A total of 288 of 313 patients ( 92 % ) attending the last visit answered the questionnaire .


The majority mentioned contributing to scientific research ( 97 % agreed ) , helping other patients ( 91 % ) , and learning about new treatment strategies ( 84 % ) and their disease ( 85 % ) as reasons to continue participation .


Next , patients mentioned tight control ( 202 of 278 patients ) , good treatment strategy ( 128 of 278 ) , good medication ( 117 of 278 ) , and good half-term results ( 102 of 278 ) as motivators .


More than 95 % of patients experienced participation `` as expected '' or `` better than expected . ''


Additional examinations during yearly visits ( extra questionnaires , imaging ) were mentioned as `` worse than expected '' ( 10 % ) , as was answering routine questionnaires ( 7 % ) .


Continued participation was relatively high in the Treatment Strategies for Rheumatoid Arthritis ( BeSt ) Study .


Higher age , functional disability , drug-free remission , little joint damage , and few adverse events predicted early study termination .


Main motives for continued participation were a willingness to contribute to research , help future patients , and because patients had good experiences with the study protocol .


The surgical results of treating thoracolumbar and lumbar burst fractures were reported to be comparable between patients with and without fusion in an intermediate-term follow-up .


To our knowledge , no prior report has compared the results of fusion and non-fusion with long-term follow-up .


This study was designed to provide long-term evaluation of patients with a burst fracture of the thoracolumbar and lumbar spine treated with short-segment fixation who were randomly assigned to a fusion or non-fusion group .


Patients older than sixty years of age at the time of injury and those who were lost to follow-up were excluded .


Functional outcomes were evaluated using the Greenough Low-Back Outcome Score and the visual analog scale for back pain .


Radiographic outcomes were focused on the vertebral body height of the injured vertebra , the kyphotic angle , and the regional segmental motion .


Twenty-two patients were enrolled in the non-fusion group , and twenty-four patients were enrolled in the fusion group .


The average follow-up period was 134 months ( range , 121 to 161 months ) .


The average preoperative kyphotic angle was 16.4 for the non-fusion group and 19.5 for the fusion group .


The average postoperative kyphotic angle was 1.5 for the non-fusion group and 4.0 for the fusion group .


At the time of the latest follow-up , the average kyphotic angle was 13.8 for the non-fusion group and 14.7 for the fusion group .


The average kyphotic angle between the two groups was similar at all follow-up times .


A progressive decrease of the kyphotic angle was significant ( p < 0.05 ) with time , regardless of fusion .


The radiographic outcomes were similar between these two groups at all follow-up times , as were functional outcomes .


More patients in the non-fusion group underwent additional surgery to remove implants .


Regional segmental motion was preserved in the non-fusion group , with a mean motion ( and standard deviation ) of 4.2 1.9 .


The long-term results of short segmental fixation with and without fusion for burst fractures of the thoracolumbar and lumbar spine were comparable .


Regional segmental motion could be preserved without fusion , and bone graft donor site complications could be eliminated .


Therapeutic Level II .


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


Little is known about the reliability of different methods of survey administration in low back pain trials .


This analysis was designed to determine the reliability of responses to self-administered paper surveys compared to computer assisted telephone interviews ( CATI ) for the primary outcomes of pain intensity and back-related function , and secondary outcomes of patient satisfaction , SF-36 , and global improvement among participants enrolled in a study of yoga for chronic low back pain .


Pain intensity , back-related function , and both physical and mental health components of the SF-36 showed excellent reliability at all three time points ; ICC scores ranged from 0.82 to 0.98 .


Pain medication use showed good reliability ; kappa statistics ranged from 0.68 to 0.78 .


Patient satisfaction had moderate to excellent reliability ; ICC scores ranged from 0.40 to 0.86 .


Global improvement showed poor reliability at 6weeks ( ICC = 0.24 ) and 12weeks ( ICC = 0.10 ) .


CATI shows excellent reliability for primary outcomes and at least some secondary outcomes when compared to self-administered paper surveys in a low back pain yoga trial .


Having two reliable options for data collection may be helpful to increase response rates for core outcomes in back pain trials .


ClinicalTrials.gov : NCT01761617 .


Date of trial registration : December 4 , 2012 .


To evaluate the efficacy of manual lymphatic drainage ( MLD ) in improving health-related quality of life ( HRQOL ) , symptomatology , and physical status in patients with chronic venous insufficiency ( CVI ) .


Single-blind randomized controlled trial .


Health community attendant service .


Subjects with CVI ( N = 41 ) were randomly assigned to an experimental group ( n = 20 ; mean age , 54.611.3 y ) or control group ( n = 21 ; mean age , 46.811.1 y ) .


The experimental group completed 10 lower extremity MLD sessions over 4 weeks and 1 educational session .


The control group only attended the educational session .


Outcome measures were taken at baseline ( t0 ) , at the end of 4 weeks ( t1 ) , and after 2 months for follow-up ( t2 ) .


HRQOL was assessed with the Chronic Venous Insufficiency Quality of Life Questionnaire-20 , symptoms ( fatigue , heaviness ) were assessed with a visual analog scale , severity of the disease was assessed with the Venous Clinical Severity Score ( VCSS ) ( total score , score for each item ) , leg volumetry was assessed with perimeters , and plantar/dorsiflexion strength and ankle range of motion ( ROM ) were assessed with dynamometry .


A significant interaction grouptime effect was found for pain on HRQOL ( F2 ,78 = 3.507 ; P = .035 ; partial 2 = .087 ) , clinical severity ( F2 ,78 = 5.231 ; P = .007 ; partial 2 = .118 ) , especially for venous edema ( assessed with the VCSS ) , fatigue ( F1 .67,65.21 = 4.690 ; P = .012 ; partial 2 = .107 ) , and heaviness ( F1 .57,61.32 = 9.702 ; P = .001 ; partial 2 = .199 ) , with the experimental group improving from t0 to t1 and t0 to t2 in all of these outcomes .


No effect of MLD treatment could be found for ankle muscle strength , ankle ROM , and leg volume .


Short-term MLD treatment ameliorates CVI severity and related edema , symptoms , and pain HRQOL in patients with CVI .


Identifying patients with recent stroke or transient ischemic attack ( TIA ) at high risk of major vascular events ( MVEs ; stroke , myocardial infarction , or vascular death ) may help optimize the intensity of secondary preventive interventions .


We evaluated the relationships between the baseline Framingham Coronary Risk Score ( FCRS ) and a novel risk prediction model and with the occurrence of MVEs after stroke or TIA in subjects enrolled in the Stroke Prevention by Aggressive Reduction in Cholesterol Level ( SPARCL ) trial .


Data from the 4731 subjects enrolled in the SPARCL study were analyzed .


Hazard ratios ( HRs ) from Cox regression models were used to determine the risk of subsequent MVEs based on the FCRS predicting 20 % or more 10-year coronary heart disease risk .


The novel risk model was derived based on multivariable modeling with backward selection .


Model discrimination ( c-statistics ) was assessed using the areas under the receiver operating characteristic curves .


Of 3969 subjects with complete data , 27 % had a baseline FCRS of 20 % or more .


In multivariable analysis , an FCRS of 20 % or more was associated with twice the risk of subsequent MVEs ( HR = 1.92 , 95 % confidence interval [ CI ] : 1.63-2 .27 ) .


The novel model based on a multivariable analysis included age ( HR = 1.37 , 95 % CI : 1.25-1 .51 per 10 years ) , diabetes ( HR = 1.82 , 95 % CI : 1.51-2 .18 ) , male sex ( HR = 1.35 , 95 % CI : 1.12-1 .61 ) , and an apolipoprotein ( APO ) - B/APO-A 1 ratio ( HR = 1.56 , 95 % CI : 1.16-2 .11 ) .


The c-statistic was .58 ( 95 % CI : .55 -.60 ) for the FCRS of 20 % or more and .65 ( 95 % CI : .63 -.67 ) for the novel model .


Both a baseline FCRS of 20 % or more and a novel predictive model were associated with future MVEs in SPARCL trial subjects .


The novel model needs to be validated , and the benefits of using either the FCRS or the novel model in clinical practice needs to be assessed .


Juvderm Voluma XC ( VYC-20L ) is approved in the United States for correction of age-related volume loss in the midface region in adults .


To characterize the effects of VYC-20L in 3 midface subregions based on injection volumes .


In this single-blind controlled trial , subjects with midface volume deficit received VYC-20L in 1 of 3 facial subregions ( zygomaticomalar , anteromedial cheek , and submalar ) , with touch-up treatment available 30 days later .


Responders achieved 1-point improvement on the Mid-Face Volume Deficit Scale ( MFVDS ) , analyzed by facial subregion and stratified by injection volume quartiles .


Subject satisfaction and safety were assessed .


The treatment arm comprised 235 subjects aged 35 to 65 years .


Month 6 MFVDS responder rates were 75.5 % for zygomaticomalar , 83.2 % for anteromedial cheek , and 76.9 % for submalar subregions .


Higher responder rates were observed with increasing injection volume quartiles for each subregion .


Similar median injection volumes ( 2.0 mL total ) of VYC-20L provided correction durations of 15 to 24 months : 24 months for anteromedial cheek , 19 months for zygomaticomalar , and 15 months for submalar subregions .


Subject satisfaction was high across injection volume quartiles .


No unanticipated treatment-site adverse reactions occurred .


VYC-20L is effective at restoring midface volume , with high subject satisfaction and an acceptable safety profile .


Intensive lifestyle change prevents type 2 diabetes but is difficult to sustain .


Preliminary evidence suggests that yoga may improve metabolic factors .


We tested a restorative yoga intervention vs. active stretching for metabolic outcomes .


In 2009-2012 , we conducted a 48-week randomized trial comparing restorative yoga vs. stretching among underactive adults with the metabolic syndrome at the Universities of California , San Francisco and San Diego .


We provided lifestyle counseling and a tapering series of 90-min group classes in the 24-week intervention period and 24-week maintenance period .


Fasting and 2-h glucose , HbA1c , triglycerides , HDL-cholesterol , insulin , systolic blood pressure , visceral fat , and quality of life were assessed at baseline , 6 - and 12-months .


180 participants were randomized and 135 ( 75 % ) completed the trial .


At 12 months , fasting glucose decreased more in the yoga group than in the stretching group ( -0.35 mmol/L vs. -0.03 mmol/L ; p = 0.002 ) ; there were no other significant differences between groups .


At 6 months favorable changes within the yoga group included reductions in fasting glucose , insulin , and HbA1c and an increase in HDL-cholesterol that were not sustained at 1 year except changes in fasting glucose .


The stretching group had a significant reduction in triglycerides at 6 months which was not sustained at 1 year but had improved quality of life at both time-points .


Restorative yoga was marginally better than stretching for improving fasting glucose but not other metabolic factors .


While the Carotid Revascularization Endarterectomy Versus Stenting Trial ( CREST ) has been widely accepted as a landmark trial establishing an equivalent risk of major adverse events following carotid endarterectomy ( CEA ) or carotid artery stenting ( CAS ) , the applicability of these findings to single centers has been questioned owing to the rigid selection criteria for investigators in the study .


Although refuted by the findings of a subsequent study , a substudy of CREST established a higher periprocedural stroke rate for CAS when the surgeon was a vascular surgeon .


To present our 30-day results of stroke , death , myocardial infarction , and composite major adverse events to determine if a single vascular surgeon 's outcomes at our hospital are consistent with the results of CREST .


A retrospective analysis of patients with high-grade carotid artery stenosis treated with CEA or CAS by a vascular surgeon at our institution from September 9 , 2005 , through December 17 , 2012 , was performed .


A 2 analysis was used to compare the incidence of specific high-risk patient characteristics in each group .


The Fisher exact test was used to compare the risks of stroke , death , myocardial infarction , and composite major adverse events between CEA and CAS .


These results were then compared with those reported in CREST .


A total of 182 cases ( 94 CAS and 88 CEA ) performed by a single vascular surgeon were included for analysis .


While in CREST the periprocedural risk of stroke was higher following CAS ( 4.1 % vs 2.3 % , P = .01 ) and the risk of myocardial infarction was higher following CEA ( 2.3 % vs 1.1 % , P = .03 ) , there was no significant difference in the incidence of these outcomes between the 2 treatment modalities in our study .


When compared with CREST , our rates of myocardial infarction , stroke , death , and composite adverse events ( CEA , 4.5 % vs 3.4 % ; P = .79 ; CAS , 5.2 % vs 4.3 % ; P > .99 ) were no different .


Similar to CREST , the 30-day risk of composite major adverse events was equivalent for the 2 treatment modalities .


We attribute our comparable incidence of perioperative stroke with CAS and CEA to improved patient selection .


We excluded most patients older than 80 years and those with complex anatomy from consideration for CAS .


Our results confirm those of CREST and demonstrate that both CEA and CAS can be performed safely by a vascular surgeon in properly selected patients .


The efficacy of functional restoration programs for the treatment of chronic back pain is well documented .


Nevertheless , there are only a few such centres in Germany and few trials have been conducted in German-speaking regions to demonstrate that implementing such programs in everyday clinical settings with large numbers of patients is just as effective as in a research setting .


The present study examined whether the positive effects of such programs can also be observed in the clinically relevant context of a standardized day clinic treatment regimen .


A total of 681 back pain patients in 2 German cities were examined at 4 measurement points ( before and immediately after the program , as well as 6 and 12 months after treatment ) using a comprehensive questionnaire on perceived pain and symptoms of anxiety and depression , as well as the work situation .


In both cities significant and long-term improvements in back pain , pain-related impairment and degree of chronification were observed , as well as a high return-to-work rate after treatment .


Hence , the quality of such programs was also confirmed for a large patient population .


We conducted a 6-month , randomized , double-blind , placebo-controlled study to assess safety , tolerability , and efficacy of deferiprone in Friedreich ataxia ( FRDA ) .


Seventy-two patients were treated with deferiprone 20 , 40 , or 60mg/kg/day or placebo , divided into 2 daily doses .


Safety was the primary objective ; secondary objectives included standardized neurological assessments ( Friedreich Ataxia Rating Scale [ FARS ] , International Cooperative Ataxia Rating Scale [ ICARS ] , 9-Hole Peg Test [ 9HPT ] , Timed 25-Foot Walk , Low-Contrast Letter Acuity ) , general functional status ( Activities of Daily Living ) , and cardiac assessments .


Deferiprone was well tolerated at 20mg/kg/day , whereas more adverse events occurred in the 40mg/kg/day than in the placebo group .


The 60mg/kg/day dose was discontinued due to worsening of ataxia in 2 patients .


One patient on deferiprone 20mg/kg/day experienced reversible neutropenia , but none developed agranulocytosis .


Deferiprone-treated patients receiving 20 or 40mg/kg/day showed a decline in the left ventricular mass index , compared to an increase in the placebo-treated patients .


Patients receiving 20mg/kg/day of deferiprone had no significant change in FARS , similar to the placebo-treated patients , whereas those receiving 40mg/kg/day had worsening in FARS and ICARS scores .


The lack of deterioration in the placebo arm impaired the ability to detect any potential protective effect of deferiprone .


However , subgroup analyses in patients with less severe disease suggested a benefit of deferiprone 20mg/kg/day on ICARS , FARS , kinetic function , and 9HPT .


This study demonstrated an acceptable safety profile of deferiprone at 20mg/kg/day for the treatment of patients with FRDA .


Subgroup analyses raise the possibility that , in patients with less severe disease , deferiprone 20mg/kg/day may reduce disease progression , whereas higher doses appear to worsen ataxia .


We describe a new approach to blocking the sciatic and saphenous nerves in the proximal thigh ( level of the lesser trochanter or immediately below ) using a single-penetration dual-injection ( SPEDI ) technique .


The popliteal-sciatic approach necessitates repositioning of the leg exposing the popliteal fossa and an extra injection for the saphenous nerve ( SAN ) block at the midthigh level .


We introduce an alternative , effective , and possibly faster method .


Sixty patients undergoing leg and foot surgery under general anesthesia were included .


We deposited 15 mL of ropivacaine 0.75 % around the sciatic nerve ( SCN ) and 5 mL of ropivacaine 0.75 % at the SAN .


Patients were randomized to the popliteal-sciatic/saphenous technique or the SPEDI technique .


The primary outcome measure was performance time .


Positioning time , pain assessment , nausea in the postanesthesia care unit , sufentanil demand , dermatomal anesthesia , and degree of motor blockade were also recorded .


Performance time was significantly faster with the SPEDI technique ( median time , 110 seconds [ range , 57-315 seconds ] vs 246 seconds [ range , 163-472 seconds ] ; P < 0.0001 ) .


Positioning time was significantly shorter with the SPEDI technique ( P < 0.0001 ) .


No other statistically significant differences were recorded .


The SPEDI block resulted in significantly faster performance time and reduced positioning time with statistically equal efficacy in relation to pain assessment , nausea , sufentanil demand , dermatomal anesthesia , and motor blockade .


The SPEDI block is statistically an equally effective alternative to the traditional popliteal-sciatic/saphenous block combination for leg and foot surgery , but it is faster , requires only 1 skin penetration , and does not require repositioning of the leg .


Near-infrared ( NIR ) light therapy is purported to act as an ergogenic aid by enhancing the contractile function of skeletal muscle .


Improving muscle function is a new avenue for research in the area of laser therapy ; however , very few researchers have examined the ergogenic effects of NIR light therapy and the influence it may have on the recovery process during rehabilitation .


To evaluate the ergogenic effect of NIR light therapy on skeletal muscle function .


Crossover study .


Controlled laboratory .


Thirty-nine healthy men ( n = 21 ) and women ( n = 18 ; age = 20.0 0.2 years , height = 169 2 cm , mass = 68.4 1.8 kg , body mass index = 23.8 0.4 kg/m ( 2 ) ) .


Each participant received active and sham treatments on the biceps brachii muscle on 2 separate days .


The order of treatment was randomized .


A class 4 laser with a cumulative dose of 360 J was used for the active treatment .


After receiving the treatment on each day , participants completed an elbow-flexion resistance-exercise protocol .


The dependent variables were elbow range of motion , muscle point tenderness , and strength ( peak torque ) .


Analysis of variance with repeated measures was used to assess changes in these measures between treatments at baseline and at follow-up , 48 hours postexercise .


Additionally , immediate strength loss postexercise was compared between treatments using a paired t test .


Preexercise to postexercise strength loss for the active laser treatment , although small , was less than with the sham treatment ( P = .05 ) .


Applied to skeletal muscle before resistance exercise , NIR light therapy effectively attenuated strength loss .


Therefore , NIR light therapy may be a beneficial , noninvasive modality for improving muscle function during rehabilitation after musculoskeletal injury .


However , future studies using higher treatment doses are warranted .


Efficient fat digestion requires fat processing within the stomach and fat sensing in the intestine .


Both processes also control gastric emptying and gastrointestinal secretions .


We aimed to visualize the influence of the intragastric stability of fat emulsions on their dynamics of gastric processing and structuring and to assess the effect this has on gastrointestinal motor and secretory functions .


Eighteen healthy subjects with normal body mass index ( BMI ) were studied on 4 separate occasions in a double-blind , randomized , crossover design .


Magnetic resonance imaging ( MRI ) data of the gastrointestinal tract and blood triglycerides were recorded before and for 240 min after the consumption of the following 4 different fat emulsions : lipid emulsion 1 ( LE1 ; acid stable , 0.33 m ) , lipid emulsion 2 ( LE2 ; acid stable , 52 m ) , lipid emulsion 3 ( LE3 ; acid unstable , solid fat , 0.32 m ) , and lipid emulsion 4 ( LE4 ; acid unstable , liquid fat , 0.38 m ) .


Intragastric emulsion instability was associated with a change in gastric emptying .


Acid-unstable emulsions exhibited biphasic and faster emptying profiles than did the 2 acid-stable emulsions ( P 0.0001 ) .


When combined with solid fat ( LE3 ) , different dynamics of postprandial gallbladder volume were induced ( P 0.001 ) .


For acid-stable emulsions , a reduction of droplet size by 2 orders of magnitude [ LE1 ( 0.33 m ) compared with LE2 ( 52 m ) ] delayed gastric emptying by 38 min .


Although acid-stable ( LE1 and LE2 ) and redispersible ( LE4 ) emulsions caused a constant increase in blood triglycerides , no increase was detectable for LE3 ( P < 0.0001 ) .


For LE3 , MRI confirmed the generation of large fat particles during gastric processing , which emptied into and progressed through the small intestine .


MRI allows the detailed characterization of the in vivo fate of lipid emulsions .


The acute effects of lipid emulsions on gastric emptying , gallbladder volume , and triglyceride absorption are dependent on microstructural changes undergone during consumption .


Gastric peristalsis and secretion were effective at redispersing pools of liquid fat in the stomach .


This trial was registered at clinicaltrials.gov as NCT01253005 .


To explore a new method of patient-involved digital design , esthetic outcome prediction and fabrication for the esthetic rehabilitation of anterior teeth , and to provide an alternative choice for the restoration of anterior teeth .


In this study , 32 patients with esthetic problems in their anterior teeth were included and divided into two groups randomly : the experimental group ( 16 patients ) and control group ( 16 patients ) .


In the experimental group , the dentition and facial images were obtained by intra-oral scanning and Three-dimensional ( 3D ) facial scanning and then calibrated .


The design of the rehabilitation and the esthetic outcome prediction were created by computer-aided design ( CAD ) software .


After morphologic modification according to the patients ' opinions , prostheses were fabricated according to the final design by computer-aided manufacturing ( CAM ) equipment .


As for the control group , the regular design method was applied to restore their anterior teeth .


The time consuming in the first insertion of each restoration in both groups was recorded .


The quality of the prostheses was assessed by another prosthedontist .


The satisfaction to prostheses and the facial appearance were evaluated by the patients .


The process of the patient-involved digital design and outcome anticipation was successfully established .


The patients were satisfied with the esthetic effects of the anterior restoration made by the digital technique .


The acceptance rate of the patients on the digital rehabilitation in the experimental group was 100 % .


There was no significant difference of the quality of the prostheses between the two groups .


The satisfaction rate of the patients on prostheses and facial appearance was significantly higher in the experimental group than in the control group ( P < 0.05 ) .


In addition , the time consuming in the first insertion of the experimental group was much shorter than that in the control group ( P < 0.01 ) .


The new method of the patient-involved digital design , esthetic outcome prediction and fabrication for the esthetic rehabilitation of anterior teeth is a practical technique .


This method is useful in shortening the time consuming of the restoration of anterior teeth and improving the patient satisfaction with the esthetic outcome .


The purpose of the study was to evaluate the clinical effects of the Shenzhu Tiaopi granule ( SZTP ) combined with a lifestyle intervention in patients with impaired glucose tolerance ( IGT ) , who also had a spleen deficiency and damp overabundance syndrome ( SDDOS ) .


After a one-month washout period , a total of 514 patients were randomly assigned to the control ( lifestyle intervention ) and experimental ( SZTP plus lifestyle intervention ) groups , with 257 patients in each group .


Patients in the control group received the lifestyle intervention ( diet and exercise ) for 12 months , while the patients in the experimental group were treated with SZTP plus the lifestyle intervention for 12 months .


The Traditional Chinese Medicinal ( TCM ) symptom scores were observed in each group before and after treatment ; the conversion rates from IGT to diabetes mellitus ( DM ) were also measured .


Following 12 months of treatment , the conversion rate from IGT to DM in the experimental group was significantly lower than in the control group ( 8.52 % vs. 15.28 % , P < 0.05 ) .


A significantly higher number of patients with IGT reverted to normal blood glucose levels in the experimental group than in the control group ( 42.15 % vs. 32.87 % , P < 0.05 ) .


In addition , after following the treatment for 12 months , the TCM symptoms of patients in the experimental group were markedly alleviated , as compared to the control group ( P < 0.01 ) .


The combination of SZTP and lifestyle intervention showed a reduction in the conversion from IGT to DM , and an increase in the conversion from IGT to normal blood glucose levels .


To determine whether a single bout of resistance exercise produces an analgesic effect in individuals with knee osteoarthritis ( OA ) .


Eleven participants with knee OA ( 65.9 10.4 yrs ) , and 11 old ( 61.3 8.2 yrs ) and 11 young ( 25.0 4.9 yrs ) healthy adults performed separate bouts of upper and lower body resistance exercise .


Baseline and post-exercise pressure pain thresholds were measured at eight sites across the body and pressure pain tolerance was measured at the knee .


Pressure pain thresholds increased following exercise for all three groups , indicating reduced pain sensitivity .


For the young and old healthy groups this exercise-induced analgesia ( EIA ) occurred following upper or lower body resistance exercise .


In contrast , only upper body exercise significantly raised pain thresholds in the knee OA group , with variable non-significant effects following lower body exercise .


Pressure pain tolerance was unchanged in all groups following either upper or lower body exercise .


An acute bout of upper or lower body exercise evoked a systemic decrease in pain sensitivity in healthy individuals irrespective of age .


The decreased pain sensitivity following resistance exercise can be attributed to changes in pain thresholds , not pain tolerance .


While individuals with knee OA experienced EIA , a systemic decrease in pain sensitivity was only evident following upper body exercise .


After vidian neurectomy , low reported rates of dry eye syndrome ( DES ) seemed incompatible with the high success rate of nerve severance in previous studies .


This study aimed at understanding of the pathophysiology of lacrimation and evaluating the effect of thermal injury through the distal stump on the sphenopalatine ganglion ( SPG ) after vidian neurectomy .


A randomized , double-blind , controlled study was performed to evaluate the DES .


Eighty precise vidian neurectomies were randomized in a 1:1 ratio to groups 1 and 2 .


Group 1 represented the cauterization and was used in both distal and proximal nerve stumps , whereas only the proximal nerve stump was cauterized in group 2 subjects .


The DES was evaluated with Schirmer 's test and ocular surface disease index ( OSDI ) before and after surgery at 7-10 days and 30 days , respectively .


In group 1 , the Schirmer 's test showed a mean decline of 20 mm ( 20/30 , 66 % ) at 7-10 days and 15 mm ( 15/30 , 50 % ) at 30 days .


In group 2 , the Schirmer 's test revealed significantly lesser dry eye problems , with a mean decline of 16 mm ( 16/30 ; 52 % ) at 7-10 days and 2 mm ( 2/30 ; 6 % ) at 30 days .


The significantly less postoperative dry eye problems in group 2 can be shown by the OSDI at 7-10 days , but not at 30 days .


The mean follow-up period was 24 months .


No recurrence of nasal allergy symptoms was noted in the follow up period .


The significant advantage of preservation of the SPG function is justified by Schirmer 's test , although the effect did not appear to be comparable with the clinical manifestations evaluated by OSDI at 30 days .


Nevertheless , the preservation of distal stump from preventive cauterization can still offer better eye ball moisture in the early evaluation of DES .


To investigate the effect of flavonoid-rich dark chocolate and non-flavonoid-rich white chocolate on retinal vessel diameter in glaucoma patients and age-matched controls .


Thirty glaucoma patients and 30 age-matched subjects were assigned to dark or white chocolate by randomization with forced equal distribution .


The number in each of the four groups was 15 .


Measured parameters included systemic blood pressure ( BP ) , blood glucose levels , static retinal vessel analysis , as measured by central retinal artery equivalent ( CRAE ) ( which relates to the diameter of the central retinal artery ) , central retinal vein equivalent ( CRVE ) ( which relates to the diameter of central retinal vein ) and the arterio-venous ratio ( AVR ) , which represents the CRAE/CRVE ratio , dynamic retinal vessel analysis as measured by the change in vessel diameter in response to flicker light stimulation .


Three recording cycles from each were averaged .


Blood pressure parameters ( systolic BP , diastolic BP and pulse ) , IOP and blood glucose levels did not differ significantly between both groups before and after consumption of white or dark chocolate .


Static vessel analysis did not show any significant changes in CRAE , CRVE or AVR before and after dark or white chocolate in both groups ( p > 0.05 ) .


Mean dilatation of the venules in the control group was 3.2 0.9 % before dark chocolate and 4.2 1.4 % after dark chocolate intake , which was statistically significantly different ( p = 0.01 ) .


Mean dilatation of the arterioles in the control group was 2.8 1.8 % before dark chocolate and 3.5 1.8 % after dark chocolate intake with a trend to statistical significance ( p = 0.14 ) , but not reaching the significance level .


Mean diameter changes in the glaucoma group did not show any significant differences after dark chocolate consumption .


The present study showed a significant improvement of venous vasodilatation 2 hr after dark chocolate intake in the control group , but not in the glaucoma group .


This effect might be indicative of an increased bioavailability of nitric oxide ( NO ) after dark chocolate consumption .


The lack of finding a significant venous response after dark chocolate in the glaucoma group might be related to the already impaired endothelial function in these patients .


The United States has the highest rate of lumbar spine surgery in the world , with rates increasing over 200 % since 1990 .


Medicare spends over $ 1 billion annually on lumbar spine surgery .


Despite surgical advances , up to 40 % of patients report chronic pain and disability following surgery .


Our work has demonstrated that fear of movement is a risk factor for increased pain and disability and decreased physical function in patients following lumbar spine surgery for degenerative conditions .


Cognitive-behavioral therapy and self-management treatments have the potential to address psychosocial risk factors and improve outcomes after spine surgery , but are unavailable or insufficiently adapted for postoperative care .


Our research team developed a cognitive-behavioral based self-management approach to postoperative rehabilitation ( Changing Behavior through Physical Therapy ( CBPT ) ) .


Pilot testing of the CBPT program demonstrated greater improvement in pain , disability , physical and mental health , and physical performance compared to education .


The current study compares which of two treatments provided by telephone - a CBPT Program or an Education Program about postoperative recovery - are more effective for improving patient-centered outcomes in adults following lumbar spine surgery for degenerative conditions .


A multi-center , comparative effectiveness trial will be conducted .


Two hundred and sixty patients undergoing lumbar spine surgery for degenerative conditions will be recruited from two medical centers and community surgical practices .


Participants will be randomly assigned to CBPT or Education at 6weeks following surgery .


Treatments consist of six weekly telephone sessions with a trained physical therapist .


The primary outcome will be disability and secondary outcomes include pain , general health , and physical activity .


Outcomes will be assessed preoperatively and at 6weeks , 6months and 12months after surgery by an assessor masked to group allocation .


Effective rehabilitation treatments that can guide clinicians in their recommendations , and patients in their actions will have the potential to effect change in current clinical practice .


NCT02184143 .


To evaluate operative time after adjunctive misoprostol or mifepristone compared with overnight osmotic dilators alone for cervical preparation before dilation and evacuation at 16-23 6/7 weeks of gestation .


This double-blind , three-arm , multicenter , randomized trial compared overnight osmotic dilators alone , dilators plus 400 micrograms buccal misoprostol 3 hours preoperatively , and dilators plus 200 mg oral mifepristone during dilator placement for dilation and evacuation .


Our primary outcome was dilation and evacuation operative time within two cohorts : 16-18 6/7 weeks of gestation ( N = 150 ) and 19-23 6/7 weeks of gestation ( N = 150 ) .


Three hundred women were required for 80 % power to detect a 2-minute difference in operative time .


Secondary outcomes included initial cervical dilation , side effects , physician satisfaction by Likert scale , and complications .


Between February 2013 and February 2014 we randomized 300 women evenly across treatment arms .


Group demographics were similar .


We found no difference in operative time in either gestational cohort ( early cohort [ minutes ] : 5.113.0 dilators alone , 4.993.3 misoprostol , 4.332.0 mifepristone , P = .34 ; late cohort [ minutes ] : 7.503.7 dilators alone , 7.625.4 misoprostol , 6.743.2 mifepristone , P = .53 ) .


In the early cohort , initial dilation was greater with misoprostol than dilators alone ( 2.4 compared with 2.0 cm , P = .007 ) .


Patients given misoprostol had significantly more pain , fever , and chills .


In the late cohort , dilation and evacuation procedures were less difficult after mifepristone ( 4.1 % , 95 % confidence interval [ CI ] 0.0-9 .6 ) than misoprostol ( 18.8 % , 95 % CI 7.7-29 .8 ) or dilators alone ( 18.8 % , 95 % CI 7.7-29 .8 ; P = .04 ) .


We had inadequate power to infer differences in complications : dilators alone ( 10 % , 95 % CI 4.2-16 .0 ) compared with misoprostol ( 2 % , 95 % CI 0-4 .7 ) compared with mifepristone ( 2 % , 95 % CI 0-4 .8 ) .


Despite no difference in operative time , adjunctive mifepristone facilitates later dilation and evacuation compared with osmotic dilators alone and is better tolerated than misoprostol .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01751087 .


I.


Rilotumumab , an investigational , monoclonal antibody , inhibits MET-mediated signalling .


In a randomized phase 2 trial of rilotumumabepirubicin/cisplatin/capecitabine in gastric or oesophagogastric junction cancer , patients receiving rilotumumab showed a trend towards improved survival , especially in MET-positive patients , but no clear dose-response relationship was observed .


Exposure-response and biomarker analyses were used for dose selection and to differentiate patient subpopulations that may benefit most from treatment .


Here , we analyse rilotumumab exposure-survival and exposure-safety and the impact of MET expression on these relationships .


Individual rilotumumab exposure parameters were generated using population pharmacokinetic modelling .


Relationships among rilotumumab dose ( 7.5 and 15mgkg ( -1 ) ) , exposure , and clinical outcomes ( progression-free survival ( PFS ) and overall survival ( OS ) ) were evaluated with Cox regression models and Kaplan-Meier plots .


MET status and other baseline covariates were evaluated in subgroup and multivariate analyses .


Treatment-emergent adverse events were summarised by exposure .


Among MET-positive patients , higher rilotumumab exposure , vs placebo and low exposure , was associated with improved median PFS ( 80 % CI : 7.0 ( 5.7-9 .7 ) vs 4.4 ( 2.9-4 .9 ) and 5.5 ( 4.2-6 .8 ) months ) and OS ( 13.4 ( 10.6-18 .6 ) vs 5.7 ( 4.7-10 .2 ) and 8.1 ( 6.9-11 .1 ) months ) without increased toxicity .


No rilotumumab benefit was seen among MET-negative patients .


Rilotumumab had an exposure-dependent treatment effect in patients with MET-positive gastric or oesophagogastric junction cancer .


Neoangiogenesis is particularly abundant in small-cell lung cancer ( SCLC ) and is associated with poor prognosis .


As a result of the promising nature of phase II studies , a randomized phase III trial was designed to assess the efficacy of adding bevacizumab to first-line chemotherapy with cisplatin-etoposide for treatment of extensive disease SCLC .


We present the treatment rationale and study design of GOIRC trial ( FARM6PMFJM study ) , a multicenter randomized phase III study , supported by AIFA ( Agenzia Italiana del Farmaco ) .


Patients are randomized to receive either cisplatin 25 mg/m ( 2 ) and etoposide 100 mg/m ( 2 ) intravenously on days 1 to 3 ( control arm ) or the same chemotherapy combined with bevacizumab 7.5 mg/kg intravenously on day 1 ( experimental arm ) .


Treatment is repeated every 3 weeks and for a maximum of 6 courses .


Patients randomized to the experimental arm in the absence of disease progression after 6 cycles continue bevacizumab alone until progression or for a maximum of 18 courses .


Tumor assessment is done every 3 cycles .


Major eligibility criteria are : age 18 years ; histologically or cytologically documented extensive disease SCLC ; Eastern Cooperative Oncology Group performance status 2 ; adequate hematological , hepatic and renal functions ; no history of grade 2 or higher hemoptysis ; and no evidence of tumor cavitation .


The primary end point of this study is overall survival .


Secondary end points include response rate , time to progression , and toxicity .


An interim futility analysis was performed by an Independent Data Monitoring Committee in September 2013 and the trial obtained approval to continue .


As of July 31 , 2014 , 171 patients of 206 planned have been randomized .


Severe mental illness ( SMI ) , including schizophrenia , bipolar disorder and severe depression , is responsible for a substantial proportion of disability in the population .


This article describes the aims and design of a research study that takes a novel approach to targeted prevention of SMI .


It is based on the rationale that early developmental antecedents to SMI are likely to be more malleable than fully developed mood or psychotic disorders and that low-risk interventions targeting antecedents may reduce the risk of SMI .


Families Overcoming Risks and Building Opportunities for Well-being ( FORBOW ) is an accelerated cohort study that includes a large proportion of offspring of parents with SMI and embeds intervention trials in a cohort multiple randomized controlled trial ( cmRCT ) design .


Antecedents are conditions of the individual that are distressing but not severely impairing , predict SMI with moderate-to-large effect sizes and precede the onset of SMI by at least several years .


FORBOW focuses on the following antecedents : affective lability , anxiety , psychotic-like experiences , basic symptoms , sleep problems , somatic symptoms , cannabis use and cognitive delay .


Enrolment of offspring over a broad age range ( 0 to 21 years ) will allow researchers to draw conclusions on a longer developmental period from a study of shorter duration .


Annual assessments cover a full range of psychopathology , cognitive abilities , eligibility criteria for interventions and outcomes .


Pre-emptive early interventions ( PEI ) will include skill training for parents of younger children and courses in emotional well-being skills based on cognitive behavioural therapy for older children and youth .


A sample enriched for familial risk of SMI will enhance statistical power for testing the efficacy of PEI .


FORBOW offers a platform for efficient and unbiased testing of interventions selected according to best available evidence .


Since few differences exist between familial and ` sporadic ' SMI , the same interventions are likely to be effective in the general population .


Comparison of short-term efficacy of PEI on antecedents and the long term efficacy for preventing the onset of SMI will provide an experimental test of the etiological role of antecedents in the development of SMI .


To evaluate the effectiveness of naproxen 500 mg taken orally 30 minutes before , endometrial biopsy for pain relief during the procedure .


A double blind , randomized , placebo-controlled trial was conducted in 80 patients with indication for endometrial biopsy at Ramathibodi Hospital between April 2013 and January 2014 .


The patients were randomly allocated into two groups to receive naproxen 500 mg ( n = 40 ) or placebo ( n = 40 ) , 30 minutes before endometrial biopsy .


Pain score was assessed using Visual Analogue Scale during and 10 minutes after the procedure .


Adverse events were observed .


The mean pain score during endometrial biopsy in the treatment group was significantly lower compared to the placebo group ( 5.11 0.18 vs. 6.49 0.17 , respectively , p-value < 0.001 ) .


However , the mean pain score at 10 minutes after endometrial sampling were minimal and had non-statistical significance in both groups .


( 0.60 0.56 vs. 0.59 0.64 , p-value 0.971 ) .


Naproxen 500 mg taken orally 30 minutes before endometrial biopsy significantly reduce pain score during the procedure .


To investigate the effects of different anesthesia depth on stress response in elderly patients undergoing elective laparoscopic surgery for colorectal cancer .


A total of 105 ASA I-III patients aged 60-91 years undergoing elective laparoscopic surgery for colorectal cancer with general anesthesia were randomized into 3 groups , namely group A with a target Narcotrend index ( NI ) maintained at D0 level , group B with a NI at D2 level , and group C with a NI at E1 level .


The anesthetics ( profopol and remifentanil ) were adjusted according to Narcotrend monitoring results to maintain the specified anesthesia depth .


The patients ' heart rate ( HR ) and mean artery pressure ( MAP ) were recorded before anesthesia ( T0 ) , before intubation ( T1 ) , immediately after intubation ( T2 ) , at 2 min before pneumoperitoneum ( T3 ) , 2 min after pneumoperitoneum ( T4 ) , at the end of the surgery ( T5 ) and extubation ( T6 ) .


Serum levels of cortisol , adrenocorticotropic hormone ( ACTH ) , endothelin-1 ( ET-1 ) , tumor necrosis factor - ( TNF - ) , interleukin-6 ( IL-6 ) and C-reactive protein ( CRP ) were measured by standard ELISA and radioimmunoassay before anesthesia ( Ta ) , at the end of the surgery ( Tb ) and 1 day after the surgery ( Tc ) .


HR and MAP in group A increased significantly at T2 , T4 , and T6 compared to those at T0 ( P < 0.05 ) , and were higher than those in group B and group C ( P < 0.05 ) .


The MAP in all the 3 groups all decreased at T1 and T3 ( P < 0.05 or P < 0.01 ) , and was markedly lower in group C than in groups A and B ( P < 0.05 ) .


The incidence of hypertension was significantly higher in group A than in groups B and C ( P < 0.05 ) , while the incidence of hypotension was much higher in group C ( P < 0.01 ) .


There were no obvious differences in serum levels of cortisol , ACTH , CRP , IL-6 , TNF-a , or ET-1 among the groups at Ta ( P > 0.05 ) .


The serum levels of ACTH in the 3 groups all significantly increased at Tb and Tc ( P < 0.01 ) .


CRP , IL-6 and TNF-a levels in group A were increased at Tb and Tc ( P < 0.05 or P < 0.01 ) and significantly higher than those in groups B and C ( P < 0.05 or P < 0.01 ) .


Cortisol in groups A and B increased at Tb and Tc ( P < 0.05 ) to a significantly higher level than that in group C ( P < 0.01 ) .


ET-1 level in group C at Tb and Tc was lower than those in groups A and B ( P < 0.05 or P < 0.01 ) .


Maintaining the anesthesia depth for a NI at the D2 and E1 level can both attenuate the stress response in elderly patients undergoing laparoscopic surgery for colorectal cancer , but the hemodynamic stability can be better at a D2 level .


The study purpose was to analyze midterm outcomes in a prospective trial of alemtuzumab ( Alem ) versus rabbit anti-thymocyte globulin ( rATG ) induction in simultaneous pancreas-kidney transplantation ( SPKT ) .


From February 2005 to October 2008 , 46 SPKTs ( 45 portal-enteric drainage ) were prospectively randomized as part of a larger kidney transplant study to receive either single-dose Alem ( 30 mg intraoperatively ) or multiple-dose rATG antibody induction ( starting intraoperatively , minimum three doses administered ) with tacrolimus/mycophenolate steroids .


Of 222 kidney transplant patients enrolled in the study , 46 received SPKTs ; 28 ( 61 % ) received Alem and 18 ( 39 % ) rATG induction .


Follow-up ranged from 67 to 111 months ( mean 80 months ) .


There were no significant differences between the two groups in 5 years actual patient ( 86 % Alem vs 89 % rATG ) , kidney ( 82 % Alem vs 61 % rATG , p = 0.17 ) or pancreas ( 68 % Alem vs 56 % rATG ) graft survival rates .


Five years death-censored kidney ( 92 % Alem vs 69 % rATG , p = 0.09 ) and pancreas ( 76 % Alem vs 56 % rATG , p = 0.198 ) graft survival rates were slightly higher in patients receiving Alem .


Acute rejection ( 21 % Alem vs 44 % rATG , p = 0.12 ) and major infection ( 39 % Alem vs 67 % rATG , p = 0.13 ) rates were slightly lower in the Alem group ; cytomegalovirus infections were significantly lower ( 0 Alem vs 17 % rATG , p = 0.05 ) .


The incidence of late acute rejection was low in both groups .


There were no differences in early pancreas thrombosis ( 3.6 % Alem vs 11 % rATG ) , postoperative bleeding ( 11 % Alem vs 0 rATG ) , other surgical complications , readmissions or freedom from steroids between groups .


In patients with functioning grafts , 5 years mean serum creatinine ( 1.4 Alem vs 1.6 mg/dl rATG ) , calculated abbreviated modification of diet in renal disease glomerular filtration rate ( 55 Alem vs 52 ml/min/1 .73 m ( 2 ) rATG ) , hemoglobin A1c ( both 5.4 % ) and C-peptide ( 2.6 Alem vs 2.3 ng/ml rATG ) levels were similar .


Single-dose Alem and multiple-dose rATG induction provide similar midterm patient survival and graft functional outcomes with no major differences in morbidity or resource utilization .


The aim of this investigation is to study the relationship between gastric morphology and serum biomarkers before and after Helicobacter pylori eradication .


First-degree relatives of gastric cancer patients underwent gastroscopy before and 2.5 years after H. pylori eradication .


The morphological changes in two categories ( normal to mild and moderate to severe ) were compared with level of pepsinogens I and II before eradication ( n = 369 ) , after eradication ( n = 115 ) , and in those with persistent infection ( n = 250 ) .


After eradication , pepsinogen I decreased to 70 % and pepsinogen II to 45 % of the previous values .


Unlike pepsinogen II and pepsinogen I to II ratio that were affected by the severity of inflammation and atrophy in corpus in all groups , pepsinogen I generally did not change .


After eradication , subjects with high mononuclear infiltration in corpus had lower pepsinogen I ( 54 versus 77.1 / mL ) , higher pepsinogen II ( 9.4 versus 6.9 / mL ) , and lower ratio ( 7.9 versus 11.6 ) than those without ( P < 0.05 ) .


Pepsinogen II is a good marker of corpus morphological changes before and after H. pylori eradication .


To study the efficacy of Xiaoyao Powder ( XYP ) combined with interferon alpha ( IFN-alpha ) in treating HBeAg positive chronic hepatitis B ( CHB ) patients and the effect on their quality of life ( QOL ) .


Totally 193 patients with HBeAg-positive CHB confirmed by liver biopsy were randomly assigned to 2 groups , Group A ( 94 cases ) and Group B ( 99 cases ) .


IFN-alpha1b was subcutaneously injected to patients in Group A at the dose of 50 microg , thrice per week .


Those in Group B additionally took XYP .


The therapeutic course for all was 24 weeks .


Clinical efficacy was observed by assessing ALT restoration rate , HBeAg negative rate , HBeAg conversion rate , HBV DNA negative rate , complete response rate , partial response rate , and symptoms integral .


The evaluation of QOL was performed by using chronic liver disease questionnaire ( CLDQ ) score .


Adverse reaction occurrence rate was observed in the two groups .


Better effects were obtained in Group A on ALT restoration rate , HBeAg negative rate , HBV DNA negative rate , complete response rate , partial response rate , TCM symptoms integral , the total effective rate of TCM sysmptoms , CLDQ score , and adverse reaction rates , showing statistical difference when compared with Group B ( P < 0.05 , P < 0.01 ) .


XYP could elevate the efficacy of TCM symptoms of HBeAg-positive CHB patients and anti-viral effect , improve their QOL , and reduce adverse reaction of IFN-alpha .


To evaluate long-term efficacy and safety profiles during 3 years of individualized ranibizumab treatment in patients with visual impairment due to diabetic macular edema ( DME ) .


Phase IIIb , multicenter , 12-month , randomized core study and 24-month open-label extension study .


Of the 303 patients who completed the randomized RESTORE 12-month core study , 240 entered the extension study .


In the extension study , patients were eligible to receive individualized ranibizumab treatment as of month 12 guided by best-corrected visual acuity ( BCVA ) and disease progression criteria at the investigators ' discretion .


Concomitant laser treatment was allowed according to the Early Treatment Diabetic Retinopathy Study guidelines .


Based on the treatments received in the core study , the extension study groups were referred to as prior ranibizumab , prior ranibizumab + laser , and laser .


Change in BCVA and incidence of ocular and nonocular adverse events ( AEs ) over 3 years .


Overall , 208 patients ( 86.7 % ) completed the extension study .


In patients treated with ranibizumab during the core study , consecutive individualized ranibizumab treatment during the extension study led to an overall maintenance of BCVA and central retinal subfield thickness ( CRST ) observed at month 12 over the 2-year extension study ( +8.0 letters , -142.1 m [ prior ranibizumab ] and +6.7 letters , -145.9 m [ prior ranibizumab + laser ] from baseline at month 36 ) with a median of 6.0 injections ( mean , 6.8 injections ; prior ranibizumab ) and 4.0 ( mean , 6.0 injections ; prior ranibizumab + laser ) .


In the prior laser group , a progressive BCVA improvement ( +6.0 letters ) and CRST reduction ( -142.7 m ) at month 36 were observed after allowing ranibizumab during the extension study , with a median of 4.0 injections ( mean , 6.5 injections ) from months 12 to 35 .


Patients in all 3 treatment groups received a mean of < 3 injections in the final year .


No cases of endophthalmitis , retinal tear , or retinal detachment were reported .


The most frequently reported ocular and nonocular adverse effects over 3 years were cataract ( 16.3 % ) and nasopharyngitis ( 23.3 % ) .


Eight deaths were reported during the extension study , but none were suspected to be related to the study drug/procedure .


Ranibizumab was effective in improving and maintaining BCVA and CRST outcomes with a progressively declining number of injections over 3 years of individualized dosing .


Ranibizumab was generally well tolerated with no new safety concerns over 3 years .


Physical therapy treatment of patients with lymphedema includes treatment based on the principles of ` Complete Decongestive Therapy ' ( CDT ) .


CDT consists of the following components ; skin care , manual lymphatic drainage , bandaging and exercises .


The scientific evidence regarding what type of treatment is most effective is sparse .


The objective of this study is to investigate whether CDT is equally effective if it includes manual lymphatic drainage or not in the treatment of arm lymphedema among patients with breast cancer .


A randomized , single-blind , equivalence trial .


A total of 160 breast cancer patients with arm lymphedema will be recruited from 3 hospitals and randomized into one of two treatment groups A : Complete Decongestive Therapy including manual drainage or B : Complete Decongestive Therapy without manual lymphatic drainage .


The intervention period will be approximately 4 weeks followed by a 6 month follow-up period ( 7 months from baseline ) .


Primary outcome variable : the percentage volume reduction of lymphedema ( % ) from baseline to 7 months .


Secondary outcome variables : Differences from baseline to week 4 and from week 4 to month 7 in circumference of the arm ( cm ) , body weight ( kg ) , patient sensation of heaviness ( scale range : 0-10 ) , patient sensation of tension ( scale range : 0-10 ) , and quality of life ( EQ-5D-5 L-questionnaire ) .


All measurements are standardized and will be performed before randomization , after 4 weeks and after 7 months .


This randomized controlled study seeks to provide data on an effective treatment for patients with breast cancer related arm lymphedema and which at the same time causes minimal patient inconvenience .


ClinicalTrials.gov : Identifier NCT02015897 .


To determine the effects of lipid based nutritional supplements with either whey or soy protein in patients with HIV during the first three months of antiretroviral treatment ( ART ) and to explore effects of timing by comparing supplementation at the start of ART and after three months delay .


Randomised controlled trial .


Three public ART facilities in Jimma , Oromia region , Ethiopia .


Adults with HIV eligible for ART with body mass index ( BMI ) > 16 .


Daily supplementation with 200 g ( 4600 kJ ) of supplement containing whey or soy during either the first three or the subsequent three months of ART .


Primary : lean body mass assessed with deuterium dilution , grip strength measured with dynamometers , and physical activity measured with accelerometer and heart rate monitors .


Secondary : viral load and CD4 counts .


Auxiliary : weight and CD3 and CD8 counts .


Of 318 patients enrolled , 210 ( 66 % ) were women , mean age was 33 ( SD 9 ) , and mean BMI was 19.5 ( SD 2.4 ) .


At three months , participants receiving the supplements containing whey or soy had increased their lean body mass by 0.85 kg ( 95 % confidence interval 0.16 kg to 1.53 kg ) and 0.97 kg ( 0.29 kg to 1.64 kg ) , respectively , more than controls .


This was accompanied by an increased gain of grip strength of 0.68 kg ( -0.11 kg to 1.46 kg ) for the whey supplement group and 0.93 kg ( 0.16 kg to 1.70 kg ) for the soy supplement group .


There were no effects on physical activity .


Total weight gain increased by 2.05 kg ( 1.12 kg to 2.99 kg ) and 2.06 kg ( 1.14 kg to 2.97 kg ) for the whey and soy groups , respectively .


In addition , in the whey supplement group overall CD3 counts improved by 150 cells/L ( 24 to 275 cells/L ) , of which 112 cells/L ( 15 to 209 cells/L ) were CD8 and 25 cells/L ( -2 to 53 cells/L ) were CD4 .


Effects of the soy containing supplement on immune recovery were not significant .


The effects of the two supplements , however , were not significantly different in direct comparison .


Exploratory analysis showed that relatively more lean body mass was gained by patients with undetectable viral load at three months .


Patients receiving delayed supplementation had higher weight gain but lower gains in functional outcomes .


Lipid based nutritional supplements improved gain of weight , lean body mass , and grip strength in patients with HIV starting ART .


Supplements containing whey were associated with improved immune recovery .


Trial registration Controlled-trials .


com ISRCTN32453477 .


Daikenchuto ( DKT ) has widely been used to improve abdominal symptoms by being expected to accelerate bowel motility .


The purpose of this study is to examine the efficacy and safety of DKT for prevention of ileus and associated gastrointestinal symptoms after total gastrectomy .


Two hundred and forty-five gastric cancer patients who underwent total gastrectomy were enrolled .


Patients received either DKT ( 15.0 g/d ) or matching placebo from postoperative days 1 to 12 .


Primary end points were time to first flatus , time to first bowel movement ( BM ) , and frequency of BM .


Secondary end points included quality of life , C-reactive protein level , symptoms indicative of a severe gastrointestinal disorder , and incidence of postoperative ileus .


A total of 195 patients ( DKT , n = 96 ; placebo , n = 99 ) were included in the per-protocol set analysis .


There were no significant differences between the groups in terms of patient background characteristics .


Median time to first BM was shorter in the DKT group than in the placebo group ( 94.7 hours vs 113.9 hours ; p = 0.051 ) .


In patients with high medication adherence , median time to first BM was significantly shorter in the DKT group than in the placebo group ( 93.8 hours vs 115.1 hours ; p = 0.014 ) .


Significantly fewer patients in the DKT group had 2 symptoms of gastrointestinal dysfunction than those in the placebo group on postoperative day 12 ( p = 0.026 ) .


Administration of DKT during the immediate postoperative period after total gastrectomy appears to promote early recovery of postoperative bowel function .


To determine the effects of Ginkgo biloba extract ( EGB ) on major periodontal pathogens in subgingival plaque .


Sixty patients with moderate to severe periodontitis were selected and randomly assigned to 3 groups : EGB group , a positive ( periocline ) and a negative control groups .


Subgingival plaque samples were collected before treatment and 1 week , 2 months and 4 months after treatment .


The detection rates of 4 major periodontal pathogens-Treponema denticola ( Td ) , Tannerella forsythus ( Tf ) , Prevotella intermedia ( Pi ) , and Porphyromonas gingivalis ( Pg ) - were detected by polymerase chain reaction ( PCR ) .


Clinical indicators were examined before treatment , 3 and 6 months after treatment .


EGB significantly decreased the detection rate of all the 4 pathogens 1 week after treatment , and then gradually increased at 2 and 4 months .


EGB 's inhibition effect was better than or comparable to periocline , except for Pg in short-term .


The difference of plaque index ( PLI ) and bleeding index ( BI ) was not statistically significant among the groups , while for probing depth ( PD ) and attachment loss ( AL ) , the difference was statistically significant between the EGB group and negative control group at 3 and 6 months after treatment .


EGB significantly inhibited major periodontal pathogens and can be used as an adjuvant for periodontitis treatment .


Instructional methods for the simple suture technique vary widely and are seldom based on educational research .


Published data indicate that video primers and structured instruction and evaluation decrease learning time and improve skill acquisition .


To determine the amount of practice needed to attain simple suture proficiency and to identify the optimal teaching schedule for retention of skill .


First-year and second-year medical students at the Icahn School of Medicine at Mount Sinai with little to no suturing experience were randomly divided into 2 equal groups , with one being taught on day 1 and tested for proficiency on day 30 ( control group ) and the other being taught on day 1 and tested for proficiency on days 10 , 20 , and 30 ( experimental group ) .


Students were evaluated using the objective structured assessment of technical skills method and a checklist .


Those initially not proficient on a given day were immediately prompted to practice and retest .


This cycle continued until proficiency was achieved for that day .


The study was conducted from April 7 , 2014 , to June 30 , 2014 .


Simple suture proficiency at 30 days and the mean number of practice sutures needed for proficiency on day 1 .


All students ultimately achieved proficiency .


The mean ( SD ) number of practice sutures required to achieve proficiency at the initial training was 41 ( 15 ) .


Students in the control group had a 0 % pass rate at the 30-day initial proficiency test , while students in the experimental group had a 91.7 % pass rate at day 30 ( P < .001 ) .


There were no differences in instructional time , cumulative number of sutures , or objective structured assessment of technical skills scores at proficiency between groups across the study .


Single instructional sessions may not be sufficient to maintain simple suture proficiency over the course of a 30-day elective .


We propose the use of preparatory instructional videos , followed by instructor demonstration to introduce the technique .


Independent practice with intermittent evaluation and critique allows for skill acquisition and time efficiency at the initial training .


Students should view instructional videos and practice at least 10 repetitions every 10 days to maintain their skill .


There have been no studies of the effect of continuous positive airway pressure ( CPAP ) therapy on erectile dysfunction ( ED ) and serum testosterone in men with type 2 diabetes and obstructive sleep apnoea ( OSA ) , a patient group at increased risk of ED and hypogonadism .


The aim of this study was to determine whether CPAP improves sexual and gonadal function in males with type 2 diabetes and a pre-CPAP apnoea-hypopnoea index > 15/h .


Substudy of a trial assessing the effect of 3 months of CPAP on cardiovascular risk in type 2 diabetes .


Of 35 males starting CPAP , 27 ( mean SD age 65.4 9.6 years , median [ interquartile range ] diabetes duration 12.1 [ 5.2-15 .3 ] years ) completed the trial .


Serum total and free testosterone , responses to the Androgen Deficiency in the Aging Aale ( ADAM ) and Sexual Health Inventory for Men ( SHIM ) questionnaires .


There were no significant changes in mean total or free testosterone ( baseline concentrations 12.7 4.5 nm and 0.26 0.07 pm , respectively ) , or SHIM score ( baseline 13 [ 5-17 ] ) , after 3 months of CPAP ( P > 0.20 ) .


The ADAM score ( baseline 6.2 2.1 ) fell after 1 month ( to 5.0 2.6 ) and was maintained at this level at 3 months ( P = 0.015 ) .


The Epworth Sleepiness Scale score decreased and self-reported physical activity increased over 3 months ( P 0.017 ) without a change in body mass index ( P = 1.00 ) .


These findings imply that CPAP therapy improves somnolence and promotes exercise in men with type 2 diabetes , but that there is no direct benefit for gonadal or sexual function .


GH treatment significantly increased adult height ( AH ) in a dose-dependent manner in short non-GH-deficient children in a randomized , controlled , clinical trial ; the mean gain in height SD score ( heightSDS ) was 1.3 ( range 0-3 ) , compared with 0.2 in the untreated group .


The objective of the study was to analyze the relationship between IGF-1SDS , IGF binding protein-3 SDS ( IGFBP3SDS ) , and their ratioSDS with a gain in the heightSDS until AH in non-GH-deficient short children .


This was a randomized , controlled , multicenter clinical trial .


The intervention included GH treatment : 33 or 67 g/kg d plus untreated controls .


One hundred fifty-one non-GH-deficient short children were included in the intent-to-treat ( ITT ) population and 108 in the per-protocol ( PP ) population ; 112 children in the ITT and 68 children in the PP populations had idiopathic short stature ( ISS ) .


Increments from baseline to on-treatment study mean IGF-1SDS ( IGF-1SDS ) , IGFBP3SDS , and IGF-1 to IGFBP3 ratioSDS were assessed in relationship to the gain in heightSDS .


Sixty-two percent of the variance in the gain in heightSDS in children on GH treatment could be explained by four variables : IGF-1SDS ( explaining 28 % ) , bone age delay , birth length ( the taller the better ) , and GH dose ( the higher the better ) .


The lower IGF-1SDS was at baseline , the higher was its increment during treatment .


For both the AllPP - and the ISSPP-treated groups , the attained IGF-1SDS study level did not correlate with height gain .


In short non-GH-deficient children , the GH dose-related increment in IGF-1SDS from baseline to mean study level was the most important explanatory variable for long-term growth response from the peripubertal period until AH , when IGF-1SDS , IGFBP3SDS , and their ratioSDS were compared concurrently .


The aim of the study was to compare intermittent ( IAD ) and continuous ( CAD ) androgen deprivation therapy ( ADT ) between locally advanced ( M0 ) and metastatic ( M1 ) prostate cancer , and the effect of ADT on the quality of life .


In total , 852 men with advanced prostate cancer were enrolled to receive goserelin acetate for 24 weeks .


Of these , 554 patients whose prostate-specific antigen ( PSA ) decreased to less than 10 ng/ml or by at least 50 % ( < 20 ng/ml at baseline ) were randomized to IAD or CAD .


In the IAD arm , ADT was resumed for at least 24 weeks whenever PSA increased to greater than 20 ng/ml or above baseline .


Median follow-up time was 65 months .


Median times from randomization to progression , death , prostate cancer death and treatment failure in M0 and M1 patients were 46.8 and 21.4 , 57.6 and 40.3 , 59.5 and 40.7 , and 41.9 and 20.0 months , respectively ( p < 0.001 ) .


No significant differences emerged between IAD and CAD .


ADT showed a beneficial effect on pain , activity limitation and social functioning in M1 patients , and a deleterious effect on physical capacity in M0 patients and on sexual functioning in both groups .


IAD offered extra benefit for activity limitation , social functioning and recovery of sexual functioning .


IAD is as efficient as CAD in treatment of locally advanced and metastatic prostate cancer .


ADT improves quality of life in M1 patients , with IAD offering extra benefit .


Recombinant interleukin-2 ( rIL-2 ) induces cellular cytotoxicity against leukemia blasts .


Patients with acute myeloid leukemia ( AML ) in first complete remission ( CR ) may harbor minimal residual disease that is susceptible to rIL-2-activated effector cells .


In the Cancer and Leukemia Group B ( CALGB ) 19808 study , patients with AML in first CR were randomly assigned after all planned chemotherapy to receive a 90-day course of subcutaneously administered rIL-2 or no further therapy .


The primary objective was to compare disease-free survival ( DFS ) between the 2 treatment arms .


A total of 534 patients achieved a CR , 214 of whom were randomized .


Six courses of low-dose daily rIL-2 were given for the expansion of cytotoxic effector cells , each followed by 3-day high-dose boluses given to trigger cytotoxicity against minimal residual disease .


On the protocol-specified intention-to-treat analysis , the hazards ratio for DFS was 0.75 ( 95 % confidence interval , 0.52-1 .09 ; P = .13 ) ; the 5-year DFS rate was 42 % in the observation arm and 53 % in the rIL-2 treatment arm .


The hazards ratio for overall survival ( OS ) was 0.88 ( 95 % confidence interval , 0.54-1 .23 ; P = .34 ) ; the 5-year OS rate was 58 % for the observation arm and 63 % for the rIL-2 treatment arm .


Twenty-five of the 107 patients randomized to treatment with rIL-2 either refused or were unable to initiate therapy and 30 patients did not complete their assigned therapy .


However , significant toxicities were not commonly observed .


The trial design did not anticipate the difficulties patients would encounter with protocol compliance .


The efficacy of immunotherapy with rIL-2 administered after intensive postremission treatment was not assessed as planned because of unexpected refusals by patients and/or their physicians to comply with protocol-directed therapy .


Neither DFS nor OS was found to be significantly improved .


Older patients discharged from the emergency department ( ED ) have difficulty comprehending discharge plans and are at high risk of adverse outcomes .


The authors investigated whether a postdischarge telephone call-mediated intervention by a nurse would improve discharge care plan adherence , specifically by expediting post-ED visit physician follow-up appointments and/or compliance with medication changes .


The second objectives were to determine if this telephone call intervention would reduce return ED visits and/or hospitalizations within 35days of the index ED visit and to determine potential cost savings of this intervention .


This was a 10-week randomized , controlled trial among patients aged 65 and older discharged to home from an academic ED .


At 1 to 3days after each patient 's index ED visit , a trained nurse called intervention group patients to review discharge instructions and assist with discharge plan compliance ; placebo call group patients received a patient satisfaction survey call , while the control group patients were not called .


Data collection calls occurred at 5 to 8days and 30 to 35days after the index ED visits for all three groups .


Chi-square or Fisher 's exact tests were performed for categorical data and the Kruskal-Wallis test examined group differences in time to follow-up .


A total of 120 patients completed the study .


Patients were 60 % female and 72 % white , with a mean age of 75years ( standard deviation [ SD ] 7.58 years ) .


Intervention patients were more likely to follow up with medical providers within 5days of their ED visits than either the placebo or the control group patients ( 54 , 20 , and 37 % , respectively ; p = 0.04 ) .


All groups performed well in medication acquisition and comprehension of medication indications and dosage .


There were no differences in return visits to the ED or hospital within 35days of the index ED visit for intervention patients , compared to placebo or control group patients ( 22 , 33 , and 27 % , respectively ; p = 0.41 ) .


An economic analysis showed an estimated 70 % chance that this intervention would reduce total costs .


Telephone call follow-up of older patients discharged from the ED resulted in expedited follow-up for patients with their primary care physicians .


Further study is warranted to determine if these results translate into improved patient outcomes , decreased return ED visits or hospital admissions , and cost savings resulting from this intervention .


To compare characteristics of hypoglycemic episodes in patients with type 2 diabetes receiving saxagliptin or glipizide add-on therapy to metformin .


This was a post hoc analysis of an international , randomized , parallel-group , double-blind , active-controlled , phase 3 trial .


The 52-week trial and 52-week extension were conducted from December 2007 to August 2010 .


Patients aged 18 years with glycated hemoglobin ( HbA1c ) > 6.5 % to 10.0 % receiving stable metformin doses ( 1500mg/d ) were randomized 1:1 to add-on therapy with saxagliptin 5mg/d or glipizide 5 to 20mg/d ( titrated to optimal effect or highest tolerable dose during the initial 18 weeks ) .


Hypoglycemic episodes were recorded in patient diaries .


Confirmed hypoglycemic events were defined as fingerstick glucose 50mg/dL ( 2.8 mmol/L ) with associated symptoms .


Of 858 patients randomized , 428 received saxagliptin + metformin , and 430 received glipizide + metformin .


Saxagliptin was noninferior to glipizide in lowering HbA1c .


Hypoglycemia with saxagliptin + metformin and glipizide + metformin was reported by 15 ( 24 events ) and 165 ( 896 events ) patients , respectively , through week 104 .


The mean ( SD ) number of hypoglycemic events per patient reporting hypoglycemia was lower with saxagliptin + metformin versus glipizide + metformin through weeks 52 ( 1.5 [ SD 0.88 ] vs 4.8 [ SD 4.9 ] , respectively ) and 104 ( 1.6 [ SD 0.99 ] vs 5.4 [ SD 5.8 ] ) .


Most patients receiving glipizide + metformin with hypoglycemia had multiple events ( 124/165 patients [ 75 % ] ) .


Confirmed hypoglycemia , major events , and severe events occurred only with glipizide + metformin .


Time to first hypoglycemic event was shorter with glipizide versus saxagliptin .


Limitations of this analysis include its post hoc nature , a high rate of study discontinuation , and exclusion of patients with serious comorbidities and complications .


Saxagliptin + metformin was associated with fewer patients reporting hypoglycemia and fewer and less severe hypoglycemic events in those experiencing hypoglycemia compared with glipizide + metformin .


ClinicalTrials.gov registration number : NCT00575588 .


This study is a comparative evaluation of the TVT , TOT , and our own modification of TOT ( mTOT ) in the treatment of female stress urinary incontinence from a single center experience .


The study was conducted on 527 patients with SUI diagnosed on the basis of urodynamic studies .


They were divided into three groups -- TVT : n = 142 , ( TOT ) : n = 129 , and mTOT : n = 256 .


All of the patients underwent evaluation at 1 , 3 , and 6 months after surgery .


Results were statistically analysed and compared .


Objective and subjective effectiveness after the surgery were not significantly different in the study groups and ranged from 90.1 % to 96.4 % .


Mean surgery time was 32.3 , 28.2 , and 26.4 in the TVT , TOT , and mTOT , respectively .


Mean hospitalization time was 2.51 days .


Mean catheter maintenance time was significantly higher in the TVT than in other groups .


In the TVT group total incidence of complications was 13.4 % , and it was significantly higher than that in TOT and mTOT ( 9.3 % and 8.6 % , resp . )


TVT , TOT , and mTOT are highly effective and safe methods in the treatment of SUI .


There are no differences in the efficacy between the methods with a little higher percentage of complications in the TVT group .


The Lower Mississippi Delta ( LMD ) region of the United States is characterized by high levels of obesity and physical inactivity .


The objective was to test the effectiveness of adapting the 2010 Dietary Guidelines for Americans ( DG ) , with and without a physical activity ( PA ) component , for attenuating weight gain .


Overall , 121 white and African-American adults ( 35-64 years ; body mass index 25-34 .9 kg/m ( 2 ) ) were randomized to a DG only group ( n = 61 ) or a DG + PA group ( n = 60 ) .


Both groups received a 12-week dietary education and behavior change intervention .


The DG + PA group also received PA education and a pedometer .


Changes in weight ( kg ) , % weight , and waist circumference ( WC ; cm ) were determined .


Analyses considered all completers ( n = 99 ) and those who engaged with 80 % of the intervention ( n = 83 ) .


General linear models compared mean changes between groups after adjustment for baseline values , race , and sex .


Weight , % weight , and WC significantly decreased from baseline to follow-up in both groups ( p < 0.05 ; unadjusted values ) .


Adjusted analysis showed a main effect of group for weight ( p = 0.041 ) and % weight ( p = 0.047 ) in the completers analysis , and WC ( p = 0.046 ) in the 80 % attendance analysis , with the DG + PA group improving weight-related outcomes more .


Low-burden behavioral interventions could be effective strategies in attenuating unhealthy weight gain in the LMD .


The goal of the present research was the examination of overlap between 2 research traditions on interpersonal personality traits in major depression .


We hypothesized that Blatt 's ( 2004 ) dimensions of depressive experiences around the dimensions of relatedness ( i.e. , dependency ) and self-definition ( i.e. , self-criticism ) are associated with specific interpersonal problems according to the interpersonal circumplex model ( Leary , 1957 ) .


In addition , we examined correlations of interpersonal characteristics with depression severity .


Analyses were conducted on 283 patients with major depressive disorder combined from 2 samples .


Of the patients , 151 participated in a randomized controlled trial in the United States , and 132 patients were recruited in an inpatient unit in Germany .


Patients completed measures of symptomatic distress , interpersonal problems , and depressive experiences .


Dependency was associated with more interpersonal problems related to low dominance and high affiliation , while self-criticism was associated with more interpersonal problems related to low affiliation .


These associations were independent of depression severity .


Self-criticism showed high overlap with cognitive symptoms of depression .


The findings support the interpersonal nature of Blatt 's dimensions of depressive experiences .


Self-criticism is associated with being too distant or cold toward others as well as greater depression severity , but is not related to the dimension of dominance .


Long-term macrolide treatment has proven benefit in inflammatory airways diseases , but whether it leads to changes in the composition of respiratory microbiota is unknown .


We aimed to assess whether long-term , low-dose erythromycin treatment changes the composition of respiratory microbiota in people with non-cystic fibrosis bronchiectasis .


Microbiota composition was determined by 16S rRNA gene sequencing of sputum samples from participants in the BLESS trial , a 12-month , double-blind , placebo-controlled trial of twice-daily erythromycin ethylsuccinate ( 400 mg ) in adult patients with non-cystic fibrosis bronchiectasis and at least two infective exacerbations in the preceding year .


The primary outcome was within-patient change in respiratory microbiota composition ( assessed by Bray-Curtis index ) between baseline and week 48 , comparing erythromycin with placebo .


The BLESS trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12608000460303 .


The BLESS trial took place between Oct 15 , 2008 , and Dec 14 , 2011 .


Paired sputum samples were available from 86 randomly assigned patients , 42 in the placebo group and 44 in the erythromycin group .


The change in microbiota composition between baseline and week 48 was significantly greater with erythromycin than with placebo ( median Bray-Curtis score 052 [ IQR 014-078 ] vs 068 [ 046-093 ] ; median difference 016 , 95 % CI 001-033 ; p = 003 ) .


In patients with baseline airway infection dominated by Pseudomonas aeruginosa , erythromycin did not change microbiota composition significantly .


In those with infection dominated by organisms other than P. aeruginosa , erythromycin caused a significant change in microbiota composition ( p = 003 [ by analysis of similarity ] ) , representing a reduced relative abundance of Haemophilus influenzae ( 353 % [ 55-916 ] vs 67 % [ 08-748 ] ; median difference 126 % , 95 % CI 04-283 ; p = 004 ; interaction p = 002 ) and an increased relative abundance of P aeruginosa ( 002 % [ 000-033 ] vs 013 % [ 001-3958 ] ; median difference 66 % , 95 % CI 01-371 ; p = 0002 ; interaction p = 045 ) .


Compared with placebo , erythromycin reduced the rate of pulmonary exacerbations over the 48 weeks of the study in patients with P. aeruginosa-dominated infection ( median 1 [ IQR 0-3 ] vs 3 [ 2-5 ] ; median difference -2 , 95 % CI -4 to -1 ; p = 001 ) , but not in those without P. aeruginosa-dominated infection ( 1 [ 0-2 ] vs 1 [ 0-3 ] ; median difference 0 , -1 to 0 ; p = 041 ; interaction p = 004 ) .


Long-term erythromycin treatment changes the composition of respiratory microbiota in patients with bronchiectasis .


In patients without P. aeruginosa airway infection , erythromycin did not significantly reduce exacerbations and promoted displacement of H. influenzae by more macrolide-tolerant pathogens including P. aeruginosa .


These findings argue for a cautious approach to chronic macrolide use in patients without P. aeruginosa airway infection .


Mater Adult Respiratory Research Trust Fund .


To evaluate whether a combination of misoprostol and oxytocin more effectively reduces blood loss during and after cesarean delivery than does oxytocin alone among women with known risk factors for postpartum hemorrhage ( PPH ) .


A prospective , randomized , double-blind , placebo-controlled trial was performed at a tertiary care center in Kolkata , India , between October 2012 and December 2013 .


Women were eligible if they were undergoing emergency cesarean under spinal anesthesia and were at high risk for PPH .


Participants were randomly assigned ( 1:1 ) to receive 400 g misoprostol or matched placebo sublingually after delivery of the newborn using a computer-generated random number sequence ( block size eight ) .


Participants and providers were masked to assignment .


All participants received 20 IU oxytocin .


The primary outcomes were intraoperative and postoperative blood loss .


Both groups contained 198 women .


Mean intraoperative blood loss was significantly lower in the misoprostol group ( 505.4215.5 mL ) than in the placebo group ( 587.3201.5 mL ; P < 0.001 ) .


Mean postoperative blood loss was slightly lower in the misoprostol group ( 96.957.3 mL ) than in the placebo group ( 103.458.4 mL ; P = 0.07 ) .


Shivering and pyrexia were more frequently associated with misoprostol ( P < 0.05 for both ) .


Misoprostol as an adjunct to oxytocin seemed to more effectively reduce blood loss than did oxytocin alone .


Clinical Trial Registry India : CTRI/2013/05 / 003645 .


This study aimed to assess cost-effectiveness of N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) - guided versus symptom-guided therapy in heart failure ( HF ) patients60 years old .


Cost-effectiveness of NT-proBNP guidance in HF patients is unclear .


It may create additional costs with uncertain benefits .


In the TIME-CHF ( Trial of Intensified versus Standard Medical Therapy in Elderly Patients with Congestive Heart Failure ) , patients with left ventricular ejection fraction ( LVEF ) of45 % were randomized to receive intensified NT-proBNP-guided therapy or standard , symptom-guided therapy .


For cost-effectiveness analysis , 467 ( 94 % ) patients ( age 76 7 years , 66 % male ) were eligible .


Incremental cost-effectiveness was calculated as incremental costs per gained life-year and quality-adjusted life-year ( QALY ) within the 18-month trial period , as defined per protocol .


NT-proBNP-guided therapy was dominant ( i.e. , more effective and less costly ) over symptom-guided therapy , saving $ 2,979 USD ( 2.5 to 97.5 % confidence interval [ CI ] : $ 8,758 to $ 3,265 ) per patient , with incremental effectiveness of +0.07 life-years and +0.05 QALYs .


The probability of NT-proBNP-guided therapy being dominant was 80 % , and the probability of saving 1 life-year or QALY at a cost of $ 50,000 was 97 % and 93 % , respectively .


Exclusion of residence costs resulted in an incremental cost-effectiveness ratio ( ICER ) of $ 5,870 per life-year gained .


Cost-effectiveness of NT-proBNP-guided therapy was most pronounced in patients < 75 years old and in those with < 2significant comorbidities , being dominant in all sensitivity analyses .


In the worst-case scenario ( excluding residence costs in those with2 comorbidities ) , the ICER was $ 11,935 per life-year gained .


NT-proBNP-guided therapy has a high probability of being cost effective in HF patients with reduced LVEF , particularly in patients age 60 to 75 years or with less than 2 comorbidities .


( Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure [ TIME-CHF ] ; ISRCTN43596477 ) .


Functional magnetic resonance imaging ( fMRI ) studies involving alcohol challenge are important for identifying neural correlates of alcohol 's psychopharmacological effects .


However , evaluating acute alcohol effects on blood oxygen level-dependent ( BOLD ) signal change is complicated by alcohol-related increases in cerebral blood flow ( CBF ) .


The present study aimed to further characterize acute alcohol effects on CBF using intravenous alcohol administration to maximize control over brain alcohol exposure .


Twenty heavy-drinking young adults ( M = 19.95 years old , SD = 0.76 ) completed alcohol and placebo imaging sessions in a within-subject , counter-balanced , placebo-controlled design .


Arterial spin labeling ( ASL ) provided estimates of perfusion change at two target blood alcohol concentrations ( 40 and 80 mg % ) relative to baseline and relative to a saline control infusion .


Voxel-wise analyses showed widespread and dose-dependent effects of alcohol on CBF increase .


Region-of-interest analyses confirmed these findings , also indicating regional variation in the magnitude of perfusion change .


Additional findings indicated that lower self-reported sensitivity to alcohol corresponded with reduced perfusion change during alcohol administration .


This study provides further evidence for widespread effects of acute alcohol on cerebral perfusion , also demonstrating regional , dose-dependent , and inter-individual variation .


Further research is needed to evaluate implications of these effects for the design and interpretation of pharmacological fMRI studies involving alcohol challenge .


Feasibility randomized controlled trial .


To assess the feasibility of a trial to investigate the effectiveness of a lumbopelvic monitor as a feedback device for modifying postural behavior during daily work-related activities .


Frequent or sustained flexed postures play a role in the development or maintenance of nonspecific low back pain .


The provision of postural feedback could help individuals with or at risk of nonspecific low back pain improve their postural awareness and avoid hazardous or pain-provoking postures .


Sixty-two participants employed in a health care organization were randomly allocated into 1 of 3 groups : a control group , an intermittent feedback group , and a constant feedback group .


Adherence and follow-up rates were assessed .


Differences in postural pattern between baseline and follow-up measurements were used to assess the effectiveness of the lumbopelvic monitor as a postural feedback device .


Adherence was approximately 75 % .


With the exception of 1 center , the follow-up overall rates exceeded the a priori desired threshold of 80 % .


Within-group comparisons revealed no significant differences in postural pattern for the control group and intermittent feedback group .


The constant feedback group showed a significant reduction in flexed posture at the follow-up period compared with the baseline period .


Differences between groups did not reach statistical significance ; however , the constant feedback group , compared with the control group , demonstrated an effect size ( d ) of 0.60 .


The provision of constant postural feedback seems promising for promoting changes in postural behavior .


This feasibility trial identified adherence and follow-up rates and sample-size estimates important to the conduct of a fully powered efficacy trial .


Level of Evidence Therapy , level 2b - .


To evaluate basal and prandial insulin initiation and titration in people with type 2 diabetes mellitus ( T2DM ) in primary care and to explore the feasibility of retrospective-continuous glucose monitoring ( r-CGM ) in guiding insulin dosing .


The new model of care features General Practitioners ( GPs ) and Practice Nurses ( PNs ) working in an expanded role , with Credentialed Diabetes Educator - Registered Nurse ( CDE-RN ) support .


Insulin-nave T2DM patients ( HbA1c > 7.5 % [ > 58 mmol/mol ] despite maximal oral therapy ) from 22 general practices in Victoria , Australia commenced insulin glargine , with glulisine added as required .


Each was randomised to receive r-CGM or self-monitoring of blood glucose ( SMBG ) .


Glycaemic control ( HbA1c ) was benchmarked against specialist ambulatory patients referred for insulin initiation .


Ninety-two patients mean age ( range ) 59 ( 28-77 ) years ; 40 % female ; mean ( SD ) diabetes duration 10.5 ( 6.1 ) years participated .


HbA1c decreased from ( median ( IQR ) ) 9.9 ( 8.8 , 11.2 ) % ; 85 ( 73 , 99 ) mmol/mol to 7.3 ( 6.9 , 7.8 ) % ; 56 ( 52 , 62 ) mmol/mol at 24 weeks ( p < 0.0001 ) .


Comparing r-CGM ( n = 46 ) with SMBG ( n = 42 ) , there were no differences in major hypoglycaemia ( p = 0.17 ) or HbA1c ( p = 0.31 ) .


More r-CGM than SMBG participants commenced glulisine ( 26/48 vs. 7/44 ; p < 0.001 ) .


Results were comparable to 82 benchmark patients , with similar low rates of major hypoglycaemia ( 2/89 vs. 0/82 ; p = 0.17 ) and less loss to follow up in the INITIATION group ( 3/92 vs. 14/82 ; p = 0.002 ) .


Insulin initiation and titration for T2DM patients in primary care was safe and improved HbA1c with low rates of major hypoglycaemia .


CDE-RNs were effective in a new consultant role .


r-CGM use in primary care was feasible and enhanced post-prandial hyperglycaemia recognition .


Trial registration ACTRN12610000797077 .


Platelet-rich plasma ( PRP ) is an autologous preparation of platelets in concentrated plasma that may be beneficial in the treatment of atrophic acne scars by promoting collagen deposition .


Skin needling is a technique that uses a sterile dermaroller to puncture the skin and release growth factors .


The combination of skin needling and PRP could enhance the efficacy of both modalities .


Chemical reconstruction of skin scars technique consists of focal application of high concentration of trichloroacetic acid ( TCA ) on the acne scars to stimulate collagen production .


To evaluate the efficacy and safety of intradermal injection of PRP , 100 % focal TCA , and combined skin needling plus topical PRP in the treatment of atrophic acne scars .


Forty-five patients with atrophic acne scars were randomly assigned to 3 equal groups ; Group A received intradermal injection of PRP , Group B received chemical reconstruction of skin scars technique with TCA 100 % , and Group C was treated by combined skin needling and PRP .


Each patient underwent 3 sessions at 2-week interval .


All the patients completed the study .


The 3 groups showed statistically highly significant improvement in the degree of acne scars after treatment ( p < .001 ) .


No major adverse effects were observed in the studied groups .


This is the first study to use intradermal injection of PRP alone for the treatment of atrophic acne scars .


The 3 modalities showed a promising efficacy and safety in the treatment of atrophic acne scars .


While the addition of targeted therapy to neoadjuvant chemotherapy ( NACT ) dramatically increases the rate of pathological complete response in HER2-positive breast cancer , no reduction in the rate of mastectomy has been observed in randomised studies .


A retrospective single centre analysis of all patients treated with anti HER2-based NACT for T2-4 breast cancer , focusing on patients treated with mastectomy .


Among 165 patients treated between June 2005 and July 2012 , surgery was performed immediately post-NACT in 152 cases ( 92 % ) .


Breast-conserving surgery could be performed for 108 of the patients ( 71 % ) , with a 4-year local relapse-free survival of 97 % .


A mastectomy was performed in two cases following patients ' wishes and in 37 cases based on pre-NACT findings ( n = 18 ) or post-NACT outcomes ( n = 19 ) .


For 21 out of the 37 cases , a good pathological response was observed , and multidisciplinary reanalysis suggests that breast-conserving surgery outright may have been sufficient for 12 patients .


Finally , a salvage mastectomy based on post-lumpectomy pathological results was decided in five cases ( 11 % ) .


The 4-year metastasis-free survival was 84 % for all patients operated on after NACT ( n = 152 ) .


Given the good efficacy of anti HER2-based NACT , breast-conserving surgery should be standard practice for most patients .


Total mastectomy on the other hand should be restricted to a few patients , mainly those with positive margins on the lumpectomy specimen .


To investigate the 20-year efficacy and safety of photorefractive keratectomy ( PRK ) .


Long-term observational case series .


In the setting of a university hospital , a study population of 42 patients ( 42 eyes ) who had , as part of a randomized prospective trial , undergone PRK 20 years previously were studied .


All had received -3.0 or -6.0 diopter ( D ) corrections with either 5.0 or 6.0 mm optical zones or a multizone treatment .


The mean preoperative spherical equivalent refractive error ( SEQ ) was -5.13 D ( range , -2.75 to -8.0 D ) .


The outcome measures included visual acuity , refractive error , corneal topography and axial length .


Between 1 and 20 years there was an increase in mean myopic SEQ of -0.54 D ( P < 0.02 ) .


In patients younger than 40 years of age at time of correction , this increase was -0.92 D ( P < 0.002 ) with an accompanying increase in variance ( P < 0.02 ) , whereas in those older than 40 it was -0.08 D ( P = 0.8 ) .


In female patients the change was -0.69 D ( P < 0.01 ) , while in males it was -0.26 D ( P = 0.6 ) .


The efficacy index at 20 years was 0.49 , and the safety index was 0.97 .


Corrected distance visual acuity improved between 1 and 20 years ( P < 0.01 ) ; 93 % of corneas were clear at 20 years ; 3 eyes had trace haze .


There was an improvement in haze scores between 1 and 20 years ( P < 0.02 ) .


Cornea power remained unchanged between 6 months and 20 years ( P = 0.4 ) .


Axial length increased by a mean of 0.84 mm ( P < 0.0001 ) .


There was no ectasia .


There was a slight but significant increase in myopic SEQ after PRK between 1 and 20 years , particularly in those under 40 at the time of treatment and in female patients .


Corneal power remained unchanged , but axial length increased .


The procedure was safe , with no long-term sight-threatening complications and with improvements in corrected distance visual acuity and corneal transparency with time .


We investigated data in 373 patients from the EXPLOR trial to determine the influence of heart rate ( HR ) and blood pressure ( BP ) on aortic stiffness in response to beta-blockade or angiotensin 2 type 1 receptor antagonism , administered during 24 weeks .


Carotid-femoral pulse wave velocity ( PWV ) was measured with aplanation tonometry ( Sphygmocor ) after 8 ( W8 ) and 24 weeks ( W24 ) of treatment by the single-pill combination valsartan-amlodipine ( 80/5 mg , then 160/10 mg ) or an atenolol-amlodipine combination ( 50/5 mg , then 100/10 mg ) in a prospective , randomized , parallel-groups multicenter trial with PROBE design .


Drugs were up-titrated at W8 .


We analyzed the changes in PWV in relation with the changes in BP and HR , and major covariates , using mixed models in each treatment arm .


The unadjusted reductions in mean BP and PWV were not significantly different between groups .


HR was significantly reduced in the atenolol group , but not in the valsartan group .


After adjustment on BP and HR , PWV significantly decreased with valsartan [ -0.37 m/s ( -0.70 to -0.08 ) at W8 and -0.43 ( -0.76 to -0.10 ) m/s at W24 ] , whereas no significant change was observed after atenolol [ -0.16 m/s ( -0.49 to 0.17 ) at W8 and -0.05 ( -0.35 to 0.44 ) m/s at W24 ] .


These findings suggest that the reduction in PWV observed after atenolol could be explained by changes in BP and HR , whereas in patients treated by valsartan , about half of the decrease in aortic stiffness was BP-independent .


To evaluate the efficacy of daily low-dose sildenafil for the treatment of nonulcer interstitial cystitis ( IC ) in women .


Forty-eight women with a clinical diagnosis of IC from 3 medical centers were randomly assigned to treatment with daily low-dose sildenafil ( 25 mg , n = 24 ) or placebo ( n = 24 ) for 3 months .


The O'Leary-Sant IC symptom and problem indices , visual analog scale scores , and a micturition diary with the interval of micturition , the frequency of nocturia , and urgency episodes were recorded before treatment , every 2 weeks after the treatment until 3 months .


Patient Overall Rating of Improvement in Symptoms was assessed and regarded as effective when the value was above 50 % .