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


Patients in HAIC groups underwent hepatic artery infusion chemotherapy ( @-FU @ mg/m@ on day @ , Oxaliplatin @ mg/m@ on day @ and Gemcitabine @ mg/m@ on day @ and @ ) starting @ weeks after operation with intervals of @ weeks .


All patients were followed up for @ 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 @ % and @ % , P < @ .


Disease-free survival rate was respectively @ % and @ % , P < @ .


Overall survival rate was @ % and @ % , P < @ .


All patients in HAIC group tolerated the therapy .


No adverse effect above grade @ 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 @ 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 @ % 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 @-bed hospital north of Sydney .


Inclusion criteria were age @ 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 , @-item ) , Selective IADL ( @-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 @ subjects were recruited but @ with subsyndromal delirium were excluded , leaving @ subjects ( mean age @ years ) .


Forty-eight percent had prior dementia .


RC from pre-delirium to admission was @ % for the Mini-Mental State Examination , @ % for Selective IADL , @ % for @-DSF , @ % for @-DSF , and @ % for the Apathy Evaluation Scale .


Improvements after admission ( RC and RC/MPC ratios ) were @ % / @ % for @-DSF , @ % / @ % for @-DSF , and @ % / @ % 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 @ 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 @ 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 ( @ mg twice a day ) or TEG-guided dosing .


Dose-adjusted patients underwent daily enoxaparin titration to achieve an R of @ minute to @ 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 @ 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 @ % , while the experimental group had a rate of @ % ( p = nonsignificant ) .


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


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


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


There was no difference in AT-III activity between the two groups ; @ % 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 @ and September @ in five Tehran , Iran health clinics .


Eighty-four consecutive married women aged @-@ 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 @ hours of group education , and the PLISSIT model , which required a total of @ hours of one-on-one consultation at an interval of @-@ 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 < @ ) .


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


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


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


A total of @ patients entered the LTE ; @ ( @ % ) completed @ years of treatment with abatacept plus MTX .


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


Safety was consistent between the DB ( n = @ ) and cumulative ( n = @ ) 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 @ % of patients who achieved low disease activity or normalised modified Health Assessment Questionnaire scores at Year @ , 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 @ 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 = @,@ ) and cohort ( n = @,@ ) analysis are from the Selenium and Vitamin E Cancer Prevention Trial .


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


There were U-shaped associations of vitamin D with total cancer risk : compared with the first quintile , HRs were @ -LSB- @ % confidence interval ( CI ) , @-@ @ ; P = @ -RSB- , @ ( @ % CI , @-@ @ ; P = @ ) , @ ( @ % CI , @-@ @ ; P = @ ) , and @ ( @ % CI , @-@ @ ; P = @ ) , for the second through fifth quintiles , respectively .


For Gleason @-@ cancer , corresponding HRs were @ ( @ % CI , @-@ @ ; P = @ ) , @ ( @ % CI , @-@ @ ; P = @ ) , @ ( @ % CI , @-@ @ ; P = @ ) , and @ ( @ % CI , @-@ @ ; P = @ ) .


Among African American men ( n = @ cases ) , higher vitamin D was associated with reduced risk of Gleason @-@ cancer only : in the a posteriori contrast of quintiles @-@ versus @-@ , the HR was @ ( @ % CI , @-@ @ ; P = @ ) , 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 ; @ ( @ ) ; @-@ @ 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 = @ ) and usual care ( n = @ ) , with a @-year follow-up .


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


Secondary endpoints were : St. George 's Respiratory Questionnaire ( SGRQ ) , Short Form-@ ( SF-@ ) 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 ( @ ) @ @ liters and were @ @ 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 , -@ @ , CI@ % -@ ; -@ , p = @ .


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


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


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 -@ ( -@ ; @ ) from healthcare provider and -@ ( -@ ; @ ) 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 @ stable preterm infants with birth weight of @-@ 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 < @ ) and respiratory rate ( p = @ ) .


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


Classical music reduced heart rate ( p = @ ) .


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 @ patients were randomly divided into @ 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 @ software package .


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


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


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 @ ( Alliance ) randomly assigned women @ years old with stages I-III breast cancer to standard adjuvant chemotherapy or capecitabine .


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


This questionnaire captures data on @ 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 @ to @ 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 @ to @ ( median @ ) ; the comorbidity burden score ranged from @ to @ ( median @ ) .


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


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


The hazard of death increased by @ % for each comorbidity ( hazard ratio -LSB- HR -RSB- = @ , @ % CI = @ to @ ) after adjusting for age , tumor size , treatment , node and receptor status .


Comorbidity burden score was similarly associated with OS ( HR = @ ; @ % CI , @ to @ ) .


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 @ potentially important design features in an Internet-based , population-level smoking intervention .


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


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


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


Outcomes were also assessed at @ and @ months and were examined among all enrolled participants ( intent-to-treat -LSB- ITT -RSB- ) and all who viewed the intervention ( modified ITT ) .


At @ year , @ % were abstinent and @ % utilized adjunct treatment .


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


In the modified ITT sample , smokers receiving testimonials were less likely to use adjunct treatment at @ months ( odds ratio = @ , @ % confidence interval = @-@ @ , p = @ ) .


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 @-year-old children identified by research criteria as being at risk of dyslexia ( n = @ ) , and their school-identified peers ( n = @ ) .


An Experimental group received two @-week blocks of daily intervention delivered by trained teaching assistants ; the Control group received @ weeks of typical classroom instruction , followed by @ 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 , @ NSCLC patients treated from October @ to April @ were randomly assigned to one of the two treatment arms .


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


In the second arm ( concurrent arm ) , @ 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 @ months for the patients in the sequential arm and @ months for those in the concurrent treatment arm ( p = @ ) .


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


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


Given the higher toxicity in the second arm , this should be reserved for younger patients ( < @ 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 @ CHD patients aged over @ years were randomly assigned into @ equal groups to receive intensive pretreatment with statin at the doses of @ , @ , or @ mg prior to PCI performed within @ to @ 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 @ days after PCI .


Thirty-four patients in @ mg statin group , @ in @ mg statin group , and @ in @ mg statin group completed this study .


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


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


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


Intensive pretreatment with @ 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 , @-thio-D-glucitol derivative and a selective sodium glucose cotransporter @ inhibitor -- has shown efficacy and tolerability in previous phase @ studies .


This phase @ , randomized , double-blind , placebo-controlled , comparative study aimed to confirm the superiority of @ week luseogliflozin @ mg monotherapy over placebo in reducing hemoglobin A@c ( HbA@c ) levels in Japanese patients with type @ diabetes mellitus ( T@DM ) .


Patients with HbA@c levels of @ % -@ % were randomized to receive luseogliflozin @ mg or placebo once daily for @ weeks ( n = @ in each group ) .


The primary endpoint was change from baseline in HbA@c 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 , HbA@c was significantly decreased from baseline in the luseogliflozin @ mg group ( -@ % ) versus the placebo group ( @ % ) , with a between-group difference of -@ % ( p < @ ) .


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


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


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 @ weeks was superior to placebo in reducing HbA@c levels .


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


Glycated hemoglobin ( HbA@c ) , 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 @-year randomized clinical trial of preventing type @ diabetes with a @-year follow-up study , the DPP Outcomes Study ( DPPOS ) .


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


We randomized @,@ 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 @-h postload glucose ( @hPG ) concentrations ( @ American Diabetes Association -LSB- ADA -RSB- criteria ) .


HbA@c was measured but not used for study eligibility or outcomes .


We now evaluate treatment effects in the @,@ participants who did not have diabetes at baseline according to FPG , @hPG , or HbA@c ( @ ADA criteria ) .


Baseline HbA@c predicted incident diabetes in all treatment groups .


Diabetes incidence defined by HbA@c @ % was reduced by @ % by metformin and @ % by lifestyle during the DPP and by @ % by metformin and @ % 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 HbA@c .


HbA@c 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 HbA@c-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 @-week baseline , a @-week titration , a @-week maintenance , and either a follow-up visit or entry into an open-label extension .


Patients with LGS ( @ to @ 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 @ days .


Of the @ patients , @ were randomized to the rufinamide group and @ 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 -@ % and -@ % , respectively , ( p = @ ) and that of total seizures was -@ % and -@ % , respectively ( p < @ ) .


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 ( @ % ) , somnolence ( @ % ) , and vomiting ( @ % ) .


Transient seizure aggravations were observed in @ ( @ % ) of the @ 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 @ and @ within @h after administration was @ 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 @/@ 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 - ( @ months ) and long-term ( @ 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 , @ 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 @-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 , @ and @ months after inclusion .


Retrospective cost questionnaires will be sent at @ , @ , @ and @ 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 .


A variant ( rs@ , C@G , and Gln@His ) 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 @ 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 @ 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-rs@ was associated with lower baseline triglycerides ( P = @ ( -@ ) ) and lower hypertriglyceridemia ( odds ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; P = @ ( -@ ) 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 , @ ; @ % CI , @-@ @ ; P = @ ( -@ ) ) than when adherence to MedDiet was low ( odds ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


Throughout the follow-up , both the MLXIPL-rs@ ( P = @ ( -@ ) ) and the MedDiet intervention ( P = @ ) 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 , @ ; @ % CI , @-@ @ ; P = @ and @ ; @ % CI , @-@ @ ; P = @ , respectively ) .


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


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 @-year , multisite , randomized , placebo-controlled trial involving @ 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 @ of @ children who received prophylaxis as compared with @ of @ children who received placebo ( relative risk , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ) .


Prophylaxis reduced the risk of recurrences by @ % ( hazard ratio , @ ; @ % CI , @ to @ ) and was particularly effective in children whose index infection was febrile ( hazard ratio , @ ; @ % CI , @ to @ ) and in those with baseline bladder and bowel dysfunction ( hazard ratio , @ ; @ % CI , @ to @ ) .


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


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


To ( @ ) 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 ( @ ) test the hypothesis that venlafaxine XR would be effective for both neuropathic and nociceptive pain .


Multisite , double-blind , randomized ( @:@ ) 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 = @ ) with SCI and major depression between @ and @ years of age , at least @ month post-SCI who also reported pain .


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


A @-to-@ numeric rating scale for pain , pain interference items of the Brief Pain Inventory ; @ % and @ % 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 = @ ) of Avicenna Medical College were randomised to movie-based simulation training ( group B , n = @ ) , traditional verbal training alone ( group C , n = @ ) , and a combination ( group A , n = @ ) .


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


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


Gender factor did not seem to influence the score .


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


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


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 ( T@d 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 @ eligible patients who achieved a pCR , @ ( @ % ) and @ ( @ % ) presented an event of interest for the RFI and DRFI analyses , respectively .


Five-year RFI , DRFI and overall survival ( OS ) were @ % ( @ % confidence interval ( CI ) , @-@ @ ) , @ % ( @ % CI , @-@ @ ) and @ % ( @ % CI , @-@ @ ) , respectively .


No predictors for RFI after pCR were identified .


For DRFI , tumour size was the only predictor : Hazard ratio ( HR ) T@ versus T@-@ = @ ( @ % CI , @-@ @ ) ; HR T@ versus T@-@ : HR , @ ( @ % CI , @-@ @ ) p = @ .


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


The purpose of this study was to determine the reliability and validity of two smartphone applications : ( @ ) GetMyROM - inclinometery-based and ( @ ) 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 @ to @ with SG at @ .


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


Concurrent validity ( when compared to SG ) ranged from @ to @ .


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 @ months of eyes treated with intravitreal injection of bevacizumab with fellow eyes treated with conventional laser photoablation in zone I type @ retinopathy of prematurity ( ROP ) .


Single randomized controlled trial .


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


One eye was randomized to receive an intravitreal injection of @ 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 @ months after treatment .


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


Thirteen infants were enrolled ; @ died @ months after birth .


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


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


At @ 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 .


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 @ days postoperatively , according to the Center of Disease Control and Prevention definition .


We randomly assigned @ patients to all three groups .


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


SSI was diagnosed in @ % ( GCS group ) , @ % ( collagen group ) , and @ % ( 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 @ fish meals per week in a weight loss diet .


A parallel randomised placebo-controlled trial was conducted in @ obese Australian adults ( mean BMI SD @ @ kg/m@ ; mean age SD @ @ y ; @ % male ) .


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


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


All groups lost weight at @ months ( CONTROL -@ kg vs. Fish -@ kg vs. Fish + S -@ kg ; p < @ ) and percentage body fat (


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


Cardiovascular disease risk factors changed as expected from weight loss .


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


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 @ healthy adult volunteers undertaking a variable loading passive auditory task , randomized into @ matched and double-masked groups : half received a @-minute @ 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 @ warned that citalopram was associated with a dose dependent risk of QT prolongation and recommended dose restriction in patients over the age of @ 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 @ mg/day ) or placebo in a @ @ ratio .


@ people , @ of whom were over the age of @ , having probable AD with clinically significant agitation were recruited from September @ to January @ .


After the FDA safety communication about citalopram , ECG was added to the required study procedures before enrollment and repeated at week @ 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 @ QTc adjusting for baseline QTc : @ ms -LSB- @ % CI : @ , @ -RSB- ; p = @ ) .


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


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


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 @ 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 @:@ ) to receive oral doxycycline ( @ 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 , @-@-@ for the Italian study and @-@-@ for the French study .


From April @ , @ , to Aug @ , @ , in Italy , and from Jan @ , @ , to Jan @ , @ , in France , @ patients with CJD were enrolled in the study , @ of whom were randomly assigned to the treatment group and @ to the placebo group .


The first interim analysis showed absence of superiority of doxycycline compared with placebo , and the trial was stopped for futility .


Efficacy analyses did not show significant differences between patients treated with doxycycline and placebo with regard to survival times ( HR @ , @ % CI @-@ @ , p = @ ) .


Serious adverse events were judged not to be related to treatment , whereas a relation was deemed probable or possible for five non-serious adverse events that occurred in each treatment group .


Doxycycline at a dose of @ mg per day was well tolerated but did not significantly affect the course of CJD , at variance with the results of previous observational studies .


Our experience could be useful in the design of large multinational controlled trials of potential anti-prion molecules in this rare disease .


The prevalence of sexual dysfunction , low vitality , and poor physical function increases with aging , as does the prevalence of low total and free testosterone ( TT and FT ) levels .


However , the relationship between sex hormones and age-related alterations in older men is not clear .


To test the hypotheses that baseline serum TT , FT , estradiol ( E@ ) , and sex hormone-binding globulin ( SHBG ) levels are independently associated with sexual function , vitality , and physical function in older symptomatic men with low testosterone levels participating in the Testosterone Trials ( TTrials ) .


Cross-sectional study of baseline measures in the TTrials .


The study was conducted at @ sites in the United States .


The @ TTrials participants were @ years and had evidence of sexual dysfunction , diminished vitality , and/or mobility disability , and an average of two TT < @ ng/dL .


None .


Question @ of Psychosocial Daily Questionnaire ( PDQ-Q@ ) , the FACIT-Fatigue Scale , and the @-minute walk test .


Baseline serum TT and FT , but not E@ or SHBG levels had small , but statistically significant associations with validated measures of sexual desire , erectile function , and sexual activity .


None of these hormones was significantly associated within or across trials with FACIT-Fatigue , PHQ-@ Depression or Physical Function-@ scores , or gait speed .


FT and TT levels were consistently , independently , and positively associated , albeit to a small degree , with measures of sexual desire , erectile function , and sexual activity , but not with measures of vitality or physical function in symptomatic older men with low T who qualified for the TTrials .


Biopure MTAD , a new root canal irrigant has shown promising results against the most common resistant microorganism , E. faecalis , in permanent teeth .


However , there is lack of studies comparing its antimicrobial effectiveness with NaOCl in primary teeth .


The purpose of this study was to compare the in vivo antimicrobial efficacy of NaOCl @ % and Biopure MTAD against E. faecalis in primary teeth .


Forty non vital single rooted primary maxillary anterior teeth of children aged @-@ years , were irrigated either with NaOCl @ % ( n = @ ) , Biopure MTAD ( n = @ ) and @ % Saline ( n = @ , control group ) .


Paper point samples were collected at baseline ( S@ ) and after chemomechanical preparation ( S@ ) during the pulpectomy procedure .


The presence of E. faecalis in S@ & S@ was evaluated using Real time Polymerase Chain Reaction .


Statistical significant difference was found in the antimicrobial efficacy of NaOCl @ % and BioPure MTAD when compared to saline ( p > @ ) .


However , no statistical significant difference was found between the efficacies of both the irrigants .


NaOCl @ % and BioPure MTAD , both irrigants are equally efficient against E. faecalis in necrotic primary anterior teeth .


MTAD is a promising irrigant , however clinical studies are required to establish it as ideal root canal irrigant in clinical practice .


To compare @-month pulp health outcomes of partial caries removal ( PCR ) and total caries removal ( TCR ) with composite restoration in primary molars .


@ children aged @-@ years with at least one molar with a deep carious lesion were included .


@ teeth were randomized to control ( TCR ; n = @ ; @ % class II ) and test ( PCR ; n = @ ; @ % class II ) groups .


Total absence of carious tissue was confirmed using a blunt-tipped probe in the TCR group .


For PCR , excavation was stopped when hardened , dried dentin with a leathery consistency was achieved .


Pulpotomy was performed in cases of pulp exposure .


Pulp exposure occurred in @ and @ % of teeth treated with PCR and TCR , respectively ( p < @ ) .


The operative time was significantly higher for TCR than PCR .


Success rates were @ and @ % in the PCR and TCR groups , respectively ( p = @ ) .


The success rate tended to be lower in occlusoproximal ( @ % ) than in occlusal ( @ % ) lesions ( p = @ ) .


The clinical and radiographic success rates of PCR and TCR in primary teeth with deep carious lesions were high and did not differ significantly , indicating that PCR is a reliable minimally invasive approach in primary teeth and that the retention of carious dentin does not interfere with pulp vitality .


Moreover , PCR provided other clinically relevant advantages over TCR , especially lower incidence of pulp exposure and lower operative time .


To determine whether maternal allopurinol treatment during suspected fetal hypoxia would reduce the release of biomarkers associated with neonatal brain damage .


A randomised double-blind placebo controlled multicentre trial .


We studied women in labour at term with clinical indices of fetal hypoxia , prompting immediate delivery .


Delivery rooms of @ Dutch hospitals .


When immediate delivery was foreseen based on suspected fetal hypoxia , women were allocated to receive allopurinol @ mg intravenous ( ALLO ) or placebo intravenous ( CONT ) .


Primary endpoint was the difference in cord S@ , a tissue-specific biomarker for brain damage .


@ women were randomised to receive allopurinol ( ALLO , n = @ ) or placebo ( CONT , n = @ ) .


Cord S@ was not significantly different between the two groups : @ pg/mL ( IQR @-@ @ ) in the ALLO group versus @ pg/mL ( IQR @-@ @ ) in the CONT group ( difference in median -@ ( @ % CI -@ to @ ) ) .


Post hoc subgroup analysis showed a potential treatment effect of allopurinol on the proportion of infants with a cord S@ value above the @th percentile in girls ( ALLO n = @ ( @ % ) vs CONT n = @ ( @ % ) ; risk ratio ( RR ) @ ( @ % CI @ to @ ) ) but not in boys ( ALLO n = @ ( @ % ) vs CONT n = @ ( @ % ) ; RR @ ( @ % CI @ to @ ) ) .


Also , cord neuroketal levels were significantly lower in girls treated with allopurinol as compared with placebo treated girls : @ pg/mL ( @ % CI @ to @ ) in the ALLO group versus @ pg/mL ( @ % CI @ to @ ) in the CONT group ( geometric mean difference -@ ( @ % CI -@ to -@ ) ) .


Maternal treatment with allopurinol during fetal hypoxia did not significantly lower neuronal damage markers in cord blood .


Post hoc analysis revealed a potential beneficial treatment effect in girls .


This randomized trial evaluated the therapeutic effect of emotional awareness training on the severity and frequency of pain in patients with irritable bowel syndrome ( IBS ) .


Patients ' level of alexithymia was also measured .


The study involved @ patients diagnosed with IBS according to the Rome-III criteria .


Patients ' mean age was @ years ( standard deviation @ years ) and @ % of the patients were female .


Seventy eligible patients were assigned randomly to one of two treatment groups .


One group received standard symptom-oriented medical treatment only ( MT group ) , while the second group , termed the emotional awareness group ( EMT ) , was educated to increase conscious awareness of eight primary emotions in addition to receiving standard symptom-oriented medical treatment .


This study was conducted over @ months .


All patients received @ weeks of symptom-oriented medical treatment ; patients in the EMT group also had two emotion awareness training sessions and recorded their emotions in a daily diary .


Sixty patients completed the study .


Patients with IBS scored significantly higher on all aspects of alexithymia compared with healthy controls .


The severity of pain decreased significantly in both groups , with a larger percentage of the patients in the EMT group who completed the study having a significant decrease in pain ( @ % in the EMT group vs. @ % in the MT group ) ; this finding was replicated in an intent-to-treat analysis .


The same results were observed for frequency of pain in patients who completed the study ( @ % in the EMT group vs @ % in the MT group ) , but this finding was not replicated in an intent-to-treat analysis .


These patterns were not influenced by level of alexithymia , age , or gender .


Adding emotional awareness training to medical treatment resulted in a better therapeutic response in abdominal pain in patients with IBS .


Despite therapeutic advances , many people with type @ diabetes are still unable to achieve optimal glycaemic control , limited by the occurrence of hypoglycaemia .


The objective of the present study is to determine the effectiveness of day and night home closed-loop over the medium term compared with sensor-augmented pump therapy in adults with type @ diabetes and suboptimal glycaemic control .


The study will adopt an open label , three-centre , multinational , randomised , two-period crossover study design comparing automated closed-loop glucose control with sensor augmented insulin pump therapy .


The study will aim for @ completed participants .


Eligible participants will be adults ( @years ) with type @ diabetes treated with insulin pump therapy and suboptimal glycaemic control ( glycated haemoglobin ( HbA@c ) @ % ( @mmol/mmol ) and @ % ( @mmol/mmol ) ) .


Following a @-week optimisation period , participants will undergo a @-month use of automated closed-loop insulin delivery and sensor-augmented pump therapy , with a @-@week washout period in between .


The order of the interventions will be random .


All analysis will be conducted on an intention to treat basis .


The primary outcome is the time spent in the target glucose range from @ to @ mmol/L based on continuous glucose monitoring levels during the @months free living phase .


Secondary outcomes include HbA@c changes ; mean glucose and time spent above and below target glucose levels .


Further , participants will be invited at baseline , midpoint and study end to participate in semistructured interviews and complete questionnaires to explore usability and acceptance of the technology , impact on quality of life and fear of hypoglycaemia .


Evaluating the impact of splitting toric power on patient tolerance to misorientation such as with intraocular lens rotation .


University vision clinic .


Healthy , non astigmats had +@ D astigmatism induced with spectacle lenses at @ , @ , @ and +@ D at @ .


Two correcting cylindrical lenses of the opposite sign and half the power each were subsequently added to the trial frame misaligned by @ , @ or @ in a random order and misorientated from the initial axis in a clockwise direction by up to @ in @ steps .


A second group of adapted astigmats with between @ and @ DC had their astigmatism corrected with two toric spectacle lenses of half the power separated by @ , @ or @ and misorientated from the initial axis in both directions by up to @ in @ steps .


Distance , high contrast visual acuity was measured using a computerised test chart at each lens misalignment and misorientation .


Misorientation of the split toric lenses caused a statistically significant drop in visual acuity ( F = @ ; p < @ ) .


Comparatively better acuities were observed around @ , as anticipated ( F = @ ; p = @ ) .


Misaligning the split toric power produced no benefit in visual acuity retention with axis misorientation when subjects had astigmatism induced with a low ( F = @ , p = @ ) or high cylinder ( F = @ , p = @ ) or in the adapted astigmats ( F = @ , p = @ ) .


Misalignment of toric lens power split across the front and back lens surfaces had no beneficial effect on distance visual acuity , but also no negative effect .


This study investigated whether hormones and pain perception are associated with exam anxiety , and also whether exam anxiety is affected by seasonal differences in testosterone and cortisol levels .


Forty-six healthy males were recruited from a medical college .


Anxiety was induced by having participants perform the Objective Structured Clinical Examination .


Pressure was applied to the participants to induce pain .


Pain thresholds , pain ratings , anxiety ratings , blood pressure , heart rate , salivary testosterone and cortisol levels were measured under resting and anxiety conditions in the spring and summer .


Data were collected from @ participants during the spring ( n = @ ) and summer ( n = @ ) .


Pain thresholds and testosterone levels were significantly lower under anxiety than at rest for all participants ( n = @ ) , while cortisol levels , pain ratings , and anxiety ratings were significantly higher under anxiety than at rest .


In the spring ( n = @ ) , testosterone levels were significantly higher at rest than under anxiety , while there was no difference in cortisol levels between resting and anxiety conditions .


In the summer ( n = @ ) , cortisol levels were significantly higher under anxiety than at rest , while there was no difference in testosterone levels between resting and anxiety conditions .


There were no significant seasonal differences in pain and anxiety ratings and pain threshold .


These results indicate that seasonal differences in testosterone and cortisol levels under anxiety and at rest may affect pain responses .


These results also suggest that acute clinical pain may be relieved by managing anxiety that is related to a decrease of testosterone in spring and a large increase of cortisol in summer .


QVA@ is a once-daily ( o.d. ) inhaled dual bronchodilator containing a fixed-dose combination of the long-acting @-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium for the treatment of COPD .


The QUANTIFY study compared QVA@ with a free-dose bronchodilator combination of tiotropium plus formoterol ( TIO+FOR ) in improving health-related quality of life ( HRQoL ) of patients with COPD .


This multicentre , blinded , triple-dummy , parallel-group , non-inferiority study randomised patients aged @years with moderate-to-severe COPD ( post-bronchodilator forced expiratory volume in @s ( FEV@ ) @ % to < @ % predicted ) to QVA@ @/@g o.d. or TIO @g o.d. + FOR @g twice daily ( @:@ ) for @weeks .


The primary endpoint was to demonstrate non-inferiority in HRQoL assessed using St George 's Respiratory Questionnaire-COPD ( SGRQ-C ) .


The prespecified non-inferiority margin was @ units .


Secondary endpoints included Transition Dyspnoea Index ( TDI ) score , pre-dose FEV@ , forced vital capacity ( FVC ) and safety .


Of the @ patients randomised ( QVA@ = @ and TIO+FOR = @ ) , @ % completed the study .


At week @ , non-inferiority was met for SGRQ-C ( QVA@ vs TIO+FOR ; difference : -@ units ; @ % CI -@ to @ ; p = @ ) .


A significantly higher percentage of patients achieved a clinically relevant @ point improvement in TDI total score with QVA@ ( @ % ) versus TIO+FOR ( @ % ; p = @ ) .


QVA@ significantly increased pre-dose FEV@ ( +@ mL , @ % CI @mL to @mL ; p < @ ) and FVC ( +@ mL , @ % CI @mL to @mL ; p = @ ) compared with TIO+FOR at week @ .


The incidence of adverse events was comparable between both treatments ( QVA@ = @ % and TIO+FOR = @ % ) .


QVA@ is non-inferior to TIO+FOR in improving HRQoL , with clinically meaningful and significant improvements in breathlessness and lung function in patients with COPD .


Tuberculosis regimens that are shorter and simpler than the current @-month daily regimen are needed .


We randomly assigned patients with newly diagnosed , smear-positive , drug-sensitive tuberculosis to one of three regimens : a control regimen that included @ months of ethambutol , isoniazid , rifampicin , and pyrazinamide administered daily followed by @ months of daily isoniazid and rifampicin ; a @-month regimen in which the isoniazid in the control regimen was replaced by moxifloxacin administered daily for @ months followed by moxifloxacin and @ mg of rifapentine administered twice weekly for @ months ; or a @-month regimen in which isoniazid was replaced by daily moxifloxacin for @ months followed by one weekly dose of both moxifloxacin and @ mg of rifapentine for @ months .


Sputum specimens were examined on microscopy and after culture at regular intervals .


The primary end point was a composite treatment failure and relapse , with noninferiority based on a margin of @ percentage points and @ % confidence intervals .


We enrolled a total of @ patients from South Africa , Zimbabwe , Botswana , and Zambia ; @ % of patients were coinfected with the human immunodefiency virus .


In the per-protocol analysis , the proportion of patients with an unfavorable response was @ % in the control group , @ % in the @-month group ( adjusted difference from control , -@ percentage points ; @ % confidence interval -LSB- CI -RSB- , -@ to @ ) , and @ % in the @-month group ( adjusted difference from control , @ percentage points ; @ % CI , @ to @ ) .


In the modified intention-to-treat analysis these proportions were @ % in the control group , @ % in the @-month group ( adjusted difference from control , @ percentage points ; @ % CI , -@ to @ ) , and @ % in the @-month group ( adjusted difference from control , @ percentage points ; @ % CI , @ to @ ) .


The @-month regimen that included weekly administration of high-dose rifapentine and moxifloxacin was as effective as the control regimen .


The @-month regimen was not noninferior to the control regimen .


( Funded by the European and Developing Countries Clinical Trials Partnership and the Wellcome Trust ; RIFAQUIN Current Controlled Trials number , ISRCTN@ . )


Treatment for displaced proximal humeral fractures is still under debate .


Few studies exist at the highest level of evidence .


Although reversed total shoulder prosthesis has gained popularity and showed promising results in the treatment for proximal humeral fractures in the elderly patients , no randomized controlled trials exist to the authors ' knowledge .


This study is a randomized semi-blinded controlled multicenter trial designed according to the Consort statement and the recommendations given by the Cochrane reviewers for proximal humeral fractures .


The study will investigate whether a reversed total shoulder prosthetic replacement gain better functional outcome compared to open reduction and internal fixation using an angular stable plate in displaced three - and four parts proximal humeral fractures after two and five years follow-up .


Participants are aged @-@ admitted in seven different hospitals with a displaced proximal humeral fracture according to AO-OTA type @-B@ or @-C@ .


The intervention group is surgical treatment using a reversed total shoulder prosthesis ( Delta X-tend ) compared to open reduction and internal fixation with an angular stable plate ( Philos ) and thread cerclage in the control group .


@ patients will be randomized to each group.The primary outcome is shoulder function ( Constant score ) .


Secondary outcomes will be patient self-assessment form ( Oxford shoulder score ) , a quality of life questionnaire ( @D score ) and resource implications ( cost-effectiveness ) .


Follow-ups take place at @ , @ , @ and @ months , and five years .


The trial design is semi-blinded with blinded physiotherapists performing the functional testing of patients at all follow-ups .


Randomization to treatment groups is electronic online , by independent supervisor ( web-CRF ) .


The recruitment of patients started at January @ .


st @ .


Inclusion of @ patients during three years is expected .


This semiblinded trial include a high number of patients compared to existing randomized trials in this field .


To our knowledge and according to ClinicalTrials.gov , this is the first study that compare these two treatments for a displaced proximal humeral fracture in elderly patients .


This may provide important information to help the surgeon to decide the best treatment in the future .


Increasing ambient temperature to prevent intraoperative patient hypothermia remains widely advocated despite unconvincing evidence of efficacy .


Heat stress is associated with decreased cognitive and psychomotor performance across multiple tasks but remains unexamined in an operative context .


We assessed the impact of increased ambient temperature on laparoscopic operative performance and surgeon cognitive stress .


Forty-two performance measures were obtained from @ surgery trainees participating in the counter-balanced , within-subjects study protocol .


Operative performance was evaluated with adaptations of the validated , peg-transfer , and intracorporeal knot-tying tasks from the Fundamentals of Laparoscopic Surgery program .


Participants trained to proficiency before enrollment .


Task performance was measured at two ambient temperatures , @ and @C ( @ and @F ) .


Participants were randomly counterbalanced to initial hot or cold exposure before crossing over to the alternate environment .


Cognitive stress was measured using the validated Surgical Task Load Index ( SURG-TLX ) .


No differences in performance of the peg-transfer and intracorporeal knot-tying tasks were seen across ambient conditions .


Assessed via use of the six bipolar scales of the SURG-TLX , we found differences in task workload between the hot and cold conditions in the areas of physical demands ( hot @ -LSB- @-@ -RSB- , cold @ -LSB- @-@ -RSB- , P = @ ) and distractions ( hot @ -LSB- @-@ @ -RSB- , cold @ -LSB- @-@ @ -RSB- , P = @ ) .


Participant perception of distraction remained greater in the hot condition on full scoring of the SURG-TLX .


Increasing ambient temperature to levels advocated for prevention of intraoperative hypothermia does not greatly decrease technical performance in short operative tasks .


Surgeons , however , do report increased perceptions of distraction and physical demand .


The impact of these findings on performance and outcomes during longer operative procedures remains unclear .


This exploratory trial was performed to determine whether Daikenchuto accelerates recovery of gastrointestinal function in patients undergoing open colectomy for colon cancer .


A total of @ patients undergoing colectomy at @ of the @ clinical trial sites in Japan from January @ to June @ were registered for the study ( JFMC@-@ ) .


Patients received either placebo or Daikenchuto ( @ g/day , t.i.d ) between post-operative day @ and post-operative day @ .


Primary end-points included time to first bowel movement , frequency of bowel movement and stool form .


The incidence of intestinal obstruction was evaluated post-operatively .


The safety profile of Daikenchuto until post-operative day @ was also evaluated .


The results for @ patients ( Daikenchuto , n = @ ; placebo , n = @ ) were available for statistical analysis .


The time to first bowel movement did not differ significantly between the two groups .


All patients reported having diarrhea or soft stools immediately after surgery , and the time until stool normalization ( @th percentile ) in the Daikenchuto and placebo groups was @ days and @ days , respectively .


The placebo group had a significantly greater number of hard stools at post-operative day @ ( P = @ ) , and bowel movement frequency continued to increase until post-operative day @ as well .


In contrast , bowel movement frequency in the Daikenchuto group increased until post-operative day @ , however decreased from post-operative day @ and was significantly lower at post-operative day @ compared with the placebo group ( P = @ ) .


The moderate effects of Daikenchuto were observed @ week after the operation .


Although Daikenchuto had an effect on gastrointestinal function after open surgery in patients with colon cancer , this study did not show its clinical benefits adequately .


Little information exists about the role of fear-avoidance beliefs and catastrophizing in subacromial pain syndrome .


The purpose of this study was to investigate the associations among pain , catastrophizing , fear , and disability and the contribution of fear-avoidance beliefs to disability at baseline and at @-month follow-up .


A cross-sectional and longitudinal analysis was conducted .


Baseline demographic and clinical data , including fear-avoidance beliefs and catastrophizing , of @ patients were assessed for this analysis .


Disability was measured with the Shoulder Pain and Disability Index at baseline and at @-month follow-up .


First , bivariate and partial correlations were calculated among pain , fear-avoidance beliefs , catastrophizing , and disability , based on the fear-avoidance model .


Second , the contribution of fear-avoidance beliefs to disability at baseline and at @-month follow-up was examined with hierarchical regression analyses .


Correlations between clinical variables and disability were largely in line with the fear-avoidance model .


Regression analyses identified a significant contribution of fear-avoidance beliefs to baseline disability but not to disability at @ months .


Patients with subacromial pain syndrome were studied ; therefore , the results should be transferred with caution to other diagnoses .


A modified version of the Fear-Avoidance Beliefs Questionnaire was used , which was not validated for this patient group .


Fear-avoidance beliefs contribute significantly to baseline disability but not to disability change scores after @-month follow-up .


Duration of complaints and baseline disability were the main factors influencing disability change scores .


Although the results help to improve understanding of the role of fear-avoidance beliefs , further studies are needed to fully understand the influence of psychological and clinical factors on the development of disability in patients with subacromial shoulder pain .


Several publications have suggested that induction chemotherapy followed by extrapleural pneumonectomy ( EPP ) for patients with malignant pleural mesothelioma ( MPM ) patients is associated with exceedingly high morbidity and mortality , and the role of EPP is controversially debated .


The present retrospective study analyzed the perioperative outcome in @ consecutively treated patients at three high-volume mesothelioma centers .


@ MPM patients completed EPP after platinum-based induction chemotherapy at three institutions for thoracic surgery over more than @ years .


The rates of @-day and @-day mortality and of major morbidities ( pulmonary embolism , postoperative bleeding , acute respiratory distress syndrome , empyema , bronchopleural fistula ( BPF ) , chylothorax , patch failure ) were recorded .


Perioperative outcome was correlated to risk factors such as smoking history ( pack years ) , age at operation , body mass index , spirometry results , C-reactive protein , American Society of Anesthesiologists classification , chemotherapy regimen used , blood loss during operation , duration of operation , and characteristics of the tumor ( laterality , histologic subtype , pT and pN stage ) to find factors predicting @-day and @-day mortality or major morbidity .


The overall @-day mortality was @ % .


Within @ days after operation , @ % of the patients died .


The rates of @-day and @-day mortality were significantly higher in patients with high preoperative C-reactive protein values ( p = @ and p < @ ) .


The spirometry values forced expiratory volume in @ second and forced vital capacity exhaled ( FVCex ) were both associated with @-day and @-day mortality ( p = @ and p < @ ; and p = @ and p < @ ) .


Major morbidity occurred in @ % of the patients , significantly more often after right-sided EPP ( p = @ ) and after longer operations ( p < @ ) .


Empyema ( p < @ ) and acute respiratory distress syndrome ( p = @ ) were associated with longer duration of operation .


EPP after induction chemotherapy is a demanding procedure but can be performed with acceptable morbidity and mortality if patients are well selected and treated at dedicated high-volume MPM centers .


To investigate the efficacy of lubiprostone compared to Senna on bowel symptoms and constipation in post-operative orthopedic patients treated with opioids .


In this double blind , randomized , active comparator trial , adults who required opioids for analgesia following orthopedic procedures and who were admitted in inpatient rehabilitation were randomized following baseline assessments to lubiprostone ( Amitza ( ) ) , orally twice a day or Senna ( generic ) two capsules administered daily for six days .


Subjects were assessed using the patient assessment of constipation ( PAC ) - symptoms ( PAC-SYM ) and the PAC-quality of life ( PAC-QOL ) scales measured at baseline and Day @ ; Subjects were assessed daily for secondary measures included the Bristol stool scale bowel consistency , specific bowel symptom score ( Nausea , cramping , straining , completeness , abdominal pain , time per lavatory attempt , assistance needed ) , adverse events and rescue medications required .


Function was measured using the functional independence measure ( FIM ) at admission and discharge ; length of stay ( LOS ) and missed treatments due to gastrointestinal symptoms were also assessed .


@ adults were enrolled ; @ participants ( @ in each group ) had baseline and follow up measures and were included in the intention to treat ( ITT ) analyses .


@ participants completed the study , @ in the active lubiprostone and @ in the active Senna group .


The mean age of the participants was @ years ( SD = @ years , range : @-@ years ) .


In the ITT analyses , participants showed significant improvement in bowel symptoms as measured by the PAC-SYM ( mean SD , -@ @ , range : -@ -@ ) and PAC-QOL ( mean SD , @ @ , range : -@ -@ ) over time , but there were no significant differences between the lubiprostone and Senna groups in mean change in the PAC-SYM ( -@ @ vs -@ @ , P = @ respectively ) or the PAC-QOL ( @ @ vs @ @ , P = @ respectively ) .


The mean change in each bowel symptom also did not significantly differ between treatment groups on ITT analyses , except for completeness of bowel movement , with the Senna group showing greater negative mean change in bowel movement completeness ( -@ @ vs -@ @ , P = @ ) and for reduction of abdominal pain , favoring Senna ( -@ @ vs -@ @ , P = @ ) .


Fifteen ( @ % ) participants in the lubiprostone and in the Senna group requested rescue treatments .


Participants made significant functional improvement from admission to discharge over a median LOS of @ d , with a mean FIM change of @ @ and no significant between group differences ( @ @ vs @ @ , P = @ ) .


Both lubiprostone and Senna improved constipation-related symptoms and QOL in opioid-induced constipation , with no significant between-group differences .


Unhealthy alcohol use is a leading contributor to the global burden of disease , particularly among young people .


Systematic reviews suggest efficacy of web-based alcohol screening and brief intervention and call for effectiveness trials in settings where it could be sustainably delivered .


To evaluate a national web-based alcohol screening and brief intervention program .


A multisite , double-blind , parallel-group , individually randomized trial was conducted at @ New Zealand universities .


In April and May of @ , invitations containing hyperlinks to the Alcohol Use Disorders Identification Test-Consumption ( AUDIT-C ) screening test were e-mailed to @,@ students aged @ to @ years .


Participants who screened positive ( AUDIT-C score @ ) were randomized to undergo screening alone or to @ minutes of assessment and feedback ( including comparisons with medical guidelines and peer norms ) on alcohol expenditure , peak blood alcohol concentration , alcohol dependence , and access to help and information .


A fully automated @-month follow-up assessment was conducted that measured @ primary outcomes : consumption per typical occasion , drinking frequency , volume of alcohol consumed , an academic problems score , and whether participants exceeded medical guidelines for acute harm ( binge drinking ) and chronic harm ( heavy drinking ) .


A Bonferroni-corrected significance threshold of @ was used to account for the @ comparisons and a sensitivity analysis was used to assess possible attrition bias .


Of @ students screened , @ scored @ or greater and were randomized , and @ % were followed up .


There was a significant effect on @ of the @ prespecified outcomes .


Relative to control participants , those who received intervention consumed less alcohol per typical drinking occasion ( median @ drinks -LSB- interquartile range -LCB- IQR -RCB- , @-@ -RSB- vs @ drinks -LSB- IQR @-@ -RSB- ; rate ratio -LSB- RR -RSB- , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) but not less often ( RR , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) or less overall ( RR , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


Academic problem scores were not lower ( RR , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) and effects on the risks of binge drinking ( odds ratio -LSB- OR -RSB- , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) and heavy drinking ( OR , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) were not significantly significant .


In a sensitivity analysis accounting for attrition , the effect on alcohol per typical drinking occasion was no longer statistically significant .


A national web-based alcohol screening and brief intervention program produced no significant reductions in the frequency or overall volume of drinking or academic problems .


There remains a possibility of a small reduction in the amount of alcohol consumed per typical drinking occasion .


To evaluate efficacy and side effects of glycididazole sodium ( CMNa ) combined with chemotherapy ( cisplatin plus @-FU/folic acid , PLF ) and radiotherapy in treating patients with locally advanced nasopharyngeal carcinoma .


Patients with III ~ IV stage nasopharyngeal carcinoma ( NPC ) , were randomly divided into treatment group ( @ patients ) and control group ( @ patients ) .


Both groups received radiotherapy concomitant with PLF chemotherapy .


The treatment group at the same time was given CMNa ( @ mg/m@ before radiotherapy ) , by l h intravenous drip , three times a week .


When the dose of radiation was over @ Gy , complete response rates of nasopharyngeal tumor and lymph node metastases in treatment group were significantly higher than in the control group ( @ % vs @ % ; @ % vs @ % , p < @ ) .


Three months after radiotherapy , complete response rate of nasopharynx cancer and lymph node metastases in treatment group was both @ % , again higher than in the control group ( @ % and @ % ) ( p < @ ) .


In the treatment group , @ , @ , @ year disease-free survival rates were @ % , @ % and @ % ; and in control group , the corresponding disease-free survival rates were @ % , @ % and @ % , respectively , the difference being statistically significant ( log-rank = @ , p = @ ) .


One , @ , @ year overall survival rates in two groups of patients were @ % , @ % , @ % and @ % , @ % , @ % , respectively , again with a statistically significant difference ( log-rank = @ , p = @ ) .


Acute toxicity and long-term radiotherapy related toxicity in the two groups did not differ ( p > @ ) .


Glycididazole sodium could improve curative effects without increasing adverse reactions when treating patients with locally advanced nasopharyngeal carcinoma .


Guided self-help is a recommended first-step treatment for bulimia nervosa , binge eating disorder and atypical variants of these disorders .


Further research is needed to compare guided self-help that is delivered face-to-face versus via email .


This clinical trial uses a randomised , controlled design to investigate the effectiveness of providing guided self-help either face-to-face or via e-mail , also using a delayed treatment control condition .


At least @ individuals are required per group , giving a minimum N of @ .


Symptom outcomes will be assessed and estimates of cost-effectiveness made .


Results are proposed to be disseminated locally and internationally ( through submission to conferences and peer-reviewed journals ) , and will hopefully inform local service provision .


The trial has been approved by an ethics review board and was registered with ClinicalTrials.gov NCT@ on @ April @ .


Although antiretroviral pre-exposure prophylaxis prevents HIV acquisition , it is not known if it alters HIV disease progression .


This study assesses whether tenofovir gel impacted on disease progression among CAPRISA @ microbicide trial seroconvertors .


Eighty-three seroconvertors from the tenofovir and placebo gel arms of the CAPRISA @ trial were monitored prospectively for a minimum of @ years by CD@ count and viral load ( VL ) .


Linear mixed models were fitted to HIV VL , and log rank test was used to compare time to reach CD@ counts of < @ cells per microliter .


Median @-week postinfection VL was @ and @ log copies per milliliter in women assigned to tenofovir gel ( n = @ ) and placebo gel ( n = @ ) ( P = @ ) .


Corresponding @-month postinfection VLs were @ and @ log copies per milliliter ( P = @ ) .


After adjusting for clinical and behavioral characteristics and protective HLA alleles , mean VLs within the first @ years were @ and @ log copies per milliliter in women from the tenofovir and placebo arms ( P = @ ) .


Among women with vaginal tenofovir measurements , mean VLs were @ and @ log copies per milliliter in those with detectable versus undetectable levels ( P = @ ) .


Overall mean CD@ counts were @ and @ cells per microliter in women assigned to tenofovir and placebo ( P = @ ) .


Thirty-two women ( @ % ) reached CD@ counts of < @ cells per microliter at median @ months postinfection , @ ( @ % ) from the tenofovir and @ ( @ % ) from the placebo arms ( P = @ ) .


Tenofovir gel had no impact on postinfection CD@ counts or the rate of CD@ decline .


Although seroconvertors from the tenofovir arm experienced higher VLs , this did not result in a need for earlier antiretroviral therapy .


To determine whether providing a controlled resistance versus assistance to the paretic leg at the ankle during treadmill training will improve walking function in individuals poststroke .


Repeated assessment of the same patients with parallel design and randomized controlled study between @ groups .


Research units of rehabilitation hospitals .


Patients ( N = @ ) with chronic stroke .


Subjects were stratified based on self-selected walking speed and were randomly assigned to the resistance or assistance training group .


For the resistance group , a controlled resistance load was applied to the paretic leg at the ankle to resist leg swing during treadmill walking .


For the assistance group , a load that assists swing was applied .


Primary outcome measures were walking speed and @-minute walking distance .


Secondary measures included clinical assessments of balance , muscle tone , and quality of life .


Outcome measures were evaluated before and after @ weeks of training and at @ weeks ' follow-up , and compared within group and between the @ groups .


After @ weeks of robotic training , walking speed significantly increased for both groups , with no significant differences in walking speed gains observed between the @ groups .


In addition , @-minute walking distance and balance significantly improved for the assistance group but not for the resistance group .


Applying a controlled resistance or an assistance load to the paretic leg during treadmill training may induce improvements in walking speed in individuals poststroke .


Resistance training was not superior to assistance training in improving locomotor function in individuals poststroke .


Newer studies suggest that carvedilol , a beta-blocker with a moderate anti-alpha-@ activity , is superior to propranolol in reducing the portal pressure and risk of variceal bleeding .


The effect on arterial blood pressure is a matter of concern especially in decompensated patients .


to assess potential differential effects of beta-blockers and beta-blockers with moderate anti-alpha-@ activity on selected haemodynamic , humoral , and respiratory characteristics in cirrhosis .


Patients with cirrhosis and portal hypertension were randomised to receive carvedilol ( n = @ ) or propranolol ( n = @ ) .


Cardiac , systemic and splanchnic parameters along with oxygen saturation and plasma renin were measured at inclusion and after @ months .


Arterial blood pressure , heart rate , and cardiac output decreased equally , central circulation time and systemic vascular resistance increased significantly but similarly .


Central blood volume , plasma volume and arterial compliance were unaltered .


The QTc interval and renin levels decreased in the carvedilol group , however not significantly different from the propranolol group .


Arterial oxygen saturation and alveolar arterial oxygen gradient remained constant in both groups .


Hepatic venous pressure gradient decreased equally in the carvedilol and propranolol groups ( -@ % and -@ % , non significant ) .


Systemic haemodynamics and pulmonary effects of carvedilol and propranolol are modest and this study could not demonstrate any significant difference between the two treatments .


To assess the efficacy of a simple , goal-directed sepsis treatment protocol for reducing mortality in patients with severe sepsis in Zambia .


Single-center nonblinded randomized controlled trial .


Emergency department , ICU , and medical wards of the national referral hospital in Lusaka , Zambia .


One hundred twelve patients enrolled within @ hours of admission with severe sepsis , defined as systemic inflammatory response syndrome with suspected infection and organ dysfunction


: Simplified Severe Sepsis Protocol consisting of up to @ L of IV fluids within @ hours , guided by jugular venous pressure assessment , and dopamine and/or blood transfusion in selected patients .


Control group was managed as usual care .


Blood cultures were collected and early antibiotics administered for both arms .


Primary outcome was in-hospital all-cause mortality .


One hundred nine patients were included in the final analysis and @ patients ( @ % ) were HIV positive .


Pulmonary infections were the most common source of sepsis .


In-hospital mortality rate was @ % in the intervention group and @ % in the control group ( relative risk , @ ; @ % CI , @-@ @ ) .


Mycobacterium tuberculosis complex was isolated from @ of @ HIV-positive patients ( @ % ) with available mycobacterial blood culture results .


Patients in Simplified Severe Sepsis Protocol received significantly more IV fluids in the first @ hours ( @ L vs @ L , p = @ ) .


The study was stopped early because of high mortality rate among patients with hypoxemic respiratory failure in the intervention arm ( @/@ , @ % ) compared with the control arm ( @/@ , @ % ; relative risk , @ ; @ % CI , @-@ @ ) .


Factors other than tissue hypoperfusion probably account for much of the end-organ dysfunction in African patients with severe sepsis .


Studies of fluid-based interventions should utilize inclusion criteria to accurately capture patients with hypovolemia and tissue hypoperfusion who are most likely to benefit from fluids .


Exclusion of patients with severe respiratory distress should be considered when ventilatory support is not readily available .


It is well known that receipt of an initial abnormal cervical cytology test can trigger considerable anxiety among women .


Less is known about the impact of follow-up by repeat cytology tests .


We quantified prevalence , and identified predictors , of distress after repeat cytologic testing in women with a single low-grade test .


Within the framework of the TOMBOLA randomized controlled trial of alternative managements , @ women aged @ to @ years with a single routine cytology test showing borderline nuclear abnormalities ( BNA ; broadly equivalent to atypical squamous cells of undetermined significance ) were assigned to follow-up by repeat cytology in primary care ( the first test was due @ months after the initial BNA result ) .


Women completed sociodemographic and psychosocial questionnaires at recruitment and the Impact of Event Scale ( IES ) @ weeks after their first follow-up cytology test .


Factors associated with significant psychologic distress ( IES @ ) were identified using logistic regression .


The response rate was @ % ( n = @/@ ) .


Of all the respondents , @ % scored in the range for significant distress .


Distress varied by follow-up cytology result : negative , @ % ; BNA or mild dyskaryosis , @ % ; other ( including high grade and inadequate ) , @ % .


After adjusting for the cytology result , risk of distress was significantly raised in women who had significant anxiety at recruitment , reported experiencing pain after the follow-up cytology , had children , or were dissatisfied with support they had received after their initial BNA test .


Substantial proportions of women experience surveillance-related psychologic distress after a follow-up cytology test , even when the result is negative .


This is an important , albeit unintended , consequence of cervical screening .


Strategies to alleviate this distress merit attention .


The World Health Organization recommends high-dose vitamin A supplementation ( VAS ) for children above six months of age in low-income countries .


VAS has been associated with up-regulation of the Th@ response .


We aimed to determine if VAS is associated with atopy in childhood .


Infants in Guinea-Bissau were randomly allocated VAS or placebo , either at six and nine months of age , or only at nine months of age .


At six months of age , children were furthermore randomized to measles vaccine or inactivated polio vaccine .


At nine months of age all children received measles vaccine .


Children were revisited seven years later and skin prick testing was performed .


Atopy was defined as a skin prick reaction @ mm .


@ of @ children ( @ % ) were atopic .


Overall VAS had no significant effect on the risk of atopy ( Prevalence Ratio @ ; @ % CI @-@ @ ) .