The OA TREAT trial will examine the clinical and radiological efficacy and safety of HCQ as a treatment option for inflammatory and erosive OA over 12 months .


OA TREAT focuses on erosive hand OA in contrast to other current studies on symptomatic hand OA , for example , HERO [ Trials 14:64 , 2013 ] .


ISRCTN46445413 , date of registration : 05-10-2011 .


Despite the often social nature of smoking , relatively little research has been conducted on the relationship between smoking and social anxiety disorder ( SAD ) .


Participants ( N = 99 ) included 34 smokers without current mental health disorders , 37 smokers with SAD , and 28 smokers who met criteria for other anxiety disorder diagnoses ( e.g. , panic disorder or generalized anxiety disorder , but not SAD ) .


Nicotine and placebo patches were administered to participants in a counterbalanced manner across two assessment days .


Urge and craving were assessed before and after a 5-h nicotine absorption/deprivation period .


Compared to smokers without current mental health disorders , smokers with SAD did not report greater nicotine dependence , but did endorse greater motivation to use nicotine to avoid negative outcomes .


In addition , after controlling for demographic variables , smoking characteristics , pre-deprivation urge and craving , and other anxiety/depression symptoms , social anxiety symptoms uniquely predicted urge and craving in the placebo patch condition ; however , social anxiety had no influence on urge and craving in the nicotine patch condition .


These findings suggest that one potential reason that smokers with SAD may have worse cessation outcomes is that they may experience higher levels of craving and urge to smoke during quit attempts .


Thus , during a quit attempt , particularly in the absence of nicotine replacement therapy , smokers with SAD are likely to benefit from additional treatment aimed at managing or reducing their social anxiety symptoms .


To analyze recurrence patterns in patients with cancer of the esophagus or gastroesophageal junction treated with either preoperative chemoradiotherapy ( CRT ) plus surgery or surgery alone .


Recurrence pattern was analyzed in patients from the previously published CROSS I and II trials in relation to radiation target volumes .


CRT consisted of five weekly courses of paclitaxel and carboplatin combined with a concurrent radiation dose of 41.4 Gy in 1.8-Gy fractions to the tumor and pathologic lymph nodes with margin .


Of the 422 patients included from 2001 to 2008 , 418 were available for analysis .


Histology was mostly adenocarcinoma ( 75 % ) .


Of the 374 patients who underwent resection , 86 % were allocated to surgery and 92 % to CRT plus surgery .


On January 1 , 2011 , after a minimum follow-up of 24 months ( median , 45 months ) , the overall recurrence rate in the surgery arm was 58 % versus 35 % in the CRT plus surgery arm .


Preoperative CRT reduced locoregional recurrence ( LRR ) from 34 % to 14 % ( P < .001 ) and peritoneal carcinomatosis from 14 % to 4 % ( P < .001 ) .


There was a small but significant effect on hematogenous dissemination in favor of the CRT group ( 35 % v 29 % ; P = .025 ) .


LRR occurred in 5 % within the target volume , in 2 % in the margins , and in 6 % outside the radiation target volume .


In 1 % , the exact site in relation to the target volume was unclear .


Only 1 % had an isolated infield recurrence after CRT plus surgery .


Preoperative CRT in patients with esophageal cancer reduced LRR and peritoneal carcinomatosis .


Recurrence within the radiation target volume occurred in only 5 % , mostly combined with outfield failures .


To explore the efficacy and feasibility of dog days moxibustion plaster therapy in treatment of allergic rhinitis of different patterns/syndromes .


Allergic rhinitis of lung deficiency and invasion of cold , spleen qi deficiency and kidney yang deficiency , 56 patients for each pattern/syndrome were randomized into a plaster therapy group and a nasal spray group , 28 cases in each one .


In the plaster therapy group , according to the pattern/syndrome differentiation , with literature retrieval method , 3 acupoints of high frequency utility in clinic were selected as one group in acupoint plaster therapy .


For lung deficiency and invasion of cold pattern/syndrome , Feishu ( BL 13 ) , Fengmen ( BL 12 ) and Hegu ( LI 4 ) were selected .


For spleen qi deficiency pattern/syndrome , Pishu ( BL 21 ) , Zusanli ( ST 36 ) and Dazhui ( GV 14 ) were selected .


For kidney yang deficiency pattern / syndrome , Shenshu ( BL 23 ) , Dingchuan ( EX-B 1 ) and Bailao ( EX-HN 15 ) were selected .


Separately , on July 13 , 2013 , July 23 , 2013 , August 2 , 2013 and August 12 , 2013 , the aucpoint plaster therapy was applied , 2 to 4 h ( 1 to 2 h for children ) each time .


In the nasal spray group , beclometasone dipropionate aqueous nasal spray , 2 presses one nostril each time , 2 to 3 times a day , continuously for 4 weeks .


The symptom score and efficacy were compared before and after treatment in the patients of the two groups .


The symptom scores of 3 patterns/syndromes were all apparently improved after treatment as compared with those before treatment in the patients of the two groups ( all P < 0.05 ) , and the result in the plaster therapy group was better than that of the nasal spray group ( P < 0.05 , P < 0.01 ) .


For lung deficiency and invasion of cold pattern/syndrome , the total effective rate was 87.3 % ( 20/24 ) in the plaster therapy group , better than 84.6 % ( 22/26 ) in the nasal spray group ( P < 0.05 ) .


For spleen qi deficiency pattern/syndrome , the total effective rate was 83.3 % ( 20/24 ) in the plaster therapy group , obviously better than 76.9 % ( 22/26 ) in the nasal spray group ( P < 0.05 ) .


For kidney yang deficiency pattern/syndrome , the total effective rate was 79.2 % ( 19/24 ) in the plaster therapy group , better than 76.9 % ( 22/26 ) in the nasal spray group ( P < 0.05 ) .


The dog days moxibustion plaster therapy achieves definite efficacy on allergic rhinitis at the acupoints selected based on the differentiation of different patterns/syndromes and the efficacy is better than beclometasone dipropionate aqueous nasal spray .


Cytotoxic chemotherapy is widely used for advanced , unresectable pancreatic and other gastrointestinal foregut neuroendocrine tumours ( NETs ) and the most commonly used regimen combines 5-fluorouracil with streptozocin .


The NET01 trial was designed to investigate whether capecitabine combined with streptozocin was an acceptable regimen with or without adding cisplatin .


Patients with advanced , unresectable NETs of pancreatic , gastrointestinal foregut or unknown primary site were randomised to receive three-weekly capecitabine ( Cap ) 625 mg/m ( 2 ) twice daily orally , streptozocin ( Strep ) 1.0 g/m ( 2 ) intravenously on day 1 , with or without cisplatin ( Cis ) 70 mg/m ( 2 ) intravenously on day 1 .


The primary outcome measure was objective response .


Secondary outcome measures included progression-free and overall survival , quality of life , toxicity and biochemical response .


86 ( 44 CapStrep , 42 CapStrepCis ) patients were randomised .


Best objective response rate was 12 % ( 95 % confidence interval ( CI ) = 2-22 % ) with CapStrep and 16 % ( 95 % CI = 4-27 .4 % ) with CapStrepCis .


Disease-control rate was 80 % with CapStrep and 74 % with CapStrepCis .


The estimated median progression-free and overall survival were 10.2 and 26.7 months for CapStrep and 9.7 and 27.5 months for CapStrepCis .


44 % of CapStrep and 68 % of CapStrepCis patients experienced grade 3 adverse events .


The efficacies of the novel CapStrepCis regimens were very similar .


CapStrep was better tolerated than CapStrepCis .


The trial was registered as EudraCT : 2004-005202-71 and ISRCTN : 35124268 .


The Trendelenburg position has a dramatic effect on circulation , consequently increasing cerebral and intraocular pressure .


We evaluated whether modifying the Trendelenburg position would minimize the increase in intraocular pressure .


In this prospective , randomized , controlled study we compared intraocular pressure in patients undergoing robot-assisted laparoscopic radical prostatectomy while in the Trendelenburg position or the modified Z Trendelenburg position .


In group 1 intraocular pressure , blood pressure and endotracheal CO2 were measured in the patient at anesthesia induction ( time 1 ) , before positioning ( time 2 ) , and while in the Trendelenburg position ( time 3 ) and in the modified Z Trendelenburg position ( time 4 ) .


They were also measured after pneumoperitoneum ( time 5 ) , every 30 minutes ( times 6 to 16 ) , while supine at the end of pneumoperitoneum ( time 17 ) and before awakening ( time 18 ) .


We modified the Trendelenburg position by placing the head and shoulders horizontally .


Group 1 included 29 patients in the modified Z Trendelenburg position .


Group 2 included 21 patients in the Trendelenburg position .


No difference was found in patient demographics or surgical outcomes .


Median intraocular pressure was in the low normal range at times 1 and 2 , and increased in time 3 in each group .


From time 4 intraocular pressure decreased and at all time points it was significantly lower in group 1 by a mean of 4.61 mm Hg ( 95 % CI -6.90 -2.30 , p < 0.001 ) .


At time 17 mean intraocular pressure decreased to normal ( 19.6 mm Hg ) in group 1 but remained in the hypertensive range ( 24.9 mm Hg ) in group 2 .


At time 18 mean intraocular pressure was 17 mm Hg in each group .


Blood pressure was significantly lower in group 1 with a mean reduction in systolic and diastolic pressure of 6.3 and 4.3 mm Hg , respectively .


Our results suggest that modifying the Trendelenburg position during robot-assisted laparoscopic radical prostatectomy has a significant positive effect on patient neuro-ocular safety by lowering intraocular pressure and accelerating its recovery to the normal range without affecting the operation .


To assess whether bezafibrate increases fatty acid oxidation ( FAO ) and lowers heart rate ( HR ) during exercise in patients with carnitine palmitoyltransferase ( CPT ) II and very long-chain acyl-CoA dehydrogenase ( VLCAD ) deficiencies .


This was a 3-month , randomized , double-blind , crossover study of bezafibrate in patients with CPT II ( n = 5 ) and VLCAD ( n = 5 ) deficiencies .


Primary outcome measures were changes in FAO , measured with stable-isotope methodology and indirect calorimetry , and changes in HR during exercise .


Bezafibrate lowered low-density lipoprotein , triglyceride , and free fatty acid concentrations ; however , there were no changes in palmitate oxidation , FAO , or HR during exercise .


Bezafibrate does not improve clinical symptoms or FAO during exercise in patients with CPT II and VLCAD deficiencies .


These findings indicate that previous in vitro studies suggesting a therapeutic potential for fibrates in disorders of FAO do not translate into clinically meaningful effects in vivo .


This study provides Class I evidence that bezafibrate 200 mg 3 times daily is ineffective in improving changes in FAO and HR during exercise in adults with CPT II and VLCAD deficiencies .


The aim of the study was to evaluate the safety and efficacy of early feeding after cesarean delivery under different anesthetic methods .


Two hundred women with elective cesarean delivery were randomly assigned to early oral feeding ( EOF ) or routine oral feeding ( ROF ) groups .


EOF patients were informed that they could begin taking fluids orally ( regime I ) as soon as 2 hours after the delivery and then gradually progress to solid foods ( regime III ) , if tolerated .


ROF patients were informed that they could start regime I right after bowel sounds were heard on examination and then gradually move on to regime III .


Hospitalization time and total time to ambulation ( primary outcomes ) , gasstool discharge time and onset of bowel sounds ( secondary outcomes ) were compared in groups A [ EOF patients after regional anesthesia ( n = 49 ) } , B [ EOF patients after general anesthesia ( n = 48 ) } , C [ ROF patients after regional anesthesia ( n = 47 ) } and 0 [ ROF patients after general anesthesia ( n = 48 ) ] .


There were significant differences in primary and secondary outcomes between group A and the remaining groups , especially group D.


The status of patients from group B was not better than group C.


In fact , the latter were discharged home sooner and passage of gas , as well as initiation of regime I occurred earlier as compared to the former


Cesarean section under regional anesthesia and encouragement of oral feeding 2 hours after the operation should be recommended in order to acnieve postoperative recovery and early hospital discharge .


Routine oral feeding ( right after bowel sounds are heard on examination ) after cesarean section under general anesthesia should be the last choice .


Hypoglycemia is a leading risk of glucose-lowering therapy .


Treatment with insulin glargine compared with standard care early in the course of dysglycemia in the Outcome Reduction with an Initial Glargine Intervention ( ORIGIN ) trial provides information on the frequency and predictors of hypoglycemia in this setting .


A total of 12,537 people with high cardiovascular risk and dysglycemia treated with one or no oral glucose-lowering agents were randomized to add glargine titrated to a fasting glucose level of 5.3 mmol/L ( 95 mg/dL ) or to use standard therapies .


Independent associations of both nonsevere hypoglycemia ( symptomatic and confirmed with a glucose level of 3 mmol/L [ 54 mg/dL ] ) and severe hypoglycemia with characteristics at baseline , treatment allocation , and average HbA1c were assessed by Cox proportional hazards models .


During a median follow-up period of 6.2 years , 28 % of participants reported nonsevere hypoglycemia , and 3.8 % reported severe hypoglycemia .


Prior use of a sulfonylurea and allocation to glargine independently predicted a higher risk for both categories of participants .


Nonsevere events were independently associated with younger age , lower BMI , the presence of diabetes , and higher baseline HbA1c level .


Severe events were associated with older age , hypertension , higher serum creatinine level , and lower cognitive function , but not baseline glycemic status .


Progressively higher on-treatment HbA1c level was associated with a lower risk of nonsevere events in both treatment groups ; a lower risk of severe events in the glargine group , and a higher risk of severe events with standard care .


Hypoglycemia was relatively uncommon in the ORIGIN trial , but was more frequent with sulfonylurea use at baseline and allocation to glargine .


Nonsevere and severe events were associated with different clinical characteristics , awareness of which may guide individualized therapy .


Few studies were conducted on hepatitis B and C virus ( HBV and HCV , respectively ) risk factors among Chinese blood donors in recent years since voluntary donors replaced commercial donors .


A case-control survey was conducted in HBV - or HCV-positive and - negative donors from five blood centers in China between September 2009 and April 2011 .


Case status was defined by having a reactive result on Monolisa HBsAg Ultra ( Bio-Rad ) for HBV and Ortho anti-HCV EIA 3.0 ( Johnson & Johnson ) for HCV .


Controls were randomly selected qualified blood donors matched to cases by donation month and blood center .


Specific test-seeking , medical-related , and behavioral risk factors were compared by HBV and HCV status using chi-square tests or Fisher 's exact tests with Bonferroni correction .


A total of 364 HBV cases , 174 HCV cases , and 689 controls completed the survey ; response rates were 66.2 , 47.3 , and 82 % , respectively .


HCV-positive donors were significantly more likely to report having a blood transfusion history ( 23.4 % vs. 3.0 % , p < 0.0001 ) and ever living with a person with illegal drug injection ( 6.0 % vs. 0.5 % , p < 0.0001 ) than controls .


Having intravenous and intramuscular injections in the past 12 months and ever having a tattoo are marginal risk factors for HCV ( p values < 0.01 ) .


No specific risk factor for HBV was identified .


History of previous transfusion and living with illegal drug users are risk factors for HCV infection among Chinese blood donors from five regions .


Test-seeking behavior is not associated with HBV or HCV infections .


Patients with a recent vertebrobasilar transient ischaemic attack or ischaemic stroke and vertebral artery stenosis of at least 50 % have a high risk of future vertebrobasilar stroke .


Stenting of vertebral artery stenosis is promising , but of uncertain benefit .


We investigated the safety and feasibility of stenting of symptomatic vertebral artery stenosis of at least 50 % , and assessed the rate of vascular events in the vertebrobasilar supply territory to inform the design of a phase 3 trial .


Between Jan 22 , 2008 , and April 8 , 2013 , patients with a recent transient ischaemic attack or minor stroke associated with an intracranial or extracranial vertebral artery stenosis of at least 50 % were enrolled from seven hospitals in the Netherlands in a phase 2 open-label trial with masked assessment of outcome .


Patients were randomly allocated in a 1:1 ratio to stenting plus best medical treatment or best medical treatment alone by the local investigators using a web-based randomisation system .


The primary outcome was the composite of vascular death , myocardial infarction , or any stroke within 30 days after the start of treatment .


The secondary outcomes were stroke in the supply territory of the symptomatic vertebral artery during follow-up , the composite outcome during follow-up , and the degree of stenosis in the symptomatic vertebral artery at 12 months .


The trial is registered , number ISRCTN29597900 .


The trial was stopped after inclusion of 115 patients because of new regulatory requirements , including the use of a few prespecified stent types and external monitoring , for which no funding was available .


57 patients were assigned to stenting and 58 to medical treatment alone .


Three patients in the stenting group had vascular death , myocardial infarction , or any stroke within 30 days after the start of treatment ( 5 % , 95 % CI 0-11 ) versus one patient in the medical treatment group ( 2 % , 0-5 ) .


During a median follow-up of 3 years ( IQR 13-41 ) , seven ( 12 % , 95 % CI 6-24 ) patients in the stenting group and four ( 7 % , 2-17 ) in the medical treatment group had a stroke in the territory of the symptomatic vertebral artery ; 11 ( 19 % ) patients in the stenting group and ten ( 17 % ) in the medical treatment group had vascular death , myocardial infarction , or any stroke .


The small size of the vertebral artery and stent artifacts did not allow exact grading of restenosis on CT angiography .


During the complete period of follow-up , there were 60 serious adverse events ( eight strokes ) in the stenting group and 56 ( seven strokes ) in the medical treatment alone group .


Stenting of symptomatic vertebral artery stenosis is associated with a major periprocedural vascular complication in about one in 20 patients .


In the population we studied , the risk of recurrent vertebrobasilar stroke under best medical treatment alone was low , questioning the need for and feasibility of a phase 3 trial .


Dutch Heart Foundation .


To evaluate preliminarily the efficacy on functional constipation treated with electroacupuncture of different acupoint prescriptions .


One hundred and four patients were randomized into a front-mu and back-shu points group ( 19 cases ) , a he-sea points group ( 34 cases ) , a he-sea , front-mu and back-shu points group ( 26 cases ) and a western medication control group ( 25 cases ) .


In the front-mu and back-shu points group , electroacupuncture was applied at bilateral Tianshu ( ST 25 ) and Dachangshu ( BL 25 ) .


In the he-sea points group , electroacupuncture was applied at bilateral Quchi ( LI 11 ) and Shangjuxu ( ST 37 ) .


In the he-sea , front-mu and back-shu points group , electroacupuncture was applied at unilateral Tianshu ( ST 25 ) , Dachangshu ( BL 25 ) , Quchi ( LI 11 ) and Shangjuxu ( ST 37 ) .


In the three groups above , the treatment was given 5 times a week in the first two weeks and 3 times a week in the next two weeks .


In the western medication control group , mosapride citrate tablets were prescribed for oral administration , 1 table ( 5 mg ) each time , 3 times a day , continuously for 4 weeks .


The period of research was 9 weeks , including 1 week for baseline evaluation , 4 weeks for treatment and 4 weeks for follow-up .


The weekly defecation frequency was taken as primary index , while the defecation difficulty and life quality score were taken as the secondary indices for the efficacy evaluation after treatment and in follow-up .


According to the intention-to-treat ( ITT ) analytic principle , 104 cases were all enrolled in the final analysis .


( 1 ) After treatment , the weekly frequency of defecation was all increased significantly in the four groups ( P < 0.05 , P < 0.01 ) .


The efficacy of the three electroacupuncture groups was similar to that of western medication control group ( P > 0.05 ) .


In follow-up , the increasing effect on the weekly frequency of defecation was maintained in the he-sea points group ( P < 0.01 ) , superior to the front-mu and back-shu points group and the western medication control group ( P < 0.05 , P < 0.01 ) ; the weekly frequency of defecation was not improved in the rest three groups ( P > 0.05 ) .


( 2 ) After treatment , defecation difficulty was relieved in the he-sea points group , the he-sea , front-mu and back-shu points group and the western medication control group ( P < 0.05 , P < 0.01 ) .


In follow-up , the improvements were still significant in the he-sea points group and the he-sea , front-mu and back-shu points group ( both P < 0.01 ) .


( 3 ) After treatment , the life quality score was significantly improved in the patients of the he-sea points group ( P < 0.05 ) .


The difference was not significant in the rest three groups as compared with that before treatment ( all P > 0.05 ) .


The weekly frequency of defecation is increased effectively after treatment in the three electroacupuncture groups and the efficacy is similar to mosapride citrate tablets .


The bilateral Quchi ( LI 11 ) and Shangjuxu ( ST 37 ) in he-sea acupoints increase significantly the weekly frequency of defecation , relieve defecation difficulty and improve life quality .


Acupuncture efficacy is sustained for 4 weeks .


This acupoints prescription is the best in the treatment of functional constipation .


Management of diabetes in elderly subjects is complex and careful management of glucose levels is of particular importance in this population because of an increased risk of diabetes-related complications and hypoglycaemia .


The aim of this study was to evaluate the pharmacokinetic and pharmacodynamic properties of insulin degludec ( IDeg ) , a basal insulin with an ultra-long duration of action , in elderly subjects with type 1 diabetes compared with younger adults .


This trial was a randomised , double-blind , two-period , crossover trial conducted in a single centre and included both inpatient and outpatient periods .


Subjects were men and women aged 18-35 years inclusive ( younger adult group ) or 65 years ( elderly group ) with type 1 diabetes who received IDeg ( 0.4 U/kg ) via subcutaneous injection in the thigh once-daily for six days .


Following 6-day dosing , a 26-hour euglycaemic glucose clamp procedure was conducted to evaluate the steady-state pharmacodynamic effects of IDeg .


Blood samples were taken for pharmacokinetic analysis up to 120 h post-dose .


Pharmacokinetic endpoints included the total exposure of IDeg , ie the area under the IDeg serum concentration curve during one dosing interval at steady state ( AUC ( IDeg , , SS ) ) ( = 0-24 h , equal to one dosing interval ) and the maximum IDeg serum concentration at steady state ( C ( max , IDeg , SS ) ) .


Pharmacodynamic endpoints included the total glucose-lowering effect of IDeg , ie the area under the glucose infusion rate ( GIR ) curve at steady state ( AUC ( GIR , , SS ) ) , and the maximum GIR at steady state ( GIR ( max , IDeg , SS ) ) .


Total exposure ( AUC ( IDeg , , SS ) ) and maximum concentration ( C ( max , IDeg , SS ) ) of IDeg were comparable between elderly subjects and younger adults .


Estimated mean age group ratios ( elderly/younger adult ) for AUC ( IDeg , , SS ) and C ( max , IDeg , SS ) and corresponding two-sided 95 % confidence intervals ( CIs ) were 1.04 ( 95 % CI 0.73-1 .47 ) and 1.02 ( 95 % CI 0.74-1 .39 ) , respectively .


Mean AUC ( IDeg,0-12h , SS ) / AUC ( IDeg , , SS ) was 53 % in both younger adult and elderly subjects , showing that in both age groups IDeg exposure was evenly distributed across the first and second 12 h of the 24-hour dosing interval .


No statistically significant differences were observed between younger adult and elderly subjects with regard to AUC ( GIR , , SS ) ( the primary endpoint of this study ) and GIR ( max , IDeg , SS ) .


Estimated mean age group ratios ( elderly/younger adult ) for AUC ( GIR , , SS ) and GIR ( max , IDeg , SS ) and corresponding two-sided 95 % CIs were 0.78 ( 95 % CI 0.47-1 .31 ) and 0.80 ( 95 % CI 0.54-1 .17 ) , respectively .


Duration of action was beyond the clamp duration of 26 h in all subjects .


The exposure of IDeg at steady state during once-daily dosing was similar in younger adult and elderly subjects .


The glucose-lowering effect of IDeg was numerically lower in elderly subjects compared with younger adults , but no significant differences were observed between age groups .


The ultra-long pharmacokinetic and pharmacodynamic properties of IDeg observed in younger adults were preserved in elderly subjects with type 1 diabetes .


Clinical trials.gov number : NCT00964418 .


This study sought to examine the possible drug-drug interactions between clopidogrel and morphine .


Because morphine-the recommended treatment for pain of myocardial infarction-is associated with poor clinical outcome , we hypothesized that morphine lowers the plasma levels of clopidogrel active metabolite as well as its effects on platelets .


Twenty-four healthy subjects received a loading dose of 600 mg clopidogrel together with placebo or 5 mg morphine intravenously in a randomized , double-blind , placebo-controlled , cross-over trial .


Pharmacokinetics was determined by liquid chromatography tandem mass spectrometry , and clopidogrel effects were measured by platelet function tests .


Morphine injection delayed clopidogrel absorption ( p = 0.025 ) and reduced the area under the curve levels of its active metabolite by 34 % ( p = 0.001 ) .


Morphine delayed the maximal inhibition of platelet aggregation on average by 2 h ( n = 24 ; p < 0.001 ) .


Residual platelet aggregation was higher 1 to 4 h after morphine injection ( n = 24 ; p < 0.005 ) .


Furthermore , morphine delayed the inhibition of platelet plug formation under high shear rates ( P2Y-Innovance ; n = 21 ; p < 0.004 ) and abolished the 3-fold prolongation in collagen adenosine diphosphate-induced closure times seen in extensive and rapid metabolizers ( n = 16 ; p = 0.001 ) .


Morphine delays clopidogrel absorption , decreases plasma levels of clopidogrel active metabolite , and retards and diminishes its effects , which can lead to treatment failure in susceptible individuals .


( Drug/Drug Interactions of Aspirin and P2Y12-inhibitors ; NCT01369186 ) .


In STEMI , grade-3 ischemia ( G3 ) on admission ECG predicts larger infarct size ( IS ) than grade-2 ( G2 ) .


We evaluated whether pre-hospital G3 and its temporal behavior are associated with IS and salvage after pPCI .


In 401 STEMI patients , pre-hospital and pre-PCI ECGs were classified as G3 or G2 .


IS was assessed by single-photon emission computed tomography ( SPECT ) at 30days .


In 245 patients , pre-PCI SPECT was available to determine myocardium at risk ( MaR ) .


G3 criteria were met by 88 , and G2 by 313 patients .


G3 was independently associated with IS ( p = 0.006 ) .


With ST resolution ( STR ) group as a reference , G2 - > G2 , G2 - > G3 and G3 - > G3 were associated with larger IS ( B = 4.4 , p = 0.004 ; B = 5.4 , p = 0.01 ; B = 10.2 , p < 0.001 , respectively ) , whereas G3 - > G2 was not .


Salvage was similar between G3 and G2 on pre-hospital ECG if treated early , however lower for G3 when treated later ( > 2.5 h ) ; 48 % ( 35-78 ) vs 62 % ( 40-87 ) ; p = 0.04 .


Development or persistence of G3 is associated with larger IS and less salvage , but decreasing grade G3 - > G2 was not .


The prevalence of type 2 diabetes has increased dramatically in the last decade , and is continuing to rise .


It is a chronic condition , often related to obesity , diet and sedentary lifestyles , and can lead to significant health complications , disability and early death .


Diabetes is commonly associated with depression , which can impact significantly on a person 's ability to manage their illness and , consequently , on disease outcomes .


Disease self-management is fundamental in diabetes and requires support from multiple health professionals and the active participation of the person , including in maintaining a healthy lifestyle .


The Whole Person Model was developed in order to integrate emotional and behavioural aspects into a self-management program for people with type 2 diabetes .


Here we describe a study designed to test the efficacy of the Whole Person Model of disease self-management in type 2 diabetes .


In a parallel-group randomised trial , 180 people with type 2 diabetes of between 2-10 years duration will be recruited via invitation through the Australian National Diabetes Services Scheme .


Participants will undergo baseline assessment , followed by randomisation to either intervention or control condition .


Control participants will receive fact sheets containing key information about diabetes self-management .


The intervention group will receive the INSPIRED ( Individual Support & Resources for Diabetes ) Manual and be assigned a Health Coach .


The INSPIRED Manual consists of six modules that provide key information about diabetes and disease management using the Whole Person Model .


Engagement is facilitated by interactive tasks and contact with a Health Coach over seven weeks -- an introductory face-to-face session , and six subsequent contacts by phone following each module .


Follow-up assessments occur at 13 weeks ( post-intervention ) and 26 weeks .


Primary outcomes include blood glucose management ( HbA1c ) , weight and mood .


Secondary outcomes include level of exercise , confidence to manage diabetes , and psychosocial well-being .


The Whole Person Model is designed to enable health professionals to address mood disturbance without pathologizing any disorders and , in the context of the chronic illness , empowering behavior change and self-management .


If proven effective , this model will strengthen capacity of the healthcare workforce to foster and support effective diabetes self-management .


Australia and New Zealand Clinical Trials Register , ACTRN12613000391774 .


Sleep disturbances are common following traumatic brain injury ( TBI ) .


The Pittsburgh Sleep Quality Index ( PSQI ) is a widely used measure of sleep quality that has been used in numerous populations .


Although this measure has been used in TBI research , there are few studies examining the psychometric properties in this population .


The current study examined the factor structure of the PSQI in a sample of persons with TBI and tested the one , two , and three factor models derived from previous studies in other populations .


A telephone interview was conducted with 243 individuals who had sustained a TBI .


All participants were approximately one year post-injury .


Factor analyses were conducted ( exploratory and confirmatory ) to examine the factor structure of the PSQI .


Results confirm the fit of models previously tested in the literature but also reveal an alternative conceptualization of sleep containing both qualitative and quantitative factors .


While the 3-factor model best fits the data in this TBI sample , the use of a 2-factor model is acceptable and may be more clinically relevant due to the grouping of time-related variables that could provide important information with regard to circadian rhythm disorders .


To compare the efficacy and safety of recombinant streptokinase ( rSK ) and phenylephrine-based suppositories in acute hemorrhoidal disease .


A multicenter ( 14 sites ) , randomized ( 1:1 ) , open , parallel groups , active controlled trial was done .


After inclusion , subjects with acute symptoms of hemorrhoids , who gave their written , informed consent to participate , were centrally randomized to receive , as outpatients , rSK ( 200000 IU ) or 0.25 % phenylephrine suppositories , which had different organoleptic characteristics .


Treatment was administered by the rectal route , one unit every 6 h during 48 h for rSK , and up to a maximum of 5 d ( 20 suppositories ) for phenylephrine .


Evaluations were performed at 3 , 5 and 10 d post-inclusion .


The main end-point was the 5 ( th ) - day complete clinical response ( disappearance of pain and edema , and 70 % reduction of the lesion size ) .


Time to response and need for thrombectomy were secondary efficacy variables .


Adverse events were evaluated too .


5 ( th ) day complete response rates were 83/110 ( 75.5 % ) and 36/110 ( 32.7 % ) with rSK and phenylephrine suppositories , respectively .


This 42.7 % difference ( 95 % CI : 30.5-54 .2 ) was highly significant ( P < 0.001 ) .


The advantage was detected since the early 3 ( rd ) day evaluation ( 37.3 % vs 6.4 % for the rSK and active control groups , respectively ; P < 0.001 ) and was kept even at the late 10 ( th ) day assessment ( 83.6 % vs 58.2 % for rSK and phenylephrine , respectively ; P < 0.001 ) .


Time for complete response was significantly shorter ( P = 0.031 ; log-rank test ) in the rSK group ( median : 4.9 d ; 95 % CI : 4.8-5 .0 ) with respect to the active control ( median : 9.8 d ; 95 % CI : 9.8-10 .0 ) .


Thrombectomy was necessary in 1/59 and 8/57 patients with baseline thrombosis in the rSK and phenylephrine groups , respectively ( P = 0.016 ) .


There were no adverse events attributable to the experimental treatment .


rSK suppositories showed a significant advantage over a widely used over-the-counter phenylephrine preparation for the treatment of acute hemorrhoidal illness , with an adequate safety profile .


The impact of different approaches to fluid management during intraoperative volume resuscitation in patients undergoing major elective surgery is poorly defined .


We compared volume effectiveness of crystalloid and colloid substitution aimed to maintain the cardiac index ( CI ) between 2.6 and 3.8 l/min/m ( 2 ) as measured by transesophageal Doppler ( TED ) .


A total of 115 urological patients were enrolled in the prospective randomized trial and then randomized into 2 groups , one with volume therapy based on crystalloids ( n = 57 ) and the other with colloids ( n = 58 ) .


A TED probe was inserted and then hemodynamic optimization ( therapy with Ringer 's solution or hydroxyethyl starch 6 % 130/0 .4 and administration of vasoactive drugs ) was started according to TED variables to maintain the CI between 2.6 and 3.8 l/min/m ( 2 ) .


We observed high incidence of CI < 2.6 l/min/m ( 2 ) after induction of anesthesia ( 75 % ) in both groups .


There were no significant differences in demographic characteristics , ASA classification , length of surgery , estimated blood loss and the CI during surgery .


To maintain the CI within the requested interval , significantly different amounts of crystalloids were needed as compared to colloid ( median : 5000 ml vs 1500 ml ) .


In the CRY group , more patients were treated by vasodilatators ( 40.4 vs 20.7 % ) .


The study confirmed that crystalloids and colloids are effective in correcting flow-related perfusion abnormalities .


The significant difference between volumes of crystalloids and colloids proved their different characteristics such as unequal distribution between compartments .


The expansion of therapeutic algorithm by using vasoactive drugs allows us to avoid adverse events resulting from fluid overload ( Tab .


1 , Fig. 5 , Ref .


35 ) .


Pedometry is an objective method to analyse part of physical activity .


The aims of this study were to evaluate physical activity ( by quantifying walking steps/day ) in Romanian chronic obstructive pulmonary disease ( COPD ) patients and healthy subjects .


A total of 58 COPD patients ( GOLD stages III and IV ) and 273 healthy subjects , divided by decades of age , wore pedometers for 2 weeks .


Significant decrease of physical activity level was observed in COPD patients vs. control group ( 3,4141,105 vs. 7,2002,452 steps/day ) .


Walking performance of patients with COPD stage III was better than that of patients with COPD stage IV .


For both groups , the lowest activity level was recorded during the weekend .


Patients with COPD could not perform any aerobic movement .


This study revealed a difference of physical activity in both healthy individuals and COPD patients , in the latter group the decrease being worse and in accordance with the disease severity .


The potential of secretory leukocyte protease inhibitor ( SLPI ) as a biomarker for colorectal cancer was studied .


A prospective , randomized , controlled , clinical trial was conducted in 2013 and 2014 to confirm whether the expression of SLPI correlates with prognosis and metastasis in colorectal cancer patients .


Immunohistochemistry was used to detect SLPI expression in colorectal cancer .


The expression of SLPI was scored by two pathologists independently .


Statistical analysis of the data was performed using a 2 test to investigate the influence of SLPI on the pathologic characteristics of colorectal cancer .


Compared with normal tissue , SLPI was overexpressed in colorectal cancer tissue .


Overexpression of SLPI correlated with different grades ( moderate or good differentiation : 2.7 % low expression versus 97.3 % high expression , low differentiation : 41.7 % low expression versus 58.3 % high expression ) , TNM stage ( I or II : 4.2 % low expression versus 95.8 % high expression ; III or IV : 19.7 % low expression versus 80.3 % high expression ) , lymphatic metastasis ( 18.6 % low expression versus 81.4 % high expression ) and distal metastasis ( 86.5 % low expression versus 13.5 % high expression ) , but not with patient age or sex ( P = 0.613 , P = 0.871 ) .


Upregulated SLPI correlates with aggressive pathologic characteristics of colorectal cancer ; SLPI could be used as an indicator of progression and metastasis in patients with colorectal cancer .


The purpose of this study was to investigate the impact of recovery by cool or warm water immersion , between two 50-m sprints on performance determinants and lactate responses in simulated competition conditions .


Eight well-trained sprint swimmers ( 21 2.4 years ) , after an initial warm-up and 15-minutes recovery with no immersion ( NI ) , performed a maximal 50 m sprint .


A second 50 m sprint followed after a second 15-minute recovery period with passive immersion in either warm ( WI , 30 C ) , or cool water ( CI , 26.7 C ) .


In a crossover design , all subjects repeated the trial 48 hours later utilizing the alternate immersion temperature .


During the 50-m sprints , time and stroke characteristics were recorded .


Blood lactate and heart rates were measured before and after the trials .


Strength and flexibility were recorded before and after immersions and ratings of perceived exertion were evaluated .


There were no significant differences in time , event velocity , or stroke rate , between any of the trials .


With WI , a significant reduction of handgrip strength was observed ( P = 0.029 ) with lower ratings of perceived exertion observed after the sprint .


Higher resting lactate levels were recorded , prior to swimming , after both the 15-minute WI and CI water recoveries ( P < 0.01 ) as compared to NI .


No correlation was observed between swim performance times and starting or peak lactate levels , with any type of recovery intervention ( R2 = 0.047 ; slope NS from zero ) .


Recovery by cool ( 26.7 C ) or warm ( 30 C ) water immersion does not affect velocity or stroke characteristics in a 50-m freestyle sprint , even when widely employed performance related determinants such as resting lactate levels and perceived exertion are not optimal .


Message framing outcomes of healthy behaviours as occurring ` every day ' vs. ` every year ' can influence the temporal proximity and perceived likelihood of these outcomes .


However , it is not known how pre-existing beliefs such as confidence in one 's ability to perform health-related behaviour interact with such messages .


The purpose of this research was to investigate whether eating self-efficacy moderates the effect of temporal framing ( day-frame vs. year-frame ) on snacking behaviour .


Participants ( N = 95 ) completed the short form of the Weight Efficacy Lifestyle Questionnaire ( WEL-SF ) and read either a day-framed or year-framed message about the health benefits associated with avoiding snacking .


Consumption of snacks was reported 7 days later .


For those with low levels of eating self-efficacy ( WEL-SF score < 4.3 on a 7-point response scale ) , the year-framed message was associated with lower levels of snacking than the day-framed message .


The current research identifies a key role for eating self-efficacy in shaping recipients ' responses to temporally framed messages about the health benefits associated with the avoidance of snacking .


Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis .


This phase 3 study evaluated the safety and efficacy of luliconazole cream 1 % in patients with tinea pedis .


A total of 321 male and female patients aged 12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1 % ( n = 159 ) or vehicle ( n = 162 ) once daily for 14 days .


Efficacy was evaluated at days 28 and 42 ( i.e. , days 14 and 28 posttreatment ) based on clinical signs ( erythema , scaling , pruritus ) and mycology ( KOH , fungal culture ) .


The primary outcome was complete clearance at day 42 .


Safety evaluations included adverse events and laboratory assessments .


Complete clearance at day 42 was achieved in 26.4 % ( 28/106 ) of patients treated with luliconazole cream 1 % compared with 1.9 % ( 2/103 ) of patients treated with vehicle ( P < 0.001 ) .


Similar safety profiles were obtained for luliconazole cream 1 % and vehicle .


This study was conducted in a relatively small population under controlled clinical trial conditions .


Luliconazole cream 1 % applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis .


Small dense low density lipoprotein-cholesterol ( sdLDL-C ) molecules are more atherogenic compared with large buoyant ones .


Phytosterols-enriched diets are effective in decreasing total cholesterol ( TC ) and low density lipoprotein-cholesterol ( LDL-C ) concentrations in hyperlipidemic children without significant adverse effects .


Limited data on the impact of such a diet on sdLDL-C levels is available in adults while there are no reports concerning children .


The purpose of this study is to prospectively evaluate the effect of the daily consumption of 2 g of plant sterols on sdLDL-C levels in children with hypercholesterolemia .


Fifty-nine children , 25 with LDL-C 3.4 mmol/l ( 130 mg/dl ) and 34 with LDL-C < 3.4 mmol/l , aged 4.5-15 .9 years , were included in the study .


A yogurt-drink enriched with 2 g of plant sterols was added to the daily diet of hypercholesterolemic children and 6-12 months later lipid profiles were reassessed .


Direct quantitative methods were used to measure LDL-C and sdLDL-C levels .


The consumption of plant sterols reduced sdLDL-C significantly ( p < 0.001 ) , but levels remained higher compared with controls ( p < 0.001 ) .


TC , LDL-C , non high density lipoprotein-cholesterol ( NonHDL-C ) and apolipoprotein B ( ApoB ) levels also decreased significantly ( p < 0.05 ) .


The median reduction of sdLDL-C and LDL-C was 16.6 % and 13 % , respectively .


These variables decreased > 10 % in sixteen children ( 64 % ) , independently from baseline levels , sex , age and body mass index ( BMI ) .


High density lipoprotein-cholesterol ( HDL-C ) , lipoprotein a [ Lp ( a ) ] , and triglycerides ( TGs ) levels remained unaffected .


Plant sterols decrease sdLDL-C significantly and may be beneficial for children with hypercholesterolemia .


Acute bowel toxicity significantly affects the quality of life of patients treated with pelvic radiotherapy .


This study was performed to assess whether pretreatment with famotidine can reduce acute radiation toxicities in patients undergoing radiotherapy for prostate cancer .


Between April 2012 and February 2013 , 36 patients undergoing radiotherapy for prostate cancer were enrolled to receive either placebo or famotidine .


The patients received external-beam radiotherapy up to 70 Gy at daily fractions of 1.8-2 Gy ( 5 days/week ) .


Oral famotidine 40 mg ( 80 mg/day ) or placebo was administered twice daily ( 4 and 3 h prior to each radiotherapy fraction ) .


Bowel and bladder acute toxicities were evaluated weekly during radiotherapy and once thereafter according to RTOG grading criteria .


Famotidine was well tolerated .


No grade III or higher acute toxicities were noted in the two groups .


Grade II rectal toxicity developed significantly more often in patients receiving placebo than in patients receiving famotidine ( 10/18 vs. 2/16 , p = 0.009 ) .


Moreover , no rectal bleeding occurred in the famotidine group , while 5 patients in the placebo group experienced rectal bleeding during treatment ( p = 0.046 ) .


The duration of rectal toxicity in the radiotherapy course was also reduced in the famotidine group ( 15.7 vs. 25.2 days , p = 0.027 ) .


No significant difference between the two groups was observed in terms of urinary toxicity .


We demonstrated for the first time that famotidine significantly reduces radiation-induced injury on rectal mucosa representing a suitable radioprotector for patients treated with radiotherapy for prostate cancer .


The aim of this study was to comparatively evaluate in vivo the disinfecting ability of conventional method and lasers in root canals .


Study criteria included 60 single rooted teeth , which were indicated for root canal therapy followed to dental caries and trauma with intact crowns .


Such selected patients were randomly divided into 2 groups , namely , Group A ( 30 teeth ) and Group B ( 30 teeth ) .


All clinical procedures were carried out under strict aseptic precautions .


The teeth in Group A were subjected to biomechanical preparation followed by the treatment with the help of diode laser containing the gallium aluminum and arsenic , which emitted 980 nm wavelengths .


The teeth in Group B were treated with routine method of biomechanical preparation along with irrigation using sodium hypochlorite and hydrogen peroxide .


The microbiological samples were taken immediately after the access preparation and after the completion of the root canal disinfection and were sent for microbiological analysis .


The teeth in Group A showed presence of common strains of bacteria ranging from Streptococci , Staphylococci , Klebsiella , and Pseudomonas .


Reduction in the growth of microorganisms was found for all types of microorganisms .


Only 8 samples exhibited the growth after treatment with laser .


Results of Group B also showed the presence of common strains of anaerobic and aerobic bacteria as shown in earlier studies , predominantly Staphylococcus , Streptococci , and Pseudomonas .


Statistical analysis showed non-significant P values for the microorganisms ; however , only 3 samples showed the growth after treatment with conventional technique using sodium hypochlorite and hydrogen peroxide .


Conventional method by using sodium hypochlorite and hydrogen peroxide as irrigating solutions is highly effective in disinfecting the root canal .


Lasers when used can also reduce the bacterial load of the infected root canal .


Combination therapy with two or more different drugs , with the intension of reaching the same therapeutic goal , was heavily criticized for a long time .


However , it is accepted today , especially when advantage over monotherapy can be proved .


Our study was undertaken to compare whether propofol priming and midazolam predosing would affect total induction dose requirement of Propofol .


A prospective randomized , double blind control study was conducted where 120 patients ( 16-65 years ) were divided into 3 groups .


Group P received 0.4 mg/kg of Propofol , Group M received 0.05 mg/kg of Midazolam and Group N received 3 ml of Normal Saline 5 minutes after intravenous pethidine 0.75 mg / kg given for analgesia .


We compared the total dose of propofol requirement for induction of anaesthesia in all the 3 groups , taking loss of verbal contact as the end point .


Additionally , changes in haemodynamic status like blood pressure and heart rate at various intervals were studied and compared among the groups .


The groups were similar in terms of age , sex , weight and American Society of Anesesthesiologists Physical Status.The dose of Propofol required to induce anesthesia in Midazolam group was 1.58 mg/kg ,1.86 mg/kg in Propofol group and 1.96 mg/kg in the control group .


There were less hemodynamic changes in Midazolam group compared to the other two .


Pre-dosing with Midazolam is more effective than Propofol priming in reducing the dose of Propofol induced anaesthesia associated with minimum hemodynamic alterations .


Most drug-eluting stents currently in use are coated with a polymer carrying the drug that is released for several weeks .


However , a durable polymer may provoke hypersensitive reaction , delayed artery healing , and eventually stent thrombosis .


The aim of this study was to investigate the safety and efficacy of a polymer-free paclitaxel-eluting stent ( PF-PES ) versus a polymer-based PES ( PB-PES ) .


Eligible patients undergoing percutaneous coronary intervention were randomized 1:1 to receive either PF-PES or PB-PES .


The primary end point was late loss at 9 months .


Intravascular ultrasound analysis at 9 months and final 2-year clinical follow-up were also performed .


From October 2007 to April 2009 , 164 patients were enrolled and randomized into 2 groups ( PF-PES : n = 84 ; PB-PES : n = 80 ) .


Mean in-stent lumen loss was 0.90 0.59 mm for PF-PES and 0.49 0.52 mm for PB-PES ( P < 0.001 ) .


Mean neointimal area by intravascular ultrasound was higher in PF-PES than in PB-PES ( 1.42 1.09 versus 0.51 0.61 mm ( 2 ) ; P < 0.001 ) .


At 2 years , a composite end point of all-cause death , any myocardial infarction , and target vessel revascularization occurred in 36.9 % for PF-PES and 16.3 % for PB-PES ( P = 0.004 ) , mainly driven by a higher rate of target vessel revascularization ( PF-PES : 35.7 % ; PB-PES : 13.8 % ; P = 0.001 ) .


One late stent thrombosis was observed in PF-PES .


Compared with PB-PES , PF-PES was associated with increased neointimal proliferation and subsequent clinical restenosis .


Polymer plays an essential role in the performance of drug-eluting stents .


http://www.clinicaltrials.gov .


Unique identifier : NCT01375855 .


Response to treatment may be useful for diagnostic confirmation of childhood tuberculosis ( TB ) .


We aimed to evaluate time to symptom resolution in children treated for pulmonary TB .


We compared pulmonary TB cases and noncases , classified by a published diagnostic algorithm , in South African children younger than 2 .


TB treatment was prescribed independently on clinical grounds .


We analyzed independent determinants of baseline symptom resolution by Cox regression .


One hundred and ninety-one symptomatic children , median age 12 months , were prescribed for TB treatment .


Chest radiograph features of TB were associated with longer time to resolution of cough ( adjusted hazard ratio , AHR 0.31 ) , wheeze ( AHR 0.26 ) and failure to thrive ( AHR 0.41 ) , ( all P < 0.05 ) .


However , median duration of baseline cough ( 63 vs. 70 days , P = 0.98 ) , wheeze ( 62 vs. 68 days , P = 0.87 ) and failure to thrive ( 76 vs. 66 days , P = 0.59 ) did not differ in TB cases ( n = 48 ) versus noncases ( n = 46 ) .


Baseline symptoms take more than 60 days to resolve in the majority of young children after starting TB treatment .


Furthermore , since time to resolution does not differentiate TB cases from noncases ; clinical response to treatment is not an appropriate diagnostic criterion for pediatric trials of TB diagnostics , drugs and vaccines .


This study sought to assess device-specific outcomes after implantation of bare-metal stents ( BMS ) , zotarolimus-eluting Endeavor Sprint stents ( ZES-S ) , paclitaxel-eluting stents ( PES ) , or everolimus-eluting stents ( EES ) ( Medtronic Cardiovascular , Santa Rosa , California ) in all-comer patients undergoing percutaneous coronary intervention .


Few studies have directly compared second-generation drug-eluting stents with each other or with BMS .


We randomized 2,013 patients to BMS , ZES-S , PES , or EES implantation .


At 30 days , each stent group received up to 6 or 24 months of clopidogrel therapy .


The key efficacy endpoint was the 2-year major adverse cardiac event ( MACE ) including any death , myocardial infarction , or target vessel revascularization , whereas the cumulative rate of definite or probable stent thrombosis ( ST ) was the key safety endpoint .


Clinical follow-up at 2 years was complete for 99.7 % of patients .


The MACE rate was lowest in EES ( 19.2 % ; 95 % confidence interval [ CI ] : 16.0 to 22.8 ) , highest in BMS ( 32.1 % ; 95 % CI : 28.1 to 36.3 ) , and intermediate in PES ( 26.2 % ; 95 % CI : 22.5 to 30.2 ) and ZES-S ( 27.8 % ; 95 % CI : 24.1 to 31.9 ) groups ( chi-square test = 18.9 , p = 0.00029 ) .


The 2-year incidence of ST in the EES group ( 1 % ; 95 % CI : 0.4 to 2.2 ) was similar to that in the ZES-S group ( 1.4 % ; 95 % CI : 0.7 to 2.8 ) , whereas it was lower compared with the PES ( 4.6 % , 95 % CI : 3.1 to 6.8 ) and BMS ( 3.6 % ; 95 % CI : 2.4 to 5.6 ) groups ( chi-square = 16.9 ; p = 0.0001 ) .


Our study shows that cumulative MACE rate , encompassing both safety and efficacy endpoints , was lowest for EES , highest for BMS , and intermediate for PES and ZES-S groups .


EES outperformed BMS also with respect to the safety endpoints with regard to definite or probable and definite , probable , or possible ST. ( PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY [ PRODIGY ] ; NCT00611286 ) .


To determine the efficacy of Rifaximin in prevention of repeated episodes of hepatic encephalopathy in patients with liver cirrhosis as compared to placebo .


Triple-blind , randomized placebo-controlled trial .


Department of Gastroenterology-Hepatology , Shaikh Zayed Hospital , Lahore , from October 2012 to April 2013 .


Patients in remission from recurrent hepatic encephalopathy resulting from cirrhosis were randomly assigned to receive either Rifaximin , at a dose of 550 mg twice daily ( 63 patients ) , or placebo ( 63 patients . )


Patients were requested to take the drug orally twice daily for 6 months or until they developed a breakthrough episode of hepatic encephalopathy .


Mean age of patients in treatment and control group was 40.21 2.33 years and 42.87 4.54 years respectively .


The most common etiology of cirrhosis was hepatitis C followed by hepatitis B. Patients who remained free of hepatic encephalopathy during study period were 40 out of 63 patients in control group and 35 patients out of 63 patients ( p = 0.56 ) .


Most of the patients who developed breakthrough hepatic encephalopathy had a MELD score range of 21-25 in both groups .


The number of deaths and adverse events was similar in both groups .


Over a 6-month period , treatment with Rifaximin failed to maintain remission from hepatic encephalopathy more effectively than placebo in the studied group .


Novel sensory inputs for the control of food intake and gastrointestinal ( GI ) function are of increasing interest due to the rapid increase in nutrition-related diseases .


The essential amino acid L-lysine was demonstrated to have a selective impact on food intake , gastric emptying , and intestinal transit in rats , thus indicating a potential novel direct sensory input to assess dietary protein content and quality .


The aim of this study was to assess translational aspects of this finding and to investigate the dose-dependent effect of L-lysine on human and rat GI function .


L-lysine doses from 0-800 mg in rats and 0.5-7 .5 g in humans were analyzed for their effect on gastric emptying and GI secretion .


Human GI function was assessed non-invasively using magnetic resonance imaging ( MRI ) , rat data were acquired using standard lethal measurement methods .


L-lysine dose dependently delayed gastric emptying and stimulated GI secretion in rats as reflected by residual phenol red content and increased gastric wet weight .


The dose-dependent delay in gastric emptying observed in rats was confirmed in humans with an increase in halftime of gastric emptying of 4 min/g L-lysine , p < 0.01 .


Moreover , a dose-dependent increase in intestinal fluid accumulation was observed ( 0.4 mL/min/g L-lysine , p < 0.0001 ) .


No effect on alkaline tide , glucose concentration , hematocrit , or visceral sensations was detected .


This translational study demonstrates comparable dose-dependent effects of intragastric L-lysine on GI function in humans and rats and suggests a broader role for individual amino acids in the control of GI motility and secretion in vivo .


To assess and compare the effects of contact lens-based artificial pupil design and contralateral balanced multifocal contact lens combination ( CBMCLC ) on visual performance .


This randomized crossover study conducted at the University of Valencia , Spain included 38 presbyopic patients using an artificial pupil contact lens in the nondominant eye and a CBMCLC .


After a month of lens wear , the binocular distance visual acuity ( BDVA ) , binocular near visual acuity ( BNVA ) , defocus curve , binocular distance , and near contrast sensitivity and near stereoacuity ( NSA ) were measured under photopic conditions ( 85 cd/m2 ) .


Moreover , BDVA and binocular distance contrast sensitivity were examined under mesopic conditions ( 5 cd/m2 ) .


Visual acuity at an intermediate distance and near vision was better with the CBMCLC than with the artificial pupil ( p < 0.05 ) .


Statistically significant differences were found in contrast sensitivity between the two types of correction for distance ( under mesopic conditions ) and for near vision , with the CBMCLC exhibiting better results in both cases ( p < 0.05 ) .


The mean NSA values obtained for the artificial pupil contact lens were significantly worse than those for the CBMCLC ( p = 0.001 ) .


The CBMCLC provided greater visual performance in terms of intermediate and near vision compared with the artificial pupil contact lens .


To verify the clinical efficacy of acupuncture and moxibustion on depressive states of stroke patients ' spouses .


Forty-four subjects who were stroke patients ' spouses and according with inclusive criteria with mild or moderate depressive states were randomly divided into an acupuncture-moxibustion group and a blank control group , 22 cases in each group .


In the acupuncture-moxibustion group , acupuncture was applied at Baihui ( GV 20 ) , Shenting ( GV 24 ) , Sishencong ( EX-HN 1 ) , Hegu ( LI 4 ) , Zusanli ( ST 36 ) and Taichong ( LR 3 ) , and suspended moxibustion was used at Shenque ( CV 8 ) , Guanyuan ( CV 4 ) and Zhongwan ( CV 12 ) .


The treatment was given twice a week for continuous 8 weeks .


In the blank control group , neither acupuncture nor moxibustion treatment was given , and the patients were only treated with health and psychological guidance .


Before treatment and after 8-week treatment , scores of self-rating depression scale ( SDS ) and numbers of insomnia severity grade were observed .


In the two groups , the scores of SDS were both reduced than those before treatment ( both P < 0.05 ) , and the decrease in the acupuncture-moxibustion group was more obvious ( P < 0.05 ) .


After treatment , the number of insomnia severity grade in the acupuncture-moxibustion group was improved than that before treatment ( P < 0.001 ) , and the improvement was evidently superior to that in the blank control group ( P < 0.05 ) .


The numbers of insomnia severity grade of the blank control group before and after treatment had no statistic significance ( P > 0.05 ) .


The acupuncture and moxibustion intervention plan has clinical treatment significance on the improvement of mild and moderate depressive states for the stroke patients ' primary caregivers who are the patients ' spouses .


Melasma has a negative impact on quality of life since it typically occurs on the face .


To evaluate the erythema and pigmentation of melasma lesions and the surrounding areas in patients receiving triple combination ( TC : hydroquinone , tretinoin , and fluocinolone acetonide ) regimens .


Patients first received an 8-week daily TC treatment and were then randomized to twice weekly or tapering regimen with TC .


Melanin and erythema levels of lesions and surrounding areas were objectively measured using a narrowband reflectance spectrophotometer .


Progressive reduction in the mean melanin levels was observed in the treatment phase .


Following both maintenance regimens , there was no difference between melanin levels in the melasma lesions .


Adverse effects were rare in both phases of the study and there was borderline reduction in erythema with regimen II .


Both maintenance regimens were effective in maintaining results obtained during the initial treatment phase , and were safe and well-tolerated .


Erythema was less intense with the tapering regimen .


We compared the longer-term impact of the two most commonly applied forms of post-discharge management designed to minimize recurrent hospitalization and prolong survival in typically older patients with chronic heart failure ( CHF ) .


We followed a multi-center randomized controlled trial cohort of Australian patients hospitalized with CHF and initially allocated to home-based or specialized CHF clinic-based intervention for 1368 216 days .


Blinded endpoints included event-free survival from all-cause emergency hospitalization or death , all-cause mortality and rate of all-cause hospitalization and stay .


280 patients ( 73 % male , aged 71 14 years and 73 % left ventricular systolic dysfunction ) were initially randomized to home-based ( n = 143 ) or clinic-based ( n = 137 ) intervention .


During extended follow-up ( complete for 274 patients ) , 1139 all-cause hospitalizations ( 7477 days of hospital stay ) and 121 ( 43.2 % ) deaths occurred .


There was no difference in the primary endpoint ; 20 ( 14.0 % ) home-based versus 13 ( 7.4 % ) clinic-based patients remained event-free ( adjusted HR 0.89 , 95 % CI 0.70 to 1.15 ; p = 0.378 ) .


Significantly fewer home-based ( 51/143 , 35.7 % ) than clinic-based intervention ( 71/137 , 51.8 % ) patients died ( adjusted HR 0.62 , 95 % CI 0.42 to 0.90 : p = 0.012 ) .


Home-based versus clinic-based intervention patients accumulated 592 and 547 all-cause hospitalizations ( p = 0.087 ) associated with 3067 ( median 4.0 , IQR 2.0 to 6.8 ) versus 4410 ( 6.0 , IQR 3.0 to 12.0 ) days of hospital stay ( p < 0.01 for rate and duration of hospital stay ) .


Relative to clinic-based intervention , home-based intervention was not associated with prolonged event-free survival .


Home-based intervention was , however , associated with significantly fewer all-cause deaths and significantly fewer days of hospital stay in the longer-term .


Australian New Zealand Clinical Trials Registry number 12607000069459 ( http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81803 ) .


To investigate the contribution of Bispectralindex monitoring on the amount of used anaesthetic substance and the quality of anaesthesia in patients with persistent atrial fibrillation who would undergo cardioversion .


The prospective , randomised , controlled clinical study was conducted at Akdeniz University , Antalya , Turkey from October 2010 to November 2011 Sedation was performed on 50 adult patients using midazolam and fentanyl .


Patients were randomised to group 1 and 2 .


In group 1 cardioversion was performed when the BispectralIndex value was seen to have decreased to < 80 and the Ramsay sedation score was 5-6 .


In Group 2 , BispectralIndex monitor was blinded to the investigator , and cardioversion was performed when Ramsay sedation score was 5-6 .


In both groups , blood pressure , heart rate and Bispectral index values were recorded .


Total anaesthetic amount , awareness and pain were also assessed .


SPSS 13 was used for statistical analysis .


Overall , 23 ( 46 % ) patients were male and 27 ( 54 % ) were female and there was no significant difference in the two groups in terms of age ( p > 0.05 ) .


No statistically significant difference was detected between the groups in terms of induction time , anaesthetic need and Bispectral Index values ( p > 0.05 ) .


In both groups , 2 ( 8 % ) patients perceived pain and 2 ( 8 % ) perceived the procedure .


In the presence of anaesthetist in the team , Bispectral Index monitoring did not contribute to the determining of anaesthetic drug dosage and the depth and quality of anaesthesia in patients with persistent atrial fibrillation during cardioversion .


To determine whether genotypes at 2 major loci associated with late age-related macular degeneration ( AMD ) , complement factor H ( CFH ) and age-related maculopathy susceptibility 2 ( ARMS2 ) , influence the relative benefits of Age-Related Eye Disease Study ( AREDS ) supplements .


Unplanned retrospective evaluation of a prospective , randomized , placebo-controlled clinical trial of vitamins and minerals for the treatment of AMD .


AREDS participants ( mean age , 69 years ) who were at risk of developing late AMD and who were randomized to the 4 arms of AREDS supplement treatment .


Analyses were performed using the Cox proportional hazards model to predict progression to late AMD ( neovascular or central geographic atrophy ) .


Statistical models , adjusted for age , gender , smoking status , and baseline AMD severity , were used to examine the influence of genotypes on the response to therapy with 4 randomly assigned arms of AREDS supplement components : placebo , antioxidants ( vitamin C , vitamin E , - carotene ) , zinc , or a combination .


The influence of the genotype on the relative treatment response to the randomized components of the AREDS supplement , measured as progression to late AMD .


Of the 1237 genotyped AREDS participants of white ethnicity , late AMD developed in 385 ( 31.1 % ) during the mean follow-up of 6.6 years .


As previously demonstrated , CFH genotype ( P = 0.005 ) , ARMS2 ( P < 0.0001 ) , and supplement were associated individually with progression to late AMD .


An interaction analysis found no evidence that the relative benefits of AREDS supplementation varied by genotype .


Analysis of ( 1 ) CFH rs1061170 and rs1410996 combined with ARMS2 rs10490924 with the 4 randomly assigned arms of AREDS supplement and ( 2 ) analysis of the combination of CFH rs412852 and rs3766405 with ARMS2 c. 372_815del443ins54 with the AREDS components resulted in no interaction ( P = 0.06 and P = 0.45 , respectively , before multiplicity adjustment ) .


The AREDS supplements reduced the rate of AMD progression across all genotype groups .


Furthermore , the genotypes at the CFH and ARMS2 loci did not statistically significantly alter the benefits of AREDS supplements .


Genetic testing remains a valuable research tool , but these analyses suggest it provides no benefits in managing nutritional supplementation for patients at risk of late AMD .


To analyze performance and fatigue effects of small-sided games ( SSG ) vs high-intensity interval training ( HIIT ) performed during a 4-wk in-season period in high-level youth football .


Nineteen players from 4 youth teams ( 16.5 [ SD 0.8 ] y , 1.79 [ 0.06 ] m , 70.7 [ 5.6 ] kg ) of the 2 highest German divisions completed the study .


Teams were randomly assigned to 1 of 2 training sequences ( 2 endurance sessions per wk ) : One training group started with SSG , whereas the other group conducted HIIT during the first half of the competitive season .


After the winter break , training programs were changed between groups .


Before and after the training periods the following tests were completed : the Recovery-Stress Questionnaire for Athletes , creatine kinase and urea concentrations , vertical-jump height ( countermovement jump [ CMJ ] , drop jump ) , straight sprint , agility , and an incremental field test to determine individual anaerobic threshold ( IAT ) .


Significant time effects were observed for IAT ( +1.3 % , ( p ) ( 2 ) = .31 ) , peak heart rate ( -1.8 % , ( p ) ( 2 ) = .45 ) , and CMJ ( -2.3 % , ( p ) ( 2 ) = .27 ) , with no significant interaction between groups ( P > .30 ) .


Players with low baseline IAT values ( +4.3 % ) showed greater improvements than those with high initial values ( 0.0 % ) .


A significant decrease was found for total recovery ( -5.0 % , ( p ) ( 2 ) = .29 ) , and an increase was found for urea concentration ( +9.2 % , ( p ) ( 2 ) = .44 ) .


Four weeks of in-season endurance training can lead to relevant improvements in endurance capacity .


The decreases in CMJ height and total-recovery score together with the increase in urea concentration might be interpreted as early signs of fatigue .


Thus , the danger of overtaxing players should be considered .


To evaluate the effects of whole body vibration ( WBV ) and local muscle vibration ( LMV ) on quadriceps function after experimental knee effusion ( ie , simulated pathology ) .


Randomized controlled trial .


Research laboratory .


Healthy volunteers ( N = 43 ) were randomized to WBV ( n = 14 ) , LMV ( n = 16 ) , or control ( n = 13 ) groups .


Saline was injected into the knee to induce quadriceps arthrogenic muscle inhibition ( AMI ) .


All groups then performed isometric squats while being exposed to WBV , LMV , or no vibration ( control ) .


Quadriceps function was assessed at baseline , immediately after effusion , and immediately and 5 minutes after each intervention ( WBV , LMV , control ) via voluntary peak torque ( VPT ) and the central activation ratio ( CAR ) during maximal isometric knee extension on a multifunction dynamometer .


The CAR improved in the WBV ( 11.4 % , P = .021 ) and LMV ( 7.3 % , P < .001 ) groups immediately postintervention , but they did not improve in the control group .


Similarly , VPT increased by 16.5 % ( P = .021 ) in the WBV group and 23 % ( P = .078 ) in the LMV group immediately postintervention , but it did not increase in the control group .


The magnitudes of improvements in the CAR and VPT did not differ between the WBV and LMV groups .


Quadriceps AMI is a common complication following knee pathology that produces quadriceps dysfunction and increases the risk of posttraumatic osteoarthritis .


Quadriceps strengthening after knee pathology is often ineffective because of AMI .


WBV and LMV improve quadriceps function equivocally after simulated knee pathology , effectively minimizing quadriceps AMI .


Therefore , these stimuli may be used to enhance quadriceps strengthening , therefore improving the efficacy of rehabilitation and reducing the risk of osteoarthritis .


Cognitive behaviour therapy ( CBT ) is an effective treatment for depression .


However , CBT is a complex therapy that requires highly trained and qualified practitioners , and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand .


Behavioural activation ( BA ) is a psychological treatment for depression that may be an effective alternative to CBT and , because it is simpler , might also be delivered by less highly trained and specialised mental health workers .


COBRA is a two-arm , non-inferiority , patient-level randomised controlled trial , including clinical , economic , and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT .


Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care .


We will analyse for non-inferiority in per-protocol and intention-to-treat populations .


Our primary outcome will be severity of depression symptoms ( Patient Health Questionnaire-9 ) at 12 months follow-up .


Secondary outcomes will be clinically significant change and severity of depression at 18 months , and anxiety ( General Anxiety Disorder-7 questionnaire ) and health-related quality of life ( Short-Form Health Survey-36 ) at 12 and 18 months .


Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions , health and social care services used , plus productivity losses .


Cost-effectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life .


The clinical and economic outcomes of this trial will provide the evidence to help policy makers , clinicians and guideline developers decide on the merits of including BA as a first-line treatment of depression .


Current Controlled Trials ISRCTN27473954 .


Eccentric muscle actions are important to the development of muscle mass and strength and may affect bone mineral density ( BMD ) .


This study 's purpose was to determine the relative effectiveness of five different eccentric : concentric load ratios to increase musculoskeletal parameters during early adaptations to resistance training .


Forty male subjects performed a supine leg press and calf press training program 3 days week ( -1 ) for 8 weeks .


Subjects were matched for pre-training leg press 1-repetition maximum strength ( 1-RM ) and randomly assigned to one of five training groups .


Concentric training load ( % 1-RM ) was constant across groups , but within groups , eccentric load was 0 , 33 , 66 , 100 , or 138 % of concentric load .


Muscle mass ( dual energy X-ray absorptiometry ; DXA ) , strength ( 1-RM ) , and BMD ( DXA ) were measured pre - and post-training .


Markers of bone metabolism were assessed pre - , mid - and post-training .


The increase in leg press 1-RM in the 138 % group ( 20 4 % ) was significantly greater ( P < 0.05 ) than the 0 % ( 8 3 % ) , 33 % ( 8 5 % ) and 66 % ( 8 4 % ) groups , but not the 100 % group ( 13 6 % ; P = 0.15 ) .


All groups , except the 0 % group , increased calf press 1-RM ( P < 0.05 ) .


Leg lean mass and greater trochanter BMD were increased only in the 138 % group ( P < 0.05 ) .


Early-phase adaptations to eccentric overload training include increases in muscle mass and site-specific increases in BMD and muscle strength which are not present or are less with traditional and eccentric underload training .


Eccentric overload provides a robust musculoskeletal stimulus that may benefit bedridden patients , individuals recovering from injury or illness , and astronauts during spaceflight .


To explore the effects of parecoxib sodium analgesia on serum concentrations of neuron-specific enolase ( NSE ) and S-100 and postoperative cognitive function of elderly patients undergoing acute replacement of femoral head .


After the approval of institutional review board and the provision of informed consent , 80 patients over 70 years old , undergoing acute replacement of femoral head under combined spinal and epidural anesthesia and midazolam sedation at Qingdao Municipal Hospital and Qingdao Hiser Medical Center from January 2011 to May 2012 , were randomly assigned into control group ( group C , n = 40 ) and parecoxib group ( group P , n = 40 ) .


In group P , parecoxib sodium 20/40 mg ( based on weight 50 kg ) was administered via an intravenous injection after admission with 12 hours intervals for six times .


In group C , morphine 2/4 mg was given initially .


Additional morphine 2 mg was given to maintain the pain visual analog scale ( VAS ) of 3 points or less in both groups .


Primary observation indices : ( 1 ) postoperative time and additional amount of morphine ; ( 2 ) rate of postoperative delirium ( POD ) and postoperative cognitive dysfunction ( POCD ) at 3 days , 1 week , 3 months and 6 months postoperation ( T1-T4 ) ; ( 3 ) se rum levels of NSE and S-100 were measured at the timepoints of before analgesia ( t0 ) , before anesthesia ( t1 ) , end of surgery ( t2 ) and 6 hours , 24 hours , 48 hours postoperation ( t3-t5 ) ; ( 4 ) other serious complications .


Compared with group C , the additional amount of morphine , postoperative time , rate of POD and POCD at T1-T4 , the level of NSE at t2-t5 and S-100 at t1-t5 were lower in group P ( P < 0.05 ) .


No other serious complications were observed .


Parecoxib sodium analgesia reduces the rate of POD and POCD in elderly patients with neuroprotective effects .


Pattern differentiation and diagnosis are fundamental principles of Traditional Chinese Medicine ( TCM ) .


Studies have shown low inter-rater reliability in TCM pattern diagnoses .


This variability may originate from both the identification and the interpretation of symptoms and signs .


To examine the inter-rater reliability in TCM pattern diagnoses made in the style of Maciocia for 25 case histories by eight acupuncturists and to explore the impact of demographic factors on the diagnostic conclusion .


Further , the association between the diagnosis and the presence of symptoms was examined for a single TCM diagnosis .


Eight acupuncturists independently diagnosed 25 women ( 15 fertile , 10 infertile ) based on written case histories .


Descriptive statistics , logistic regression and inter-rater reliability ( ) were used .


Poor inter-rater reliability on TCM patterns ( < 0.20 ) and large variation in the number of TCM pattern diagnoses were found .


Sex , duration of practice and education had a highly significant effect ( p < 0.001 ) on the use of TCM patterns and working hours had a significant effect ( p = 0.029 ) .


There was considerable intra - and inter-rater variation in the use of symptoms to make a diagnosis .


Symptoms occurring frequently as well as infrequently were inconsistently used to diagnose Liver Qi Stagnation .


The study was limited by a small sample size .


The results showed extensive variation and poor inter-rater reliability in TCM diagnoses .


Demographic variables influenced the frequency of diagnoses and symptoms were used inconsistently to set a diagnosis .


The variability shown could impede individually tailored treatment .


This randomized phase III trial was conducted to confirm noninferiority of amrubicin plus cisplatin ( AP ) compared with irinotecan plus cisplatin ( IP ) in terms of overall survival ( OS ) in chemotherapy-naive patients with extensive-disease ( ED ) small-cell lung cancer ( SCLC ) .


Chemotherapy-naive patients with ED-SCLC were randomly assigned to receive IP , composed of irinotecan 60 mg/m ( 2 ) on days 1 , 8 , and 15 and cisplatin 60 mg/m ( 2 ) on day 1 every 4 weeks , or AP , composed of amrubicin 40 mg/m ( 2 ) on days 1 , 2 , and 3 and cisplatin 60 mg/m ( 2 ) on day 1 every 3 weeks .


A total of 284 patients were randomly assigned to IP ( n = 142 ) and AP ( n = 142 ) arms .


The point estimate of OS hazard ratio ( HR ) for AP to IP in the second interim analysis exceeded the noninferior margin ( HR , 1.31 ) , resulting in early publication because of futility .


In updated analysis , median survival time was 17.7 ( IP ) versus 15.0 months ( AP ; HR , 1.43 ; 95 % CI , 1.10 to 1.85 ) , median progression-free survival was 5.6 ( IP ) versus 5.1 months ( AP ; HR , 1.42 ; 95 % CI , 1.16 to 1.73 ) , and response rate was 72.3 % ( IP ) versus 77.9 % ( AP ; P = .33 ) .


Adverse events observed in IP and AP arms were grade 4 neutropenia ( 22.5 % v 79.3 % ) , grade 3 to 4 febrile neutropenia ( 10.6 % v 32.1 % ) , and grade 3 to 4 diarrhea ( 7.7 % v 1.4 % ) .


AP proved inferior to IP in this trial , perhaps because the efficacy of amrubicin as a salvage therapy was differentially beneficial to IP .


IP remains the standard treatment for extensive-stage SCLC in Japan .


It has been reported that the direction of the guidewire J-tip is associated with misplacement of a central venous catheter .


We hypothesized that real-time ultrasound-guided infraclavicular subclavian venous cannulation would be less influenced by the direction of guidewire J-tip compared to landmark method .


Sixty adult patients who required subclavian venous catheterization for neurosurgery were enrolled in this prospective randomized controlled study .


Patients were randomly divided into a landmark group ( n = 30 ) or an ultrasound group ( n = 30 ) .


After the subclavian vein was punctured , the guidewire was advanced with the guidewire J-tip directed cephalad .


Misplacement or advancement failure of the guidewire was regarded as an unsuccessful placement .


Postoperative chest radiography was performed to confirm pneumothorax and the location of the catheter tip .


The two groups were comparable with respect to age , gender , height , and weight distribution .


The incidence of unsuccessful guidewire placement was lower in the ultrasound group than in the landmark group ( 13 % vs. 47 % , P = 0.01 ) .


Among the unsuccessful guidewire placements , the incidence of misplacement were comparable between the groups and were all located in the ipsilateral internal jugular vein ( 7 % vs. 7 % ) .


However , the incidence of advancement failure was significantly higher in landmark group ( 40 % vs. 7 % , P = 0.005 ) .


There were no complications such as pneumothorax or hemothorax .


The proper placement of guidewire was less influenced by the direction of the guidewire J-tip with ultrasound-guided subclavian venous cannulation than with the landmark approach .


Human papillomavirus ( HPV ) - based screening needs triage .


In most randomized controlled trials ( RCTs ) on HPV testing with cytological triage , cytology interpretation has been blind to HPV status .


Women age 25 to 60 years enrolled in the New Technology in Cervical Cancer ( NTCC ) RCT comparing HPV testing with cytology were referred to colposcopy if HPV positive and , if no cervical intraepithelial neoplasia ( CIN ) was detected , followed up until HPV negativity .


Cytological slides taken at the first colposcopy were retrieved and independently interpreted by an external laboratory , which was only aware of patients ' HPV positivity .


Sensitivity , specificity , and positive ( PPV ) and negative ( NPV ) predictive values were computed for histologically proven CIN2 + with HPV status-informed cytology for women with a determination of atypical squamous cells of undetermined significance ( ASCUS ) or more severe .


All statistical tests were two-sided .


Among HPV-positive women , informed cytology had cross-sectional sensitivity , specificity , PPV and 1-NPV for CIN2 + of 85.6 % ( 95 % confidence interval [ CI ] = 76.6 to 92.1 ) , 65.9 % ( 95 % CI = 63.1 to 68.6 ) , 16.2 % ( 95 % CI = 13.0 to 19.8 ) , and 1.7 ( 95 % CI = 0.9 to 2.8 ) , respectively .


Cytology was also associated with subsequent risk of newly diagnosed CIN2 + and CIN3 + .


The cross-sectional relative sensitivity for CIN2 + vs blind cytology obtained by referring to colposcopy and following up only HPV positive women who had HPV status-informed cytology greater than or equal to ASCUS was 1.58 ( 95 % CI = 1.22 to 2.01 ) , while the corresponding relative referral to colposcopy was 0.95 ( 95 % CI = 0.86 to 1.04 ) .


Cytology informed of HPV positivity is more sensitive than blind cytology and could allow longer intervals before retesting HPV-positive , cytology-negative women .


We tested the hypothesis that observationally and genetically elevated YKL-40 is associated with elevated lipids and lipoproteins and with increased risk of ischemic vascular disease .


We conducted cohort and Mendelian randomization studies in 96 110 individuals from the Danish general population , with measured plasma levels of YKL-40 ( n = 21 647 ) , plasma lipids and lipoproteins ( n = 94 461 ) , and CHI3L1 rs4950928 genotype ( n = 94 579 ) .


From 1977 to 2013 , 3256 individuals developed ischemic stroke , 5629 ischemic cerebrovascular disease , 4183 myocardial infarction , and 10 271 developed ischemic heart disease .


The 91 % to 100 % versus 0 % to 33 % YKL-40 percentile category was associated with a 34 % increase in triglycerides , but only with minor changes in other lipids and lipoproteins .


For these categories , the multifactorially adjusted hazard ratio was 1.99 ( 95 % confidence interval , 1.49-2 .67 ) for ischemic stroke , 1.85 ( 1.44-2 .37 ) for ischemic cerebrovascular disease , 1.28 ( 0.95-1 .73 ) for myocardial infarction , and 1.23 ( 1.01-1 .51 ) for ischemic heart disease .


When compared with rs4950928 CC homozygosity , the presence of G-allele was associated with a doubling ( GC ) or tripling ( GG ) in YKL-40 levels , but not with triglyceride levels or with risk of ischemic vascular disease .


A doubling in YKL-40 was associated with a multifactorially adjusted observational hazard ratio for ischemic stroke of 1.18 ( 1.11-1 .27 ) , and a genetic odds ratio of 1.04 ( 0.95-1 .15 ) .


Corresponding risk estimates were 1.15 ( 1.09-1 .22 ) observationally and 1.06 ( 0.99-1 .14 ) genetically for ischemic cerebrovascular disease , 1.08 ( 1.00-1 .15 ) observationally and 1.04 ( 0.96-1 .13 ) genetically for myocardial infarction , and 1.07 ( 1.02-1 .12 ) observationally and 1.01 ( 0.96-1 .07 ) genetically for ischemic heart disease .


Elevated YKL-40 was associated with a 34 % increase in triglyceride levels and with a 2-fold increased risk of ischemic stroke , whereas genetically elevated YKL-40 were not .


The association of QRS duration ( QRSd ) with morbidity and mortality is understudied in patients with atrial fibrillation ( AF ) .


We sought to assess any association of prolonged QRS with increased risk of death or hospitalization among patients with AF .


QRS duration was retrieved from the baseline electrocardiograms of patients enroled in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management ( AFFIRM ) study and divided into three categories : < 90 , 90-119 , 120 ms. Cox models were applied relating the hazards of mortality and hospitalizations to QRSd .


Among 3804 patients with AF , 593 died and 2305 were hospitalized .


Compared with those with QRS < 90 ms , patients with QRS 120 ms , had an increased mortality [ hazard ratio ( HR ) 1.61 , 95 % confidence interval ( CI ) : 1.29-2 .03 , P < 0.001 ] and hospitalizations ( HR 1.14 , 95 % CI : 1.07-1 .34 , P = 0.043 ) over an average follow-up of 3.5 years .


Importantly , for patients with QRS 90-119 ms , mortality and hospitalization were also increased ( HR 1.31 , P = 0.005 and 1.11 , P = 0.026 , respectively ) .


In subgroup analysis based on heart failure ( HF ) status ( previously documented or ejection fraction < 40 % ) , mortality was increased for QRS 120 ms patients with ( HR 1.87 , P < 0.001 ) and without HF ( HR 1.63 , P = 0.02 ) .


In the QRS 90-119 ms group , mortality was increased ( HR 1.38 , P = 0.03 ) for those with HF , but not significantly among those without HF ( HR 1.23 , P = 0.14 ) .


Among patients with AF , QRSd 120 ms was associated with a substantially increased risk for mortality ( all-cause , cardiovascular , and arrhythmic ) and hospitalization .


Interestingly , an increased mortality was also observed among those with QRS 90-119 ms and concomitant HF .


This study sought to examine the association between thyroid status and clinical outcomes in patients in the CORONA ( Controlled Rosuvastatin Multinational Trial in Heart Failure ) study .


Hypo - and hyperthyroidism were associated with worse clinical outcomes in the SCD-HeFT ( Sudden Cardiac Death in Heart Failure Trial ) .


In CORONA , 4,987 patients underwent baseline thyroid-stimulating hormone ( TSH ) measurement , 237 of which ( 4.8 % ) were receiving thyroid replacement therapy ( TRT ) .


Patients were classified as euthyroid ( TSH : 0.3 to 5.0 U/ml , and no TRT ) , hyperthyroid ( < 0.3 U/ml and no TRT ) , or hypothyroid ( > 5.0 U/ml and no TRT ) .


The outcome composites of cardiovascular ( CV ) death or hospitalization for heart failure ( HF ) , the components of this composite , and all-cause death were compared among hyperthyroid , hypothyroid , and euthyroid states , using multivariable models adjusting for previously reported prognostic variables .


A total of 91.3 % of patients were euthyroid , 5.0 % were hypothyroid , and 3.7 % were hyperthyroid .


Compared with euthyroid patients , hypothyroid patients were more likely to have a history of stroke , had worse renal function and higher N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) levels , were more likely to be treated with an antiarrhythmic drug ( or have an implantable cardioverter defibrillator ) , and were less likely to smoke or be treated with a beta-blocker or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker .


In univariate analyses , hypothyroidism was associated with an increased risk of the composite outcome of CV death or HF hospitalization ( hazard ratio : 1.29 ; 95 % confidence interval : 1.07 to 1.57 ; p = 0.008 ) , as well as all-cause death ( HR : 1.36 ; 95 % confidence interval : 1.03 to 1.76 ; p = 0.004 ) .


However , after adjustment for other known predictors of outcome , the associations were weakened , and when NT-proBNP was added to the models , the association between hypothyroidism and all outcomes was eliminated .


Thyroid status is not an independent predictor of outcome in heart failure with reduced ejection fraction .


( Controlled Rosuvastatin Multinational Study in Heart Failure [ CORONA ] ; NCT00206310 ) .


To report long-term efficacy and safety results of the SANTE trial investigating deep brain stimulation of the anterior nucleus of the thalamus ( ANT ) for treatment of localization-related epilepsy .


This long-term follow-up is a continuation of a previously reported trial of 5 - vs 0-V ANT stimulation .


Long-term follow-up began 13 months after device implantation with stimulation parameters adjusted at the investigators ' discretion .


Seizure frequency was determined using daily seizure diaries .


The median percent seizure reduction from baseline at 1 year was 41 % , and 69 % at 5 years .


The responder rate ( 50 % reduction in seizure frequency ) at 1 year was 43 % , and 68 % at 5 years .


In the 5 years of follow-up , 16 % of subjects were seizure-free for at least 6 months .


There were no reported unanticipated adverse device effects or symptomatic intracranial hemorrhages .


The Liverpool Seizure Severity Scale and 31-item Quality of Life in Epilepsy measure showed statistically significant improvement over baseline by 1 year and at 5 years ( p < 0.001 ) .


Long-term follow-up of ANT deep brain stimulation showed sustained efficacy and safety in a treatment-resistant population .


This long-term follow-up provides Class IV evidence that for patients with drug-resistant partial epilepsy , anterior thalamic stimulation is associated with a 69 % reduction in seizure frequency and a 34 % serious device-related adverse event rate at 5 years .


To investigate the effects of elastic tubing training compared with conventional resistance training on the improvement of functional exercise capacity , muscle strength , fat-free mass , and systemic inflammation in patients with chronic obstructive pulmonary disease .


A prospective , randomized , eight-week clinical trial .


The study was conducted in a university-based , outpatient , physical therapy clinic .


A total of 49 patients with moderate chronic obstructive pulmonary disease .


Participants were randomly assigned to perform elastic tubing training or conventional resistance training three times per week for eight weeks .


The primary outcome measure was functional exercise capacity .


The secondary outcome measures were peripheral muscle strength , health-related quality of life assessed by the Chronic Respiratory Disease Questionnaire ( CRDQ ) , fat-free mass , and cytokine profile .


After eight weeks , the mean distance covered during six minutes increased by 73 meters ( 69 ) in the elastic tubing group and by 42 meters ( 59 ) in the conventional group ( p < 0.05 ) .


The muscle strength and quality of life improved in both groups ( P < 0.05 ) , with no significant differences between the groups .


There was a trend toward an improved fat-free mass in both groups ( P = 0.05 ) .


After the first and last sessions , there was an increase in interleukin 1 ( IL-1 ) and interleukin 10 ( IL-10 ) in both groups , while tumour necrosis factor alpha ( TNF - ) was stimulated only in the conventional training group .


Elastic tubing training had a greater effect on functional exercise capacity than conventional resistance training .


Both interventions were equally effective in improving muscle strength and quality of life .


To determine whether daily self-weighing ( DSW ) is associated with disordered eating ( DE ) symptoms within an adult lifestyle intervention ( LI ) , and to examine changes in DE symptoms during the 18-month trial .


One-hundred and seventy-eight adults ( 53 % female , 90 % White , 52.0 8.6 years , BMI = 35.0 4.4 kg/m2 ) were enrolled in a randomized trial testing 2 dietary prescriptions within a LI ( standard vs. limited dietary variety ) .


Both arms were taught DSW and had the same contact schedule and calorie and activity goals .


Frequency of weighing and DE were assessed at 0 , 6 , 12 , and 18 months .


Analyses controlled for treatment arm .


At baseline , 16.3 % of participants reported weighing daily compared with 83.7 % , 72.3 % , and 68.2 % at 6 , 12 , and 18 months , respectively .


There was no relationship between change in frequency of self-weighing and change in DE symptoms at any time point .


Further , there were no significant differences between those who weighed daily versus < daily on DE composite scores at baseline or 6 months ; at 12 and 18 months participants who weighed daily reported lower DE scores compared with those who weighed < daily ( p = .008 and .043 at 12 and 18 months , respectively ) .


Participants who weighed daily achieved better weight losses than those weighing < daily at 12 and 18 months ( p = .003 and < .001 ) .


There was a significant reduction over time in DE symptoms ( p < .0001 ) and a reduction in odds of meeting criteria for Binge Eating Disorder ( BED ; ps < .001 ) .


Daily self-weighing did not appear to be related to increased disordered eating behavior and was associated with better weight loss outcomes .


The benefit of antibiotic prophylaxis for simple hand lacerations ( lacerations that do not involve special structures ) has not been adequately studied .


To assess the feasibility of a randomized controlled trial to determine the role of antibiotic prophylaxis in emergency department ( ED ) patients with simple hand lacerations .


Randomized , double-blind , placebo-controlled pilot trial in 2 urban academic EDs .


Adult ( 18 years old ) patients with simple hand lacerations were randomized to cephalexin , 500 mg ; clindamycin , 300 mg ; or placebo ( every 6 hours for 7 days , all in identical capsules ) .


( 1 ) feasibility determined by the number of patients who agreed to enroll and number of patients who completed follow-up , ( 2 ) infection rate ( determined by 2 physicians at 10-14 days ) , ( 3 ) satisfaction with wound appearance ( measured by a visual analogue scale at 30 days via phone ) .


Medians , quartiles , and percentages with 95 % confidence intervals ( CI ) were used to present data .


Groups were compared with Kruskal-Wallis and Fisher exact tests , when appropriate .


Over a 5-month period , 123 patients were approached , and 78 consented to enrollment ( 63 % ; 95 % CI , 55-71 % ) .


Five were lost to follow-up ( 5/78 , 6 % ; 95 % CI , 2 % -14 % ) .


Only one patient had infection on follow-up for an infection rate of 1 % ( 95 % CI , 0.01 % -8 % ) .


Patient 's satisfaction with wound appearance did not differ among the groups .


The findings of this pilot study support the feasibility of a randomized , double-blind , controlled trial .


The low rate of infection suggests the need of a large sample size for the trial .


To determine the effect of prior oophorectomy in healthy postmenopausal women on the rate of loss of bone mineral density ( BMD ) and rate of increase in carotid artery intima-media thickness ( CIMT ) .


Secondary analysis from a randomized controlled trial .


University-based research clinic .


Two hundred twenty-two healthy postmenopausal women in the Greater Los Angeles area .


Baseline and annual screening of BMD and assessment of CIMT every 6 months for a total of 3 years .


Changes in BMD and CIMT during postmenopausal years .


Among women who were menopausal for more than 10 years , the rate of CIMT progression was statistically significantly less in women with intact ovaries compared with those in women with prior oophorectomy .


In women 5-10 years postmenopause , there was a trend toward a slower loss of BMD in those who retained their ovaries , and in women more than 10 years postmenopause there was significantly less BMD loss in those who retained their ovaries .


As time from menopausal transition increases , retained ovaries are associated with a slower rate of bone loss and a slower rate of thickening of the carotid artery wall compared with rates in menopausal women with oophorectomy .