We compared the calculated volumes based on ultrasound parameters and estimated volume based on bimanual examination with either the calculated volumes of the pelvic MRI parameters or the calculated volume based on the exact weight during histological examinations .


Our study demonstrated poor agreement between ultrasound and bimanual examination compared with exact volume during histopathologic examination and MRI-based volume .


The agreement within the patient group with uterine volume > 233 g and > 747 g was fair to good .


For those women with a uterine volume between 233 and 747 g , the agreement was poor when comparing bimanual estimates with volume obtained from MRI or histolopathologic examination .


Within this volume group , the agreement on uterine volume between ultrasound and MRI or histopathologic examination was fair .


Our study shows that uterine volume as estimated by ultrasound and bimanual examination can be used for small or large uteri .


For uteri with an intermediate volume , bimanual examination and ultrasound are less reliable .


To test the hypothesis that the administration of antithrombin concentrate improves disseminated intravascular coagulation ( DIC ) , resulting in recovery from DIC and better outcomes in patients with sepsis , we conducted a prospective , randomized controlled multicenter trial at 13 critical care centers in tertiary care hospitals .


We enrolled 60 DIC patients with sepsis and antithrombin levels of 50 to 80 % in this study .


The participating patients were randomly assigned to an antithrombin arm receiving antithrombin at a dose of 30IU/kg per day for three days or a control arm treated with no intervention .


The primary efficacy end point was recovery from DIC on day 3 .


The analysis was conducted with an intention-to-treat approach .


DIC was diagnosed according to the Japanese Association for Acute Medicine ( JAAM ) scoring system .


The systemic inflammatory response syndrome ( SIRS ) score , platelet count and global markers of coagulation and fibrinolysis were measured on day 0 and day 3 .


Antithrombin treatment resulted in significantly decreased DIC scores and better recovery rates from DIC compared with those observed in the control group on day 3 .


The incidence of minor bleeding complications did not increase , and no major bleeding related to antithrombin treatment was observed .


The platelet count significantly increased ; however , antithrombin did not influence the sequential organ failure assessment ( SOFA ) score or markers of coagulation and fibrinolysis on day 3 .


Moderate doses of antithrombin improve DIC scores , thereby increasing the recovery rate from DIC without any risk of bleeding in DIC patients with sepsis .


UMIN Clinical Trials Registry ( UMIN-CTR ) UMIN000000882 .


To investigate the effect of virtual reality ( VR ) rehabilitation on upper extremity motor performance of patients with early stroke .


Pilot randomized controlled trial .


Rehabilitation wards .


Twenty three adults with stroke ( mean age ( SD ) = 58.35 ( 13.45 ) years and mean time since stroke ( SD ) = 16.30 ( 7.44 ) days ) .


Participants were randomly assigned to VR group ( n = 11 ) or control group ( n = 12 ) .


VR group received nine 30 minutes upper extremity VR therapy in standing ( five weekdays in two weeks ) plus conventional therapy , which included physical and occupational therapy .


Control group received only conventional therapy , which was comparable to total training time received by VR group ( mean training hours ( SD ) : VR = 17.07 ( 2.86 ) ; control = 15.50 ( 2.79 ) ) .


The main outcome measure was the Fugl-Meyer Assessment ( FMA ) .


Secondary outcomes included Action Research Arm Test , Motor Activity Log and Functional Independence Measure .


Results were taken at baseline , post intervention and 1-month post intervention .


Participants ' feedback and adverse effects were recorded .


All participants improved in FMA scores ( mean change ( SD ) = 11.65 ( 8.56 ) , P < .001 ) .


These effects were sustained at one month after intervention ( mean ( SD ) change from baseline = 18.67 ( 13.26 ) , P < .001 ) .


All other outcome measures showed similar patterns .


There were no significant differences in improvement between both groups .


Majority of the participants found VR training useful and enjoyable , with no serious adverse effects reported .


Although additional VR training was not superior to conventional therapy alone , this study demonstrates the feasibility of VR training in early stroke .


n-3 fatty acids inhibit neuronal excitability and reduce seizures in animal models .


High-dose fish oil has been explored in two randomised trials in drug resistant epilepsy with negative results .


We performed a phase II randomised controlled crossover trial of low-dose and high-dose fish oil in participants with drug resistant epilepsy to explore whether low-dose or high-dose fish oil reduces seizures or improves cardiovascular health .


Randomised placebo-controlled trial of low-dose and high-dose fish oil versus placebo ( corn oil , linoleic acid ) in 24 participants with drug resistant epilepsy .


A three-period crossover design was utilised lasting 42weeks , with three 10-week treatment periods and two 6-week washout periods .


All participants were randomised in double-blind fashion to receive placebo , high dose or low dose in different sequences .


The primary outcome was per cent change in total seizure frequency .


Low-dose fish oil ( 3 capsules/day , 1080mg eicosapentaenoic acid + docosahexaenoic acid ) was associated with a 33.6 % reduction in seizure frequency compared with placebo .


Low-dose fish oil was also associated with a mild but significant reduction in blood pressure .


High-dose fish oil was no different than placebo in reducing seizures or improving cardiac risk factors .


In this phase II randomised crossover trial , low-dose fish oil was effective in reducing seizures compared with placebo .


The magnitude of improvement is similar to that of recent antiepileptic drug trials in drug resistant epilepsy ( DRE ) .


The results indicate that low-dose fish oil may reduce seizures and improve the health of people with epilepsy .


These findings justify a large multicentre randomised trial of low-dose fish oil ( n-3 fatty acids < 1080mg/day ) in drug resistant epilepsy .


NCT00871377 .


To assess the patency of the pedicled right internal thoracic artery with an anteroaortic course and compare it to the patency of the left internal thoracic artery , in anastomosis to the left anterior descending artery in coronary artery bypass grafting by using coronary CT angiography at 6 months postoperatively .


Between December 2008 and December 2011 , 100 patients were selected to undergo a prospective coronary artery bypass grafting procedure without cardiopulmonary bypass .


The patients were randomly divided by a computer-generated list into Group-1 ( G-1 ) and Group-2 ( G-2 ) , comprising 50 patients each , the technique used was known at the beginning of the surgery .


In G-1 , coronary artery bypass grafting was performed using the left internal thoracic artery for the left anterior descending and the free right internal thoracic artery for the circumflex , and in G-2 , coronary artery bypass grafting was performed using the right internal thoracic artery pedicled to the left anterior descending and the left internal thoracic artery pedicled to the circumflex territory .


The groups were similar with regard to the preoperative clinical data .


A male predominance of 75.6 % and 88 % was observed in G-1 and G-2 , respectively .


Five patients migrated from G-1 to G-2 because of atheromatous disease in the ascending aorta .


The average number of distal anastomoses was 3.48 ( SD = 0.72 ) in G-1 and 3.20 ( SD = 0.76 ) in G-2 .


Coronary CT angiography in 96 re-evaluated patients showed that all ITAs , right or left , used in situ for the left anterior descending were patent .


There were no deaths in either group .


Coronary artery bypass grafting surgery involving anastomosis of the anteroaortic right internal thoracic artery to the left anterior descending artery has an outcome similar to that obtained using the left internal thoracic artery for the same coronary site .


Dual-energy CT technology enables acquisition of virtual unenhanced ( VUE ) images from contrast-enhanced scans .


To assess the feasibility of coronary artery calcium ( CAC ) scoring on VUE images derived from fast kVp-switching dual-energy coronary CT angiography .


Twenty-seven patients underwent true noncontrast CAC-scoring CT followed by routine single-energy ( 120-kVp ) and fast kVp-switching dual-energy coronary CT angiography , in a random acquisition order on the same day .


We calculated the CAC scores on true noncontrast and VUE images .


The image noises and the signal-to-noise and contrast-to-noise ratios of the aorta and coronary arteries were measured on both the single-energy coronary CT angiography images and dual-energy coronary CT angiography images ( 70 keV virtual monochromatic spectral images ) .


The Pearson correlation coefficient test and paired t test were used for statistical analysis .


Excellent correlation was observed between the CAC scores on the true noncontrast and those on the VUE images ( r = 0.88 ; P < .001 ) .


Compared with single-energy coronary CT angiography , dual-energy coronary CT angiography showed significantly reduced image noise and increased signal-to-noise and contrast-to-noise ratios in all regions ( all P < .001 ) .


The effective dose of dual-energy coronary CT angiography ( 4.3 0.3 mSv ) was significantly lower than that of true noncontrast CAC-scoring CT plus single-energy coronary CT angiography ( 5.4 0.7 mSv ; P < .0001 ) .


Excellent correlation was observed between the CAC scores on the VUE images and true noncontrast images .


Thus , fast kVp-switching dual-energy coronary CT angiography could allow prediction of the true CAC scores , potentially reducing the total radiation exposure and image acquisition time by obviating the need for true noncontrast CAC-scoring CT. .


To evaluate the efficacy of tamsulosin therapy in reducing ureteral double-J stent morbidity by evaluating USSQ , IPSS , QOL and VAS ( primary objective ) and to evaluate the morbidity and or complication ( s ) associated with indwelling double-J ureteral stent ( s ) and to evaluate the safety of tamsulosin therapy for `` morbidity associated with double-J stents '' by evaluating its tolerability , side effects and adverse events if any ( secondary objective ) as per protocol .


After institutional review board approval , 60 consecutive patients with a double-J ureteral stent inserted after percutaneous nephrolithotomy or ureteroscopic stone treatment were randomly assigned to receive tamsulosin 0.4 mg , or a placebo for 4 weeks .


The validated USSQ , VAS and IPSS were completed before stent insertion , at 3 days and 4 weeks after stent insertion and at 2 weeks after stent removal .


Data were statistically analyzed for efficacy and tolerability of one drug over the other using Wilcoxon signed-rank test , Mann-Whitney test and Student 's t test .


Patients receiving tamsulosin compared with the placebo showed significant decrease in urinary index score , pain index score , work performance score , VAS score at loin area , VAS score at flank , VAS score at suprapubic area , average VAS score , need for antibiotics , number of hospital visits ( P < 0.05 ) at the end of fourth weeks .


Decrease in values were also observed in IPSS score , general health score , quality of sex score and IPSS-quality of life ( QOL ) score in patients taking tamsulosin but , however , the decrease was not significant .


No patients discontinued medication because of side effects .


We conclude that ureteral stenting using double-J stents with concomitant tamsulosin therapy was generally well tolerated , safe , effective and significantly beneficial in reducing stent morbidity in the majority of our patients .


We advocate the routine use of concomitant tamsulosin therapy in eligible patients undergoing ureteral stenting in order to minimize stent morbidity .


Parents of children with special needs are vigilant as their child may have difficulty independently escaping a burning home .


The purpose of this study was to evaluate if providing home fire safety information via a digital video disc ( DVD ) increases families ' knowledge , behavior and ability regarding home fire safety .


A school based classroom intervention ( using a home fire safety DVD ) was provided to parents ( n = 40 ) of children with and without special needs to improve home fire safety knowledge , behavior and ability .


In addition , parents seen at the Kentucky Commission for Children with Special Health Care Needs clinics ( n = 47 ) received the same intervention in cohorts of 1-2 children .


For both groups , knowledge , and behavior were measured before and after intervention .


Repeated measures ANOVA were used to test for differences between groups and over time .


Significance was set at p < 0.05 .


No difference in scores between pre - and post-test scores existed between groups ( with special needs vs. without special needs , or classroom vs. individualized instruction ) .


However , some differences were noted for some individual survey questions during post-hoc comparisons .


Having a smoke alarm in the home ( 90 % vs. 95 % , p = 0.029 ) and having a smoke alarm outside of where everyone sleeps ( 75 % vs. 95 % , p = 0.005 ) increased over time and was retained .


Having a fire escape plan increased at post intervention ( 58 % vs. 79 % , p = 0.033 ) , but returned to pre levels at follow-up ( 58 % ) .


Perceived knowledge ( 7.7 vs. 9.3 , p < 0.001 ) and ability ( 8.7 vs. 9.1 , p = 0.069 ) increased over time .


Parents of children with special needs had a significant increase in knowledge and behavior over those parents of children without special needs .


They also perceived having a high fire safety ability .


Many of the post-test questions/behaviors ( e.g. , capable of exiting home during a fire , etc. ) were reported at 100 % .


The intervention was well received , but may not necessarily be needed .


Focus for home fire safety may need to look at younger children and smaller families .


Parents of special needs children may have had frequent interaction with health care professionals .


To compare pain response outcomes for patients with spinal bone metastases treated with resistance training of the spinal musculature versus passive physical therapy during radiotherapy ( RT ) .


In this randomized trial , 60 consecutive patients were treated from September 2011 until March 2013 within one of the two groups : resistance training ( Arm A ) or passive physical therapy ( Arm B ) with thirty patients in each group during RT. .


The course of pain according to visual analog scale ( VAS ) , concurrent medication , and oral morphine equivalent dose ( OMED ) were assessed at baseline , three months , and six months after RT. .


Pain response was determined using International Bone Consensus response definitions .


The course of VAS in the intervention group ( Arm A ) was significantly lower both during and after RT ( AUC , p < .001 ) .


The use of analgetic medication showed the same result , with significantly fewer analgetics being necessary both during and after RT in arm A ( p < .001 ) .


In the course of time , the OMED decreased in arm A , but increased in arm B.


After 6 month , 72.2 % of patients in arm A , and 22.2 % in arm B were responders ( p = .014 ) .


Our trial demonstrated that guided isometric resistance training of the paravertebral muscles can improve pain relief over a 6-months period in patients with stable spinal metastases .


Importantly , the intervention was able to reduce OMED as well as concomitant pain medication .


The trial is registered in Clinical trial identifier NCT 01409720 ( http://www.clinicaltrials.gov/ ) since 2nd of August 2011 .


Prostate cancer is a major public health issue .


Its incidence is rising , especially in Nigeria .


Prompt diagnosis is necessary by histology .


Transperineal and transrectal approaches to prostate biopsy are well-documented .


Both methods are fraught with complications though , most times minor .


Studies carried out to compare both methods were carried out mainly on Caucasians , generating conflicting results .


This study aims to compare the complication rates and tissue yield of these two methods in Nigerian men .


Seventy-five patients completed the study .


Forty-five patients had transperineal prostate biopsy ( TPbx ) , while 30 patients had transrectal prostate biopsy .


Pain perception for all patients was determined by visual analog scale ; whereas the complications were ascertained by a validated purpose designed questionnaire administered on the 7 th and 30 th day post operatively .


The risk of rectal bleeding was higher for transrectal prostate biopsy compared to transperineal ( Odds ratio : 0.03 ; 95 % confidence interval ( CI ) : 0.001-0 .450 ; P = 0.012 ) .


TPbx was more painful than transrectal ( P < 0.0001 ; df : 75 ; t : 4.98 ; 95 % CI of difference in mean : -2.98 - [ -1.28 ] ) .


There was no statistical difference between transperineal and transrectal prostate biopsy in hemospermia , fever , prostatic abscess , urethral bleeding , acute retention and tissue yield .


TPbx is more painful than transrectal prostate biopsy though with a significantly reduced risk of rectal bleeding .


There appears to be no significant difference with respect to risk of fever , urethral bleeding , hematospermia , prostatic abscess and acute retention .


Both routes provided sufficient prostate tissue for histology .


To document the rate and outcome of trastuzumab-associated cardiac dysfunction in patients following 1 or 2 years of adjuvant therapy .


The Herceptin Adjuvant ( HERA ) trial is a three-arm , randomized trial comparing 2 years or 1 year of trastuzumab with observation in 5,102 patients with human epidermal growth factor receptor 2 ( HER2 ) - positive early-stage breast cancer .


Cardiac function was closely monitored .


Eligible patients had left ventricular ejection fraction ( LVEF ) 55 % at study entry following neoadjuvant chemotherapy with or without radiotherapy .


This 8-year median follow-up analysis considered patients randomly assigned to 2 years or 1 year of trastuzumab or observation .


The as-treated safety population for 2 years of trastuzumab ( n = 1,673 ) , 1 year of trastuzumab ( n = 1,682 ) , and observation ( n = 1,744 ) is reported .


Cardiac adverse events leading to discontinuation of trastuzumab occurred in 9.4 % of patients in the 2-year arm and 5.2 % of patients in the 1-year arm .


Cardiac death , severe congestive heart failure ( CHF ) , and confirmed significant LVEF decrease remained low in all three arms .


The incidence of severe CHF ( 0.8 % , 0.8 % , and 0.0 % , respectively ) and confirmed significant LVEF decrease ( 7.2 % , 4.1 % , and 0.9 % , respectively ) was significantly higher in the 2-year and 1-year trastuzumab arms compared with the observation arm .


Severe CHF was the same for 2-year and 1-year trastuzumab .


Of patients with confirmed LVEF decrease receiving 2-year trastuzumab , 87.5 % reached acute recovery .


Of patients with confirmed LVEF decrease receiving 1-year trastuzumab , 81.2 % reached acute recovery .


Long-term assessment at 8-year median follow-up confirms the low incidence of cardiac events for trastuzumab given sequentially after chemotherapy and radiotherapy , and cardiac events were reversible in the vast majority of patients .


Combination of fluoropyrimidines and a platinum derivative are currently standards for systemic chemotherapy in advanced adenocarcinoma of the stomach and gastroesophageal junction ( GEJ ) .


Nevertheless , individual likelihood for response to these therapeutic regimes remains uncertain .


Even more , no predictive markers are available to determine which patients may benefit more from oxaliplatin versus cisplatin or vice versa .


The new invasion and stem cell markers VEGFR-3 and CXCR4 have been linked prognostically with more aggressive esophagogastric cancer types .


Thus , we aimed to assess correlations of VEGFR-3 and CXCR4 expression levels with clinical outcome in a randomized phase III study of patients with oxaliplatin/leucovorin/5-FU ( FLO ) versus cisplatin/leucovorin/5-FU ( FLP ) .


The patients data examined in this study ( n = 72 ) were from the collective of the FLO vs. FLP phase III AIO trial .


Tumour tissues were stained via immunohistochemistry for VEGFR-3 and CXCR4 expression and results were evaluated by two independent , blinded investigators.Outcome parameter : Survival analysis was calculated for patients receiving FLO vs. FLP in relation to VEGFR-3 and CXCR4 expression .


54 % and 36 % of the examined tumour tissues showed strong positive expression of VEGFR-3 and CXCR4 respectively .


No superiority of each regime was detected in terms of overall survival ( OS ) in the whole population .


Patients with strong expression of CXCR4 on their tumour tissues profited more in terms of OS under the treatment of FLP ( mOS : 28 vs 15 months , p = 0.05 respectively ) .


Patients with negative VEGFR-3 and CXCR4 expression had a trend to live longer when FLO regime was applied ( mOS : 22 vs. 9 months , p = 0.099 and 20 vs. 10 months , p = 0.073 respectively ) .


In an exploratory analysis of patients older than 60 years at diagnosis , we observed a significant benefit in overall survival for VEGFR-3 and CXCR4-positive patients when treated with FLP ( p = 0.002 , p = 0.021 respectively ) .


CXCR4 positive patients profited in terms of OS from FLP , whereas FLO proved to be more effective in CXCR4 and VEGFR-3 negative patients .


Our results suggest , despite the limited size of the study , a predictive value of these biomarkers concerning chemotherapy with FLP or FLO in advanced esophagogastric cancer .


The aim of this study was to investigate the significance of the combined use of BMI and AEC in reducing the radiation dose of CT volume scans of the lumbar spine .


A prospective study was performed to continuously collect data from 50 patients ( age range from 19 to 60 years , male versus female 20/30 ) whose BMIs were less than 25 kg/m <formula> ^ { 2 } </formula> ( group A ) and 50 patients ( age range from 21 to 82 years , male versus female 24/26 ) whose BMIs were equal to or more than 25 kg/m <formula> ^ { 2 } </formula> ( group B ) .


The 50 patients in each group were randomly divided into 5 subgroups with each subgroup having lower radiation dose from subgroup 1 to 5 .


All the patients were performed lumbar spiral CT scans ( GE LightSpeed VCT 64-slice scanner ) and the scan parameters were different in different subgroups .


Volume CT dose index ( CTDIvol ) was recorded .


The qualities of the images were graded .


The one-way ANOVA and Kruskal-Wallis test were done .


Both in group A and B , there were significant differences in CTDIvol among the 5 subgroups ( P < 0.001 ) .


The quality of the images in the 5 subgroups of group A did n't show statistical difference .


The standard deviation ( SD ) and signal to noise ratio ( SNR ) values of the L4-5 psoas major muscles in subgroup 5 of group B was statistical different from the other 4 subgroups ( P < 0.01 ) .


Use of BMI combined with AEC reduces radiation dosage , without compromising the image quality .


For patients in group A and group B , parameters of subgroup 5 and subgroup 4 may respectively be applied for lower dose CT scanning .


To evaluate the distribution and extent of myocardial fibrosis identified by either contrast-enhanced Look-Locker or late gadolinium enhancement magnetic resonance imaging ( LGE MRI ) and their relationships between ventricular tachyarrhythmia or risk factors in apical hypertrophic cardiomyopathy ( APH ) .


Twenty-five APH patients were examined using a 3.0 T or 1.5 T instrument .


We used MRI to evaluate myocardial T1 values and scar .


We compared the myocardial fibrosis assessed by contrast-enhanced Look-Locker or LGE MRI with ventricular tachyarrhythmia or risk factors for hypertrophic cardiomyopathy .


Myocardial scar was present in 17 of the 25 patients with APH .


Myocardial scar was distributed predominantly in the apical myocardium ( P < 0.01 ) , whereas myocardial T1 values did not differ between the apical , midventricular , and basal septum .


The extent of myocardial scar according to 16-segment model and ejection fraction were related to ventricular tachyarrhythmia or risk factors in APH ( P < 0.05 for both ) .


The myocardial T1 value was not associated with the tachyarrhythmia or risk factors .


In APH , the extent of myocardial scar on LGE MRI is associated with ventricular tachyarrhythmia and risk factors .


Quantification of the myocardial T1 value is not necessary for its risk stratification .


To compare the difference in clinical efficacy on children attention deficit hyperactivity disorder ( ADHD ) between the combined therapy of scalp acupuncture and EGG biofeedback and the simple EEG biofeedback therapy so as to search the better therapeutic method for ADHD .


One hundred patients were randomized into an observation group and a control group , 50 cases in each one .


In the control group , the simple EEG biofeedback therapy was adopted .


In the observation group , on the basis of biofeedback therapy , scalp acupuncture was added and applied to Dingzhongxian ( MS 5 ) , Dingpangyixian ( MS 8 ) , Baihui ( GV 20 ) , Sishencong ( EX-HN 1 ) , etc. .


The ten treatments made one session .


After four sessions of treatment , FIQ value in Wechsler intelligence scale , CIH score in Conners children behavior questionnaire , the ratio of 0 wave and p wave in EEG , FRCQ and FAQ in the integrated visual and auditory continuous performance test ( IVA-CPT ) and clinical comprehensive efficacy were observed before and after treatment in the two groups separately .


Three cases were dropped out in the observation group and 2 cases were out in the control group .


In the two groups , FIQ , FRCQ and FAQ were all increased after treatment ( P < 0.01 , P < 0.05 ) ; the increases in the observation group were much more significant than those in the control group after treatment ( all P < 0.05 ) .


In the two groups , CIH score and the ratio of 0 wave and p wave were all reduced after treatment ( P < 0.01 , P < 0.05 ) ; the reduction in the observation group were much more apparent as compared with those in the control group ( both P < 0.05 ) .


The total effective rate was 91.5 % ( 43/47 ) in the observation group and better than 83.3 % ( 40/48 , P < 0.01 ) in the control group .


The combined therapy of scalp acupuncture and EEG biofeedback achieves the superior efficacy on children ADHD as compared with the simple biofeedback therapy .


This combined therapy rapidly relieves the essential symptoms of ADHD and improves EEG waveform in children patients .


Importantly , this therapy obtains and consolidates the significant efficacy .


Although p16 protein expression , a surrogate marker of oncogenic human papillomavirus ( HPV ) infection , is recognized as a prognostic marker in oropharyngeal squamous cell carcinoma ( OPSCC ) , its prevalence and significance have not been well established in cancer of the oral cavity , hypopharynx , or larynx , collectively referred as non-OPSCC , where HPV infection is less common than in the oropharynx .


p16 expression and high-risk HPV status in non-OPSCCs from RTOG 0129 , 0234 , and 0522 studies were determined by immunohistochemistry ( IHC ) and in situ hybridization ( ISH ) .


Hazard ratios from Cox models were expressed as positive or negative , stratified by trial , and adjusted for clinical characteristics .


p16 expression was positive in 14.1 % ( 12 of 85 ) , 24.2 % ( 23 of 95 ) , and 19.0 % ( 27 of 142 ) and HPV ISH was positive in 6.5 % ( six of 93 ) , 14.6 % ( 15 of 103 ) , and 6.9 % ( seven of 101 ) of non-OPSCCs from RTOG 0129 , 0234 , and 0522 studies , respectively .


Hazard ratios for p16 expression were 0.63 ( 95 % CI , 0.42 to 0.95 ; P = .03 ) and 0.56 ( 95 % CI , 0.35 to 0.89 ; P = .01 ) for progression-free ( PFS ) and overall survival ( OS ) , respectively .


Comparing OPSCC and non-OPSCC , patients with p16-positive OPSCC have better PFS and OS than patients with p16-positive non-OPSCC , but patients with p16-negative OPSCC and non-OPSCC have similar outcomes .


Similar to results in patients with OPSCC , patients with p16-negative non-OPSCC have worse outcomes than patients with p16-positive non-OPSCC , and HPV may also have a role in outcome in a subset of non-OPSCC .


However , further development of a p16 IHC scoring system in non-OPSCC and improvement of HPV detection methods are warranted before broad application in the clinical setting .


Fatigue and emotional reactivity are common among women suffering from breast cancer and might detrimentally affect these women 's quality of life .


This study evaluates if the stress management delivered either in a group or individual setting would improve fatigue and emotional reactivity among women with a newly diagnosed breast cancer .


Participants ( n = 304 ) who reported elevated levels of distress at three-month post-inclusion were randomised between stress management in a group ( GSM ) ( n = 77 ) or individual ( ISM ) ( n = 78 ) setting .


Participation was declined by 149 women .


Participants completed the Multidimensional Fatigue Inventory ( MFI-20 ) and the Everyday Life Stress Scale ( ELSS ) at the time of inclusion , 3 - and 12-month post-inclusion .


Analyses were made according to intention to treat and per-protocol principles .


Mann-Whitney tests were used to examine differences between the two intervention groups .


No significant differences were detected between the GSM and ISM groups on fatigue or emotional reactivity .


In addition , there were no changes over time for these outcomes .


There were no differences between the two intervention arms with reference to fatigue or emotional reactivity ; however , a clinically interesting finding was the low number of women who were interested in participating in a psychosocial intervention .


This finding may have clinical implications when psychosocial support is offered to women with a newly diagnosed breast cancer and also in the planning of future studies .


To improve the quality of chest compression ( CC ) , we developed the assistant-push method , whereby the second rescuer pushes the back of the chest compressor during CC .


We investigated the effectiveness and feasibility of assistant push in achieving and maintaining the CC quality .


This was a randomized crossover trial in which 41 subjects randomly performed both of standard CC ( single-rescuer group ) and CC with instructor-driven assistant push ( assistant-push group ) in different order .


Each session of CC was performed for 2 minutes using a manikin .


Subjects were also assigned to both roles of chest compressor and assistant and together performed CC with subject-driven assistant push .


Depth of CC , compression to recoil ratio , duty cycle , and rate of incomplete recoil were quantified .


The mean depth of CC ( 57.0 [ 56.0-59 .0 ] vs 55.0 [ 49.5-57 .5 ] , P < .001 ) was significantly deeper , and the compression force ( 33.8 [ 29.3-36 .4 ] vs 23.3 [ 20.4-25 .3 ] , P < .001 ) was stronger in the assistant-push group .


The ratio of compression to recoil , duty cycle , and rate of incomplete chest recoil were comparable between the 2 groups .


The CC depth in the single-rescuer group decreased significantly every 30 seconds , whereas in the assistant-push group , it was comparable at 60 - and 90-second time points ( P = .004 ) .


The subject assistant-push group performed CCs at a depth comparable with that of the instructor assistant-push group .


The assistant-push method improved the depth of CC and attenuated its decline , eventually helping maintain adequate CC depth over time .


Subjects were able to feasibly learn assistant push and performed effectively .


Midodrine is an - agonist prodrug of desglymidodrine used for the management of hypotension .


Midodrine has demonstrated usefulness in hepatorenal syndrome .


The objective of the present work was to study the role of midodrine in patients with non-azotemic cirrhosis with tense ascites .


This prospective randomized double blind placebo-controlled study was conducted on 67 non azotemic inpatients with liver cirrhosis and tense ascites ( 52 men and 15 women ; age range , 45-72 ) .


One patient declined to participate in the study , 33 patients were randomly assigned to take midodrine hydrochloride , and 33 patients were randomly assigned to take placebo .


Out of 67 enrolled patients , 60 patients ( 30 : in midodrine group ; 30 : in placebo group ) completed the study and 6 patients lost to follow up .


Patients were assessed for patients characteristics , history of tapping their ascetic fluid , laboratory values , and Doppler parameters before and after the study .


Average 24-h urine volume was assessed before and after the start of the study .


significant reduction in body weight and abdominal girth was observed after 2 weeks of midodrine therapy .


Midodrine appeared to be effective in lowering body weights and abdominal girths of non azotemic cirrhotic patients with tense ascites .


Antiarrhythmic drugs ( AADs ) and anticoagulation are mainstays of atrial fibrillation ( AF ) treatment .


To study the use and outcomes of AAD therapy in anticoagulated patients with AF .


Patients in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation trial ( N = 14,264 ) were stratified by AAD use at baseline : amiodarone , other AAD , or no AAD .


Multivariable adjustment was performed to compare stroke , bleeding , and death across AAD groups as well as across treatment assignment ( rivaroxaban or warfarin ) .


Of 14,264 patients randomized , 1681 ( 11.8 % ) were treated with an AAD ( 1144 [ 8 % ] with amiodarone and 537 [ 3.8 % ] with other AADs ) .


Amiodarone-treated patients were less often female ( 38 % vs 48 % ) , had more persistent AF ( 64 % vs 40 % ) , and more concomitant heart failure ( 71 % vs 41 % ) than were patients receiving other AADs .


Patients receiving no AAD more closely resembled amiodarone-treated patients .


Time in therapeutic range was significantly lower in warfarin-treated patients receiving amiodarone than in those receiving no AAD ( 50 % vs 58 % ; P < .0001 ) .


Compared with no AAD , neither amiodarone ( adjusted hazard ratio [ HR ] 0.98 ; 95 % confidence interval [ CI ] 0.74-1 .31 ; P = .9 ) nor other AADs ( adjusted HR 0.66 ; 95 % CI 0.37-1 .17 ; P = .15 ) were associated with increased mortality .


Similar results were observed for embolic and bleeding outcomes .


Treatment effects of rivaroxaban vs warfarin in patients receiving no AAD were consistent with results from the overall trial ( primary end point : adjusted HR 0.82 ; 95 % CI 0.68-0 .98 ; Pinteraction = .06 ; safety end point : adjusted HR 1.12 ; 95 % CI 0.90-1 .24 ; Pinteraction = .33 ) .


Treatment with AADs was not associated with increased morbidity or mortality in anticoagulated patients with AF .


The effect of amiodarone on outcomes in patients receiving rivaroxaban requires further investigation .


Mental stress-induced myocardial ischemia ( MSIMI ) is common in patients with ischemic heart disease ( IHD ) and associated with a poorer cardiovascular prognosis .


Platelet hyperactivity is an important factor in acute coronary syndrome .


This study examined associations between MSIMI and resting and mental stress-induced platelet activity .


Eligible patients with clinically stable IHD underwent a battery of 3 mental stress tests during the recruitment phase of REMIT study .


MSIMI was assessed by echocardiography and electrocardiography .


Ex vivo platelet aggregation in response to ADP , epinephrine , collagen , serotonin , and combinations of serotonin plus ADP , epinephrine , and collagen were evaluated as was platelet serotonin transporter expression .


Of the 270 participants who completed mental stress testing , and had both resting and post-stress platelet aggregation evaluation , 43.33 % ( n = 117 ) met criteria for MSIMI and 18.15 % ( n = 49 ) had normal left ventricular response to stress ( NLVR ) .


The MSIMI group , relative to the NLVR groups , demonstrated heightened mental stress-induced aggregation responses , as measured by area under the curve , to collagen 10M ( 6.95 [ 5.54 ] vs. -14.23 [ 8.75 ] .


; P = 0.045 ) , epinephrine 10M ( 12.84 [ 4.84 ] vs. -6.40 [ 7.61 ] .


; P = 0.037 ) and to serotonin 10 M plus ADP 1 M ( 6.64 [ 5.29 ] vs. -27.34 [ 8.34 ] ; P < .001 ) .


The resting platelet aggregation and serotonin transporter expression , however , were not different between the two groups .


These findings suggest that the dynamic change of platelet aggregation caused by mental stress may underlie MSIMI .


While the importance of these findings requires additional investigation , they raise concern given the recognized relationship between mental stress-induced platelet hyperactivity and cardiovascular events in patients with IHD .


Surgical and medical treatments for emphysema may affect both quality and quantity of life .


The purpose of this article is to report outcomes from the National Emphysema Treatment Trial ( NETT ) using an index that combines quality and quantity of life .


This was a prospective randomized clinical trial .


Following pulmonary rehabilitation , 1,218 patients with severe emphysema were randomly assigned to maximal medical therapy or to lung volume reduction surgery ( LVRS ) .


A generic quality-of-life measure , known as the Quality of Well-being Scale ( QWB ) , was administered at baseline and again at 6 , 12 , 24 , 36 , 48 , 60 , and 72 months following treatment assignment .


At baseline , QWB scores were comparable for the Medical and LVRS groups .


For both groups , scores significantly improved following the rehabilitation program .


The QWB scores before death for patients in the LVRS group improved up to the year 2 visit , whereas scores for the Medical group dropped significantly following the baseline visit .


Imputing zeros ( 0 ) for death , QWB scores decreased significantly for both groups .


With or without scoring death as 0 , the LVRS group achieved better outcomes , and the significant differences were maintained until the sixth year .


Over 6 years of follow-up , LVRS produced an average of 0.30 quality-adjusted life years ( QALYs ) , or the equivalent of about 3.6 months of well life .


Compared with maximal medical therapy alone , patients undergoing maximal medical therapy plus LVRS experienced improved health-related quality of life and gained more QALYs .


ClinicalTrials.gov ; No. : NCT00000606 ; URL : www.clinicaltrials.gov .


To observe the effect of combination of Immune 1 and HAART on the CD4 + T cell count and its immune reconstitution rate .


Two hundred and twenty eight HIV/AIDS patients were randomly divided into treatment group and control group , patients from treatment group received Immune 1 combined HAART therapy , patients from control group was given placebo combined HAART and evaluate the change of CD4 + T cell count and its immune reconstitution rate .


In patients with CD4 + T cells baseline level ( 200-350 cell x microL ( -1 ) ) , Immune reconstitution rate of treatment group is significantly higher than the control group .


Immune 1 combined HAART can effectively promote the immune reconstitution of patients with high CD4 + T cells baseline level ( 200-350 cell x microL ( -1 ) ) and show little side effect and is safe to treat HIV/AIDS disease .


Concurrent treatment of HIV and tuberculosis is complicated by drug interactions .


We explored the safety and efficacy of raltegravir as an alternative to efavirenz for patients co-infected with HIV and tuberculosis .


We did a multicentre , phase 2 , non-comparative , open-label , randomised trial at eight sites in Brazil and France .


Using a computer-generated randomisation sequence , we randomly allocated antiretroviral-naive adult patients with HIV-1 and tuberculosis ( aged 18 years with a plasma HIV RNA concentration of > 1000 copies per mL ) to receive raltegravir 400 mg twice a day , raltegravir 800 mg twice daily , or efavirenz 600 mg once daily plus tenofovir and lamivudine ( 1:1:1 ; stratified by country ) .


Patients began study treatment after the start of tuberculosis treatment .


The primary endpoint was virological suppression at 24 weeks ( HIV RNA < 50 copies per mL ) in all patients who received at least one dose of study drug ( modified intention-to-treat analysis ) .


We recorded death , study drug discontinuation , and loss to follow-up as failures to achieve the primary endpoint .


We assessed safety in all patients who received study drugs .


This study is registered in ClinicalTrials.gov , number NCT00822315 .


Between July 3 , 2009 , and June 6 , 2011 , we enrolled and randomly assigned treatment to 155 individuals ; 153 ( 51 in each group ) received at least one dose of the study drug and were included in the primary analysis .


133 patients ( 87 % ) completed follow-up at week 48 .


At week 24 , virological suppression was achieved in 39 patients ( 76 % , 95 % CI 65-88 ) in the raltegravir 400 mg group , 40 patients ( 78 % , 67-90 ) in the raltegravir 800 mg group , and 32 patients ( 63 % , 49-76 ) in the efavirenz group .


The adverse-event profile was much the same across the three groups .


Three ( 6 % ) patients allocated to efavirenz and three ( 6 % ) patients allocated to raltegravir 800 mg twice daily discontinued the study drugs due to adverse events .


Seven patients died during the study ( one in the raltegravir 400 mg group , four in the raltegravir 800 mg group , and two in the efavirenz group ) : none of the deaths was deemed related to study treatment .


Raltegravir 400 mg twice daily might be an alternative to efavirenz for the treatment of patients co-infected with HIV and tuberculosis .


French National Agency for Research on AIDS and Viral Hepatitis ( ANRS ) , Brazilian National STD/AIDS Program-Ministry of Health .


Panobinostat is a potent oral pan-deacetylase inhibitor that in preclinical studies has synergistic anti-myeloma activity when combined with bortezomib and dexamethasone .


We aimed to compare panobinostat , bortezomib , and dexamethasone with placebo , bortezomib , and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma .


PANORAMA1 is a multicentre , randomised , placebo-controlled , double-blind phase 3 trial of patients with relapsed or relapsed and refractory multiple myeloma who have received between one and three previous treatment regimens .


Patients were randomly assigned ( 1:1 ) via an interactive web-based and voice response system , stratified by number of previous treatment lines and by previous use of bortezomib , to receive 21 day cycles of placebo or panobinostat ( 20 mg ; on days 1 , 3 , 5 , 8 , 10 , 12 , orally ) , both in combination with bortezomib ( 13 mg/m ( 2 ) on days 1 , 4 , 8 , 11 , intravenously ) and dexamethasone ( 20 mg on days 1 , 2 , 4 , 5 , 8 , 9 , 11 , 12 , orally ) .


Patients , physicians , and the investigators who did the data analysis were masked to treatment allocation ; crossover was not permitted .


The primary endpoint was progression-free survival ( in accordance with modified European Group for Blood and Marrow Transplantation criteria and based on investigators ' assessment ) and was analysed by intention to treat .


The study is ongoing , but no longer recruiting , and is registered at ClinicalTrials.gov , number NCT01023308 .


768 patients were enrolled between Jan 21 , 2010 , and Feb 29 , 2012 , with 387 randomly assigned to panobinostat , bortezomib , and dexamethasone and 381 to placebo , bortezomib , and dexamethasone .


Median follow-up was 647 months ( IQR 181-1347 ) in the panobinostat group and 559 months ( 214-1130 ) in the placebo group .


Median progression-free survival was significantly longer in the panobinostat group than in the placebo group ( 1199 months [ 95 % CI 1033-1294 ] vs 808 months [ 756-923 ] ; hazard ratio [ HR ] 063 , 95 % CI 052-076 ; p < 00001 ) .


Overall survival data are not yet mature , although at the time of this analysis , median overall survival was 3364 months ( 95 % CI 3134-not estimable ) for the panobinostat group and 3039 months ( 2687-not estimable ) for the placebo group ( HR 087 , 95 % CI 069-110 ; p = 026 ) .


The proportion of patients achieving an overall response did not differ between treatment groups ( 235 [ 607 % , 95 % CI 557-656 ] for panobinostat vs 208 [ 546 % , 494-597 ] for placebo ; p = 009 ) ; however , the proportion of patients with a complete or near complete response was significantly higher in the panobinostat group than in the placebo group ( 107 [ 276 % , 95 % CI 232-324 ] vs 60 [ 157 % , 122-198 ] ; p = 000006 ) .


Minimal responses were noted in 23 ( 6 % ) patients in the panobinostat group and in 42 ( 11 % ) in the placebo group .


Median duration of response ( partial response or better ) was 1314 months ( 95 % CI 1176-1492 ) in the panobinostat group and 1087 months ( 923-1176 ) in the placebo group , and median time to response ( partial response or better ) was 151 months ( 141-164 ) in the panobinostat group and 200 months ( 161-279 ) in the placebo group .


Serious adverse events were reported in 228 ( 60 % ) of 381 patients in the panobinostat group and 157 ( 42 % ) of 377 patients in the placebo group .


Common grade 3-4 laboratory abnormalities and adverse events ( irrespective of association with study drug ) included thrombocytopenia ( 256 [ 67 % ] in the panobinostat group vs 118 [ 31 % ] in the placebo group ) , lymphopenia ( 202 [ 53 % ] vs 150 [ 40 % ] ) , diarrhoea ( 97 [ 26 % ] vs 30 [ 8 % ] ) , asthenia or fatigue ( 91 [ 24 % ] vs 45 [ 12 % ] ) , and peripheral neuropathy ( 67 [ 18 % ] vs 55 [ 15 % ] ) .


Our results suggest that panobinostat could be a useful addition to the treatment armamentarium for patients with relapsed or relapsed and refractory multiple myeloma .


Longer follow up will be necessary to determine whether there is any effect on overall survival .


Novartis Pharmaceuticals .


Corn peptides ( CPs ) are a novel food prepared from corn gluten meal , which is a main by-product of the corn starch industry .


Recently , significant beneficial effects of CPs on early alcoholic liver injury in rats and on acute alcoholic injury in mice were observed .


To our knowledge , the present study is the first report showing that CPs supplementation has beneficial effects on lipid profile , oxidative stress and alcoholic liver injury in men with chronic alcohol consumption .


A 9-week , randomized , double-blind , placebo-controlled study was conducted between September 2011 and August 2012 to assess the hepatoprotective effect of CPs .


A total of 161 men were randomized to receive CPs ( n = 53 ) , whey protein ( n = 54 ) , or corn starch placebo ( n = 54 ) at the same dose of 2 g twice daily .


146 participants completed the study .


Serum lipid profile , serum markers of liver injury , oxidative stress and inflammation , and fatty liver based on the results of abdominal ultrasonography were assessed at the beginning and end of the intervention .


CPs supplementation ( 4 g/d ) for 9 weeks significantly lowered serum levels or activities of total cholesterol , triglyceride , alanine aminotransferase , aspartate aminotransferase , malondialdehyde and tumor necrosis factor - , and significantly increased serum activities of superoxide dismutase and glutathione peroxidase , but the same dose of whey protein and corn starch ( placebo ) did not demonstrate these effects .


Our results indicate that CPs may have protective effects on alcohol-induced liver damage via modulation of lipid metabolism and oxidative stress .


CPs may potentially be used as a functional food for the management of alcoholic liver disease in subjects with chronic alcohol consumption .


The aim of this study was to investigate the effect of i.v. infusion of magnesium sulphate during spinal anesthesia on duration of spinal block and postoperative pain .


Forty ASA physical status I and status II , aged between 18 and 65 , female patients undergoing abdominal hysterectomy under spinal anesthesia were enrolled in this study .


Patients in the magnesium group ( Group M , n = 20 ) received magnesium sulphate 65 mg kg ( -1 ) infusion in 250 mL 5 % dextrose at 3.5 mL/min rate , and control group ( Group C , n = 20 ) received at the same volume of saline during operation in a double-blind randomized manner .


Duration of sensory and motor block , systolic , diastolic , and mean arterial blood pressures , heart rates , pain scores ( VAS values ) , and side effects were recorded for each patient .


Blood and CSF samples were taken for analysis of magnesium concentrations .


Regression of sensorial block was longer in Group M when compared with that in Group C ( 175 39 versus 136 32 min ) ( P < 0.01 ) .


The VAS scores were lower in Group M than those in Group C at the 2 time points postoperatively ( P < 0.01 ) .


65 mg kg ( -1 ) of magnesium sulphate i.v. infusion under spinal anesthesia prolongs spinal sensorial block duration and decreases pain VAS scores without complication in patients undergoing abdominal hysterectomy .


To explore effects of a pre-screening life style survey on the subsequent attendance proportion in colorectal cancer screening .


Finnish colorectal cancer screening programme in 2011 .


Double randomized and controlled follow-up design .


The study population comprised of 31,951 individuals born in 1951 .


In 2010 to a random sample of every sixth ( n = 5,312 ) person we sent a 7-paged life style questionnaire , and to another random sample of every sixth person ( n = 5,336 ) a 10-paged life style and quality of life questionnaire .


One year later , in 2011 , 31,484 individuals of the original cohort were independently randomized ( 1:1 ) for colorectal cancer screening ( n = 15,748 ) or control group ( n = 15,736 ) .


Of those who were invited for screening , 5185 had received a questionnaire during the previous year .


5870 individuals ( 55.1 % ) responded to the questionnaire in 2010 .


The overall attendance at screening in 2011 was 59.0 % in those born in 1951 ( i.e. the 60-year-olds ) .


In those who had been sent the survey the attendance in screening was 56.6 % ( 57.3 % for the short and 56.0 % for the long questionnaire ) and in those who had not received the questionnaire it was 60.2 % ( P < 0.001 ) .


We believe that the observed reduction in attendance in those who had been sent a questionnaire earlier is generally true .


Thus , if any survey is enclosed in the screening invitation , this finding should be taken into account when planning the programme .


Any extra effort requested may reduce the attendance proportion for screening , reducing the population level impact of screening .


Under the directly observed treatment , short course ( DOTS ) program , antituberculosis ( anti-TB ) medications were possibly taken at random time , regardless of whether it was prior to or after meals .


This study was to evaluate the impact of food intake on pharmacokinetic profiles of first-line TB drugs in Taiwanese TB patients , as well as the relationship between drug levels and pharmacogenetics .


This open-label , randomized , cross-over study included newly diagnosed Taiwanese TB patients treated between January 2010 and February 2011 at Taipei Medical University-Wan Fang Hospital .


Rifater [ a fixed-dose combination formulation of isoniazid ( INH ) , rifampicin ( RIF ) , and pyrazinamide ( PZA ) ] and ethambutol ( EMB ) were given according to national TB guidelines .


Blood samples were collected prior to and 1 hour , 2 hours , 4 hours , 6 hours , and 10 hours after dosing under fasting or postprandial conditions .


Pharmacokinetic parameters of the maximum serum concentration ( Cmax ) , time to Cmax , and area under the serum concentration-time curve from the beginning to the 10 ( th ) hour ( AUC0-10 ) were calculated .


Sixteen TB patients were included and received anti-TB treatment under the DOTS program after discharge .


The overall effects showed that food intake reduced the mean Cmax ( INH : 40.6 % , RIF : 40.2 % , EMB 34.4 % , PZA : 24.4 % ) and AUC0-10 ( INH : 21.3 % , RIF : 26.4 % , EMB : 12.2 % , PZA : 12.0 % ) .


Meanwhile , food increased the time to Cmax ( INH : 78.1 % , RIF : 151.3 % , EMB : 41.4 % , PZA : 148.9 % ) .


Significantly lower serum drug concentrations were observed under postprandial conditions than fasting conditions for INH , RIF , and PZA .


The impact of taking random anti-TB drugs under the DOTS program instead of taking drugs regularly prior to meals requires further study .


Bevacizumab has broad anti-tumour activity , but substantial risk of hypertension .


No reliable markers are available for predicting bevacizumab-induced hypertension .


A genome-wide association study ( GWAS ) was performed in the phase III bevacizumab-based adjuvant breast cancer trial , ECOG-5103 , to evaluate for an association between genotypes and hypertension .


GWAS was conducted in those who had experienced systolic blood pressure ( SBP ) > 160mmHg during therapy using binary analysis and a cumulative dose model for the total exposure of bevacizumab .


Common toxicity criteria ( CTC ) grade 3-5 hypertension was also assessed .


Candidate SNP validation was performed in the randomised phase III trial , ECOG-2100 .


When using the phenotype of SBP > 160mmHg , the most significant association in SV2C ( rs6453204 ) approached and met genome-wide significance in the binary model ( P = 6.0 10 ( -8 ) ; OR = 3.3 ) and in the cumulative dose model ( P = 4.7 10 ( -8 ) ; HR = 2.2 ) , respectively .


Similar associations with rs6453204 were seen for CTC grade 3-5 hypertension but did not meet genome-wide significance .


Validation study from ECOG-2100 demonstrated a statistically significant association between this SNP and grade 3/4 hypertension using the binary model ( P-value = 0.037 ; OR = 2.4 ) .


A genetic variant in SV2C predicted clinically relevant bevacizumab-induced hypertension in two independent , randomised phase III trials .


This thorough QT/QTc ( TQT ) study assessed the effects of a supratherapeutic dose of pomaglumetad methionil , a potential treatment for schizophrenia , compared to placebo on the QT interval in subjects with schizophrenia .


This double-blind , 3-period crossover study enrolled 86 subjects aged 22 - 63 years , who met Diagnostic and Statistical Manual , Fourth Edition , Test Revision ( DSM-IV-TR ) criteria for schizophrenia ; 78 subjects completed the study .


Subjects were randomly assigned to sequences of 3 treatment periods of single oral doses of pomaglumetad methionil 400 mg , moxifloxacin 400 mg , and placebo .


Quadruplicate electrocardiograms ( ECGs ) were extracted from 2 hours predose to 12 hours postdose and were overread by a blinded central reader .


Time-matched pharmacokinetic ( PK ) parameters were assessed .


At all-time points , the upper bound of the 90 % 2-sided confidence interval ( CI ) for the least squares ( LS ) mean difference in changes from baseline in Fridericia 's corrected QT interval ( QTcF ) between pomaglumetad methionil and placebo was < 10 milliseconds ( msec ) .


Sufficient assay sensitivity was not achieved , likely due to food effect ; although the maximum observed drug concentration ( Cmax ) with moxifloxacin ( 1,410 ng/mL ) was lower than expected , the slope of the regression line of moxifloxacin plasma concentrations versus placebo-subtracted QTcF was similar to that reported in the literature .


A single supratherapeutic dose of 400 mg pomaglumetad methionil did not prolong QTcF to a clinically significant degree and , importantly , did not result in any absolute QTcF > 450 msec or increase in QTcF from predose > 30 msec .


The purpose of this study was to evaluate the efficacy of once-daily guanfacine extended release ( GXR ) monotherapy administered either in the morning or evening , using a modified Conners ' Parent Rating Scale-Revised : Short Form ( CPRS-R : S ) assessed three times/day in children with attention-deficit/hyperactivity disorder ( ADHD ) .


This multicenter , double-blind , placebo-controlled study randomized children 6-12 years of age with ADHD into three groups : GXR a.m. ( GXR in the morning and placebo in the evening ) , GXR p.m. ( placebo in the morning and GXR in the evening ) , or twice-daily placebo .


The CPRS-R : S , administered in the morning , afternoon , and evening prior to each study visit , was a secondary measure of efficacy .


A total of 333 subjects were included in the analysis population ( GXR a.m. , n = 107 ; GXR p.m. , n = 114 ; placebo , n = 112 ) .


At visit 10 , last observation carried forward ( LOCF ) , subjects receiving GXR demonstrated significantly greater improvement from baseline in the daily mean CPRS-R : S total score , as well as in each of the morning , afternoon , and evening CPRS-R : S assessments , compared with placebo , regardless of the time of GXR administration ( p < 0.001 vs. placebo for GXR a.m. and GXR p.m. ) .


In addition , subjects receiving GXR showed significantly greater improvements from baseline in each subscale score ( oppositional , cognitive problems/inattention , hyperactivity , and ADHD index ) compared with those receiving placebo , regardless of time of administration ( p < 0.003 vs. placebo across all subscales for GXR a.m. and GXR p.m. ) .


These results provide further support for the demonstrated efficacy of once-daily GXR in reducing ADHD symptoms , and demonstrate that response is consistent throughout the day regardless of the time of administration , with improvement seen in ratings of oppositional as well as of ADHD symptoms .


Disease progression in patients with HER2-positive breast cancer receiving trastuzumab might be associated with activation of the PI3K/Akt/mTOR intracellular signalling pathway .


We aimed to assess whether the addition of the mTOR inhibitor everolimus to trastuzumab might restore sensitivity to trastuzumab .


In this randomised , double-blind , placebo-controlled , phase 3 trial , we recruited women with HER2-positive , trastuzumab-resistant , advanced breast carcinoma who had previously received taxane therapy .


Eligible patients were randomly assigned ( 1:1 ) using a central patient screening and randomisation system to daily everolimus ( 5 mg/day ) plus weekly trastuzumab ( 2 mg/kg ) and vinorelbine ( 25 mg/m ( 2 ) ) or to placebo plus trastuzumab plus vinorelbine , in 3-week cycles , stratified by previous lapatinib use .


The primary endpoint was progression-free survival ( PFS ) by local assessment in the intention-to-treat population .


We report the final analysis for PFS ; overall survival follow-up is still in progress .


This trial is registered with ClinicalTrials.gov , number NCT01007942 .


Between Oct 26 , 2009 , and May 23 , 2012 , 569 patients were randomly assigned to everolimus ( n = 284 ) or placebo ( n = 285 ) .


Median follow-up at the time of analysis was 20.2 months ( IQR 15.0-27 .1 ) .


Median PFS was 7.00 months ( 95 % CI 6.74-8 .18 ) with everolimus and 5.78 months ( 5.49-6 .90 ) with placebo ( hazard ratio 0.78 [ 95 % CI 0.65-0 .95 ] ; p = 0.0067 ) .


The most common grade 3-4 adverse events were neutropenia ( 204 [ 73 % ] of 280 patients in the everolimus group vs 175 [ 62 % ] of 282 patients in the placebo group ) , leucopenia ( 106 [ 38 % ] vs 82 [ 29 % ] ) , anaemia ( 53 [ 19 % ] vs 17 [ 6 % ] ) , febrile neutropenia ( 44 [ 16 % ] vs ten [ 4 % ] ) , stomatitis ( 37 [ 13 % ] vs four [ 1 % ] ) , and fatigue ( 34 [ 12 % ] vs 11 [ 4 % ] ) .


Serious adverse events were reported in 117 ( 42 % ) patients in the everolimus group and 55 ( 20 % ) in the placebo group ; two on-treatment deaths due to adverse events occurred in each group .


The addition of everolimus to trastuzumab plus vinorelbine significantly prolongs PFS in patients with trastuzumab-resistant and taxane-pretreated , HER2-positive , advanced breast cancer .


The clinical benefit should be considered in the context of the adverse event profile in this population .


Opioid consumption after posterior spinal fusion is known to be high and often exceeds those reported in other major surgical procedures .


A number of clinical trials provide evidence that the perioperative use of subanesthetic doses of ketamine reduces pain and opioid requirements in some surgical procedures , but the effect of prolonged perioperative low-dose ketamine infusion in patients undergoing posterior spinal fusion for pediatric scoliosis surgery is unknown .


To test the hypothesis that a 72-h perioperative low-dose ketamine infusion would decrease opioid use in pediatric patients undergoing posterior spinal fusion .


In a double-blind prospective controlled trial , patients undergoing posterior spinal fusion for scoliosis were randomized to receive perioperative low-dose ketamine or placebo control .


Patients received general anesthesia , intraoperative remifentanil , and morphine patient-controlled analgesia postoperatively .


Daily opioid consumption , self-reported pain scores , and sedation scores were measured .


Fifty-four patients were enrolled and 50 completed the study .


Contrary to our hypothesis , ketamine - and control-treated patients had similar postoperative opioid use , pain scores , and sedation scores measurements .


In contrast , ketamine-treated patients required less intraoperative remifentanil compared with control ( mean 2.9 mg vs. 4mg , P = 0.0415 ) .


Number of vertebrae instrumented , time between end-of-surgery and 24h assessment , or remifentanil doses did not impact on postoperative opioid use .


Over 96-h postoperatively , morphine-equivalent consumption was lower ( -0.40 , P = 0.006 ) and sedation score was higher ( 0.47 , P = 0.0211 ) in male patients , compared with female patients .


These findings do not support the use of perioperative low-dose ketamine to decrease opioid use in children with scoliosis undergoing posterior spinal fusion .


Emollient therapy is used frequently to prevent nosocomial infection in the management of preterm infants , despite a lack of adequate evidence of its efficacy .


To assess the efficacy of prophylactic whole-body application of pure preservative-free topical petroleum jelly on the incidence of nosocomial sepsis in very low-birthweight ( VLBW ) infants .


A prospective , randomised controlled trial of the application of topical petroleum jelly was conducted .


Infants weighing < 1250 g at birth and with a gestational age of 32 weeks were included .


The intervention group received twice-daily topical therapy of 2 g/kg pure , preservative-free topical petroleum jelly until the completion of 34 weeks of gestation .


The control group received no topical petroleum jelly treatment .


The primary outcome was the incidence of late-onset sepsis during hospitalisation .


Other data collected included the pattern of temperature control , weight changes , fluid requirements , serum bilirubin level , electrolyte imbalance and skin condition .


Thirty-five infants in the intervention group and 39 in the control group were recruited .


Birthweight , gestational age , gender and perinatal variables were comparable in the two groups .


There was a trend towards an increased incidence of culture-proven nosocomial sepsis in the intervention group - 19 episodes ( 54 % ) in the intervention group vs 16 ( 41 % ) in the control group , and an increased rate of NEC - 20 % in the intervention group vs 8 % in the control group .


The intervention group had better skin condition throughout their stay and the incubator ambient temperature was lower in the intervention group in the 1st week of life .


The fluid balance of the infants in the intervention group was better , as reflected by their mean ( SD ) shorter time to regain birthweight [ 12 ( 5 ) vs 14 ( 6 ) days ] , and there were fewer episodes of hypernatraemia in the 1st week of life , although none of these reached statistical significance .


However , there was a significantly lower mean ( SD ) level of maximum hyperbilirubinaemia [ 157 ( 40 ) vs 182 ( 46 ) mmol/L , P = 002 ) in the intervention group .


Although prophylactic topical application of pure , preservative-free petroleum jelly brought substantial improvement of skin condition and temperature control , it was associated with a trend towards an increased rate of nosocomial sepsis .


To study the efficacy and safety of drotaverine hydrochloride ( HCl ) 80 mg tablet given thrice a day in the symptomatic relief of patients with irritable bowel syndrome ( IBS ) .


The study was a multicentric , randomized , double-blind , placebo-controlled parallel group study performed at three centers .


The patients who fulfilled Rome II Criteria of IBS were included in the study .


A total of 180 patients with IBS were randomized to drotaverine and placebo treatment groups .


Abdominal pain and stool frequency were measured every week in both the groups for all the 4 weeks of treatment duration .


Subject Global Assessment of Relief ( SGA ) of IBS symptoms was assessed at the end of the study .


Appropriate statistical analysis was done using SPSS software .


Mann-Whitney U-test ( two-tailed ) , Wilcoxon signed ranks test , and McNemar tests .


Pain frequency decreased significantly ( P < 0.01 ) in 22 ( 25.9 % ) , 51 ( 60 % ) , and 66 ( 77.7 % ) patients in the drotaverine group , at the end of 2nd , 3rd , and 4th weeks , respectively , as compared with 8 ( 9.4 % ) , 18 ( 21.2 % ) , and 26 ( 30.6 % ) in the placebo group .


Pain severity scores also decreased significantly in the drotaverine group 66 ( 77.7 % ) as compared with placebo 26 ( 30.6 % ) after 4 weeks .


Drotaverine HCl was shown to provide significant improvement ( P < 0.01 ) in global relief in abdominal pain as perceived by the patient ( 85.9 % vs 39.5 % ) and the clinician ( 82.4 % vs 36.5 % ) in the drotaverine group as compared with placebo .


There is significant ( P < 0.01 ) improvement in stool frequency in drotaverine HCl treatment group as compared with placebo .


The drug is well tolerated without any major side effects .


A 4-week treatment with drotaverine significantly improves abdominal symptoms in patients with IBS .


Patients with end-stage renal failure ( ESRF ) need integrated health care to maintain a desirable quality of life .


Studies suggest that post-discharge nurseled telephone support has a positive effect for patients suffering from chronic diseases .


But the post-discharge care is under-developed in mainland China and the effects of post-discharge care on patients with peritoneal dialysis have not been conclusive .


The purpose of this study is to test the effectiveness of postdischarge nurse-led telephone support on patients with peritoneal dialysis in mainland China .


A randomized controlled trial was conducted in the medical department of a regional hospital in Guangzhou .


135 patients were recruited , 69 in the study group and 66 in the control group .


The control group received routine hospital discharge care .


The study group received post-discharge nurse-led telephone support .


The quality of life ( Kidney Disease Quality of Life Short Form , KDQOL-SF ) , blood chemistry , complication control , readmission and clinic visit rates were observed at three time intervals : baseline before discharge ( T1 ) , 6 ( T2 ) and 12 ( T3 ) weeks after discharge .


Statistically significant effects were found for symptom/problem , work status , staff encouragement , patient satisfaction and energy/fatigue in KDQOL-SF and 84-day ( 12-week ) clinic visit rates between the two groups .


The study group had more significant improvement than the control group for sleep , staff encouragement at both T2 and T3 , and pain at T2 and patient satisfaction at T3 .


No significant differences were observed between the two groups for the baseline measures , other dimensions in KDQOL-SF , blood chemistry , complication control , readmission rates at all time intervals and clinic visit rates at the first two time intervals .


Post-discharge nurse-led telephone support for patients undergoing peritoneal dialysis is effective to enhance patients ' well-being in the transition from hospital to home in mainland China .


Neoadjuvant treatment provides a unique opportunity to evaluate individual tumor sensitivity .


This study evaluated whether a response-guided strategy could improve clinical outcome compared with a standard treatment .


Overall , 264 previously untreated stage II-III operable breast cancer patients were randomized to receive either standard treatment ( arm A , n = 131 ) , consisting of fluorouracil , epirubicin , and cyclophosphamide ( FEC100 : 500 , 100 , and 500 mg/m ( 2 ) , respectively , for 3 cycles ) followed by docetaxel ( 100 mg/m ( 2 ) for 3 cycles ) , or adapted treatment ( arm B , n = 133 ) , beginning with 2 cycles of FEC100 and switching to docetaxel if tumor size decreased by < 30 % after 2 cycles or < 50 % after 4 cycles of FEC100 ( ultrasound assessments according to World Health Organization criteria ) .


Otherwise , FEC100 was given for six cycles before surgery .


Intent-to-treat analysis was performed .


Similar results were observed for clinical response ( objective response was 54 % vs 56 % , p = .18 ) , breast conservation surgery ( BCS ; 67 % vs 68 % , p = .97 ) , and pathological complete response rate ( Chevallier classification : 14 % vs 11 % , p = .68 ; Statloff classification : 16 % vs 13 % , p = .82 ) between arms A and B. Similar toxicities were observed , even with unbalanced numbers of FEC100 and docetaxel courses .


Adapted and standard treatments had similar results in terms of tumor response , BCS rate , and tolerability .


Further survival outcome data are expected .


To evaluate the influence of at least three abutment changes against the placement of a definitive abutment , which was no longer removed , on hard and soft tissue changes , and to compare the clinical outcomes of immediate non-occlusal loading versus conventional loading .


Eighty patients requiring one single crown or one fixed partial prosthesis supported by a maximum of three implants were randomised , after implants were placed with more than 35 Ncm , according to a parallel group design to receive definitive abutments which were loaded immediately ( definitive abutment or immediate loading group ) or transmucosal abutments which experienced delayed loading after 3 months and were removed at least three times : 1 ) during the making of the impression ( 3 months after implant placement ) ; 2 ) when checking the zirconium core of titanium abutments at single crowns or the fitting of the metal structure at prostheses supported by multiple implants ; 3 ) at delivery of the definitive prostheses ( repeated disconnection or conventional loading group ) .


Patients were treated in four centres and each patient contributed to the study with only one prosthesis followed for 4 months after initial loading .


Outcome measures were : prosthesis/implant failures , any complication , peri-implant marginal bone level changes , and patient satisfaction .


Forty patients were randomly allocated to each group according to a parallel group design .


No patient dropped-out and no implants failed .


However four provisional prostheses and one definitive prosthesis had to be remade because of misfitting ( five single crowns ) in the repeated disconnection group ; and one provisional prosthesis had to be remade because of frequent debondings in the immediate loading group ( difference = 10 % ; 95 % CI : -1 % , 21 % ; P = 0.109 ) .


Five complications ( all debondings of the provisional prostheses ) were reported in two patients of the immediate loading group , in comparison to three biological complications in three patients of the repeated disconnection group ( difference = 2 % ; 95 % CI : -8 % , 13 % ; P = 1 ) .


All patients were very satisfied or satisfied with the function and aesthetics of the prostheses , and would undergo the same procedure again .


Mean peri-implant marginal bone loss 4 months after loading was -0.08 ( 0.16 ) mm for the definitive abutment group and -0.09 ( 0.20 ) mm for the repeated abutment changes group ( difference = 0.01 ; 95 % CI : -0.07 , 0.09 ; P = 0.97 ) .


There were no statistically significant differences for any of the outcome measures between the two procedures up to 4 months after initial loading .


Preliminary short-term data ( 4-month post-loading ) showed that repeated abutment changes do not alter bone levels significantly .


Immediate non-occlusal loading of dental implants are a viable alternative to conventional loading .


Therefore clinicians can use the procedure they find more convenient for their specific patient .


To observe the efficacy difference of electroacupuncture and auricular acupuncture in the treatment of methamphetamine withdrawal syndrome .


Ninety male patients of methamphetamine addiction were randomized into an electroacupuncture group , an auricular acupuncture group and a control group , 30 cases in each one .


In the electroacupuncture group , Neiguan ( PC 6 ) , Shenmen ( HT 7 ) , Zusanli ( ST 36 ) , Sanyinjiao ( SP 6 ) , Jiaji ( EX-B 2 ) at T5 and L2 were selected bilaterally .


In the auricular acupuncture group , jiaogan ( AH ( 6a ) ) , shenmen ( TF4 ) , fei ( CO14 ) and gan ( CO12 ) were selected unilaterally .


The treatment was given 3 times a week , totally 12 treatments were required .


In the control group , no any intervention was applied .


Separately , before treatment and after 1 , 2 , 3 and 4 weeks treatment , the scores of methamphetamine withdrawal syndrome , Hamilton anxiety scale and Hamilton depression scale were observed in each group .


The total score of methamphetamine withdrawal syndrome , anxiety score and depression score were obviously reduced in 2 , 3 and 4 weeks of treatment as compared with those before treatment in the electroacupuncture group and the auricular acupuncture group ( all P < 0.05 ) , and showed a trend of gradual decline as the extension of treatment .


In 1,2,3,4 weeks of treatment , the total score of withdrawal syndrome , anxiety score and depression score in the electroacupuncture group and auricular acupuncture group were lower significantly than those in the control group ( all P < 0.05 ) , in which , the total score of withdrawal syndrome in the electroacupuncture group was lower significantly than that in the auricular acupuncture group in the 4th week of treatment ( 3.69 + / - 2.446 vs 5.73 + / - 3.169 , P < 0.05 ) ; the anxiety scores were lower significantly than those in the auricular acupuncture group in 3 and 4 weeks of treatment ( 8.19 + / - 4.57 vs 9.65 + / - 4.24 , 5.27 + / - 2.89 vs 7.38 + / - 3.10 , both P < 0.05 ) ; the depression scores were lower significantly than those in the auricular acupuncture group in 2 , 3 and 4 weeks of treatment ( 15.35 + / - 5.64 vs 19.81 + / - 5.37 , 10.96 + / - 4.52 vs 15.00 + / - 4.53 , 7.96 + / - 2.69 vs 12.35 + / - 3.59 , all P < 0.05 ) .


Electroacupuncture at the body points and auricular acupuncture play the therapeutic role in the treatment of methamphetamine withdrawal syndrome , anxiety and depression .


The longer time the treatment is with electroacupuncture at the body points , the more obvious the efficacy will be on the above symptoms .


Influenza vaccination coverage for U.S. school-aged children is below the 80 % national goal .


Primary care practices may not have the capacity to vaccinate all children during influenza vaccination season .


No real-world models of school-located seasonal influenza ( SLV-I ) programs have been tested .


Determine the feasibility , sustainability , and impact of an SLV-I program providing influenza vaccination to elementary school children during the school day .


In this pragmatic randomized controlled trial of SLV-I during two vaccination seasons , schools were randomly assigned to SLV-I versus standard of care .


Seasonal influenza vaccine receipt , as recorded in the state immunization information system ( IIS ) , was measured .


Intervention and control schools were located in a single western New York county .


Participation ( intervention or control ) included the sole urban school district and suburban districts ( five in Year 1 , four in Year 2 ) .


After gathering parental consent and insurance information , live attenuated and inactivated seasonal influenza vaccines were offered in elementary schools during the school day .


Data on receipt of 1 seasonal influenza vaccination in Year 1 ( 2009-2010 ) and Year 2 ( 2010-2011 ) were collected on all student grades K through 5 at intervention and control schools from the IIS in the Spring of 2010 and 2011 , respectively .


Additionally , coverage achieved through SLV-I was compared to coverage of children vaccinated elsewhere .


Preliminary data analysis for Year 1 occurred in Spring 2010 ; final quantitative analysis for both years was completed in late Fall 2012 .


Results are shown for 2009-2010 and 2010-2011 , respectively : Children enrolled in suburban SLV-I versus control schools had vaccination coverage of 47 % vs 36 % , and 52 % vs 36 % ( p < 0.0001 both years ) .


In urban areas , coverage was 36 % vs 26 % , and 31 % vs 25 % ( p < 0.001 both years ) .


On multilevel logistic analysis with three nested levels ( student , school , school district ) during both vaccination seasons , children were more likely to be vaccinated in SLV-I versus control schools ; ORs were 1.6 ( 95 % CI = 1.4 , 1.9 ; p < 0.001 ) and 1.5 ( 95 % CI = 1.3 , 1.8 ; p < 0.001 ) .


Delivering influenza vaccine during school is a promising approach to improving pediatric influenza vaccination coverage .


ClinicalTrials.govNCT01224301 .


Our aim was to evaluate the feasibility of a hydrotherapy treatment in patients with Parkinson 's disease and the effectiveness of this treatment on balance parameters in comparison to a traditional land-based physical therapy .


A randomized single-blind controlled trial .


Outpatients .


Thirty-four patients with Parkinson 's disease in Hoehn-Yahr stage 2.5-3 .


Group 1 hydrotherapy treatment , group 2 land-based rehabilitation treatment .


The two groups underwent the same rehabilitation period ( 60 minutes of treatment , five days a week for two months ) .


The primary outcome measures were the centre of the pressure sway area recorded with open and closed eyes , using a stabilometric platform .


Secondary outcome measures were Unified Parkinson 's Disease Rating Scale II and III , Timed Up and Go Test , Berg Balance Scale , Activities-specific Balance Confidence Scale , Falls Efficacy Scale , Falls diary and Parkinson 's Disease Questionnaire-39 .


Hydrotherapy treatment proved to be feasible and safe .


Patients in both groups had a significant improvement in all outcome variables .


There was a better improvement in patients who underwent hydrotherapy than in patients treated with land-based therapy in the centre of pressure sway area closed eyes ( mean SD change : 45.4 SD64 .9 vs. 6.9 SD45 .3 , p = 0.05 ) , Berg Balance Scale ( 51.2 SD3 .1 vs. 6.0 SD3 .1 , p = 0.005 ) , Activities-specific Balance Confidence Scale ( 16.8 SD10 .6 vs. 4.1 SD5 .4 , p = 0.0001 ) , Falls Efficacy Scale ( -5.9 SD4 .8 vs. -1.9 SD1 .4 , p = 0.003 ) , Parkinson 's Disease Quetionnaire-39 ( -18.4 SD12 .9 vs. -8.0 SD7 .0 , p = 0.006 ) and falls diary ( -2.4 SD2 .2 vs. -0.4 SD0 .5 , p = 0.001 ) .


Our study suggests that hydrotherapy may constitute a possible treatment for balance dysfunction in Parkinsonian patients with moderate stage of disease .


To compare the demographic characteristics and intra - and postoperative outcomes in elderly adults ( 75 ) with those of younger adults undergoing early ( < 5 days after onset of complaints ) cholecystectomy .


Retrospective analysis from May 2010 to August 2012 .


Randomized , multicenter , clinical trial ( ABCAL Study , NCT01015417 ) .


Individuals with mild or moderate acute calculous cholecystitis ( ACC ) according to the Tokyo Guidelines ( N = 414 ; n = 78 aged 75-94 , median 82 ; n = 336 aged 18-74 , median 49 ) .


Demographic characteristics and pre - , intra - , and postoperative data .


The elderly group was more likely to have an American Society of Anesthesiologists score of 3 or greater ( 62 % vs 23 % , P < .001 ) , higher serum creatinine ( 103 vs 74 mol/L , P < .001 ) , and more-severe ACC ( moderate ACC ( 62 % vs 50 % , P = .05 ) , gangrenous cholecystitis ( 38 % vs 15 % , P = .001 ) ) on preoperative imaging and confirmed intraoperatively .


Ulcerated mucosa ( 76 % vs 61 % , P = .001 ) was significantly more frequent in the elderly group .


Operative time , postoperative mortality , and postoperative infectious ( 18 % vs 14 % , P = .35 ) and noninfectious ( 9 % vs 3 % , P = .80 ) complications were similar between the two groups .


Median length of stay ( 7.0 vs 5.0 days , P = .54 ) and readmission rate ( 15 % vs 4 % , P = .07 ) were not significantly higher in the elderly group .


No significant difference was observed for the subgroup of participants aged 80 and older .


In this randomized trial that included a selected sample of older adults , there was no difference in major outcomes between elderly adults and their younger counterparts after early cholecystectomy .


The findings are limited because important geriatric outcomes such as delirium and functional decline were not examined .


The aim of present study was to find a better procedure to prevent synkinesis in facial nerve palsy .


A randomized clinical trial .


Clinical rehabilitation faculty and general rehabilitation centers .


Twenty - nine patients with facial nerve palsy were selected via electrodiagnosis tests .


The experimental group ( n = 16 ) was treated with biofeedback electromyography , whereas the control group ( n = 13 ) received common physiotherapy .


All patients received 1-year treatment .


Evaluation of facial grading scale before and after treatment and severity of synkinesia .


At the end of treatment , there was a rise in facial grading system in both groups compared with baseline ( p < 0.05 , paired t test ) .


There were significant differences in the facial grading system between 2 groups at the end of the study , but the experimental group showed better result than the other one .


The number of patients with synkinesis and the severity of their synkinesis in the experimental group were lesser than those of the control group .


Biofeedback therapy is more efficient than common physiotherapy .


By using this approach , controlling and reducing synkinesis is more feasible .


The aim of study was to evaluate setting-specific quality indicators ( QIs ) for shared-housing arrangements ( SHA ) regarding effects of a guided quality development process on resident 's quality of life ( QoL ) .


SHA are a specific German kind of small-scale living facilities for care-dependent persons with dementia .


SHA are disconnected from residential facilities and served by community care services .


In a longitudinal cluster-randomised design 104 residents of 34 SHA were surveyed for 1 year ; the intervention group took part in a quality development process .


QIs , physical and psychological health outcomes including QoL were surveyed .


During the 1 year follow-up , analyses show a positive trend regarding QI-outcomes in the intervention group , but no statistically significant differences could be proved regarding QoL .


Setting-sensitive QIs are absolutely essential to measure quality of care in multi-professional settings like SHA .


Further research as well as longer study intervals is essential .


In clinical trials , treatment with a combination of the nucleotide polymerase inhibitor sofosbuvir and the antiviral drug ribavirin was associated with high response rates among patients with hepatitis C virus ( HCV ) genotype 2 infection , with lower response rates among patients with HCV genotype 3 infection .


We conducted a study involving patients with HCV genotype 2 or 3 infection , some of whom had undergone previous treatment with an interferon-based regimen .


We randomly assigned 91 patients with HCV genotype 2 infection and 328 with HCV genotype 3 infection , in a 4:1 ratio , to receive sofosbuvir-ribavirin or placebo for 12 weeks .


On the basis of emerging data from phase 3 trials indicating that patients with HCV genotype 3 infection had higher response rates when they were treated for 16 weeks , as compared with 12 weeks , the study was unblinded , treatment for all patients with genotype 3 infection was extended to 24 weeks , the placebo group was terminated , and the goals of the study were redefined to be descriptive and not include hypothesis testing .


The primary end point was a sustained virologic response at 12 weeks after the end of therapy .


Of the 419 patients who were enrolled and treated , 21 % had cirrhosis and 58 % had received previous interferon-based treatment .


The criterion for a sustained virologic response was met in 68 of 73 patients ( 93 % ; 95 % confidence interval [ CI ] , 85 to 98 ) with HCV genotype 2 infection who were treated for 12 weeks and in 213 of 250 patients ( 85 % ; 95 % CI , 80 to 89 ) with HCV genotype 3 infection who were treated for 24 weeks .


Among patients with HCV genotype 3 infection , response rates were 91 % and 68 % among those without and those with cirrhosis , respectively .


The most common adverse events were headache , fatigue , and pruritus .


Therapy with sofosbuvir-ribavirin for 12 weeks in patients with HCV genotype 2 infection and for 24 weeks in patients with HCV genotype 3 infection resulted in high rates of sustained virologic response .


( Funded by Gilead Sciences ; VALENCE ClinicalTrials.gov number , NCT01682720 . )


Herbal remedies play an important role in treatment of psychiatric disorders .


The aim of this study was to assess the efficacy of crocin , the main active constituent of saffron , as an adjunctive treatment in major depressive disorder ( MDD ) .


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


It was carried out during 4 weeks in two groups ( placebo and treatment ) on 40 MDD patients between 24 and 50 years old in Ibn-e-Sina psychiatric hospital , Mashhad , Iran , from March 2013 to December 2013 .


The crocin group ( n = 20 ) was given one selective serotonin reuptake inhibitor ( SSRI ) drug ( fluoxetine 20mg/day or sertraline 50mg/day or citalopram 20mg/day ) plus crocin tablets ( 30mg/day ; 15mg BID ) and placebo group ( n = 20 ) was administered one SSRI ( fluoxetine 20mg/day or sertraline 50mg/day or citalopram 20mg/day ) plus placebo ( two placebo tablets per day ) for 4 weeks .


Both groups filled beck depression inventory ( BDI ) , beck anxiety inventory ( BAI ) , general health questionnaire ( GHQ ) , the mood disorder questionnaire ( MDQ ) , side effect evaluation questionnaire , and demographic questionnaire before and after one month intervention .


The crocin group showed significantly improved scores on BDI , BAI and GHQ compared to placebo group ( Pvalue < 0.0001 ) .


The averages of decrease in BDI , BAI and GHQ scores in placebo group were 6.15 , 2.6 and 10.3 respectively , whereas the values in crocin group were 17.6 , 12.7 and 17.2 after 4 weeks trial .


Poor patient compliance with medications and short trial period , small sample size and self-report assessments were the major limitations of this study .


These results demonstrated the effect of crocin in depression and could be administered in treatment of MDD patients .


We aimed to determine the relationship between blood lactate , carboxy-hemoglobin ( COHb ) levels and the severity of clinical findings in patients with CO poisoning .


Patients over 18 years old and of both gender who were admitted to Emergency Department with the diagnosis of CO poisoning between 10.02.2008 and 17.03.20011 were enrolled in this study .


Detailed physical examination of each patient was performed , patients and their relatives were informed about the study and written consents were noted .


The levels of consciousness , physical examination findings , electrocardiographic findings , Glasgow Coma Scale ( GCS ) scores , laboratory results ( lactate , COHb , CK-MB , Troponin-I levels ) and applied treatments [ normobaric oxygen therapy ( NBOT ) , hyperbaric oxygen therapy ( HBOT ) ] were recorded to standart data entry form for each patient .


SPSS for Windows version 18 package program was used for statistical analysis of the data .


Total 201 patients were included in this study .


Thirty five patients ( 17.4 % ) received HBOT and lactate , COHb , CKMB , Troponin-I levels of this group were higher than the other patients .


Lactate and COHb levels were statistically significantly higher in patients with GCS < 15 than the ones with GCS = 15 ( p < 0.01 ) .


The patients whose both Troponin-I and CK-MB levels increased have higher lactate levels ( p = 0.038 ) , but COHb levels of these patients did not change ( p = 0.495 ) .


According to our study , blood lactate and COHb levels were both correlated with the changes of consciousness in CO poisoning .


Blood lactate levels together with COHb in defining indications for HBO treatment might be suggested .


Internet-based cognitive behavioural therapy ( ICBT ) is a promising approach to the prevention and reduction of depressive symptoms among adolescents .


This study aimed to evaluate the feasibility and efficacy of disseminating a self-directed internet-based mental health intervention ( MoodGYM ) in senior high schools .


It also sought to investigate possible effects of tailored and weekly e-mail reminders on initial uptake and adherence to the intervention .


A baseline survey was conducted in four senior high schools in two Norwegian municipalities ( n = 1337 ) .


52.8 % ( 707/1337 ) of the students consented to further participation in the trial and were randomly allocated to one of three MoodGYM intervention groups ( tailored weekly e-mail reminder ( n = 175 ) , standardized weekly e-mail reminder ( n = 176 ) or no e-mail reminder ( n = 175 ) ) or a waitlist control group ( n = 180 ) .


We tested for effects of the intervention on depression and self-esteem using multivariate analysis of variance , effects of tailored e-mail and self-reported current need of help on initial uptake of the intervention using logistic regression and the effect of weekly e-mails on adherence using ordinal regression .


There was substantial non-participation from the intervention , with only 8.5 % ( 45/527 ) participants logging on to MoodGYM , and few proceeding beyond the first part of the programme .


No significant effect on depression or self-esteem was found among the sample as a whole or among participants with elevated depression scores at baseline .


Having a higher average grade in senior high school predicted initial uptake of the intervention , but tailored e-mail and self-reported current need of help did not .


Weekly e-mail prompts did not predict adherence .


The main reasons for non-use reported were lack of time/forgetting about it and doubt about the usefulness of the program .


Overall , disseminating a self-directed internet-based intervention to a school population proved difficult despite steps taken to reduce barriers in terms of tailoring feedback and dispatching weekly e-mail reminders .


Providing mental health interventions within the school environment is likely to ensure better uptake among senior high school students , but there is a need to effectively communicate that such programmes can be helpful .


The trial was registered retrospectively as ACTRN12612001106820 .


Osteoarthritis is a relatively common musculoskeletal disorder that increases in prevalence with age .


Worldwide , knee osteoarthritis is one of the leading causes of disability , particularly in the elderly .


In numerous trials of agents for long-term pain therapy , no well-established and replicable results have been achieved .


Complementary and alternative medical approaches have been employed for thousands of years to relieve knee osteoarthritis pain .


Among herbal medicines , the golden plaster is the preferred and most commonlyused method in China to reduce pain in patients with knee osteoarthritis , as it causes few adverse effects .


The purpose of this study will be to evaluate the efficacy and safety of golden plaster on pain in patients with knee osteoarthritis .


This study will be a multicenter randomized , double-blind , placebo-controlled trial .


A total of 320 participants aged 45 to 79 years with knee osteoarthritis , whose scores on a visual analog scale ( VAS ) are more than 20 mm , will be randomly allocated into a treatment group and a control group .


A golden plaster will be administered externally to participants in the treatment group for 2 weeks , while the control group will receive a placebo plaster externally for 2 weeks .


Follow-up will be at regular intervals during a 4-week period with a VAS score for pain , quality of life , and complications .


This study will be a methodologically sound randomized controlled trial to assess pain relief after the intervention of golden plaster , compared to a placebo intervention in patients with knee osteoarthritis .


ClinicalTrials.gov identifier : ChiCTR-TRC-13003418 .


Tenofovir disoproxil fumarate ( TDF ) pre-exposure prophylaxis decreases sexual acquisition of HIV infection .


We sought to evaluate the renal safety of TDF in HIV-uninfected persons .


The Iniciativa Profilaxis Pre-Exposicin ( iPrEx ) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men ( MSM ) to receive oral daily TDF coformulated with emtricitabine ( FTC/TDF ) or placebo .


Serum creatinine and phosphorus during randomized treatment and after discontinuation were measured , and creatinine clearance ( CrCl ) was estimated by the Cockcroft-Gault equation .


Indicators of proximal renal tubulopathy ( fractional excretion of phosphorus and uric acid , urine protein , and glucose ) were measured in a substudy .


There was a small but statistically significant decrease in CrCl from baseline in the active arm , compared to placebo , which was first observed at week 4 ( mean change : -2.4 vs. -1.1 ml/min ; P = 0.02 ) , persisted through the last on-treatment visit ( mean change : +0.3 vs. +1.8 ml/min ; P = 0.02 ) , and resolved after stopping pre-exposure prophylaxis ( mean change : -0.1 vs. 0.0 ml/min ; P = 0.83 ) .


The effect was confirmed when stratifying by drug detection .


The effect of FTC/TDF on CrCl did not vary by race , age , or history of hypertension .


There was no difference in serum phosphate trends between the treatment arms .


In the substudy , two participants receiving placebo had indicators of tubulopathy .


In HIV-seronegative MSM , randomization to FTC/TDF was associated with a very mild nonprogressive decrease in CrCl that was reversible and managed with routine serum creatinine monitoring .


Statin use is frequently associated with muscle-related symptoms .


Coenzyme Q10 supplementation has yielded conflicting results in decreasing statin myopathy .


Herein , we tested whether coenzyme Q10 supplementation could decrease statin-associated muscular pain in a specific group of patients with mild-to-moderate muscle symptoms .


Fifty patients treated with statins and reporting muscle pain were recruited .


The Q10 group ( n = 25 ) received coenzyme Q10 supplementation over a period of 30 days ( 50 mg twice daily ) , and the control group ( n = 25 ) received placebo .


The Brief Pain Inventory ( BPI ) questionnaire was used and blood testing was performed at inclusion in the study and after 30 days of supplementation .


The intensity of muscle pain , measured as the Pain Severity Score ( PSS ) , in the Q10 group was reduced from 3.90.4 to 2.90.4 ( P < 0.001 ) .


The Pain Interference Score ( PIS ) after Q10 supplementation was reduced from 4.00.4 to 2.60.4 ( P < 0.001 ) .


In the placebo group , PSS and PIS did not change .


Coenzyme Q10 supplementation decreased statin-related muscle symptoms in 75 % of patients .


The relative values of PSS and PIS significantly decreased ( -33.1 % and -40.3 % , respectively ) in the Q10 group compared to placebo group ( both P < 0.05 ) .


From baseline , no differences in liver and muscle enzymes or cholesterol values were found .


The present results show that coenzyme Q10 supplementation ( 50 mg twice daily ) effectively reduced statin-related mild-to-moderate muscular symptoms , causing lower interference of statin-related muscular symptoms with daily activities .


To observe the clinical effect of Guilu Erxian Glue Cataplasm ( GEGC ) on carcinoma of the large intestine patients with myelosuppression after chemotherapy , and further to confirm its efficiency and safety .


Totally 60 patients with carcinoma of the large intestine were randomly assigned to two groups .


Meanwhile , they all accepted FOLFIRI chemotherapy .


Patients in the treatment group were additionally applied at Shenque ( RN8 ) , exchanging once per every other day , for 14 successive days .


Patients in the control group took placebos with the same dose and dosage as the treatment group .


The blood cell counts ( WBC , NE , and PLT ) were detected before chemotherapy , at day 7 , 10 , and 14 .


The TCM symptoms integrals , Karnofsky performance score ( KPS ) , liver and kidney functions were observed before chemotherapy , at day 7 and day 14 .


Adverse skin reactions were observed each day .


And the usage of hematopoietic growth factors was recorded .


( 1 ) The KPS score at day 7 was more stable in the treatment group than in the control group ; the WBC and NE counts in the peripheral blood at day 14 were higher in the treatment group than in the control group ; and TCM symptoms integrals at day 14 was lower in the treatment group than in the control group , all with statistical difference ( P < 0.05 ) .


( 2 ) Compared with the control group , the PLT count was higher in the treatment group than in the control group , the usage of rhG-CSF and antibiotics was less in the treatment group than in the control group , all with no statistical difference ( P > 0.05 ) .