The OS HR was @ ( @ % CI , @ to @ ; P < @ ; median OS , @ v @ months , respectively ) .


Grade @ hypertension and proteinuria were more common with bevacizumab .


GI perforation occurred in @ % of bevacizumab-treated patients .


Adding bevacizumab to chemotherapy statistically significantly improved PFS and ORR ; the OS trend was not significant .


No new safety signals were observed .


Tissue inhibitor of metalloproteinases-@ ( TIMP-@ ) has anti-apoptotic functions , which may protect TIMP-@ positive cancer cells from the effects of chemotherapy such as docetaxel and gemcitabine .


The purpose of the present study was to evaluate TIMP-@ immunoreactivity as a prognostic and predictive marker in advanced breast cancer patients receiving docetaxel ( D ) or gemcitabine plus docetaxel ( GD ) .


Patients with locally advanced or metastatic breast cancer who were assigned to D or GD by participation in a randomized phase III trial were included in the study .


Assessment of TIMP-@ status was performed retrospectively on primary tumor whole-tissue sections by immunohistochemistry and tumor samples were considered positive if epithelial breast cancer cells were stained by the anti-TIMP-@ monoclonal antibody VT@ .


Time to progression ( TTP ) was the primary endpoint .


Overall survival ( OS ) and response rate ( RR ) were secondary endpoints .


Associations between TIMP-@ status and outcome after chemotherapy were analyzed by Kaplan-Meier estimates and Cox proportional hazards regression models .


TIMP-@ status was available from @ of @ patients and @ ( @ % ) of the tumors were classified as cancer cell TIMP-@ positive .


No significant difference for TTP between TIMP-@ positive versus TIMP-@ negative patients was observed in multivariate analysis , and RR did not differ according to TIMP-@ status .


However , patients with TIMP-@ positive tumors had a significant reduction in OS events ( hazard ratio = @ , @ % confidence interval ( CI ) = @-@ @ , P = @ ) .


Additionally , a borderline significant interaction for OS was observed between TIMP-@ status and benefit from GD compared to D ( Pinteraction = @ ) such that median OS increased by nine months for TIMP-@ negative patients receiving GD .


TIMP-@ status was an independent prognostic factor for OS but not TTP in patients with advanced breast cancer receiving either D or GD .


There was no statistically significant interaction between TIMP-@ status and treatment , but a trend towards an incremental OS from the addition of gemcitabine to docetaxel in patients with TIMP-@ negative tumors suggests further investigation .


Cellulitis is a common and costly problem , often diagnosed in the outpatient setting .


Many cutaneous conditions may clinically mimic cellulitis , but little research has been done to assess the magnitude of the problem .


To determine if obtaining dermatology consultations in the outpatient primary care setting could assist in the diagnosis of pseudocellulitic conditions and reduce the rate of unnecessary antibiotic use .


Nonblinded randomized clinical trial of competent adults who were diagnosed as having cellulitis by their primary care physicians ( PCPs ) , conducted at outpatient internal medical primary care offices affiliated with a large academic medical center .


Outpatient dermatology consultation .


Primary outcomes were final diagnosis , antibiotic use , and need for hospitalization .


A total of @ patients ( @ male and @ female ) were enrolled for participation in this trial .


Nine patients were randomized to continue with PCP management ( control group ) , and @ patients were randomized to receive a dermatology consultation ( treatment group ) .


Of the @ patients in the dermatology consultation group , @ ( @ % ) were diagnosed as having cellulitis .


In the control group , all @ patients were diagnosed as having cellulitis by PCPs , but dermatologist evaluation determined that @ ( @ % ) of these patients had a psuedocellulitis rather than true infection .


All @ patients ( @ % ) in the control group were treated for cellulitis with antibiotics vs @ patients ( @ % ) in the treatment group ( P < @ ) .


One patient in the control group was hospitalized .


All patients in the treatment group reported improvement of their cutaneous condition at the @-week follow-up examination .


Dermatology consultation in the primary care setting improves the diagnostic accuracy of suspected cellulitis and decreases unnecessary antibiotic use in patients with pseudocellulitic conditions .


Obtaining an outpatient dermatology consultation may be a cost-effective strategy that improves quality of care .


We conducted a randomized and unblinded @ @ sequential-factorial trial , composed of an induction arm ( part @ ) comparing single-dose ( SD ) versus divided-dose rabbit antithymocyte globulin ( rATG ) , and a maintenance arm ( part @ ) comparing tacrolimus minimization versus withdrawal .


We report the long-term safety and efficacy of SD-rATG induction in the context of early steroid withdrawal and tacrolimus minimization or withdrawal .


Patients ( n = @ ) received @ mg/kg rATG , SD or four alternate-day doses ( @ mg/kg/dose ) , with early steroid withdrawal and tacrolimus or sirolimus maintenance .


After @ months targeted maintenance levels were tacrolimus , @ to @ ng/mL and sirolimus , @ to @ ng/mL or , if calcineurin inhibitor-withdrawn , sirolimus @ to @ ng/mL with mycophenolate mofetil @ g two times per day .


Primary endpoints were renal function ( abbreviated modification of diet in renal disease ) and chronic graft histopathology ( Banff ) .


Secondary endpoints included patient survival , graft survival , biopsy-proven rejection , and infectious or noninfectious complications .


Follow-up averaged longer than @ years .


Tacrolimus or sirolimus and mycophenolate mofetil exposure was identical between groups .


The SD-rATG associated with improved renal function ( @-@ months ; P < @ ) in deceased donor recipients .


The SD-rATG associated with quicker lymphocyte , CD@ T cell , and CD@-CD@ recovery and fewer infections .


Cox multivariate hazard modeling showed divided-dose-rATG ( P = @ ) , deceased donor ( P = @ ) , serious infection ( P = @ ) , and lower lymphocyte count ( P = @ ) associated with increased mortality .


Patients with all four covariates showed a @-fold increased likelihood of death ( P = @ ) .


Chronic graft histopathology , rejection rates , and death-censored graft survival were not significantly different between groups .


The SD-rATG induction improves the @-year renal function in recipients of deceased donor kidneys .


This benefit , along with possibly improved patient survival and fewer infections suggest that how rATG is administered may impact its efficacy and safety .


Saxagliptin reduced glycated hemoglobin ( HbA@c ) , fasting plasma glucose ( FPG ) , and postprandial glucose ( PPG ) in Asian patients with type @ diabetes mellitus ( T@DM ) .


To understand the physiology of this effect , indices of - and - cell function were measured in a subpopulation of Chinese patients following a noodle mixed-meal tolerance test .


Data from Chinese patients were pooled from two phase @ , @-week studies of saxagliptin @mg/d as monotherapy in drug-naive patients and as add-on to metformin in patients inadequately controlled with metformin alone .


The end points for - and - cell function were change from baseline in C-peptide , insulin , and glucagon areas under the curve from @ to @ min ( AUC@-@ ) , insulinogenic index , and insulin sensitivity from Matsuda index after a mixed meal .


Also glycemic variables , HbA@c , FPG , and PPG ( AUC@-@ ) , and homeostasis model assessment ( HOMA ) @ were measured .


At @ weeks , greater improvements in adjusted mean change from baseline HbA@c ( difference vs placebo -LSB- @ % CI -RSB- , -@ % -LSB- -@ % , -@ % -RSB- , -LSB- -@ ( -@ , -@ ) mmol/mol -RSB- , P < @ ) , FPG ( -@ -LSB- -@ , -@ -RSB- mmol/L , P = @ ) , PPG AUC@-@ ( -@ -LSB- -@ , -@ -RSB- mmol min/L , P < @ ) , C-peptide AUC@-@ ( @ -LSB- @ , @ -RSB- nmol min/L , P = @ ) , insulinogenic index ( @ % -LSB- @ % , @ % -RSB- , P = @ ) , and greater suppression of glucagon secretion ( glucagon AUC@-@ , -@ -LSB- -@ , -@ -RSB- pmol min/L , P = @ ) were observed with saxagliptin versus placebo .


In Chinese patients with T@DM , saxagliptin as monotherapy or as add-on to metformin improved glycemic control by modulating - and - cell function .


Low plasma vitamin D levels have been associated with heart failure ( HF ) .


This research attempts to explain the role of vitamin D supplementation on myocardial function in elderly patients with HF .


Twenty-three chronic HF patients were randomized in a small parallel group , double-blind , placebo-controlled trial .


All patients , with a mean age of @ years and vitamin D levels < @ ng/mL , received @,@ IU ( @ IU/daily ) of cholecalciferol or placebo for @ months .


The outcomes measured at baseline and after @ months were ejection fraction ( EF ) and other echocardiography parameters , carboxyterminal propeptide of procollagen type I ( PIP ) , natriuretic peptides , lipid profile , renin , parathyroid hormone , blood pressure , and body mass index ( BMI ) .


In @ patients under active treatment for @ months , mean plasma @-hydroxy vitamin D concentrations ( @ vs. -@ ng/mL , p < @ ) and plasma calcium ( from @ to @ mmol/L , p < @ ) increased significantly .


However , other biomarkers of bone metabolism did not differ between the treatment and placebo groups .


EF increased significantly in the intervention group ( @ vs. -@ % ; p < @ ) , and the serum concentration of PIP increased only in the placebo group after @ months ( @ vs. -@ mcg/L ; p < @ ) .


Systolic blood pressure was lower after @ months of cholecalciferol treatment ( from @ to @ mm Hg , p < @ ) .


No significant variations were observed for other parameters .


Six months of vitamin D supplementation significantly improves EF in elderly patients with HF and vitamin D deficiency .


Complex regional pain syndrome ( CRPS ) is characterized by signs and symptoms of peripheral inflammation , which leads to peripheral neural sensitization associated most frequently ( in about @ % ) with blunt pressure hyperalgesia .


Therefore , we hypothesized that treatment of CRPS patients with a selective COX-@-inhibitor would alleviate the abnormally low pressure pain threshold ( PPT ) and reduce pain intensity and edema .


Twenty patients with CRPS type I ( n = @ ) and II of the upper limb and abnormally low PPT were double-blind randomised into @ groups of @ patients each to receive a @-day intravenous treatment of either @ mg parecoxib per day ( group I ) or placebo ( NaCl @ % , group II ) .


Standardized quantitative sensory testing ( QST ) using the DFNS protocol was performed before and after treatment .


Pain intensity ( NRS @ - @ ) ; circumferences of the fingers II , IV , and V ( mm ) ; PPT ( kPa , thenar/hypothenar ) ; and adverse events were recorded daily .


Wilcoxon-test , Mann-Whitney-U-test , Friedman-test , Fisher-test , significance level : P < @ .


Proof of concept trial performed in randomized , placebo-controlled , double blind style .


Pain Management Center in Germany .


There were no group differences in PTT or other QST parameters .


After treatment , PPT decreased insignificantly in group I ( median -LSB- range -RSB- ; before : @ -LSB- @ - @ -RSB- kPa , afterwards : @ -LSB- @ - @ -RSB- kPa ) and increased insignificantly in group II ( before : @ -LSB- @ - @ -RSB- kPa ; afterwards : @ -LSB- @ - @ -RSB- kPa ) .


Pain scores and finger circumferences remained unchanged in both groups .


Due to difficulty in recruitment the trial was closed after inclusion of @ patients .


In the present proof-of-concept trial , short-term treatment with the selective COX-@-inhibitor parecoxib influenced neither PPT nor edema or pain .


COX-@ might be less important than previously assumed .


However , the results are limited due to the small number of patients , short-term treatment , and focus on the PPT , which could have led to false negative results of the present study and covered the expected therapeutic effect .


Repeated exposure to peritoneal dialysis ( PD ) solutions contributes to cumulative intraperitoneal inflammation and peritoneal injury .


The present study aimed to explore the capacity of dialysate interleukin-@ ( IL-@ ) to a ) predict peritoneal membrane function and peritonitis in incident PD patients , and b ) to evaluate the influence of neutral pH , low glucose degradation product ( GDP ) PD solution on dialysate IL-@ levels .


The study included @ incident participants from the balANZ trial who had completed @-months of follow-up .


Change in peritoneal solute transport rate ( PSTR ) and peritonitis were primary outcome measures , and the utility of IL-@ and IL-@ appearance rate ( IL-@ AR ) in predicting these outcomes was analyzed using multilevel linear regression and Cox proportional hazards models , respectively .


Sensitivity analyses were performed by analyzing outcomes in a peritonitis-free cohort ( n = @ ) .


Dialysate IL-@ concentration significantly increased from baseline to @months ( mean difference @ pg/mL ; P < @ ) but was not affected by the type of PD solution received ( P = @ ) .


An increase in PSTR from baseline was associated with higher levels of IL-@ ( P = @ ) , the use of standard solutions ( P = @ ) and longer PD duration ( P < @ ) .


Baseline IL-@ level was not associated with a shorter time to first peritonitis ( adjusted hazard ratio @ , @ % CI @-@ @ , P = @ ) .


Analysis of IL-@ AR as well as sensitivity analyses in a peritonitis-free cohort yielded comparable results .


Dialysate IL-@ concentration increased with longer PD duration and was a significant , independent predictor of PSTR .


The use of biocompatible PD solutions exerted no significant effect on dialysate IL-@ levels but did abrogate the increase in PSTR associated with standard PD solutions .


This is the first study to examine the impact of biocompatible solutions on the utility of IL-@ in predicting PSTR and peritonitis .


The TARGIT-A trial compared risk-adapted radiotherapy using single-dose targeted intraoperative radiotherapy ( TARGIT ) versus fractionated external beam radiotherapy ( EBRT ) for breast cancer .


We report @-year results for local recurrence and the first analysis of overall survival .


TARGIT-A was a randomised , non-inferiority trial .


Women aged @ years and older with invasive ductal carcinoma were enrolled and randomly assigned in a @:@ ratio to receive TARGIT or whole-breast EBRT , with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy : randomisation occurred either before lumpectomy ( prepathology stratum , TARGIT concurrent with lumpectomy ) or after lumpectomy ( postpathology stratum , TARGIT given subsequently by reopening the wound ) .


Patients in the TARGIT group received supplemental EBRT ( excluding a boost ) if unforeseen adverse features were detected on final pathology , thus radiotherapy was risk-adapted .


The primary outcome was absolute difference in local recurrence in the conserved breast , with a prespecified non-inferiority margin of @ % at @ years ; prespecified analyses included outcomes as per timing of randomisation in relation to lumpectomy .


Secondary outcomes included complications and mortality .


This study is registered with ClinicalTrials.gov , number NCT@ .


Patients were enrolled at @ centres in @ countries , between March @ , @ , and June @ , @ patients were randomised to TARGIT and @ to EBRT .


Supplemental EBRT after TARGIT was necessary in @ % -LSB- @ of @ -RSB- of patients who received TARGIT ( @ % prepathology , @ % postpathology ) .


@ patients had a median follow-up of @ years and @ months ( IQR @-@ months ) , @ of @ years , and @ of @ years .


The @-year risk for local recurrence in the conserved breast was @ % ( @ % CI @-@ ) for TARGIT versus @ % ( @-@ ) for EBRT ( p = @ ) .


TARGIT concurrently with lumpectomy ( prepathology , n = @ ) had much the same results as EBRT : @ % ( @-@ ) versus @ % ( @-@ ; p = @ ) .


With delayed TARGIT ( postpathology , n = @ ) the between-group difference was larger than @ % ( TARGIT @ % -LSB- @-@ -RSB- vs EBRT @ % -LSB- @-@ -RSB- ; p = @ ) .


Overall , breast cancer mortality was much the same between groups ( @ % -LSB- @-@ -RSB- for TARGIT vs @ % -LSB- @-@ -RSB- for EBRT ; p = @ ) but there were significantly fewer non-breast-cancer deaths with TARGIT ( @ % -LSB- @-@ -RSB- vs @ % -LSB- @-@ -RSB- ; p = @ ) , attributable to fewer deaths from cardiovascular causes and other cancers .


Overall mortality was @ % ( @-@ ) for TARGIT versus @ % ( @-@ ) for EBRT ( p = @ ) .


Wound-related complications were much the same between groups but grade @ or @ skin complications were significantly reduced with TARGIT ( four of @ vs @ of @ , p = @ ) .


TARGIT concurrent with lumpectomy within a risk-adapted approach should be considered as an option for eligible patients with breast cancer carefully selected as per the TARGIT-A trial protocol , as an alternative to postoperative EBRT .


We evaluated the effect of intravitreal triamcinolone acetonide ( IVTA ) or intravitreal bevacizumab ( IVB ) on subfoveal choroidal thickness ( SFCT ) in eyes with diabetic macular edema ( DME ) .


In this prospective , randomized , interventional comparative study , @ DME eyes of @ patients were randomized to receive either IVTA or IVB .


The central macular thickness ( CMT ) and SFCT were determined by optical coherence tomography at @ hours , @ days , and @ , @ , and @ weeks .


The SFCT at @ and @ m nasal or temporal to the central fovea also was measured .


The values obtained before were compared to those obtained @ weeks after the injections .


The eyes were randomly assigned to the IVTA ( @ eyes ) and IVB ( @ eyes ) groups .


The SFCT was reduced significantly in the IVTA group from @ hours to @ weeks .


The average SD of the SFCT expressed as the ratio to baseline thickness decreased to @ % @ % ( P < @ ) at @ hours after IVTA and remained unchanged up to @ weeks ( @ % @ % , P < @ , Wilcoxon signed-rank test ) .


In the IVB group , no significant difference was found in the SFCT after IVB for @ weeks .


The CMT decreased significantly in both groups from @ hours to @ weeks ; however , the decrease was not significant at @ weeks or later in the IVB group .


The decrease in choroidal thickness in eyes with DME after IVTA suggests that the choroidal pathology in diabetic retinopathy might be due to steroid-sensitive factors rather than vascular endothelial growth factor .


( www.umin.ac.jp/ctr number , clinical trials number UMIN@ . )


Metatarsal fractures are managed using different types of forefoot offloading orthosis .


Theaim of this prospective study was to evaluate the clinical and pedographic results of a vacuum shoe system in comparison to a forefoot unloading shoe .


@ patients ( @ women/@ men -- age : @ + / - @ years ) were prospectively included in the study .


The patients were followed up at four different time points .


Detailed clinical and radiological examinations were carried out , functional scores were measured and a pedographic assessment was performed .


Between the study groups no differences were seen in functional scoring .


A complete bony healing was achieved within the @ months of followup in all patients .


The heelstrike to heelstrike time was without significant differences in the pedographic analysis .


Adequate forefoot unloading was achieved with both orthosis .


The load sharing between fore - , mid - and hindfoot showed no significant differences in the pedographic analysis .


Patients ' satisfaction was rated with higher values for the vacuum shoe system , but without significance .


Both shoe systems show an adequate unloading of the forefoot .


Therefore both orthosis may be used for the treatment of metatarsal fractures .


Research indicates that music therapy can improve social behaviors and joint attention in children with Autism Spectrum Disorder ( ASD ) ; however , more research on the use of music therapy interventions for social skills is needed to determine the impact of group music therapy .


To examine the effects of a music therapy group intervention on eye gaze , joint attention , and communication in children with ASD .


Seventeen children , ages @ to @ , with a diagnosis of ASD were randomly assigned to the music therapy group ( MTG ) or the no-music social skills group ( SSG ) .


Children participated in ten @-minute group sessions over a period of @ weeks .


All group sessions were designed to target social skills .


The Social Responsiveness Scale ( SRS ) , the Autism Treatment Evaluation Checklist ( ATEC ) , and video analysis of sessions were used to evaluate changes in social behavior .


There were significant between-group differences for joint attention with peers and eye gaze towards persons , with participants in the MTG demonstrating greater gains .


There were no significant between-group differences for initiation of communication , response to communication , or social withdraw/behaviors .


There was a significant interaction between time and group for SRS scores , with improvements for the MTG but not the SSG .


Scores on the ATEC did not differ over time between the MTG and SSG .


The results of this study support further research on the use of music therapy group interventions for social skills in children with ASD .


Statistical results demonstrate initial support for the use of music therapy social groups to develop joint attention .


to assess efficacy , safety , and tolerability of @ fixed irbesartan/amlodipine combinations in hypertensive patients resistant to monotherapy with @ mg irbesartan or @ mg amlodipine in a @ week prospective open uncontrolled randomized multicenter study .


We included in this study @ patients with essential arterial hypertension ( AH ) ( mean age @ @ years , @ women ) receiving monotherapy with @ mg irbesartan ( n = @ ; @ % ) or @ mg amlodipine ( n = @ ; @ % ) .


Patients not achieving target arterial pressure ( AP ) < @/@ mm ( n = @ ) Hg were given fixed irbesartan/amlodipine combination @/@ mg .


If target AP was not achieved patients were randomized to @/@ or @/@ mg combinations .


If necessary after @ more weeks these doses were increased to maximal ( @/@ mg ) .


Thus @ fixed irbesartan/amlodipine combinations were used : @/@ , @/@ , @/@ , @/@ mg .


Primary criterion of efficacy was portion of patients with target AP at last visit .


Safety was assessed by presence of unfavorable events , clinical and laboratory parameters .


After @ weeks @ , @ , @ and @ % of patients received @/@ , @/@ , @/@ and @/@ mg combinations , respectively .


At final visit @ % of patients had AP < @/@ mm Hg .


Mean AP lowering in the total group was -@ @ / -@ @ mm Hg ( < @ ) .


There were @ cases of ankle edema ( @ % ) but no withdrawals due to unfavorable events .


There were no differences between @ dosing regimens in laboratory and clinical parameters of safety and tolerability .


In patients with AH not achieving target AP on monotherapy with irbesartan @ or amlodipine @ mg administration of irbesartan/amlodipine combination with possibility of dose titration using @ fixed combinations was effective in @ % of patients , resulted in significant systolic and diastolic AP lowering in all therapeutic groups , was well tolerated and safe .


To determine if a pharmacist-initiated multidisciplinary strategy provides value for money compared to usual care in participants with previously undiagnosed knee osteoarthritis .


Pharmacies were randomly allocated to provide either @ ) usual care and a pamphlet or @ ) intervention care , which consisted of education , pain medication management by a pharmacist , physiotherapy-guided exercise , and communication with the primary care physician .


Costs and quality-adjusted life-years ( QALYs ) were determined for patients assigned to each treatment and incremental cost-effectiveness ratios ( ICERs ) were determined .


From the Ministry of Health perspective , the average patient in the intervention group generated slightly higher costs compared with usual care .


Similar findings were obtained when using the societal perspective .


The intervention resulted in ICERs of $ @ ( @ % confidence interval -LSB- @ % CI -RSB- -@,@ , @,@ ) per QALY gained from the Ministry of Health perspective and $ @,@ ( @ % CI @,@ , @,@ ) per QALY gained from the societal perspective , compared with usual care .


A pharmacist-initiated , multidisciplinary program was good value for money from both the societal and Ministry of Health perspectives .


This Phase III , randomized , double-blind , placebo-controlled study investigated the efficacy and tolerability of flexibly-dosed cariprazine in patients with acute manic or mixed episodes associated with bipolar I disorder .


Patients were randomized to @ weeks of double-blind treatment with cariprazine @-@mg / day ( n = @ ) or placebo ( n = @ ) .


The primary efficacy parameter was change from baseline to Week @ in Young Mania Rating Scale ( YMRS ) total score .


The secondary efficacy parameter was change from baseline to Week @ in Clinical Global Impressions-Severity ( CGI-S ) score .


Mean change from baseline to Week @ in YMRS total score was significantly greater for patients receiving cariprazine @-@mg / day versus placebo ( P = @ ) .


Significant differences between groups in YMRS total score mean change were observed by Day @ ( first postbaseline assessment ) and maintained throughout double-blind treatment ( all assessments , P < @ ) .


Cariprazine also demonstrated statistically significant superiority over placebo on YMRS response ( @ % improvement : cariprazine , @ % ; placebo , @ % ; P = @ ) and remission ( YMRS total score@ : cariprazine , @ % ; placebo , @ % ; P = @ ) and mean change in CGI-S ( P = @ ) score and Positive and Negative Syndrome Scale ( PANSS ) ( P = @ ) total score .


The most common cariprazine-related ( @ % and twice placebo ) treatment emergent adverse events ( TEAEs ) were akathisia , extrapyramidal disorder , tremor , dyspepsia , and vomiting .


Mean change from baseline in metabolic parameters were generally small and similar between groups .


Lack of active comparator arm ; short duration of study .


In this study , cariprazine @-@mg / day was effective and generally well tolerated in the treatment of manic and mixed episodes associated with bipolar I disorder .


Fasting period before surgery may change metabolic status of the patient and have influence on perioperative stress response .


The aim of the study was to investigate effects of preoperative carbohydrate-rich beverage on stress response after laparoscopic cholecystectomy .


Patients admitted for laparoscopic cholecystectomy were included into study and they were randomized into a group that was fed prior to surgery and in a group that was in the regime of nothing by mouth from the evening one day before surgery .


Concentrations of C-reactive protein and cortisol , were measured before and subsequently up to @ h postoperatively .


Postoperative serum C-reactive protein increased significantly in both groups , but the increase was more evident in the group with fasting protocol both @ and @ hours postoperatively .


In fed patients cortisol concentration measured in the afternoon immediately after the operation showed physiological decline .


In patients with fasting protocol postoperative cortisol values rise above the values measured in the morning .


Preoperative feeding has advantage over overnight fasting by reducing preoperative discomfort in patients after laparoscopic cholecystectomy .


In fed patients , smaller increase in C-reactive protein and better regulation of cortisol levels are an indicator of decreased perioperative stress response .


Proximal cerebral protection devices have been developed as an alternative to filter protection devices for reducing neurological complications during carotid artery stenting ( CAS ) .


The aim of the present study was to evaluate the frequency of silent cerebral embolism after CAS using different cerebral embolic protection devices and the impact of silent cerebral embolism on neurocognitive function .


One hundred consecutive patients who underwent CAS were enrolled .


The patients were randomized to either proximal balloon occlusion or filter protection .


Neurocognitive tests were performed before and six months after CAS .


Cerebral embolisms were evaluated with diffusion-weighted magnetic resonance imaging ( DW-MRI ) .


The number and volume of new ischemic lesions found with DW-MRI were higher in the filter protection group than in the proximal balloon occlusion group .


According to our definition , nine ( @ % ) patients in the balloon occlusion group and @ ( @ % ) patients in the filter protection group showed neurocognitive decline , and ten ( @ % ) patients in the balloon occlusion group and four ( @ % ) patients in the filter protection group showed neurocognitive improvement ( NS ) .


Regarding the group of patients with new cerebral ischemic lesions on DW-MRI , neurocognitive decline occurred in @ ( @ % ) of @ patients with DW-MRI lesions and @ ( @ % ) of @ patients without DW-MRI lesions ( NS ) .


Neurocognitive outcome after CAS is unpredictable ; both neurocognitive decline and improvement can occur .


In this study , the proximal balloon occlusion system significantly decreased cerebral microemboli during CAS compared to filter protection .


Cerebral microembolism was not found to be associated with neurocognitive decline .


Community-acquired pneumonia ( CAP ) is a leading cause of mortality , morbidity and hospital admission , which places strain on our healthcare system .


Procalcitonin ( PCT ) is a biomarker of bacterial infection which may help gauge the severity and prognosis of patients with CAP .


In addition to clinical predictors , PCT may assist in decisions pertaining to timing of discharge from hospital and the discontinuation of antibiotics .


This study aimed to determine the predictive role of PCT measurement in reducing hospital admissions , length of stay ( LOS ) and antibiotic ( AB ) usage in patients with CAP .


A prospective , single-blinded , externally controlled study of consenting adult patients admitted with CAP .


PCT levels were obtained on day @ and day @ ( when indicated ) .


Investigator-evaluated clinical parameters , together with results of PCT levels , determined the timing of oral AB switch and discharge from hospital .


This process was compared against standard practice , but was not actually implemented , for the purpose of this study .


Sixty patients were included in the study .


The mean age was @ @ years ( @ % male ) .


The average Pneumonia Severity Index was @ @ ( class IV ) and the median CURB-@ was @ .


The mean LOS for the standard practice cohort was @ @ days versus calculated LOS using the PCT guidance pathway of @ @ days .


( P = @ ) .


Our study supports the hypothesis that by incorporation of PCT levels , hospital admission and LOS in patients with CAP can be reduced .


A randomised prospective clinical trial is planned in an attempt to help confirm these findings .


The aim of this single center study is to evaluate the effectiveness of performing ultrasound-guided thyroid fine-needle aspiration biopsies ( FNAB ) performed by the radiologist alone without an on-site cytopathologist .


In this prospective randomized study , @ patients with single nodules measuring @mm or more underwent ultrasound-guided FNAB : @ patients underwent FNAB performed by the radiologist accompanied by a cytopathologist ( control group ) ; @ patients underwent FNAB by the radiologist alone ( study group ) .


In both groups biopsy time , specimen adequacy ratio , total aspiration number , cytopathologist 's cytological diagnosis time ( t@ ) , cytopathologist 's total time consumption ( t@ ) were evaluated .


Mean total biopsy time was @ @ min in the study group and was significantly shorter than the control group 's @ @ min ( p = @ ) .


The average number of aspirations per patient in the study group was @ @ ; compared to the control group 's @ @ this was significantly higher ( p = @ ) .


t@ of the study group was @ @ s ; compared to @ @ s in the control group , there was no statistically significant difference ( p = @ ) .


t@ of the study group was @ @ s ; compared to the control group ( @ @ s ) there was no statistically significant difference ( p = @ ) .


Diagnostic adequacy of aspirated specimens was reassessed in the pathology laboratory .


In the study group , @ out of @ aspirations and in the control group @ out of @ aspirations was determined as adequate with no statistically significant difference ( p = @ ) .


We believe that in centers where a cytopathologist is not available , ultrasound-guided thyroid FNAB can be adequately performed by an experienced radiologist who was effectively trained in smear preparation .


In the United States , use of oral opioid analgesics has been associated with increasing rates of addiction , abuse , and diversion .


However , little is known about the recent national use of non-illicit prescription opioid analgesics ( those prescribed in a physician-patient relationship ) , the primary source of these drugs for the general US population .


Our primary objective was to examine trends in the use of prescription opioid analgesics in the United States and to identify defining characteristics of patient users of prescribed opioids from @ to @ .


We used the nationally representative Medical Expenditure Panel Survey to examine trends in prescription oral opioid analgesic use from @ to @ .


We used survey design methods to make national estimates of adults ( @ years and older ) who reported receiving an opioid analgesic prescription ( referred to as opioid users ) and used logistic regression to examine predictors of opioid analgesic use .


Our primary outcome measures were national estimates of total users of prescription opioid analgesics and total number of prescriptions .


Our secondary outcome was that of observing changes in the disability and health of the users .


The estimated total number of opioid analgesic prescriptions in the United States increased by @ % , from @ million in @ to @ million in @ .


In @ , an estimated @ % ( @ % confidence interval , @-@ @ ) of adult Americans were prescription opioid users compared with @ % ( @ % confidence interval , @-@ @ ) in @ .


On the basis of estimates adjusted for changes in the general population , each year was associated with a @ % increase in the likelihood of receiving an opioid prescription from @ to @ .


Despite the apparent increase in use , there were no demonstrable improvements in the age - or sex-adjusted disability and health status measures of opioid users .


The use of prescription opioid analgesics among adult Americans has increased in recent years , and this increase does not seem to be associated with improvements in disability and health status among users .


On a public health level , these data suggest that there may be an opportunity to reduce the prescribing of opioid analgesics without worsening of population health metrics .


Although accumulating data support the efficacy of intramyocardial cell-based therapy to improve left ventricular ( LV ) function in patients with chronic ischemic cardiomyopathy undergoing CABG , the underlying mechanism and impact of cell injection site remain controversial .


Mesenchymal stem cells ( MSCs ) improve LV structure and function through several effects including reducing fibrosis , neoangiogenesis , and neomyogenesis .


To test the hypothesis that the impact on cardiac structure and function after intramyocardial injections of autologous MSCs results from a concordance of prorecovery phenotypic effects .


Six patients were injected with autologous MSCs into akinetic/hypokinetic myocardial territories not receiving bypass graft for clinical reasons .


MRI was used to measure scar , perfusion , wall thickness , and contractility at baseline , at @ , @ , and @ months and to compare structural and functional recovery in regions that received MSC injections alone , revascularization alone , or neither .


A composite score of MRI variables was used to assess concordance of antifibrotic effects , perfusion , and contraction at different regions .


After @ months , subjects receiving MSCs exhibited increased LV ejection fraction ( +@ @ % , P = @ ) and decreased scar mass ( -@ @ % ; P < @ ) compared with baseline .


MSC-injected segments had concordant reduction in scar size , perfusion , and contractile improvement ( concordant score : @ @ ) , whereas revascularized ( @ @ ) and nontreated segments ( -@ @ ) demonstrated nonconcordant changes ( P < @ versus injected segments ) .


Intramyocardial injection of autologous MSCs into akinetic yet nonrevascularized segments produces comprehensive regional functional restitution , which in turn drives improvement in global LV function .


These findings , although inconclusive because of lack of placebo group , have important therapeutic and mechanistic hypothesis-generating implications .


To investigate the effect of supplementing qi , activating blood circulation and tonifying kidney therapy on the postoperative outcomes of patients undergoing lumber intervertebral disc herniation .


From January @ to May @ , @ patients with lumbar intervertebral disc herniation undergoing surgical treatment in Nanfang hospital were randomized into two equal groups to receive routine therapy ( control group ) and additional treatment with Yiqi Houxue Bushen Decoction ( treatment group ) .


The effect of the interventions was evaluated by assessing the Visual Analogue Scale ( VAS ) , Japanese Orthopedic Association Scores ( JOA ) , WHO Quality of Life-BREF ( WHOQOL-BREF ) , length of hospital stay and adverse event .


All the @ patients were followed up and analyzed .


Significant differences were found between the treatment and control groups in VAS , JOA Scores , and WHOQOL-BREF ( P < @ ) at @ , @ , and @ week and at @ and @ months after the surgery .


At @ and @ months postoperatively , the JOA Scores ( P < @ ) , but not the VAS and WHOQOL-BREF , differed significantly between the two groups .


Blood-activating and kidney-nourishing therapy is effective in promoting postoperative recovery and helps reduce the clinical symptoms and minimize the adverse events in patients undergoing surgery for lumber intervertebral disc herniation .


Pharmacological stimulation of D@ receptors modulates prefrontal neural activity associated with working memory ( WM ) processing .


The T allele of a functional single-nucleotide polymorphism ( SNP ) within DRD@ ( rs@ G > T ) predicts reduced relative expression of the D@S receptor isoform and less efficient neural cortical responses during WM tasks .


We used functional MRI to test the hypothesis that DRD@ rs@ genotype interacts with pharmacological stimulation of D@ receptors with bromocriptine on prefrontal responses during different loads of a spatial WM task ( N-Back ) .


Fifty-three healthy subjects ( @ GG and @ GT ) underwent two @-T functional MRI scans while performing the @ - , @ - and @-Back versions of the N-Back WM task .


Before the imaging sessions , either bromocriptine or placebo was administered to all subjects in a counterbalanced order .


A factorial repeated-measures ANOVA within SPM@ ( p < @ , family-wise error corrected ) was used .


On bromocriptine , GG subjects had reduced prefrontal activity at @-Back together with a significant decrement in performance , compared with placebo .


On the other hand , GT subjects had lower activity for the same level of performance at @-Back but a trend for reduced behavioral performance in the face of unchanged activity at @-Back .


These results indicate that bromocriptine stimulation modulates prefrontal activity in terms of disengagement or of efficiency depending on DRD@ genotype and working memory load .


Bibersteinia trehalosi causes respiratory disease in ruminants particularly in wild and domestic sheep .


Recently , there has been an increased number of B. trehalosi isolates obtained from diagnostic samples from bovine respiratory disease cases .


This study evaluated the role of B. trehalosi in bovine respiratory disease using an intra-tracheal inoculation model in calves .


Thirty six cross bred @-@ month old dairy calves were inoculated intra-tracheally with either leukotoxin negative B. trehalosi , leukotoxin positive B. trehalosi isolate , Mannheimia haemolytica , a combination of leukotoxin negative B. trehalosi and M. haemolytica or negative control .


Calves were euthanized and necropsy performed on day @ of study .


B. trehalosi inoculated calves did not have increased lung involvement compared to control calves .


Additionally , B. trehalosi was only cultured once from the lungs of inoculated calves at necropsy .


Based on these findings B. trehalosi may not be a primary pathogen of respiratory disease in cattle .


Culture of B. trehalosi from diagnostic submissions should not be immediately identified as a primary cause of respiratory disease .


This study was intended to evaluate the efficacy of fibrin glue ( FG ) in preventing post-traumatic focal pancreatitis ( PTFP ) after radical gastrectomy by examining the drainage fluids over @ days post-op .


Ninety-five patients who underwent D@ radical gastrectomy for gastric cancer were randomly assigned to a fibrin glue group ( n = @ ) receiving fibrin glue on the raw surface of the pancreas during surgery and a control group ( n = @ ) , which did not receive fibrin glue .


We found no significant difference in operation time and intraoperative blood loss between groups ( p > @ ) ; no deaths occurred during surgery .


The volume of ascitic fluid containing blood cells in the fibrin glue group was significantly lower than that in the control group ( p < @ ) at all times observed .


Amylase levels in the drained fluids were highest at @ h postoperatively in both groups , suggesting pancreatitis , but gradually decreased to normal levels within @ days .


The amylase in the drains in the control group was significantly higher than that in the FG group ( p < @ ) at all times observed , but it returned to normal @ h postoperatively in the FG group .


One death by hemorrhagic shock associated with PTFP was recorded in the control group .


Fibrin glue is safe and effective in preventing PTFP following gastric surgery and shortens the clinical course of the disease .


This study aimed to investigate the duration of gingival healing after the stage II surgery of dental implantation for periodontitis patients and to provide clinical guidelines for implant restoration .


Twenty-nine periodontitis patients who had implantation surgery and achieved osseointegration were operated with stage II surgery ( a total of @ pieces of implants ) .


The height of buccal gingival of each implant was measured twice after the stage II surgery .


All implants were measured at the lowest point ofbuccal gingival after one week .


The implants were randomly divided into four groups according to the schedule of the next test time : group one at one week from the initial test point , group two at two weeks , group three at three weeks , and group four at four weeks .


Each group includes @ pieces of implants .


The amount of the buccal gingival change in each group between the second and first tests was determined , and the data were analyzed statistically .


The amount of gingival change of groups one , two , three , and four was ( -@ + / - @ ) , ( -@ + / - @ ) , ( -@ + / - @ ) , and ( -@ + / - @ ) mm , respectively .


No significant difference was observed between groups one and two in terms of the amount of gingival changes ( P > @ ) .


However , a significant difference was found between groups two and three ( P < @ ) , and the amount of gingival recession was @ mm .


No significant difference was found between groups three and four ( P > @ ) , and the gingival achieved stability .


The gingival recession achieves stability at the fourth week ( after @ d ) after stage II surgery .


At this time , the implant can be restored , and the abutment can be selected according to the amount of gingival change of the periodontitis patient .


Previous research has identified several aspects of behavioral undercontrol that are associated with heavy drinking and problems .


Further , research on the acquired preparedness model ( Smith and Anderson , @ ) has identified biased learning as a potential mechanism of these effects .


Traits like sensation seeking have been linked to stronger positive and weaker negative expectancies , which , in turn , contribute to increased risk for heavy drinking and problems .


Although expectancies are thought to represent potentially biased expectations about drinking outcomes , they may also reflect individual differences in alcohol response .


The present study examined the strength of associations between sensation seeking and both expectancies ( response to placebo ) and subjective response under alcohol .


Using a between-subjects design , young adult social drinkers ( N = @ ) were randomly assigned to receive alcohol ( target breath alcohol concentration of @ % ) or placebo , after which they reported on subjective experiences of stimulation and sedation .


Sensation seeking was significantly related to stimulant response , and the strength of this association did not differ by beverage condition ( alcohol vs. placebo ) .


The findings argue against a pharmacological explanation for results of prior studies of the acquired preparedness model and support a biased learning interpretation of relations between sensation seeking and positive expectancies .


Results also extend the findings on the acquired preparedness model to an implicit measure of positive alcohol expectancies ( subjective response to placebo ) .


Future studies using additional measures of implicit expectancies ( e.g. , Implicit Association Test ) would be helpful in determining the relative strength of implicit and explicit expectancies as mediators within the acquired preparedness model .


To prospectively evaluate the efficacy of Removing Stasis and Reducing Heat Formula in accelerating calculus clearance and improving lower urinary tract symptoms of patients with proximal ureteral calculi after ureteroscopic Ho : YAG laser lithotripsy .


A total of @ patients with proximal ureteral calculi underwent ureteroscopic Ho : YAG laser lithotripsy by a single endocrinologist .


Stone size varied from @ to @ mm .


After operation , the patients were randomly divided into three groups : the control group ( group A ) , tamsulosin group ( group B ) , and Removing Stasis and Reducing Heat Formula group ( group C ) .


The treatment lasted for @ weeks or until stone clearance .


The primary and secondary outcomes of the three groups at follow-up were assessed .


Of the @ patients available for follow-up , @ cases were in the group A , @ in the group B , and @ in the group C , respectively .


The stone free rate at @ weeks in the groups B and C were significantly higher than that in the group A ( @ % , @ % vs. @ % ; all P < @ ) .


The ureteral colic rate and mean time of fragment expulsion were significantly reduced in the groups B ( @ % and @ days ) and C ( @ % and @ days ) compared with the group A ( @ % and @ days , all P < @ ) .


On the day of double-J ureteric stent removal , the group C differed significantly from the group A in the total International Prostate Symptom Score , irritative subscore , obstructive subscore , and quality of life score ( all P < @ ) .


Removing Stasis and Reducing Heat Formula in the medical expulsive therapy might be an effective modality for patients with calculus in the proximal uretera after ureteroscopic Ho : YAG laser lithotripsy .


High-fidelity patient simulation ( HFPS ) has been used in medical education to bridge gaps in medical knowledge and clinical skills .


Few studies have analyzed the impact of HFPS in subspecialty rotations for pediatric residents .


We hypothesized that pediatric residents exposed to HFPS with a structured content curriculum would perform better on a case quiz than residents without exposure to HFPS .


Prospective randomized controlled


Tertiary-care free standing children 's hospital


During a cardiology rotation , senior pediatric residents completed an online pediatric cardiology curriculum and a cardiology quiz .


After randomization into two groups , the study group participated in a fully debriefed HFPS session .


The control group had no HFPS .


Both groups completed a case quiz .


Confidence surveys pre - and postsimulation were completed .


From October @ through March @ , @ residents who rotated through the pediatric cardiology rotation were used in the final analysis ( @ control , @ in the study group ) .


There was no significant difference between groups on the initial cardiology quiz .


The study group scored higher on the case quiz compared with the control group ( P = @ ) .


Based on pre - and postsimulation questionnaires , residents ' confidence in approaching a pediatric cardiology patient improved from an average Likert score of @ to @ ( on scale of @-@ ) ( P < @ ) .


Incorporation of HFPS into a preexisting pediatric cardiology rotation was feasible and well received .


Our study suggests that simulation promotes increased confidence and may modestly improve clinical reasoning compared to traditional educational techniques .


Targeted simulation sessions may readily be incorporated into pediatric subspecialty rotations .


To assess whether immediate ( @h ) , intermediate ( after @h ) or delayed ( after @h ) removal of an indwelling urinary catheter after uncomplicated abdominal hysterectomy can affect the rate of re-catheterization due to urinary retention , rate of urinary tract infection , ambulation time and length of hospital stay .


Prospective randomized controlled trial conducted at Suez Canal University Hospital , Egypt .


Two hundred and twenty-one women underwent total abdominal hysterectomy for benign gynecological diseases and were randomly allocated into three groups .


Women in group A ( @ patients ) had their urinary catheter removed immediately after surgery .


Group B ( @ patients ) had the catheter removed @h post-operatively while in group C ( @ patients ) the catheter was removed after @h .


The main outcome measures were the frequency of urinary retention , urinary tract infections , ambulation time and length of hospital stay .


There was a significantly higher number of urinary retention episodes requiring re-catheterization in the immediate removal group compared to the intermediate and delayed removal groups ( @ % versus @ % and @ % respectively ) .


Delayed urinary catheter removal was associated with a higher incidence of urinary tract infections ( @ % ) , delayed ambulation time ( @ h ) and longer hospital stay ( @ days ) compared to the early ( @ % , @ h and @ days respectively ) and intermediate ( @ % , @ h and @ days respectively ) removal groups .


Removal of the urinary catheter @h postoperatively appears to be more advantageous than early or late removal in cases of uncomplicated total abdominal hysterectomy .


Transvaginal cholecystectomy ( TVC ) is regarded as a model operation in the newly developed field of natural orifice transluminal endoscopic surgery ( NOTES ) .


Randomized , controlled trials to assess TVC as a surgical strategy are largely missing .


The study was a double blind , randomized , controlled , single center trial in female patients > @ years with symptomatic cholecystolithiasis comparing laparoscopic cholecystectomy ( CLC ) and TVC .


The study investigated pain reduction of @ point on a visual-numeric rating scale with a follow-up after @ days .


Secondary endpoints were complications and patient reported outcome .


Groups were established using computer-generated randomization and sealed envelopes in the operating theatre .


At the end of the surgical procedure all patients received a standard @-trocar dressing as for CLC and a vaginal tamponade .


A total of @ patients were asked to participate , of which @ were randomized , @ in the CLC , @ in the TVC groups and @ were excluded from the study .


Patients were comparable regarding age , body mass index ( BMI ) and American Society of Anesthesiologists ( ASA ) grade .


Surgical and anesthesia times were significantly different .


There was no difference in postoperative pain .


The majority of patients were satisfied with both procedures and TVC was recommended to other patients by @ % of patients in the TVC group .


The results did not show superiority of TVC over CLC with regards to postoperative pain .


With no differences in postoperative pain and high patient satisfaction , TVC can be recommended to future patients as an alternative method .


For confirmation of this evaluation of TVC further randomized trials are needed .


It has been previously demonstrated that listening to @/f sound effectively reduces stress .


However , these findings have been inconsistent and further study on the relationship between @/f sound and the stress response is consequently necessary .


The present study examined whether sound with @/f properties ( @/f sound ) affects stress-induced electroencephalogram ( EEG ) changes .


Twenty-six subjects who voluntarily participated in the study were randomly assigned to the experimental or control group .


Data from four participants were excluded because of EEG artifacts .


A mental arithmetic task was used as a stressor .


Participants in the experiment group listened to @/f sound for @ minutes and @ seconds , while participants in the control group sat quietly for the same duration .


EEG recordings were obtained at various points throughout the experiment .


After the experiment , participants completed a questionnaire on the affective impact of the @/f sound .


The results indicated that the mental arithmetic task effectively induced a stress response measurable by EEG .


Relative theta power at all electrode sites was significantly lower than baseline in both the control and experimental group .


Relative alpha power was significantly lower , and relative beta power was significantly higher in the T@ and T@ areas .


Secondly , @/f sound and simple resting affected task-associated EEG changes in a similar manner .


Finally , participants reported in the questionnaire that they experienced a positive feeling in response to the @/f sound .


Our results suggest that a commercialized @/f sound product is not more effective than simple resting in alleviating the physiological stress response .


We aimed to examine the effect of high-fat diet ( HFD ) on prostate cancer ( PCa ) development and progression and to investigate whether metformin would postpone PCa development and progression promoted by HFD .


TRAMP mice were randomly divided into three groups : normal diet group , HFD group and metformin-HFD ( Met-HFD ) group .


Mortality rate and tumor formation rate were examined .


TRAMP mice were sacrificed and sampled on the @th , @ ( th ) , and @th week , respectively .


Serum levels of insulin and IGF-@ were tested by ELISA .


Prostate tissue of TRAMP mice was used for HE staining .


A total of @ deaths of TRAMP mice were observed , including @ ( @ % ) from the normal diet group , @ ( @ % ) from the HFD group , and @ ( @ % ) from Met-HFD group .


The mortality rate of TRAMP mice from HFD group was significantly higher than that of normal diet group ( P = @ ) , and metformin could moderately decrease the mortality rate by @ % ( P = @ ) .


Tumor formation rates were not significantly different among the three groups .


Levels of glucose , insulin , and IGF-@ tended to increase with TRAMP mice 's age in HFD group .


TRAMP mice from HFD group had higher serum insulin and IGF-@ levels .


A moderate decrease in IGF-@ was also seen in Met-HFD group .


HFD could promote TRAMP mouse PCa development and progression and metformin had moderate effect of reducing PCa mortality rate with a decrease in serum IGF-@ level .


Worldwide , sentinel node biopsy ( SNB ) is now a standard staging procedure for most patients with melanomas @ mm or more in thickness , but its therapeutic benefit is not clear , pending randomized trial results .


This study sought to assess the therapeutic benefit of SNB in a large , nonrandomized patient cohort .


Patients with primary melanomas @ mm or more thick or with adverse prognostic features treated with wide local excision ( WLE ) at a single institution between @ and @ were identified .


The outcomes for those who underwent WLE plus SNB ( n = @ ) were compared with the outcomes for patients in an observation ( OBS ) group who had WLE only ( n = @ ) .


Median follow-up was @ months .


Melanoma-specific survival ( MSS ) was not significantly different for patients in the SNB and OBS groups .


However , a stratified univariate analysis of MSS for different thickness subgroups indicated a significantly better MSS for SNB patients with T@ and T@ melanomas ( > @ to @ mm thick ) ( P = @ ) , but this was not independently significant in multivariate analysis .


Compared with OBS patients , SNB patients demonstrated improved disease-free survival ( DFS ) ( P < @ ) and regional recurrence-free survival ( P < @ ) .


There was also an improvement in distant metastasis-free survival ( DMFS ) for SNB patients with T@ and T@ melanomas ( P = @ ) .


In this study , the outcome for the overall cohort after WLE alone did not differ significantly from the outcome after additional SNB .


However , the outcome for the subgroup of patients with melanomas more than @ to @ mm in thickness was improved if they had a SNB , with significantly improved disease-free and DMFS .


The trapeziometacarpal ( TMC ) joint of the human thumb is the second most common joint in the hand affected by osteoarthritis .


TMC arthroplasty is a common procedure used to alleviate symptoms .


No randomized controlled trials have been published on the efficacy of different post-operative orthotic regimes .


Fifty six participants who underwent TMC arthroplasty were allocated to either rigid orthotic or semi-rigid orthotic groups .


Both groups started an identical exercise program at two weeks following surgery .


Outcome measures were assessed by an assessor blinded to group allocation .


The primary outcome was the Patient Rated Wrist and Hand Evaluation ( PRWHE ) and secondary outcomes included the Michigan Hand Questionnaire ( MHQ ) , thumb palmar abduction , first metacarpophalangeal extension and three point pinch grip .


Measures were taken pre-operatively , at six weeks , three months and one year post-operatively .


Between-group differences were analyzed with linear regression .


Both groups performed equally well .


There was no significant between-group difference for PRWHE scores ( @ , CI -@ to @ ) , including subscales for pain and function , or for any of the secondary outcomes at one year follow-up .


We found no difference in outcomes between using a rigid or semi-rigid orthosis after TMC arthroplasty .


Patient comfort , cost and availability may determine choice between orthoses in clinical practice .


@b RCT .


The aim of this article was to evaluate afatinib ( BIBW @ ) , an ErbB family blocker , and nintedanib ( BIBF @ ) , a triple angiokinase inhibitor , in castration-resistant prostate cancer patients .


Patients were randomized to receive nintedanib ( @ mg twice daily ) , afatinib ( @ mg once daily -LSB- q.d. -RSB- ) , or alternating sequential @-day nintedanib ( @ mg twice daily ) and afatinib ( @ mg q.d. -LSB- Combi@ -RSB- ) , which was reduced to @ mg q.d. ( Combi@ ) due to adverse events .


The primary end point was progression-free rate at @ weeks .


Of the @ patients treated @ , @ , @ and three received nintedanib , afatinib , Combi@ and Combi@ , respectively .


At @ weeks , the progression-free rate was @ % ( seven out of @ patients ) for nintedanib , and @ % for afatinib and Combi@ groups .


Two patients had a @ % decline in PSA ( nintedanib and the Combi@ groups ) .


The most common drug-related adverse events were diarrhea , nausea , vomiting and lethargy .


Nintedanib and/or afatinib demonstrated limited anti-tumor activity in unselected advanced castration-resistant prostate cancer patients .


Bone marrow stem cell ( BMSC ) therapy for cardiovascular disease has shown considerable preclinical and clinical promise , but there remains a need for mechanistic studies to help bridge the transition from bench to bedside .


We have designed a substudy to our REGENERATE-IHD trial ( ClinicalTrial.gov Identifier : NCT@ ) to assess the feasibility of a novel imaging technique to detect angiogenesis following BMSC therapy .


Nine patients who had been randomized to receive intracoronary injection of G-CSF-mobilized BMSCs or control ( serum ) were included in this substudy .


Patients underwent SPECT imaging using a novel radiolabelled peptide ( Tc-NC@ ) , which has a high affinity for the v@ integrin , an angiogenesis-related integrin .


This was repeated @ days after intracoronary injection of BMSCs/control to assess for neoangiogenesis .


The imaging study was well tolerated with no adverse effects .


Myocardial tracer uptake was detectable at baseline in all nine patients , with no myocardial uptake seen in two control patients used for comparison .


Baseline uptake appeared to correlate with baseline ejection fraction but changes with therapy did not reach statistical significance .


SPECT imaging with a Tc-NC@ is feasible in patients with heart failure , with baseline activity suggesting persistent angiogenesis in patients with remote myocardial infarction .


To compare long-term health outcome of Sanders type IV calcaneal fractures treated with open reduction and internal fixation ( ORIF ) versus ORIF plus primary subtalar arthrodesis ( PSTA ) .


Randomized prospective multicenter trial .


Four Level @ trauma hospitals in Canada .


Thirty-one patients with @ Sanders IV displaced intraarticular calcaneal fractures .


Seventeen patients were treated with a standard protocol involving a lateral approach for ORIF .


Fourteen patients were treated with a standard protocol involving a lateral approach with ORIF + PSTA .


Health outcomes were assessed with @ validated instruments : ( @ ) the Short Form @ version @ ( SF-@ ) , ( @ ) the Musculoskeletal Functional Assessment Survey , ( @ ) the American Orthopaedic Foot and Ankle Society 's Ankle-Hindfoot Scale , and ( @ ) the Visual Analogue Scale .


From @ to @ , @ patients ( @ displaced intraarticular calcaneal fractures ) were followed for a minimum of @ years ( @ % follow-up ) .


No statistical difference was found between the results for ORIF compared with ORIF + PSTA : the mean SF-@ physical component scores were , respectively , @ ( SD = @ ) and @ ( SD = @ ) ( P = @ ) ; the mean Musculoskeletal Functional Assessment Survey scores were @ ( SD = @ ) and @ ( SD = @ ) ( P = @ ) ; the mean Ankle-Hindfoot Scale scores were @ ( SD = @ ) and @ ( SD = @ ) , ( P = @ ) ; and the mean Visual Analogue Scale scores were @ ( SD = @ ) and @ ( SD = @ ) ( P = @ ) .


We were unable to demonstrate a significant difference between treating Sanders type IV fractures with either ORIF or ORIF + PSTA .


It remains the choice of the surgeon and patient to take into account patient specific factors to determine treatment .


However , ORIF + PSTA may be advantageous for both patients with Sanders type IV fractures and the health care system as patients heal quickly .


Furthermore , ORIF + PSTA may prevent the need for late secondary subtalar fusion adding to increased costs and lost time from work .


Therapeutic Level II .


See Instructions for Authors for a complete description of levels of evidence .


Foods that have similar carbohydrate content can differ in the amount they raise blood glucose .


The effects of this property , called the glycemic index , on risk factors for cardiovascular disease and diabetes are not well understood .


To determine the effect of glycemic index and amount of total dietary carbohydrate on risk factors for cardiovascular disease and diabetes .


Randomized crossover-controlled feeding trial conducted in research units in academic medical centers , in which @ overweight adults ( systolic blood pressure , @-@ mm Hg ) were given @ complete diets that contained all of their meals , snacks , and calorie-containing beverages , each for @ weeks , and completed at least @ study diets .


The first participant was enrolled April @ , @ ; the last participant finished December @ , @ .


For any pair of the @ diets , there were @ to @ participants contributing at least @ primary outcome measure .


( @ ) A high-glycemic index ( @ % on the glucose scale ) , high-carbohydrate diet ( @ % energy ) ; ( @ ) a low-glycemic index ( @ % ) , high-carbohydrate diet ; ( @ ) a high-glycemic index , low-carbohydrate diet ( @ % energy ) ; and ( @ ) a low-glycemic index , low-carbohydrate diet .


Each diet was based on a healthful DASH-type diet .


The @ primary outcomes were insulin sensitivity , determined from the areas under the curves of glucose and insulin levels during an oral glucose tolerance test ; levels of low-density lipoprotein ( LDL ) cholesterol , high-density lipoprotein ( HDL ) cholesterol , and triglycerides ; and systolic blood pressure .


At high dietary carbohydrate content , the low - compared with high-glycemic index level decreased insulin sensitivity from @ to @ units ( -@ % , P = @ ) ; increased LDL cholesterol from @ to @ mg/dL ( @ % , P. @ ) ; and did not affect levels of HDL cholesterol , triglycerides , or blood pressure .


At low carbohydrate content , the low - compared with high-glycemic index level did not affect the outcomes except for decreasing triglycerides from @ to @ mg/dL ( -@ % , P = @ ) .


In the primary diet contrast , the low-glycemic index , low-carbohydrate diet , compared with the high-glycemic index , high-carbohydrate diet , did not affect insulin sensitivity , systolic blood pressure , LDL cholesterol , or HDL cholesterol but did lower triglycerides from @ to @ mg/dL ( -@ % , P. @ ) .


In this @-week controlled feeding study , diets with low glycemic index of dietary carbohydrate , compared with high glycemic index of dietary carbohydrate , did not result in improvements in insulin sensitivity , lipid levels , or systolic blood pressure .


In the context of an overall DASH-type diet , using glycemic index to select specific foods may not improve cardiovascular risk factors or insulin resistance .


Early interventions for toddlers with expressive and receptive language delays have not resulted in positive expressive language outcomes .


This randomized controlled trial tested the effects on language outcomes of a caregiver-implemented communication intervention targeting toddlers at risk for persistent language delays .


Participants included @ toddlers , who were between @ and @ months with language scores at least @ SDs below the normative mean and no other developmental delays , and their caregivers .


Toddlers were randomly assigned to the caregiver-implemented intervention or a usual-care control group .


Caregivers and children participated in @ sessions in which caregivers were taught to implement the intervention .


The primary outcome was the Preschool Language Scale , Fourth Edition , a broad-based measure of language .


Outcome measurement was not blinded .


Caregivers in the intervention improved their use of all language facilitation strategies , such as matched turns ( adjusted mean difference , intervention-control , @ ; @ % confidence interval @ to @ ; P < @ ) .


Children in the intervention group had significantly better receptive language skills ( @ ; @ % confidence interval @ to @ ) , but not broad-based expressive language skills ( @ , @ % confidence interval -@ to @ ; P = @ ) .


This trial provides preliminary evidence of the short-term effects of systematic caregiver instruction on caregiver use of language facilitation strategies and subsequent changes in children 's language skills .


Future research should investigate the ideal dosage levels for optimizing child outcomes and determine which language facilitation strategies are associated with specific child outcomes .


Research on adaptations for families from culturally and linguistically diverse backgrounds is needed .


New antibiotics are needed to treat infections caused by drug-resistant bacteria .


Tedizolid is a novel oxazolidinone antibacterial drug designed to provide enhanced activity against Gram-positive pathogens .


We aimed to assess the efficacy and safety of intravenous to oral tedizolid for treatment of patients with acute bacterial skin and skin-structure infections .


ESTABLISH-@ was a randomised , double-blind , phase @ , non-inferiority trial done between Sept @ , @ , and Jan @ , @ , at @ centres in nine countries .


Patients ( aged @ years ) with acute bacterial skin and skin-structure infections ( cellulitis or erysipelas , major cutaneous abscess , or wound infection ) that had a minimum lesion area of @ cm ( @ ) and were suspected or documented to be associated with a Gram-positive pathogen , were randomly assigned ( @:@ ) , via an interactive voice-response system with block randomisation , to receive intravenous once-daily tedizolid ( @ mg for @ days ) or twice-daily linezolid ( @ mg for @ days ) , with optional oral step-down .


Randomisation was stratified by geographic region and type of acute bacterial skin and skin-structure infection .


The primary endpoint was early clinical response ( @ % reduction in lesion area at @-@ h compared with baseline ) , with a non-inferiority margin of -@ % .


Analysis was by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT@ .


@ patients were randomly assigned to receive tedizolid ( n = @ ) or linezolid ( n = @ ) .


@ ( @ % ) patients in the tedizolid group and @ ( @ % ) in the linezolid group achieved early clinical response ( difference @ % , @ % CI -@ to @ ) , meeting the prespecified non-inferiority margin .


Gastrointestinal adverse events were less frequent with tedizolid than linezolid , taking place in @ ( @ % ) of @ patients and @ ( @ % ) of @ patients in the safety population .


Treatment-emergent adverse events leading to discontinuation of study drug were reported by one ( < @ % ) patient in the tedizolid group and four ( @ % ) patients in the linezolid group .


Intravenous to oral once-daily tedizolid @ mg for @ days was non-inferior to twice-daily linezolid @ mg for @ days for treatment of patients with acute bacterial skin and skin-structure infections .


Tedizolid could become a useful option for the treatment of acute bacterial skin and skin-structure infections in the hospital and outpatient settings .


Epidemiological evidence suggests an association between psychological factors and functional dyspepsia ( FD ) .


Yet few randomized controlled trials ( RCTs ) of psychological interventions have been conducted for FD .


We conducted an RCT to evaluate the efficacy of psychotherapy among chronic FD .


One hundred fifty-eight consecutive patients with FD were randomized to medical therapy plus psychotherapy consisted in @ group and @ individual sessions focused on teaching techniques for coping with FD ( intensive treatment ( IT ) ; n = @ ) or medical therapy alone ( conventional treatment ( CT ) ; n = @ ) .


Patients completed validated self-reported questionnaires before and after the @-week treatment and @ months later .


Linear mixed-effects models were used , in intention-to-treat analysis .


At the end of treatment period , statistically significant improvements were observed for IT compared with CT for dyspepsia-related quality of life ( DRQoL ) .


DRQoL mean changes of @ and @ were obtained in IT and CT patients , respectively ( p = < @ ) ; and SS mean changes of @ and @ were obtained in IT and CT patients , respectively ( p = @ ) .


Those improvements , measured by minimum clinically important difference ( MCID ) , were clinically significant ( DRQoL : @ % of the IT patients exceeded the MCID vs. the @ % of the CT ; SS : @ % vs. @ % ) .


Six months after treatment , those statistically significant improvements persisted for DRQoL ( p = @ ) and for SS ( p = @ ) .


Clinical improvements persisted for SS ( @ % vs. @ % ) .


These findings suggest that adding psychotherapy to standard medical therapy improves short-term outcomes in patients with FD and may have long-term effects as well .


The cost-effectiveness of intensive therapy needs to be evaluated .


Registration number and name of trial registry : NCT@ .


EURAMOS-@ , an international randomized controlled trial , investigated maintenance therapy with pegylated interferon alfa-@b ( IFN -- @b ) in patients whose osteosarcoma showed good histologic response ( good response ) to induction chemotherapy .


At diagnosis , patients age @ years with resectable high-grade osteosarcoma were registered .


Eligibility after surgery for good response random assignment included two cycles of preoperative MAP ( methotrexate , doxorubicin , and cisplatin ) , macroscopically complete surgery of primary tumor , < @ % viable tumor , and no disease progression .


These patients were randomly assigned to four additional cycles MAP with or without IFN -- @b ( @ to @ g/kg per week subcutaneously , after chemotherapy until @ years postregistration ) .


Outcome measures were event-free survival ( EFS ; primary ) and overall survival and toxicity ( secondary ) .


Good response was reported in @,@ of @,@ registered patients ; @ consented to random assignment ( MAP , n = @ ; MAP plus IFN -- @b , n = @ ) , with baseline characteristics balanced by arm .


A total of @ of @ started IFN -- @b ; @ stopped early , and @ continued to receive treatment at data freeze .


Refusal and toxicity were the main reasons for never starting IFN -- @b and for stopping prematurely , respectively .


Median IFN -- @b duration , if started , was @ weeks .


A total of @ of @ patients who started IFN -- @b and provided toxicity information reported grade @ toxicity during IFN -- @b treatment .


With median follow-up of @ months , @-year EFS for all @ randomly assigned patients was @ % ( @ % CI , @ % to @ % ) ; @ EFS events were reported ( MAP , n = @ ; MAP plus IFN -- @b , n = @ ) .


Hazard ratio was @ ( @ % CI , @ to @ ; P = @ ) from an adjusted Cox model .


At the preplanned analysis time , MAP plus IFN -- @b was not statistically different from MAP alone .


A considerable proportion of patients never started IFN -- @b or stopped prematurely .


Long-term follow-up for events and survival continues .


To evaluate differences in uteroplacental blood flow and pregnancy outcome in women with idiopathic recurrent spontaneous miscarriage ( IRSM ) following administration of micronized vaginal progesterone and oral dydrogesterone .


One hundred and thirty-three women ( aged @-@ years ) who had had early miscarriages and spontaneous conception participated .


Oral dydrogesterone ( group A , n = @ ) and micronized vaginal progesterone ( group B , n = @ ) were administrated for luteal support and compared .


Pregnant women without history of recurrent miscarriage served as controls ( group C , n = @ ) .


The outcome measures consisted of endometrial blood flow parameters by Doppler indices and ongoing pregnancy rate .


Before progesterone supplementation , resistivity index ( RI ) and pulsatility index ( PI ) were found to be significantly higher in groups A and B as compared to controls .


Although statistically not significant , end diastolic velocity ( EDV ) and systolic/diastolic ( S/D ) ratio was found to be superior in controls than IRSM women .


Peak systolic velocity ( PSV ) was comparable between IRSM and non-IRSM groups .


Following progesterone supplementation , groups A and B showed a highly significant reduction in RI , PI and an increase in EDV .


A relative increase in the value of PSV was observed in group A as compared to group B.


There was remarkable difference in S/D in both groups .


Although not statistically significant , group C showed reduction in RI , PI , PSV , EDV and S/D ratio .


Pregnancy salvage rates were higher in group A ( @ % ) as compared to group B ( @ % ) .


Progesterone supplementation appears to lower vascular resistance in women with IRSM .


Oral dydrogesterone appears to be equally effective in improving endometrial blood flow as compared with micronized progesterone .


To examine the relationship between the dose of fentanyl sublingual spray needed to control breakthrough cancer pain ( BTCP ) and the dose of around-the-clock ( ATC ) opioid used to control background pain .


Analysis was based on the open-label , dose-titration phase ( up to @ days ) of a randomized , double-blind , placebo-controlled trial .


Opioid-tolerant cancer patients ( aged @ years ) with chronic pain of moderate severity in the @ hours before screening while receiving stable doses of scheduled ATC opioid therapy for @ week and @ to @ episodes of BTCP per day .


Fentanyl sublingual spray was initiated at @ g. Dose titration proceeded until a dose was reached that provided adequate pain relief for two consecutive BTCP episodes without intolerable adverse effects ( AEs ) .


Overall , @/@ ( @ percent ) patients completed the dose-titration phase and achieved pain relief , and @ percent of those who completed the titration period attained an effective dose of @ g ( median effective dose , @ g ) .


No clinically relevant correlation was found between effective doses of fentanyl sublingual spray for the treatment of BTCP and the ATC opioid doses used to control persistent pain ( Spearman rank correlation -LSB- rs -RSB- = @ , n = @ ) .


Sixty percent of patients reported @ AE during the dose-titration phase .


The most common AEs considered related to study treatment were nausea ( @ percent ) , somnolence ( @ percent ) , dizziness ( @ percent ) , and vomiting ( @ percent ) .


These findings highlight the importance of titrating the dose of fentanyl sublingual spray to optimize dosing for individual patients .


The objective was to test the clinical utility of Quantose M ( Q ) to monitor changes in insulin sensitivity after pioglitazone therapy in prediabetic subjects .


Quantose M ( Q ) is derived from fasting measurements of insulin , - hydroxybutyrate , linoleoyl-glycerophosphocholine , and oleate , three nonglucose metabolites shown to correlate with insulin-stimulated glucose disposal .


Participants were @ of the total of @ ACT NOW impaired glucose tolerance ( IGT ) subjects randomized to pioglitazone ( @ mg/d ) or placebo and followed for @ years .


At baseline and study end , fasting plasma metabolites required for determination of Quantose , glycated hemoglobin , and oral glucose tolerance test with frequent plasma insulin and glucose measurements to calculate the Matsuda index of insulin sensitivity were obtained .


Pioglitazone treatment lowered IGT conversion to diabetes ( hazard ratio = @ ; @ % confidence interval = @-@ @ ; P < @ ) .


Although glycated hemoglobin did not track with insulin sensitivity , Quantose M ( Q ) increased in pioglitazone-treated subjects ( by @ -LSB- @ -RSB- mgmin ( -@ ) kgwbm ( -@ ) ) ( median -LSB- interquartile range -RSB- ) ( P < @ vs placebo ) , as did the Matsuda index ( by @ -LSB- @ -RSB- units ; P < @ ) .


Quantose M ( Q ) correlated with the Matsuda index at baseline and change in the Matsuda index from baseline ( rho , @ and @ , respectively ; P < @ ) and was progressively higher across closeout glucose tolerance status ( diabetes , IGT , normal glucose tolerance ) .


In logistic models including only anthropometric and fasting measurements , Quantose M ( Q ) outperformed both Matsuda and fasting insulin in predicting incident diabetes .


In IGT subjects , Quantose M ( Q ) parallels changes in insulin sensitivity and glucose tolerance with pioglitazone therapy .


Due to its strong correlation with improved insulin sensitivity and its ease of use , Quantose M ( Q ) may serve as a useful clinical test to identify and monitor therapy in insulin-resistant patients .


Preterm-born or asphyxiated term-born children show more emotional and behavioral problems at preschool age than term-born children without a medical condition .


It is uncertain whether parenting intervention programs aimed at the general population , are effective in this specific group .


In earlier findings from the present trial , Primary Care Triple P was not effective in reducing parent-reported child behavioral problems .


However , parenting programs claim to positively change child behavior through enhancement of the parent-child interaction .


Therefore , we investigated whether Primary Care Triple P is effective in improving the quality of parent-child interaction and increasing the application of trained parenting skills in parents of preterm-born or asphyxiated term-born preschoolers with behavioral problems .


For this pragmatic , open randomized clinical trial , participants were recruited from a cohort of infants admitted to the neonatal intensive care units of two Dutch hospitals .


Children aged @-@ years , with a gestational age < @ weeks and/or birth weight < @ g and children with a gestational age @-@ weeks and perinatal asphyxia were included .


After screening for a t-score @ on the Child Behavior Checklist , children were randomly assigned to Primary Care Triple P ( n = @ ) or a wait-list control group ( n = @ ) .


Trial outcomes were the quality of parent-child interaction and the application of trained parenting skills , both scored from structured observation tasks .


There was no effect of the intervention on either of the observational outcome measures at the @-month trial endpoint .


Primary Care Triple P , is not effective in improving the quality of parent-child interaction nor does it increase the application of trained parenting skills in parents of preterm-born or asphyxiated term-born children with behavioral problems .


Further research should focus on personalized care for these parents , with an emphasis on psychological support to reduce stress and promote self-regulation .


Vitamin K@ ( VK@ ) reverses the effects of vitamin K antagonists ( VKAs ) .


The literature shows that the bioavailability from solutions might be higher than that from tablets , possibly resulting in different effects .


To compare the bioavailability and effect on the International Normalized Ratio ( INR ) of @-mg VK@ tablets and solution in three randomized clinical trials .


The bioavailability was determined in a crossover trial with @ healthy volunteers .


VK@ plasma concentrations were assessed at @ , @ , @ , @ , @ , @ , @ and @ h , and the area under the curve was higher in the solution group than in the tablet group ( mean difference @ g L ( -@ ) h , @ % confidence interval -LSB- CI -RSB- @-@ , P < @ ) .


In the other two trials , the effects of both formulations on the INR were measured at @ , @ and @ h.


In the second trial , on @ patients on phenprocoumon with planned invasive procedures , both formulations were similarly effective , because all patients reached an INR of < @ , which was the primary endpoint .


In the last trial , on @ patients on phenprocoumon with an INR of @-@ @ , the INR decreased slightly more in the solution group ( @ , @ % CI @-@ @ ) than in the tablet group ( @ , @ % CI @-@ @ ) .


The solution group had a @-fold increased likelihood ( @ % CI @-@ @ ) of reaching an INR of < @ at @ h. Additionally , the increases in VK@ concentrations were similar ( tablets , @ g L ( -@ ) ; solution , @ g L ( -@ ) ; P = @ ) after @ h.


VK@ tablets are at least as clinically effective as the solution in countering VKAs .


For cholecystectomy ( CHE ) , both the needlescopic three-trocar technique with @-@-mm instruments ( needlescopic cholecystectomy ( NC ) ) and the umbilically assisted transvaginal technique with rigid instruments ( transvaginal cholecystectomy ( TVC ) ) have been established for further reduction of the trauma remaining from laparoscopy .


To compare the further outcome of both techniques for elective CHE in female patients , we analyzed the secondary end points of a prospective randomized single-center trial ( needlescopic versus transvaginal cholecystectomy ( NATCH ) trial ; ClinicalTrials.gov Identifier : NCT@ ) , in particular , satisfaction with aesthetics , overall satisfaction , abdominal pain , and incidence of trocar hernias postoperatively at both @ and @ months .


After @ months , the domains `` satisfaction '' and `` pain '' of the German version of the Female Sexual Function Index ( FSFI-d ) were additionally evaluated to detect respective complications .


A gynecological control examination was conducted in all TVC patients after @ months .


Forty patients were equally randomized into the therapy and the control groups between February @ and June @ .


No significant differences were found for overall satisfaction with the surgical result , abdominal pain , sexual function , and the rate of trocar hernias .


However , aesthetics were rated significantly better by TVC patients both after @ and after @ months ( P = @ and P < @ ) .


There were no postoperative pathological gynecological findings .


Following TVC , there is a significantly better aesthetic result as compared to NC , even at @ and @ months after the procedure .


No difference was found for sexual function .


This randomized , @-group study compared the efficacy and tolerability of @ treatment modalities for facial actinic keratoses .


Twenty-four healthy adult male and female subjects who had @ to @ clinically visible and discrete actinic keratoses on the face in a contiguous @cm@ treatment area .


Subjects were randomized into one of three treatment groups : @ treatments with @-aminolevulinic acid ( ALA ) and photodynamic therapy ( PDT ) , @ ALA-PDT treatment and @ course of ingenol mebutate ( ingenol mebutate ) @ % gel daily for @ consecutive days , or @ course of ingenol mebutate gel alone .


Actinic keratoses in the treatment field were counted at the baseline visit , and at the completion of the study ( day @ or day @ ) .


At the site of application , local site reactions were graded at each visit .


Subjects in the two ALA-PDT treatment group had a @ % mean reduction ( P < @ ) from the number of baseline actinic keratosis ; ALA-PDT plus ingenol mebutate gel group had an @ % mean reduction ( P < @ ) ; while subjects in the ingenol mebutate gel alone group had a @ % mean reduction from the number of baseline actinic keratoses .


The peak composite LSR score was @ for the ALA-PDT group , @ for the ALA-PDT followed by ingenol mebutate gel group , and @ for the ingenol mebutate gel alone group ( P = @ and @ , respectively ) .


ALA-PDT , ingenol mebutate gel , and a combination of the two treatment modalities are successful topical therapies for the reduction of actinic keratoses on the face .


The group of subjects receiving @ consecutive treatments with ALA-PDT , compared to treatment with ingenol mebutate gel alone or sequentially after one course of ALA-PDT had a significantly lower mean composite LSR score and a non-significant trend for greater efficacy .


To determine the efficacy of two quintuple regimens for eradication of Helicobacter pylori ( H. pylori ) in patients who failed previous therapies .


This prospective , open-label , randomized controlled trial was a phase II study conducted from April @ to March @ at the Gastrointestinal and Liver Diseases Research Center in Rasht , Iran .


A total of @ patients with dyspepsia who failed previous H. pylori eradication with a ten-day quadruple therapy were enrolled .


A random block method was used to assign patients to one of two treatment groups .


Patients in the first group were treated with @ mg bismuth subcitrate , @ mg omeprazole , @ mg amoxicillin , @ mg clarithromycin and @ mg tinidazole ( BOACT group ) .


Patients in the second group received a regimen containing @ mg bismuth subcitrate , @ mg omeprazole , @ mg tetracycline , @ mg metronidazole and @ mg ofloxacin ( BOTMO group ) .


Both regimens were given twice daily for a duration of seven days .


The eradication was confirmed by a ( @ ) C urea breath test @ wk after completion of therapy .


Patient compliance and drug side effects were evaluated at the end of the treatment period .


The success rates were calculated by intention-to-treat and per-protocol analyses .


A total of @ patients completed the course of treatment , with three patients excluded due to drug intolerance .


The mean age of patients did not differ between the BOACT and BOTMO groups ( @ @ years vs @ @ years ) , and no significant differences were found between the two groups in terms of age , sex , smoking habits or the initial eradication regimen .


The intention-to-treat and per-protocol eradication rates were significantly higher in the BOTMO group ( @ % , @ % CI : @-@ @ and @ % , @ % CI : @-@ @ , respectively ) compared with the BOACT group ( @ % , @ % CI : @-@ @ and @ % , @ % CI : @-@ @ , respectively ) ( P < @ ) .


Univariate analyses for both groups did not show any association of sex , smoking and initial therapeutic regimen with eradiation rate ( P > @ for all ) .


Significantly more patients experienced side effects in the BOACT group compared to the BOTMO group ( @ % vs @ % , P < @ ) .


This difference was exemplified by increases in headache and taste disturbance ( P < @ ) .


Quintuple therapy with a BOTMO regimen is an alternative second-line rescue therapy for Iranian patients with failed first-line eradication treatment of H. pylori .


To investigate the effect of sexual intercourse on spontaneous passage of distal ureteral stones .


The patients were randomly divided into @ groups with random number table envelope method .


Patients in group @ were asked to have sexual intercourse at least @-@ times a week .


Patients in group @ were administered tamsulosin @ mg/d .


Patients in group @ received standard medical therapy alone and acted as the controls .


The expulsion rate was controlled after @ and @ weeks .


Differences in the expulsion rate between groups were compared with the chi-square test for @ @ tables .


P < @ was considered as statistically significant .


The mean stone size was @ @ mm in group @ , @ @ mm group @ , and @ @ mm group @ ( P = @ ) .


Two weeks later , @ of @ patients ( @ % ) in the sexual intercourse group , and @ of @ patients ( @ % ) in tamsulosin group passed their stones , whereas @ of @ patients ( @ % ) in the control group passed their stones ( P = @ ) .


The mean stone expulsion time was @ @ days in group @ , @ @ days in group @ , and @ @ days in group @ ( P = @ ) .


Our results have indicated that patients who have distal ureteral stones @ mm and a sexual partner may be advised to have sexual intercourse @-@ times a week to increase the probability of spontaneous passage of the stones .


Drugs for migraine attacks include triptans and NSAIDs ; their combination could provide greater symptom relief .


A total of @ subjects with history of migraine , with or without aura , were randomized to frovatriptan @ mg alone ( Frova ) , frovatriptan @ mg + dexketoprofen @ mg ( FroDex@ ) or frovatriptan @ mg + dexketoprofen @ mg ( FroDex@ @ ) and treated at least one migraine attack .


This was a multicenter , randomized , double-blind , parallel-group study .


The primary end point was the proportion of pain free ( PF ) at two hours .


Secondary end points were PF at one and four hours , pain relief ( PR ) at one , two , four hours , sustained PF ( SPF ) at @ and @ hours , recurrence at @ hours , resolution of nausea , photophobia and phonophobia at two and four hours , the use of rescue medication and the judgment of the treatment .


The results were assessed in the full analysis set ( FAS ) population , which included all subjects randomized and treated for whom at least one post-dose intensity of headache was recorded .


The proportions of subjects PF at two hours ( primary end point ) were @ % ( @/@ ) with Frova compared with @ % ( @/@ FroDex@ and @/@ FroDex@ @ ) with each combination therapies ( P < @ ) .


Proportions of SPF at @ hours were @ % ( @/@ ) for Frova , @ % ( @/@ ) for FroDex@ ( P < @ ) and @ % ( @/@ ) for FroDex@ @ ( P < @ ) .


SPF at @ hours was @ % ( @/@ ) with Frova , @ % ( @/@ ) with FroDex@ and @ % ( @/@ ) with FroDex@ @ ( P = NS ) .


Recurrence was similar for Frova ( @ % , @/@ ) , FroDex@ ( @ % , @/@ ) and FroDex@ @ ( @ % , @/@ ) ( P = NS ) , meaning a lack of improvement with the combination therapy .


Statistical adjustment for multiple comparisons was not performed .


No statistically significant differences were reported in the occurrence of total and drug-related adverse events .


FroDex@ and FroDex@ @ showed a similar efficacy both for primary and secondary end points .


There did not seem to be a dose response curve for the addition of dexketoprofen .


FroDex improved initial efficacy at two hours compared to Frova whilst maintaining efficacy at @ hours in this study .


Tolerability profiles were comparable .


Intrinsic pharmacokinetic properties of the two single drugs contribute to this improved efficacy profile .


The aim of this study was to compare the efficacy and side effects of prednisolone acetate @ % versus fluorometholone @ % after Descemet membrane endothelial keratoplasty ( DMEK ) .


DMEK recipients used prednisolone acetate @ % for @ month , and they were randomized to either prednisolone or fluorometholone for months @ through @ .


Dosing was @ times daily in months @ to @ , thrice daily in month @ , twice daily in month @ , and once daily in months @ to @ .


The main outcomes were immunologic rejection episodes and intraocular pressure ( IOP ) elevation ( defined as @ mm Hg or @ mm Hg increase over the preoperative baseline level ) , assessed by the Kaplan-Meier survival analysis .


The study included @ eyes ( @ % were white , @ % had Fuchs dystrophy , and @ % had a previous glaucoma diagnosis ) .


No eyes ( @ % ) assigned to prednisolone versus @ eyes ( @ % ) assigned to fluorometholone experienced a possible ( n = @ ) or probable ( n = @ ) rejection episode ( P = @ ) .


Both rejection episodes resolved successfully with increased topical steroids .


In the prednisolone arm , a significantly higher proportion exceeded the defined IOP elevation threshold ( @ % vs. @ % , P = @ ) , and glaucoma medications were initiated or increased more often ( @ % vs. @ % , P = @ ) .


The most frequent reasons for discontinuing the assigned intervention were IOP management ( n = @ eyes assigned to prednisolone ) or inflammation management ( n = @ eyes assigned to fluorometholone ) .


One-year endothelial cell loss was comparable in both arms ( @ % vs. @ % , P = @ ) .


DMEK has a remarkably low rejection episode rate ( < @ % through @ year ) , as confirmed in this prospective randomized study .


This provides a unique opportunity to reduce postoperative topical corticosteroid strength and thereby reduce the risk of steroid-associated complications .


Vitamin D deficiency in pregnancy is associated with an increased risk of gestational diabetes mellitus ( GDM ) and neonatal vitamin D deficiency .


We conducted a double-blind , randomized controlled trial of low-dose ( LD ) versus high-dose ( HD ) vitamin D supplementation to investigate the effects of vitamin D supplementation on glucose metabolism during pregnancy .


Women with plasma @-hydroxyvitamin D ( @OHD ) levels < @ ng/mL before @ weeks ' gestation were randomized to oral vitamin D@ at @,@ IU daily ( HD ) ( n = @ ) or the recommended pregnancy dose of @ IU daily ( LD ) ( n = @ ) until delivery .


The primary end point was maternal glucose levels on oral glucose tolerance test ( OGTT ) at @-@ weeks ' gestation .


Secondary end points included neonatal @OHD , obstetric and other neonatal outcomes , and maternal homeostasis model assessment of insulin resistance .


Analysis was by intention to treat .


There was no difference in maternal glucose levels on OGTT .


Twelve LD women ( @ % ) developed GDM versus seven ( @ % ) HD women ( P = @ ) .


Neonatal cord @OHD was higher in HD offspring ( @ @ vs. @ @ ng/mL , P < @ ) , and deficiency was more common in LD offspring ( @ vs. @ % , P = @ ) .


Post hoc analysis in LD women showed an inverse relationship between pretreatment @OHD and both fasting and @-h blood glucose level on OGTT ( both P < @ ) .


Baseline @OHD remained an independent predictor after multiple regression analysis .


HD vitamin D supplementation commencing at a mean of @ weeks ' gestation does not improve glucose levels in pregnancy .


However , in women with baseline levels < @ ng/mL , @,@ IU per day was well tolerated and highly effective at preventing neonatal vitamin D deficiency .


The Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial ( ICH ADAPT ) demonstrated blood pressure ( BP ) reduction does not affect mean perihematoma or hemispheric cerebral blood flow .


Nonetheless , portions of the perihematoma and borderzones may reach ischemic thresholds after BP reduction .


We tested the hypothesis that BP reduction after intracerebral hemorrhage results in increased critically hypoperfused tissue volumes .


Patients with Intracerebral hemorrhage were randomized to a target systolic BP ( SBP ) of < @ or < @ mm Hg and imaged with computed tomographic perfusion @ hours later .


The volumes of tissue below cerebral blood flow thresholds for ischemia ( < @ mL/@ g/min ) and infarction ( < @ mL/@ g/min ) were calculated as a percentage of the total volume within the internal and external borderzones and the perihematoma region .


Seventy-five patients with intracerebral hemorrhage were randomized a median ( interquartile range ) of @ ( @ ) hours from onset .


Acute hematoma volume was @ ( @ ) mL and mean SBP was @ mm Hg .


At the time of computed tomographic perfusion ( @ -LSB- @ -RSB- hours after randomization ) , SBP was lower in the < @ mm Hg ( n = @ ; @ mm Hg ) than in the < @ mm Hg group ( n = @ ; @ mm Hg ; P < @ ) .


BP treatment did not affect the percentage of total borderzone tissue with cerebral blood flow < @ ( @ versus @ % ; P = @ ) or < @ mL/@ g/min ( @ versus @ % ; P = @ ) .


Similar results were found in the perihematoma region .


Low SBP load ( fraction of time with SBP < @ mmHg ) did not predict borderzone tissue volume with cerebral blood flow < @ mL/@ g/min ( = @ -LSB- -@ , @ -RSB- ) .


BP reduction does not increase the volume of critically hypoperfused borderzone or perihematoma tissue .