Immediately , and 4 h post-exercise , subjects consumed either 500 mL of whey protein ( 25 g ; PRO ) , alcohol ( 1.5 gkg body mass ) , 122 standard drinks ) co-ingested with protein ( ALC-PRO ) , or an energy-matched quantity of carbohydrate also with alcohol ( 25 g maltodextrin ; ALC-CHO ) .


Subjects also consumed a CHO meal ( 1.5 g CHOkg body mass ) 2 h post-exercise .


Muscle biopsies were taken at rest , 2 and 8 h post-exercise .


Blood alcohol concentration was elevated above baseline with ALC-CHO and ALC-PRO throughout recovery ( P < 0.05 ) .


Phosphorylation of mTOR ( Ser2448 ) 2 h after exercise was higher with PRO compared to ALC-PRO and ALC-CHO ( P < 0.05 ) , while p70S6K phosphorylation was higher 2 h post-exercise with ALC-PRO and PRO compared to ALC-CHO ( P < 0.05 ) .


Rates of MPS increased above rest for all conditions ( 29-109 % , P < 0.05 ) .


However , compared to PRO , there was a hierarchical reduction in MPS with ALC-PRO ( 24 % , P < 0.05 ) and with ALC-CHO ( 37 % , P < 0.05 ) .


We provide novel data demonstrating that alcohol consumption reduces rates of MPS following a bout of concurrent exercise , even when co-ingested with protein .


We conclude that alcohol ingestion suppresses the anabolic response in skeletal muscle and may therefore impair recovery and adaptation to training and/or subsequent performance .


Postprandial hyperglycemia and blood glucose fluctuations increase the risk of macroangiopathy in patients with type 2 diabetes mellitus ( T2DM ) .


However , few studies have examined the effects of oral hypoglycemic drugs on blood glucose fluctuations in daily life .


Twenty-nine T2DM patients treated with acarbose were randomized to receive either sitagliptin ( 14 patients ) or mitiglinide ( 15 patients ) together with acarbose for 4 weeks .


Patients were then switched to a combination of 10 mg mitiglinide and 0.2 mg voglibose for 4 weeks .


All patients wore a continuous glucose monitoring ( CGM ) device for 5 - 7 days in week 3 of each treatment period .


The percentage of blood glucose levels in the hyperglycemic range , blood glucose indices derived from 24-h CGM profiles and the glycemic parameters ( HbA1c , glycated albumin and fasting plasma glucose ) were significantly improved by adding sitagliptin or mitiglinide to ongoing acarbose therapy .


These parameters also tended to improve in the mitiglinide/voglibose combination period .


Daily blood glucose fluctuations were significantly improved by adding sitagliptin or mitiglinide to acarbose , and improved after switching to the mitiglinide/voglibose combination .


Larger controlled studies are needed to verify the effects of adding sitagliptin or mitiglinide to acarbose on glucose fluctuations .


Premenstrual syndrome ( PMS ) may have negative effects on women 's health and sometimes need therapeutic non-pharmacological management .


To determine the effect of oral consumption of 1000 mg Royal Jelly capsule on premenstrual syndrome .


This is a randomized , triple-blind , placebo-controlled clinical trial , which was conducted in Tehran University of Medical Sciences female dormitories between December 2011 and October 2012 .


The study population comprised 110 medical sciences student with PMS , whom were randomly assigned to an intervention or a control group .


Each participant in the intervention group took one Royal jelly capsule orally per day , starting on the first day of menstruation and continued the same treatment daily throughout two consecutive menstrual cycles , while participants in the intervention group took placebo capsules as same method .


The outcome measure in this study was PMS score as obtained through the Premenstrual Profile 2005 .


The mean of personal characteristics and baseline level of the premenstrual score before intervention did not differ between groups .


After two consecutive months consumption of Royal Jelly , PMS score had decreased from 23.17 17.43 to 11.42 14.58 ( mean change : 11.75 ; 95 % confidence interval [ CI ] : 8.31-15 .19 ) and in Placebo , PMS score changed from 21.48 16.39 to 20.27 15.76 ( mean change : 1.20 ; 95 % CI : -1.69 to 4.10 ) .


Also difference between mean changes was significant ( mean difference : 10.54 ; 95 % CI : 6.10-14 .98 ) .


The results of the study have demonstrated that 2 months consumption of Royal Jelly was effective in reducing PMS .


An earlier randomized controlled trial found that two middle school sexual education programs-a risk avoidance ( RA ) program and a risk reduction ( RR ) program-delayed initiation of sexual intercourse ( oral , vaginal , or anal sex ) and reduced other sexual risk behaviors in ninth grade .


We examined whether these effects extended into 10th grade .


Fifteen middle schools were randomly assigned to RA , RR , or control conditions .


Follow-up surveys were conducted with participating students in 10th grade ( n = 1,187 ; 29.2 % attrition ) .


Participants were 60 % female , 50 % Hispanic , and 39 % black ; seventh grade mean age was 12.6 years .


In 10th grade , compared with the control condition , both programs significantly delayed anal sex initiation in the total sample ( RA : adjusted odds ratio [ AOR ] , .64 , 95 % confidence interval [ CI ] , .42 -.99 ; RR : AOR , .65 , 95 % CI , .50 -.84 ) and among Hispanics ( RA : AOR , .53 , 95 % CI , .31 -.91 ; RR : AOR , .82 , 95 % CI , .74 -.93 ) .


Risk avoidance students were less likely to report unprotected vaginal sex , either by using a condom or by abstaining from sex ( AOR : .61 , 95 % CI , .45 -.85 ) ; RR students were less likely to report recent unprotected anal sex ( AOR : .34 , 95 % CI , .20 -.56 ) .


Both programs sustained positive impact on some psychosocial outcomes .


Although both programs delayed anal sex initiation into 10th grade , effects on the delayed initiation of oral and vaginal sex were not sustained .


Additional high school sexual education may help to further delay sexual initiation and reduce other sexual risk behaviors in later high school years .


Lutein accumulates in the macula and brain , where it is assumed to play physiologic roles .


The bioavailability of lutein is assumed to display a high interindividual variability that has been hypothesized to be attributable , at least partly , to genetic polymorphisms .


We characterized the interindividual variability in lutein bioavailability in humans , assessed the relation between this variability and the fasting blood lutein concentration , and identified single nucleotide polymorphisms ( SNPs ) involved in this phenomenon .


In a randomized , 2-way crossover study , 39 healthy men consumed a meal that contained a lutein supplement or the same meal for which lutein was provided through a tomato puree .


The lutein concentration was measured in plasma chylomicrons isolated at regular time intervals over 8 h postprandially .


Multivariate statistical analyses were used to identify a combination of SNPs associated with the postprandial chylomicron lutein response ( 0-8-h area under the curve ) .


A total of 1785 SNPs in 51 candidate genes were selected .


Postprandial chylomicron lutein responses to meals were very variable ( CV of 75 % and 137 % for the lutein-supplement meal and the meal with tomato-sourced lutein , respectively ) .


Postprandial chylomicron lutein responses measured after the 2 meals were positively correlated ( r = 0.68 , P < 0.0001 ) and positively correlated to the fasting plasma lutein concentration ( r = 0.51 , P < 0.005 for the lutein-supplement-containing meal ) .


A significant ( P = 1.9 10 ( -4 ) ) and validated partial least-squares regression model , which included 29 SNPs in 15 genes , explained most of the variance in the postprandial chylomicron lutein response .


The ability to respond to lutein appears to be , at least in part , genetically determined .


The ability is explained , in large part , by a combination of SNPs in 15 genes related to both lutein and chylomicron metabolism .


Finally , our results suggest that the ability to respond to lutein and blood lutein status are related .


This trial was registered at clinicaltrials.gov as NCT02100774 .


Mindfulness interventions to reduce psychological distress are well-suited to pregnancy , due to their brief and non-pharmacological nature , but there is a need for more robust evidence determining their usefulness .


This pilot study was designed to explore the feasibility of a randomised controlled trial of a mindfulness intervention to reduce antenatal depression , anxiety and stress .


The study was designed in two parts 1 ) a non-randomised trial targeting women at risk of mental health problems ( a selected population ) and 2 ) a randomised controlled trial ( RCT ) of a universal population .


Process evaluation focused on feasibility of recruitment pathways , participant retention , acceptability of study measures , and engagement with mindfulness practices .


Measurement of psychological distress was taken pre and post intervention through the Centre for Epidemiologic Studies Depression Scale Revised , the Depression Anxiety and Stress Scale-21 , the State-Trait Anxiety Inventory , and the Perceived Stress Scale .


20 women were recruited to the non-randomised trial , and 32 to the RCT .


Recruitment through a mailed study brochure at the time of booking-in to the hospital resulted in the largest number of participants in the RCT ( 16/32 ; 50 % ) , and resulted in considerably earlier recruitment ( 50 % in first trimester , 50 % second trimester ) compared to recruitment through the antenatal clinic waiting room ( 86 % in second trimester , 14 % third trimester ) .


Over a third of women in the universal population scored above clinical cut-offs for depression and anxiety , indicating a sample with more symptomology than the general population .


The most common reason for loss to follow-up was delivery of baby prior to follow-up ( n = 9 ) .


In the non-randomised study , significant within group improvements to depression and anxiety were observed .


In the intervention arm of the RCT there were significant within group improvements to anxiety and mindfulness .


No between group differences for the intervention and ` care as usual ' control group were observed .


This small pilot study provides evidence on the feasibility of an antenatal mindfulness intervention to reduce psychological distress .


Major challenges include : finding ways to facilitate recruitment in early pregnancy and engaging younger women and other vulnerable populations .


Australian New Zealand Clinical Trials Registry ACTRN12613000742774 ( 31/10/2012 ) .


Prevention of iron deficiency in infancy may promote neurodevelopment .


Delayed umbilical cord clamping ( CC ) prevents iron deficiency at 4 to 6 months of age , but long-term effects after 12 months of age have not been reported .


To investigate the effects of delayed CC compared with early CC on neurodevelopment at 4 years of age .


Follow-up of a randomized clinical trial conducted from April 16 , 2008 , through May 21 , 2010 , at a Swedish county hospital .


Children who were included in the original study ( n = 382 ) as full-term infants born after a low-risk pregnancy were invited to return for follow-up at 4 years of age .


Wechsler Preschool and Primary Scale of Intelligence ( WPPSI-III ) and Movement Assessment Battery for Children ( Movement ABC ) scores ( collected between April 18 , 2012 , and July 5 , 2013 ) were assessed by a blinded psychologist .


Between April 11 , 2012 , and August 13 , 2013 , parents recorded their child 's development using the Ages and Stages Questionnaire , Third Edition ( ASQ ) and behavior using the Strengths and Difficulties Questionnaire .


All data were analyzed by intention to treat .


Randomization to delayed CC ( 180 seconds after delivery ) or early CC ( 10 seconds after delivery ) .


The main outcome was full-scale IQ as assessed by the WPPSI-III .


Secondary objectives were development as assessed by the scales from the WPPSI-III and Movement ABC , development as recorded using the ASQ , and behavior using the Strengths and Difficulties Questionnaire .


We assessed 263 children ( 68.8 % ) .


No differences were found in WPPSI-III scores between groups .


Delayed CC improved the adjusted mean differences ( AMDs ) in the ASQ personal-social ( AMD , 2.8 ; 95 % CI , 0.8-4 .7 ) and fine-motor ( AMD , 2.1 ; 95 % CI , 0.2-4 .0 ) domains and the Strengths and Difficulties Questionnaire prosocial subscale ( AMD , 0.5 ; 95 % CI , > 0.0-0 .9 ) .


Fewer children in the delayed-CC group had results below the cutoff in the ASQ fine-motor domain ( 11.0 % vs 3.7 % ; P = .02 ) and the Movement ABC bicycle-trail task ( 12.9 % vs 3.8 % ; P = .02 ) .


Boys who received delayed CC had significantly higher AMDs in the WPPSI-III processing-speed quotient ( AMD , 4.2 ; 95 % CI , 0.8-7 .6 ; P = .02 ) , Movement ABC bicycle-trail task ( AMD , 0.8 ; 95 % CI , 0.1-1 .5 ; P = .03 ) , and fine-motor ( AMD , 4.7 ; 95 % CI , 1.0-8 .4 ; P = .01 ) and personal-social ( AMD , 4.9 ; 95 % CI , 1.6-8 .3 ; P = .004 ) domains of the ASQ .


Delayed CC compared with early CC improved scores in the fine-motor and social domains at 4 years of age , especially in boys , indicating that optimizing the time to CC may affect neurodevelopment in a low-risk population of children born in a high-income country .


clinicaltrials.gov Identifier : NCT01581489 .


The Alberta Stroke Program Early CT Score ( ASPECTS ) on baseline imaging is an established predictor of acute ischemic stroke outcomes .


We analyzed change on serial ASPECTS at baseline and 24-hour imaging in the Solitaire Flow Restoration with the Intention for Thrombectomy ( SWIFT ) study to determine prognostic value and to identify subgroups with extensive injury after intervention .


ASPECTS at baseline and 24 hours was independently scored in all anterior circulation SWIFT cases , blinded to all other trial data .


ASPECTS at baseline , at 24 hours , and serial changes were analyzed with univariate and multivariate approaches .


One hundred thirty-nine patients ( mean age , 67 [ SD , 12 ] years ; 52 % women ; median National Institutes of Health Stroke Scale , 18 [ interquartile range , 8-28 ] ) with complete data at both time points were studied .


Multivariate analyses showed that higher 24-hour ASPECTS predicted good clinical outcome ( day 90 modified Rankin Scale , 0-2 ; odds ratio , 1.67 ; P < 0.001 ) .


Among patients with high baseline ASPECTS ( 8-10 ; n = 109 ) , dramatic infarct progression ( decrease in ASPECTS 6 points at 24 hours ) was noted in 31 of 109 ( 28 % ) .


Such serial ASPECTS change was predicted by higher baseline systolic blood pressure ( P = 0.019 ) , higher baseline blood glucose ( P = 0.133 ) , and failure to achieve Thrombolysis in Cerebral Infarction score of 2b/3 reperfusion ( P < 0.001 ) , culminating in worse day 90 modified Rankin Scale outcomes ( mean modified Rankin Scale , 4.4 versus 2.7 ; P < 0.001 ) .


Twenty-four-hour ASPECTS provides better prognostic information compared with baseline ASPECTS .


Predictors of dramatic infarct progression on ASPECTS are hyperglycemia , hypertension , and nonreperfusion .


Serial ASPECTS change from baseline to 24 hours predicts clinical outcome , providing an early surrogate end point for thrombectomy trials .


http://www.clinicaltrials.gov .


Unique identifier : NCT01054560 .


We tested the hypothesis that direct intramyocardial injection of bone marrow mononuclear cells in patients with non-ischemic dilated cardiomyopathy can improve left ventricular function and physical capacity .


Thirty non-ischemic dilated cardiomyopathy patients with left ventricular ejection fraction < 35 % were randomized at a 1:2 ratio into two groups , control and treated .


The bone marrow mononuclear cells group received 1.06108 bone marrow mononuclear cells through mini-thoracotomy .


There was no intervention in the control group .


Assessment was carried out through clinical evaluations as well as a 6-min walk test , nuclear magnectic resonance imaging and echocardiogram .


The bone marrow mononuclear cells group showed a trend toward left ventricular ejection fraction improvement , with magnectic resonance imaging - at 3 months , showing an increase from 27.806.86 % to 30.139.06 % ( P = 0.08 ) and returning to baseline at 9 months ( 28.78 % , P = 0.77 ) .


Magnectic resonance imaging showed no changes in left ventricular ejection fraction during follow-up of the control group ( 28.004.32 % , 27.427.41 % , and 29.574.50 % ) .


Echocardiogram showed left ventricular ejection fraction improved in the bone marrow mononuclear cells group at 3 months , 25.093.98 to 30.949.16 ( P = 0.01 ) , and one year , 30.077.25 % ( P = 0.001 ) .


The control group showed no change ( 26.14.4 vs 26.54.7 and 30.27.39 % , P = 0.25 and 0.10 , respectively ) .


Bone marrow mononuclear cells group showed improvement in New York Heart Association functional class , from 3.400.50 to 2.410.79 ( P = 0.002 ) ; patients in the control group showed no change ( 3.370.51 to 2.710.95 ; P = 0.17 ) .


Six-minute walk test improved in the bone marrow mononuclear cells group ( 348.0093.51 m at baseline to 370.4191.56 m at 12 months , P = 0.66 ) and there was a non-significant decline in the control group ( 361.2590.78 m to 330.00123.42 m after 12 months , P = 0.66 ) .


Group comparisons were non-significant .


The trend of intragroup functional and subjective improvement was not confirmed when compared to the control group .


Direct intramyocardial application of bone marrow mononuclear cells in non-ischemic dilated cardiomyopathy was not associated with significant changes in left ventricular function .


Differences observed within the bone marrow mononuclear cells group could be due to placebo effect or low statistical power .


The aim of this study was to investigate whether infiltration of the upper eyelid skin is less painful with prilocaine than with lidocaine .


In 40 consecutive patients scheduled for bilateral upper blepharoplasty , one upper eyelid was anaesthetised with lidocaine with epinephrine and the other with prilocaine with felypressin .


After injection of each upper eyelid , the patient scored the pain experienced on infiltration using a visual analogue scale ( 0-10 ) .


In addition , the surgeon scored the need for reinjection during the operation ; differences in perioperative bleeding ; and degree of oedema , erythema and haematoma before discharge on a four-point rating scale ( no , minimal , moderate or severe ) .


Pain scores were significantly lower in upper eyelids injected with lidocaine than in those injected with prilocaine ( p = 0.036 ) .


In addition , scores for oedema , erythema and haematoma were significantly lower in upper eyelids anaesthetised with lidocaine than in those anaesthetised with prilocaine ( respectively , p = 0.001 , p = 0.004 and p = 0.000 ) .


Compared with prilocaine with felypressin , lidocaine with epinephrine is significantly less painful in anaesthetising the upper eyelids ; gives significantly less postoperative oedema , erythema and haematoma ; and provides better haemostasis during upper blepharoplasty .


This was a level II , randomised double-blinded crossover study .


The aim of this study was to investigate the potential drug-drug interaction between Bencycloquidium bromide ( BCQB ) and paroxetine , and between BCQB and roxithromycin .


Two studies were conducted on healthy male Chinese volunteers .


Study A was an open-label , two-period , one-sequence crossover study ( n = 21 ) .


Each participant received a single nasal spray dose of BCQB 180g on day 1 .


After a 7-day wash-out period , subjects received 20mg of paroxetine from day 8 to 17 , and were co-administered 20mg of paroxetine and BCQB 180g on day 18 .


In study B , participants ( n = 12 ) were randomly assigned to two groups .


In period I , group A received BCQB 180g on day 1 , followed by the same dose four times daily from day 4 to 10 , then , on day 11 a single dose of 150mg roxithromycin with BCQB 180g were co-administered .


In parallel , group B received a single dose of roxithromycin 150mg on day 1 , followed by 300mg of roxithromycin from day 4 to 10 , then , on day 11 a single dose of BCQB 180g with roxithromycin 300mg were co-administered .


After a wash-out time of 7days the respective treatments of each group ( A and B ) were swapped in period II .


Blood samples were collected for pharmacokinetic analysis .


Statistical comparison of pharmacokinetic parameters was performed to identify a possible drug interaction between treatments .


Tolerability was evaluated by recording adverse events .


Study A : Geometric mean AUC0-36 for BCQB alone and co-administered with paroxetine were 474.3 and 631.3 pgh/ml , respectively .


The geometric mean ratio ( GMR ) of AUC0-36 was 1.33 ( 1.13-1 .46 ) , 90 % C.Is , and was out the predefined bioequivalence interval ( 90 % C.Is , 0.80-1 .25 ) .


Geometric mean Cmax were 187.0 and 181.2 pg/ml .


Study B : The GMR of AUC0-36 was 0.98 ( 0.90-1 .07 ) , 90 % C.Is for BCQB , and the GMR of AUC0-72 was 0.98 ( 0.87-1 .11 ) , 90 % C.Is for roxithromycin .


Both GMRs were within the predefined bioequivalence interval ( 90 % C.Is , 0.80-1 .25 ) .


Other pharmacokinetic parameters were within the predefined interval .


No serious adverse events were reported and no significant clinical changes were observed in laboratory test results , vital signs and ECGs in any of the studies .


All treatments were well tolerated .


The co-administration of BCQB with paroxetine showed a moderate increase in BCQB exposure , but was not clinically relevant .


Also , no drug interaction was found between BCQB and roxithromycin .


The aim of this study was to determine the safety and efficacy of induction with rabbit antithymocyte globulin ( RATG ) compared with interleukin-2 receptor antagonists in a racially diverse kidney transplant patient population under modern immunosuppression .


The optimal induction therapy in patients at risk for rejection , particularly black recipients , in the modern era of immunosuppression with flow cytometry-based cross-matching is unclear .


This was a prospective , risk-stratified , randomized , single-center , open-label study of 200 consecutively enrolled patients in a large academic teaching center .


Patients were randomized to receive either daclizumab or basiliximab versus RATG for induction in combination with tacrolimus , mycophenolate mofetil , and corticosteroids .


Patients were stratified between groups to ensure equal numbers of black , retransplants , high panel reactive antibodies ( PRAs ) ( > 20 % ) , and prolonged cold ischemic times ( > 24 hours ) in each group .


Primary outcome measure is treatment efficacy defined as the incidence of biopsy-proven acute rejection and estimated creatinine clearance .


Patients were followed up for 12 months .


Renal transplant recipients were included if they were adult ( 18 years old ) and received an allograft from a deceased , living unrelated , or nonhuman leukocyte antigen identical living-related donor .


A total of 200 patients ( n = 98 in the interleukin-2 receptor antagonists , and n = 102 in the RATG ) were enrolled from February 2009 through July 2011 .


One-year acute rejection rates were low and similar between groups ( 10 % in the interleukin-2 receptor antagonist group vs 6 % in the RATG group ; P = 0.30 ) .


Creatinine clearance was also similar between groups ( interleukin-2 receptor antagonist group 56 20 mL/min per 1.73 m2 vs RATG group 55 22 mL/min per 1.73 m2 ; P = 0.73 ) .


Subanalysis of recipient race revealed that in blacks only RATG was protective against 6 - and 12-month acute rejection , without an increased risk of infection .


Induction did not affect rejection rates according to recipient calculated PRAs ; however , RATG was associated with an increased risk of BK virus in low-PRA patients .


RATG induction provides improved protection against early acute rejection in black renal transplant recipients , whereas sensitized patients do not seem to demonstrate a similar benefit from this therapy .


This study is registered at Clinicaltrials.gov ( NCT00859131 ) .


Postoperative adhesions constitute a substantial clinical problem in hand surgery .


Fexor tendon injury and repair result in adhesion formation around the tendon , which restricts the gliding function of the tendon , leading to decreased digit mobility and impaired hand recovery .


This study evaluated the efficacy and safety of the peptide PXL01 in preventing adhesions , and correspondingly improving hand function , in flexor tendon repair surgery .


This prospective , randomised , double-blind trial included 138 patients admitted for flexor tendon repair surgery .


PXL01 in carrier sodium hyaluronate or placebo was administered around the repaired tendon .


Efficacy was assessed by total active motion of the injured finger , tip-to-crease distance , sensory function , tenolysis rate and grip strength , and safety parameters were followed , for 12 months post-surgery .


The most pronounced difference between the treatment groups was observed at 6 months post-surgery .


At this timepoint , the total active motion of the distal finger joint was improved in the PXL01 group ( 60 vs. 41 degrees for PXL01 vs. placebo group , p = 0.016 in PPAS ) .


The proportion of patients with excellent/good digit mobility was higher in the PXL01 group ( 61 % vs. 38 % , p = 0.0499 in PPAS ) .


Consistently , the PXL01 group presented improved tip-to-crease distance ( 5.0 vs. 15.5 mm for PXL01 vs. placebo group , p = 0.048 in PPAS ) .


Sensory evaluation showed that more patients in the PXL01 group felt the thinnest monofilaments ( FAS : 74 % vs. 35 % , p = 0.021 ; PPAS : 76 % vs. 35 % , p = 0.016 ) .


At 12 months post-surgery , more patients in the placebo group were considered to benefit from tenolysis ( 30 % vs. 12 % , p = 0.086 in PPAS ) .


The treatment was safe , well tolerated , and did not increase the rate of tendon rupture .


Treatment with PXL01 in sodium hyaluronate improves hand recovery after flexor tendon repair surgery .


Further clinical trials are warranted to determine the most efficient dose and health economic benefits .


ClinicalTrials.gov NCT01022242 ; EU Clinical Trials 2009-012703-25 .


Free oxygen radicals might have an adverse effect on platelets which might be reflected either on its count and/or degree of bleeding severity .


To assess oxidant-antioxidant systems and evaluate effect of antioxidant therapy on platelet count ( PC ) and bleeding score ( BS ) in children and adolescents with ITP .


Six months prospective randomized single blind study registered as ( NCT 01763658 ) including 39 patients with newly diagnosed ( ND ) ITP ; group 1 ( G1 ) and 39 patients with chronic ITP ( G2 ) , each group was randomly allocated ( 2:1 ) to one of two subgroups respectively ; ( G1A and G2A ) interventional arm received daily antioxidant therapy , while G1B and G2B ; received a placebo .


Both groups were compared with healthy controls ( n = 39 ) .


The primary efficacy endpoints were the difference in the change from baseline to 6 month in ITP specific bleeding assessment tool ( ITP-BAT ) , PC , total antioxidant capacity ( TAC ) , catalase ( CAT ) , reduced glutathione ( GSH ) and serum malondialdehyde ( MDA ) .


Baseline TAC was significantly lower in patients with ( ND ) ITP compared to patients with chronic ITP ( P < 0.05 ) , both showed significantly lower levels than healthy controls ( P < 0.001 ) .


At end of study both BS and PC significantly improved in patients receiving antioxidant compared to placebo ( P < 0.05 ) .


Patients with chronic ITP receiving antioxidant showed better improvement .


Reduced antioxidant mechanisms were reported in patients with ITP .


Antioxidant therapy ameliorated the oxidative stress in both ND and chronic ITP groups which might explain the improvement in both BS and PC .


The choice between operative or nonoperative treatment is questioned for partial articular fractures of the radial head that have at least 2 millimeters of articular step-off on at least one radiograph ( defined as displaced ) , but less than 2 millimeter of gap between the fragments ( defined as stable ) and that are not associated with an elbow dislocation , interosseous ligament injury , or other fractures .


These kinds of fractures are often classified as Mason type-2 fractures .


Retrospective comparative studies suggest that operative treatment might be better than nonoperative treatment , but the long-term results of nonoperative treatment are very good .


Most experts agree that problems like reduced range of motion , painful crepitation , nonunion or bony ankylosis are infrequent with both nonoperative and operative treatment of an isolated displaced partial articular fracture of the radial head , but determining which patients will have problems is difficult .


A prospective , randomized comparison would help minimize bias and determine the balance between operative and nonoperative risks and benefits .


The RAMBO trial ( Radial Head - Amsterdam - Amphia - Boston - Others ) is an international prospective , randomized , multicenter trial .


The primary objective of this study is to compare patient related outcome defined by the ` Disabilities of Arm , Shoulder and Hand ( DASH ) score ' twelve months after injury between operative and nonoperative treated patients .


Adult patients with partial articular fractures of the radial head that comprise at least 1/3rd of the articular surface , have 2 millimeters of articular step-off but less than 2 millimeter of gap between the fragments will be enrolled .


Secondary outcome measures will be the Mayo Elbow Performance Index ( MEPI ) , the Oxford Elbow Score ( OES ) , pain intensity through the ` Numeric Rating Scale ' , range of motion ( flexion arc and rotational arc ) , radiographic appearance of the fracture ( heterotopic ossification , radiocapitellar and ulnohumeral arthrosis , fracture healing , and signs of implant loosening or breakage ) and adverse events ( infection , nerve injury , secondary interventions ) after one year .


The successful completion of this trial will provide evidence on the best treatment for stable , displaced , partial articular fractures of the radial head .


The trial is registered at the Dutch Trial Register : NTR3413 .


The immunosuppressant tacrolimus is usually administered orally .


When this is not feasible , other routes of administration may be useful .


Previous research suggested that tacrolimus may be applied sublingually or rectally .


Pharmacokinetic data are sparse .


The aim of this study was to investigate and compare the pharmacokinetics of these alternative formulations with orally administered tacrolimus .


Three single , fixed-dose formulations of tacrolimus were administered in a random sequence in 18 healthy subjects , using a cross-over study design .


For sublingual administration , 3mg of powder obtained from oral capsules was applied under the tongue for a period of 15min without swallowing , with mouth rinsing afterwards .


For rectal administration , a suppository containing 15mg of the oral powder was used .


Oral administration consisted of 7mg of instant-release tacrolimus capsules ( Prograf ) .


Main pharmacokinetic outcome parameters were compared by anova .


Sublingual administration showed no clinically significant exposure , contrary to rectal administration , where all subjects had clinically relevant exposure , with a lower relative bioavailability ( 78 % ) , a lower maximal blood concentration and a later time of maximal blood concentration compared with oral administration .


Sublingual administration of a single dose of tacrolimus does not result in systemic exposure if care is taken not to swallow saliva and to rinse the oral cavity afterwards .


Rectal administration of tacrolimus results in clinically relevant systemic exposure and might represent an alternative formulation in case oral administration is not feasible .


When used as a topical agent , systemic side-effects should be considered .


Helicobacter pylori ( Hp ) is a common and potentially curable cause of gastric mucosa lesion .


This study investigated the relationship of Hp infection with histological changes in gastric mucosa and gastric cancer in Hp-positive patients compared with Hp-eradication patients followed up for ten years .


From an initial group of 1 006 adults , 552 Hp-positive subjects were randomly assigned to a treatment group ( T ; n = 276 ) or a placebo group ( P ; n = 276 ) .


In the randomized , double-blind , placebo-controlled , parallel trial , T group subjects received oral doses of omeprazole , amoxicillin and clarithromycin for 1 week ; those in the P group received a placebo .


One month after treatment ended , a 13C urea breath test was performed , and Hp was undetectable in 88.89 % of the T group .


All subjects were followed at 1 , 5 , 8 , and 10 years after treatment , with endoscopy and biopsies for histological examination .


Gastric mucosa inflammation was significantly milder in the T group than that in the P group one year after Hp eradication and this persisted for 10 years .


Glandular atrophy and intestinal metaplasia ( IM ) had deteriorated in both groups during ten years .


However , the increased score of glandular atrophy at both the gastric antrum and corpus , and IM only at the gastric antrum , in the P group was more obvious than that in the T group .


During the 10 years , 9 patients were diagnosed with gastric cancer ( 2 in the T group ; 7 in the P group ; P = 0.176 ) .


When mucosal atrophy was absent at the gastric antrum and corpus when entering the study , the incidence of gastric cancer in the P group ( n = 6 ) was much higher than that in the T group ( n = 0 , P = 0.013 ) .


Hp eradication may significantly diminish and help halt progression of gastric mucosal inflammation and delay the development of IM and atrophy gastritis .


Hp eradication is helpful for reducing the risk for gastric cancer , especially in the early stage of Hp infection .


Pelvic adhesions are found in up to 50 % of women with CPP during investigative surgeries and adhesiolysis is often performed as part of their management although the causal or casual association of adhesions , and the clinical benefit of adhesiolysis in the context of CPP is still unclear .


Our aim was to test the hypothesis of whether laparoscopic adhesiolysis leads to significant pain relief and improvement in quality of life ( QoL ) in patients with chronic pelvic pain ( CPP ) and adhesions .


This was a double-blinded RCT .


This study was conducted in 2 tertiary referral hospitals in United Kingdom over 4years .


Women with chronic pelvic pain ( CPP ) were randomized into having laparoscopic adhesiolysis or diagnostic laparoscopy .


Women were assessed at 0 , 3 and 6months for Visual analogue scale scores ( VAS ) and Quality of Life ( QoL ) measures ( SF-12 and EHP-30 ) .


A total of 92 participants were recruited ; 50 qualified to be randomized , with 26 in the adhesiolysis and 24 in the control group .


The results are expressed in median ( interquartile ranges ) .


In women who underwent adhesiolysis , there was a significant improvement at 6months in VAS scores ( -17.5 ( -36.0 - -5.0 ) compared to controls ( -1.5 ( -15.0 - 4.5 ; p = 0.048 ) ; SF-12 scores physical component score ( 25.0 ( 18.8 - 43.8 ) ) compared to controls ( 6.3 ( -6.3 - 18.8 ) ; p = 0.021 ) , SF-12 emotional component score 32.5 ( 4.4 - 48.8 ) compared to controls -5 ( -21.3 - 15.0 ) ; p < 0.0074 ) and EHP-30 emotional well being domain 32.5 ( 4.4 - 48.8 ) compared to the controls -5 ( -21.3 - 15.0 ; p < 0.0074 ) .


This study stopped before recruitment reached the statistically powered sample size due to difficulty with enrollment and lack of continued funding .


In selected population of women presenting to the gynecological clinic with chronic pelvic pain , adhesiolysis in those who have adhesions may be of benefit in terms of improvement of pain and their quality of life .


ISRCTN 43852269 .


This study reports the long-term follow-up of the randomised controlled HEBE trial .


The HEBE study is a multicentre trial that randomised 200 patients with large first acute myocardial infarction ( AMI ) treated with primary percutaneous coronary intervention to either intracoronary infusion of bone marrow mononuclear cells ( BMMCs ) ( n = 69 ) , peripheral blood mononuclear cells ( PBMCs ) ( n = 66 ) or standard therapy ( n = 65 ) .


In addition to 3-5days , and 4months after AMI , all patients underwent cardiac MRI after 2years .


A follow-up for 5years after AMI was performed to assess clinical adverse events , including death , myocardial reinfarction and hospitalisation for heart failure .


Of the 200 patients enrolled , 9 patients died and 12 patients were lost to follow-up at 5years after AMI .


BMMC group showed less increase in LV end-diastolic volume ( LVEDV ) ( 3.516.9 mL/m ( 2 ) ) compared with ( 11.219.8 mL/m ( 2 ) , p = 0.03 ) in the control group , with no difference between the PBMC group ( 9.220.9 mL/m ( 2 ) ) and controls ( p = 0.69 ) .


Moreover , the BMMC group showed a trend for decrease in LV end systolic volume ( -1.815.0 mL/m ( 2 ) ) as compared with controls ( 3.016.3 mL/m ( 2 ) , p = 0.07 ) , with again no difference between PBMC ( 3.318.8 mL/m ( 2 ) ) and controls ( p = 0.66 ) .


The combined endpoint of death and hospitalisation for heart failure was non-significantly less frequent in the BMMC group compared with the control group ( n = 4 vs n = 1 , p = 0.20 ) , with no difference between PBMC and controls ( n = 6 vs n = 4 , p = 0.74 ) .


The composite endpoint of death or recurrent myocardial infarction was significantly higher in the PBMC group compared with controls ( 14 patients vs 3 patients , p = 0.008 ) , with no difference between the BMMC group and controls ( 2 vs 3 patients , p = 0.67 ) .


Long-term follow-up of the HEBE trial showed that increase in LVEDV was lower in the BMMC group .


This study supports the long-term safety of intracoronary BMMC therapy .


However , major clinical cardiovascular adverse events were significantly more frequent in the PBMC group .


The Netherlands Trial Register #NTR 166 ( http://www.trialregister.nl ) and the International Standard Randomised Controlled Trial , #ISRCTN 95796863 ( http://isrctn.org ) .


Renal dysfunction is a common comorbidity in patients with heart failure and preserved ejection fraction ( HFpEF ) .


We sought to determine whether renal dysfunction was associated with measures of cardiovascular structure/function in patients with HFpEF .


We studied 217 participants from the PARAMOUNT study with HFpEF who had echocardiography and measures of kidney function .


We evaluated the relationships between renal dysfunction [ estimated glomerular filtration rate ( eGFR ) > 30 and < 60 mL/min/1 .73 m ( 2 ) and/or albuminuria ] and cardiovascular structure/function .


The mean age of the study population was 71 years , 55 % were women , 94 % hypertensive , and 40 % diabetic .


Impairment of at least one parameter of kidney function was present in 62 % of patients ( 16 % only albuminuria , 23 % only low eGFR , 23 % both ) .


Renal dysfunction was associated with abnormal LV geometry ( defined as concentric hypertrophy , or eccentric hypertrophy , or concentric remodelling ) ( adjusted P = 0.048 ) , lower midwall fractional shortening ( MWFS ) ( P = 0.009 ) , and higher NT-proBNP ( P = 0.006 ) .


Compared with patients without renal dysfunction , those with low eGFR and no albuminuria had a higher prevalence of abnormal LV geometry ( P = 0.032 ) and lower MWFS ( P < 0.01 ) , as opposed to those with only albuminuria .


Conversely , albuminuria alone was associated with greater LV dimensions ( P < 0.05 ) .


Patients with combined renal impairment had mixed abnormalities ( higher LV wall thicknesses , NT-proBNP ; lower MWFS ) .


Renal dysfunction , as determined by both eGFR and albuminuria , is highly prevalent in HFpEF , and associated with cardiac remodelling and subtle systolic dysfunction .


The observed differences in cardiac structure/function between each type of renal damage suggest that both parameters of kidney function might play a distinct role in HFpEF .


The purpose of this study was to compare the safety and efficacy of a new cationic emulsion ( CE ) with a formulation of polyvinyl alcohol and povidone ( PVA-P ) for the treatment of mild to moderate dry eye disease .


This was a multicenter , open-label , comparative study .


Patients were randomised to receive CE ( Cationorm ) or PVA-P ( Refresh ) ( 1:1 ) .


The following objective criteria were assessed to compare the two eye drops : tear Break-up Time ( TBUT ) , Schirmer 's test , lissamine green staining ( Van Bijsterveld score ) , corneal fluorescein staining ( Oxford scale ) and oculopalpebral examination , on D7 and D28 ( end of study ) .


At these visits , ocular symptoms and safety were also assessed .


Seventy-nine patients were randomised : CE : 44 patients ; PVA-P : 35 patients .


At D28 , improvement was significantly better for TBUT [ CE : 1.7 2.4 s ; PVA-P : 0.6 1.8 s ; P = 0.015 ] and for the Van Bijsterveld score [ CE : -1.4 1.2 ; PVA-P : -0.9 1.2 ; P = 0.046 ] in the CE group .


The same applied for the palpebral erythema score ( P = 0.023 ) , overall efficacy assessed by the investigators ( P < 0.001 ) , and symptoms not related to eye drop instillation ( P = 0.021 ) .


Improvement was observed from D7 .


No difference was observed between the two treatments with regard to ocular safety .


These results suggest that in patients with mild to moderate dry eye , Cationorm , in addition to its moisturizing and lubricating properties , also helps stabilize the tear film due to its oily component .


This study demonstrates the benefit of this new pharmaceutical form for the treatment of mild to moderate dry eye disease .


The EndoFlex is a new type of tracheal tube with an adjustable distal tip that can be bent without the use of a stylet .


The aim of this study was to compare a standard endotracheal tube with the EndoFlex tracheal tube for intubation in patients with simulated cervical spine injury .


A group of 60 patients without any kind of the cervical spine injury , classified as the ASA physiological scale I or II and qualified for elective surgery procedures were intubated with the use of classical Macintosh laryngoscope , and either a standard endotracheal tube with the intubation stylet in it or EndoFlex tube without stylet .


The subjects were randomized into two subgroups .


All patients have had the cervical collar placed on their neck for the simulation of intubation procedure in case of the spinal injury .


The intubation procedure was performed by 16 anesthetists with different experience ( 5-19 yrs ) .


Time of intubation with the use of EndoFlex tube was similar to that with a the use of standard endotracheal tube and intubation stylet : Me ( median ) 19.5 s [ IQR ( interquatile range ) 18-50 ] vs. Me 20 s [ IQR 17-60 ] respectively ( p = 0.9705 ) .


No significant additional maneuvers were necessary during intubation with the use of EndoFlex tube in comparison with standard endotracheal tube ( 70 % vs. 56.6 % ) ( p = 0.4220 ) .


Subjective assessment of the usability of both tubes revealed that more anesthesiologists found intubations with the use of EndoFlex more demanding than intubation with conventional tracheal tube and intubation stylet .


The assessment of usability : very easy 3.3 % vs. 20 % , easy 83.4 % vs. 56.7 % , difficult 10 % vs. 20 % and very difficult 3.3 % vs. 3.3 % for standard endotracheal tube with stylet and EndoFlex , respectively .


In conclusion we asses , that the EndoFlex tube does not improve intubation success rate , in fact it requires more maneuvers facilitating intubation and was found to be more difficult to use .


The present study evaluated the efficacy of preoperative pregabalin for prevention of catheter-related bladder discomfort .


Prospective , randomized , placebo controlled , double blinded study .


Sixty patients of either sex undergoing elective spine surgery and requiring urinary bladder catheterization were randomly assigned to two groups .


The patients in Group P ( pregabalin group ) received 150mg of pregabalin orally 1h prior to induction of anesthesia with sips of water and the patients in Group C ( control group ) received placebo .


Anesthesia technique was identical in both the groups .


Catheter-related bladder discomfort ( CRBD ) was evaluated on a 4-point scale ( 1 = no discomfort , 2 = mild , 3 = moderate , 4 = severe ) , on arrival ( 0h ) and again at 1 , 2 , and 6h postoperatively .


Patients were provided patient-controlled analgesia with fentanyl for postoperative pain relief .


The incidence of CRBD was significantly less in the pregabalin group compared with the control group at all time intervals ( P < 0.05 ) .


The severity of CRBD was reduced in the pregabalin group compared with the control group at all time intervals except 6h .


The postoperative consumption of fentanyl was significantly less in group P , while the sedation score was significantly higher in the group P compared to group C.


Pretreatment with pregabalin 150mg prevents CRBD and also decreases postoperative fentanyl consumption .


Clinical Trials.gov identifier : ( ref : CTRI/2013/11 / 004170 ) .


Many patients report discomfort because of the unpleasant taste of bowel preparation solutions .


This study aimed to determine whether adding orange juice to 2 L of polyethylene glycol plus ascorbic acid is effective for reducing patient discomfort and improving palatability during bowel preparation .


This was a single-blinded , randomized controlled trial .


The study was conducted at a tertiary referral hospital and a generalized hospital .


Consecutive outpatients and inpatients were randomly allocated to drink 2 L of polyethylene glycol-ascorbic acid or 2 L of polyethylene glycol-ascorbic acid with orange juice in a single dose or a split dose .


Tolerability , palatability score , willingness , and related adverse events were investigated by questionnaires .


Bowel cleansing was rated using the Aronchick scale .


Each score was graded on a 5-point scale .


A total of 107 patients , 53 in the orange juice group and 54 in the polyethylene glycol-ascorbic acid group who underwent elective colonoscopy were enrolled .


The palatability score ( mean SD ) was higher in the orange juice group than in the control group ( 2.36 0.76 vs 1.78 0.88 ; p = 0.005 ) .


Nausea was less frequent in the orange juice group ( 26.4 % vs 59.3 % ; p = 0.001 ) .


Total amount of bowel preparation ingested was not significantly different between the groups ( p = 0.44 ) .


The bowel preparation score ( mean SD ) was not significantly different ( 1.49 0.80 vs 1.43 0.77 ; p = 0.94 ) .


Willingness to repeat the same process was higher in the orange juice group ( 90.4 % vs 66.7 % ; p = 0.003 ) .


This study is limited because only ambulatory patients were enrolled .


Orange juice intake before drinking 2 L of polyethylene glycol-ascorbic acid for colonoscopy can reduce patient discomfort , resulting in improved acceptability and patient compliance .


This method is as effective for bowel cleansing as polyethylene glycol .


We compared the angiotensin receptor-neprilysin inhibitor LCZ696 with enalapril in patients who had heart failure with a reduced ejection fraction .


In previous studies , enalapril improved survival in such patients .


In this double-blind trial , we randomly assigned 8442 patients with class II , III , or IV heart failure and an ejection fraction of 40 % or less to receive either LCZ696 ( at a dose of 200 mg twice daily ) or enalapril ( at a dose of 10 mg twice daily ) , in addition to recommended therapy .


The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure , but the trial was designed to detect a difference in the rates of death from cardiovascular causes .


The trial was stopped early , according to prespecified rules , after a median follow-up of 27 months , because the boundary for an overwhelming benefit with LCZ696 had been crossed .


At the time of study closure , the primary outcome had occurred in 914 patients ( 21.8 % ) in the LCZ696 group and 1117 patients ( 26.5 % ) in the enalapril group ( hazard ratio in the LCZ696 group , 0.80 ; 95 % confidence interval [ CI ] , 0.73 to 0.87 ; P < 0.001 ) .


A total of 711 patients ( 17.0 % ) receiving LCZ696 and 835 patients ( 19.8 % ) receiving enalapril died ( hazard ratio for death from any cause , 0.84 ; 95 % CI , 0.76 to 0.93 ; P < 0.001 ) ; of these patients , 558 ( 13.3 % ) and 693 ( 16.5 % ) , respectively , died from cardiovascular causes ( hazard ratio , 0.80 ; 95 % CI , 0.71 to 0.89 ; P < 0.001 ) .


As compared with enalapril , LCZ696 also reduced the risk of hospitalization for heart failure by 21 % ( P < 0.001 ) and decreased the symptoms and physical limitations of heart failure ( P = 0.001 ) .


The LCZ696 group had higher proportions of patients with hypotension and nonserious angioedema but lower proportions with renal impairment , hyperkalemia , and cough than the enalapril group .


LCZ696 was superior to enalapril in reducing the risks of death and of hospitalization for heart failure .


( Funded by Novartis ; PARADIGM-HF ClinicalTrials.gov number , NCT01035255 . )


This study was conducted to determine the effects of folate supplementation on metabolic profiles in obese women with polycystic ovary syndrome ( PCOS ) .


This randomized double-blind placebo-controlled clinical trial was conducted among 81 obese women ( weight range : 65-110 kg ) aged 18-40 year old diagnosed with PCOS .


Participants were randomly assigned to three groups receiving : ( 1 ) Folate-1 : 1 mg/day folate supplements ( n = 27 ) ; ( 2 ) Folate-5 : 5 mg/day folate supplements ( n = 27 ) , and ( 3 ) placebo ( n = 27 ) for 8 weeks .


Fasting blood samples were taken at baseline and after 8 weeks ' intervention to quantify glucose metabolism and lipid concentrations .


Folate supplementation ( 5 mg ) , compared with folate-1 and placebo , resulted in reduced plasma homocysteine ( p-interaction = 0.009 ) , homeostasis model of assessment-insulin resistance score ( p-interaction = 0.01 ) , and total cholesterol/HDL-C ratio ( p-interaction = 0.01 ) .


Furthermore , we found a significant difference in mean change of serum total cholesterol ( p-interaction = 0.01 ) , LDL - ( p-interaction = 0.007 ) , and non-HDL-cholesterol levels ( p = 0.01 ) in the folate-5 group compared with folate-1 and placebo .


5 mg/day folate supplementation for 8 weeks among women with PCOS had beneficial effects on metabolic profiles .


Patients with Pulmonary Tuberculosis ( PTB ) often develop impairment in pulmonary function due to anatomical changes secondary to the illness .


Physiotherapy in the form of pulmonary rehabilitation has been advocated .


The aim of the study was to determine whether adherence to a six-week home-based pulmonary rehabilitation programme ( PRP ) improved the baseline measurements of lung function , exercise tolerance and health-related quality of life ( HRQoL ) in patients receiving out-patient treatment for PTB .


A single blinded randomized control study design was used to assess the effects of a six-week home - based PRP in patients receiving treatment for PTB at a local clinic in Khayelitsha , Western Cape .


We evaluated lung function by spirometry ( MINATO AUTOSPIRO-model no .


AZ-505 ) , exercise tolerance using the 6-min-walk test ( 6MWT ) , the Borg exercise exertion scale and HRQoL using the EQ-5 D questionnaire in an intervention group ( n = 34 ) and a control group ( n = 33 ) .


The trend of the effects of the PRP on lung function was towards increases , but there was no statistical difference between the intervention and control groups at the end of the sixth week in the values of FVC ( p = 0.2 ; 95 % CI -0.9 to 0.51 ) as well as FEV1 ( p = 0.1 ; 95 % CI -0.07 to 0.51 ) .


Similar trend was observed for exercise tolerance , and there was no significant difference in HRQoL ( p = 0.789 ) .


The outcome of the study provides motivation for further consideration and implementation of a pulmonary rehabilitation programme for patients with PTB .


Although the potential advantages of the Endocut mode ( E-mode ) of endoscopic sphincterotomy ( EST ) over the conventional blended cut mode ( C-mode ) have been reported , the problems , including the small sample size and retrospective analysis , that occurred in previous studies make it difficult to conclude the advantage of the E-mode regarding the safety and efficacy .


We performed a prospective randomized controlled study to compare these modes .


A total of 360 patients with choledocholithiasis or stenosis of the bile duct were randomly assigned to one of the modes .


To avoid the technical bias due to multiple operators or institutions , the main operator and the institution were restricted to only one experienced doctor and 3 institutions at his place of employment , respectively .


We defined pancreatitis , bleeding , and perforation as complications of EST. .


Besides , bleeding includes endoscopically evident bleeding that was defined as visible during the procedure of sphincterotomy and temporary slight oozing .


The complications occurred in 20 ( 11.2 % ) patients from the E-mode group : pancreatitis in 6 ( 3.4 % ) and endoscopically evident bleeding in 14 ( 7.8 % ) .


In contrast , the complications occurred in 25 ( 13.8 % ) patients from the C-mode group : pancreatitis in 7 ( 3.9 % ) and endoscopically evident bleeding in 18 ( 9.9 % ) , although these findings were not statistically significant .


Overall , there were no severe complications .


There were no significant differences in completion ratio of EST and the time taken for the sphincterotomy between both groups .


The E-mode could not surpass the C-mode in safety and efficacy under the operation by a single endoscopist .


This study aims to evaluate the efficacy and tolerability of vortioxetine 2.5 - , 5 - and 10-mg once-daily doses vs. placebo in the treatment of generalised anxiety disorder ( GAD ) .


In this 8-week , multicentre , double-blind , placebo-controlled , parallel-group , phase 3 study , patients with a primary GAD diagnosis were randomised to receive placebo ( n = 157 ) , vortioxetine 2.5 mg , vortioxetine 5 mg , vortioxetine 10 mg or duloxetine 60 mg once daily ( n = 156 each ) .


The primary end-point , mean change from baseline in Hamilton Anxiety Scale ( HAM-A ) total score and key secondary end-points for the 5 - and 10-mg vortioxetine doses were analysed in a prespecified sequential testing procedure ( all at week 8 ) .


Sexual dysfunction was evaluated using the Arizona Sexual Experiences Scale .


Differences from placebo in the primary efficacy end-point were not statistically significant for the vortioxetine groups .


The mean difference from placebo was significant in the duloxetine arm .


For all secondary efficacy end-points , results were similar among the vortioxetine groups and did not reach statistical significance .


The vortioxetine 10-mg group showed separation from placebo on the Hospital Anxiety and Depression anxiety subscore ( nominal p = 0.036 ) .


Duloxetine 60 mg significantly improved the primary end-point ( p < 0.05 vs. placebo ) , validating the study .


Nausea , dry mouth , diarrhoea , nasopharyngitis , headache , dizziness , somnolence , vomiting , dyspepsia , constipation and fatigue were reported in 5 % of patients receiving vortioxetine .


Rates of treatment-emergent sexual dysfunction ( TESD ) in the vortioxetine dosing groups were similar to placebo .


In this study , vortioxetine 2.5 - , 5 - and 10-mg once-daily doses showed no significant improvement in HAM-A total scores vs. placebo .


Vortioxetine was well tolerated at all doses and was not associated with TESD .


The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear , but its use is increasing .


To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck .


A pragmatic , multicenter , parallel-group , randomized clinical trial , the Proximal Fracture of the Humerus Evaluation by Randomization ( PROFHER ) trial , recruited 250 patients aged 16 years or older ( mean age , 66 years [ range , 24-92 years ] ; 192 [ 77 % ] were female ; and 249 [ 99.6 % ] were white ) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 within 3 weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck .


Patients were followed up for 2 years ( up to April 2013 ) and 215 had complete follow-up data .


The data for 231 patients ( 114 in surgical group and 117 in nonsurgical group ) were included in the primary analysis .


Fracture fixation or humeral head replacement were performed by surgeons experienced in these techniques .


Nonsurgical treatment was sling immobilization .


Standardized outpatient and community-based rehabilitation was provided to both groups .


Primary outcome was the Oxford Shoulder Score ( range , 0-48 ; higher scores indicate better outcomes ) assessed during a 2-year period , with assessment and data collection at 6 , 12 , and 24 months .


Sample size was based on a minimal clinically important difference of 5 points for the Oxford Shoulder Score .


Secondary outcomes were the Short-Form 12 ( SF-12 ) , complications , subsequent therapy , and mortality .


There was no significant mean treatment group difference in the Oxford Shoulder Score averaged over 2 years ( 39.07 points for the surgical group vs 38.32 points for the nonsurgical group ; difference of 0.75 points [ 95 % CI , -1.33 to 2.84 points ] ; P = .48 ) or at individual time points .


There were also no significant between-group differences over 2 years in the mean SF-12 physical component score ( surgical group : 1.77 points higher [ 95 % CI , -0.84 to 4.39 points ] ; P = .18 ) ; the mean SF-12 mental component score ( surgical group : 1.28 points lower [ 95 % CI , -3.80 to 1.23 points ] ; P = .32 ) ; complications related to surgery or shoulder fracture ( 30 patients in surgical group vs 23 patients in nonsurgical group ; P = .28 ) , requiring secondary surgery to the shoulder ( 11 patients in both groups ) , and increased or new shoulder-related therapy ( 7 patients vs 4 patients , respectively ; P = .58 ) ; and mortality ( 9 patients vs 5 patients ; P = .27 ) .


Ten medical complications ( 2 cardiovascular events , 2 respiratory events , 2 gastrointestinal events , and 4 others ) occurred in the surgical group during the postoperative hospital stay .


Among patients with displaced proximal humeral fractures involving the surgical neck , there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence .


These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus .


isrctn.com Identifier : ISRCTN50850043 .


First generation drug-eluting stents ( DES ) were associated with a high incidence of late stent thrombosis ( ST ) , mainly due to delayed healing and re-endothelization by the durable polymer coating .


This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent ( SES ) in the treatment of patients with de novo coronary artery lesions .


The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES ( Lepu Medical Technology , Beijing , China ) in the treatment of patients with de novo native coronary lesions .


The primary endpoint was in-stent late lumen loss ( LLL ) at 9-month follow-up .


The secondary endpoint was major adverse cardiac events ( MACE ) , a composite of cardiac death , myocardial infarction or target lesion revascularization .


A total of 291 patients ( Nano group : n = 143 , Partner group : n = 148 ) were enrolled in this trial from 19 Chinese centers .


The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months ( P < 0.001 ) .


The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES ( 0.34 0.42 ) mm vs. ( 0.30 0.48 ) mm , P = 0.21 ) .


The incidence of MACE in the Nano group were 7.6 % compared to the Partner group of 5.9 % ( P = 0.75 ) at 2 years follow-up .


The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES ( 0.8 % vs. 0.7 % , 0.8 % vs. 1.5 % , both P = 1.00 ) .


In this multicenter randomized Nano trial , the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions .


Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES .


To investigate the effect of parenteral nutrition support with a lipid emulsion formulation ( containing soybean oil , medium chain triglycerides , olive oil , and fish oil [ SMOF ] ) in intensive care patients following major gastrointestinal surgeries .


According to a randomized , prospective and case-controlled design , 72 intensive care patients following major gastrointestinal surgeries between January and December , 2014 were randomized equally into SMOF group and control group to receive parenteral nutrition support with SMOF and medium or long chain lipid emulsion , respectively .


Before and at 4 and 9 days after commencement of parenteral nutrition support , the patients were examined for alanine aminotransferase ( ALT ) , total bilirubin ( TBIL ) , albumin ( propagated ) , C-reactive protein ( CRP ) , interleukin 6 ( IL-6 ) , and endotoxin levels .


The patients ' average length of stay in intensive care unit ( ICU ) , the days of using antibiotics , and the incidence rate of postoperative complication were recorded .


On day 4 postoperatively , the levels of CRP and IL-6 were significantly lower in SMOF group than in the control group ( t = 2.669 and 2.676 , respectively ; P < 0.05 ) , and on day 9 , the patients in SMOF group showed significantly lower levels of ALT , TBIL , CRP and IL-6 ( t = 2.487 , 3.497 , 3.762 , 2.180 , respectively ; P < 0.05 ) than the control group , but ALB and endotoxin levels remained comparable between the two groups .


The average length of stay in ICU and the days of using antibiotics were significantly shorter in SMOF group than in the control group ( t = 2.94 and 2.17 , respectively ; P < 0.05 ) ; SMOF group showed a lower incidence of postoperative infections than the control group , but the difference was not statistically significant ( = 1.047 , P > 0.05 ) .


For intensive care patients following major gastrointestinal surgeries , postoperative parenteral nutrition support with SMOF can effectively reduce the release of inflammatory mediators , protect important visceral functions , reduce postoperative complications , shorten the length of ICU stay , and improve the prognosis of the patients .


Physical activity ( PA ) interventions typically include components or doses that are static across participants .


Adaptive interventions are dynamic ; components or doses change in response to short-term variations in participant 's performance .


Emerging theory and technologies make adaptive goal setting and feedback interventions feasible .


To test an adaptive intervention for PA based on Operant and Behavior Economic principles and a percentile-based algorithm .


The adaptive intervention was hypothesized to result in greater increases in steps per day than the static intervention .


Participants ( N = 20 ) were randomized to one of two 6-month treatments : 1 ) static intervention ( SI ) or 2 ) adaptive intervention ( AI ) .


Inactive overweight adults ( 85 % women , M = 36.9 9.2 years , 35 % non-white ) in both groups received a pedometer , email and text message communication , brief health information , and biweekly motivational prompts .


The AI group received daily step goals that adjusted up and down based on the percentile-rank algorithm and micro-incentives for goal attainment .


This algorithm adjusted goals based on a moving window ; an approach that responded to each individual 's performance and ensured goals were always challenging but within participants ' abilities .


The SI group received a static 10,000 steps/day goal with incentives linked to uploading the pedometer 's data .


A random-effects repeated-measures model accounted for 180 repeated measures and autocorrelation .


After adjusting for covariates , the treatment phase showed greater steps/day relative to the baseline phase ( p < .001 ) and a group by study phase interaction was observed ( p .017 ) .


The SI group increased by 1,598 steps/day on average between baseline and treatment while the AI group increased by 2,728 steps/day on average between baseline and treatment ; a significant between-group difference of 1,130 steps/day ( Cohen 's d = .74 ) .


The adaptive intervention outperformed the static intervention for increasing PA. .


The adaptive goal and feedback algorithm is a `` behavior change technology '' that could be incorporated into mHealth technologies and scaled to reach large populations .


ClinicalTrials.gov NCT01793064 .


Prior chemotherapy may affect the efficacy of endocrine therapy .


The tamoxifen exemestane adjuvant multinational ( TEAM ) trial compared 5years of adjuvant exemestane with the sequence of tamoxifen followed by exemestane in postmenopausal women with hormone-receptor-positive breast cancer .


A total of 1,502 patients were enrolled in Germany ( 739 received tamoxifen followed by exemestan and 610 exemestan alone ) .


A retrospective analysis of the German cohort of TEAM was conducted to determine whether prior chemotherapy affected clinical outcome of endocrine therapy .


Overall survival , disease-free survival and distant recurrence were similar between patients who received sequential therapy and those who received exemestane monotherapy , irrespective of prior chemotherapy .


Overall survival was not significantly different between patients who had received prior chemotherapy and those who had not ( P = 0.2836 ) .


Disease-free survival and distant recurrence were significantly better in patients who had not received prior chemotherapy versus those who had ( P = 0.0308 and P = 0.0001 ) .


In patients receiving sequential therapy , there were no significant differences in overall survival according to prior chemotherapy use ( P = 0.1812 ) .


However , disease-free survival and distant recurrence were significantly different dependent on prior chemotherapy ( P = 0.0143 and P = 0.0053 ) .


In conclusion , there was no difference in overall survival between breast cancer patients who did receive prior chemotherapy before endocrine therapy and those who had not .


Patients who had not received prior chemotherapy had significantly improved disease-free survival and less distant recurrence versus those who had received chemotherapy .


An open-label phase I/II study of single-agent obatoclax determined a maximum tolerated dose ( MTD ) and schedule , safety , and efficacy in older patients ( 70 yr ) with untreated acute myeloid leukemia ( AML ) .


Phase I evaluated the safety of obatoclax infused for 3 hours on 3 consecutive days ( 3 h 3 d ) in 2-week cycles .


Initial obatoclax dose was 30 mg/day ( 3 h 3 d ; n = 3 ) .


Obatoclax was increased to 45 mg/day ( 3 h 3 d ) if 1 patient had a dose-limiting toxicity ( DLT ) and decreased to 20 mg/day ( 3 h 3 d ) if DLT occurred in 2 patients .


In the phase II study , 12 patients were randomized to receive obatoclax at the dose identified during phase I ( 3 h 3 d ) or 60 mg/day administered by continuous infusion over 24 hours for 3 days ( 24 h 3 d ) to determine the morphologic complete response rate .


In phase I , two of three patients receiving obatoclax 30 mg/day ( 3 h 3 d ) experienced grade 3 neurologic DLTs ( confusion , ataxia , and somnolence ) .


Obatoclax was decreased to 20 mg/day ( 3 h 3 d ) .


In phase II , no clinically relevant safety differences were observed between the 20 mg/day ( 3 h 3 d ; n = 7 ) and 60 mg/day ( 24 h 3 d ; n = 5 ) arms .


Neurologic and psychiatric adverse events were most common and were generally transient and reversible .


Complete response was not achieved in any patient .


Obatoclax 20 mg/day was the MTD ( 3 h 3 d ) in older patients with AML .


In the schedules tested , single-agent obatoclax was not associated with an objective response .


Evaluation in additional subgroups or in combination with other chemotherapy modalities may be considered for future study .


ClinicalTrials.gov NCT00684918 .


Although inpatient stroke rehabilitation provides clinicians with the opportunity to prepare patients for continuation of prestroke activities , little is known about the patients ' ability to safely resume driving at the point of discharge to the community .


To compare foot pedal response times of 20 stroke patients with right hemiplegia ( RH ) or left hemiplegia ( LH ) and 10 controls .


A cross-sectional design was used .


Response times were measured using 3 foot pedal operation techniques : ( 1 ) right-sided accelerator with right leg operating accelerator and brake , ( 2 ) right-sided accelerator with left leg operating accelerator and brake , and ( 3 ) left-sided accelerator with left leg operating accelerator and brake .


Outcomes included reaction time ( RT ) , movement time ( MT ) , and total response time ( TRT ) .


Controls demonstrated faster RT than patients with RH ( 263 vs 348 ms ; P < .001 ) or LH ( 316 ms ; P < .05 ) for all conditions , as well as faster MT than patients with RH ( P < .05 for all ) but not LH when using the right leg ( 258 vs 251 ms ; P = .82 ) .


Controls demonstrated faster TRT than patients with RH ( P < .001 for all ) but not LH when using the right leg ( 515 vs 553 ms ; P = .44 ) .


When using the nonparetic leg , patients with LH had braking response times comparable to controls , but patients with RH demonstrated significant impairment of both the paretic and nonparetic legs .


A recent randomized trial compared a policy of no prophylaxis with a policy of prophylactic platelet ( PLT ) transfusions at counts of fewer than 1010 ( 9 ) / L in patients with hematologic malignancies .


The results suggested the effectiveness of prophylactic PLT transfusions may vary according to patient diagnosis and treatment plan .


This article presents full subgroup analyses and compares treatment effects between autologous hematopoietic stem cell transplantation ( autoHSCT ; n = 421 ) and chemotherapy/allogeneic HSCT ( chemo/alloHSCT ; n = 179 ) patients .


Prespecified subgroup analysis found that the reduction in proportion of patients experiencing WHO Grade 2 to 4 bleeds ( main trial outcome ) seen in the prophylaxis arm was of greater magnitude in chemo/alloHSCT than autoHSCT patients ( interaction p = 0.04 ) .


Analysis of secondary outcomes showed a shorter time to first bleeding episode with no prophylaxis in the chemo/alloHSCT group ( hazard ratio , 1.84 ; 95 % confidence interval CI , 1.21-2 .79 ; p = 0.004 ) compared to the autoHSCT group ( hazard ratio , 1.12 ; 95 % CI , 0.85-1 .48 ; p = 0.4 ; interaction p = 0.08 ) .


The increased number of days with Grade 2 to 4 bleeds with a no-prophylaxis policy was similar in chemo/alloHSCT ( rate ratio , 1.89 ; 95 % CI , 1.10-3 .26 ) and in autoHSCT patients ( rate ratio , 1.43 ; 95 % CI , 1.04-1 .97 ) .


Both subgroups showed significant reductions in PLT transfusions with a no-prophylaxis strategy .


There is evidence that the effectiveness of prophylactic PLT transfusions may differ between subgroups , with chemo/alloHSCT patients receiving prophylactic PLT transfusions appearing to show a greater reduction in bleeding outcomes compared to patients following a no-prophylaxis policy .


Experimental animal studies provided evidence for a synergistic effect of immunological and psychological stressors on subsequent sickness behaviours .


Up to now , little corroborating evidence for such synergy exists for humans , in whom it may provide a mechanism leading to the expression of functional somatic symptoms .


The aim of the present study was to determine an interaction between stress ( - vulnerability ) and an immunological activation on experimental pain sensitivity , i.e. , pressure pain threshold and tolerance in healthy humans .


In healthy female participants ( n = 25 , mean age 22.3 years ) , negative affectivity ( NA ) and experienced stress were assessed by questionnaire before receiving a Salmonella typhi vaccine or saline control in a randomized blinded cross-over design .


Pressure pain threshold was assessed at the lower back and calves and pain tolerance was assessed at the thumbnail , before and six hours after each injection .


Vaccination induced leukocytosis ( +100 % ) and increased serum IL-6 ( +670 % ) .


NA predicted decreased pain tolerance after vaccination ( = -.57 , p = .007 ) , but not after placebo ( = .25 , p = .26 ) .


Post-hoc analyses also demonstrated an association with administration order .


NA moderated the effects of inflammation on pain tolerance .


This finding is consistent with a synergistic model whereby inflammation may lower the threshold for pain reporting in individuals with increased vulnerability for somatic symptom reporting .


Devices such as diode laser and intense pulsed light ( IPL ) are in constant development aiming at permanent hair removal , but there are few comparative studies between these technologies .


The objective was to comparatively assess axillary hair removal performed by diode laser and IPL and to obtain parameters of referred pain and evolution response for each method .


A comparative prospective , double-blind , and randomized study of axillary hair removal performed by the diode laser and IPL was conducted in 21 females .


Six sessions were held with application of the diode laser in one axilla and the IPL in the other , with intervals of 30 days and follow-up of 6 months after the last session .


Clinical photographs and digital dermoscopy for hair counts in predefined and fixed fields of the treated areas were performed before , 2 weeks after the sixth session , and 6 months after the end of treatment .


A questionnaire to assess the pain was applied .


The number of hair shafts was significantly reduced with the diode laser and IPL .


The diode laser was more effective , although more painful than the IPL .


No serious , adverse , or permanent effects were observed with both technologies .


Both diode laser and the IPL are effective , safe , and able to produce lasting results in axillary hair removal .


Stroke treatment is constrained by limited treatment windows and the clinical inefficacy of agents that showed preclinical promise .


Yet animal and clinical data suggest considerable poststroke plasticity , which could allow treatment with recovery-modulating agents .


Memantine is a well-tolerated N-methyl-D-aspartate glutamate receptor antagonist in common use for Alzheimer disease .


Memantine , 30 mg/kg per day , or vehicle , was delivered chronically in drinking water beginning > 2 hours after photothrombotic stroke .


Although there was no difference in infarct size , behavior , or optical intrinsic signal maps in the first 7 days after stroke , mice treated chronically with memantine showed significant improvements in motor control , measured by cylinder test and grid-walking performance , compared with vehicle-treated animals .


Optical intrinsic signal revealed an increased area of forepaw sensory maps at 28 days after stroke .


There was decreased reactive astrogliosis and increased vascular density around the infarcted cortex .


Peri-infarct Western blots revealed increased brain-derived neurotrophic factor and phosphorylated-tropomyosin-related kinase-B receptor expression .


Our results suggest that memantine improves stroke outcomes in an apparently non-neuroprotective manner involving increased brain-derived neurotrophic factor signaling , reduced reactive astrogliosis , and improved vascularization , associated with improved recovery of sensory and motor cortical function .


The clinical availability and tolerability of memantine make it an attractive candidate for clinical translation .


To demonstrate benefits for speech perception and everyday listening in quiet and in noise with a speech-enhancement strategy called ClearVoice , which was designed to improve listening in complex acoustic environments without compromising hearing in quiet .


A 2-week randomized crossover design was used to evaluate ClearVoice in 46 adults unilaterally implanted with a CII/HiRes 90K cochlear implant who had at least 6 months experience with HiRes Fidelity 120 sound processing .


Speech perception was assessed using the AzBio sentences presented in quiet , in speech-spectrum noise and in multitalker babble .


Subjective listening benefit and strategy preference were assessed with a questionnaire .


ClearVoice has 3 gain settings ( low , medium , and high ) , each intended as a full-time listening option according to individual preference .


Speech understanding after acute use of ClearVoice-low was compared with HiRes Fidelity 120 during an initial test session .


Speech perception abilities were compared with HiRes Fidelity 120 after 2 weeks of exclusive use of ClearVoice-medium , and after 2 weeks of exclusive use of ClearVoice-high .


During a fifth week , participants were fit with 3 programs for comparison ( HiRes Fidelity 120 , ClearVoice-medium , and ClearVoice-high ) , after which , they reported preference and everyday listening benefits via a questionnaire .


ClearVoice significantly improved speech understanding in speech-spectrum noise and multitalker babble , did not compromise listening in quiet , was preferred for everyday listening , and provided improved hearing in real-life situations .


ClearVoice improves hearing in noise for cochlear implant recipients who use HiRes Fidelity 120 sound processing .


Acute pulmonary embolism ( PE ) can worsen quality of life due to persistent dyspnea or exercise intolerance .


Test if tenecteplase increases the probability of a favorable composite patient-oriented outcome after submassive PE .


Normotensive patients with PE and right ventricular ( RV ) strain ( by echocardiography or biomarkers ) were enrolled from eight hospitals .


All patients received low-molecular-weight heparin followed by random assignment to either a single weight-based bolus of tenecteplase or placebo , administered in a double-blinded fashion .


The primary composite outcome included : ( i ) death , circulatory shock , intubation or major bleeding within 5days or ( ii ) recurrent PE , poor functional capacity ( RV dysfunction with either dyspnea at rest or exercise intolerance ) or an SF36 ( ) Physical Component Summary ( PCS ) score < 30 at 90-day follow-up .


Eighty-three patients were randomized ; 40 to tenecteplase and 43 to placebo .


The trial was terminated prematurely .


Within 5days , adverse outcomes occurred in three placebo-treated patients ( death in one and intubation in two ) and one tenecteplase-treated patient ( fatal intracranial hemorrhage ) .


At 90days , adverse outcomes occurred in 13 unique placebo-treated patients and five unique tenecteplase-treated patients Thus , 16 ( 37 % ) placebo-treated and six ( 15 % ) tenecteplase-treated patients had at least one adverse outcome ( exact two-sided P = 0.017 ) .


Treatment of patients with submassive pulmonary embolism with tenecteplase was associated with increased probability of a favorable composite outcome .


We investigated whether the prokinetic activity of mosapride , a 5-hydroxytryptamine 4 receptor agonist , in combination with proton pump inhibitor ( PPI ) would ameliorate symptoms of gastroesophageal reflux disease ( GERD ) in Japanese patients .


Patients who experienced reflux symptoms more than twice weekly were eligible for this study .


In all , 60 patients were randomized to receive mosapride 5mg thrice daily combined with omeprazole 10mg once daily ( GO group ) , or omeprazole alone ( O group ) for 4 weeks .


The patients completed the frequency scale for the symptoms of GERD ( FSSG ) at the beginning and the end of the study .


The primary outcome compared changes in the FSSG reflux-related symptom ( RS ) score between treatment groups during the study period .


The FSSG RS scores significantly decreased both in the GO group and the O group , with no differences in improvement between the groups ( -5.86 for the GO group vs -4.89 for the O group , P = 0.49 ) .


In non-erosive reflux disease ( NERD ) patients the improvement was significantly lower than that in erosive GERD patients ( -4.00 vs -7.67 , P = 0.02 ) .


However , the addition of mosapride was effective in subgroup analyses of specific symptoms , such as burping .


Combining mosapride with PPI provided no additional amelioration of reflux symptoms compared to PPI alone .


Both regimens provided less relief from reflux symptoms in NERD than in erosive GERD patients .


The addition of mosapride ameliorated reflux in patients with symptoms like burping .


Web-based personalized feedback interventions , particularly personalized normative feedback ( PNF ) , are efficacious in improving college drinking outcomes ; however , no personalized feedback interventions to date have provided college drinkers with feedback about their own decisional balance .


This study tested the relative efficacy of a novel decisional balance feedback ( DBF ) intervention , PNF , and an assessment-only control condition .


Participants ( N = 724 ; 56 % female ) were undergraduate students at a 4-year university in the U.S. Pacific Northwest and were randomized to receive one-time exposure to web-based DBF , PNF , or assessment only .


Web-based assessment occurred at baseline and at 1 - , 6 - , and 12-month follow-ups and included measures of motivation to change , drinking quantity norms , drinking frequency/quantity , and alcohol-related problems .


At the 1-month follow-up , DBF and PNF participants reported reductions in alcohol-related problems ; however , only PNF participants reduced their drinking frequency and quantity .


At the 6-month follow-up , only DBF participants showed significant reductions in drinking quantity and alcohol-related problems .


Neither group maintained reductions in alcohol use or alcohol-related problems at the 12-month follow-up .


This study provided preliminary evidence that web-based DBF and PNF are efficacious interventions for college drinkers , with DBF having somewhat longer lasting effects .


To evaluate the efficacy and safety of prophylactic ceftazidime on early bacterial infection in APBSCT recipients during neutropenia .


APBSCT recipients were prospectively randomly assigned to intravenous ceftazidime treatment group and control group ( no prophylaxis of antibiotics ) .


The treatment started from the first day until resolution of neutropenia or the appearance of early bacterial infection .


From March 2010 to January 2013 , 70 APBSCT recipients were enrolled in the study with 36 in treatment and 34 in control group .


Overall , 29 ( 41.4 % ) patients developed early bacterial infection , among which , 9 ( 25.0 % ) in the treatment group and 20 ( 58.8 % ) in the control group ( P = 0.004 ) .


The median infection free survival ( IFS ) was not reached in the treatment group and was 8 days in the control group ( P = 0.005 ) .


Despite whether patients received single high dose melphalan or other conditioning regimes , the early bacterial infection rate was lower in the treatment group than in the control group , and the median IFS was longer in the treatment group than that in the control group .


The mean courses of antibiotic administration were ( 8.08 2.03 ) days and ( 3.68 3.56 ) days respectively in the treatment and control groups ( P < 0.001 ) .


However , the duration of empirical carbapenems were ( 1.67 3.03 ) days and ( 3.68 3.56 ) days respectively ( P = 0.013 ) .


There was no significant difference of antibiotics cost per patient between the two groups .


Four patients in the treatment group had a transient elevated serum creatinine .


Overall , no infection related mortality was observed in either group .


Prophylaxis of intravenous ceftazidime for APBSCT recipients is effective in preventing early bacterial infection with an acceptable toxicity and cost profile .


However , it does n't have effect on infection related mortality .


Therefore , our results do not support the use of antibiotic prophylaxis for patients undergoing APBSCT .


To observe the curative effect of a recipe for warming the kidney and fortifying the spleen on diarrhea-predominant irritable bowel syndrome ( IBS-D ) .


This multi-center , double-blind , randomized , and controlled trial included 240 patients that met the inclusion criterion and were then divided into two groups of 120 .


Patients in the treatment group ( group A ) took modified Sishen Wan orally for warming the kidney and fortifying the spleen and patients in the control group ( group B ) took a placebo , Chao Maiya , for 4 weeks .


28 days after withdrawal , there was a 6-month follow-up to observe patient recurrence condition .


The total effective rate , curative effect , and recurrence rate were evaluated after treatment .


There was statistical difference ( P < 0.01 ) between the two groups in total effective rate ( 92.24 % in the treatment group and 49.07 % in the control group ) , in curative effect of TCM syndrome ( 90.52 % and 47.22 % , respectively ) , and in the recurrence rate ( 15.79 % and 56.86 % , respectively ) within 6 months after treatment .


Modified Sishen Wan , for warming the kidney and fortifying the spleen , can effectively treat IBS-D and better control its recurrence .


The purpose of this study was to explore the feasibility of high-intensity focused ultrasound combined with sonographically guided intratumoral ethanol injection in the treatment of uterine fibroids and to compare its therapeutic effects and potential side effects with those of simple high-intensity focused ultrasound treatment .


Forty patients with uterine fibroids from the Department of Ultrasonography in our hospital were randomly divided into 2 groups of the same size : group H , which only underwent high-intensity focused ultrasound treatment ; and group H + A , which underwent sonographically guided intratumoral ethanol injection therapy first and then high-intensity focused ultrasound treatment the following day .


The treatment times , treatment doses , pain scores , side effects , and therapeutic effect rates of the groups were then recorded and compared .


Both the treatment time and dose of group H + A were significantly less than those of group H , and the differences were statistically significant ( P < .05 ) .


A lower pain score and fewer side effects were achieved in group H + A , also with statistically significant differences ( P < .05 ) .


The therapeutic effect rate of group H + A was also higher than that of group H , and the difference was also statistically significant ( P < .05 ) .


In the treatment of uterine fibroids , high-intensity focused ultrasound combined with sonographically guided intratumoral ethanol injection requires less treatment time and a lower dose than simple high-intensity focused ultrasound treatment and significantly reduces the pain and side effects commonly experienced by patients .


High-intensity focused ultrasound combined with sonographically guided intratumoral ethanol injection is a feasible , safe , and more effective way to treat patients with uterine fibroids .


The purpose of this study was to compare 5-minute delayed transitional phase imaging using a 30 flip angle ( hereafter , 5 min-FA30 ) and 20-minute hepatocyte phase imaging using a 10 flip angle ( hereafter , 20 min-FA10 ) in gadoxetic acid-enhanced MRI for focal hepatic lesion detection and lesion-to-liver contrast-to-noise ratio ( CNR ) , and to determine whether 5 min-FA30 could replace 20 min-FA10 with a 15-minute time saving .


One hundred sixteen patients with 282 focal hepatic lesions ( size range , 0.2-12 .5 cm ; malignant , n = 146 ; benign , n = 136 ) underwent gadoxetic acid-enhanced MRI with 5 min-FA30 and 20 min-FA10 with a 3D T1-weighted gradient-echo sequence .


Three radiologists independently assessed the presence of focal hepatic lesions using a 4-point scale , and detection sensitivity of focal hepatic lesions was calculated .


Lesion-to-liver CNRs were calculated and compared in two image groups .


There was no significant difference in detection sensitivity of focal hepatic lesions for all three readers between 5 min-FA30 ( mean , 95.4 % ) and 20 min-FA10 ( mean , 95.6 % ) , irrespective of lesion size or malignancy .


The mean CNR on 5 min-FA30 ( 167.9 84.1 ) was significantly higher than that on 20 min-FA10 ( 160.2 79.5 ) .


However , the mean CNR difference between the two image groups was relatively small ( 7.8 41.9 ) .


Compared with 20 min-FA10 , 5 min-FA30 provided higher CNR and similar sensitivity .


These findings indicate that 5 min-FA30 could replace 20-min delayed hepatocyte phase imaging using a 10 flip angle with similar diagnostic performance and 15 minutes of time saving .


Perineal reeducation of stress urinary incontinence is beneficial in 80 % of cases .


However , patients have to perform self-retraining exercises of the perineal muscles at home , in order to maintain the benefit of the physiotherapy .


The aim of this study is to assess the benefit of GYNEFFIK ( ) , a perineal electro-stimulator , during this home-care phase .


Women with stress urinary incontinence ( UI ) or with mixed UI ( composed predominantly of stress UI ) that responded to physiotherapy were included in this study in two parallel groups .


The groups followed a self-reeducation program , with or without GYNEFFIK ( ) electro-stimulation sessions .


The comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained ( defined as non-worsening ICIQ and Ditrovie scales ' score ) .


According to the protocol , an interim analysis was performed on 95 patients ( i.e. almost half of the expected sample size ) who had had at least one evaluation under treatment , among which 44 patients had finished the study .


The therapeutic benefit of the initial perineal reeducation was maintained in 87.8 % of the GYNEFFIK ( ) patient group , while it was maintained in 52.2 % ( P = 0.0001 ) in the usual care group ( i.e. who did not use electro-stimulation ) .


Likewise , patient had a more favorable subjective impression when using GYNEFFIK ( ) ( 83.7 % versus 60.0 % in the usual care group ) as they felt that they improved during the study .


In the GYNEFFIK ( ) group , no increase in symptoms was reported , whereas almost one out of five patients in the usual care group felt that their condition had worsened .


The 1R ,2 S stereoisomer of methoxamine hydrochloride , NRL001 , is a highly selective 1-adrenoceptor agonist being developed for the local treatment of non-structural faecal incontinence caused by weak internal anal sphincter tone .


This study investigated the steady state pharmacokinetics ( PK ) and safety of 2 g rectal suppositories containing NRL001 in different strengths ( 7.5 , 10 , 12.5 or 15 mg ) .


Healthy volunteers aged 18-45 years received 14 daily doses of NRL001 2 g suppositories or matching placebo .


In each dose group nine participants received NRL001 and three received placebo .


Blood samples to determine NRL001 concentrations were taken on Days 1 , 7 and 14 .


Cardiovascular parameters were collected via electrocardiograms , Holter monitoring ( three lead Holter monitor ) and vital signs .


Forty-eight volunteers were enrolled ; 43 completed the study and were included in the PK analysis population .


AUC and Cmax broadly increased with increasing dose , Tmax generally occurred between 4.0 and 5.0 h. Although the data did not appear strongly dose proportional , dose proportionality analysis did not provide evidence against dose proportionality as the log ( dose ) coefficients were not significantly < 1 .


NRL001 did not accumulate over time for any dose .


Increasing NRL001 concentrations were related to changes in vital sign variables , most notably decreased heart rate .


The most commonly reported adverse events ( AEs ) in the active treatment groups were paraesthesia and piloerection .


Treatment with NRL001 was generally well tolerated over 14 days once daily dosing and plasma NRL001 did not accumulate over time .


Treatment was associated with changes in vital sign variables , most notably decreased heart rate .


AEs commonly reported with NRL001 treatment were events indicative of a systemic - adrenergic effect .


To show whether a clinically significant difference in success rates exists between expectant and surgical management of early pregnancy loss .


Randomised controlled trial comparing expectant versus surgical management of early pregnancy loss over a 1-year period from 1st January to 31st December 2009 at Sultanah Aminah Hospital , Johor Bahru .


Pregnant women with missed or incomplete miscarriages at gestations up to 14 weeks were recruited in this study .


The success rate in the surgical group was measured as curettage performed without any complications during or after the procedure , while the success rate in the expectant group was defined as complete spontaneous expulsion of products of conception within 6 weeks without any complication .


A total of 360 women were recruited and randomised to expectant or surgical management , with 180 women in each group .


There was no statistically significant difference in the success rate between the groups and between the different types of miscarriage .


With expectant management , 131 ( 74 % ) patients had a complete spontaneous expulsion of products of conception , of whom 106 ( 83 % ) women miscarried within 7 days .


However , the rates of unplanned admissions ( 18.1 % ) and unplanned surgical evacuations ( 17.5 % ) in the expectant group were significantly higher than the rates ( 7.4 % and 8 % respectively ) in the surgical group .


The complications in both groups were similar .


To observe the clinical effect and safety of modified Bushen Zhuanggu Recipe ( BZR ) in treating ankylosing spondylitis ( AS ) .


Recruited were 96 AS outpatients of Shen deficiency induced cold-dampness syndrome ( SDCDS ) or Shen deficiency dampness-heat syndrome ( SDDHS ) at clinics of China-Japan Friendship Hospital from May 2010 to May 2011 .


They were randomly assigned to the traditional Chinese medicine ( TCM ) treatment group and the Western medicine ( WM ) treatment group in the ratio of 1:1 .


Those in the TCM treatment group were syndrome typed as the SDCDS group ( group A , 22 cases , treated by Bushen Zhuanggu Quhan Decoction + WM placebos ) and the SDDHS group ( group B , 26 cases , treated by Bushen Zhuanggu Qinghua Decoction + WM placebos ) .


Those in the WM treatment group were syndrome typed as SDCDS group ( group C , 27 cases , treated by SASP + TCM placebos ) and the SDDHS group ( group D , 21 cases , treated by SASP + TCM placebos ) .


Totally 12 weeks consisted of one therapeutic course .


BAS-G , BASFI , BASDAI , spine pain , pain at night , TCM symptom score , distance between occipital and wall , distance between finger and ground , thoracic activity , spine activity , Schober test , ESR , CRP were observed as the observing indices ; ASAS20 , ASAS50 , ASAS70 , BASDAI50 , and criteria of TCM were explored for clinical evaluation and safety evaluation .


In comparison with the same group before treatment,BAS-G , BASFI , BASDAI , spine pain , pain at night , TCM syndrome score , distance between finger and ground , Schober test , ESR , and CRP were improved after treatment ( P < 0.01 , P < 0.05 ) .


In group A and C , thoracic activity and spine activity were getting better ( P < 0.01 , P < 0.05 ) .


In group B distance between occipital and wall and spine activity were getting better ( P < 0.01 , P < 0.05 ) .


In comparison with group C , BAS-G , BASFI , BASDAI , spine pain , distance between finger and ground , thoracic activity , spine activity , Schober test , ESR , CRP were getting better in group A after treatment ( P < 0.01 , P < 0.05 ) .


In comparison with group D , BASFI , BASDAI , spine pain , pain at night , distance between finger and ground , distance between occipital and wall , spine activity , Schober test , and ESR were getting better in group B after treatment ( P < 0.01 , P < 0.05 ) .


The total effective rate , ASAS20 , ASAS50 , ASAS70 , and BASDAI50 were higher in the TCM treatment group than in the WM treatment group ( P < 0.05 ) .


Modified BZR was more effective than SASP method in relieving clinical symptoms and signs , TCM syndrome scores , and inflammatory activity indicators of AS patients .


Statins are currently the preferred pharmacological therapy in individuals with familial hypercholesterolemia ( FH ) with the aim to prevent premature atherosclerosis .


In adults , these agents have been proven to be safe and well tolerated ; however , non-adherence is a significant clinical issue .


In this study , we evaluated tolerability and adherence to statin therapy in young adult FH patients 10 years after this was initiated in their childhood .


A questionnaire including items on medical history , adherence and reasons for discontinuation was sent to 214 young adult FH patients that initiated statin therapy at least 10 years ago .


Tolerability was defined as 100 % minus the percentage of patients that discontinued statin therapy due to side effects .


Adherence was defined as the extent to which patients took their medication as prescribed by their physician .


We labelled patients adherent if they took 80 % or more of their pills in the month preceding our assessment .


Follow-up was successful in 205 ( 95.8 % ) subjects ( age 18-30 years ) .


A history of side effects was reported by 40 ( 19.5 % ) of the patients , and mainly consisted of muscle complaints and gastrointestinal symptoms .


Three patients ( 1.5 % ) discontinued statin therapy because of side effects .