In selected individuals , these changes appear to be a conserved response to HDT .


Optimisation of patient comfort during flexible bronchoscopy is achieved with the use of intravenous sedation and vocal anaesthesia .


The effect of transcricoid lignocaine injection was investigated with regards to ease of procedure and frequency of cough .


A single-blinded study was carried out and two visual analogue scales were used as markers of efficacy .


Treatment groups were matched for age , gender and total dose of lignocaine administered .


The results highlighted a significant improvement in the perceived ease of procedure ( p < 0.0001 ) and frequency of coughing during the procedure ( p < 0.0001 ) .


The findings of the study demonstrate that the use of transcricoid injection of lignocaine provided a safe adjunct for anaesthesia in flexible bronchoscopy .


To evaluate a novel sleep education program for low-income preschool children and their families .


Randomized trial of an educational intervention .


Community-based .


Head Start preschool families ( n = 152 ) in greater Lansing and Detroit , Michigan .


Classrooms or Head Start sites were randomized to an intervention group ( prompt intervention ) versus a control group ( delayed intervention ) .


Parents attended a one-time , 45-min sleep education program and preschoolers received 2 w ( 320 total min ) of classroom sleep curriculum .


Parent knowledge , attitudes , self-efficacy , and beliefs were assessed as the primary outcomes just before the 45-min sleep intervention , immediately postintervention , and approximately 1 mo postintervention .


Parents reported their child 's bedtimes and wake times on 7-day sleep diaries at baseline and at 1-mo follow-up .


Average weeknight sleep durations and bedtimes served as secondary outcomes .


Linear mixed models showed a time treatment effect for parents ' knowledge , attitudes , and self-efficacy ( each P < 0.05 ) but not beliefs .


These improvements were found immediately postintervention but were not retained at 1-mo follow-up .


Children in the intervention group improved their weeknight sleep duration at 1-mo follow-up by 30 min ( 11.0 0.9 h vs. 10.5 1.0 hours at baseline ) compared to controls ( 10.4 0.9 h versus 10.5 0.9 h at baseline ) ( P = 0.04 for difference between groups ) .


Children did not show statistically significant improvements in bedtime .


Educational interventions in early childhood can have an effect on parents ' sleep knowledge , attitudes , and self-efficacy , and on children 's sleep behavior .


However , repeated exposure to the new information may be important for parents as well as their children .


The objective of the study was to estimate the effect of Burch and fascial sling surgery on out-of-pocket urinary incontinence ( UI ) management costs at 24 months postoperatively and identify predictors of change in cost among women enrolled in a randomized trial comparing these procedures .


Resources used for UI management ( supplies , laundry , dry cleaning ) were self-reported by 491 women at baseline and 24 months after surgery , and total out-of-pocket costs for UI management ( in 2012 US dollars ) were estimated .


Data from the 2 surgical groups were combined to examine the change in cost for UI management over 24 months .


Univariate and bivariate changes in cost were analyzed using the Wilcoxon signed rank test .


Predictors of change in cost were examined using multivariate mixed models .


At baseline mean ( SD ) age of participants was 53 10 years , and the frequency of weekly UI episodes was 23 21 .


Weekly UI episodes decreased by 86 % at 24 months ( P < .001 ) .


The mean weekly cost was $ 16.60 $ 27.00 ( median $ 9.39 ) at baseline and $ 4.57 $ 15.00 ( median $ 0.10 ) at 24 months ( P < .001 ) , a decrease of 72 % .


In multivariate analyses , cost decreased by $ 3.38 $ 0.77 per week for each decrease of 1 UI episode per day ( P < .001 ) and was strongly associated with greater improvement in Urogenital Distress Inventory and Incontinence Impact Questionnaire scores ( P < .001 ) and decreased 24-hour pad weight ( P < .02 ) .


Following Burch or fascial sling surgery , the UI management cost at 24 months decreased by 72 % ( $ 625 per woman per year ) and was strongly associated with decreasing UI frequency .


Reduced out-of-pocket expenses may be a benefit of these established urinary incontinence procedures .


To describe and evaluate the effectiveness of tailored intervention on village doctor 's use of electronic health records ( EHR ) in rural community health services in less developed areas .


Ten townships were selected .


In each township , two similar health service station ( CHSS ) were chosen .


One was randomly as allocated to the intervention group , the other to the control group .


Over six monthly visits , a structured on-site intervention including education , supervision and technical support was provided to village doctors in the intervention group tailored to their needs .


The Control group received no visits .


A sample of 20 families from each CHSS was randomly chosen .


An online evaluation of each family 's EHR was conducted by the investigators at baseline and at the end of the 6month intervention .


In the intervention group , the proportion of households with complete records increased : basic personal information from 2.6 % to 32.5 % , ( Z = -15.099 , P = 0.000 ) and health education records from 0.3 % to 1.6 % ( Z = -4.459 , P = 0.000 ) .


Similarly at baseline none of the 80 elders had her records .


This increased in the intervention group to 16.4 % recorded in part and 37.0 % in full ( Z = -7.480 , P = 0.000 ) .


The proportion of complete health management records for children aged 1 to 2years and 3 to 6years increased from 28.6 % and 33.3 % to 66.7 % and 74.2 % respectively ( the difference of children group 3 to 6years of age was statistically significant , Z = -3.860 , p = 0.000 ) .


The proportion of complete basic clinic records in the intervention group increased from 7.6 % to 13.9 % ( Z = -3.252 , P = 0.001 ) .


There were no significant differences in the control group .


The pilot study showed that a on-site education , supervision and technical support tailored to their needs was associated with improvements in village doctors use of EHR .


This model is worthy of implementation in other rural areas .


Blood management is critical in total knee arthroplasty ( TKA ) .


In bilateral , single stage TKA , blood loss seems more prominent .


We believe it is important to control all potential bleeding within the wound tissue .


The purpose of the study was to evaluate a series of topical procedures used to reduce blood loss and transfusion in single-stage bilateral cemented total knee arthroplasty : antifibrinolysis with tranexamic acid , vasoconstriction with epinephrine , sealing of the bone section intraoperatively , and closure of the drainage tube within the first 4 h postoperatively .


Patients with osteoarthritis of the knees were randomly divided into two groups .


In group A , 5 ml ( 25 mg/ml ) tranexamic acid ( TXA ) and 5 ml analgesic containing epinephrine ( 3 g/ml ) solution were injected at several points into the posterior capsule before installation of the prosthesis .


The femoral medullar canal was closed with autograft bone and then sealed compressively with cement .


Before the tourniquet was released , 10 ml TXA solution and 10 ml analgesic containing epinephrine were injected at several points into the periosteum , synovium , joint capsule , tendons , and deep fascia tissue ( injection of analgesic containing epinephrine into subcutaneous fat and dermis was avoided ) .


The residual nail holes in the bone and the uncovered bone section were covered with bone wax .


The tourniquet was then removed , and active bleeding points were stanched .


TXA solution ( 20 ml ) was injected into the articular cavity after wound closure .


The drainage tube was clamped for 4 h , then opened .


In group B , injection of analgesic containing epinephrine into soft tissue , control of active bleeding , and clamping of the drainage tube for 4-h , only , were performed .


Ninety patients were enrolled in the study .


Compared with those in group B , intraoperative blood loss , drainage volume , total postoperative blood loss , and number of patients requiring allogenic blood transfusion were significantly reduced in group A.


There was no significant difference between the incidence of complications in the groups .


Our topical procedures enable effective and safe reduction of blood loss and the number of patients requiring transfusion in single-stage bilateral osteoarthritic TKA .


Evaluate the discal morpho-structural changes as a predictive sign in the clinical outcome after ozone therapy in lumbar disc herniation using the T2-shine through effect in diffusion-weighted imaging ( DWI ) .


One hundred and fifty-four patients suffering from lumbosciatica ( 89 men and 65 women ; age range , 23-62 years ) were included , previous MR study performed with FSE-T2 and T2-fat , SE-T1 and DWI sequences , and were randomly assigned to two groups .


Seventy-seven patients ( control group ) underwent conservative treatment with intraforaminal injection of steroid and anaesthetic .


The remaining 77 patients ( study group ) underwent the same treatment with the addition of oxygen-ozone ( O2-O3 ) .


During the following six months , a MRI follow-up with the same sequences was performed .


An intervertebral disc volumetric analysis ( IDVA ) , DWI signal score and post treatment clinical outcome evaluation were performed for an assessment of hernia reduction .


test , Student 's t test and analysis of covariance were used for comparison of variables .


In the study group , 58 of 77 patients had a successful outcome ( responders ) .


In the responders group , DWI T2-shine through effect was present during MRI follow-up and in particular in 53 of 77 patients in six months of follow-up ( p < 0.05 ) .


Moreover , in the same group a statistically significant disc shrinkage was shown by IDVA in sixth months of follow-up ( p < 0.05 ) .


T2-shine through effect in DWI is present before morphological disc reduction and moreover could be considered as a predictive sign of response to oxygen-ozone treatment .


This update outlines changes to the MObile Technology for Improved Family Planning study statistical analysis plan and plans for long-term follow-up .


These changes result from obtaining additional funding and the decision to restrict the primary analysis to participants with available follow-up data .


The changes were agreed prior to finalising the statistical analysis plan and sealing the dataset .


The primary analysis will now be restricted to subjects with data on the primary outcome at 4-month follow-up .


The extreme-case scenario , where all those lost to follow-up are counted as non-adherent , will be used in a sensitivity analysis .


In addition to the secondary outcomes outlined in the protocol , we will assess the effect of the intervention on long-acting contraception ( implant , intra-uterine device and permanent methods ) .


To assess the long-term effect of the intervention , we plan to conduct additional 12-month follow-up by telephone self-report for all the primary and secondary outcomes used at 4 months .


All participants provided informed consent for this additional follow-up when recruited to the trial .


Outcome measures and analysis at 12 months will be similar to those at the 4-month follow-up .


The primary outcomes of the trial will be the use of an effective modern contraceptive method at 4 months and at 12 months post-abortion .


Secondary outcomes will include long-acting contraception use , self-reported pregnancy , repeat abortion and contraception use over the 12-month post-abortion period .


Restricting the primary analysis to those with follow-up data is the standard approach for trial analysis and will facilitate comparison with other trials of interventions designed to increase contraception uptake or use .


Undertaking 12-month trial follow-up will allow us to evaluate the long-term effect of the intervention .


ClinicalTrials.gov NCT01823861 .


Diuretic unresponsiveness often occurs during hospital admission for acute heart failure ( AHF ) and is associated with adverse outcome .


This study aims to investigate determinants , clinical outcome , and the effects of nesiritide on diuretic response early after admission for AHF .


Diuretic response , defined as weight loss per 40 mg of furosemide or equivalent , was examined from hospital admission to 48 hours in 4,379 patients from the ASCEND-HF trial .


As an additional analysis , a urinary diuretic response metric was investigated in 5,268 patients using urine volume from hospital admission to 24 hours per 40 mg of furosemide or equivalent .


Mean diuretic response was -0.42 kg/40 mg of furosemide ( interquartile range -1.0 , -0.05 ) .


Poor responders had lower blood pressure , more frequent diabetes , long-term use of loop diuretics , poorer baseline renal function , and lower urine output ( all P < .01 ) .


Randomized nesiritide treatment was not associated with diuretic response ( P = .987 ) .


Good diuretic response was independently associated with a significantly decreased risk of 30-day all-cause mortality or heart failure rehospitalization ( odds ratio 0.44 , 95 % CI 0.29-0 .65 , highest vs lowest quintile , P < .001 ) .


Diuretic response based on urine output per 40 mg of furosemide showed similar results in terms of clinical predictors , association with outcome , and the absence of an effect of nesiritide .


Poor diuretic response early after hospital admission for AHF is associated with low blood pressure , renal impairment , low urine output , and an increased risk of death or rehospitalization early after discharge .


Nesiritide had a neutral effect on diuretic response .


- Blockers have a class 1a recommendation in the treatment of patients with ST-elevation myocardial infarctions ( STEMIs ) , as they are associated with a reduced mortality , recurrent myocardial infarction , life-threatening arrhythmias , and with prevention of unfavorable left ventricular remodeling .


Whether early administration before primary percutaneous coronary intervention ( PCI ) of intravenous - blockers reduces the infarct size in the current era is unknown .


We postulate that the early administration of - blockers will reduce the myocardial infarcted area as assessed by magnetic resonance imaging ( MRI ) at 30 days .


In a multinational , multicenter , double-blind , placebo-controlled , randomized trial , patients with symptoms and signs of STEMI and transferred to a hospital for primary PCI will be randomized in a 1:1 fashion to intravenous metoprolol ( 5 mg twice daily ) administration or placebo .


Before admission , study treatment will be started as soon as possible after the diagnosis of STEMI .


After admission , primary PCI will be performed as per standard of care .


After primary PCI , medical treatment will occur as per current guidelines in all patients , including the use of oral - blockers .


The primary end point is the myocardial infarct size as assessed by MRI at 30 days .


Based on a superiority design and assuming an 18 % relative infarct size reduction ( from 28 % to 23.5 % ) , 408 patients are required to be enrolled , accounting for 20 % drop-out ( = .05 and power = 80 % ) .


The EARLY-BAMI trial is a multinational , multicenter , double-blind , placebo-controlled , randomized clinical trial that will investigate the impact of intravenous metoprolol administration before primary PCI for STEMI on myocardial infarct size as measured with MRI at 30 days .


This randomized controlled multicenter trial evaluated coenzyme Q10 ( CoQ10 ) as adjunctive treatment in chronic heart failure ( HF ) .


CoQ10 is an essential cofactor for energy production and is also a powerful antioxidant .


A low level of myocardial CoQ10 is related to the severity of HF .


Previous randomized controlled trials of CoQ10 in HF were underpowered to address major clinical endpoints .


Patients with moderate to severe HF were randomly assigned in a 2-year prospective trial to either CoQ10 100 mg 3 times daily or placebo , in addition to standard therapy .


The primary short-term endpoints at 16 weeks were changes in New York Heart Association ( NYHA ) functional classification , 6-min walk test , and levels of N-terminal pro-B type natriuretic peptide .


The primary long-term endpoint at 2 years was composite major adverse cardiovascular events as determined by a time to first event analysis .


A total of 420 patients were enrolled .


There were no significant changes in short-term endpoints .


The primary long-term endpoint was reached by 15 % of the patients in the CoQ10 group versus 26 % in the placebo group ( hazard ratio : 0.50 ; 95 % confidence interval : 0.32 to 0.80 ; p = 0.003 ) by intention-to-treat analysis .


The following secondary endpoints were significantly lower in the CoQ10 group compared with the placebo group : cardiovascular mortality ( 9 % vs. 16 % , p = 0.026 ) , all-cause mortality ( 10 % vs. 18 % , p = 0.018 ) , and incidence of hospital stays for HF ( p = 0.033 ) .


In addition , a significant improvement of NYHA class was found in the CoQ10 group after 2 years ( p = 0.028 ) .


Long-term CoQ10 treatment of patients with chronic HF is safe , improves symptoms , and reduces major adverse cardiovascular events .


( Coenzyme Q10 as adjunctive treatment of chronic heart failure : a randomised , double-blind , multicentre trial with focus on SYMptoms , BIomarker status [ Brain-Natriuretic Peptide ( BNP ) ] , and long-term Outcome [ hospitalisations/mortality ] ; ISRCTN94506234 ) .


In ARDS , the extent of fibroproliferative activity on chest high-resolution CT ( HRCT ) scan has been reported to correlate with poorer short-term outcomes and pulmonary-associated quality of life .


However , clinical factors associated with HRCT scan fibroproliferation are incompletely characterized .


We questioned if lung compliance assessed at the bedside would be associated with fibroproliferation on HRCT scans obtained during the resolution phase of ARDS .


We used data from a published randomized , controlled clinical trial in ARDS .


All patients were cared for using a low tidal volume strategy .


Demographic data and ventilator parameters were examined in association with radiologic scores from chest HRCT scans obtained 14 days after diagnosis .


Data from 82 patients with ARDS were analyzed .


Average static respiratory compliance over the first 14 days after diagnosis was inversely associated with chest HRCT scan reticulation ( = -0.46 ) ; this relationship persisted in multivariable analysis including APACHE ( Acute Physiology and Chronic Health Evaluation ) II scores , initial Pao2/Fio2 , pneumonia diagnosis , and ventilator days .


Average static respiratory compliance was also lower among patients with bronchiectasis at day 14 ( P = .007 ) .


Initial static respiratory compliance obtained within the first day after ARDS diagnosis was correlated inversely with the presence of HRCT scan reticulation ( = -0.38 ) and was lower among patients who demonstrated bronchiectasis on the day 14 HRCT scan ( P = .008 ) .


In patients with ARDS , diminished lung compliance measured bedside was associated with radiologic fibroproliferation 14 days post diagnosis .


Establishing factors that predispose to development of excessive fibroproliferation with subsequent confirmation by chest HRCT scan represents a promising strategy to identify patients with ARDS at risk for poorer clinical outcomes .


To tackle the problems associated with high-dose dexamethasone ( HD-DXM ) in patients with immune thrombocytopenia ( ITP ) .


To compare the efficacy of HD-DXM with or without low-dose dexamethasone maintenance in untreated ITP patients .


Dexamethasone ( 40 mg/day ) was given in 4-day pulses every 14 days for 3 cycles in 61 patients with ITP .


Among them , 30 cases were given dexamethasone ( 0.035 mg/kg per day ) for maintenance between pulsed HD-DXM and after 3 HD-DXM courses ( HD-DXM-M group ) and another 31 cases did not receive dexamethasone maintenance ( HD-DXM-nM group ) .


The control group comprised the patients who received prednisone ( prednisone group ) .


The following results were obtained : ( 1 ) at the end of the 3rd cycle , the overall response rate ( ORR ) was higher in the HD-DXM group than in the prednisone group ; ( 2 ) the ORR of the HD-DXM group peaked after the 3rd cycle ; ( 3 ) the ORR after each course was higher in the HD-DXM-M group than in the HD-DXM-nM group ; ( 4 ) in the 12th month after HD-DXM discontinuation , the relapse rate of the HD-DXM-M group was lower than that of the other groups ( prednisone and HD-DXM-nM ) .


Treatment with 3 cycles of HD-DXM pulses with low-dose dexamethasone maintenance is an effective method for untreated ITP .


Budesonide inhalation suspension ( BIS ) and montelukast provide acceptable asthma control , whereas overall measures favored BIS in children aged 2 to 8 years with mild persistent asthma .


We compared BIS and montelukast over a 1-year period in children aged 2 to 4 years with asthma .


Data were derived from a 52-week , open-label , randomized , active-controlled , multicenter study ( NCT00641472 ) .


Children with mild asthma received either BIS 0.5 mg or montelukast 4 to 5 mg once daily .


Patients were stepped up to twice-daily BIS or oral corticosteroids for mild or severe asthma worsening , respectively .


Primary efficacy assessment was time to first additional asthma medication for exacerbation over 52 weeks .


Two hundred two patients , age 2 to 4 years , received BIS ( n = 105 ) or montelukast ( n = 97 ) .


No difference was observed between the BIS and montelukast groups in median time to first additional asthma medication over 52 weeks ( 183 vs 86 days ) .


Statistically significant differences were observed in favor of BIS over montelukast in the percentage of patients requiring oral steroids at 52 weeks ( 21.9 % vs 37.1 % ; P = .022 ) , the rate ( number/patient/year ) of additional courses of medication ( 1.35 vs 2.30 ; P = .003 ) , the rate of additional oral steroid therapy ( 0.44 vs 0.88 ; P = .008 ) , and caregivers ' ability to manage the patient 's symptoms ( P = .026 ) .


Both treatments were well tolerated .


BIS and montelukast provided acceptable asthma control in children aged 2 to 4 years with mild persistent asthma with no significant difference between treatments in the primary end point ; however , several secondary outcomes showed statistically significant differences ( and many had numerical differences ) in favor of BIS over montelukast .


Anxiety and affective disorders can be disabling and have a major impact on the ability to work .


In Denmark , people with a mental disorder , and mainly non-psychotic disorders , represent a substantial and increasing part of those receiving disability pensions .


Previous studies have indicated that Individual Placement and Support ( IPS ) has a positive effect on employment when provided to people with severe mental illness .


This modified IPS intervention is aimed at supporting people with recently diagnosed anxiety or affective disorders in regaining their ability to work and facilitate their return to work or education .


To investigate whether an early modified IPS intervention has an effect on employment and education when provided to people with recently diagnosed anxiety or affective disorders in a Danish context .


The trial is a randomised , assessor-blinded , clinical superiority trial of an early modified IPS intervention in addition to treatment-as-usual compared to treatment-as-usual alone for 324 participants diagnosed with an affective disorder or anxiety disorder living in the Capital Region of Denmark .


The primary outcome is competitive employment or education at 24 months .


Secondary outcomes are days of competitive employment or education , illness symptoms and level of functioning including quality of life at follow-up 12 and 24 months after baseline .


If the modified IPS intervention is shown to be superior to treatment-as-usual , a larger number of disability pensions can probably be avoided and long-term sickness absences reduced , with major benefits to society and patients .


This trial will add to the evidence of how best to support people 's return to employment or education after a psychiatric disorder .


NCT01721824 .


Chronic pain and disability of the arm , shoulder , and hand severely affect labor market participation .


Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain .


An alternative strategy could be to increase physical capacity of the worker by physical conditioning .


To investigate the effect of 2 contrasting interventions , conventional ergonomic training ( usual care ) versus resistance training , on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work .


Examiner-blinded , parallel-group randomized controlled trial with allocation concealment .


Slaughterhouses located in Denmark , Europe .


Sixty-six adults with chronic pain in the shoulder , elbow/forearm , or hand/wrist and work disability were randomly allocated to 10 weeks of specific resistance training for the shoulder , arm , and hand muscles for 3 x 10 minutes per week , or ergonomic training and education ( usual care control group ) .


Pain intensity ( average of shoulder , arm , and hand , scale 0 - 10 ) was the primary outcome , and disability ( Work module of DASH questionnaire ) as well as isometric shoulder and wrist muscle strength were secondary outcomes .


Pain intensity , disability , and muscle strength improved more following resistance training than usual care ( P < 0.001 , P = 0.05 , P < 0.0001 , respectively [ corrected ] ) .


Pain intensity decreased by 1.5 points ( 95 % confidence interval -2.0 to -0.9 ) following resistance training compared with usual care , corresponding to an effect size of 0.91 ( Cohen 's d ) .


Blinding of participants is not possible in behavioral interventions .


However , at baseline outcome expectations of the 2 interventions were similar .


Resistance training at the workplace results in clinical relevant improvements in pain , disability , and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work .


NCT01671267 .


Diabetes is a serious metabolic disorder and oxidative stress and inflammation contribute to its pathogenesis and complications .


Since Silybum marianum ( L. ) Gaertn .


( silymarin ) extract is an antioxidant with anti-inflammatory properties , this randomized clinical trial was conducted to evaluate the effects of silymarin supplementation on oxidative stress indices and hs-CRP in type 2 diabetes mellitus patients .


For the present paralleled , randomized , triple-blinded , placebo-controlled clinical trial , 40 type 2 diabetes patients aged 25-50 yr old and on stable medication were recruited from the Iranian Diabetes Society and endocrinology clinics in East Azarbayjan ( Tabriz , Iran ) and randomly assigned into two groups .


Patients in the silymarin treatment group received 140mg , thrice daily of dried extracts of Silybum marianum ( n = 20 ) and those in the placebo group ( n = 20 ) received identical placebos for 45 days .


Data pertaining to height , weight , waist circumference and BMI , as well as food consumption , were collected at base line and at the conclusion of the study .


Fasting blood samples were obtained and antioxidant indices and hs-CRP were assessed at baseline , as well as at the end of the trial .


All 40 patients completed the study and did not report any adverse effects or symptoms with the silymarin supplementation .


Silymarin supplementation significantly increased superoxide dismutase ( SOD ) , glutathione peroxidase ( GPX ) activity and total antioxidant capacity ( TAC ) compared to patients taking the placebo , by 12.85 % , 30.32 % and 8.43 % , respectively ( p < 0.05 ) .


There was a significant reduction in hs-CRP levels by 26.83 % ( p < 0.05 ) in the silymarin group compared to the placebo group .


Malondialdehyde ( MDA ) concentration significantly decreased by 12.01 % ( p < 0.05 ) in the silymarin group compared to the baseline .


Silymarin supplementation improves some antioxidant indices ( SOD , GPX and TAC ) and decrease hs-CRP levels in T2DM patients .


In previous phase 1-2 clinical trials involving older adults , a subunit vaccine containing varicella-zoster virus glycoprotein E and the AS01B adjuvant system ( called HZ/su ) had a clinically acceptable safety profile and elicited a robust immune response .


We conducted a randomized , placebo-controlled , phase 3 study in 18 countries to evaluate the efficacy and safety of HZ/su in older adults ( 50 years of age ) , stratified according to age group ( 50 to 59 , 60 to 69 , and 70 years ) .


Participants received two intramuscular doses of the vaccine or placebo 2 months apart .


The primary objective was to assess the efficacy of the vaccine , as compared with placebo , in reducing the risk of herpes zoster in older adults .


A total of 15,411 participants who could be evaluated received either the vaccine ( 7698 participants ) or placebo ( 7713 participants ) .


During a mean follow-up of 3.2 years , herpes zoster was confirmed in 6 participants in the vaccine group and in 210 participants in the placebo group ( incidence rate , 0.3 vs. 9.1 per 1000 person-years ) in the modified vaccinated cohort .


Overall vaccine efficacy against herpes zoster was 97.2 % ( 95 % confidence interval [ CI ] , 93.7 to 99.0 ; P < 0.001 ) .


Vaccine efficacy was between 96.6 % and 97.9 % for all age groups .


Solicited reports of injection-site and systemic reactions within 7 days after vaccination were more frequent in the vaccine group .


There were solicited or unsolicited reports of grade 3 symptoms in 17.0 % of vaccine recipients and 3.2 % of placebo recipients .


The proportions of participants who had serious adverse events or potential immune-mediated diseases or who died were similar in the two groups .


The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older .


Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups .


( Funded by GlaxoSmithKline Biologicals ; ZOE-50 ClinicalTrials.gov number , NCT01165177 . )


Optimal emergent management of traumatic hemorrhagic shock patients requires a better understanding of treatment provided in the prehospital/Emergency Medical Services ( EMS ) and emergency department ( ED ) settings .


Hypothesis/Problem Described in this research are the initial clinical status , airway management , fluid and blood infusions , and time course of severely-injured hemorrhagic shock patients in the EMS and ED settings from the diaspirin cross-linked hemoglobin ( DCLHb ) clinical trial .


Data were analyzed from 17 US trauma centers gathered during a randomized , controlled , single-blinded efficacy trial of a hemoglobin solution ( DCLHb ) as add-on therapy versus standard therapy .


Among the 98 randomized patients , the mean EMS Glasgow Coma Scale ( GCS ) was 10.6 ( SD = 5.0 ) , the mean EMS revised trauma score ( RTS ) was 6.3 ( SD = 1.9 ) , and the mean injury severity score ( ISS ) was 31 ( SD = 17 ) .


Upon arrival to the ED , the GCS was 20 % lower ( 7.8 ( SD = 5.3 ) vs 9.7 ( SD = 6.3 ) ) and the RTS was 12 % lower ( 5.3 ( SD = 2.0 ) vs 6.0 ( SD = 2.1 ) ) than EMS values in blunt trauma patients ( P < .001 ) .


By ED disposition , 80 % of patients ( 78/98 ) were intubated .


Rapid sequence intubation ( RSI ) was utilized in 77 % ( 60/78 ) , most often utilizing succinylcholine ( 65 % ) and midazolam ( 50 % ) .


The mean crystalloid volume infused was 4.2 L ( SD = 3.4 L ) , 80 % of which was infused within the ED .


Emergency department blood transfusion occurred in 62 % of patients , with an average transfused volume of 1.2 L ( SD = 2.0 L ) .


Blunt trauma patients received 2.1 times more total fluids ( 7.4 L vs 3.5 L , < .001 ) and 2.4 times more blood ( 2.4 L vs 1.0 L , P < .001 ) .


The mean time of patients taken from injury site to operating room ( OR ) was 113 minutes ( SD = 87 minutes ) .


Twenty-one ( 30 % ) of the 70 patients taken to the OR from the ED were sent within 60 minutes of the estimated injury time .


Penetrating trauma patients were taken to the OR 52 % sooner than blunt trauma patients ( 72 minutes vs 149 minutes , P < .001 ) .


Both GCS and RTS decreased prior to ED arrival in blunt trauma patients .


Intubation was performed using RSI , and crystalloid infusion of three times the estimated blood loss volume ( L ) and blood transfusion of the estimated blood loss volume ( L ) were provided in the EMS and ED settings .


Surgical intervention for these trauma patients most often occurred more than one hour from the time of injury .


Penetrating trauma patients received surgical intervention more rapidly than those with a blunt trauma mechanism .


The purpose of this study was to use CT texture analysis to predict overall survival ( OS ) in patients with metastatic melanoma and stable disease ( SD ) according to the Response Evaluation Criteria in Solid Tumors ( RECIST ) on initial posttherapy CT images .


This retrospective study included 42 patients with metastatic melanoma who received bevacizumab therapy in the context of a randomized prospective phase II clinical trial .


Target lesions on the baseline and initial posttherapy contrast-enhanced CT examinations were evaluated by CT texture analysis using TexRAD software before and after image filtering in patients with RECIST SD on initial posttherapy images .


Cox proportional hazards models were used to assess the associations of CT texture analysis measurements and of other patient factors with OS .


The AUC was used to evaluate predictive accuracy .


In multivariate analysis ( in 23 patients with RECIST SD ; median OS , 1.51 years ) , absolute change in mean positive pixels at spatial scaling filter of 4 mm , change in tumor size , and baseline serum lactate dehydrogenase ( LDH ) level were predictors of OS ( hazard ratio [ HR ] = 5.05 for decrease in mean positive pixels at spatial scaling filter of 4 mm vs increase , p = 0.007 ; HR = 4.14 for > 5 % increase in tumor size vs otherwise , p = 0.025 ; and HR = 1.29 for every 100 IU/L increase in baseline LDH level , p = 0.068 ) .


A prognostic index containing these three factors was highly accurate for predicting OS at 18 months ( AUC = 0.917 ) .


In patients with metastatic melanoma and RECIST SD on initial post-therapy CT images , a model incorporating CT texture analysis of target lesions , tumor size changes , and baseline LDH levels was highly accurate in predicting OS .


To determine the vitamin D dose necessary to achieve serum 25-hydroxyvitamin D ( 25 ( OH ) D ) concentration 20 ng/mL during infancy .


A randomized , double-blind , placebo-controlled trial in New Zealand .


Pregnant mothers , from 27 weeks ' gestation to birth , and then their infants , from birth to age 6 months , were randomly assigned to 1 of 3 mother/infant groups : placebo/placebo , vitamin D3 1000/400 IU , or vitamin D3 2000/800 IU .


Serum 25 ( OH ) D and calcium concentrations were measured at enrollment , 36 weeks ' gestation , in cord blood , and in infants at 2 , 4 , and 6 months of age .


Two-hundred-and-sixty pregnant women were randomized .


At enrollment , the proportions with serum 25 ( OH ) D 20 ng/mL for placebo , lower-dose , and higher-dose groups were 54 % , 64 % , and 55 % , respectively .


The proportion with 25 ( OH ) D 20 ng/mL was larger in both intervention groups at 36 weeks ' gestation ( 50 % , 91 % , 89 % , P < .001 ) .


In comparison with placebo , the proportion of infants with 25 ( OH ) D 20 ng/mL was larger in both intervention groups to age 4 months : cord blood ( 22 % , 72 % , 71 % , P < .001 ) , 2 months ( 50 % , 82 % , 92 % , P < .001 ) , and 4 months ( 66 % , 87 % , 87 % , P = .004 ) , but only in the higher-dose group at age 6 months ( 74 % , 82 % , 89 % , P = .07 ; higher dose versus placebo P = .03 , lower dose versus placebo P = .21 ) .


Daily vitamin D supplementation during pregnancy and then infancy with 1000/400 IU or 2000/800 IU increases the proportion of infants with 25 ( OH ) D 20 ng/mL , with the higher dose sustaining this increase for longer .


Botulinum toxin injection for lateral canthal rhytids has been reported to result in dry eye , but its effect on tear film stability and tear production has not been studied thoroughly .


To investigate the effect of botulinum toxin type A on tear film stability and tear production after treatment of lateral canthal rhytids .


We performed a clinical intervention study at a regional hospital in Taiwan of 58 women 30 to 60 years of age with lateral canthal rhytids from January 1 through December 31 , 2011 .


Botulinum toxin type A at 2 different preparations and doses ( dose A : 3 injections of 2 U in 0.05 mL of normal saline per injection ; dose B : 3 injections of 4 U in 0.05 mL of normal saline per injection ) was injected at the lateral canthal areas .


One eye of each study participant was randomly chosen for dose A , and the other eye received dose B.


Baseline tear film break-up time ( TBUT ) and Schirmer tests without and with anesthesia were measured before and at 1 week , 1 month , 3 months , and 6 months after botulinum toxin injection .


The TBUT and Schirmer test results were compared between different periods and doses .


The TBUT decreased significantly at 1 week after botulinum toxin type A injection ( P = .003 ) , and the effect persisted at 1 month and 3 months after treatment ( P = .01 and .02 , respectively ) .


In younger participants , the TBUT recovered faster than in older patients .


The results of the Schirmer tests without and with anesthesia decreased gradually , with significant reduction at 1 month after treatment ( P = .05 and .02 , respectively ) and then recovered gradually .


Both the TBUT and Schirmer test results decreased more in eyes that received dose B than in those that received dose A ; however , none of the differences were statistically significant .


Tear film stability decreased as early as 1 week after botulinum toxin type A treatment for lateral canthal rhytids , and the effect persisted for more than 3 months .


Tear production decreased to the trough at 1 month after treatment and then recovered gradually .


Contrast sensitivity sometimes increases in patients with open-angle glaucoma when intraocular pressure ( IOP ) is decreased .


Although often interpreted as demonstrating reversible glaucoma-induced dysfunction , this result , if true , could simply reflect a general relationship between sensitivity and IOP in visual mechanisms unaffected by glaucoma .


To investigate this relationship , we test the hypothesis that reducing IOP in eyes without glaucoma ( ocular hypertension ) does not increase perimetric contrast sensitivity .


Comparative case series .


A total of 692 participants drawn from the Ocular Hypertension Treatment Study ( OHTS ) ( 22 clinical centers ) .


Commercially available topical ocular hypotensive medications .


Post hoc analysis of IOP and perimetric contrast sensitivity ( mean deviation [ MD ] and pattern standard deviation [ PSD ] ) both at baseline ( 0 months , immediately before ocular antihypertensive therapy ) and at 6-month review .


An additional 618 control eyes from OHTS that did not receive treatment were examined over the same period .


Data from the second phase of OHTS also were examined , and control eyes then received treatment .


Treated eyes had a decrease in IOP at 6 months ( 5.1 mmHg , P < 0.001 ) but no significant change in MD ( 0.04 decibels [ dB ] , P = 0.59 ) or PSD ( 0.03 dB , P = 0.19 ) , relative to controls .


A similar decrease in IOP was found for eyes that began treatment in the second phase of OHTS , but no significant change in MD or PSD .


Despite using a large sample size , we found no relationship between perimetric contrast sensitivity and IOP reduction in ocular hypertension , which suggests that previous sensitivity changes seen in patients with glaucoma , if true , are indicative of reversible glaucoma-induced dysfunction rather than a general relationship between sensitivity and IOP in visual mechanisms unaffected by glaucoma .


Utilization rates ( URs ) for implantable cardioverter-defibrillators ( ICDs ) for primary prevention of sudden cardiac death ( PPSCD ) are lacking in the community .


The purpose of this study was to establish the ICD UR in central Indiana .


A query run on 2 hospitals in a health information exchange database in Indianapolis identified patients between 2011 and 2012 with left ventricular ejection fraction ( EF ) 0.35 .


ICD eligibility and utilization were determined from chart review .


We identified 1863 patients with at least 1 low EF study .


Two cohorts were analyzed : 1672 patients without and 191 patients with International Classification of Diseases , Ninth Revision , Clinical Modification procedure code 37.94 for ICD placement .


We manually reviewed a stratified ( by hospital ) random sample of 300 patients from the no-ICD procedure code cohort and found that 48 ( 16 % ) had no ICD but had class I indications for ICD .


Eight of 300 ( 2.7 % ) actually had ICD implantation for PPSCD .


Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD .


The ICD UR ( ratio between patients with ICD for PPSCD and all with indication ) was 38 % overall ( 95 % confidence interval [ CI ] 28 % -49 % ) .


URs were 48 % for males ( 95 % CI 34 % -61 % ) , 21 % for females ( 95 % CI 16 % -26 % , P = .0002 vs males ) , 40 % for whites ( 95 % CI 27 % -53 % ) , and 37 % for blacks ( 95 % CI 28 % -46 % , P = .66 vs whites ) .


ICD UR is 38 % among patients meeting class I indications , suggesting further opportunities for improving guideline compliance .


This study also illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review .


Diabetic foot wounds are a highly morbid and costly complication of diabetes mellitus .


Targeted amino acid supplementation , by increasing tissue hydroxyproline concentrations , has been implicated in improved wound outcomes in surgical incisions and chronic wounds , and after radiation injury .


A major component of collagen , hydroxyproline is a surrogate marker used commonly for tissue collagen concentrations .


This paper reviews the literature pertaining to amino acid supplementation and wound healing , and also evaluates our pilot data relating to supplementation with arginine , glutamine , and beta-hydroxy-beta-methylbutyrate ( HMB ) in the treatment of diabetic foot ulcers .


For the pilot study , nine patients scheduled to undergo wound debridement for diabetic foot ulcers were randomized prospectively to be a part of either a placebo group or a treatment group that received supplementation twice daily for 2 wks .


Tissue samples were collected both before and after 2 wk of supplementation .


The results of assay of the samples for hydroyproline were then analyzed via a one tailed Student t-test to evaluate tissue concentrations of hydroxyproline .


For the literature review in the study , the MEDLINE/PubMed database was reviewed , using search terms contained in the Medical Subject Headings ( MeSH ) .


The treatment group in the study exhibited a significantly greater hydroxyproline concentration after supplementation than before it ( p = 0.03 ) .


The mean percent change in the tissue hydroxyproline concentration for arginine , glutamine , and HMB group was +67.8 % , with a standard deviation ( SD ) of 129.89 .


The mean percent change for the corresponding amino acids in the placebo group was -78.4 % , with an SD of 20.55 .


The review of the MEDLINE/PubMed literature revealed only two human studies of amino acid supplementation in patients with diabetic foot wounds , one of which found a significant improvement in wound-depth and wound-appearance scores .


Given the results of our pilot study , and on the basis of a review of the literature , the administration of a simple amino acid supplement may improve the healing of diabetic foot wounds via increased collagen production .


Using a through-the-needle local anesthetic bolus technique , ultrasound-guided infraclavicular perineural catheters have been shown to provide greater analgesia compared to supraclavicular catheters .


A through-the-catheter bolus technique , which arguably `` tests '' the anesthetic efficacy of the catheter before initiating an infusion , has been validated for infraclavicular catheters but not supraclavicular catheters .


This study investigated the through-the-catheter bolus technique for supraclavicular catheters and tested the hypothesis that infraclavicular catheters provide faster onset of brachial plexus anesthesia .


Preoperatively , patients were randomly assigned to receive either a supraclavicular or an infraclavicular catheter using an ultrasound-guided nonstimulating catheter insertion technique with a mepivacaine bolus via the catheter and ropivacaine perineural infusion initiated postoperatively .


The primary outcome was time to achieve complete sensory anesthesia in the ulnar and median nerve distributions .


Secondary outcomes included procedural time , procedure-related pain and complications , and postoperative pain , opioid consumption , sleep disturbances , and motor weakness .


Fifty patients were enrolled in the study ; all but 2 perineural catheters were successfully placed per protocol .


Twenty-one of 24 ( 88 % ) and 24 of 24 ( 100 % ) patients in the supraclavicular and infraclavicular groups , respectively , achieved complete sensory anesthesia by 30 minutes ( P = .088 ) .


There was no difference in the time to achieve complete sensory anesthesia .


Supraclavicular patients reported more sleep disturbances postoperatively , but there were no statistically significant differences in other outcomes .


Both supraclavicular and infraclavicular perineural catheters using a through-the-catheter bolus technique provide effective brachial plexus anesthesia .


Idarucizumab is a monoclonal antibody fragment that binds dabigatran with high affinity in a 1:1 molar ratio .


We investigated the safety , tolerability , and efficacy of increasing doses of idarucizumab for the reversal of anticoagulant effects of dabigatran in a two-part phase 1 study ( rising-dose assessment and dose-finding , proof-of-concept investigation ) .


Here we present the results of the proof-of-concept part of the study .


In this randomised , placebo-controlled , double-blind , proof-of-concept phase 1 study , we enrolled healthy volunteers ( aged 18-45 years ) with a body-mass index of 185-299 kg/m ( 2 ) into one of four dose groups at SGS Life Sciences Clinical Research Services , Belgium .


Participants were randomly assigned within groups in a 3:1 ratio to idarucizumab or placebo using a pseudorandom number generator and a supplied seed number .


Participants and care providers were masked to treatment assignment .


All participants received oral dabigatran etexilate 220 mg twice daily for 3 days and a final dose on day 4 .


Idarucizumab ( 1 g , 2 g , or 4 g 5-min infusion , or 5 g plus 25 g in two 5-min infusions given 1 h apart ) was administered about 2 h after the final dabigatran etexilate dose .


The primary endpoint was incidence of drug-related adverse events , analysed in all randomly assigned participants who received at least one dose of dabigatran etexilate .


Reversal of diluted thrombin time ( dTT ) , ecarin clotting time ( ECT ) , activated partial thromboplastin time ( aPTT ) , and thrombin time ( TT ) were secondary endpoints assessed by measuring the area under the effect curve from 2 h to 12 h ( AUEC2-12 ) after dabigatran etexilate ingestion on days 3 and 4 .


This trial is registered with ClinicalTrials.gov , number NCT01688830 .


Between Feb 23 , and Nov 29 , 2013 , 47 men completed this part of the study .


12 were enrolled into each of the 1 g , 2 g , or 5 g plus 25 g idarucizumab groups ( nine to idarucizumab and three to placebo in each group ) , and 11 were enrolled into the 4 g idarucizumab group ( eight to idarucizumab and three to placebo ) .


Drug-related adverse events were all of mild intensity and reported in seven participants : one in the 1 g idarucizumab group ( infusion site erythema and hot flushes ) , one in the 5 g plus 25 g idarucizumab group ( epistaxis ) ; one receiving placebo ( infusion site haematoma ) , and four during dabigatran etexilate pretreatment ( three haematuria and one epistaxis ) .


Idarucizumab immediately and completely reversed dabigatran-induced anticoagulation in a dose-dependent manner ; the mean ratio of day 4 AUEC2-12 to day 3 AUEC2-12 for dTT was 101 with placebo , 026 with 1 g idarucizumab ( 74 % reduction ) , 006 with 2 g idarucizumab ( 94 % reduction ) , 002 with 4 g idarucizumab ( 98 % reduction ) , and 001 with 5 g plus 25 g idarucizumab ( 99 % reduction ) .


No serious or severe adverse events were reported , no adverse event led to discontinuation of treatment , and no clinically relevant difference in incidence of adverse events was noted between treatment groups .


These phase 1 results show that idarucizumab was associated with immediate , complete , and sustained reversal of dabigatran-induced anticoagulation in healthy men , and was well tolerated with no unexpected or clinically relevant safety concerns , supporting further testing .


Further clinical studies are in progress .


Boehringer Ingelheim Pharma GmbH & Co KG .


Recent studies indicate that persistent intestinal inflammation in patients with Crohn 's disease ( CD ) might be caused by abnormal intestinal microbiota .


This hypothesis may suggest a beneficial effect of antibiotics in CD therapy .


So far , guidelines do not recommend antibiotics except in the treatment of complicated CD , and there are few studies on the effects of rifaximin in these patients .


Between December 2011 and December 2012 , we performed a blinded randomized trial in 168 patients with a previous history of moderately active CD concerning the efficacy of rifaximin .


All the patients had previously achieved remission with standard therapy ( prednisone/budesonide ) .


Data from patients receiving 800 mg of rifaximin ( 83 patients ) twice a day for 12 weeks were compared with those from patients who received placebo ( 83 patients ) .


The primary endpoint was maintaining remission during the follow-up .


All the patients ( 100 % ; 83/83 ) on 800 mg of rifaximin were in remission after 12 weeks of treatment in comparison with 84 % ( 70/83 ) of the placebo group .


This significant difference was also persistent at the 24-week follow-up [ 78 % ( 65/83 ) vs. 41 % ( 34/83 ) , respectively ] .


The last evaluation performed at 48 weeks revealed disease activity in 45 % ( 38/83 ) of the patients of the rifaximin group , i.e. a significant decrease compared with the placebo group [ 75 % ( 63 of 83 ) ] .


Remission previously obtained with standard treatment can be sustained in patients with moderately active CD after the administration of 800 mg of rifaximin .


It is well known that to acquire sensorimotor ( SMR ) - based brain-computer interface ( BCI ) control requires a training period before users can achieve their best possible performances .


Nevertheless , the effect of this training procedure on the cortical activity related to the mental imagery ability still requires investigation to be fully elucidated .


The aim of this study was to gain insights into the effects of SMR-based BCI training on the cortical spectral activity associated with the performance of different mental imagery tasks .


Linear cortical estimation and statistical brain mapping techniques were applied on high-density EEG data acquired from 18 healthy participants performing three different mental imagery tasks .


Subjects were divided in two groups , one of BCI trained subjects , according to their previous exposure ( at least six months before this study ) to motor imagery-based BCI training , and one of subjects who were naive to any BCI paradigms .


Cortical activation maps obtained for trained and naive subjects indicated different spectral and spatial activity patterns in response to the mental imagery tasks .


Long-term effects of the previous SMR-based BCI training were observed on the motor cortical spectral activity specific to the BCI trained motor imagery task ( simple hand movements ) and partially generalized to more complex motor imagery task ( playing tennis ) .


Differently , mental imagery with spatial attention and memory content could elicit recognizable cortical spectral activity even in subjects completely naive to ( BCI ) training .


The present findings contribute to our understanding of BCI technology usage and might be of relevance in those clinical conditions when training to master a BCI application is challenging or even not possible .


To observe the intervention effect of Leihong Granule ( LG ) in in-stent restenosis ( ISR ) after endovascular therapy for lower extremity arterial occlusive diseases ( LEAOD ) .


Recruited 80 LEAOD patients who successfully underwent endovascular therapy ( balloon dilation and stent implantation ) were randomly assigned to two groups , the control group and the LG group , 40 in each group .


Patients in the control group received basic treatment , while those in the LG group additionally took LG for 3 months .


Plasma levels of IL-10 , IL-18 , CRP , and the intima-media thickness ( IMT ) of lower extremity artery were observed in the two groups between and after treatment .


The rate of stent patency , ABI , intermittent claudication , rest pain , and the incidence of amputation the two groups were recorded and observed in the two groups .


In the control group , serum levels of IL-10 , IL-18 , CRP , and IMT were significantly higher one month after surgery than before surgery ( P < 0.05 ) .


There was no significant difference in serum levels of IL-10 , IL-18 , CRP , or IMT between the two groups before surgery ( P > 0.05 ) .


These indices were obviously lower in the LG group than in the control group after surgery ( P < 0.05 ) .


Compared with the control group , the incidence rates of intermittent claudication and the rest pain at 6 months and 12 months after surgery significantly decreased ( P < 0.05 ) .


The stent patency rate at 6 months and 12 months after surgery , and ABI were significantly higher than those of the control group ( P < 0.05 ) .


There was no statistical difference in the amputation rate between the two groups ( P > 0.05 ) .


LG might effectively improve ischemic symptoms of affected limbs possibly through lowering the ISR rate after endovascular therapy for LEAOD through preventing immunosuppressive actions .


The aim of the study ; LCoMotion - Learning , Cognition and Motion was to develop , document , and evaluate a multi-component physical activity ( PA ) intervention in public schools in Denmark .


The primary outcome was cognitive function .


Secondary outcomes were academic skills , body composition , aerobic fitness and PA. .


The primary aim of the present paper was to describe the rationale , design and methods of the LCoMotion study .


LCoMotion was designed as a cluster-randomized controlled study .


Fourteen schools from all five regions in Denmark participated .


All students from 6th and 7th grades were invited to participate ( n = 869 ) and consent was obtained for 87 % ( n = 759 ) .


Baseline measurements were obtained in November/December 2013 and follow-up measurements in May/June 2014 .


The intervention lasted five months and consisted of a `` package '' of three main components : PA during academic lessons , PA during recess and PA homework .


Furthermore a cycling campaign was conducted during the intervention period .


Intervention schools should endeavor to ensure that students were physically active for at least 60 min every school day .


Cognitive function was measured by a modified Eriksen flanker task and academic skills by a custom made mathematics test .


PA was objectively measured by accelerometers ( ActiGraph , GT3X and GT3X + ) and aerobic fitness assessed by an intermittent shuttle-run test ( the Andersen intermittent running test ) .


Furthermore , compliance with the intervention was assessed by short message service ( SMS ) - tracking and questionnaires were delivered to students , parents and teachers .


LCoMotion has ability to provide new insights on the effectiveness of a multicomponent intervention on cognitive function and academic skills in 6th and 7th grade students .


Clinicaltrials.gov : NCT02012881 ( 10/10/2013 ) .


Medication treatment decisions in heart failure ( HF ) are currently informed by measurements of brachial artery pressure , but ventricular afterload is more accurately represented by central aortic pressure , which differs from brachial pressure .


We sought to determine whether aggressive titration of vasoactive medicines beyond goal-directed heart failure medical therapy ( GDMT ) based upon aortic pressure improves exercise capacity and cardiovascular structure-function .


Subjects with chronic HF ( n = 50 ) underwent cardiopulmonary exercise testing , echocardiography , and arterial tonometry to measure aortic pressure and augmentation index , and were then randomized to aortic pressure-guided treatment ( active , n = 23 ) or conventional therapy ( control , n = 27 ) .


Subjects returned for 6 monthly visits wherein GDMT was first optimized .


Additional vasoactive therapies were then sequentially added with the goal to reduce aortic augmentation index to 0 % ( active ) or if brachial pressure remained elevated ( control ) .


Subjects randomized to active treatment experienced greater improvement in peak oxygen consumption compared with controls ( 1.373.76 versus -0.652.21 mL min ( -1 ) kg ( -1 ) , P = 0.025 ) though reductions in aortic augmentation index were similar ( -79 % versus -56 % , P = 0.46 ) .


Forward stroke volume increased while arterial elastance and left ventricular volumes decreased in all participants , with no between-group difference .


Subjects randomized to active treatment were more likely to receive additional vasoactive therapies including nitrates , aldosterone antagonists and hydralazine , with no increased risk of hypotension or worsening renal function .


Maximization of goal-directed medical therapy in heart failure patients may enhance afterload reduction and lead to reverse remodeling , while additional medicine titration based upon aortic pressure data improves exercise capacity in patients with heart failure .


Haemorrhage is a common cause of death in trauma patients .


Although transfusions are extensively used in the care of bleeding trauma patients , there is uncertainty about the balance of risks and benefits and how this balance depends on the baseline risk of death .


Our objective was to evaluate the association of red blood cell ( RBC ) transfusion with mortality according to the predicted risk of death .


A secondary analysis of the CRASH-2 trial ( which originally evaluated the effect of tranexamic acid on mortality in trauma patients ) was conducted .


The trial included 20,127 trauma patients with significant bleeding from 274 hospitals in 40 countries .


We evaluated the association of RBC transfusion with mortality in four strata of predicted risk of death : < 6 % , 6 % -20 % , 21 % -50 % , and > 50 % .


For this analysis the exposure considered was RBC transfusion , and the main outcome was death from all causes at 28 days .


A total of 10,227 patients ( 50.8 % ) received at least one transfusion .


We found strong evidence that the association of transfusion with all-cause mortality varied according to the predicted risk of death ( p-value for interaction < 0.0001 ) .


Transfusion was associated with an increase in all-cause mortality among patients with < 6 % and 6 % -20 % predicted risk of death ( odds ratio [ OR ] 5.40 , 95 % CI 4.08-7 .13 , p < 0.0001 , and OR 2.31 , 95 % CI 1.96-2 .73 , p < 0.0001 , respectively ) , but with a decrease in all-cause mortality in patients with > 50 % predicted risk of death ( OR 0.59 , 95 % CI 0.47-0 .74 , p < 0.0001 ) .


Transfusion was associated with an increase in fatal and non-fatal vascular events ( OR 2.58 , 95 % CI 2.05-3 .24 , p < 0.0001 ) .


The risk associated with RBC transfusion was significantly increased for all the predicted risk of death categories , but the relative increase was higher for those with the lowest ( < 6 % ) predicted risk of death ( p-value for interaction < 0.0001 ) .


As this was an observational study , the results could have been affected by different types of confounding .


In addition , we could not consider haemoglobin in our analysis .


In sensitivity analyses , excluding patients who died early ; conducting propensity score analysis adjusting by use of platelets , fresh frozen plasma , and cryoprecipitate ; and adjusting for country produced results that were similar .


The association of transfusion with all-cause mortality appears to vary according to the predicted risk of death .


Transfusion may reduce mortality in patients at high risk of death but increase mortality in those at low risk .


The effect of transfusion in low-risk patients should be further tested in a randomised trial .


www.ClinicalTrials.gov NCT01746953 .


The objective of this trial was to determine how a mucoadhesive hydrogel ( MuGard ) , a marketed medical device , would fare when tested with the strictness of a conventional multi-institutional , double-blind , randomized , placebo-controlled study format .


A total of 120 subjects planned to receive chemoradiation therapy ( CRT ) for treatment of head and neck cancers were randomized to receive either MuGard or sham control rinse ( SC ) during CRT .


Subjects completed the validated Oral Mucositis Daily Questionnaire .


Weight , opiate use , and World Health Organization ( WHO ) oral mucositis ( OM ) scores were recorded .


Subjects who dosed at least once daily during the first 2.5 weeks of CRT were included in the efficacy analysis .


Of 120 subjects enrolled , 78 ( SC , N = 41 ; MuGard , N = 37 ) were eligible for efficacy analysis .


Both cohorts were similar in demographics , baseline characteristics , primary tumor type , and planned CRT regimen .


MuGard effectively mitigated OM symptoms as reflected by area under the curve of daily patient-reported oral soreness ( P = .034 ) and WHO scores on the last day of radiation therapy ( P = .038 ) .


MuGard was also associated with nonsignificant trends related to therapeutic benefit including opioid use duration , and OM scores ( WHO criteria ) at CRT week 4 .


Rinse compliance was identical between cohorts .


No significant adverse events were reported , and the adverse event incidence was similar between cohorts .


Testing MuGard , a rinse marketed as a device , in a standard clinical trial format demonstrated its superiority to SC in mitigating OM symptoms , delaying OM progression , and its safety and tolerability .


The European Organization for Research and Treatment of Cancer ( EORTC ) 24954 phase 3 randomized clinical trial compared 2 schemes of combined chemotherapy for patients with resectable cancers of the hypopharynx and larynx : sequential induction chemotherapy and radiotherapy versus alternating chemoradiotherapy .


The current study reports detailed effects of both treatment arms on health-related quality of life ( HRQOL ) and symptoms .


A total of 450 patients aged 35 years to 76 years ( World Health Organization performance status ( WHO PS ) 2 ) with untreated , resectable advanced squamous cell carcinoma of the larynx ( tumor classification of T3-T4 ) or hypopharynx ( tumor classification of T2-T3-T4 ) with regional lymph nodes in the neck classified as N0 to N2 with no metastases were randomized in this prospective phase 3 trial into either the sequential arm ( control ) or the alternating arm ( experimental ) .


QOL assessment was performed at randomization ; at baseline ; at 42 days ; and at 6 , 12 , 24 , 36 , and 48 months .


There were no observed differences with regard to the primary endpoint of Fatigue and secondary endpoint of Dyspnea .


Significant differences were found in the secondary endpoints of Swallowing and Speech problems at 42 days after randomization in favor of patients in the sequential arm .


Explanatory and sensitivity analysis revealed that the primary analysis favored the sequential arm , but the majority of differences in HRQOL did not exist at the end of treatment , and returned to baseline levels .


In the current study , a trend toward worse scores was noted in the patients treated on the alternating chemoradiotherapy arm but very few differences reached the level of statistical significance .


The HRQOL scores of the majority of patients returned to baseline after therapy .


This study sought to establish the efficacy of single-lead , 3-wk peripheral nerve stimulation ( PNS ) therapy for pain reduction in stroke survivors with chronic hemiplegic shoulder pain .


This study is a single-site , pilot , randomized controlled trial of adults with chronic shoulder pain after stroke .


Participants were randomized to receive a 3-wk treatment of single-lead PNS or usual care .


The primary outcome was the worst pain in the last week ( Brief Pain Inventory , Short Form , question 3 ) measured at baseline and weeks 1 , 4 , 12 , and 16 .


The secondary outcomes included pain interference ( Brief Pain Inventory , Short Form , question 9 ) , pain measured by the ShoulderQ Visual Graphic Rating Scales , and health-related quality-of-life ( Short-Form 36 version 2 ) .


Twenty-five participants were recruited , 13 to PNS and 12 to usual care .


There was a significantly greater reduction in pain for the PNS group compared with the controls , with significant differences at 6 and 12 wks after treatment .


Both PNS and usual care were associated with significant improvements in pain interference and physical health-related quality-of-life .


Short-term PNS is a safe and efficacious treatment of shoulder pain .


Pain reduction is greater compared with usual care and is maintained for at least 12 wks after treatment .


When a surgeon uses a percutaneous volar approach to treat scaphoid waist fractures , central screw placement is complicated by the shape of the scaphoid and by obstruction by the trapezium .


In this study , we used radiographs and biomechanical tests to compare the standard volar percutaneous approach with the transtrapezial approach , with regard to central screw placement at the distal pole of the scaphoid .


Fourteen matched pairs of cadaveric wrists were randomly assigned to two treatment groups .


Under fluoroscopic control , a guidewire was drilled into the scaphoid , either through a transtrapezial approach or through a standard volar approach that avoided the trapezium .


Guidewire position was measured in the coronal and sagittal planes .


A transverse osteotomy was performed along the scaphoid waist , and this was followed by the insertion of the longest possible cannulated headless bone screw .


Each specimen was placed into a fixture with a pneumatically driven plunger resting on the surface of the distal pole .


Load was applied by using a load-controlled test protocol in a hydraulic testing machine .


All guidewires were inside the central one-third of the proximal pole .


The guidewire positions at the distal pole differed significantly between the transtrapezial and standard volar approach groups ( p < 0.001 ) .


The load to 2 mm of displacement and the load to failure averaged , respectively , 324.4 N ( standard error of the mean [ SEM ] = 73.5 N ) and 386.4 N ( SEM = 65.6 N ) for the transtrapezial approach group compared with 125.7 N ( SEM = 22.6 N ) ( p = 0.002 ) and 191.4 N ( SEM = 36.30 N ) ( p = 0.005 ) for the standard volar approach group .


The data suggest that , in a cadaveric osteotomy-simulated scaphoid waist fracture model , the transtrapezial approach reliably achieves central positioning of a screw in the proximal and distal poles .


This position offers a biomechanical advantage compared with central placement in only the proximal pole .


The characteristics of each inhalation maneuver when patients use dry powder inhalers ( DPIs ) are important , because they control the quality of the emitted dose .


We have measured the inhalation profiles of asthmatic children [ CHILD ; n = 16 , mean forced expiratory volume in 1sec ( FEV1 ) 79 % predicted ] , asthmatic adults ( ADULT ; n = 53 , mean predicted FEV1 72 % ) , and chronic obstructive pulmonary disease ( COPD ; n = 29 , mean predicted FEV1 42 % ) patients when they inhaled through an Aerolizer , Diskus , Turbuhaler , and Easyhaler using their `` real-life '' DPI inhalation technique .


These are low - , medium - , medium/high - , and high-resistance DPIs , respectively .


The inhalation flow against time was recorded to provide the peak inhalation flow ( PIF ; in L/min ) , the maximum pressure change ( P ; in kPa ) , acceleration rates ( ACCEL ; in kPa/sec ) , time to maximum inhalation , the length of each inhalation ( in sec ) , and the inhalation volume ( IV ; in liters ) of each inhalation maneuver .


PIF , P , and ACCEL values were consistent with the order of the inhaler 's resistance .


For each device , the inhalation characteristics were in the order ADULT > COPD > CHILD for PIF , P , and ACCEL ( p < 0.001 ) .


The results showed a large variability in inhalation characteristics and demonstrate the advantages of P and ACCEL rather than PIFs .


Overall inhaled volumes were low , and only one patient achieved an IV > 4L and P > 4kPa .


The large variability of these inhalation characteristics and their range highlights that if inhalation profiles were used with compendial in vitro dose emission measurements , then the results would provide useful information about the dose patients inhale during routine use .


The inhalation characteristics highlight that adults with asthma have greater inspiratory capacity than patients with COPD , whereas children with asthma have the lowest .


The significance of the inhaled volume to empty doses from each device requires investigation .


Median survival of non-small cell lung cancer ( NSCLC ) patients with brain metastases is poor .


We examined concurrent erlotinib and whole brain radiotherapy ( WBRT ) followed by maintenance erlotinib in patients with untreated brain metastases , given the potential radiosensitizing properties of erlotinib and its direct effect on brain metastases and systemic activity .


Eighty NSCLC patients with KPS of 70 and greater and multiple brain metastases were randomly assigned to placebo ( n = 40 ) or erlotinib ( 100mg , n = 40 ) given concurrently with WBRT ( 20 Gy in 5 fractions ) .


Following WBRT , patients continued with placebo or erlotinib ( 150 mg ) until disease progression .


The primary end point was neurological progression-free survival ( nPFS ) ; hazard ratios ( HRs ) were calculated using Cox regression .


All P values were two-sided .


Fifteen patients ( 37.5 % ) from each arm were alive and without neurological progression 2 months after WBRT .


Median nPFS was 1.6 months in both arms ; nPFS HR 0.95 ( 95 % CI = 0.59 to 1.54 ; P = .84 ) .


Median overall survival ( OS ) was 2.9 and 3.4 months in the placebo and erlotinib arms ; HR 0.95 ( 95 % CI = 0.58 to 1.55 ; P = .83 ) .


The frequency of epidermal growth factor receptor ( EGFR ) mutations was low with only 1 of 35 ( 2.9 % ) patients with available samples had activating EGFR-mutations .


Grade 3/4 adverse event rates were similar between the two groups ( 70.0 % in each arm ) , except for rash 20.0 % ( erlotinib ) vs 5.0 % ( placebo ) , and fatigue 17.5 % vs 35.0 % .


No statistically significant quality of life differences were found .


Our study showed no advantage in nPFS or OS for concurrent erlotinib and WBRT followed by maintenance erlotinib in patients with predominantly EGFR wild-type NSCLC and multiple brain metastases compared to placebo .


Future studies should focus on the role of erlotinib with or without WBRT in patients with EGFR mutations .


Osmotic-controlled release oral delivery system ( OROS ) hydromorphone - an extended-release preparation - is recommended long-term therapy for chronic pain patients .


Dose proportionality of OROS hydromorphone has been shown in healthy Caucasian volunteers ; however , no studies have been conducted in Asian populations .


To determine whether ethnic differences affect the drug 's pharmacokinetic ( PK ) profile , we evaluated the dose proportionality of OROS hydromorphone in healthy Taiwanese adults .


This 12-week , open-label , 4-way crossover , phase 1 study randomly assigned subjects to 1 of 4 treatment sequences - single oral dose OROS hydromorphone : 8 mg , 16 mg , 32 mg , or 64 mg - along with 50 mg naltrexone .


Dose proportionality was assessed using a linear mixed-effects model to estimate the slope of the regression line and its 90 % CI for Cmax , AUC0-48h , and AUClast .


Descriptive statistics measured plasma hydromorphone concentrations , PK parameters , laboratory analytes , and vital signs .


23 subjects completed the study ; a single-dose of OROS hydromorphone increased plasma concentration steadily for 6 hours and sustained it at or near maximum levels for ~ 24 hours .


After dose normalization to a 16 mg dose , all studied doses demonstrated dose proportionality for Cmax , AUClast , and AUC0-48h , as the slopes of the regression lines for Cmax , AUClast , and AUC0-48h were close to zero , and the 90 % CIs within pre-specified limits .


Adverse events were as expected for hydromorphone administered with concomitant naltrexone .


Single doses of 8 mg , 16 mg , 32 mg , and 64 mg of OROS hydromorphone were found to be dose proportional for Cmax , AUClast , and AUC0-48h and were generally safe and well-tolerated in healthy Taiwanese adults .


Treatment with inhaled glucocorticoids in combination with long-acting bronchodilators is recommended in patients with frequent exacerbations of severe chronic obstructive pulmonary disease ( COPD ) .


However , the benefit of inhaled glucocorticoids in addition to two long-acting bronchodilators has not been fully explored .


In this 12-month , double-blind , parallel-group study , 2485 patients with a history of exacerbation of COPD received triple therapy consisting of tiotropium ( at a dose of 18 g once daily ) , salmeterol ( 50 g twice daily ) , and the inhaled glucocorticoid fluticasone propionate ( 500 g twice daily ) during a 6-week run-in period .


Patients were then randomly assigned to continued triple therapy or withdrawal of fluticasone in three steps over a 12-week period .


The primary end point was the time to the first moderate or severe COPD exacerbation .


Spirometric findings , health status , and dyspnea were also monitored .


As compared with continued glucocorticoid use , glucocorticoid withdrawal met the prespecified noninferiority criterion of 1.20 for the upper limit of the 95 % confidence interval ( CI ) with respect to the first moderate or severe COPD exacerbation ( hazard ratio , 1.06 ; 95 % CI , 0.94 to 1.19 ) .


At week 18 , when glucocorticoid withdrawal was complete , the adjusted mean reduction from baseline in the trough forced expiratory volume in 1 second was 38 ml greater in the glucocorticoid-withdrawal group than in the glucocorticoid-continuation group ( P < 0.001 ) ; a similar between-group difference ( 43 ml ) was seen at week 52 ( P = 0.001 ) .


No change in dyspnea and minor changes in health status occurred in the glucocorticoid-withdrawal group .


In patients with severe COPD receiving tiotropium plus salmeterol , the risk of moderate or severe exacerbations was similar among those who discontinued inhaled glucocorticoids and those who continued glucocorticoid therapy .


However , there was a greater decrease in lung function during the final step of glucocorticoid withdrawal .


( Funded by Boehringer Ingelheim Pharma ; WISDOM ClinicalTrials.gov number , NCT00975195 . )


To evaluate the anti-gingivitis benefits of a 0.454 % highly bioavailable stannous fluoride dentifrice ( SnF2 ) relative to a 0.3 % triclosan/copolymer dentifrice ( triclosan/copolymer ) among triclosan/copolymer dentifrice users with residual gingivitis .


This was a randomized , controlled , double-blind , parallel group , 2-month clinical study .


Self-reported triclosan/copolymer dentifrice users were recruited and provided with triclosan/copolymer dentifrice to use for 1 month .


After this 1-month acclimation period , subjects who had residual gingivitis at the baseline visit were randomized to either the SnF2 dentifrice or the triclosan/copolymer dentifrice ( positive control ) .


Subjects performed their treatment unsupervised using their assigned dentifrice following manufacturers ' usage instructions for 2 months .


The Gingival Bleeding Index ( GBI ) and Modified Gingival Index ( MGI ) were used to measure gingivitis benefits at baseline and Month 2 .


An analysis of covariance was performed to compare treatment groups for the post-baseline scores as well as change from baseline , with the baseline score as a covariate .


All comparisons were two-sided at the 0.05 level of significance .


A total of 150 subjects were randomized to treatment .


Both treatment groups experienced significant reductions in number of bleeding sites , gingival bleeding index ( GBI ) , and gingival inflammation ( MGI ) relative to baseline ( P < 0.001 ) .


At Month 2 , the SnF2 dentifrice group demonstrated significantly lower adjusted mean scores versus the triclosan/copolymer group for number of bleeding sites , GBI , and MGI ( P < 0.001 ) .


Between-treatment group comparisons for change from baseline values showed that the improvement in number of bleeding sites from baseline for the SnF2 group was 49 % greater versus that of the triclosan/copolymer group ( P < 0.001 ) , and the GBI and MGI improvements from baseline for the SnF2 group were 48 % and 37 % , greater , respectively , relative to the triclosan/copolymer group ( P < 0.001 ) .


To compare two different vitrification methods to slow freezing method for cryopreservation of human cleavage stage embryos .


Prospective randomised trial .


University assisted reproduction centre .


568 patients ( mean age 33.4 5.2 ) from April 2009 to April 2011 .


1798 supernumerary good-quality cleavage stage embryos in 645 IVF cycles intended to be cryopreserved were randomly allocated to three groups : slow freezing , vitrification with the Irvine method , vitrification with the Vitrolife method .


Embryo survival and cleavage rates , implantation rate .


A total of 1055 embryos were warmed , 836 ( 79.2 % ) survived and 676 were finally transferred ( 64.1 % ) .


Post-warming embryos survival rate was significantly higher after vitrification ( Irvine : 89.4 % ; Vitrolife : 87.6 % ) than after slow freezing ( 63.8 % ) ( p < 0.001 ) .


No differences in survival rates were observed between the two vitrification methods , but a significant higher cleavage rate was observed using Irvine compared to Vitrolife method ( p < 0.05 ) .


Implantation rate ( IR ) per embryo replaced and per embryo warmed were respectively 15.8 % ( 41/259 ) and 12.4 % ( 41/330 ) for Irvine , 17.0 % ( 40/235 ) and 12.1 % ( 40/330 ) for Vitrolife , 21.4 % ( 39/182 ) and 9.9 % ( 39/395 ) for slow-freezing ( NS ) .


Both vitrification methods ( Irvine and Vitrolife ) are more efficient than slow freezing for cryopreservation of human cleavage stage embryos in terms of post-warming survival rate .


No significant difference in the implantation rate was observed between the three cryopreservation methods .


To evaluate rectal dose and post-treatment patient-reported bowel quality of life ( QOL ) following radiation therapy for prostate cancer .


Patient-reported QOL was measured at baseline and 2-years via the expanded prostate cancer index composite ( EPIC ) for 90 patients .


Linear regression modeling was performed using the baseline score for the QUANTEC normal tissue complication probability model and dose volume histogram ( DVH ) parameters for the whole and segmented rectum ( superior , middle , and inferior ) .


At 2-years the mean summary score declined from a baseline of 96.0-91 .8 .


The median volume of rectum treated to 70 Gy ( V70 ) was 11.7 % for the whole rectum and 7.0 % , 24.4 % , and 1.3 % for the inferior , middle , and superior rectum , respectively .


Mean dose to the whole and inferior rectum correlated with declines in bowel QOL while dose to the mid and superior rectum did not .


Low ( V25-V40 ) , intermediate ( V50-V60 ) and high ( V70-V80 ) doses to the inferior rectum influenced bleeding , incontinence , urgency , and overall bowel problems .


Only the highest dose ( V80 ) to the mid-rectum correlated with rectal bleeding and overall bowel problems .


Segmental DVH analysis of the rectum reveals associations between bowel QOL and inferior rectal dose that could significantly influence radiation planning and prognostic models .


To evaluate the effect of intravitreal aflibercept injection on visual function in wet age-related macular degeneration ( AMD ) .


Prospective , multicenter , double-masked , active-controlled , parallel-group , randomized phase 3 clinical studies ( VEGF Trap-Eye : Investigation of Efficacy and Safety in Wet AMD [ VIEW ] 1 and 2 [ clinicaltrials.gov identifiers , NCT00509795 and NCT00637377 , respectively ] ) .


Patients ( n = 2419 ) with active , treatment-nave , exudative AMD .


This analysis included patients who received intravitreal aflibercept 2.0 mg every 8 weeks ( 2q8 ; n = 607 ) or ranibizumab 0.5 mg every 4 weeks ( 0.5 q4 ; n = 595 ) .


Patients were randomized 1:1:1:1 to receive intravitreal aflibercept 2q8 ( after 3 initial monthly doses ) , intravitreal aflibercept 2q4 , intravitreal aflibercept 0.5 q4 , or ranibizumab 0.5 q4 in the study eye .


Patients in the intravitreal aflibercept 2q8 group received a sham injection alternating with active treatment .


The 25-item National Eye Institute Visual Function Questionnaire ( NEI VFQ-25 ) was administered at baseline and at weeks 12 , 24 , 36 , and 52 .


The NEI VFQ-25 subscale scores were compared between intravitreal aflibercept 2q8 and ranibizumab 0.5 q4 treatment arms , the approved dosing for each agent worldwide .


Change in composite NEI VFQ-25 score was evaluated based on categorical change in visual acuity ( worsened , unchanged , improved ) .


Baseline NEI VFQ-25 scores were similar for both treatments in both studies .


Mean change from baseline to 52 weeks was similar for ranibizumab 0.5 q4 and intravitreal aflibercept 2q8 across all 12 subscales , with the greatest improvements noted for mental health and general vision ( 9.0-11 .6 points , both treatments , both studies ) .


Improvement of 4 points or more ( both treatments , both studies ) also was observed for subscales near vision , distance vision , role difficulties , and dependency .


Mean change from baseline to 52 weeks in NEI VFQ-25 composite score ( pooled data ) stratified by clinical response showed meaningful improvement only in patients who gained 5 Early Treatment Diabetic Retinopathy letters or more ( 7.3 and 7.8 points for intravitreal aflibercept 2q8 and ranibizumab 0.5 q4 , respectively ) .


Visual function outcomes were similar across all NEI VFQ-25 subscales over 52 weeks for intravitreal aflibercept 2q8 and ranibizumab 0.5 q4 , with clinically meaningful improvement recorded in 6 of 12 subscales .


To evaluate the effect of length of tibial stump on proprioceptive recovery after anterior cruciate ligament ( ACL ) reconstruction .


From March 2011 to December 2011,42 patients with ACL tear were performed with reconstruction .


The patients were divided randomly into three groups : group A , the patients with remained length of tibial stump ranging from 15 to 20 mm , including 8 males and 6 females , with an average age of ( 28.2 6.6 ) years old ; group B , the patients with remained length of tibial stump ranging from 5 to 10 mm , including 9 males and 5 females , with an average age of ( 27.9 6.4 ) years old ; group C , the patients with remained length of tibial stump less than 2 mm , including 9 males and 5 females , with an average age of ( 28.6 6.8 ) years , old .


The stability of knee were assessed by Lanchman test and anterior drawer test .


The function of knee was assessed by Lysholm score and Tegner activity rating .


The proprioceptive recovery was evaluated by assessing the passive reproduction of the angles with limb movement into flexion and extension in no weight bearing position .


Lanchman test and anterior drawer test of all patients were negative at 6 months postoperatively. , and there was one case of positive outcome in each group at 12 month and 18 month postoperatively .


Lysholm score and Tegner activity score of all patients at 18 month postoperatively were significantly better than that preoperatively , and there were no significant difference among three groups at 18 month postoperatively .


There were no significant difference in the production of the angles at flexion to 20 and extention to 80 and 20 among these groups before and after operation .


The reproduction of the angles of group A and B at flexion to 50 and extention to 50 at 6 month postoperatively were significantly better than that of group A and B preoperatively and that of group C at 6 month postoperatively , and there were no significant difference among three groups at 18 month postoperatively .


The reproduction of the angles of group A and B at flexion to 80 at 12 month postoperatively were significantly better than that of group A and B preoperatively and that of group C at 12 month postoperatively , and there were no significant difference among three groups at 18 month postoperatively .


Preservation of tibial stump in ACL reconstruction has benefit in proprioceptive recovery at early stage postoperatively and the length of tibial stump should be reserved with a range from 5 to 10 mm .


To determine whether a single treatment of botulinum toxin A in the forehead ( glabellar ) region can improve symptoms of depression in patients with major depressive disorder ( MDD ) , as defined by DSM-IV criteria .


Thirty participants were randomly assigned to receive either placebo or botulinum toxin A ( BTA ; onabotulinumtoxinA ) injections in the forehead .


Female participants received 29 units ; male participants received 39 units .


At week 12 , the groups were crossed over .


Participants were evaluated at weeks 0 , 3 , 6 , 12 , 15 , 18 , and 24 for improvement in MDD symptoms using the Patient Health Care Questionnaire-9 , Beck Depression Inventory ( BDI ) , and 21-Item Hamilton Depression Rating Scale ( HDRS-21 ) objective measurement scales .


The primary outcome was the rate of HDRS-21 response , defined as 50 % score reduction from baseline .


The study occurred from July 2011 to November 2012 .


Patients who received BTA at week 0 ( BTA-first group ) and at week 12 ( BTA-second group ) had a statistically significant reduction in MDD symptoms as compared to placebo .


Improvement in MDD continued over 24 weeks in the group that received BTA first even though the cosmetic effects of BTA wore off at 12 to 16 weeks .


HDRS-21 response rates were 55 % ( 6/11 ) in the BTA-first group , 24 % ( 4/17 ) in the BTA-second group , and 0 % ( 0/19 ) in the placebo group ( P < .0001 ) .


HDRS-21 remission rates ( score 7 ) were 18 % ( 2/11 ) , 18 % ( 3/17 ) , and 0 % ( 0/19 ) , respectively ( P = .057 ) .


HDRS-21 scores dropped -46 % and -35 % in the BTA-first and - second groups versus -2 % in the placebo group ( P < .0001 ) .


The BDI response rate ( 50 % reduction from baseline ) was 45 % ( 5/11 ) in the BTA-first group , 33 % ( 6/18 ) in the BTA-second group , and 5 % ( 1/19 ) in the placebo group ( P = .0067 ) .


BDI remission rates ( score 9 ) were 27 % ( 3/11 ) , 33 % ( 6/18 ) , and 5 % ( 1/19 ) , respectively ( P = .09 ) .


BDI scores dropped -42 % and -35 % in the BTA-first and - second groups versus -15 % in the placebo group ( P < .0001 ) .


Botulinum toxin A injection in the glabellar region was associated with significant improvement in depressive symptoms and may be a safe and sustainable intervention in the treatment of MDD .


ClinicalTrials.gov identifier : NCT01392963 .


To compare 2 omega-3 ( n-3 ) preparations enriched with eicosapentaenoic acid ( EPA ) versus docosahexaenoic acid ( DHA ) as monotherapy for major depressive disorder ( MDD ) in a 2-site , placebo-controlled , randomized , double-blind clinical trial .


196 adults ( 53 % female ; mean [ SD ] age = 44.7 [ 13.4 ] years ) with DSM-IV MDD and a baseline 17-item Hamilton Depression Rating Scale ( HDRS-17 ) score 15 were randomized equally from May 18 , 2006 , to June 30 , 2011 , to 8 weeks of double-blind treatment with oral EPA-enriched n-3 1000 mg/d , DHA-enriched n-3 1,000 mg/d , or placebo .


154 subjects completed the study .


Modified intent-to-treat ( mITT ) analysis ( n = 177 subjects with 1 postbaseline visit ; 59.3 % female , mean [ SD ] age 45.8 [ 12.5 ] years ) employed mixed-model repeated measures ( MMRM ) .


All 3 groups demonstrated statistically significant improvement in the HDRS-17 ( primary outcome measure ) , 16-item Quick Inventory of Depressive Symptomatology-Self Report ( QIDS-SR-16 ) , and Clinical Global Improvement-Severity Scale ( CGI-S ) ( P < .05 ) , but neither n-3 preparation separated from placebo ( P > .05 ) .


Response and remission rates were in the range of 40 % -50 % and 30 % , respectively , for all treatments , with no significant differences between groups .


One subject receiving EPA-enriched n-3 discontinued due to worsening depression , and 1 subject receiving placebo discontinued due to an unspecified `` negative reaction '' to pills .


Neither EPA-enriched nor DHA-enriched n-3 was superior to placebo for the treatment of MDD .


ClinicalTrials.gov identifier : NCT00517036 .


To compare the 3-year stability , survival , and tolerability of 2 osseointegrated implants for bone conduction hearing : a wide 4.5-mm-diameter moderately roughened implant with a rounded 6-mm abutment ( test ) and a 3.75-mm diameter as-machined implant with a conically shaped 5.5-mm abutment ( control ) .


In this randomized , prospective , controlled , multicenter clinical study , 77 adult patients were included .


Test and control implants were randomly assigned in proportions of 2:1 .


The implants were loaded with the sound processor from 6 weeks postimplantation .


Follow-up after surgery was conducted at 10 days ; at 4 , 6 , 8 , and 12 weeks ; and at 6 , 12 , 24 , and 36 months after surgery .


At every visit , implant stability quotient ( ISQ ) values were recorded by means of resonance frequency analysis ( RFA ) , and skin reactions were evaluated according to Holgers ' classification .


Statistically significantly higher mean ISQ values were recorded for the test implant compared with the control implant at each evaluation time point .


Between 2 and 3 years after surgery , ISQ values decreased but remained above baseline values .


Implant survival was high for both implants : 96.2 % of the test implants and 100 % of the control implants survived these 3 years .


Statistically significantly improved soft tissue outcomes were observed in the test implant group .


This extensive long-term clinical investigation demonstrated that the test implant is more stable in terms of ISQ-values and provides high tolerability for the soft tissue .


The results show that implant loading at 6 weeks is safe .


To evaluate the short-term effects of three different resistance training programs , conducted at low intensity , on physical performance , muscle cross-sectional area ( CSA ) and the capacity to perform daily tasks in older adults living in a geriatric nursing home .


Randomized controlled trial , with a 4-month intervention period .


A geriatric nursing home in Valencia , Spain .


Eighty-nine adults aged 75 to 96 who were independent in their daily activities .


After a baseline assessment , the participants were randomly assigned to the control group or one of the three intervention groups : volitional contraction ( VC ; n = 22 ) , neuromuscular electrical stimulation ( NMES ; n = 22 ) , or neuromuscular electrical stimulation superimposed onto voluntary contractions ( NMES + ; n = 22 ) .


The intervention focused on knee extension exercises and its intensity was set at 40 % of one-repetition maximum ( 1RM ) .


The primary outcome measure was mobility .


Secondary outcomes were rectus femoris CSA , balance , aerobic endurance , upper-body strength and the capacity to perform daily tasks .


All data were collected at baseline and after the 4-month intervention period .


The two-way ANOVA analysis showed a significant grouptime interaction effect for the mobility ( P = .022 ) , rectus femoris CSA ( P = .001 ) , and the capacity to perform daily tasks ( P = .05 ) .


The within-group analysis found a more prominent effect in the NMES + group .


Significant improvements were seen in rectus femoris CSA and the capacity to perform daily tasks in all intervention groups .


Mobility only improved in the NMES + group ( P = .026 ) .


From a short-term perspective , NMES + exercise training , performed at low intensity , can improve physical performance , muscle CSA , and the capacity to perform daily activities , and to partially mitigate age-related consequences in older adults .


Treatment motivation is a key component in the early rehabilitative stages for people with substance use disorders .


To date , no music therapy researcher has studied how lyric analysis interventions might affect motivation in a randomized controlled design .


The primary purpose of this study was to determine the effect of lyric analysis interventions on treatment motivation in patients on a detoxification unit using a single-session wait-list control design .


A secondary purpose was to determine if there were between-group differences concerning two contrasting songs used for the lyric analyses .


Participants ( N = 104 ) were cluster randomized to a group lyric analysis condition or a wait-list control condition .


Participants received either a `` Hurt '' or a `` How to Save a Life '' lyric analysis treatment .


The Texas Christian University Treatment Motivation Scale-Client Evaluation of Self at Intake ( CESI ) ( Simpson , 2008 [ 2005 ] ) was used to measure aspects of treatment motivation : problem recognition , desire for help , treatment readiness , pressures for treatment , and total motivation .


Results indicated significant between-group differences in measures of problem recognition , desire for help , treatment readiness , and total motivation , with experimental participants having higher treatment motivation means than control participants .


There was no difference between the two lyric analysis interventions .


Although the song used for lyric analysis interventions did not affect outcome , a single group-based music therapy lyric analysis session can be an effective psychosocial treatment intervention to enhance treatment motivation in patients on a detoxification unit .


Limitations , implications for clinical practice , and suggestions for future research are provided .


The effects of two interventions , Integrated Management of Infectious Disease ( IMID ) training program and On-Site Support ( OSS ) , were tested on 23 facility performance indicators for emergency triage assessment and treatment ( ETAT ) , malaria , pneumonia , tuberculosis , and HIV .


The trial was implemented in 36 primary care facilities in Uganda .


From April 2010 , two mid-level practitioners per facility participated in IMID training .


Eighteen of 36 facilities were randomly assigned to Arm A , and received OSS in 2010 ( nine monthly two-day sessions ) ; 18 facilities assigned to Arm B did not receive OSS in 2010 .


Data were collected from Nov 2009 to Dec 2010 using a revised Ministry of Health outpatient medical form and nine registers .


We analyzed the effect of IMID training alone by measuring changes before and during IMID training in Arm B , the combined effect of IMID training and OSS by measuring changes in Arm A , and the incremental effect of OSS by comparing changes across Arms A and B.


IMID training was associated with statistically significant improvement in three indicators : outpatients triaged ( adjusted relative risks ( aRR ) = 1.29 , 99 % CI = 1.01,1.64 ) , emergency and priority patients admitted , detained , or referred ( aRR = 1.59 , 99 % CI = 1.04,2.44 ) , and pneumonia suspects assessed ( aRR = 2.31 , 99 % CI = 1.50,3.55 ) .


IMID training and OSS combined was associated with improvements in six indicators : three ETAT indicators ( outpatients triaged ( aRR = 2.03 , 99 % CI = 1.13,3.64 ) , emergency and priority patients admitted , detained or referred ( aRR = 3.03 , 99 % CI = 1.40,6.56 ) , and emergency patients receiving at least one appropriate treatment ( aRR = 1.77 , 99 % CI = 1.10,2.84 ) ) ; two malaria indicators ( malaria cases receiving appropriate antimalarial ( aRR = 1.50 , 99 % CI = 1.04,2.17 ) , and patients with negative malaria test results prescribed antimalarial ( aRR = 0.67 , 99 % CI = 0.46,0.97 ) ) ; and enrollment in HIV care ( aRR = 1.58 , 99 % CI = 1.32,1.89 ) .


OSS was associated with incremental improvement in emergency patients receiving at least one appropriate treatment ( adjusted ratio of RR = 1.84,99 % CI = 1.09,3.12 ) .


The trial showed that the OSS intervention significantly improved performance in one of 23 facility indicators .


Glaucoma is one of the leading causes of blindness .


Reduction of intraocular pressure is the only proven way to prevent progression of glaucomatous optic neuropathy .


The majority of glaucoma patients need to use antiglaucoma ophthalmic solutions over the course of their life .


Thus , good adherence and persistency of glaucoma treatment are important factors for better glaucoma care .


The purpose of this study was to investigate the impact of an Internet-based glaucoma care support system on glaucoma medication use .


Patients were randomly divided into two groups .