The side-to-side difference in posterior translation decreased to 4.1 1.3 mm ( range , 5.5 to 2.5 mm ) in the SB group and 2.2 1.3 mm ( range , 4.5 to 2.0 mm ) in the DB group , and there was a significant difference between the 2 groups ( P < .05 ) .


According to the International Knee Documentation Committee ( both objective and subjective ) , the DB group had a better grade distribution ( P < .05 ) and had a statistically higher grade ( 71.6 6.7 ; range , 63 to 80 ) than the SB group ( 65.5 7.8 ; range , 56 to 75 ) ( P < .05 ) .


Although both techniques resulted in similar patient satisfaction as measured by outcome assessment , the DB procedure significantly improved knee stability .


Level II , lesser-quality randomized controlled trial .


Pedometer-based programs have elicited increased walking behaviors associated with improvements in blood pressure in sedentary/low active postmenopausal women , a population at increased risk of cardiovascular disease .


Such programs typically encourage increasing the volume of physical activity with little regard for its intensity .


Recent advances in commercially available pedometer technology now permit tracking of both steps/day and time in moderate ( or greater ) intensity physical activity on a daily basis .


It is not known whether the dual message to increase steps/day while also increasing time spent at higher intensity walking will elicit additional improvements in blood pressure relative to a message to only focus on increasing steps/day .


The purpose of this paper is to present the rationale , study design , and protocols employed in WalkMore , a 3-arm 3-month blinded and randomized controlled trial ( RCT ) designed to compare the effects of two community pedometer-based walking interventions ( reflecting these separate and combined messages ) relative to a control group on blood pressure in sedentary/low active post-menopausal women , a population at increased risk of cardiovascular disease .


120 sedentary/low active post-menopausal women ( 45-74years of age ) will be randomly assigned ( computer-generated ) to 1 of 3 groups : A ) 10,000 steps/day ( with no guidance on walking intensity/speed/cadence ; BASIC intervention , n = 50 ) ; B ) 10,000 steps/day and at least 30minutes in moderate intensity ( i.e. , a cadence of at least 100 steps/min ; ENHANCED intervention , n = 50 ) ; or a Control group ( n = 20 ) .


An important strength of the study is the strict control and quantification of the pedometer-based physical activity interventions .


The primary outcome is systolic blood pressure .


Secondary outcomes include diastolic blood pressure , anthropometric measurements , fasting blood glucose and insulin , flow mediated dilation , gait speed , and accelerometer-determined physical activity and sedentary behavior .


This study can make important contributions to our understanding of the relative benefits that walking volume and/or intensity may have on blood pressure in a population at risk of cardiovascular disease .


ClinicalTrials.gov Record NCT01519583 , January 18 , 2012 .


Cognitive behavioral therapy ( CBT ) and U.S. Food and Drug Administration ( FDA ) - recommended pharmacologic treatments ( RPTs ; pregabalin , duloxetine , and milnacipran ) are effective treatment options for fibromyalgia ( FM ) syndrome and are currently recommended by clinical guidelines .


We compared the cost-utility from the healthcare and societal perspectives of CBT versus RPT ( combination of pregabalin + duloxetine ) and usual care ( TAU ) groups in the treatment of FM .


The economic evaluation was conducted alongside a 6-month , multicenter , randomized , blinded , parallel group , controlled trial .


In total , 168 FM patients from 41 general practices in Zaragoza ( Spain ) were randomized to CBT ( n = 57 ) , RPT ( n = 56 ) , or TAU ( n = 55 ) .


The main outcome measures were Quality-Adjusted Life Years ( QALYs , assessed by using the EuroQoL-5D questionnaire ) and improvements in health-related quality of life ( HRQoL , assessed by using EuroQoL-5D visual analogue scale , EQ-VAS ) .


The costs of healthcare use were estimated from patient self-reports ( Client Service Receipt Inventory ) .


Cost-utility was assessed by using the net-benefit approach and cost-effectiveness acceptability curves ( CEACs ) .


On average , the total costs per patient in the CBT group ( 1,847 ) were significantly lower than those in patients receiving RPT ( 3,664 ) or TAU ( 3,124 ) .


Patients receiving CBT reported a higher quality of life ( QALYs and EQ-VAS scores ) ; the differences between groups were significant only for EQ-VAS .


From a complete case-analysis approach ( base case ) , the point estimates of the cost-effectiveness ratios resulted in dominance for the CBT group in all of the comparisons performed , by using both QALYs and EQ-VAS as outcomes .


These findings were confirmed by bootstrap analyses , net-benefit curves , and CEACs .


Two additional sensitivity analyses ( intention-to-treat analysis and per-protocol analysis ) indicated that the results were robust .


The comparison of RPT with TAU yielded no clear preference for either treatment when using QALYs , although RPT was determined to be more cost-effective than TAU when evaluating EQ-VAS .


Because of lower costs , CBT is the most cost-effective treatment for adult FM patients .


Implementation in routine medical care would require policymakers to develop more-widespread public access to trained and experienced therapists in group-based forms of CBT .


Current Controlled Trials ISRCTN10804772 .


Registered 29 September 2008 .


Phosphate binders are the cornerstone of hyperphosphatemia management in dialysis patients .


Ferric citrate is an iron-based oral phosphate binder that effectively lowers serum phosphorus levels .


52-week , open-label , phase 3 , randomized , controlled trial for safety-profile assessment .


Maintenance dialysis patients with serum phosphorus levels 6.0 mg/dL after washout of prior phosphate binders .


2:1 randomization to ferric citrate or active control ( sevelamer carbonate and/or calcium acetate ) .


Changes in mineral bone disease , protein-energy wasting/inflammation , and occurrence of adverse events after 1 year .


Serum calcium , intact parathyroid hormone , phosphorus , aluminum , white blood cell count , percentage of lymphocytes , serum urea nitrogen , and bicarbonate .


There were 292 participants randomly assigned to ferric citrate , and 149 , to active control .


Groups were well matched .


For mean changes from baseline , phosphorus levels decreased similarly in the ferric citrate and active control groups ( -2.041.99 [ SD ] vs -2.182.25 mg/dL , respectively ; P = 0.9 ) ; serum calcium levels increased similarly in the ferric citrate and active control groups ( 0.220.90 vs 0.310.95 mg/dL ; P = 0.2 ) .


Hypercalcemia occurred in 4 participants receiving calcium acetate .


Parathyroid hormone levels decreased similarly in the ferric citrate and active control groups ( -167.1399.8 vs -152.7392.1 pg/mL ; P = 0.8 ) .


Serum albumin , bicarbonate , serum urea nitrogen , white blood cell count and percentage of lymphocytes , and aluminum values were similar between ferric citrate and active control .


Total and low-density lipoprotein cholesterol levels were lower in participants receiving sevelamer than those receiving ferric citrate and calcium acetate .


Fewer participants randomly assigned to ferric citrate had serious adverse events compared with active control .


Open-label study , few peritoneal dialysis patients .


Ferric citrate was associated with similar phosphorus control compared to active control , with similar effects on markers of bone and mineral metabolism in dialysis patients .


There was no evidence of protein-energy wasting/inflammation or aluminum toxicity , and fewer participants randomly assigned to ferric citrate had serious adverse events .


Ferric citrate is an effective phosphate binder with a safety profile comparable to sevelamer and calcium acetate .


We report detailed safety analyses by geographic region from the phase III study CLEOPATRA with pertuzumab , trastuzumab , and docetaxel in patients with human epidermal growth factor receptor 2 ( HER2 ) - positive first-line metastatic breast cancer .


Patients received pertuzumab/placebo at 840 mg in cycle 1 and 420 mg in subsequent cycles , and trastuzumab at 8 mg/kg in cycle 1 and 6 mg/kg in subsequent cycles ; docetaxel was initiated at 75 mg/m ( 2 ) .


All study drugs were given intravenously , 3 times weekly .


Docetaxel dose reductions below 75 mg/m ( 2 ) were more common in patients from Asia ( 47.0 % ) than other regions ( 13.4 % ) ; docetaxel dose escalations to 100 mg/m ( 2 ) were less frequent in Asia ( 2.4 % ) than other regions ( 18.7 % ) .


Rates of edema ( 26.1 % and 5.4 % for Asia and other regions , respectively ) , myalgia ( 42.3 % , 14.7 % ) , nail disorder ( 39.9 % , 15.1 % ) , febrile neutropenia ( 18.6 % , 7.1 % ) , upper respiratory tract infection ( 25.7 % , 10.2 % ) , decreased appetite ( 47.0 % , 19.1 % ) , and rash ( 44.3 % , 22.0 % ) were at least twice as high in Asia as in other regions .


Adverse events did not result in a reduction in the median number of study treatment cycles administered in patients from Asia .


Efficacy analyses per region showed hazard ratios similar to those of the whole intention-to-treat ( ITT ) population for progression-free survival ( ITT : 0.63 ; Asia : 0.68 ; other regions : 0.61 ) and overall survival ( ITT : 0.66 ; Asia : 0.64 ; other regions : 0.66 ) .


Despite a higher proportion of docetaxel dose reductions in patients from Asia , survival benefits were comparable between regions .


The benefit-risk profile of pertuzumab , trastuzumab , and docetaxel supports this regimen as the first-line therapy for patients with HER2-positive metastatic breast cancer from all geographic regions .


The purpose of this study was to assess the feasibility of an endoscopic , optical-fiber-based , laser delivery system ( LDS ) developed to perform sole-therapy transmyocardial revascularization ( TMR ) in a totally endoscopic , robotically assisted operation .


Forty-two patients were enrolled in a multicenter , prospective , single-arm clinical trial conducted at four US centers between 2005 and 2007 .


Transmyocardial revascularization was performed completely endoscopically with robotic assistance , introducing the Holmium : Yttrium aluminum garnet ( YAG ) LDS via a 5-mm port .


Completion of the operation endoscopically defined procedural success .


Clinical data were recorded before , during , and at least 30 days after the procedure .


All patients had Canadian Cardiovascular Score angina class IV at baseline .


The mean ejection fraction was 49 % ( range [ R ] , 28-71 ) , the mean age was 59.1 years ( R , 36-80 ) , 71 % ( 30/42 ) were men , 86 % ( 36/42 ) underwent previous coronary artery bypass grafting surgery , and 76 % ( 32/42 ) underwent prior coronary stenting .


Procedural success was accomplished in 93 % ( 39/42 ) .


For the procedural successes , the mean number of TMR channels was 32 ( R , 16-50 ) , the median operative time was 88 minutes ( R , 48-250 minutes ) , and the median length of stay postoperatively was 2.5 days ( R , 1-10 ) .


There was no operative or 30-day mortality , and no patient received any transfusion .


At 30 days , freedom from major adverse cardiac events was 95 % ( two patients had transient congestive heart failure ) .


At the median 6-month follow-up ( single-center data , n = 12 ) , the mean ( SD ) Canadian Cardiovascular Score angina score was 1.3 ( 0.05 ) ( P < 0.001 vs baseline ) .


Robotically assisted TMR can be performed using an endoscopic , optical-fiber-based LDS , with high procedural success , avoidance of early adverse clinical events , and potential for successful angina relief .


DBCare ( Ace Continental Exports Inc. , London , UK ) is a traditional Indian herbal food supplement marketed as an antidiabetes remedy .


This study evaluated the efficacy and safety of DBCare in patients with inadequately controlled type 2 diabetes mellitus ( T2DM ) despite oral hypoglycemic treatment .


A 12-week randomized double-blind placebo-controlled trial was conducted .


Patients with T2DM on oral hypoglycemic agents with HbA1C > 7.0 % were randomized to receive DBCare or placebo tablets .


Thirty-five patients ( 20 male/15 female ; mean age 61.2 7.6 years ) , with a mean baseline HbA1C of 7.9 % 0.6 % , received DBCare ( N = 18 ) or placebo ( N = 17 ) .


During the study period , HbA1C declined 0.4 0.7 % in the DBCare group and 0.2 % 0.8 % in the placebo group ( p = 0.806 ) .


No significant changes occurred in fasting plasma glucose , lipid profile , or homeostasis model assessment throughout the study or in body mass index , waist circumference , or blood pressure values .


Hypoglycemic episodes ( glucose < 70 mg/dL ) were more frequent in the treatment group ( 7 vs 1 , p = 0.043 ) , necessitating a decrease in other hypoglycemic medications in 2 patients .


DBCare was generally well tolerated , with mild side effects that were not different from those of the placebo group .


This preliminary study did not demonstrate that DBCare was efficacious in improving glycemic control in inadequately controlled patients with T2DM on oral hypoglycemics .


A trend toward improved glycemic control was noted in the DBCare group , which correlates with more frequent hypoglycemic episodes .


Further studies are needed to elucidate DBCare 's hypoglycemic effect in patients with T2DM in general and in specific clinical settings , such as HbA1C 8 % , short ( 10-year ) duration of diabetes , or young age in particular .


Postprandial hypoglycemia after gastric bypass surgery is a serious problem .


Available treatments are often ineffective .


The objective was to test the hypotheses that injection of rapid-acting insulin before a high-carbohydrate meal or replacement of other carbohydrates with fructose in the meal would prevent hypoglycemia .


This was a randomized , crossover trial comparing a high-carbohydrate meal with premeal saline injection ( control ) , a high-carbohydrate meal with premeal insulin injection , and a high-fructose meal with total carbohydrate content similar to the control meal .


The setting was an academic medical center .


Ten patients with post-gastric bypass hyperinsulinemic hypoglycemia participated .


Interventions included lispro insulin injected before test meals and replacement of other carbohydrates with fructose in test meals .


The main outcome measure was plasma glucose < 60 mg/dL after test meals .


After the control meal , mean peak glucose and insulin were 173 47 mg/dL and 134 55 mU/L , respectively ; mean glucose nadir was 44 15 mg/dL ; and eight of 10 subjects demonstrated glucose < 60 mg/dL .


Five subjects demonstrated a glucose nadir < 40 mg/dL .


There were no significant differences in the corresponding values after premeal insulin treatment , except that the mean glucose nadir of 34 10 mg/dL was lower ( P < .05 ) .


After the fructose meal , mean peak postprandial glucose and insulin were 117 20 mg/dL and 45 31 mU/L , respectively ( both P < .001 for comparison with control ) , mean glucose nadir was 67 10 mg/dL ( P < .001 ) , and two of 10 subjects demonstrated glucose < 60 mg/dL ( P < .05 ) .


People with post-gastric bypass hypoglycemia can consume a meal sweetened with fructose with little risk of hypoglycemia .


Treatment with rapid-acting insulin before a carbohydrate-containing meal did not prevent hypoglycemia .


Randomised controlled trials have shown that bariatric surgery is more effective than conventional treatment for the short-term control of type-2 diabetes .


However , published studies are characterised by a relatively short follow-up .


We aimed to assess 5 year outcomes from our randomised trial designed to compare surgery with conventional medical treatment for the treatment of type 2 diabetes in obese patients .


We did our open-label , randomised controlled trial at one diabetes centre in Italy .


Patients aged 30-60 years with a body-mass index of 35 kg/m ( 2 ) or more and a history of type 2 diabetes lasting at least 5 years were randomly assigned ( 1:1:1 ) , via a computer-generated randomisation procedure , to receive either medical treatment or surgery by Roux-en-Y gastric bypass or biliopancreatic diversion .


Participants were aware of treatment allocation before the operation and study investigators were aware from the point of randomisation .


The primary endpoint was the rate of diabetes remission at 2 years , defined as a glycated haemaglobin A1c ( HbA1c ) concentration of 65 % or less ( 475 mmol/mol ) and a fasting glucose concentration of 56 mmol/L or less without active pharmacological treatment for 1 year .


Here we analyse glycaemic and metabolic control , cardiovascular risk , medication use , quality of life , and long-term complications 5 years after randomisation .


Analysis was by intention to treat for the primary endpoint and by per protocol for the 5 year follow-up .


This study is registered with ClinicalTrials.gov , number NCT00888836 .


Between April 27 , 2009 , and Oct 31 , 2009 , we randomly assigned 60 patients to receive either medical treatment ( n = 20 ) or surgery by gastric bypass ( n = 20 ) or biliopancreatic diversion ( n = 20 ) ; 53 ( 88 % ) patients completed 5 years ' follow-up .


Overall , 19 ( 50 % ) of the 38 surgical patients ( seven [ 37 % ] of 19 in the gastric bypass group and 12 [ 63 % ] of 19 in the bilipancreatic diversion group ) maintained diabetes remission at 5 years , compared with none of the 15 medically treated patients ( p = 00007 ) .


We recorded relapse of hyperglycaemia in eight ( 53 % ) of the 15 patients who achieved 2 year remission in the gastric bypass group and seven ( 37 % ) of the 19 patients who achieved 2 year remission in the biliopancreatic diversion group .


Eight ( 42 % ) patients who underwent gastric bypass and 13 ( 68 % ) patients who underwent biliopancreatic diversion had an HbA1c concentration of 65 % or less ( 475 mmol/mol ) with or without medication , compared with four ( 27 % ) medically treated patients ( p = 00457 ) .


Surgical patients lost more weight than medically treated patients , but weight changes did not predict diabetes remission or relapse after surgery .


Both surgical procedures were associated with significantly lower plasma lipids , cardiovascular risk , and medication use .


Five major complications of diabetes ( including one fatal myocardial infarction ) arose in four ( 27 % ) patients in the medical group compared with only one complication in the gastric bypass group and no complications in the biliopancreatic diversion group .


No late complications or deaths occurred in the surgery groups .


Nutritional side-effects were noted mainly after biliopancreatic diversion .


Surgery is more effective than medical treatment for the long-term control of obese patients with type 2 diabetes and should be considered in the treatment algorithm of this disease .


However , continued monitoring of glycaemic control is warranted because of potential relapse of hyperglycaemia .


Catholic University of Rome .


Lipoabdominoplasty is nearly a daily aesthetic procedure .


Despite the emergence of laser-assisted liposuction , to date , it has not been clearly evaluated combined with abdominoplasty .


This prospective study aimed to evaluate the effectiveness and safety of laser-assisted liposuction relative to traditional liposuction combined with high-lateral-tension abdominoplasty .


This study investigated 36 consecutive female patients who underwent high-lateral-tension abdominoplasty combined with liposuction of the upper central abdomen and both flanks .


The patients were divided into three equal groups based on the technique used for liposuction .


Group 1 underwent conventional liposuction with abdominoplasty .


Group 2 underwent a mixture of conventional and laser-assisted liposuction with abdominoplasty .


Group 3 underwent laser-assisted liposuction with abdominoplasty .


The patients in groups 2 and 3 had a better aesthetic outcome than those in group 1 with regard to abdominal contour and skin tightness .


No major complications were observed in groups 1 and 2 .


The patients in group 3 had a higher incidence of complications ( 3 seromas , 3 central necroses and dehiscence ) , and one patient underwent secondary sutures .


Laser-assisted liposuction combined with abdominoplasty in the lateral abdomen seems to be a safe technique with good aesthetic outcomes .


Although the combined use of laser-assisted liposuction in the lateral and central abdomen can achieve relatively better aesthetic results , it is associated with significant complications , and its use can not be supported .


Proper laser parameters in the central abdominal area still need further study .


This journal requires that authors assign a level of evidence to each article .


For a full description of these Evidence-Based Medicine ratings , please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .


This study was performed to compare patient outcomes after Reamer-Irrigator-Aspirator ( RIA ) - harvested bone grafting with the current gold standard , either anterior or posterior iliac crest bone graft ( ICBG ) .


Prospective randomized controlled trial .


Multicenter study at 3 geographically separate Level 1 trauma centers .


One hundred thirty-three patients with nonunion or posttraumatic segmental bone defect requiring operative intervention .


Patients were prospectively randomized to receive ICBG or RIA autograft .


Supplemental internal fixation was performed per surgeon preference .


Operative data included amount of graft , time of harvest , and associated surgical costs .


The Short Musculoskeletal Functional Assessment and the Visual Analog Scale were used to document baseline and postoperative function and pain .


Clinical and radiographic union was the defined end point ; patients considered to have failed treatment if they either developed an infection requiring operative treatment or had a persistent nonunion of the grafted extremity .


One hundred thirteen of the 133 enrolled patients were followed until union and included in the final analysis .


Intraoperative data showed anterior ICBG to yield 20.7 12.8 ( 5-60 ) cm of autograft with an average harvest time of 33.2 16.2 minutes , posterior ICBG yielded 36.1 21.3 ( 20-100 ) cm of autograft in 40.6 11.2 minutes , and RIA yielded 37.7 12.9 ( 5-90 ) cm in 29.4 15.1 minutes .


Anterior ICBG produced significantly less bone graft than either RIA or posterior ICBG ( P < 0.001 ) .


The RIA harvest was completed in significantly less operative time compared with posterior ICBG ( P = 0.005 ) .


At $ 738 , the RIA setup was considerably more expensive than the $ 100 cost of a bone graft tray ; however , when compared with posterior ICBG , the longer operative time required for a posterior harvest came at an additional incremental cost of $ 990-1880 , making RIA the less expensive option .


Patients were followed for an average of 56.9 42.1 ( 11-250 ) weeks .


Forty-nine of 57 patients ( 86.0 % ) who received ICBG united in an average of 22.5 13.2 weeks ; 46 of 56 patients ( 82.1 % ) who received RIA healed in an average of 25.8 17.0 weeks .


Union rates and time to union were comparable between the 2 procedures .


There was no difference in complications requiring reoperation for persistent nonunion or infection at the grafted site , nor there was any difference in donor-site complications .


Postoperative follow-up showed that RIA patients had significantly lower donor-site pain scores throughout follow-up .


When compared with autograft obtained from the iliac crest , autograft harvested using the RIA technique achieves similar union rates with significantly less donor-site pain .


RIA also yields a greater volume of graft compared with anterior ICBG and has a shorter harvest time compared with posterior ICBG .


For larger volume harvests , cost analysis favors using RIA .


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


The early biological impact of short-term mechanical ventilation on healthy lungs is unknown .


The authors aimed to characterize the immediate tidal volume ( VT ) - related changes on lung injury biomarkers in patients with healthy lungs and low risk of pulmonary complications .


Twenty-eight healthy patients for knee replacement surgery were prospectively randomized to volume-controlled ventilation with VT 6 ( VT6 ) or 10 ( VT10 ) ml/kg predicted body weight .


General anesthesia and other ventilatory parameters ( positive end-expiratory pressure , 5 cm H2O , FIO2 , 0.5 , respiratory rate titrated for normocapnia ) were managed similarly in the two groups .


Exhaled breath condensate and blood samples were collected for nitrite , nitrate , tumor necrosis factor - , interleukins-1 , -6 , -8 , -10 , -11 , neutrophil elastase , and Clara Cell protein 16 measurements , at the onset of ventilation and 60 min later .


No significant differences in biomarkers were detected between the VT groups at any time .


The coefficient of variation of exhaled breath condensate nitrite and nitrate decreased in the VT6 but increased in the VT10 group after 60-min ventilation .


Sixty-minute ventilation significantly increased plasma neutrophil elastase levels in the VT6 ( 35.2 30.4 vs. 56.4 51.7 ng/ml , P = 0.008 ) and Clara Cell protein 16 levels in the VT10 group ( 16.4 8.8 vs. 18.7 9.5 ng/ml , P = 0.015 ) .


Exhaled breath condensate nitrite correlated with plateau pressure ( r = 0.27 , P = 0.042 ) and plasma neutrophil elastase ( r = 0.44 , P = 0.001 ) .


Plasma Clara Cell protein 16 correlated with compliance ( r = 0.34 , P = 0.014 ) .


No tidal volume-related changes were observed in the selected lung injury biomarkers of patients with healthy lungs after 60-min ventilation .


Plasma neutrophil elastase and plasma Clara Cell protein 16 might indicate atelectrauma and lung distention , respectively .


Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting multiple sclerosis .


We aimed to assess the efficacy and safety of teriflunomide in patients with a first clinical episode suggestive of multiple sclerosis .


In this randomised , double-blind , placebo-controlled , parallel-group study , we enrolled patients aged 18-55 years with clinically isolated syndrome ( defined as a neurological event consistent with demyelination , starting within 90 days of randomisation , and two or more T2-weighted MRI lesions 3 mm in diameter ) from 112 centres ( mostly hospitals ) in 20 countries .


Participants were randomly assigned ( 1:1:1 ) in a double-blind manner ( by an interactive voice response system ) to once-daily oral teriflunomide 14 mg , teriflunomide 7 mg , or placebo , for up to 108 weeks .


Patients , staff administering the interventions , and outcome assessors were masked to treatment assignment .


The primary endpoint was time to relapse ( a new neurological abnormality separated by 30 days from a preceding clinical event , present for 24 h in the absence of fever or known infection ) , which defined conversion to clinically definite multiple sclerosis .


The key secondary endpoint was time to relapse or new gadolinium-enhancing or T2 lesions on MRI , whichever occurred first .


The primary outcome was analysed for the modified intention-to-treat population ; safety analyses included all randomised patients who were exposed to the study drug , as treated .


This trial is registered with ClinicalTrials.gov , number NCT00622700 .


Between Feb 13 , 2008 , and Aug 22 , 2012 , 618 patients were enrolled and randomly assigned to teriflunomide 14 mg ( n = 216 ) , teriflunomide 7 mg ( n = 205 ) , or placebo ( n = 197 ) .


Two patients in each of the teriflunomide groups did not receive the study drug , so the modified intention-to-treat population comprised 214 patients in the teriflunomide 14 mg group , 203 in the teriflunomide 7 mg group , and 197 in the placebo group .


Compared with placebo , teriflunomide significantly reduced the risk of relapse defining clinically definite multiple sclerosis at the 14 mg dose ( hazard ratio [ HR ] 0574 [ 95 % CI 0379-0869 ] ; p = 00087 ) and at the 7 mg dose ( 0628 [ 0416-0949 ] ; p = 00271 ) .


Teriflunomide reduced the risk of relapse or a new MRI lesion compared with placebo at the 14 mg dose ( HR 0651 [ 95 % CI 0515-0822 ] ; p = 00003 ) and at the 7 mg dose ( 0686 [ 0540-0871 ] ; p = 00020 ) .


During the study , six patients who were randomly assigned to placebo accidently also received teriflunomide at some point : four received 7 mg and two received 14 mg .


Therefore , the safety population comprised 216 patients on teriflunomide 14 mg , 207 on teriflunomide 7 mg , and 191 on placebo .


Adverse events that occurred in at least 10 % of patients in either teriflunomide group and with an incidence that was at least 2 % higher than that with placebo were increased alanine aminotransferase ( 40 [ 19 % ] of 216 patients in the 14 mg group , 36 [ 17 % ] of 207 in the 7 mg group vs 27 [ 14 % ] of 191 in the placebo group ) , hair thinning ( 25 [ 12 % ] and 12 [ 6 % ] vs 15 [ 8 % ] ) , diarrhoea ( 23 [ 11 % ] and 28 [ 14 % ] vs 12 [ 6 % ] ) , paraesthesia ( 22 [ 10 % ] and 11 [ 5 % ] vs 10 [ 5 % ] ) , and upper respiratory tract infection ( 20 [ 9 % ] and 23 [ 11 % ] vs 14 [ 7 % ] ) .


The most common serious adverse event was an increase in alanine aminotransferase ( four [ 2 % ] and five [ 2 % ] vs three [ 2 % ] ) .


TOPIC is to our knowledge the first study to report benefits of an available oral disease-modifying therapy in patients with early multiple sclerosis .


These results extend the stages of multiple sclerosis in which teriflunomide shows a beneficial effect .


Genzyme , a Sanofi company .


ABT-288 , a highly selective histamine-3 receptor antagonist , demonstrated efficacy across several preclinical cognitive domains , and safety in healthy subjects and elderly volunteers .


Evaluate the efficacy and safety of ABT-288 in subjects with mild-to-moderate Alzheimer 's dementia .


The study used a randomized , double-blind , placebo - and active-controlled , parallel group design with pre-defined futility criteria to permit early study termination .


A total of 242 subjects were randomized in an equal ratio to ABT-288 1 mg or 3 mg , donepezil 10 mg , or placebo once daily for 12 weeks .


The primary efficacy endpoint was the change from baseline to final evaluation on the 13-item Alzheimer 's Disease Assessment Scale-cognitive subscale ( ADAS-Cog ) total score .


The study was prematurely terminated because futility criteria were met .


Point estimates on the ADAS-Cog scores for both ABT-288 dose groups were numerically inferior to placebo but no statistical differences were detected .


Donepezil demonstrated statistically significant improvement .


Adverse events were generally mild and self-limiting .


ABT-288 did not demonstrate efficacy in the symptomatic treatment of Alzheimer 's dementia .


Failure in complete healing of the wound is one of the probable complications of cesarean .


The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound .


This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital ( Gerash , Iran ) .


The participants were randomly divided into two groups each containing 45 patients .


In one group , the wound was dressed with aloe vera gel , while simple dressing was used in the control group .


Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale .


The data were analyzed through Chi-square and t-test .


The participants ' mean age was 27.564.20 in the aloe vera group and 26.624.88 in the control group , but the difference was not statistically significant .


However , a significant difference was found between the two groups concerning body mass index , heart rate , and systolic blood pressure ( P < 0.05 ) .


Also , a significant difference was observed between the two groups with respect to the wound healing score 24 hours after the operation ( P = 0.003 ) .


After 8 days , however , the difference in the wound healing score was not significant ( P = 0.283 ) .


Overall , 45 participants in the aloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation .


These measures were respectively obtained as 42 and 41eight days after the operation .


According to the findings of this study , the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel .


To determine the protective effect of zero-balanced ultrafiltration and modified ultrafiltration on infants ' pulmonary function after cardiac surgery .


Sixty infants with congenital heart diseases were randomly divided into 3 groups : a zero-balanced ultrafiltration group ( Z group ) , a modified ultrafiltration group ( M group ) and a zero-balanced ultrafiltration with modified ultrafiltration group ( Z+M group ) .


Oxygenation index ( OI ) , difference of alveoli-arterial oxygen pressure ( P ( A - ) O2 ) , static lung compliance ( Cstat ) , and airway resistance ( Raw ) were measured before caridopulmonary bypass ( CPB , T1 ) , 20 minutes after the CPB ( T2 ) , 2 h after the operation ( T3 ) , 6 h after the operation ( T4 ) and 12 h after the operation ( T5 ) .


The time of mechanical ventilation was also monitored .


After the CPB , OI and Cstat in all groups decreased significantly , while Raw and P ( A - ) O2 increased significantly .


At T3 , T4 and T5 , OI and Cstat in the Z+M group were significantly higher than those in the Z group and the M group ( P < 0.05 ) , Raw and P ( A - ) O2 in the Z+M group were significantly lower than those in the Z group and the M group ( P < 0.05 ) .


The ventilation time in the Z+M group was significantly shorter than that in the Z group and the M group ( P < 0.05 ) .


Zero-balanced ultrafiltration and modified ultrafiltration can effectively promote the pulmonary function after cardiac surgery in infants .


Exposure to ozone has acute respiratory effects , but few human clinical studies have evaluated cardiovascular effects .


We hypothesized that ozone exposure alters pulmonary and systemic vascular function , and cardiac function , with more pronounced effects in subjects with impaired antioxidant defense from deletion of the glutathione-S-transferase M1 gene ( GSTM1 null ) .


Twenty-four young , healthy never-smoker subjects ( 12 GSTM1 null ) inhaled filtered air , 100ppb ozone and 200ppb ozone for 3h , with intermittent exercise , in a double-blind , randomized , crossover fashion .


Exposures were separated by at least 2 weeks .


Vital signs , spirometry , arterial and venous blood nitrite levels , impedance cardiography , peripheral arterial tonometry , estimation of pulmonary capillary blood volume ( Vc ) , and blood microparticles and platelet activation were measured at baseline and during 4h after each exposure .


Ozone inhalation decreased lung function immediately after exposure ( meanstandard error change in FEV1 , air : -0.030.04 L ; 200ppb ozone : -0.300.07 L ; p < 0.001 ) .


The immediate post-exposure increase in blood pressure , caused by the final 15-min exercise period , was blunted by 200ppb ozone exposure ( meanstandard error change for air : 16.72.6 mmHg ; 100ppb ozone : 14.52.4 mmHg ; 200ppb ozone : 8.52.5 mmHg ; p = 0.02 ) .


We found no consistent effects of ozone on any other measure of cardiac or vascular function .


All results were independent of the GSTM1 genotype .


We did not find convincing evidence for early acute adverse cardiovascular consequences of ozone exposure in young healthy adults .


The ozone-associated blunting of the blood pressure response to exercise is of unclear clinical significance .


To report a study protocol that tests the effectiveness of an educational intervention on outcomes of parents and their children who undergo inpatient elective surgery .


Inadequate children 's postoperative pain management remains a global problem .


Parents are required to be involved in their child 's pain assessment and management , yet they often lack relevant knowledge and skills .


Education is an effective strategy for enhancing a person 's knowledge , attitudes and behaviour .


However , few studies have examined its effectiveness in parents and their children undergoing inpatient elective surgery .


Randomized controlled trial and embedded qualitative process evaluation .


One hundred and sixty-two pairs of participants ( each comprised of one parent and his/her child undergoing inpatient elective surgery ) will be recruited ( protocol approved in January 2013 ) .


Participants will be randomized to either a Control group ( routine care ) , an Intervention group 1 ( routine care and an educational intervention with face-to-face teaching ) , or an Intervention group 2 ( routine care and an educational intervention without face-to-face teaching ) .


Outcome measures will include parents ' knowledge , attitude and behaviour related to postoperative pain management ; their child 's postoperative pain ; and parents ' satisfaction with their child 's pain management at baseline and around 6 , 12 and 24 hours after the operation .


A standardized educational intervention protocol and detailed study procedure have been developed in this study to improve parents ' knowledge , attitude and behaviour related to postoperative pain management and reduce their child 's postoperative pain .


Urolithiasis ( kidney stones ) is a common reason for Emergency Department ( ED ) visits , accounting for nearly 1 % of all visits in the United States .


Computed tomography ( CT ) has become the most common imaging test for these patients but there are few comparative effectiveness data to support its use in comparison to ultrasound .


This paper describes the rationale and methods of STONE ( Study of Tomography Of Nephrolithiasis Evaluation ) , a pragmatic randomized comparative effectiveness trial comparing different imaging strategies for patients with suspected urolithiasis .


STONE is a multi-center , non-blinded pragmatic randomized comparative effectiveness trial of patients between ages 18 and 75 with suspected nephrolithiasis seen in an ED setting .


Patients were randomized to one of three initial imaging examinations : point-of-care ultrasound , ultrasound performed by a radiologist or CT. .


Participants then received diagnosis and treatment per usual care .


The primary aim is to compare the rate of severe SAEs ( Serious Adverse Events ) between the three arms .


In addition , a broad range of secondary outcomes was assessed at baseline and regularly for six months post-baseline using phone , email and mail questionnaires .


Excluding 17 patients who withdrew after randomization , a total of 2759 patients were randomized and completed a baseline questionnaire ( n = 908 , 893 and 958 in the point-of-care ultrasound , radiology ultrasound and radiology CT arms , respectively ) .


Follow-up is complete , and full or partial outcomes were assessed on over 90 % of participants .


The detailed methodology of STONE will provide a roadmap for comparative effectiveness studies of diagnostic imaging conducted in an ED setting .


To assess pain intensity with and without subcutaneous local anesthesia prior to intraarticular administration of contrast medium for magnetic resonance arthrography ( MRa ) of the shoulder .


This single-center study was conducted after an IRB waiver of authorization , between January 2010 and December 2012 .


All patients provided written , informed consent for the procedure .


Our prospectively populated institutional database was searched , based on our inclusion criteria .


There were 249 outpatients ( 178 men and 71 women ; mean age , 44.4 years 14.6 ; range , 15-79 ) who underwent MRa and were enrolled in this study .


Patients were excluded if they had received surgery of the shoulder before MRa , had undergone repeated MRa of the same shoulder , and/or had undergone MRa of both shoulders on the same day .


Patients were randomly assigned into one of three groups .


Patients in group A ( n = 61 ) received skin infiltration with local anesthesia .


Patients in control group B ( n = 92 ) and group C ( n = 96 ) did not receive local anesthesia .


Pain levels were immediately assessed after the injection for MRa using a horizontal visual analog scale ( VAS ) that ranged from 0 to 10 .


To compare the pain scores of the three groups for male and female patients , a two-way analysis of variance was used .


A p-value equal to or less than 0.05 was considered to indicate a significant result .


Patients who received local anesthesia ( group A ) showed a mean pain level on the VAS of 2.6 2.3 .


In patients who did not receive local anesthetics ( groups B and C ) , a mean pain level on the VAS of 2.6 2.2 and 2.7 2.4 were detected , respectively .


Between the three groups , no statistically significant difference in pain intensity was detected ( p = .960 ) .


There were significant differences in subjective pain perception between men and women ( p = .009 ) .


Moreover , the sex difference in all three groups was equal ( p = .934 ) .


Local anesthesia is not required to lower a patient 's pain intensity when applying intra-articular contrast media for MR arthrography of the shoulder .


This could result in reduced costs and a reduced risk of adverse reactions , without an impact on patient comfort .


To observe the difference in the efficacy on traumatic nerve injury among electroacupuncture , warm needling therapy and electroacupuncture plus warm needling therapy and explore the better therapeutic method .


The electromyography ( EMG ) and electroneurography ( ENG ) of 93 cases showed traumatic nerve injury of moderate damage .


According to the single blind randomization principle , they were divided into an electroacupuncture ( EA ) group , a warm needling therapy ( WN ) group and an EA plus WN group , 31 cases in each one .


The main acupoints were selected from Yangming Meridian and Shaoyang Meridian corresponding to the distribution of damaged nerves .


EA , WN and EA plus WN were applied separately .


The treatment was given once every day , 15 treatments made one session .


After 3 sessions of treatment ( 45 treatments in total ) , EMG and ENG were re-checked and the results were analyzed statistically .


Regarding the total effective rate and effective rate , it was 96.8 % ( 30/31 ) in the EA plus WN group , which was better than 74.2 % ( 23/31 ) in the EA group and 77.4 % ( 24/31 ) in the WN group ( P < 0.05 ) .


Concerning to the improvements of EMG , the result in the EA plus WN group was 96.8 % ( 30/31 ) , which was better than the other two groups [ 74.2 % ( 23/31 ) ,74.2 % ( 23/31 ) ] ( P < 0.05 ) .


In terms of the recovery of nerve conduction and amplitude , the results in EA plus WN group [ ( 50.9 + / -4.6 ) m/s , ( 8.8 + / -2.9 ) , microVx1 000 ] were better than the other two groups [ ( 43.7 + / -3.1 ) m/s , ( 4.2 + / -1.9 ) microV X 1 000 , ( 43.8 + / -3.3 ) m/s , ( 4.5 + / -2.2 ) microV X 1 000 ] ( P < 0.05 ) .


EA combined with WN is a better therapy of acupuncture and moxibustion in the treatment of traumatic nerve injury .


The aim of this study was to compare the skeletal and dental effects of the EVAA appliance with those of an activator appliance in growing children with skeletal Class II anomalies .


A total of 34 subjects with Class II anomalies were recruited for this study .


They were divided into three groups : the EVAA group ( n = 13 ; mean chronological age : 11 years 9 months ) , activator group ( n = 13 ; mean chronological age : 11 years 8 months ) and control group ( n = 8 ; mean chronological age : 10 years 8 months ) .


Lateral cephalometric radiographs were taken at the beginning and end of functional therapy .


Fixed orthodontic treatment was completed in the EVAA group .


A statistical software program ( SPSS 18 ) was used for one-way analysis of variance and multiple comparisons with the Duncan test .


We observed a significant decrease in the ANB , convexity , and 1NA ( ) , while a significant increase appeared in upper anterior facial height , posterior facial height , 1NB ( mm ) , SN-lower occlusal plane values in the EVAA and activator groups after treatment ( p < 0.05 ) .


No significant difference in study parameters in the control group during the treatment period except for the increase in SNA and 1NA ( mm ) values ( p < 0.05 ) were observed .


There were no significant differences between EVAA and activator treatment groups in terms of study parameters except for the articular angle , which was significantly higher in the EVAA group after therapy ( p < 0.05 ) .


The effects of EVAA appliances were similar to those of activator treatment .


The objectives of this study were to present the rationale for the main aspects of the study design and describe the trial methodology for the Idiopathic Intracranial Hypertension Treatment Trial ( IIHTT ) .


Eligible candidates with mild visual field loss ( automated perimetric mean deviation [ PMD ] -2 to -7 dB ) were randomized to receive either acetazolamide or matching placebo tablets .


Randomized participants were offered participation in a supervised dietary program .


The primary outcome variable , PMD , was measured at 6 months .


Additionally , cerebrospinal fluid from subjects and serum from study participants and matched controls were collected for genetic analysis and vitamin A studies .


An ancillary optical coherence substudy was added to investigate the changes of papilledema in the optic nerve head and retina that correlate with Frisn grading , visual field deficits , and low-contrast visual acuity .


The randomized trial entered 165 participants from March 17 , 2010 , through November 27 , 2012 , from the United States and Canada .


The primary outcome ( month 6 ) visits were successfully completed by June 15 , 2013 .


Blood specimens were obtained from 165 controls without IIH to investigate vitamin A metabolism and genetic markers of potential risk factors for IIH .


The IIHTT is the first randomized , double-masked placebo-controlled trial to study the effectiveness of medical treatment for patients with IIH .


The aim of this study was to assess the efficacy of a 12-month prevention program conducted in 42 community pharmacies in reducing the risk for diabetes .


In a cluster-randomized controlled trial in 1,092 participants , mean change in the risk for diabetes ( indicated by the Finnish Diabetes Risk Score [ FINDRISC ] ) between intervention and control groups was calculated .


In the intervention program GLICEMIA , three appointments with individual counseling and five educational group sessions were combined , whereas in the control group , only information about the participants ' health was obtained in three assessments .


After adjusting for cluster structure and differences in baseline characteristics , improvement in FINDRISC in the intervention group was 0.74 points ( 95 % CI 0.42-1 .04 ) above the control group .


The GLICEMIA program shows the feasibility of a pharmacy-based intervention and leads to a significant modest reduction in diabetes risk score but does not reduce the rate of diabetes progression over 1 year .


Telavancin is approved in Europe for the treatment of nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus when other alternatives are not suitable .


The approved European prescribing information contraindicates the use of telavancin in patients with severe renal impairment ( creatinine clearance < 30 mL/min , including patients on haemodialysis ) and pre-existing acute renal failure owing to the higher observed mortality in these patients .


Data from the ATTAIN studies were reanalysed , excluding patients with these contraindicating conditions at baseline .


( At the time of submission of this article , the European marketing authorization of telavancin for the treatment of nosocomial pneumonia was suspended pending evidence of a new European Medicines Agency-approved supplier .


Clinigen Healthcare Ltd , Theravance 's commercialization partner for telavancin in Europe , is in the process of seeking approval of a new manufacturing source . )


A post hoc analysis of data from two Phase 3 ATTAIN trials of telavancin for the treatment of Gram-positive nosocomial pneumonia assessing clinical outcomes and safety .


The all-treated population for this analysis represented 84.2 % ( 1266/1503 ) of the ATTAIN all-treated population .


The cure rates in the clinically evaluable population were similar in the telavancin ( 82.5 % , 231/280 ) and vancomycin ( 81.3 % , 243/299 ) groups [ treatment difference ( 95 % CI ) : 1.3 % ( -5.0 % to 7.6 % ) ] , and were consistent with the overall ATTAIN study results .


The cure rate was higher in the telavancin than the vancomycin treatment group in microbiologically evaluable patients with only Gram-positive pathogens isolated at baseline [ 85.0 % ( 130/153 ) versus 75.2 % ( 109/145 ) , respectively ; treatment difference ( 95 % CI ) : 9.7 % ( 0.6 % -18.8 % ) ] .


The incidences of adverse events were similar between treatment groups and consistent with the overall findings of the ATTAIN study .


This analysis demonstrated that in the subset of patients without severe renal impairment or pre-existing acute renal failure , clinical and safety outcomes were similar in the telavancin and vancomycin treatment groups .


To evaluate the safety and efficacy of adjuvant intensity-modulated radiotherapy ( IMRT ) with concurrent paclitaxel and cisplatin ( TP ) in early stage cervical cancer patients with high risk factors after radical hysterectomy .


Patients who underwent radical hysterectomy for FIGO stage IB-IIA cervical cancer and had high risk factors for recurrence were recruited .


One cycle of TP was delivered before and after concurrent chemoradiotherapy , respectively .


Concurrent chemoradiotherapy began 21 days after the start of the initial cycle of the chemotherapy with two cycles of TP delivered on day 1 and day 29 of radiotherapy .


Primary endpoints were overall survival ( OS ) and relapse-free survival ( RFS ) , with toxicities , local-regional control ( LC ) and distant failure ( DF ) rate as secondary endpoints .


Between 2008 and 2012 , 67 patients were evaluable .


The 2 and 4-year RFS rates were 98.2 % and 92.9 % .


Corresponding OS rates were 100 % , and 98.0 % , respectively .


The 4-year LC and DF rates were 98.0 % and 5.2 % , respectively .


Grade 3-4 acute leucopenia , neutropenia and thrombocytopenia occurred in 25.4 % , 11.9 % and 1.5 % of patients , respectively .


There were 89.6 % and 59.7 % patients experienced acute vomiting and diarrhea , but only 6.0 % and 6.0 % patients were grade 3 , respectively .


No case of chronic toxicity exceeded grade 2 .


Adjuvant concurrent IMRT with paclitaxel plus cisplatin are safe and effective in early stage cervical cancer patients with high risk factors for recurrence following radical hysterectomy .


To observe the effection of immune reconstitution efficiency and the immune function on Immune 2 with HAART to HIV/AIDS patients which poor immune reconstitution after HAART .


Two hundred and sixty four patients failure to immune reconstitution after HAART were randomly divided into treatment group ( 131 cases ) and control group ( 133 cases ) , respectively , using Immune 2 plus HAART and placebo combined with HAART for 6 months .


the CD4 , CD8 , CD45RA , CD45RO , CD4CD28 , CD8CD28 , CD8CD38 , HLA-DR and CD4CD25 were observed in order to evaluate the immune reconstitution efficiency .


After the intervention for 6 months , the effective rate of treatment group ( 34.48 % ) was significantly superior to the control group ( 21.37 % ) ( P = 0.0217 ) .


Treated group could significantly increased the CD4 , CD45RA , CD45RO cell counts compared with control group ( P < 0.05 ) ; CD8 , CD3 , CD4CD28 absolute count comparison between the two groups had no significant difference ; CD8CD28 relative counting the treatment group group significantly increased ( P < 0.05 ) compared to the control ; CD4CD28 , CD8CD38 , CD8DR , CD4CD25 relative counting groups showed no significant difference .


Immune 2 can effectively improve the immune reconstitution efficiency , CD4 counts , CD45RA counts and CD45RO counts of patients after HAART , therefore promoting immune reconstitution .


The purpose of this study was to compare the analgesic properties of levobupivacaine with or without fentanyl for patient-controlled epidural analgesia after Cesarean section in a randomized , double-blinded study .


We enrolled American Society of Anesthesiologists class I/II , full-term pregnant women at National Taiwan University Hospital who received patient-controlled epidural analgesia after Cesarean section between 2009 and 2010 .


Eighty women were randomly assigned into two groups .


In group A , the 40 subjects received drug solutions made of 0.6 mg/ml levobupivacaine plus 2mcg/ml fentanyl , and in group B the 40 subjects received 1mg/ml levobupivacaine .


Maintenance was self-administered boluses and a continuous background infusion .


There were no significant differences in the resting and dynamic pain scales and total volume of drug used between the two groups .


Patient satisfaction was good in both groups .


Our study showed that pure epidural levobupivacaine can provide comparative analgesic properties to the levobupivacaine-fentanyl combination after Cesarean section .


Pure levobupivacaine may serve as an alternative pain control regimen to avoid opioid-related adverse events in parturients .


To determine whether physiotherapy is more effective when applied in blocks or continuously in children with cerebral palsy ( CP ) .


A prospective randomized cross-over design study compared the effect of regular physiotherapy ( baseline ) with blocks of physiotherapy alternating with no physiotherapy over one year .


Thirty-nine institutionalized children with CP and clinically similar syndromes ( 6-16 years old , Gross Motor Function Classification Scale II-IV ) were included .


During the first scholastic year , group A received regular physiotherapy , group B blocks of physiotherapy and vice versa in the second year .


The Gross Motor Function Measure 66 ( GMFM-66 ) was the outcome measure .


Thirteen children in each group completed the study .


GMFM-66 improved ( p < 0.05 ) over the study period in both groups in total ; changes ( p < 0.05 ) were seen only in dimension D ( group B ) and E ( both groups ) during regular therapy .


Physiotherapy may be more effective when provided regularly rather than in blocks .


To investigate the effectiveness of a combined social and physical environmental intervention as well as the effectiveness of both separate interventions .


In a 2 2 factorial design , 412 office employees were allocated to the combined social and physical environmental intervention , to the social environmental intervention only , to the physical environmental intervention only , or were part of the control group .


Data on presenteeism , absenteeism , work performance , and work engagement were obtained with questionnaires at baseline , 6 , and 12 months .


Multilevel analyses were performed .


The combined intervention showed a decrease in contextual performance and dedication .


The social environmental intervention showed an improvement in task performance .


The physical environmental intervention revealed an improvement in absorption .


Although the study showed some promising results , it is not recommended to implement the current interventions .


We examine the cross-sectional associations between baseline characteristics and sexual function and the longitudinal associations between change in lower urinary tract symptoms and change in sexual function among men with benign prostatic hyperplasia .


We studied lower urinary tract symptoms assessed by the AUA-SI and sexual function determined by the BMSFI in men enrolled in the MTOPS study .


The cross-sectional cohort included 2,916 men who completed the BMSFI at baseline .


The longitudinal cohort included 672 men who were randomized to placebo and had completed the BMSFI at baseline and at least once during a 4-year followup .


Multiple adjusted linear modeling for each domain of the BMSFI was performed to assess associations of sexual function with lower urinary tract symptoms .


After adjustment for baseline demographic and clinical characteristics , increased age , less education , obesity and severe lower urinary tract symptoms were each significantly associated with poorer sexual drive , erectile function , ejaculatory function , sexual problem assessment and overall satisfaction in the cross-sectional cohort .


However , none of these baseline characteristics predicted change in sexual function in the longitudinal cohort .


Decline in sexual function in all sexual function domains associated with worsening of lower urinary tract symptoms in this group was small .


Increased age , less education , obesity and more severe lower urinary tract symptoms were individually associated cross-sectionally , but not longitudinally , with poorer sexual function in men with lower urinary tract symptoms/benign prostatic hyperplasia .


The decline in sexual function associated with worsening of lower urinary tract symptoms in men assigned to placebo was small .


This study was conducted to compare and evaluate the effect of adding lornoxicam or nitroglycerine as adjuncts to lidocaine in intravenous regional anesthesia ( IVRA ) .


60 patients were randomly separated into three groups , lidocaine group ( group L ) , lidocaine + lornoxicam group ( group LL ) , and lidocaine + lornoxicam + transdermal nitroglycerine group ( group LL-N ) .


Hemodynamic parameters , sensory and motor blocks onset , and recovery times were recorded .


Analgesic consumption for tourniquet pain and postoperative period were recorded .


Sensory block onset times and motor block onset times were shorter in the LL-N and LL groups compared with L group .


Sensory block recovery time and motor block recovery time were prolonged in the LL and LL-N groups compared with group L.


The amount of fentanyl required for tourniquet pain was less in group LL and group LL-N when compared with group L. VAS scores of tourniquet pain were higher in group L compared with the other study groups .


Postoperative VAS scores were higher for the first 4 hours in group L compared with the other study groups .


The adjuvant drugs ( lornoxicam or TNG ) when added to lidocaine in IVRA were effective in improving the overall quality of anesthesia , reducing tourniquet pain , increasing tourniquet tolerance , and improving the postoperative analgesia .


To reduce the risk of adjustment problems associated with hematopoietic stem cell transplant ( HSCT ) for adolescents/young adults ( AYAs ) , we examined efficacy of a therapeutic music video ( TMV ) intervention delivered during the acute phase of HSCT to : 1 ) increase protective factors of spiritual perspective , social integration , family environment , courageous coping , and hope-derived meaning ; 2 ) decrease risk factors of illness-related distress and defensive coping ; and 3 ) increase outcomes of self-transcendence and resilience .


This was a multisite randomized , controlled trial ( COG-ANUR0631 ) conducted at 8 Children 's Oncology Group sites involving 113 AYAs aged 11-24 years undergoing myeloablative HSCT .


Participants , randomized to the TMV or low-dose control ( audiobooks ) group , completed 6 sessions over 3 weeks with a board-certified music therapist .


Variables were based on Haase 's Resilience in Illness Model ( RIM ) .


Participants completed measures related to latent variables of illness-related distress , social integration , spiritual perspective , family environment , coping , hope-derived meaning , and resilience at baseline ( T1 ) , postintervention ( T2 ) , and 100 days posttransplant ( T3 ) .


At T2 , the TMV group reported significantly better courageous coping ( Effect Size [ ES ] , 0.505 ; P = .030 ) .


At T3 , the TMV group reported significantly better social integration ( ES , 0.543 ; P = .028 ) and family environment ( ES , 0.663 ; P = .008 ) , as well as moderate nonsignificant effect sizes for spiritual perspective ( ES , 0.450 ; P = .071 ) and self-transcendence ( ES , 0.424 ; P = .088 ) .


The TMV intervention improves positive health outcomes of courageous coping , social integration , and family environment during a high-risk cancer treatment .


We recommend the TMV be examined in a broader population of AYAs with high-risk cancers .


To report the 12-month results of the first head-to-head comparison of a dexamethasone implant ( Ozurdex ; Allergan , Inc. , Irvine , CA ) versus bevacizumab ( Avastin ; Genentech , South San Francisco , CA ) for center-involving diabetic macular edema ( DME ) .


Phase 2 , prospective , multicenter , randomized , single-masked clinical trial ( clinicaltrials.gov identifier NCT01298076 ) .


We enrolled 88 eyes of 61 patients with center-involving DME .


Forty-two eyes were randomized to receive bevacizumab every 4 weeks and 46 eyes were randomized to receive a dexamethasone implant every 16 weeks , both pro re nata .


Results were analyzed using linear regression with generalized estimation equation methods to account for between-eye correlation .


The primary outcome was the proportion of eyes that improved vision by 10 logarithm of minimum angle of resolution letters .


Secondary outcomes included mean change in best-corrected visual acuity ( BCVA ) , change in central macular thickness ( CMT ) , injection frequency , and adverse events .


Patient-reported outcomes were measured using the Impact of Vision Impairment ( IVI ) questionnaire .


Improvement in BCVA of 10 or more letters was found in 17 of 42 eyes ( 40 % ) treated with bevacizumab compared with 19 of 46 dexamethasone implant-treated eyes ( 41 % ; P = 0.83 ) .


None of the 42 bevacizumab eyes lost 10 letters or more , whereas 5 of 46 ( 11 % ) dexamethasone implant eyes did , mostly because of cataract .


Mean CMT decreased by 122 m for bevacizumab eyes and by 187 m for dexamethasone implant eyes ( P = 0.015 ) .


Bevacizumab-treated eyes received a mean of 8.6 injections compared with 2.7 injections for dexamethasone implant eyes .


Significant improvement in IVI scores occurred for both treatment groups .


Dexamethasone implant achieved similar rates of visual acuity improvement compared with bevacizumab for DME , with superior anatomic outcomes and fewer injections .


Both treatments were associated with improvement in visual quality-of-life scores .


However , more dexamethasone implant-treated eyes lost vision , mainly because of cataract .


As tau aggregation pathology correlates with clinical dementia in Alzheimer 's disease ( AD ) , a tau aggregation inhibitor ( TAI ) could have therapeutic utility .


Methylthioninium ( MT ) acts as a selective TAI in vitro and reduces tau pathology in transgenic mouse models .


To determine the minimum safe and effective dose of MT required to prevent disease progression on clinical and functional molecular imaging outcomes .


An exploratory double-blind , randomized , placebo-controlled , dose-finding trial of MT ( 69 , 138 , and 228 mg/day ) was conducted in 321 mild/moderate AD subjects .


The primary outcome was change on the Alzheimer 's Disease Assessment Scale-cognitive subscale ( ADAS-cog ) at 24 weeks relative to baseline severity .


Effect of treatment on regional cerebral blood flow decline was determined in a sub-study in 135 subjects .


After 24 weeks , subjects were re-consented to enter sequential 6 - and 12-month blinded extension phases .


Registered with ClinicalTrials.gov ( NCT00515333 ) .


At 24 weeks , there were significant treatment benefits in two independent populations at the 138 mg/day dose : in moderate subjects on the ADAS-cog scale ( treatment effect : -5.42 units , corrected p = 0.047 ) and two other clinical scales ; in mild subjects on the more sensitive regional cerebral blood flow measure ( treatment effect : 1.97 % , corrected p < 0.001 ) .


With continued treatment for 50 weeks , benefit was seen on the ADAS-cog scale in both mild and moderate subjects .


The delivery of the highest dose was impaired due to dose-dependent dissolution and absorption limitations .


The minimum safe and effective daily MT dose is 138 mg and suggests that further study of MT is warranted in AD .


Infarct size and location are thought to correlate with different mechanisms of lacunar infarcts .


We examined the relationship between the size and shape of lacunar infarcts and vascular risk factors and outcomes .


We studied 1679 participants in the Secondary Prevention of Small Subcortical Stroke trial with a lacunar infarct visualized on diffusion-weighted imaging .


Infarct volume was measured planimetrically , and shape was classified based on visual analysis after 3-dimensional reconstruction of axial MRI slices .


Infarct shape was ovoid/spheroid in 63 % , slab in 12 % , stick in 7 % , and multicomponent in 17 % .


Median infarct volume was smallest in ovoid/spheroid relative to other shapes : 0.46 , 0.65 , 0.54 , and 0.90 mL , respectively ( P < 0.001 ) .


Distributions of vascular risk factors were similar across the 4 groups except that patients in the ovoid/spheroid and stick groups were more often diabetic and those with multicomponent had significantly higher blood pressure at study entry .


Intracranial stenosis did not differ among groups ( P = 0.2 ) .


Infarct volume was not associated with vascular risk factors .


Increased volume was associated with worse functional status at baseline and 3 months .


Overall , 162 recurrent strokes occurred during an average of 3.4 years of follow-up with no difference in recurrent ischemic stroke rate by shape or volume .


In patients with recent lacunar stroke , vascular risk factor profile was similar among the different infarct shapes and sizes .


Infarct size correlated with worse short-term functional outcome .


Neither shape nor volume was predictive of stroke recurrence .


http://www.clinicaltrials.gov .


Unique identifier : NCT00059306 .


To develop a model to predict EuroQol five-dimensional questionnaire ( EQ-5D ) values from clinical chronic obstructive pulmonary disease ( COPD ) questionnaire ( CCQ ) scores .


We used data from three clinical trials ( the Randomized Clinical Trial on Effectiveness of Integrated COPD Management in Primary Care [ RECODE ] , the Assessment Of Going Home Under Early Assisted Discharge [ GO-AHEAD ] , and the Health Status Guided COPD Care [ MARCH ] ) .


Data were randomly split into an estimation sample and a validation sample .


The conceptual similarity between patient-reported CCQ and preference-based EQ-5D scores was assessed using correlation and principal-component analysis .


Different types of models were estimated with increasing complexity .


We selected the final models on the basis of mean absolute error and root mean square error when comparing predicted and observed values from the same population ( internal validity ) and from different trial populations ( external validity ) .


We also developed models for different country-specific EQ-5D value sets .


The principal-component analysis showed that the CCQ domains functional state and mental state are associated with four dimensions of the EQ-5D .


The EQ-5D dimension pain/discomfort formed a separate construct on which no CCQ item loaded .


The mean observed EQ-5D values were not significantly different from the mean predicted EQ-5D values in internal validation samples but did significantly differ in external validation samples .


The models underestimated EQ-5D values in milder health states and overestimated them in more severe health states .


The predictive ability of the models was similar across different EQ-5D value sets .


The models can predict mean EQ-5D values that are similar to observed mean values in a similar population .


The overestimating/underestimating of the low/high EQ-5D values , however , limits its use in Markov models .


Therefore , mapping should be used cautiously .


To evaluate quetiapine XR in patients with anxious depression , as defined by HAM-A total and HAM-D anxiety/somatisation factor scores .


Post hoc analyses of pooled data from two 6-week , double-blind , randomised , placebo-controlled studies of adjunctive quetiapine XR ( 150 or 300 mg/day ) in patients with MDD and inadequate response to antidepressants .


Patients were stratified in a primary analysis using HAM-A ( HAM-A total score at baseline 20 [ `` high '' ] or < 20 [ `` low '' ] ) and a secondary analysis using HAM-D ( anxious depression defined as HAM-D anxiety/somatisation factor score 7 ) .


Outcomes included change in MADRS total score .


In patients with high anxiety levels ( HAM-A total score 20 ) , reductions in MADRS total score were -15.20 ( P = 0.122 ) and -15.92 ( P < 0.05 ) for quetiapine XR 150 and 300 mg/day , respectively , vs. placebo ( -13.49 ) .


In patients with low levels of anxiety ( HAM-A total score < 20 ) , both quetiapine XR doses ( P < 0.001 ) improved MADRS total scores vs. placebo .


In the secondary analysis , quetiapine XR 150 ( P < 0.01 ) and 300 mg/day ( P < 0.001 ) improved MADRS total score vs. placebo in patients with HAM-D anxiety/somatisation factor score 7 .


Adjunct quetiapine XR demonstrates efficacy in patients with anxious and non-anxious depression , assessed using HAM-A total score , and anxious depression assessed using HAM-D anxiety/somatisation factor score .


To develop a population pharmacokinetic model for intravenous omeprazole in critically ill children .


One hundred eighty-six omeprazole concentration-time data from 40 critically ill children were analyzed using the nonlinear mixed-effects approach with the nonlinear mixed-effects modeling software , version 7.2 software .


Patients were randomized into 2 groups and received intravenous omeprazole at a dose of 0.5 or 1 mg/kg twice daily .


Blood samples were drawn at 0.5 , 2 , 6 , 12 , 24 , and 48 hours after the first infusion .


The pharmacokinetic profile was best described by a 2-compartment model with a first-order elimination process .


Between-patient variability could only be associated with plasma clearance ( CL ) .


The typical values for plasma CL were 24.9 Lh70 kg ( 10.08 % ) , with a distributional clearance of 53.9 Lh70 kg ( 11.00 % ) and central and peripheral compartment distribution volumes of 4.23 L/70 kg ( 19.62 % ) and 674 L/70 kg ( 0.89 % ) , respectively .


Allometric size models seemed to predict changes adequately in all the pharmacokinetic parameters .


High values of between-patient variability of CL [ 75.50 % ( 2.60 % ) ] and residual variability [ 130.0 % ( 5.26 % ) ] were still found in the final model .


Model-based simulations suggested that the most suitable dose was 1 mg/kg because this yielded similar exposure ( defined by the area under the concentration-time curve ) to that obtained in adults after a 20-mg dose of omeprazole intravenously .


An allometric size model allows changes to be predicted in all the pharmacokinetic parameters , making dose adjustment by body weight important to achieve the most effective omeprazole exposure .


This is the first step toward a population pharmacokinetic study , including more data to develop a predictable model to be used during therapeutic drug monitoring .


Instructor feedback reduces the number of repetitions and time to reach proficiency during laparoscopic simulator training .


The objective of this study was to examine the effect of instructor feedback on long-term skill retention .


A 6-month follow-up of a randomized trial .


Participants were surgical novices ( medical students ) .


All participants ( n = 99 ) initially practiced a laparoscopic salpingectomy on the LapSim virtual reality simulator to proficiency .


The intervention group could request instructor feedback , whereas the control group could not .


After 6 months , the participants ( n = 65 ) practiced on the simulator until they reached proficiency again .


The primary outcomes were the total time and the number of repetitions .


Initially , the intervention group used significantly fewer repetitions ( 29 vs 65 , p < 0.0005 ) and less total training time ( 162 vs 342 min , p < 0.0005 ) than the control group to reach the proficiency level .


At follow-up , both the groups used an equal number of repetitions ( 21 vs 20 , p = 0.72 ) and time ( 83 vs 73 min , p = 0.37 ) to reach the same proficiency level .


Instructor feedback during proficiency-based laparoscopic simulator training does not affect the long-term retention of skills .


To assess the effect of food on the pharmacokinetics ( PK ) of canagliflozin and metformin following administration of a canagliflozin/metformin ( 150/1 ,000 mg ) immediate-release ( IR ) fixed-dose combination ( FDC ) tablet .


A randomized , open-label , singlecenter , single-dose , 2-period , 2-sequence crossover study was conducted in healthy participants .


Participants were randomized to 2 sequences of fasted and fed ( or vice versa ) administration of one 150/1 ,000 mg canagliflozin/metformin IR FDC , with 10-14 day washout between treatments PK parameters ( AUC , Cmax , tmax , t1/2 ) were assessed for canagliflozin and metformin .


Safety was evaluated .


When comparing the IR FDC tablet administered with and without food , PK parameters of canagliflozin were bioequivalent as the 90 % confidence intervals ( CIs ) for log-transformed AUClast , AUC , and Cmax were within the bioequivalence limits of 80-125 % .


For metformin , overall exposure was similar under fed and fasted conditions as geometric mean ratios for AUC and associated 90 % CI were contained within the bioequivalence limits , but geometric mean Cmax decreased by 16 % in the fed compared to fasted state .


Both treatments were well tolerated with similar adverse events and most common were gastrointestinal events , generally attributed to metformin .


Food did not affect canagliflozin bioavailability parameters ( Cmax and AUCs ) or AUCs of metformin .


The Cmax of metformin was decreased by 16 % , which is not considered clinically meaningful .


The canagliflozin/metformin FDC tablet is recommended to be taken with meals to reduce the symptoms of gastrointestinal intolerability associated with metformin .


Routine prophylaxis with replacement factor VIII ( FVIII ) - the standard of care for severe hemophilia A - often requires frequent intravenous infusions ( three or four times weekly ) .


An FVIII molecule with an extended half-life could reduce infusion frequency .


The A-LONG study established the safety , efficacy and prolonged pharmacokinetics of recombinant FVIII Fc fusion protein ( rFVIIIFc ) in previously treated adolescents and adults with severe hemophilia A.


In this post hoc analysis , we investigated the relationship between subjects ' prestudy ( FVIII ) and on-study ( rFVIIIFc ) regimens .


We analyzed two subgroups of subjects : prior prophylaxis and on-study individualized prophylaxis ( n = 80 ) , and prior episodic treatment and on-study weekly prophylaxis ( n = 16 ) .


Subjects ' prestudy dosing regimens and bleeding rates were compared with their final rFVIIIFc regimens and annualized bleeding rates ( ABRs ) in the last 3 months on-study .


Dosing regimen simulations based on population pharmacokinetics models for rFVIII and rFVIIIFc were performed .


As compared with their prestudy regimen , 79 of 80 ( 98.8 % ) subjects on individualized rFVIIIFc prophylaxis decreased their infusion frequency .


Overall ABRs were low , with comparable factor consumption .


Longer dosing intervals , including 5-day dosing , were associated with higher baseline von Willebrand factor antigen levels .


Simulated dosing regimens predicted a greater proportion of subjects with steady-state FVIII activity trough levels of 1 IU dL ( -1 ) ( 1 % ) with rFVIIIFc than with equivalent rFVIII regimens .


These results suggest that patients on rFVIIIFc prophylaxis can reduce their infusion frequency as compared with their prior FVIII regimen while maintaining low bleeding rates , affording more patients trough levels of 1 IU dL ( -1 ) than with rFVIII products requiring more frequent dosing regimens .


Compared to other children , those with disability have additional challenges to being physically active .


Prader-Willi Syndrome is a genetic form of childhood obesity that is characterized by hypotonia , growth hormone deficiency , behavioral , and cognitive disability .


In children , the low prevalence of this syndrome ( 1 in 10,000 to 15,000 live births ) makes group-based physical activity interventions difficult .


In contrast , the home environment presents a natural venue to establish a physical activity routine for this population .


This manuscript describes the design of a parent-led physical activity intervention incorporating playground and interactive console-based games to increase physical activity participation in youth with and without Prader-Willi Syndrome .


The study participants will be 115 youth ages 8-15 y ( 45 with the syndrome and 70 without the syndrome but categorized as obese ) .


The study will use a parallel design with the control group receiving the intervention after serving as control .


Participants will be expected to complete a physical activity curriculum 4 days a week for 6 months including playground games 2 days a week and interactive console games 2 days a week .


Parents will be trained at baseline and then provided with a curriculum and equipment to guide their implementation of the program .


Tips related to scheduling and coping with barriers to daily program implementation will be provided .


Throughout , parents will be contacted by phone once a week ( weeks 1-4 ) and then every other week to receive support in between visits .


Measurements of children and parents will be obtained at baseline , 12 weeks , and at the end ( week 24 ) of the intervention .


Children main outcomes include physical activity ( accelerometry ) , body composition ( dual x-ray absorptiometry ) , motor proficiency ( Bruininks-Oseretsky Test of Motor Proficiency ) , quality of life and physical activity self-efficacy ( questionnaires ) .


Intervention compliance will be monitored using mail-in daily self-report checklists .


This parent-guided physical activity intervention aims to increase physical activity by using a curriculum that builds physical activity related self-confidence through the development and/or enhancement of motor skill competency .


Ultimately , helping children develop these skills as well as joy in being physically active will translate into sustained behavior change .


Current Controlled Trial : NCT02058342 .


Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints .


The Physical Activity during Cancer Treatment ( PACT ) study was designed to primarily examine the effects of an 18-week exercise intervention , offered in the daily clinical practice setting and starting within 6 weeks after diagnosis , on preventing an increase in fatigue .


This multi-centre controlled trial randomly assigned 204 breast cancer patients to usual care ( n = 102 ) or supervised aerobic and resistance exercise ( n = 102 ) .


By design , all patients received chemotherapy between baseline and 18 weeks .


Fatigue ( i.e. , primary outcome at 18 weeks ) , quality of life , anxiety , depression , and physical fitness were measured at 18 and 36 weeks .


Intention-to-treat mixed linear model analyses showed that physical fatigue increased significantly less during cancer treatment in the intervention group compared to control ( mean between-group differences at 18 weeks : -1.3 ; 95 % CI -2.5 to -0.1 ; effect size -0.30 ) .


Results for general fatigue were comparable but did not reach statistical significance ( -1.0 , 95 % CI -2.1 ; 0.1 ; effect size -0.23 ) .


At 18 weeks , submaximal cardiorespiratory fitness and several muscle strength tests ( leg extension and flexion ) were significantly higher in the intervention group compared to control , whereas peak oxygen uptake did not differ between groups .


At 36 weeks these differences were no longer statistically significant .


Quality of life outcomes favoured the exercise group but were not significantly different between groups .


A supervised 18-week exercise programme offered early in routine care during adjuvant breast cancer treatment showed positive effects on physical fatigue , submaximal cardiorespiratory fitness , and muscle strength .


Exercise early during treatment of breast cancer can be recommended .


At 36 weeks , these effects were no longer statistically significant .


This might have been caused by the control participants ' high physical activity levels during follow-up .


Current Controlled Trials ISRCTN43801571 , Dutch Trial Register NTR2138 .


Trial registered on December 9th , 2009 .


In 1993-1994 , a psychosocial intervention conducted in New York City significantly improved outcomes for parents living with HIV and their adolescent children over six years .


We examine if the intervention benefits are similar for adolescents of mothers living with HIV ( MLH ) in 2004-2005 in Los Angeles when MLH 's survival had increased substantially .


Adolescents of MLH in Los Angeles ( N = 256 ) aged 12-20 years old were randomized with their MLH to either : 1 ) a standard care condition ( n = 120 adolescent-MLH dyads ) ; or 2 ) an intervention condition consisting of small group activities to build coping skills ( n = 136 adolescent-MLH dyads , 78 % attended the intervention ) .


At 18 months , 94.7 % of adolescents were reassessed .


Longitudinal structural equation modeling examined if intervention participation impacted adolescents ' relationships with parents and their sexual risk behaviors .


Compared to the standard care , adolescents in the intervention condition reported significantly more positive family bonds 18 months later .


Greater participation by MLH predicted fewer family conflicts , and was indirectly associated with less adolescent sexual risk behavior at the 18 month follow-up assessment .


Anticipated developmental patterns were observed -- sexual risk acts increased with age .


Reports were also consistent with anticipated gender roles ; girls reported better bonds with their mothers at 18 months , compared to boys .


Adolescents of MLH have better bonds with their mothers as a function of participating in a coping skills intervention and reduced sexual risk-taking as a function of MLH intervention involvement .


To assess the effectiveness of supportive counselling after miscarriage .


Randomised controlled trial .


University hospital .


Two hundred and eighty women with miscarriage .


Women were randomised to receive supportive counselling from a nurse ( at diagnosis and 2 weeks later ) or routine care .


Psychological wellbeing was measured with the General Health Questionnaire ( GHQ-12 ) and Beck Depression Inventory ( BDI ) .


Primary outcome measured the proportion of women suffering psychological distress ( GHQ-12 score 4 ) at 3 months after miscarriage .


Secondary outcomes were GHQ-12 and BDI scores at 6 weeks , 3 and 6 months .


There was no difference in the proportion of women suffering psychological distress at 3 months after miscarriage ( 17.1 % in counselling group versus 24.4 % in control group ; 95 % CI -0.034 to 0.177 ; P = 0.19 ) .


However , for the subgroup of women ( n = 152 ) with high baseline GHQ-12 scores , the median GHQ-12 score in the counselling group was significantly lower than the control group at 6 weeks ( median score 3 versus 4.5 in counselling and control groups ; P = 0.04 ) and 3 months ( median score 1 versus 2.5 in counselling and control groups ; P = 0.03 ) .


Similarly , for women with high baseline BDI scores ( BDI > 12 ) , the proportion for women continuing to score high was significantly lower in the counselling group 6 weeks after miscarriage ( 33.3 versus 61.1 % in counselling group and control group ; P = 0.03 ) .


Although the results of current study do not justify routine counselling of all women following miscarriage , a supportive counselling programme for selected women with high levels of psychological distress is promising and merits further investigation .


The susceptibility to type 2 diabetes of people of south Asian descent is established , but there is little trial-based evidence for interventions to tackle this problem .


We assessed a weight control and physical activity intervention in south Asian individuals in the UK .


We did this non-blinded trial in two National Health Service ( NHS ) regions in Scotland ( UK ) .


Between July 1 , 2007 , and Oct 31 , 2009 , we recruited men and women of Indian and Pakistani origin , aged 35 years or older , with waist circumference 90 cm or greater in men or 80 cm or greater in women , and with impaired glucose tolerance or impaired fasting glucose determined by oral glucose tolerance test .


Families were randomised ( using a random number generator program , with permuted blocks of random size , stratified by location [ Edinburgh or Glasgow ] , ethnic group [ Indian or Pakistani ] , and number of participants in the family [ one vs more than one ] ) to intervention or control .


Participants in the same family were not randomised separately .


The intervention group received 15 visits from a dietitian over 3 years and the control group received four visits in the same period .


The primary outcome was weight change at 3 years .


Analysis was by modified intention to treat , excluding participants who died or were lost to follow-up .


We used linear regression models to provide mean differences in baseline-adjusted weight at 3 years .


This trial is registered , number ISRCTN25729565 .


Of 1319 people who were screened with an oral glucose tolerance test , 196 ( 15 % ) had impaired glucose tolerance or impaired fasting glucose and 171 entered the trial .


Participants were in 156 family clusters that were randomised ( 78 families with 85 participants were allocated to intervention ; 78 families with 86 participants were allocated to control ) .


167 ( 98 % ) participants in 152 families completed the trial .


Mean weight loss in the intervention group was 1.13 kg ( SD 4.12 ) , compared with a mean weight gain of 0.51 kg ( 3.65 ) in the control group , an adjusted mean difference of -1.64 kg ( 95 % CI -2.83 to -0.44 ) .


Modest , medium-term changes in weight are achievable as a component of lifestyle-change strategies , which might control or prevent adiposity-related diseases .


National Prevention Research Initiative , NHS Research and Development ; NHS National Services Scotland ; NHS Health Scotland .


Neurobiologically , panic disorder ( PD ) is supposed to be characterised by cerebral hypofrontality .


Via functional near-infrared spectroscopy ( fNIRS ) , we investigated whether prefrontal hypoactivity during cognitive tasks in PD-patients compared to healthy controls ( HC ) could be replicated .


As intermittent theta burst stimulation ( iTBS ) modulates cortical activity , we furthermore investigated its ability to normalise prefrontal activation .


Forty-four PD-patients , randomised to sham or verum group , received 15 iTBS-sessions above the left dorsolateral prefrontal cortex ( DLPFC ) in addition to psychoeducation .


Before first and after last iTBS-treatment , cortical activity during a verbal fluency task was assessed via fNIRS and compared to the results of 23 HC .


At baseline , PD-patients showed hypofrontality including the DLPFC , which differed significantly from activation patterns of HC .


However , verum iTBS did not augment prefrontal fNIRS activation .


Solely after sham iTBS , a significant increase of measured fNIRS activation in the left inferior frontal gyrus ( IFG ) during the phonological task was found .


Our results support findings that PD is characterised by prefrontal hypoactivation during cognitive performance .


However , verum iTBS as an `` add-on '' to psychoeducation did not augment prefrontal activity .


Instead we only found increased fNIRS activation in the left IFG after sham iTBS application .


Possible reasons including task-related psychophysiological arousal are discussed .


To compare the outcomes of phacoemulsification with either a 2.5-mm clear corneal incision and a foldable intraocular lens ( IOL ) or a 5-mm sclerocorneal tunnel incision and a rigid polymethyl methacrylate ( PMMA ) IOL .


In a prospective , randomised clinical trial of phacoemulsification cataract surgery , 1200 patients received either a foldable hydrophilic acrylic IOL through a 2.5-mm corneal incision or an inexpensive rigid PMMA IOL via a 5-mm sclerocorneal tunnel .


Intra - and post-operative data and visual acuity at discharge , 6 weeks , and 1 year follow-up were analysed .


At 1 year after surgery , 996 ( 83.0 % ) patients were followed up with an uncorrected visual acuity of 6/18 or better in 90.3 % of the foldable and 94.3 % in the rigid IOL group ( risk ratio ( RR ) 0.96 , 95 % confidence intervals ( CI ) 0.92-0 .99 ) .


Poor outcome ( best-corrected acuity 6/60 or worse ) occurred in 1.0 % and 0.4 % , respectively ( RR 4.28 , 95 % CI 0.48-38 .18 ) .


The surgical cost of consumables and overall surgical time were similar in both groups ; however , the cost of the foldable IOL was eight times higher than the PMMA IOL .


Posterior capsule opacification was more common in the rigid IOL group at 12 months ( 36.1 % vs 23.3 % ) ; however , this did not affect post-operative vision .


In the hands of experienced cataract surgeons , phacoemulsification with implantation of a foldable or a rigid IOL gives excellent results .


Using an inexpensive rigid PMMA IOL will make phacoemulsification more affordable for poor patients in low - and middle-income countries .


Calcium folinate ( leucovorin ) , which is converted in vivo into biologically active folate , enhances the potency of 5-fluorouracil ( 5-FU ) - based chemotherapy in colorectal cancer .


A common dosage of leucovorin in adjuvant and palliative settings is 60mg/m ( 2 ) .


The aim was to determine the levels of tetrahydrofolate ( THF ) , 5,10-methylenetetrahydrofolate ( methyleneTHF ) , and 5-methyltetrahydrofolate ( methylTHF ) in tumour and mucosa of colorectal cancer patients who received different dosages of leucovorin intravenously at time of surgery .


Eighty patients scheduled for colorectal resection with indication of colorectal cancer were randomised into four groups to receive leucovorin at 0 , 60 , 200 , or 500mg/m ( 2 ) , respectively .


Blood samples were taken 10 and 30min after leucovorin administration .


Biopsy samples from tumour and mucosa were collected and snap-frozen at surgery .


The levels of THF , methyleneTHF , and methylTHF in tumour and mucosa were assessed by liquid chromatography electrospray ionisation tandem mass spectrometry ( LC-MS/MS ) and the results were related to clinical diagnosis and therapeutic regimens .


The folate levels in tissue revealed extensive inter-individual variability .


The mean methyleneTHF value for the four treatment groups were 880 , 1,769 , 3,024 and 3,723 pmol/gww .


Only half of the patients who received 60mg/m ( 2 ) leucovorin had higher levels of methyleneTHF in tumour than patients who received 0mg/m ( 2 ) leucovorin .


Rectal cancer patients had significantly lower levels of methyleneTHF compared with colon cancer patients .


There was a large inter-patient variability of tissue folate levels in colorectal cancer patients after supplementation with leucovorin at standardised dosage .


High leucovorin doses were needed to exceed baseline methyleneTHF values , especially in rectal cancer patients .


The results indicate that the standardised leucovorin dose may be insufficient to attain the full antitumour effect of 5-FU .


Further studies are needed to establish whether higher dosage yields a better treatment response .


Evaluate baseline factors that may explain the influence of study site on decisional conflict ( DC ) in men from the Personal Patient Profile : Prostate ( P3P ) randomized trial .


476 cases from 5 P3P sites were included .


Participants completed baseline demographic assessments , 4 subscales of the DC scale at baseline ( uncertainty , informed , values clarity , and support ) , the Expanded Prostate Cancer Index Composite ( short form ) and the State-Trait Anxiety Inventory .


Site data regarding typical practices were collected .


Linear regressions were used to model the relation between baseline DC scores and study site adjusting for the list of variables .


Baseline decisional uncertainly ( p = 0.001 ) and informed ( p = 0.03 ) subscales were significantly different across sites .


Participant demographic and baseline measures were significantly different ( p < 0.05 ) between sites except for trait anxiety .


We identified participant level factors that explained study site differences at baseline for the decisional uncertainty and values clarity subscales : a preferred treatment choice at study entry , whether the study program was accessed at home vs. in clinic , number of doctors consulted pre-study , working status , state anxiety , information from the media or a health care provider , and perceived knowledge level .


State anxiety was associated with higher DC across all subscales .


Individual characteristics of men seeking consultation for LPC were associated with DC at baseline , not the site alone ; anxiety contributed to higher conflict .


These findings will inform future development and implementation of the P3P and other decision support interventions .


NCT00692653 .


An immune function assay shows promise for identifying solid organ recipients at risk for infection or rejection .


The following randomized prospective study was designed to assess the clinical benefits of adjusting immunosuppressive therapy in liver recipients based on immune function assay results .


Adult liver recipients were randomized to standard practice ( control group ; n = 102 ) or serial immune function testing ( interventional group ; n = 100 ) performed with a commercially available in vitro diagnostic assay ( ImmuKnow ; Viracor-IBT Laboratories , Lee 's Summit , MO ) before transplantation , immediately after surgery and at day 1 , weeks 1 to 4 , 6 , and 8 , and months 3 to 6 , 9 , and 12 .


The assay was repeated within 7 days of suspected/confirmed rejection/infection and within 1 week after event resolution .


Based on immune function values , tacrolimus doses were reduced 25 % when values were less than 130 ng/mL adenosine triphosphate ( low immune cell response ) and increased 25 % when values were greater than 450 ng/mL adenosine triphosphate ( strong immune cell response ) .


The 1-year patient survival was significantly higher in the interventional arm ( 95 % vs 82 % ; P < 0.01 ) and the incidence of infections longer than 14 days after transplantation was significantly lower among patients in the interventional arm ( 42.0 % vs. 54.9 % , P < 0.05 ) .


The difference in infection rates was because of lower bacterial ( 32 % vs 46 % ; P < 0.05 ) and fungal infection ( 2 % vs 11 % ; P < 0.05 ) .


Among recipients without adverse events , the study group had lower tacrolimus dosages and blood levels .


Immune function testing provided additional data which helped optimize immunosuppression and improve patient outcomes .


There are scarce reports regarding the prognosis of a second course of antithyroid drug ( ATD ) therapy on recurrent Graves ' disease ( GD ) .


The aim of this study was to assess the long-term remission rate after a second ATD therapy and verify significant clinical predictors of a remission .


A prospective randomized clinical trial with long-term follow-up was conducted to evaluate the effects of a second course of ATD therapy .


A total of 128 recurrent GD patients who had finished a first regular ATD therapy were enrolled in this study , and prescribed methimazole ( MMI ) treatment with titration regimen .


The patients were randomly assigned to two groups when the drug doses were reduced to 2.5 mg daily ( qd ) .


Group 1 was discontinued with 2.5 mg qd after about 5 months .


Group 2 was continuously reduced to 2.5 mg every other day ( qod ) after 5 months and then discontinued with 2.5 mg qod after about a further 5 months .


The patients were followed for 48 months after drug withdrawal .


Of the total number of patients , 97 cases ( 75.78 % ) achieved permanent remission at the end of follow-up , with the recurrence of 31 cases ( 24.22 % ) .


The remission rate of group 2 ( 84.62 % ) was significantly higher than that of group 1 ( 66.67 % ) ( P = 0.024 ) .


Cox regression showed that the hazard ratio for recurrence decreased under a high or high normal TSH level at drug withdrawal .


A second course of ATD therapy can bring about a satisfying long-term remission on recurrent GD .


The drug dose of 2.5 mg qod and a high or high normal TSH level at drug withdrawal may increase the likelihood of permanent remission .


Kidney stones are one of the most common disorders of the urinary tract and cause a great deal of morbidity and economic loss .


Because of the side effects and costs of current interventional procedures , researchers are interested in finding medicinal therapies .


In this regard , some reports have focused on traditional medicines as a drug discovery resource .


Iranian scholars in the medieval era recommended Lapis judaicus for the prevention and treatment of kidney stones .


The present study assessed the efficacy and safety of Lapis judaicus on the size of calcium kidney stones and some related biochemical factors in blood and urine .


Sixty patients with kidney stone disease were included in this double-blind randomized clinical study .


Thirty patients received 2g of Lapis judaicus powder in hard capsules per day for 10 weeks , and another 30 patients received a placebo for the same period .


Ultrasonography was performed on patients , and blood and urine samples were collected before and after the study to evaluate the efficacy and safety of Lapis judaicus in calcium kidney stone patients .


The size of the kidney stones was reduced significantly ( p < 0.001 ) in the drug group .