Follow-up rate was 100 % up to the 8 h time point in both groups , and 86 % ( 62 of 72 ) in the cinnamon group and 85 % ( 61 of 72 ) in the placebo group at day 10-11 after delivery .


Pain score in the cinnamon group was significantly lower than that in the placebo group at ( 41 ) h ( adjusted difference : -0.6 , 95 % confidence interval : -1.0 to -0.2 ) and ( 81 ) h ( -0.9 , -1.4 to -0.3 ) after intervention , and on the 10-11th day after delivery ( -1.4 , -2.0 to -0.7 ) .


Also the cinnamon group showed significantly more improvement than the control group in healing score at ( 81 ) h ( -0.2 , -0.4 to -0.04 ) and the 10-11th day after delivery ( -1.6 , -2.0 to -1.1 ) .


Cinnamon can be used for reducing perineal pain and improving healing of episiotomy incision .


Research suggests that the food environment influences individual eating practices .


To date , little is known about effective interventions to improve the food environment of restaurants and food stores and promote healthy eating in rural communities .


We tested `` Waupaca Eating Smart '' ( WES ) , a pilot intervention to improve the food environment and promote healthy eating in restaurants and supermarkets of a rural community .


WES focused on labeling , promoting , and increasing the availability of healthy foods .


We conducted a randomized community trial , with two Midwestern U.S. communities randomly assigned to serve as intervention or control site .


We collected process and outcome data using baseline and posttest owner and customer surveys and direct observation methods .


The RE-AIM framework was used to guide the evaluation and organize the results .


Seven of nine restaurants and two of three food stores invited to participate in WES adopted the intervention .


On a 0-4 scale , the average level of satisfaction with WES was 3.14 ( SD = 0.69 ) for restaurant managers and 3 ( SD = 0.0 ) for store managers .


On average , 6.3 ( SD = 1.1 ) out of 10 possible intervention activities were implemented in restaurants and 9.0 ( SD = 0.0 ) out of 12 possible activities were implemented in food stores .


One month after the end of the pilot implementation period , 5.4 ( SD = 1.6 ) and 7.5 ( SD = 0.7 ) activities were still in place at restaurants and food stores , respectively .


The intervention reached 60 % of customers in participating food outlets .


Restaurant food environment scores improved from 13.4 to 24.1 ( p < 0.01 ) in the intervention community and did not change significantly in the control community .


Food environment scores decreased slightly in both communities .


No or minimal changes in customer behaviors were observed after a 10-month implementation period .


The intervention achieved high levels of reach , adoption , implementation , and maintenance , suggesting the feasibility and acceptability of restaurant-and food store-based interventions in rural communities .


Pilot outcome data indicated very modest levels of effectiveness , but additional research adequately powered to test the impact of this intervention on food environment scores and customer behaviors needs to be conducted in order to identify its potential to promote healthy eating in rural community settings .


Shortening the pulse width to 0.3 millisecond holds neurophysiological and clinical promise of making electroconvulsive therapy ( ECT ) safer by reducing cognitive adverse effects .


The exclusive effects of pulse width on autobiographical and subjective memory are largely unstudied .


The aim was to principally investigate during the acute ECT course and at 3 months after ECT autobiographical and subjective memory effects of 0.3-millisecond ultrabrief and 1-millisecond brief-pulse ECT .


Patient with severe depression were randomized to 1-millisecond brief-pulse ( n = 20 ) or 0.3-millisecond ultrabrief-pulse ( n = 20 ) right unilateral ECT , both at 6 times the threshold stimulus dose given thrice weekly .


Autobiographical Memory Interview ( Kopelman ) and Squire Subjective Memory Questionnaire were administered at baseline , after 8 sessions , end of the acute course , and 3 months later .


Early adult semantic memory worsened significantly over time with brief-pulse compared with ultrabrief ECT : F3 ,88 = 2.60 , P = 0.05 .


There was a significant decline in brief-pulse treatment vis -- vis a significant improvement with ultrabrief-pulse treatment with childhood semantic memory ( P = 0.022 ) , early adult semantic ( P = 0.03 ) , and recent semantic memory ( P = 0.018 ) only at 24 hours after the eighth ECT treatment .


Clinically meaningful and significant improvement in semantic autobiographical memory occurred in ultrabrief treatment vis -- vis brief-pulse ECT after 8 treatments .


Ultrabrief treatment offered a small but significant advantage over 1-millisecond brief-pulse high-dose right unilateral ECT with early adult semantic autobiographical memory , which persisted up to 3 months .


Although femoral nerve block provides good analgesia after total knee arthroplasty ( TKA ) , residual posterior knee pain may decrease patient satisfaction .


We compared the efficacy of periarticular infiltration analgesia ( PIA ) and sciatic nerve block ( SNB ) for posterior knee pain .


Forty-nine patients scheduled for TKA were prospectively randomized into the PIA group ( n = 25 ) or SNB group ( n = 24 ) and received general anesthesia with ultrasound-guided femoral nerve block ( FNB ) .


In the PIA group , 60 ml 0.5 % ropivacaine and 0.3 mg epinephrine were injected intraoperatively into the periarticular soft tissue before inserting the components .


In the SNB group , patients received ultrasound-guided SNB with 20 ml 0.375 % ropivacaine and periarticular infiltration with 20 ml normal saline and 0.3 mg epinephrine .


We evaluated postoperative pain scores , posterior knee pain , frequency of rescue analgesics for 36 h , and performance time of PIA and SNB .


Visual analogue pain scores at 12-24 h were significantly lower in the PIA group than in the SNB group ( p < 0.05 ) .


The majority of patients had no posterior knee pain .


There were no significant differences between the groups in frequency and time of first administration of rescue analgesics and in side effects .


Time for performance of periarticular infiltration was significantly shorter than that for SNB ( p < 0.05 ) .


The dose of intraoperative remifentanil was significantly lower in the SNB group than in the PIA group ( p < 0.001 ) .


The combination of FNB and PIA provides sufficient analgesia after TKA .


The rapid and convenient periarticular infiltration technique could be a good alternative to SNB .


In Canada , cesarean delivery rates have increased substantially over the past decade .


Effective , safe strategies are needed to reduce these rates .


We conducted a cluster-randomized , controlled trial of a multifaceted 1.5-year intervention at 32 hospitals in Quebec .


The intervention involved audits of indications for cesarean delivery , provision of feedback to health professionals , and implementation of best practices .


The primary outcome was the cesarean delivery rate in the 1-year postintervention period .


Among the 184,952 participants , 53,086 women delivered in the year before the intervention and 52,265 women delivered in the year following the intervention .


There was a significant but small reduction in the rate of cesarean delivery from the preintervention period to the postintervention period in the intervention group as compared with the control group ( change , 22.5 % to 21.8 % in the intervention group and 23.2 % to 23.5 % in the control group ; odds ratio for incremental change over time , adjusted for hospital and patient characteristics , 0.90 ; 95 % confidence interval [ CI ] , 0.80 to 0.99 ; P = 0.04 ; adjusted risk difference , -1.8 % ; 95 % CI , -3.8 to -0.2 ) .


The cesarean delivery rate was significantly reduced among women with low-risk pregnancies ( adjusted risk difference , -1.7 % ; 95 % CI , -3.0 to -0.3 ; P = 0.03 ) but not among those with high-risk pregnancies ( P = 0.35 ; P = 0.03 for interaction ) .


The intervention group also had a reduction in major neonatal morbidity as compared with the control group ( adjusted risk difference , -0.7 % ; 95 % CI , -1.3 to -0.1 ; P = 0.03 ) and a smaller increase in minor neonatal morbidity ( adjusted risk difference , -1.7 % ; 95 % CI , -2.6 to -0.9 ; P < 0.001 ) .


Changes in minor and major maternal morbidity did not differ significantly between the groups .


Audits of indications for cesarean delivery , feedback for health professionals , and implementation of best practices , as compared with usual care , resulted in a significant but small reduction in the rate of cesarean delivery , without adverse effects on maternal or neonatal outcomes .


The benefit was driven by the effect of the intervention in low-risk pregnancies .


( Funded by the Canadian Institutes of Health Research ; QUARISMA Current Controlled Trials number , ISRCTN95086407 . )


To determine the effect of elastic taping on patients with patellofemoral pain and its impact on the onset time of vastusmedialis and vastuslateralis .


Eligible patients were assigned into the treatment and control groups randomly .


Patients in the treatment group received a 5-day taping with therapeutic stretch .


Patients in the control group were give placebo taping without therapeutic stretch .


Ultrasound therapy was applied to all of the participants as a basic treatment .


The levels of pain and surface electromyography were evaluated before treatment , after the first taping and on the Gh day ( without taping ) .


Patients in the treatment group experienced immediate improvement in pain and onset time of vastusmedialis and vastuslateralis compared with the controls .


On the 6th day ( without taping ) , further improvement was achieved in pain and onset time of vastusmedialis and vastuslateralis in the treatment group compared with the controls ( P < 0.05 ) .


Elastic taping can effectively improve pain and onset time of vastusmedialis and vastuslateralis .


Heparin is often prescribed during pregnancy with the intention of improving perinatal outcomes on the basis that it exerts an anticoagulant action in the inter-villous space .


Accumulating in-vitro and in-vivo evidence indicates that heparin 's beneficial effects in pregnancy may result from ` non-anticoagulant ' effects including the promotion of angiogenesis .


To study the effect of heparin within the placenta , we performed secondary analyses on a pilot trial where 32 women with negative thrombophilia screens and second-trimester evidence of placental insufficiency were randomized to standard care or antenatal self-administration of unfractionated heparin ( UFH ) 7500 IU twice-daily .


Serial placental ultrasound images were reviewed and compared with histo-pathologic findings following delivery .


There were no differences between the two arms in either the evolution of abnormal placental lesions on ultrasound ( p = 0.75 ) or evidence of maternal vascular under-perfusion on histopathology ( p = 0.89 ) .


In pregnancies considered at increased risk for adverse pregnancy outcomes based on previous history or abnormal serum marker screen , early ( second-trimester ) placental ultrasound , reflecting developmental pathology had better test characteristics ( sensitivity 77.8 % ; positive predictive value 80.8 % ) for predicting adverse pregnancy outcomes than third-trimester ultrasound that is reflective of placental thrombotic injury .


Administration of UFH did not prevent the development or evolution of abnormal placental lesions on placental ultrasound or evidence of maternal vascular underperfusion on placental histo-pathology .


Second-trimester placental ultrasound may be of value in predicting those at greatest risk of adverse outcomes .


Benefits of plant sterols ( PS ) for cholesterol lowering are compromised by large variability in efficacy across individuals .


High fractional cholesterol synthesis measured by deuterium incorporation has been associated with nonresponse to PS consumption ; however , prospective studies that show this association have yet to be conducted .


The goal was to test whether the lathosterol-to-cholesterol ratio ( L : C ratio ) , a surrogate marker of endogenous cholesterol synthesis , serves as an a priori predictor of cholesterol lowering in response to PS consumption .


Sixty-three mildly hypercholesterolemic adults who were preselected as possessing either high endogenous cholesterol synthesis [ HS ; n = 24 ; L : C = 2.03 0.39 mol/mmol ( mean SD ) ] or low endogenous cholesterol synthesis ( LS ; n = 39 ; L : C = 0.99 0.28 mol/mmol ) on the basis of baseline L : C consumed 2 g PS/d or a placebo for 28 d with the use of a dual-center , single-blind , randomized crossover design .


Plasma lipid and noncholesterol sterol concentrations were measured at the end of each phase .


PS consumption lowered total cholesterol ( TC ; -0.25 0.05 mmol/L ; P < 0.0001 ) and LDL cholesterol ( -0.17 0.04 mmol/L ; P < 0.0001 ) overall .


Specifically , LS individuals responded to PS treatment with a reduction in TC ( -0.40 0.07 mmol/L ; P < 0.0001 ) and LDL cholesterol ( -0.29 0.05 mmol/L ; P = 0.0002 ) , whereas HS individuals failed to show cholesterol lowering ( TC : -0.09 0.09 mmol/L ; P = 0.2843 ; LDL cholesterol : -0.05 0.07 mmol/L ; P = 0.4917 ) .


The odds of LS participants responding to PS consumption with cholesterol lowering better than the mean cholesterol lowering in all participants were 4.25 ( 95 % CI : 1.242 , 14.556 ; P = 0.0211 ) for TC and 3.36 ( 95 % CI : 1.112 , 10.161 ; P = 0.0317 ) for LDL cholesterol , which was higher than for HS participants .


The L : C ratio predicts the extent of reduction in circulating TC and LDL cholesterol in response to PS consumption .


Cholesterol synthesis assessment may thus have a use in identifying responders and nonresponders to PS therapy .


Immunization quality improvement programs are often limited by the cost and inconvenience associated with delivering face-to-face consultations to primary care providers .


To investigate a more efficient mode of intervention delivery , we conducted a process evaluation that compared in-person consultations to those delivered via interactive webinar .


The Centers for Disease Control and Prevention 's Assessment , Feedback , Incentives , and eXchange ( AFIX ) Program is an immunization quality improvement program implemented in all 50 states .


In 2011 , we randomly assigned 61 high-volume primary care clinics in North Carolina to receive an in-person or webinar AFIX consultation focused on adolescent immunization .


We used surveys of participating vaccine providers and expense tracking logs to evaluate delivery modes on participation , satisfaction , and cost .


Clinics served 71,874 patients , ages 11 to 18 .


Clinics that received in-person and webinar consultations reported similar levels of participation on key programmatic activities with one exception : more webinar clinics reported improving documentation of previously administered , ` historical ' vaccine doses .


Both in-person and webinar clinics showed sustained improvement in confidence to use reminder/recall systems ( both p < 0.05 ) .


Participants rated delivery modes equally highly on satisfaction measures such as convenience ( mean = 4.6 of 5.0 ) .


Delivery cost per clinic was $ 152 for in-person consultations versus $ 100 for webinar consultations .


In-person and webinar delivery modes were both well received , but webinar AFIX consultations cost substantially less .


Interactive webinar delivery shows promise for considerably extending the reach of immunization quality improvement programs .


Clinicaltrials.gov , NCT01544764 .


Recent evidence has indicated that flavanol consumption may have many health benefits in humans , including improved cognitive activities .


The aim was to evaluate the effect of flavanol consumption on cognitive performance in cognitively intact elderly subjects .


This was a double-blind , controlled , parallel-arm study conducted in 90 elderly individuals without clinical evidence of cognitive dysfunction who were randomly assigned to consume daily for 8 wk a drink containing 993 mg [ high flavanol ( HF ) ] , 520 mg [ intermediate flavanol ( IF ) ] , or 48 mg [ low flavanol ( LF ) ] cocoa flavanols ( CFs ) .


Cognitive function was assessed at baseline and after 8 wk by using the Mini-Mental State Examination ( MMSE ) , the Trail Making Test ( TMT ) A and B , and the Verbal Fluency Test ( VFT ) .


The changes in MMSE score in response to the 3 different treatments were not different .


In contrast , there was a positive impact of the intervention on specific aspects of cognitive function .


Mean changes ( SEs ) in the time required to complete the TMT A and B after consumption of the HF ( -8.6 0.4 and -16.5 0.8 s , respectively ) and IF ( -6.7 0.5 and -14.2 0.5 s , respectively ) drinks significantly ( P < 0.0001 ) differed from that after consumption of the LF drinks ( -0.8 1.6 and -1.1 0.7 s , respectively ) .


Similarly , VFT scores significantly improved among all treatment groups , but the magnitude of improvement in the VFT score was significantly ( P < 0.0001 ) greater in the HF group ( 7.7 1.1 words/60 s ) than in the IF ( 3.6 1.2 words/60 s ) and LF ( 1.3 0.5 words/60 s ) groups .


Significantly different improvements in insulin resistance ( P < 0.0001 ) , blood pressure ( P < 0.0001 ) , and lipid peroxidation ( P = 0.001 ) were also observed for the HF and IF groups in comparison with the LF group .


Changes in insulin resistance explained 17 % of changes in composite z score ( partial r = 0.1703 , P < 0.0001 ) .


This dietary intervention study provides evidence that regular CF consumption can reduce some measures of age-related cognitive dysfunction , possibly through an improvement in insulin sensitivity .


These data suggest that the habitual intake of flavanols can support healthy cognitive function with age .


Authors have reported better outcomes , by reducing surgical dissection for carpal tunnel syndromes requiring surgery .


Recently , a new sonographically guided technique for ultra minimally invasive ( Ultra-MIS ) carpal tunnel release ( CTR ) through 1mm incision has been described .


We hypothesized that a clinical trial for comparing Ultra-MIS versus Mini-open Carpal Tunnel Release ( Mini-OCTR ) was feasible .


To test our hypothesis , we conducted a pilot study for studying Ultra-MIS versus Mini-OCTR respectively performed through a 1mm or a 2 cm incision .


We defined success if primary feasibility objectives ( safety and efficacy ) as well as secondary feasibility objectives ( recruitment rates , compliance , completion , treatment blinding , personnel resources and sample size calculation for the clinical trial ) could be matched .


Score for Quick-DASH questionnaire at final follow-up was studied as the primary variable for the clinical trial .


Turnover times were studied for assessing learning curve stability .


Forty patients were allotted .


Primary and secondary feasibility objectives were matched with the following occurrences : 70.2 % of eligible patients finally recruited ; 4.2 % of randomization refusals ; 26.6 patients/month recruited ; 100 % patients receiving a blinded treatment ; 97.5 % compliance and 100 % completion .


A sample size of 91 patients was calculated for clinical trial validation .


At final follow-up , preliminary results for Quick-Dash substantially favored Ultra-MIS over Mini-OCTR ( average 14.54 versus 7.39 ) and complication rates were lower for Ultra-MIS ( 5 % versus 20 % ) .


A stable learning curve was observed for both groups .


The clinical trial is feasible .


There is currently no evidence to contraindicate nor withhold the use of Ultra-MIS for CTR .


III .


To investigate the effectiveness of polycystic ovary syndrome ( PCOS ) of damp-phlegm constitution treated with embedding therapy on back-shu points and front-mu points and needle-pricking therapy on Sifeng ( EX-UE 10 ) .


Eighty-five patients were randomly divided into 2 groups of observation group ( 42 cases ) and control group ( 43 cases ) .


Embedding therapy on back-shu points and front-mu points and needle-pricking therapy on Sifeng ( EX-UE 10 ) were applied to the observation group .


Points such as Zhongwan ( CV 12 ) , Guanyuan ( CV 4 ) , Tianshu ( ST 25 ) , Zhangmen ( LR 13 ) , Jingmen ( GB 25 ) , Qimen ( LR 14 ) , Ganshu ( BL 18 ) , Weishu ( BL 21 ) , Pishu ( BL 20 ) , Shenshu ( BL 23 ) , Dachangshu ( BL 25 ) and Xiaochangshu ( BL 27 ) , etc. were adopted for embedding therapy .


At the same time , needle-pricking therapy on Sifeng ( EX-UE 10 ) was also applied once a week .


0.5 g metformin hydrochloride tablet was given to the control group , once a day for the first week , and twice a day from the second week .


Estimation on therapeutic effect was made for both groups after 3 months treatment .


Change of symptoms and signs scores , fasting insulin ( FINS ) , 2 hour insulin after meal ( 2hINS ) and insulin resistance index ( HOMA-IR ) of both groups before and after treatment were observed , and therapeutic effect estimated .


The total effective rate of the observation group is 97.6 % ( 41/42 ) , and that of the control group was 95.4 % ( 41/43 ) .


There was no significant difference between the two groups ( P > 0.05 ) .


Scores of symptoms and signs after treatment were significantly improved in both groups ( all P < 0.01 ) , and the observation group was better than the control group ( 7.01 + / -4.23 vs 8.47 + / -2.82 , P < 0.05 ) .


Compare with those before the treatment , FINS , 2hINS and HOMA-IR after the treatment were all decreased in both groups ( all P < 0.05 ) .


The comparison between the two groups showed that differences of FIN had no statistic significance ( P > 0.05 ) after the treatment , while both differences of 2hINS and HOMA-IR had statistic significance [ 2hlNS : ( 443.531 + / - 93.90 ) pmol/L vs ( 621.29 + / -93.87 ) pmol/L ; HOMA-IR : 4.88 + / -0.30 vs 5.06 + / -0.32 , both P < 0.05 ] .


The improvement of 2hINS and HOMA-IR in the observation group was better than that of the control group .


Treatment of PCOS of damp-phlegm constitution with embedding therapy on back-shu points and front-mu points and needle-pricking therapy on Sifeng ( EX-UE 10 ) have positive effect , which can effectively reduce the insulin resistance , meanwhile , reduce the side-effects of western medication .


To examine the use of handheld methodology to assess mechanical nociceptive threshold ( MNT ) on cows kept loose-housed .


Prospective randomized partial cross-over experimental study .


A one-factor ( test day ) design was used to evaluate MNT over time .


One hundred and fifteen healthy , loose-housed Danish Holstein cattle .


We evaluated intra-individual variation , inter-observer agreement and variation over time of MNT using two handheld devices and two stimulation sites .


Mechanical , ramped stimulations were performed with an algometer ( 6.5 mm diameter steel probe , 0-10 .0 kgf ) or an electronic von Frey device ( plastic tip with diameter 0.8 mm , 0-1000 gf ) .


Each cow received 5-6 consecutive stimulations within a 2 5 cm skin area on the dorsal or lateral aspect of the left third metatarsus until an avoidance reaction occurred .


We investigated the difference in precision [ expressed as coefficient of variation ( CV ) ] between the combinations of devices and stimulation sites .


The inter-observer agreement and the difference in MNT between test day 1 , 3 , 7 , 10 and 24 were investigated for selected combinations .


Data were analysed in mixed models and Bland-Altman as relevant .


The CVs did not differ [ range 0.34-0 .52 ( p = 0.1 ) ] .


Difference between observers ( 95 % limits ) was 0.2 kgf ( 2.8 ) and 4 gf ( 369 ) for the algometer and von Frey device , respectively .


Mechanical nociceptive threshold increased from 361 on test day one to 495 gf on test day 24 ( p < 0.01 ) .


All methods showed a high degree of intra-individual variation , and no combination of device and stimulation site showed superior precision .


Mean difference between observers was low , and MNT was not consistent over time .


Further development of the methods is required before they can be used in research to investigate possible relations between claw lesions and hyperalgesia .


We evaluated the effectiveness and cost-effectiveness of alternative interventions designed to promote mammography in safety-net settings .


A three-arm , quasi-experimental evaluation was conducted among eight federally qualified health clinics in predominately rural Louisiana .


Mammography screening efforts included : 1 ) enhanced care , 2 ) health literacy-informed education of patients , and 3 ) education plus nurse support .


Outcomes included mammography screening completion within 6 months and incremental cost-effectiveness .


Overall , 1,181 female patients ages 40 and over who were eligible for routine mammography were recruited .


Baseline screening rates were < 10 % .


Post intervention screening rates were 55.7 % with enhanced care , 51.8 % with health literacy-informed education and 65.8 % with education and nurse support .


After adjusting for race , marital status , self-efficacy and literacy , patients receiving health-literacy informed education were not more likely to complete mammographic screening than those receiving enhanced care ; those additionally receiving nurse support were 1.37-fold more likely to complete mammographic screening than those receiving the brief education ( 95 % Confidence Interval 1.08-1 .74 , p = 0.01 ) .


The incremental cost per additional women screened was $ 2,457 for literacy-informed education with nurse support over literacy-informed education alone .


Mammography rates were increased substantially over existing baseline rates in all three arms with the educational initiative , with nurse support and follow-up being the most effective option .


However , it is not likely to be cost-effective or affordable in resource-limited clinics .


Ingrown toenail ( IGTN ) is a common problem that can affect walking and can preclude daily activities .


To compare the safety and efficacy of lateral nail avulsion with phenolization ( LNAP ) versus sleeve ( nail tube splinting ) surgical techniques in the treatment of IGTN .


Patients older than 15 years with IGTN were included .


Patients were evaluated for the duration and severity of pain , drainage , complete healing periods , recurrence rate , and overall success rate .


Assessment was performed at baseline and at 1 , 3 , and 6 months .


Complications were noted .


A total of 53 patients , including 46 males ( 87.8 % ) , were treated .


The mean age was 27.7 1.3 years .


Thirty patients underwent LNAP , and 23 underwent sleeve methods .


The surgical success rate , defined as > 90 % improvement , was found to be 80 % to 82 % for both groups .


Recurrence was observed in only 1 patient of each group .


None of the observed differences in healing , discharge , and recovery were statistically significant except in reporting shoe-wear discomfort , which was shorter in the sleeve group ( p < .05 ) .


Postoperative pain experience was also noted to be less in the sleeve group ( p = .057 ) .


Both methods , LNAP and sleeve , seem to be equally effective for the treatment of IGTNs .


Postoperative shoe-wearing discomfort and pain are shorter when the sleeve method was used .


Cilengitide is a selective v3 and v5 integrin inhibitor .


Data from phase 2 trials suggest that it has antitumour activity as a single agent in recurrent glioblastoma and in combination with standard temozolomide chemoradiotherapy in newly diagnosed glioblastoma ( particularly in tumours with methylated MGMT promoter ) .


We aimed to assess cilengitide combined with temozolomide chemoradiotherapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter .


In this multicentre , open-label , phase 3 study , we investigated the efficacy of cilengitide in patients from 146 study sites in 25 countries .


Eligible patients ( newly diagnosed , histologically proven supratentorial glioblastoma , methylated MGMT promoter , and age 18 years ) were stratified for prognostic Radiation Therapy Oncology Group recursive partitioning analysis class and geographic region and centrally randomised in a 1:1 ratio with interactive voice response system to receive temozolomide chemoradiotherapy with cilengitide 2000 mg intravenously twice weekly ( cilengitide group ) or temozolomide chemoradiotherapy alone ( control group ) .


Patients and investigators were unmasked to treatment allocation .


Maintenance temozolomide was given for up to six cycles , and cilengitide was given for up to 18 months or until disease progression or unacceptable toxic effects .


The primary endpoint was overall survival .


We analysed survival outcomes by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT00689221 .


Overall , 3471 patients were screened .


Of these patients , 3060 had tumour MGMT status tested ; 926 patients had a methylated MGMT promoter , and 545 were randomly assigned to the cilengitide ( n = 272 ) or control groups ( n = 273 ) between Oct 31 , 2008 , and May 12 , 2011 .


Median overall survival was 263 months ( 95 % CI 238-288 ) in the cilengitide group and 263 months ( 239-347 ) in the control group ( hazard ratio 102 , 95 % CI 081-129 , p = 086 ) .


None of the predefined clinical subgroups showed a benefit from cilengitide .


We noted no overall additional toxic effects with cilengitide treatment .


The most commonly reported adverse events of grade 3 or worse in the safety population were lymphopenia ( 31 [ 12 % ] in the cilengitide group vs 26 [ 10 % ] in the control group ) , thrombocytopenia ( 28 [ 11 % ] vs 46 [ 18 % ] ) , neutropenia ( 19 [ 7 % ] vs 24 [ 9 % ] ) , leucopenia ( 18 [ 7 % ] vs 20 [ 8 % ] ) , and convulsion ( 14 [ 5 % ] vs 15 [ 6 % ] ) .


The addition of cilengitide to temozolomide chemoradiotherapy did not improve outcomes ; cilengitide will not be further developed as an anticancer drug .


Nevertheless , integrins remain a potential treatment target for glioblastoma .


Merck KGaA , Darmstadt , Germany .


The Cappella Sideguard ( CS ) sidebranch stent is a self-expanding , thin-strut , nitinol device with anatomic flaring at the sidebranch ostium designed to treat bifurcation lesions .


To evaluate the mechanism of long-term lumen patency of the novel , self-expanding CS sidebranch stent compared with a balloon-expandable stent in the main vessel .


We performed intravascular ultrasound postintervention and at follow-up in 24 CS stents and in 28 balloon-expandable drug-eluting stents deployed in the corresponding main vessel .


Thirteen patients also had optical coherence tomography ( OCT ) at follow-up to evaluate neointimal hyperplasia and strut coverage .


CS stent area at the sidebranch carina increased significantly from 3.8 1.2 mm ( 2 ) postintervention to 4.6 1.2 mm ( 2 ) at follow-up ( P < 0.001 ) , resulting in no change in lumen area ( 3.8 1.2 mm ( 2 ) to 3.7 1.2 mm ( 2 ) , P = 0.72 ) despite a neointimal area at follow-up of 0.9 0.8 mm ( 2 ) .


Volumetric changes were similar , and the distribution of neointimal hyperplasia peaked 1-2 mm distal to the carina .


Change of lumen volume inversely correlated to the neointimal volume ( R = -0.48 , P < 0.001 ) , but correlated positively to the change in stent volume ( R = 0.52 , P < 0.0001 ) .


By OCT , most CS struts were covered ( 100 % [ 98.9 , 100 ] ) at the bifurcation site , whereas 61 % of floating DES struts that crossed the sidebranch were covered by smooth tissue with a similar texture compared with neointima .


Although neointimal hyperplasia accumulates within the CS stent mainly 1-2 mm distal to the carina , the self-expanding CS stent may be effective in maintaining an adequate patency in the sidebranch by continued stent expansion noted at follow-up .


To examine upper limb physical function and adverse effects after axillary lymph node dissection ( ALND ) and sentinel lymph node biopsy ( SLNB ) in patients with breast cancer to identify impairments that can inform rehabilitation strategies .


Prospective longitudinal cohort .


Upper limb measurements were studied preoperatively and 2.5 years after breast cancer treatment .


Hospital setting .


Two groups of patients with early-stage primary breast cancer ( N = 391 ) : the ALND surgery group ( mean age , 5510y ) and the SLNB group ( mean age , 5710y ) .


Not applicable .


Arm lymphedema ( 10 % increased arm volume relative to control arm volume ) , grip strength ( in kilograms ) , shoulder mobility , pain intensity during isometric shoulder abduction ( on a 100-mm visual analog scale ) , and body mass index ( kg/m ( 2 ) ) .


Parametric/nonparametric tests were used for hypothesized changes and differences , and regression analysis was used for confounding factors .


We observed more adverse effects in women treated with ALND than with SLNB after 2.5 years ( P < .05 ) : arm lymphedema ( 17 % vs 3 % ) , grip strength reduction ( 12 % vs 2 % ) , and shoulder abduction-provoked pain ( increase of 6 % vs decrease of 50 % ) .


The adverse effects were similar for affected and control upper limbs for all outcomes except arm lymphedema , which occurred only on the affected side .


Adverse effects in both affected and control/unaffected upper limb were observed after 2.5-year follow-up in both ALND and SLNB groups , but a higher prevalence was observed in the ALND group .


Thus , women going through ALND surgery may benefit from further postoperative physical therapy , including resistance and strength exercise , focusing on pain management .


The aim of this study was to investigate whether directional steering through a novel 32-contact electrode is safe and can modulate the thresholds for beneficial and side effects of stimulation .


The study is a single-center , performance and safety study .


Double-blind intraoperative evaluations of the thresholds for therapeutic benefit and for side effects were performed in 8 patients with Parkinson disease while stimulating in randomized order in spherical mode and in 4 different steering modes with the 32-contact electrode , and in monopolar mode with a commercial electrode .


In addition , simultaneous recordings of local field potentials through all 32 contacts were performed .


There were no adverse events related to the experimental device .


For 13 of 15 side effects ( 87 % ) , the threshold could be increased by 1 mA while steering in at least one direction in comparison to conventional spherical stimulation , thereby increasing the therapeutic window by up to 1.5 mA .


Recording local field potentials through all 32 electrode contacts yielded spatiotemporal information on pathologic neuronal activity .


Controlled steering of current through the brain may improve the effectiveness of deep brain stimulation ( DBS ) , allow for novel applications , and provide a tool to better explore pathophysiologic activity in the brain .


This study provides Class IV evidence that for patients with Parkinson disease , steering DBS current is well tolerated , increases the threshold for side effects , and may improve the therapeutic window of subthalamic nucleus DBS as compared with current standard spherical stimulation .


To explore the efficacy and safety of vitamin D ( VD ) in the treatment of idiopathic oligoasthenozoospermia .


This study included 86 infertile men with idiopathic oligoasthenozoospermia , who were randomized to a VD and a control group of equal number , the former given oral VD 200 IU/d and calcium 600 mg/d , qd , while the latter administered oral vitamin E 100 mg and vitamin C 100 mg , tid .


After 3 months of medication , we compared the semen parameters , adverse reactions , and pregnancy rate between the two groups .


After medication , the count of progressively motile sperm per ejaculate was increased from ( 9.82 3.72 ) x 10 ( 6 ) to ( 21.47 6.52 ) x 10 ( 6 ) ( P < 0.05 ) and the proportion of progressively motile sperm from ( 18.41 9.82 ) % to ( 28.27 4.47 ) % ( P < 0.05 ) in the VD group .


In comparison , the count of progressively motile sperm per ejaculate was elevated from ( 9.51 6.31 ) x 10 ( 6 ) to ( 12.36 4.43 ) x 10 ( 6 ) ( P > 0.05 ) and the proportion of progressively motile sperm from ( 17.79 5.25 ) % to ( 21.35 2.41 ) % ( P > 0.05 ) in the control group .


Pregnancy was achieved in 7 cases ( 16.3 % ) in the VD group , but only lease ( 2.3 % ) in the control ( P < 0.05 ) .


No adverse reactions were observed in either of the groups .


Vitamin D , as a safe option for the treatment of idiopathic oligoasthenozoospermia , can effectively improve the semen quality , especially the progressive sperm motility of the patient .


To evaluate the cost-effectiveness of medical yoga as an early intervention compared with evidence-based exercise therapy and self-care advice for non-specific low back pain .


Randomized controlled trial with a cost-effectiveness analysis .


A total of 159 participants randomized into the medical yoga group ( n = 52 ) , the exercise therapy group ( n = 52 ) and the self-care advice group ( n = 55 ) .


The health outcome measure EQ-5D was applied to measure quality of life data combined with cost data collected from treatment groups from baseline to 12 months follow-up .


Outcome measure was health-related quality of life ( HRQL ) .


Incremental cost per quality adjusted life year ( QALY ) was also calculated .


Cost-effectiveness analysis was conducted primarily from the societal and employer perspectives .


Medical yoga is cost-effective compared with self-care advice if an employer considers the significant improvement in the HRQL of an employee with low back pain justifies the additional cost of treatment ( i.e. in this study EUR 150 ) .


From a societal perspective , medical yoga is a cost-effective treatment compared with exercise therapy and self-care advice if an additional QALY is worth EUR 11,500 .


Sensitivity analysis suggests that medical yoga is more cost-effective than its alternatives .


Six weeks of uninterrupted medical yoga thera-py is a cost-effective early intervention for non-specific low back pain , when treatment recommendations are adhered to .


Dyslipidaemia remains a significant risk factor for cardiovascular disease and additional lipid-modifying treatments are warranted to further decrease the cardiovascular disease burden .


We assessed the safety , tolerability and efficacy of a novel cholesterol esterase transfer protein ( CETP ) inhibitor TA-8995 in patients with mild dyslipidaemia .


In this randomised , double-blind , placebo-controlled , parallel-group phase 2 trial , we recruited patients ( aged 18-75 years ) from 17 sites ( hospitals and independent clinical research organisations ) in the Netherlands and Denmark with fasting LDL cholesterol levels between 25 mmol/L and 45 mmol/L , HDL cholesterol levels between 08 and 18 mmol/L and triglyceride levels below 45 mmol/L after washout of lipid-lowering treatments .


Patients were randomly allocated ( 1:1 ) by a computer-generated randomisation schedule to receive one of the following nine treatments : a once a day dose of 1 mg , 25 mg , 5 mg , or 10 mg TA-8995 or matching placebo ; 10 mg TA-8995 plus 20 mg atorvastatin ; 10 mg TA-8995 plus 10 mg rosuvastatin or 20 mg atorvastatin or 10 mg rosuvastatin alone .


We overencapsulated statins to achieve masking .


The primary outcome was percentage change in LDL cholesterol and HDL cholesterol from baseline at week 12 , analysed by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT01970215 .


Between Aug 15 , 2013 , and Jan 10 , 2014 , 364 patients were enrolled .


At week 12 , LDL cholesterol levels were reduced by 274 % in patients assigned to the 1 mg dose , 327 % in patients given the 25 mg dose , 453 % in those given the 5 mg dose , and 453 % in those given the 10 mg dose ( p < 00001 ) .


LDL cholesterol levels were reduced by 682 % in patients given 10 mg TA-8995 plus atorvastatin , and by 633 % in patients given rosuvastatin plus 10 mg TA-8995 ( p < 00001 ) .


A daily dose of 1 mg TA-8995 increased HDL cholesterol levels by 758 % , 25 mg by 1243 % , 5 mg by 1571 % , and 10 mg dose by 1790 % ( p < 00001 ) .


In patients receiving 10 mg TA-8995 and 20 mg atorvastatin HDL cholesterol levels increased by 1521 % and in patients receiving 10 mg TA-8995 and 10 mg rosuvastatin by 1575 % .


We recorded no serious adverse events or signs of liver or muscle toxic effects .


TA-8995 , a novel CETP inhibitor , is well tolerated and has beneficial effects on lipids and apolipoproteins in patients with mild dyslipidaemia .


A cardiovascular disease outcome trial is needed to translate these effects into a reduction of cardiovascular disease events .


Dezima .


Addition of viscous fiber to foods has been shown to significantly reduce postprandial glucose excursions .


However , palatability issues and the variability in effectiveness due to different methods of administration in food limits it use .


This study explores the effectiveness of a viscous fiber blend ( VFB ) in lowering postprandial glycemia using different methods of incorporation .


Two acute , randomized , controlled studies were undertaken : Study 1 : Twelve healthy individuals ( mean SD , age : 36 13years , body mass index [ BMI ] : 27 4kg/m ( 2 ) ) consumed 8 different breakfasts .


All meals consisted of 50g of available carbohydrate from white bread ( WB ) and 10g margarine .


Zero , 1 , 2 , or 4g of the VFB was baked into WB or mixed with the margarine .


Study 2 : Thirteen healthy individuals ( mean SD , age : 39 17years , BMI : 25 5kg/m ( 2 ) ) consumed 6 test meals , consisting of 50g of available carbohydrate from WB .


Six capsules containing either cornstarch or VFB were taken at 4 different time points during the glucose tolerance test .


After obtaining a fasting finger-prick blood sample , volunteers consumed the test meal over a 10-minute period .


Additional blood samples were taken at 15 , 30 , 45 , 60 , 90 , and 120 minutes from the start of the meal .


For study 2 , an additional fasting sample was obtained at -30 minutes .


Study 1 : Irrespective of VFB dose , glucose levels were lower at 30 and 45 minutes when VFB was mixed into the margarine compared to the control ( p < 0.05 ) .


Incremental areas under the curve were significantly lower compared to control when 4g of VFB was mixed into the margarine .


Study 2 : There was no effect of the VFB on postprandial glucose levels when administered in capsules .


Incorporation of VFB into margarine was more effective in lowering postprandial glycemia than when the VFB was baked into bread and no effect when given in capsules .


Non-surgical therapies are needed to reduce the rate of progression of low-grade cervical intraepithelial neoplasia ( CIN 1 ) to high grade CIN ( CIN 2/3 ) .


The aim of this study was to assess the efficacy and safety of hexaminolevulinate ( HAL ) photodynamic therapy ( PDT ) in the treatment of patients with CIN 1 .


This phase IIa prospective double-blind study randomized patients with CIN 1 into three groups : HAL vaginal suppository , placebo vaginal suppository or follow-up only .


Patients in the first two groups received HAL or placebo suppositories 5hours before illumination with 50J/cm ( 2 ) red coherent light ( 633nm ) using a special light catheter .


All patients had a follow up including colposcopy , cytology and human papilloma virus ( HPV ) testing 3 and 6 months and additional biopsy 6 months after PDT .


The main outcome measure was efficacy , defined as complete histologic remission 6 months after PDT .


Secondary outcomes were histologic remission 3 months and HPV eradication 6 months after first PDT .


Seventy patients were randomized : 47 to HAL , 12 to placebo , 11 to follow up only .


After 6 months CIN lesions had cleared in 57 % of patients in the HAL-PDT group compared to 25 % in the combined control group ( per protocol population , P = 0.04 ) .


Twenty-six patients ( 37 % ) reported 44 adverse events ( AEs ) , of which 40 were mild or moderate .


Nineteen treatment-related AEs were reported by 15 patients ( 32 % ) in the HAL PDT group , one in the placebo PDT group ( 8 % ) , and none in the follow-up group .


The most common adverse events were local discomfort including mild pain/cramping ( 11 ) and leucorrhoea ( 2 ) .


HAL PDT shows a favorable efficacy and safety profile and represents a promising alternative to observation and surgical procedures in patients with CIN 1 .


Low back pain is a common and disabling condition leading to large health service and societal costs .


Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection .


The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments .


This was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service .


We included adults with non-specific low back pain referred for physiotherapy .


Intervention participants were sent an information booklet prior to their first consultation .


Intervention physiotherapists were trained to enhance their skills in shared informed decision making .


Those in the control arm received care as usual .


The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into `` satisfaction '' ( very satisfied or somewhat satisfied ) and `` non-satisfaction '' ( neither satisfied nor dissatisfied , somewhat dissatisfied or very dissatisfied ) .


We recruited 148 participants .


In the control arm 67 % of participants were satisfied with their treatment and in the intervention arm 53 % .


The adjusted relative risk of being satisfied was 1.28 ( 95 % confidence interval 0.79 to 2.09 ) .


For most secondary outcomes the trend was towards worse outcomes in the intervention group .


For one measure ; the Roland Morris Disability Questionnaire , this difference was clinically important ( 2.27 , 95 % confidence interval 0.08 to 4.47 ) .


Mean healthcare costs were slightly lower ( 38 saving per patient ) within the intervention arm but health outcomes were also less favourable ( 0.02 fewer QALYs ) ; the estimated probability that the intervention would be cost-effective at an incremental threshold of 20,000 per QALY was 16 % .


We did not find that this decision support package improved satisfaction with treatment ; it may have had a substantial negative effect on clinical outcome , and is very unlikely to prove cost-effective .


That a decision support package might have a clinically important detrimental effect is of concern .


To our knowledge this has not been observed previously .


Decision support packages should be formally tested for clinical and cost-effectiveness , and safety before implementation .


Current Controlled Trials ISRCTN46035546 registered on 11/02/10 .


Promising clinical outcomes have been reported with the combination of enamel matrix derivative ( EMD ) and allograft materials .


Direct comparison between EMD with a freeze-dried bone allograft ( FDBA ) and a demineralized FDBA ( DFDBA ) was evaluated in one case series study .


To date , no randomized controlled trial has been reported .


Therefore , a well-controlled randomized clinical trial was conducted to determine the relative efficacy of EMD/FDBA versus EMD/DFDBA when managing intrabony defects .


A randomized parallel trial was conducted in a private practice from April 2004 to October 2011 .


Sixty-nine patients were randomly assigned to one of three groups : EMD/FDBA ( EF ) intervention group ( n = 23 ) , EMD/DFDBA ( ED ) intervention group ( n = 23 ) , and EMD alone without graft material ( E ) as a negative control group ( n = 23 ) .


All of the grafting material had minocycline added .


Each patient had an intrabony defect .


The primary outcomes were the absolute change in probing depth ( PD ) reduction and clinical attachment level ( CAL ) gain from baseline to 1 - and 3-year follow-up .


Intrabony defects were surgically treated with EMD/FDBA , EMD/DFDBA , or EMD alone .


Sixty-seven patients ( EF , n = 21 : ED , n = 23 ; E , n = 23 ) were analyzed .


All groups demonstrated significant improvement in PD reduction and CAL gain from baseline .


The changes for PD were as follows ( mm , 95 % confidence interval [ CI ] ) : at 1 year : EF ( 4.4 mm , 4.0 to 4.7 ) , ED ( 3.7 mm , 3.4 to 4.0 ) , and E ( control ) ( 3.3 mm , 3.0 to 3.6 ) ; at 3 years : EF ( 4.4 mm , 4.1 to 4.8 ) , ED ( 3.7 mm , 3.4 to 4.0 ) , and E ( 3.1 mm , 2.8 to 3.4 ) .


The changes for CAL were as follows ( mm , 95 % CI ) : at 1 year : EF ( 4.1 mm , 3.8 to 4.5 ) , ED ( 3.5 mm , 3.0 to 4.0 ) , and E ( 3.0 mm , 2.5 to 3.6 ) ; at 3 years : EF ( 4.2 mm , 3.7 to 4.7 ) , ED ( 3.6 mm , 3.1 to 4.1 ) , and E ( 3.0 mm , 2.5 to 3.5 ) .


The intervention groups ( EF and ED ) showed better treatment outcomes than the control group at 1 and 3 years .


Statistically , the two bone-graft groups were not significantly different from each other at 1 and 3 years .


Both EMD/FDBA and EMD/DFDBA interventions resulted in greater soft tissue improvement at 1 and 3 years of follow-up compared to EMD alone .


Both graft materials worked well in managing deep intrabony defects when combined with EMD .


To test the hypothesis that chocolate consumption is associated with a lower risk of heart failure ( HF ) .


We prospectively studied 20 278 men from the Physicians ' Health Study .


Chocolate consumption was assessed between 1999 and 2002 via a self-administered food frequency questionnaire and HF was ascertained through annual follow-up questionnaires with validation in a subsample .


We used Cox regression to estimate multivariable adjusted relative risk of HF .


During a mean follow-up of 9.3 years there were 876 new cases of HF .


The mean age at baseline was 66.49.2 years .


Hazard ratios [ 95 % confidence intervals ( CI ) ] for HF were 1.0 ( ref ) , 0.86 ( 0.72-1 .03 ) , 0.80 ( 0.66-0 .98 ) , 0.92 ( 0.74-1 .13 ) , and 0.82 ( 0.63-1 .07 ) , for chocolate consumption of less than 1/month , 1-3 / week , 2-4 / week , and 5 + / week , respectively , after adjusting for age , body mass index ( BMI ) , smoking , alcohol , exercise , energy intake , and history of atrial fibrillation ( P for quadratic trend = 0.62 ) .


In a secondary analysis , chocolate consumption was inversely associated with risk of HF in men whose BMI was < 25kg/m ( 2 ) [ HR ( 95 % CI ) = 0.59 ( 0.37-0 .94 ) for consumption of 5 + servings/week , P for linear trend = 0.03 ) but not in those with BMI of 25 + kg/m ( 2 ) [ HR ( 95 % CI ) = 1.01 ( 0.73-1 .39 ) , P for linear trend = 0.42 , P for interaction = 0.17 ) .


Our data suggest that moderate consumption of chocolate might be associated with a lower risk of HF in male physicians .


To assess the cardiovascular changes of a continuous rate infusion of lidocaine in calves anesthetized with xylazine , midazolam , ketamine and isoflurane during mechanical ventilation .


Prospective , randomized , cross-over , experimental trial .


A total of eight , healthy , male Holstein calves , aged 10 1 months and weighing 114 11 kg were included in the study .


Calves were administered xylazine followed by ketamine and midazolam , orotracheal intubation and maintenance on isoflurane ( 1.3 % ) using mechanical ventilation .


Forty minutes after induction , lidocaine ( 2 mg kg bolus ) or an equivalent volume of saline ( 0.9 % ) was administered IV followed by a continuous rate infusion ( 100 g kg minute ) of lidocaine ( treatment L ) or saline ( treatment C ) .


Heart rate ( HR ) , systolic , diastolic and mean arterial pressures ( SAP , DAP and MAP ) , central venous pressure ( CVP ) , mean pulmonary arterial pressure ( mPAP ) , pulmonary arterial occlusion pressure ( PAOP ) , cardiac output , end-tidal carbon dioxide ( Pe'CO 2 ) and core temperature ( CT ) were recorded before lidocaine or saline administration ( Baseline ) and at 20-minute intervals ( T20-T80 ) .


Plasma concentrations of lidocaine were measured in treatment L.


The HR was significantly lower in treatment L compared with treatment C.


There was no difference between the treatments with regards to SAP , DAP , MAP and SVRI .


CI was significantly lower at T60 in treatment L when compared with treatment C. PAOP and CVP increased significantly at all times compared with Baseline in treatment L.


There was no significant difference between times within each treatment and between treatments with regards to other measured variables .


Plasma concentrations of lidocaine ranged from 1.85 to 2.06 g mL during the CRI .


At the studied rate , lidocaine causes a decrease in heart rate which is unlikely to be of clinical significance in healthy animals , but could be a concern in compromised animals .


Antimicrobial prophylaxis is still a matter of debate in ear surgeries .


Previous studies have focused on prophylaxis in middle ear surgery alone without inclusion of mastoidectomy .


We therefore investigated efficacy of two regimes of antimicrobial prophylaxis in tympanoplasty with cortical mastoidectomy done for mild middle ear disease in chronic otitis media .


Prospective , randomized , controlled , double-blind study .


Patients undergoing tympanoplasty with cortical mastoidectomy were included and randomized into two study groups .


The group I patients received parenteral perioperative antimicrobials ; only group II patients received additional extended oral antimicrobials for 8 days more postoperatively .


Primary outcomes evaluated were postaural wound infection and graft success , assessed weekly until 1 month .


Adverse events and length of hospital stay were evaluated as secondary outcome .


Seventy-eight patients were randomized into group I ( n = 39 ) and group II ( n = 39 ) .


The two groups showed no difference in wound infection rate .


The graft success rate in both the group was comparable ( 94.87 % in group I and 97.44 % in group II , respectively ; P = 1.00 ) .


The length of hospital stay was significantly longer ( P = 0.00001 ) in group II ( 3.05 [ 0.72 ] , mean [ SD ] ) as compared to group I ( 2.36 [ 0.49 ] ) .


During the first postoperative week , a significantly higher incidence of gastrointestinal disturbances were observed in group II ( 19 [ 48.72 % ] as compared to 1 [ 2.56 % ] in group I , P = 0.00001 ) .


The present study shows that there is no need of extended antimicrobial prophylaxis for tympanoplasty with cortical mastoidectomy done for mild middle ear disease .


An indiscriminate use of antimicrobials may lead to increase incidence of adverse events and prolonged hospital stay .


1b .


Acute on chronic liver failure ( AoCLF ) is associated with a high mortality rate .


Plasma exchange ( PE ) is useful to bridge AoCLF patients to liver transplantation .


The aim of this study was to assess the effects of PE on plasma ammonia levels ( PAL ) in AoCLF patients .


Seventy patients with AoCLF in 2 groups ( PE plus standard medical treatment group , n = 32 ; and standard medical treatment group , n = 38 ) were enrolled in study .


PAL was detected on admission and on days 7 , 14 , 21 , and 30 during hospitalization .


All AoCLF patients showed PAL more than the upper limit of the normal range .


More dramatic decreased in the PE survivors ( form 116.8 + / - 36.3 to 44.8 + / - 16.3 , p < 0.01 ) than the medical survivors ( form 105.7 + / - 30.2 to 57.1 + / - 20.3 , p < 0.05 ) after 30 days of treatment .


Furthermore , PAL after medical treatment were still higher than those of PE treatment in the survivors ( 57.1 + / - 20.3 vs. 44.8 + / - 16.3 , p < 0.05 ) .


Among the non-survivors in the medical group , PAL remained at high levels throughout the examination period .


Importantly , an increased PAL associated with high mortality and reduced survival time of AoCLF patients .


Ammonia may be important in the pathogenesis of the AoCLF and PE may represent a reliable hepatic support device for AoCLF .


In Lynch syndrome , flat and diminutive adenomas are particularly prone to malignant transformation , but they can be missed by standard colonoscopy .


It is not known whether chromocolonoscopy is able to detect more adenomas than standard colonoscopy in patients with Lynch syndrome .


We conducted a prospective , multicenter , randomized trial to compare standard colonoscopy with standard colonoscopy followed by pancolonic chromoscopy with indigo carmine in patients with a proven germline mutation in a mismatch-repair gene related to Lynch syndrome and who were undergoing screening or surveillance colonoscopy .


Standard colonoscopy was used first to detect visible lesions .


Colonoscopy with chromoscopy was then performed by a second gastroenterologist ( blinded to the findings of the first colonoscopy ) to detect additional lesions .


The primary end point was the number of patients in whom at least one adenoma was detected .


A total of 78 eligible patients ( median age , 45 years ) were enrolled at 10 centers from July 2008 to August 2009 .


Significantly more patients with at least one adenoma were identified by chromocolonoscopy ( 32/78 ( 41 % ) ) than by standard colonoscopy ( 18/78 ( 23 % ) ; P < 0.001 ) .


The percentage of patients in whom at least one additional adenoma was detected during the chromoscopy was 31 % ( 24/78 ) .


Overall , chromocolonoscopy plus colonoscopy detected a total of 55 adenomas in 32 patients ( mean number of adenomas detected per patient : 0.7 vs. standard colonoscopy alone : 0.3 ; P < 0.001 ) .


The results support the proposition that chromocolonoscopy may significantly improve the detection rate of colorectal adenomas in patients undergoing screening or surveillance colonoscopy for Lynch syndrome .


Several studies suggest that surgical manipulation of the intestine and increased intra-abdominal pressure promotes bacterial translocation ( BT ) .


This prospective randomized study has investigated the effect of surgery on BT in patients undergoing elective colectomy for colon cancer by comparing the laparoscopic with the open approach .


One hundred nineteen consecutive patients underwent colectomy for colon cancer : 59 cases underwent open resection and 60 cases underwent laparoscopic resection .


For bacterial identification , tissue samples were taken from the liver , spleen , and mesenteric lymph nodes .


The incidence of BT increased in laparoscopic and open group after bowel mobilization ( prior to ligation of the vascular pedicle ) , compared with the before mobilization ( P < .05 ) .


There was not a statistically significant difference in BT value between the 2 groups .


BT increase was observed during the open and laparoscopic resection for colon cancer , without significant statistical difference between the 2 groups .


To investigate the effectiveness of exercise as treatment for vasomotor menopausal symptoms .


Three-group randomised controlled trial , two exercise interventions and a control group .


Primary Care , West Midlands UK .


Perimenopausal and postmenopausal women experiencing at least five hot flushes/night sweats per day and not taken MHT in previous 3 months were recruited from 23 general practices .


Participants in both exercise interventions groups were offered two face-to-face consultations with a physical activity facilitator to support engagement in regular exercise .


In addition , one exercise group received a menopause-specific information DVD and written materials to encourage regular exercise and the other exercise group was offered the opportunity to attend exercise social support groups in their communities .


Interventions lasted 6 months .


The primary outcome was frequency of hot flushes/night sweats at 6-month up .


Two hundred and sixty-one women were randomised ( n = 87 per group ) .


Neither of the exercise intervention groups reported significantly less frequent hot flushes/night sweats per week than controls ( exercise-DVD versus control : -8.9 , 95 % CI -20.0 to 2.2 ; exercise-social support versus control : -5.2 , 95 % CI -16.7 to 6.3 ) .


This trial indicates that exercise is not an effective treatment for hot flushes/night sweats .


Contrary to current clinical guidance , women should not be advised that exercise will relieve their vasomotor menopausal symptoms .


To fully analyze and compare BMI among Han , Tibetan , and Uygur university students , to discuss the differences in their physical properties and physical health , and thus to provide some theoretical suggestions for the improvement of students ' physical health .


The cross-sectional random cluster sampling was used to investigate 10103 Han , Tibetan , and Uygur university students , aged 20-24 in Northwest China , and their height and weight were measured to calculate BMI .


The BMI classification criteria for Chinese established by Work Group on Obesity in China ( WGOC ) were used for screening .


Han , Tibetan , and Uygur university students show low obesity rates but high overweight rates .


Han , Tibetan , and Uygur university students present a high rate of underweight , normal weight , and overweight , respectively .


Female Han students show higher underweight and normal weight rates , but lower overweight and obesity rates , than male Han students .


Female Tibetan students show higher normal weight rate , but lower overweight and obesity rates , than male Tibetan students .


BMI increases with age for male students but decreases with age for female students .


Male Uygur students show higher obesity rate than female Uygur students .


Tibetan and Uygur university students have higher BMI than other minorities in South China .


Although couples ' alcohol use has been associated with intimate partner aggression and poorer marital functioning , few studies have examined the proximal effects of alcohol on couple interactions .


The current experimental study examined the effects of alcohol , administered independently to male and female intimate partners , on positive and negative interaction behaviors within a naturalistic conflict resolution paradigm .


Married and cohabiting couples ( n = 152 ) were recruited from the community and each partner randomly assigned to receive either alcohol ( target dose : .08 mg/kg ) or no alcohol .


They engaged in two 15-minute interactions regarding current disagreements in their relationship , one before and one after beverage administration .


Videotaped interactions were coded by trained observers using the Rapid Marital Interaction Coding System , and positive and negative interaction behaviors were analyzed using the Actor-Partner Interdependence Model .


Participants displayed decreased negativity and increased positivity following alcohol consumption when their partners were sober but no differences in negativity or positivity when their partners also consumed alcohol .


There were no gender differences .


Although participants with a history of perpetrating intimate partner aggression displayed more negativity , prior aggression did not interact with beverage condition .


The immediate effects of alcohol consumption on couple interaction behaviors appeared more positive than negative .


Contrary to hypotheses , congruent partner drinking had neither particularly positive nor particularly negative effects .


These unique findings represent a rare glimpse into the immediate consequences of alcohol consumption on couple interaction and stand in contrast to its delayed or long-term effects .


Colorectal cancer ( CRC ) screening is cost-effective but underused .


The objective of this study was to determine the cost-effectiveness of a mailed standard intervention ( SI ) and tailored navigation interventions ( TNIs ) to increase CRC screening use in the context of a randomized trial among primary care patients .


Participants ( n = 945 ) were randomized either to a usual care control group ( n = 317 ) , to an SI group ( n = 316 ) , or to a TNI group ( n = 312 ) .


The SI group was sent both colonoscopy instructions and stool blood tests irrespective of baseline preference .


TNI group participants were sent instructions for scheduling a colonoscopy , a stool blood test , or both based on their test preference , as determined at baseline ; then , they received a navigation telephone call .


Activity cost estimation was used to determine the cost of each intervention and to compute incremental cost-effectiveness ratios .


Statistical uncertainty within the base case was assessed with 95 % confidence intervals derived from net benefit regression analysis .


The effects of uncertain parameters , such as the cost of planning , training , and involvement of those receiving `` investigator salaries , '' were assessed with sensitivity analyses .


Program costs of the SI were $ 167 per participant .


The average cost of the TNI was $ 289 per participant .


The TNI was more effective than the SI but substantially increased the cost per additional individual screened .


Decision-makers need to consider cost structure , level of planning , and training required to implement these 2 intervention strategies and their willingness to pay for additional individuals screened to determine whether a tailored navigation would be justified and feasible .


Posterior wall fractures are one of the most common acetabular fractures .


However , only 30 % of these fractures involve a single large fragment , and comminuted acetabular posterior wall fractures pose a particular surgical challenge .


The purpose of this study was to compare outcomes between patients who received fixation for comminuted posterior wall fracture using the Acetabular Tridimensional Memory Fixation System ( ATMFS ) and patients who underwent fixation with conventional screws and buttress plates ( Plates group ) .


Between April 2003 and May 2007 , 196 consecutive patients who sustained a comminuted posterior wall fracture of acetabulum were treated with ATMFS or conventional screws and buttress plates .


Operative time , fluoroscopy time , blood loss , and any intra-operative complications were recorded .


Plain AP and lateral radiographs were obtained at all visits ( Matta 's criteria ) .


Modified Merle d' Aubigne-Postel score , and Mos SF-36 score were compared between groups .


Fifty patients were included in the analysis with 26 in the ATMFS group and 24 in the Plates group .


The mean follow-up time was 57.5 months , ranging from 31 to 69 months .


All patients had fully healed fractures at the final follow-up .


There was no difference in clinical outcomes or radiological evaluations between groups .


Patients with comminuted posterior wall fractures of the acetabulum treated with the ATMFS or conventional screws and buttress plate techniques achieve a good surgical result .


Both techniques are safe , reliable , and practical .


Use of the ATMFS technique may reduce blood loss and improve rigid support to marginal bone impaction .


The use ATMFS may need additional support when fractures involve the superior roof .


Both valganciclovir and high-dose valacyclovir are recommended for cytomegalovirus prophylaxis after renal transplantation .


A head-to-head comparison of both regimens is lacking .


The objective of the study was to compare valacyclovir prophylaxis with valganciclovir , which constituted the control group .


In a randomized , open-label , single-center trial , recipients of renal transplants ( recipient or donor cytomegalovirus-seropositive ) were randomly allocated ( 1:1 ) to 3-month prophylaxis with valacyclovir ( 2 g four times daily ) or valganciclovir ( 900 mg daily ) .


Enrollment occurred from November of 2007 to April of 2012 .


The primary end points were cytomegalovirus DNAemia and biopsy-proven acute rejection at 12 months .


Analysis was by intention to treat .


In total , 119 patients were assigned to valacyclovir ( n = 59 ) or valganciclovir prophylaxis ( n = 60 ) .


Cytomegalovirus DNAemia developed in 24 ( 43 % ) of 59 patients in the valacyclovir group and 18 ( 31 % ) of 60 patients in the valganciclovir group ( adjusted hazard ratio , 1.35 ; 95 % confidence interval , 0.71 to 2.54 ; P = 0.36 ) .


The incidence of cytomegalovirus disease was 2 % with valacyclovir and 5 % with valganciclovir prophylaxis ( adjusted hazard ratio , 0.21 ; 95 % confidence interval , 0.01 to 5.90 ; P = 0.36 ) .


Significantly more patients with valacyclovir prophylaxis developed biopsy-proven acute rejection ( 18 of 59 [ 31 % ] versus 10 of 60 [ 17 % ] ; adjusted hazard ratio , 2.49 ; 95 % confidence interval , 1.09 to 5.65 ; P = 0.03 ) .


The incidence of polyomavirus viremia was higher in the valganciclovir group ( 18 % versus 36 % ; adjusted hazard ratio , 0.43 ; 95 % confidence interval , 0.19 to 0.96 ; P = 0.04 ) .


Valganciclovir shows no superior efficacy in cytomegalovirus DNAemia prevention compared with valacyclovir prophylaxis .


However , the risk of biopsy-proven acute rejection is higher with valacyclovir .


To assess the effects of using Chinese herbs in assisted reproductive technology .


Four hundred and thirty-three subjects aged less than 42 years with infertility due to Fallopian tube or male-related factors who were willing to undertake in vitro fertilization and embryo transplantation were randomly allocated to a Chinese herb intervention group ( n = 216 ) or a conventional treatment control group ( n = 217 ) .


All subjects received one of four routine ultra-ovulation-promoting therapies at the Reproductive Center in the Third Hospital Affiliated to Beijing University according to their physician 's assessments .


The subjects in the intervention group received various Chinese herbs depending on their conventional treatment .


Endometrial thickness , number of acquired eggs , and rates of normal fertility , high-quality embryos , biochemical and clnical pregnancy of subjects were assessed in both groups .


The high-quality embryo rate of 51.9 % , biochemical pregnancy rate of 51.0 % , clinical pregnancy rate of 44.2 % and endometrial thickness of ( 10.84 + / - 1.75 ) mm in the intervention group were all significantly higher than those in the control group [ 48.7 % , 38.9 % , 34.8 % , and ( 10.52 + / - 1.50 ) mm , respectively ; P < 0.05 ] .


The normal fertility rate of 58.5 % in the Chinese herb group was also significantly superior to the 54.7 % achieved in the control group ( P < 0.01 ) .


There were no statistically significant differences ( P > 0.05 ) in the average number of acquired eggs within a single cycle , incidence of excessive stimulation of ovary , rates of embryo transplantation or early abortion and birth of living babies between the two groups .


Our findings indicate that Chinese herbs increase endometrial thickness , improve the quality of fertility and embryo , and promote embryonic nidation , thus enhancing the success rate of in vitro fertilization/intracytoplasmic sperm injection-embryo transplantation cycle .


Using Chinese herbs improves the outcomes and safety of assisted reproductive technologies .


To compare the efficacy and safety of 3 % diquafosol ophthalmic solution with those of 0.1 % sodium hyaluronate ophthalmic solution in patients with dry eye in China and Singapore .


A total of 497 patients with dry eye ( Schirmer 's test , 5mm ; fluorescein and RB score , 3 points ) from China and Singapore were randomised to receive either diquafosol ophthalmic solution ( diquafosol ) or sodium hyaluronate ophthalmic solution ( HA ) at 1:1 ratio .


The fluorescein staining scores and rose bengal ( RB ) subjective symptom scores and tear film breakup time were evaluated before treatment and 2 and 4weeks after start of treatment .


In the diquafosol group , changes in fluorescein and RB scores compared with baseline at week 4 or at the time of discontinuation were -2.11.5 and -2.52.0 , respectively .


Compared with the HA group , changes in fluorescein score were non-inferior and changes in RB score were superior ( p = 0.019 ) .


In addition , diquafosol and HA improved tear film breakup time by 1.0461.797 and 0.8321.775 s , respectively ( no significant intergroup difference ) .


Adverse event onset rates were 16.3 % ( 40 of 246 subjects ) and 10.0 % ( 25 of 251 subjects ) in the diquafosol group and HA group , respectively , with borderline significant intergroup differences ( p = 0.046 ) , while adverse drug reaction incidence rates were 12.2 % ( 30 of 246 subjects ) and 6.0 % ( 15 of 251 subjects ) , respectively ( p = 0.019 ) .


Only mild adverse drug reactions ( > 2 % ) in the form of eye discharge , itching or irritation were observed .


Diquafosol improved fluorescein staining score in a manner similar to HA , and significantly improved RB score compared with HA .


NCT01101984 .


Epidural injections are the most common minimally invasive intervention used to manage low back pain with lumbosacral radicular pain .


It can be delivered through either transforaminal ( TF ) , interlaminar , or caudal approaches .


The TF approach is considered more efficacious than the interlaminar approach probably because of ventral epidural spread .


However , catastrophic complications reported with the TF approach have raised concerns regarding its use .


These concerns regarding the safety of the TF approach lead to the search for a technically better route with lesser complications with drug delivery into the ventral epidural space .


The parasagittal interlaminar ( PIL ) route is reported to have good ventral epidural spread .


However , there is a paucity of literature comparing the effectiveness of PIL with TF .


To compare effectiveness of PIL and TF epidural injections for managing low back pain with lumbosacral radicular pain .


Randomized , double-blind , active-control study .


Interventional pain management clinic in a tertiary care center in India .


Sixty-two patients were randomized to receive fluoroscopically guided epidural injection of methylprednisolone ( 80 mg ) either through the PIL ( n = 32 ) or TF ( n = 30 ) approach .


Patients were evaluated for effective pain relief ( 50 % from baseline ) by 0 - 100 visual analogue scale ( VAS ) and functional improvement by Modified Oswestry Disability Questionnaire ( MODQ ) at 2 weeks , 1 , 2 , 3 , 6 , 9 , and 12 months .


Patients who failed to respond to the treatment or when the patient 's response deteriorated received additional injection of same injectate , dose , and approach .


Only if the pain returns should there be a maximum of 3 injections .


Other outcome measures were overall VAS and MODQ , number of injections , and presence of ventral and perineural spread .


Effective pain relief ( 50 % pain relief from baseline on VAS ) was observed in 76 % ( 90 % CI 60.6 - 88.5 % ) of patients in the TF group and 78 % ( 90 % CI 62.8 - 89.3 % ) of patients in the PIL ( P = 1.00 ) group at 3 months .


The pain relief survival period was comparable in both groups ( P = 0.98 ) .


Significant reduction in VAS and improvement in MODQ were observed at all time points post-intervention compared to baseline ( P < 0.001 ) in both groups .


On average , patients in the PIL group received 1.84 and patients in the TF group received 1.92 procedures annually .


The majority received injection at L4-L5 intervertebral level ( 24 in TF and 23 in PIL ) .


Ventral epidural spread was comparable in both groups ( PIL - 91.6 % and TF - 89.6 % ) .


No major complications were encountered in either group ; however , initial intravascular spread of contrast was observed in 3 patients in the TF group .


Limitations included lack of documentation of adjuvant analgesic drug therapy and procedures performed by a single experienced interventionalist .


Epidural injection delivered through the PIL approach is equivalent in achieving effective pain relief and functional improvement to the TF approach for the management of low back pain with lumbosacral radicular pain .


The PIL approach can be considered a suitable alternative to the TF approach for its equivalent effectiveness , probable better safety profile , and technical ease .


CTRI/2012/08 / 002938 .


In recent years , virtual reality has been introduced to neurorehabilitation , in particular with the intention of improving upper-limb training options and facilitating motor function recovery .


The proposed study incorporates a quantitative part and a qualitative part , termed a mixed-methods approach : ( 1 ) a quantitative investigation of the efficacy of virtual reality training compared to conventional therapy in upper-limb motor function are investigated , ( 2a ) a qualitative investigation of patients ' experiences and expectations of virtual reality training and ( 2b ) a qualitative investigation of therapists ' experiences using the virtual reality training system in the therapy setting .


At three participating clinics , 60 patients at least 6 months after stroke onset will be randomly allocated to an experimental virtual reality group ( EG ) or to a control group that will receive conventional physiotherapy or occupational therapy ( 16 sessions , 45 minutes each , over the course of 4 weeks ) .


Using custom data gloves , patients ' finger and arm movements will be displayed in real time on a monitor , and they will move and manipulate objects in various virtual environments .


A blinded assessor will test patients ' motor and cognitive performance twice before , once during , and twice after the 4-week intervention .


The primary outcome measure is the Box and Block Test .


Secondary outcome measures are the Chedoke-McMaster Stroke Assessments ( hand , arm and shoulder pain subscales ) , the Chedoke-McMaster Arm and Hand Activity Inventory , the Line Bisection Test , the Stroke Impact Scale , the MiniMentalState Examination and the Extended Barthel Index .


Semistructured face-to-face interviews will be conducted with patients in the EG after intervention finalization with a focus on the patients ' expectations and experiences regarding the virtual reality training .


Therapists ' perspectives on virtual reality training will be reviewed in three focus groups comprising four to six occupational therapists and physiotherapists .


The interviews will help to gain a deeper understanding of the phenomena under investigation to provide sound recommendations for the implementation of the virtual reality training system for routine use in neurorehabilitation complementing the quantitative clinical assessments .


Cliniclatrials.gov Identifier : NCT01774669 ( 15 January 2013 ) .


Cochlear implants ( CIs ) are typically activated 3 to 6 weeks after the surgery .


For some patients who live in remote areas , this waiting period could impose some personal and financial burdens .


The current study examined whether CI recipients can be safely and effectively fitted with their speech processor five days after their implantation .


Randomized controlled trial .


Tertiary referral center .


A total of 23 patients ( 2-30 yr of age ) undergoing traditional CI surgery were recruited to participate in this study .


Participants were divided into 2 groups : an early-fit group whose devices were activated 5 days after surgery and standard-fit group whose devices were activated using the recommended waiting period .


Measures of impedance and most comfortable levels were used to compare differences across the 2 groups of patients .


Data were measured at the activation session and also at 4 weeks after the initial session .


No adverse events were reported postoperatively .


Electrode impedances were significantly lower for the early-fit group than that for the standard-fit group in the initial activation session but not in the 4-week follow-up session .


There were no significant differences between the 2 groups in the stimulation fitting levels in any of the sessions .


The results presented in this article demonstrated that early activation for this sample did not seem to interfere with wound healing or with the fitting parameters suggesting that early activation should be considered as viable option to better serve CI patients ' individual needs .


The implications of geographical variation are unknown following adjustment for hospital length of stay ( LOS ) in heart failure ( HF ) trials that included patients whether or not they had systolic dysfunction .


We investigated regional differences in an international acute HF trial .


The PROTECT trial investigated 2033 patients with acute HF and renal dysfunction hospitalized at 173 sites in 17 countries with randomization to rolofylline or placebo .


We grouped enrolling countries into six regions .


Baseline characteristics , in-hospital management , and outcomes were explored by region .


The primary study outcome was 60-day mortality or cardiovascular/renal hospitalization .


Secondary outcomes included 180-day mortality .


Of 2033 patients , 33 % were from Eastern Europe , 19 % from Western Europe , 16 % from Israel , 15 % from North America , 14 % from Russia , and 3 % from Argentina .


Marked differences in baseline characteristics , HF phenotype , in-hospital diuretic and vasodilator strategies , and LOS were observed by region .


LOS was shortest in North America and Israel ( median 5 days ) and longest in Russia ( median 15 days ) .


Regional event rates varied significantly .


Following multivariable adjustment , region was an independent predictor of the risk of mortality/hospitalization at 60 days , with the lowest risk in Russia ( hazard ratio 0.39 , 95 % confidence interval 0.23-0 .64 vs. Western Europe ) due to lower rehospitalization ; mortality differences were attenuated by 180 days .


In an international HF trial , there were differences in baseline characteristics , treatments , LOS , and rehospitalization amongst regions , but little difference in longer term mortality .


Rehospitalization differences exist independent of LOS .


This analysis may help inform future trial design and should be externally validated .


Ipilimumab is an approved treatment for patients with advanced melanoma .


We aimed to assess ipilimumab as adjuvant therapy for patients with completely resected stage III melanoma at high risk of recurrence .


We did a double-blind , phase 3 trial in patients with stage III cutaneous melanoma ( excluding lymph node metastasis 1 mm or in-transit metastasis ) with adequate resection of lymph nodes ( ie , the primary cutaneous melanoma must have been completely excised with adequate surgical margins ) who had not received previous systemic therapy for melanoma from 91 hospitals located in 19 countries .


Patients were randomly assigned ( 1:1 ) , centrally by an interactive voice response system , to receive intravenous infusions of 10 mg/kg ipilimumab or placebo every 3 weeks for four doses , then every 3 months for up to 3 years .


Using a minimisation technique , randomisation was stratified by disease stage and geographical region .


The primary endpoint was recurrence-free survival , assessed by an independent review committee , and analysed by intention to treat .


Enrollment is complete but the study is ongoing for follow-up for analysis of secondary endpoints .


This trial is registered with EudraCT , number 2007-001974-10 , and ClinicalTrials.gov , number NCT00636168 .


Between July 10 , 2008 , and Aug 1 , 2011 , 951 patients were randomly assigned to ipilimumab ( n = 475 ) or placebo ( n = 476 ) , all of whom were included in the intention-to-treat analyses .


At a median follow-up of 274 years ( IQR 228-322 ) , there were 528 recurrence-free survival events ( 234 in the ipilimumab group vs 294 in the placebo group ) .


Median recurrence-free survival was 261 months ( 95 % CI 193-393 ) in the ipilimumab group versus 171 months ( 95 % CI 134-216 ) in the placebo group ( hazard ratio 075 ; 95 % CI 064-090 ; p = 00013 ) ; 3-year recurrence-free survival was 465 % ( 95 % CI 415-513 ) in the ipilimumab group versus 348 % ( 301-395 ) in the placebo group .


The most common grade 3-4 immune-related adverse events in the ipilimumab group were gastrointestinal ( 75 [ 16 % ] vs four [ < 1 % ] in the placebo group ) , hepatic ( 50 [ 11 % ] vs one [ < 1 % ] ) , and endocrine ( 40 [ 8 % ] vs none ) .


Adverse events led to discontinuation of treatment in 245 ( 52 % ) of 471 patients who started ipilimumab ( 182 [ 39 % ] during the initial treatment period of four doses ) .


Five patients ( 1 % ) died due to drug-related adverse events .


Five ( 1 % ) participants died because of drug-related adverse events in the ipilimumab group ; three patients died because of colitis ( two with gastrointestinal perforation ) , one patient because of myocarditis , and one patient because of multiorgan failure with Guillain-Barr syndrome .


Adjuvant ipilimumab significantly improved recurrence-free survival for patients with completely resected high-risk stage III melanoma .


The adverse event profile was consistent with that observed in advanced melanoma , but at higher incidences in particular for endocrinopathies .


The risk-benefit ratio of adjuvant ipilimumab at this dose and schedule requires additional assessment based on distant metastasis-free survival and overall survival endpoints to define its definitive value .


Bristol-Myers Squibb .


To compare sedation outcomes for chloral hydrate ( CH ) and midazolam ( MD ) as sedative agents for diagnostic procedures in children .


A prospective , randomized , double-blinded study conducted between July 2005 and October 2006 , at the Pediatric Day Care Unit ( DCU ) , King Abdulaziz Medical City , Riyadh , Saudi Arabia .


After meeting the inclusion criteria and getting informed consent , patients were randomized , given the study drug , and monitored for sedation outcomes .


Two hundred and seventy-five patients who had 292 sedation sessions for diagnostic procedures were included in the study .


Due to missing data , 286 sedations were included in the final analysis ; 144 in the CH and 142 in the MD group .


Both groups were comparable with respect to demographic and baseline characteristics .


The CH compared to MD group , had a higher sedation success rate , shorter time to achieve sedation , shorter length of stay in DCU , and longer sedation duration .


In both study groups , patients who required a second dose tended to be older and heavier .


No major side effects were encountered .


The CH group had a significantly higher mean sedation scores at 15 , 30 , 45 , and 60 minutes .


Chloral hydrate compared to MD , had a shorter time to achieve sedation , a higher success rate , less need for a second dose , and decreased the time spent in the DCU .


Older and heavier patients are more likely to require a second dose of the study drug to be sedated .


Hapatitis B visus ( CHB ) - induced fibrosis is a precancerous condition of liver .


To explore the influence of Chongcao Preparation ( Chongcao Yigan Capsule ) on the function of intestinal flora and chemoprevention for patients with CHB-induced liver fibrosis .


A total of 136 patients with CHB-induced liver fibrosis were randomly divided into control group treated with lamivudine ( LAM ) and research group added with Chongcao Yigan Capsule for totally 48 weeks .


The changes of intestinal flora , secretory immunoglobin A ( SIgA ) , serum albumin ( ALB ) , prealbumin ( PALB ) , IgA and IgG at different time points in both groups were observed .


Before treatment , there was no significant difference between two groups in each index ( P > 0.05 ) .


After treatment , the intestinal flora were evidently optimized in research group than treatment before ( P < 0.05 or P < 0.01 ) , and were apparently better than those in control group ( P < 0.05 or P < 0.01 ) ; SIgA was obviously increased and ALB , PALB , IgA and IgG were markedly improved in research group than treatment before ( P < 0.05 or P < 0.01 ) , and were significantly better than those in control group ( P < 0.05 or P < 0.01 ) .


Chongcao Yigan Capsule could regulate the intestinal flora , increase SIgA , serum ALB and PALB concentrations and significantly improve serum IgA and IgG as well as strengthen the immunological function and autologous repair capacity of patients with CHB-induced liver fibrosis .


Our objective was to evaluate the prevention of incisional hernia ( IH ) during the postoperative period of a midline laparotomy during elective surgery .


A controlled , prospective , randomized , and blind study was carried out .


The patients in group A ( mesh ) were fitted with a polypropylene mesh , to reinforce the standard abdominal wall closure .


The patients in group B ( non-mesh ) underwent a standard abdominal wall closure and were not fitted with the mesh .


In group A , 2/80 his were diagnosed , whereas in group B the number was 30/80 .


The Kaplan-Meier survival curves show that the likelihood of IH at 12 months is 1.5 % in group A compared with 35.9 % in group B ( p < 0.0001 ) , which means that the differences are statistically significant .


Fitting a prophylactic supra-aponeurotic mesh prevents IH independently of other factors .


Ankle sprain is a frequently encountered traumatic injury in emergency departments and is associated with important health expenses .


However , the appropriate care of this traumatic injury remains a matter of debate .


We tested the hypothesis that compression stockings speed up recovery from ankle sprain .


Recent ( < 48 hours ) cases of ankle sprain without other traumatic injury in patients aged between 18 and 55 years were included .


Patients were randomly allocated to placebo Jersey or class II compression stockings ( Venoflex ; Thuasne , Levallois-Perret , France ) .


The primary end point was the time to recovery of normal painless walking without requirement for analgesic drug .


Secondary end points were time to return to sport activity , pain , analgesic consumption , and ankle edema ( bimalleolar and midfoot circumferences ) .


We randomized 126 patients and analyzed 117 patients ( 60 in the placebo group and 57 in the compression group ) .


The median time to normal painless walking was not significantly decreased ( P = .16 ) .


No significant differences were observed in pain , analgesic consumption , and bimalleloar and midfoot circumferences .


No safety issue was reported .


In the subgroup of patients with regular sport activity , the time to return to sport activity was shorter in patients treated with compression stockings ( P = .02 ) .


Compression stockings failed to significantly modify the time to return to normal painless walking in ankle sprain .


A beneficial effect was observed only in a subgroup of patients , as compression stockings significantly decreased the time to return to sport activity .


With HIV treatment prolonging survival and HIV infection now managed as a chronic illness , quality of life ( QOL ) is important to evaluate in persons living with HIV ( PLWH ) .


We assessed at study entry the QOL of antiretroviral-nave PLWH with CD4 counts > 500 cells/L in the Strategic Timing of AntiRetroviral Treatment ( START ) clinical trial .


QOL was assessed with : ( 1 ) a visual analogue scale ( VAS ) for self-assessment of overall current health ; ( 2 ) the Short-Form 12-Item Version 2 Health Survey ( ) ( SF-12V2 ) , for which responses are summarized into eight individual QOL domains plus component summary scores for physical health [ the Physical Health Component Summary ( PCS ) ] and mental health [ the Mental Health Component Summary ( MCS ) ] .


The VAS and eight domain scores were scaled from 0 to 100 .


Mean QOL measures were calculated overall and by demographic , clinical and behavioural factors .


A total of 4631 participants completed the VAS and 4119 the SF-12 .


The mean VAS score ( with standard deviation ) was 80.915.7 .


Mean SF-12 domain scores were lowest for vitality ( 66.326.4 ) and mental health ( 68.621.4 ) , and highest for physical functioning ( 89.323.0 ) and bodily pain ( 88.021.4 ) .


Using multiple linear regression , PCS scores were lower ( P < 0.001 ) for Asians , North Americans , female participants , older participants , and those with less education , longer duration of known HIV infection , alcoholism/substance dependence and body mass index 30kg/m ( 2 ) .


MCS scores were highest ( P < 0.001 ) for Africans , South Americans and older participants , and lowest for female participants , current smokers and those with alcoholism/substance dependence .


In this primarily healthy population , QOL was mostly favourable , emphasizing that it is important that HIV treatments do not negatively impact QOL .


Self-assessed physical health summary scores were higher than mental health scores .


Factors such as older age and geographical region had different effects on perceived physical and mental health .


Mechanical chest compression devices have the potential to help maintain high-quality cardiopulmonary resuscitation ( CPR ) , but despite their increasing use , little evidence exists for their effectiveness .


We aimed to study whether the introduction of LUCAS-2 mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest .


The pre-hospital randomised assessment of a mechanical compression device in cardiac arrest ( PARAMEDIC ) trial was a pragmatic , cluster-randomised open-label trial including adults with non-traumatic , out-of-hospital cardiac arrest from four UK Ambulance Services ( West Midlands , North East England , Wales , South Central ) .


91 urban and semi-urban ambulance stations were selected for participation .


Clusters were ambulance service vehicles , which were randomly assigned ( 1:2 ) to LUCAS-2 or manual CPR .


Patients received LUCAS-2 mechanical chest compression or manual chest compressions according to the first trial vehicle to arrive on scene .


The primary outcome was survival at 30 days following cardiac arrest and was analysed by intention to treat .


Ambulance dispatch staff and those collecting the primary outcome were masked to treatment allocation .


Masking of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible .


The study is registered with Current Controlled Trials , number ISRCTN08233942 .


We enrolled 4471 eligible patients ( 1652 assigned to the LUCAS-2 group , 2819 assigned to the control group ) between April 15 , 2010 and June 10 , 2013.985 ( 60 % ) patients in the LUCAS-2 group received mechanical chest compression , and 11 ( < 1 % ) patients in the control group received LUCAS-2 .


In the intention-to-treat analysis , 30 day survival was similar in the LUCAS-2 group ( 104 [ 6 % ] of 1652 patients ) and in the manual CPR group ( 193 [ 7 % ] of 2819 patients ; adjusted odds ratio [ OR ] 086 , 95 % CI 064-115 ) .


No serious adverse events were noted .


Seven clinical adverse events were reported in the LUCAS-2 group ( three patients with chest bruising , two with chest lacerations , and two with blood in mouth ) .


15 device incidents occurred during operational use .


No adverse or serious adverse events were reported in the manual group .


We noted no evidence of improvement in 30 day survival with LUCAS-2 compared with manual compressions .


On the basis of ours and other recent randomised trials , widespread adoption of mechanical CPR devices for routine use does not improve survival .


National Institute for Health Research HTA - 07/37/69 .


The authors compared the reduction of migraine headache frequency , days , severity , and duration after surgical decompression versus avulsion of the zygomaticotemporal branch of the trigeminal nerve for treatment of temporal migraine headache .


Twenty patients with bilateral temporal migraine headache were randomized to undergo avulsion of the zygomaticotemporal branch of the trigeminal nerve on one side and decompression via fasciotomy and removal of the zygomaticotemporal artery on the other side .


Results were analyzed after a minimum of 12 months of follow-up .


Nineteen patients completed the study .


The patients experienced greater than 50 percent improvement in frequency , migraine days , severity , and duration in 34 of the 38 operative sites ( 89 percent ) .


Complete elimination of symptoms was noted in 21 of the 38 operative sites ( 55 percent ) .


In the decompression group , migraine frequency was reduced from 14.6 to 2.2 per month , migraine days from 14.1 to 2.3 , severity from 7.0 to 2.9 , duration from 9.6 to 4.8 hours , and Migraine Headache Index score from 42 to 2.9 .


In the neurectomy group , frequency decreased from 14.2 to 1.9 per month , migraine days from 14.1 to 2.3 , severity from 6.8 to 2.6 , migraine duration from 10.1 to 5.3 hours , and the Migraine Headache Index score from 41 to 2.5 .


There was no statistical significance in reduced migraine headache frequency , days , severity , and duration between the two groups .


Neurectomy and decompression of the zygomaticotemporal branch of the trigeminal nerve are both appropriate treatment for temporal migraine headache .


If decompression fails to provide sufficient relief , neurectomy is another option .


Therapeutic , I.


The success of ACL reconstruction is predicated on a variety of factors .


Tunnel placement plays one of the most significant roles in achieving knee kinematics and function .


The purposes of this study were to compare femoral tunnel position , angle , length and posterior wall blow-out after ACL reconstruction with hamstring tendons autograft through either a farmedial portal or an anteromedial portal technique .


We evaluated 36 patients who underwent ACL reconstruction between January 2014 and July 2014 in our institute , in a prospective , randomised cohort study .


All the surgical procedures were performed by a sports fellowship-trained orthopaedic surgeon with experience in both portal reaming .


The operated knees were evaluated with 0.5 mm fine CT scans of 3-D CT between days 3 and 5 postoperatively .


According to the 3-D CT measurements , the mean femoral tunnel length was significantly longer ( p < 0.05 ) in the FAM group compared with the AM group .


The femoral bone tunnel length averaged 34.2 3.6 mm versus 36.6 3.0 mm ( p = 0.042 ) in AM and the FAM groups , respectively .


The femoral tunnel position , as evaluated with use of the quadrant method , was more anterior in the FAM transportal technique group , and the difference between the two groups was significant ( p < 0.05 ) .


FAM tranportal drilling of the femoral tunnel creates longer and anterior femoral tunnels with regard to the AM portal drilling techniques .