Duration of wound discharge after drain removal was 2.2 ( 2.7 ) days in the dabigatran group and 1.2 ( 1.9 ) days in the enoxaparin group ( p < 0.05 ) .


Significant increase in serous discharge was found in the dabigatran group ( p < 0.05 ) on third and seventh postoperative days compared to the enoxaparin group .


Both thromboprophylactic agents were found to have appropriate antithrombotic effects after THR .


However , dabigatran was associated with an increased incidence of prolonged serous wound discharge , which might cause longer hospitalization and might instigate the use of prolonged antibiotic prophylaxis .


Infant colic is a frequent problem affecting up to 10-30 % of infants in first 3 months of life .


Results from previous trials have shown that manipulation of gut microbiota can lead to symptomatic improvements .


In a randomised clinical trial , we aimed to determine efficacy of synbiotic in reducing average infant crying time at day 7 and day 30 after starting intervention .


Fifty breastfed infants aged 15-120 days with infantile colic randomly assigned to receive either the synbiotic sachet containing 1 billion CFU of : Lactobacillus casei , L.rhamnosus , Streptococcus thermophilus , Bifidobacterium breve , L.acidophilus , B.infantis , L.bulgaricus and fructooligosacharide ( Protexin Healthcare , Somerset , UK ) , or placebo daily for 30 days .


Parents were asked to record details of crying times in a symptoms diary .


The primary outcome measure was the treatment success ( reduction in the daily crying time > 50 % ) and the secondary outcome measure was symptom resolution ( reduction in the daily crying time > 90 % ) .


The treatment success was significantly higher in synbiotic group ( 82.6 % ) compared with placebo ( 35.7 % ) at day 7 ( P < 0.005 ) .


At day30 , treatment success was 87 % and 46 % in synbiotic and placebo group , respectively ( P < 0.01 ) .


Symptom resolution was also higher in synbiotic group ( 39 % ) compared with placebo ( 7 % ) at day 7 ( P < 0.03 ) but not at day 30 ( 56 % vs. 36 % , P = 0.24 ) .


We encountered no complication related to synbiotic use .


This synbiotic ( a mixture of seven probiotic strains plus FOS ) significantly improved colic symptoms in comparison with placebo .


To study the clinical and laboratory efficiency and safety of different etoricoxib ( ET ) regimens in patients with axial spondyloarthritis ( axSpA ) , including ankylosing spondylitis .


Forty patients with high axSpA activity ( Bath Ankylosing Disease Activity Index ( BASDAI 4 ) were examined and randomized to 2 groups : 1 ) 30 patients who received ET 90 mg continuously every day ; 2 ) 10 patients who took the drug in the same dose intermittently 1-3 times weekly .


The activity of axSpA ( BASDAI , Ankylosing Spondylitis Disease Activity Score ( ASDAS ) , erythrocyte sedimentation rate ( ESR ) , and high-sensitivity C-reactive protein ( hs-CRP ) ) was evaluated at baseline , 2 and 12 weeks ; adverse events were recorded at baseline , 2 , 6 , and 12 weeks .


The number of patients who had achieved an ASAS40 response at 2 and 12 weeks were taken into consideration .


RESULTS At 12 weeks , the continuous administration group displayed decreases in BASDAI from 8 to 4 , in ASDAS from 3.8 to 2.6 , and in hs-CRP levels from 9.5 to 3.9 mg/l ; the intermittent administration group exhibited decreases in BASDAI from 7.6 to 6.0 , in ASDAS from 3.5 to 3.1 , and hs-CRP from 8.8 to 4.5 mg/l ( p < 0.05 ) .


At this time , an AS40 response was achieved by 22 ( 73.3 % ) and 2 ( 20 % ) patients in Groups 1 and 2 , respectively ( p < 0.05 for all ) .


No serious adverse events were recorded .


The efficacy of ET given in a daily dose of 90 mg was much higher than that of the drug used thrice or less weekly in the patients with axSpA .


To compare the outcome of Rhomboid excision and Modified Limberg 's flap closure with excision and primary closure for the treatment of Sacrococcygeal Pilonidal sinus .


The study was conducted at the Surgical Department of Mayo Hospital , Lahore , from 2009 to 2012 .


A total of 60 patients of pilonidal sinus were randomly divided into two equal groups .


The patients were operated under general anaesthesia in prone position by Rhomboid excision and Modified Limberg 's flap closure with a closed suction drain in group 1 , and excision and primary closure over a drain in group 2 .


Patients were followed up for 12 months for surgical complications of the treatment .


SPSS 17 was used for statistical analysis .


In group 1 there were 27 ( 90 % ) males and 3 ( 10 % ) females , while group 2 had 28 ( 93.3 % ) males and 2 ( 6.7 % ) females .


The infection rates were observed to be 2 ( 7 % ) in group 1 and 8 ( 26.6 % ) ( p < 0.038 ) in group 2 .


The recurrence rate was only 1 ( 3.3 % ) in group 1 compared to 4 ( 13.3 % ) in group 2 .


Average hospital stay was 1.630.67 days group 1 and 2.81.24 days in group 2 .


Modified Limberg 's flap closure is an effective treatment modality for pilonidal sinus disease with 1.5 times less infection rate , 4 times less recurrence rate and 40 % in-hospital time .


Late-onset sepsis frequently complicates prematurity , contributing to morbidity and mortality .


Probiotics may reduce mortality and necrotizing enterocolitis ( NEC ) in preterm infants , with unclear effect on late-onset sepsis .


This study aimed to determine the effect of administering a specific combination of probiotics to very preterm infants on culture-proven late-onset sepsis .


A prospective multicenter , double-blinded , placebo-controlled , randomized trial compared daily administration of a probiotic combination ( Bifidobacterium infantis , Streptococcus thermophilus , and Bifidobacterium lactis , containing 1 10 ( 9 ) total organisms ) with placebo ( maltodextrin ) in infants born before 32 completed weeks ' gestation weighing < 1500 g.


The primary outcome was at least 1 episode of definite late-onset sepsis .


Between October 2007 and November 2011 , 1099 very preterm infants from Australia and New Zealand were randomized .


Rates of definite late-onset sepsis ( 16.2 % ) , NEC of Bell stage 2 or more ( 4.4 % ) , and mortality ( 5.1 % ) were low in controls , with high breast milk feeding rates ( 96.9 % ) .


No significant difference in definite late-onset sepsis or all-cause mortality was found , but this probiotic combination reduced NEC of Bell stage 2 or more ( 2.0 % versus 4.4 % ; relative risk 0.46 , 95 % confidence interval 0.23 to 0.93 , P = .03 ; number needed to treat 43 , 95 % confidence interval 23 to 333 ) .


The probiotics B infantis , S thermophilus , and B lactis significantly reduced NEC of Bell stage 2 or more in very preterm infants , but not definite late-onset sepsis or mortality .


Treatment with this combination of probiotics appears to be safe .


Most parental smokers are deeply invested in their child 's health , but it is unknown what factors influence parent risk perceptions of the effects of smoking on their child 's health and benefits to the child of cessation .


To explore differences in former versus current smokers ' beliefs about harm of continuing to smoke , benefits of quitting , and how much smoking interferes with their parenting .


As part of a cluster RCT to increase tobacco control in the pediatric setting , we analyzed data collected at the ten control arm practices for 24 months starting in May 2010 ; a cross-sectional secondary data analysis was conducted in 2013 .


Parents were asked about smoking status and perceived harm , benefit , and well-being related to smoking behaviors .


Of the 981 enrolled smoking parents , 710 ( 72.4 % ) were contacted at 12 months .


The odds of having successfully quit at 12 months was 4.12 times more likely ( 95 % CI = 1.57 , 10.8 ) for parents who believed that quitting will benefit their children ; 1.68 times more likely ( 95 % CI = 1.13 , 2.51 ) for parents with more than a high school education ; and 1.74 times greater ( 95 % CI = 1.13 , 2.68 ) for parents with children under age 3 years .


Another factor associated with having successfully quit was a prior quit attempt .


Providers ' smoking-cessation advice and support should begin early and underscore how cessation will benefit the health and well-being of patients ' children .


Additionally , parents who have recently attempted to quit may be particularly primed for another attempt .


The effectiveness of methadone as an opioid maintenance treatment ( OMT ) for opioid dependence has been widely demonstrated .


However many patients continue to use other opioids while on methadone treatment .


Studies assessing avoidable cases of continued non-prescribed opioid use during methadone treatment are sparse .


At 12 months of treatment ( M12 ) , 158 subjects had available data on opioid use , measured using the Opiate Treatment Index .


We identified variables associated with non-prescribed opioid use at M12 , using a univariate logistic regression and two multivariate models , one incorporating only pre-treatment variables , the second adding the in-treatment variables .


We also calculated attributable fractions for risk factors .


At M12 , 32.3 % of the patients had used non-prescribed opioids during the previous month .


A good patient-physician relationship was the most influential factor associated with not using non-prescribed opioids after one year .


Living with a heroin user after one year of treatment , using cocaine during treatment and hazardous alcohol consumption at enrolment were all associated with an increased risk of non-prescribed opioid use at M12 .


Analysis of attributable fractions indicated that living with a heroin user at M12 accounted for 21 % of patients reporting non-prescribed opioid use at M12 , while the lack of a good relationship with the physician accounted for 26 % .


The attributable risk approach suggests that continued non-prescribed opioid use by a considerable proportion of individuals could potentially be reduced by improving patient-physician relationships , enhancing care for co-dependent patients and encouraging patients to modify their social network .


Serum C-reactive protein ( CRP ) is a marker of acute inflammatory response and has been associated with health outcomes in some studies .


Inflammation and immune response may have potential prognostic implications for breast cancer survivors .


The Women 's Healthy Eating and Living Study includes 2,919 early-stage breast cancer survivors with serum collected 2 years postdiagnosis and follow-up for clinical outcomes over approximately 7 years .


CRP concentrations were measured using high-sensitivity electrochemiluminescence assay .


Outcomes , including all-cause mortality , breast cancer-specific mortality , and additional breast cancer events were oncologist verified from medical records and death certificates .


Cox proportional hazards models were conducted with adjustment for potential confounding factors to generate HRs and 95 % confidence intervals ( CI ) .


CRP concentrations in women diagnosed with breast cancer were associated with death due to any cause , death due to breast cancer , and additional breast cancer events , after adjustment for sociodemographic and cancer characteristics ( lnCRP : P < 0.05 for all three outcomes ) .


The HR for women with ( vs. without ) acute inflammation suggests a threshold effect on overall survival , rather than a dose-response relationship ( 10.0 mg/L vs. < 1 mg/L : HR , 1.96 ; 95 % CI , 1.22-3 .13 ) .


Associations were similar for breast cancer-specific mortality ( HR , 1.91 ; 95 % CI , 1.13-3 .23 ) and any additional breast cancer-related event ( HR , 1.69 ; 95 % CI , 1.17-2 .43 ) .


Acute inflammation status ( CRP 10 mg/L ) may be an important independent biomarker for long-term survival in breast cancer survivors .


Interventions to decrease circulating CRP concentrations in breast cancer survivors with acute inflammation may improve prognosis .


We sought to investigate the use of tissue contact monitoring by means of the electrical coupling index ( ECI ) in a prospective randomised control trial of patients undergoing cavotricuspid isthmus ( CTI ) ablation for atrial flutter .


Patients with ECG-documented typical flutter undergoing their first CTI ablation were randomised to ECI-guided or non-ECI-guided ablation .


An irrigated-tip ablation catheter was used in all cases .


Consecutive 50-W , 60-s radiofrequency lesions were applied to the CTI , from the tricuspid valve to inferior vena cava , with no catheter movement permitted during radiofrequency ( RF ) delivery .


The ablation endpoint was durable CTI block at 20 min post-ablation .


Patients underwent routine clinic follow-up post-operatively .


A total of 101 patients ( 79 male ) , mean age 66 ( + / -11 ) , 50 ECI-guided and 51 control cases were enrolled in the study .


CTI block was achieved in all .


There were no acute complications .


All patients were alive at follow-up .


CTI block was achieved in a single pass in 36 ECI-guided and 30 control cases ( p = 0.16 ) , and at 20 min post-ablation , re-conduction was seen in 5 and 12 cases , respectively ( p = 0.07 ) .


There was no significant difference in total procedure time ( 62.733 vs. 62.333 min , p = 0.92 ) , RF requirement ( 580312 vs. 574287 s , p = 0.11 ) or fluoroscopy time ( 718577 vs. 721583 s , p = 0.78 ) .


After 64 months , recurrence of flutter had occurred in 1 ( 2 % ) ECI vs. 8 ( 16 % ) control cases ( OR 0.13 , 95 % CI 0.01-1 .08 , p = 0.06 ) .


ECI-guided CTI ablation demonstrated a non-statistically significant reduction in late recurrence of atrial flutter , at no cost to procedural time , radiation exposure or RF requirement .


Our objective was to compare the efficacy and safety of imidafenacin over fesoterodine in patients with overactive bladder ( OAB ) .


This study is a randomised , double-blind , parallel-group , fesoterodine-controlled study in patients with continuous OAB symptoms for 3months , daily mean voiding frequency ( DMVF ) 8 , and daily mean urgency or urgency incontinence frequency 2 .


A twice-daily 0.1 mg imidafenacin with placebo , or once-daily 4mg fesoterodine with placebo were administered for 12weeks .


The primary efficacy end-point was the difference in DMVF at 12weeks .


The secondary efficacy end-points were differences in daily mean : ( i ) voiding frequency at 4 and 8weeks ; ( ii ) urgency frequency ; ( iii ) urgency incontinence frequency ; ( iv ) incontinence frequency ; ( v ) nocturia frequency ; and ( vi ) quality of life score .


The variables for safety analysis were adverse events , vital signs , residual urine volume and clinical laboratory tests .


An efficacy analysis was conducted in per-protocol patients and the safety analysis was conducted in all randomised patients .


The differences in DMVF at 12weeks were -3.383.63 and -2.453.73 in the imidafenacin and fesoterodine groups , respectively , and the difference was not significant between the two groups .


Imidafenacin was non-inferior to fesoterodine , and the lower limit of 95 % two-sided confidence intervals was -0.53 .


The other six secondary end-points and variables for safety analysis showed no difference between the two groups .


Imidafenacin was non-inferior to fesoterodine in terms of efficacy , and showed no significant difference in terms of safety .


Progress during early labour may impact subsequent labour trajectories .


Women admitted to hospital in latent phase ( < 3cm cervical dilation ) labour have been shown to be at higher risk of obstetrical interventions .


We conducted a secondary analysis of data from a randomized controlled trial of 1247 healthy nulliparous women in spontaneous labour at term with a singleton fetus in cephalic presentation at seven hospitals in Southwestern British Columbia .


We computed relative risks and their 95 % confidence intervals to examine our primary outcome of cesarean section and secondary outcomes including obstetrical interventions and maternal and newborn outcomes according to women 's perception of length of pre-hospital labour .


Women were asked on admission to hospital how long they had been experiencing contractions prior to coming to hospital .


Women indicating that they had been in labour for 24hours or longer at the time of hospital admission were at elevated risk for cesarean birth , relative risk ( RR ) 1.40 , ( 95 % Confidence Intervals 1.15-1 .72 ) , admission with a cervical dilation of 3cm or less , RR 1.21 ( 1.07-1 .36 ) , more obstetrical interventions including continuous electronic fetal monitoring RR 1.11 ( 1.03-1 .20 ) , augmentation of labour RR 1.33 ( 1.23-1 .44 ) , use of narcotic RR 1.21 ( 1.06-1 .37 ) and epidural analgesia RR 1.18 ( 1.09-1 .28 ) .


Adverse neonatal outcomes did not differ apart from a significant increase in meconium-stained amniotic fluid RR 1.60 ( 1.09-2 .35 ) .


A single question asked of women on presentation to hospital was an important predictor of cesarean birth and may have utility in identifying women who would benefit from close observation and more active management of labour .


To describe the effects of six interventions for menopausal vasomotor symptoms relative to control in a pooled analysis , facilitating translation of the results for clinicians and symptomatic women .


The Menopause Strategies : Finding Lasting Answers for Symptoms and Health network tested these interventions in three randomized clinical trials .


An analysis of pooled individual-level data from three randomized clinical trials is presented .


Participants were 899 perimenopausal and postmenopausal women with at least 14 bothersome vasomotor symptoms per week .


Interventions included 10-20 mg escitalopram per day , nonaerobic yoga , aerobic exercise , 1.8 g per day omega-3 fatty acid supplementation , 0.5 mg low-dose oral 17-beta-estradiol ( E2 ) per day , and 75 mg low-dose venlafaxine XR per day .


The main outcome measures were changes from baseline in mean daily vasomotor symptom frequency and bother during 8-12 weeks of treatment .


Linear regression models estimated differences in outcomes between each intervention and corresponding control group adjusted for baseline characteristics .


Models included trial-specific intercepts , effects of the baseline outcome measure , and time .


The 8-week reduction in vasomotor symptom frequency from baseline relative to placebo was similar for escitalopram at -1.4 per day ( 95 % confidence interval [ CI ] -2.7 to -0.2 ) , low-dose E2 at -2.4 ( 95 % CI -3.4 to -1.3 ) , and venlafaxine at -1.8 ( 95 % CI -2.8 to -0.8 ) ; vasomotor symptom bother reduction was minimal and did not vary across these three pharmacologic interventions ( mean -0.2 to -0.3 relative to placebo ) .


No effects on vasomotor symptom frequency or bother were seen with aerobic exercise , yoga , or omega-3 supplements .


These analyses suggest that escitalopram , low-dose E2 , and venlafaxine provide comparable , modest reductions in vasomotor symptom frequency and bother among women with moderate hot flushes .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT00894543 ( MsFLASH 01 ) , NCT01178892 ( MsFLASH 02 ) , and NCT01418209 ( MsFLASH 03 ) .


Most patients with tinnitus also have hearing loss .


Hearing aids have been well-documented to provide amelioration for both hearing and tinnitus problems .


Some hearing aids have built-in noise/sound generators that are intended to provide added benefit to patients with tinnitus .


It has not been proven , however , whether these `` combination instruments '' are more effective for tinnitus management than hearing aids alone .


The purpose of this study was to collect initial data addressing this question .


Thirty individuals meeting study requirements ( bothersome tinnitus , hearing aid candidate , and no use of hearing aids for the previous 12 months ) were enrolled .


All participants initially completed the primary outcome questionnaire ( Tinnitus Functional Index [ TFI ] ) and then returned to be fitted with combination instruments .


The hearing aid portion of the devices was adjusted to optimize hearing ability .


Participants were then randomized to either the experimental group ( n = 15 ) or the control group ( n = 15 ) .


The experimental group had the noise feature of the instruments activated and adjusted to achieve optimal relief from tinnitus .


The control group did not have the noise portion activated .


Following the hearing aid fitting , all study participants also received brief tinnitus counseling .


Participants returned 1 to 2 weeks later for a follow-up appointment to confirm proper fit of the instruments and to make any necessary programming adjustments .


Additionally , they returned 3 months after the fitting to complete the TFI , which also concluded their participation in the study .


Both groups revealed significant improvement , as indicated by reductions in mean TFI index scores .


Differences between groups at 3 months were not statistically significant .


However , the experimental group showed a mean reduction in the TFI score that was 6.4 points greater than that for the control group .


The difference approached significance ( p = 0.09 ) , suggesting that a larger group of participants may have resulted in a significant difference between groups .


This possibility is tempered by the fact that effect sizes , which control for variation , were very similar between groups .


Results of this study suggest that the use of hearing aids alone or hearing aids plus the use of sound generators both provide significant benefit with respect to alleviating effects of tinnitus .


A larger controlled clinical trial is needed to obtain more definitive results regarding the two configurations of hearing aids .


To compare bidirectional knotless barbed suture versus standard sutures , with either extracorporeal or intracorporeal knots , and to assess the feasibility , safety , and rapidity in repairing a uterine wall defect after laparoscopic myomectomy .


This was a randomized clinical study having a Canadian Task Force Classification of I.


In tertiary-care university-based teaching hospitals , 117 women who underwent laparoscopic myomectomy were enrolled .


In accord with randomization , uterine wall defects were closed with either extracorporeal ( poliglecaprone 25 ; Monocryl-1 ; Ethicon Inc. , Somerville , NJ ) or intracorporeal ( polyglactin 910 ; Vicryl-1 ; Ethicon Inc. ) knots or a bidirectional knotless barbed suture ( Quill-0 ; Angiotech Pharmaceuticals , Inc. , Vancouver , BC , Canada ) .


Time required to suture was significantly lower in the group operated on with a bidirectional suture than in groups with traditional sutures ( P < .001 ) .


No significant difference was observed in operative time among the study groups .


The degree of surgical difficulty was significantly lower in the Quill group than in the other groups .


Use of barbed sutures reduces the time required to repair a uterine wall defect during laparoscopic myomectomy .


In a follow-up of patients carried out at 3 months , 6 months , and 1 year after the surgery , there were no wound dehiscence , no bleeding , and no other potential major complications .


To estimate the effectiveness of candidate microbicides BufferGel and 0.5 % PRO 2000 Gel ( P ) ( PRO 2000 ) for prevention of non-ulcerative sexually transmitted infections ( STIs ) .


Between 2005 and 2007 , 3099 women were enrolled in HIV Prevention Trials Network ( HPTN ) protocol 035 , a phase II/IIb evaluation of the safety and effectiveness of BufferGel and PRO 2000 for prevention of STIs , including Neisseria gonorrhoeae ( NG ) , Chlamydia trachomatis ( CT ) and Trichomonas vaginalis ( TV ) .


Incidences of STIs were determined by study arm , and HRs of BufferGel and PRO 2000 versus placebo gel or no gel control groups were computed using discrete time Andersen-Gill proportional hazards model .


The overall incidence rates were 1.6 / 100 person-years at risk ( PYAR ) for NG , 3.9 / 100 PYAR for CT and 15.3 / 100 PYAR for TV .


For BufferGel versus placebo gel , HRs were 0.99 ( 95 % CI 0.49 to 2.00 ) , 1.00 ( 95 % CI 0.64 to 1.57 ) and 0.95 ( 95 % CI 0.71 to 1.25 ) for prevention of NG , CT and TV , respectively .


For PRO 2000 , HRs were 1.66 ( 95 % CI 0.90 to 3.06 ) , 1.16 ( 95 % CI 0.76 to 1.79 ) and 1.18 ( 95 % CI 0.90 to 1.53 ) for prevention of NG , CT and TV , respectively .


The incidence of STIs was high during HIV Prevention Trials Network 035 despite provision of free condoms and comprehensive risk-reduction counselling , highlighting the need for effective STI prevention programmes in this population .


Unfortunately , candidate microbicides BufferGel and PRO2000 had no protective effect against gonorrhoea , chlamydia or trichomoniasis .


NCT00074425 .


Basiliximab is a chimeric monoclonal antibody directed against the alpha chain of interleukin-2 receptor ( IL-2R ) .


When administered intravenously at a dosage of 20 mg at the time of transplantation and 4 days later , basiliximab saturates the alpha chain of IL-2R for 4 weeks .


This review evaluates the efficacy and safety of basiliximab in kidney transplantation .


Randomized controlled trials showed that basiliximab can significantly reduce the incidence of acute rejection without increasing the risk of adverse events .


When compared with other antibodies used for induction , basiliximab showed efficacy and safety profiles similar to daclizumab , another monoclonal antibody directed against the alpha chain of IL-2R .


In comparison with rabbit anti-thymocyte globulins ( rATG ) , basiliximab showed a similar efficacy .


However , in patients at higher risk of rejection , rATG proved to be more effective .


No serious safety problems related to basiliximab have been reported .


There is a solid evidence that basiliximab can significantly decrease the risk of acute rejection in kidney transplant recipients without increasing adverse events .


This can allow decreased dosage or avoidance of glucocorticoids and reduced dosage of calcineurin inhibitors .


On the basis of efficacy , tolerability , ease of administration , and cost effectiveness , basiliximab may be considered the drug of choice for the prophylaxis of acute rejection in standard renal transplant recipients .


Few studies have examined the long-term sustainability of complete seizure freedom on the ketogenic diet ( KD ) .


The purpose of this study was to describe the risk of seizure recurrence in children who achieved at least 1month of seizure freedom on the KD , and to assess clinical features associated with sustained seizure freedom .


Records of patients initiated on the KD at The Children 's Hospital of Philadelphia ( CHOP ) from 1991 to 2009 were reviewed .


Subjects who attained seizure freedom for at least 1month within 2years were included in the study .


Seizure frequency was recorded based on caregiver-reported seizure diaries as unchanged , improved , or worse compared to baseline .


Those patients with seizure freedom 1year were compared to those with seizure freedom < 1year in terms of demographics , age of seizure onset , number of antiepileptic drugs ( AEDs ) prior to KD , and epilepsy classification .


Of 276 patients initiated on the KD , 65 patients ( 24 % ) attained seizure freedom for a minimum of 1month .


The majority of these patients had daily seizures .


The median time to seizure freedom after KD initiation was 1.5 months .


Seizures recurred in 53 patients ( 82 % ) , with a median time to seizure recurrence of 3months .


However , seizure frequency after initial recurrence remained far less than baseline .


No clinical features were identified as risk factors for seizure recurrence .


Seizure recurrence on the KD after 1month of seizure freedom most often occurred as occasional breakthrough seizures and not a return to baseline seizure frequency .


This study provides evidence to support the continued use of the KD in patients with initial seizure freedom even after breakthrough seizures .


A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .


The objectives of this research were to compare a Web-based curriculum with a traditional lecture format on medical students ' cultural competency attitudes using a standardized instrument and to examine the internal consistency of the standardized instrument .


In 2010 , we randomized all 180 1st-year medical students into a Web-based ( intervention group ) or a lecture-based ( control group ) cultural competency training .


The main outcome was the overall score on the Health Belief Attitudes Survey ( 1 = lowest , 6 = highest ) .


We examined internal consistency with factor analysis .


No differences were observed in the overall median scores between the intervention ( median 5.2 ; 25th percentile [ Q1 ] 4.9 , 75th percentile [ Q3 ] 5.5 ) and the control groups ( median 5.3 , Q1 4.9 , Q3 5.6 ) ( P = 0.77 ) .


The internal consistency of the 2 main subcomponents was good ( Cronbach 's alpha = 0.83 ) to acceptable ( Cronbach 's alpha = 0.69 ) .


A Web-based and a lecture-based cultural competency training strategies were associated with equally high positive attitudes among 1st-year medical students .


These findings warrant further evaluation of Web-based cultural competency educational interventions .


During arthroscopy , the localization of calcific deposit in patients suffering from calcifying tendinitis can be demanding and time consuming , frequently using ionizing radiation .


Intraoperative ultrasound has been recently promoted , facilitating deposit localization and reducing radiation dose .


In this prospective , randomized , controlled and clinical observer-blinded pilot trial , 20 patients with calcific tendinitis were operated .


In group I , the deposit was localized conventionally .


In group II , the deposit was localized using intraoperative ultrasound .


The needle punctures to detect the deposit and operation times were noted .


Patients were postoperatively evaluated after 2 and 6weeks and 9months .


In group II , the needle punctures to detect the deposit were significantly lower than in group I ( p < 0.0001 ) .


Operation time to localize the deposit was also significantly less in group II ( p < 0.033 ) .


In both groups , patients improved significantly with increased shoulder function ( p < 0.0001 ) and decreased pain ( p < 0.0001 ) 2weeks and 9months ( p < 0.001 ) after surgery .


The difference between the groups was not significant .


Excellent radiological findings were obtained in both groups after 9months .


Intraoperative US significantly facilitates the detection of calcific deposits during arthroscopic debridement by speeding up surgery and reducing the number of needle punctures .


Hence , we have changed our method of detecting calcific deposits intraoperatively from fluoroscopy to ultrasound .


Dislocation of epidural catheters ( EC ) is associated with early termination of regional analgesia and rare complications like epidural bleeding .


We tested the hypothesis that maximum effort in fixation by tunneling and suture decreases the incidence of catheter dislocation .


Patients scheduled for major surgery ( n = 121 ) were prospectively randomized in 2 groups .


Thoracic EC were subcutaneously tunneled and sutured ( tunneled ) or fixed with adhesive tape ( taped ) .


The difference of EC length at skin surface level immediately after insertion and before removal was determined and the absolute values were averaged .


Postoperative pain was evaluated by numeric rating scale twice daily and EC tips were screened microbiologically after removal .


Both groups did not differ with respect to treatment duration ( tunneled : 109 hours 46 , taped : 97 37 ) and postoperative pain scores .


Tunneling significantly reduced average extent ( tunneled : 3 mm 7 , taped : 10 18 ) and incidence of clinically relevant EC dislocation ( > 20 mm , tunneled : 1/60 , taped : 9/61 ) .


Bacterial contamination showed a tendency to be lower in patients with tunneled catheters ( 8/59 , taped : 14/54 , P = 0.08 ) .


Thorough fixation of EC by tunneling and suturing decreases the incidence and extent of dislocation and potentially even that of bacterial contamination .


Since general anaesthesia invariably accompanies surgery , the contribution of each to the development of postoperative cognitive dysfunction ( POCD ) has been difficult to identify .


A prospective randomized controlled trial was undertaken in elderly patients undergoing extracorporeal shock wave lithotripsy ( ESWL ) .


Between 2005 and 2011 , 2706 individuals were screened to recruit 100 eligible patients .


Patients were randomly assigned to receive general or spinal anaesthesia alone .


A battery of eight neuropsychological tests was administered before operation and at 7 days and 3 months after operation .


The reliable change index was used to calculate the incidence of POCD .


Intention-to-treat analysis was used to compare rates of POCD .


Futility analysis led to stopping of the trial after recruitment of 100 patients .


Fifty patients were randomly assigned to general anaesthesia , and 48 patients to spinal anaesthesia without sedation or postoperative opioids .


At 3 months , POCD was detected in 6.8 % [ 95 % confidence interval ( CI ) : 1.4-18 .7 % ] of patients in the general anaesthesia group and 19.6 % ( 95 % CI : 9.4-33 .9 % ) in the spinal group ( P = 0.07 ) .


At 7 days after operation , the incidence of POCD was 4.1 % ( 95 % CI : 0.5-14 % ) in the general anaesthesia group and 11.9 % ( 95 % CI : 4.0-26 .6 % ) in the spinal group ( P = 0.16 ) .


We found no significant difference in the rates of POCD when comparing general anaesthesia with spinal anaesthesia , suggesting that the surgical or procedural process itself may contribute to the development of POCD .


Australian Clinical Trials Registry number ACTRN12605000150640 .


The objective of this study was to compare combined internal and external fixation ( CIEF ) with minimally invasive percutaneous plate osteosynthesis ( MIPPO ) in the treatment of distal third tibial fractures , and explore the benefits and defects of these two techniques .


From April 2004 to February 2012 , a total of 44 patients were randomised to operative stabilisation either by two closed titanium elastic nails combined with an external fixator ( CIEF , 22 ) or by minimally invasive percutaneous osteosynthesis with a locking plate ( MIPPO , 22 ) .


Pre-operative variables included the patients ' age , sex , fracture side , cause of injury , Tscherne classification of soft tissue injury , fracture pattern , presence of open fracture and interval from injury to surgery .


Peri-operative variables were the operating time and the radiation time .


Postoperative variables were wound problems , bone union time , time of recovery to work , the functional American Orthopaedic Foot and Ankle surgery ( AOFAS ) score and removal of hardware .


There was no significant difference in the time to union , the time of recovery to work , function , alignment and total AOFAS scores between the two groups ( P = 0.704 , 0.835 , 0.551 , 0.716 and 0.212 , respectively ) .


The mean operating time and radiation time were longer in the MIPPO group than in the CIEF group ( 85.312.5 vs. 73.212.0 minutes , P = 0.002 , and 3.11.5 vs. 2.11.2 minutes , P = 0.019 , respectively ) .


Wound complications were more common in the MIPPO group ( 18.2 % vs. 0 % with CIEF , P = 0.105 ) .


There was a trend for patients with MIPPO to have a higher incidence of ankle pain ( 31.8 % vs. 9.1 % with CIEF , P = 0.135 ) .


Painful implants were removed in 31.8 % of patients with MIPPO versus 9.1 % with CIEF ( P = 0.135 ) .


Of the 165 self-tapping locking screws of the locking plates seven ( four patients ) were removed with some difficulty because of stripping of the hexagonal recess .


Our results indicated that both CIEF and MIPPO were all efficient methods for treating distal third tibial fractures .


However , CIEF had the advantages of a shorter operating and radiation time , less wound complication and ankle pain , less secondary operations for implant removal and easier removal of the implants .


For patients with type 2 diabetes who do not achieve target glycaemic control with conventional insulin treatment , advancing to a basal-bolus insulin regimen is often recommended .


We aimed to compare the efficacy and safety of long-acting glucagon-like peptide-1 receptor agonist dulaglutide with that of insulin glargine , both combined with prandial insulin lispro , in patients with type 2 diabetes .


We did this 52 week , randomised , open-label , phase 3 , non-inferiority trial at 105 study sites in 15 countries .


Patients ( aged 18 years ) with type 2 diabetes inadequately controlled with conventional insulin treatment were randomly assigned ( 1:1:1 ) , via a computer-generated randomisation sequence with an interactive voice-response system , to receive once-weekly dulaglutide 15 mg , dulaglutide 075 mg , or daily bedtime glargine .


Randomisation was stratified by country and metformin use .


Participants and study investigators were not masked to treatment allocation , but were unaware of dulaglutide dose assignment .


The primary outcome was a change in glycated haemoglobin A1c ( HbA1c ) from baseline to week 26 , with a 04 % non-inferiority margin .


Analysis was by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT01191268 .


Between Dec 9 , 2010 , and Sept 21 , 2012 , we randomly assigned 884 patients to receive dulaglutide 15 mg ( n = 295 ) , dulaglutide 075 mg ( n = 293 ) , or glargine ( n = 296 ) .


At 26 weeks , the adjusted mean change in HbA1c was greater in patients receiving dulaglutide 15 mg ( -164 % [ 95 % CI -178 to -150 ] , -1793 mmol/mol [ -1944 to -1642 ] ) and dulaglutide 075 mg ( -159 % [ -173 to -145 ] , -1738 mmol/mol [ -1889 to -1587 ] ) than in those receiving glargine ( -141 % [ -155 to -127 ] , -1541 mmol/mol [ -1692 to -1390 ] ) .


The adjusted mean difference versus glargine was -022 % ( 95 % CI -038 to -007 , -240 mmol/mol [ -415 to -077 ] ; p = 0005 ) for dulaglutide 15 mg and -017 % ( -033 to -002 , -186 mmol/mol [ -361 to -022 ] ; p = 0015 ) for dulaglutide 075 mg .


Five ( < 1 % ) patients died after randomisation because of septicaemia ( n = 1 in the dulaglutide 15 mg group ) ; pneumonia ( n = 1 in the dulaglutide 075 mg group ) ; cardiogenic shock ; ventricular fibrillation ; and an unknown cause ( n = 3 in the glargine group ) .


We recorded serious adverse events in 27 ( 9 % ) patients in the dulaglutide 15 mg group , 44 ( 15 % ) patients in the dulaglutide 075 mg group , and 54 ( 18 % ) patients in the glargine group .


The most frequent adverse events , arising more often with dulaglutide than glargine , were nausea , diarrhoea , and vomiting .


Dulaglutide in combination with lispro resulted in a significantly greater improvement in glycaemic control than did glargine and represents a new treatment option for patients unable to achieve glycaemic targets with conventional insulin treatment .


Eli Lilly and Company .


The evidence base for effects of nutritional interventions for malnourished HIV-infected patients starting antiretroviral therapy ( ART ) is limited and inconclusive .


We hypothesized that both vitamin and mineral deficiencies and poor appetite limit weight gain in malnourished patients starting ART and that vitamin and mineral supplementation would improve appetite and permit nutritional recovery .


The randomized controlled Nutritional Support for Africans Starting Antiretroviral Therapy trial was conducted in Mwanza , Tanzania , and Lusaka , Zambia .


ART-naive adults referred for ART and with body mass index < 18.5 kg/m received lipid-based nutritional supplements either without ( LNS ) or with added vitamins and minerals ( LNS-VM ) , beginning before ART initiation .


Participants were given 30 g/d LNS from recruitment until 2 weeks after starting ART and 250 g/d from weeks 2 to 6 of ART .


Of 1815 patients recruited , 365 ( 20 % ) died during the study and 813 ( 45 % ) provided data at 12 weeks .


Controlling for baseline values , anthropometric measures were consistently higher at 12-week ART in the LNS-VM than in the LNS group but statistically significant only for calf and mid-upper arm circumferences and triceps skinfold .


Appetite did not differ between groups .


Using piecewise mixed-effects quadratic models including all patients and time points , the main effects of LNS-VM were seen after starting ART and were significant for weight , body mass index , and mid-upper arm circumference .


Provision of high levels of vitamins and minerals to patients referred for ART , delivered with substantial macronutrients , increased nutritional recovery but did not seem to act through treatment group differences in appetite .


Negative effects of dehydration on the human brain and cognitive function have been reported .


In this study , we examined the effects of dehydration on pain thresholds and cortical activations in response to pain , compared with rehydration with an oral rehydration solution ( ORS ) by functional magnetic resonance imaging .


Five healthy adult men were subjected to dehydration and rehydration on 2 different days .


The condition on the first day was randomly assigned to each subject .


They completed a 40-minute exercise protocol using a walking machine after 12 hours of fasting under both conditions .


For rehydration , the subjects consumed up to 3000 mL ORS starting from the night before the test day .


After exercise , a painful stimulus ( cold pressor test ) was applied to the subjects ' medial forearm in a magnetic resonance imaging scanning gantry , and pain-evoked brain activation was analyzed .


On the rehydration day , each of the subjects consumed an average of 2040 mL ( range ; 1800-2500 mL ) ORS .


Physiological data revealed that subjects when dehydrated lost more weight from exercise than subjects when rehydrated had a larger heart rate increase , a higher tympanic temperature , and a higher urine osmolality .


Subjective data revealed that the subjects reported significantly stronger thirst while dehydrated than while rehydrated with ORS , although the levels of hunger and anxiety and mood did not significantly differ between conditions .


The cold pressor test robustly activated the pain-related neural network , notably the anterior cingulate cortex , insula , and thalamus .


Such activations in the dehydrated subjects were greater than those in the rehydrated subjects in terms of peak and cluster , accompanied by a decrease in pain threshold ( P = 0.001 ) .


Our findings suggest that dehydration brings about increased brain activity related to painful stimuli together with enhanced thirst , whereas rehydration with ORS alleviates thirst and decreases brain activity related to painful stimuli .


During emergence from anesthesia , breathing 100 % oxygen is frequently used to provide a safety margin toward hypoxemia in case an airway problem occurs .


Oxygen breathing has been shown to cause pulmonary gas exchange disorders in healthy individuals .


This study investigates how oxygen breathing during emergence affects lung function specifically whether oxygen breathing causes added hypoxemia in patients with chronic obstructive pulmonary disease .


This trial has been conducted in a parallel-arm , case-controlled , open-label manner .


Fifty-three patients with chronic obstructive pulmonary disease were randomly allocated ( computer-generated lists ) to breathe either 100 or 30 % oxygen balanced with nitrogen during emergence from anesthesia .


Arterial blood gas measurements were taken before induction and at 5 , 15 , and 60 min after extubation .


All participants tolerated the study well .


Patients treated with 100 % oxygen had a higher alveolar-arterial oxygen pressure gradient ( primary outcome ) compared with patients treated with 30 % oxygen ( 25 vs. 20 mmHg ) and compared with their baseline at the 60-min measurement ( 25 vs. 17 mmHg ) .


At the 60-min measurement , arterial partial pressure of oxygen was lower in the 100 % group ( 62 vs. 67 mmHg ) .


Arterial partial pressure of carbon dioxide and pH were not different between groups or measurements .


In this experiment , the authors examined oxygen breathing during emergence-a widely practiced maneuver known to generate pulmonary blood flow heterogeneity .


In the observed cohort of patients already presenting with pulmonary blood flow disturbances , emergence on oxygen resulted in deterioration of oxygen-related blood gas parameters .


In the perioperative care of patients with chronic obstructive pulmonary disease , oxygen breathing during emergence from anesthesia may need reconsideration .


Rifampicin is a potent inducer of P-glycoprotein ( P-gp ) and inhibitor of organic anion-transporting polypeptides ( OATPs ) , with fexofenadine acting as a substrate for both mechanisms .


Simultaneous administration of single - or multiple-dose rifampicin 600 mg significantly increases the concentrations of fexofenadine enantiomers by inhibiting OATP transporters .


However , the effects of rifampicin 450 mg are unknown .


Here , we evaluated the effects of multiple doses of rifampicin 450 mg on the pharmacokinetics of fexofenadine enantiomers in healthy Japanese volunteers .


In this randomized , two-phase , double-blind crossover study , 10 healthy volunteers received rifampicin 450 mg/day or placebo for 7 days .


On day 7 , fexofenadine 60 mg was co-administered simultaneously .


Rifampicin significantly increased the mean area under the plasma concentration-time curve ( AUC ) of ( R ) - and ( S ) - fexofenadine ( 3.10-fold and 3.48-fold , respectively ) and decreased the renal clearance of ( R ) - and ( S ) - fexofenadine ( 0.40-fold and 0.47-fold , respectively ) , causing marked differences in the mean amounts of these enantiomers excreted into the urine in the rifampicin phase ( P < 0.001 ) .


These results indicated that multiple doses of rifampicin 450 mg may be sufficient to inhibit the renal influx transporter and OATP-mediated hepatic uptake of both enantiomers .


Moreover , these effects may be greater than the P-gp-inductive effects of rifampicin .


Therefore , the interactive mechanism of multidose rifampicin may occur through a combination of OATP and P-gp transporters , thereby altering the pharmacokinetics of fexofenadine enantiomers .


In this study of rifampicin 450 mg , the interactive magnitude of the mean AUC values of fexofenadine enantiomers was higher than that observed in the previous study of rifampicin 600 mg , and no dose-dependent inhibitory effects of rifampicin were observed .


These effects may be clinically significant in patients receiving fexofenadine and rifampicin .


Since oxidative stress plays a pathogenetic role in chronic neck pain ( CNP ) , we investigated whether a combination of - lipoic acid ( ALA ) and superoxide dismutase ( SOD ) might improve pain control and the efficacy of physiotherapy ( `` multimodal therapy '' ) in patients with CNP .


This study was conducted in the Rehabilitation Unit of the Department of Surgical and Oncological Sciences at the University Policlinic in Palermo , Italy .


This was a prospective , randomized , open study in outpatients .


Patients randomly received either physiotherapy alone ( group 2 ; n = 45 ) or a combination of ALA 600 mg and SOD 140 IU daily in addition to physiotherapy ( group 1 ; n = 51 ) , for 60 days .


Pain was assessed by a visual analogue scale ( VAS ) and a modified Neck Pain Questionnaire ( mNPQ ) .


Treatment compliance and safety were also evaluated .


Both groups experienced a significant reduction in the VAS and mNPQ scores after 1 month ; however , while no further improvement was observed in group 2 at 60 days , group 1 showed a further VAS reduction ( p < 0.001 ) .


In addition , in the mNPQ at 60 days , more patients in group 1 than in group 2 reported that their neck pain was improved ( p < 0.01 ) , and they showed greater compliance with prescribed physiotherapy ( p = 0.048 ) .


No drug reaction was observed .


Use of ALA/SOD in combination with physiotherapy may be a useful approach to CNP , being antioxidants that act on nerve inflammation and disease progression .


These preliminary observations suggest that some interesting goals ( better pain control and physical wellbeing ) can be achieved by multimodal therapy in CNP patients .


To identify whether advanced cancer patients receiving home hospice care and their primary caregivers view artificial hydration ( AH ) as food or medicine , and the demographic and clinical factors influencing these perceptions .


Participants were enrolled in a randomised , double-blind controlled trial examining the efficacy of AH in cancer hospice patients .


In-depth interviews at days 1 and 4 of study enrolment explored the meanings attributed to AH at the end of life .


Responses to the question , ` Are these fluids more like food or more like medicine ? '


were categorised as ` food ' , ` medicine ' , ` both ' or ` other ' .


( 2 ) analyses were conducted with data from 122 interviews ( 54 patients and 68 caregivers ) to identify differences between patients and caregivers , and by gender , age , ethnicity and caregiver relationship .


Predictors of perceptions were identified using logistic regression analysis .


Overall , 47 participants ( 38 % ) understood the fluids to be more like food , 41 ( 34 % ) as medicine , 17 ( 14 % ) as both , and 17 ( 14 % ) as ` other ' .


Ethnic minority participants ( n = 34 , 66 % ) were significantly more likely than non-Hispanic European Americans ( n = 30 , 42 % ) to view AH as food , or both as food and medicine ( p = 0.034 ) .


Ethnic differences persisted in the final regression model ( OR 2.7 ; 95 % CI 1.3 to 5.7 , p = 0.010 ) .


No significant differences were detected between patients and caregivers , or across gender , age , caregivers ' relationship to the patients , group assignment , disease severity or cancer type .


AH was perceived as food/nutrition by many cancer patients and caregivers in the study , particularly among ethnic minorities .


This perception may lead to greater distress if fluids are discontinued or withheld .


Asking patients/caregivers about their AH perceptions may enhance patient/provider communication and culturally appropriate end-of-life care .


Whether prasugrel plus bivalirudin is a superior strategy to unfractionated heparin plus clopidogrel in patients with ST-segment elevation myocardial infarction ( STEMI ) undergoing primary percutaneous coronary intervention ( PCI ) has never been assessed in specifically designed randomized trials .


The Bavarian Reperfusion Alternatives Evaluation ( BRAVE ) 4 study is an investigator-initiated , randomized , open-label , multicentre trial , designed to test the hypothesis that in STEMI patients with planned primary PCI a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus heparin in terms of net clinical outcome .


Owing to slow recruitment , the trial was stopped prematurely after enrolment of 548 of 1240 planned patients .


At 30 days , the primary composite endpoint of death , myocardial infarction , unplanned revascularization of the infarct related artery , stent thrombosis , stroke , or bleeding was observed in 42 patients ( 15.6 % ) randomized to prasugrel plus bivalirudin and 40 patients ( 14.5 % ) randomized to clopidogrel plus heparin [ relative risk , 1.09 ; one-sided 97.5 % confidence interval ( CI ) 0-1 .79 , P = 0.680 ] .


The composite ischaemic endpoint of death , myocardial infarction , unplanned revascularization of the infarct-related artery , stent thrombosis , or stroke occurred in 13 patients ( 4.8 % ) in the prasugrel plus bivalirudin group and 15 patients ( 5.5 % ) in the clopidogrel plus heparin group ( relative risk , 0.89 ; 95 % CI 0.40-1 .96 , P = 0.894 ) .


Bleeding according to the HORIZONS-AMI definition was observed in 38 patients ( 14.1 % ) in the prasugrel plus bivalirudin group and 33 patients ( 12.0 % ) in the clopidogrel plus heparin group ( relative risk , 1.18 ; 95 % CI 0.74-1 .88 , P = 0.543 ) .


Results were consistent across various subgroups of patients .


In this randomized trial of STEMI patients , we were unable to demonstrate significant differences in net clinical outcome between prasugrel plus bivalirudin and clopidogrel plus heparin .


Neither the composite of ischaemic complications nor bleeding were favourably affected by prasugrel plus bivalirudin compared with a regimen of clopidogrel plus unfractionated heparin .


However , the results must be interpreted in view of the premature termination of the trial .


Unique identifier NCT00976092 ( www.clinicaltrials.gov ) .


The ABCB1 gene encodes P-glycoprotein , which limits brain concentrations of certain antidepressants .


ABCB1 variation has been associated with antidepressant efficacy and side effects in small-sample studies .


Cognitive impairment in major depressive disorder predicts poor treatment outcome , but ABCB1 genetic effects in patients with cognitive impairment are untested .


The authors examined ABCB1 genetic variants as predictors of remission and side effects in a large clinical trial that also incorporated cognitive assessment .


The authors genotyped 10 ABCB1 single-nucleotide polymorphisms ( SNPs ) in 683 patients with major depressive disorder treated for at least 2 weeks , of whom 576 completed 8 weeks of treatment with escitalopram , sertraline , or extended-release venlafaxine ( all substrates for P-glycoprotein ) in a large randomized , prospective , pragmatic trial .


Antidepressant efficacy was assessed with the 16-item Quick Inventory of Depressive Symptomatology-Self-Rated ( QIDS-SR ) , and side effects with a rating scale for frequency , intensity , and burden of side effects .


General and emotional cognition was assessed with a battery of 13 tests .


The functional SNP rs10245483 upstream from ABCB1 had a significant effect on remission and side effect ratings that was differentially related to medication and cognitive status .


Common homozygotes responded better and had fewer side effects with escitalopram and sertraline .


Minor allele homozygotes responded better and had fewer side effects with venlafaxine , with the better response most apparent for patients with cognitive impairment .


The functional polymorphism rs10245483 differentially affects remission and side effect outcomes depending on the antidepressant .


The predictive power of the SNP for response or side effects was not lessened by the presence of cognitive impairment .


Currently there is no evidence on the effectiveness of Individual Placement and Support ( IPS ) in Sweden .


To determine the effectiveness of IPS on vocational outcomes among people with severe mental illness ( SMI ) in a Swedish context .


A secondary aim was to evaluate a community integration effect .


A randomized controlled trial with a parallel design was used .


Mental health outpatients with SMI were randomized to IPS or traditional vocational rehabilitation ( TVR ) services .


The allocation status was assessor-blinded .


The primary outcome was competitive employment .


All vocational outcomes were collected continuously , and socio-demographic and clinical variables at baseline , 6 and 18 months .


The trial is registered with ClinicalTrials.gov : NCT00960024 .


One hundred and twenty participants were randomized .


Eighty seven per cent were assessed after 6 months , and 73 % after 18 months .


IPS was more effective than TVR in terms of gaining employment at 18-month follow-up ( 46 % vs. 11 % ; difference 36 % , 95 % CI 18-54 ) , along with the amount of working hours and weeks , longer job tenure periods and income .


Cox regression analysis showed that IPS participants gained employment five times quicker than those in TVR .


Ninety per cent of the IPS participants became involved in work , internships or education , i.e. activities integrated in mainstream community settings , while 24 % in the TVR group achieved this .


IPS is effective in a Swedish context in terms of gaining employment and becoming integrated within the local community .


The welfare system presented obstacles for gaining competitive employment directly and it was indicated that internships delayed time to first competitive employment .


Treatments for open-angle glaucoma aim to prevent vision loss through lowering of intraocular pressure , but to our knowledge no placebo-controlled trials have assessed visual function preservation , and the observation periods of previous ( unmasked ) trials have typically been at least 5 years .


We assessed vision preservation in patients given latanoprost compared with those given placebo .


In this randomised , triple-masked , placebo-controlled trial , we enrolled patients with newly diagnosed open-angle glaucoma at ten UK centres ( tertiary referral centres , teaching hospitals , and district general hospitals ) .


Eligible patients were randomly allocated ( 1:1 ) with a website-generated randomisation schedule , stratified by centre and with a permuted block design , to receive either latanoprost 0005 % ( intervention group ) or placebo ( control group ) eye drops .


Drops were administered from identical bottles , once a day , to both eyes .


The primary outcome was time to visual field deterioration within 24 months .


Analyses were done in all individuals with follow-up data .


The Data and Safety Monitoring Committee ( DSMC ) recommended stopping the trial on Jan 6 , 2011 ( last patient visit July , 2011 ) , after an interim analysis , and suggested a change in primary outcome from the difference in proportions of patients with incident progression between groups to time to visual field deterioration within 24 months .


This trial is registered , number ISRCTN96423140 .


We enrolled 516 individuals between Dec 1 , 2006 , and March 16 , 2010 .


Baseline mean intraocular pressure was 196 mm Hg ( SD 46 ) in 258 patients in the latanoprost group and 201 mm Hg ( 48 ) in 258 controls .


At 24 months , mean reduction in intraocular pressure was 38 mm Hg ( 40 ) in 231 patients assessed in the latanoprost group and 09 mm Hg ( 38 ) in 230 patients assessed in the placebo group .


Visual field preservation was significantly longer in the latanoprost group than in the placebo group : adjusted hazard ratio ( HR ) 044 ( 95 % CI 028-069 ; p = 00003 ) .


We noted 18 serious adverse events , none attributable to the study drug .


This is the first randomised placebo-controlled trial to show preservation of the visual field with an intraocular-pressure-lowering drug in patients with open-angle glaucoma .


The study design enabled significant differences in vision to be assessed in a relatively short observation period .


Pfizer , UK National Institute for Health Research Biomedical Research Centre .


To explore the therapeutic effect of Neurac training on patients with cervical radiculopathy ( CR ) .


Sixty patients with CR were enrolled and randomly assigned into control group ( CG ) and Neurac training group ( NG ) with 30 patients for each group .


The patients in CG group received conventional treatments for 2 weeks , including cervical traction , manual therapy and electrical therapy .


The patients in NG group received Neurac training as well as conservative treatments for 2 weeks .


The pain level and it impact on daily life were assessed by the numerical pain rating scale ( NPRS ) and the neck disability index ( NDI ) before the treatments and at the time of 1 week , 2 weeks after the treatments , respectively .


Following the treatment , significant improvements for NPRS and NDI were observed in both the two groups at the end of the first and second week .


The improvements for both NPRS and NDI were higher in the NG than those in the CG , with P < 0.05 .


The results of this study indicate that Neurac training can bring additional therapeutic benefits to conventional treatments for patients with CR .


Implementation of interventions in real-life settings requires a comprehensive evaluation approach .


The aim of this article is to describe the evaluation design of the SLIMMER diabetes prevention intervention in a Dutch real-life setting .


The SLIMMER study is a randomised , controlled intervention study including subjects aged 40 through 70years with impaired fasting glucose or high risk of diabetes .


The 10-month SLIMMER intervention involves a dietary and physical activity intervention , including case management and a maintenance programme .


The control group receives usual health care and written information about a healthy lifestyle .


A logic model of change is composed to link intervention activities with intervention outcomes in a logical order .


Primary outcome is fasting insulin .


Measurements are performed at baseline and after 12 and 18months and cover quality of life , cardio-metabolic risk factors ( e.g. glucose tolerance , serum lipids , body fatness , and blood pressure ) , eating and physical activity behaviour , and behavioural determinants .


A process evaluation gives insight in how the intervention was delivered and received by participants and health care professionals .


The economic evaluation consists of a cost-effectiveness analysis and a cost-utility analysis .


Costs are assessed from both a societal and health care perspective .


This study is expected to provide insight in the effectiveness , including its cost-effectiveness , and delivery of the SLIMMER diabetes prevention intervention conducted in Dutch primary health care .


Results of this study provide valuable information for primary health care professionals , researchers , and policy makers .


The SLIMMER study is registered with ClinicalTrials.gov ( NCT02094911 ) since March 19 , 2014 .


Unconditional regard refers to the feeling that one is accepted and valued by others without conditions .


Psychological theory suggests that experiences of unconditional regard lead children to feel that they are valuable despite setbacks .


We hypothesized that reflecting on experiences of unconditional regard would buffer children 's negative self-feelings ( eg , shame , insecurity , powerlessness ) in the face of setbacks .


To test this hypothesis , we randomized children to reflect on experiences of unconditional regard or other experiences , and examined their response to an academic setback 3 weeks later .


Participants ( 11-15 years old ) were randomly assigned to reflect for 15 minutes on experiences of unconditional regard ( n = 91 ) , conditional regard ( n = 80 ) , or other social experiences ( n = 76 ) .


Research personnel , teachers , and classmates remained blind to condition assignment .


Three weeks later , after receiving their course grades , children reported their self-feelings .


Course grades were obtained from school records .


Receiving low course grades represents a salient and painful real-world setback for children .


Replicating previous research , children who received lower grades experienced more negative self-feelings ( P < .001 ) .


As predicted , this well-established relationship was significantly attenuated among children who had reflected , 3 weeks previously , on experiences of unconditional regard ( Ps < .03 ) .


Reflecting on unconditional regard specifically reduced negative self-feelings after low grades ( P = .01 ) , not after average or high grades ( Ps > .17 ) .


Reflecting on unconditional regard buffered children 's selves against the adverse impact of an academic setback over an extended period of time .


Unconditional regard may thus be an important psychological lever to reduce negative self-feelings in youth .


The intestine efficiently incorporates and rapidly secretes dietary fat as chylomicrons ( lipoprotein particles comprising triglycerides , phospholipids , cholesterol , and proteins ) that contain the apolipoprotein isoform apoB-48 .


The gut can store lipids for many hours after their ingestion , and release them in chylomicrons in response to oral glucose , sham feeding , or unidentified stimuli .


The gut hormone glucagon-like peptide-2 ( GLP-2 ) facilitates intestinal absorption of lipids , but its role in chylomicron secretion in human beings is unknown .


We performed a randomized , single-blind , cross-over study , with 2 study visits 4 weeks apart , to assess the effects of GLP-2 administration on triglyceride-rich lipoprotein ( TRL ) apoB-48 in 6 healthy men compared with placebo .


Subjects underwent constant intraduodenal feeding , with a pancreatic clamp and primed constant infusion of deuterated leucine .


In a separate randomized , single-blind , cross-over validation study , 6 additional healthy men ingested a high-fat meal containing retinyl palmitate and were given either GLP-2 or placebo 7 hours later with measurement of TRL triglyceride , TRL retinyl palmitate , and TRL apoB-48 levels .


GLP-2 administration resulted in a rapid ( within 30 minutes ) and transient increase in the concentration of TRL apoB-48 , compared with placebo ( P = .03 ) .


Mathematic modeling of stable isotope enrichment and the mass of the TRL apoB-48 suggested that the increase resulted from the release of stored , presynthesized apoB-48 from the gut .


In the validation study , administration of GLP-2 at 7 hours after the meal , in the absence of additional food intake , robustly increased levels of TRL triglycerides ( P = .007 ) , TRL retinyl palmitate ( P = .002 ) , and TRL apoB-48 ( P = .04 ) compared with placebo .


Administration of GLP-2 to men causes the release of chylomicrons that comprise previously synthesized and stored apoB-48 and lipids .


This transiently increases TRL apoB-48 levels compared with placebo .


Clinical trials number at www.clinicaltrials.gov : NCT 01958775 .


To determine the effects of high-dose vitamin D on insulin sensitivity in polycystic ovary syndrome ( PCOS ) .


Randomized , placebo-controlled trial .


Academic medical center .


Twenty-eight women with PCOS .


Vitamin D3 , 12,000 IU , or placebo daily for 12 weeks .


The primary outcome was quantitative insulin sensitivity check index .


Secondary outcomes included glucose and insulin levels during a 75-g oral glucose tolerance test and blood pressure .


Twenty-two women completed the study .


Compared with placebo , vitamin D significantly increased 25-hydroxyvitamin D ( mean [ 95 % confidence interval ] in vitamin D group 20.1 [ 15.7 to 24.5 ] ng/mL at baseline and 65.7 [ 52.3 to 79.2 ] ng/mL at 12 weeks ; placebo 22.5 [ 18.1 to 26.8 ] ng/mL at baseline and 23.8 [ 10.4 to 37.2 ] ng/mL at 12 weeks ) .


There were no significant differences in quantitative insulin sensitivity check index and other measures of insulin sensitivity ; however , we observed trends toward lower 2-hour insulin and lower 2-hour glucose .


We also observed a protective effect of vitamin D on blood pressure .


In women with PCOS , insulin sensitivity was unchanged with high-dose vitamin D , but there was a trend toward decreased 2-hour insulin and a protective effect on blood pressure .


NCT00907153 .


The 2012 Guidelines for Diagnosis and Management of Patients with Stable Ischemic Heart Disease recommend intensive antianginal and risk factor treatment ( optimal medical management [ OMT ] ) before considering revascularization to relieve symptoms .


The Bypass Angioplasty Revascularization Investigation 2 Diabetes ( BARI 2D ) trial randomized patients with ischemic heart disease and anatomy suitable to revascularization to ( 1 ) initial OMT with revascularization if needed or ( 2 ) initial revascularization plus OMT and found no difference in major cardiovascular events .


Ultimately , however , 37.9 % of the OMT group was revascularized during the 5-year follow-up period .


Data from the 1192 patients randomized to OMT were analyzed to identify subgroups in which the incidence of revascularization was so high that direct revascularization without a trial period could be justified .


Multivariate logistic analysis , Cox regression models of baseline data , and a landmark analysis of participants who did not undergo revascularization at 6 months were constructed .


The models that used only data available at the time of study entry had limited predictive value for revascularization by 6 months or by 5 years ; however , the model incorporating severity of angina during the first 6 months could better predict revascularization ( C statistic = 0.789 ) .


With the possible exception of patients with severe angina and proximal left anterior descending artery disease , this analysis supports the recommendation of the 2012 guidelines for a trial of OMT before revascularization .


Patients could not be identified at the time of catheterization , but a short period of close follow-up during OMT identified the nearly 40 % of patients who underwent revascularization .


There is no head on comparison of amitriptyline ( AMT ) and pregabalin ( PG ) in relieving pain and disability in chronic low backache ( CLBA ) .


This randomized controlled trial reports the efficacy and safety of AMT and PG in CLBA .


Patients with CLBA , 15-65 years of age without specific cause and significant neurological deficit were included .


Severity of pain was assessed by Visual Analogue Scale ( VAS ) and disability by Oswestry Disability Index ( ODI ) .


Patients were followed up at 6 and 14 weeks and their VAS score , ODI and side effect were noted .


Primary outcome was pain relief ( > 50 % improvement in VAS score ) at 14 weeks and secondary outcome were reduction in ODI ( > 20 % ) and side effects .


200 patients with CLBA were randomized to AMT ( n = 103 ) and PG ( n = 97 ) using random numbers .


The VAS score and ODI improved significantly following AMT and PG at 6 and 14 weeks compared to baseline .


The improvement in pain ( 57.3 % Vs 39.2 % ; P = 0.01 ) and disability ( 65 % Vs 49.5 % ; P = 0.03 ) however was more in AMT group .


The composite side effects were similar in both groups .


AMT and PG are effective in CLBA but AMT reduced pain and disability significantly compared to PG .


Neck pain , common among the elderly population , has considerable implications on health and quality of life .


Evidence supports the use of spinal manipulative therapy ( SMT ) and exercise to treat neck pain ; however , no studies to date have evaluated the effectiveness of these therapies specifically in seniors .


To assess the relative effectiveness of SMT and supervised rehabilitative exercise , both in combination with and compared to home exercise ( HE ) alone for neck pain in individuals ages 65 years or older .


Randomized clinical trial .


Individuals 65 years of age or older with a primary complaint of mechanical neck pain , rated 3 ( 0-10 ) for 12 weeks or longer in duration .


Patient self-report outcomes were collected at baseline and 4 , 12 , 26 , and 52 weeks after randomization .


The primary outcome was pain , measured by an 11-box numerical rating scale .


Secondary outcomes included disability ( Neck Disability Index ) , general health status ( Medical Outcomes Study Short Form-36 ) , satisfaction ( 7-point scale ) , improvement ( 9-point scale ) , and medication use ( days per week ) .


This study was funded by the US Department of Health and Human Services , Health Resources and Services Administration .


Linear mixed model analyses were used for comparisons at individual time points and for short - and long-term analyses .


Blinded evaluations of objective outcomes were performed at baseline and 12 weeks .


Adverse event data were collected at each treatment visit .


A total of 241 participants were randomized , with 95 % reporting primary outcome data at all time points .


After 12 weeks of treatment , the SMT with home exercise group demonstrated a 10 % greater decrease in pain compared with the HE-alone group , and 5 % change over supervised plus home exercise .


A decrease in pain favoring supervised plus HE over HE alone did not reach statistical significance .


Compared with the HE group , both combination groups reported greater improvement at week 12 and more satisfaction at all time points .


Multivariate longitudinal analysis incorporating primary and secondary patient-rated outcomes showed that the SMT with HE group was superior to the HE-alone group in both the short - and long-term .


No serious adverse events were observed as a result of the study treatments .


SMT with HE resulted in greater pain reduction after 12 weeks of treatment compared with both supervised plus HE and HE alone .


Supervised exercise sessions added little benefit to the HE-alone program .


To evaluate the safety , effectiveness and compliance of Bronuck ( bromfenac sodium ophthalmic solution 0.1 % ) following LASEK in comparison with glucocorticoids .


In this prospective trial , 60 patients ( 120 eyes ) undergoing LASEK were randomized into the bromfenac sodium group ( 60 eyes ) and control group ( 60 eyes ) .


Patients in both groups initially received dexamethasone 0.1 % four times a day after LASEK for 7 days , and then the patients in the bromfenac sodium group were given Bronuck twice a day for the next 11 weeks , while the patients from the control group were given fluorometholone 0.1 % with gradually decreased doses during the same period .


Results of the routine examinations done before and 3 , 10 , 30 , 90 and 180 days after LASEK were recorded , including uncorrected visual acuity , best corrected visual acuity , intraocular pressure ( IOP ) , corneal topography , ocular symptoms and signs , which were used for comparison between the two groups .


All data of right eyes were analyzed for their independence , normality and homogeneity of variance .


Independent samples t-test or non-parametric Mann-Whitney test was performed accordingly .


There was no statistically significant difference in IOP and corneal topography ( K1 , K2 , SAI , SRI and CY ) between the two groups postoperatively .


The IOP was ( 16.33 6.21 ) mmHg ( 1 mmHg = 0.133 kPa ) , ( 15.67 2.82 ) mmHg , ( 15.35 2.22 ) mmHg and ( 13.10 3.41 ) mmHg in the bromfenac sodium group , and ( 16.87 3.68 ) mmHg , ( 14.05 2.23 ) mmHg , ( 14.39 2.22 ) mmHg and ( 13.18 2.49 ) mmHg in the control group at 10 , 30 , 90 and 180 days , respectively .


The bromfenac sodium group showed significantly better uncorrected visual acuity ( 5.16 0.08 ) than the control group ( 5.02 0.09 ) on day 30 ( t = 2.32 , P < 0.05 ) .


In the bromfenac sodium group , four eyes had visual fatigue , and four eyes had dry eye symptoms on day 180 .


Epithelial flaps were all well positioned with satisfying healing process .


Each group had one case ( two eyes ) of haze on day 30 , and the bromfenac sodium group had another case ( 2 eyes ) of new-onset haze on day 60 .


But all the cases of haze were graded 0.5 according to the Fantes Standard , too mild to compromise their visual acuities , and were resolved after frequent topical medication for 1 month .


Four patients from the control group were prescribed antiglaucoma medications due to elevated IOP .


The refractive status remained stable for patients from both groups .


Administration of Bronuck can reduce the amount of or partially substitute for corticosteroids .


Mild haze early after LASEK may disappear after intensive treatment .


In vitro and animal model data suggest that intraoperative preservation solutions may influence endothelial function and vein graft failure ( VGF ) after coronary artery bypass graft ( CABG ) surgery .


Clinical studies to validate these findings are lacking .


To evaluate the effect of vein graft preservation solutions on VGF and clinical outcomes in patients undergoing CABG surgery .


Data from the Project of Ex-Vivo Vein Graft Engineering via Transfection IV ( PREVENT IV ) study , a phase 3 , multicenter , randomized , double-blind , placebo-controlled trial that enrolled 3014 patients at 107 US sites from August 1 , 2002 , through October 22 , 2003 , were used .


Eligibility criteria for the trial included CABG surgery for coronary artery disease with at least 2 planned vein grafts .


Preservation of vein grafts in saline , blood , or buffered saline solutions .


One-year angiographic VGF and 5-year rates of death , myocardial infarction , and subsequent revascularization .


Most patients had grafts preserved in saline ( 1339 [ 44.4 % ] ) , followed by blood ( 971 [ 32.2 % ] ) and buffered saline ( 507 [ 16.8 % ] ) .


Baseline characteristics were similar among groups .


One-year VGF rates were much lower in the buffered saline group than in the saline group ( patient-level odds ratio [ OR ] , 0.59 [ 95 % CI , 0.45-0 .78 ; P < .001 ] ; graft-level OR , 0.63 [ 95 % CI , 0.49-0 .79 ; P < .001 ] ) or the blood group ( patient-level OR , 0.62 [ 95 % CI , 0.46-0 .83 ; P = .001 ] ; graft-level OR , 0.63 [ 95 % CI , 0.48-0 .81 ; P < .001 ] ) .


Use of buffered saline solution also tended to be associated with a lower 5-year risk for death , myocardial infarction , or subsequent revascularization compared with saline ( hazard ratio , 0.81 [ 95 % CI , 0.64-1 .02 ; P = .08 ] ) and blood ( 0.81 [ 0.63-1 .03 ; P = .09 ] ) solutions .


Patients undergoing CABG whose vein grafts were preserved in a buffered saline solution had lower VGF rates and trends toward better long-term clinical outcomes compared with patients whose grafts were preserved in saline - or blood-based solutions .


clinicaltrials.gov Identifier : NCT00042081 .


Fatigue is the most common and disabling symptom affecting quality of life ( QOL ) and daily function in patients who have completed treatment for acute myeloid leukemia ( AML ) .


Although trials in patients with various solid tumors have reported improved fatigue and QOL following exercise interventions , there have been no studies in AML patients post treatment .


Forty patients aged 40 years who had completed treatment for AML were enrolled in a 12-week randomized phase II exercise intervention to determine feasibility ( recruitment , retention , and adherence ) , efficacy , and safety of the intervention .


Patients assigned to the exercise group received an individualized , moderate-intensity , 12-week home-based exercise program with weekly telephone support from a certified exercise physiologist .


QOL , fatigue , and fitness outcomes were measured at baseline , 6 weeks , and 12 weeks .


Between-group differences in 12-week change scores were calculated using linear regression adjusting for age and baseline function .


Recruitment and retention rates were 38 % and 91 % , respectively .


Adherence was low at 28 % .


Analyses did not suggest statistically significant or clinically important benefits in QOL , fatigue , or physical fitness with the intervention .


The level of adherence did not appear to impact outcomes .


There were no adverse events .


A home-based exercise program for post-treatment AML patients age 40 years or older can be safely delivered with reasonable recruitment and high retention .


However , feasibility was hampered by low adherence .


Further research and program modification are needed to better understand and overcome barriers to exercise delivery and adherence in AML survivors .


To evaluate the 3-year clinical durability of the flowable bulk-fill resin composite SDR in Class I and Class II restorations .


Thirty-eight pairs of Class I and 62 pairs of Class II restorations were placed in 44 male and 42 female patients ( mean age 52.4 years ) .


Each patient received at least two extended Class I or Class II restorations that were as similar as possible .


In all cavities , a one-step self-etching adhesive ( XenoV + ) was applied .


One of the cavities of each pair was randomly assigned to receive the flowable bulk-fill resin composite SDR in increments up to 4 mm as needed to fill the cavity 2 mm short of the occlusal cavosurface .


The occlusal part was completed with an ormocer-based nanohybrid resin composite ( Ceram X mono + ) .


In the other cavity , only the resin composite CeramX mono + was placed in 2 mm increments .


The restorations were evaluated using slightly modified USPHS criteria at baseline and then annually for 3 years .


Caries risk and bruxing habits of the participants were estimated .


No post-operative sensitivity was reported .


At the 3-year follow-up , 196 restorations - 74 Class I and 122 Class II - were evaluated .


Seven restorations failed ( 3.6 % ) , 4 SDR-CeramX mono + and 3 CeramX mono + only restorations , all of which were Class II .


The main reason for failure was tooth fracture , followed by resin composite fracture .


The annual failure rate ( AFR ) for all restorations ( Class I and II ) was 1.2 % for the bulkfilled restorations and 1.0 % for the resin composite-only restorations ( p > 0.05 ) .


For the Class II restorations , the AFR was 2.2 % and 1.6 % , respectively .


The 4-mm bulk-fill technique showed good clinical effectiveness during the 3-year follow-up .


Tadalafil significantly improves lower urinary tract symptoms suggestive of benign prostatic hyperplasia .


We post hoc characterized changes in the maximum urinary flow rate using integrated data from 4 international , placebo controlled studies of tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia .


After a 4-week placebo lead-in period 1,500 men were randomized to tadalafil 5 mg or placebo for 12 weeks .


Data were analyzed using ANCOVA .


Maximum urinary flow rate values were rank transformed for analysis .


Baseline maximum urinary flow rate data were available on 1,371 men with a mean age of 63.1 years and end point data were available on 1,197 .


Tadalafil 5 mg significantly increased maximum urinary flow vs placebo ( median 1.1 vs 0.4 ml per second , p = 0.003 ) .


At a baseline voided volume of 125 to less than 250 ml the median change in the maximum urinary flow rate was 0.9 and 1.2 ml per second ( p = 0.142 ) in 731 patients , at a baseline of 250 to 450 ml the change was -0.3 and 0.7 ml per second ( p = 0.011 ) in 428 , and at a baseline of greater than 450 ml the change was -0.2 and 2.0 ml per second ( p = 0.186 ) in 38 for placebo and tadalafil , respectively .


The difference was 0.3 , 1.0 and 2.2 ml per second , respectively .


At a baseline maximum urinary flow rate of greater than 15 ml per second in 128 patients the median flow rate change was -2.1 and -0.8 ml per second ( p = 0.246 ) , at a maximum of 10 to 15 ml per second in 522 the change was 0.2 and 0.8 ml per second ( p = 0.044 ) , and at a maximum of less than 10 ml per second in 547 the change was 1.2 and 1.8 ml per second ( p = 0.189 ) for placebo and tadalafil , respectively .


Tadalafil improved I-PSS ( International Prostate Symptom Score ) voiding subscores significantly vs placebo across all baseline maximum urinary flow subgroups ( each p < 0.001 ) .


This integrated analysis revealed a small but statistically significant median maximum urinary flow rate improvement for tadalafil vs placebo .


The numerical difference in the maximum urinary flow change from baseline between tadalafil and placebo increased with increased voided volume .


It has been hypothesized that incomplete endothelialization and delayed vascular healing may trigger stent thrombosis events after drug-eluting stent ( DES ) implantation .


We aimed to demonstrate non-inferiority in terms of neointimal coverage of novel Cre8 DES at 3 months , compared to Vision/Multilink8 Bare Metal Stent ( BMS ) at 1month .


The ranDomizEd coMparisOn betweeN novel Cre8 DES and BMS to assess neoinTimal coveRAge by OCT Evaluation ( DEMONSTRATE ) was a multicenter , randomized , parallel group study .


Thirty-eight patients undergoing angioplasty of de-novo coronary lesion were randomized to Cre8 ( 19 ) or Vision/Multilink8 ( 19 ) stent placement at 6 OCT-experienced centers .


Primary end-point was the Ratio of Uncovered to Total Stent Struts Per Cross Section ( RUTTS ) score of < 30 % , determined by OCT at 3 and 1 months for Cre8 and Vision/Multilink8 , respectively .


Percentage of uncovered/malapposed stent struts , neointimal growth and thickness were the main secondary end-points .


The primary end-point of RUTTS score < 30 % occurred in 99.8 % ( 899/901 ) of Cre8 struts and in 99.6 % ( 1116/1121 ) of Vision/Multilink8 struts ( difference 0.2 , CI 95 % -0.2 to 0.6 , p for noninferiority < 0.001 ) .


The percentage of uncovered/malapposed struts was comparable ( 0.360.64 vs. 0.120.24 , p = 0.145 ) in the two study groups , while both neointimal percentage area ( 8.465.29 vs. 19.8415.93 , p < 0.001 ) and thickness ( 0.070.04 vs. 0.160.12 , p < 0.001 ) were significantly reduced by Cre8 stent .


The Cre8 DES at 3 months has comparable strut coverage to Vision/Multilink8 BMS at 1 month while preserving a greater efficacy in neo-intima formation reduction .


Further studies to assess clinical implication of these Cre8 characteristics are warranted .


To determine predictors for decision-making on a differential approach to choosing glucocorticosteroids ( GCS ) for children and adolescents with acute lymphoblastic leukemia ( ALL ) .


The analysis covered 1064 primary patients aged to 1 to 18 years with ALL who had been registered at the clinics of Russia and Belorussia in April 2002 to November 2006 .


Before induction therapy , the patients were randomized into a dexamethasone ( DEXA ) 6 mg/m2 group ( n = 539 ) and a methylprednisolone ( MePRED ) 60 mg/m2 one ( n = 525 ) .


The entire group showed no statistically significant differences in survival rates between the patients receiving DEXA or MePRED .


However , an analysis of age groups revealed the benefits of DEXA in children younger than 14 years ( the event-free survival ( EFS ) was 762 and 712 % , respectively ( p = 0.048 ) ; the overall survival ( OS ) was 812 and 772 % , respectively ( p = 0.046 ) ; therapy-induced mortality was 6.4 % ( DEXA ) andl 1.1 % ( MePRED ) ( p = 0.01 4 ) ; the rate of isolated extramedullary relapses was 1.5 % ( DEXA ) and 4.4 % ( MePRED ) ( p = 0.009 ) .


At the same time , EFS and OS in 14-to-18-year-old adolescents were statistically significantly higher than in those who used MePRED ( EFS , 656 and 526 % , respectively ( p = 0.087 ) ; OS , 726 and 616 % , respectively ; ( p = 0 .


l 7 ) .


The findings suggest that it is possible that the choice of a GCS for ALL therapy must be also based on a patient 's age .


There is a need for further studies of this matter in prospective randomized multicenter trials in children and adolescents .


Community case management of malaria ( CCMm ) and seasonal malaria chemoprevention ( SMC ) are anti-malarial interventions that can lead to substantial reduction in malaria burden acting in synergy .


However , little is known about the social acceptability of these interventions .


A study was undertaken to assess whether combining the interventions would be an acceptable approach to malaria control for community health workers ( CHWs ) .


Sixty-one interviews and six focus group discussions were conducted nested in a cluster-randomized trial assessing the impact of combining CCMm and SMC in a rural area of Senegal .


Participants consisted of : ( i ) members of village associations , ( ii ) members of families who had access to the interventions as well as members of families who did not access the interventions , ( iii ) CHWs , and ( iv ) community leaders , e g , religious guides and village chiefs .


The interventions were acceptable to the local population and perceived as good strategy to make health care services available to community members and thus , to reduce the delays in access to anti-malarial treatment as well as expenses related to patients ' transfer to the health post .


The use of malaria rapid diagnostic test ( RDT ) contributed to improving CHWs diagnostic capacity as well as malaria treatment practices .


Study participants notified RDT and drugs stock-out as the major risk for sustainability of the intervention at community level .


Combining CCMm and SMC is a well accepted , community-based approach that can contribute to control malaria in areas where malaria transmission is seasonal .


Inappropriate drug prescription is a common problem in people living in nursing homes and is linked to adverse health outcomes .


This study assessed the effect of an educational intervention directed to nursing home physicians in reducing inappropriate prescription and improving health outcomes and resource utilization .


Prospective , randomized , multicenter study .


A private organization of nursing homes in Spain .


Sixty nursing home physicians caring for approximately 3900 nursing home residents in 37 centers were randomized to receive an educational intervention ( 30 ) or as a control group ( 30 ) .


10 hours educational program , followed by on demand support by phone .


Outcomes were assessed in 1018 randomly selected nursing home residents .


Appropriateness of drug use [ measured by the Screening Tool of Older Persons Prescriptions ( STOPP ) and Screening Tool to Alert Doctors to Right Treatment ( START ) criteria ] , incidence of selected geriatric syndromes ( falls , delirium ) and health resource utilization ( visits to physicians and nursing homes , visits to the emergency room , days of hospitalization ) were recorded for 3 months before the intervention started and 3 months after the intervention finished .


O total of 716 residents finished the study ( 344 cared for by the intervention group physicians , 372 cared for by control physicians ) .


Mean age was 84.4 12.7 years ; 73 % were women .


The mean number of inappropriate drugs ( STOPP criteria ) was higher at the end of the study in the control than in the intervention group ( 1.29 1.56 vs 0.81 1.13 ) , as was the number of residents on 6 or more drugs ( 76.5 % vs. 67.0 % ) , using antipsychotics ( 9.1 % vs 3.2 % ) or duplicate medications ( 32.5 % vs 9.2 % ) .


The number of fallers increased in the control group ( from 19.3 % to 28 % ) and did not significantly change in the intervention group ( from 25.3 % to 23.9 % ) ; the number of residents with delirium increased in the control group ( from 3.8 % to 9.1 % ) and decreased in the intervention group ( from 6.1 % to 3.2 % ) .


The number of visits to a physician did not change in the control group ( -0.22 , P = .3 ) but were significantly reduced in the intervention group ( -0.76 , P = .01 ) , the same happened with the number of visits to a nurse ( -0.38 , P = .4 in controls , -1.43 in the intervention group , P < .001 ) .


Visits to the emergency room and days in hospital significantly increased in the control group ( +0.12 and +0.38 ) but were unchanged in the intervention group ( +0.03 and +0.01 ) .


An educational intervention on drug use is feasible in nursing home physicians and improves the use of inappropriate drugs , use of antipsychotics , and drug duplications in their residents .


It may also improve the risk of delirium and falls , and reduce the use of health care resources .


This study investigated the isolated and combined effects of heat [ temperate ( 22C/30 % rH ) vs. hot ( 35C/40 % rH ) ] and hypoxia [ sea level ( FiO2 0.21 ) vs. moderate altitude ( FiO2 0.15 ) ] on exercise capacity and neuromuscular fatigue characteristics .


Eleven physically active subjects cycled to exhaustion at constant workload ( 66 % of the power output associated with their maximal oxygen uptake in temperate conditions ) in four different environmental conditions [ temperate/sea level ( control ) , hot/sea level ( hot ) , temperate/moderate altitude ( hypoxia ) and hot/moderate altitude ( hot + hypoxia ) ] .


Torque and electromyography ( EMG ) responses following electrical stimulation of the tibial nerve ( plantar-flexion ; soleus ) were recorded before and 5min after exercise .


Time to exhaustion was reduced ( P < 0.05 ) in hot ( -3515 % ) or hypoxia ( -3614 % ) compared to control ( 6128min ) , while hot + hypoxia ( -5120 % ) further compromised exercise capacity ( P < 0.05 ) .


However , the effect of temperature or altitude on end-exercise core temperature ( P = 0.089 and P = 0.070 , respectively ) and rating of perceived exertion ( P > 0.05 ) did not reach significance .


Maximal voluntary contraction torque , voluntary activation ( twitch interpolation ) and peak twitch torque decreased from pre - to post-exercise ( -91 , -41 and -61 % all trials compounded , respectively ; P < 0.05 ) , with no effect of the temperature or altitude .


M-wave amplitude and root mean square activity were reduced ( P < 0.05 ) in hot compared to temperate conditions , while normalized maximal EMG activity did not change .


Altitude had no effect on any measured parameters .


Moderate hypoxia in combination with heat stress reduces cycling time to exhaustion without modifying neuromuscular fatigue characteristics .


Impaired oxygen delivery or increased cardiovascular strain , increasing relative exercise intensity , may have also contributed to earlier exercise cessation .


To evaluate to what extent a twice daily dose of Transcranial Pulsating ElectroMagnetic Fields ( T-PEMF ) was superior to once daily in patients with treatment-resistant depression as to obtaining symptom remission after 8 weeks of augmentation therapy .


A self-treatment set-up of the T-PEMF device was used allowing self-administration by patients in own homes .


All patients were treated for 30 min per T-PEMF session .


The antidepressant medication the patients were receiving at baseline remained unchanged during the trial .


The patients were randomised to either one T-PEMF dose ( active dose in the morning and sham in the afternoon ) or two T-PEMF doses ( active dose both morning and afternoon ) in a double-blind procedure .


A score of 7 or less on the Hamilton Depression Scale ( HAM-D17 ) was the criterion of remission .


In total 34 patients received active T-PEMF once a day and 31 patients twice daily .


After 5 weeks of therapy remission was obtained in 26.5 % and 32.3 % on one dose and two doses of T-PEMF , respectively .


After 8 weeks the rate of remission was 73.5 % and 67.7 % , respectively .


The side effects as measured by the Udvalget for Kliniske Undersgelser scale showed a better toleration of the antidepresssive medication in both treatment groups , which was reflected by the WHO-5 well-being scale with increased scores in both groups of patients .


The high remission rate obtained by the T-PEMF augmentation was not a dose effect ( one versus two daily T-PEMF sessions ) but was explained by the extension of the treatment period from 5 to 8 weeks .


Broadband ultraviolet A ( BB-UVA ) has been successfully used in the treatment of scleroderma , a UVA1-responsive dermatosis .


To compare the efficacy of BB-UVA versus psoralen + UVA ( PUVA ) in psoriasis treatment and assess apoptosis as an effector mechanism .


This randomized controlled trial included 61 patients with chronic plaque psoriasis randomly divided into group I or II .


Group I were further randomized to either IA or IB who received UVA 10 or 15J/cm ( 2 ) per session , respectively , while group II received PUVA .


Therapy was delivered thrice weekly until clearance or 48 treatments at most .


The primary outcome measured was clearance of psoriasis .


Dermal lymphocytic counts and bcl-2 expression were measured in 20 patients from each group .


Final Psoriasis Area Severity Index scores were reduced within each group .


The UVA group achieved results comparable to PUVA until session 24 but failed to match it at final evaluation , with significantly better clinical , immunohistochemical , and histopathological results achieved by PUVA ( P0 .05 ) .


Both modalities caused a reduction in dermal lymphocytic counts and epidermal bcl-2 expression .


BB-UVA appears to be safe and acceptable for the treatment of chronic plaque psoriasis possibly through bcl-2-mediated apoptosis of keratinocytes and epidermal lymphocytes .


The public reporting of health outcomes has become one of the most popular topics and is accepted as a quality improvement method in the healthcare field .


However , little research has been conducted on the transparency mechanism , and results are mixed with regard to the evaluation of the effect of public reporting on quality improvement .


The objectives of this trial are to investigate the transparency mechanism and to evaluate the effect of public reporting on prescription at the level of individual participants .


This study involves a cluster randomized controlled trial conducted in 20 primary-care facilities ( clusters ) .


Eligible clusters are those facilities with excellent hospital information systems and that have agreed to participate in the trial .


The 20 clusters are matched into 10 pairs according to Technique for Order Preference by Similarity to Ideal Solution score .


As the unit of randomization , each pair of facilities is assigned at random to a control or an intervention group through coin flipping .


Prescribed ranking information is publicly reported in the intervention group .


The public materials include the posters of individuals and of facilities , the ranking lists of general practitioners , and brochures of patients , which are updated monthly .


The intervention began on 13th November 2013 and lasted for one year .


Specifically , participants are surveyed at five points in time ( baseline , quarterly following the intervention ) through questionnaires , interviews , and observations .


These participants include an average of 600 patients , 300 general practitioners , 15 directors , and 6 health bureau administrators .


The primary outcomes are the transparency mechanism model and the changes in medicine-prescribe .


Subsequently , the modifications in the transparency mechanism constructs are evaluated .


The outcomes are measured at the individual participant level , and the professional who analyzes the data is blind to the randomization status .


This study protocol outlines a design that aims to examine the transparency mechanism and to evaluate the effect of public reporting on prescription .


The research design is significant in the field of public policy .


Furthermore , this study intends to fill the gap of the investigation of the transparency mechanism and the evaluation of public reporting on prescription .


New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions .


To address this need , two new skin test antigens were developed to assess safety and efficacy in human trials .


A Phase I safety trial was first conducted in a non-endemic region for leprosy ( U.S.A. ) .