Twenty-five participants ( 59.5 % ) completed the OLE .


Off therapy , TLVs increased a mean SD of 3.4 % 8.2 % per year ; after resuming therapy , TLVs decreased a mean SD of -4.7 % 6.1 % per year .


Despite regrowth off treatment , overall reductions were observed , with a median ( interquartile range ) TLV of 4047 mL ( 3107-7402 mL ) at baseline and 3477 ( 2653-7131 mL ) at study completion ( -13.2 % ; P < .001 ) and with improved health-related QoL .


Total kidney volumes increased , and glomerular filtration rates declined from 58.2 mL/min to 54.5 mL/min ( n = 16 ) in patients with ADPKD on therapy from baseline to study completion .


Therapy with OctLAR over 4 years in selected patients with symptomatic PLD arrested PLD progression , alleviating symptoms and improving health-related QoL .


Discontinuation led to organ regrowth .


clinicaltrials.gov Identifier : NCT00426153 .


The best suture method to prevent incisional surgical-site infection ( SSI ) after clean-contaminated surgery has not been clarified .


Patients undergoing elective colorectal cancer surgery at one of 16 centres were randomized to receive either subcuticular sutures or skin stapling for skin closure .


The primary endpoint was the rate of incisional SSI .


Secondary endpoints of interest included time required for wound closure , incidence of wound problems , postoperative length of stay , wound aesthetics and patient satisfaction .


A total of 1264 patients were enrolled .


The cumulative incidence of incisional SSI by day 30 after surgery was similar after subcuticular sutures and stapled closure ( 87 versus 98 per cent respectively ; P = 0576 ) .


Comparison of cumulative incidence curves revealed that SSI occurred later in the subcuticular suture group ( P = 0019 ) ( hazard ratio 066 , 95 per cent c.i. 045 to 097 ) .


Wound problems ( P = 0484 ) , wound aesthetics ( P = 0182 ) and postoperative duration of hospital stay ( P = 0510 ) did not differ between the groups ; subcuticular sutures took 5min longer than staples ( P < 0001 ) .


Patients in the subcuticular suture group were significantly more satisfied with their wound ( 524 per cent versus 427 per cent in the staple group ; P = 0002 ) .


Compared with skin stapling , subcuticular sutures did not reduce the risk of incisional SSI after colorectal surgery .


UMIN000004001 ( http://www.umin.ac.jp/ctr ) .


Chronic prostatitis displays a variety of symptoms ( mainly local pain exhibiting variability in origin and intensity ) .


The purpose of this article is to briefly present the preliminary results of our study examining the role of phytotherapeutic agents in the treatment of chronic prostatitis patients .


The study included in total fifty-six consecutive patients who visited the outpatient department .


Subjects were randomized into two groups .


Subjects in the first group ( 28 patients ) received prulifloxacin 600 mg for 15 days , while subjects in the second group ( 28 patients ) received prulifloxacin 600 mg for 15 days and Serenoa repens extract for 8 weeks .


The response was tested using laboratory and clinical criteria .


We found statistically significant differences between the two groups regarding pain regression and no statistically significant regarding bacterial eradication .


Moreover however while sexual dysfunction improvement was equally achieved in both groups , improvement of urinary symptoms was more evident in the 2nd group especially after the completion of the antibiotic treatment .


Serenoa repens extract for 8 weeks seems to improve prostatitis related pain .


Further randomized , placebo-controlled studies are needed to substantiate safer conclusions .


This study aims to identify the optimal mini-invasive treatment for extrahepatic bile duct stones .


One hundred and seventy eight patients with EHBD stones were randomized into 4 groups : laparoscopic cholecystectomy ( LC ) and laparoscopic common bile duct exploration ( LCBDE ) plus T-tube drainage ( group LT ) , LC and LCBDE with endonasobiliary drainage ( ENBD ) tube ( group LE ) , and endoscopic sphincterotomy with ENBD followed by LC ( group EE ) and T-tube drainage of open CBDE ( group OT ) .


Demographic data , perioperative findings , postoperative outcomes , hospital expense , gastrointestinal quality of life index ( GIQLI ) scores and cost per quality-adjusted life year ( QALY ) were analyzed .


The operating time was longest in group EE .


There was less bleeding in group OT and EE .


Group LE and EE had shorter hospital stay and recovery time of intestinal motility .


The postoperative white blood cell count and serum C-reaction protein level were higher in group LT and OT .


Postoperatively , the mean GIQLI scores in group LE and EE were higher .


Mean cost were highest in group EE .


Patients in group LE had lowest cost per QALY .


The modified laparoscopic procedure , LC combined with LCBDE followed by a primary closure over the ENBD tubes , appears to be the best option for patients with EHBD stones .


Because of the restrictions applied to the conduct of randomized clinical trials , the risks reported in their comparison of open and endovascular aneurysm repair ( EVAR ) of abdominal aortic aneurysms ( AAA ) may not be applicable to real-world vascular surgical practice .


The magnitude of this deviation is indeterminate .


To compare 30-day mortality from the recent Open Vs Endovascular Repair ( OVER ) Veterans Affairs Cooperative trial with results obtained from the American College of Surgeons National Surgical Quality Improvement Program ( NSQIP ) and to assess temporal trends in perioperative mortality .


We analyzed data from 21,115 patients who received elective EVAR or open repair for asymptomatic infrarenal AAA between January 1 , 2005 , and December 31 , 2011 , in the NSQIP database .


We used 2 and t tests to compare perioperative mortality between groups .


Logistic regression was used to analyze perioperative mortality , adjusting for age , sex , race , and comorbidities .


The outcomes of the OVER trial were then compared with the national estimates obtained from the NSQIP .


Death within 30 days of surgery .


Perioperative mortality was 3.7 % ( 95 % CI , 3.2 % -4.3 % ) after open repair and 1.3 % ( 95 % CI , 1.2 % -1.5 % ) after EVAR .


There was a 70 % reduction in operative mortality after EVAR compared with open repair ( adjusted odds ratio [ aOR ] , 0.30 ; 95 % CI , 0.25-0 .38 ; P < .001 ) .


Mortality was significantly lower in men compared with women ( aOR , 0.73 ; 95 % CI , 0.57-0 .92 ; P = .009 ) .


Thirty-day mortality in the NSQIP cohort was higher than that reported in the OVER trial for both EVAR and open repair ( EVAR , 1.3 % vs 0.2 % ; open , 3.7 % vs 2.3 % ) .


There was an increase in the proportion of patients who received EVAR during the 7 years studied ( 65 % in 2005 and 80 % in 2011 ) .


There has been no significant decrease in perioperative mortality during these years ( P > .05 ) .


Perioperative mortality reported by the OVER trial is significantly lower than outcomes from practices outside the restriction of randomized clinical trials .


We attribute this difference to the fact that the OVER trial excluded high-risk patients deemed unfit for open repair .


This finding supports the need for individualized assessment of risk and treatment selection for patients with infrarenal AAA .


There has been no change in perioperative mortality after EVAR in recent years despite improvements in techniques , devices , and proficiency .


We hypothesized that immediate laparoscopic surgery for appendiceal abscess would result in faster recovery than conservative treatment .


On the basis of the retrospective studies , conservative management of appendiceal abscess is recommended as a first line treatment , but some controversy exists .


Sixty adult patients diagnosed with appendiceal abscess were randomly assigned to either laparoscopic surgery ( n = 30 ) or conservative treatment ( n = 30 ) .


Hospital stay , recurrences , additional interventions , and complications within 60 days from randomization were recorded .


There was no difference in hospital stay : 4 days ( interquartile range : 3-5 days ) in the laparoscopy group versus 5 days ( 3-8 ) in the conservative group , P = 0.105 .


Patients in the laparoscopy group had 10 % risk for bowel resection and 13 % risk for incomplete appendectomy .


There were significantly fewer patients with unplanned readmissions in the laparoscopy group : 1 ( 3 % ) versus 8 ( 27 % ) , P = 0.026 .


Additional interventions were required in 2 ( 7 % ) patients in the laparoscopy group ( percutaneous drainage ) and in 9 ( 30 % ) patients in the conservative group ( surgery ) , P = 0.042 .


Recurrent abscesses and failure to respond to conservative treatment were the main reasons for additional interventions .


Open surgery was required in 3 ( 10 % ) patients in the laparoscopy group and in 4 ( 13 % ) patients in the conservative group .


Postoperative complications occurred in 3 patients in laparoscopic group versus 2 patients in the conservative group .


The rate of uneventful recovery was 90 % in the laparoscopy group versus 50 % in the conservative group , P = 0.002 .


Laparoscopic surgery in experienced hands is safe and feasible first-line treatment for appendiceal abscess .


It is associated with fewer readmissions and fewer additional interventions than conservative treatment with comparable hospital stay .


Home and community-based combined treatment of malaria and pneumonia has been promoted in Uganda since mid 2011 .


The combined treatment is justified given the considerable overlap between the symptoms of malaria and pneumonia among infants .


There is limited evidence about the extent to which community-based care reduces healthcare-seeking costs at the household level in rural and urban settings .


This paper assesses the rural-urban differences in direct and indirect costs of seeking care from formal health facilities compared to community medicine distributors ( CMDs ) .


Exit interviews were conducted for 282 ( 159 rural and 123 urban ) caregivers of children below five years who had received treatment for fever-related illnesses at selected health centres in Iganga and Mayuge districts .


Data on the direct and indirect costs incurred while seeking care at the health centre visited were obtained .


Using another tool , household level direct and indirect costs of seeking care from CMDs were collected from a total of 470 caregivers ( 304 rural and 166 urban ) .


Costs incurred at health facilities were then compared with costs of seeking care from CMDs .


Household direct costs of seeking care from health facilities were significantly higher for urban-based caregivers than the rural ( median cost = US$ 0.42 for urban and zero for rural ; p < 0.0001 ) .


The same is true for seeking care from CMDs ( p = 0.0038 ) .


Overall , caregivers travelled for an average of 75min to reach health centres and spent an average of 80min at the health centre while receiving treatment .


However , households in rural areas travelled for a significantly longer time ( p < 0.001 to reach health care facilities than the urban-based caregivers .


Besides travelling longer distances , rural caregivers spent 150min seeking care from health facilities compared to 30min from CMDs .


Time and monetary savings for seeking care from CMDs are significantly larger for rural than urban households .


Thus , home and community-based treatment of child febrile illnesses is much more cost-saving for rural poor communities , who would spend more time travelling to health facilities - which time could be re-directed to productive and income-generating activities .


Use of pretest probability can reduce unnecessary testing .


We hypothesize that quantitative pretest probability , linked to evidence-based management strategies , can reduce unnecessary radiation exposure and cost in low-risk patients with symptoms suggestive of acute coronary syndrome and pulmonary embolism .


This was a prospective , 4-center , randomized controlled trial of decision support effectiveness .


Subjects were adults with chest pain and dyspnea , nondiagnostic ECGs , and no obvious diagnosis .


The clinician provided data needed to compute pretest probabilities from a Web-based system .


Clinicians randomized to the intervention group received the pretest probability estimates for both acute coronary syndrome and pulmonary embolism and suggested clinical actions designed to lower radiation exposure and cost .


The control group received nothing .


Patients were followed for 90 days .


The primary outcome and sample size of 550 was predicated on a significant reduction in the proportion of healthy patients exposed to > 5 mSv chest radiation .


A total of 550 patients were randomized , and 541 had complete data .


The proportion with > 5 mSv to the chest and no significant cardiopulmonary diagnosis within 90 days was reduced from 33 % to 25 % ( P = 0.038 ) .


The intervention group had significantly lower median chest radiation exposure ( 0.06 versus 0.34 mSv ; P = 0.037 , Mann-Whitney U test ) and lower median costs ( $ 934 versus $ 1275 ; P = 0.018 ) for medical care .


Adverse events occurred in 16 % of controls and 11 % in the intervention group ( P = 0.06 ) .


Provision of pretest probability and prescriptive advice reduced radiation exposure and cost of care in low-risk ambulatory patients with symptoms of acute coronary syndrome and pulmonary embolism .


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


Unique identifier : NCT01059500 .


To evaluate vasopressin vs dopamine as initial therapy in extremely low birth weight ( ELBW ) infants with hypotension during the first 24 hours of life .


ELBW infants with hypertension 30 weeks ' gestation and 24 hours old randomly received treatment with vasopressin or dopamine in a blinded fashion .


Normotensive infants not receiving vasopressor support served as a comparison group .


Twenty ELBW infants with hypertension received vasopressin ( n = 10 ) or dopamine ( n = 10 ) , and 50 were enrolled for comparison .


Mean gestational age was 25.6 1.4 weeks and birth weight 705 154 g. Response to vasopressin paralleled that of dopamine in time to adequate mean blood pressure ( Kaplan-Meier curve , P = .986 ) ; 90 % of infants in each treatment group responded with adequate blood pressure .


The vasopressin group received fewer doses of surfactant ( P < .05 ) , had lower PaCO2 values ( P < .05 ) , and were not tachycardic ( P < .001 ) during vasopressin administration , compared with the dopamine group .


Vasopressin in ELBW infants as the initial agent for early hypotension appeared safe .


This pilot study supports a larger randomized controlled trial of vasopressin vs dopamine therapy in ELBW infants with hypotension .


Approximately 5 % to 10 % of asthmatic patients achieve incomplete symptom control on current therapies .


The association of IL-13 with asthma pathology and reduced corticosteroid sensitivity suggests a potential benefit of anti-IL-13 therapy in refractory asthma .


GSK679586 , a humanized mAb , inhibits IL-13 binding to both IL-13 receptor 1 and 2 .


We sought to evaluate the efficacy and safety of GSK679586 in patients with severe asthma refractory to maximally indicated doses of inhaled corticosteroids .


Patients who remained symptomatic ( Asthma Control Questionnaire score 1.5 ) after uptitration to 1000 g/d fluticasone propionate or greater were randomized to 3 once-monthly intravenous infusions of 10 mg/kg GSK679586 ( n = 99 ) or placebo ( n = 99 ) .


Treatment differences in adjusted mean change from baseline over 12 weeks were nonsignificant for Asthma Control Questionnaire symptom scores ( the primary end point ; GSK679586 = -0.31 , placebo = -0.17 , P = .058 ) and FEV ( GSK679586 = -0.01 , placebo = 0.03 , P = .276 ) .


Similar analyses in patients with increased serum IgE levels , blood eosinophil counts , or both were also negative .


Incidence of asthma exacerbations was similar between treatments .


Most adverse events were nonserious and unrelated to treatment .


Two GSK679586-treated patients had treatment-related serious adverse events ( lethargy and supraventricular extrasystoles ) .


Although well tolerated , GSK679586 did not demonstrate clinically meaningful improvements in asthma control , pulmonary function , or exacerbations in patients with severe asthma .


Further studies are needed to determine whether therapies targeting IL-13 , the functionally related IL-4 cytokine , or both can provide clinical benefit in patients with severe refractory asthma or a subpopulation of these patients beyond that achievable with high-dose corticosteroids .


Gold standard treatment for symptomatic gall stones is laparoscopic cholecystectomy ( LC ) .


Ultrasonically activated devices have been used for gall bladder dissection in LC .


Harmonic scalpel ( HS ) is the leading ultrasonically cutting coagulation device offering surgeons important benefits .


The main aim of our study was to compare the surgical outcomes of LC performed by HS to that performed by conventional mono-polar diathermy ( electro-cautery ) .


This prospective randomized study was conducted in surgical department of Jinnah Postgraduate Medical Centre , Karachi , during May-October 2013 .


During this period we selected 92 patients with symptomatic gallstones who underwent LC ; these patients were randomly recruited into two groups using sealed opaque envelopes .


Group A underwent gallbladder dissection from its bed using mono-polar diathermy , while on the other hand in Group B the dissection was carried out using harmonic scalpel .


The outcomes like gallbladder perforation with bile spillage , intra-operative bleeding and operative time were assessed .


The harmonic scalpel ( HS ) usage in surgery results in shorter operative time , it also leads to less gallbladder injury , bile leakage and stone spillage ( due to minimal lateralization of heat energy ) not only this it also leads to less intra-operative blood loss .


Harmonic scalpel is a new innovation in gallbladder surgery it has multiple functions like cutting , coagulation , coaptaion and cavitation which have made it safe , handy , effective and reliable instrument .


The main objective of the present analysis was to assess the effect of treatment with aspirin compared with apixaban on ischemic stroke and major bleeding in women compared with men .


Female patients with atrial fibrillation are at increased stroke risk compared with male patients , and the underlying reasons for higher risk are uncertain .


Ancillary analysis of the Apixaban Versus Acetylsalicylic Acid [ ASA ] to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment ( AVERROES ) trial , comparing aspirin and apixaban , focused on sex differences .


Mean follow-up was 1.1 years .


Women compared with men tended to be older ( aspirin , 71.8 versus 68.8 years ; apixaban , 71.4 versus 68.6 years ) , with a higher proportion of those aged75 years .


Also , women had less peripheral artery disease ( aspirin , 2.4 % versus 3.7 % ; apixaban , 1.4 % versus 3.0 % ) , more heart failure , and higher mean CHADS2 ( congestive heart failure , hypertension , age of 75 years or older , diabetes [ 1 point each ] , stroke or transient ischemic attack [ 2 points ] ) scores ( aspirin , 2.2 versus 2.0 ; apixaban , 2.1 versus 2.0 ) .


Women compared with men had higher ischemic stroke rates ( aspirin , 3.99 % versus 2.28 % ; apixaban , 1.55 % versus 0.82 % ) but similar bleeding rates ( aspirin , 1.29 % versus 1.22 % ; apixaban , 1.15 % versus 1.36 % ) .


The relative effect of apixaban compared with aspirin was similar in men and women for both ischemic stroke ( women , 3.99 % versus 1.55 % ; hazard ratio , 0.39 ; 95 % confidence interval , 0.23-0 .64 ; men , 2.28 % versus 0.82 % ; hazard ratio , 0.36 ; 95 % confidence interval , 0.19-0 .63 ; Pint = 0.84 ) and major bleeding ( women , 1.29 % versus 1.15 % ; hazard ratio , 1.15 ; 95 % confidence interval , 0.59-2 .23 ; men , 1.36 % versus 1.22 % ; hazard ratio , 1.13 ; 95 % confidence interval , 0.64-2 .02 ; Pint = 0.96 ) .


Female patients with atrial fibrillation had higher ischemic stroke rates compared with male patients , but the relative effects of apixaban compared with aspirin on both ischemic stroke and bleeding were similar in men and women .


Magnetic resonance imaging ( MRI ) of patients with conventional implantable cardioverter-defibrillators ( ICD ) is contraindicated .


This multicenter , randomized trial evaluated safety and efficacy of a novel ICD system specially designed for full-body MRI without restrictions on heart rate or pacing dependency .


The primary safety objective was > 90 % freedom from MRI-related events composite endpoint within 30 days post-MRI .


The primary efficacy endpoints were ventricular pacing capture threshold and ventricular sensing amplitude .


Subjects received either a single - or dual-chamber ICD .


In a 2:1 randomization , subjects either underwent MRIat 1.5-T of the chest , cervical , and head regions to maximize radiofrequency exposure up to 2 W/kg specific absorption rate and gradient field exposure to 200 T/m/s per axis ( MRI group , n = 175 ) , or they underwent a 1-h waiting period without MRI ( control group , n = 88 ) .


A subset of MRI patients underwent ventricular fibrillation induction testing post-MRI to characterize defibrillation function .


In 42 centers , 275 patients were enrolled ( 76 % male , age 60.4 13.8 years ) .


The safety endpoint was met with 100 % freedom from the composite endpoint ( p < 0.0001 ) .


Both efficacy endpoints were met with minimal differences in the proportion of MRI and control patients who demonstrated a0 .5 V increase in ventricular pacing capture threshold ( 100 % MRI vs. 98.8 % control , noninferiority p < 0.0001 ) or a50 % decrease in R-wave amplitude ( 99.3 % MRI vs. 98.8 % control , noninferiority p = 0.0001 ) .


A total of 34 ventricular tachyarrhythmia/ventricular fibrillation episodes ( 20 induced ; 14 spontaneous ) occurred in 24 subjects post-MRI , with no observed effect on sensing , detection , or treatment .


This is the first randomized clinical study of an ICD system designed for full-body MRI at 1.5-T .


These data support that the system is safe and the MRI scan does not adversely affect electrical performance or efficacy .


( Confirmatory Clinical Trial of the Evera MRI System for Conditionally-Safe MRI Access ; NCT02117414 ) .


A strategy of early transfer for coronary angiography and intervention is superior to a standard approach of delayed coronary angiography after fibrinolysis for ST-elevation myocardial infarction ( STEMI ) .


STEMI patients with lesions in noninfarct-related arteries have a worse prognosis compared with patients with single vessel disease .


This study aimed to assess whether the benefits of an early invasive strategy differ in patients with single vessel and multivessel disease .


The Trial of Routine ANgioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction ( TRANSFER-AMI ) randomized STEMI patients receiving fibrinolysis to a strategy of early transfer and coronary angiography vs a standard approach .


In this post hoc analysis , we stratified 992 patients into 2 groups according to the presence or absence of multivessel disease .


We compared the 2 groups in terms of baseline characteristics , in-hospital management , and patient outcomes , and tested for treatment heterogeneity .


Multivessel disease was present in 369 ( 37 % ) patients .


Patients with multivessel disease had a greater rate of the primary composite end point of in-hospital death , recurrence of infarction , recurrent ischemia , shock , or heart failure at 30 days ( 18.2 % vs 10.8 % ; P < 0.001 ) .


An early invasive strategy was efficacious in both groups for the primary outcome .


In multivariable analysis adjusting for Global Registry of Acute Coronary Events ( GRACE ) risk score , there was no significant treatment heterogeneity ( all P interaction > 0.40 ) for the primary end point , or death/recurrence of infarction at 6 months and 1 year .


Multivessel disease is present in a significant proportion of STEMI patients treated with fibrinolysis and is associated with worse outcomes .


A strategy of early transfer and coronary intervention after fibrinolysis was beneficial regardless of the presence or absence of multivessel disease .


Heavy menstrual bleeding ( HMB ) diminishes individual quality-of-life and poses substantial societal burden .


In HMB endometrium , inactivation of cortisol ( by enzyme 11 hydroxysteroid dehydrogenase type 2 ( 11HSD2 ) ) , may cause local endometrial glucocorticoid deficiency and hence increased angiogenesis and impaired vasoconstriction .


We propose that ` rescue ' of luteal phase endometrial glucocorticoid deficiency could reduce menstrual bleeding .


DexFEM is a double-blind response-adaptive parallel-group placebo-controlled trial in women with HMB ( 108 to be randomised ) , with active treatment the potent oral synthetic glucocorticoid dexamethasone , which is relatively resistant to 11HSD2 inactivation .


Participants will be aged over 18years , with mean measured menstrual blood loss ( MBL ) for two screening cycles 50mL .


The primary outcome is reduction in MBL from screening .


Secondary end points are questionnaire assessments of treatment effect and acceptability .


Treatment will be for 5days in the mid-luteal phases of three treatment menstrual cycles .


Six doses of low-dose dexamethasone ( ranging from 0.2 to 0.9 mg twice daily ) will be compared with placebo , to ascertain optimal dose , and whether this has advantage over placebo .


Statistical efficiency is maximised by allowing randomisation probabilities to ` adapt ' at five points during enrolment phase , based on the response data available so far , to favour doses expected to provide greatest additional information on the dose-response .


Bayesian Normal Dynamic Linear Modelling , with baseline MBL included as covariate , will determine optimal dose ( re reduction in MBL ) .


Secondary end points will be analysed using generalised dynamic linear models .


For each dose for all end points , a 95 % credible interval will be calculated for effect versus placebo .


Dexamethasone is widely used and hence well-characterised safety-wise .


Ethical approval has been obtained from Scotland A Research Ethics Committee ( 12/SS/0147 ) .


Trial findings will be disseminated via open-access peer-reviewed publications , conferences , clinical networks , public lectures , and our websites .


ClinicalTrials.gov NCT01769820 ; EudractCT 2012-003405-98 .


Disrupting the physical structure of pulses by blending them or by using a digestive supplement ( - galactosidase ) to reduce intestinal discomfort could potentially negate the previously observed beneficial effects of whole pulses of lowering appetitive and glycemic responses because of more rapid digestion .


We hypothesized that blended lentils , - galactosidase , or both increase postprandial appetite and blood glucose responses vs. whole lentils .


Men and women [ n = 12 ; means SDs body mass index ( kg/m ( 2 ) ) : 23.3 3.1 ; aged 28 10 y ] consumed breakfast meals containing whole ( W ) , blended ( B ) , or no lentils [ control ( C ) ] , each with 3 - galactosidase or placebo capsules in a randomized , crossover , double-blind placebo-controlled trial .


Between each test day there was a 3 - to 5-d washout period .


Mixed-model ANOVA showed effects of meal on postprandial appetite and glucose ( P = 0.0001-0 .031 ) .


The B meal resulted in higher postprandial appetite ratings than did the W meal but not the C meal for hunger , desire to eat , and prospective consumption ( = 0.4-0 .5 points ; P = 0.002-0 .044 ) .


Postprandial glucose concentration was 4.5 mg/dL lower for the B meal than for the C meal ( P < 0.0001 ) but did not differ from the W meal .


There were no main effects of - galactosidase , but there were meal - galactosidase interaction effects , with a greater postprandial desire to eat and lower postprandial fullness with the B meal than with the 2 other meals in the placebo condition but not in the - galactosidase condition .


Blending lentils increased appetite ( 6 % ) , but not glycemic response , compared with whole lentils , whereas - galactosidase did not .


Both B and W meals may be consumed ( with or without an - galactosidase supplement ) with little impact on appetite , without increasing glycemic response .


This trial was registered at clinicaltrials.gov as NCT02110511 .


To determine whether patients prefer topical anesthesia or subconjunctival anesthesia for intravitreal injection .


Consecutive patients receiving bilateral simultaneous injections of anti-vascular endothelial growth factor agents were asked to participate in this within-patient , prospective , single-blinded , randomized , factorial study .


Fifty-seven patients completed the study .


Both eyes were treated with topical anesthesia .


One eye was also injected with subconjunctival lidocaine .


Anesthesia for the next treatment visit was based on patient preference at the conclusion of the study visit and at a 4-hour and 24-hour follow-up telephone call .


Patients were allowed to change their anesthesia preference during the next three visits .


The final endpoint for the study was anesthesia preference for ongoing intravitreal injections .


Fifty patients ( 88 % ) preferred subconjunctival anesthesia and seven patients ( 12 % ) preferred topical anesthesia for ongoing treatments .


( P = .0003 ) CONCLUSION : Given the choice , most patients prefer subconjunctival anesthesia to topical anesthesia for intravitreal injections .


To describe the experience and results from the roll-in phase of the Cardiovascular Outcomes with Renal Atherosclerotic Lesions ( CORAL ) study .


The CORAL roll-in database was used to describe the baseline characteristics of the patients in the roll-in cohort , all of whom underwent renal artery stent placement ; to evaluate CORAL site performance ; to compare estimates of lesion ( stenosis ) severity made by site interventionalists with the central CORAL angiographic core laboratory readings ; and to report outcomes after renal artery stent placement .


During the roll-in phase , 239 patients ( mean age , 70.2 y 9.0 ; 49 % male ) underwent renal artery stent procedures .


Angiographic core laboratory analysis of renal arteriograms was done , and participants were followed at 1 month and 9 months .


Major angiographic complications were identified in 28 ( 13 % ) subjects .


Kidney function remained unchanged at the short ( 2-4 weeks ) follow-up interval .


Improvement in systolic blood pressure with use of distal embolic protection devices ( n = 161 ) did not show any clinical benefit over nonuse of such devices ( n = 78 ) in this small series .


At 9 months , there were significantly more endpoints reported by site in subjects with bilateral renal artery stenosis ( P = .01 ) and prior history of stroke ( P = .03 ) .


In the roll-in phase of the CORAL study , a significant number of angiographic complications were identified .


No effect was seen on estimated glomerular filtration rate after renal artery stent placement , but systolic blood pressure decreased significantly .


There is a strong reciprocal association between two highly prevalent public health problems : intimate partner violence and heavy drinking , both of which remain major sources of morbidity and mortality .


Brief interventions in the Emergency Department setting have been found to be effective in reducing alcohol-related injury but neither classic intimate partner violence nor substance abuse interventions have adequately integrated assessment and treatment for these co-occurring conditions .


The overall goal of this study is to determine whether a motivational intervention delivered at the time of an Emergency Department visit will reduce heavy drinking and improve the safety of women experiencing intimate partner violence .


We are completing data collection for a randomized controlled trial enrolling 600 female patients , age 18-64 , presenting to one of two urban Emergency Departments , who self-disclose both problem drinking and intimate partner violence .


Eligible patients are randomized to a brief manual-guided motivational intervention , and a phone booster at 10 days .


The intervention , which is delivered by masters-level therapists during the Emergency Department visit , is recorded and monitored for fidelity .


Primary outcomes are episodes of heavy drinking and incidents of intimate partner violence , assessed weekly by Interactive Voice Response System for 12 weeks and at 3 , 6 and 12 months by interviewers blinded to group assignment .


To identify the impact of assessment alone , we included a no-contact control group assessed only once at 3 months .


Secondary outcomes include violence severity , changes in the Composite Abuse Scale and alcohol quantity/frequency , along with other health-related behaviors .


The analysis will also explore the impact of likely mediators and moderators of the intervention .


While screening and intervention for intimate partner violence is now recommended for women of child bearing age in health care settings , there is a need for rigorous evaluations of what works for whom .


Upon completion , we will have high-quality evidence regarding the effectiveness of a low-intensity , brief motivational intervention , delivered by social workers in the Emergency Department setting , for decreasing episodes of heavy drinking and intimate partner violence .


Ultimately , this is a model could be generalizable to other acute health care settings .


ClinicalTrials.gov


NCT01207258 .


Phytotherapy has been used to treat patients with lower urinary tract symptoms ( LUTS ) .


We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens ( SeR ) , Lycopene ( Ly ) , and Selenium ( Se ) + tamsulosin versus single therapies .


PROCOMB trial ( ISRCTN78639965 ) was a randomized double-blinded , double-dummy multicenter study of 225 patients between 55 and 80 years old , PSA4ng/ml , IPSS 12 , prostate volume 60 cc , Qmax 15ml/sec , postvoid residual urine ( PVR ) < 150ml .


Participants were randomized group A ( SeR-Se-Ly ) , group B ( tamsulosin 0.4 mg ) , group C ( SeR-Se-Ly + tamsulosin 0.4 mg ) .


The primary endpoints of the study were the reduction of IPSS , PVR , and increase of Qmax in group C versus monotherapy groups .


The decrease for combination therapy was significantly greater versus group A ( P < 0.05 ) and group B ( P < 0.01 ) for IPSS and versus group A ( P < 0.01 ) for PVR from baseline to 6 months .


A greater decrease in IPSS was observed for Group C versus group A ( P < 0.01 ) and increase in Qmax versus group B ( P < 0.01 ) , from 6 months to 12 months .


At one year , the changes of IPSS and Qmax were greater for Group C versus monotherapies ( each comparison < 0.05 ) .


The proportions of men with a decrease of at least three points ( each comparison P < 0.05 ) and decrease of 25 % for IPSS ( each comparison P < 0.01 ) were greater for Group C.


SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS .


Severe alcoholic hepatitis has high short-term mortality .


The aim of this study was to test the hypothesis that treatment of patients with alcoholic hepatitis with granulocyte colony-stimulating factor ( G-CSF ) might mobilize bone marrow-derived stem cells and promote hepatic regeneration and thus improve survival .


Forty-six patients with severe alcoholic hepatitis were prospectively randomized in an open study to standard medical therapy ( SMT ) plus G-CSF ( group A ; n = 23 ) at a dose of 5g/kg subcutaneously every 12h for 5 consecutive days or to SMT alone ( group B ; n = 23 ) at a tertiary care center .


We assessed the mobilization of CD34 ( + ) cells on day 6 , Child-Turcotte-Pugh ( CTP ) , model for end-stage liver disease ( MELD ) , and modified Maddrey 's discriminant function ( mDF ) scores , and survival until day 90 .


There was a statistically significant increase in the number of CD34 ( + ) cells in peripheral blood in group A as compared with group B ( P = 0.019 ) after 5 days of G-GSF therapy .


There was a significant reduction in median change % in CTP , MELD , and mDF at 1 , 2 , and 3 months in group A as compared with group B ( P < 0.05 ) .


There was marked improvement in survival in group A as compared with group B ( 78.3 % vs. 30.4 % ; P = 0.001 ) at 90 days .


G-CSF is safe and effective in the mobilization of hematopoietic stem cells and improves liver function as well as survival in patients with severe alcoholic hepatitis .


Multiple studies have been conducted that demonstrate the superiority of patch angioplasty over primary closure for carotid endarterectomy ( CEA ) .


Patch angioplasty with polytetrafluorethylene patches ( ACUSEAL ) have shown results comparable to patch angioplasty with saphenous vein and polyester patches .


This is a prospective randomized study to compare the clinical outcomes of CEA using ACUSEAL versus bovine pericardium patching ( Vascu-Guard ) .


Two hundred patients were randomized ( 1:1 ) to either ACUSEAL or Vascu-Guard patching .


Demographic data/clinical characteristics were collected .


Intraoperative hemostasis times and the frequency of reexploration for neck hematoma were recorded .


All patients received immediate and 1-month postoperative duplex ultrasound studies , which were repeated at 6-month intervals .


A Kaplan-Meier analysis was used to estimate the risk of restenosis and the stroke-free survival rates .


The demographics were similar in both groups , except for a higher incidence of current smokers in the ACUSEAL group and more patients with congestive heart failure in the Vascu-Guard group ( P = 0.02 and 0.03 , respectively ) .


The mean operative internal carotid artery diameter and the mean arteriotomy length were similar in both groups .


The mean hemostasis time was 4.90 min for ACUSEAL patching vs. 3.09 min for Vascu-Guard ( P = 0.027 ) ; however , the mean operative times were similar for both groups ( ACUSEAL 2.09 hr vs. Vascu-Guard 2.16 hr , P = 0.669 ) .


The incidence of reexploration for neck hematoma was higher in the Vascu-Guard group ; 6.12 % vs. 1.03 % ( P = 0.1183 ) .


The incidence of perioperative ipsilateral neurologic events was 3.09 % for ACUSEAL patching vs. 1.02 % for Vascu-Guard patching ( P = 0.368 ) .


The mean follow-up period was 15 months .


The respective freedom from 70 % carotid restenosis at 1 , 2 , and 3 years were 100 % , 100 % , and 100 % for ACUSEAL patching vs. 100 % , 98 % , and 98 % for Vascu-Guard patching ( P = 0.2478 ) .


The ipsilateral stroke-free rates at 1 , 2 , and 3 years were 96 % for ACUSEAL and 99 % for Vascu-Guard patching .


Although CEA patching with ACUSEAL versus Vascu-Guard differed in hemostasis time , the frequency of reexploration for neck hematomas was more frequent in the pericardial patch group ; however , only 1 patient had documented suture line bleeding and the surgical reexploration rate is not likely to be patch related .


There were not any significant differences in perioperative/late neurologic events and late restenosis in the 2 groups .


Uptake of chlamydia screening by men in England has been substantially lower than by women .


Non-traditional settings such as sports clubs offer opportunities to widen access .


Involving people who are not medically trained to promote screening could optimise acceptability .


We developed two interventions to explore the acceptability and feasibility of urine-based sexually transmitted infection ( STI ) screening interventions targeting men in football clubs .


We tested these interventions in a pilot cluster randomised control trial .


Six clubs were randomly allocated , two to each of three trial arms : team captain-led and poster STI screening promotion ; sexual health adviser-led and poster STI screening promotion ; and poster-only STI screening promotion ( control/comparator ) .


Primary outcome was test uptake .


Across the three arms , 153 men participated in the trial and 90 accepted the offer of screening ( 59 % , 95 % CI 35 % to 79 % ) .


Acceptance rates were broadly comparable across the arms : captain-led : 28/56 ( 50 % ) ; health professional-led : 31/46 ( 67 % ) ; and control : 31/51 ( 61 % ) .


However , rates varied appreciably by club , precluding formal comparison of arms .


No infections were identified .


Process evaluation confirmed that interventions were delivered in a standardised way but the control arm was unintentionally ` enhanced ' by some team captains actively publicising screening events .


Compared with other UK-based community screening models , uptake was high but gaining access to clubs was not always easy .


Use of sexual health advisers and team captains to promote screening did not appear to confer additional benefit over a poster-promoted approach .


Although the interventions show potential , the broader implications of this strategy for UK male STI screening policy require further investigation .


Agitation is a major problem in acute schizophrenia .


Only a few studies have tested antipsychotic agents in severely agitated patients , mainly because of legal issues .


Furthermore , most studies were limited to the first 24 hours .


We aimed to investigate the efficacy of oral haloperidol , risperidone , and olanzapine in reducing psychotic agitation in severely agitated patients with schizophrenia or schizophreniform or schizoaffective disorder over 96 hours using a prospective , randomized , rater-blinded , controlled design within a naturalistic treatment regimen .


In total , 43 severely agitated patients at acute care psychiatric units were enrolled .


Participants were randomly assigned to receive either daily haloperidol 15 mg , olanzapine 20 mg , or risperidone 2 to 6 mg over 5 days .


Positive and Negative Syndrome Scale psychotic agitation subscale score was the primary outcome variable .


A mixed-model analysis was applied .


All drugs were effective for rapid tranquilization within 2 hours .


Over 5 days , the course differed between agents ( P < 0.001 ) , but none was superior .


Dropouts occurred only in the risperidone and olanzapine groups .


Men responded better to treatment than did women during the initial 2 hours ( P = 0.046 ) as well as over the 5-day course ( P < 0.001 ) .


No difference between drug groups was observed regarding diazepam or biperiden use .


Oral haloperidol , risperidone , and olanzapine seem to be suitable for treating acute severe psychotic agitation in schizophrenia spectrum disorders .


Response to oral antipsychotics demonstrated a gender effect with poorer outcome in women throughout the study .


Early dysfunction of transplanted kidney is a serious complication that can lead to the premature loss of transplant .


Ischemic and reperfusion injury of donor kidney leads to the disturbance of the function of the graft , which is a form of post-transplantation acute kidney injury that causes the relevance of search of early markers for diagnosis .


Evaluation of the diagnostic value of determination in the urine neutrophilgelatinase-associated lipocalin ( u-NGAL ) in patients in the early period after kidney transplantation .


An open , randomized , retrospective comparative study of 80 patients , who underwent kidney transplantation from a living human-related donor ( group 1 , 50 patients ) and from donor with brain death documentation ( group 2 , 30 patients ) was carried out .


In 20 patients of the second group ( group 2a ) rapid recovery of graft function was observed , and in 10 patients ( group 2b ) -- delayed graft recovery as a result of postischemic acute kidney injury .


During the first five post-transplantation days investigated biochemical analysis of blood and urine , as well as the marker u-NGAL .


Because of kidney transplantation was performed to the patients with end-stage chronic renal failure , high values of urea and creatinine in the blood samples during the first postoperative days were noted , that reflected the severity of the preoperative state of the patients .


In the patients , who underwent human-related kidney transplantation , a more favorable picture of the investigated laboratory parameters was seen .


Values of u-NGAL in this group in the early post-transplant period were normal , which attested to the absence of significant ischemic injury of transplanted kidney .


In 30 patients with cadaver kidney transplantation average u-NGAL value during the first post-transplant day was 14-times fold exceeded normal range ( 160 ng/ml ) , while in 50 patients of the group with human-related transplantation -- only 2 times .


In the first day in group 2a average u-NGAL value decreased to normal , while in group 2b , where renal replacement therapy was carried out from the first day , remained extremely high ( more than 2000 ng/ml , p < 0.001 to compare with other two groups ) during all 5 days of investigation .


Conducting of hemodialysis sessions during the first week was required in 10 patients of group 2b , on the 2nd week -- 9 patients , on the 3 and 4 week in 5 patients 5 , and on the fifth week -- in 3 patients .


Due to prolonged period of ischemia in kidney transplantation from a donor with established brain death the level of u-NGAL in these patients was significantly higher than in the kidneys transplantation from living human-related donor .


In patients after transplantation dynamics of u-NGAL allows to identify patients with delayed graft function recovery and the need for renal replacement therapy already in the early postoperative period .


Ultrasonic surgery can dissect structures and divide vessels by the effect produced by vibrations in the tissues .


It is believed to be less traumatic than the more commonly used monopolar electrosurgery ( ELC ) .


Laparoscopic techniques are being used increasingly in surgical conditions complicated by peritonitis .


This randomized study compares the acute inflammatory and systemic immune response after laparoscopic cholecystectomy in patients with acute calculous cholecystitis , complicated by peritonitis , performed using either ultrasonic energy or ELC .


Forty-three patients , scheduled for laparoscopic cholecystectomy , were randomly assigned to treatment using either an ultrasonic device ( UC ) ( n = 22 patients ) or ELC ( n = 21 patients ) .


Bacteremia , endotoxemia , white blood cells , the peripheral lymphocyte subpopulation , human leukocyte antigen-DR ( HLA-DR ) , neutrophil-elastase , interleukin-6 and -1 , and C-reactive protein ( CRP ) were investigated .


Significantly higher concentration of systemic endotoxin , neutrophil , neutrophil-elastase , interleukin-6 and -1 , and CRP were detected intraoperatively and/or postoperatively in the ELC group of patients in comparison with the UC group ( P < .05 ) .


A statistically significant change in HLA-DR expression was recorded on postoperative Day 1 as a reduction of this antigen expressed on the monocyte surface in patients from the ELC group ; no changes were noted in UC patients ( P < .05 ) .


We recorded 4 patients ( 22.2 % ) who developed an intraabdominal abscess in the ELC group and 1 ( 4 % ) in the UC group ( P < .05 ) .


Laparoscopic cholecystectomy after biliary peritonitis , conducted by ELC , increased the incidence of bacteremia and systemic inflammation compared with the UC group .


Early enhanced postoperative systemic inflammation may cause lower transient immunologic defense in the ELC group , leading to enhanced sepsis .


Elevated serum digoxin concentration can cause toxicity , including death .


Dronedarone increases digoxin concentration by P-glycoprotein interaction .


In Permanent Atrial Fibrillation Outcome Study Using Dronedarone On Top Of Standard Therapy Trial ( PALLAS ) , dronedarone was associated with both increased cardiovascular death and heart failure in patients with permanent atrial fibrillation .


The present analysis examines whether the dronedarone-digoxin interaction might explain these adverse outcomes .


Subgroup analysis was performed to compare outcomes of patients on digoxin at baseline or not .


In PALLAS , 1619 patients were randomized to dronedarone and 1617 to placebo , of whom 544 ( 33.6 % ) and 526 ( 32.5 % ) were receiving digoxin , respectively .


Median ( Q1 , Q3 ) digoxin serum concentration on day 7 was 1.1 ( 0.7,1.5 ) ng/mL on dronedarone and 0.7 ( 0.5,1.1 ) ng/mL on placebo ( P < 0.001 ) .


Among patients on digoxin , there were 15 ( 8.6 % / year ) cardiovascular deaths on dronedarone and 2 ( 1.2 % / year ) on placebo ( adjusted hazard ratio , 7.31 ; 95 % confidence interval , 1.66-32 .20 ; P = 0.009 ) .


Among patients not on digoxin , there were 6 cardiovascular deaths on dronedarone ( 1.7 % / year ) and 8 on placebo ( 2.2 % / year ; adjusted hazard ratio , 0.67 ; 95 % confidence interval , 0.23-1 .95 ; P = 0.46 ; interaction P value 0.01 ) .


In patients on digoxin , there were 11 arrhythmic deaths on dronedarone and none on placebo ; and in patients not on digoxin , there were 2 arrhythmic deaths on dronedarone and 4 on placebo ( P value for interaction 0.002 ) .


There was no interaction between baseline digoxin use and the adverse effect of dronedarone on heart failure events .


In PALLAS , there was a strong effect of concurrent digoxin use on the adverse effect of dronedarone on cardiovascular death , but not on occurrence of heart failure .


http://www.clinicaltrials.gov .


Unique identifier : NCT01151137 .


Activation of the ileal brake , by infusing lipid directly into the distal part of the small intestine , alters gastrointestinal ( GI ) motility and inhibits food intake .


The ileal brake effect on eating behavior of the other macronutrients is currently unknown .


The objective of this study was to investigate the effects of ileal infusion of sucrose and casein on food intake , release of GI peptides , gastric emptying rate and small-bowel transit time with safflower oil as positive control .


This randomized , single-blind , crossover study was performed in 13 healthy subjects ( 6 male ; mean age 26.42.9 years ; mean body mass index 22.80.4 kgm ( -2 ) ) who were intubated with a naso-ileal catheter .


Thirty minutes after the intake of a standardized breakfast , participants received an ileal infusion , containing control ( ( C ) saline ) , safflower oil ( ( HL ) 51.7 kcal ) , low-dose casein ( ( LP ) 17.2 kcal ) or high-dose casein ( ( HP ) 51.7 kcal ) , low-dose sucrose ( ( LC ) 17.2 kcal ) and high-dose sucrose ( ( HC ) 51.7 kcal ) , over a period of 90min .


Food intake was determined during an ad libitum meal .


Visual analogue score questionnaires for hunger and satiety and blood samples were collected at regular intervals .


Ileal infusion of lipid , protein and carbohydrate resulted in a significant reduction in food intake compared with control ( HL : 464.390.7 kcal , P < 0.001 ; HP : 458.078.6 kcal , P < 0.005 ; HC : 399.057.0 kcal , P < 0.0001 vs control : 586.770.2 kcal , P < 0.001 , respectively ) .


A reduction in energy intake was still apparent when the caloric amount of infused nutrients was added to the amount eaten during the ad libitum meal.Secretion of cholecystokinin and peptide YY but not of glucagon-like peptide-1 ( 7-36 ) was increased during ileal perfusion of fat , carbohydrates and protein .


During ileal perfusion of all macronutrients , a delay in gastric emptying and intestinal transit was observed , but differences were not significant compared with control .


Apart from lipids , also sucrose and casein reduce food intake on ileal infusion , thereby activating the ileal brake .


In addition to food intake , also satiety and GI peptide secretion were affected .


To determine if the glucagon-like peptide-1 ( GLP-1 ) receptor agonist albiglutide , once weekly , impairs counter-regulatory responses during hypoglycaemia .


We conducted a randomized , double-blind , parallel , placebo-controlled study in subjects with type 2 diabetes mellitus .


A single dose of albiglutide 50mg ( n = 22 ) or placebo ( n = 22 ) was administered on day 1 .


Glucose was clamped on day 4 ( to coincide with the approximate albiglutide maximum plasma concentration ) at 9.0 , 5.0 , 4.0 , 3.3 and 2.8 mmol/l ( 162 , 90 , 72 , 59.4 and 50.4 mg/dl ) , with a post-clamp recovery period to 3.9 mmol/l ( 70mg/dl ) .


Hormone measurements were made at each plateau and adverse events ( AEs ) were recorded .


The counter-regulatory hormones glucagon , epinephrine , norepinephrine , growth hormone and cortisol were appropriately suppressed when plasma glucose levels were > 4.0 mmol/l ( > 72mg/dl ) , but increased in the albiglutide and placebo groups with glucose levels < 3.3 mmol/l ( < 59.4 mg/dl ) in response to hypoglycaemia .


The area under the curve geometric mean ratios ( albiglutide : placebo ) , calculated from the clamped plateau of 4.0 mmol/l ( 72mg/dl ) to the glucose recovery point , were not significantly different for any of the counter-regulatory hormones .


When plasma glucose levels were > 5.0 mmol/l ( > 90mg/dl ) , albiglutide increased pancreatic - cell secretion of C-peptide in a glucose-dependent manner to a greater extent than did placebo , and it was suppressed in each group when levels were < 4.0 mmol/l ( < 72mg/dl ) .


No significant difference between groups was observed in the recovery time to glucose level 3.9 mmol/l ( 70mg/dl ) .


There were no clinically relevant differences in AEs or other safety variables .


A single 50-mg dose of albiglutide was well tolerated and did not impair the counter-regulatory response to hypoglycaemia .


These data provide mechanistic evidence supporting the low intrinsic hypoglycaemic potential of albiglutide .


A step stool is an ordinary device to improve the quality of chest compression ( CC ) during in-hospital cardiopulmonary resuscitation ( CPR ) .


We investigated the effect of an inclined step stool on the quality of CC during CPR on a hospital bed .


We conducted a randomized crossover study of simulation using a manikin .


Two different methods of CC were performed and compared : CC using a flat stool and CC using an inclined ( 20 ) stool .


Each session of CC was performed for 2 minutes using a metronome at a rate of 110 beats per minute .


The primary outcome was the depth of CC .


The adequate CC rate , duty cycle , rate of incomplete recoil , and the angle between the arm of the participants and the bed were also measured .


The median value of the mean depth of CC was 50.5 mm ( 45.0-57 .0 mm ) in the flat stool group and 54.5 mm ( 47.0-58 .3 mm ) in the inclined stool group ( P = .014 ) .


The adequate CC rate was significantly higher in the inclined stool group ( 84.2 % [ 37.6 % -99.1 % ] vs 57.0 % [ 15.2 % -95.0 % ] ; P = .016 ) .


The duty cycle and the rate of incomplete recoil were comparable between the 2 groups .


The angles between the arm of the participants and the bed were more vertical in the inclined stool group ( 84.0 5.2 vs 81.0 4.8 ; P = .014 ) .


Using an inclined stool resulted in an improvement in the depth of CC and the adequate CC rate without increasing the rate of incomplete chest recoil .


Interlaminar epidural steroid injection is a well-established intervention for the treatment of radicular pain .


Pain is commonly reported during the injection into the epidural space ; this provocation is typically either concordant or discordant with the patient 's baseline pain .


It is not well known how this provocation pain relates to treatment outcomes .


To determine the relationship between concordant versus discordant provocation during interlaminar epidural steroid injection and its effects on pain reduction at follow-up .


Secondary analysis of a single center , prospective randomized double-blind study .


Interlaminar epidural steroid injections under fluoroscopic guidance were performed on 48 patients with radicular lumbosacral pain .


After injection with 80 mg methylprednisolone and 2 mL of normal saline at a single level , patients were asked to report if pain was provoked , and whether the pain was concordant or discordant with their baseline pain .


The primary outcome measure was self-rated percentage of pain reduction from baseline at 2-week follow-up .


Secondary outcomes included improvement in activity level and decreased analgesic consumption .


Provocation was observed in 37 out of 48 patients ( 77 % ) .


This was further classified as concordant ( 22/37 , 60 % ) or discordant ( 15/37 , 40 % ) pain .


The concordant group achieved a significant decrease in self-reported pain as compared to the discordant group at 2-week follow-up ( 61 % , t = 2.45 , P < 0.01 ) .


There were also significantly more patients in the concordant group who reported 75 % pain reduction as compared to the discordant group ( X = 6.44 , df ( 1 ) , P < 0.05 ) .


There were no significant differences between concordant and discordant groups in regard to improvements in activity level ( X = 2.56 ) and decreased analgesic use ( X = 3.28 ) .


The secondary analysis did not examine long-term outcomes .


The concordant group demonstrated significantly higher pain reduction as compared to the discordant group .


There were no significant differences between the 2 groups in terms of improved function or reduced analgesic requirements .


Concordant provocation during interlaminar epidural injection may be a predictor of outcome .


Previous small studies have indicated that commonly prescribed drugs may be associated with microscopic colitis ( MC ) .


With an increasing incidence of MC , it is important to explore the association between exposure to proton pump inhibitors ( PPIs ) , nonsteroidal anti-inflammatory drugs , statins , and selective serotonin reuptake inhibitors and MC in a larger setting .


Case-control study based on nationwide Danish registries .


The study included all patients with MC diagnosis during the period 2005 to 2011 .


One hundred sex - and age-matched controls per case were randomly selected among the Danish population .


Prescriptions were recorded in a Prescription Register in the year before the first recorded MC diagnosis .


Effect measure is the adjusted odds ratio ( OR ) of collagenous colitis ( CC ) and lymphocytic colitis ( LC ) according to prescriptions of PPIs , nonsteroidal anti-inflammatory drugs , statins , and selective serotonin reuptake inhibitors .


Within the control group , we identified a subgroup with MC-free colonic biopsies .


We identified 3474 patients with CC and 2277 with LC and found a positive association between redemption of prescriptions for PPIs and both CC ( OR = 7.04 ; 95 % confidence interval , 6.55-7 .56 ) and LC ( OR = 3.37 ; 95 % confidence interval , 3.08-3 .69 ) .


Among patients with MC-free colon biopsies in the control group , the association between PPIs and CC was strongly positive ( OR = 3.47 ; 95 % confidence interval , 3.08-3 .89 ) .


Adding this parameter to the model attenuated all of the associations , but they remained positive for PPIs versus CC and selective serotonin reuptake inhibitors versus LC .


We found positive associations between exposure to all 4 medication classes and MC .


Variations in endoscopic frequency by drug category indicate a potential impact of bias .


Antiretroviral therapy reduces the risk of tuberculosis , but tuberculosis is more common in people with HIV than in people without HIV .


We aimed to assess the effect of isoniazid preventive therapy on the risk of tuberculosis in people infected with HIV-1 concurrently receiving antiretroviral therapy .


For this pragmatic randomised double-blind , placebo-controlled trial in Khayelitsha , South Africa , we randomly assigned ( 1:1 ) patients to receive either isoniazid preventive therapy or a placebo for 12 months ( could be completed during 15 months ) .


Randomisation was done with random number generator software .


Participants , physicians , and pharmacy staff were masked to group assignment .


The primary endpoint was time to development of incident tuberculosis ( definite , probable , or possible ) .


We excluded tuberculosis at screening by sputum culture .


We did a modified intention-to-treat analysis and excluded all patients randomly assigned to groups who withdrew before receiving study drug or whose baseline sputum culture results suggested prevalent tuberculosis .


This study is registered with ClinicalTrials.gov , number NCT00463086 .


1329 participants were randomly assigned to receive isoniazid preventive therapy ( n = 662 ) or placebo ( n = 667 ) between Jan 31 , 2008 , and Sept 31 , 2011 , and contributed 3227 person-years of follow-up to the analysis .


We recorded 95 incident cases of tuberculosis ; 37 were in the isoniazid preventive therapy group ( 23 per 100 person-years , 95 % CI 16-31 ) , and 58 in the placebo group ( 36 per 100 person-years , 28-47 ; hazard ratio [ HR ] 063 , 95 % CI 041-094 ) .


Study drug was discontinued because of grade 3 or 4 raised alanine transaminase concentrations in 19 of 662 individuals in the isoniazid preventive therapy group and ten of the 667 individuals in the placebo group ( risk ratio 19 , 95 % CI 090-409 ) .


We noted no evidence that the effect of isoniazid preventive therapy was restricted to patients who were positive on tuberculin skin test or interferon gamma release assay ( adjusted HR for patients with negative tests 043 [ 021-086 ] and 043 [ 020-096 ] ; for positive tests 086 [ 037-200 ] and 055 [ 026-124 ] , respectively ) .


Without a more predictive test or a multivariate algorithm that predicts benefit , isoniazid preventive therapy should be recommended to all patients receiving antiretroviral therapy in moderate or high incidence areas irrespective of tuberculin skin test or interferon gamma release assay status .


Department of Health of South Africa , the Wellcome Trust , Mdecins Sans Frontires , European and Developing Countries Clinical Trials Partnership , Foundation for Innovation and New Diagnostics , the European Union , and Hasso Plattner ( Institute of Infectious Diseases and Molecular Medicine , University of Cape Town ) .


Utilization of energy-dense lipid fuels is critical to the rapid development and growth of neonates .


To increase efficiency of milk fat utilization by newborn pigs , the effect of clofibrate on in vivo and in vitro long-chain fatty acid ( LCFA ) oxidation was evaluated .


Newborn male pigs were administered 5 mL of vehicle ( 2 % Tween 80 ) with or without clofibrate ( 75 mg/kg body weight ) once daily via i.g. gavage for 4 d. Total LCFA oxidative capacity was measured in respiration chambers after gastric infusion ( n = 5 per treatment ) with isoenergetic amounts of [ 1 - ( 14 ) C ] triglycerides ( TGs ) , either oleic acid ( 18:1 n-9 ) TG [ 3.02 mmol/kg body weight ( BW ) ( 0.75 ) ] or erucic acid ( 22:1 n-9 ) TG ( 2.46 mmol/kg BW ( 0.75 ) ) .


Total expired ( 14 ) CO2 was collected and quantified at 20-min intervals over 24 h. Hepatic in vitro LCFA oxidation was determined simultaneously using [ 1 - ( 14 ) C ] oleic acid and erucic acid substrates .


The in vivo 24-h accumulative [ 1 - ( 14 ) C ] TG oxidation ( percentage of energy intake/kg BW ( 0.75 ) ) tended to increase with clofibrate supplementation ( P = 0.10 ) , although there was no difference in the peak or mean utilization rate .


The maximal extent of oleic acid TG oxidation was 1.6-fold that of erucic acid TG ( P < 0.006 ) .


Hepatic in vitro LCFA oxidation increased 61 % with clofibrate ( P < 0.0008 ) .


The increase in mitochondria was 4-fold greater than in peroxisomes .


The relative abundance of mRNA increased 2 - to 3-fold for hepatic peroxisome proliferator-activated receptor and its target genes ( fatty acyl-coenzyme A oxidase and carnitine palmitoyltransferase ) in the pigs that were administered clofibrate ( P < 0.04 ) .


Clofibrate may improve in vivo LCFA oxidative utilization in neonatal pigs .


This study sought to characterize major bleeding on the basis of the components of the major bleeding definition , to explore major bleeding by location , to define 30-day mortality after a major bleeding event , and to identify factors associated with major bleeding .


Apixaban was shown to reduce the risk of major hemorrhage among patients with atrial fibrillation in the ARISTOTLE ( Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ) trial .


All patients who received at least 1 dose of a study drug were included .


Major bleeding was defined according to the criteria of the International Society on Thrombosis and Haemostasis .


Factors associated with major hemorrhage were identified using a multivariable Cox model .


The on-treatment safety population included 18,140 patients .


The rate of major hemorrhage among patients in the apixaban group was 2.13 % per year compared with 3.09 % per year in the warfarin group ( hazard ratio [ HR ] 0.69 , 95 % confidence interval [ CI ] : 0.60 to 0.80 ; p < 0.001 ) .


Compared with warfarin , major extracranial hemorrhage associated with apixaban led to reduced hospitalization , medical or surgical intervention , transfusion , or change in antithrombotic therapy .


Major hemorrhage followed by mortality within 30 days occurred half as often in apixaban-treated patients than in those receiving warfarin ( HR 0.50 , 95 % CI : 0.33 to 0.74 ; p < 0.001 ) .


Older age , prior hemorrhage , prior stroke or transient ischemic attack , diabetes , lower creatinine clearance , decreased hematocrit , aspirin therapy , and nonsteroidal anti-inflammatory drugs were independently associated with an increased risk .


Apixaban , compared with warfarin , was associated with fewer intracranial hemorrhages , less adverse consequences following extracranial hemorrhage , and a 50 % reduction in fatal consequences at 30 days in cases of major hemorrhage .


Dislocation of the shoulder joint is one of the most common dislocations .


The reduction procedure is a painful procedure .


In this study , 2 different treatment groups were compared for pain control during shoulder dislocation reduction .


It was aimed to evaluate the differences between the groups in reduction , success , length of hospital stay , complications , side effects , patient-physician satisfaction , and ease of application .


The study was planned to be prospective and randomized .


As procedural sedation analgesia ( SA ) , titration of ketamine 1 to 2 mg/kg was administered intravenously to group 1 .


Suprascapular nerve block ( SNB ) was applied under ultrasound guidance ( USG ) to group 2 .


Conformity to normal distribution of variables was examined with the Kolmogorov-Smirnov test .


The 2 test and Fisher test were used to evaluate differences between the groups in categorical variables and the Mann-Whitney U test , and a value of P < .05 was accepted as statistically significant .


The study comprised a total of 41 patients ; 20 in the group 1 and 21 in the group 2 .


No statistically significant difference was determined between the groups in terms of age ( P = .916 ) , sex ( P = .972 ) , reduction success ( P = .540 ) , and patient-physician satisfaction ( P = .198 ) .


The time spent in the emergency department ( ED ) by patients in the SA group was signficantly longer compared with the SNB group .


No side effects were observed in the SNB group .


Suprascapular nerve block , which can be easily applied under USG in the ED , can be evaluated as a good alternative to SA in the reduction of shoulder dislocations .


Eicosapentaenoic acid ( EPA ) plus docosahexaenoic acid ( DHA ) supplementation has beneficial cardiovascular effects , but postprandial influences of these individual fatty acids are unclear .


The primary objective was to determine the vascular effects of EPA + DHA compared with DHA only during postprandial lipemia relative to control high-oleic acid meals ; the secondary objective was to characterize the effects of linoleic acid-enriched high-fat meals relative to the control meal .


We conducted a randomized , controlled , double-blind crossover trial of 4 high-fat ( 75-g ) meals containing 1 ) high-oleic acid sunflower oil ( HOS ; control ) , 2 ) HOS + fish oil ( FO ; 5 g EPA and DHA ) , 3 ) HOS + algal oil ( AO ; 5 g DHA ) , and 4 ) high-linoleic acid sunflower oil ( HLS ) in 16 healthy men ( aged 35-70 y ) with higher than optimal fasting triacylglycerol concentrations ( mean SD triacylglycerol , 1.9 0.5 mmol/L ) .


Elevations in triacylglycerol concentration relative to baseline were slightly reduced after FO and HLS compared with the HOS control ( P < 0.05 ) .


The characteristic decrease from baseline in plasma nonesterified fatty acids after a mixed meal was inhibited after AO ( 0-3 h , P < 0.05 ) .


HLS increased the augmentation index compared with the other test meals ( P < 0.05 ) , although the digital volume pulse-reflection index was not significantly different .


Plasma 8-isoprostane F2 analysis revealed opposing effects of FO ( increased ) and AO ( reduced ) compared with the control ( P < 0.05 ) .


No differences in nitric oxide metabolites were observed .


These data show differential postprandial 8-isoprostane F2 responses to high-fat meals containing EPA + DHA-rich fish oil compared with DHA-rich AO , but these differences were not associated with consistent effects on postprandial vascular function or lipemia .


More detailed analyses of polyunsaturated fatty acid-derived lipid mediators are required to determine possible divergent functional effects of single meals rich in either DHA or EPA .


This trial was registered at clinicaltrials.gov as NCT01618071 .


Clonidine is used with local anaesthetics to improve analgesia .


However , the improvement conferred when clonidine is used together with ropivacaine is controversial .


Thus , the present study aimed to evaluate the improvement in analgesia when clonidine is used together with ropivacaine for supraclavicular brachial plexus block .


This was a prospective , randomised , double-blind controlled study .


A total of 75 patients who were scheduled to undergo supraclavicular block were randomly assigned into three groups ( i.e. clonidine , lignocaine and control groups ) of 25 .


Patients in all three groups received 20 mL of 0.75 % ropivacaine .


In addition to that , patients in the clonidine group received 1 mL of clonidine ( 150 g ) plus 9 mL of saline , patients in the lignocaine group received 10 mL of 2 % lignocaine with adrenaline ( 1:200,000 ) , and patients in the control group received 10 mL of saline .


The characteristics of anaesthesia and analgesia for these three groups were assessed .


The addition of 2 % lignocaine with adrenaline to ropivacaine led to earlier onset of the sensory block ( by 4.88 mins ) , but no increase in the duration of analgesia when compared to analgesia using ropivacaine alone .


The addition of clonidine to ropivacaine led to earlier onset of sensory and motor blocks ( by 2.88 mins and 3.28 mins , respectively ) , as well as an increased duration of sensory and motor blocks ( by 222.64 mins and 192.92 mins , respectively ) when compared to analgesia using ropivacaine alone .


The total duration of analgesia was increased by 208.24 mins with clonidine when compared to analgesia using ropivacaine alone .


There were no significant differences in sedation score and no side effects in all three groups .


When compared to the use of ropivacaine alone , the addition of 150 g clonidine to ropivacaine for brachial plexus block achieved earlier analgesic onset and improved duration of analgesia , without unwanted side effects .


To explore the effect and the mechanism of Danhong Injection ( DI ) , Ligustrazine Injection ( LI ) , and adsorbable biomembranes in preventing the adhesion of tendons and tissues .


Totally 120 patients all suffering from simple flexor digitorum tendon rupture on the hand zone two damaged by sharp weapons were randomly assigned to Group A ( Dikang adsorbable biomembrane ) , Group B ( Tianxinfu adsorbable biomembrane ) , Group C ( Tianxinfu adsorbable biomembrane + Ligustrazine group ) , and Group D ( Tianxinfu adsorbable biomembrane + DI group ) in accordance with random digit table , 30 cases in each group .


Indicators such as total active movement ( TAM ) of the hand tendon , Minnesota manual dexterity test ( MMDT ) , and finger flex strength test ( FFST ) were observed .


The TAM and the favorable rate were higher in Group C and D than in Group A and B at post-operative 4 and 8 week ( P < 0.05 , P < 0.01 ) .


There was no statistical difference between Group C and D ( P > 0.05 ) .


Each index of MMDT was lower in Group C and D than in Group A and B ( P < 0.05 ) .


There was no statistical difference in FFST among all the 4 groups ( P > 0.05 ) .


Combined application of LI or DI with Tianxinfu adsorbable biomembranes could effectively prevent the adhesion of tendons .


DI showed equivalent effect as LI did .


Besides , the combined application was superior in preventing adhesion to using Xintianfu adsorbable biomembrane or Dikan adsorbable biomembrane alone .


Sham acupuncture turned out to be more effective than expected .


The effect of acupuncture can not be assessed by optical rhinometry ( ORM ) .


In most cases nasal congestion is caused by hypertrophy of the inferior turbinate as a result of allergic and chronic rhinitis .


Topical decongestants cause severe side effects .


As a consequence , there is an increasing demand for alternative treatment options such as traditional Chinese medicine ( TCM ) .


A total of 25 patients with nasal congestion due to hypertrophic inferior turbinate were recruited .


The mucosal swelling status of the inferior turbinate was assessed by continuous ORM for 20 min .


Patients were asked to score the severity of their nasal congestion on a visual analogue scale ( VAS ) before and 10 and 20 min after acupuncture .


Specific verum acupuncture points related to nasal congestion were tested against non-specific control sham acupuncture points .


Sham acupuncture improved VAS scores , whereas ORM measured an increase in nasal swelling .


The ORM revealed a quicker onset of the effect of verum acupuncture on the nasal blood flow .


Also , verum acupuncture reaches its maximum effect in a shorter time period , so that the net reaction time was much shorter .


However , ORM could not prove a decongestant effect of verum acupuncture on inferior turbinate .


To compare the efficacy of gait training using a single-leg version of the Hybrid Assistive Limb ( HAL ) on the paretic side with conventional gait training in individuals with subacute stroke .


Randomized open controlled pilot trial .


Hospitalized care .


Convenience sample of 44 patients who met the criteria ; 12 patients refused .


After randomization ( N = 32 ) , 10 patients withdrew and a total of 22 poststroke participants ( HAL group : n = 11 ; conventional group : n = 11 ) completed the randomized controlled trial .


All participants received twelve 20-minute sessions in 4 weeks of either HAL ( wearing the single-leg version of the HAL on their paretic side ) or conventional ( performed by skilled and experienced physical therapists ) gait training .


Outcome measures were evaluated prior to training and after 12 sessions .


Functional Ambulation Category ( FAC ) was the primary outcome measure , whereas secondary outcome measures included maximum walking speed , timed Up and Go test , 6-minute walk distance , Short Physical Performance Battery , Fugl-Meyer Assessment of Lower Extremity , and isometric muscle strength ( hip flexion and extension , knee flexion and extension ) .


No participants withdrew because of adverse effects .


Participants who received gait training with the HAL showed significantly more improvement in the FAC than those who received conventional gait training ( 95 % confidence interval , .02 -.88 ; P = .04 ) .


Secondary measures did not differ between the 2 groups .


The results obtained in this randomized controlled trial suggest that a gait training program with the HAL could improve independent walking more efficiently than conventional gait training .


To investigate the effectiveness of a program that utilizes community involvement to improve the self-management strategies among people living with hypertension .


Forty-four subjects , aged 35 to 59-year-old , with hypertension in Nakhon Pathom Province , Thailand , were randomly allocated to either an experimental group ( n = 22 ) or a control group ( n = 20 ) .


The experimental group attended a program to improve self-management methods based on social cognitive theory ( SCT ) .


The program lasted 12 weeks , consisted of 1 1/2 hours meeting once a week , including group meetings and home visit monitoring .


Mann-Whitney U test and Friedman test were employed to analyze the program 's effectiveness .


After the program , the mean rank of the perceived self-efficacy for the self-management strategies was statistically different between the two groups ( p = 0.023 ) .


In the experimental group , after the twelve week , the mean rank of perceived self-efficacy and outcome expectancy increased and diastolic blood pressure decreased after the eight week .


The program applied social cognitive theory ( SCT ) to promote self-management techniques , increased the health promoting behavior among hypertensive people .


The antiepileptic drug topiramate reduces levodopa-induced dyskinesia without exacerbating parkinsonism in animal models .


We report a randomized , double-blind , placebo-controlled crossover trial in patients with Parkinson 's disease and levodopa-induced dyskinesia .


Fifteen patients with Parkinson 's disease and stable levodopa-induced dyskinesia were enrolled into the study , of whom 13 were randomized to topiramate or placebo .


The study medication was titrated to 100mg/day over four weeks , and assessments were carried out after a further two weeks .


Dyskinesia severity assessed by a blinded rater from video recordings was the primary outcome measure .


Seven patients ( mean age 58.912.8 years ) completed the study .


Patients taking topiramate vs. placebo showed a significant increase in dyskinesia severity compared to baseline ( Wilcoxon signed rank test , P = 0.043 ) .


Five patients withdrew from the study whilst taking topiramate due to adverse effects .


Topiramate tended to worsen dyskinesia in patients with Parkinson 's disease , and was poorly tolerated .


Does functional electrical stimulation ( FES ) cycling increase urine output and decrease lower limb swelling and spasticity in people with recent spinal cord injury ?


Randomised cross-over trial .


Fourteen participants with a recent motor complete spinal cord injury were consecutively recruited from two spinal cord injury units in Sydney .


Participants were randomised to an experimental phase followed by a control phase or vice versa , with a 1-week washout period in between .


The experimental phase involved FES cycling four times a week for two weeks and the control phase involved standard rehabilitation for two weeks .


Assessments by a blinded assessor occurred at the beginning and end of each phase .


Allocation was concealed and an intention-to-treat analysis was performed .


The primary outcome was urine output ( mL/hr ) and the secondary outcomes were lower limb circumference , and spasticity using the Ashworth Scale , and the Patient Reported Impact of Spasticity Measure ( PRISM ) .


In addition , participants were asked open-ended questions to explore their perceptions about treatment effectiveness .


All participants completed the study .


The mean between-group difference ( 95 % CI ) for urine output was 82mL/hr ( -35 to 199 ) .


The mean between-group differences ( 95 % CI ) for lower limb swelling , spasticity ( Ashworth ) , and PRISM were -0.1 cm ( -1.5 to 1.2 ) , -1.9 points ( -4.9 to 1.2 ) and -5 points ( -13 to 2 ) , respectively .


All point estimates of treatment effects favoured FES cycling .


Participants reported many benefits from FES cycling .


There were no clear effects of FES cycling on urine output , swelling and spasticity even though all point estimates of treatment effects favoured FES cycling and participants perceived therapeutic effects .


ACTRN12611000923965 .


Coronary artery bypass grafting ( CABG ) has been considered the standard of care for patients with three-vessel disease ( 3VD ) , but long-term comparative results from randomized trials of CABG vs. percutaneous coronary intervention ( PCI ) using drug-eluting stents ( DES ) remain limited .


Patients with de novo 3VD or left main disease were randomly assigned to PCI with the paclitaxel-eluting first-generation stent or CABG in the SYNTAX trial .


This pre-specified analysis presents the 5-year outcomes of patients with 3VD ( n = 1095 ) .


The rate of major adverse cardiac and cerebrovascular events ( MACCE ) was significantly higher in patients with PCI compared with CABG ( 37.5 vs. 24.2 % , respectively ; P < 0.001 ) .


Percutaneous coronary intervention as opposed to CABG resulted in significantly higher rates of the composite of death/stroke/myocardial infarction ( MI ) ( 22.0 vs. 14.0 % , respectively ; P < 0.001 ) , all-cause death ( 14.6 vs. 9.2 % , respectively ; P = 0.006 ) , MI ( 9.2 vs. 4.0 % , respectively ; P = 0.001 ) , and repeat revascularization ( 25.4 vs. 12.6 % , respectively ; P < 0.001 ) ; however , stroke was similar between groups at 5 years ( 3.0 vs. 3.5 % , respectively ; P = 0.66 ) .


Results were dependent on lesion complexity ( P for interaction = 0.12 ) ; in patients with a low ( 0-22 ) SYNTAX score , PCI vs. CABG resulted in similar rates of MACCE ( 33.3 % vs. 26.8 % , respectively ; P = 0.21 ) but significantly more repeat revascularization ( 25.4 % vs. 12.6 % , respectively ; P = 0.038 ) , while in intermediate ( 23-32 ) or high ( 33 ) SYNTAX score terciles , CABG demonstrated clear superiority in terms of MACCE , death , MI , and repeat revascularization .


Differences in MACCE between PCI and CABG were larger in diabetics [ hazard ratio ( HR ) = 2.30 ] than non-diabetics ( HR = 1.51 ) , although the P for interaction failed to reach significance for MACCE ( P for interaction = 0.095 ) or any of the other endpoints .


Five-year results of patients with 3VD treated with CABG or PCI using the first-generation paclitaxel-eluting DES suggest that CABG should remain the standard of care as it resulted in significantly lower rates of death , MI , and repeat revascularization , while stroke rates were similar .


For patients with low SYNTAX scores , PCI is an acceptable revascularization strategy , although at a price of significantly higher rates of repeat revascularization .


NCT00114972 .


This study aimed to compare the effects of topical and systemic lignocaine on the circulatory response to direct laryngoscopy performed under general anaesthesia .


Ninety-nine patients over 20 years of age , with a physical status of I-II ( classified according to the American Society of Anesthesiologists ) , were randomly allocated to 3 groups .


One group received 5ml of 0.9 per cent physiological saline intravenously , one group received 1.5 mg/kg lignocaine intravenously , and another group received seven puffs of 10 per cent lignocaine aerosol applied topically to the airway .


Mean arterial pressures , heart rates and peripheral oxygen saturations were recorded , and changes in mean arterial pressure and heart rate ratios were calculated .


Changes in the ratios of mean arterial pressure and heart rate were greater in the saline physiological group than the other groups at 1 minute after intubation .


Changes in the ratios of mean arterial pressure ( at the same time point ) were greater in the topical lignocaine group than in the intravenous lignocaine group , but this finding was not statistically significant .


Lignocaine limited the haemodynamic responses to laryngoscopy and endotracheal intubation during general anaesthesia in rigid suspension laryngoscopy .


To investigate whether planning target volume ( PTV ) margins may be safely reduced in radiotherapy of localized prostate cancer incorporating daily online tube potential-cone beam CT ( CBCT ) image guidance and the anticipated benefit in predicted rectal toxicity .


The prostate-only clinical target volume ( CTV2 ) and rectum were delineated on 1 pre-treatment CBCT each week in 18 randomly selected patients .


By transposing these contours onto the original plan , dose-volume histograms ( DVHs ) for CTV2 and the rectum were each calculated and combined , for each patient , to produce a single mean DVH representative of the dose delivered over the treatment course .


Plans were reoptimized using reduced CTV2 to PTV2 margins and the consequent radiobiological impact modelled by the tumour control probability ( TCP ) and normal tissue complication probability ( NTCP ) of the rectum .


All CBCT images were deemed of sufficient quality to identify the CTV and rectum .


No loss of TCP was observed when plans using the standard 5-mm CTV2 to PTV2 margin of the centre were reoptimized with a 4 - or 3-mm margin .


Margin reduction was associated with a significant decrease in rectal NTCP ( 5-4mm ; p < 0.05 and 5-3mm ; p < 0.01 ) .


Using daily online image guidance with CBCT , a reduction in CTV2 to PTV2 margins to 3mm is achievable without compromising tumour control .


The consequent sparing of surrounding normal tissues is associated with reduced anticipated rectal toxicity .


Margin reduction is feasible and potentially beneficial .


Centres with image-guided radiotherapy capability should consider assessing whether margin reduction is possible within their institutes .


Risk of cancer progression is reduced for patients with human papillomavirus ( HPV ) - positive oropharynx cancer ( OPC ) relative to HPV-negative OPC , but it is unknown whether risk of death after progression is similarly reduced .


Patients with stage III-IV OPC enrolled onto Radiation Therapy Oncology Group trials 0129 or RTOG 0522 who had known tumor p16 status plus local , regional , and/or distant progression after receiving platinum-based chemoradiotherapy were eligible for a retrospective analysis of the association between tumor p16 status and overall survival ( OS ) after disease progression .


Rates were estimated by Kaplan-Meier method and compared by log-rank ; hazard ratios ( HRs ) were estimated by Cox models .


Tests and models were stratified by treatment protocol .


A total of 181 patients with p16-positive ( n = 105 ) or p16-negative ( n = 76 ) OPC were included in the analysis .


Patterns of failure and median time to progression ( 8.2 v 7.3 months ; P = .67 ) were similar for patients with p16-positive and p16-negative tumors .


After a median follow-up period of 4.0 years after disease progression , patients with p16-positive OPC had significantly improved survival rates compared with p16-negative patients ( 2-year OS , 54.6 % v 27.6 % ; median , 2.6 v 0.8 years ; P < .001 ) .


p16-positive tumor status ( HR , 0.48 ; 95 % CI , 0.31 to 0.74 ) and receipt of salvage surgery ( HR , 0.48 ; 95 % CI ; 0.27 to 0.84 ) reduced risk of death after disease progression whereas distant versus locoregional progression ( HR , 1.99 ; 95 % CI , 1.28 to 3.09 ) increased risk , after adjustment for tumor stage and cigarette pack-years at enrollment .


Tumor HPV status is a strong and independent predictor of OS after disease progression and should be a stratification factor for clinical trials for patients with recurrent or metastatic OPC .


We analyzed the potential of abiraterone acetate ( henceforth abiraterone ) to reduce androgen levels below lower limits of quantification ( LLOQ ) and explored the association with changes in PSA decline in metastatic castration-resistant prostate cancer ( mCRPC ) patients .


COU-AA-301 is a 2:1 randomized , double-blind , placebo-controlled study comparing abiraterone ( 1000mg q.d. ) plus low-dose prednisone ( 5mg b.i.d. ) with placebo plus prednisone in mCRPC patients post docetaxel .


Serum testosterone , androstenedione and dehydroepiandrosterone sulfate from baseline to week 12 were measured by novel ultrasensitive two-dimensional liquid chromatography coupled to tandem mass spectrometry assays in a subset of subjects in each arm ( abiraterone plus prednisone , n = 80 ; prednisone , n = 38 ) .


The association between PSA response ( < or = 50 % baseline ) and undetectable androgens ( week 12 androgen level below LLOQ ) was analyzed using logistic regression .


A significantly greater reduction in serum androgens was observed with abiraterone plus prednisone versus prednisone ( all P < or = 0.0003 ) , reaching undetectable levels for testosterone ( 47.2 % versus 0 % , respectively ) .


A positive association was observed between achieving undetectable serum androgens and PSA decline ( testosterone : odds ratio = 1.54 ; 95 % confidence interval : 0.546-4 .347 ) .


Reduction of androgens to undetectable levels did not occur in all patients achieving a PSA response , and a PSA response did not occur in all patients achieving undetectable androgen levels .


Abiraterone plus prednisone significantly reduced serum androgens , as measured by ultrasensitive assays and was generally associated with PSA response .


However , androgen decline did not uniformly predict PSA decline suggesting ligand-independent or other mechanisms for mCRPC progression .


Maintaining quality of life ( QOL ) and physical and mental health status are important outcomes throughout the aging process .


Although cross-sectional studies suggest a relationship between global QOL and physical activity , it is unclear whether such a relationship exists as a function of exercise training .


We examined the effects of two exercise intervention arms on health-related quality of life ( HRQOL ) and global QOL .


Low-active , older adults ( n = 179 ) were randomly assigned to either a 12-month aerobic walking group or a strengthening and flexibility group .


HRQOL and QOL were measured at baseline , 6 , and 12 months .


There was a significant group by time effect on QOL [ F ( 2,176 ) = 3.11 , p = 0.047 , ( 2 ) = 0.03 ] .


There was also a significant overall group by time effect for HRQOL [ F ( 4,174 ) = 2.46 , p = 0.047 , ( 2 ) = 0.05 ] , which was explained by the significant group by time interaction for mental health status ( p = 0.041 , ( 2 ) = 0.02 ) favoring the walking condition .


Further analyses using latent class analysis revealed three classes of individuals with differential patterns of change in QOL and HRQOL across time .


These classes reflected no change , declines , and improvements in these constructs across time .


Walking appears to enhance the mental aspect of HRQOL and global QOL when compared to a non-aerobic intervention .


Additionally , the patterns of change in QOL and HRQOL were not linear over time .


Our findings are in contrast to previous reports that these outcomes change a little or not at all in randomized trials .


This study explores the usefulness of virtual simulation training for learning to place pedicle screws in the lumbar spine .


Twenty-six senior medical students anonymously participated and were randomized into two groups ( A = no simulation ; B = simulation ) .


Both groups were given 15 minutes to place two pedicle screws in a sawbones model .


Students in Group A underwent traditional visual/verbal instruction whereas students in Group B underwent training on pedicle screw placement in the ImmersiveTouch simulator .


The students in both groups then placed two pedicle screws each in a lumbar sawbones models that underwent triplanar thin slice computerized tomography and subsequent analysis based on coronal entry point , axial and sagittal deviations , length error , and pedicle breach .


The average number of errors per screw was calculated for each group .


Semi-parametric regression analysis for clustered data was used with generalized estimating equations accommodating a negative binomial distribution to determine any statistical difference of significance .


A total of 52 pedicle screws were analyzed .


The reduction in the average number of errors per screw after a single session of simulation training was 53.7 % ( P = 0.0067 ) .


The average number of errors per screw in the simulation group was 0.96 versus 2.08 in the non-simulation group .


The simulation group outperformed the non-simulation group in all variables measured .


The three most benefited measured variables were length error ( 86.7 % ) , coronal error ( 71.4 % ) , and pedicle breach ( 66.7 % ) .


Computer-based simulation appears to be a valuable teaching tool for non-experts in a highly technical procedural task such as pedicle screw placement that involves sequential learning , depth perception , and understanding triplanar anatomy .


We compared nab-paclitaxel or ixabepilone once per week to paclitaxel with bevacizumab as first-line therapy for patients with advanced breast cancer ( BC ) to evaluate progression-free survival ( PFS ) for nab-paclitaxel or ixabepilone versus paclitaxel .


Eligible patients were age 18 years with chemotherapy-naive advanced BC .


Patients were randomly assigned to bevacizumab with paclitaxel 90 mg/m ( 2 ) ( arm A ) , nab-paclitaxel 150 mg/m ( 2 ) ( arm B ) , or ixabepilone 16 mg/m ( 2 ) ( arm C ) , once per week for 3 of 4 weeks .


Planned enrollment was 900 patients , which would give 88 % power to detect a hazard ratio of 0.73 .


In all , 799 patients were enrolled , and 783 received treatment ( 97 % received bevacizumab ) .


Arm C was closed for futility at the first interim analysis ( n = 241 ) , and arm A ( n = 267 ) and arm B ( n = 275 ) were closed for futility at the second interim analysis .


Median PFS for paclitaxel was 11 months , ixabepilone was inferior to paclitaxel ( PFS , 7.4 months ; hazard ratio , 1.59 ; 95 % CI , 1.31 to 1.93 ; P < .001 ) , and nab-paclitaxel was not superior to paclitaxel ( PFS , 9.3 months ; hazard ratio , 1.20 ; 95 % CI , 1.00 to 1.45 ; P = .054 ) .


Results were concordant with overall survival ; time to treatment failure was significantly shorter in both experimental arms v paclitaxel .


Hematologic and nonhematologic toxicity , including peripheral neuropathy , was increased with nab-paclitaxel , with more frequent and earlier dose reductions .


In patients with chemotherapy-naive advanced BC , ixabepilone once per week was inferior to paclitaxel , and nab-paclitaxel was not superior with a trend toward inferiority .


Toxicity was increased in the experimental arms , particularly for nab-paclitaxel .


Paclitaxel once per week remains the preferred palliative chemotherapy in this setting .


The aim of the present study was to assess the efficacy and safety of vildagliptin as add-on to sulfonylurea therapy in Chinese patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled on sulfonylurea monotherapy .


The 24-week randomized double-blind placebo-controlled study compared vildagliptin 50mg , q.d. , with placebo as add-on to glimepiride in T2DM patients who were inadequately controlled ( HbA1c 7.5 % -11.0 % [ 58-97mmol / mol ] ) on a stable dose of sulfonylurea for 12 weeks before study entry .


In all , 279 patients were randomized to receive either vildagliptin ( n = 143 ) or placebo ( n = 136 ) .


At baseline , overall mean age was 58.5 years , body weight 68.1 kg , duration of diabetes 6.9 years and daily glimepiride dose 3.3 mg .


After 24 weeks , the adjusted mean change ( AM ) in HbA1c was -0.7 % ( -8 mmol/mol ; baseline 8.6 % , 70mmol/mol ) in the vildagliptin group and -0.2 % ( -2 mmol/mol ; baseline 8.7 % , 72mmol/mol ) in the placebo group , with a treatment difference of -0.5 % ( -5 mmol/mol ; P < 0.001 ) .


The between-group difference in AM in fasting plasma glucose was -0.4 mmol/L ( P = 0.160 ) .


There was a slight , but not significant , decrease in body weight in both groups .


No hypoglycemic events were reported in either group , including those patients reaching HbA1c < 7.0 % .


Patients in the vildagliptin and placebo groups reported low and comparable incidences of adverse events ( 14.0 % vs. 17.8 % ) and serious adverse events ( 0.7 % in each group ) .


Vildagliptin 50mg , q.d. , added to sulfonylurea monotherapy is effective in Chinese patients with T2DM , without increasing the risk of hypoglycemia and weight gain .


A distinct suppressive effect of a whey protein ( including glycomacropeptide ) - enriched preload drink on subsequent food intake in comparison with a maltodextrin carbohydrate-enriched preload was demonstrated in an earlier companion study with the same female subjects ; however , the potential mediators underlying the effect are unclear .


The objective of this study was to investigate how the ingestion of a whey protein-enriched preload beverage affected postprandial plasma concentrations of several satiety-related gastrointestinal hormones and metabolites in comparison with a maltodextrin carbohydrate-enriched preload .


Eighteen normal-weight women were studied in a single-blind , randomized block design .


Blood samples were collected at various time intervals for 120min after consumption of a test drink ( 300ml , ~ 1300kJ ) enriched ( 45g ) with either maltodextrin carbohydrate or whey protein containing naturally present glycomacropeptide .


Plasma-active ghrelin concentrations decreased after both maltodextrin carbohydrate - and whey protein-enriched test drinks ( P < 0.05 ) .


The whey protein-enriched beverage led to increased plasma concentrations of cholecystokinin ( CCK ) at 60 and 75min ( P < 0.05 ) , glucagon-like peptide-1 ( GLP-1 ) at 90min ( P < 0.001 ) , peptide tyrosine-tyrosine ( PYY ) at 90 and 120min ( P < 0.01 ) and pancreatic polypeptide ( PP ) from 15 to 120min ( P < 0.05 ) compared with maltodextrin carbohydrate .


Total amino acid , urea and ammonia plasma concentrations were also higher after whey protein compared with maltodextrin carbohydrate ingestion ( P < 0.01 ) .


Increased plasma concentrations of some gastrointestinal hormones related to satiety , particularly PP , and of amino acids and their metabolites , may have acted either singly or together to mediate the observed satiety response to whey protein .


Sleep deprivation in hospitalized patients is common and can have serious detrimental effects on recovery from illness .