Consumption of caffeine 1 h before exercise induced improvements in exercise capacity and muscular strength in prostate cancer survivors .


However , there was no change in exercise-related fatigue when compared with placebo despite reduction in timed performance of the 400-m walk .


Caffeine seems to enhance exercise tolerance through improved performance with no subsequent increase in fatigue or perception of exertion and may be an appropriate strategy to promote exercise participation in prostate cancer survivors .


To determine whether initiation of cholinesterase inhibitors is associated with significant weight loss in a real-word clinical setting .


Retrospective cohort study from 2007 to 2010 comparing weight loss in individuals with dementia newly prescribed cholinesterase inhibitors and those newly prescribed other chronic medications .


National Veterans Affairs data .


Individuals aged 65 and older with a diagnosis of dementia who received a new prescription for a cholinesterase inhibitor or other new chronic medication .


The primary outcome was time to 10-pound weight loss over 12 months .


Propensity score matching was used to control for the likelihood of receiving a cholinesterase inhibitor based on baseline characteristics .


Data were analyzed in a priori defined subgroups according to age , comorbid burden , and initial weight .


Of 6,504 individuals that met study criteria , 1,188 started on cholinesterase inhibitors were matched to 2,189 started on other medications .


The propensity-matched cohorts were well balanced on baseline covariates .


Participants initiated on cholinesterase inhibitors had a higher risk of weight loss than matched controls at 12 months ( hazard ratio = 1.23 , 95 % confidence interval ( CI ) = 1.07-1 .41 ) .


At 12 months , 29.3 % of participants taking cholinesterase inhibitors had experienced weight loss , compared with 22.8 % of nonusers , corresponding to a number needed to harm of 21.2 ( 95 % CI = 12.5-71 .4 ) over 1 year .


There were no significant differences in the risk of weight loss within subgroups .


These results are consistent with the available data from randomized controlled trials .


Clinicians should consider the risk of weight loss when prescribing cholinesterase inhibitors .


To evaluate whether the calcitonin gene-related peptide ( CGRP ) receptor antagonist telcagepant might be effective for migraine prevention .


In this randomized , double-blind , placebo-controlled , multicenter trial ( ClinicalTrials.gov NCT00797667 ) , patients experiencing 3-14 migraine days during a 4-week baseline were randomized to telcagepant 140 mg , telcagepant 280 mg , or placebo twice daily for 12 weeks .


Efficacy was assessed by mean monthly headache days and migraine/probable migraine days ( headache plus 1 associated symptom ) .


The trial was terminated following a recommendation from the Safety Monitoring Board due to hepatotoxicity concerns .


At termination , the planned 660 patients had been randomized , 656 had been treated with 1 dose of study medication , and 14 had completed the trial .


The mean treatment duration was 48-50 days .


Thirteen patients , all in the telcagepant groups , had an alanine aminotransferase ( ALT ) elevation 3 the upper limit of normal and 7 of these also had an aspartate aminotransferase elevation 3 the upper limit of normal .


Two patients had very high symptomatic transaminase elevations that occurred within 2-6 weeks of treatment initiation and resolved after treatment discontinuation .


The originally planned efficacy analysis over 12 weeks was not performed due to limited data at later time points , but there was evidence that telcagepant resulted in a larger reduction from baseline than placebo for mean monthly headache days ( month 1 : 140 mg = -2.9 , 280 mg = -3.1 , placebo = -1.7 ; p < 0.05 ) and migraine/probable migraine days ( month 1 : 140 mg = -2.7 , 280 mg = -3.0 , placebo = -1.6 ; p < 0.05 ) .


These data suggest a potential role for CGRP receptor antagonism in migraine prophylaxis .


However , the observed aminotransferase elevations do not support the use of telcagepant for daily administration .


This study provides Class II evidence that in patients with migraine , telcagepant taken daily reduces headache days by 1.4 days per month compared to placebo and causes 2.5 % of patients to have elevations of serum ALT levels .


Healthcare professionals play a critical role in women 's choice of contraceptive methods .


However , national surveys on sexual and reproductive health ( SRH ) among physicians are rare and present low participation rates .


We conducted a randomized trial to test for the effectiveness of three interventions to improve survey participation of private physicians delivering reproductive health services in France .


The study comprised a national random sample of 500 general practitioners and 500 gynecologists working in private offices .


All received a postal invitation to participate either by completing a paper , phone or online questionnaire .


Physicians were randomly assigned to six groups to test for the effect of three interventions : a non-monetary incentive in the form of a scientific book , telephone contact , and the possibility of completing the questionnaire by phone .


Overall , 362 questionnaires were collected ( 26 online , 2 by phone ) and 58 physicians were ineligible .


The completion rate increased from 26.7 % in physicians who received no intervention to 42.7 % in those who received the book and a phone call .


The phone call increased the completion rate by 11 % percentage points ( P = 0.01 ) , while the book had no significant effect .


Results from multivariate logistic regressions also indicate that gynecologists ( OR = 1.6 ) and female physicians ( OR = 1.5 ) were more likely to participate than others .


The results suggest that phone calls substantially increase participation of physicians in sexual and reproductive health surveys but have little impact on sampling distortion .


Differentials in response rates by physicians ' characteristics should be considered in future SRH studies among physicians .


Allogeneic stem-cell transplantation has had limited success for patients with refractory and relapsed aggressive B-cell or T-cell lymphoma .


We investigated the effect of adding rituximab to standard prophylaxis for graft-versus-host disease after transplantation and estimated overall survival when using a lymphoma-directed myeloablative conditioning regimen .


We did this randomised , open-label , phase 2 study at seven German transplantation centres .


We enrolled patients with aggressive B-cell or T-cell lymphoma and primary refractory disease , early relapse ( < 12 months after first-line treatment ) , or relapse after autologous transplantation .


Conditioning with fludarabine ( 125 mg/m ( 2 ) ) , busulfan ( 12 mg/kg oral or 96 mg/kg intravenous ) , and cyclophosphamide ( 120 mg/kg ) was followed by allogeneic stem-cell transplantation .


Patients were randomly assigned ( 1:1 ) to receive rituximab ( 375 mg/m ( 2 ) on days 21 , 28 , 35 , 42 , 175 , 182 , 189 , and 196 ) or not .


Allocation was done with a centralised computer-generated procedure ; patients were stratified by histological subtype ( B-cell vs T-cell lymphoma ) and donor match ( HLA-identical vs non-identical ) .


Neither investigators nor patients were masked to allocation .


The primary endpoints were the incidence of acute graft-versus-host disease grade 2-4 in each treatment group and overall survival at 1 year in both groups combined .


All analyses were done for the intention-to-treat population .


The study is registered with ClinicalTrials.gov , number NCT00785330 .


Between June 16 , 2004 , and March 24 , 2009 , we screened 86 patients and enrolled 84 ; 42 were randomly assigned to each group .


The cumulative incidence of grade 2-4 acute graft-versus-host disease was 46 % ( 95 % CI 32-62 ) in the rituximab group and 42 % ( 95 % CI 29-59 ) in the no rituximab group ( hazard ratio [ HR ] 091 , 95 % CI 052-160 ; p = 074 ) .


Overall survival at 1 year for the whole study population was 52 % ( 95 % CI 41-62 ) .


Grade 4 haematological toxic effects and grade 3 alopecia occurred in all patients .


The most common non-haematological grade 5 toxic effects were pneumonia ( nine in the no rituximab group vs ten in the rituximab group ) and other infections ( seven vs four ) .


The lymphoma-directed myeloablative conditioning regimen developed here is promising for patients with refractory and relapsed aggressive B-cell and T-cell lymphomas .


However , the addition of rituximab did not affect the incidence of graft-versus-host disease or overall survival .


Hoffmann-La Roche , Amgen , Astellas Pharma .


This study , based on Oklahoma 's statewide Child Development Accounts ( CDAs ) program , presents findings from the first experimental test of the hypothesis that creating lifelong savings accounts for children at birth promotes their long-term well-being .


To examine the effects of CDAs , an innovative social policy to encourage lifelong saving and asset building for long-term development , on parent-reported social-emotional development in early childhood .


A statewide randomized experiment of CDAs was conducted in 2008 , drawing a probability sample of 7328 children from all infants born in two 3-month periods in Oklahoma ( April 1 through June 30 and August 1 through October 31 , 2007 ) .


After agreeing to participate in the experiment , caregivers of 2704 infants completed a baseline survey and were randomly assigned to treatment ( n = 1358 ) and control groups ( n = 1346 ) .


Approximately 84 % of participants completed a follow-up survey in the spring of 2011 .


The intervention offered CDAs , built on the existing Oklahoma 529 college-savings plan , to treatment participants .


It also provided additional financial incentives and information .


The primary outcome-child social-emotional development-is measured by scores from a 17-item version of the Ages and Stages Questionnaire : Social-Emotional .


Caregivers completed it in the 3-year follow-up survey .


Lower scores indicate better functioning .


The CDAs have positive effects on social-emotional development for children at approximately age 4 years .


The nonweighted treatment-control difference is -1.56 ( 90 % CI , -2.87 to -0.22 ; P = .06 ) , but the weighted difference is nonsignificant .


The effects appear to be greater for disadvantaged subsamples , such as low-income households ( weighted mean difference,-2 .21 ; 90 % CI , -4.01 to -0.42 ; P = .04 ) .


As a complement to other early education and health interventions , CDAs may improve social-emotional development in early childhood .


Their effects may be explained as a mediating process that influences parents .


Child Development Accounts may influence parental attitudes , behaviors , expectations , and involvement ; in turn , these may affect child development .


Asthma with neutrophil predominance is challenging to treat with corticosteroids .


Novel treatment options for asthma include those that target innate immune activity .


Recent literature has indicated a significant role for IL-1 in both acute and chronic neutrophilic asthma .


This study used inhaled endotoxin ( LPS ) challenge as a model of innate immune activation to ( 1 ) assess the safety of the IL-1 receptor antagonist anakinra in conjunction with inhaled LPS and ( 2 ) to test the hypothesis that IL-1 blockade will suppress the acute neutrophil response to challenge with inhaled LPS .


In a phase I clinical study 17 healthy volunteers completed a double-blind , placebo-controlled crossover study in which they received 2 daily subcutaneous doses of 1 mg/kg anakinra ( maximum dose , 100 mg ) or saline ( placebo ) .


One hour after the second treatment dose , subjects underwent an inhaled LPS challenge .


Induced sputum was assessed for neutrophils 4 hours after inhaled LPS .


The effect of anakinra compared with placebo on airway neutrophil counts and airway proinflammatory cytokine levels after LPS challenge was compared by using a linear mixed-model approach .


Anakinra pretreatment significantly diminished airway neutrophilia compared with placebo .


LPS-induced IL-1 , IL-6 , and IL-8 levels were significantly reduced during the anakinra treatment period compared with those seen after placebo .


Subjects tolerated the anakinra treatment well without an increased frequency of infections attributable to anakinra treatment .


Anakinra effectively reduced airway neutrophilic inflammation and resulted in no serious adverse events in a model of inhaled LPS challenge .


Anakinra is a potential therapeutic candidate for treatment of asthma with neutrophil predominance in diseased populations .


To validate a magnetic resonance imaging sequence suitable for quantitative assessment of acid suppression by a proton pump inhibitor ( PPI ) on gastric secretion and emptying in clinical practice .


A golden angle radial sequence ( GOLD ) was validated in a series of in vitro and in vivo experiments and clinical feasibility was shown in two studies .


The impact of free breathing and image plane orientation on T1 values was evaluated in a controlled in vivo experiment .


The free-breathing GOLD sequence was compared against a standard breath-hold gradient echo sequence for gastric half emptying time in 23 subjects during a gastric emptying study .


Pilot data from five subjects assessed the sensitivity of the GOLD sequence to detect changes in acid secretion volume produced by PPI treatment .


The coronal free-breathing GOLD sequence and the axial breath-hold standard gradient echo sequence showed good agreement of the gastric half emptying time ( 6 3 min , P = 0.053 ) .


The GOLD sequence demonstrated sensitivity to reduction of gastric secretion volumes induced by PPI treatment ( 55 5 mL , P < 0.001 ) .


The GOLD sequence allowed for free breathing , multislice , combined imaging and T1 mapping of the stomach content .


GOLD presents a promising multipurpose , noninvasive imaging tool for monitoring gastric function in clinical studies .


In spite of several studies , the impact of homocysteine level and folic acid supplementation on bone metabolism is yet to be recognized .


In this registered clinical trial ( IRCT2014042217385N1 ) , we aimed to find out the power of 6-month folic acid supplementation on homocysteine level and bone metabolism .


Forty postmenopausal osteoporotic women ( 50 to 87years ) were enrolled in the study .


All participants were randomized to receive folic acid 1mg ( n = 17 ) or placebo ( n = 14 ) .


At baseline , 3months , and finally 6months post intervention , the level of homocysteine , vitamin B12 , and bone biomarkers were measured .


Both groups were similar at baseline .


The homocysteine decreased in both groups but statistically non-significant ( P > 0.05 ) .


The changes of the serum level of vitamin B12 , osteocalcin , and cross laps were significant between groups after 6months ( P0 .05 ) .


The trend of changes of bone biomarkers after 6months folic acid supplementation shows that homocysteine concentration and/or folic acid supplementation have impact on the rate of bone metabolism .


However , further investigations by larger sample size and differentiating age and gender are still needed to clarify the exact role of folate , homocysteine and vitamin B12 .


Theta-burst transcranial magnetic stimulation ( TBS ) has been shown to induce potent and long lasting effects on cortical excitability .


In a previous open study , we demonstrated safety , tolerability and antidepressant properties of continuous TBS ( cTBS ) in major depression ( MD ) .


The present study was aimed to evaluate the therapeutic efficacy of cTBS in depressed patients using a double-blind , sham-controlled design .


Twenty nine patients with MD were randomized to receive either active cTBS to the right dorsolateral prefrontal cortex ( n = 15 ) or sham cTBS ( n = 14 ) for 10 consecutive work days .


After the 10th session , patients who received sham TBS were crossed over to active cTBS which consisted of 10 daily sessions .


Patients who received active cTBS continued with the same treatment protocol for additional 10 treatments .


Each treatment session consisted of 3600 stimuli at an intensity of 100 % of the active motor threshold .


Severity of depression was assessed weekly .


Overall , there was no significant difference in the degree of clinical improvement between active and sham cTBS groups .


However , in patients whose medication status remained unchanged before the trial ( n = 8 ) and in those who were medication-free ( n = 3 ) , active cTBS resulted in a significantly greater reduction of Hamilton depression scores as compared to sham cTBS .


A small sample size , confounding effect of medication and short treatment period .


Our results suggest that the antidepressant effect of cTBS is modest , yet it might be beneficial to patients nonresponsive to ongoing pharmacological treatment .


A direct comparison between cTBS and conventional rTMS protocols is warranted .


To study the effects of continuous ultrasonic phacoemulsification performed with and without an anterior chamber maintainer ( ACM ) on corneal endothelial damage in patients with hard nuclear cataract .


Sixty eyes in 60 patients with hard nuclear cataract ( grade IV ) , one lesion per eye , were randomly allocated into 2 groups : continuous ultrasonic phacoemulsification with ( group A ) or without ( group B ) ACM .


The intraoperative accumulated energy complex parameter ( AECP ) , frequency of shallow anterior chamber , and postoperative corneal incision edema , corneal endothelial cell counts , and visual recovery were compared between the groups .


The intraoperative AECP , postoperative corneal incision edema , and postoperative visual recovery showed no significant differences between the groups ( p > 0.05 ) .


At 1 month postoperatively , the corneal endothelial cell loss rate and hexagonal cell percentage ( postoperative compared to preoperative ) in groups A and B were 0.117 0.12 and 9.97 9.52 % and 0.15 0.73 and 8.5 4.60 % , respectively , with no significant difference noted ( p > 0.05 ) .


The endothelial cell mutation rate was significantly lower in group A than in group B at 6.41 6.78 % and 28.27 27.95 % , respectively ( p < 0.05 ) .


The frequency of intraoperative shallow anterior chamber was significantly lower in group A than in group B ( 2 vs 17 times , p < 0.05 ) .


Continuous ultrasonic phacoemulsification with ACM is a safe , effective , simple , and easy method to treat hard nuclear cataract and causes minimal damage to corneal endothelial cells .


It is an ideal surgical option and is worth popularizing .


Shorter resident duty periods are increasingly mandated to improve patient safety and physician well-being .


However , increases in continuity-related errors may counteract the purported benefits of reducing fatigue .


We evaluated the effects of 3 resident schedules in the intensive care unit ( ICU ) on patient safety , resident well-being and continuity of care .


Residents in 2 university-affiliated ICUs were randomly assigned ( in 2-month rotation-blocks from January to June 2009 ) to in-house overnight schedules of 24 , 16 or 12 hours .


The primary patient outcome was adverse events .


The primary resident outcome was sleepiness , measured by the 7-point Stanford Sleepiness Scale .


Secondary outcomes were patient deaths , preventable adverse events , and residents ' physical symptoms and burnout .


Continuity of care and perceptions of ICU staff were also assessed .


We evaluated 47 ( 96 % ) of 49 residents , all 971 admissions , 5894 patient-days and 452 staff surveys .


We found no effect of schedule ( 24 - , 16 - or 12-h shifts ) on adverse events ( 81.3 , 76.3 and 78.2 events per 1000 patient-days , respectively ; p = 0.7 ) or on residents ' sleepiness in the daytime ( mean rating 2.33 , 2.61 and 2.30 , respectively ; p = 0.3 ) or at night ( mean rating 3.06 , 2.73 and 2.42 , respectively ; p = 0.2 ) .


Seven of 8 preventable adverse events occurred with the 12-hour schedule ( p = 0.1 ) .


Mortality rates were similar for the 3 schedules .


Residents ' somatic symptoms were more severe and more frequent with the 24-hour schedule ( p = 0.04 ) ; however , burnout was similar across the groups .


ICU staff rated residents ' knowledge and decision-making worst with the 16-hour schedule .


Our findings do not support the purported advantages of shorter duty schedules .


They also highlight the trade-offs between residents ' symptoms and multiple secondary measures of patient safety .


Further delineation of this emerging signal is required before widespread system change .


ClinicalTrials.gov , no .


NCT00679809 .


Postpericardiotomy syndrome , postoperative atrial fibrillation ( AF ) , and postoperative effusions may be responsible for increased morbidity and health care costs after cardiac surgery .


Postoperative use of colchicine prevented these complications in a single trial .


To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome , postoperative AF , and postoperative pericardial or pleural effusions .


Investigator-initiated , double-blind , placebo-controlled , randomized clinical trial among 360 consecutive candidates for cardiac surgery enrolled in 11 Italian centers between March 2012 and March 2014 .


At enrollment , mean age of the trial participants was 67.5 years ( SD , 10.6 years ) , 69 % were men , and 36 % had planned valvular surgery .


Main exclusion criteria were absence of sinus rhythm at enrollment , cardiac transplantation , and contraindications to colchicine .


Patients were randomized to receive placebo ( n = 180 ) or colchicine ( 0.5 mg twice daily in patients 70 kg or 0.5 mg once daily in patients < 70 kg ; n = 180 ) starting between 48 and 72 hours before surgery and continued for 1 month after surgery .


Occurrence of postpericardiotomy syndrome within 3 months ; main secondary study end points were postoperative AF and pericardial or pleural effusion .


The primary end point of postpericardiotomy syndrome occurred in 35 patients ( 19.4 % ) assigned to colchicine and in 53 ( 29.4 % ) assigned to placebo ( absolute difference , 10.0 % ; 95 % CI , 1.1 % -18.7 % ; number needed to treat = 10 ) .


There were no significant differences between the colchicine and placebo groups for the secondary end points of postoperative AF ( colchicine , 61 patients [ 33.9 % ] ; placebo , 75 patients [ 41.7 % ] ; absolute difference , 7.8 % ; 95 % CI , -2.2 % to 17.6 % ) or postoperative pericardial/pleural effusion ( colchicine , 103 patients [ 57.2 % ] ; placebo , 106 patients [ 58.9 % ] ; absolute difference , 1.7 % ; 95 % CI , -8.5 % to 11.7 % ) , although there was a reduction in postoperative AF in the prespecified on-treatment analysis ( placebo , 61/148 patients [ 41.2 % ] ; colchicine , 38/141 patients [ 27.0 % ] ; absolute difference , 14.2 % ; 95 % CI , 3.3 % -24.7 % ) .


Adverse events occurred in 21 patients ( 11.7 % ) in the placebo group vs 36 ( 20.0 % ) in the colchicine group ( absolute difference , 8.3 % ; 95 % CI ; 0.76 % -15.9 % ; number needed to harm = 12 ) , but discontinuation rates were similar .


No serious adverse events were observed .


Among patients undergoing cardiac surgery , perioperative use of colchicine compared with placebo reduced the incidence of postpericardiotomy syndrome but not of postoperative AF or postoperative pericardial/pleural effusion .


The increased risk of gastrointestinal adverse effects reduced the potential benefits of colchicine in this setting .


clinicaltrials.gov Identifier : NCT01552187 .


It is uncertain whether HIV-1 antiretroviral exposure and clinical response varies between males and females or different race/ethnic groups .


We describe ritonavir-enhanced atazanavir pharmacokinetics in relation to virological failure , safety and tolerability in treatment-naive individuals to investigate potential differences .


Plasma samples were collected from participants in AIDS Clinical Trials Group Study A5202 for measurement of antiretroviral concentrations .


Individual estimates of apparent oral clearance of atazanavir ( L/h ) were calculated from a one-compartment model and divided into tertiles as slow ( < 7 ) , middle ( 7 to < 9 ; reference group ) and fast ( 9 ) .


Associations between atazanavir clearance and clinical outcomes were estimated with a hazard ratio ( HR ) from Cox proportional hazards models .


Interactions between atazanavir clearance and sex , race/ethnicity and NRTIs were investigated for each of the outcomes .


Among 786 participants , average atazanavir clearance was slower in females ( n = 131 ) than males ( n = 655 ) .


Atazanavir clearance was associated with time to virological failure ( P = 0.053 ) and this relationship differed significantly by sex ( P = 0.003 ) .


Females in the fast atazanavir clearance group had shorter time to virological failure ( HR 3.49 ; 95 % CI 1.24-9 .84 ) compared with the middle ( reference ) atazanavir clearance group .


Among males , the slow atazanavir clearance group had a higher risk of virological failure ( HR 2.10 ; 95 % CI 1.16-3 .77 ) .


Atazanavir clearance differed by sex .


Females with fast clearance and males with slow clearance had increased risk of virological failure .


Transthoracic oesophagectomy requires prolonged one-lung ventilation causing systemic and local inflammatory responses .


Application of continuous positive airway pressure ( CPAP ) to the collapsed lung potentially reduces pulmonary damage , hypoxia , and consequent inflammation .


This randomized controlled trial studied the influence of CPAP applied to the collapsed right lung during thoracoscopic oesophagectomy on local and systemic inflammatory response .


Broncho-alveolar lavage fluid ( BALF ) from the right collapsed and left ventilated lung and serum samples were obtained during surgery from 30 patients undergoing thoracolaparoscopic oesophagectomy for cancer who were randomized for one-lung ventilation with or without CPAP applied to the collapsed right lung .


Concentrations of cytokines and chemokines , in BALF and serum , were determined with Luminex .


Patients from the control ( no CPAP ) group had significantly increased concentrations of interleukin ( IL ) -1 , IL-1 , IL-10 , tumour necrosis factor-alpha , macrophage inflammatory protein ( MIP ) -1 , pulmonary and activation-regulated chemokine ( PARC ) , and IL-8 in the collapsed ( right ) lung when compared with patients from the CPAP group ( P < 0.05 ) .


The ventilated ( left ) lung of the control group showed increased concentrations of monocyte chemoattractant protein ( MCP ) -1 and MIP-1 ( P < 0.05 ) .


Serum concentrations of cytokines and chemokines increased during surgery , but did not differ between the control and CPAP groups .


A significantly lower local immune response was observed during one-lung ventilation when CPAP was applied to the collapsed lung .


The findings suggest a beneficial effect of CPAP on the collapsed lung during oesophagectomy with one-lung ventilation .


To identify the factors underlying prostate cancer ( PCa ) patients ' depression-anxiety , sexual problems , urinary dysfunction and androgen deprivation therapy ( ADT ) - linked breast changes and hot flushes , and test these as predictors of loss of masculinity ( LoM ) over 36 months following diagnosis .


One thousand seventy patients from the TROG 03.04 ( RADAR ) trial the EORTC QLQ C-30 and PR 25 questionnaires , and the International Prostate Cancer Symptom Score of the American Urological Association at baseline , 3 , 7 , 12 , 18 , 24 and 36 months .


Selected items from these scales were factor-analysed to identify a four-component solution for responses at 18 and 36 months , and these components were regressed against a single-item measuring LoM .


Depression-anxiety factor was the most powerful predictor of LoM at both time points , followed by sexual problems of ADT side effects ( breast changes and hot flushes ) .


Urinary dysfunction was not a consistent predictor of LoM .


Depression-anxiety was also the most significant factor distinguishing between those men who reported LoM and those who did not .


Although LoM is often reported as arising from ADT , the relative power of depression-anxiety in predicting LoM , both at the selected time points and using a time-lagged analysis , plus the finding that depression-anxiety was the most consistent difference between men who reported LoM and those who did not , argues for the presence of adverse mood states as being the key ingredient in deciding if PCa patients experience loss of their feelings of masculinity .


The insulin-like growth factor 1 receptor ( IGF1R ) has yet to be established as a biomarker in non-small cell lung cancer ( NSCLC ) but could prove useful in customized chemotherapy .


We explored its prognostic value using both quantitative real-time reverse transcriptase polymerase chain reaction ( qRT-PCR ) and immunohistochemistry ( IHC ) .


Analyses of IGF1R were performed on patients with advanced NSCLC , included in a randomized chemotherapy trial , having large , representative tissue samples .


IGF1R mRNA and protein expression were correlated to clinical end-points .


Surgical tissue samples were available from 33 patients deemed inoperable .


IGF1R status varied according to histopathology .


Patients with tumors positive for IGF1R mRNA expression had a shorter progression-free and overall survival when compared to the negative sub-group ( 6.1 vs. 7.4 months , p = 0.039 and 10.9 vs. 14.3 months , p = 0.038 , respectively ) .


IGF1R protein expression showed a similar , although non-significant tendency .


IGF1R mRNA expression may be a prognostic biomarker in advanced NSCLC and should be investigated in a larger population .


The ideal spread of local anesthetic for effective , rapid , and safe sciatic nerve block is debated .


We hypothesized that subparaneural ultrasound-guided injection results in faster onset and has a better success rate than extraneural circumferential spread .


Patients undergoing elective tibial , foot , and ankle surgery with popliteal sciatic nerve blocks were prospectively enrolled .


After randomization , the needle tip position was adjusted to ensure circumferential extraneural or subparaneural spread ; 0.3 mL/kg of mepivacaine 10 mg/mL was injected .


Post hoc video analysis was used to group the patients according to extraneural , subparaneural , and unintentional intraepineural spread .


There were 26 ( 43.3 % ) patients in the subparaneural group and 22 ( 36.7 % ) in the extraneural group .


Block onset time was shorter in the subparaneural group than in the extraneural group ( 11 [ 3-21 ] minutes ; mean [ 95 % confidence interval ] , 11 [ 8.97-13 .02 ] minutes and 17 [ 6-30 ] minutes ; mean [ 95 % confidence interval ] 18.37 [ 14.17-22 .57 ] minutes , respectively ; P = 0.002 ) .


The duration of sensory blockade increased ( 397 [ 178-505 ] minutes vs 265 [ 113-525 ] minutes ; P = 0.04 ) .


The success rate of the block also increased .


Unintentional intraepineural injection occurred in 8 % of patients ( 3 patients in the subparaneural group and 1 patient in the extraneural group ; NS ) .


Block onset time was shorter than for the subparaneural and extraneural groups ( 6 [ 3-12 ] minutes , 12 [ 3-21 ] minutes , and 18 [ 6-30 ] minutes ; P = 0.01 ) .


A subparaneural injection accelerated the onset time and increased the duration of tibial nerve sensory blockade compared with circumferential extraneural injection .


With unintentional intraepineural spread , the onset time was significantly shorter than for the other groups .


The optimal agents and duration of primary antifungal prophylaxis in recipients of allogeneic hematopoietic stem cell transplantation ( allo-HSCT ) remain a matter of discussion .


Our objective was to compare the efficacy and safety of long-term and short-term administration of itraconazole ( ITCZ ) for primary antifungal prophylaxis in allo-HSCT recipients .


This multicenter , randomized , open-label pilot study was performed in 4 transplant centers in China .


Recipients of allo-HSCT without a history of invasive fungal disease ( IFD ) were randomly assigned to the long-term or the short-term arm .


Randomization was carried out by a center computer system .


Intravenous ITCZ was given to the patients in both study arms with a loading dose of 400 mg/day for 2 days followed by 200 mg/day until day +14 or when the white blood cell count was > 1.0 10 ( 9 ) / L , and then switched to oral ITCZ solution ; prophylaxis was continued until day +30 post transplantation in the short-term arm or until day +90 in the long-term arm .


The trough serum concentrations of ITCZ also were measured .


The primary study endpoint was the incidence of IFD ( proven , probable , and possible ) within day +90 post transplantation .


A total of 128 recipients were enrolled in this study ; 59 of them were randomized to the long-term arm and 62 were randomized to the short-term arm , forming the modified intent-to-treat ( mITT ) set .


The incidence of IFD within day +90 , the primary endpoint , was not significantly different between the 2 arms for the mITT set ( 6.78 % in the long-term arm vs. 6.45 % in the short-term arm , P = 0.94 ) , or for the per-protocol set ( 6.90 % in the long-term arm vs. 6.67 % in the short-term arm , P = 0.96 ) .


From day +30 to day +90 , the incidence of IFD was 0 % and 6.45 % , respectively , in the patients with long-term and short-term prophylaxis for the mITT set ( P = 0.11 ) .


The mean trough serum concentrations of ITCZ was maintained at > 500 ng/mL throughout administration .


The incidences of withdrawal because of drug-related adverse events in patients with long-term and short-term prophylaxis were 6.78 % and 0 % , respectively ( P = 0.05 ) .


Long-term and short-term administration of ITCZ both seemed effective in preventing IFD in recipients of allo-HSCT .


Further study with large sample size should be performed to evaluate this result .


ITCZ shows the same pharmacokinetics in recipients of allo-HSCT as in non-recipients .


Fixed-dose rate gemcitabine plus docetaxel achieves objective response in 35 % of patients with uterine leiomyosarcoma ( uLMS ) .


This study aimed to determine whether the addition of bevacizumab to gemcitabine-docetaxel increases progression-free survival ( PFS ) in uLMS .


In this phase III , double-blind , placebo-controlled trial , patients with chemotherapy-naive , metastatic , unresectable uLMS were randomly assigned to gemcitabine-docetaxel plus bevacizumab or gemcitabine-docetaxel plus placebo .


PFS , overall survival ( OS ) , and objective response rates ( ORRs ) were compared to determine superiority .


Target accrual was 130 patients to detect an increase in median PFS from 4 months ( gemcitabine-docetaxel plus placebo ) to 6.7 months ( gemcitabine-docetaxel plus bevacizumab ) .


Treatment effects on PFS and OS were described by hazard ratios ( HRs ) , median times to event , and 95 % CIs .


In all , 107 patients were accrued : gemcitabine-docetaxel plus placebo ( n = 54 ) and gemcitabine-docetaxel plus bevacizumab ( n = 53 ) .


Accrual was stopped early for futility .


No statistically significant differences in grade 3 to 4 toxicities were observed .


Median PFS was 6.2 months for gemcitabine-docetaxel plus placebo versus 4.2 months for gemcitabine-docetaxel plus bevacizumab ( HR , 1.12 ; P = .58 ) .


Median OS was 26.9 months for gemcitabine-docetaxel plus placebo and 23.3 months for gemcitabine-docetaxel plus bevacizumab ( HR , 1.07 ; P = .81 ) .


Objective responses were observed in 17 ( 31.5 % ) of 54 patients randomly assigned to gemcitabine-docetaxel plus placebo and 19 ( 35.8 % ) of 53 patients randomly assigned to gemcitabine-docetaxel plus bevacizumab .


Mean duration of response was 8.6 months for gemcitabine-docetaxel plus placebo versus 8.8 months for gemcitabine-docetaxel plus bevacizumab .


The addition of bevacizumab to gemcitabine-docetaxel for first-line treatment of metastatic uLMS failed to improve PFS , OS , or ORR .


Gemcitabine-docetaxel remains a standard first-line treatment for uLMS .


This pilot study aimed to investigate the feasibility of two different training programs in patients with advanced gastrointestinal cancer undergoing palliative chemotherapy .


Potential effects of training programs on the patients ' quality of life , physical performance , physical activity in daily living , and biological parameters were exploratorily evaluated .


Patients were randomly assigned to a resistance ( RET ) and aerobic exercise training group ( AET ) .


Both underwent supervised training sessions twice a week for 12 weeks .


RET was performed at 60-80 % of the one-repetition maximum and consisted of 2-3 sets of 15-25 repetitions .


The AET group performed endurance training at 60-80 % of their predetermined pulse rate ( for 10 to 30 min ) .


A total of 26 gastrointestinal cancer patients could be randomized .


Twenty-one patients completed the 12 weeks of intervention .


The median adherence rate to exercise training of all 26 patients was 65 % , while in patients who were able to complete 12 weeks , adherence was 75 % .


The fatigue score of all patients decreased from 66 to 43 post-intervention .


Sleeping duration increased in both groups and muscular strength increased in the RET group .


A higher number of steps in daily living was associated with higher levels of physical and social functioning as well as lower scores for pain and fatigue .


RET and AET are feasible in gastrointestinal cancer patients undergoing palliative chemotherapy .


Both training programs seem to improve cancer-related symptoms as well as the patient 's physical activities of daily living .


The aims of the study were to 1 ) determine the effectiveness of QuikClot Combat Gauze ( QCG ) ; 2 ) determine the arterial blood pressure at which rebleeding occurs ; 3 ) determine how much intravenous fluid could be administered before hemorrhage reoccurred , and 4 ) determine the number extremity movement on rebleeding when QCG was used .


This was a prospective , randomized , experimental study .


Adult Yorkshire pigs were randomly assigned to two groups QCG ( n = 10 ) or control ( n = 10 ) .


After the swine were anesthetized , the investigators transected the femoral artery and vein .


After 1 minute of uncontrolled bleeding , QCG was placed in the wound followed by standard wound packing .


The control group underwent the same procedures without QCG .


After 5 minutes of firm , manual pressure , a pressure dressing was applied .


Following 30 minutes , the dressings were removed and blood loss was calculated .


If hemostasis occurred , phenylephrine was administered until there was rebleeding .


If no bleeding , up to 5 L of IV crystalloid was administered until there was hemorrhage .


If no bleeding , the extremity on the side of the hemorrhage was moved through flexion , extension , abduction , and adduction 10 times or until rebleeding occurred .


QCG compared to a control was more effective in controlling hemorrhage , withstanding increases in systolic blood pressure , more latitude in resuscitation fluid , and movement ( p < 0.05 ) .


Benign prostatic hyperplasia ( BPH ) is the most common cause of lower urinary tract symptoms in elderly men .


Selective alfa1-adrenergic antagonists are now first-line drugs in the medical management of BPH .


We conducted a single-blind , parallel group , randomized , controlled trial to compare the effectiveness and safety of the new alfa1-blocker silodosin versus the established drug tamsulosin in symptomatic BPH .


Ambulatory male BPH patients , aged above 50 years , were recruited on the basis of International Prostate Symptom Score ( IPSS ) .


Subjects were randomized in 1:1 ratio to receive either tamsulosin 0.4 mg controlled release or silodosin 8 mg once daily after dinner for 12 weeks .


Primary outcome measure was reduction in IPSS .


Proportion of subjects who achieved IPSS < 8 , change in prostate size as assessed by ultrasonography and changes in peak urine flow rate and allied uroflowmetry parameters , were secondary effectiveness variables .


Treatment emergent adverse events were recorded .


Data of 53 subjects - 26 on silodosin and 27 on tamsulosin were analyzed .


Final IPSS at 12-week was significantly less than baseline for both groups .


However , groups remained comparable in terms of IPSS at all visits .


There was a significant impact on sexual function ( assessed by IPSS sexual function score ) in silodosin arm compared with tamsulosin .


Prostate size and uroflowmetry parameters did not change .


Both treatments were well-tolerated .


Retrograde ejaculation was encountered only with silodosin and postural hypotension only with tamsulosin .


Silodosin is comparable to tamsulosin in the treatment of BPH in Indian men .


However , retrograde ejaculation may be troublesome for sexually active patients .


Invastigation of macrolides in the treatment of drug effects in chronic rhinosinusit .


The 165 patients with chronic rhinosinusit were randomly divided into 80 cases of macrolides drug group and 85 cases of cephalosporins group , and therapeutic effect was observed .


The therapeutic effect of macrolides was also observed in refractory chronic rhinosinusit .


Comparing macrolides group and cephalosporins group , there is not statistically significant ( P > 0.05 ) .


Treatment with macrolides cefixime tablet ineffective treatment of patients for 3 months , compared before and after treatment was statistically significant ( P < 0.01 ) .


Treatment with cefixime tablet macrolides ineffective treatment of patients for 3 months , compared before and after treatment was not statistically significant ( P > 0.05 ) .


Long-term low-dose applications of macrolides have a good effect in patients with chronic rhinosinusit , particularly for refractory chronic rhinosinusit have a significant effect .


To assess sublingual asenapine for acute agitation .


Agitated adults 18-65 years ( any diagnosis ) presenting for treatment in an emergency department and found to have a score of 14 on the Positive and Negative Syndrome Scale-Excited Component ( PANSS-EC ) were randomized to receive either a single dose of a sublingual 10 mg tablet of asenapine or placebo .


Primary outcome measure was change in the PANSS-EC score from baseline to 2 h after medication or placebo administration .


Secondary outcomes included the percentage of responders with a 40 % reduction from baseline on the PANSS-EC score at 2 h.


A total of 120 subjects were randomized , 60 each to sublingual asenapine or placebo .


Mean ( SE ) baseline PANSS-EC scores for the asenapine-treated and placebo-treated subjects were 19.4 0.66 and 20.1 0.61 , respectively .


Mean PANSS-EC scores at endpoint ( LOCF ) was 7.4 0.65 for the asenapine-treated subjects and 14.7 0.98 for the placebo-treated subjects .


Change in PANSS-EC score at 2 h was statistically significantly greater for the asenapine-treated subjects compared with the placebo-treated subjects .


NNT for response vs. placebo was 3 ( 95 % CI 2-4 ) .


Sublingual asenapine was efficacious in the treatment of agitation with an effect size comparable to that observed in prior studies of intramuscular antipsychotics .


The aim of this study was to evaluate the effects of an mHealth intervention ( intervention using mobile technology ) consisting of tailored advice regarding exposure to daylight , sleep , physical activity , and nutrition , and aiming to improve health-related behavior , thereby reducing sleep problems and fatigue and improving health perception of airline pilots .


A randomized controlled trial was conducted among 502 airline pilots .


The intervention group was given access to both the MORE Energy mobile application ( app ) with tailored advice and a website with background information .


The control group was directed to a website with standard information about fatigue .


Health-related behavior , fatigue , sleep , and health perception outcomes were measured through online questionnaires at baseline and at three and six months after baseline .


The effectiveness of the intervention was determined using linear and Poisson mixed model analyses .


After six months , compared to the control group , the intervention group showed a significant improvement on fatigue ( = -3.76 , P < 0.001 ) , sleep quality ( = -0.59 , P = 0.007 ) , strenuous physical activity ( = 0.17 , P = 0.028 ) , and snacking behavior ( = -0.81 , P < 0.001 ) .


No significant effects were found for other outcome measures .


The MORE Energy mHealth intervention reduced self-reported fatigue compared to a minimal intervention .


Some aspects of health-related behavior ( physical activity and snacking behavior ) and sleep ( sleep quality ) improved as well , but most did not .


The results show offering tailored advice through an mHealth intervention is an effective means to support employees who have to cope with irregular flight schedules and circadian disruption .


This kind of intervention might therefore also be beneficial for other working populations with irregular working hours .


To explore the effect of prophylactic hepatic artery infusion chemotherapy ( HAIC ) on survival probability after curative resection in patients with hepatocellular carcinoma ( HCC ) .


85 patients with HCC were randomly assigned to HAIC group ( 42 cases ) and control group ( 43 patients ) , all the database of two groups had no significant difference .


Patients in HAIC groups underwent hepatic artery infusion chemotherapy ( 5-FU 1000 mg/m2 on day 1 , Oxaliplatin 85 mg/m2 on day 1 and Gemcitabine 1000 mg/m2 on day 1 and 8 ) starting 3 weeks after operation with intervals of 4 weeks .


All patients were followed up for 3 years and intrahepatic recurrence-free survival , disease-free survival rate and overall survival rate were recorded .


Intrahepatic recurrence rate of HAIC group and the control group was respectively 19.05 % and 39.53 % , P < 0.05 .


Disease-free survival rate was respectively 57.14 % and 44.19 % , P < 0.05 .


Overall survival rate was 66.67 % and 46.51 % , P < 0.05 .


All patients in HAIC group tolerated the therapy .


No adverse effect above grade 3 was reported in HAIC group .


HAIC effectively and safely prevents intrahepatic recurrence and improves the prognosis of patients with HCC after curative resection .


Traditional models for delirium based on the Diagnostic and Statistical Manual for Mental Disorders and its 1990 offspring , the Confusion Assessment Method ( CAM ) , were not designed to distinguish behavioral and psychological symptoms of dementia from rapid cognitive decline .


We examined a new diagnostic criterion for delirium plus exclusion of behavioral and psychological symptoms of dementia and recent inattention with a 25 % decline in digit span forward ( DSF ) .


This was a prospective , randomized controlled trial comparing management of prevalent delirium in general medical with that in geriatric medical wards in a 370-bed hospital north of Sydney .


Inclusion criteria were age 65 years and prevalent delirium in the emergency department based on : CAM ; proof that CAM elements were not better explained by behavioral and psychological symptoms of dementia ; proof of recent inattention on DSF ; evidence of cognitive decline not due to sedatives or antipsychotics in the emergency department .


Measurements included the Instrumental Activities of Daily Living ( IADL , 22-item ) , Selective IADL ( 8-item ) , Mini-Mental State Examination , DSF daily , Delirium Index daily , and Apathy Evaluation Scale .


Pre-delirium scores from past cognitive tests and best scores were imputed after admission .


Relative change ( RC ) was calculated as absolute change/test range and RC/MPC ratio was calculated as RC after admission/maximal possible change .


A total of 130 subjects were recruited but 14 with subsyndromal delirium were excluded , leaving 116 subjects ( mean age 83.6 years ) .


Forty-eight percent had prior dementia .


RC from pre-delirium to admission was 42 % for the Mini-Mental State Examination , 41 % for Selective IADL , 34 % for 5-DSF , 54 % for 6-DSF , and 37 % for the Apathy Evaluation Scale .


Improvements after admission ( RC and RC/MPC ratios ) were 32 % / 98 % for 5-DSF , 54 % / 82 % for 6-DSF , and 45 % / 80 % for the Delirium Index .


General medicine and geriatric medicine groups had similar outcomes .


This delirium phenotype selects for a rapid high amplitude critical decline in attention , executive function , IADL , and apathy that recovers almost as rapidly .


The incidence of deep venous thrombosis ( DVT ) remains high in general surgery and trauma patients despite widespread prophylaxis with enoxaparin .


A recent study demonstrated decreased incidence of DVT if patients on enoxaparin had a change in R time ( R ) of greater than 1 minute when heparinase-activated thromboelastography ( TEG ) was compared with normal TEG .


We hypothesized that using R-guided dosing would result in decreased DVT rates .


A prospective , randomized controlled trial was performed at a Level 1 trauma center .


Both trauma and general surgery patients were included .


Upon enrollment , demographic data including age , sex , body mass index , and Acute Physiology and Chronic Health Evaluation II score were obtained .


Enrolled patients were randomized to standard ( 30 mg twice a day ) or TEG-guided dosing .


Dose-adjusted patients underwent daily enoxaparin titration to achieve an R of 1 minute to 2 minutes .


Venous thromboembolism screening was performed per institutional protocol .


Antithrombin III ( AT-III ) and anti-Xa levels were drawn at peak enoxaparin concentrations .


A total of 87 patients were enrolled .


There was no difference in demographic data between the groups .


No pulmonary emboli were identified .


The control group had a DVT rate of 16 % , while the experimental group had a rate of 14 % ( p = nonsignificant ) .


The experimental group 's median enoxaparin dosage , 50 mg twice a day , was significantly higher than that of the control ( p < 0.01 ) .


TEG R was not different between the control and experimental groups .


Beginning at Day 3 , anti-Xa levels were higher in the experimental group ( p < 0.05 ) .


There was no difference in AT-III activity between the two groups ; 67 % of the patients demonstrated AT-III deficiency .


TEG adjusted enoxaparin dosing led to significant increases in anti-Xa activity , which did not correlate with a decreased DVT rate .


Failure to reduce the DVT rate and increase R despite increased dosing and increased anti-Xa activity is consistent with the high rate of AT-III deficiency detected in this study cohort .


These data suggest that the future of DVT prevention may not lie in the optimization of low molecular weight heparin therapy but rather in compounds that increase antithrombin directly or operate independently of the AT-III pathway .


Therapeutic study , level III .


Sexuality is an important aspect of human life and sexual problems are common , but there is limited evidence for cost-effective treatments of women 's sexual dysfunctions .


The aim of this study was to assess whether group therapy such as Sexual Health Model ( SHM ) can be as effective as individual therapy like Permission , Limited Information , Specific Suggestions , and Intensive Therapy ( PLISSIT ) model in women with sexual problems .


A randomized controlled trial was conducted between May 2012 and September 2013 in five Tehran , Iran health clinics .


Eighty-four consecutive married women aged 20-52 years , with sexual problems who were admitted for the first time , were recruited and randomized into two groups .


The intervention included two therapeutic models : the SHM , which consisted of two sessions of 3 hours of group education , and the PLISSIT model , which required a total of 6 hours of one-on-one consultation at an interval of 1-2 weeks .


Sexual function and sexual distress were assessed , respectively , with the Brief Index of Sexual Function for Women and Female Sexual Distress Scale Revised questionnaires .


Seven months after intervention , the mean ( SD ) of the sexual distress score decreased and sexual composite score increased significantly in both groups ( P < 0.001 ) .


The overall analysis of repeated measure manova revealed borderline significance differences for combined outcomes between two groups ( P = 0.051 ) .


Due to the considerable human resource , time , and cost spent conducting the PLISSIT , it seems that group education based on SHM could be more cost-efficient and nearly as effective .


This conclusion may be more applicable in communities where the treatment of sexual problems is in the beginning stages and where people have not received any sexual education or knowledge during their lifetime .


To assess the safety and efficacy of intravenous ( IV ) abatacept plus methotrexate ( MTX ) over 7 years , the longest observational period to date , in patients with established rheumatoid arthritis ( RA ) and an inadequate response to MTX .


Patients randomised to IV abatacept ( 10 or 2 mg/kg ) or placebo , plus MTX , during the 1-year double-blind ( DB ) period of a Phase 2b study could enter the long-term extension ( LTE ) and receive IV abatacept 10 mg/kg monthly .


Safety was assessed in patients who received 1 dose of abatacept ; efficacy was assessed in patients originally randomised to 10 mg/kg abatacept ( as-observed data ) .


A total of 219 patients entered the LTE ; 114 ( 52.1 % ) completed 7 years of treatment with abatacept plus MTX .


Cumulative ( DB + LTE ) incidence rates of serious adverse events , serious infections , malignancies , and autoimmune events were 17.6 , 3.2 , 1.8 , and 1.2 / 100 patient-years , respectively .


Safety was consistent between the DB ( n = 220 ) and cumulative ( n = 287 ) periods .


Improvements in American College of Rheumatology responses , disease activity , and normalisation of physical function and health-related quality of life were maintained over time .


Approximately 80 % of patients who achieved low disease activity or normalised modified Health Assessment Questionnaire scores at Year 1 , and who remained in the study , sustained these responses in each subsequent year .


IV abatacept in combination with MTX demonstrated consistent safety and sustained efficacy over 7 years in MTX inadequate responders with established RA .


Furthermore , some patients demonstrated a normalisation of physical function and health-related quality of life that was sustained over time .


In vitro , animal , and ecological studies suggest that inadequate vitamin D intake could increase prostate cancer risk , but results of biomarker-based longitudinal studies are inconsistent .


Data for this case ( n = 1,731 ) and cohort ( n = 3,203 ) analysis are from the Selenium and Vitamin E Cancer Prevention Trial .


Cox proportional hazard models were used to test whether baseline plasma vitamin D ( 25-hydroxy ) concentration , adjusted for season of blood collection , was associated with the risk of total and Gleason score 2-6 , 7-10 , and 8-10 prostate cancer .


There were U-shaped associations of vitamin D with total cancer risk : compared with the first quintile , HRs were 0.83 [ 95 % confidence interval ( CI ) , 0.66-1 .03 ; P = 0.092 ] , 0.74 ( 95 % CI , 0.59-0 .92 ; P = 0.008 ) , 0.86 ( 95 % CI , 0.69-1 .07 ; P = 0.181 ) , and 0.98 ( 95 % CI , 0.78-1 .21 ; P = 0.823 ) , for the second through fifth quintiles , respectively .


For Gleason 7-10 cancer , corresponding HRs were 0.63 ( 95 % CI , 0.45-0 .90 ; P = 0.010 ) , 0.66 ( 95 % CI , 0.47-0 .92 ; P = 0.016 ) , 0.79 ( 95 % CI , 0.56-1 .10 ; P = 0.165 ) , and 0.88 ( 95 % CI , 0.63-1 .22 ; P = 0.436 ) .


Among African American men ( n = 250 cases ) , higher vitamin D was associated with reduced risk of Gleason 7-10 cancer only : in the a posteriori contrast of quintiles 1-2 versus 3-5 , the HR was 0.55 ( 95 % CI , 0.31-0 .97 ; P = 0.037 ) , with no evidence of dose-response or a U-shaped association .


Both low and high vitamin D concentrations were associated with increased risk of prostate cancer , and more strongly for high-grade disease .


The optimal range of circulating vitamin D for prostate cancer prevention may be narrow .


Supplementation of men with adequate levels may be harmful .


Cancer Epidemiol Biomarkers Prev ; 23 ( 8 ) ; 1494-504 .2014 AACR .


Traditionally , outpatient visits for COPD are fixed , pre-planned by the pulmonologist .


This is not a patient centered method , nor , in times of increasing COPD prevalence and resource constraints , perhaps the optimal method .


This pilot study , determined the effect of an on-demand-system , patient initiated outpatient visits , on health status , COPD-related healthcare resource-use and costs .


Patients were randomized between on-demand-system ( n = 49 ) and usual care ( n = 51 ) , with a 2-year follow-up .


Primary , health status was assessed with Clinical COPD Questionnaire ( CCQ ) .


Secondary endpoints were : St. George 's Respiratory Questionnaire ( SGRQ ) , Short Form-36 ( SF-36 ) scores , visits to general practitioners ( GP ) , pulmonologists , and pulmonary nurse practitioners ( PNP ) , exacerbations and total treatment costs from healthcare providers and healthcare insurance perspectives .


Participants had a mean FEV ( 1 ) 1.3 0.4 liters and were 69 9 years .


CCQ total scores deteriorated in both groups , with no significant difference between them .


CCQ symptom domain did show a significant and clinically relevant difference in favor of the on-demand-group , -0.4 0.21 , CI95 % -0.87 ; -0.02 , p = 0.04 .


Similar tendency was found for the SGRQ whereas results for SF-36 were inconsistent .


Patients in the on-demand-group visited GP significantly less ( p = 0.01 ) , but PNP significantly more , p = 0.003 .


Visits to pulmonologists and exacerbations were equally frequent in both groups .


Mean total costs per patient were lower in the on-demand-group in comparison with usual care , difference of -518 ( -1993 ; 788 ) from healthcare provider and -458 ( -2700 ; 1652 ) insurance perspective .


The on-demand-system was comparable with usual care , had a cost-saving tendency , and can be instituted with confidence in the COPD outpatient care setting .


Music is considered a subset of developmental supportive care .


It may act as a suitable auditory stimulant in preterm infants .


Also , it may reduce stress responses in autonomic , motor and state systems .


To assess and compare the influence of lullaby and classical music on physiologic parameters .


This is a randomized clinical trial with cross-over design .


A total of 25 stable preterm infants with birth weight of 1000-2500 grams were studied for six consecutive days .


Each infant was exposed to three phases : lullaby music , classical music , and no music ( control ) for two days each .


The sequence of these phases was assigned randomly to each subject .


Babies were continuously monitored for heart rate , respiratory rate , and oxygen saturation and changes between phases were analyzed .


Lullaby reduced heart rate ( p < 0.001 ) and respiratory rate ( p = 0.004 ) .


These effects extended in the period after the exposure ( p < .001 and p = 0.001 , respectively ) .


Classical music reduced heart rate ( p = 0.018 ) .


The effects of classical music disappeared once the music stopped .


Oxygen saturation did not change during intervention .


Music can affect vital signs of preterm infants ; this effect can possibly be related to the reduction of stress during hospitalization .


The implications of these findings on clinical and developmental outcomes need further study .


To assess the effects of DICLORAL 's alleviation of pain caused by radiation-induced oral mucositis .


With compound borax solution as a comparative drugs ' the solution of DICLORAL was adopted for patients with radiation-induced oral mucositis due to radiotherapy for nasal NK/T cell lymphoma .


All 59 patients were randomly divided into 2 groups : experimental group ( using DICLORAL ) and control group ( using Compound Borax Solution ) .


During the treatment , we observed drugs ' ability of alleviate oral pain or pain on swallowing , when it worked and how long it could sustain in controlling pain .


Statistical analysis was performed using SPSS 16.0 software package .


Drugs ' ability of alleviate oral pain or pain on swallowing and the onset time was not significantly different between the 2 groups ( P > 0.05 ) .


Effective duration in experimental group was longer than that in control group ( P < 0.05 ) .


DICORAL can alleviate and cease pain caused by radiation-induced oral mucositis effectively .


We evaluated associations among comorbidity , toxicity , time to relapse ( TTR ) , and overall survival ( OS ) in older women with early-stage breast cancer receiving adjuvant chemotherapy .


Cancer and Leukemia Group B 49907 ( Alliance ) randomly assigned women 65 years old with stages I-III breast cancer to standard adjuvant chemotherapy or capecitabine .


We reviewed data from 329 women who participated in the quality of life companion study CALGB 70103 and completed the Physical Health Subscale of the Older American Resources and Services Questionnaire .


This questionnaire captures data on 14 comorbid conditions and the degree to which each interferes with daily activities .


A comorbidity burden score was computed by multiplying the total number of conditions by each condition 's level of interference with function .


Outcomes were grade 3 to 5 toxicity , TTR , and OS .


Logistic regression was used to evaluate associations between comorbidity and toxicity , and Cox proportional hazards models for TTR and survival .


Number of comorbidities ranged from 0 to 10 ( median 2 ) ; the comorbidity burden score ranged from 0 to 25 ( median 3 ) .


The most common conditions were arthritis ( 58 % ) and hypertension ( 55 % ) .


Comorbidity was associated with shorter OS , but not with toxicity or TTR .


The hazard of death increased by 18 % for each comorbidity ( hazard ratio [ HR ] = 1.18 , 95 % CI = 1.06 to 1.33 ) after adjusting for age , tumor size , treatment , node and receptor status .


Comorbidity burden score was similarly associated with OS ( HR = 1.08 ; 95 % CI , 1.03 to 1.14 ) .


Among older women enrolled onto a clinical trial , comorbidity was associated with shorter OS , but not toxicity or relapse .


Research needs to systematically identify which components increase online intervention effectiveness ( i.e. , active ingredients ) .


This study explores the effects of 4 potentially important design features in an Internet-based , population-level smoking intervention .


Smokers ( n = 1,865 ) were recruited from a large health care organization , regardless of readiness to quit .


Using a full factorial design , participants were randomized to 1 of the 2 levels of each experimental factor ( message tone [ prescriptive vs. motivational ] , navigation autonomy [ dictated vs. not ] , e-mail reminders [ yes vs. no ] , and receipt of personally tailored testimonials [ yes vs. no ] ) and provided access to the online intervention .


Primary outcomes were self-reported 7-day point-prevalent smoking abstinence and confirmed utilization of adjunct treatment ( pharmacotherapy or phone counseling ) available through the health plan at 1 year .


Outcomes were also assessed at 2 and 6 months and were examined among all enrolled participants ( intent-to-treat [ ITT ] ) and all who viewed the intervention ( modified ITT ) .


At 1 year , 13.7 % were abstinent and 26.0 % utilized adjunct treatment .


None of the contrasting factor levels differentially influenced abstinence or treatment utilization at 12 months .


In the modified ITT sample , smokers receiving testimonials were less likely to use adjunct treatment at 6 months ( odds ratio = 0.54 , 95 % confidence interval = 0.30-0 .98 , p = .04 ) .


None of the design features enhanced treatment outcome .


The negative effect observed for testimonials is provocative , but it should be viewed with caution .


This study offers a model for future research testing the `` active ingredients '' of online interventions .


Intervention studies for children at risk of dyslexia have typically been delivered preschool , and show short-term effects on letter knowledge and phoneme awareness , with little transfer to literacy .


This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children identified by research criteria as being at risk of dyslexia ( n = 56 ) , and their school-identified peers ( n = 89 ) .


An Experimental group received two 9-week blocks of daily intervention delivered by trained teaching assistants ; the Control group received 9 weeks of typical classroom instruction , followed by 9 weeks of intervention .


Following mixed effects regression models and path analyses , small-to-moderate effects were shown on letter knowledge , phoneme awareness and taught vocabulary .


However , these were fragile and short lived , and there was no reliable effect on the primary outcome of word-level reading .


This new intervention was theoretically motivated and based on previous successful interventions , yet failed to show reliable effects on language and literacy measures following a rigorous evaluation .


We suggest that the intervention may have been too short to yield improvements in oral language ; and that literacy instruction in and beyond the classroom may have weakened training effects .


We argue that reporting of null results makes an important contribution in terms of raising standards both of trial reporting and educational practice .


Combined modality therapy is standard of care for patients with unresectable locally advanced non-small cell lung cancer ( NSCLC ) , however , insufficient data exist regarding prognostic factors in this disease setting .


To evaluate the treatment results and prognostic variables , 85 NSCLC patients treated from October 2005 to April 2008 were randomly assigned to one of the two treatment arms .


In the first arm ( sequential arm ) , 45 patients received sequential chemotherapy with 4 cycles of carboplatin and etoposide followed by conformal 3-dimensional ( 3D ) radiotherapy ( RT ) .


In the second arm ( concurrent arm ) , 40 patients received concomitant chemotherapy with cisplatin and etoposide and conformal RT , followed by two cycles of consolidation chemotherapy with carboplatin and etoposide .


The median survival was 13 months for the patients in the sequential arm and 19 months for those in the concurrent treatment arm ( p = 0.0039 ) .


The disease-free survival ( DFS ) was 9 months in the sequential arm and 16 months in the concurrent treatment arm ( p = 0.0023 ) .


The following prognostic factors significantly influenced the survival of the patients treated with combination of RT and chemotherapy : age ( p < 0.05 ) , performance status ( PS ) ( p < 0.001 ) , weight loss ( p < 0.001 ) , tumor size ( p < 0.05 ) , nodal involvement ( p < 0.05 ) .


Given the higher toxicity in the second arm , this should be reserved for younger patients ( < 70 years ) , having good PS and minimal weight loss .


We highly recommend precise stage and prognostic factors definitions in such patients so that they receive the most beneficial treatment .


To observe the effects of different loading doses of atorvastatin calcium on the outcomes of percutaneous coronary intervention ( PCI ) in elderly patients with coronary heart disease ( CHD ) .


A total of 120 CHD patients aged over 80 years were randomly assigned into 3 equal groups to receive intensive pretreatment with statin at the doses of 20 , 40 , or 60 mg prior to PCI performed within 48 to 72 h after admission .


The changes of postoperative cardiac biochemical markers including creatine kinase isoenzyme ( CKMB ) , troponin I ( cTNI ) and high-sensitivity c-reactive protein ( hs-CRP ) were observed and the incidence of major adverse cardiac events ( MACE , including cardiac death , myocardial infarction , and target vessel revascularization ) were recorded within 30 days after PCI .


Thirty-four patients in 20 mg statin group , 40 in 40 mg statin group , and 38 in 60 mg statin group completed this study .


In all the 3 groups , hs-CRP level significantly increased at 12 and 24 h after PCI compared with the preoperative levels ( P < 0.05 ) .


The patients in 60 mg statin group showed significantly lower levels of CKMB , cTNI , and hs-CRP at 24 h after PCI than those in 20 mg statin group ( P < 0.05 ) , and had also a significantly lower incidence of total MACE within 30 days after PCI ( 2.6 % vs 26.5 % , P = 0.003 ) resulting primarily from significantly reduced myocardial infarction associated with PCI ( 2.6 % vs 20.6 % , P = 0.016 ) .


The adverse drug reactions were comparable among the 3 groups ( P > 0.05 ) .


Intensive pretreatment with 60 mg/day atorvastatin calcium can significantly reduce myocardial infarction related to PCI with good safety in elderly patients with CHD .


Luseogliflozin -- a novel , orally bioavailable , 1-thio-D-glucitol derivative and a selective sodium glucose cotransporter 2 inhibitor -- has shown efficacy and tolerability in previous phase 2 studies .


This phase 3 , randomized , double-blind , placebo-controlled , comparative study aimed to confirm the superiority of 24 week luseogliflozin 2.5 mg monotherapy over placebo in reducing hemoglobin A1c ( HbA1c ) levels in Japanese patients with type 2 diabetes mellitus ( T2DM ) .


Patients with HbA1c levels of 6.9 % -10.5 % were randomized to receive luseogliflozin 2.5 mg or placebo once daily for 24 weeks ( n = 79 in each group ) .


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


Secondary endpoints included change from baseline in fasting plasma glucose ( FPG ) and postprandial plasma glucose ( PPG ) following a meal tolerance test , body weight , and abdominal circumference .


Safety assessments included adverse events ( AEs ) , clinical laboratory tests , and vital signs .


At the end of treatment , HbA1c was significantly decreased from baseline in the luseogliflozin 2.5 mg group ( -0.63 % ) versus the placebo group ( 0.13 % ) , with a between-group difference of -0.75 % ( p < 0.001 ) .


Additionally , significant reductions in FPG , PPG , body weight , and abdominal circumference were noted with luseogliflozin compared with placebo ( all p < 0.05 ) .


Luseogliflozin was well tolerated ; there was no significant difference between groups in the incidence of AEs ( luseogliflozin , 59.5 % ; placebo , 57.0 % ) .


No AEs led to study drug discontinuation .


Most AEs were mild in severity , with no severe AE reported .


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


Luseogliflozin monotherapy for 24 weeks was superior to placebo in reducing HbA1c levels .


It also reduced FPG , PPG , body weight , and abdominal circumference and was well tolerated in Japanese patients with T2DM .


JapicCTI-111661 .


Glycated hemoglobin ( HbA1c ) , a standard measure of chronic glycemia for managing diabetes , has been proposed to diagnose diabetes and identify people at risk .


The Diabetes Prevention Program ( DPP ) was a 3.2-year randomized clinical trial of preventing type 2 diabetes with a 10-year follow-up study , the DPP Outcomes Study ( DPPOS ) .


We evaluated baseline HbA1c as a predictor of diabetes and determined the effects of treatments on diabetes defined by an HbA1c 6.5 % ( 48 mmol/mol ) .


We randomized 3,234 nondiabetic adults at high risk of diabetes to placebo , metformin , or intensive lifestyle intervention and followed them for the development of diabetes as diagnosed by fasting plasma glucose ( FPG ) and 2-h postload glucose ( 2hPG ) concentrations ( 1997 American Diabetes Association [ ADA ] criteria ) .


HbA1c was measured but not used for study eligibility or outcomes .


We now evaluate treatment effects in the 2,765 participants who did not have diabetes at baseline according to FPG , 2hPG , or HbA1c ( 2010 ADA criteria ) .


Baseline HbA1c predicted incident diabetes in all treatment groups .


Diabetes incidence defined by HbA1c 6.5 % was reduced by 44 % by metformin and 49 % by lifestyle during the DPP and by 38 % by metformin and 29 % by lifestyle throughout follow-up .


Unlike the primary DPP and DPPOS findings based on glucose criteria , metformin and lifestyle were similarly effective in preventing diabetes defined by HbA1c .


HbA1c predicted incident diabetes .


In contrast to the superiority of the lifestyle intervention on glucose-defined diabetes , metformin and lifestyle interventions had similar effects in preventing HbA1c-defined diabetes .


The long-term implications for other health outcomes remain to be determined .


To evaluate the efficacy , safety , and pharmacokinetics of rufinamide as an adjunctive therapy for patients with Lennox-Gastaut syndrome ( LGS ) in a randomized , double-blind , placebo-controlled trial .


We conducted a multicenter clinical trial with a 4-week baseline , a 2-week titration , a 10-week maintenance , and either a follow-up visit or entry into an open-label extension .


Patients with LGS ( 4 to 30 years old ) taking between one and three antiepileptic drugs were recruited .


After the baseline period , patients were randomly assigned to rufinamide or placebo .


The primary efficacy variable was the percent change in the tonic-atonic seizure frequency per 28 days .


Of the 59 patients , 29 were randomized to the rufinamide group and 30 to the placebo group .


The frequency of epileptic seizures was significantly decreased in the rufinamide group than in the placebo group ; the median percent change in frequency of tonic-atonic seizures was -24.2 % and -3.3 % , respectively , ( p = 0.003 ) and that of total seizures was -32.9 % and -3.1 % , respectively ( p < 0.001 ) .


Subgroup analyses indicated that the efficacy of rufinamide was consistent independent of clinical background characteristics .


The common treatment-related adverse events in the rufinamide group were decreased appetite ( 17.2 % ) , somnolence ( 17.2 % ) , and vomiting ( 13.8 % ) .


Transient seizure aggravations were observed in 13 ( 22.0 % ) of the 59 patients , though a causal relationship with rufinamide was suspected in only one patient .


All adverse events were mild to moderate in severity .


The mean plasma concentration of rufinamide between 1 and 9 within 12h after administration was 17.2 g/mL .


The present results showed a favorable risk-benefit profile for rufinamide as an adjunctive therapy for patients with LGS .


Exercise therapy in patients with hip and/or knee osteoarthritis is effective in reducing pain , increasing physical activity and physical functioning , but costly and a burden for the health care budget .


A web-based intervention is cheap in comparison to face-to-face exercise therapy and has the advantage of supporting in home exercises because of the 24/7 accessibility .


However , the lack of face-to-face contact with a professional is a disadvantage of web-based interventions and is probably one of the reasons for low adherence rates .


In order to combine the best of two worlds , we have developed the intervention e-Exercise .


In this blended intervention face-to-face contacts with a physical therapist are partially replaced by a web-based exercise intervention .


The aim of this study is to investigate the short - ( 3 months ) and long-term ( 12 months ) ( cost ) - effectiveness of e-Exercise compared to usual care physical therapy .


Our hypothesis is that e-Exercise is more effective and cost-effective in increasing physical functioning and physical activity compared to usual care .


This paper presents the protocol of a prospective , single-blinded , multicenter cluster randomized controlled trial .


In total , 200 patients with OA of the hip and/or knee will be randomly allocated into either e-Exercise or usual care ( physical therapy ) .


E-Exercise is a 12-week intervention , consisting of maximum five face-to-face physical therapy contacts supplemented with a web-based program .


The web-based program contains assignments to gradually increase patients ' physical activity , strength and stability exercises and information about OA related topics .


Primary outcomes are physical activity and physical functioning .


Secondary outcomes are health related quality of life , self-perceived effect , pain , tiredness and self-efficacy .


All measurements will be performed at baseline , 3 and 12 months after inclusion .


Retrospective cost questionnaires will be sent at 3 , 6 , 9 and 12 months and used for the cost-effectiveness and cost-utility analysis .


This study is the first randomized controlled trial in the ( cost ) - effectiveness of a blended exercise intervention for patients with osteoarthritis of the hip and/or knee .


The findings will help to improve the treatment of patients with osteoarthritis .


NTR4224 .


A variant ( rs3812316 , C771G , and Gln241His ) in the MLXIPL ( Max-like protein X interacting protein-like ) gene encoding the carbohydrate response element binding protein has been associated with lower triglycerides .


However , its association with cardiovascular diseases and gene-diet interactions modulating these traits are unknown .


We studied 7166 participants in the PREvencin with DIeta MEDiterrnea trial testing a Mediterranean diet ( MedDiet ) intervention versus a control diet for cardiovascular prevention , with a median follow-up of 4.8 years .


Diet , lipids , MLXIPL polymorphisms , and cardiovascular events were assessed .


Data were analyzed at baseline and longitudinally .


We used multivariable-adjusted Cox regression to estimate hazard ratios for cardiovascular outcomes .


The MLXIPL-rs3812316 was associated with lower baseline triglycerides ( P = 5.510 ( -5 ) ) and lower hypertriglyceridemia ( odds ratio , 0.73 ; 95 % confidence interval [ CI ] , 0.63-0 .85 ; P = 1.410 ( -6 ) in G-carriers versus CC ) .


This association was modulated by baseline adherence to MedDiet .


When adherence to MedDiet was high , the protection was stronger ( odds ratio , 0.63 ; 95 % CI , 0.51-0 .77 ; P = 8.610 ( -6 ) ) than when adherence to MedDiet was low ( odds ratio , 0.88 ; 95 % CI , 0.70-1 .09 ; P = 0.219 ) .


Throughout the follow-up , both the MLXIPL-rs3812316 ( P = 3.810 ( -6 ) ) and the MedDiet intervention ( P = 0.030 ) were significantly associated with decreased triglycerides .


Likewise in G-carriers MedDiet intervention was associated with greater total cardiovascular risk reduction and specifically for myocardial infarction .


In the MedDiet , but not in the control group , we observed lower myocardial infarction incidence in G-carriers versus CC ( hazard ratios , 0.34 ; 95 % CI , 0.12-0 .93 ; P = 0.036 and 0.90 ; 95 % CI , 0.35-2 .33 ; P = 0.830 , respectively ) .


Our novel results suggest that MedDiet enhances the triglyceride-lowering effect of the MLXIPL-rs3812316 variant and strengthens its protective effect on myocardial infarction incidence .


URL : www.controlled-trials.com .


Unique Identifier : ISRCTN35739639 .


Children with febrile urinary tract infection commonly have vesicoureteral reflux .


Because trial results have been limited and inconsistent , the use of antimicrobial prophylaxis to prevent recurrences in children with reflux remains controversial .


In this 2-year , multisite , randomized , placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infection , we evaluated the efficacy of trimethoprim-sulfamethoxazole prophylaxis in preventing recurrences ( primary outcome ) .


Secondary outcomes were renal scarring , treatment failure ( a composite of recurrences and scarring ) , and antimicrobial resistance .


Recurrent urinary tract infection developed in 39 of 302 children who received prophylaxis as compared with 72 of 305 children who received placebo ( relative risk , 0.55 ; 95 % confidence interval [ CI ] , 0.38 to 0.78 ) .


Prophylaxis reduced the risk of recurrences by 50 % ( hazard ratio , 0.50 ; 95 % CI , 0.34 to 0.74 ) and was particularly effective in children whose index infection was febrile ( hazard ratio , 0.41 ; 95 % CI , 0.26 to 0.64 ) and in those with baseline bladder and bowel dysfunction ( hazard ratio , 0.21 ; 95 % CI , 0.08 to 0.58 ) .


The occurrence of renal scarring did not differ significantly between the prophylaxis and placebo groups ( 11.9 % and 10.2 % , respectively ) .


Among 87 children with a first recurrence caused by Escherichia coli , the proportion of isolates that were resistant to trimethoprim-sulfamethoxazole was 63 % in the prophylaxis group and 19 % in the placebo group .


Among children with vesicoureteral reflux after urinary tract infection , antimicrobial prophylaxis was associated with a substantially reduced risk of recurrence but not of renal scarring .


( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; RIVUR ClinicalTrials.gov number , NCT00405704 . )


To ( 1 ) determine the efficacy of venlafaxine XR for the treatment of pain ( secondary aim ) in individuals with spinal cord injury ( SCI ) enrolled in a randomized controlled trial ( RCT ) on the efficacy of venlafaxine XR for major depressive disorder ( MDD ) ( primary aim ) ; and ( 2 ) test the hypothesis that venlafaxine XR would be effective for both neuropathic and nociceptive pain .


Multisite , double-blind , randomized ( 1:1 ) controlled trial with subjects block randomized and stratified by site , lifetime history of substance abuse , and prior history of MDD .


Six Departments of Physical Medicine and Rehabilitation in university-based medical schools .


Individuals ( N = 123 ) with SCI and major depression between 18 and 64 years of age , at least 1 month post-SCI who also reported pain .


Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule .


A 0-to-10 numeric rating scale for pain , pain interference items of the Brief Pain Inventory ; 30 % and 50 % responders .


The effect of venlafaxine XR on neuropathic pain was similar to that of placebo .


However venlafaxine XR resulted in statistically significant and clinically meaningful reductions in nociceptive pain site intensity and interference even after controlling for anxiety , depression , and multiple pain sites within the same individual .


For those who achieved a minimally effective dose of venlafaxine XR , some additional evidence of effectiveness was noted for those with mixed ( both neuropathic and nociceptive ) pain sites .


Venlafaxine XR could complement current medications and procedures for treating pain after SCI and MDD that has nociceptive features .


Its usefulness for treating central neuropathic pain is likely to be limited .


Research is needed to replicate these findings and determine whether the antinociceptive effect of venlafaxine XR generalizes to persons with SCI pain without MDD .


Movie-based simulation training may be useful in delivering the preclinical observed OSPE curriculum , minimising the need of subjects/patients : however , a double-control trial needs to be performed and optimal timing and duration of training is yet to be defined .


Likewise , gender-based response and students ' feedback has to be assessed .


The objective of this study was to compare the movie-based and traditional verbal demonstration teaching methodologies .


Second-year medical undergraduates ( n = 90 ) of Avicenna Medical College were randomised to movie-based simulation training ( group B , n = 30 ) , traditional verbal training alone ( group C , n = 30 ) , and a combination ( group A , n = 30 ) .


The scores were marked by observers using a standardised key and were compared for performance at 2 observed OSPE stations .


Group B and A performed significantly better than group C on station 1 and 2 .


Gender factor did not seem to influence the score .


A total of 99 % students reported that combination of the 2 teaching modes is the best option .


They believed it offers more clear understanding with interest ( 61 % ) , long term memory ( 21 % ) , use of both senses ; seeing & hearing ( 10 % ) & better focus of attention ( 3 % ) .


Even half an hour of movie-based simulation training with traditional instructor-based training may improve student performance significantly , and the students prefer a combination of the both .


Although achieving a pathological complete response ( pCR ) after neoadjuvant chemotherapy ( NACT ) in breast cancer predicts a better outcome , some patients still relapse .


The objectives of this study were to describe the types of events in this group of patients and to identify predictive factors for relapse .


Patients with large operable or locally advanced breast cancers ( T4d tumours were excluded ) were randomised to receive either six cycles of anthracycline-based chemotherapy or three cycles of docetaxel followed by three cycles of eprirubicin/docetaxel .


pCR was defined as no evidence of residual invasive cancer ( or very few scattered tumour cells ) in the primary tumour and axillary lymph nodes at surgery .


Two Cox regression analyses were performed to identify predictive factors of relapse : one for recurrence-free interval ( RFI ) and one for distant recurrence-free interval ( DRFI ) .


Out of 283 eligible patients who achieved a pCR , 40 ( 14.1 % ) and 28 ( 9.9 % ) presented an event of interest for the RFI and DRFI analyses , respectively .


Five-year RFI , DRFI and overall survival ( OS ) were 85.3 % ( 95 % confidence interval ( CI ) , 80.1-89 .3 ) , 89.6 % ( 95 % CI , 85.0-92 .9 ) and 91.9 % ( 95 % CI , 87.2-94 .9 ) , respectively .


No predictors for RFI after pCR were identified .


For DRFI , tumour size was the only predictor : Hazard ratio ( HR ) T3 versus T1-2 = 3.62 ( 95 % CI , 1.66-7 .89 ) ; HR T4 versus T1-2 : HR , 2.80 ( 95 % CI , 0.62-12 .64 ) p = 0.0048 .


In this study , clinical tumour size emerged as the only predictor for DRFI after pCR , with T3 and T4 tumours having an increased risk for distant recurrence compared to T1-2 tumours .


The purpose of this study was to determine the reliability and validity of two smartphone applications : ( 1 ) GetMyROM - inclinometery-based and ( 2 ) DrGoniometry - photo-based in the measurement of active shoulder external rotation ( ER ) as compared to standard goniometry ( SG ) .


Ninety-four Texas Woman 's University Doctor of Physical Therapy students from the School of Physical Therapy - Houston campus , were recruited to participate in this study .


Two iPhone applications were compared to SG using both novice and experienced raters .


Active shoulder ER range of motion was measured over two time periods in random order by blinded novice and experienced raters .


Intra-rater reliability using novice raters for the two applications ranged from an intraclass correlation coefficient ( ICC ) of 0.79 to 0.81 with SG at 0.82 .


Inter-rater reliability ( novice/expert ) for the two applications ranged from an ICC of 0.92 to 0.94 with SG at 0.91 .


Concurrent validity ( when compared to SG ) ranged from 0.93 to 0.94 .


There were no significant differences between the novice and experienced raters .


Both applications were found to be reliable and comparable to SG .


A photo-based application potentially offers a superior method of measurement as visualizing the landmarks may be simplified in this format and it provides a record of measurement .


Further study using patient populations may find the two studied applications are useful as an adjunct for clinical practice .


To compare the structural outcome at 9 months of eyes treated with intravitreal injection of bevacizumab with fellow eyes treated with conventional laser photoablation in zone I type 1 retinopathy of prematurity ( ROP ) .


Single randomized controlled trial .


All inborn babies with type 1 zone I ROP at a single institution were included in the study .


One eye was randomized to receive an intravitreal injection of 0.5 mg bevacizumab ; the fellow eye received conventional laser photoablation .


Digital fundus photographs and fluorescein angiography ( FA ) using the RetCam ( Clarity Medical Systems Inc. , Pleasanton , CA ) were performed before treatment and 9 months after treatment .


Presence of retinal and choroidal abnormalities on FA at 9 months .


Thirteen infants were enrolled ; 1 died 3 months after birth .


One laser-treated eye progressed to stage 5 retinal detachment .


The remaining 23 eyes had favorable structural results at the 9-month follow-up and provided FA results .


At 9 months of age , all eyes treated with a bevacizumab injection were noted to have abnormalities at the periphery ( large avascular area , abnormal branching , shunt ) or the posterior pole ( hyperfluorescent lesion , absence of foveal avascular zone ) .


These posterior and peripheral lesions were not observed in the majority of the lasered eyes .


This study documents significant vascular and macular abnormalities of eyes in the bevacizumab group .


Long-lasting implications of these abnormalities for visual function of the child need to be studied .


This randomized control trial assesses the effectiveness of motivational interviewing ( MI ) to encourage behavior change in new mothers relating to caries prevention when caring for their newborn American Indian ( AI ) infants and young AI children .


The study is a randomized control trial .


We hypothesize that when motivational interviewing is added to enhanced community oral health education services , the new mothers will achieve greater reduction of caries experience in their AI children compared to those who are receiving enhanced community services ( ECS ) alone .


Six hundred mothers or caregivers of AI newborns will be enrolled into the study and randomized to one of the two intervention groups over a two-year period .


The children will be followed until the child 's third birthday .


A cost analysis of the study is being conducted in tandem with the enhanced community services , motivational interviewing behavioral interventions , and the dental screenings for the length of the study .


The trial is now in the implementation phase and a number of threats to successful completion , such as recruitment and retention challenges in a vast , rural geographic area , have been addressed .


The protocol provides a unique model for oral health interventions using principles of community-based participatory research and is currently on schedule to meet study objectives .


If the study is successful , motivational interviewing intervention can be applied in AI communities to reduce ECC disparities in this disadvantaged population , with study of further applicability in other populations and settings .


ClinicalTrials.gov , NCT01116726 .


Despite a standardized prophylaxis with antibiotics , surgical site infections ( SSI ) are a characteristic problem in colorectal surgery .


Local administration of gentamicin-collagen sponges ( GCS ) has been shown to decrease the infection rate after contaminated procedures .


So far , the effect has not been tested for standardized laparoscopic colorectal resections .


We conducted a randomized , double-blind , placebo-controlled trial to investigate the efficacy of GCS to reduce wound infection after laparoscopic colorectal resections .


Patients underwent a standardized operative procedure with standardized incision treatment .


The intervention was the application of a GCS in the subcutaneous tissue of the bowel extraction site ( GCS group ) .


In the collagen group , a collagen sponge without antibiotics was used , and no sponge was used in the control group .


The primary endpoint was SSI within 30 days postoperatively , according to the Center of Disease Control and Prevention definition .


We randomly assigned 291 patients to all three groups .


There was no difference between the groups regarding demographic characteristics and perioperative course .


SSI was diagnosed in 8.2 % ( GCS group ) , 13.5 % ( collagen group ) , and 11.3 % ( control group ) of patients .


No significant difference was found among the groups .


The local administration of GCS showed no significant benefit regarding wound infection after standardized laparoscopic colorectal resections .


However , there was a trend toward reduced SSI in the GCS group .


Therefore , a larger trial or meta-analysis is necessary to validate this result .


There is some evidence in the literature that emphasising fish consumption may assist with weight loss .


The aim was to assess the effects of advice to consume 2 fish meals per week in a weight loss diet .


A parallel randomised placebo-controlled trial was conducted in 118 obese Australian adults ( mean BMI SD 31.3 3.5 kg/m2 ; mean age SD 45 10 y ; 28 % male ) .


Participants received low calorie dietary advice + placebo ( 1 g olive oil ; CONTROL ) , low calorie dietary advice emphasising fish + placebo ( Fish ) , or low calorie dietary advice emphasising fish diet + LCn3PUFA supplements ( Fish + S ) .


Individualised advice targeted 2 MJ energy deficit ( 30 % E fat , 45 % E carbohydrate and 25 % E protein ) with or without two servings ( 180 g ) fatty fish/wk .


All groups lost weight at 12 months ( CONTROL -4.5 kg vs. Fish -4.3 kg vs. Fish + S -3.3 kg ; p < 0.001 ) and percentage body fat (


-1.5 % vs. Fish : -1.4 % vs. Fish + S : -0.7 % ; p < 0.001 ) but there were no significant differences between groups .


Cardiovascular disease risk factors changed as expected from weight loss .


Advice to consume 2 fish meals per week did not enhance the effects on weight loss of a healthy low calorie diet .


ACTRN12608000425392 .


Repetitive transcranial magnetic stimulation ( rTMS ) has attracted attention as a putative clinical neuromodulatory tool , including for ameliorating hallucinations , although existing clinical data are inconsistent .


There is a notable paucity of research on its physiological effects on normal neuronal functioning .


We neuroimaged 24 healthy adult volunteers undertaking a variable loading passive auditory task , randomized into 2 matched and double-masked groups : half received a 17-minute 1 Hz right temporoparietal rTMS paradigm and half sham rTMS .


One hertz rTMS led to attenuation of the underlying auditory cortex response to the stimulus and a contralateral increase in cortical activity .


Subanalysis of the auditory tasks demonstrated that rTMS effects varied with stimulus frequency and differences between the active and sham conditions were lost at the highest frequency .


This work is , to the best of our knowledge , the first to neuroimage the effects of a `` hallucinatory rTMS protocol '' on basic auditory processing in healthy controls .


Our data demonstrated that a so-called `` inhibitory paradigm '' can also produce distal neuronal activation and that effects can vary with neural loading .


These results highlight the insufficient knowledge of the effects of rTMS on normal physiology , and this , combined with a lack of consensus on clinical trial parameters , may be contributing to the ambivalent data in therapeutic trials .


A Food and Drug Administration ( FDA ) safety communication in August 2011 warned that citalopram was associated with a dose dependent risk of QT prolongation and recommended dose restriction in patients over the age of 60 but did not provide data for this age group .


CitAD was a randomized , double-masked , placebo-controlled , multicenter clinical trial for agitation in Alzheimer 's disease ( AD ) .


Participants were assigned to citalopram ( target dose of 30 mg/day ) or placebo in a 1 1 ratio .


186 people , 181 of whom were over the age of 60 , having probable AD with clinically significant agitation were recruited from September 2009 to January 2013 .


After the FDA safety communication about citalopram , ECG was added to the required study procedures before enrollment and repeated at week 3 to monitor change in QTc interval .


Forty-eight participants were enrolled after enhanced monitoring began .


Citalopram treatment was associated with a larger increase in QTc interval than placebo ( difference in week 3 QTc adjusting for baseline QTc : 18.1 ms [ 95 % CI : 6.1 , 30.1 ] ; p = 0.004 ) .


More participants in the citalopram group had an increase 30 ms from baseline to week 3 ( 7 in citalopram versus 1 in placebo ; Fisher 's exact p = 0.046 ) , but only slightly more in the citalopram group met a gender-specific threshold for prolonged QTc ( 450 ms for males ; 470 ms for females ) at any point during follow-up ( 3 in citalopram versus 1 in placebo , Fisher 's exact p = 0.611 ) .


One of the citalopram participants who developed prolonged QTc also displayed ventricular bigeminy .


No participants in either group had a cardiovascular-related death .


Citalopram at 30 mg/day was associated with improvement in agitation in patients with AD but was also associated with QT prolongation .


ClinicalTrials.gov NCT00898807 .


Creutzfeldt-Jakob disease ( CJD ) is a fatal , untreatable prion encephalopathy .


Previous studies showed that doxycycline is effective in in-vitro and in-vivo models of disease , and patients with CJD who received compassionate treatment with doxycycline showed increased survival time compared with historical series .


We therefore did a randomised , double-blind study of doxycycline versus placebo in CJD .


We recruited patients older than 18 years old who had a diagnosis of definite or probable sporadic CJD or genetic forms of the disease via Italian reference centres and the French national referral system .


Patients were randomly assigned ( ratio 1:1 ) to receive oral doxycycline ( 100 mg daily ) or placebo under double-blind conditions from the day of randomisation to death .


Centralised randomisation was done independently of enrolment or evaluation of patients using a minimisation method in Italy and a simple randomisation in France .


Participants , caregivers , and clinicians were masked to group assignment .


The primary efficacy variable was the survival time from randomisation .


Interim analyses were planned to detect a significant effect of treatment as early as possible .


This trial is registered with EudraCT , 2006-001858-27 for the Italian study and 2007-005553-34 for the French study .