Clinicians should actively screen for anemia in women with HMB and emphasize early iron substitution as an integral part of treatment .


People with diabetes frequently develop vascular disease .


We investigated the relationship between blood 25-hydroxyvitamin D ( 25OH-D ) concentration and vascular disease risk in type 2 diabetes .


The relationships between blood 25OH-D concentration at baseline and the incidence of macrovascular ( including myocardial infarction and stroke ) and microvascular ( retinopathy , nephropathy , neuropathy , and amputation ) disease were analyzed with Cox proportional hazards models and logistic regression in an observational study of patients in the 5-year Fenofibrate Intervention and Event Lowering in Diabetes trial .


A total of 50 % of the patients had low vitamin D concentrations , as indicated by median blood 25OH-D concentration of 49 nmol/L .


These patients with a blood 25OH-D concentration < 50 nmol/L had a higher cumulative incidence of macrovascular and microvascular events than those with levels 50 nmol/L .


Multivariate analysis , stratified by treatment and adjusted for relevant confounders , identified blood 25OH-D concentration as an independent predictor of macrovascular events .


A 50 nmol/L difference in blood 25OH-D concentration was associated with a 23 % ( P = 0.007 ) change in risk of macrovascular complications during the study , and further adjustments for seasonality , hs-CRP , and physical activity level had little impact .


The unadjusted risk of microvascular complications was 18 % ( P = 0.006 ) higher during the study , though the excess risk declined to 11-14 % and lost significance with adjustment for HbA1c , seasonality , or physical activity .


Low blood 25OH-D concentrations are associated with an increased risk of macrovascular and microvascular disease events in type 2 diabetes .


However , a causal link remains to be demonstrated .


Asthma clinical guidelines suggest written asthma action plans are essential for improving self-management and outcomes .


To assess the efficacy of written instructions in the form of a written asthma action plan provided by subspecialist physicians as part of usual asthma care during office visits .


A total of 407 children and adults with persistent asthma receiving first-time care in pulmonary and allergy practices at 4 urban medical centers were randomized to receive either written instructions ( n = 204 ) or no written instructions other than prescriptions ( n = 203 ) from physicians .


Using written asthma action plan forms as a vehicle for providing self-management instructions did not have a significant effect on any of the primary outcomes : ( 1 ) asthma symptom frequency , ( 2 ) emergency visits , or ( 3 ) asthma quality of life from baseline to 12-month follow-up .


Both groups showed similar and significant reductions in asthma symptom frequency ( daytime symptoms [ P < 0.0001 ] , nocturnal symptoms [ P < 0.0001 ] , - agonist use [ P < 0.0001 ] ) .


There was also a significant reduction in emergency visits for the intervention ( P < 0.0001 ) and control ( P < 0.0006 ) groups .


There was significant improvement in asthma quality-of-life scores for adults ( P < 0.0001 ) and pediatric caregivers ( P < 0.0001 ) .


Our results suggest that using a written asthma action plan form as a vehicle for providing asthma management instructions to patients with persistent asthma who are receiving subspecialty care for the first time confers no added benefit beyond subspecialty-based medical care and education for asthma .


Clinical trial registered with www.clinicaltrials.gov ( NCT 00149461 ) .


Gentamicin is used as a therapeutic agent for Mnire 's disease because of its vestibulotoxicity causing chemo-ablation of the vestibular sensory epithelia .


Its use has increased in recent years .


However , there is still no consensus about the dose regimen of gentamicin in the treatment of Mnire 's disease .


In this study two different dose regimen treatment protocols are compared in a placebo controlled study design .


The primary objective is to quantify the treatment effect on dizziness , the secondary objective is hearing evaluation .


We performed a randomized , double-blind , placebo-controlled study in adults with unilateral Mnire 's disease according to the AAO-HNS guidelines resistant to conservative medication .


Three groups received four injections , administered weekly ( four intratympanic injections with 40mg/mL gentamicin solution , two injections gentamicin solution and two injections of placebo in random order , or four injections with placebo ) .


Outcome measures were the score on the Dizziness Handicap Inventory and pure tone audiometry ( PTA ) .


Intended follow-up was 2years .


During follow-up one patient exceeded the accepted amount of hearing loss .


Further , enrollment was very slow ( until 12months between two patients ) and new insights showed an apparent benefit of intratympanic gentamicin treatment ( ITG ) .


Therefore we performed an unscheduled interim analysis which showed that PTA threshold shifts reached the stopping criteria in two more patients .


Because of this , this study was ended .


Of the three patients with the significant PTA threshold shift two were enrolled in the gentamicin group .


No conclusions can be drawn concerning doses regimens .


Now that new publications have shown that ITG treatment can be an effective and safe treatment , a placebo-controlled randomized controlled trial may not pass the ethical committee because of these recent reports in literature .


Still , a dose regimen study ( without placebo ) on ITG treatment needs to be performed .


This trial was registered in The University Medical Center Utrecht / Gelre hospital Apeldoorn .


Protocol ID : 07/343 , EudraCT number 2006-005913-37 .


The purpose of this study was to investigate whether the availability of both dextroamphetamine and methylphenidate provides an opportunity to minimize adverse events in a pediatric attention-deficit/hyperactivity disorder ( ADHD ) stimulant trial .


Thirty-six medication-nave children 9-14 years of age , diagnosed with ADHD , were enrolled for 6 weeks in a crossover trial , with 2 weeks of methylphenidate , dextroamphetamine , and a placebo in a randomly assigned , counterbalanced sequence .


Barkley 's Side-Effect Rating Scale ( SERS ) , rated by parents , was used to assess adverse events .


SERS were available for 34 children , and data were analyzed both at the group and the single-subject level .


The side-effect profiles of dextroamphetamine and methylphenidate appeared similar at the group level .


Overall , insomnia and decreased appetite were the only adverse events associated with the stimulants as compared with placebo .


No significant increase from placebo to stimulant conditions was detected on SERS items reflecting emotional symptoms .


Furthermore , dextroamphetamine and methylphenidate did not differ from each other on any SERS item , except that dextroamphetamine was associated with higher severity of `` insomnia '' and a higher prevalence of `` unusually happy . ''


Single-subject analyses showed that one or more adverse events were reported in 14 children ( 41 % ) , and were evenly distributed between those with dextroamphetamine as the drug that showed the greatest reduction in their ADHD symptoms ( `` best drug '' ) and those with methylphenidate as their best drug .


Among children in whom both stimulants were associated with a decrease in ADHD symptoms , a clinically valid difference between the two stimulants in total adverse events score was found in 7 ( 39 % ) of the 18 cases .


In these children , the availability of both stimulants provided an opportunity to minimize adverse events , while maintaining a reduction in ADHD symptoms .


The availability of both dextroamphetamine and methylphenidate may contribute to minimize adverse events in a subsample of children in pediatric ADHD stimulant trials .


The study was first registered in clinical trials September 28 , 2010 .


Clinical Trials.gov Identifier : NCT01220440 .


Optimal starting point for antiretroviral treatment ( ART ) has been uncertain .


Parallel group , single blind , randomised controlled study of adult HIV positive patients consulting at the Protestant Hospital , Ngaoundere , Cameroon in 2007-8 .


Simple randomisation of patients in WHO clinical stage 1-2 to start of ART early or deferred , i.e. when CD4 counts dropped below 350 versus 250 cells/mm ( 3 ) , or when they reached clinical stage 3-4 .


Clinical follow-up every three months were offered for all patients .


Main outcomes were clinical stage , CD4 differences and mortality .


Of 424 consulting patients , most were excluded , mainly because they were already in WHO stage 3-4 .


Forty-four patients were randomised .


In the ` early ' group two patients died and five were lost to follow-up .


In the ` deferred ' group , six patients died and nine were lost to follow-up ( Hazard ratio for death by early compared to deferred treatment 0.26 , 95 % confidence interval 0.05-1 .29 ) .


Of the patients lost to follow-up , three patients in the ` early ' group and four patients in the ` deferred ' group were known to be alive when the study ended .


Fourteen patients in the early group and 11 in the deferred group started ART .


Twenty-two patients were evaluated clinically six to seven months after the study period was terminated .


Except for one patient with AIDS , these were all still in clinical stage 1-2 .


In our small sample , relative risk for death did not differ significantly , but deferred treatment seemed to carry no increased survival or other clinical advantage .


During the study period , other studies made WHO change its guidelines to conform to our early treatment .


The tendency in our study lends support to this policy .


ISRCTN22114173 .


To determine whether tumor grade , molecular subtype and hypoxia predict response to hypofractionated versus standard radiotherapy ( RT ) following breast-conserving surgery ( BCS ) for node-negative breast cancer in a randomized controlled trial ( RCT ) .


Formalin-fixed paraffin-embedded ( FFPE ) tumor blocks were available on 989 of 1234 patients enrolled in the Hypofractionation Whole Breast Irradiation ( HWBI ) Trial .


A central pathology review and assessment of tumor grade using the Nottingham grading system was carried out .


Tumors were classified by molecular subtype as luminal A , luminal B , HER2 enriched , basal-like or unclassified using a six-biomarker panel ; ER , PR , HER-2 , Ki67 , CK5/6 and EGFR .


Tumors were also classified as hypoxic based on the expression of HIF1 , CAIX or GLUT-1 .


The primary end point was local recurrence ( LR ) .


Median follow-up was 12 years .


In the multivariable Cox model , molecular subtype was the only factor predictive of LR , the 10-year cumulative incidence was 4.5 % for luminal A and basal-like , 7.9 % for luminal B and 16.9 % for HER-2 enriched tumors ( P < 0.01 ) .


Tumor grade , molecular subtype or hypoxia did not predict response to hypofractionation .


In women enrolled in the HWBI trial following BCS tumor molecular subtype predicted LR .


However tumor grade , molecular subtype and hypoxia did not predict response to hypofractionation suggesting that patients with node-negative breast tumors of all grades and molecular subtypes may be safely treated with hypofractionated RT regimens .


To compare the efficacy of etanercept ( ETN ) and methotrexate ( MTX ) versus MTX monotherapy for remission induction in patients with early inflammatory arthritis .


In a 78-week multicentre randomised placebo-controlled superiority trial , 110 DMARD-nave patients with early clinical synovitis ( 1 tender and swollen joint , and within 3 months of diagnosis ) and either rheumatoid factor , anticitrullinated protein antibodies or shared epitope positive were randomised 1:1 to receive MTX+ETN or MTX + placebo ( PBO ) for 52 weeks .


Injections ( ETN or PBO ) were stopped in all patients at week 52 .


In those with no tender or swollen joints ( NTSJ ) for > 26 weeks , injections were stopped early .


If patients had NTSJ > 12 weeks after stopping the injections , MTX was weaned .


The primary endpoint was NTSJ at week 52 .


No statistically significant difference was seen for the primary endpoint ( NTSJ at week 52 ( 32.5 % vs 28.1 % [ adjusted OR 1.32 ( 0.56 to 3.09 ) , p = 0.522 ] ) in the MTX+ETN and MTX+PBO groups , respectively ) .


The secondary endpoints did not differ between groups at week 52 or 78 .


Exploratory analyses showed a higher proportions of patients with DAS28-CRP < 2.6 in the MTX+ETN group at week 2 ( 38.5 % vs 9.2 % , adjusted OR 8.87 ( 2.53 to 31.17 ) , p = 0.001 ) and week 12 ( 65.1 % vs 43.8 % , adjusted OR 2.49 ( 1.12 to 5.54 ) , p = 0.026 ) .


In this group of patients with early inflammatory arthritis , almost a third had no tender , swollen joints after 1 year .


MTX+ETN was not superior to MTX monotherapy in achieving this outcome .


Clinical responses , however , including DAS28-CRP < 2.6 , were achieved earlier with MTX+ETN combination therapy .


The EMPIRE trial is registered on the following trial registries : Eudract-2005-005467-29 ; ISRCTN 55428162 ( http://www.controlled-trials.com/ISRCTN55428162/EMPIRE ) .


The full trial protocol can be obtained from the corresponding author .


Selective serotonin reuptake inhibitors ( SSRI ) and serotonin-norepinephrine reuptake inhibitors ( SNRI ) are effective in treating anxiety disorders associated with major depressive disorder ( MDD ) .


This randomized , controlled , parallel-group , open-label , phase 4 trial ( CTRI/2012/08 / 002895 ) was undertaken to compare the effectiveness and safety of desvenlafaxine versus escitalopram , a standard antidepressant .


Effectiveness was assessed using the Hamilton Depression Rating Scale ( HAM-D17 ) and Hamilton Anxiety Rating Scale ( HAM-A ) .


Response to treatment was assessed by 50 % decrease of baseline scores ( responder rate ) .


Safety and tolerability was evaluated by changes in routine laboratory parameters , vital signs , and adverse events reported by the subject and/or observed by the clinician .


Responder rates for both HAM-A and HAM-D scores at 8 weeks were better in the escitalopram group compared to the desvenlafaxine group ( HAM-A 76.92 % vs. 71.05 % ; HAM-D 79.48 % vs 73.68 % ) but the differences were not statistically significant ( P = 0.59 and P = 0.61 ) .


Within group changes of both scores , from baseline to subsequent visits in both treatment arms were statistically significant ( P < 0.01 ) .


The effectiveness of desvenlafaxine was comparable to escitalopram , but escitalopram was better tolerated .


To examine if a small token monetary incentive ( NZ$ 5 ) increases mail survey response rates and participant retention of 40-50 year old New Zealand women .


In 2009 , 2500 women were randomly selected from the New Zealand electoral rolls for a prospective study investigating factors related to the prevention of weight gain .


At baseline , 400 women were randomly assigned to receive NZ$ 5 with the initial survey mail-out in addition to nonmonetary gifts to encourage participation ( pen , tea bag , entry in lottery draw ) received by all women .


At 2 years , 400 women ( 200 received NZ$ 5 at baseline and 200 had not ) were randomly assigned to receive the same token monetary incentive .


At 3 years , all women identifying as an ethnic minority ( n = 234 ) and 300 randomly selected women of other ethnicities received the token monetary incentive with the initial mail out .


The baseline response rate for women who received NZ$ 5 was significantly higher than for women who did not ( 76 % vs 64 % , p < 0.001 ) .


At 2 years , retention rate for all women who received NZ$ 5 was significantly higher than for women who did not ( 88 % vs 80 % , p < 0.001 ) .


At 3 years , among those women not identifying as an ethnic minority , the retention rate for those who received NZ$ 5 was significantly higher than for those who did not ( 84 % vs 77 % , p = 0.014 ) .


Inclusion of a small token monetary incentive significantly increases mail survey response rates and participant retention in mid-age New Zealand women .


Co-sleeping is associated with disturbance of the natural sleep pattern , including sleep fragmentation and daytime sleepiness .


Nocturnal enuresis ( NE ) or bed-wetting , although benign , is a significant cause of distress to affected children and their caregiver ( s ) .


This study investigated the relationship between co-sleeping and NE in primary school children from China .


Data from a previous sleep study of primary school children from 8 cities across China were analyzed .


Multivariable regression analysis was performed to assess the relationship between co-sleeping and NE while controlling for a number of confounding factors .


The prevalence of NE in co-sleeping and non-co-sleeping children in different age groups was evaluated .


The prevalence of co-sleeping and NE in children aged 5 to 12 years was 22.8 % and 4.6 % , respectively .


Co-sleeping was associated with a higher prevalence of NE in primary school age children ( odds ratio [ OR ] , 1.50 ; 95 % confidence interval [ CI ] , 1.27-1 .77 ; p < .001 ) after adjusting for confounding factors .


The differences in the prevalence of NE between co-sleepers and non-co-sleepers were significant in the 9-year age group ( OR , 1.49 ; 95 % CI , 1.06-2 .11 ; p = .025 ) and 11 - to 12-year age group ( OR , 3.16 ; 95 % CI , 2.19-4 .57 ; p < .001 ) .


Co-sleeping may increase the risk of NE in primary school children , particularly in those aged 11 to 12 years .


To investigate the effect of nicotine on choroidal thickness using optical coherence tomography ( OCT ) .


Prospective , case-control study .


Sixteen young , healthy subjects and 16 age and gender matched control cases were included in this study ; 4 mg nicotine gum was given to the study group and placebo gum to the control group .


All participants underwent OCT scanning with a high-speed and resolution spectral-domain OCT device ( 3D OCT 2000 , Topcon , Japan ) at baseline , and 1 h following nicotine or placebo administration .


The measurements were taken in the morning ( 10:00 -12:00 hours ) to avoid diurnal fluctuation .


The median foveal choroidal thickness at baseline was 337.00 m ( IQR 84.50 ) , which decreased to 311.00 m ( IQR 78.00 ) at 1 h following oral nicotine intake ( p = 0.001 ) .


The median choroidal thickness was also significantly decreased at five other extrafoveal points ( p < 0.05 for all ) .


In the control group , the median baseline choroidal thickness at the fovea was 330.50 m ( IQR 104.25 ) , and was 332.00 m ( IQR 103.75 ) at 1 h ( p = 0.271 ) .


Nicotine causes a significant decrease in choroidal thickness following oral intake .


This acute decrease might be a result of reduced ocular blood flow due to the vasoconstrictive effect of nicotine .


To describe successful methods of recruitment and identify practice characteristics related to increased recruitment of older people for a randomised controlled trial .


General practices in three regions of New Zealand and community-dwelling patients aged 75 + were recruited for the Brief Risk Identification Geriatric Health Tool trial .


General practitioners ( GPs ) were faxed invitations with telephone follow-up .


Reply-paid cards with telephone follow-up were used to invite older people .


GP and practice characteristics were examined in relationship to recruitment rate .


During 2007-2008 , 158 of 438 GPs ( 36 % ) in 60 of 116 practices approached ( 52 % ) were recruited .


Regional variation was marked and 3893 of 8308 invited ( 49 % ) older people were recruited .


The GP 's length of time at the practice and training in New Zealand was associated with recruitment success .


Despite variability in practice recruitment , a reasonably large and representative sample of older people was recruited through general practices .


Complaints of knee pain secondary to early osteoarthritis may account for up to 30 % of visits to primary care physicians .


Due to the proposed inflammatory changes in early osteoarthritis , intra-articular injections of corticosteroids ( IACS ) have been considered as an option for disease progression modification , pain control , and improvement of function .


However , some studies have suggested poor accuracy rates of IA injections depending on the entry site chosen .


It is therefore the aim of this study to evaluate the efficacy of IA knee corticosteroid injection in reducing pain and improving function in patients with early osteoarthritis and whether the low accuracy rates reported with the Anterolateral joint line injection site translate to worse functional and pain outcome measures as compared to Suprapatellar lateral injections .


The study was carried out as an open-label , randomized controlled trial with 60 sequential patients recruited .


Simple randomization separated groups into anterolateral joint line or suprapatellar lateral injection sites .


Improvements were measured with WOMAC and VAS scores after injection of Lidocaine and steroid solution .


Patients receiving IACS injections had a measurable improvement in self-reported outcomes as evidenced by standard deviation change in WOMAC and VAS scores .


The majority of patients had a clinically significant improvement in VAS scores as compared to their initial measures with a notable amount of patients improving significantly as well on their WOMAC scores , irrespective of the injection site chosen .


We have therefore continued the use of palpation-guided intra-articular knee injections in an effort to reduce costs as compared to other injection modalities with positive results in our osteoarthritis patients .


Artificial ulcers remain a major complication after Endoscopic submucosal dissection ( ESD ) .


The development of more effective treatment regimen for this ulcer is required than the use of proton pump inhibitor ( PPI ) alone .


Patients with ESD-derived artificial ulcers were randomly assigned to two groups : a group of patients who received rabeprazole 20 mg daily for 8 weeks ( PPI group ) and a group of patients who received a combination of rebamipide 300 mg daily for 8 weeks and rabeprazole 20 mg dairy for the first 4 weeks ( reb + PPI group ) .


The area reduction ratio and healing status of ulcers were evaluated endoscopically on postoperative 7 , 28 and 56 days .


The overall ulcer area reduction ratio was higher in the reb + PPI group than in the PPI group , especially at an early stage .


The ratio of progression to the H1 stage in the reb + PPI group was significantly higher than that in the PPI group , especially at an early stage .


Treatment with 8 weeks of rebamipide plus the first 4 weeks of PPI demonstrated a reduction ratio of artificial ulcers superior to that with 8 weeks of PPI mono-therapy .


This combination treatment is , therefore , one of the candidate treatment strategies against ESD-derived artificial ulcers .


To evaluate the effectiveness of magnetotherapy in the treatment of hand osteoarthritis ( HO ) .


In this randomized controlled single-blind follow-up study , patients with HO were randomly assigned into 2 groups ( G1 and G2 ) .


The subjects in G1 ( n = 25 ) received 25Hz , 450 pulse/s , 5-80G , magnetotherapy of totally 10 days and 20 min/day combined with active range of motion/strengthening exercises for the hand .


G2 ( n = 25 ) received sham-magnetotherapy for 20 min/day for the same duration combined with the same hand exercises .


Outcome measures were pain and joint stiffness evaluation , handgrip and pinchgrip strength ( HPS ) , Duruz and Auscan Hand Osteoarthritis Indexes ( DAOI ) and Short Form-36 Health Questionnaire ( SF-36 ) administered at baseline , immediately after treatment and at the follow up .


When the groups were compared with each other , improvement observed in SF-36 Pain ( p < 0.001 ) , SF-36 Social Function ( p = 0.030 ) , SF-36 Vitality ( p = 0.002 ) , SF-36 General Health ( p = 0.001 ) , Pain at rest ( p < 0.001 ) , Pain at motion ( p < 0.001 ) , Joint stiffness ( p < 0.001 ) , DAOI ( p < 0.001 ) were in favor of G1 .


Changes in pain , function and quality of life scores showed significant advantage in favor of the applied electromagnetic intervention in patients with HO .


To determine the frequency of pharmacogenomic variants and concurrent medications that may alter the efficacy and tolerability of acetylcholinesterase inhibitors ( AChEIs ) .


A multisite cross-sectional study was carried out across four memory care practices in the greater Indianapolis area .


Participants were adults aged 65 years and older with a diagnosis of probable or possible Alzheimer 's disease ( AD ) ( n = 105 ) .


Blood samples and self-reported medication data were collected .


Since two of the three AChEIs are metabolized by cytochrome P450 ( CYP ) -2 D6 , we determined the frequency of functional genetic variants in the CYP2D6 gene and calculated their predicted CYP2D6-activity scores .


Concurrent medication data were collected from self-reported medication surveys , and their predicted effect on the pharmacokinetics of AChEIs was determined based on their known effects on CYP2D6 and CYP3A4/5 enzyme activities .


Among the 105 subjects enrolled , 72 % were female and 36 % were African American .


Subjects had a mean age of 79.6 years .


The population used a mean of eight medications per day ( prescription and nonprescription ) .


The CYP2D6 activity score frequencies were 0 ( 3.8 % ) , 0.5 ( 4.8 % ) , 1.0 ( 36.2 % ) , 1.5-2 .0 ( 51.4 % ) , and > 2.0 ( 3.8 % ) .


Nineteen subjects ( 18.1 % ) used a medication considered a strong or moderate inhibitor of CYP2D6 , and eight subjects ( 7.6 % ) used a medication considered a strong or moderate inhibitor of CYP3A4/5 .


In total , 28.6 % of the study population was predicted to have reduced activity of the CYP2D6 or CYP3A4/5 enzymes due to either genetic variants or concomitant medications .


Both pharmacogenetic variants and concurrent drug therapies that are predicted to alter the pharmacokinetics of AChEIs should be evaluated in older adults with AD .


Pharmacogenetic and drug-interaction data may help personalize AD therapy and increase adherence by improving tolerability .


In this study , our goal was to compare intraoperative and postoperative analgesic effects of lornoxicam and fentanyl when added to lidocaine Intravenous Regional Anesthesia ( IVRA ) in a group of outpatients who underwent hand surgery .


This is a double blind randomized study .


A total of 45 patients were included , randomized into three groups .


Patients in Group I ( L ) received 3mg .


kg ( -1 ) of 2 % lidocaine 40 mL ; patients in Group II ( LL ) received 3mg .


kg ( -1 ) lidocaine 38 mL + 2 mL lornoxicam ; patients in Group III ( LF ) received 3mg .


kg ( -1 ) lidocaine 38 mL + 2 mL fentanyl .


Our primary outcome was first analgesic requirement time at postoperative period .


Lornoxicam added to lidocaine IVRA increased the sensory block recovery time without increasing side effects and increased first analgesic requirement time at the postoperative period when compared to lidocaine IVRA ( p < 0.001 , p < 0.001 respectively ) and fentanyl added to lidocaine IVRA ( p < 0.001 , p < 0.001 respectively ) .


In addition , we also found that fentanyl decreased tourniquet pain ( p < 0.01 ) when compared to lidocaine but showed similar analgesic effect with lornoxicam ( p > 0.05 ) although VAS scores related to tourniquet pain were lower in fentanyl group .


Lornoxicam added to lidocaine IVRA was not superior to lidocaine IVRA in decreasing tourniquet pain .


Addition of fentanyl to lidocaine IVRA seems to be superior to lidocaine IVRA and lornoxicam added to lidocaine IVRA groups in decreasing tourniquet pain at the expense of increasing side effects .


However , lornoxicam did not increase side effects while providing intraoperative and postoperative analgesia .


Therefore , lornoxicam could be more appropriate for clinical use .


Employing waiting list control designs in psychological and behavioral intervention research may artificially inflate intervention effect estimates .


This exploratory randomized controlled trial tested this proposition in a study employing a brief intervention for problem drinkers , one domain of research in which waiting list control designs are used .


All participants ( N = 185 ) were provided with brief personalized feedback intervention materials after being randomly allocated either to be told that they were in the intervention condition and that this was the intervention or to be told that they were in the waiting list control condition and that they would receive access to the intervention in four weeks with this information provided in the meantime .


A total of 157 participants ( 85 % ) were followed-up after 4weeks .


Between-group differences were found in one of four outcomes ( proportion within safe drinking guidelines ) .


An interaction was identified between experimental manipulation and stage of change at study entry such that participant change was arrested among those more ready to change and told they were on the waiting list .


Trials with waiting list control conditions may overestimate treatment effects , though the extent of any such bias appears likely to vary between study populations .


Arguably they should only be used where this threat to valid inference has been carefully assessed .


A substantial proportion of patients with gastro-oesophageal reflux disease ( GERD ) have only a partial response to proton pump inhibitor ( PPI ) therapy .


Prokinetic drugs may improve reflux symptoms by enhancing oesophageal motility and gastric emptying .


To evaluate the effect of revexepride , a novel prokinetic 5-hydroxytryptamine type 4 ( 5-HT4 ) receptor agonist , compared with placebo , in patients with GERD who have a partial response to PPIs .


A phase 2b , double-blind , parallel-group study was conducted , in which patients were randomised to one of three revexepride treatment groups ( 0.1 , 0.5 and 2.0 mg three times daily ) or placebo ( 1:1:1:1 ratio ) .


Daily e-diary data captured patients ' symptoms over an 8-week treatment period .


The primary efficacy outcome was the weekly percentage of regurgitation-free days in the second half of the study ( weeks 5-8 ) .


In total , 480 patients were randomised and 477 received treatment ( mean age 47.9 years ; 61 % women ) .


The mean percentage of regurgitation-free days increased from baseline ( range , 15.0-18 .8 % ) to week 8 ( 62.3-70 .5 % ) in all four study arms ; however , there were no statistically significant differences in this change between placebo and the three treatment arms .


No dose-dependent relationship in treatment effect was observed for any of the study endpoints .


The incidence of treatment-emergent adverse events ( TEAEs ) was revexepride dose-dependent .


Only one serious TEAE occurred and none resulted in death .


Revexepride was no more effective than placebo in controlling regurgitation in patients with GERD symptoms partially responsive to PPIs .


Revexepride was well tolerated .


ClinicalTrials.gov Identifier : NCT01472939 .


Despite improvements in the diagnosis and treatment of depression , primary care provider ( PCP ) discussion regarding suicidal thoughts among patients with depressive symptoms remains low .


To determine whether a targeted depression public service announcement ( PSA ) video or an individually tailored interactive multimedia computer program ( IMCP ) leads to increased primary care provider ( PCP ) discussion of suicidal thoughts in patients with elevated risk for clinical depression when compared to an attention control .


Randomized control trial at five different healthcare systems in Northern California ; two academic , two Veterans Affairs ( VA ) , and one group-model health maintenance organization ( HMO ) .


Eight-hundred sixty-seven participants , with mean age 51.7 ; 43.9 % women , 43.4 % from a racial/ethnic minority group .


The PSA was targeted to gender and socio-economic status , and designed to encourage patients to seek depression care or request information regarding depression .


The IMCP was an individually tailored interactive health message designed to activate patients to discuss possible depressive symptoms .


The attention control was a sleep hygiene video .


Clinician reported discussion of suicidal thoughts .


Analyses were stratified by depressive symptom level ( Patient Health Questionnaire [ PHQ-9 ] score < 9 [ mild or lower ] versus 10 [ at least moderate ] ) .


Among patients with a PHQ-9 score 10 , PCP discussion of suicidal thoughts was significantly higher in the IMCP group than in the control group ( adjusted odds ratio = 2.33 , 95 % confidence interval = 1.5 , 5.10 , p = 0.03 ) .


There were no significant effects of either intervention on PCP discussion of suicidal thoughts among patients with a PHQ-9 score < 9 .


Exposure of patients with at least moderate depressive symptoms to an individually tailored intervention designed to increase patient engagement in depression care led to increased PCP discussion of suicidal thoughts .


Division of the parenchymal lung for lobectomy is performed in patients who have an incomplete fissure .


A stapler device can reduce postoperative air leak , but it is expensive .


to investigate the advantage of using a stapler , in terms of postoperative air leak and cost , compared to hand-sewn techniques .


A Non-blinded randomized controlled trial was conducted in Chiang Mai University Hospital , Thailand , from November 15 , 2011 to September 30 , 2012 .


Fifty-three adult patients were randomized to undergo a hand-sewn technique ( 27 patients ) or stapler closure ( 26 patients ) .


Postoperative air leak in the stapler group was less than that in the hand-sewn group ( 7.7 % vs. 29.6 % , p = 0.044 ) , and the duration of air leak in the stapler group was significantly shorter than that in the hand-sewn group ( 1.0 vs. 13.4 days , p = 0.032 ) .


The cost of treatment was not significantly different between groups ; however , the total cost in the stapler group was less than that in the hand-sewn group ( mean difference 4454 Thai baht ( US$ 144.75 ) .


A stapler reduces postoperative air leaks and the duration of air leaks .


Furthermore , the total cost of treatment was comparable .


Therefore , using staples may provide substantial financial benefits .


During perioperative fasting , lipid metabolism gradually increases , resulting in free fatty acids ( FFA ) and/or ketone bodies .


Suppression of surgical stress by remifentanil may allow the safe administration of glucose infusions , avoiding both hyperglycemia and ketogenesis .


The effects of glucose infusion on glucose and lipid metabolism were therefore investigated in patients undergoing minor surgery with remifentanil anesthesia .


Thirty-four patients were randomized 1:1 to receive no glucose ( 0G group ) or low-dose glucose ( 0.1 g/kg/h for 1h followed by 0.05 g/kg/h for 1h ; LG group ) .


The concentrations of glucose , adrenocorticotropic hormone ( ACTH ) , 3-methylhistidine ( 3-MH ) , insulin , cortisol , FFA , creatinine ( Cr ) , and ketone bodies were measured before anesthetic induction , 1 and 2h after glucose infusion , at the end of surgery , and the next morning .


The concentrations of cortisol and ACTH decreased during surgery in both groups when compared with the concentrations before anesthesia and at the end of surgery ( P < 0.05 ) .


Glucose and insulin concentrations were significantly higher in the LG than in the 0G group at 1 and 2h after infusion .


No patient experienced hyperglycemia .


The concentrations of FFA and ketone bodies were lower in the LG than in the 0G group during surgery , but there were no significant between group differences in 3-MH/Cr .


Infusion of low-dose glucose attenuated fat catabolism without causing hyperglycemia , indicating that infusion of low-dose glucose during remifentanil-induced anesthesia may be safe for patients .


To explore the clinical roles of Jiawei Shentong Zhuyu Decoction ( JSZD ) in preventing the occurrence of failed back surgery syndrome ( FBSS ) , and to observe its effect on serum tumor necrosis factor-alpha ( TNF-alpha ) .


Totally 100 patients prepared for surgical operation due to lumbar intervertebral disc herniation were randomly assigned to the treatment group and the control group according to random number table , 50 cases in each group .


Patients in the treatment group additionally took JSZD , one dose per day , taken in two portions , once in the morning and once in the evening .


Those in the control group took Celecoxib Capsule ( 200 mg each time , once per day ) and Mecobalamin Tablet ( 0.5 mg each time , 3 times per day ) .


They only took Mecobalamin Tablet from the 11th day .


All patients were treated for 30 days .


Japanese Orthopaedic Association ( JOA ) score was performed before treatment , at week 1 , after treatment , at 6 months of followed-ups , and at 12 months of followed-ups .


And the levels of TNF-alpha in the peripheral blood were observed before treatment and at one month after treatment .


Totally 93 patients completed the followed-up study .


The JOA scores were improved after treatment , at 6 and 12 months of followed-ups ( P < 0.05 , P < 0.01 ) .


The JOA score at 6 months of followed-ups was superior in the treatment group to that of the control group ( P < 0.05 ) .


Five patients ( accounting for 10.6 % ) suffered from FBSS in the treatment group , while 9 ( accounting for 19.6 % ) suffered from FBSS in the control group .


The treatment group was superior to the control group ( P < 0.05 ) .


The TNFalpha level was improved after treatment in the two groups .


Of them , the improvement of TNF-alpha in the treatment group was better than that of the control group ( P < 0.05 ) .


The application of JSZD was effective for preventing the occurrence of FBSS , and improved the serum TNF-alpha level .


The current study was conducted to investigate the dependence between progression-free survival ( PFS ) and overall survival ( OS ) in patients with metastatic renal cell carcinoma ( mRCC ) and to explore whether PFS can be used as an intermediate endpoint of OS in this patient population .


A total of 1381 patients from 2 prospective phase 3 trials ( Cancer and Leukemia Group B [ CALGB ] 90206 and AVOREN ) of interferon-alpha with or without bevacizumab were analyzed .


Both trials recruited previously untreated patients with clear cell mRCC with an Eastern Cooperative Oncology Group performance status of 0 to 2 ; adequate bone marrow , hepatic , cardiac , and renal function ; and controlled blood pressure .


The CALGB study served as the training data set , and the AVOREN study served as the testing data set .


The dependence between PFS and OS was investigated using the Kendall tau for bivariate time-to-event endpoints .


In the training data set , the median OS times among patients who experienced progressive disease at 3 months or 6 months were 6 months and 8 months , respectively , compared with 25 months and 30 months , respectively , ( P < .001 ) in patients who did not develop disease progress .


The adjusted hazard ratios ( HR ) were 2.6 ( P < .0001 ) and 2.8 ( P < .0001 ) , respectively , for patients who did and did not progress at 3 months or 6 months .


The dependence between PFS and OS was 0.53 .


These associations were confirmed in the testing data set .


In patients with mRCC who were treated with interferon-alpha with or without bevacizumab , the PFS at 3 months and 6 months was found to be predictive of OS .


A high dependence between PFS and OS was observed , suggesting that PFS may be used as a surrogate endpoint for OS .


Although this is a novel observation for RCC , these findings require validation in patients with mRCC who are treated with other targeted agents .


Clinical application of an antibiotic 's pharmacokinetic/pharmacodynamic ( PK/PD ) properties may improve the outcome of severe infections .


No data are available on the use of linezolid ( LNZ ) continuous infusion in critically ill obese patients affected by ventilator-associated pneumonia ( VAP ) .


We conducted a prospective randomized controlled trial to compare LNZ concentrations in plasma and epithelial lining fluid ( ELF ) , when administered by intermittent and continuous infusion ( II , CI ) , in obese critically ill patients affected by VAP .


Twenty-two critically ill obese patients were enrolled .


At the steady state , in the II group , mean SD total and unbound maximum-minimum concentrations ( C max/C max , u - C min/Cmin , u ) were 10 3.7 / 6.8 2.6 mg/L and 1.7 1.1 / 1.2 0.8 mg/L , respectively .


In the CI group , the mean SD total and unbound plasma concentrations ( C ss and C ss , u ) were 6.2 2.3 and 4.3 1.6 mg/L , respectively .


Within a minimum inhibitory concentration ( MIC ) range of 1-4 mg/L , the median ( IQR ) time LNZ plasma concentration persisted above MIC ( % T > MIC ) was significantly higher in the CI than the II group [ 100 ( 100-100 ) vs 100 ( 89-100 ) , p = 0.05 ; 100 ( 100-100 ) vs 82 ( 54.8-98 .8 ) , p = 0.009 ; 100 ( 74.2-100 ) vs 33 ( 30.2-78 .5 ) , p = 0.005 ; respectively ] .


Pulmonary penetration ( % ) was higher in the CI group , as confirmed by a Monte Carlo simulation [ 98.8 ( IQR 93.8-104 .3 ) vs 87.1 ( IQR 78.7-95 .4 ) ; p < 0.001 ] .


In critically ill obese patients affected by VAP , LNZ CI may overcome the limits of standard administration but these advantages are less evident with difficult to treat pathogens ( MIC = 4 mg/L ) .


These data support the usefulness of LNZ continuous infusion , combined with therapeutic drug monitoring ( TDM ) , in selected critically ill populations .


The long-term efficacy and safety of responsive direct neurostimulation was assessed in adults with medically refractory partial onset seizures .


All participants were treated with a cranially implanted responsive neurostimulator that delivers stimulation to 1 or 2 seizure foci via chronically implanted electrodes when specific electrocorticographic patterns are detected ( RNS System ) .


Participants had completed a 2-year primarily open-label safety study ( n = 65 ) or a 2-year randomized blinded controlled safety and efficacy study ( n = 191 ) ; 230 participants transitioned into an ongoing 7-year study to assess safety and efficacy .


The average participant was 34 ( 11.4 ) years old with epilepsy for 19.6 ( 11.4 ) years .


The median preimplant frequency of disabling partial or generalized tonic-clonic seizures was 10.2 seizures a month .


The median percent seizure reduction in the randomized blinded controlled trial was 44 % at 1 year and 53 % at 2 years ( p < 0.0001 , generalized estimating equation ) and ranged from 48 % to 66 % over postimplant years 3 through 6 in the long-term study .


Improvements in quality of life were maintained ( p < 0.05 ) .


The most common serious device-related adverse events over the mean 5.4 years of follow-up were implant site infection ( 9.0 % ) involving soft tissue and neurostimulator explantation ( 4.7 % ) .


The RNS System is the first direct brain responsive neurostimulator .


Acute and sustained efficacy and safety were demonstrated in adults with medically refractory partial onset seizures arising from 1 or 2 foci over a mean follow-up of 5.4 years .


This experience supports the RNS System as a treatment option for refractory partial seizures .


This study provides Class IV evidence that for adults with medically refractory partial onset seizures , responsive direct cortical stimulation reduces seizures and improves quality of life over a mean follow-up of 5.4 years .


Patients with diabetes often develop ocular complications .


The most common and most blinding of these complications , however , is diabetic retinopathy .


The objective of this study was to compare the retinal neovessels regression in Proliferative Diabetic Retinopathy ( PDR ) treated with Pan Retinal Photocoagulation ( PRP ) versus panretinal photocoagulation plus Intra Vitreal Bevacizumab ( IVB ) .


A comparative study was conducted at Khyber Institute of Ophthalmic Medical Sciences , Hayatabad Medical Complex , Peshawar from 1st October 2010 to 31st August 2011 .


A total of 54 eyes were randomised into two groups .


Neovessels status was assessed before and at every follow up visit .


Neo Vessels on the Disc ( NVDs ) were assessed as per percentage of NVD occupying the disc surface whereas Neo Vessels Elsewhere ( NVE ) were also assessed as per reference to disc surface diameter .


Neovascularization on the disc was 40 + / - 5 % at presentation which increased to 50 + / - 7 % on 30th day and stabilised to 40 + / - 6 % on day 90 in PRP group .


In PRP-plus group , 40 + / - 7 % NVD regressed to 10 + / - 5 % on 30th day and 11 + / - 3 % on day 90 .


The NVE in PRP group was 2 + / - 0.75 % at baseline , 2.25 + / - 0.75 % on 30th day , and 2.00 + / - 0.50 % on day 90 .


In PRP-plus group it was 2 + / - 0.50 % at baseline , 1 + / - 0.5 % on day 30 , and 0.75 + / - 0.25 % on day 90 .


On day 90 both the groups had highly significant different NVD ( p = 0.00008 ) and NVE ( p = 0.0001 ) .


Intra Vitreal Bevacizumab in short term is effective as adjunctive treatment to PRP with early and higher rate of retinal neovessels regression than PRP alone in PDR patients .


To determine the efficacy of combining of Boswellia serrata L. resin and the root of Cyperus scariosus L. plus PFMT in reproductive age women with stress urinary incontinence .


A prospective , single-blind , placebo-controlled , randomized trial was conducted .


The patients were randomized to receive orally either combination of equal quantity of B.serrata and C.scariosus ( 2g ) ( n = 30 ) or placebo ( n = 30 ) respectively twice daily for 8 weeks in addition to pelvic floor muscle training in both groups .


The outcome was one hour pad test .


The results were analyzed using parametric and nonparametric test .


The improvement in the test and control group was 60 % and 37 % respectively .


Between the group comparison was statistically significant ( P = 0.035 ) .


The intra group comparison of one hour pad test was statistically significant in both groups ( P < 0.001 ) .


No adverse effects were noted .


The test group was more effective than control group in women with SUI .


Surgical resection has been the mainstay of curative treatment of early stage lung cancer in selected patients .


We evaluated survival and patterns of recurrence after surgical resection for early stage lung cancer from the American College of Surgeons Oncology Group Z0030/Alliance trial .


One thousand eighteen patients enrolled in the Z0030 trial were analyzed according to clinical T stage .


Differences between groups were compared using the 2-sample rank test or ( 2 ) test .


Log rank test and Cox proportional hazards regression were used to compare survival and recurrence .


To compare patients who underwent open versus video-assisted thoracoscopic surgery ( VATS ) resections , propensity-score matched analysis was performed .


Seven hundred fifty-two patients ( 66 undergoing VATS and 686 undergoing open surgery ) were classified into 5 equal-sized propensity-score groups .


Proportional hazards regression was used to compare these outcomes .


There were 578 patients with cT1 tumors and 440 patients with cT2 tumors .


Median follow-up was 6.7 years .


Median overall survival was 9.1 years ( stage T1 ) and 6.5 years ( stage T2 ) .


Overall survival at 5 years was 72 % ( stage T1 ) and 55 % ( stage T2 ) .


Local recurrence-free survival at 5 years was 95 % ( stage T1 ) and 91 % ( stage T2 ) ( P = .015 ) .


Among patients with stage T1 cancer , 4.2 % ( 23 out of 542 ) had local recurrences , whereas 7.3 % ( 30 out of 409 ) of those with stage T2 tumors had local failure .


There was no difference in the development of new primary tumors between stage T1 and stage T2 groups .


In the propensity-score matched analysis of VATS versus open lobectomy patients , there was no difference in overall survival , disease-free survival , and freedom from development of a new primary tumor .


Results of patients with resected early stage non-small cell carcinoma from a large-scale , multicenter trial serve as benchmarks against which to compare nonsurgical therapies for early stage lung cancer .


Propensity-score matched analysis shows no difference in survival between patients undergoing VATS and open lobectomy .


This study was conducted to investigate the effects of creatine loading and resistance training on the homocysteine and lipid profiles of young males .


Sixty male University students ( 22.34 2.19 years , 1.79 0.08 m , 77.18 12.57 kg , 15.48 4.57 % body fat ) were randomly divided in to three groups ; control ( CG = 20 ) , creatine supplement ( CEG = 20 ) and placebo ( PEG = 20 ) .


Both CEG and PEG participated in a same resistance-training regimen and either taking a creatine supplement ( 25 g/d for the first 5 days followed 5 g/d thereafter ) or the same amount of placebo for 8 weeks .


Participants in CG did not take any creatine supplementation and not engage any exercise program .


After the body composition were assessed , the homocysteine ( Hcy ) concentrations , blood lipids , folic acid and vitamin B12 levels of all the participants were measured at the beginning and end of the eight weeks of resistance training .


The analysis of the data indicated that the Hcy levels of the CEG after resistance training and receiving the creatine supplement ( 9.33 4.60 ) was significantly lower than that of baseline ( 12.66 5.89 ) measurements , F ( 1,18 ) = 12.28 , P = 0.00 .


No significant differences were seen in the Hcy levels of the PEG ( 15.01 10.87 ) after 8 weeks of training and receiving a placebo ( 12.46 12.50 ) , F ( 1,16 ) = 4.65 , P = 0.05 .


Furthermore , there were no significant differences among groups in terms of Hcy levels , F ( 2,52 ) = 1.72 , P = 0.19 .


The present study suggests that as well as strength gain ; creatine supplementation with resistance training may afford some protection against emerging cardiovascular risk factors .


To compare rates and severity of complications between infants undergoing cataract surgery with and without intraocular lens ( IOL ) implantation .


Prospective randomized clinical trial .


A total of 114 infants were enrolled in the Infant Aphakia Treatment Study , a randomized , multi-center ( 12 ) clinical trial comparing the treatment of unilateral aphakia in patients under 7 months of age with a primary IOL implant or contact lens .


The rate , character , and severity of intraoperative complications , adverse events , and additional intraocular surgeries during the first 5 postoperative years in the 2 groups were examined .


There were more patients with intraoperative complications ( 28 % vs 11 % , P = .031 ) , adverse events ( 81 % vs 56 % , P = .008 ) , and more additional intraocular surgeries ( 72 % vs 16 % , P < .0001 ) in the IOL group than in the contact lens group .


However , the number of patients with adverse events in the contact lens group increased ( 15 to 24 ) in postoperative years 2-5 compared to the first postoperative year , while it decreased ( 44 to 14 ) in years 2-5 compared to the first postoperative year in the IOL group .


If only one half of the patients in the contact lens ( aphakic ) group eventually undergo secondary IOL implantation , the number of additional intraocular surgeries in the 2 groups will be approximately equal .


The increased rate of complications , adverse events , and additional intraocular surgeries associated with IOL implantation in infants < 7 months of age militates toward leaving babies aphakic if it is considered likely that the family will be successful with contact lens correction .


The aims of this study were ( 1 ) to assess the long-term effects of a collaborative care intervention for patients with depression on process of care outcomes , and ( 2 ) to describe whether case management was continued after the end of the original one-year intervention .


This 24-month follow-up of a randomized controlled trial took place 12 months after the end of the 1-year intervention .


Data collection occurred by means of self-rating questionnaires and from medical records .


We calculated linear mixed and logistic generalized estimating equation models .


Of the 626 patients included at baseline , 439 ( 70.1 % ) participated in this follow-up .


Intervention recipients gave higher ratings than control recipients in terms of mean overall Patient Assessment of Chronic Illness Care ( PACIC ) scores ( 3.12 vs. 2.86 ; P = .019 ) , but no difference was found in medication adherence ( mean Morisky score 2.59 vs. 2.65 , P = .56 ) , prescribed antidepressant medications ( 60.2 % vs. 55.1 % ; P = .25 ) , visits to the family physician ( 15.96 vs. 14.46 , P = .58 ) or mental health specialist ( 3.01 vs. 2.94 , P = .94 ) over the 12 month follow-up period .


Case management was continued for 47 ( 22.5 % ) selected intervention patients after the original intervention had ended .


At 24 months , intervention and control recipients had different PACIC ratings , but other process of care outcomes did not differ .


The main effects of the intervention are apparent at 12 months .


Effective lifestyle interventions are needed to prevent noncommunicable diseases in low - and middle-income countries .


We analyzed the effects of a school-based health promotion intervention on physical fitness after 28 months and explored if the effect varied with important school characteristics .


We also assessed effects on screen time , physical activity and BMI .


We performed a cluster-randomized pair matched trial in schools in urban Ecuador .


The intervention included an individual and environmental component tailored to the local context and resources .


Primary outcomes were physical fitness ( EUROFIT battery ) , screen time ( questionnaires ) and physical activity ( accelerometers ) .


Change in BMI was a secondary outcome .


A total of 1440 grade 8 and 9 adolescents ( intervention : n = 700 , 48.6 % ) and 20 schools ( intervention : n = 10 , 50 % ) participated .


Data of 1083 adolescents ( intervention : n = 550 , 50.8 % ) from 20 schools were analyzed .


A school-based intervention with an individual and environment component can improve physical fitness and can minimize the decline in physical activity levels from childhood into adolescence in urban Ecuador .


Clinicaltrials.gov identifier NCT01004367 .


Recently , various near-infrared vascular imaging devices aimed at facilitating peripheral intravenous cannulation ( PIC ) were introduced , all claiming to increase success rate of PIC .


We evaluated the clinical utility of a near-infrared vascular imaging device ( VascuLuminator ( ) ) in pediatric patients who were referred to the anesthesiologist because of difficult cannulation .


There were 226 consecutive children referred to pediatric anesthesiologists by the treating pediatrician of the in - and outpatient clinic , because of difficulties with intravenous cannulation , were included in this cluster randomized clinical trial .


The presence and use of the near-infrared vascular imaging device for PIC was randomized in clusters of 1 week .


Success at first attempt ( Fisher exact test ) and time to successful cannulation ( Log-rank test ) were assessed to evaluate differences between groups .


Success at first attempt in the group with the VascuLuminator ( ) ( 59 % ) was not significantly different from the control group ( 54 % , P = 0.41 ) , neither was the median time to successful cannulation : 246 s and 300 s , respectively ( P = 0.54 ) .


Visualization of blood vessels with near-infrared light and with near-infrared vascular imaging device did not improve success of PIC in pediatric patients who are known difficult to cannulate .


The high prevalence of obstructive sleep apnea in patients with resistant hypertension could be mediated by an activation of the renin-angiotensin-aldosterone system .


This study assessed the impact of continuous positive airway pressure ( CPAP ) treatment on plasma aldosterone concentration ( PAC ) .


One hundred and twenty-four patients with resistant hypertension were assessed , and those who fulfilled inclusion criteria ( n = 116 ) underwent full night polysomnography , 24-h ambulatory blood pressure monitoring , and PAC measurement .


Patients with an apnea-hypopnea index above 15 ( n = 102 ) were randomized to CPAP ( n = 50 ) or to conventional treatment ( n = 52 ) for 3 months .


Seventy-eight patients completed the follow-up ( 36 CPAP , 42 conventional treatment ) ; 58 had true resistant hypertension ( 74.3 % ) , whereas 20 had white-coat resistant hypertension ( 25.6 % ) .


Most patients were men ( 70.7 % ) , age 58.39.4 years , and the mean apnea-hypopnea index was 50.121.6 .


In patients with true resistant hypertension , CPAP achieved a significant decrease in most 24-h BP measurements and a nonsignificant decrease in PAC ( 258.7 vs. 22.79 ng/dl ; P < 0.182 ) .


In patients with white-coat resistant hypertension , CPAP achieved a significant decrease in PAC ( 26.111.2 vs. 18.910.1 ng/dl ; P < 0.041 ) and in night-time DBP .


After adjustment , a weak but significant association was found between cumulative time spent with SaO2 below 90 % ( CT90 % ) and baseline PAC ( P < 0.047 , R 0.019 ) , and between changes in PAC and changes in office DBP ( P < 0.020 , R 0.083 ) CONCLUSIONS : : Night-time hypoxemia and changes in DBP showed an association with baseline and changes in PAC , respectively .


CPAP achieved a significant reduction in PAC only in patients with white-coat resistant hypertension , although the CPAP effect on BP was highest in patients with true resistant hypertension .


The Swiss health ministry launched a national quality program ` QualiCCare ' in 2011 to improve health care for patients with COPD.The aim of this study is to determine whether participation in the COPD quality initiative ( ` QualiCCare ' ) improves adherence to recommended clinical processes and shows impact on patients ' COPD care and on the impact of COPD on a person 's life .


CAROL is a cluster-randomized controlled trial with randomization on the general practioner ( GP ) level .


Thirty GPs will be randomly assigned to equally sized intervention group or control group.Each GP will approach consecutively and regardless of the reason for the current consultation , patients aged 45 years or older , with a smoking history of ten pack-years ( PY ) .


Patients with confirmed ( by spirometric evaluation ) COPD will be included in the study .


GPs in the intervention group will receive ` QualiCCare ' education , which addresses knowledge , decision-making and behavioural aspects as well as delivery of care according to COPD quality indicators and evidence-based key elements .


In the control group , no educational intervention will be applied and COPD patients will be treated as usual .


The study period is one year.The primary outcome measure is an aggregated score of relevant clinical processes defining elements in the care of patients with COPD : smoking cessation counseling , influenza vaccination , motivation for physical activity , appropriate pharmacotherapy , patient education and collaborative care .


Given a power of 90 % and a significance level alpha of 5 % , 15 GPs recruiting eight patients each will be necessary in both study arms .


With an assumed dropout rate of 20 % , 288 patients will need to be included .


It is important to develop and implement interventions that add value to COPD care considering quality and efficiency .


Care pathways modifying the knowledge and behavior of physicians have the potential for improving care by transferring knowledge to clinical practice .


ClinicalTrials.gov : NCT01921556 .


There is a lack of knowledge about the patient 's experience of excess skin after bariatric surgery in patients with body mass index , ( BMI ) > 50 kg/m ( 2 ) .


The objective of this study was to evaluate experience of excess skin after laparoscopic biliopancreatic diversion with duodenal switch ( BPD/DS ) or laparoscopic Roux-en-Y gastric bypass ( LRYGB ) and explore possible gender differences .


Another aim was to analyze possible correlation between the reported experiences of excess skin with changes in weight , BMI , and hip and waist circumference after surgery .


One and/or 2 years after gastric bypass or duodenal switch surgery 57 patients responded to a specific questionnaire .


The questionnaire included questions about the amount of excess skin and how much discomfort it caused .


Furthermore , the patients were measured concerning weight and waist and hip circumference .


One year after surgery , a majority of the patients experienced excess skin scored as > 2 ( `` a lot of '' or `` very much '' ) .


The patients in the BPD/DS group experienced significantly more excess skin compared to patients in the LRYGB group .


Women experienced more excess skin and discomfort on several body parts than men .


The correlations between changes in BMI and the reported experience and discomfort of excess skin were low .


There was a low to moderate correlation between changes in waist and hip circumference measures and the experience of excess skin on stomach and buttocks .


Weight loss after LRYGB and BPD/DS in super-obese patients is associated with substantial discomfort from excess skin .


Women reported more discomfort and experienced more excess skin than men .


There was a low correlation between experience of excess skin and changes in weight , BMI , and circumference measures .


To compare the efficacy of 4 mg and 8 mg doxazosin XL treatments in patients with benign prostatic hyperplasia-related lower urinary tract symptoms and determine the efficiency of 8 mg in those patients with inadequate response to 4 mg .


A total of 162 patients were included in this study .


Of the patients , 108 were randomized to receive 4 mg doxazosin XL ( group 1 ) , and 54 were randomized to receive 8 mg ( group 2 ) treatments .


After 1 month of treatment , 31 patients in group 1 whose quality of life ( QoL ) score was unchanged or had deteriorated were switched to 8 mg doxazosin XL treatment ( group 1b ) .


The mean age was 59.8 years .


After 1 month of treatment , the mean alteration in the International Prostate Symptom Score was 3.9 and 5.2 ( P = .028 ) , for the maximum urinary flow rate ( Q ( max ) ) , it was 3.0 and 3.6 mL/s ( P = .206 ) , and for the QoL score it was 1.3 and 1.7 ( P = .038 ) in groups 1 and 2 , respectively .


For group 1b , during the period in which the patients were receiving 4 and 8 mg doxazosin XL treatments ; the International Prostate Symptom Score changes were 1.3 and 3.6 ( P < .001 ) , the Q ( max ) changes were 1.6 and 3.2 mL/s ( P < .019 ) , and the QoL changes were 0.4 and 1.8 ( P < .001 ) in groups 1 and 2 , respectively .


With no changes in side effects , 8 mg doxazosin XL treatment is an efficient choice for patients who did not have an adequate response to 4 mg doxazosin XL treatment .


Studies conducted in large populations of patients and providing full information on Helicobacter pylori ( H. pylori ) antibiotic resistance are needed to determine the efficacy of sequential therapy ( SQT ) against this pathogen .


This study compared eradication rates with SQT and standard triple therapy ( STT ) , and evaluated the impact of antibiotic resistance on outcomes .


The study population included adults with positive H. pylori culture presenting at four centers in China between March 2008 and December 2010 .


Patients were randomly assigned to 10 days of treatment with esomeprazole , amoxicillin , and clarithromycin ( STT ; n = 140 ) or to 5 days of treatment with esomeprazole and amoxicillin , followed by 5 days of esomeprazole , clarithromycin , and tinidazole ( SQT ; n = 140 ) .


Eradication was assessed 8-12 weeks after treatment .


There was no significant difference between the eradication rates achieved with STT ( 66.4 % ( 95 % confidence interval ( CI ) 59.3-74 .3 ) ) and SQT ( 72.1 % ( 65.0-79 .3 ) ; P = 0.300 ) in either the intention-to-treat analysis or the per-protocol analysis ( 72.7 % ( 65.6-79 .7 ) and 76.5 % ( 69.7-83 .3 ) , respectively ; P = 0.475 ) .


Clarithromycin resistance ( CLA-R , odds ratio ( OR ) = 8.34 ( 3.13-22 .26 ) , P < 0.001 ) and metronidazole resistance ( MET-R , OR = 7.14 ( 1.52-33 .53 ) , P = 0.013 ) both independently predicted treatment failure in the SQT group .


Patients in the SQT group with dual CLA-R and MET-R had a lower eradication rate ( 43.9 % ) than those with isolated CLA-R ( 88.9 % , P = 0.024 ) or isolated MET-R ( 87.8 % , P < 0.001 ) .


H. pylori eradication rates with STT and SQT were compromised by antibiotic resistance .


SQT may be suitable in regions with high prevalence of isolated CLA-R , but it is unsatisfactory when both CLA-R and MET-R are present .


Pruritus is common among patients with end-stage renal disease undergoing dialysis , and the pathogenesis can be explained by several mechanisms .


However , there is no definite evidence supporting them , which limits the relative efficacy of any individual treatment option .


In this paper , we aimed to compare pregabalin with ondansetron in treatment of uraemic pruritus ( UP ) in dialysis patients .


In this 12-week prospective , randomized , and double-blind trial , we assessed the efficacy and side effects in UP patients undergoing dialysis .


Patients were randomly assigned to receive 12 weeks of 75 mg twice-weekly pregabalin or 8 mg/day ondansetron or a placebo .


Visits were scheduled at 0 , 2 , 4 , 6 , 8 , and 12 weeks after treatment .


The severity of pruritus was evaluated using Visual Analogue Scale and modified Duo 's VAG Scale .


Quality of sleep was evaluated using the Pittsburgh sleep quality index .


The effect of UP on health-related quality of life was assessed using the Chinese version of the 12-item short-form ( SF-12 ) general health survey .


Baseline laboratory data and demographic characteristics were recorded from patient charts .


Finally , 179 ( 108 males , 71 females , aged 54.711.3 years old ) out of the 188 patients completed the 12-week study .


Of five patients who stopped pregabalin treatment due to side effects , two patients reported an improvement in nausea and vomiting among those receiving ondansetron .


Two patients dropped out for renal transplantation .


The 179 patients included 62 cases from the pregabalin group , 60 from the ondansetron group , and 57 from the placebo group .


Over the 12 weeks , only pregabalin improved UP significantly .


The severity of pruritus was reduced significantly in the pregabalin group compared with the ondansetron and the placebo groups .


The final pruritus scores were not different between the ondansetron and the placebo groups .


Pruritus absolutely disappeared in two patients following renal transplantation .


Pregabalin is an effective alternative for treatment of uraemic pruritus .


Ondansetron has negligible effect on uremic pruritus and is expensive .


A larger sample size may be needed to demonstrate the effect of ondansetron in uraemic pruritus .


To investigate whether granulocyte colony-stimulating factor ( G-CSG ) affects endometrial thickness , implantation rates , and clinical pregnancy rates in routine , unselected IVF cycles .


Registered , individually randomized , two-group , parallel double-blinded placebo-controlled clinical trial .


Academically affiliated private clinical and research center .


141 consecutive , unselected , consenting women with no history of renal disease , sickle cell disease , or malignancy who were undergoing IVF .


Sealed , numbered , opaque envelopes assigned 73 patients to receive G-CSF ( Filgrastim , Amgen , 300 g/1 .0 mL ) and 68 to receive placebo ( saline ) .


Endometrial thickness , clinical pregnancy , and embryo implantation rates .


The mean age for the whole study group was 39.59 5.56 years ( G-CSF : 39.79 5.13 years ; placebo : 39.38 6.03 years ) .


Endometrial thickness statistically significantly increased over the 5-day observation period for the whole group by approximately 1.36 mm .


The increase in the G-CSF group was not statistically significantly different from the control group .


Statistical models looking at treatment effects on clinical pregnancy and implantation rates demonstrated no effect of G-CSF treatment .


There were no adverse events for either treatment group .


In normal IVF patients , G-CSF does not affect endometrial thickness , implantation rates , or clinical pregnancy rates .


Because these results were obtained in an older patient population , they may not necessarily apply to younger women .


NCT01202656 .


Dilated cardiomyopathy is characterized by left ventricular dilatation and dysfunction .


Inflammation and adverse remodeling of the extracellular matrix may be involved in the pathogenesis .


Statins reduce levels of low density lipoprotein cholesterol , but may also attenuate inflammation and affect matrix remodeling .


We hypothesized that treatment with rosuvastatin would reduce or even reverse left ventricular remodeling in dilated cardiomyopathy .


In this multicenter , randomized , double blind , placebo-controlled study , 71 patients were randomized to 10 mg of rosuvastatin or matching placebo .


Physical examination , blood sampling , echocardiography and cardiac magnetic resonance imaging were performed at baseline and at six months ' follow-up .


The pre-specified primary end point was the change in left ventricular ejection fraction from baseline to six months .


Over all , left ventricular ejection fraction improved 5 percentage points over the duration of the study , but there was no difference in the change in left ventricular ejection fraction between patients allocated to rosuvastatin and those allocated to placebo .


Whereas serum low density lipoprotein cholesterol concentration fell significantly in the treatment arm , rosuvastatin did not affect plasma or serum levels of a wide range of inflammatory variables , including C-reactive protein .


The effect on markers of extracellular matrix remodeling was modest .


Treatment with rosuvastatin does not improve left ventricular ejection fraction in patients with dilated cardiomyopathy .


ClinicalTrials.gov NCT00505154 .


Current studies have demonstrated the efficacy and safety of laser intervention in the treatment of onychomycosis .


The objective of this study was to compare the efficacy of long-pulsed Nd : YAG 1064 nm laser for treatment of toenails onychomycosis with fingernails onychomycosis .


One hundred and twelve affected fingernails or toenails in 37 patients with onychomycosis were randomized into Group 1 ( 22 patients with 50 affected fingernails ) and Group 2 ( 15 patients with 62 affected toenails ) .


These patients were further classified into three subgroups ( Grade II , III , and IV ) according to Scoring Clinical Index of Onychomycosis .


All the affected nails were treated with long-pulse Nd : YAG 1064 nm laser intervention , once weekly , for continuous weeks , and were followed up for 24 weeks .


The response rates at weeks 8 , 16 , and 24 were 0 , 0 and 52 % , respectively , for Group 1 , and 10 , 32 and 71 % for Group 2 .


The inter-group difference in efficacy was statistically significant ( P < 0.05 ) .


Even in the same subgroup , the response rate of Group 2 was higher than that of Group 1 .


The efficacy of long-pulsed Nd : YAG 1064 nm laser intervention against affected toenails is superior to that against fingernails .


It is also effective for treatment of onychomycosis with different severity .


Physical therapy is recommended for the management of axial spondyloarthritis ( axSpA ) and flexibility exercises have traditionally been the main focus .


Cardiovascular ( CV ) diseases are considered as a major health concern in axSpA and there is strong evidence that endurance and strength exercise protects against CV diseases .


Therefore , the aim of this study was to investigate the efficacy of high intensity endurance and strength exercise on disease activity and CV health in patients with active axSpA .


In a single blinded randomized controlled pilot study the exercise group ( EG ) performed 12 weeks of endurance and strength exercise while the control group ( CG ) received treatment as usual .


The primary outcome was the Ankylosing Spondylitis ( AS ) Disease Activity Score ( ASDAS ) .


Secondary outcomes included patient reported disease activity ( Bath AS Disease Activity Index [ BASDAI ] ) , physical function ( Bath AS Functional Index [ BASFI ] ) , and CV risk factors measured by arterial stiffness ( Augmentation Index [ Alx ] ) and Pulse Wave Velocity [ PWV ] ) , cardiorespiratory fitness ( VO2 peak ) and body composition .


ANCOVA on the post intervention values with baseline values as covariates was used to assess group differences , and Mann Whitney U-test was used for outcomes with skewed residuals .


Twenty-eight patients were included and 24 ( EG , n = 10 , CG , n = 14 ) completed the study .


A mean treatment effect of -0.7 ( 95 % CI : -1.4 , 0.1 ) was seen in ASDAS score .


Treatment effects were also observed in secondary outcomes ( mean group difference [ 95 % CI ] ) : BASDAI : -2.0 ( -3.6 , -0.4 ) , BASFI : -1.4 ( -2.6 , -0.3 ) , arterial stiffness ( estimated median group differences [ 95 % CI ] ) : AIx ( % ) : -5.3 ( -11.0 , -0.5 ) , and for PVW ( m/s ) : -0.3 ( -0.7 , 0.0 ) , VO2 peak ( ml/kg/min ) ( mean group difference [ 95 % CI ] : 3.7 ( 2.1 , 5.2 ) and trunk fat ( % ) : -1.8 ( -3.0 , -0.6 ) .


No adverse events occurred .


High intensity exercise improved disease activity and reduced CV risk factors in patients with active axSpA .


These effects will be further explored in a larger trial .


ClinicalTrials.gov NCT01436942 .


Low vitamin D status is linked to increased mortality and morbidity in patients who are critically ill .


It is unknown if this association is causal .


To investigate whether a vitamin D3 treatment regimen intended to restore and maintain normal vitamin D status over 6 months is of health benefit for patients in ICUs .


A randomized double-blind , placebo-controlled , single-center trial , conducted from May 2010 through September 2012 at 5 ICUs that included a medical and surgical population of 492 critically ill adult white patients with vitamin D deficiency ( 20 ng/mL ) assigned to receive either vitamin D3 ( n = 249 ) or a placebo ( n = 243 ) .


Vitamin D3 or placebo was given orally or via nasogastric tube once at a dose of 540,000 IU followed by monthly maintenance doses of 90,000 IU for 5 months .


The primary outcome was hospital length of stay .


Secondary outcomes included , among others , length of ICU stay , the percentage of patients with 25-hydroxyvitamin D levels higher than 30 ng/mL at day 7 , hospital mortality , and 6-month mortality .


A predefined severe vitamin D deficiency ( 12 ng/mL ) subgroup analysis was specified before data unblinding and analysis .


A total of 475 patients were included in the final analysis ( 237 in the vitamin D3 group and 238 in the placebo group ) .


The median ( IQR ) length of hospital stay was not significantly different between groups ( 20.1 days [ IQR , 11.1-33 .3 ] for vitamin D3 vs 19.3 days [ IQR , 11.1-34 .9 ] for placebo ; P = .98 ) .


Hospital mortality and 6-month mortality were also not significantly different ( hospital mortality : 28.3 % [ 95 % CI , 22.6 % -34.5 % ] for vitamin D3 vs 35.3 % [ 95 % CI , 29.2 % -41.7 % ] for placebo ; hazard ratio [ HR ] , 0.81 [ 95 % CI , 0.58-1 .11 ] ; P = .18 ; 6-month mortality : 35.0 % [ 95 % CI , 29.0 % -41.5 % ] for vitamin D3 vs 42.9 % [ 95 % CI , 36.5 % -49.4 % ] for placebo ; HR , 0.78 [ 95 % CI , 0.58-1 .04 ] ; P = .09 ) .


For the severe vitamin D deficiency subgroup analysis ( n = 200 ) , length of hospital stay was not significantly different between the 2 study groups : 20.1 days ( IQR , 12.9-39 .1 ) for vitamin D3 vs 19.0 days ( IQR , 11.6-33 .8 ) for placebo .


Hospital mortality was significantly lower with 28 deaths among 98 patients ( 28.6 % [ 95 % CI , 19.9 % -38.6 % ] ) for vitamin D3 compared with 47 deaths among 102 patients ( 46.1 % [ 95 % CI , 36.2 % -56.2 % ] ) for placebo ( HR , 0.56 [ 95 % CI , 0.35-0 .90 ] , P for interaction = .04 ) , but not 6-month mortality ( 34.7 % [ 95 % CI , 25.4 % -45.0 % ] for vitamin D3 vs 50.0 % [ 95 % CI , 39.9 % -60.1 % ] for placebo ; HR , 0.60 [ 95 % CI , 0.39-0 .93 ] , P for interaction = .12 ) .


Among critically ill patients with vitamin D deficiency , administration of high-dose vitamin D3 compared with placebo did not reduce hospital length of stay , hospital mortality , or 6-month mortality .


Lower hospital mortality was observed in the severe vitamin D deficiency subgroup , but this finding should be considered hypothesis generating and requires further study .


clinicaltrials.gov Identifier : NCT01130181 .


To assess the role of sexual relationships on levels and patterns of adherence to medication for pre-exposure prophylaxis against HIV .


We enrolled 1147 HIV-negative individuals in long-term serodiscordant relationships at 3 sites in Uganda from the Partners Pre-exposure Prophylaxis Study , a randomized placebo-controlled trial of daily oral tenofovir and emtricitabine/tenofovir .


We used generalized estimation equations to assess the effects of sexual relationships on low adherence ( < 80 % ) and on gaps in adherence .


Fifty-three percent were male , 51 % were 18-34 years and 24 % were polygamous .


Participants who reported sex in the past month with someone other than their primary partner and with < 100 % condom use were more than twice as likely to have low adherence [ adjusted odds ratio ( aOR ) = 2.48 , 95 % CI : 1.70 to 3.62 ] compared with those who had sex with only their primary partners and 100 % condom use .


Using the same reference group , those who abstained from sex in the previous month had 30 % increased odds of low adherence ( aOR = 1.30 , 95 % CI : 1.05 to 1.62 ) and participants in nonpolygamous marriages who reported sex with both their primary and other partners and < 100 % condom use were almost twice as likely to be low adherers ( aOR = 1.76 , 95 % CI : 1.01 to 3.08 ) .


At least one 72-hour gap in adherence was seen in 598 participants ( 54.7 % ) ; 23.2 % had at least one 1-week gap .


Risk of low overall adherence was higher in participants who reported sex outside primary partnerships and suboptimal condom use , as well as in those who abstained from sex .


Adherence gaps were common , potentially creating risk for HIV acquisition .


Excessive and inadequate gestational weight gain can complicate a woman 's pregnancy and put her and her child at risk for poor delivery and birth outcomes .


Further , feeding and activity habits established early in life can significantly impact the development of childhood obesity .


The on-going Delta Healthy Sprouts Project is a randomized , controlled , comparative trial testing the efficacy of two Maternal , Infant , and Early Childhood Home Visiting programs on weight status and health behaviors of 150 mothers and their infants residing in the rural Mississippi Delta region of the United States .


Women are enrolled in their second trimester of pregnancy and randomized to one of two treatment arms .


The control arm curriculum is based on Parents as Teachers , an evidence based approach to increase parental knowledge of child development and improve parenting practices .


The experimental arm , labeled Parents as Teachers Enhanced , builds upon the control curriculum by including culturally tailored nutrition and physical activity components specifically designed for the gestational and postnatal periods .


We hypothesize that , as compared to the control arm , the experimental arm will be more effective in preventing inappropriate gestational weight gain , reducing postnatal weight retention , and decreasing infant obesity rates .


We also will evaluate mother and child dietary and physical activity outcomes , breastfeeding initiation and continuation , and child feeding practices .


The Delta Healthy Sprouts Project tests a novel , combined approach to maternal weight management and childhood obesity prevention in pregnant women and their children at high risk for obesity and chronic disease .


General practitioners/dermatologists may be aware of musculoskeletal symptoms in patients with psoriasis but may have difficulty accurately detecting psoriatic arthritis ( PsA ) .


We sought to evaluate 3 PsA screening questionnaires-the Psoriasis and Arthritis Screening Questionnaire ( PASQ ) , Psoriasis Epidemiology Screening Tool ( PEST ) , and Toronto Psoriatic Arthritis Screen ( ToPAS ) - based on rheumatologist assessment in patients with psoriasis .


Consecutive unselected patients with psoriasis , initially evaluated by dermatologists for plaque psoriasis , were randomized to receive 1 of 3 questionnaires .


Patients were subsequently evaluated by rheumatologists to establish/exclude clinical PsA diagnosis .


Using clinical PsA diagnosis as the standard for comparison , questionnaire accuracy was assessed by calculating sensitivity/specificity and positive/negative predictive values .


Of 949 patients with psoriasis evaluated by rheumatologists , 285 ( 30 % ) received a clinical diagnosis of PsA ( 95 % confidence interval 27 % -33 % ) .


Probable PsA was detected in 45.1 % , 43.0 % , and 42.9 % of patients using PASQ , PEST , and ToPAS , respectively .


Sensitivity ranged from 0.67 to 0.84 ; specificity , 0.64 to 0.75 ; positive predictive value , 0.43 to 0.60 ; and negative predictive value , 0.83 to 0.91 .


Not all patients completed all questionnaires ; lack of standardized diagnostic criteria introduced possible bias .


PASQ , PEST , and ToPAS are useful screening tools that can help dermatologists identifypatients without PsA and patients with possible PsA who may benefit from rheumatologist assessment .


The purpose of this study was to assess the time of onset and time course of efficacy over 12.0 hours of extended-release multilayer bead formulation of methylphenidate ( MPH-MLR ) compared with placebo in children 6-12 years of age with attention-deficit/hyperactivity disorder ( ADHD ) in a laboratory school setting .


This randomized double-blind placebo-controlled study included children 6-12 years of age with ADHD .


Enrolled children went through four study phases : 1 ) Screening period ( 4 weeks ) and a 2 day medication washout period ; 2 ) open-label period with dose initiation of MPH-MLR 15mg daily and individual dose optimization treatment period ( 2-4 weeks ) ; 3 ) double-blind crossover period in which participants were randomized to sequences ( 1 week each ) of placebo and the optimized MPH-MLR dose given daily ; and 4 ) follow-up safety call .


Analog classroom time course evaluations were performed at the end of each double-blind week .


The primary efficacy end-point was the mean of the on-treatment/postdose Swanson , Kotkin , Agler , M-Flynn , and Pelham ( SKAMP ) - Total scores over time points collected 1.0-12 .0 hours after dosing .


End-points were evaluated using a mixed-effects analysis of covariance .


The evaluable population included 20 participants .


The least-squares mean postdose SKAMP-Total score was higher for placebo than for MPH-MLR ( 2.18 vs. 1.32 , respectively ; p = 0.0001 ) , indicating fewer symptoms with MPH-MLR therapy than with placebo .


No difference in SKAMP-Total score between participants who received sequence 1 or sequence 2 was noted .


From each of hours 1.0-12 .0 , least-squares mean SKAMP-Total score was significantly lower for those receiving MPH-MLR than for those receiving placebo ( p0 .0261 ) .


Neither serious adverse events nor new or unexpected safety findings were noted during the study .


MPH-MLR showed a significant decrease in SKAMP scores compared with placebo in children with ADHD 6-12 years of age , indicating a decrease in ADHD symptoms .


The estimated onset was observed within 1.0 hour , and duration was measured to 12.0 hours postdose .


ClinicalTrials.gov Identifier : NCT01269463 .


Examine the short-term ( acute ) effects of methylphenidate ( MPH ) on math performance in children with attention-deficit hyperactivity disorder ( ADHD ) and what factors predict improvement in math performance .


One hundred ninety-eight children with ADHD participated in a double-blind , placebo-controlled , randomized crossover MPH trial .


Math response to MPH was determined through administration of math problems adjusted to their academic level during the Restricted Academic Situation Scale ( RASS ) .


Student t tests were conducted to assess change in math performance with psychostimulants .


Correlation between change on the RASS and change on the math performance was also examined .


Linear regression was performed to determine predictor variables .


Children with ADHD improved significantly in their math with MPH ( P < 0.001 ) .


The degree of improvement on the RASS ( which evaluates motor activity and orientation to task ) and on math performance on MPH was highly correlated .


A child 's age at baseline and Wechsler Individual Achievement Test ( WIAT ) - Numerical Operations standard scores at baseline accounted for 15 % of variances for acute math improvement .


MPH improves acute math performance in children with ADHD .


Younger children with lower math scores ( as assessed by the WIAT ) improved most on math scores when given psychostimulants .


NCT00483106 .


Atopic dermatitis ( AD ) is an inflammatory skin disease arising as a result of immune system and skin barrier defects .


Topical corticosteroids are safe and effective treatments for AD , when used in short courses .


Prolonged use is associated with skin barrier damage .


Topical calcineurin inhibitors are alternative immune-modulating treatments for AD purported to have no negative effects on the skin barrier .


To compare the effects of betamethasone valerate 01 % cream ( BMVc ) and tacrolimus 01 % ointment ( TACo ) on the skin barrier .


Twenty volunteers with quiescent AD ( no active signs for 6months ) participated in a randomized observer-blind study , wherein BMVc was applied to one forearm and TACo to the other , twice daily for 4weeks .


The biophysical/biological properties of the stratum corneum were assessed before and after treatment .


Nine volunteers with active disease and 10 with healthy skin were assessed at untreated sites .


BMVc significantly reduced skin barrier function , integrity and cohesion , and the levels of pyrrolidone carboxylic acid ( PCA ) and urocanic acid ( UCA ) towards the subclinical barrier defect observed in patients with AD ( nonlesional sites ) .


TACo preserved skin barrier function , integrity , cohesion and PCA and UCA levels , while significantly increasing skin hydration to levels comparable with healthy skin .


Both treatments reduced skin surface pH and trypsin-like protease activity , with TACo doing so to a significantly greater degree .


In quiescent AD , 4weeks of BMVc treatment adversely affected the biophysical properties of the skin and reduced the levels of natural moisturizing factor , whereas TACo improved the condition of the skin barrier .


Mental and physical fatigue while at work is common among emergency medical services ( EMS ) shift workers .


Extended shifts ( for example 24 hours ) and excessive amounts of overtime work increase the likelihood of negative safety outcomes and pose a challenge for EMS fatigue-risk management .


Text message-based interventions are a potentially high-impact , low-cost platform for sleep and fatigue assessment and distributing information to workers at risk of negative safety outcomes related to sleep behaviors and fatigue .


We will conduct a pilot randomized trial with a convenience sample of adult EMS workers recruited from across the United States using a single study website .


Participants will be allocated to one of two possible arms for a 90-day study period .


The intervention arm will involve text message assessments of sleepiness , fatigue , and difficulty with concentration at the beginning , during , and end of scheduled shifts .


Intervention subjects reporting high levels of sleepiness or fatigue will receive one of four randomly selected intervention messages promoting behavior change during shiftwork .


Control subjects will receive assessment only text messages .


We aim to determine the performance characteristics of a text messaging tool for the delivery of a sleep and fatigue intervention .


We seek to determine if a text messaging program with tailored intervention messages is effective at reducing perceived sleepiness and/or fatigue among emergency medicine clinician shift workers .


Additional aims include testing whether a theory-based behavioral intervention , delivered by text message , changes ` alertness behaviors ' .


The SleepTrackTXT pilot trial could provide evidence of compliance and effectiveness that would support rapid widespread expansion in one of two forms : 1 ) a stand-alone program in the form of a tailored/individualized sleep monitoring and fatigue reduction support service for EMS workers ; or 2 ) an add-on to a multi-component fatigue risk management program led and maintained by employers or by safety and risk management services .


Clinicaltrials.gov NCT02063737 , Registered on 10 January 2014 .


This study reports 12-month follow-up data from a randomized controlled trial of preschool-based social communication treatment for young children with autism .


A total of 61 children ( 48 males ) with autism , 29 to 60 months of age , had earlier been randomized either to 8 weeks of preschool-based social communication treatment in addition to standard preschool program ( n = 34 ) or to standard preschool program only ( n = 27 ) .


Significant short-term effects on targeted social communication skills have previously been published .


Long-term gains in social communication , language and global social functioning and communication were assessed from video-taped preschool teacher-child and mother-child interactions , Early Social Communication Scales , Reynell Developmental Language Scale , and Social Communication Questionnaire .


Compared with those in the control group , the treated children achieved significantly larger improvements in joint attention and joint engagement from baseline to 12-month follow-up .


However , no effects were detected on language and global ratings of social functioning and communication .


The treatment effect on child initiation of joint attention increased with increasing level of sociability at baseline , whereas nonverbal IQ and expressive language had no moderating effect .


This study is the first to show that , similar to specialist-delivered treatment , preschool-based treatment may produce small but possibly clinically important long-term changes in social communication in young children with autism .


The treatment did not affect language and global ratings of social functioning and communication .


More studies are needed to better understand whether treatment effects may be improved by increasing the intensity and duration of the treatment .


Clinical trial registration information -- Joint Attention Intervention and Young Children With Autism ; http://clinicaltrials.gov/; NCT00378157 .


Protocolized sedation improves clinical outcomes in critically ill adults , but its effect in children is unknown .


To determine whether critically ill children managed with a nurse-implemented , goal-directed sedation protocol experience fewer days of mechanical ventilation than patients receiving usual care .


Cluster randomized trial conducted in 31 US pediatric intensive care units ( PICUs ) .


A total of 2449 children ( mean age , 4.7 years ; range , 2 weeks to 17 years ) mechanically ventilated for acute respiratory failure were enrolled in 2009-2013 and followed up until 72 hours after opioids were discontinued , 28 days , or hospital discharge .


Intervention PICUs ( 17 sites ; n = 1225 patients ) used a protocol that included targeted sedation , arousal assessments , extubation readiness testing , sedation adjustment every 8 hours , and sedation weaning .


Control PICUs ( 14 sites ; n = 1224 patients ) managed sedation per usual care .


The primary outcome was duration of mechanical ventilation .


Secondary outcomes included time to recovery from acute respiratory failure , duration of weaning from mechanical ventilation , neurological testing , PICU and hospital lengths of stay , in-hospital mortality , sedation-related adverse events , measures of sedative exposure ( wakefulness , pain , and agitation ) , and occurrence of iatrogenic withdrawal .


Duration of mechanical ventilation was not different between the 2 groups ( intervention : median , 6.5 [ IQR , 4.1-11 .2 ] days ; control : median , 6.5 [ IQR , 3.7-12 .1 ] days ) .


Sedation-related adverse events including inadequate pain and sedation management , clinically significant iatrogenic withdrawal , and unplanned endotracheal tube/invasive line removal were not significantly different between the 2 groups .


Intervention patients experienced more postextubation stridor ( 7 % vs 4 % ; P = .03 ) and fewer stage 2 or worse immobility-related pressure ulcers ( < 1 % vs 2 % ; P = .001 ) .


In exploratory analyses , intervention patients had fewer days of opioid administration ( median , 9 [ IQR , 5-15 ] days vs 10 [ IQR , 4-21 ] days ; P = .01 ) , were exposed to fewer sedative classes ( median , 2 [ IQR , 2-3 ] classes vs 3 [ IQR , 2-4 ] classes ; P < .001 ) , and were more often awake and calm while intubated ( median , 86 % [ IQR , 67 % -100 % ] of days vs 75 % [ IQR , 50 % -100 % ] of days ; P = .004 ) than control patients , respectively ; however , intervention patients had more days with any report of a pain score 4 ( median , 50 % [ IQR , 27 % -67 % ] of days vs 23 % [ IQR , 0 % -46 % ] of days ; P < .001 ) and any report of agitation ( median , 60 % [ IQR , 33 % -80 % ] vs 40 % [ IQR , 13 % -67 % ] ; P = .003 ) , respectively .


Among children undergoing mechanical ventilation for acute respiratory failure , the use of a sedation protocol compared with usual care did not reduce the duration of mechanical ventilation .


Exploratory analyses of secondary outcomes suggest a complex relationship among wakefulness , pain , and agitation .


clinicaltrials.gov Identifier : NCT00814099 .


Pertrochanteric hip fractures occur in an elderly population and cause considerable morbidity and loss of functional ability as the fracture heals .


Recently , parathyroid hormone ( PTH ) , which is licensed for the treatment of osteoporosis , has been shown to potentially accelerate bone healing in animal and human studies .


If its administration could allow a faster functional recovery after pertrochanteric hip fracture , then a patient 's hospital stay may be reduced and rehabilitation could be potentially accelerated .


PTH can currently only be administered by subcutaneous injection .


The acceptability of this intervention is unknown in this elderly population .


The aim of this pilot study is to inform the design of a future powered study comparing the functional recovery after pertrochanteric hip fracture in patients undergoing standard care versus those who undergo administration of subcutaneous injection of PTH .


The study is an open label , prospective , randomised , comparative pilot study with blinded outcomes assessment to establish feasibility of the trial design .


Patients will be randomised to receive a 6-week course of PTH or usual treatment .


Functional outcomes will be assessed at 6 weeks and 12 weeks .


Blinded assessment will be used to minimise the effect of bias of an open label study design .


A nested qualitative study will investigate the patient experience of , and expectations following , hip fracture and the patient important aspects of recovery compared with the outcome measures proposed .


Results will be analysed to establish the potential recruitment , compliance and retention rates using 95 % CIs , and trial outcomes quoted with SDs and 95 % CIs for the effect size .


The study has been approved by the South West 2 Research Ethics committee ( reference 10/H0206/34 ) .


The findings of this study will be disseminated to the medical community via presentations to orthopaedic , orthogeriatric and osteoporosis societies , and their relevant specialist journals .


ISRCTN Register reference number : ISRCTN03362357 .


Eudract Number : 2010-020081-22 .


Myrtle ( Myrtus communis L. ) has been used in the Iranian Traditional Medicine as a treatment for abnormal uterine bleeding-menometrorrhagia .


The main aim of this study is to evaluate the effect of myrtle fruit syrup on abnormal uterine bleeding-menometrorrhagia .


A randomized , double-blind , placebo-controlled pilot study was conducted on 30 women suffering from abnormal uterine bleeding-menometrorrhagia .


Treatment comprised of giving 15ml oral myrtle syrup daily ( 5ml three times a day ) for 7days starting from the onset of bleeding .


The myrtle syrup along with placebo was repeated for 3 consecutive menstrual periods .


Menstrual duration and number of used pads were recorded by the Pictorial Blood loss Assessment Chart at the end of each menstrual period .


The quality of life was also evaluated using the menorrhagia questionnaire .


The mean number of bleeding days significantly declined from 10.62.7 days to 8.21.9 days after 3months treatment with the syrup ( p = 0.01 ) and consequently the participants in the intervention group used fewer pads after 3months ( 16.410.7 ) compared with the number of pads used at the beginning of the treatment ( 22.712.0 , p = 0.01 ) .


Bleeding days and number of pads used by the participants in the placebo group did not change significantly .


Also significant changes of quality of life scores were observed in the intervention group after 3months compared to the baseline .


Myrtle syrup is introduced as a potential remedy for abnormal uterine bleeding-menometrorrhagia .


Despite positive effects of incretins on insulin secretion , little is known about the effect of exercise on these hormones .


Metformin can affect incretin concentrations and is prescribed to a large proportion of people with diabetes .


We , therefore , examined the effects of aerobic exercise and/or metformin on incretin hormones .