To identify and characterize cases of glaucoma and glaucoma-related adverse events ( glaucoma + glaucoma suspect ) among children in the Infant Aphakia Treatment Study by the age of 5 years .


A multicenter randomized clinical trial of 114 infants with unilateral congenital cataract in referral centers who were between ages 1 and 6 months at surgery .


Mean follow-up was 4.8 years .


This secondary analysis was conducted from December 23 , 2004 , to November 13 , 2013 .


Participants were randomized at cataract surgery to either primary IOL or no IOL implantation ( contact lens ) .


Standardized definitions of glaucoma and glaucoma suspect were created for the Infant Aphakia Treatment Study and applied for surveillance and diagnosis .


Development of glaucoma and glaucoma + glaucoma suspect in operated on eyes for children up to age 5 years , plus intraocular pressure , visual acuity , and axial length at age 5 years .


Product limit estimates of the risk for glaucoma and glaucoma + glaucoma suspect at 4.8 years after surgery were 17 % ( 95 % CI , 11 % -25 % ) and 31 % ( 95 % CI , 24 % -41 % ) , respectively .


The contact lens and IOL groups were not significantly different for either outcome : glaucoma ( hazard ratio [ HR ] , 0.8 ; 95 % CI , 0.3-2 .0 ; P = .62 ) and glaucoma + glaucoma suspect ( HR , 1.3 ; 95 % CI , 0.6-2 .5 ; P = .58 ) .


Younger ( vs older ) age at surgery conferred an increased risk for glaucoma ( 26 % vs 9 % , respectively ) at 4.8 years after surgery ( HR , 3.2 ; 95 % CI , 1.2-8 .3 ) , and smaller ( vs larger ) corneal diameter showed an increased risk for glaucoma + glaucoma suspect ( HR , 2.5 ; 95 % CI , 1.3-5 .0 ) .


Age and corneal diameter were significantly positively correlated .


Glaucoma was predominantly open angle ( 19 of 20 cases , 95 % ) , most eyes received medication ( 19 of 20 , 95 % ) , and 8 of 20 eyes ( 40 % ) underwent surgery .


These results suggest that glaucoma-related adverse events are common and increase between ages 1 and 5 years in infants after unilateral cataract removal at 1 to 6 months of age ; primary IOL placement does not mitigate their risk but surgery at a younger age increases the risk .


Longer follow-up of these children may further characterize risk factors , long-term outcomes , potential differences between eyes having primary IOL vs aphakia , and optimal timing of unilateral congenital cataract removal .


clinicaltrials.gov Identifier : NCT00212134 .


DSM-5 has dropped subtyping of bulimia nervosa ( BN ) , opting to continue inclusion of the somewhat contentious diagnosis of BN-nonpurging subtype ( BN-NP ) within a broad BN category .


Some contend however that BN-NP is more like binge eating disorder ( BED ) than BN-P .


This study examines clinical characteristics , eating disorder symptomatology , and Axis I comorbidity in BN-NP , BN-P , and BED groups to establish whether BN-NP more closely resembles BN-P or BED .


Women with BN-P ( n = 29 ) , BN-NP ( n = 29 ) , and BED ( n = 54 ) were assessed at baseline in an outpatient psychotherapy trial for those with binge eating .


Measures included the Structured Clinical Interviews for DSM-IV , Eating Disorder Examination , and Eating Disorder Inventory-2 .


The BN-NP subtype had BMIs between those with BN-P and BED .


Both BN subtypes had higher Restraint and Drive for Thinness scores than BED .


Body Dissatisfaction was highest in BN-NP and predicted BN-NP compared to BN-P .


Higher Restraint and lower BMI predicted BN-NP relative to BED .


BN-NP resembled BED with higher lifetime BMIs ; and weight-loss clinic than eating disorder clinic attendances relative to the BN-P subtype .


Psychiatric comorbidity was comparable except for higher lifetime cannabis use disorder in the BN-NP than BN-P subtype


These results suggest that BN-NP sits between BN-P and BED however the high distress driving inappropriate compensatory behaviors in BN-P requires specialist eating disorder treatment .


These results support retaining the BN-NP group within the BN category .


Further research is needed to determine whether there are meaningful differences in outcome over follow-up .


Preclinical studies and early pilot clinical investigations have suggested that N-acetylcysteine ( NAC ) may be useful in treatment of methamphetamine ( METH ) dependence .


The present study evaluated whether NAC would suppress craving to the METH .


In a double-blind , controlled crossover clinical trial , 32 METH-dependent volunteers were chosen to receive either NAC ( 1200 mg/day ) or placebo , randomly .


They were intervened in two four-week sessions .


During first session they received either 1200 mg/day of NAC ( group A ) or placebo ( group B ) .


After three days of washout period , next session started with the crossover intervention of the previous regimen .


During these eight weeks , all participants received standardized , and Matrix Model of treatment .


Craving was assessed using the Cocaine Craving Questionnaire-Brief ( CCQ-Brief ) .


The data were analyzed using SPSS version 20.0 ( SPSS Inc. .


Chicago , Illinois , USA ) .


In 23 subjects who completed the study , the mean score of CCQ-Brief reduced in four consecutive weeks with NAC treatment .


The mean ( SD ) scores of carving in group A and B were 3.38 ( 1.16 ) and 5.96 ( 1.03 ) , at the end of first session ; and 4.57 ( 1.88 ) and 3.2 ( 0.86 ) , at the end of the second session , respectively .


Our findings indicate that the main effect was significant for NAC ( P < 0.001 ) .


Across placebo and NAC conditions , only mild side effects were noted , and the number of subjects who reported side effects did not differ .


The NAC showed good efficacy in suppressing METH craving , and may be a useful pharmacological treatment for METH dependency .


Stroke is a leading cause of death worldwide .


Infections after stroke occur in 30 % of stroke patients and are strongly associated with unfavourable outcome .


Preventive antibiotic therapy lowers infection rate in patients after stroke , however , the effect of preventive antibiotic treatment on functional outcome after stroke has not yet been investigated.The Preventive Antibiotics in Stroke Study ( PASS ) is an ongoing , multicentre , prospective , randomised , open-label , blinded end point trial of preventive antibiotic therapy in acute stroke .


Patients are randomly assigned to either ceftriaxone at a dose of 2g , given every 24hours intravenously for four-days , in addition to stroke-unit care , or standard stroke-unit care without preventive antibiotic therapy .


Aim of the study is to assess whether preventive antibiotic treatment improves functional outcome at three months by preventing infections .


To date , 2,470 patients have been included in PASS .


Median stroke severity of the first 2,133 patients ( second interim analysis ) is 5 ( IQR 3 to 9 ) on the National Institutes of Health Stroke Scale ( NIHSS ) .


Due to the PROBE design , no outcome data are available yet .


In the initial trial protocol we proposed a dichotomisation of the mRS as primary analysis of outcome and ordinal regression analysis as secondary analysis of primary outcome , requiring a sample size of 3,200 patients .


However , ordinal analysis of outcome data is becoming increasingly more common in acute stroke trials , as it increases statistical power .


For PASS , funding is insufficient for inclusion of 3,200 patients with the overall inclusion rate of 15 patients per week .


Therefore we change the analysis of our primary outcome from dichotomisation to ordinal regression analysis on the mRS. Power analysis showed that with similar assumptions 2,550 patients are needed using ordinal regression analysis .


We expect to complete follow-up in June 2014 .


A full statistical analysis plan will be submitted for publication before treatment allocation will be unblinded .


The data from PASS will establish whether preventive antibiotic therapy in acute stroke improves functional outcome by preventing infection .


In this update , we changed our primary outcome analysis from dichotomisation to ordinal regression analysis .


Current controlled trials ; ISRCTN66140176 .


Date of registration : 6 April 2010 .


HIV counselling and testing and linkage to care are crucial for successful HIV prevention and treatment .


Abbreviated counselling could save time ; however , its effect on HIV risk is uncertain and methods to improve linkage to care have not been studied .


We did this factorial randomised controlled study at Mulago Hospital , Uganda .


Participants were randomly assigned to abbreviated or traditional HIV counselling and testing ; HIV-infected patients were randomly assigned to enhanced linkage to care or standard linkage to care .


All study personnel except counsellors and the data officer were masked to study group assignment .


Participants had structured interviews , given once every 3 months .


We compared sexual risk behaviour by counselling strategy with a 65 % non-inferiority margin .


We used Cox proportional hazards analyses to compare HIV outcomes by linkage to care over 1 year and tested for interaction by sex .


This trial is registered with ClinicalTrials.gov ( NCT00648232 ) .


We enrolled 3415 participants ; 1707 assigned to abbreviated counselling versus 1708 assigned to traditional .


Unprotected sex with an HIV discordant or status unknown partner was similar in each group ( 232/823 [ 279 % ] vs 251/890 [ 282 % ] , difference -03 % , one-sided 95 % CI 32 ) .


Loss to follow-up was lower for traditional counselling than for abbreviated counselling ( adjusted hazard ratio [ HR ] 061 , 95 % CI 044-083 ) .


1003 HIV-positive participants were assigned to enhanced linkage ( n = 504 ) or standard linkage to care ( n = 499 ) .


Linkage to care did not have a significant effect on mortality or receipt of co-trimoxazole .


Time to treatment in men with CD4 cell counts of 250 cells per L or fewer was lower for enhanced linkage versus standard linkage ( adjusted HR 060 , 95 % CI 041-087 ) and time to HIV care was decreased among women ( 080 , 066-096 ) .


Abbreviated HIV counselling and testing did not adversely affect risk behaviour .


Linkage to care interventions might decrease time to enrolment in HIV care and antiretroviral treatment and thus might affect secondary HIV transmission and improve treatment outcomes .


US National Institute of Mental Health .


Tinea cruris , a pruritic superficial fungal infection of the groin , is the second most common clinical presentation for dermatophytosis .


This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1 % in patients with tinea cruris .


483 patients were enrolled and 256 male and female patients aged 12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1 % ( n = 165 ) or vehicle ( n = 91 ) once daily for 7 days .


Efficacy was evaluated at baseline and at days 7 , 14 , 21 , and 28 based on mycology ( potassium hydroxide , fungal culture ) and clinical signs ( erythema , scaling , pruritus ) .


The primary outcome was complete clearance at day 28 ( 21 days posttreatment ) .


Safety evaluations included adverse events and laboratory assessments .


Complete clearance was obtained in 21.2 % ( 35/165 ) of patients treated with luliconazole cream 1 % compared with 4.4 % ( 4/91 ) treated with vehicle ( P < 0.001 ) .


The safety profile of luliconazole cream 1 % was similar to vehicle .


The study was conducted under controlled conditions in a relatively small population .


Luliconazole cream 1 % applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris .


To compare the postoperative analgesic effects of lidocaine , morphine and lidocaine plus morphine administered by constant rate infusion ( CRI ) and analyzing their effects on opioid requirements after orthopedic surgery in dogs .


Twenty-four dogs underwent fracture repairs were premedicated with IM acepromazine ( 0.05 mg/kg ) combined with morphine ( 0.3 mg/kg ) .


Anesthesia was induced with IV propofol ( 4 to 5 mg / kg ) and maintained with isoflurane .


The dogs were randomly assigned to 3 groups and administered a CRI IV of lidocaine ( T-L ) , morphine ( T-M ) or lidocaine plus morphine ( T-LM ) at the same doses .


Postoperative analgesia was assessed for 24 hours using a Visual Analog Scale ( VAS ) and the Glasgow Composite Pain Scale ( GCPS ) .


Rescue analgesia was performed if the evaluation score exceeded 50 % of the VAS and/or 33 % of the GCPS .


The pain score and postoperative opioid requirements did not differ among the treatments .


Rescue analgesia was administered to 1/8 dogs in the T-M and T-LM , and to 3/8 dogs in the T-L .


Lidocaine , morphine or lidocaine/morphine CRI may be efficacious techniques for pain management in the first 24 hours post-surgery .


However , the two drugs administered together did not reduce the postoperative opioid requirement in dogs undergoing fracture repair .


Key words : Anesthesia .


Analgesics .


Analgesics , Opioid .


Lidocaine .


Morphine .


Dogs .


The risk of cardiovascular diseases ( CVD ) is increased tremendously among menopausal women , and there is an increasing demand for alternative therapies for managing factors like dyslipidemia that contribute to CVD development .


In this study , Nigella sativa was evaluated for its hypolipidemic effects among menopausal women .


In a randomised trial , hyperlipidemic menopausal women were assigned to treatment ( n = 19 ) or placebo groups ( n = 18 ) , and given N. sativa or placebo for two months after their informed consents were sought .


At baseline , blood samples were taken and at one month intervals thereafter until one month after the end of the study .


The results showed that N. sativa significantly improved lipid profiles of menopausal women ( decreased total cholesterol , low density lipoprotein cholesterol and triglyceride , and increased high density lipoprotein cholesterol ) more than the placebo treatment over 2 months of intervention .


One month after cessation of treatment , the lipid profiles in the N. sativa-treated group tended to change towards the pretreatment levels .


N. sativa is thought to have multiple mechanisms of action and is cost-effective .


Therefore , it could be used by menopausal women to remedy hypercholesterolemia , with likely more benefits than with single pharmacological agents that may cause side effects .


The use of N. sativa as an alternative therapy for hypercholesterolemia could have profound impact on the management of CVD among menopausal women especially in countries where it is readily available .


Overweight and obesity among young , adult women are increasing problems in Sweden as in many other countries .


The postpartum period may be a good opportunity to improve eating habits and lose weight in a sustainable manner .


The aim was to make a cost-utility analysis of a dietary behavior modification treatment alongside usual care , compared to usual care alone , among lactating overweight and obese women .


This study was a cost-utility analysis based on a randomized controlled and longitudinal clinical diet intervention .


Between 2007-2010 , 68 women living in Sweden were , after baseline measurement at 8-12weeks postpartum , randomly assigned to a 12-week dietary behavior modification treatment or control group .


Inclusion criteria were : self-reported pre-pregnancy body mass index ( BMI ) 25-35kg / m2 , non-smoker , singleton term delivery , birth weight > 2500g , intention to breastfeed for 6 mo and no diseases ( mother and child ) .


The women in the intervention group received 1.5 hour of individual counseling at study start and 1 hour at follow-up home visits after 6 weeks of intervention , with support through cell phone text messages every two wk .


Dietary intervention aimed to reduce dietary intake by 500kcal/day .


The control group received usual care .


Weight results have previously been reported .


Here we report on analyses carried out during 2012-2013 of cost per quality adjusted life years ( QALY ) , based on the changes in quality of life measured by EQ-5D-3L and SF-6D .


Likelihood of cost-effectiveness was calculated using Net Monetary Benefit method .


Based on conservative assumptions of no remaining effect after 1 year follow-up , the diet intervention was cost-effective .


Costs per gained QALY were 8 643 - 9 758 USD .


The likelihood for cost-effectiveness , considering a willingness to pay 50 000 USD for a QALY , was 87-93 % .


The diet intervention is cost-effective .


ClinicalTrials.gov Identifier : NCT01343238 Registered April 27 , 2011 .


The regional ethics committee in Gothenburg , Sweden , approved the study on November 15 , 2006 .


The energy source used for stone fragmentation is important in miniperc .


In this study , we compared the stone fragmentation characteristics and outcomes of laser lithotripsy and pneumatic lithotripsy in miniperc for renal calculi .


After Institutional Review Board approval , 60 patients undergoing miniperc for renal calculi of 15 to 30 mm were equally randomized to laser and pneumatic lithotripsy groups .


Miniperc was performed using 16.5 F Karl Storz miniperc sheath and a 12F nephroscope .


Laser lithotripsy was performed using a 550-m laser fiber and 30 W laser with variable settings according to the need .


Pneumatic lithotripsy was performed using the EMS Swiss lithoclast .


Patient demographics , stone characteristics , intraoperative parameters , and postoperative outcomes were analyzed .


The baseline patient demographics and stone characteristics were similar in both groups .


The total operative time ( P = 0.433 ) and fragmentation time ( P = 0.101 ) were similar between the groups .


The surgeon assessed that the Likert score ( 1 to 5 ) for fragmentation was similar in both groups ( 2.1 0.8 vs 1.9 0.9 , P = 0.313 ) .


Stone migration was lower with the laser ( 1.3 0.5 vs 1.7 0.8 , P = 0.043 ) , and fragment removal was easier with the laser ( 1.1 0.3 vs 1.7 1.1 , P = 0.011 ) .


The need for fragment retrieval using a basket was significantly more in the pneumatic lithotripsy group ( 10 % vs 37 % , P = 0.002 ) .


The hemoglobin drop , complication rates , auxiliary procedures , postoperative pain , and stone clearance rates were similar between the groups ( P > 0.2 ) .


Both laser lithotripsy and pneumatic lithotripsy are equally safe and efficient stone fragmentation modalities in miniperc .


Laser lithotripsy is associated with lower stone migration and easier retrieval of the smaller fragments it produces .


The role of nutrition in the treatment of attention-deficit hyperactivity disorder ( ADHD ) is gaining international attention ; however , treatments have generally focused only on diet restriction or supplementing with one nutrient at a time .


To investigate the efficacy and safety of a broad-based micronutrient formula consisting mainly of vitamins and minerals , without omega fatty acids , in the treatment of ADHD in adults .


This double-blind randomised controlled trial assigned 80 adults with ADHD in a 1:1 ratio to either micronutrients ( n = 42 ) or placebo ( n = 38 ) for 8 weeks ( trial registered with the Australian New Zealand Clinical Trials Registry : ACTRN12609000308291 ) .


Intent-to-treat analyses showed significant between-group differences favouring active treatment on self - and observer - but not clinician-ADHD rating scales .


However , clinicians rated those receiving micronutrients as more improved than those on placebo both globally and on ADHD symptoms .


Post hoc analyses showed that for those with moderate/severe depression at baseline , there was a greater change in mood favouring active treatment over placebo .


There were no group differences in adverse events .


This study provides preliminary evidence of efficacy for micronutrients in the treatment of ADHD symptoms in adults , with a reassuring safety profile .


Patients with stable COPD show improvements in exercise capacity and muscular function after the application of whole body vibration .


We aimed to evaluate whether this modality added to conventional physiotherapy in exacerbated hospitalised COPD patients would be safe and would improve exercise capacity and quality of life .


49 hospitalised exacerbated COPD patients were randomized ( 1:1 ) to undergo physiotherapy alone or physiotherapy with the addition of whole body vibration .


The primary endpoint was the between-group difference of the 6-minute walking test ( day of discharge - day of admission ) .


Secondary assessments included chair rising test , quality of life , and serum marker analysis .


Whole body vibration did not cause procedure-related adverse events .


Compared to physiotherapy alone , it led to significantly stronger improvements in 6-minute walking test ( 95.55 76.29 m vs. 6.13 81.65 m ; p = 0.007 ) and St. Georges Respiratory Questionnaire ( -6.43 14.25 vs. 5.59 19.15 , p = 0.049 ) .


Whole body vibration increased the expression of the transcription factor peroxisome proliferator receptor gamma coactivator-1 - and serum levels of irisin , while it decreased serum interleukin-8 .


Whole body vibration during hospitalised exacerbations did not cause procedure-related adverse events and induced clinically significant benefits regarding exercise capacity and health-related quality of life that were associated with increased serum levels of irisin , a marker of muscle activity .


German Clinical Trials Register DRKS00005979 .


Registered 17 March 2014 .


The purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders .


In this 6 month ( 26 week ) open-label extension ( OLE ) study , patients ( 5-17 years of age , who completed the previous fixed-dose , 6 week , double-blind [ DB ] phase ) were flexibly dosed with risperidone based on body weight .


The maximum allowed dose was 1.25 mg/day for those weighing 20 to < 45 kg , and 1.75 mg/day for those weighing 45 kg .


The study primarily assessed risperidone 's safety ; efficacy was assessed as a secondary end-point .


Fifty-six ( 71 % ) out of 79 enrolled patients completed the OLE ; the most common discontinuations were for insufficient response ( 7 [ 9 % ] ) or adverse events ( AE ) ( 5 [ 6 % ] ) .


The most common ( 5 % frequency in the total group ) AEs were increased appetite ( 11 % [ n = 9 ] ) ; increased weight and vomiting ( 9 % [ n = 7 ] each ) ; sedation , pyrexia , and upper respiratory tract infection ( 8 % [ n = 6 ] each ) ; nasopharyngitis ( 6 % [ n = 5 ] ) ; and somnolence and fatigue ( 5 % [ n = 4 ] each ) .


Extrapyramidal AEs were reported in 6 ( 8 % ) patients .


Increase in mean weight ( 11-15 % ) and body mass index ( 5-10 % ) occurred ; one patient discontinued because of weight increase .


One potentially prolactin-related AE ( irregular menstruation ) was reported .


The risperidone high-dose group had the greatest mean improvement in sleep visual analog scale ( 24.6 ) .


All groups showed additional improvement in efficacy scale scores during the OLE .


During this OLE , safety findings with risperidone treatment ( maximum weight-based dose of 1.25 mg/day or 1.75 mg/day ) were consistent with those observed in the DB phase , and with the current safety information for risperidone in autistic , psychiatric , and behavioral disorders .


Patients experienced some additional improvement in irritability and related behaviors .


This phase-4 study is registered at ClinicalTrials.gov ( NCT00576732 ) .


For patients with acute iliofemoral deep vein thrombosis , it remains unclear whether the addition of intravascular high-frequency , low-power ultrasound energy facilitates the resolution of thrombosis during catheter-directed thrombolysis .


In a controlled clinical trial , 48 patients ( mean age 50 21 years , 52 % women ) with acute iliofemoral deep vein thrombosis were randomized to receive ultrasound-assisted catheter-directed thrombolysis ( N = 24 ) or conventional catheter-directed thrombolysis ( N = 24 ) .


Thrombolysis regimen ( 20 mg r-tPA over 15 hours ) was identical in all patients .


The primary efficacy end point was the percentage of thrombus load reduction from baseline to 15 hours according to the length-adjusted thrombus score , obtained from standardized venograms and evaluated by a core laboratory blinded to group assignment .


The percentage of thrombus load reduction was 55 % 27 % in the ultrasound-assisted catheter-directed thrombolysis group and 54 % 27 % in the conventional catheter-directed thrombolysis group ( P = 0.91 ) .


Adjunctive angioplasty and stenting was performed in 19 ( 80 % ) patients and in 20 ( 83 % ) patients , respectively ( P > 0.99 ) .


Treatment-related complications occurred in 3 ( 12 % ) and 2 ( 8 % ) patients , respectively ( P > 0.99 ) .


At 3-month follow-up , primary venous patency was 100 % in the ultrasound-assisted catheter-directed thrombolysis group and 96 % in the conventional catheter-directed thrombolysis group ( P = 0.33 ) , and there was no difference in the severity of the post-thrombotic syndrome ( mean Villalta score : 3.0 3.9 [ range 0-15 ] versus 1.9 1.9 [ range 0-7 ] ; P = 0.21 ) , respectively .


In this randomized controlled clinical trial of patients with acute iliofemoral deep vein thrombosis treated with a fixed-dose catheter thrombolysis regimen , the addition of intravascular ultrasound did not facilitate thrombus resolution .


http://www.clinicaltrials.gov .


Unique identifier : NCT01482273 .


To compare vaginoscopic hysteroscopic sterilization with traditional hysteroscopic approach for differences in pain , bilateral microinsert placement rates , and procedure time .


We performed a prospective , randomized , single-blinded study of hysteroscopic sterilization using the Essure System .


The study setting was an inner city ObGyn clinic .


Ninety patients were randomized to either vaginoscopy or traditional approach .


The traditional approach was speculum insertion , paracervical analgesia , and tenaculum .


All procedures were done with a 5 mm , 30 degree rigid hysteroscope .


Main outcome measures were pain scores ( 10-point visual analog scale ) , bilateral placement rates , and procedure times .


Vaginoscopy was successful in 42/45 patients ( 93 % ) .


There was no statistically significant difference in pain-scores for microinsert placement between the groups ( p = 0.71 ) .


First attempt , bilateral microinsert placement rate was 95 % ( 40/42 ) with vaginoscopy and 95 % ( 43/45 ) with traditional ( p = 0.89 ) .


Time for treatment completion was 16 minutes ( mean ) ( range , 13-21 ) in the traditional group versus vaginoscopy time of 9 minutes ( mean ) ( range , 7-11 ) ( p = 0.03 ) .


Hysteroscopic sterilization via vaginoscopy is feasible with bilateral microinsert rates comparable to those of traditional hysteroscopy .


Vaginoscopy is associated with less overall discomfort and is faster to perform .


To study sevoflurane inhalation general anesthesia using the laryngeal mask airway ( LMA ) and nasal endotracheal ( ET ) intubation to maintain the airway in pediatric day-case dental surgery .


A total of 171 children aged 2 to 7 years received elective day-case dental surgical procedure under general anesthesia .


Children were randomly grouped into LMA groups ( L ) and nasal ET intubation group ( N ) .


In L groups , LMA was inserted after induction of anesthesia using 8 % sevoflurane and were allowed to breathe spontaneously .


Rocuronium and remifentanil were given intravenously during 8 % sevoflurane induction by nasal ET intubation in the N group .


The time of anesthetic induction , maintenance , recovery , surgical access , and bispectral index score were recorded .


Postoperative nausea and vomiting and the incidence of adverse events during induction and recovery period were also recorded .


The insertion time of LMA was significantly shorter than nasal ET ( P < 0.05 ) .


The incidence of airway complications , the surgeons ' access , and bispectral index were not different between the 2 groups .


However , recovery time was significantly shorter in group L ( P < 0.05 ) .


The incidence of sore throat and postoperative nausea and vomiting ( P < 0.01 ) were much less in group L as well .


Sevoflurane inhalation anesthesia through LMA is a safe and reliable method for pediatric day-case dental surgery .


Keloids are a burden for patients due to physical , aesthetic and social complaints and treatment remains a challenge because of therapy resistance and high recurrence rates .


The main goal of treatment is to improve the quality of life ( QoL ) ; this implies that , apart from surgical outcomes , patient-reported outcome measures ( PROMs ) need to be taken into account .


Decision making in keloid treatment is difficult due to heterogeneity of the condition and the lack of comparative studies .


This is a multicentre , randomised controlled open trial that compares 1 ) intralesional cryotherapy versus excision and corticosteroids for primary keloids , and 2 ) intralesional cryotherapy versus excision and brachytherapy for therapy-resistant keloids .


The primary outcome is the Patient and Observer Scar Assessment Scale ( POSAS ) , a 12-item scale ( with score 12 indicating the best and 120 indicating the worst scar imaginable ) .


A difference of six points on the total score is considered to be of clinical importance .


Secondary outcomes are recurrence rates , volume reduction , Skindex-29 scores , SF-36 scores and complication rates .


Primary and secondary outcome measurements are taken at baseline , and at 2 , 12 , 26 and 52 weeks postoperatively .


For analysis , a linear mixed model is used .


A total of 176 patients will be included over a period of 2.5 years .


The protocol is approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam and follows good clinical practice guidelines .


The outcomes of this study will improve evidence-based decision making for the treatment of keloids , as well as patient education .


Dutch Trial Register NTR4151 .


The prevalence of depression is high and the elderly have an increased risk of developing chronic course .


International data suggest that depression in the elderly is under-recognised , the latency before clinicians provide a treatment plan is longer and elderly patients with depression are not offered psychotherapy to the same degree as younger patients .


Although recommendations for the treatment of elderly patients with depression exist , health-care professionals adhere to these recommendations to a limited degree only .


We conducted a systematic review to identify recommendations for managing depression in the elderly and prioritised six recommendations .


We identified and prioritised the determinants of practice related to the implementation of these recommendations in primary care , and subsequently discussed and prioritised interventions to address the identified determinants .


The objective of this study is to evaluate the effectiveness of these tailored interventions for the six recommendations for the management of elderly patients with depression in primary care .


We will conduct a pragmatic cluster randomised trial comparing the implementation of the six recommendations using tailored interventions with usual care .


We will randomise 80 municipalities into one of two groups : an intervention group , to which we will deliver tailored interventions to implement the six recommendations , and a control group , to which we will not deliver any intervention .


We will randomise municipalities rather than patients , individual clinicians or practices , because we will deliver the intervention for the first three recommendations at the municipal level and we want to minimise the risk of contamination across GP practices for the other three recommendations .


The primary outcome is the proportion of actions taken by GPs that are consistent with the recommendations .


This trial will investigate whether a tailored implementation approach is an effective strategy for improving collaborative care in the municipalities and health-care professionals ' practice towards elderly patients with depression in primary care .


The effectiveness evaluation described in this protocol will be accompanied with a process evaluation exploring why and how the interventions were effective or ineffective .


ClinicalTrials.gov : NCT01913236 .


The objective of this study was to use a randomized controlled trial design to test the impact of an educational intervention delivered by specially trained community health workers among Chinese , Korean , and Vietnamese participants ages 50 to 75 years on knowledge , attitudes , beliefs , and intentions regarding colorectal cancer screening .


Baseline data were collected on participants ' demographic characteristics , knowledge , attitudes , beliefs about cancer , its risk factors , and intention to keep up to date on cancer screening in the future .


Fifteen intervention sessions were held between April and June of 2011 .


Follow-up surveys were administered in the postintervention period to both intervention and control participants .


Those randomized to the control group received educational pamphlets in their native language .


The intervention had the greatest influence on the Chinese subgroup , which had improved scores relative to the control group for perceived behavior control and intentions ( preintervention vs postintervention change : control group , -0.16 ; intervention group , 0.11 ; P = .004 ) , behavioral beliefs on cancer screening ( preintervention vs postintervention change : control group , -0.06 ; intervention group , 0.24 ; P = .0001 ) , and attitudes toward behavior ( preintervention vs postintervention change : control group , -0.24 ; intervention group , 0.35 ; P .0001 ) .


The intervention had no effect on behavioral beliefs about cancer , control beliefs , or perceived behavioral control ( reliance on family ) .


Although the intention to stay up to date for cancer screening increased in 2 study groups ( Chinese and Vietnamese ) , these increases were not significant .


An educational program delivered by culturally specific community health educators using culturally appropriate language influences some knowledge , attitude , and behavioral beliefs but not others .


Dumping syndrome is characterized by distinct pathophysiological features such as postprandial increase in hematocrit ( HT ) and pulse rate ( PR ) and delayed hypoglycemia ( HG ) .


Treatment is based on dietary measures and somatostatin analogs ( SA ) , but current SAs have incomplete efficacy , possibly through limited affinity for various somatostatin receptor subtypes .


We evaluated the effect of pasireotide , a novel SA with high affinity for 4/5 human somatostatin receptors , on pathophysiological events and symptoms in dumping .


Randomized double-blind placebo-controlled cross-over study of nine patients ( six women , 474years ) with postoperative dumping .


Baseline measurements included oral glucose tolerance testing ( OGTT ) , abdominal ultrasound , and dumping symptom severity score ( DSSS ) .


Patients were treated for 2weeks with placebo or pasireotide 300g s.c. t.i.d. with a 1-week wash-out in a randomized fashion .


On day 13 and 14 of each treatment OGTT , DSSS , and solid and liquid gastric emptying ( GE ) were obtained .


Baseline OGTT was pathological in all patients based on PR ( n = 5 ) , HT ( n = 1 ) or HG ( n = 7 ) .


Compared to placebo , pasireotide suppressed the increase in PR ( 17.12.8 vs 8.23.5 bpm ; p < 0.05 ) and late HG ( nadir glycemia 55.64.3 vs 83.39.5 mg/dL ; p = 0.007 ) , increased peak glycemia ( 294.133.3 vs 221.023.1 mg/dL ; p = 0.001 ) and delayed GE of solids ( t1/2 8323 vs 439min ; p = 0.05 ) and liquids ( t1/2 7010 vs 404min , p = 0.05 ) .


The differences in DSSS did not reach statistical significance .


Two patients dropped out because of adverse gastrointestinal events under pasireotide .


Pasireotide affects pathophysiological features of both early and late dumping syndrome .


The aim of the present double-blind , randomized , controlled study was to evaluate and compare the efficacy of amnion allograft and connective tissue graft in covering denuded root surfaces .


Seventy-one teeth in 22 patients with gingival recession were treated randomly with coronally displaced flap plus connective tissue graft ( control group , n = 29 recessions in 10 patients ) or coronally displaced flap plus amnion allograft ( test group , n = 42 recessions in 12 patients ) .


The amount of root coverage and clinical parameters ( probing depth , recession depth , clinical attachment level , recession width , gingival width , and papilla dimensions ) were measured at baseline and at 3 and 6 months postoperatively .


Average root coverage percentages after 6 months in the test and control groups were 67 % ( 2.3 + / - 0.289 mm ) and 54 % ( 2.24 + / - 0.519 mm ) , respectively , with no statistically significant differences ( p = 0.054 ) .


The changes in depth and width of recessions and in gingival width were significant 3 and 6 months after surgery compared to baseline ( p = 0.000 ) .


Variations in the level of attachment and probing depths after 6 months were statistically significant in the test group compared to the control group ( p = 0.002 ) .


Papilla dimensions were significantly correlated with root coverage ( p = 0.00 ) .


Amnion allograft might be a suitable alternative to connective tissue graft in procedures to cover denuded root surfaces and can reduce recession depth .


Based on the growing evidence of risk reduction from fresh fruit and vegetable consumption and an inverse relationship between serum 25-hydroxyvitamin D ( 25OHD ) and the risk of type 2 diabetes ( T2D ) , we determined the benefits of regularly consuming vitamin D-enriched mushrooms in a prediabetic cohort .


Exposing edible mushrooms to ultraviolet B ( UVB ) light increases vitamin D2 ( D2 ) and raises serum 25OHD2 in healthy young adults ; however , their benefit to deficient prediabetics and glucose metabolism remains untested .


Forty-three prediabetic , D-deficient adults ( 25OHD20ng/ml ) , BMI > 25 were randomized to four groups consuming daily entres containing 100g fresh sliced cooked mushrooms prepared by a chef for 16 weeks .


Two groups were fed UVB-treated mushrooms initially containing : 600IU D2 or 4000IU D2 ; each one also received one capsule of placebo daily .


Two control groups were fed untreated mushrooms and D3 dietary supplements at two label doses : 600IU D3 and 4000IU D3 .


D2 and D3 content were analyzed in mushrooms , before and after cooking and in over-the-counter supplements .


After 16 weeks , both D2-UVB-mushroom entre doses , which were significantly lower after cooking , produced modest or no increases in 25OHD2 or total 25OHD relative to the positive control subjects who actually consumed about 1242 and 7320IU per day of D3 ( higher than stated on the label ) .


Unanticipated D2 cooking loss from fresh UVB mushrooms and probable low absorption and/or hydroxylation may explain the smaller increase in 25OHD2 in our prediabetic overweight/obese cohort compared with past findings in younger , healthy subjects .


Moreover , no dose or vitamin D source was associated with modifying T2D risk factors .


To investigate the relationship between breastfeeding and snoring in childhood .


In a cohort of children with a family history of asthma who were recruited antenatally we prospectively recorded data on infant feeding practices throughout the first year of life .


Snoring status and witnessed sleep apnea were measured at age 8 years by parent-completed questionnaire .


Associations were estimated by logistic regression with , and without , adjustment for sets of confounders designed to exclude biasing effects .


Habitual snoring was reported in 18.8 % of the sample , and witnessed apnea in 2.7 % .


Any breastfeeding for longer than one month was associated with a reduced risk of habitual snoring at age 8 ( adjusted OR 0.48 , 95 % CI 0.29 to 0.81 ) and duration of breastfeeding was inversely associated with the prevalence of habitual snoring ( adjusted OR 0.79 , 95 % CI 0.62 to 1.00 ) .


Any breastfeeding for longer than 1 month was associated with a lower risk of witnessed sleep apnea ( adjusted OR 0.17 , 95 % CI 0.04 to 0.71 ) .


The protective associations were not mediated by BMI , current asthma , atopy or rhinitis at age 8 years .


Breastfeeding for longer than one month decreases the risk of habitual snoring and witnessed apneas in this cohort of children with a family history of asthma .


The underlying mechanism remains unclear but the finding would be consistent with a beneficial effect of the breast in the mouth on oropharyngeal development with consequent protection against upper airway dysfunction causing sleep-disordered breathing .


The purpose of this study was to assess accuracy of lung nodule volumetry in low-dose CT with application of iterative reconstruction ( IR ) according to nodule size , nodule density and CT tube currents , using artificial lung nodules within an anthropomorphic thoracic phantom .


Eight artificial nodules ( four diameters : 5 , 8 , 10 and 12 mm ; two CT densities : -630 HU that represents ground-glass nodule and +100 HU that represents solid nodule ) were randomly placed inside a thoracic phantom .


Scans were performed with tube current-time product to 10 , 20 , 30 and 50 mAs .


Images were reconstructed with IR and filtered back projection ( FBP ) .


We compared volume estimates to a reference standard and calculated the absolute percentage error ( APE ) .


The APE of all nodules was significantly lower when IR was used than with FBP ( 7.5 4.7 % compared with 9.0 6.9 % ; p < 0.001 ) .


The effect of IR was more pronounced for smaller nodules ( p < 0.001 ) .


IR showed a significantly lower APE than FBP in ground-glass nodules ( p < 0.0001 ) , and the difference was more pronounced at the lowest tube current ( 11.8 5.9 % compared with 21.3 6.1 % ; p < 0.0001 ) .


The effect of IR was most pronounced for ground-glass nodules in the lowest CT tube current .


Lung nodule volumetry in low-dose CT by application of IR showed reliable accuracy in a phantom study .


Lung nodule volumetry can be reliably applicable to all lung nodules including small , ground-glass nodules even in ultra-low-dose CT with application of IR .


IR significantly improved the accuracy of lung nodule volumetry compared with FBP particularly for ground-glass ( -630 HU ) nodules .


Volumetry in low-dose CT can be utilized in patient with lung nodule work-up , and IR has benefit for small , ground-glass lung nodules in low-dose CT. .


To evaluate the anatomical and functional efficacy of combination therapy of intravitreal ranibizumab with laser or intravitreal bevacizumab with laser treatment compared to only laser treatment for macular edema due to branch retinal vein occlusion ( BRVO ) .


Thirty eyes of 30 patients with BRVO of at least 6 weeks duration were randomized into three groups : Group 1 received a single dose of intravitreal Ranibizumab followed by grid laser treatment , Group 2 received a single dose of intravitreal Bevacizumab followed by grid laser treatment , and Group 3 received grid laser alone .


Outcomes at 6 months follow-up were reported .


Data were collected on best corrected visual acuity ( BCVA ) , central foveal thickness ( CFT ) , and gain in lines of Snellen acuity .


At 6 month follow-up , the difference in the mean BCVA and CFT between the three treatment groups was not statistically significant ( P > 0.05 , all comparisons ) .


Six eyes ( 60 % ) in Group 1 , four eyes ( 40 % ) in Group 2 and two eyes ( 20 % ) in Group 3 had a statistically significant gain of 3 lines of Snellen acuity ( P < 0.05 ) .


Both ranibizumab and bevacizumab combined with laser photocoagulation , resulted in better outcomes than grid laser treatment .


Tubeless percutaneous nephrolithotoomy ( PCNL ) , although an accepted technique by now , continues to suffer from two major limitations : The need for postoperative cystoscopy for ureteral stent removal and inability to perform a `` second-look '' procedure for any residual fragments .


We share our experience with a modification of the standard tubeless PCNL technique that allows us to overcome these shortcomings .


A total of 166 patients selected to have PCNL were randomized into two groups of 83 each .


In group A ( control group ) , the patients underwent standard PCNL with the insertion of a nephrostomy tube at completion ; in group B ( intervention group ) , modified tubeless PCNL was performed with a Double-J ( DJ ) stent inserted with a tether attached to its proximal end , taken out through the percutaneous tract .


The nephrostomy tube in group A was removed postoperatively on the second or third day , whereas those in group B had the stent removed directly by pulling the attached tether within the office setting 10 to 14 days postoperatively .


The need for postoperative analgesia was significantly higher in group A compared with group B ( mean dose of tramadol needed , 128 mg vs 81.3 mg ) ( P < 0.001 ) .


Four patients in group A had postoperative urinary leakage from the nephrostomy site , whereas there were no leaks in patients in group B. Group B patients spent significantly shorter average time in hospital ( 21.6 hours ) compared with group A ( 54 hours ) ( P < 0.001 ) .


Two of the patients in group B needed a second-look procedure , performed by the insertion of a guidewire down the stent , which was pulled out partially by its tether .


Presence of the tether in the flank or the process of subsequent removal did not cause any discomfort to any patient .


The present study demonstrates that tubeless PCNL with a tethered DJ stent overcomes its main drawback , namely , the need for cystoscopy for stent removal , and also allows access to the pelvicaliceal system for second-look nephroscopy .


The Y-75 ( Ginsan ) acidic polysaccharide from Korean Panax ginseng has been shown to function as an immunomodulatory molecule .


However , the efficacy of Y-75 has not been evaluated in clinical trial .


We verified Y-75 ( 6 g/day ) for safety and immune efficacy in 72 healthy volunteers aged 50-75 years using a randomized , placebo-controlled , parallel , double-blind study .


The activities of natural killer ( NK ) cells and peripheral blood phagocytes , as well as serum levels of monocyte-derived mediators , were assessed before and after administration for 8 and 14 weeks .


This trial is registered at ClinicalTrials.gov ( NCT02161198 ) .


Y-75 significantly enhanced NK cell cytotoxic activity by 35.2 % and 40.2 % from baseline after administration for 8 and 14 weeks , respectively .


The phagocytic activity of peripheral blood cells was also significantly increased by 25.2 % and 39.4 % and serum level of TNF - by 38.2 % and 44.5 % after treatment for 8 and 14 weeks , respectively .


Differences in the efficacy of variables compared to the placebo group were also significant .


Administration of Y-75 was well tolerated without treatment-related adverse events or alteration of complete blood cell count or blood chemistry over the entire study period .


Y-75 was shown to be a safe and potentially effective natural alternative for enhancing immune function .


To evaluate the chronic effects of a static stretching program on the muscle architecture of biceps femoris ( BF ) and vastus lateralis ( VL ) muscles in ultrasound ( US ) images .


Randomized controlled longitudinal trial .


Biomechanics Laboratory of Physical Education School of the Army , Rio de Janeiro , Brazil .


The study included 24 healthy and physically active male volunteers ( 19.05 1.40 years , 1.73 0.07 m , and 73.15 8.33 kg ) , randomly allocated to 1 of 2 groups : stretching group ( SG , n = 12 ) and control group ( n = 12 ) .


The SG was submitted to 3 sets of 30 seconds of static stretching 3 times a week during 8 weeks .


Ultrasound equipment ( 7.5 MHz ) was used for the evaluation of BF and VL muscle architecture variables ( pennation angle , fiber length , muscle thickness , and fascicle displacement ) before and after training .


Knee range of motion ( ROM ) and isometric flexion and extension torque ( TQ ) were also measured .


There were no significant changes in muscle architecture , TQ , and maximum knee flexion angle ( P > 0.05 ) .


However , maximum knee extension angle ( MEA ) increased significantly in the SG ( pretraining : 159.37 7.27 degrees and posttraining : 168.9 3.7 degrees ; P < 0.05 ) .


Volume or intensity ( or both ) of the stretching protocol was insufficient to cause structural changes in the VL and BF muscles .


The increase in MEA could not be explained by muscle architecture changes .


To describe changes in the VL and BF muscle tendon unit using US after a long-term stretching program to identify which structures are responsible for ROM increase .


To evaluate the influence of low-dose , enteric-coated aspirin tablets ( 100mg/day for 2years ) on colorectal tumour recurrence in Asian patients with single/multiple colorectal tumours excised by endoscopy .


A double-blinded , randomised , placebo-controlled multicentre clinical trial was conducted .


311 subjects with single/multiple colorectal adenomas and adenocarcinomas excised by endoscopy were enrolled in the study ( 152 patients in the aspirin group and 159 patients in the placebo group ) .


Enrolment began at the hospitals ( n = 19 ) in 2007 and was completed in 2009 .


The subjects treated with aspirin displayed reduced colorectal tumourigenesis and primary endpoints with an adjusted OR of 0.60 ( 95 % CI 0.36 to 0.98 ) compared with the subjects in the placebo group .


Subgroup analysis revealed that subjects who were non-smokers , defined as those who had smoked in the past or who had never smoked , had a marked reduction in the number of recurrent tumours in the aspirin-treated group .


The adjusted OR for aspirin treatment in non-smokers was 0.37 ( CI 0.21 to 0.68 , p < 0.05 ) .


Interestingly , the use of aspirin in smokers resulted in an increased risk , with an OR of 3.44 .


In addition , no severe adverse effects were observed in either group .


Low-dose , enteric-coated aspirin tablets reduced colorectal tumour recurrence in an Asian population .


The results are consistent with those obtained from other randomised controlled trials in Western countries .


THE CLINICAL TRIAL REGISTRY WEBSITE AND THE CLINICAL TRIAL NUMBER : http://www.umin.ac.jp ( number UMIN000000697 ) .


Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis .


It has a major impact on the psychological wellbeing of patients and their partners .


Recently , it has been shown that Mindfulness-Based Stress Reduction ( MBSR ) is effective in reducing anxiety and depressive symptoms in cancer patients .


The generalization of these results is limited since most participants were female patients with breast cancer .


Moreover , only one study examined the effectiveness of MBSR in partners of cancer patients .


Therefore , in the present trial we study the effectiveness of MBSR versus treatment as usual ( TAU ) in patients with lung cancer and their partners .


A parallel group , randomized controlled trial is conducted to compare MBSR with TAU .


Lung cancer patients who have received or are still under treatment , and their partners are recruited .


Assessments will take place at baseline , post intervention and at three-month follow-up .


The primary outcome is psychological distress ( i.e. anxiety and depressive symptoms ) .


Secondary outcomes are quality of life ( only for patients ) , caregiver appraisal ( only for partners ) , relationship quality and spirituality .


In addition , cost-effectiveness ratio ( only in patients ) and several process variables are assessed .


This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners .


Photodynamic therapy ( PDT ) is approved for selected nodular basal cell carcinomas ( nBCC ) but efficacy is reduced for large and thick tumours .


Ablative fractional lasers ( AFXL ) facilitate uptake of methyl aminolaevulinate ( MAL ) and may thus improve PDT outcome .


To evaluate efficacy and safety of AFXL-mediated PDT ( AFXL-PDT ) compared with conventional PDT of high-risk nBCC .


Patients with histologically verified facial nBCC ( n = 32 ) defined as high-risk tumours were included ; diameter > 15mm , tumours located in high-risk zones , or on severely sun-damaged skin .


Tumours were debulked and patients randomized to either AFXL-PDT ( n = 16 ) or PDT ( n = 16 ) .


Fractional CO2 laser treatment was applied at 5 % density and 1000m ( 80mJ ) ablation depth .


MAL was applied under occlusion for 3h and illuminated with a 633-nm light-emitting diode source , 37Jcm ( -2 ) .


Clinical assessments were performed at 3 , 6 , 9 and 12months and biopsies were taken at 12months .


Clinical cure rates at 3months were 100 % ( 16 of 16 AFXL-PDT ) and 88 % ( 14 of 16 PDT , P = 0484 ) .


Recurrences tended to occur later and in lower numbers after AFXL-PDT at 6 , 9 and 12months ( 6 % , 19 % , 19 % ) than PDT ( 25 % , 38 % , 44 % ) ( P = 0114 ) .


Histology at 12months documented equal tumour clearance after AFXL-PDT ( 63 % , 10 of 16 ) and PDT ( 56 % , 9 of 16 ) .


Cosmetic outcomes were highly satisfactory after both treatments ( P > 0090 ) .


Long-term efficacy was similar after PDT and AFXL-PDT with a trend for a favourable short-term cure rate after AFXL-PDT .


AFXL-PDT needs further refinement for nBCC and at present is not recommended over PDT .


To examine the effects of activity-based therapy ( ABT ) on neurologic function , walking ability , functional independence , metabolic health , and community participation .


Randomized controlled trial with delayed treatment design .


Outpatient program in a private , nonprofit rehabilitation hospital .


Volunteer sample of adults ( N = 48 ; 37 men and 11 women ; age , 18-66y ) with chronic ( 12mo postinjury ) , motor-incomplete ( ASIA Impairment Scale grade C or D ) spinal cord injury ( SCI ) .


A total of 9h/wk of ABT for 24 weeks including developmental sequencing ; resistance training ; repetitive , patterned motor activity ; and task-specific locomotor training .


Algorithms were used to guide group allocation , functional electrical stimulation utilization , and locomotor training progression .


Neurologic function ( International Standards for Neurological Classification of Spinal Cord Injury ) ; walking speed and endurance ( 10-meter walk test , 6-minute walk test , and Timed Up and Go test ) ; community participation ( Spinal Cord Independence Measure , version III , and Reintegration to Normal Living Index ) ; and metabolic function ( weight , body mass index , and Quantitative Insulin Sensitivity Check ) .


Significant improvements in neurologic function were noted for experimental versus control groups ( International Standards for Neurological Classification of Spinal Cord Injury total motor score [ 5.16.3 vs 0.95.0 ; P = .024 ] and lower extremity motor score [ 4.25.2 vs -0.64.2 ; P = .004 ] ) .


Significant differences between experimental and control groups were observed for 10-meter walk test speed ( 0.0960.14 m/s vs 0.0270.10 m/s ; P = .036 ) and 6-minute walk test total distance ( 35.9748.2 m vs 3.025.5 m ; P = .002 ) .


ABT has the potential to promote neurologic recovery and enhance walking ability in individuals with chronic , motor-incomplete SCI .


However , further analysis is needed to determine for whom ABT is going to lead to meaningful clinical benefits .


Patients with recurrent and/or metastatic ( R/M ) head and neck squamous cell carcinoma ( HNSCC ) receiving platinum-based chemotherapy as their first-line treatment have a dismal prognosis , with a median overall survival ( OS ) of ~ 7 months .


Methotrexate is sometimes used following platinum failure or in patients not fit enough for platinum therapy , but this agent has not demonstrated any OS improvement .


Targeted therapies are a novel approach , with the EGFR-targeting monoclonal antibody cetuximab ( plus platinum-based chemotherapy ) approved in the US and Europe in the first-line R/M setting , and as monotherapy following platinum failure in the US .


However , there is still a high unmet medical need for new treatments that improve outcomes in the second-line R/M setting following failure on first-line platinum-containing regimens .


Afatinib , an irreversible ErbB family blocker , was recently approved for the first-line treatment of EGFR mutation-positive metastatic non-small cell lung cancer .


Afatinib has also shown clinical activity similar to cetuximab in a Phase II proof-of-concept HNSCC trial .


Based on these observations , the Phase III , LUX-Head & Neck 1 study is evaluating afatinib versus methotrexate in R/M HNSCC patients following progression on platinum-based chemotherapy in the R/M setting .


Patients with progressive disease after one first-line platinum-based chemotherapy are randomised 2:1 to oral afatinib ( starting dose 40 mg once daily ) or IV methotrexate ( starting dose 40 mg/m ( 2 ) once weekly ) administered as monotherapy with best supportive care until progression or intolerable adverse events .


Efficacy of afatinib versus methotrexate will be assessed in terms of progression-free survival ( primary endpoint ) .


Disease progression will be evaluated according to RECIST v1 .1 by investigator and independent central review .


Secondary endpoints include OS , tumour response and safety .


Health-related quality of life and biomarker assessments will also be performed .


If the LUX-Head & Neck 1 trial meets its primary endpoint , it will demonstrate the ability of afatinib to elicit an improved treatment benefit versus a commonly used chemotherapy agent in the second-line treatment of R/M HNSCC patients who have failed on first-line platinum-based therapy , confirm the clinical efficacy of afatinib observed in the Phase II proof-of-concept study , and establish a new standard of care for this patient population .


The present randomized controlled trial evaluated the impact of different exercise training modalities on functional fitness responses in apparently healthy older men .


A total of 59 community-dwelling older men were randomly assigned to an aerobic training group ( ATG , n = 19 ) , a combined aerobic and resistance training group ( CTG , n = 20 ) or a control group ( n = 20 ) .


Both exercise training programs were moderate-to-vigorous intensity , 3 days/week for 9 months .


Six independent functional fitness tests ( back scratch , chair sit-and-reach , 30-s chair stand , arm curl , 8-ft up-and-go , 6-min walk ) were measured on five different occasions .


The data were analyzed using a mixed-model ANOVA .


ANOVA showed a significant main effect of group ( P < 0.001 ) for all functional fitness tests , with significant differences between both training groups and controls .


However , the ATG only improved the chair sit-and-reach and the 30-s chair stand performance , whereas CTG improved in all functional fitness tests .


ANOVA also identified a significant main effect of time for 8-ft up-and-go ( P = 0.031 ) in the CTG .


Only the combined exercise program was effective in improving all functional fitness components related to daily living activities .


Luseogliflozin is a selective sodium glucose cotransporter 2 inhibitor under development for the treatment of type 2 diabetes mellitus ( T2DM ) .


This phase II study was conducted to confirm the efficacy and safety of luseogliflozin monotherapy at doses of up to 10mg in Japanese patients with T2DM .


Patients with hemoglobin A1c ( HbA1c ) of 6.9-10 .5 % on diet therapy were randomized in a double-blind manner to treatment with 1 , 2.5 , 5 , or 10mg luseogliflozin or placebo for 12 weeks ( n = 56 , 56 , 54 , 58 , and 58 , respectively ) .


Japan Pharmaceutical Information Center ( identifier : Japic CTI-101191 ) .


The primary endpoint was the change in HbA1c from baseline to the end of treatment .


Other endpoints included fasting plasma glucose ( FPG ) , postprandial plasma glucose ( PPG ) and body weight .


Adverse events were recorded throughout the study .


HbA1c decreased significantly at the end of treatment in the 1 , 2.5 , 5 , and 10mg luseogliflozin groups compared with placebo ( -0.29 , -0.39 , -0.46 , and -0.43 % , respectively , versus +0.22 % ; all P < 0.001 ) , as did FPG and PPG ( all P < 0.001 ) .


Body weight also decreased significantly in all luseogliflozin groups compared with placebo ( all P < 0.001 ) .


The incidence rates of adverse events ( 40.0-50 .0 % ) were not significantly different among the five groups .


The overall incidence of hypoglycemia was low .


Limitations of this study include the short study duration and the relatively small sample size .


In Japanese patients with T2DM , luseogliflozin was well tolerated , improved glycemic control , and reduced body weight over 12 weeks of treatment at all tested doses .


Doses of 2.5 mg achieved similar improvements in glycemic control .


The Individual Placement and Support ( IPS ) approach is an evidence-based form of supported employment for people with severe and persistent mental illness .


This approach is not yet widely available in Australia even though there is mounting evidence of its generalisability outside the USA .


One previous Australian randomised controlled trial found that IPS is effective for young people with first episode psychosis .


The aim of the current trial was to assess the effectiveness of evidence-based supported employment when implemented for Australian adult consumers of public mental health services by utilising existing service systems .


A four-site randomised control trial design ( n = 208 ) was conducted in Brisbane ( two sites ) , Townsville and Cairns .


The intervention consisted of an IPS supported employment service hosted by a community mental health team .


The control condition was delivered at each site by mental health teams referring consumers to other disability employment services in the local area .


At 12 months , those in the IPS condition had 2.4 times greater odds of commencing employment than those in the control condition ( 42.5 % vs. 23.5 % ) .


The conditions did not differ on secondary employment outcomes including job duration , hours worked , or job diversity .


Attrition was higher than expected in both conditions with 28.4 % completing the baseline interview but taking no further part in the study .


The results support previous international findings that IPS-supported employment is more effective than non-integrated supported employment .


IPS can be successfully implemented this way in Australia , but with a loss of effect strength compared to previous USA trials .


Compared to eccentric contractions , concentric contractions result in higher cardiovascular stress .


However , we do not know how these two types of contractions influence cardiac autonomic modulation during the post-exercise recovery period .


to compare the effect of resistance training that is performed with concentric vs. eccentric emphasis on muscle strength and on post-exercise recovery which was assessed by examining heart rate variability ( HRV ) , for the knee extensor muscle group in young healthy adults .


For this study , 105 men between 18 and 30 years of age were randomized into 4 groups : concentric control ( CONCC ) , eccentric control ( ECCC ) , concentric training ( CONCT ) and eccentric training ( ECCT ) .


The CONCC and ECCC groups underwent one session of resistance exercise ( RE ) using the knee extensor muscle group ( 3 sets of 1 repetition at 100 % of the maximal repetition [ 1MR ] ) and the CONCT and ECCT groups performed 10 training sessions .


The HRV was analyzed at baseline and across four recovery periods ( T1 , T2 , T3 and T4 ) .


The ECCT group exhibited increased muscle strength at the end of the study .


Regarding cardiac autonomic modulation , the CONCC and ECCC groups exhibited increases in overall variability ( SDNN and SD2 ) at T1 compared to baseline , and the ECCT group demonstrated increases in variables reflecting vagal modulation and the recovery process ( RMSSD , SD1 and HF [ ms2 ] ) at T1 , T2 and T4 compared to baseline .


Resistance training with emphasis on eccentric contractions promoted strength gain and an increase in cardiac vagal modulation during recovery compared to baseline .


The objective of this study is to examine the independent associations of time spent in moderate-to-vigorous physical activity ( MVPA ) and sedentary ( SED-time ) , with total and abdominal body fat ( BF ) , and the bidirectionality of these associations in adults at high risk of type 2 diabetes .


We measured MVPA ( min per day ) and SED-time ( h per day ) by accelerometry , and indices of total ( body weight , fat mass ( FM ) , BF % and FM index ) and abdominal BF ( waist circumference ( WC ) ) using standard procedures in 231 adults ( 41.3 6.4 years ) with parental history of type 2 diabetes ( ProActive UK ) at baseline , 1-year and 7-year follow-up .


Mixed effects models were used to quantify the independent associations ( expressed as standardised - coefficients ( 95 % confidence interval ( CI ) ) ) of MVPA and SED-time with fat indices , using data from all three time points .


All models were adjusted for age , sex , intervention arm , monitor wear time , follow-up time , smoking status , socioeconomic status and MVPA/SED-time .


MVPA was inversely and independently associated with all indices of total BF ( for example , 1 s.d. higher MVPA was associated with a reduction in FM , = -0.09 ( 95 % CI : -0.14 , -0.04 ) s.d. ) and abdominal BF ( for example , WC : = -0.07 ( -0.12 , -0.02 ) ) .


Similarly , higher fat indices were independently associated with a reduction in MVPA ( for example , WC : = -0.25 ( -0.36 , -0.15 ) ; FM : = -0.27 ( -0.36 , -0.18 ) ) .


SED-time was positively and independently associated with most fat indices ( for example , WC : = 0.03 ( -0.04 , 0.09 ) ; FM : = 0.10 ( 0.03 , 0.17 ) ) .


Higher values of all fat indices independently predicted longer SED-time ( for example , WC : = 0.10 ( 0.02 , 0.18 ) , FM : = 0.15 ( 0.07 , 0.22 ) ) .


The associations of MVPA and SED-time with total and abdominal BF are bidirectional and independent among individuals at high risk for type 2 diabetes .


The association between BF and MVPA is stronger than the reciprocal association , highlighting the importance of considering BF as a determinant of decreasing activity and a potential consequence .


Promoting more MVPA and less SED-time may reduce total and abdominal BF .


The objective of the study was to investigate the efficacy and safety of hexaminolevulinate ( HAL ) photodynamic therapy ( PDT ) , a novel therapy for women with cervical intraepithelial neoplasia ( CIN ) 1/2 , to define the appropriate population and endpoints for a phase 3 program .


This was a double-blind , randomized , placebo-controlled , dose-finding study that included a total of 262 women with biopsy-confirmed CIN 1/2 based on local pathology .


Patients received 1 or 2 topical treatments of HAL hydrochloride 0.2 % , 1 % , 5 % , and placebo ointment and were evaluated for response after 3-6 months based on biopsy , Papanicolaou test , and oncogenic human papillomavirus ( HPV ) test .


All efficacy analyses were performed on blinded central histology review to avoid interreader variability .


Adverse events , blood biochemistry , and vital signs were assessed after 3 months .


There were no statistically significant differences between placebo and either the CIN 1 or combined CIN 1/2 populations .


A cleardose effect with a statistically significant response in theHAL5 % group of 95 % ( 18/19 patients ) compared to 57 % ( 12/21 patients ) in the placebo group ( P < .001 ) was observed at 3months in women with CIN 2 , including an encouraging 83 % ( 5/6 patients ) clearance of HPV 16/18 compared to 33 % ( 2/6 patients ) in the placebo group at 6 months .


The treatment was easy to use and well accepted by patients and gynecologists .


Only local self-limiting adverse reactions including discharge , discomfort , and spotting were reported .


HAL PDT is a novel therapy that shows promise in the treatment of CIN 2 including clearance of oncogenic HPV , but not of CIN 1 .


The positive risk/benefit balance makes HAL PDT a tissue-preserving alternative in women of childbearing age who wish to preserve the cervix .


Confirmatory studies are planned .


Airway management and endotracheal intubation are essential skills for pediatric residents .


Simulation-based technology is used for training residents but it remains unclear whether high fidelity simulation results in better retention of skills compared to low fidelity .


The study assesses high fidelity simulation of endotracheal intubation and traditional low fidelity training in improving pediatric residents ' knowledge retention and technical skills ; and if the difference translates into higher `` real time '' intubation success rates .


Second and third year pediatric residents were randomized into high fidelity ( intervention ) or low fidelity simulation ( control ) groups .


Airway management and intubation skills were taught using a didactic lecture and demonstration on low fidelity mannequins .


Knowledge was assessed before randomization ( T0 ) and 6 months after training ( T6 ) .


Other outcome measures were : 1 ) airway management and intubation skills at T6 and T12 ( 12 months later ) and 2 ) successful intubation of actual patients by T12 .


10 out of 11 residents completed the intervention .


Theoretical knowledge improved for both groups .


Participants made less mistakes ( M ) overtime : M ( T0 ) = 3.2 and M ( T6 ) = 2.6 for the intervention group , and M ( T0 ) = 4 and M ( T6 ) = 2.40 for the control .


There was no significant effect of fidelity on intubation skills or the number of successful intubations recorded in logbooks ( allp > 0.05 ) .


In some instances intubation skills showed regression over time .


High fidelity simulation showed no impact on residents ' airway management and intubation skills .


Retention of theoretical knowledge persisted over time while practical skills remained at baseline or declined .


Endoscopic submucosal dissection ( ESD ) is a technically difficult and lengthy procedure requiring optimal depth of sedation .


The bispectral index ( BIS ) monitor is a non-invasive tool that objectively evaluates the depth of sedation .


The purpose of this prospective randomized controlled trial was to evaluate whether BIS guided sedation with propofol and remifentanil could reduce the number of patients requiring rescue propofol , and thus reduce the incidence of sedation - and/or procedure-related complications .


A total of 180 patients who underwent the ESD procedure for gastric adenoma or early gastric cancer were randomized to two groups .


The control group ( n = 90 ) was monitored by the Modified Observer 's Assessment of Alertness and Sedation scale and the BIS group ( n = 90 ) was monitored using BIS .


The total doses of propofol and remifentanil , the need for rescue propofol , and the rates of complications were recorded .


The number of patients who needed rescue propofol during the procedure was significantly higher in the control group than the BIS group ( 47.8 % vs. 30.0 % , p = 0.014 ) .


There were no significant differences in the incidence of sedation - and/or procedure-related complications .


BIS-guided propofol infusion combined with remifentanil reduced the number of patients requiring rescue propofol in ESD procedures .


However , this finding did not lead to clinical benefits and thus BIS monitoring is of limited use during anesthesiologist-directed sedation .


The critical nursing shortage is particularly apparent in specialty areas such as intensive care units ( ICUs ) .


Some nurses develop resilient coping strategies and adapt to stressful work experiences , mitigating the development of common maladaptive psychological symptoms .


To determine if a multimodal resilience training program for ICU nurses was feasible to perform and acceptable to the study participants .


In a randomized and controlled 12-week intervention study , treatment and control groups completed demographic questions and measures of resilience , anxiety , depression , posttraumatic stress disorder ( PTSD ) , and burnout syndrome before and after the intervention .


The intervention included a 2-day educational workshop , written exposure sessions , event-triggered counseling sessions , mindfulness-based stress reduction exercises , and a protocolized aerobic exercise regimen .


Nurses in the intervention arm also completed satisfaction surveys for each component of the intervention .


This mulitmodal resilience training program was feasible to conduct and acceptable to ICU nurses .


Both nurses randomized to the treatment group and nurses randomized to the control group showed a significant decrease in PTSD symptom score after the intervention .


A multifaceted resilience training program for ICU nurses was both feasible and acceptable .


A sufficiently powered , randomized clinical trial is needed to assess the effect of the intervention on improving individuals ' level of resilience and improving psychological outcomes such as symptoms of anxiety , depression , burnout syndrome , and PTSD .


Depression is common among dialysis patients and is associated with adverse outcomes .


Problem-solving therapy ( PST ) is effective for treating depression in older patients with chronic illness , but its effectiveness has never been reported in hemodialysis ( HD ) patients .


We investigated the feasibility and satisfaction of PST and its impact on depression scores among older HD patients .


Patients at least 60 years of age receiving maintenance HD at a single outpatient dialysis center were eligible for the study .


Randomized patients received either 6 weeks of PST from a licensed renal social worker or usual care .


This study modeled the staff-patient ratio standard of most dialysis clinics , and therefore only one social worker provided the interventions .


Study outcomes included feasibility ( successful completion of 6 weekly sessions ) and patient satisfaction with PST as well as impact on depression scores ( between-group comparison of mean Beck depression inventory ( BDI ) and Patient health questionnaire-9 ( PHQ-9 ) scores at 6 weeks , and of mean change-from-baseline scores ) .


The recruitment rate was 92 % ( 35/38 ) .


All subjects randomized to the intervention arm ( n = 17 ) and who initiated PST ( n = 15 ) completed the study , and all reported overall satisfaction with the intervention .


87 % reported that PST helped them to better solve problems and improved their ability to cope with their medical condition .


At 6 weeks , there were no significant differences in mean BDI and PHQ scores between the usual care and the intervention group ( BDI 11.3 vs. 9.3 , p = 0.6 ; PHQ 5.7 vs. 3.3 , p = 0.1 ) .


Mean change-from-baseline depression scores were significantly improved in the intervention group relative to the control group ( change in BDI 6.3 vs. - 0.6 , p = 0.004 ; change in PHQ 7.2 vs. 0.3 , p < 0.001 ) .


The results demonstrate that PST is feasible in the dialysis unit setting , acceptable to patients , and may positively impact depression among maintenance hemodialysis patients .


To examine the amount of objectively measured MVPA and LPA that is associated with long-term weight loss and the maintenance of clinically significant weight loss .


Adults ( N = 260 ; BMI : 25 to < 40 kg/m ( 2 ) ; age : 18-55 years ) participated in an 18-month behavioral weight loss intervention and were prescribed a low-calorie diet and increased physical activity .


Change in weight and objectively measured physical activity were assessed .


MVPA > 10 ( MET-min/week ) was computed from bouts > 10 min and > 3.0 METs and MVPA < 10 was computed from bouts < 10 min in duration and > 3.0 METs .


LPA was computed from bouts between 1.5 to < 3.0 METs .


When grouped on percent weight loss at 18 months , there was a significant group time interaction effect ( P < 0.0001 ) for both MVPA > 10 and LPA , with both measures being significantly greater at 18 months in those with > 10 % weight loss .


Similar results were observed for MVPA > 10 and LPA with participants grouped on achieving > 10 % weight loss at 6 months and sustaining this at 18 months .


MVPA > 10 of 200-300 min per week , coupled with increased amounts of LPA , are associated with improved long-term weight loss .


Interventions should promote engagement in these amounts and types of physical activity .


Studies with platelet glycoprotein IIb/IIIa receptor inhibitors ( GPIs ) showed conflicting results in primary percutaneous coronary intervention ( PPCI ) patients who were pretreated with 600 mg clopidogrel .


We sought to investigate the short - and long-term efficacy and safety of the periprocedural administration of tirofiban in a largest Serbian PPCI centre .


We analysed 2995 consecutive PPCI patients enrolled in the Clinical Center of Serbia STEMI Register , between February 2007 and March 2012 .


All patients were pretreated with 600 mg clopidogrel and 300 mg aspirin .


Major adverse cardiovascular events , comprising all-cause death , nonfatal infarction , nonfatal stroke , and ischaemia-driven target vessel revascularization , was the primary efficacy end point .


TIMI major bleeding was the key safety end point .


Analyses drawn from the propensity-matched sample showed improved primary efficacy end point in the tirofiban group at 30-day ( OR 0.72 , 95 % CI 0.53-0 .97 ) and at 1-year ( OR 0.74 , 95 % CI 0.57-0 .96 ) follow up .


Moreover , tirofiban group had a significantly lower 30-day all-cause mortality ( secondary end point ; OR 0.63 , 95 % CI 0.40-0 .90 ) , compared with patients who were not administered tirofiban .


At 1 year , a trend towards a lower all-cause mortality was observed in the tirofiban group ( OR 0.74 , 95 % CI 0.53-1 .04 ) .


No differences were found with respect to the TIMI major bleeding during the follow-up period .


Tirofiban administered with PPCI , following 600 mg clopidogrel pretreatment , improved primary efficacy outcome at 30 days and at 1 year follow up without an increase in major bleeding .


Chronic transplant dysfunction ( CTD ) is the leading cause of long-term loss of the renal allograft .


So far , no single test is available to reliably predict the risk for CTD .


Monitoring of tryptophan ( trp ) metabolism through indoleamine 2.3-dioxygenase ( IDO ) has been previously proposed to predict acute rejection of human kidney transplants .


Here , we investigate the potential of IDO/trp degradation along the kynurenine ( kyn ) pathway to predict the long-term outcome of human kidney transplantation .


During the 2-year follow-up blood , urine , and kidney biopsies were collected from 48 renal transplant patients .


Concentrations of kyn and trp in serum and urine were measured at 2 weeks , 6 months , and 2 years after transplantation .


Kynurenine to tryptophan ratio was calculated as an estimate of trp degradation .


To evaluate the histological changes and IDO expression , respectively , periodic acid schiff staining and immunohistochemistry for IDO were performed on biopsies taken at 6 months and 2 years .


Two years after transplantation , kyn/trp was increased in urine and decreased in serum as compared to 2-week values .


In 2-year biopsies , IDO expression was mainly found in infiltrating inflammatory cells and in the glomeruli .


The urine level of trp 2 weeks after transplantation predicted the serum creatinine 6 months and the estimated creatinine clearance 2 years after transplantation .


Additionally , serum level of kyn 6 months after transplantation predicted the serum creatinine 2 years after transplantation .


Early serum and urine levels of trp and kyn may offer a novel route for early detection of patients at risk for developing CTD .


Regular aspirin use reduces colon adenoma and carcinoma incidence .


UDP-glucuronosyltransferases ( UGT ) are involved in aspirin metabolism and clearance , and variant alleles in UGT1A6 have been shown to alter salicylic acid metabolism and risk of colon neoplasia .


In a randomized , cross-over , placebo-controlled trial of 44 healthy men and women , homozygous for UGT1A6 * 1 or UGT1A6 * 2 , we explored differences between global epithelial and stromal expression , using Affymetrix U133 +2.0 microarrays and tested effects of 60-day aspirin supplementation ( 325 mg/d ) on epithelial and stromal gene expression and colon prostaglandin E2 ( PGE2 ) levels .


No statistically significant differences in gene expression were observed in response to aspirin or UGT1A6 genotype , but tissue PGE2 levels were lower with aspirin compared to placebo ( p < 0.001 ) .


Transcripts differentially expressed between epithelium and stroma ( N = 4916 , P < 0.01 , false discovery rate < 0.001 ) , included a high proportion of genes involved in cell signaling , cellular movement , and cancer .


Genes preferentially expressed in epithelium were involved in drug and xenobiotic metabolism , fatty acid and lipid metabolism , apoptosis signaling , and ion transport .


Genes preferentially expressed in stroma included those involved in inflammation , cellular adhesion , and extracellular matrix production .


Wnt-Tcf4 pathway genes were expressed in both epithelium and stroma but differed by subcellular location .


These results suggest that , in healthy individuals , subtle effects of aspirin on gene expression in normal colon tissue are likely overwhelmed by inter-individual variability in microarray analyses .


Differential expression of critical genes between colonic epithelium and stroma suggest that these tissue types need to be considered separately .


To investigate the effect of nutrient stimulation of gut hormones by oligofructose supplementation on appetite , energy intake ( EI ) , body weight ( BW ) and adiposity in overweight and obese volunteers .


In a parallel , single-blind and placebo-controlled study , 22 healthy overweight and obese volunteers were randomly allocated to receive 30 g day ( -1 ) oligofructose or cellulose for 6 weeks following a 2-week run-in .


Subjective appetite and side effect scores , breath hydrogen , serum short chain fatty acids ( SCFAs ) , plasma gut hormones , glucose and insulin concentrations , EI , BW and adiposity were quantified at baseline and post-supplementation .


Oligofructose increased breath hydrogen ( P < 0.0001 ) , late acetate concentrations ( P = 0.024 ) , tended to increase total area under the curve ( tAUC ) 420 mins peptide YY ( PYY ) ( P = 0.056 ) and reduced tAUC450 mins hunger ( P = 0.034 ) and motivation to eat ( P = 0.013 ) when compared with cellulose .


However , there was no significant difference between the groups in other parameters although within group analyses showed an increase in glucagon-like peptide 1 ( GLP-1 ) ( P = 0.006 ) in the cellulose group and a decrease in EI during ad libitum meal in both groups .


Oligofructose increased plasma PYY concentrations and suppressed appetite , while cellulose increased GLP-1 concentrations .


EI decreased in both groups .


However , these positive effects did not translate into changes in BW or adiposity .


Triple-negative breast cancer ( TNBC ) patients without pathological complete response ( pCR ) to neoadjuvant chemotherapy have an unfavourable prognosis .


TNBC harbouring BRCA-1 germline mutations may be less responsive to taxanes , while sensitivity to DNA-damaging agents is retained .


A similar effect was seen in tumours with epigenetic BRCA-1 silencing .


Patients without pCR to neoadjuvant chemotherapy consisting of epirubicin plus docetaxel routinely received post-operative CMF at our centre .


Here , we investigated the effect of adjuvant CMF in patients with or without BRCA-1 methylation or TP53 mutation .


DNA was extracted from formalin-fixed paraffin-embedded tissue .


For determining BRCA-1 methylation status , quantitative methylation-specific PCR was performed .


For the investigation of TP53 mutation status , DNA was PCR amplified and sequenced by Sanger sequencing .


Twenty-four patients were included ; BRCA-1 methylation was present in 41.7 % , while TP53 mutations were observed in 66.7 % .


At a median follow-up of 27.5 months , 20 % of patients with BRCA-1 methylation had a disease-free survival ( DFS ) event , as compared to 64.3 % in the non-methylated group ( p = 0.0472 ) .


Median DFS in the non-methylated group was 16 months and was not reached in the methylated group ( n.s. ) .


No association TP53 mutation status with clinical outcome was observed .


Adjuvant CMF is of limited activity in TNBC refractory to taxane-based neoadjuvant chemotherapy .


In this population , BRCA-1 methylation was associated with a significant decrease in DFS events suggesting a better prognosis and potentially retained activity of DNA-damaging agents .


New evidence indicates that increased dietary protein ingestion promotes health and recovery from illness , and also maintains functionality in older adults .


The present study aimed to investigate whether a novel food service concept with protein-supplementation would increase protein and energy intake in hospitalised patients at nutritional risk .


A single-blinded randomised controlled trial was conducted .


Eighty-four participants at nutritional risk , recruited from the departments of Oncology , Orthopaedics and Urology , were included .


The intervention group ( IG ) received the protein-supplemented food service concept .


The control group ( CG ) received the standard hospital menu .


Primary outcome comprised the number of patients achieving 75 % of energy and protein requirements .


Secondary outcomes comprised mean energy and protein intake , body weight , handgrip strength and length of hospital stay .


In IG , 76 % versus 70 % CG patients reached 75 % of their energy requirements ( P = 0.57 ) ; 66 % IG versus 30 % CG patients reached 75 % of their protein requirements ( P = 0.001 ) .


The risk ratio for achieving 75 % of protein requirements : 2.2 ( 95 % confidence interval = 1.3-3 .7 ) ; number needed to treat = 3 ( 95 % confidence interval = 2-6 ) .


IG had a higher mean intake of energy and protein when adjusted for body weight ( CG : 82kJkg ( -1 ) versus IG : 103kJkg ( -1 ) , P = 0.013 ; CG : 0.7 g proteinkg ( -1 ) versus 0.9 g proteinkg ( -1 ) , P = 0.003 ) .


Body weight , handgrip strength and length of hospital stay did not differ between groups .


The novel food service concept had a significant positive impact on overall protein intake and on weight-adjusted energy intake in hospitalised patients at nutritional risk .


To compare the efficacy of different points combination in the treatment of menopausal insomnia .


Ninety-six cases of menopausal insomnia were randomized into 3 groups , Xinshu ( BL 15 ) , Shenshu ( BL 23 ) , Sishencong ( EX-HN 1 ) , Shenmen ( HT 7 ) , Sanyinjiao ( SP 6 ) were chosen in the restore interaction between the heart and the kidney group ( group A , 32 cases ) ; Zhaohai ( KI 6 ) , Jiaoxin ( KI 8 ) , Shenmai ( BL 62 ) , Pucan ( BL 61 ) were chosen in the acupuncturing qiao mai group ( group B , 32 cases ) ; auricular Shenmen ( TF4 ) and sensitive spot at the distribution area of auricular vagus nervus were chosen in the ear acupuncture group ( group C , 32 cases ) .


Six days made one session and the treatments were finished after 4 courses .


The polysomnography ( PSG ) and Pittsburgh sleep quality index ( PSQI ) were employed before and after treatment to evaluate the alleviation of insomnia .


The parameters of the sleep latency ( SL ) , rapid wave sleep latency ( RL ) and sleep efficiency ( SE ) were significantly improved in the three groups , and the differences were statistically significant ( P < 0.05 , P < 0.01 ) .


The SL and awaking time ( AT ) in group C [ SL ( 401.08 + / - 16.54 ) min and AT ( 4.87 + / - 2.64 ) times ] were significantly superior to those in the other two groups [ SL ( 50.36 + / - 18.47 ) min , ( 54.87 + / - 20.92 ) min , AT ( 5.98 + / - 2.11 ) times , ( 6.13 + / - 3.04 ) times , all P < 0.05 ] .


The S ( 3 +4 ) ( % ) in group C was also significantly higher than those in the other two groups ( both P < 0.05 ) .


It was indicated by PSQI that the sleep quality of group C ( 0.78 + / - 0.12 ) was significantly superior to that in group B ( 1.32 + / - 0.29 ) , the total score and cured and markedly effective rate in group C [ ( 4.34 + / - 1.43 ) , 68.8 % ( 22/32 ) ] were superior to those in group A [ ( 7.48 + / - 3.09 ) , 53.1 % ( 17/32 ) , both P < 0.05 ] .


Ear acupuncture has a better curative effect than the restore interaction between the heart and the kidney group and acupuncturing qiao mai group , it is worth of being promoted .


Latinas with breast cancer suffer symptom and psychosocial health disparities .


Effective interventions have not been developed for or tested in this population .


We describe community-based participatory research methods used to develop and implement the Nuevo Amanecer program , a culturally tailored , peer-delivered cognitive-behavioral stress management intervention for low-income Spanish-speaking Latinas with breast cancer , and unique considerations in implementing a randomized controlled trial to test the program in community settings .


We applied an implementation science framework to delineate the methodological phases used to develop and implement the Nuevo Amanecer program and trial , emphasizing community engagement processes .


In phase 1 , we established project infrastructure : academic and community co-principal investigators , community partners , community advisory board , steering committee , and funding .


In phase 2 , we identified three program inputs : formative research , a community best-practices model , and an evidence-based intervention tested in non-Latinas .


In phase 3 , we created the new program by integrating and adapting intervention components from the three sources , making adaptations to accommodate low literacy , Spanish language , cultural factors , community context , and population needs .


In phase 4 , we built community capacity for the program and trial by training field staff ( recruiters and interventionists embedded in community sites ) , compensating field staff , and creating a system for identifying potential participants .


In phase 5 , we implemented and monitored the program and trial .


Engaging community partners in all phases has resulted in a new , culturally tailored program that is suitable for newly diagnosed Latinas with breast cancer and a trial that is acceptable and supported by community and clinical partners .


Lessons learned Engagement of community-based organizations and cancer survivors as research partners and hiring recruiters and interventionists from the community were critical to successful implementation in community settings .


Having culturally and linguistically competent research staff with excellent interpersonal skills facilitated implementation .


Facilitating and maintaining excellent communication among community partners was imperative to troubleshoot implementation issues .


Randomization was challenging due to community concerns about assigning women to a control group .


Patient privacy regulations and the need for extensive outreach to establish relationships between community partners and clinical sites hampered initial recruitment .


These were resource-intensive processes to develop and implement the program that need to be compared to less-intensive alternatives .


Engaging community members in design and implementation of community-based programs and trials enhances cultural appropriateness and congruence with the community context .


If the randomized trial demonstrates that the intervention is effective , it will fill a gap in evidence-based programs to address ethnic disparities in quality of life among Spanish-speaking Latinas with breast cancer .


Exercise intolerance is a hallmark of chronic obstructive pulmonary disease ( COPD ) .


Patients with COPD were randomized in two multicentre , double-blind , incomplete block crossover studies .


Patients received two of six treatments in sequence ( 12 weeks each ) : placebo , umeclidinium ( UMEC ) / vilanterol ( VI ) ( 125/25 mcg or 62.5 / 25 mcg ) , VI ( 25 mcg ) or UMEC ( 62.5 mcg or 125 mcg ) .


Exercise endurance time ( EET ) and trough forced expiratory volume in 1 second ( FEV1 ) ( Week 12 ) were co-primary endpoints .


Safety was monitored throughout .


Both studies showed similar 3-hour post-dose EET improvements from baseline for UMEC/VI ( Week 12 ) .


Significant EET improvements were observed with both UMEC/VI doses versus placebo at Week 12 in Study 418 ( UMEC/VI 125/25 mcg : 65.8 s ; p = 0.005 ; UMEC/VI 62.5 / 25 mcg : 69.4 s ; p = 0.003 ) , but not in Study 417 , where a placebo effect was evident .


Post hoc integrated data analysis showed significant but smaller EET improvements for both UMEC/VI doses versus placebo at Week 12 ( UMEC/VI 125/25mcg : 47.5 s ; p = 0.002 ; UMEC/VI 62.5 / 25 mcg : 43.7 s ; p = 0.001 ) .


Both studies showed trough FEV1 improvements at Week 12 for both UMEC/VI doses .


The incidence of adverse events was similar between treatment groups within each study .


UMEC/VI improved lung function and EET .


Fear of falling ( FOF ) is commonly experienced in people with Parkinson 's disease ( PD ) .


It is a predictor of recurrent falls , a barrier to physical exercise , and negatively associated with health-related quality of life .


A variety of rating scales exist that assess different aspects of FOF but comprehensive head-to-head comparisons of their psychometric properties in people with PD are lacking .


The aim of this study was to evaluate the psychometric properties of four FOF rating scales in people with PD .


More specifically , we investigated and compared the scales ' data completeness , scaling assumptions , targeting , and reliability .


The FOF rating scales were : the Falls Efficacy Scale-International ( FES-I ) , the Swedish FES ( FES ( S ) ) , the Activities-specific Balance Confidence scale ( ABC ) , and the modified Survey of Activities and Fear of Falling in the Elderly ( mSAFFE ) .


A postal survey was administered to 174 persons with PD .


Responders received a second survey after two weeks .


The mean ( SD ) age and PD duration of the 102 responders were 73 ( 8 ) and 7 ( 6 ) years , respectively .


ABC had worse data completeness than the other scales ( 6.9 vs. 0.9-1 .3 % missing data ) .


All scales had corrected item-total correlations exceeding 0.4 and showed acceptable reliabilities ( Cronbach 's alpha and Intraclass Correlation Coefficient ( ICC ) > 0.80 ) but only FES-I had ICC > 0.90 .


The standard error of measurements ranged from 7 % ( FES-I ) to 12 % ( FES ( S ) ) , and the smallest detectable differences ranged from 20 % ( FES-I ) to 33 % ( FES ( S ) ) of the total score ranges .


ABC and FES ( S ) had substantially more outliers than mSAFFE and FES-I ( 10 and 15 vs. 3 and 4 , respectively ) when the two test occasions were compared .


When assessing FOF in people with PD , the findings in the present study favoured the choice of FES-I or mSAFFE .


However , FES-I was the only scale with ICC > 0.90 which has been suggested as a minimum when using a scale for individual comparisons .


Agreement between client and therapist on treatment goals has been consistently linked with improved treatment outcomes .


Having clear and collaborative goals may be particularly important when working with clients diagnosed with personality disorders who are often difficult to engage and test the boundaries of therapy .


This paper outlines the development of a personality disorder treatment goal checklist aimed at helping clients and therapists to identify and prioritize their goals for therapy .


The checklist was developed using self-reported problems of the first 90 participants randomized into the psychoeducation and problem solving ( PEPS ) trial .


Problems were coded and categorized into problem areas .


The checklist was viewed by two service users who gave suggestions for improvements .


The final checklist consists of 161 items in 16 problem areas .


The checklist may provide a clinically useful tool for working with this client group .


LCn-3PUFA comprised of eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) offer cardioprotection involving a decrease in coagulant activity ; however , the evidence is equivocal .


We have previously demonstrated that the acute ( 24 h ) effects and chronic ( 4 weeks ) effects of LCn-3PUFA supplementation on platelet aggregation in human subjects are sex specific .


This study investigated the mechanisms of the sex-dependent effects of LCn-3PUFA with 4 weeks supplementation of EPA-rich vs. DHA-rich oils on procoagulant and platelet activity in healthy subjects .


A double-blinded , placebo-controlled randomised trial was conducted in 94 healthy adults : male ( n = 41 ) and female ( n = 53 ) .


Platelet coagulation parameters including factors I , II , V , VII , VIII , IX , X , vWF : Ag and endogenous thrombin potential were measured at baseline and 4 weeks postsupplementation with EPA-rich or DHA-rich oil capsules .


We have previously reported that platelet aggregation is specifically reduced by supplementation with EPA in males and DHA in females .


This sex-specific effect was also observed for decreases in plasma levels of Factor II ( -7.9 3.8 % , P = .026 ) , Factor V ( -6.5 4.5 % , P = .022 ) and vWF : Ag ( -7.3 2.1 % , P = .034 ) and was most pronounced in males supplemented with EPA .


In contrast , DHA-mediated reduction in platelet aggregation in females was not accompanied by any significant changes in the coagulation parameters tested .


Significant interactions between sex and specific LCn-3PUFA exist to reduce procoagulant activity differentially in males vs. females and could have profound effects on managing risk of thrombotic disease .


Over the past decades , the operative treatment of displaced midshaft clavicular fractures has increased .