Kaplan-Meier survival analysis and the Long-rank test were used to compare total vascular end point incidence between the two groups .


Comparison of median values between two groups was done by the Student t test , one-way analysis of variance ( ANOVA ) , or non-parametric rank sum test .


A total of 310 patients were enrolled , 192 patients in the treatment group and 118 patients in the control group .


Compared to the control group , the treatment group showed favorable outcomes in the Fg level , carotid IMT , the detection rate of vulnerable plaques , the volume of carotid plaques , NIHSS scores , and incidence of total vascular ( 6.78 % and 2.08 % , respectively ) and cerebral vascular events ( 5.93 % and 1.04 % , respectively ) ( P < 0.05 ) .


In the treatment group , the volume of carotid plaques was significantly related to the carotid IMT , the plaque diameter , width and number ( P = 0.000 , 0.000 , 0.000 , 0.022 ; F = 13.51 , 2.52 , 11.33 , -3.29 , but there was a weak correlation with the Fg level ( P = 0.056 ) .


After 1-year therapy , the incidence of overall vascular end points was reduced by 4.7 % .


Long-term oral fibrinogen-depleting therapy may be beneficial for secondary ischemic stroke prevention .


This 52-week , randomised , double-blind phase IIIb study assessed efficacy and safety of certolizumab pegol ( CZP ) as add-on therapy to non-biologic disease-modifying antirheumatic drugs ( DMARDs ) in rheumatoid arthritis ( RA ) patients with low to moderate disease activity , and stopping therapy in patients in sustained remission .


Patients were randomised 1:1 to CZP ( 400mg at weeks 0 , 2 and 4 , then 200mg every 2weeks ) or placebo ( every 2weeks ) plus current non-biologic DMARDs .


At week 24 , patients who achieved the primary endpoint of Clinical Disease Activity Index ( CDAI ) remission at both weeks 20 and 24 stopped study treatment and continued in the study until week 52 .


Of 194 patients ( CZP = 96 ; placebo = 98 ) , > 90 % had moderate disease activity at baseline .


Significantly more CZP patients met the primary endpoint than placebo patients ( week 20 and 24 CDAI remission rates : 18.8 % vs 6.1 % ; p0 .05 ) .


At week 24 , 63.0 % vs 29.7 % of CZP versus placebo patients ( p < 0.001 ) achieved LDA .


Disease activity score ( ESR ) based on 28-joint count and Simplified Disease Activity Index remission rates were also significantly higher with CZP versus placebo ( 19.8 % vs 3.1 % ; p0 .01 and 14.6 % vs 4.1 % ; p0 .05 ) .


CZP patients reported improvements in physical function versus placebo ( mean Health Assessment Questionnaire-Disability-Index change from baseline : CZP , -0.25 vs placebo , -0.03 ; p0 .01 ) .


During the period following withdrawal of CZP or placebo , only 3/17 prior CZP patients and 2/6 prior placebo patients maintained CDAI remission until week 52 , but CZP reinstitution allowed renewed improvement .


Adverse and serious adverse event rates were comparable between CZP and placebo groups .


Addition of CZP to non-biologic DMARDs is an effective treatment in RA patients with predominantly moderate disease activity , allowing low-disease activity or remission to be reached in a majority of the patients .


However , the data suggest that CZP can not be withdrawn in patients achieving remission .


NCT00674362 .


The purpose of this analysis is to report the incremental costs and benefits of different doses of spinal manipulative therapy ( SMT ) in patients with chronic low back pain ( LBP ) .


We randomized 400 patients with chronic LBP to receive a dose of 0 , 6 , 12 , or 18 sessions of SMT .


Participants were scheduled for 18 visits for 6 weeks and received SMT or light massage control from a doctor of chiropractic .


Societal costs in the year after study enrollment were estimated using patient reports of health care use and lost productivity .


The main health outcomes were the number of pain-free days and disability-free days .


Multiple regression was performed on outcomes and log-transformed cost data .


Lost productivity accounts for most societal costs of chronic LBP .


Cost of treatment and lost productivity ranged from $ 3398 for 12 SMT sessions to $ 3815 for 0 SMT sessions with no statistically significant differences between groups .


Baseline patient characteristics related to increase in costs were greater age ( P = .03 ) , greater disability ( P = .01 ) , lower quality-adjusted life year scores ( P = .01 ) , and higher costs in the period preceding enrollment ( P < .01 ) .


Pain-free and disability-free days were greater for all SMT doses compared with control , but only SMT 12 yielded a statistically significant benefit of 22.9 pain-free days ( P = .03 ) and 19.8 disability-free days ( P = .04 ) .


No statistically significant group differences in quality-adjusted life years were noted .


A dose of 12 SMT sessions yielded a modest benefit in pain-free and disability-free days .


Care of chronic LBP with SMT did not increase the costs of treatment plus lost productivity .


To examine whether a phenylalanine-free protein substitute with prolonged release may be beneficial to the protein status of children with phenylketonuria ( PKU ) compared to conventional substitutes .


Sixty children with PKU , 7 to 16 years of age , were randomly allocated to receive either a prolonged-release ( test ) or the current conventional protein substitute for 30 days .


Subjects were additionally sex and age matched with 60 subjects with mild hyperphenylalaninemia and 60 unaffected subjects .


The protein status in children with PKU was assessed by albumin , transthyretin , and retinol-binding protein ( RBP ) , and changes throughout the trial period were the primary outcome measures .


Children with PKU did not differ in anthropometry from children with mild hyperphenylalaninemia or unaffected children but they ingested lower amounts of proteins ( p < 0.01 ) .


No differences occurred throughout the trial between or within children with PKU who received the test or conventional substitute for macronutrient intake .


Albumin and RBP concentrations were within the age-specific reference range for all children .


The rate of protein insufficiency ( transthyretin concentration less than 20 mg/dL ) did not differ statistically between children receiving test or conventional substitute ( recruitment 51.8 % vs 53.6 % ; end of the trial 44.4 % vs 50.0 % ) but mean transthyretin recovered over 20 mg/dL in children who received the test substitute , increasing from 19.1 to 20.7 mg/dL ( mean change , 1.6 mg/dL ; 95 % confidence interval 0.4 to 2.8 mg/dL ) .


In children receiving conventional substitute mean transthyretin changed from 19.0 to 19.2 mg/dL ( 0.2 ; -0.2 to 0.6 ) mg/dL .


Protein substitutes with prolonged release might be beneficial to protein status in children with phenylketonuria .


Spinal cord stimulation ( SCS ) for the treatment of chronic pain is a well-established therapy .


However , the requirement that paresthesia be continually felt by the patient has important downsides .


This study evaluated the effectiveness of a new paresthesia-free SCS paradigm , called burst stimulation , for the treatment of failed back surgery syndrome ( FBSS ) with a prospective , randomized , double-blind , placebo-controlled design .


Twenty patients with FBSS and a preexisting SCS system each received three treatment allocations in random order for a period of one week : 500-Hz tonic stimulation , burst stimulation , and placebo stimulation .


The primary outcome measure was pain intensity measured on a numerical rating scale ( NRS ) .


Secondary outcome measures were pain quality measured using the Short-Form McGill Pain Questionnaire ( SFMPQ ) and safety .


Additional data were collected relating to pain-related disability measured using the Oswestry Disability Index ( ODI ) .


The lowest mean NRS and SFMPQ scores were observed under burst stimulation .


For the burst stimulation treatment group , mean NRS and SFMPQ scores were significantly decreased compared with the other treatment groups .


Mean NRS and SFMPQ scores were not significantly different between 500-Hz tonic stimulation and placebo stimulation .


Although the lowest mean ODI score was observed under burst stimulation , no significant differences were found between the ODI categories .


No adverse events occurred , and burst stimulation was significantly preferred by 16 patients ( 80 % ) .


Overall , burst stimulation resulted in significantly better pain relief and improved pain quality in the short term compared with 500-Hz tonic stimulation and placebo stimulation and was preferred by the majority of patients .


During recent years scientific research has demonstrated a growing interest in elastic and anaelastics adhesive taping techniques .


However , only a few studies investigating the principles behind the effects of taping .


At present , the action mechanisms of kinesiology taping remain speculative .


To investigate the effects of taping application on the tone of the pectoralis major muscle at rest , in absence of any relevant pathologies .


The study involved a prospective , randomised and blinded clinical trial on healthy individuals and a repeated measures study design .


Two different taping techniques ( facilitatory and inhibitory ) were applied over the pectoralis major of 24 healthy volunteers .


The outcome measure was passive range of motion of external rotation of the glenohumeral joint .


Facilitatory taping significatively enhanced the activity of the underlying muscle .


Results showed a negative correlation between facilitatory taping application and the contralateral pectoralis major length , indicating a possible effect on the muscle tone of areas outside the site of direct application .


The inhibitory taping application did not produce significant results .


effects on ipsilateral and contralateral muscle physiology could be interpreted through the initial hypothesis of taping inducing changes in fascial stiffness .


These could be transmitted along the continuing system .


Further studies are needed to inform the possible uses of taping in clinical practice .


The objective of the current study was to assess mean self-monitored blood glucose ( SMBG ) , on day 6 of 6 days of continuous reservoir wear ( 6D ) , with insulin lispro ( Lis ) or insulin aspart ( Asp ) .


Two 24-week , randomized trials were conducted in subjects with type 1 diabetes treated by continuous subcutaneous insulin infusion ( CSII ) for 6 months , with a mean total daily insulin dose capable of supporting 6 days of in-reservoir use .


Study 1 had an open-label , six-sequence , three-treatment , three-period , cross-over design .


Study 2 had a double-blind , two-sequence , two-treatment , two-period , cross-over design .


The primary efficacy measure was the mean of Day 6 , seven-point SMBG profiles for insulin lispro 6D ( Lis6D ) and insulin aspart 6D ( Asp6D ) treatment periods .


Safety measures were also assessed .


Lis did not achieve noninferiority ( SMBG ; margin = 0.6 mmol/L [ 10.8 mg/dL ] ) to Asp on Day 6 of reservoir wear in either Study ( least-squares mean difference : Study 1 = 0.48 mmol/L [ 8.64 mg/dL ] ; 95 % confidence interval [ CI ] [ 0.20 , 0.76 ] , Study 2 = 0.36 mmol/L [ 6.49 mg/dL ] ; 95 % CI [ 0.06 , 0.66 ] ) .


Noninferiority was demonstrated for overall daily mean of SMBG values over days 1 to 6 of reservoir use during each treatment period .


In the Lis treatment period , subjects reported a lower documented and total hypoglycemia rate per 30 days and a higher rate of non-explained hyperglycemia than in the Asp treatment period .


While the mean blood glucose on Day 6 of Lis6D did not meet non-inferiority , the overall daily mean blood glucose was not different , with a decreased rate of hypoglycemia with Lis .


Two types of material are used to manufacture double-lumen endobronchial tubes ( DLTs ) : Polyvinylchloride ( PVC ) and silicon .


PVC DLTs ( Broncho-Cath ) and silicon DLTs ( Silbroncho ) not only differ in material , but also subtly differ in structure .


The goal of this study was to determine whether the incidences of postoperative sore throat and hoarseness differed between PVC DLTs and silicon DLTs .


Prospective , single-blind , balanced ( 1:1 ) , randomized , controlled trial .


Single university hospital .


Sixty ASA I-II patients , aged 20 to 65 years , scheduled for thoracoscopic pulmonary lobectomy .


Patients were randomized into the Broncho-cath group ( group B , n = 30 ) and the Silbroncho group ( group S , n = 30 ) .


Intubation was performed with DLT according to the allocated group by an anesthesiologist .


The incidence of sore throat and hoarseness was evaluated at 1 hour and 24 hours after DLT extubation .


The intensity of sore throat was assessed by visual analog scale ( VAS < 0-10 ) at 1 , 2 , 4 , 12 , and 24 hours after DLT extubation .


The incidence of sore throat was significantly lower in group S compared with that in group B at 1 h ( 30 % v 66.7 % , p = 0.018 ) and 24 hours ( 10 % v 43.3 % , p = 0.014 ) .


No significant difference was observed in the incidence of hoarseness between the 2 groups .


The VAS scores for sore throat in group B were significantly higher than those in group S throughout the study ( p < 0.05 ) .


The use of silicon DLTs resulted in a lower incidence of postoperative sore throat than did the use of PVC DLTs .


Pyridoxamine dihydrochloride ( Pyridorin ) blocks pathogenic oxidative pathways in the progression of diabetic nephropathy .


The pyridoxamine pilot study was designed to test entry criteria and outcomes .


Subjects had SCr 1.3-3 .5 mg/dl , protein-to-creatinine 1,200 mg/g and used a surrogate outcome of SCr over 52 weeks .


Subjects had to be on a maximally tolerated dose of ACE/ARB for 3 months ; stable other antihypertensive doses for 2 months ; stable diuretic dose for 2 weeks , and BP 160/90 mm Hg ; or enter a Pharmaco-Stabilization Phase ( PSP ) .


This pilot failed to detect an effect on SCr in intent-to-treat analysis .


We queried the locked clinical trial database for subgroups in which there was a treatment effect .


Subjects not requiring PSP and those with entry SCr < 2.0 mg/dl had a treatment effect .


Subjects entering PSP required more changes in antihypertensive medications and experienced larger SCr over 52 weeks .


PSP subjects with BP > 140/90 mm Hg had no treatment effect , but those 140/90 mm Hg did .


Time required for acute effects of ACE/ARB to stabilize is unknown , but these data suggest > 3 months .


Thus , subjects in the pivotal trial must be on ACE/ARB for 6 months .


Frequent antihypertensive adjustment could engender SCr changes unrelated to CKD progression .


Thus , we will require subjects to have BP 150/90 mm Hg and on stable antihypertensives for 26 weeks , or 140/90 mm Hg and on stable antihypertensives for 13 weeks .


Since SCr over 52 weeks is limited as a surrogate outcome , the pivotal trial uses a time-to-event analysis of baseline SCr to at least a 50 % increase in SCr or ESRD as the primary outcome .


This substantial SCr is protected from noise and is clinically relevant .


The pyridoxamine pilot provided critical information to inform the design of PIONEER-CSG-17 , which we conducted under the SPA agreement with FDA .


The efficacy of coronary angiography may be different in the right radial approach ( RRA ) and the left radial approach ( LRA ) due to more common vascular tortuosity in the RRA .


The aim of the study was to determine whether LRA is a valid alternative for coronary angiography compared with RRA in Asian populations .


This is a single-center , prospective , randomized controlled study .


A total of 1,400 consecutive patients undergoing diagnostic coronary angiography were recruited and randomized to the RRA ( number [ n ] = 700 ) or LRA ( n = 700 ) group .


The primary end point was total procedural duration .


Secondary end points included fluoroscopy time , dose of radiation including cumulative air kerma and dose area product , contrast volume , and the incidence of vascular complications .


Coronary procedural success was achieved in 682 of 700 ( 97.4 % ) patients in the RRA and 680 of 700 ( 97.1 % ) in the LRA .


The total procedural time ( RRA 14.16.3 minutes versus LRA 13.26.0 minutes ; P = 0.006 ) and fluoroscopy time ( RRA 3.83.3 minutes versus LRA 3.42.8 minutes ; P = 0.046 ) were significantly shorter via LRA in comparison to RRA .


The percentage of hydrophilic wire use was also lower in the LRA group ( 14 % [ RRA ] versus 10 % [ LRA ] ; P = 0.016 ) .


The dose of radiation and contrast volume were not different between the two approaches .


No cases of major bleeding and vascular complications requiring surgical intervention were reported , other than with one patient who experienced a symptomatic stroke and died in the RRA group compared with none in the LRA group .


The LRA seems to be a feasible alternative for coronary angiography in Asian patients due to shorter procedural duration and fluoroscopy time , as well as less hydrophilic wire use in comparison to RRA .


The potential health benefits of curcumin are limited by its poor solubility , low absorption from the gut , rapid metabolism and rapid systemic elimination .


The purpose of this study was the comparative measurement of the increases in levels of curcuminoids ( curcumin , demethoxycurcumin , bisdemethoxycurcumin ) and the metabolite tetrahydrocurcumin after oral administration of three different curcumin formulations in comparison to unformulated standard .


The relative absorption of a curcumin phytosome formulation ( CP ) , a formulation with volatile oils of turmeric rhizome ( CTR ) and a formulation of curcumin with a combination of hydrophilic carrier , cellulosic derivatives and natural antioxidants ( CHC ) in comparison to a standardized curcumin mixture ( CS ) was investigated in a randomized , double-blind , crossover human study in healthy volunteers .


Samples were analyzed by HPLC-MS/MS .


Total curcuminoids appearance in the blood was 1.3-fold higher for CTR and 7.9-fold higher for CP in comparison to unformulated CS .


CHC showed a 45.9-fold higher absorption over CS and significantly improved absorption over CP ( 5.8-fold ) and CTR ( 34.9-fold , all p < 0.001 ) .


A formulation of curcumin with a combination of hydrophilic carrier , cellulosic derivatives and natural antioxidants significantly increases curcuminoid appearance in the blood in comparison to unformulated standard curcumin CS , CTR and CP .


After pancreaticoduodenectomy , the Finnish binding pancreaticojejunal anastomosis ( FBPJ ) seems to reduce the risk for pancreatic fistula ( POPF ) .


Our aim was to investigate whether FBPJ is feasible and prevents the risk for POPF even after left pancreatectomy ( LP ) .


47 consecutive patients underwent LP .


27 patients were recruited on the basis of CT and , of these , 16 patients were randomized on the basis of findings during surgery ( transection line must be left of portal vein , as 2-3cm pancreatic mobilization is required for FBPJ ) to receive either Roux-Y FBPJ or hand-sewn closure of the pancreatic remnant .


Only 34 % ( 16/47 ) of the patients met the randomization criteria .


Clinically significant POPF rate was higher in FBPJ group ( 60 % ) compared to thand-sewn closure group ( 13 % ; P < 0.05 ) .


POPF rate in FBPJ group was higher even when compared to all patients with hand-sewn closure ( 60 % versus 37 % ; P < 0.05 ) .


Overall , FBPJ was technically feasible for only 28 % of patients .


FBPJ can not be recommended for the routine closure of the pancreatic remnant after LP , as it was not technically achievable in 72 % of the cases .


Moreover , the technique does not seem to reduce the risk for POPF compared to the hand-sewn closure .


Disulfiram and naltrexone were evaluated in treatment of individuals with co-occurring alcohol dependence and other Axis I disorders ( e.g. , Major Depression ) .


We explored pharmacogenetic interactions in genotyped subjects .


Alcohol dependent ( AD ) subjects received naltrexone alone , placebo alone , disulfiram with placebo or disulfiram with naltrexone .


They were genotyped for OPRM1 rs1799971 ( Asn40Asp ) , and DBH rs1611115 ( C-1021T ) .


N = 107 male European-American subjects were included .


There were no significant interactions with OPRM1 .


DBH interacted with naltrexone on the primary outcome of abstinence from heavy drinking ( ( 2 ) ( 1 ) = 5.23 , p = .02 ) .


`` T '' allele carriers on naltrexone had more abstinence compared to `` CC '' subjects on naltrexone ( FET , p = .01 ) .


`` T '' allele carriers on naltrexone had the highest overall rates of abstinence from heavy drinking ( > 90 % ) .


Also , DBH genotype interacted with disulfram ( F ( 1,17 ) = 7.52 , p = .01 ) on drinks per drinking day with less drinking for subjects with the `` CC '' genotype than for T allele carriers on disulfiram .


DBH * rs1611115 * T associated with better response to naltrexone , while for those on disulfiram that drank , `` CC '' subjects drank less than T carriers .


For rs1799971 * G , we did not replicate findings from previous studies showing a more favorable response to NTX , possibly due to the small available sample .


Genotyping rs1611115 may be useful in understanding inter-individual differences in AD treatment response .


Further study of rs1611115 pharmacogenetics is warranted .


Hip fracture is a condition with high mortality and morbidity in elderly frail patients .


Intraoperative fluid optimization may be associated with benefit in this population .


We investigated whether intraoperative fluid management using pulse-contour analysis cardiac monitoring , compared with standard care in patients undergoing spinal anaesthesia , would provide benefits in terms of reduced time until medically fit for discharge and postoperative complications .


Patients undergoing surgical repair of fractured neck of femur , aged > 60 yr , receiving spinal anaesthesia were enrolled in this single-centre , blinded , randomized , parallel group trial .


Patients were allocated to either anaesthetist-directed fluid therapy or a pulse-contour-guided fluid optimization strategy using colloid ( Gelofusine ) boluses to optimize stroke volume .


The primary outcome was time until medically fit for discharge .


Secondary outcomes included postoperative complications , mobility , and mortality .


We updated a systematic review to include relevant trials to 2014 .


We recruited 130 patients .


Time until medically fit for discharge was similar in both groups , mean [ 95 % confidence interval ( CI ) ] 12.2 ( 11.1-13 .5 ) vs 13.1 ( 11.9-14 .5 ) days ( P = 0.31 ) , as was total length of stay 14.2 ( 12.9-15 .8 ) vs 15.3 ( 13.8-17 .2 ) days ( P = 0.32 ) .


There were no significant differences in complications , function , or mortality .


An updated meta-analysis ( four studies , 355 patients ) found non-significant reduction in early mortality [ relative risk 0.66 ( 0.24-1 .79 ) ] and in-hospital complications [ relative risk 0.80 ( 0.61-1 .05 ) ] .


Goal-directed fluid therapy during hip fracture repair under spinal anaesthesia does not result in a significant reduction in length of stay or postoperative complications .


There is insufficient evidence to either support or discount its routine use .


ISRCTN88284896 .


We recently published that platelet-activating factor receptor ( PAFr ) is upregulated on the epithelium of the proximal airways of current smokers and also in bronchial epithelial cells exposed to cigarette smoke extract .


These treated cells also showed upregulation of Streptococcus pneumoniae adhesion .


Bacterial wall phosphorylcholine specifically binds to PAFr expressed on airway epithelium , thus facilitating adherence and tissue invasion , which may be relevant to chronic obstructive pulmonary disease ( COPD ) .


Moreover , the use of inhaled corticosteroids ( ICS ) in COPD patients is associated with an increased risk of invasive respiratory pneumococcal infections .


In this study , we have investigated whether PAFr expression is especially upregulated in airway epithelium in COPD patients and whether this expression may be modulated by ICS therapy .


We cross-sectionally evaluated PAFr expression in bronchial biopsies from 15 COPD patients who were current smokers ( COPD-smokers ) and 12 COPD-ex-smokers , and we compared these to biopsies from 16 smokers with normal lung function .


We assessed immunostaining with anti-PAFr monoclonal antibody .


We also used material from a previous double-blinded randomized placebo-controlled 6-month ICS intervention study in COPD patients to explore the effect of ICS on PAFr expression .


We employed computer-aided image analysis to quantify the percentage of epithelium stained for PAFr .


Markedly enhanced expression of PAFr was found in both COPD-smokers ( P < 0.005 ) and COPD-ex-smokers ( P < 0.002 ) compared to smokers with normal lung function .


There was little evidence that PAFr expression was affected by ICS therapy over 6 months .


Epithelial PAFr expression is upregulated in smokers , especially in those with COPD , and is not obviously affected by ICS therapy .


Intramedullary nailing of displaced proximal humerus fractures is an attractive option in the elderly patient .


However , in recent reports , some existing intramedullary nails have shown high rate of complications , so new designs are being developed .


The objective of the present study is to report on outcomes and complications when comparing a straight to a curvilinear nail design .


We prospectively include 54 patients with Neer 's 2 - or 3-part proximal humerus fractures .


Two were lost to follow-up , 26 were surgically treated with a new straight humeral nail ( MultiLoc , Synthes ) mean age 69 ( range , 47-87 years ) , and 26 with a curvilinear nail ( Polarus , Acumed ) mean age 71 ( range , 38-89 years ) .


At final follow-up ( average 14 months ) , patients underwent a clinical and radiographic evaluation .


Clinical outcome was assessed with the adjusted Constant score .


All but 1 fracture went on to radiographic union .


Mean Constant score in the Polarus nail was 72.7 16.0 and 83.3 16.7 in the MultiLoc ( P = .246 ) .


Symptoms related with rotator cuff disease were present in 19/26 patients ( 73 % ) and in 9/26 ( 34.6 % ) , respectively ( P = .001 ) .


The mean neck-shaft angle at final follow-up was 135 in the MultiLoc group and 130 in the Polarus group ( P > .05 ) .


Reoperation rate was 42 % for Polarus and 11.5 % for MultiLoc .


Straight intramedullary nails had a comparable union rate to an accepted curvilinear design , with a much lower incidence of complications .


Rotator cuff pain and dysfunction can be minimized with the use of newer generation straight nails .


This was a prospective , randomized , controlled multicenter study with 24-month follow-up .


The purpose of this study was to evaluate the safety and efficacy in a Food and Drug Administration Investigation Device Exemption of a new lumbar total disc replacement ( TDR ) by comparing it to an earlier TDR approved for sale .


Randomized trials have reported TDR to produce results similar or superior to lumbar fusion .


Results for various TDRs seem to be similar , but differences in study design and outcome measures pose challenges in definitively comparing devices .


The purpose of this study was to perform a direct comparison of 2 lumbar TDRs in a prospective , randomized trial .


TDR was performed in 457 patients from 21 sites ( 261 patients in the investigational group ( Kineflex-L Disc ; metal-on-metal design anchored with keels , 204 randomized and 57 nonrandomized training cases ) , and 196 in the control group ( CHARITE artificial disc ; metal with polyethylene core with teeth for anchoring ; 190 randomized and 6 nonrandomized training cases ) .


All patients were treated nonoperatively for single-level symptomatic disc degeneration for at least 6 months prior to surgery .


Perioperative data were collected .


Clinical outcome data were collected prospectively , as approved by the Food and Drug Administration , through 24-month follow-up .


Primary outcome measures used were the Oswestry Disability Index , visual analogue scales assessing pain , patient satisfaction , and reoperations .


Success was defined to be at least 15-point improvements in Oswestry Disability Index scores , no reoperation , and no major adverse events .


Radiographical measures included range of motion , disc space height , and assessment for device migration , subsidence , and fusion at the TDR level .


There were no significant differences between the groups when comparing operative time , blood loss , or length of hospital stay .


Both groups improved significantly on Oswestry Disability Index and visual analogue scale scores ( P < 0.01 ) with no differences between the groups .


Success rates were similar ( 68.1 % investigational vs. 67.4 % control ) .


At 24-month follow-up , 94.1 % of the investigational group and 91.9 % of controls were satisfied with outcome .


Reoperation was performed in 10.3 % of the investigational group and 8.4 % of the control group .


This prospective , randomized , controlled study comparing 2 TDRs , the first to the authors ' knowledge , found the devices produced very similar clinical outcomes .


Both groups improved significantly by 6 weeks postoperatively and remained improved throughout follow-up with a high patient satisfaction rate .


A single bout of exercise improves postprandial glycemia and insulin sensitivity in prediabetic patients ; however , the impact of exercise intensity is not well understood .


The present study compared the effects of acute isocaloric moderate ( MIE ) and high-intensity ( HIE ) exercise on glucose disposal and insulin sensitivity in prediabetic adults .


Subjects ( n = 18 ; age 4914 y ; fasting glucose 10511 mg/dL ; 2 h glucose 17032 mg/dL ) completed a peak O2 consumption/lactate threshold ( LT ) protocol plus three randomly assigned conditions : 1 ) control , 1 hour of seated rest , 2 ) MIE ( at LT ) , and 3 ) HIE ( 75 % of difference between LT and peak O2 consumption ) .


One hour after exercise , subjects received an oral glucose tolerance test ( OGTT ) .


Plasma glucose , insulin , and C-peptide concentrations were sampled at 5 - to 10-minute intervals at baseline , during exercise , after exercise , and for 3 hours after glucose ingestion .


Total , early-phase , and late-phase area under the glucose and insulin response curves were compared between conditions .


Indices of insulin sensitivity ( SI ) were derived from OGTT data using the oral minimal model .


Compared with control , SI improved by 51 % ( P = .02 ) and 85 % ( P < .001 ) on the MIE and HIE days , respectively .


No differences in SI were observed between the exercise conditions ( P = .62 ) .


Improvements in SI corresponded to significant reductions in the glucose , insulin , and C-peptide area under the curve values during the late phase of the OGTT after HIE ( P < .05 ) , with only a trend for reductions after MIE .


These results suggest that in prediabetic adults , acute exercise has an immediate and intensity-dependent effect on improving postprandial glycemia and insulin sensitivity .


Bleomycin-etoposid-cisplatin ( BEP ) chemotherapy is curative in most patients with disseminated germ cell cancer ( GCC ) but also associated with toxic actions and dysfunction in non-targeted tissues .


We investigated changes in muscle function during BEP and the safety and efficacy of resistance training to modulate these changes .


Thirty GCC patients were randomly assigned to resistance training ( resistance training group ( INT ) , n = 15 ) or usual care ( CON , n = 15 ) during 9 weeks of BEP therapy .


Resistance training consisted of thrice weekly sessions of four exercises , 3-4 sets/exercise of 10-15 repetitions at 12-15 repetition maximum load .


The primary endpoint was muscle fibre size , assessed in muscle biopsies from musculus vastus lateralis .


Secondary endpoints were fibre phenotype composition , body composition , strength , blood biochemistry and patient-reported endpoints .


Healthy age-matched subjects ( REF , n = 19 ) performed the same RT-programme for comparison purposes .


Muscle fibre size decreased by -322 m ( 2 ) ( 95 % confidence interval ( CI ) : -899 to 255 ; P = 0.473 ) in the CON-group and increased by +206 m ( 2 ) ( 95 % CI : -384 to 796 ; P = 0.257 ) in the INT-group ( adjusted mean difference ( AMD ) , +625 m ( 2 ) , 95 % CI : -253 to 1503 , P = 0.149 ) .


Mean differences in type II fibre size ( AMD , +823 m ( 2 ) , P = 0.09 ) and lean mass ( AMD , +1.49 kg , P = 0.07 ) in favour of the INT-group approached significance .


The REF-group improved all muscular endpoints and had significantly superior changes compared with the INT-group ( P < 0.05 ) .


BEP was associated with significant reduction in lean mass and strength and trends toward unfavourable changes in muscle fibre size and phenotype composition .


Resistance training was safe and attenuated dysfunction in selected endpoints , but BEP blunted several positive adaptations observed in healthy controls .


Thus , our study does not support the general application of resistance training in this setting but larger-scaled trials are required to confirm this finding .


Purse-string suture is a closure method that purportedly reduces the scar area compared with second intention healing .


Randomized clinical trials comparing these 2 methods appear to be limited or absent .


To determine if purse-string suture improves cosmetic outcome , healing time , and scar to defect area compared with second intention healing for circular defects on the trunk and extremities .


Prospective , 2-arm , randomized , evaluator-blinded clinical trial in a single-center outpatient academic dermatology center .


Patients were eligible if they were older than 18 years , able to give informed consent , and had circular or oval postoperative defects larger than 8 mm on the trunk or extremities .


For the purse-string treatment arm , wounds were sewn in circumferential fashion using polydiaxanone suture .


Patients in the other treatment arm were allowed to heal by second intent .


The primary outcome measures were the mean total Patient and Observer Scar Assessment Scale ( POSAS ) scores ascertained from the patient and 2 blinded observers .


Secondary outcomes included the ratio of scar to initial defect size , healing time , pain scores , and complication rates .


Fifty-two patients were screened , and a total of 44 patients with 50 surgical sites were enrolled .


Forty-two patients with 48 surgical sites completed the study .


The mean total observer POSAS score was 18.38 for the purse-string group vs 19.91 for the secondary intention group , a nonsignificant difference ( P = .41 ) .


Similarly , there were no significant differences for any of the following secondary outcome measures : mean total patient POSAS score ( P = .96 ) , mean scar-to-defect area ( P = .61 ) , and mean pain level at week 1 ( P = .19 ) .


Statistical trends toward significance were seen in the mean healing time in favor of purse-string suture ( P = .10 ) and scar relief , which favored second intention healing ( P = .07 ) .


The purse-string suture results in similar cosmetic outcomes , scar sizes , and pain levels compared with second intention healing for circular or oval wounds on the trunk and extremities .


A larger study might better define the potential differences in our secondary outcome measures of healing time and scar relief .


clinicaltrials.gov Identifier : NCT02062866 .


To evaluate the effect of health education on prevention from schistosome infection in engineering construction workers in Poyang Lake area .


The workers for constructing `` De Chang '' highway in Poyang Lake area were divided randomly into an experiment group and a control group , `` health education + protective skill training '' was carried out in the experiment group , whereas , no intervention was implemented in the control group .


In the experiment group , the awareness rates of schistosomiasis control knowledge were 7.96 % and 96.39 % before and after the intervention , respectively ; the rates of contacting infested water were 100 % and 1.77 % pre - and post-intervention , respectively ; the work protective rates increased from zero before the intervention to 100 % after the intervention ; there was no person infected with schistosome after the intervention .


However , in the control group , all the indexes above-mentioned had no significant changes .


The intervention model `` health education + protective skill training '' , can effectively prevent from schistosome infection in engineering construction workers in Poyang Lake area .


Research has consistently identified a disparity between the prevalence of mental health concerns among young adults and their rates of formal help seeking .


However , a few randomised controlled trials have identified effective interventions for increasing formal help seeking among young adults .


The aim of this study was to evaluate the effectiveness of a brief online psychoeducational intervention , targeting depression , anxiety and suicide stigma , for increasing positive attitudes towards help seeking and increasing help seeking intentions among young adults .


The study followed a single-blind parallel group randomized controlled trial design with 67 young adult ( 18-25 years ) Australian participants , assigned to receive online psychoeducation ( n = 33 ) or online attention-matched control information ( n = 34 ) over 3 weeks .


Participants in the experimental group received information on depression , anxiety , and suicide .


The control group received information unrelated to mental health .


Primary outcome measures were mental health literacy , mental illness stigma , attitudes toward professional help seeking and intentions to seek help .


Secondary outcome variables were symptomology , satisfaction and adherence .


Significant between-group differences were found for the pre - to post-test , including increased anxiety literacy ( Cohens d = 0.65 ) , decreased depression stigma ( d = 0.53 ) , and increased help seeking attitudes and intentions for the experimental group ( d = 0.58 and d = 0.53 , respectively ) .


Due to the small sample size and homogenous nature of the sample , generalisations should be made with caution .


This study demonstrates the utility and effectiveness of a brief online psychoeducation intervention for promoting help seeking among young adults .


Antimicrobial pharmacokinetic and pharmacodynamic data are limited in obesity .


To evaluate the steady-state pharmacokinetics and pharmacodynamics of doripenem and meropenem in obese patients hospitalized on a general ward .


Patients with a body mass index ( BMI ) 40 kg/m or total body weight ( TBW ) 100 pounds over their ideal body weight randomly received doripenem 500 mg ( 1-hour infusion ) or meropenem 1 g ( 0.5-hour infusion ) every 8 hours .


Differences in pharmacokinetic parameters were determined by unpaired t test .


Monte Carlo simulations were performed for 500 mg and 1 g every 8 hours , infused over 1 and 4 hours for doripenem and 0.5 and 3 hours for meropenem .


Probability of target attainment ( PTA ) was calculated using a pharmacodynamic target of 40 % fT > MIC ( free drug concentrations above the minimum inhibitory concentration [ MIC ] ) , and cumulative fraction of response ( CFR ) was calculated using MIC data for 8 Gram-negative pathogens .


Twenty patients were studied .


Volume of distribution at steady state , corrected for TBW , was significantly larger ( 0.18 0.04 vs 0.13 0.05 L/kg , P = .048 ) and systemic clearance was significantly faster for doripenem ( 11.7 4.1 vs 8.1 2.6 L/h , P = .03 ) .


PTA was > 90 % for all regimens at MICs 2 g/mL .


CFR was > 90 % for all regimens against 6 enteric Gram-negative pathogens and for 3 of 4 regimens for each drug against Pseudomonas aeruginosa .


Doripenem and meropenem pharmacokinetics differ in obesity .


However , currently approved dosing regimens provide adequate pharmacodynamic exposures for susceptible bacteria in obese patients .


Increased circulating cathepsin S levels have been linked to increased risk of cardiometabolic diseases and cancer .


However , whether cathepsin S is a modifiable risk factor is unclear .


We aimed to investigate the effects of a prudent diet on plasma cathepsin S levels in healthy individuals .


Explorative analyses of a randomized study were performed in 88 normal to slightly overweight and hyperlipidemic men and women ( aged 25 to 65 ) that were randomly assigned to ad libitum prudent diet , i.e. healthy Nordic diet ( ND ) or a control group ( habitual Western diet ) for 6weeks .


Whereas all foods in the ND were provided , the control group was advised to consume their habitual diet throughout the study .


The ND was in line with dietary recommendations , e.g. low in saturated fats , sugars and salt , but high in plant-based foods rich in fibre and unsaturated fats.The ND significantly decreased cathepsin S levels ( from 20.1 ( + / -4.0 SD ) to 19.7 g/L ( + / -4.3 SD ) ) compared with control group ( from 18.2 ( + / -2.9 SD ) to 19.1 g/L ( + / -3.8 SD ) ) .


This difference remained after adjusting for sex and change in insulin sensitivity ( P = 0.03 ) , and near significant after adjusting for baseline cathepsin S levels ( P = 0.06 ) , but not for change in weight or LDL-C .


Changes in cathepsin S levels were directly correlated with change in LDL-C .


Compared with a habitual control diet , a provided ad libitum healthy Nordic diet decreased cathepsin S levels in healthy individuals , possibly mediated by weight loss or lowered LDL-C .


These differences between groups in cathepsin S were however not robust and therefore need further investigation .


The purpose of the study was to assess what effect daily cleaning of contact lenses with a multipurpose disinfection solution ( MPDS ) , during 30 nights extended wear , would have on contact lens-related adverse events .


This was a prospective , open-label , randomized , controlled , parallel-group , 3-month clinical study in which 193 participants were dispensed with lotrafilcon A silicone hydrogel lenses for a 30-day extended-wear schedule and with lenses replaced monthly .


Participants were randomized to a control or test group .


Test subjects were required to remove lenses daily after waking , clean them with the MPDS , and reinsert the lenses .


Control subjects wore lenses without removal for 30 days extended wear .


Handling-related lens contamination was assessed at the baseline visit .


There was no significant difference between the test and control groups for the incidence of significant corneal infiltrative events ( 1.3 vs. 4.9 % , p = 0.368 ) , total corneal infiltrative events ( 2.6 vs. 4.9 % , p = 0.682 ) , or mechanical events ( 1.3 vs. 2.5 % , p = 1.00 ) .


The test group had greater corneal staining ( p < 0.047 ) and fewer mucin balls ( p = 0.033 ) .


Handling-related lens contamination ( unworn lenses ) resulted in isolation of Gram-positive bacteria from 92.5 % of test lenses compared with 87.5 % of control lenses ( p = 0.712 ) .


Gram-negative bacteria were isolated from 5 % of test subjects compared with 2.5 % of control subjects ( p = 1.00 ) .


Fungus was isolated from 2.5 % of subjects in both the test and control groups ( p = 1.00 ) .


The intervention of daily morning cleaning of the lens surface with an MPDS during extended wear did not significantly influence the incidence of adverse events .


For economic reasons , i.e. , to reduce costs of in-hospital patient accommodations , constant pressure has been applied in recent years to increase the percentage of ambulatory surgeries .


Effective control of post-operative pain after ambulatory surgery is challenging to all health professionals .


Computerised systems are being implemented more frequently for remote patient monitoring , including during the at-home post-operative period .


This study evaluates the feasibility of delivering a computerised system , developed in-house , for remote pain monitoring .


It evaluates the user-friendliness of the system and the extent of patient compliance .


Finally , a comparative assessment of the system is made with respect to the quality of pain treatment in ambulatory surgery .


The participants included 32 adults , aged 18-75 , randomly assigned to a control group or to a computerised treatment group .


The primary treatment outcome was measured by pain intensity ratings ( 0-10 NRS ) reported several times per day during a five-day monitoring period , using an electronic pain diary combined with a web-based personal health record .


The findings demonstrated the feasibility and suitability of the proposed system for pain management .


Its handling was user-friendly , without requiring advanced skill or prior experience .


In addition , the results showed that the guidance of health care professionals is essential to patients ' satisfaction and positive experience with the system .


There were no significant group differences with respect to improvements in the quality of pain treatment ; however , this can be explained by the low pain scores registered in both groups , related to the type of surgical interventions recruited and the degrees of pain that are easily treated .


To evaluate the benefits from a patient-centred perspective , studies of major ambulatory surgeries or of patients in chronic pain , including oncologic and non-oncologic pain resistant to treatment , are necessary .


A wide variety of orthodontic wires made of different alloys is available to be used in orthodontic practice and may produce different clinical responses during tooth movement .


This research evaluated the alignment and leveling of lower dental arches after the use of three types of orthodontic wires .


A sample of 36 patients was randomly divided into 3 groups : stainless steel , multistranded steel and superelastic nickel-titanium , according to the first leveling arches used .


In order to observe differences in tooth position and axial inclination of the lower incisors , all patients had lateral cephalometric radiographs taken before the insertion of the first arches and 2 months later .


The irregularity index and the curve of Spee were measured , compared between groups and considered influential on the proclination of incisors during the initial phase of alignment and leveling .


TheReflex microscope was used to measure the irregularity index , whereas the ANOVA analysis of variance was used to verify differences between groups with regard to the degree of dental alignment and leveling .


There were significant differences between groups only at T2 for the irregularity index .


The NiTi and multistranded steel wires showed greater aligning capacity when compared with stainless steel wires .


The objectives of this study are to compare the effects of two nursing intervention models on the ability of preschool children with malignant tumors to socialize and to determine if these interventions improved their social adaption capability ( SAC ) and quality of life .


Inpatient preschool children with malignant tumors admitted to the hospital between December 2009 and March 2012 were recruited and randomized into either the experimental or control groups .


The control group received routine nursing care , and the experimental group received family-centered nursing care , including physical , psychological , and social interventions .


The Infants-Junior Middle School Student 's Social-Life Abilities Scale was used to evaluate SAC development of participants .


Participants ( n = 240 ) were recruited and randomized into two groups .


After the intervention , the excellent and normal SAC rates were 27.5 % and 55 % in the experimental group , respectively , compared with 2.5 % and 32.5 % in the control group ( p < 0.001 ) .


After the intervention , SAC in experimental group was improved compared with before intervention ( 54.6810.85 vs 79.922.3 , p < 0.001 ) .


However , no differences in SAC were observed between baseline and after intervention in the control group ( 54.7011.47 vs. 5215.8 , p = 0.38 ) .


The family-centered nursing care model that included physical , psychological , and social interventions improved the SAC of children with malignancies compared with children receiving routine nursing care .


Establishing a standardized family-school-community-hospital hierarchical multi-management intervention model for children is important to the efficacy of long-term interventions and to the improvement of SAC of children with malignancies .


Most trials comparing percutaneous coronary intervention ( PCI ) with coronary-artery bypass grafting ( CABG ) have not made use of second-generation drug-eluting stents .


We conducted a randomized noninferiority trial at 27 centers in East Asia .


We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG .


The primary end point was a composite of death , myocardial infarction , or target-vessel revascularization at 2 years after randomization .


Event rates during longer-term follow-up were also compared between groups .


After the enrollment of 880 patients ( 438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group ) , the study was terminated early owing to slow enrollment .


At 2 years , the primary end point had occurred in 11.0 % of the patients in the PCI group and in 7.9 % of those in the CABG group ( absolute risk difference , 3.1 percentage points ; 95 % confidence interval [ CI ] , -0.8 to 6.9 ; P = 0.32 for noninferiority ) .


At longer-term follow-up ( median , 4.6 years ) , the primary end point had occurred in 15.3 % of the patients in the PCI group and in 10.6 % of those in the CABG group ( hazard ratio , 1.47 ; 95 % CI , 1.01 to 2.13 ; P = 0.04 ) .


No significant differences were seen between the two groups in the occurrence of a composite safety end point of death , myocardial infarction , or stroke .


However , the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG .


Among patients with multivessel coronary artery disease , the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG .


( Funded by CardioVascular Research Foundation and others ; BEST ClinicalTrials.gov number , NCT00997828 . )


There is a paucity of data on the use of optimal medical therapy ( OMT ) in patients with complex coronary artery disease undergoing revascularization with percutaneous coronary intervention or coronary artery bypass grafting ( CABG ) and its long-term prognostic significance .


The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery ( SYNTAX ) trial is a multicenter , randomized , clinical trial of patients ( n = 1800 ) with complex coronary disease randomized to revascularization with percutaneous coronary intervention or CABG .


Detailed drug history was collected for all patients at discharge and at the 1-month , 6-month , 1-year , 3-year , and 5-year follow-ups .


OMT was defined as the combination of at least 1 antiplatelet drug , statin , - blocker , and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker .


Five-year clinical outcomes were stratified by OMT and non-OMT .


OMT was underused in patients treated with coronary revascularization , especially CABG .


OMT was an independent predictor of survival .


OMT was associated with a significant reduction in mortality ( hazard ratio , 0.64 ; 95 % confidence interval , 0.48-0 .85 ; P = 0.002 ) and composite end point of death/myocardial infarction/stroke ( hazard ratio , 0.73 ; 95 % confidence interval , 0.58-0 .92 ; P = 0.007 ) at the 5-year follow-up .


The treatment effect with OMT ( 36 % relative reduction in mortality over 5 years ) was greater than the treatment effect of revascularization strategy ( 26 % relative reduction in mortality with CABG versus percutaneous coronary intervention over 5 years ) .


On stratified analysis , all the components of OMT were important for reducing adverse outcomes regardless of revascularization strategy .


The use of OMT remains low in patients with complex coronary disease requiring coronary intervention with percutaneous coronary intervention and even lower in patients treated with CABG .


Lack of OMT is associated with adverse clinical outcomes .


Targeted strategies to improve OMT use in postrevascularization patients are warranted .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00114972 .


To determine whether an education programme targeted at schoolchildren could lower salt intake in children and their families .


Cluster randomised controlled trial , with schools randomly assigned to either the intervention or control group .


28 primary schools in urban Changzhi , northern China .


279 children in grade 5 of primary school , with mean age of 10.1 ; 553 adult family members ( mean age 43.8 ) .


Children in the intervention group were educated on the harmful effects of salt and how to reduce salt intake within the schools ' usual health education lessons .


Children then delivered the salt reduction message to their families .


The intervention lasted for one school term ( about 3.5 months ) .


The primary outcome was the difference between the groups in the change in salt intake ( as measured by 24 hour urinary sodium excretion ) from baseline to the end of the trial .


The secondary outcome was the difference between the two groups in the change in blood pressure .


At baseline , the mean salt intake in children was 7.3 ( SE 0.3 ) g/day in the intervention group and 6.8 ( SE 0.3 ) g/day in the control group .


In adult family members the salt intakes were 12.6 ( SE 0.4 ) and 11.3 ( SE 0.4 ) g/day , respectively .


During the study there was a reduction in salt intake in the intervention group , whereas in the control group salt intake increased .


The mean effect on salt intake for intervention versus control group was -1.9 g/day ( 95 % confidence interval -2.6 to -1.3 g/day ; P < 0.001 ) in children and -2.9 g/day ( -3.7 to -2.2 g/day ; P < 0.001 ) in adults .


The mean effect on systolic blood pressure was -0.8 mm Hg ( -3.0 to 1.5 mm Hg ; P = 0.51 ) in children and -2.3 mm Hg ( -4.5 to -0.04 mm Hg ; P < 0.05 ) in adults .


An education programme delivered to primary school children as part of the usual curriculum is effective in lowering salt intake in children and their families .


This offers a novel and important approach to reducing salt intake in a population in which most of the salt in the diet is added by consumers.Trial registration ClinicalTrials.gov NCT01821144 .


Arthritis and musculoskeletal conditions are the leading cause of long-term work disability ( WD ) , an outcome with a major impact on quality of life and a high cost to society .


The importance of decreased at-work productivity has also recently been recognized .


Despite the importance of these problems , few interventions have been developed to reduce the impact of arthritis on employment .


We have developed a novel intervention called `` Making It Work '' , a program to help people with inflammatory arthritis ( IA ) deal with employment issues , prevent WD and improve at-work productivity .


After favorable results in a proof-of-concept study , we converted the program to a web-based format for broader dissemination and improved accessibility .


The objectives of this study are : 1 ) to evaluate in a randomized controlled trial ( RCT ) the effectiveness of the program at preventing work cessation and improving at-work productivity ; 2 ) to perform a cost-utility analysis of the intervention .


526 participants with IA will be recruited from British Columbia , Alberta , and Ontario in Canada .


The intervention consists of a ) 5 online group sessions ; b ) 5 web-based e-learning modules ; c ) consultations with an occupational therapist for an ergonomic work assessment and a vocational rehabilitation counselor .


Questionnaires will be administered online at baseline and every 6months to collect information about demographics , disease measures , costs , work-related risk factors for WD , quality of life , and work outcomes .


Primary outcomes include at-work productivity and time to work cessation of > 6months for any reason .


Secondary outcomes include temporary work cessation , number of days missed from work per year , reduction in hours worked per week , quality adjusted life year for the cost utility analysis , and changes from baseline in employment risk factors .


Analysis of Variance will evaluate the intervention 's effect on at-work productivity , and multivariable Cox regression models will estimate the risk of work cessation associated with the intervention after controlling for risk factors for WD and other important predictors imbalanced at baseline .


This program fills an important gap in arthritis health services and addresses an important and costly problem .


Knowledge gained from the RCT will be useful to health care professionals , policy planners and arthritis stakeholders .


ClinicalTrials.gov NCT01852851 ; registered April 13 , 2012 ; first participant randomized on July 6 , 2013 .


Closure of abdominal incisions with different suture materials has been a matter of great controversy .


Polypropylene and Polylactide with Polyglycolide are among the commonest suture materials used for closure of abdominal incisions .


Objectives of this study were to assess optimal suture material used for closure of elective abdominal incisions and to see complications associated with these suture materials .


This prospective , comparative , randomised study was conducted at public and private sector hospitals of Nawabshah and Hyderabad from 1st Jan 2005 to 31st October 2009 .


All patients who underwent abdominal surgery under the investigators ' supervision were included in the study .


Patients were divided into 2 groups on even or odd numbers .


In group-A patients ' incision was closed with monofilament , non-absorbable Polypropylene ( Prolene ) No. 1 suture material and in group-B incision was closed with Polyfilament , absorbable , co-polymer of Polylactide with Polyglycolide ( Vicryle ) No. 1 .


A total 274 patients were finally analysed for closure of elective abdominal incisions , with 138 ( 50.4 % ) patients in Group-A and 136 ( 49.6 % ) patients in Group-B .


Vicryle was found superior in knot security and suture handling .


Superficial wound infection was found in 5.79 % patients of Group-A and 6.61 % of Group-B .


Discharging sinus was found in 3.62 % of Group-A vs 0.73 % of Group-B .


Burst abdomen was seen in 2.17 % patients in Group-A and 1.47 % in Group-B .


Incisional hernia was present in 4.34 % of Group-A and 0.73 % patients of Group-B .


No patient in Group-B developed persistent pain at incisional site while it was found in 8.69 % patients of Group-A .


Polylactide is an optimal suture material in closure of elective abdominal incisions .


Memantine , an uncompetitive N-methyl-d-aspartate receptor antagonist , is currently approved by the US Food and Drug Administration for the treatment of moderate to severe Alzheimer 's disease .


Anecdotal reports have suggested that memantine may improve neurologic and cognitive symptoms of individuals with the neurodegenerative disease fragile X-associated tremor/ataxia syndrome ( FXTAS ) ; however , its efficacy and safety in this population have not been assessed in a controlled trial .


Individuals with FXTAS aged 34-80 years were enrolled in a randomized , double-blind , placebo-controlled , 1-year trial between September 2007 and August 2012 .


Inclusion required definite , probable , or possible FXTAS in clinical stages 1-5 according to previously published criteria .


Primary outcome measures were the Behavioral Dyscontrol Scale ( BDS ) score and CATSYS intention tremor severity .


Ninety-four participants were randomized from 205 screened ; of those , 43 and 45 started treatment with memantine ( titrated to 10 mg twice daily ) and placebo , respectively .


Thirty-four participants receiving memantine and 36 receiving placebo completed the 1-year endpoint assessment ( n = 70 ) .


Intention-to-treat analysis showed no improvement with respect to intention tremor severity ( mean [ SD ] values with memantine vs placebo : 1.05 [ 0.73 ] vs 1.89 [ 2.19 ] , P = .047 ) or BDS score ( 16.12 [ 5.43 ] vs 15.72 [ 3.93 ] , P = .727 ) at follow-up .


Post hoc analyses of participants with early FXTAS ( stage 3 ) , those with late FXTAS ( stage > 3 ) , and those in different age groups ( 65 years and > 65 years ) also indicated no significant improvement .


More frequent mild adverse events were observed in the placebo group , while more frequent moderate adverse events occurred in the memantine group ( P = .007 ) .


This randomized , double-blind , placebo-controlled trial of memantine for individuals with FXTAS showed no benefit compared to placebo with respect to the selected outcome measures .


ClinicalTrials.gov identifier : NCT00584948 .


Falling can lead to severe health issues in the elderly and importantly contributes to morbidity , death , immobility , hospitalization , and early entry to long-term care facilities .


The aim of this study was to devise a recurrent fall prevention program for elderly women in rural areas .


This study adopted an assessor-blinded , randomized , controlled trial methodology .


Subjects were enrolled in a 12-week recurrent fall prevention program , which comprised strength training , balance training , and patient education .


Muscle strength and endurance of the ankles and the lower extremities , static balance , dynamic balance , depression , compliance with preventive behavior related to falls , fear of falling , and fall self-efficacy at baseline and immediately after the program were assessed .


Sixty-two subjects ( mean age 69.24.3 years old ) completed the program -- 31 subjects in the experimental group and 31 subjects in the control group .


When the results of the program in the 2 groups were compared , significant differences were found in ankle heel rise test , lower extremity heel rise test , dynamic balance , depression , compliance with fall preventative behavior , fear of falling , and fall self-efficacy ( p < 0.05 ) , but no significant difference was found in static balance .


This study shows that the fall prevention program described effectively improves muscle strength and endurance , balance , and psychological aspects in elderly women with a fall history .


To study the diagnostic importance of a new Indis software package for the postprocessing of the results of radionuclude examinations ( Center for Information and Diagnostic Systems , St. Petersburg , Russia ) when analyzing the results of lacrimal scintigraphy .


Dynamic lacrimal scintigraphy was carried out in 6 volunteers ( 12 eyes ) and 20 patients ( 32 years ) with dacryostenosis .


The examined Indis program and the known Syngo program ( Siemens , Germany ) were used to calculate the elimination half-life of a radiopharmaceutical from the interest region corresponding to the whole ocular surface .


The time taken to postprocess the results of the examination was also determined .


When calculations were made using the Indis program and the Syngo system , the elimination half-lives of a tracer in the volunteers was 6.57 2.46 and 7.54 3.21 min , respectively .


These in the patents with dacryostenosis were 69.39 65.52 and 74.85 64.59 min .


With these programs , the times taken for postprocessing were 12.3 4.2 and 26.3 7.9 min , respectively .


The investigation showed the practical significance of the Indis software package in processing the data of lacrimal scintigraphy .


The calculations made with the Indis program correspond to those made with the known Syngo program .


The convenience and ergonomics of the program can precisely identify the region of interest .


The economic justification of the system is associated with the shorter time taken to postprocess and interpret the results of lacrimal scintigraphy .


The Indis software package may be recommended for use in the examination and treatment monitoring in patients with abnormal lacrimaton .


This study examined in - and post-treatment mediation effects of a 12-session dose of Seeking Safety ( SS ) - an integrative cognitive behavioral treatment for comorbid PTSD and SUDs-on alcohol and cocaine outcomes in comparison to Women 's Health Education ( WHE ) in a seven-site randomized controlled effectiveness trial .


Women ( n = 353 ) enrolled in outpatient substance abuse treatment , who had experienced multiple traumas in childhood and/or adulthood and who had comorbid PTSD , were randomly assigned to receive SS or WHE delivered in open enrollment groups for 12 sessions in 6 weeks ( unlike the full 25-topic SS protocol ) .


Data were analyzed under two forms of longitudinal mediation analysis , each accounting for changes over time in group membership and group context , respectively .


Women in SS , compared to WHE , showed significantly steeper decreases in PTSD frequency and severity , which in turn , showed significant impact in reducing both cocaine and alcohol use .


This pattern was strongest for those who completed most of the treatment sessions , which was the majority of patients in the trial ; these patterns only emerged during the in-treatment phase .


Use of an integrated approach to PTSD/SUD such as SS can be helpful to more rapidly reduce PTSD , which consequently reduce SUD symptoms , particularly for those who attend most of the available treatment sessions .


This is one of the first studies to illustrate such effects in treating comorbid PTSD and SUD in the context of a highly impaired population delivered by community-based providers .


( Am J Addict 2014 ; 23:218 -225 ) .


Ivabradine is a negative chronotropic drug with minimal effects on central hemodynamics .


Its effect on dynamic obstruction of the left ventricular outflow tract ( LVOT ) in cats with hypertrophic cardiomyopathy ( HCM ) remains unknown .


Ivabradine reduces dynamic obstruction of the LVOT in cats with HCM .


Twenty-eight client-owned cats with preclinical HCM and dynamic LVOT obstruction .


Randomized , double-blind , active-control single dose study .


Cats received a single dose of either ivabradine ( 0.3 mg/kg PO ) or atenolol ( 2 mg/kg PO ) .


Heart rate , echocardiographic variables , and systolic blood pressure ( SBP ) were recorded before and 3 hours after drug administration .


Statistical comparisons were made using ANCOVA .


Peak velocity in the LVOT was significantly decreased compared to baseline for both drugs ; however , the effect was more prominent with atenolol ( mean reduction 2.53 m/s ; 95 % CI 2.07-3 .13 m/s ) compared to ivabradine ( mean reduction 0.32 m/s ; 95 % CI -0.04 to 0.71 m/s ; P < .0001 ) .


Echocardiographic indices of systolic function were largely unchanged by ivabradine , but significantly reduced by atenolol .


A single dose of ivabradine decreases dynamic LVOT obstruction in cats with HCM , but the clinical effect is negligible and inferior compared to that achieved by atenolol .


Age-related macular degeneration ( AMD ) is the leading cause of blindness among older adults in the developed world .


The only treatments currently available , such as ranibizumab injections , are for neovascular AMD , which accounts for only 10 to 15 % of people with the condition .


Hypoxia has been implicated as one of the primary causes of AMD , and is most acute at night when the retina is most metabolically active .


By increasing light levels at night , the metabolic requirements of the retina and hence the hypoxia will be considerably reduced .


This trial seeks to determine whether wearing a light mask that emits a dim , green light during the night can prevent the progression of early AMD .


ALight is a Phase I/IIa , multicentre , randomized controlled trial .


Sixty participants ( 55 to 88years old ) with early AMD in one eye and neovascular AMD ( nAMD ) in the fellow eye will be recruited from nAMD clinics .


They will be randomized ( in the ratio 1:1 ) , either to receive the intervention or to be in the untreated control group , stratified according to risk of disease progression .


An additional 40 participants with healthy retinal appearance , or early AMD only , will be recruited for a baseline cross-sectional analysis .


The intervention is an eye mask that emits a dim green light to illuminate the retina through closed eyelids at night .


This is designed to reduce the metabolic activity of the retina , thereby reducing the potential risk of hypoxia .


Participants will wear the mask every night for 12months .


Ophthalmologists carrying out monthly assessments will be masked to the treatment group , but participants will be aware of their treatment group .


The primary outcome measure is the proportion of people who show disease progression during the trial period in the eye with early AMD .


A co-primary outcome measure is the rate of retinal adaptation .


As this is a trial of a CE-marked device for an off-label indication , a further main aim of this trial is to assess safety of the mask in the cohort of participants with AMD .


International Standard Randomised Controlled Trials Register : ISRCTN82148651 .


Erythropoietic protoporphyria is a severe photodermatosis that is associated with acute phototoxicity .


Patients with this condition have excruciating pain and a markedly reduced quality of life .


We evaluated the safety and efficacy of an - melanocyte-stimulating hormone analogue , afamelanotide , to decrease pain and improve quality of life .


We conducted two multicenter , randomized , double-blind , placebo-controlled trials of subcutaneous implants containing 16 mg of afamelanotide .


Patients in the European Union ( 74 patients ) and the United States ( 94 patients ) were randomly assigned , in a 1:1 ratio , to receive a subcutaneous implant containing either afamelanotide or placebo every 60 days ( a total of five implants in the European Union study and three in the U.S study ) .


The type and duration of sun exposure , number and severity of phototoxic reactions , and adverse events were recorded over the respective 180-day and 270-day study periods .


Quality of life was assessed with the use of validated questionnaires .


A subgroup of U.S. patients underwent photoprovocation testing .


The primary efficacy end point was the number of hours of direct exposure to sunlight without pain .


In the U.S. study , the duration of pain-free time after 6 months was longer in the afamelanotide group ( median , 69.4 hours , vs. 40.8 hours in the placebo group ; P = 0.04 ) .


In the European Union study , the duration of pain-free time after 9 months was also longer in the afamelanotide group than in the placebo group ( median , 6.0 hours vs. 0.8 hours ; P = 0.005 ) , and the number of phototoxic reactions was lower in the the afamelanotide group ( 77 vs. 146 , P = 0.04 ) .


In both trials , quality of life improved with afamelanotide therapy .


Adverse events were mostly mild ; serious adverse events were not thought to be related to the study drug .


Afamelanotide had an acceptable side-effect and adverse-event profile and was associated with an increased duration of sun exposure without pain and improved quality of life in patients with erythropoietic protoporphyria .


( Funded by Clinuvel Pharmaceuticals and others ; ClinicalTrials.gov numbers , NCT01605136 and NCT00979745 . )


Mild head injuries commonly present to emergency departments .


The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury , and which patients can safely be sent home .


Traumatic brain injuries may exist with subtle symptoms or signs , but can still lead to adverse outcomes .


Despite the existence of several high quality clinical practice guidelines , internationally and in Australia , research shows inconsistent implementation of these recommendations .


The aim of this trial is to test the effectiveness of a targeted , theory - and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients ( 18years of age or older ) who present following mild head injuries ( concussion ) , compared with passive dissemination of these recommendations .


The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed .


The design of this study is a cluster randomised trial .


We aim to include 34 Australian 24-hour emergency departments , which will be randomised to an intervention or control group .


Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries .


The intervention group will receive an implementation intervention based on an analysis of influencing factors , which include local stakeholder meetings , identification of nursing and medical opinion leaders in each site , a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3month period of time .


Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2month period following intervention delivery ( patient level outcomes ) .


In consenting hospitals , eligible patients will be recruited for a follow-up telephone interview conducted by trained researchers .


A cost-effectiveness analysis and process evaluation using mixed-methods will be conducted .


Sample size calculations are based on including 30 patients on average per department .


Outcome assessors will be blinded to group allocation .


Australian New Zealand Clinical Trials Registry ACTRN12612001286831 ( date registered 12 December 2012 ) .


The population of obese patients is progressively growing and bariatric operations are becoming increasingly common .


Morbidly obese patients require special anesthetic care and are often considered to be difficult to ventilate and intubate .


The VivaSight Single Lumen tube is an endotracheal tube with a camera embedded in its tip .


The view from the tip appears continuously on a monitor in the anesthesiologist 's vicinity .


The aim of this study was to assess the VivaSight in comparison with conventional endotracheal tube as an aid in the intubation and surveillance of tube position during surgery of obese patients .


This is a prospective study of 72 adult obese patients who underwent laparoscopic sleeve gastrectomy .


The patients were randomly assigned to be intubated by either the VivaSight ( 40 patients , test group ) or a conventional endotracheal tube ( 32 patients , control group ) .


Data on the patients , the pre-operative airway evaluation , the endotracheal intubation and the post-operative outcome were collected and compared .


The Mallampati scores were significantly higher in the test group than in the control group .


Endotracheal intubation took 2910 and 248seconds using the VivaSight and a conventional tube respectively ( p = 0.02 ) .


Three of the patients in the control group , while none of those in the test group , had soft tissue injury ( p < 0.05 ) .


We found the VivaSight SL to be helpful in the endotracheal intubation and continuous surveillance of tube position in morbidly obese patients undergoing laparoscopic sleeve gastrectomy .


Non-small-cell lung cancer ( NSCLC ) with a mutation in the gene encoding epidermal growth factor receptor ( EGFR ) is sensitive to approved EGFR inhibitors , but resistance develops , mediated by the T790M EGFR mutation in most cases .


Rociletinib ( CO-1686 ) is an EGFR inhibitor active in preclinical models of EGFR-mutated NSCLC with or without T790M .


In this phase 1-2 study , we administered rociletinib to patients with EGFR-mutated NSCLC who had disease progression during previous treatment with an existing EGFR inhibitor .


In the expansion ( phase 2 ) part of the study , patients with T790M-positive disease received rociletinib at a dose of 500 mg twice daily , 625 mg twice daily , or 750 mg twice daily .


Key objectives were assessment of safety , side-effect profile , pharmacokinetics , and preliminary antitumor activity of rociletinib .


Tumor biopsies to identify T790M were performed during screening .


Treatment was administered in continuous 21-day cycles .


A total of 130 patients were enrolled .


The first 57 patients to be enrolled received the free-base form of rociletinib ( 150 mg once daily to 900 mg twice daily ) .


The remaining patients received the hydrogen bromide salt ( HBr ) form ( 500 mg twice daily to 1000 mg twice daily ) .


A maximum tolerated dose ( the highest dose associated with a rate of dose-limiting toxic effects of less than 33 % ) was not identified .


The only common dose-limiting adverse event was hyperglycemia .


In an efficacy analysis that included patients who received free-base rociletinib at a dose of 900 mg twice daily or the HBr form at any dose , the objective response rate among the 46 patients with T790M-positive disease who could be evaluated was 59 % ( 95 % confidence interval [ CI ] , 45 to 73 ) , and the rate among the 17 patients with T790M-negative disease who could be evaluated was 29 % ( 95 % CI , 8 to 51 ) .


Rociletinib was active in patients with EGFR-mutated NSCLC associated with the T790M resistance mutation .


( Funded by Clovis Oncology ; ClinicalTrials.gov number , NCT01526928 . )


Although pain in knee osteoarthritis ( OA ) commonly affects activity engagement , the daily pain experience has not been fully characterized .


Specifically , the nature and impact of pain flares is not well understood .


This study characterized pain flares as defined by participants with knee OA .


Pain flare occurrence and experience were measured over 7 days .


This was a multiple methods study ; qualitative methods were dominant .


Data were collected during the baseline portion of a randomized controlled trial .


Participants met criteria for knee OA and had moderate to severe pain .


They completed questionnaires and a 7-day home monitoring period that captured momentary symptom reports simultaneously with physical activity via accelerometry ( n = 45 ) .


Participants also provided individual definitions of pain flare that were used throughout the home monitoring period to indicate whether a pain flare occurred .


Pain flares were described most often by quality ( often sharp ) , followed by timing ( seconds , minutes ) and by antecedents and consequences .


When asked if their definition of a flare agreed with a supplied definition , 49 % of the sample reported only `` somewhat , '' `` a little , '' or `` not at all . ''


Using individual definitions , 78 % experienced at least 1 daily pain flare over the home monitoring period ; 24 % had a flare on more than 50 % of the monitored days .


Pain flares were common , fleeting , and often experienced in the context of activity engagement .


Participants ' views on what constitutes a pain flare differ from commonly accepted definitions .


Pain flares are an understudied aspect of the knee OA pain experience and require further characterization .


Gestational diabetes mellitus ( GDM ) is increasing worldwide and has been associated with adverse perinatal outcomes and high risk for chronic disease both for the mother and for the child .


Physical exercise is feasible for diabetic pregnant women and contributes to better glycemic control and to a decrease in adverse perinatal outcomes .


However , there are no randomized controlled trials ( RCT ) assessing the effects of aquatic physical exercise on GDM control and adverse maternal and fetal outcomes .


An RCT will be conducted at Instituto de Medicina Integral Prof Fernando Figueira ( IMIP ) , Brazil .


A total of 72 pregnant women will be studied ; 36 gestational diabetics will undergo an aquatic physical exercise program in a thermal pool , 3 times per week over 2 months .


The primary endpoint will be glucose level control and use of insulin ; secondary endpoints will be the following maternal and fetal outcomes : weight gain during pregnancy , blood pressure , pre-eclampsia diagnosis , intrauterus growth restriction , preterm birth , Cesarean section , macrosomia and maternal or neonatal intensive care admission .


Endpoints between intervention and control group will analyzed by t test for unpaired data and test , and the level of significance will set at < 0.05 .


The physical proprieties of water make aquatic exercises ideal for pregnant women .


An aquatic physical exercise program developed for GDM women will be trialed in a thermal pool and under the supervision of physiotherapist to ensure compliance .


It is expected that this study will provide evidence as to the effect of aquatic physical exercise on GDM control .


ClinicalTrial.gov , NCT01940003 .


To compare the long-term efficacy of a corneal limbal conjunctival autograft combined with pterygium excision in the treatment of primary pterygium .


This random control study included 63 patients ( 63 eyes ) with primary pterygium .


These were randomly divided into a group with corneal limbal conjunctival autograft combined with pterygium excision ( group A ) and a group with pterygium excision with exposed sclera ( group B ) and subjected to long-term follow up .


The surgical outcomes were classified and evaluated ( grade I-IV ) .


Several indexes were analyzed , including ocular surface irritation symptom , tear film stability , surgical complication , and recurrence rate .


The follow up ranged from 24 to 38 months , ( 26.9 + / -3.4 ) months on average .


No recurrence was noted at 6 weeks postoperatively .


At 6 months postoperatively , the recurrence rate of pterygium was 5.2 % in group A and 8.0 % in group B.


At 1 year postoperatively , the recurrence rate in group A was 10.5 % and 20.0 % in group B.


At the end of follow up , the recurrence rates were 13.1 % in group A and 24.0 % in group B. No statistical significance was found between two groups regarding the recurrence rates at each time point ( P > 0.05 ) .


After the follow up ( > 2 years ) , the severity of ocular surface conditions was significantly milder in patients in group A than in group B ( P < 0.01 ) .


No statistically significant differences were noted between the two groups at 6 weeks , 6 months , and 1 year after surgery .


No statistically significant differences were observed between the two groups regarding postoperative tear film break-up time .


Fewer postoperative complications and milder ocular surface irritation symptoms occurred in patients in group A.


Corneal limbal conjunctival autograft combined with pterygium excision yields sound long-term efficacy and a low recurrence rate and induces only mild damage on the ocular surface when used as a treatment for pterygium .


Young adulthood ( age 18 to 35 ) is a high-risk period for unhealthy weight gain .


Few studies have recruited for prevention of weight gain , particularly in young adults .


This paper describes the recruitment protocol used in the Study of Novel Approaches to Prevention ( SNAP ) .


We conducted extensive formative work to inform recruitment methods and message development .


We worked with a professional marketing firm to synthesize major themes and subsequently develop age-appropriate messages for recruitment .


A variety of approaches and channels were used across two clinical centers to recruit young adults who were normal or overweight ( body mass index ( BMI ) 21 to 30kg/m2 ) for a 3-year intervention designed to prevent weight gain .


We tracked recruitment methods , yields , and costs by method .


Logistic regression was used to identify recruitment methods that had the highest relative yield for subgroups of interest with covariate adjustments for clinic .


The final sample of 599 participants ( 27 % minority , 22 % male ) was recruited over a 19-month period of sustained efforts .


About 10 % of those who initially expressed interest via a screening website were randomized .


The most common reason for ineligibility was already being obese ( BMI > 30kg/m2 ) .


The top two methods for recruitment were mass mailing followed by email ; together they were cited by 62 % of those recruited .


Television , radio , paid print advertising , flyers and community events each yielded fewer than 10 % of study participants .


Email was the most cost-effective method per study participant recruited .


These findings can guide future efforts to recruit young adults and for trials targeting weight gain prevention .


ClinicalTrials.gov NCT01183689 ( registered 13 August 2010 ) .


To evaluate immune responses in fingolimod-treated patients with multiple sclerosis ( MS ) against influenza vaccine ( to test for responses against anticipated novel antigens in seronegative patients ) and recall ( tetanus toxoid [ TT ] booster dose ) antigens .


This was a blinded , randomized , multicenter , placebo-controlled study .


Patients aged 18 to 55 years with relapsing MS were randomized ( 2:1 ) to fingolimod 0.5 mg or placebo for 12 weeks .


At week 6 , patients received seasonal influenza vaccine ( containing antigens of California , Perth , and Brisbane virus strains ) and TT booster dose .


Antibody titers against influenza and TT were estimated at baseline ( prevaccination ) and 3 and 6 weeks postvaccination .


The primary efficacy variable was responder rate ( proportion of patients showing seroconversion or significant increase [ 4-fold ] in antibody titers against at least one influenza virus strain ) at 3 weeks postvaccination and vs placebo .


Of 138 randomized patients ( fingolimod 95 , placebo 43 ) , 136 completed the study ( 2 discontinued in fingolimod group ) .


The responder rates ( odds ratio ; 95 % confidence interval ) for influenza vaccine ( fingolimod vs placebo ) were 54 % vs 85 % ( 0.21 ; 0.08-0 .54 ) at 3 weeks and 43 % vs 75 % ( 0.25 ; 0.11-0 .57 ) at 6 weeks postvaccination .


For TT , responder rates were 40 % vs 61 % ( 0.43 ; 0.20-0 .92 ) at 3 weeks and 38 % vs 49 % ( 0.62 ; 0.29-1 .33 ) at 6 weeks postvaccination .


Adverse events were reported in 86.3 % and 79.1 % of patients receiving fingolimod and placebo , respectively .


Most fingolimod-treated patients with MS were able to mount immune responses against novel and recall antigens and the majority met regulatory criteria indicating seroprotection .


However , response rates were reduced compared with placebo-treated patients .


This should be kept in mind when vaccinating patients on fingolimod .


This study provides Class I evidence that in some patients with MS receiving immunizations , concurrent fingolimod treatment in comparison to placebo decreases vaccination-induced immune responses .


New femtosecond laser platforms may reduce ocular surface interference and LASIK-associated dry eye .


This study investigated tear protein profiles in subjects who underwent LASIK using two femtosecond lasers to assess differences in protein expression .


This was a randomized interventional clinical trial involving 22 patients who underwent femtosecond laser refractive surgery with a contralateral paired eye design .


Corneal flaps of 22 subjects were created by either Visumax or Intralase laser .


Tear samples were collected preoperatively , and at 1 week and 3 months postoperatively using Schirmer 's strips .


Tear protein ratios were calculated relative to preoperative protein levels at baseline .


The main outcome measures were the levels of a panel of dry eye protein markers analyzed using isobaric tagging for relative and absolute quantitation ( iTRAQ ) mass spectrometry .


A total of 824 unique proteins were quantifiable .


Tear protein ratios were differentially regulated between the eyes treated with different lasers .


The secretoglobulins Lipophilin A ( 1.80-fold ) and Lipophilin C ( 1.77 ) were significantly upregulated ( P < 0.05 ) at 1 week postoperatively in Visumax but not in Intralase-treated eyes .


At 1 week , orosomucoid1 was upregulated ( 1.78 ) in Intralase but not Visumax-treated eyes .


In the same eyes , lysozyme , cathepsin B , and lipo-oxygenase were downregulated at 0.44 - , 0.64 - , and 0.64-folds , respectively .


Transglutaminase-2 was downregulated in both groups of eyes .


Different laser platforms induce distinct biological responses in the cornea and ocular surface , which manifests as different levels of tear proteins .


This study has implications for surgical technology and modulation of wound healing responses .


( ClinicalTrials.gov number , NCT01252654 . )


To determine if atomoxetine would improve attention impairment following traumatic brain injury ( TBI ) .


Outpatients from a free-standing , private , not-for-profit rehabilitation hospital .


Fifty-five adult participants with a history of a single moderate-to-severe TBI , who were at least 1 year from injury and with self-reported complaints of attention difficulties .


Atomoxetine , a selective norepinephrine re-uptake inhibitor with a primary indication for attention dosed at 40mg twice a day for 2 weeks , compared to placebo .


Randomized double-blind placebo controlled trial , with placebo run-in .


Cognitive Drug Research ( CDR ) , Computerized Cognitive Assessment System , Stroop Color and Word Test , Adult ADHD Self-Report Scale ( ASRS-v1 .1 ) , Neurobehavioural Functioning Inventory ( NFI ) .


Atomoxetine was well-tolerated by the subject sample .


The use of atomoxetine by individuals with reported attention difficulty following TBI did not significantly improve scores on measures of attention , the CDR Power of Attention domain or the Stroop Interference score .


In addition , no significant relationship was found between atomoxetine use and self-reported symptoms of attention or depression .


Atomoxetine did not significantly improve performance on measures of attention among individuals post-TBI with difficulties with attention .


This study follows a trend of other pharmacological studies not demonstrating significant results among those with a history of TBI .


Various possibilities are discussed , including the need for a more sophisticated system of classification of TBI .


To assess the efficacy and safety of enzyme replacement therapy ( ERT ) with BMN 110 ( elosulfase alfa ) in patients with Morquio A syndrome ( mucopolysaccharidosis IVA ) .


Patients with Morquio A aged 5years ( N = 176 ) were randomised ( 1:1:1 ) to receive elosulfase alfa 2.0 mg/kg/every other week ( qow ) , elosulfase alfa 2.0 mg/kg/week ( weekly ) or placebo for 24weeks in this phase 3 , double-blind , randomised study .


The primary efficacy measure was 6-min walk test ( 6MWT ) distance .


Secondary efficacy measures were 3-min stair climb test ( 3MSCT ) followed by change in urine keratan sulfate ( KS ) .


Various exploratory measures included respiratory function tests .


Patient safety was also evaluated .


At week 24 , the estimated mean effect on the 6MWT versus placebo was 22.5 m ( 95 % CI 4.0 , 40.9 ; P = 0.017 ) for weekly and 0.5 m ( 95 % CI -17.8 , 18.9 ; P = 0.954 ) for qow .


The estimated mean effect on 3MSCT was 1.1 stairs/min ( 95 % CI -2.1 , 4.4 ; P = 0.494 ) for weekly and -0.5 stairs/min ( 95 % CI -3.7 , 2.8 ; P = 0.778 ) for qow .


Normalised urine KS was reduced at 24weeks in both regimens .


In the weekly dose group , 22.4 % of patients had adverse events leading to an infusion interruption/discontinuation requiring medical intervention ( only 1.3 % of all infusions in this group ) over 6months .


No adverse events led to permanent treatment discontinuation .


Elosulfase alfa improved endurance as measured by the 6MWT in the weekly but not qow dose group , did not improve endurance on the 3MSCT , reduced urine KS , and had an acceptable safety profile .


The availability of less resource-intensive alternatives to home visits for rehabilitation following orthopaedic surgeries is important , given the increasing need for home care services and the shortage of health resources .


The goal of this trial was to determine whether an in-home telerehabilitation program is not clinically inferior to a face-to-face home visit approach ( standard care ) after hospital discharge of patients following a total knee arthroplasty .


Two hundred and five patients who had a total knee arthroplasty were randomized before hospital discharge to the telerehabilitation group or the face-to-face home visit group .


Both groups received the same rehabilitation intervention for two months after hospital discharge .


Patients were evaluated at baseline ( before total knee arthroplasty ) , immediately after the rehabilitation intervention ( two months after discharge ) , and two months later ( four months after discharge ) .


The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) questionnaire at the last follow-up evaluation .


Secondary outcome measures included the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) questionnaire , functional and strength tests , and knee range of motion .


The noninferiority margin was set at 9 % for the WOMAC .


The demographic and clinical characteristics of the two groups of patients were similar at baseline .


At the last follow-up evaluation , the mean differences between the groups with regard to the WOMAC gains , adjusted for baseline values , were near zero ( for 182 patients in the per-protocol analysis ) : -1.6 % ( 95 % confidence interval [ CI ] : -5.6 % , 2.3 % ) for the total score , -1.6 % ( 95 % CI : -5.9 % , 2.8 % ) for pain , -0.7 % ( 95 % CI : -6.8 % , 5.4 % ) for stiffness , and -1.8 % ( 95 % CI : -5.9 % , 2.3 % ) for function .


The confidence intervals were all within the predetermined zone of noninferiority .


The secondary outcomes had similar results , as did the intention-to-treat analysis , which was conducted afterward for 198 patients .


Our results demonstrated the noninferiority of in-home telerehabilitation and support its use as an effective alternative to face-to-face service delivery after hospital discharge of patients following a total knee arthroplasty .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


Closed-loop insulin delivery is a promising option to improve glycaemic control and reduce the risk of hypoglycaemia .


We aimed to assess whether overnight home use of automated closed-loop insulin delivery would improve glucose control .


We did this open-label , multicentre , randomised controlled , crossover study between Dec 1 , 2012 , and Dec 23 , 2014 , recruiting patients from three centres in the UK .


Patients aged 18 years or older with type 1 diabetes were randomly assigned to receive 4 weeks of overnight closed-loop insulin delivery ( using a model-predictive control algorithm to direct insulin delivery ) , then 4 weeks of insulin pump therapy ( in which participants used real-time display of continuous glucose monitoring independent of their pumps as control ) , or vice versa .


Allocation to initial treatment group was by computer-generated permuted block randomisation .


Each treatment period was separated by a 3-4 week washout period .


The primary outcome was time spent in the target glucose range of 39-80 mmol/L between 0000 h and 0700 h. Analyses were by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT01440140 .


We randomly assigned 25 participants to initial treatment in either the closed-loop group or the control group , patients were later crossed over into the other group ; one patient from the closed-loop group withdrew consent after randomisation , and data for 24 patients were analysed .


Closed loop was used over a median of 83 h ( IQR 60-96 ) on 555 ( 86 % ) of 644 nights .


The proportion of time when overnight glucose was in target range was significantly higher during the closed-loop period compared to during the control period ( mean difference between groups 135 % , 95 % CI 73-197 ; p = 00002 ) .


We noted no severe hypoglycaemic episodes during the control period compared with two episodes during the closed-loop period ; these episodes were not related to closed-loop algorithm instructions .


Unsupervised overnight closed-loop insulin delivery at home is feasible and could improve glucose control in adults with type 1 diabetes .


Diabetes UK .


Advanced colorectal cancer is treated with a combination of cytotoxic drugs and targeted treatments .


However , how best to minimise the time spent taking cytotoxic drugs and whether molecular selection can refine this further is unknown .


The primary aim of this study was to establish how cetuximab might be safely and effectively added to intermittent chemotherapy .


COIN-B was an open-label , multicentre , randomised , exploratory phase 2 trial done at 30 hospitals in the UK and one in Cyprus .


We enrolled patients with advanced colorectal cancer who had received no previous chemotherapy for metastases .


Randomisation was done centrally ( by telephone ) by the Medical Research Council Clinical Trials Unit using minimisation with a random element .


Treatment allocation was not masked .


Patients were assigned ( 1:1 ) to intermittent chemotherapy plus intermittent cetuximab or to intermittent chemotherapy plus continuous cetuximab .


Chemotherapy was FOLFOX ( folinic acid and oxaliplatin followed by bolus and infused fluorouracil ) .


Patients in both groups received FOLFOX and weekly cetuximab for 12 weeks , then either had a planned interruption ( those taking intermittent cetuximab ) or planned maintenance by continuing on weekly cetuximab ( continuous cetuximab ) .


On RECIST progression , FOLFOX plus cetuximab or FOLFOX was recommenced for 12 weeks followed by further interruption or maintenance cetuximab , respectively .


The primary outcome was failure-free survival at 10 months .


The primary analysis population consisted of patients who completed 12 weeks of treatment without progression , death , or leaving the trial .


We tested BRAF and NRAS status retrospectively .


The trial was registered , ISRCTN38375681 .