO2max with simvastatin with or without CoQ10 ( all p > 0.10 ) .


Marginally more subjects reported pain with CoQ10 ( 14 of 20 vs 7 of 18 ; p = 0.05 ) .


There was no difference in time to pain onset in the CoQ10 ( 3.02.0 weeks ) vs. placebo ( 2.42.1 wks ) groups ( p = 0.55 ) .


A similar lack of CoQ10 effect was observed in 24 subjects who were then crossed over to the alternative treatment .


Only 36 % of patients complaining of statin myalgia develop symptoms during a randomized , double-blind crossover of statin vs placebo .


CoQ10 supplementation does not reduce muscle pain in patients with statin myalgia .


Trial RegistrationNCT01140308 ; www.clinicaltrials.gov .


The purpose of this study was to investigate the effects of whole-body vibration training on muscle strength and balance in children with diplegic cerebral palsy .


Fifteen children were assigned to the experimental group , which received whole-body vibration training ( 9 mins per day , 5 days per week ) .


Another 15 were assigned to the control group , which participated in a traditional physical therapy exercise program for 3 successive months .


Baseline and posttreatment assessments were performed using the Biodex isokinetic dynamometer to evaluate the knee extensors peak torque at 60 degrees per second and 90 degrees per second and using the Biodex balance system to evaluate stability index .


The children in the experimental group showed a significant improvement when compared with those in the control group ( P < 0.001 ) .


The peak torque at 60 degrees per second and 90 degrees per second after treatment was 28.8 0.45 and 47.5 0.7 N m and 30.9 0.68 and 54.2 1.7 N m for the control and the experimental group , respectively .


The overall stability index after treatment was 2.75 and 2.2 for the control group and the experimental group , respectively .


Whole-body vibration training may be a useful tool for improving muscle strength and balance in children with diplegic cerebral palsy .


To evaluate the short-term and long-term effects on treatment of neck pain caused by cervical spondylosis with the combination of acupuncture and moxibustion with seed-size moxa cone .


One hundred and forty-five patients of neck pain were randomly divided into an acupuncture-moxibustion group ( 49 cases ) , an acupuncture group ( 48 cases ) and a moxibustion group ( 48 cases ) .


Acupoints of Bailao ( Extra ) , Dazhui ( GV 14 ) , Jianzhongshu ( SI15 ) and Zhongzhu ( TE 3 ) were adopted for all the 3 groups .


Acupuncture was applied at all the acupoints with 20 min needling retention for the acupuncture group .


Moxibustion with seed-size moxa cone was used with 5 cones on each point for the moxibustion group .


And both acupuncture and moxibustion with seed-size moxa cone were adopted for the acupuncture-moxibustion group .


The treatment was applied once every 3 days , and 10 treatments should be finished within 4 weeks .


Follow-up should be carried out for 3 months .


The short-term and long-term effects were evaluated with the scores of Northwick Park Pain Questionnaire ( NPQ ) and McGill Pain Questionnaire ( MPQ ) as the indices of therapeutic effect .


The NPQ score and MPQ score of all the 3 groups after the treating course and the 3-month follow-up were both decreased when compared with those before the treatment ( all P < 0.05 ) .


The scores of NPQ and MPQ the acupuncture-moxibustion group were lower than that of the other two groups .


And the difference had obvious significance ( P < 0.05 ) .


High efficiency of pain relieving for cervical spondylosis could be found in all the 3 groups , which showed that short-term and long-term effects were good for all the 3 groups .


And the highest curative effect could be found in acupuncture-moxibustion group .


Combination of acupuncture and moxibustion with seed-size moxa cone has reached a superior effect in short-term and long-term for neck pain caused by cervical spondylosis .


Polycystic ovary syndrome ( PCOS ) patients are at increased risk of pregnancy complications , which may impair pregnancy outcome .


Transfer of fresh embryos after superovulation may lead to abnormal implantation and placentation and further increase risk for pregnancy loss and complications .


Some preliminary data suggest that elective embryo cryopreservation followed by frozen-thawed embryo transfer into a hormonally primed endometrium could result in a higher clinical pregnancy rate than that achieved by fresh embryo transfer .


This study is a multicenter , prospective , randomized controlled clinical trial ( 1:1 treatment ratio of fresh vs. elective frozen embryo transfers ) .


A total of 1,180 infertile PCOS patients undergoing the first cycle of in vitro fertilization ( IVF ) or intracytoplasmic sperm injection will be enrolled and randomized into two parallel groups .


Participants in group A will undergo fresh embryo transfer on day 3 after oocyte retrieval , and participants in group B will undergo elective embryo cryopreservation after oocyte retrieval and frozen-thawed embryo transfer in programmed cycles .


The primary outcome is the live birth rate .


Our study is powered at 80 to detect an absolute difference of 10 at the significance level of 0.01 based on a two-sided test .


We hypothesize that elective embryo cryopreservation and frozen-thawed embryo transfer will reduce the incidence of pregnancy complications and increase the live birth rate in PCOS patients who need IVF to achieve pregnancy .


ClinicalTrials.gov Identifier : NCT01841528 .


To compare the safety and efficiency of plasmakinetic enucleation of the prostate ( PKEP ) with that of plasmakinetic resection of the prostate ( PKRP ) in the treatment of benign prostatic hyperplasia ( BPH ) .


Three hundred ten patients diagnosed to have BPH were randomized to undergo either PKEP or PKRP .


The perioperative data and postoperative outcomes followed at 1 , 3 , 6 , 12 , 18 , and 24 months after surgery were recorded and compared in the groups classified according to the baseline prostate volume : 60 mL and > 60 mL .


There were no significant differences in the preoperative data .


Compared with PKRP , PKEP costs longer operative time ( 56.1 14.6 vs 41.3 9.6 min ; P < .001 ) for prostate volume 60 mL , but reduced operative time ( 75.6 12.3 vs 88.7 14.3 minutes ; P < .001 ) and caused less blood loss ( 167.6 44.4 vs 225.7 49.5 mL ; P < .001 ) for prostate volume > 60 mL .


However , regardless of prostate size , the incidence of transient incontinence after PKEP was higher .


The postoperative improvement among these groups in International Prostate Symptom Score , quality of life , and maximal flow rate was similar at 24-month follow-up .


PKEP and PKRP are both safe and effective treatments for BPH independent of prostate size .


Despite that the incidence of transient incontinence after PKEP was higher , PKEP was significantly superior to PKRP in operative time and blood loss for prostate volume > 60 mL and may become the modern alternative to PKRP for large BPH .


Paravertebral block ( PVB ) has been shown to be an ideal aid for analgesia after thoracic or abdominal surgery .


The authors studied the safety and efficacy of the single-dose and bilateral ultrasound-guided ( USG ) - PVB before combined thoracoscopic-laparoscopic esophagectomy ( TLE ) along with intravenous sufentanil analgesia as a method of pain relief in comparison with intravenous sufentanil as a sole analgesic agent .


Prospective , randomized study .


Single university hospital .


Fifty-two patients undergoing TLE .


A USG-PVB was performed before surgery using a solution of 30 mL of 0.5 % ropivacaine by 3 injections of 10 mL each at the right T5 and bilateral T8 ( PVB group , n = 26 ) or the saline injection of 10 mL at every site ( control group , n = 26 ) .


Successful PVBs were achieved in all patients of the PVB group .


Intraoperative mean remifentanil usage and end-tidal sevoflurane concentration were lower in the PVB group ( p < 0.001 ) .


Hemodynamic parameters were stable in both groups .


Postoperative pain scores both at rest and on coughing were lower during the first 8 hours in the PVB group than those in the control group ( p < 0.05 ) .


Cumulative sufentanil consumption delivered by patient-controlled analgesia ( PCA ) was significantly lower in the PVB group at all time points ( p < 0.05 ) .


Postoperative pulmonary function was better at the third postoperative day in the PVB group ( p < 0.05 ) , with quicker hospital discharge and lower hospital costs ( p < 0.05 ) .


The single-dose and bilateral PVB given before TLE combined with sufentanil may provide better postoperative analgesia and early discharge in patients undergoing TLE .


Dysregulation of lipid homeostasis is related to multiple major healthcare problems .


The aim of this study was to investigate the effects of n-3 fatty acid ( FA ) and polyphenol rich diets on plasma and HDL fraction lipidomic profiles in subjects at high cardiovascular risk .


Ultra performance LC coupled to quadrupole TOF/MS mass spectrometry global lipidomic profiling was applied to plasma and HDL fraction from an 8 wk randomized intervention with four isoenergetic diets , differing in their natural n-3 FA and polyphenols content , in 78 subjects with a high BMI , abdominal obesity , and at least one other feature of the metabolic syndrome .


Dependency network analysis showed a different pattern of associations between lipidomics , dietary , and clinical variables after the dietary interventions .


The most remarkable associations between variables were observed after the diet high in n-3 FA and polyphenols , as the inverse association between gallic acid intake and LDL cholesterol levels , which was indirectly associated with a HDL cluster exclusively comprised lysophospholipids .


This is the first human randomized controlled trial showing direct and indirect associations with lipid molecular species and clinical variables of interest in the evaluation of the metabolic syndrome after diets naturally rich in polyphenols .


Chemotherapy-induced peripheral neuropathy ( CIPN ) is a significant side effect of taxane and platinum-based chemotherapy .


Several studies have supported the potential benefit of glutathione for the prevention of platinum-induced CIPN .


The current trial was designed to determine whether glutathione would prevent CIPN as a result of carboplatin/paclitaxel therapy .


In total , 185 patients who received treatment with paclitaxel and carboplatin were accrued between December 4 , 2009 and December 19 , 2011 .


Patients were randomized to receive either placebo ( n = 91 ) or 1.5 g/m ( 2 ) glutathione ( n = 94 ) over 15 minutes immediately before chemotherapy .


CIPN was assessed using the European Organization for Research and Treatment of Cancer Quality-of-Life ( EORTC-QLQ ) 20-item , CIPN-specific ( CIPN20 ) sensory subscale and the National Cancer Institute Common Terminology Criteria for Adverse Events ( CTCAE ) , version 4.0 .


There were no statistically significant differences between the 2 study arms with regard to : 1 ) peripheral neurotoxicity , as assessed using both the EORTC-QLQ-CIPN20 ( P = .21 ) and the CTCAE scales ( P = .449 for grade 2 neurotoxicity ; P = .039 for time to development of grade 2 neuropathy , in favor of the placebo ) ; 2 ) the degree of paclitaxel acute pain syndrome ( P = .30 for patients who received paclitaxel every 3-4 weeks and P = .002 , in favor of the placebo , for patients who received weekly paclitaxel ) ; 3 ) the time to disease progression ( P = .63 ) ; or 4 ) apparent toxicities .


Subgroup analyses did not reveal any evidence of benefit in any particular subgroup .


The results from this study do not support the use of glutathione for the prevention of paclitaxel/carboplatin-induced CIPN .


The single most distressing symptom for patients with advanced esophageal cancer is dysphagia .


Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent ( SEMS ) .


It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit .


The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion .


The study is a randomized multicenter phase III trial , with an internal pilot phase , comparing stent alone versus stent plus palliative radiotherapy in patients with incurable esophageal cancer .


Eligible participants are those with advanced esophageal cancer who are in need of stent insertion for primary management of dysphagia .


Radiotherapy will be administered as 20 Gray ( Gy ) in five fractions over one week or 30 Gy in 10 fractions over two weeks , within four weeks of stent insertion .


The internal pilot will assess rates and methods of recruitment ; pre-agreed criteria will determine progression to the main trial .


In total , 496 patients will be randomized in a 1:1 ratio with follow up until death .


The primary outcome is time to progression of patient-reported dysphagia .


Secondary outcomes include survival , toxicity , health resource utilization , and quality of life .


An embedded qualitative study will explore the feasibility of patient recruitment by examining patients ' motivations for involvement and their experiences of consent and recruitment , including reasons for not consenting .


It will also explore patients ' experiences of each trial arm .


The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis .


The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time .


As a pragmatic trial , study strengths include collection of all follow-up data in the usual place of care , and a focus on patient-reported , rather than disease-orientated , outcomes .


Exploration of patient experience and health economic analyses will be integral to the assessment of benefit for patients and the NHS .


The trial was registered with Current Controlled Trials ( registration number : ISRCTN12376468 ) on 10 July 2012 .


Pathophysiology of tinnitus known to accompany nearly all disorders in hearing system has not been fully understood , and therefore , there are some difficulties in evaluation and treatment thereof .


The objective of the current study is to research the effectiveness of transcranial magnetic stimulation ( TMS ) application in treatment of tinnitus .


Sixty patients aged between 15 and 70 years who applied to a polyclinic of Ear-Nose-Throat Department , Cerrahpasa Medical Faculty , Istanbul University , because of the complaint of tinnitus between January 2009 and July 2009 were selected using simple random sampling method .


The treatment group and the placebo group were separated randomly as to include 30 patients .


The tinnitus loudness , tinnitus frequency , tinnitus subjective score , and tinnitus handicap inventory results were compared before application of TMS and after 1 month .


It was found that the difference of tinnitus handicap inventory score within the TMS group ( before the treatment : mean , 52.76 ; SD , 15.8 ; after the treatment : mean , 44.4 ; SD , 13.57 ) was statistically significant ( P < 0.0001 ) and the difference of tinnitus handicap inventory score within the placebo group ( before the treatment : mean , 51.46 ; SD , 15.41 ; after the treatment : mean , 51.13 ; SD , 16.86 ) was significantly insignificant ( P = 0.848 ) .


When tinnitus severities determined at the beginning and end of the treatment were evaluated within each group , it was found that the difference of loudness within the group subjected to TMS was statistically significant ( P < 0.0001 ) but the difference of loudness within the placebo group was statistically insignificant ( P = 0.490 ) .


When tinnitus subjective scores were evaluated within each group before and after the treatment , the difference of subjective score within the group subjected to transcranial magnetic stimulation was statistically significant ( P < 0.0001 ) , and the difference of subjective score within the placebo group was statistically significant ( P = 0.168 ) .


The studies showed that low-frequency repeating TMS is useful in the treatment of chronic tinnitus .


In the current study performed on the patients with chronic tinnitus , it was shown that low-frequency repeating TMS has a statistically significant success when compared with the placebo group .


Although prompt reperfusion treatment restores normal epicardial flow , microvascular dysfunction may persist in some patients with acute coronary syndrome ( ACS ) .


Impaired myocardial perfusion is caused by intraluminal platelets , fibrin thrombi and neutrophil plugging ; antiplatelet agents play a significant role in terms of protecting against thrombus microembolization .


A novel antiplatelet agent , ticagrelor , is a non-thienopyridine , direct P2Y12 blocker that has shown greater , more rapid and more consistent platelet inhibition than clopidogrel .


However , the effects of ticagrelor on the prevention of microvascular dysfunction are uncertain .


The present study is a comparison between clopidogrel and ticagrelor use for preventing microvascular dysfunction in patients with ST elevation or non-ST elevation myocardial infarction ( STEMI or NSTEMI , respectively ) .


The TIME trial is a single-center , randomized , open-label , parallel-arm study designed to demonstrate the superiority of ticagrelor over clopidogrel .


A total of 152 patients with a spectrum of STEMI or NSTEMI will undergo prospective random assignment to clopidogrel or ticagrelor ( 1:1 ratio ) .


The primary endpoint is an index of microcirculatory resistance ( IMR ) measured after percutaneous coronary intervention ( PCI ) ; the secondary endpoint is wall motion score index assessed at 3 months by using echocardiography .


The TIME trial is the first study designed to compare the protective effect of clopidogrel and ticagrelor on coronary microvascular dysfunction in patients with STEMI and NSTEMI .


ClinicalTrials.gov : NCT02026219 .


Registration date : 24 December 2013 .


Opioid-dependent patients often use the emergency department ( ED ) for medical care .


To test the efficacy of 3 interventions for opioid dependence : ( 1 ) screening and referral to treatment ( referral ) ; ( 2 ) screening , brief intervention , and facilitated referral to community-based treatment services ( brief intervention ) ; and ( 3 ) screening , brief intervention , ED-initiated treatment with buprenorphine/naloxone , and referral to primary care for 10-week follow-up ( buprenorphine ) .


A randomized clinical trial involving 329 opioid-dependent patients who were treated at an urban teaching hospital ED from April 7 , 2009 , through June 25 , 2013 .


After screening , 104 patients were randomized to the referral group , 111 to the brief intervention group , and 114 to the buprenorphine treatment group .


Enrollment in and receiving addiction treatment 30 days after randomization was the primary outcome .


Self-reported days of illicit opioid use , urine testing for illicit opioids , human immunodeficiency virus ( HIV ) risk , and use of addiction treatment services were the secondary outcomes .


Seventy-eight percent of patients in the buprenorphine group ( 89 of 114 [ 95 % CI , 70 % -85 % ] ) vs 37 % in the referral group ( 38 of 102 [ 95 % CI , 28 % -47 % ] ) and 45 % in the brief intervention group ( 50 of 111 [ 95 % CI , 36 % -54 % ] ) were engaged in addiction treatment on the 30th day after randomization ( P < .001 ) .


The buprenorphine group reduced the number of days of illicit opioid use per week from 5.4 days ( 95 % CI , 5.1-5 .7 ) to 0.9 days ( 95 % CI , 0.5-1 .3 ) vs a reduction from 5.4 days ( 95 % CI , 5.1-5 .7 ) to 2.3 days ( 95 % CI , 1.7-3 .0 ) in the referral group and from 5.6 days ( 95 % CI , 5.3-5 .9 ) to 2.4 days ( 95 % CI , 1.8-3 .0 ) in the brief intervention group ( P < .001 for both time and intervention effects ; P = .02 for the interaction effect ) .


The rates of urine samples that tested negative for opioids did not differ statistically across groups , with 53.8 % ( 95 % CI , 42 % -65 % ) in the referral group , 42.9 % ( 95 % CI , 31 % -55 % ) in the brief intervention group , and 57.6 % ( 95 % CI , 47 % -68 % ) in the buprenorphine group ( P = .17 ) .


There were no statistically significant differences in HIV risk across groups ( P = .66 ) .


Eleven percent of patients in the buprenorphine group ( 95 % CI , 6 % -19 % ) used inpatient addiction treatment services , whereas 37 % in the referral group ( 95 % CI , 27 % -48 % ) and 35 % in the brief intervention group ( 95 % CI , 25 % -37 % ) used inpatient addiction treatment services ( P < .001 ) .


Among opioid-dependent patients , ED-initiated buprenorphine treatment vs brief intervention and referral significantly increased engagement in addiction treatment , reduced self-reported illicit opioid use , and decreased use of inpatient addiction treatment services but did not significantly decrease the rates of urine samples that tested positive for opioids or of HIV risk .


These findings require replication in other centers before widespread adoption .


clinicaltrials.gov Identifier : NCT00913770 .


In cerebrospinal fluid ( CSF ) leakage endoscopic repair , lumbar drains ( LDs ) were used in an attempt to increase success rates .


To critically assess the relationship between use of LDs and recurrent leaks , we embarked on this randomized prospective study .


Patients undergoing CSF leak repair between 2000 and 2012 were randomized into two groups : 75 patients were managed without LDs and in the other group of 75 patients an LD was always placed .


Different parameters were analyzed to identify their relationship with failures : occurrence of increased intracranial pressure ( ICP ) , body mass index , smoking habits , existence of diabetes , chronic corticosteroid use , previous sinus surgery , etiology ( traumatic , iatrogenic , or spontaneous leak ) , site , and size of the CSF leak .


Success rate was 93 % for the whole group .


Patients managed with LDs attained 95 % success rate and those without LD attained 92 % ; the difference is not significant ( p = 0.2 ) .


The only factor predictive of recurrence is increased ICP : 77 % success rate versus 97 % for traumatic leaks and 96 % for iatrogenic leaks .


Recurrence rates were identical in the two groups with increased ICP , regardless of the use of a LD ( 23 % ) .


In this study , success rates of CSF repair were not associated with the use of LDs .


However , the small number of cases with high success rates precludes appropriate statistical analysis .


Migraine is a common form of headache that is a major burden for patients who often seek emergency care .


The goal of this study was to compare the effectiveness of intravenous non-steroidal anti-inflammatory medication ( dexketoprofen ) with paracetamol ( acetaminophen ) in the treatment of an acute migraine attack .


This prospective , randomised , double blind , controlled study was conducted in a tertiary care emergency unit .


Study patients were randomised into two groups to receive either 50 mg of dexketoprofen trometamol or 1000 mg of paracetamol intravenously by rapid infusion in 150 mL of normal saline .


Pain reduction was measured at baseline , and after 15 and 30 min , using a Visual Analogue Scale ( VAS ) ) as the primary outcome .


VAS is a measurement tool ranging from 0 ( no pain ) to 100 mm ( worst pain ) .


200 patients were included in the final analysis .


Mean ( SD ) age of the study subjects was 30.1 11 years and 81 % ( n = 162 ) were women .


Median reduction in VAS score at 30 min was 56 ( IQR 30-78 .5 ) for the paracetamol group and 55 ( IQR 34-75 ) for the dexketoprofen group , with a difference of 1 mm ( 95 % CI -7 to 10 ) between the two groups .


Intravenous paracetamol and dexketoprofen appear to produce equivalent pain relief for migraine in the emergency department .


CLINICALTRIALS.GOV NO : NCT01730326 .


The prognosis for locally advanced gastric cancer is poor despite advances in adjuvant chemotherapy .


We did the Stomach cancer Adjuvant Multi-Institutional group Trial ( SAMIT ) to assess the superiority of sequential treatment ( paclitaxel then tegafur and uracil [ UFT ] or paclitaxel then S-1 ) compared with monotherapy ( UFT or S-1 ) and also the non-inferiority of UFT compared with S-1 .