The IC symptom and problem indices scores and urodynamic index were significantly improved in sildenafil treatment group as compared with placebo group and baselines at week 4 , 6 , 8 , 10 , and 12 , as well as 3 months after treatment ( P < .05 ) .


Urodynamic index including first desire to void , strong desire to void , and maximum cystometric capacity was significantly improved in sildenafil treatment group at week 12 and at 3 months after treatment ( P < .05 ) .


The efficiency of treatment reached 62.5 % .


However , no significant change of the visual analog scale values was observed between 2 groups except at week 12 in the sildenafil treatment group ( P < .05 ) .


All adverse events were mild to moderate and transient .


Daily low-dose sildenafil is an easy , well-tolerated , and effective treatment for IC in women .


Girls in the child welfare system are at high risk of revictimization in adolescence .


The present study compared two interventions designed to decrease revictimization in a diverse sample of adolescent child welfare-involved girls .


The social learning/feminist ( SL/F ) intervention focused on concepts derived from social learning and feminist models of risk , such as sexism and beliefs about relationships .


The risk detection/executive function ( RD/EF ) intervention focused on development of specific executive function abilities related to detecting and responding to risky situations/people .


Participants were randomized to RD/EF ( n = 67 ) or SL/F intervention ( n = 67 ) .


A group of youth ( n = 42 ) engaged in the research assessments only .


Participants ( n = 180 ) were assessed before intervention , immediately after intervention , 2 months after intervention , and 6 months after intervention .


We examined revictimization ( the presence/absence of sexual or physical assault in any relationship ) over time .


Adolescent girls in the RD/EF condition were nearly five times less likely to report sexual revictimization compared with girls in the no-treatment group .


A trend suggested that girls who participated in the SL/F intervention were 2.5 times less likely to report sexual revictimization relative to the no-treatment group .


For physical revictimization , the odds of not being physically revictimized were three times greater in the SL/F condition and two times greater in the RD/EF condition compared with the no-treatment group .


The active interventions did not differ significantly from one another in rates of revictimization , suggesting that practitioners have at least two viable options to engage high-risk youth in revictimization prevention .


To investigate whether magnesium oxide reduces the interfraction motion of the prostate and the amount of rectal filling and rectal gas , which influences prostate position during radiotherapy for prostate cancer .


From December 2008 to February 2010 , 92 prostate cancer patients scheduled for intensity-modulated radiotherapy ( 77 Gy in 35 fractions ) using fiducial marker-based position verification were randomly assigned to receive magnesium oxide ( 500 mg twice a day ) or placebo during radiotherapy .


In a previous study , we investigated the effect on intrafraction motion and did not find a difference between the treatment arms .


Here , we compared the interfraction prostate motion between the two treatment arms as well as the amount of rectal filling and rectal air pockets using pretreatment planning computed tomography and magnetic resonance imagingscans .


There was no statistically significant difference between the treatment arms in translation and rotation of the prostate between treatment fractions , except for the rotation around the cranial caudal axis .


However , the difference was less than 1 and therefore considered not clinically relevant .


There was no significant difference in the amount of rectal filling and rectal air pockets between the treatment arms .


Magnesium oxide is not effective in reducing the interfraction prostate motion or the amount of rectal filling and rectal gas during external-beam radiotherapy .


Therefore , magnesium oxide is not recommended in clinical practice for these purposes .


The primary aim of rheumatoid arthritis ( RA ) treatment is to induce remission , the absence of disease activity .


The objective of this study was to explore the association between clinical endpoints used to gauge RA treatment efficacy and patient-reported outcomes of health-related quality of life , fatigue , and physical function in RA patients treated with secukinumab in a phase 2 randomized controlled trial ( RCT ) .


Adult RA patients ( n = 237 ) with incomplete responses to methotrexate were randomized equally to receive monthly s.c. injections of secukinumab 25mg , 75mg , 150mg , 300mg or placebo .


Clinical endpoints used in this study included the ACR response criteria and its components and simplified disease activity score .


Patient-reported outcomes ( PRO ) included Health Assessment Questionnaire-Disability Index ( HAQ-DI ) , Medical Outcomes Study Short Form-36 [ SF-36 ] Survey , and Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-Fatigue ) .


Patients were categorized into mutually exclusive groups according to the magnitude and direction of change from baseline to week 16 in each clinical endpoint .


Definitions of minimal important differences [ MID ] in each clinical endpoint were used to categorize patients , as well as thresholds beyond MID .


Mean changes from baseline to week 16 were computed for each PRO and analyses of variance to test the differences in PRO changes observed across groups of patients that differed in each clinical endpoint .


Analyses were limited to patients randomized to secukinumab treatment .


All dose groups were combined ( n = 187 ) .


Mean changes from baseline in each PRO differed significantly across groups of patients in the expected direction .


With few exceptions , there was considerable agreement between clinical endpoints and PROs concerning the magnitude of change defined as clinically meaningful .


More importantly , results demonstrated that greater improvements in clinical endpoints were associated with incrementally better improvements in HRQoL , fatigue , and physical function .


Results of this study show considerable agreement between minimal thresholds of improvement established for PROs and clinical outcome measures used in RA treatment studies and provide thresholds to be considered in gauging the importance of a treatment effect that goes beyond what is considered as minimally important for PRO measures .


Computed tomography is widely used to diagnose acute appendicitis .


Many adolescents and young adults are exposed to the associated radiation .


A recent single-institution trial has reported promising results for low-dose computed tomography ; however , this technique has not yet been widely adopted .


LOCAT ( low-dose computed tomography for appendicitis trial ) , a multi-institution randomized controlled non-inferiority trial , aims to compare low-dose computed tomography and standard-dose computed tomography as the first-line imaging tests for adolescents and young adults , and therefore to test the generalizability of the previous single-institution trial results .


Participants with suspected appendicitis are randomly assigned to either the low-dose group ( with a typical effective dose of 2mSv ) or the standard-dose group ( as used in normal practice at each participating site , typically 8mSv ) .


The primary end point is the negative appendectomy rate ( the percentage of the number of uninflamed appendices that were removed among all non-incidental appendectomies ) , which is a consequence of false-positive diagnoses , with a non-inferiority margin of 4.5 percentage points .


The key secondary end point is the appendiceal perforation rate , which is a consequence of delayed ( or false-negative ) diagnoses .


Participant recruitment will be continued until the number of non-incidental appendectomies for each group exceeds 444 .


The total number of expected participants approximates 3,000 , including those not undergoing appendectomy .


In addition to the study protocol , we elaborate on several challenging or potentially debatable components of the study design , including the broad eligibility criteria , choice of the primary end point , potential effect of using advanced imaging techniques on study results , determining and adjusting the radiation doses , ambiguities in reference standards , rationale for the non-inferiority margin , use of the intention-to-treat approach and difficulties in defining adverse events .


ClinicalTrials.gov NCT01925014 .


Vitamin D insufficiency has been associated with impaired pancreatic beta-cell function .


We aimed to determine if high dose oral vitamin D3 ( D ) improves beta-cell function and glycaemia in type 2 diabetes .


Fifty adults with type 2 diabetes diagnosed less than 12 months , with normal baseline serum 25-OH D ( 25D ) , were randomised to 6000 IU D ( n = 26 ) or placebo ( n = 24 ) daily for 6 months .


Beta-cell function was measured by glucagon-stimulated serum C-peptide ( delta C-peptide [ DCP ] , nmol/l ) .


Secondary outcome measures were fasting plasma glucose ( FPG ) , post-prandial blood glucose ( PPG ) , HbA1c and insulin resistance ( HOMA-IR ) .


In the D group , median serum 25D ( nmol/l ) increased from 59 to 150 ( 3 months ) and 128 ( 6 months ) and median serum 1,25 D ( pmol/l ) from 135 to 200 and 190 .


After 3 months , change in DCP from baseline in D ( +0.04 ) and placebo ( -0.08 ) was not different ( P = 0.112 ) .


However , change in FPG ( mmol/l ) was significantly lower in D ( -0.40 ) compared to placebo ( +0.1 ) ( P = 0.007 ) , as was the change in PPG in D ( -0.30 ) compared to placebo ( +0.8 ) ( P = 0.005 ) .


Change in HbA1c ( % ) between D ( -0.20 ) and placebo ( -0.10 ) was not different ( P = 0.459 ) .


At 6 months , changes from baseline in DCP , FPG , PPG and HbA1c were not different between groups .


Oral D3 supplementation in type 2 diabetes was associated with transient improvement in glycaemia , but without a measurable change in beta-cell function this effect is unlikely to be biologically significant .


High dose D3 therefore appears to offer little or no therapeutic benefit in type 2 diabetes .


This study sought to evaluate the short - and long-term outcomes for smokers with non-ST-segment elevation acute coronary syndromes ( NSTE-ACS ) .


Smoking has been associated with the `` paradox '' of reduced mortality after acute myocardial infarction ( MI ) .


This is thought to be due to favorable baseline characteristics and less diffuse coronary artery disease ( CAD ) among smokers .


In the ACUITY ( Acute Catheterization and Urgent Intervention Triage Strategy ) trial , 13,819 patients ( 29.1 % smokers ) with moderate - to high-risk NSTE-ACS underwent angiography and , if indicated , revascularization .


Smokers were significantly younger and had fewer comorbidities than nonsmokers .


Incidence of death and MI were comparable at 30 days , although smokers had significantly reduced risks of 30-day major bleeding ( hazard ratio [ HR ] : 0.80 , 95 % confidence interval [ CI ] : 0.67 to 0.96 ; p = 0.016 ) and 1-year mortality ( HR : 0.797 , 95 % CI : 0.65 to 0.97 ; p = 0.027 ) .


After correction for baseline and clinical differences , smoking was no longer predictive of major bleeding ( odds ratio : 1.06 , 95 % CI : 0.86 to 1.32 ; p = 0.56 ) and was associated with higher 1-year mortality ( HR : 1.37 , 95 % CI : 1.07 to 1.7 ; p = 0.013 ) .


This pattern of reversed risk after multivariable correction held true for those smokers requiring percutaneous coronary intervention .


Core laboratory angiographic analysis showed that smokers and nonsmokers were comparable in terms of the extent of CAD , Thrombolysis In Myocardial Infarction flow , myocardial blush , and the presence of thrombi .


In contrast to the paradox previously described in ST-segment elevation MI , our analysis finds smoking to be an independent predictor of higher 1-year mortality in patients presenting with NSTE-ACS , and our angiographic study demonstrates CAD in smokers that is comparable to that in nonsmokers but evident 1 decade earlier .


( Acute Catheterization and Urgent Intervention Triage Strategy [ ACUITY ] ; NCT00093158 ) .


Despite empirical evidence demonstrating the effectiveness of collaborative stepped care program ( SCP ) in Western countries , such programs have not been evaluated in the east , which has a different services system structure and cultural nuances in seeking help for mental illness .


Furthermore , only a few studies have used SCP for depression and anxiety prevention .


We conducted a trial to test its effectiveness in preventing major depressive disorder and generalized anxiety disorder among primary care patients with subthreshold depression and/or anxiety in Hong Kong .


Subthreshold depression and/or anxiety patients were randomized into the SCP group ( n = 121 ) or care as usual ( CAU ) group ( n = 119 ) .


The SCP included watchful waiting , telephone counseling , problem solving therapy , and family doctor treatment within one year .


The primary outcome was the onset of major depressive disorder or generalized anxiety disorder in 15 months .


The secondary outcomes were depressive and anxiety symptoms , quality of life and time absent from work due to any illness .


Survival analysis showed no differences between the SCP and CAU groups ( the cumulative probability of onset at 15 month was 23.1 % in the SCP group and 20.5 % in the CAU group ; Hazard Ratio = 1.62 ; 95 % Confidence Interval : 0.82-3 .18 ; p = 0.16 ) .


No significant differences were found in secondary outcomes .


Sample size might not have been large enough .


SCP did not show beneficial effect on depression/anxiety prevention compared with CAU in Hong Kong primary care .


As a large majority of patients improved overtime without any intervention , we are not able to exclude the possibility that the intervention might be effective .


Future studies would need to have a larger sample size and conduct on patients with more severe symptoms or perform a second screening .


Compare the impact of two interventions , a web-based support and a folder support , for young persons who care for people who suffer from mental illness .


This study was a randomized control trial , following the CONSORT statements , which compared the impact of two interventions .


Primary outcome variable was stress , and secondary outcome variables were caring situation , general self-efficacy , well-being , health , and quality of life of young informal carers ( N = 241 ) .


Data were collected in June 2010 to April 2011 , with self-assessment questionnaires , comparing the two interventions and also to detect changes .


The stress levels were high in both groups at baseline , but decreased in the folder group .


The folder group had improvement in their caring situation ( also different from the web group ) , general self-efficacy , well-being , and quality of life .


The web group showed increase in well-being .


Young informal carers who take on the responsibility for people close to them ; suffer consequences on their own health .


They live in a life-situation characterized by high stress and low well-being .


This signals a need for support .


The non-significant differences show that each intervention can be effective , and that it depends upon the individual 's preferences .


This highlights the importance of adopting person-centered approach , in which young persons can themselves choose support strategy .


Hydroxyethyl starch ( HES ) is commonly used as plasma expander during surgery but may be nephrotoxic as seen in studies in patients with sepsis .


The authors hypothesized that the possible nephrotoxicity of 6 % HES 130/0 .4 could be revealed by measurements of urinary excretion of neutrophil gelatinase-associated lipocalin ( u-NGAL ) in patients with normal renal function during hip arthroplasty .


In this randomized , double-blinded , placebo-controlled study , 40 patients referred for hip arthroplasty received either 6 % HES 130/0 .4 or isotonic saline 0.9 % ; 7.5 ml/kg during the first hour of surgery and 5 ml/kg during the following hours ; 38 patients completed the study .


U-NGAL , urine albumin , blood pressure , and plasma concentrations of creatinine , renin , NGAL , albumin , angiotensin-II , and aldosterone were measured before , during , and after surgery .


U-NGAL was defined as primary outcome .


There were no significant differences in U-NGAL ( mean difference and 95 % CI ) , plasma creatinine , and urine albumin during the study .


U-NGAL and urine albumin increased significantly in both groups the morning after surgery but was normalized at follow-up after 10 to 12 days .


Mean arterial pressure was significantly higher during the recovery period in the HES group compared with that in the control group ( 91 [ 13 ] and 83 [ 6 ] mmHg , mean [ SD ] , P < 0.03 ) .


Plasma renin and angiotensin-II were nonsignificantly different in both groups , whereas plasma aldosterone was significantly lower in the HES group .


Plasma albumin was reduced in both groups , but to a significantly lower level in the HES group .


The study showed no evidence of a harmful effect of intraoperative infusion of 6 % HES 130/0 .4 on renal function in patients during hip arthroplasty .


We performed a multicentre randomised controlled trial to evaluate the effect on participation in organised screening programmes of a self-sampling device mailed home or picked up at a pharmacy compared with the standard recall letter .


Women aged 30-64 non-responding to screening invitation were eligible .


Response rate to first invitation ranged from 30 % to 60 % between centres .


The control was the standard reminder letter to undergo the test used by the programme ( Pap test in three centres and HPV DNA test in three other centres ) .


Home mailing of the self-sampler was preceded by a letter with a leaflet about HPV .


The analysis was intention-to-treat .


In all , 14041 women were randomised and recruited : 5012 in the control arm , 4516 to receive the self-sampler at home , and 4513 to pick up the self-sampler at a pharmacy .


Participation was 11.9 % in the control , 21.6 % ( relative participation : 1.75 ; 95 % CI 1.60-1 .93 ) in home , and 12.0 % ( relative participation : 0.96 ; 95 % CI 0.86-1 .07 ) in the pharmacy arms , respectively .


The heterogeneity between centres was high ( excess heterogeneity of that expected due to chance , i.e. , I ( 2 ) , 94.9 % and 94.1 % for home and pharmacy arm , respectively ) .


The estimated impact on the overall coverage was +4.3 % for home mail self-sampling compared with +2.2 % for standard reminder .


Home mailing of self-sampler proved to be an effective way to increase participation in screening programmes , even in those with HPV as primary testing .


Picking up at pharmacies showed effects varying from centre to centre .


Excessive menstrual bleeding , the most common complication caused by intrauterine devices ( IUDs ) , often leads to discontinuation of use .


Our study investigates the effect of vitamin B1 on menstrual bleeding and spotting after insertion of the TCu380A IUD .


This double-blind , randomised controlled trial involved 110 Iranian women .


We recruited women who noted that their menstrual flow ( duration , amount , and number of sanitary pads needed ) or intermenstrual spotting had increased one month after the insertion of a TCu380A , and randomly assigned them to two groups .


The intervention group and the control group received 100 mg of vitamin B1 or a placebo , respectively , daily , for three months .


We followed all participants for four months .


The Higham scale was used for estimating the volume of menstrual bleeding .


The Mann-Whitney test , paired t-test , independent t-test and Repeated Measure test were used for statistical purposes .


In the intervention group the duration of menstrual bleeding , the number of sanitary pads and the amount of spotting decreased significantly compared to the control group ( p < 0.001 ) .


Vitamin B1 is a safe , natural and cost-effective supplement that is devoid of side effects and reduces menstrual bleeding and spotting caused by a copper bearing-IUD .


The RITUXVAS trial reported similar remission induction rates and safety between rituximab and cyclophosphamide based regimens for antineutrophil cytoplasm antibody ( ANCA ) - associated vasculitis at 12months ; however , immunosuppression maintenance requirements and longer-term outcomes after rituximab in ANCA-associated renal vasculitis are unknown .


Forty-four patients with newly diagnosed ANCA-associated vasculitis and renal involvement were randomised , 3:1 , to glucocorticoids plus either rituximab ( 375mg/m ( 2 ) / week4 ) with two intravenous cyclophosphamide pulses ( n = 33 , rituximab group ) , or intravenous cyclophosphamide for 3-6months followed by azathioprine ( n = 11 , control group ) .


The primary end point at 24months was a composite of death , end-stage renal disease and relapse , which occurred in 14/33 in the rituximab group ( 42 % ) and 4/11 in the control group ( 36 % ) ( p = 1.00 ) .


After remission induction treatment all patients in the rituximab group achieved complete B cell depletion and during subsequent follow-up , 23/33 ( 70 % ) had B cell return .


Relapses occurred in seven in the rituximab group ( 21 % ) and two in the control group ( 18 % ) ( p = 1.00 ) .


All relapses in the rituximab group occurred after B cell return .


At 24months , rates of the composite outcome of death , end-stage renal disease and relapse did not differ between groups .


In the rituximab group , B cell return was associated with relapse .


ISRCTN28528813 .


Physical activity is a common stimulus of asthmatic symptoms manifestation .


Airway hyperreactivity is a predisposing cause of exercise induced bronchial obstruction , diagnosed by histamine inhalation .


The aim of this study was to determine the relation between the amounts of histamine needed to induce non-specific airway hyperreactivity and exercise-induced bronchial obstruction .


This randomized cross-over study included 160 male patients ( age 19-27 years ) suffering from bronchial asthma who showed positive results as the reaction after the histamine bronchial provocation test .


Histamine concentrations were in a range of 0.03 to 4 mg/mL .


Each patient participated in the exercise stress test conducted on a conveyor belt .


The results of the exercise stress test were considered positive if the FEV1 level dropped by at least 15 % from its initial value , 5-10 minutes after the test .


All the patients showed positive results as the reaction after the histamine bronchial provocation test , while 50 of them showed positive results after the exercise-induced stress test .


There was a statistically highly significant difference in administrated histamine concentrations between the group of patients that had positive results on exercise stress test and those who did not ( 1 mg/mL vs 0.5 mg/mL ; U = 1678 ; p < 0.01 ) .


Also , there was a statistically significant difference concerning the frequency of the positive results regarding histamine concentration after induced stress test ( chi2 = 10.885 ; p = 0.001 ) .


Among the patients with positive results , there was a statistically highly significant number of patients with bronchial obstruction induced by less than 2 mg/mL of histamine ( p < 0.01 ) .


A statistically significant relation between the amount of histamine needed to induce bronchial obstruction and the results of the exercise stress test ( p < 0.01 ) was also observed after the testing .


In the group of patients with positive results after the exercise-induced stress test , there were significantly more patients with positive results to non-specific bronchial provocation test with lower histamine concentrations .


Histamine concentrations needed to induce non-specific hyperreactivity of asthmatic airway were shown to be related to the reactivity to physical effort .


The question of whether the placement of the dominant hand against the sternum could improve the quality of manual chest compressions remains controversial .


In the present study , we evaluated the influence of dominant vs nondominant hand positioning on the quality of conventional cardiopulmonary resuscitation ( CPR ) during prolonged basic life support ( BLS ) by rescuers who performed optimal and suboptimal compressions .


Six months after completing a standard BLS training course , 101 medical students were instructed to perform adult single-rescuer BLS for 8 minutes on a manikin with a randomized hand position .


Twenty-four hours later , the students placed the opposite hand in contact with the sternum while performing CPR .


Those with an average compression depth of less than 50 mm were considered suboptimal .


Participants who had performed suboptimal compressions were significantly shorter ( 170.2 6.8 vs 174.0 5.6 cm , P = .008 ) and lighter ( 58.9 7.6 vs 66.9 9.6 kg , P < .001 ) than those who performed optimal compressions .


No significant differences in CPR quality were observed between dominant and nondominant hand placements for these who had an average compression depth of greater than 50 mm .


However , both the compression depth ( 49.7 4.2 vs 46.5 4.1 mm , P = .003 ) and proportion of chest compressions with an appropriate depth ( 47.6 % 27.8 % vs 28.0 % 23.4 % , P = .006 ) were remarkably higher when compressing the chest with the dominant hand against the sternum for those who performed suboptimal CPR .


Chest compression quality significantly improved when the dominant hand was placed against the sternum for those who performed suboptimal compressions during conventional CPR .


To investigate whether cabergoline ( Cb2 ) , a dopamine agonist , reduces ovarian hyperstimulation syndrome ( OHSS ) in high-risk women undergoing assisted reproductive technology ( ART ) , and to analyze whether cabergoline affects the outcome of ART .


Forty infertile women at risk of developing OHSS were enrolled in the trial .


The inclusion criteria were as follows : infertile women undergoing IVF with serum estradiol concentration > 4,000 pg/mL or with > 20 follicles > 12 mm on the day of human chorionic gonadotropin ( hCG ) administration , and 18-40 years of age .


They were randomized into 2 groups : the Cb2 group ( n = 20 ) received 0.5 mg oral Cb2 per day for 8 consecutive days beginning on the day of hCG , and the control group ( n = 20 ) received no medication .


Ascites was significantly lower ( p = 0.008 ) in the Cb2 group as compared with the control group .


The incidence of moderate OHSS was also significantly lower ( p = 0.04 ) in the Cb2 as compared to the control group .


There was no evidence of statistically significant differences regarding the parameters of ART outcome .


Our data supports the use of Cb2 in the management of high-risk women undergoing ART and , consequently , achieving lowered risk of OHSS , with no deleterious impact on ART outcomes .


The use of peripherally inserted central venous catheters ( PICC lines ) has reduced the mortality and morbidity of premature newborns .


The usual sites of insertion are the veins in the upper arms but other locations are being used as well .


To examine whether using the axillary vein as a site of insertion of a PICC line affects the frequency of complications .


Our study has a clinical trial design .


A total of 62 neonates that had a PICC line inserted were recruited and randomly divided equally in two groups : in Group A ( mean birth weight , standard deviation ( s.d. ) = 1353 ( 142 ) g ) , the PICC line was inserted through the axillary vein , and in Group B ( birth weight = 1308 ( 112 ) g ) , the PICC line was inserted in other sites further from the axillary vein .


The outcomes measured were the total PICC line-related complications , the reason for removing the catheter , the number of total attempts until successful insertion and the mean duration of stay of the catheter .


The likelihood of having an adverse outcome was assessed with Mantel-Haenszel odds ratio ( OR ) .


Premature neonates with axillary PICC lines were 12 times less likely to have line-related complications ( inflammation , blockage , edema , infection ) as compared with any other site of insertion ( OR = 95 % , confidence interval ( CI ) = 0.10 ( 0.01 to 0.8 ) ) and they were seven times more likely to have the PICC line removed because they achieved full enteral nutrition as compared with the other causes ( OR 95 % , confidence interval ( CI ) = 10.35 ( 4.88 to 21.96 ) ) .


There was no statistical difference between the two groups in the number of attempts until successful PICC line insertion ( P = 0.667 ) and the mean duration of stay of the PICC line ( P = 0.97 ) .


The use of the axillary vein as a site of insertion of a PICC line was correlated with significantly less complications in premature newborns as opposed to the other sites of insertion .


Human equilibrative nucleoside transporter 1 ( hENT1 ) levels in pancreatic adenocarcinoma may predict survival in patients who receive adjuvant gemcitabine after resection .


Microarrays from 434 patients randomized to chemotherapy in the ESPAC-3 trial ( plus controls from ESPAC-1 / 3 ) were stained with the 10D7G2 anti-hENT1 antibody .


Patients were classified as having high hENT1 expression if the mean H score for their cores was above the overall median H score ( 48 ) .


High and low hENT1-expressing groups were compared using Kaplan-Meier curves , log-rank tests , and Cox proportional hazards models .


All statistical tests were two-sided .


Three hundred eighty patients ( 87.6 % ) and 1808 cores were suitable and included in the final analysis .


Median overall survival for gemcitabine-treated patients ( n = 176 ) was 23.4 ( 95 % confidence interval [ CI ] = 18.3 to 26.0 ) months vs 23.5 ( 95 % CI = 19.8 to 27.3 ) months for 176 patients treated with 5-fluorouracil/folinic acid ( ( 2 ) 1 = 0.24 ; P = .62 ) .


Median survival for patients treated with gemcitabine was 17.1 ( 95 % CI = 14.3 to 23.8 ) months for those with low hENT1 expression vs 26.2 ( 95 % CI = 21.2 to 31.4 ) months for those with high hENT1 expression ( ( 2 ) = 9.87 ; P = .002 ) .


For the 5-fluorouracil group , median survival was 25.6 ( 95 % CI = 20.1 to 27.9 ) and 21.9 ( 95 % CI = 16.0 to 28.3 ) months for those with low and high hENT1 expression , respectively ( ( 2 ) = 0.83 ; P = .36 ) .


hENT1 levels were not predictive of survival for the 28 patients of the observation group ( ( 2 ) = 0.37 ; P = .54 ) .


Multivariable analysis confirmed hENT1 expression as a predictive marker in gemcitabine-treated ( Wald ( 2 ) = 9.16 ; P = .003 ) but not 5-fluorouracil-treated ( Wald ( 2 ) = 1.22 ; P = .27 ) patients .


Subject to prospective validation , gemcitabine should not be used for patients with low tumor hENT1 expression .


To evaluate the clinical efficacy of a series of Tongfeng Granule ( TG ) in treating gouty arthritis patients in different stages .


Ninety primary gout patients were randomly assigned to two groups , the TCM treatment group ( 60 cases ) and the Western medicine control group ( 30 cases ) .


Huzhang Tongfeng Granule in combination of external application of Jinhuang Ointment were given to those in the TCM treatment group in the acute phase , and Yinlian Tongfeng Granule in the remission phase .


Diclofenac Sodium Sustained Release Capsule in combination of external application of Jinhuang Ointment were given to those in the Western medicine control group in the acute phase , and Benzbromarone in the remission phase .


All were treated for three months .


The severity integral of symptoms , effective time , effective rate in the acute phase , the recurrence rate , blood uric acid ( BUA ) , urine uric acid ( UUA ) , serum creatinine ( SCr ) , blood urea nitrogen ( BUN ) , triglyceride ( TG ) , total cholesterol ( TC ) , fasting plasma glucose ( FPG ) , and the incidence of adverse reactions were observed in the two groups during the course of treatment .


The severity integral of symptoms was lowered in the two groups when compared with a former time point ( P < 0.05 ) .


There was no statistical difference in markedly effective rate or the effective rate in the acute phase between the two groups ( P > 0.05 ) .


There was statistical difference in the difference of BUA or UUA between before and after treatment in the two groups ( P < 0.05 ) .


There was statistical difference in TG and SCr in the TCM group between after treatment and before treatment ( P < 0.05 ) .


There was statistical difference in TG and SCr in the two groups between after treatment and before treatment ( P < 0.05 ) .


The recurrence rate was 3.3 % in the TCM treatment group ( 2/60 ) , lower than that of the Western medicine control group ( 20 % , 6/30 , P < 0.05 ) .


A series of Tongfeng Granule could promote the excretion of UUA , reduce the BUA level in the intermission phase , and play a favorable role in the prevention of relapse .


Huzhang Tongfeng Granule could significantly improve inflammatory symptoms and signs of gouty arthritis patients in the acute phase .


National Surgical Adjuvant Breast and Bowel Project ( NSABP ) R-04 was a randomized controlled trial of neoadjuvant chemoradiotherapy in patients with resectable stage II-III rectal cancer .


We hypothesized that patients who underwent abdominoperineal resection ( APR ) would have a poorer quality of life than those who underwent sphincter-sparing surgery ( SSS ) .


To obtain patient-reported outcomes ( PROs ) we administered two symptom scales at baseline and 1 year postoperatively : the Functional Assessment of Cancer Therapy-Colorectal ( FACT-C ) and the European Organization for the Research and Treatment of Cancer module for patients with Colorectal Cancer Quality of Life Questionnaire ( EORTC QLQ-CR38 ) .


Scoring was stratified by nonrandomly assigned definitive surgery ( APR vs SSS ) .


Analyses controlled for baseline scores and stratification factors : age , sex , stage , intended surgery , and randomly assigned chemoradiotherapy .


Of 1,608 randomly assigned patients , 987 had data for planned analyses ; 62 % underwent SSS ; 38 % underwent APR. .


FACT-C total and subscale scores were not statistically different by surgery at 1 year .


For the EORTC QLQ-CR38 functional scales , APR patients reported worse body image ( 70.3 vs 77.0 , P = 0.0005 ) at 1 year than did SSS patients .


Males undergoing APR reported worse sexual enjoyment ( 43.7 vs 54.7 , P = 0.02 ) at 1 year than did those undergoing SSS .


For the EORTC QLQ-CR38 symptom scale scores , APR patients reported worse micturition symptoms than the SSS group at 1 year ( 26.9 vs 21.5 , P = 0.03 ) .


SSS patients reported worse gastrointestinal tract symptoms than did the APR patients ( 18.9 vs 15.2 , P < 0.0001 ) , as well as weight loss ( 10.1 vs 6.0 , P = 0.002 ) .


Symptoms and functional problems were detected at 1 year by EORTC QLQ-CR38 , reflecting different symptom profiles in patients who underwent APR than those who underwent SSS .


Information from these PROs may be useful in counseling patients anticipating surgery for rectal cancer .


Proximal humeral fractures are mainly associated with osteoporosis and are becoming more common with the aging of our society .


The best surgical approach for internal fixation of displaced proximal humeral fractures is still being debated .


In this prospective randomized study , we aimed to investigate whether the deltoid-split approach is superior to the deltopectoral approach with regard to ( 1 ) complication rate ; ( 2 ) shoulder function ( Constant score ) ; and ( 3 ) pain ( visual analog scale [ VAS ] ) for internal fixation of displaced humeral fractures with a polyaxial locking plate .


We randomized 120 patients with proximal humeral fractures to receive one of these two approaches ( 60 patients for each approach ) .


We prospectively documented demographic and perioperative data ( sex , age , fracture type , hospital stay , operation time , and fluoroscopy time ) as well as complications .


Followup examinations were conducted at 6 weeks , 6 months , and 12 months postoperatively , including radiological and clinical evaluations ( Constant score , activities of daily living , and pain [ VAS ] ) .


Baseline and perioperative data were comparable for both approaches .


The sample size was chosen to provide 80 % power , but it reached only 68 % as a result of the loss of followups to detect a 10-point difference on the Constant score , which we considered the minimum clinically important difference .


Complications or reoperations between the approaches were not different .


Eight patients in the deltoid-split group ( 14 % ) needed surgical revisions compared with seven patients in the deltopectoral group ( 13 % ; p = 1.00 ) .


Deltoid-split and deltopectoral approaches showed similar Constant scores 12 months postoperatively ( Deltoid-split 81 ; 95 % confidence interval [ CI ] , 74-87 versus deltopectoral 73 ; 95 % CI , 64-81 ; p = 0.13 ) , and there were no differences between the groups in terms of pain at 1 year ( deltoid-split 1.8 ; 95 % CI , 1.2-1 .4 versus deltopectoral 2.5 ; 95 % CI , 1.7-3 .2 ; p = 0.14 ) .


No learning-curve effects were noted ; fluoroscopy use during surgery and function and pain scores during followups were similar among the first 30 patients and the next 30 patients treated in each group .


The treatment of proximal humeral fractures with a polyaxial locking plate is reliable using both approaches .


For a definitive recommendation for one of these approaches , further studies with appropriate sample size are necessary .


Level II , therapeutic study .


See the Guidelines for Authors for a complete description of levels of evidence .


To assess whether chewing gum prevents postoperative ileus after laparotomy for benign gynecologic surgery .


A randomized study was conducted from December 1 , 2010 , to February 29 , 2012 .


Patients scheduled to undergo laparotomy were randomly assigned to receive chewing gum or routine care after surgery .


A chart review was performed to establish incidence of nausea and vomiting , use of antiemetics , cases of postoperative ileus ( 2 episodes of emesis of 100 mL or more , with abdominal distention and absence of bowel sounds ) , and time to discharge .


Inpatient surveys recorded the time to specific events .


A total of 109 patients were randomly assigned to receive chewing gum ( n = 51 ) or routine postoperative care ( n = 58 ) .


Fewer participants assigned to receive chewing gum than routine care experienced postoperative nausea ( 16 [ 31.4 % ] versus 29 [ 50.0 % ] ; P = 0.049 ) and postoperative ileus ( 0 vs. 5 [ 8.6 % ] ; P = 0.032 ) .


There were no differences in the need for postoperative antiemetics , episodes of postoperative vomiting , readmissions , repeat surgeries , time to first hunger , time to toleration of clear liquids , time to regular diet , time to first flatus , or time to discharge .


Chewing gum after laparotomy for gynecologic surgery is safe and lowers the incidence of postoperative ileus and nausea .


ClinicalTrials.gov : NCT01579175 .


Among patients without cardiovascular disease ( CVD ) and low 10-year CVD risk , the risks of gastrointestinal bleeding and hemorrhagic strokes associated with aspirin use outweigh any potential atheroprotective benefit .


According to the guidelines on primary prevention of CVD , aspirin use is considered appropriate only in patients with 10-year CVD risk 6 % and inappropriate in patients with 10-year CVD risk < 6 % .


The goal of this study was to examine the frequency and practice-level variation in inappropriate aspirin use for primary prevention in a large U.S. nationwide registry .


Within the National Cardiovascular Disease Registry 's Practice Innovation and Clinical Excellence registry , we assessed 68,808 unique patients receiving aspirin for primary prevention from 119 U.S. practices .


The frequency of inappropriate aspirin use was determined for primary prevention ( aspirin use in those with 10-year CVD risk < 6 % ) .


Using hierarchical regression models , the extent of practice-level variation using the median rate ratio ( MRR ) was assessed .


Inappropriate aspirin use frequency was 11.6 % ( 7,972 of 68,808 ) in the overall cohort .


There was significant practice-level variation in inappropriate use ( range 0 % to 71.8 % ; median 10.1 % ; interquartile range 6.4 % ) for practices ; adjusted MRR was 1.63 ( 95 % confidence interval [ CI ] : 1.47 to 1.77 ) .


Results remained consistent after excluding 21,052 women age 65 years ( inappropriate aspirin use 15.2 % ; median practice-level inappropriate aspirin use 13.8 % ; interquartile range 8.2 % ; adjusted MRR 1.61 [ 95 % CI : 1.46 to 1.75 ] ) and after excluding patients with diabetes ( inappropriate aspirin use 13.9 % ; median practice-level inappropriate aspirin use 12.4 % ; interquartile range 7.6 % ; adjusted MRR 1.55 [ 95 % CI : 1.41 to 1.67 ] ) .


More than 1 in 10 patients in this national registry were receiving inappropriate aspirin therapy for primary prevention , with significant practice-level variations .


Our findings suggest that there are important opportunities to improve evidence-based aspirin use for the primary prevention of CVD .


Combining bronchodilators with different mechanisms of action may improve efficacy and reduce risk of side effects compared to increasing the dose of a single agent in chronic obstructive pulmonary disease ( COPD ) .


We investigated this by combining two long-acting bronchodilators : once-daily muscarinic antagonist tiotropium and once-daily 2-agonist olodaterol .


Two replicate , double-blind , randomized , 12-week studies ( ANHELTO 1 [ NCT01694771 ] and ANHELTO 2 [ NCT01696058 ] ) evaluated the efficacy and safety of olodaterol 5 g once daily ( via Respimat ( ) ) combined with tiotropium 18 g once daily ( via HandiHaler ( ) ) versus tiotropium 18 g once daily ( via HandiHaler ( ) ) combined with placebo ( via Respimat ( ) ) in patients with moderate to severe COPD .


Primary efficacy end points were area under the curve from 0-3 hours of forced expiratory volume in 1 second ( FEV1 AUC0-3 ) and trough FEV1 after 12 weeks ( for the individual trials ) .


A key secondary end point was health status by St George 's Respiratory Questionnaire ( SGRQ ) total score ( combined data set ) .


Olodaterol + tiotropium resulted in significant improvements over tiotropium + placebo in FEV1 AUC0-3 ( treatment differences : 0.117 L [ P < 0.001 ] , ANHELTO 1 ; 0.106 L [ P < 0.001 ] , ANHELTO 2 ) and trough FEV1 ( treatment differences : 0.062 L [ P < 0.001 ] , ANHELTO 1 ; 0.040 L [ P = 0.0029 ] , ANHELTO 2 ) ; these were supported by secondary end points .


These effects translated to improvements in SGRQ total scores ( treatment difference -1.85 ; P < 0.0001 ) .


The tolerability profile of olodaterol + tiotropium was similar to tiotropium monotherapy .


These studies demonstrated that olodaterol ( Respimat ( ) ) and tiotropium ( HandiHaler ( ) ) provided bronchodilatory effects above tiotropium alone in patients with COPD .


In general , both treatments were well tolerated .


To compare surgical outcomes of volar locking plates ( VP ) and external fixation ( EF ) ( with or without intra-focal fixation ) for AO-type C2 and C3 fractures of the distal radius .


From an initial group of 92 patients with AO-type C2 and C3 distal radius fractures who were enrolled in a prospective , randomized study comparing volar plate fixation with external fixation ( with or without intra-focal fixation ) , 74 patients were studied .


The researchers evaluated functional assessments ( wrist range of motion , grip strength , and Michigan Hand Questionnaire ) at each patient visit and measured radiographic assessment ( radial inclination , volar tilt , ulnar variance , and articular congruity ) at 12 months .


The grip strength of the VP group was significantly greater than that of the EF group at 3 and 6 months .


The range of motion was significantly greater in the VP group than in the EF group at 3 months .


There were no significant differences in the range of motion and grip strength between the 2 groups at 12 months .


The Michigan Hand Questionnaire score was higher in the VP group than in the EF group at 3 months but was same at 12 months .


There was no significant difference between groups with respect to volar tilt or radial inclination .


The VP group showed superior radiologic outcomes in terms of the ulnar variance .


One patient in the VP group and 3 in the EF group had an intra-articular stepoff deformity greater than 2 mm .


This difference did not reach statistical significance .


These results for functional recovery after distal radius surgery offer insight into treatment decisions and interpretations of treatment outcomes for patients with comminuted intra-articular distal radius fractures .


Currently , antiangiogenic strategies in metastatic breast cancer have demonstrated modest improvements in progression-free survival ( PFS ) but not improved quality or duration of survival , warranting evaluation of new agents in a placebo-controlled setting .


Ramucirumab is a human immunoglobulin G1 antibody that binds vascular endothelial growth factor receptor-2 and blocks ligand-stimulated activation .


The ROSE/TRIO -012 trial evaluated ramucirumab with docetaxel in unresectable , locally recurrent , or metastatic breast cancer .


In this double-blind , placebo-controlled , randomized , multinational phase III trial , 1,144 patients with human epidermal growth factor receptor 2 ( HER2 ) - negative breast cancer who had not received cytotoxic chemotherapy in the advanced setting were randomly assigned at a two-to-one ratio to receive docetaxel 75 mg/m ( 2 ) plus ramucirumab 10 mg/kg or docetaxel 75 mg/m ( 2 ) plus placebo once every 3 weeks .


Treatment continued until disease progression , unacceptable toxicity , or other withdrawal criteria .


Patients were stratified by previous taxane therapy , visceral metastasis , hormone receptor status , and geographic region .


An independent data monitoring committee oversaw the trial .


The primary end point was investigator-assessed PFS .


Median PFS in patients treated with ramucirumab plus docetaxel was 9.5 months , compared with 8.2 months in patients who received placebo plus docetaxel ( hazard ratio [ HR ] , 0.88 ; P = .077 ) .


Median overall survival was 27.3 months in patients who received ramucirumab plus docetaxel , compared with 27.2 months in patients who received placebo plus docetaxel ( HR , 1.01 ; P = .915 ) .


Toxicities seen at significantly higher rates in patients receiving ramucirumab included fatigue , hypertension , febrile neutropenia , palmar-plantar erythrodysesthesia syndrome , and stomatitis .


Addition of ramucirumab to docetaxel in HER2-negative advanced breast cancer did not meaningfully improve important clinical outcomes .


The Focused Abdominal Sonography in Trauma ( FAST ) scan is used to detect free fluid in the peritoneal cavity , or pericardium , to quickly assess for injuries needing immediate surgical intervention .


Mass-casualty incidents ( MCIs ) are settings where paramedics must make triage decisions in minutes .


The Simple Triage and Rapid Transport ( START ) system is used to prioritize transport .


The FAST scan can be added to the triage of critical patients , and may aid in triage .


This was a single-blinded , randomized control trial .


Ten paramedics with field experience were trained with an ultrasound machine in the performance of the FAST scan .


Two weeks were allowed to pass before testing to simulate the time between training of standard procedures and their implementation .


On test day , five peritoneal dialysis patients with instilled dialysis fluid and five matched control patients were placed in a room in a random order where the paramedics performed FAST scans on each patient .


The paramedics were assessed by declaring positive or negative for each evaluation , as well as being timed for the total exercise .


Of the ninety tests ( one paramedic dropped out due to family emergency ) , the paramedics had a mean accuracy of 60 % and median of 62 % ( range 40 % -80 % ) .


There was a statistically significant higher false-positive rate of 59 % than false-negative rate of 41 % ( P < .01 ) .


Sensitivity was 67 % with a specificity of 56 % .


Average time taken was 1,218 seconds ( 121.8 seconds per patient ) with a range of 735-1 ,701 seconds and a median of 1,108 seconds .


In this simulation study , paramedics had difficulty performing FAST scans with a high degree of accuracy .


However , they were more apt to call a patient positive , limiting the likelihood for false-negative triage .


To investigate the role of Platelet Activating Factor ( PAF ) in the pathogenesis and development of Age-Related Macular Degeneration ( ARMD ) .


Fifty six patients with ARMD ( 24 patients with dry ARMD and 32 patients with wet ARMD ) and 25 age-matched control participants underwent ophthalmological examination , including visual acuity measurement and evaluation of the retina .


The participants were classified into three groups according to their retinal status , based on indirect fundoscopy , Optical Coherence Tomography and fluorescein angiography findings .


In order to evaluate the concentrations of PAF in serum , blood samples were collected from all participants and were analyzed with ELISA technique .


The concentrations of PAF differed significantly according to macular lesions and were found to be lower in patients with ARMD than control participants .


PAF levels are decreased along with the severity of ARMD .


Understanding the role of PAF in pathogenesis of ARMD could be the impetus for the development of new therapies field of treatment of ARMD or even other retinal diseases .


In a previous UK multi-center randomized study 278 children received three doses of 7-valent ( PCV-7 ) or 13-valent ( PCV-13 ) pneumococcal conjugate vaccine at 2 , 4 and 12 months of age .


At 13 months of age , most of these children had pneumococcal serotype-specific IgG concentrations 0.35 g/ml and opsonophagocytic assay ( OPA ) titers 8 .


Children who had participated in the original study were enrolled again at 3.5 years of age .


Persistence of immunity following infant immunization with either PCV-7 or PCV-13 and the immune response to a PCV-13 booster at pre-school age were investigated .


In total , 108 children were followed-up to the age of 3.5 years and received a PCV-13 booster at this age .


At least 76 % of children who received PCV-7 or PCV-13 in infancy retained serotype-specific IgG concentrations 0.35 g/ml against each of 5/7 shared serotypes .


For serotypes 4 and 18C , persistence was lower at 22-42 % .


At least 71 % of PCV-13 group participants had IgG concentrations 0.35 g/ml against each of 4/6 of the additional PCV-13 serotypes ; for serotypes 1 and 3 this proportion was 45 % and 52 % .


In the PCV-7 group these percentages were significantly lower for serotypes 1 , 5 and 7F .


A pre-school PCV-13 booster was highly immunogenic and resulted in low rates of local and systemic adverse effects .


Despite some decline in antibody from 13 months of age , these data suggest that a majority of pre-school children maintain protective serotype-specific antibody concentrations following conjugate vaccination at 2 , 4 and 12 months of age .


ClinicalTrials.gov NCT01095471 .


Asymmetric movements with both hands contributed to the improvement of spatially coupled motion .


Thus , the aim of this study was to investigate the effects of an asymmetric training program using virtual reality reflection equipment on upper limb function in stroke patients .


Twenty-four stroke patients were randomly allocated to an experimental group ( n = 12 ) or a control group ( n = 12 ) .


Both groups participated in conventional physical therapy for 230 min/d , 5 d/wk , for 4 weeks .


The experimental group also participated in an asymmetric training program using virtual reality reflection equipment , and the control group participated in a symmetric training program .


Both asymmetric and symmetric programs were conducted for 30 min/d , 5 d/wk , for 4 weeks .


To compare upper limb function before and after intervention , the Fugl-Meyer Assessment ( FMA ) , the Box and Block Test ( BBT ) , grip strength , range of motion ( ROM ) , and spasticity were assessed .


Both groups showed significant increases in upper limb function , excepting spasticity , after intervention ( P < .05 , 1-way repeated-measures analysis of variance [ ANOVA ] ) .


A significant group-time interaction was demonstrated only for shoulder/elbow/wrist items of FMA , BBT , grip strength , and ROM of wrist flexion , extension , and ulnar deviation ( P < .05 , 2-way repeated-measures ANOVA ) .


This study confirms that the asymmetric training program using virtual reality reflection equipment is an effective intervention method for improving upper limb function in stroke patients .


We consider that an additional study based on a program using virtual reflection , which is more functional than performing simple tasks , and consisting of tasks relevant to the activities of daily living be conducted .


We aimed to evaluate the clinical efficacy of ciprofloxacin plus fluocinolone acetonide ( antibiotic plus corticosteroid ) ear drops compared to ciprofloxacin ( antibiotic ) ear drops in diffuse otitis externa .


This was a multicentre , randomised , parallel-group , double-blind study involving 590 patients of both sexes aged 7years or older .


The rate of clinical cure was higher ( p = 0.01 ) with ciprofloxacin plus fluocinolone acetonide than with ciprofloxacin alone .


The mean total symptom score was lower with ciprofloxacin plus fluocinolone acetonide ( p = 0.005 ) .


No differences were found in the percentage of patients reporting resolution of otalgia between patients receiving ciprofloxacin plus fluocinolone acetonide and patients receiving only ciprofloxacin .


Resolution of oedema and otorrhoea ( p = 0.003 and p = 0.002 , respectively ) was higher with ciprofloxacin plus fluocinolone acetonide , as was eradication or presumed eradication ( p = 0.003 ) .


There were eight mild adverse events , three with the ciprofloxacin plus fluocinolone acetonide combination ( not related to the treatment ) and five when ciprofloxacin was administered alone ( directly related to the treatment ) .


Ciprofloxacin plus fluocinolone acetonide is a more effective treatment for diffuse otitis externa than ciprofloxacin alone .


The ciprofloxacin plus fluocinolone acetonide combination also has an excellent safety profile .


Prophylactic use of fresh-frozen plasma ( FFP ) is common practice in patients with a coagulopathy undergoing an invasive procedure .


Evidence that FFP prevents bleeding is lacking , while risks of transfusion-related morbidity after FFP have been well demonstrated .


We aimed to assess whether omitting prophylactic FFP transfusion in nonbleeding critically ill patients with a coagulopathy who undergo an intervention is noninferior to a prophylactic transfusion of FFP .


A multicenter randomized open-label trial with blinded endpoint evaluation was performed in critically ill patients with a prolonged international normalized ratio ( INR ; 1.5-3 .0 ) .


Patients undergoing placement of a central venous catheter , percutaneous tracheostomy , chest tube , or abscess drainage were eligible .


Patients with clinically overt bleeding , thrombocytopenia , or therapeutic use of anticoagulants were excluded .


Patients were randomly assigned to omitting or administering a prophylactic transfusion of FFP ( 12mL/kg ) .


Outcomes were occurrence of postprocedural bleeding complications , INR correction , and occurrence of lung injury .


Due to slow inclusion , the trial was stopped before the predefined target enrollment was reached .


Eighty-one patients were randomly assigned , 40 to FFP and 41 to no FFP transfusion .


Incidence of bleeding did not differ between groups , with a total of one major and 13 minor bleedings ( p = 0.08 for noninferiority ) .


FFP transfusion resulted in a reduction of INR to less than 1.5 in 54 % of transfused patients .


No differences in lung injury scores were observed .


In critically ill patients undergoing an invasive procedure , no difference in bleeding complications was found regardless whether FFP was prophylactically administered or not .


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


These symptoms often persist despite bacterial eradication .


The purpose of this article is to exam the role of phytotherapeutic agents as complementary treatment in patients with bacterial prostatitis .


The material consisted of individuals with reported pelvic discomfort and genital pain with or without lower urinary tract symptoms ( LUTS ) and sexual dysfunction visiting our department from March 2009 to March 2011 .


Patients underwent Stamey-Meares test ( several cases underwent the two glass test ) .


Depending on history and specific symptoms urethral smear and semen cultures were additionally obtained from several patients .


All patients were randomized into two groups .


Subjects in the first group ( 72 patients ) received appropriate antibiotic ( according to the sensitivity test ) for 15 days , while subjects in the second group ( 72 patients ) received phytotherapeutic agents for 30 days , additionally the conventional 15 days antibiotic treatment .


The response was tested using laboratory and clinical criteria .


We found no statistically significant differences between the two groups regarding bacterial and symptom persistence rate , however , symptoms burden was lower in patients receiving combinational treatment .


Phytotherapeutic agents may improve pain and prostatitis related difficulty in urination .


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


To observe the effect and safety of Xiaozhi particles , integrated taohong Siwu tang and Erchen tang and Xuezhikang capsule in treating hyperlipidaemia ( HLP ) associated with highly active antiretroviral therapy ( HAART ) .


In the multi-centered , randomized controlled clinical study , 180 hyperlipidaemia associated with highly active antiretroviral therapy cases were divided into the treatment group treated by Xiaozhi particles , integrated Taohong Siwu tang and Erchen tang , and the control group treated by Xuezhikang capsule .


The treatment course was 12 weeks .


The total cholesterol ( Tch ) , triglyceride ( TG ) , low density lipoprotein ( LDL ) and high-density lipoprotein ( HDL ) were observed .


After 12 weeks , compared with Xuezhikang capsule , the change difference of Tch , LDL , HDL in the Chinese traditional medicine formula groups of patients is significant ( P < 0.05 ) , the change of the TG has no significant difference .


The effect of Tch , LDL in Xuezhikang capsule groups is better than in traditional Chinese medicine formula group , but the effect of HDL in traditional Chinese medicine formula group is better than in Xuezhikang capsule groups .


Integrated Taohong Siwu tang and Erchen tang , Xiaozhi particles and Xuezhikang capsule can be used to control the hyperlipidaemia associated with highly active antiretroviral therapy as one of the main Chinese native medicine preparation .


Primary care is an ideal setting to treat pediatric obesity .


Effective , low-intensity ( 25 contact hours over 6 months ) interventions that reduce standardized body mass index ( z-BMI ) and can be delivered by primary care providers are needed .


This pilot randomized controlled trial investigated the effect of 3 low-intensity ( 25 contact hours over 6 months ) pediatric obesity treatments on z-BMI .


Twenty-two families ( children 8.0 1.8 years , z-BMI of 2.34 0.48 ) were randomized into 1 of 3 , 6-month , low-intensity conditions : newsletter ( N ) , newsletter and growth monitoring ( N + GM ) , or newsletter and growth monitoring plus family-based behavioral counseling ( N + GM + BC ) .


Anthropometrics and child eating and leisure-time behaviors were measured .


Mixed-factor analyses of variance found a significant ( P < .05 ) main effect of time for z-BMI and servings per day of sugar sweetened beverages , with both decreasing over time .


Low-intensity obesity treatments can reduce z-BMI and may be more feasible in primary care .


To evaluate the efficacy of low-level laser therapy ( LLLT ) applied to acupuncture points on the knee joint in combination with exercise and advice in patients with knee osteoarthritis .


Randomised , double-blind , comparative clinical trial .


Forty-nine patients with knee osteoarthritis were assigned at random into two groups : active laser group ( n = 26 ) and placebo laser group ( n = 23 ) .


Using a gallium aluminium arsenide laser device , patients received either active or placebo LLLT at five acupuncture points on the affected knee during nine sessions .


Patients were assessed using a visual analogue scale ( VAS ) and the Saudi Knee Function Scale ( SKFS ) at baseline , the fifth treatment session , the last treatment session , 6 weeks post intervention and 6 months post intervention .


VAS scores showed a significant improvement in the active laser group compared with the placebo laser group at 6 weeks post intervention [ mean difference -1.3 , 95 % confidence interval ( CI ) of the difference -2.4 to -0.3 ; P = 0.014 ] and 6 months post intervention ( mean difference -1.8 , 95 % CI of the difference -3.0 to -0.7 ; P = 0.003 ) using the independent samples test .


SKFS scores also showed a significant improvement in the active laser group compared with the placebo laser group at the last treatment session ( median difference -15 , 95 % CI of the difference -27 to -2 ; P = 0.035 ) and 6 months post intervention ( median difference -21 , 95 % CI of the difference -34 to -7 ; P = 0.006 ) using the Mann-Whitney U test .


The results demonstrate that short-term application of LLLT to specific acupuncture points in association with exercise and advice is effective in reducing pain and improving quality of life in patients with knee osteoarthritis .


Passive smoking is associated with tuberculosis ( TB ) .


Measures are required to protect non-smoking TB patients from second-hand smoke ( SHS ) .


We developed a behavioural intervention to encourage TB patients to implement smoking restrictions at home in Pakistan .


To assess the likelihood of such an intervention being successful and to inform a definitive trial in future .


This was a pilot randomised controlled trial in which non-smoking TB patients were randomised to receive either individual-based support or individual-based support combined with family reminders .


We recruited patients living with at least one smoker in their homes .


Our primary outcome was urinary cotinine level as a measure of SHS exposure 2 months post-randomisation .


Of 273 patients assessed for eligibility , 150 ( 56 % ) patients were recruited and all but one were retained throughout the trial .


A statistically significant absolute reduction was observed in non-smoking participants ' exposure to SHS based on urinary cotinine levels in both Arm 1 ( 71 % , 95 % CI 61-79 ) and Arm 2 ( 76 % , 95 % CI 67-83 ) between baseline and follow-up at 2 months .


The recruitment and retention rates for trial participants make it feasible to conduct a definitive trial in future .


The observed effect size makes it worthwhile to conduct such a trial .


In this study , we aimed to determine the effect of carbon dioxide laser irradiation on enamel surface microhardness .


In this single-blind interventional clinical trial , 16 patients needing at least 2 premolars extracted for orthodontic purposes participated .


In each subject , 1 premolar was treated with the carbon dioxide laser ( beam diameter , 0.2 mm ; power , 0.7 W ) ; the other was exposed to a visible guiding light as the control .


A t-loop was ligated to the bonded brackets to increase caries risk .


After at least 2 months , the teeth were extracted , and the surface microhardness was measured .


Scanning electron microscope evaluation was performed on 1 sample from each group .


Normal distribution of the data was assessed by the Kolmogorov-Smirnov and Shapiro-Wilks tests .


Mean microhardness values of the 2 groups were compared using paired t tests .


The data had normal distributions .


Means and standard deviations of the microhardness in the laser-treated and control groups were 301.81 94.29 and 183.9 72.08 Vickers hardness numbers , respectively ; this was different significantly ( P < 0.001 ) .


Scanning electron microscopy showed the enamel surface melting in the laser-treated specimens .


Carbon dioxide laser treatment results in higher enamel surface microhardness around orthodontic brackets .


Patients at high risk of caries might benefit from this intervention .


Exact control of the laser irradiation parameters is recommended .


Down syndrome ( DS ) is the most common human chromosomal abnormality .


It is characterized by mental retardation and several metabolic disturbances , including elevated oxidative stress , which may be causally linked .


Treatment with dietary antioxidants has been suggested as a potential method to alleviate the oxidative damage and retardation of DS patients , but prior supplementation work has been equivocal .


To evaluate the effects of supplementation with antioxidants - tocopherol and - lipoic acid ( ALA ) on oxidative stress biomarkers in DS children .


Ninety-three DS children aged 7-15 years from both sexes were randomly allocated to three groups : - tocopherol ( 400 IU/day ) , ALA ( 100mg/day ) and placebo .


The intervention period was 4 months .


A healthy control group consisted 26 non-DS siblings .


Serum thiobarbituric acid reactive substances ( TBARS ) and urinary 8-hydroxy-2 ' - deoxyguanosine ( 8OHdG ) were used as biomarkers of oxidative stress .


DS children had greater levels of baseline oxidative stress than their siblings .


Moreover , males had greater levels of 8OHdG than females ( P < 0.001 ) but there was no significant association between age and biomarkers of oxidative stress .


Serum levels of TBARS did not change significantly over time , or relative to placebo .


Although urinary 8OHdG concentrations decreased significantly in both - tocopherol and ALA , groups compared with the baseline levels ( P < 0.001 ) , mean final levels of urinary 8OHdG concentrations differed significantly only between - tocopherol and placebo groups ( P < 0.01 ) .


- Tocopherol supplementation of the diets of DS children may attenuate oxidative stress at the DNA level .


The only subgroups of patients with heart failure and atrial fibrillation in which the efficacy of cardiac resynchronization therapy has been scientifically proven are patients with indications for right ventricular pacing and patients after atrioventricular junction ablation .


However it is unlikely that atrioventricular junction ablation would be a standard procedure in the majority of the heart failure patients with cardiac resynchronization therapy and concomitant atrial fibrillation due to the irreversible character of the procedure and a spontaneous sinus rhythm resumption that occurs in about 10 % of these patients .


Pilot-CRAfT is the first randomized controlled trial evaluating the efficacy of a rhythm control strategy in atrial fibrillation patients with cardiac resynchronization therapy devices .


The aim of this prospective , single center randomized controlled pilot study is to answer the question whether the patients with cardiac resynchronization therapy and permanent atrial fibrillation would benefit from a strategy to restore and maintain sinus rhythm ( that is ` rhythm control ' strategy ) in comparison to rate control strategy .


The study population consists of 60 patients with heart failure and concomitant long-standing persistent or permanent atrial fibrillation who underwent a cardiac resynchronization therapy device implantation at least 3 months before qualification .


Study participants are randomly assigned to the rhythm control strategy ( including electrical cardioversion and pharmacotherapy ) or to the rate control group whose goal is to control ventricular rate .


The follow-up time is 12 months .


The primary endpoint is the ratio of effectively captured biventricular beats .


The secondary endpoints include peak oxygen consumption , six-minute walk test distance , heart failure symptom escalation , reverse remodelling of the heart on echo and quality of life .


NCT01850277 registered on 22 April 2013 ( ClinicalTrails.gov ) .


The American Heart Association has defined a new metric of ideal cardiovascular health as part of its 2020 Impact Goals .


We examined whether psychosocial factors in youth predict ideal cardiovascular health in adulthood .


Participants were 477 men and 612 women from the nationwide Cardiovascular Risk in Young Finns Study .


Psychosocial factors were measured from cohorts 3 to 18 years of age at the baseline of the study , and ideal cardiovascular health was examined 27 years later in adulthood .


The summary measure of psychosocial factors in youth comprised socioeconomic factors , emotional factors , parental health behaviors , stressful events , self-regulation of the child , and social adjustment of the child .


There was a positive association between a higher number of favorable psychosocial factors in youth and greater ideal cardiovascular health index in adulthood ( = 0.16 ; P < 0.001 ) that persisted after adjustment for age , sex , medication use , and cardiovascular risk factors in childhood ( = 0.15 ; P < 0.001 ) .


The association was monotonic , suggesting that each increment in favorable psychosocial factors was associated with improvement in cardiovascular health .


Of the specific psychosocial factors , a favorable socioeconomic environment ( = 0.12 ; P < 0.001 ) and participants ' self-regulatory behavior ( = 0.07 ; P = 0.004 ) were the strongest predictors of ideal cardiovascular health in adulthood .


The findings suggest a dose-response association between favorable psychosocial factors in youth and cardiovascular health in adulthood , as defined by the American Heart Association metrics .


The effect seems to persist throughout the range of cardiovascular health , potentially shifting the population distribution of cardiovascular health rather than simply having effects in a high-risk population .


Effects of depression treatment are obscured by heterogeneity among patients .


Personality types could be one source of heterogeneity that explains variability in treatment response .


Clinically meaningful variations in personality patterns could be captured with data-driven subgroups .


The aim of this study was to identify such personality types and to explore their predictive value for treatment efficacy .


Participants ( N = 146 ) in the current exploratory study came from a randomized controlled trial in primary care depressed patients , conducted between January 1998 and June 2003 , comparing different treatments .


All participants were diagnosed with a major depressive disorder ( MDD ) according to the DSM-IV .


Primary ( care as usual [ CAU ] or CAU plus a psychoeducational prevention program [ PEP ] ) and specialized ( CAU + PEP + psychiatric consultation or cognitive-behavioral therapy ) treatment were compared .


Personality was assessed with the Neuroticism-Extraversion-Openness Five-Factor Inventory ( NEO-FFI ) .


Personality classes were identified with latent profile analysis ( LPA ) .


During 1 year , weekly depression ratings were obtained by trimonthly assessment with the Composite International Diagnostic Interview .


Mixed models were used to analyze the effects of personality on treatment efficacy .


A 2-class LPA solution fit best to the NEO-FFI data : Class 1 ( vulnerable , n = 94 ) was characterized by high neuroticism , low extraversion , and low conscientiousness , and Class 2 ( resilient , n = 52 ) by medium neuroticism and extraversion and higher agreeableness and conscientiousness .


Recovery was quicker in the resilient class ( class time : P < .001 ) .


Importantly , specialized treatment had added value only in the vulnerable class , in which it was associated with quicker recovery than primary treatment ( class time treatment : P < .001 ) .


Personality profile may predict whether specialized clinical efforts have added value , showing potential implications for planning of treatments .


Selective laser trabeculoplasty ( SLT ) should be explored as a therapeutic option in eyes with angle closure .


To assess the intraocular pressure ( IOP ) - lowering efficacy of SLT in eyes with primary angle closure ( PAC ) and PAC glaucoma ( PACG ) .


Randomized clinical trial at tertiary eye care institutions of 100 patients diagnosed as having PAC or PAC glaucoma in which the angles had opened at least 180 ( visible posterior trabecular meshwork on gonioscopy ) after laser iridotomy .


Recruitment and baselinewere completed from June 2009 to April 2012 and 6-month follow-up was completed from December 2009 to November 2012 .


Eligible patients with a baseline IOP greater than 21 mm Hg were randomized to either SLT or prostaglandin analog ( PGA ; travoprost , 0.004 % ) .


The SLT was repeated if the IOP reduction was less than 20.0 % from baseline at the 1 - or 3-month follow-up visit .


The primary outcome measure was the change in IOP from baseline to the final follow-up visit ( at 6 months ) .


The frequency of additional postoperative treatments and complications were secondary outcomes .


Fifty patients ( 96 eyes ) were randomized to SLT and 50 patients ( 99 eyes ) to PGA medical therapy .


At 6 months , 49 patients in the SLT group and 47 in the PGA group completed follow-up .


Analysis was based on intent to treat .


At 6 months , IOP decreased by 4.0 mm Hg ( 95 % CI , 3.2-4 .8 ) in the SLT group ( P < .001 ) and by 4.2 mm Hg ( 95 % CI , 3.5-4 .9 ) in the PGA group ( P < .001 ) .


There were no differences between the SLT and PGA groups in the absolute mean reduction of IOP ( 4.0 vs 4.2 mm Hg , respectively ; P = .78 ) or in the percentage of reduction in IOP ( 16.9 % vs 18.5 % , respectively ; P = .52 ) .


Complete success ( IOP 21 mm Hg without medications ) was achieved in 60.0 % eyes of the SLT group , compared with 84.0 % of eyes in the PGA group ( P = .008 ) .


No patients required glaucoma surgery .


Additional medications were required in 22.0 % of patients in the SLT group compared with 8.0 % in the PGA group ( P = .05 ) .


One patient in the SLT group ( 2.0 % ) had a transient posttreatment IOP spike greater than 5 mm Hg .


The mean endothelial cell count showed a significant decrease from baseline in the SLT arm ( 4.8 % decrease ; P = .001 ) .


No other events such as persistent uveitis or increase in peripheral anterior synechiae were noted in eyes that underwent SLT .


Two patients in the PGA group exited owing to drug-related complications ( 1 patient with uveitis and 1 with allergic conjunctivitis ) .


Eyes with PAC or PACG respond to SLT in the short term , but the overall long-term therapeutic effectiveness needs further evaluation .


clinicaltrials.gov Identifier : NCT01004900 .


The antiseptic effectiveness of 5 % anerdian III , 0.016 % gentamicin , and 0.5 % tobramycin solutions in pre-surgical irrigation of conjunctival sac were compared .


A total of 295 cataract patients ( 302 eyes ) who had undergone phacoemulsification aspiration combined with intraocular lens insertion ( IOL ) were recruited in this prospective study .


Operative eyes were given 0.3 % levofloxacin eye drops for 3 days and then were randomized into three treatment groups : anerdian ( A ) , gentamicin ( B ) and tobramycin ( C ) .


The patients received conjunctival sac irrigation using the respective solutions at 10 minutes preoperatively .


Conjunctival sac sampling was performed before and after irrigation and the samples were used for subsequent bacterial culture and swab tests .


The positive culture rate was used as the main outcome .


The positive rates of bacterial culture before conjunctival sac irrigation were 17.31 % ( 18 eyes ) in group A , 13.86 % ( 14 eyes ) in group B and 17.3 % ( 14 eyes ) in group C. Post irrigation , the positive rates in the three groups decreased to 5.76 % ( 6 eyes ) , 5.94 % ( 6 eyes ) and 7.22 % ( 7 eyes ) , respectively .


The positive rates among the three groups did not differ significantly .


However , the positive rate in group A only significantly differed before and after the irrigation ( P < 0.05 ) .


No toxic or allergic reactions were observed on the ocular surface of any patient after irrigation .


The antiseptic effects of the three types of con junctival sac irrigations did not differ .


Observing or hearing about illness in another person can lead to reports of similar symptoms .


Reports can occasionally be widespread .


However , it has been difficult to document whether this is the result of genuine illness or the expression of anxiety with physical terminology .


This study examined the effects of being able to see another blood donor experience vasovagal symptoms .


Data were collected in mobile university blood collection clinics .


Bedside research assistants coded whether the donor was able or not able to see another donor being treated for vasovagal symptoms .


Dependent variables included subjective vasovagal symptoms indicated on the Blood Donation Reactions Inventory ( BDRI ) and the need for treatment oneself .


Given the population of inexperienced donors , many ( 26 % of the 1,209 participants ) were able to see another donor treated for symptoms .


Being able to see another donor treated was associated with higher scores on the BDRI and an increased likelihood of treatment for vasovagal symptoms oneself .


However , this was limited to non-first-time blood donors , perhaps because of higher levels in first-time donors ( ceiling effects ) or greater attention to the environment in less `` overwhelmed '' repeat donors .


In general , donors who were able to see another react rated themselves as less relaxed and had smaller increases in heart rate .


During the 2-year follow-up , first-time donors who were able to see another react were slower to return to give blood again .


Seeing another donor being treated for symptoms contributed to the vasovagal process in many donors .


This environment provides a useful context to study social influences on symptoms and illness .


Prostate cancer is a major public health problem with considerable uncertainties about the effectiveness of population screening and treatment options .


We report the study design , participant sociodemographic and clinical characteristics , and the initial results of the testing and diagnostic phase of the Prostate testing for cancer and Treatment ( ProtecT ) trial , which aims to investigate the effectiveness of treatments for localised prostate cancer .


In this randomised phase 3 trial , men aged 50-69 years registered at 337 primary care centres in nine UK cities were invited to attend a specialist nurse appointment for a serum prostate-specific antigen ( PSA ) test .


Prostate biopsies were offered to men with a PSA concentration of 30 g/L or higher .


Consenting participants with clinically localised prostate cancer were randomly assigned to active monitoring ( surveillance strategy ) , radical prostatectomy , or three-dimensional conformal external-beam radiotherapy by a computer-generated allocation system .


Randomisation was stratified by site ( minimised for differences in participant age , PSA results , and Gleason score ) .


The primary endpoint is prostate cancer mortality at a median 10-year follow-up , ascertained by an independent committee , which will be analysed by intention to treat in 2016 .


This trial is registered with ClinicalTrials.gov , number NCT02044172 , and as an International Standard Randomised Controlled Trial , number ISRCTN20141297 .


Between Oct 1 , 2001 , and Jan 20 , 2009 , 228,966 men were invited to attend an appointment with a specialist nurse .


Of the invited men , 100,444 ( 44 % ) attended their initial appointment and 82,429 ( 82 % ) of attenders had a PSA test .


PSA concentration was below the biopsy threshold in 73,538 ( 89 % ) men .


Of the 8566 men with a PSA concentration of 30-199 g/L , 7414 ( 87 % ) underwent biopsies .


2896 men were diagnosed with prostate cancer ( 4 % of tested men and 39 % of those who had a biopsy ) , of whom 2417 ( 83 % ) had clinically localised disease ( mostly T1c , Gleason score 6 ) .


With the addition of 247 pilot study participants recruited between 1999 and 2001 , 2664 men were eligible for the treatment trial and 1643 ( 62 % ) agreed to be randomly assigned ( 545 to active monitoring , 545 to radiotherapy , and 553 to radical prostatectomy ) .


Clinical and sociodemographic characteristics of randomly assigned participants were balanced across treatment groups .


The ProtecT trial randomly assigned 1643 men with localised prostate cancer to active monitoring , radiotherapy , or surgery .


Participant clinicopathological features are more consistent with contemporary patient characteristics than in previous prostate cancer treatment trials .


UK National Institute for Health Research Health Technology Assessment Programme .


We examined the therapeutic effects of avanafil 15 minutes after dosing in men with mild to severe erectile dysfunction .


This randomized , double-blind , placebo controlled , 12-week study ( 4-week run-in and 8-week treatment ) randomized 145 men to placebo , 147 to avanafil 100 mg and 148 to avanafil 200 mg on demand .


The primary efficacy variable was the per subject proportion of sexual attempts during the treatment period in which subjects achieved erection sufficient for vaginal penetration within approximately 15 minutes after dosing as measured by a stopwatch .


The attempt had to enable successful completion of sexual intercourse according to SEP question 3 .


Significantly greater mean per subject percentages of successful intercourse attempts within approximately 15 minutes after dosing were observed for avanafil 100 mg ( mean 25.9 % , LS mean SE 24.7 % 2.9 % ) and 200 mg ( mean 29.1 % , LS mean 28.2 % 2.9 % ) vs placebo ( mean 14.9 % , LS mean 13.8 % 2.9 % , p = 0.001 and < 0.001 , respectively ) .


After treatment we noted a statistically significant difference between avanafil and placebo in the average per subject proportion of successful intercourse attempts according to SEP question 3 as early as 10 minutes in the 200 mg group and 12 minutes in the 100 mg group .


Treatment emergent adverse events included headache , upper respiratory tract infection and nasal congestion , and most such events were mild or moderate in severity .


Avanafil was efficacious within approximately 15 minutes of dosing compared to placebo .


A statistically significant treatment difference in the percentage of successful sexual attempts was demonstrated as early as 10 minutes after treatment .


The objective of this study was to compare the efficacy and comfort of inelastic bandages ( IBs ) and adjustable Velcro compression devices ( AVCDs ) in reducing venous leg edema in the initial treatment phase .


Forty legs from 36 patients with untreated venous edema ( C3EpsAsdPr ) were randomized to two groups .


Patients in the first group received IBs ( n = 20 ) and those in the second AVCDs ( n = 20 ) .


Both compression devices were left on the leg day and night , and were renewed after 1 day .


Patients in the AVCD group were asked to re-adjust the device as needed when it felt loose .


Leg volume was calculated using the truncated cone formula at baseline ( T0 ) , after 1 day ( T1 ) and after 7 days ( T7 ) .


The interface pressure of the two compression devices was measured by an air filled probe , and the static stiffness index calculated after applying compression at T0 and T1 , and just before removal of compression on T1 and T7 .


Patient comfort with regard to the two compression systems was assessed by grading signs and symptoms using a visual analog scale .


At T1 , the median percent volume reduction was 13 % for the IB group versus 19 % for the AVCD group ; at T7 it was 19 % versus 26 % , respectively ( p < .001 ) .


The pressure of the IBs was significantly higher compared with the AVCDs at T0 ( 63 vs. 43 mmHg ) but dropped by > 50 % over time , while it remained unchanged with AVCDs owing to the periodic readjustment by the patient .


Comfort was reported to be similar with the two compression devices .


Re-adjustable AVCDs with a resting pressure of around 40 mmHg are more effective in reducing chronic venous edema than IBs with a resting pressure of around 60 mmHg .


AVCDs are effective and well tolerated , not only during maintenance therapy , but also in the initial decongestive treatment phase of patients with venous leg edema .


Gastroparesis is common in surgical patients and frequently leads to the need for enteral tube feeding .


Nasoenteral feeding tubes are usually placed endoscopically by gastroenterologists , but this procedure is relatively cumbersome for patients and labor-intensive for hospital staff .


Electromagnetic ( EM ) guided bedside placement of nasoenteral feeding tubes by nurses may reduce patient discomfort , workload and costs , but randomized studies are lacking , especially in surgical patients .


We hypothesize that EM guided bedside placement of nasoenteral feeding tubes is at least as effective as endoscopic placement in surgical patients , at lower costs .


The CORE trial is an investigator-initiated , parallel-group , pragmatic , multicenter randomized controlled non-inferiority trial .


A total of 154 patients admitted to gastrointestinal surgical wards in five hospitals , requiring nasoenteral feeding , will be randomly allocated to undergo EM guided or endoscopic nasoenteral feeding tube placement .


Primary outcome is reinsertion of the feeding tube , defined as the insertion of an endoscope or tube in the nose/mouth and esophagus for ( re ) placement of the feeding tube ( e.g. after failed initial placement or dislodgement or blockage of the tube ) .


Secondary outcomes include patient-reported outcomes , costs and tube ( placement ) related complications .


The CORE trial is designed to generate evidence on the effectiveness of EM guided placement of nasoenteral feeding tubes in surgical patients and the impact on costs as compared to endoscopic placement .


The trial potentially offers a strong argument for wider implementation of this technique as method of choice for placement of nasoenteral feeding tubes .


Dutch Trial Register : NTR4420 , date registered 5-feb-2014 .


The purpose of this study was to describe hospital and geographic variation in 30-day risk of surgical complications and death among colorectal cancer ( CRC ) patients and the extent to which patient - , hospital - , and census-tract-level characteristics increased risk of these outcomes .


We included patients at least 66years old with first primary stage I-III CRC from the 2000-2005 National Cancer Institute 's Surveillance , Epidemiology , and End Results data linked with 1999-2005 Medicare claims .


A multilevel , cross-classified logistic model was used to account for nesting of patients within hospitals and within residential census tracts .


Outcomes were risk of complications and death after a complication within 30days of surgery .


Data were analyzed for 35,946 patients undergoing surgery at 1,222 hospitals and residing in 12,187 census tracts ; 27.2 % of patients developed complications , and of these 13.4 % died .


Risk-adjusted variability in complications across hospitals and census tracts was similar .


Variability in mortality was larger than variability in complications , across hospitals and across census tracts .


Specific characteristics increased risk of complications ( e.g. , census-tract-poverty rate , emergency surgery , and being African-American ) .


No hospital characteristics increased complication risk .


Specific characteristics increased risk of death ( e.g. census-tract-poverty rate , being diagnosed with colon ( versus rectal ) cancer , and emergency surgery ) , while hospitals with at least 500 beds showed reduced death risk .


Large , unexplained variations exist in mortality after surgical complications in CRC across hospitals and geographic areas .


The potential exists for quality improvement efforts targeted at the hospital and/or census-tract levels to prevent complications and augment hospitals ' ability to reduce mortality risk .


Clinicians require portable , valid , and cost-effective methods to monitor knee joint-position-sense ( JPS ) ability .


To examine the criterion-related validity of image-capture JPS measures against an isokinetic-dynamometer ( IKD ) procedure .


Random crossover design providing a comparison of knee JPS measures from image capture and IKD procedures .


10 healthy participants , 5 female , age 28.0 13.29 y , mass 60.3 9.02 kg , height 1.65 0.07 m , and 5 male , 29.6 10.74 y , mass 73.6 5.86 kg , height 1.75 0.07 m.


The dependent variables were absolute error scores ( AES ) provided by 2 knee directions ( flexion and extension ) .


The independent variables were the method ( image capture and IKD ) .


There was no significant difference between clinical and IKD AES into knee-flexion data ( P = .263 , r = 0.55 ) .


There was a significant difference between clinical and IKD AES into knee-extension data ( P = .016 , r = .70 ) .


Analysis of photographic images to assess JPS measurements using knee flexion is valid against an IKD positioning method , but JPS measurements using knee extension may not be valid against IKD techniques .


However , photo-analysis measurements provided a lower error score using knee-extension data and thus may provide an optimal environment to produce maximal knee JPS acuity .


Therefore , clinicians do not need expensive equipment to collect representative JPS ability .


Lung volume reduction ( LVR ) techniques improve lung function in selected patients with emphysema , but the impact of LVR procedures on the asynchronous movement of different chest wall compartments , which is a feature of emphysema , is not known .


We used optoelectronic plethysmography to assess the effect of surgical and bronchoscopic LVR on chest wall asynchrony .


Twenty-six patients were assessed before and 3 months after LVR ( surgical [ n = 9 ] or bronchoscopic [ n = 7 ] ) or a sham/unsuccessful bronchoscopic treatment ( control subjects , n = 10 ) .


Chest wall volumes were divided into six compartments ( left and right of each of pulmonary ribcage [ Vrc , p ] , abdominal ribcage [ Vrc , a ] , and abdomen [ Vab ] ) and phase shift angles ( ) calculated for the asynchrony between Vrc , p and Vrc , a ( RC ) , and between Vrc , a and Vab ( DIA ) .


Participants had an FEV of 34.6 18 % predicted and a residual volume of 217.8 46.0 % predicted with significant chest wall asynchrony during quiet breathing at baseline ( RC , 31.3 38.4 ; and DIA , -38.7 36.3 ) .


Between-group difference in the change in RC and DIA during quiet breathing following treatment was 44.3 ( 95 % CI , -78 to -10.6 ; P = .003 ) and 34.5 ( 95 % CI , 1.4 to 67.5 ; P = .007 ) toward 0 ( representing perfect synchrony ) , respectively , favoring the LVR group .


Changes in RC and DIA were statistically significant on the treated but not the untreated sides .


Successful LVR significantly reduces chest wall asynchrony in patients with emphysema .


To assess the impact of passive and active promotional strategies on patient acceptance of medication therapy management ( MTM ) services , and to identify reasons for patient acceptance or refusal .


Four promotional approaches were developed to offer MTM services to eligible patients , including letters and bag stuffers ( `` passive '' approaches ) , and face-to-face offers and telephone calls ( `` active '' approaches ) .


Thirty pharmacies in a grocery store chain were randomized to one of the four approaches .


Patient acceptance rates were compared among the four groups , and between active and passive approaches using hierarchical logistic regression techniques .


Depending on their decision to accept or decline the service , patients were invited to take part in one of two brief telephone surveys .


No significant differences were identified among the four promotional methods or between active and passive methods in the analyses .


Patients ' most frequent reasons for accepting MTM services were potential cost savings , review of how the medications were working , the expert opinion of the pharmacist , and education about medications .


Patients ' most frequent reasons for declining MTM services were that the participant already felt comfortable with their medications and felt their pharmacist provides these services on a regular basis .


No significant difference was found among any of the four groups or between active or passive approaches .


Further research is warranted to identify strategies for improving patient engagement in MTM services .


To compare the effect on surgical indicators and functional outcome between preoperative skeletal traction and skin traction for adult femoral fracture and guide the choice of preoperative traction method of adult femoral fractures .


From February 2008 to September 2012 , 68 patients aged greater than 18-year-old with femoral fractures were treated and randomly divided into two groups according hospitalization order , the odd with skeletal traction of tibial tubercle ( group A ) and the even with skin traction ( group B ) .


In group A , there were 25 males and 9 females with an average age of ( 36.39.9 ) years old , including 11 cases with transverse fracture , 15 cases with oblique fracture , 8 cases with spiral fracture .


In group B , there 26 males and 8 females with an average age of ( 37.111.0 ) years old , including 10 cases with transverse fracture , 13 cases with oblique fracture ,11 cases with spiral fracture .


The operative time , blood loss , the number and amount of blood transfusion , fracture healing time , hemoglobin , pain scores and functional scores between two groups were analyzed and compared .


Results : All patients were followed up , the follow-up time was ( 33.56.5 ) months in group A , ( 31.37.5 ) months in groupB .


In group A , the operation time was ( 108.814.2 ) min and the intraoperative blood loss was ( 383.1117.1 ) ml and the postoperative blood transfusion was 14 cases and the blood transfusion was ( 350.0122.5 ) ml and the average bone healing time was ( 15.03.3 ) weeks .


In group B , the operation time was ( 111.612.7 ) min and the intraoperative blood loss was ( 392.0 116.7 ) ml and the blood transfusion was 11 cases and the blood transfusion was ( 327.3129.1 ) ml and the average healing time was ( 15.53.4 ) weeks .


These obseration indicators had no significant difference between two groups .


There was no significant difference between two groups in terms of Hemoglobin , the pain scores before and after traction , the femoral fractures efficacy score , knee function score and knee range .


Preoperative skeletal traction does not reduce surgery time , blood loss and pain and so on .


The bone healing time and limb functional outcomes were also not significantly improved .


To evaluate the benefit of aromatic therapy using menthol for decrease pain perception during amniocentesis .


A prospective randomized study was conducted to compare pain level between groups ofpregnant women who underwent amniocentesis with and without aromatic therapy using menthol .


Visual analogue scale ( VAS ) was usedfor pain assessment .


The participants were askedfor their anticipated pain and anxiety level and level ofpain before and immediately after the procedure .


Three hundred seventeen pregnant women were recruited into the present study , 158 in the menthol group and 159 in the non-menthol group .


Mean VAS score of the post-procedure pain and anxiety did not differ significantly between the two groups .


Mean VAS score of the anticipated pain influenced the mean VAS score of the pre-procedure anxiety and post-procedure pain and anxiety irrespective of the group .


Mean VAS score of the pre-procedure anxiety and post-procedure pain and anxiety increased about 0.3 cm for each 1 cm of increasing mean VAS score of anticipated pain .


Aromatic therapy using menthol was not significantly effective in reducing pain and anxiety during second trimester genetic amniocentesis .


Immune response and consequent inflammatory process which originate on ocular surface after a trauma are mediated by cytokines .


Photoablation of corneal stroma performed by excimer laser causes surgically induced trauma .


Interleukin-6 ( IL-6 ) is mostly known as a proinflammatory cytokine .


However , it also has regenerative and anti-inflammatory effects .


It is supposed that this cytokine is likely to play a significant role in the process of corneal wound healing response after photoablation of stroma carried out by laser in situ keratomileusis ( LASIK ) or photorefractive keratectomy ( PRK ) methods .


The aim of this study was to determine and compare the levels of IL-6 in tears before and after treatment with LASIK and PRK methods .


The study included 68 shortsighted eyes up to -3.0 diopter sphere , i.e. 198 samples of tears ( per three samples taken from each of the eyes ) , divided into two groups according to the kind of excimer laser intervention performed : the group 1 -- eyes treated by LASIK method ( n = 31 ) , and the group 2 -- eyes treated by the PRK method ( n = 37 ) .


The samples of tears were taken from each eye at the following time points : before excimer laser treatment ( 0 h , the control group ) , 1 h after the treatment ( 1 h ) and 24 h after the treatment ( 24 h ) .


The patients did not use anti-inflammatory therapy 24 h after the intervention .


Tear samples were collected using microsurgical sponge .


Level of IL-6 in tear fluid was determined by the flow cytometry method , applying a commercial test kit which allowed cytokine detection from a small sample volume .


Results .


The values of IL-6 were detectable in 16 % of samples before LASIK treatment and in 30 % of samples before PRK treatment .