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[ "To determine dose-dependent effects of T administration on cardiovascular risk markers in women with low T levels .", "Seventy-one hysterectomized women with or without oophorectomy with total T < 31 ng/dL and/or free T < 3.5 pg/mL received a standardized transdermal estradiol regimen during the 12-week run-in period and were then randomized to receive weekly im injections of placebo or 3 - , 6.25 - , 12.5 - , or 25-mg T enanthate for 24 weeks .", "Total and free T levels were measured by liquid chromatography-tandem mass spectrometry and equilibrium dialysis , respectively .", "Insulin resistance and inflammatory markers were measured at baseline and 24 weeks .", "In a subset of women , magnetic resonance imaging of the abdomen was performed to quantify abdominal fat volume .", "Fifty-nine women who completed the 24-week intervention were included in the final analysis .", "The five groups were similar at baseline .", "Mean on-treatment nadir total T concentrations were 14 , 79 , 105 , 130 , and 232 ng/dL in the placebo group and the 3 - , 6.25 - , 12.5 - , and 25-mg groups , respectively .", "No significant changes in fasting glucose , fasting insulin , homeostatic model assessment of insulin resistance , high sensitivity C-reactive protein , adiponectin , blood pressure , and heart rate were observed at any T dose when compared to placebo .", "Similarly , no dose - or concentration-dependent changes were observed in abdominal fat on magnetic resonance imaging .", "Short-term T administration over a wide range of doses for 24 weeks in women with low T levels was not associated with worsening of cardiovascular risk markers ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "The phe508del CFTR mutation causes cystic fibrosis by limiting the amount of CFTR protein that reaches the epithelial cell surface .", "We tested combination treatment with lumacaftor , an investigational CFTR corrector that increases trafficking of phe508del CFTR to the cell surface , and ivacaftor , a CFTR potentiator that enhances chloride transport of CFTR on the cell surface .", "In this phase 2 clinical trial , we assessed three successive cohorts , with the results of each cohort informing dose selection for the subsequent cohort .", "We recruited patients from 24 cystic fibrosis centres in Australia , Belgium , Germany , New Zealand , and the USA .", "Eligibility criteria were : confirmed diagnosis of cystic fibrosis , age at least 18 years , and a forced expiratory volume in 1 s ( FEV1 ) of 40 % or more than predicted .", "Cohort 1 included phe508del CFTR homozygous patients randomly assigned to either lumacaftor 200 mg once per day for 14 days followed by addition of ivacaftor 150 mg or 250 mg every 12 h for 7 days , or 21 days of placebo .", "Together , cohorts 2 and 3 included phe508del CFTR homozygous and heterozygous patients , randomly assigned to either 56 days of lumacaftor ( cohort 2 : 200 mg , 400 mg , or 600 mg once per day , cohort 3 : 400 mg every 12 h ) with ivacaftor 250 mg every 12 h added after 28 days , or 56 days of placebo .", "The primary outcomes for all cohorts were change in sweat chloride concentration during the combination treatment period in the intention-to-treat population and safety ( laboratory measurements and adverse events ) .", "The study is registered with ClinicalTrials.gov , number NCT01225211 , and EudraCT , number 2010-020413-90 .", "Cohort 1 included 64 participants .", "Cohort 2 and 3 combined contained 96 phe508del CFTR homozygous patients and 28 compound heterozygotes .", "Treatment with lumacaftor 200 mg once daily and ivacaftor 250 mg every 12 h decreased mean sweat chloride concentration by 9.1 mmol/L ( p < 0.001 ) during the combination treatment period in cohort 1 .", "In cohorts 2 and 3 , mean sweat chloride concentration did not decrease significantly during combination treatment in any group .", "Frequency and nature of adverse events were much the same in the treatment and placebo groups during the combination treatment period ; the most commonly reported events were respiratory .", "12 of 97 participants had chest tightness or dyspnoea during treatment with lumacaftor alone .", "In pre-planned secondary analyses , a significant decrease in sweat chloride concentration occurred in the treatment groups between day 1 and day 56 ( lumacaftor 400 mg once per day group -9.1 mmol/L , p < 0.001 ; lumacaftor 600 mg once per day group -8.9 mmol/L , p < 0.001 ; lumacaftor 400 mg every 12 h group -10.3 mmol/L , p = 0.002 ) .", "These changes were significantly greater than the change in the placebo group .", "In cohort 2 , the lumacaftor 600 mg once per day significantly improved FEV1 from day 1 to 56 ( difference compared with placebo group : +5.6 percentage points , p = 0.013 ) , primarily during the combination period .", "In cohort 3 , FEV1 did not change significantly across the entire study period compared with placebo ( difference +4.2 percentage points , p = 0.132 ) , but did during the combination period ( difference +7.7 percentage points , p = 0003 ) .", "Phe508del CFTR heterozygous patients did not have a significant improvement in FEV1 .", "We provide evidence that combination lumacaftor and ivacaftor improves FEV1 for patients with cystic fibrosis who are homozygous for phe508del CFTR , with a modest effect on sweat chloride concentration .", "These results support the further exploration of combination lumacaftor and ivacaftor as a treatment in this setting .", "Vertex Pharmaceuticals , Cystic Fibrosis Foundation Therapeutics Development Network ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "The aim of this study was to assess the glucose-lowering and lipid-modifying effects , and safety profile of lobeglitazone , a novel peroxisome proliferator-activated receptor - agonist , compared to placebo as a monotherapy in patients with type 2 diabetes .", "In this 24-week , multicenter , randomized , double-blind , parallel-group , placebo controlled study , 173 patients were randomly assigned ( a 21 ratio ) to lobeglitazone 0.5 mg ( n = 115 ) or matching placebo ( n = 58 ) orally once daily .", "The primary endpoint was the change in glycated hemoglobin ( HbA1c ) from baseline to the end of treatment .", "The secondary endpoints included various glycemic parameters , lipid parameters and safety profile ( ClinicalTrials.gov number NCT01001611 ) .", "At 24 weeks , a significant reduction in HbA1c was observed with lobeglitazone versus placebo ( -0.44 % vs 0.16 % , mean difference -0.6 % , p < 0.0001 ) .", "The goal of HbA1c < 7 % was achieved significantly more in the lobeglitazone group compared to the placebo group ( 44 % vs 12 % , p < 0.0001 ) .", "Markers of insulin resistance were also improved in the lobeglitazone group .", "In addition , lobeglitazone treatment significantly improved triglycerides , high density lipoprotein cholesterol , small dense low density lipoprotein cholesterol , free fatty acid , and apolipoprotein-B/CIII compared to placebo ( p < 0.01 , respectively ) .", "More weight gain was observed in the lobeglitazone group than the placebo group ( 0.89 kg vs - 0.63 kg , mean difference 1.52 kg , p < 0.0001 ) .", "The safety profile was comparable between the two groups and lobeglitazone was well tolerated .", "Lobeglitazone 0.5 mg showed a favorable balance in the efficacy and safety profile .", "The results support a potential role of lobeglitazone in treating type 2 diabetes .", "Clinicaltrials.gov NCT01001611 ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Pulsed electromagnetic fields have been shown to reduce postoperative pain , inflammation , and narcotic requirements after breast reduction and augmentation surgical procedures .", "This study examined whether pulsed electromagnetic field therapy could produce similar results in patients undergoing unilateral transverse rectus abdominis myocutaneous ( TRAM ) flap breast reconstruction , a significantly more complex and painful surgical procedure .", "In this double-blind , placebo-controlled , randomized study , 32 patients undergoing unilateral TRAM flap breast reconstruction received active or sham pulsed electromagnetic field therapy .", "Pain levels were measured by using a visual analogue scale ; narcotic use and wound exudate volume were recorded starting 1 hour postoperatively .", "Wound exudates were analyzed for interleukin-1 .", "Mean visual analogue scale pain scores were 2-fold higher in the sham cohort at 5 hours and 4-fold higher at 72 hours ( p < 0.01 ) , along with a concomitant 2-fold increase in narcotic use in sham patients ( p < 0.01 ) .", "Wound exudate volume was 2-fold higher in the sham cohort at 24 hours ( p < 0.01 ) , and mean interleukin-1 concentration in wound exudates of sham patients was 5-fold higher at 24 hours ( p < 0.001 ) .", "Pulsed electromagnetic field therapy significantly reduced postoperative pain , inflammation , and narcotic use following TRAM flap breast reconstruction , paralleling its effect in breast reduction patients .", "Both studies also report a significant reduction of interleukin-1 in the wound exudate , supporting a mechanism involving a pulsed electromagnetic field effect on nitric oxide/cyclic guanosine monophosphate signaling , which modulates the body 's antiinflammatory pathways .", "Adjunctive pulsed electromagnetic field therapy could impact the speed and quality of wound repair in many surgical procedures .", "Therapeutic , I." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "METHODS" ]

[ "The objective of this study was to investigate the hypouricemic effects of green tea extract ( GTE ) in healthy individuals .", "This study comprised 1-week control , 2-week interventional , and 1-week follow-up periods .", "Participants were assigned randomly at the interventional period to consume GTE at 2 ( GTE2 ) , 4 ( GTE4 ) , or 6 ( GTE6 ) g/d .", "Levels of serum uric acid ( SUA ) , uric acid clearance , and serum antioxidant power ( using trolox equivalent antioxidant capacity assay ) were measured at both ends of each study period .", "Of 30 participants , 11 , 11 , and 8 received GTE2 , GTE4 , and GTE6 , respectively .", "After 2 weeks of consumption , the mean SUA level tended to decrease in all groups , with no statistical significance .", "Serum uric acid reduction was greatest in GTE2 ( from 4.81 0.81 mg/dL to 4.64 0.92 mg/dL , 3.53 % ) .", "Uric acid clearance decreased significantly in GTE2 ( from 11.37 6.41 mL/min per 1.73 m to 7.44 2.74 mL/min per 1.73 m , 34.56 % , P < 0.05 ) and GTE4 ( from 8.36 3.41 mL/min per 1.73 m to 5.78 2.33 mL/min per 1.73 m , 30.86 % , P < 0.05 ) .", "Serum antioxidant capacity ( TEAC ) increased significantly in GTE6 ( from 32.77 3.39 mg/mL to 35.41 3.17 mg/mL , 8.06 % , P < 0.05 ) .", "There was no significant change in creatinine clearance .", "Gastrointestinal adverse events were common , but usually mild , with no medical treatment required .", "Green tea extract may modestly lower SUA level and decreases uric acid clearance .", "Green tea extract also significantly elevated serum antioxidant capacity with a positive dosage effect .", "The effect of GTE on SUA in healthy individuals was short term .", "The effects of GTE on urate handling in patients with hyperuricemia or gout need to be determined ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "An intradermal ( ID ) trivalent split-virion influenza vaccine ( IIV3-ID ) ( Fluzone ( ) Intradermal , Sanofi Pasteur , Swiftwater , PA ) has been available in the US since the 2011/2012 influenza season for adults aged 18-64 years .", "This study examined whether adding a second B-lineage strain affects immunogenicity and safety .", "This randomized , double-blind , multicentre trial evaluated the immunogenicity and safety of an intradermal quadrivalent split-virion influenza vaccine ( IIV4-ID ) in adults 18-64 years of age in the US during the 2012-2013 influenza season .", "Participants were randomized 2:1:1 to receive a single injection of IIV4-ID , licensed IIV3-ID , or an investigational IIV3-ID containing the alternate B-lineage strain .", "Haemagglutination inhibition antibody titres were assessed in two-thirds of participants before vaccination and 28 days after vaccination .", "1672 participants were vaccinated with IIV4-ID , 837 with licensed IIV3-ID , and 846 with an investigational IIV3-ID .", "For all four vaccine strains , antibody responses to IIV4-ID were statistically non-inferior to the response to the IIV3-ID vaccines containing the matched strains .", "For both B strains , post-vaccination antibody responses to IIV4-ID were statistically superior to the responses to IIV3-ID lacking the corresponding B strain .", "Adverse events were similar for IIV4-ID and IIV3-ID .", "The most commonly reported solicited reactions were pain , pruritus , myalgia , headache , and malaise ; and most were grade 1 or 2 and appeared and resolved within 3 days of vaccination .", "IIV4-ID was statistically non-inferior to the two pooled IIV3-ID vaccines for the proportions of participants with at least one grade 2 or 3 systemic reaction .", "Antibody responses to the IIV4-ID were non-inferior to IIV3-ID for the A and matched B strains and superior for the unmatched B strains .", "IIV4-ID was well tolerated without any safety concerns .", "IIV4-ID may help address an unmet need due to mismatched B strains in previous influenza vaccines ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Blood transfusions are frequently given to patients with septic shock .", "However , the benefits and harms of different hemoglobin thresholds for transfusion have not been established .", "In this multicenter , parallel-group trial , we randomly assigned patients in the intensive care unit ( ICU ) who had septic shock and a hemoglobin concentration of 9 g per deciliter or less to receive 1 unit of leukoreduced red cells when the hemoglobin level was 7 g per deciliter or less ( lower threshold ) or when the level was 9 g per deciliter or less ( higher threshold ) during the ICU stay .", "The primary outcome measure was death by 90 days after randomization .", "We analyzed data from 998 of 1005 patients ( 99.3 % ) who underwent randomization .", "The two intervention groups had similar baseline characteristics .", "In the ICU , the lower-threshold group received a median of 1 unit of blood ( interquartile range , 0 to 3 ) and the higher-threshold group received a median of 4 units ( interquartile range , 2 to 7 ) .", "At 90 days after randomization , 216 of 502 patients ( 43.0 % ) assigned to the lower-threshold group , as compared with 223 of 496 ( 45.0 % ) assigned to the higher-threshold group , had died ( relative risk , 0.94 ; 95 % confidence interval , 0.78 to 1.09 ; P = 0.44 ) .", "The results were similar in analyses adjusted for risk factors at baseline and in analyses of the per-protocol populations .", "The numbers of patients who had ischemic events , who had severe adverse reactions , and who required life support were similar in the two intervention groups .", "Among patients with septic shock , mortality at 90 days and rates of ischemic events and use of life support were similar among those assigned to blood transfusion at a higher hemoglobin threshold and those assigned to blood transfusion at a lower threshold ; the latter group received fewer transfusions .", "( Funded by the Danish Strategic Research Council and others ; TRISS ClinicalTrials.gov number , NCT01485315 . )" ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Most patients with acute coronary syndrome ( ACS ) are treated with statins , which reduce atherogenic triglyceride-rich lipoproteins .", "It is uncertain whether triglycerides predict risk after ACS on a background of statin treatment .", "This study examined the relationship of fasting triglyceride levels to outcomes after ACS in patients treated with statins .", "Long-term and short-term relationships of triglycerides to risk after ACS were examined in the dal-OUTCOMES trial and atorvastatin arm of the MIRACL ( Myocardial Ischemia Reduction with Acute Cholesterol Lowering ) trial , respectively .", "Analysis of dal-OUTCOMES included 15,817 patients ( 97 % statin-treated ) randomly assigned 4 to 12 weeks after ACS to treatment with dalcetrapib ( a cholesteryl ester transfer protein inhibitor ) or placebo and followed for a median 31 months .", "Analysis of MIRACL included 1,501 patients treated with atorvastatin 80 mg daily beginning 1 to 4 days after ACS and followed for 16 weeks .", "Fasting triglycerides at initial random assignment were related to risk of coronary heart disease death , nonfatal myocardial infarction , stroke , and unstable angina in models adjusted for age , sex , hypertension , smoking , diabetes , high-density lipoprotein cholesterol , and body mass index .", "Fasting triglyceride levels were associated with both long-term and short-term risk after ACS .", "In dal-OUTCOMES , long-term risk increased across quintiles of baseline triglycerides ( p < 0.001 ) .", "The hazard ratio in the highest/lowest quintile ( > 175/80 mg/dl ) was 1.61 ( 95 % confidence interval : 1.34 to 1.94 ) .", "There was no interaction of triglycerides and treatment assignment on the primary outcome .", "In the atorvastatin group of MIRACL , short-term risk increased across tertiles of baseline triglycerides ( p = 0.03 ) , with a hazard ratio of 1.50 [ corrected ] ( 95 % confidence interval : 1.05 to 2.15 ) in highest/lowest tertiles ( > 195/135 mg/dl ) .", "The relationship of triglycerides to risk was independent of low-density lipoprotein cholesterol in both studies .", "Among patients with ACS treated effectively with statins , fasting triglycerides predict long-term and short-term cardiovascular risk .", "Triglyceride-rich lipoproteins may be an important additional target for therapy .", "( A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome ; NCT00658515 ) ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Both hepatitis C virus ( HCV ) mono-infected and HIV/HCV co-infected patients are in need of safe , effective , all-oral HCV regimens .", "In a phase 2 study we aimed to assess the efficacy and safety of grazoprevir ( MK-5172 ; HCV NS3/4A protease inhibitor ) and two doses of elbasvir ( MK-8742 ; HCV NS5A inhibitor ) in patients with HCV mono-infection and HIV/HCV co-infection .", "The C-WORTHY study is a phase 2 , multicentre , randomised controlled trial of grazoprevir plus elbasvir with or without ribavirin in patients with HCV ; here , we report findings for previously untreated ( genotype 1 ) patients without cirrhosis who were HCV mono-infected or HIV/HCV co-infected .", "Eligible patients were previously untreated adults aged 18 years or older with chronic HCV genoype 1 infection and HCV RNA at least 10000 IU/mL in peripheral blood without evidence of cirrhosis , hepatocellular carcinoma , or decompensated liver disease .", "In part A of the study we randomly assigned HCV-mono-infected patients to receive 12 weeks of grazoprevir ( 100 mg ) plus elbasvir ( 20 mg or 50 mg ) with or without ribavirin ( arms A1-3 ) ; in part B we assigned HCV-mono-infected patients to 8 or 12 weeks of grazoprevir ( 100 mg ) plus elbasvir ( 50 mg ) with or without ribavirin ( arms B1-3 ) and HIV/HCV co-infected patients to 12 weeks of therapy with or without ribavirin .", "The primary endpoint was the proportion of patients achieving HCV RNA less than 25 IU/mL 12 weeks after end of treatment ( SVR12 ) .", "Randomisation was by presence or absence of ribavirin , 8 or 12 weeks of treatment , and dosage of elbasvir .", "Patients were stratified by gentoype 1a versus 1b .", "The patients , investigators , and study site personnel were masked to treatment group assignements but the funder was not .", "Analysis was by intention to treat .", "This trial is registered at ClinicalTrials.gov , number NCT01717326 .", "218 patients with HCV mono-infection ( n = 159 ) and HIV/HCV co-infection ( n = 59 ) were enrolled .", "SVR12 for patients treated for 12 weeks with or without ribavirin ranged from 93-98 % in mono-infected and 87-97 % in co-infected patients .", "SVR12 rates in mono-infected and co-infected patients treated for 12 weeks without ribavirin were 98 % ( 95 % CI 88-100 ; 43/44 ) and 87 % ( 95 % CI 69-96 ; 26/30 ) , respectively , and with ribavirin were 93 % ( 95 % CI 85-97 ; 79/85 ) and 97 % ( 95 % CI 82-100 ; 28/29 ) , respectively .", "Among mono-infected patients with genotype 1a infection treated for 8 weeks , SVR12 was 80 % ( 95 % CI 61-92 ; 24/30 ) .", "Five of six patients who discontinued early for reasons other than virological failure had HCV RNA less than 25 IU/mL at their last study visit .", "Virological failure among patients treated for 12 weeks occurred in seven patients ( 7/188 , 4 % ) and was associated with emergence of resistance-associated variants to one or both drugs .", "The safety profile of grazoprevir plus elbasvir with or without ribavirin was similar in mono-infected and co-infected patients .", "No patient discontinued due to an adverse event or laboratory abnormality .", "The most common adverse events were fatigue ( 51 patients , 23 % ) , headache ( 44 , 20 % ) , nausea ( 32 , 15 % ) , and diarrhoea ( 21 , 10 % ) .", "Once-daily grazoprevir plus elbasvir with or without ribavirin for 12 weeks in previously untreated HCV-mono-infected and HIV/HCV-co-infected patients without cirrhosis achieved SVR12 rates of 87-98 % .", "These results support the ongoing phase 3 development of grazoprevir plus elbasvir .", "Merck & Co , Inc. ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Treatment options for adults with attention deficit hyperactivity disorder ( ADHD ) are limited .", "The study was conducted to confirm the clinically effective and safe dose of methylphenidate hydrochloride modified-release ( MPH-LA ) in adults with ADHD and evaluate the maintenance of effect of MPH-LA .", "The study consisted of three treatment phases .", "The double-blind dose-confirmation phase : 9-week double-blind period ( 3-week titration period , 6-week fixed dose ) with randomization to MPH-LA 40 , 60 , or 80mg/day or placebo .", "The real-life dose-optimization phase : a 5-week re-titration period to optimal dose ; and the double-blind maintenance of effect phase , a 6-month double-blind randomized placebo-controlled maintenance of effect phase .", "The three co-primary endpoints were change in Diagnostic and Statistical Manual of Mental Disorders-IV ADHD Rating Scale ( DSM-IV ADHD RS ) and Sheehan Disability Scale ( SDS ) total scores from baseline to end of 9-week confirmation phase and the percentage of treatment failures during the 6-month maintenance of effect phase .", "725 of 863 screened patients were randomized to 40 ( N = 181 ) , 60 ( N = 182 ) , or 80mg ( N = 181 ) MPH-LA or placebo ( N = 181 ) , and 584 ( 80.6 % ) completed .", "489 ( 83.7 % ) of completers were re-randomized to the double-blinded maintenance of effect phase and 235 ( 48.1 % ) of them completed .", "Improvement from baseline in DSM-IV ADHD RS ( P < 0.0001 for all comparisons ) and SDS ( 40mg , P = 0.0003 ; 60mg , P = 0.0176 ; 80mg , P < 0.0001 ) total scores was significantly greater vs. placebo for all MPH-LA doses .", "Treatment failure rate was significantly lower with MPH-LA ( 21.3 % ) versus placebo ( 49.6 % ) during the 6-month maintenance of effect phase .", "Safety profile was consistent with the profile for MPH-LA in children ; percentage of serious adverse events was comparable between all MPH-LA arms ( 1.3 % ) and placebo ( 1.5 % ) , while percentage of adverse events was higher in MPH-LA arms .", "MPH-LA provided and maintained significant symptomatic and functional improvement in adult ADHD patients ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To compare the effect of melatonin and gabapentin on anxiety , pain , sedation scores , and satisfaction of surgeon in patients of cataract surgery .", "One hundred thirty patients aged between 35 and 85 years scheduled for cataract surgery were randomly allocated to three study groups to receive melatonin ( 6 mg ) , gabapentin ( 600 mg ) or placebo 90 min before arrival in the operating room .", "Pain , anxiety , and sedation scores during block and surgery as well as the surgeon 's satisfaction with the surgery were assessed .", "Anxiety scores decreased significantly in melatonin and gabapentin groups compared to the placebo group after premedication and extended to early postoperative period .", "The level of anxiety showed no statistically significant difference between melatonin and gabapentin groups at any time of measurement .", "There were significant differences between the pain scores during retrobulbar placement in gabapentin versus placebo ( 95 % CI 3 to 4 ; P = 0.001 ) and melatonin ( 95 % CI 3 to 4 ; P = 0.040 ) groups .", "Also , there were significant differences between the sedation scores during retrobulbar placement in gabapentin and placebo groups ( 95 % CI 2 to 2.5 ; P = 0.046 ) .", "The difference in sedation scores during retrobulbar placement in melatonin versus gabapentin and placebo groups was not significant .", "Neither the intraoperative pain scores nor the postoperative pain scores were different between the three groups .", "The surgeon reported similar quality of operation conditions during surgery for the three study groups .", "The level of anxiety was significantly lower with both anxiolytic drugs compared to placebo .", "Furthermore , gabapentin decreased the pain and improved the sedation scores only during retrobulbar placement compared to the placebo ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To investigate whether a 12-week physical and cognitive exercise program can improve cognitive function and brain activation efficiency in community-dwelling older adults .", "Randomized controlled trial .", "Kyoto , Japan .", "Community-dwelling older adults ( N = 48 ) were randomized into an exercise group ( n = 24 ) and a control group ( n = 24 ) .", "Exercise group participants received a weekly dual task-based multimodal exercise class in combination with pedometer-based daily walking exercise during the 12-week intervention phase .", "Control group participants did not receive any intervention and were instructed to spend their time as usual during the intervention phase .", "The outcome measures were global cognitive function , memory function , executive function , and brain activation ( measured using functional magnetic resonance imaging ) associated with visual short-term memory .", "Exercise group participants had significantly greater postintervention improvement in memory and executive functions than the control group ( P < .05 ) .", "In addition , after the intervention , less activation was found in several brain regions associated with visual short-term memory , including the prefrontal cortex , in the exercise group ( P < .001 , uncorrected ) .", "A 12-week physical and cognitive exercise program can improve the efficiency of brain activation during cognitive tasks in older adults , which is associated with improvements in memory and executive function ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To explore potential predictors of self-reported paretic arm use at baseline and after task-specific training ( TST ) in survivors of stroke .", "Data were obtained from a randomized controlled trial of somatosensory stimulation and upper limb TST in chronic stroke .", "University laboratory .", "Chronic ( 3mo ) survivors of stroke ( N = 33 ; mean age , 62y ; mean stroke duration , 38mo ) .", "Participants received 12 sessions of TST preceded by either active ( n = 16 ) or sham ( n = 17 ) somatosensory stimulation to all 3 peripheral nerves .", "Demographic and clinical characteristics were entered stepwise into multiple linear regression analyses to determine the factors that best predict baseline Motor Activity Log ( MAL ) amount of use rating and change 3 months after TST .", "The Action Research Arm Test ( ARAT ) score predicted the amount of use at baseline ( R ( 2 ) = .47 , P < .001 ) ; in using this model , an ARAT score of 54 ( maximum of 57 ) is required to score 2.5 on the MAL ( use described as between rarely and sometimes ) .", "After TST the change in the ARAT score predicted the change in the amount of use ( R ( 2 ) = .31 , P = .001 ) .", "The predictive power of the model for change at 3 months increased if the Fugl-Meyer Assessment wrist component score was added ( R ( 2 ) = .41 , P = .001 ) .", "Utilization of the paretic upper limb in activities of daily living requires high functional ability .", "The increase in self-reported arm use after TST is dependent on the change in functional ability .", "These results provide further guidance for rehabilitation decisions ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "There are limited data comparing ultrafiltration with standard medical therapy as first-line treatment in patients with severe congestive heart failure ( HF ) .", "We compared ultrafiltration and conventional therapy in patients hospitalized for HF and overt fluid overload .", "Fifty-six patients with congestive HF were randomized to receive standard medical therapy ( control group ; n = 29 ) or ultrafiltration ( ultrafiltration group ; n = 27 ) .", "The primary end point of the study was rehospitalizations for congestive HF during a 1-year follow-up .", "Despite similar body weight reduction at hospital discharge in the 2 groups ( 7.5 5.5 and 7.9 9.0 kg , respectively ; P = .75 ) , a lower incidence of rehospitalizations for HF was observed in the ultrafiltration-treated patients during the following year ( hazard ratio 0.14 , 95 % confidence interval 0.04-0 .48 ; P = .002 ) .", "Ultrafiltration-induced benefit was associated with a more stable renal function , unchanged furosemide dose , and lower B-type natriuretic peptide levels .", "At 1 year , 7 deaths ( 30 % ) occurred in the ultrafiltration group and 11 ( 44 % ) in the control group ( P = .33 ) .", "In HF patients with severe fluid overload , first-line treatment with ultrafiltration is associated with a prolonged clinical stabilization and a greater freedom from rehospitalization for congestive HF ." ]

[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Pediatric inflammatory bowel disease ( IBD ) is associated with high rates of depression .", "This study compared the efficacy of cognitive behavioral therapy ( CBT ) to supportive nondirective therapy ( SNDT ) in treating youth with comorbid IBD and depression .", "Youth ( 51 % female and 49 % male ; age 9-17 years , mean age 14.3 years ) with depression and Crohn 's disease ( n = 161 ) or ulcerative colitis ( n = 56 ) were randomly assigned to a 3-month course of CBT or SNDT .", "The primary outcome was comparative reduction in depressive symptom severity ; secondary outcomes were depression remission , increase in depression response , and improved health-related adjustment and IBD activity .", "A total of 178 participants ( 82 % ) completed the 3-month intervention .", "Both psychotherapies resulted in significant reductions in total Children 's Depression Rating Scale Revised score ( 37.3 % for CBT and 31.9 % for SNDT ) , but the difference between the 2 treatments was not significant ( p = .16 ) .", "There were large pre-post effect sizes for each treatment ( d = 1.31 for CBT and d = 1.30 for SNDT ) .", "More than 65 % of youth had a complete remission of depression at 3 months , with no difference between CBT and SNDT ( 67.8 % and 63.2 % , respectively ) .", "Compared to SNDT , CBT was associated with a greater reduction in IBD activity ( p = .04 ) but no greater improvement on the Clinical Global Assessment Scale ( p = .06 ) and health-related quality of life ( IMPACT-III scale ) ( p = .07 ) .", "This is the first randomized controlled study to suggest improvements in depression severity , global functioning , quality of life , and disease activity in a physically ill pediatric cohort treated with psychotherapy .", "Clinical trial registration information-Reducing Depressive Symptoms in Physically Ill Youth ; http://clinical trials.gov ; NCT00534911 ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The HIV/AIDS epidemic continues to disproportionately affect African American communities in the US , particularly those located in urban areas .", "Despite the fact that HIV is often transmitted from one sexual partner to another , most HIV prevention interventions have focused only on individuals , rather than couples .", "This five-year study investigates community-based implementation , effectiveness , and sustainability of ` Eban II , ' an evidence-based risk reduction intervention for African-American heterosexual , serodiscordant couples .", "This hybrid implementation/effectiveness implementation study is guided by organizational change theory as conceptualized in the Texas Christian University Program Change Model ( PCM ) , a model of phased organizational change from exposure to adoption , implementation , and sustainability .", "The primary implementation aims are to assist 10 community-based organizations ( CBOs ) to implement and sustain Eban II ; specifically , to partner with CBOs to expose providers to the intervention ; facilitate its adoption , implementation and sustainment ; and to evaluate processes and determinants of implementation , effectiveness , fidelity , and sustainment .", "The primary effectiveness aim is to evaluate the effect of Eban II on participant ( n = 200 couples ) outcomes , specifically incidents of protected sex and proportion of condom use .", "We will also determine the cost-effectiveness of implementation , as measured by implementation costs and potential cost savings .", "A mixed methods evaluation will examine implementation at the agency level ; staff members from the CBOs will complete baseline measures of organizational context and climate , while key stakeholders will be interviewed periodically throughout implementation .", "Effectiveness of Eban II will be assessed using a randomized delayed enrollment ( waitlist ) control design to evaluate the impact of treatment on outcomes at posttest and three-month follow-up .", "Multi-level hierarchical modeling with a multi-level nested structure will be used to evaluate the effects of agency - and couples-level characteristics on couples-level outcomes ( e.g. , condom use ) .", "This study will produce important information regarding the value of the Eban II program and a theory-guided implementation process and tools designed for use in implementing Eban II and other evidence-based programs in demographically diverse , resource-constrained treatment settings .", "NCT00644163 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]

[ "The incidence of community-acquired methicillin-resistant Staphylococcus aureus infections is rising at an alarming pace .", "Effective treatment has historically involved early dbridement and antibiotic administration .", "This study was designed to prospectively determine the effectiveness of empiric therapy in treating hand infections .", "A prospective randomized trial was conducted at a level I county hospital .", "Patients with a hand infection received either empiric intravenous vancomycin at admission or intravenous cefazolin .", "Outcomes were tracked using severity of infection , appropriate clinical response , and length of stay .", "Cost-effectiveness was calculated using total cost for each patient in both groups .", "Statistical analyses were performed .", "Forty-six patients were enrolled in the study .", "Twenty-four were randomized to cefazolin ( 52.2 percent ) and 22 ( 47.8 percent ) to vancomycin .", "There was no statistical difference between cost of treatment ( p < 0.20 ) or mean length of stay ( p < 0.18 ) between the groups .", "Patients randomized to cefazolin had higher mean costs of treatment compared with patients who were randomized to vancomycin ( p < 0.05 ) .", "Patients with more severe infections had more expensive mean costs of treatment ( p < 0.0001 ) and longer mean length of stay ( p = 0.0002 ) .", "Near the end of the study , the incidence of community-acquired methicillin-resistant S. aureus at the authors ' county hospital was discovered to be 72 percent , which caused the study to be terminated prematurely by the institutional review board because of the high incidence precluding further randomization .", "Appropriate early treatment for methicillin-resistant S. aureus has not been definitively established .", "No difference in outcome using cefazolin versus vancomycin as a first-line agent was identified ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Deficient nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate signaling results from endothelial dysfunction and may underlie impaired cardiac relaxation in patients with heart failure with preserved left ventricular ejection fraction ( HFpEF ) and pulmonary hypertension ( PH ) .", "The acute hemodynamic effects of riociguat , a novel soluble guanylate cyclase stimulator , were characterized in patients with PH and HFpEF .", "Clinically stable patients receiving standard HF therapy with a left ventricular ejection fraction > 50 % , mean pulmonary artery pressure ( mPAP ) 25 mm Hg , and pulmonary arterial wedge pressure ( PAWP ) > 15 mm Hg at rest were randomized to single oral doses of placebo or riociguat ( 0.5 , 1 , or 2 mg ) .", "The primary efficacy variable was the peak decrease in mPAP from baseline up to 6 h. Secondary outcomes included hemodynamic and echocardiographic parameters , safety , and pharmacokinetics .", "There was no significant change in peak decrease in mPAP with riociguat 2 mg ( n = 10 ) vs placebo ( n = 11 , P = .6 ) .", "However , riociguat 2 mg significantly increased stroke volume ( +9 mL [ 95 % CI , 0.4-17 ] ; P = .04 ) and decreased systolic BP ( -12 mm Hg [ 95 % CI , -22 to -1 ] ; P = .03 ) and right ventricular end-diastolic area ( -5.6 cm2 [ 95 % CI , -11 to -0.3 ] ; P = .04 ) , without significantly changing heart rate , PAWP , transpulmonary pressure gradient , or pulmonary vascular resistance .", "Riociguat was well tolerated .", "In patients with HFpEF and PH , riociguat was well tolerated , had no significant effect on mPAP , and improved exploratory hemodynamic and echocardiographic parameters .", "ClinicalTrials.gov ; No. : NCT01172756 ; URL : www.clinicaltrials.gov ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "Posttraumatic stress disorder ( PTSD ) is prevalent , persistent , and disabling .", "Although psychotherapy and pharmacotherapy have proven efficacious in randomized clinical trials , geographic barriers impede rural veterans from engaging in these evidence-based treatments .", "To test a telemedicine-based collaborative care model designed to improve engagement in evidence-based treatment of PTSD .", "The Telemedicine Outreach for PTSD ( TOP ) study used a pragmatic randomized effectiveness trial design with intention-to-treat analyses .", "Outpatients were recruited from 11 Department of Veterans Affairs ( VA ) community-based outpatient clinics serving predominantly rural veterans .", "Inclusion required meeting diagnostic criteria for current PTSD according to the Clinician-Administered PTSD Scale .", "Exclusion criteria included receiving PTSD treatment at a VA medical center or a current diagnosis of schizophrenia , bipolar disorder , or substance dependence .", "Two hundred sixty-five veterans were enrolled from November 23 , 2009 , through September 28 , 2011 , randomized to usual care ( UC ) or the TOP intervention , and followed up for 12 months .", "Off-site PTSD care teams located at VA medical centers supported on-site community-based outpatient clinic providers .", "Off-site PTSD care teams included telephone nurse care managers , telephone pharmacists , telepsychologists , and telepsychiatrists .", "Nurses conducted care management activities .", "Pharmacists reviewed medication histories .", "Psychologists delivered cognitive processing therapy via interactive video .", "Psychiatrists supervised the team and conducted interactive video psychiatric consultations .", "The primary outcome was PTSD severity as measured by the Posttraumatic Diagnostic Scale .", "Process-of-care outcomes included medication prescribing and regimen adherence and initiation of and adherence to cognitive processing therapy .", "During the 12-month follow-up period , 73 of the 133 patients randomized to TOP ( 54.9 % ) received cognitive processing therapy compared with 16 of 132 randomized to UC ( 12.1 % ) ( odds ratio , 18.08 [ 95 % CI , 7.96-41 .06 ] ; P < .001 ) .", "Patients in the TOP arm had significantly larger decreases in Posttraumatic Diagnostic Scale scores ( from 35.0 to 29.1 ) compared with those in the UC arm ( from 33.5 to 32.1 ) at 6 months ( = -3.81 ; P = .002 ) .", "Patients in the TOP arm also had significantly larger decreases in Posttraumatic Diagnostic Scale scores ( from 35.0 to 30.1 ) compared with those in the UC arm ( from 33.5 to 31.7 ) at 12 months ( = -2.49 ; P = .04 ) .", "There were no significant group differences in the number of PTSD medications prescribed and adherence to medication regimens were not significant .", "Attendance at 8 or more sessions of cognitive processing therapy significantly predicted improvement in Posttraumatic Diagnostic Scale scores ( = -3.86 [ 95 % CI , -7.19 to -0.54 ] ; P = .02 ) and fully mediated the intervention effect at 12 months .", "Telemedicine-based collaborative care can successfully engage rural veterans in evidence-based psychotherapy to improve PTSD outcomes .", "clinicaltrials.gov Identifier : NCT00821678 ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "Pregnancy is a recognised high risk period for excessive weight gain , contributing to postpartum weight retention and obesity development long-term .", "We aimed to reduce postpartum weight retention following a low-intensity , self-management intervention integrated with routine antenatal care during pregnancy .", "228 women at increased risk of gestational diabetes , < 15 weeks gestation were randomised to intervention ( 4 self-management sessions ) or control ( generic health information ) .", "Outcomes , collected at baseline and 6 weeks postpartum , included anthropometrics ( weight and height ) , physical activity ( pedometer ) and questionnaires ( health behaviours ) .", "Mean age ( 32.34.7 and 31.74.4 years ) and body mass index ( 30.45.6 and 30.35.9 kg/m2 ) were similar between intervention and control groups , respectively at baseline .", "By 6 weeks postpartum , weight change in the control group was significantly higher than the intervention group with a between group difference of 1.455.1 kg ( 95 % CI : -2.86 , -0.02 ; p < 0.05 ) overall , with a greater difference in weight found in overweight , but not obese women .", "Intervention group allocation , higher baseline BMI , GDM diagnosis , country of birth and higher age were all independent predictors of lower weight retention at 6 weeks postpartum on multivariable linear regression .", "Other factors related to weight including physical activity , did not differ between groups .", "A low intensity intervention , integrated with standard antenatal care is effective in limiting postpartum weight retention .", "Implementation research is now required for scale-up to optimise antenatal health care .", "Australian New Zealand Clinical Trial Registry Number : ACTRN12608000233325 .", "Registered 7/5/2008 ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "Categorization of colon cancers into distinct subtypes using a combination of pathway-based biomarkers could provide insight into stage-independent variability in outcomes .", "We used a polymerase chain reaction-based assay to detect mutations in BRAF ( V600E ) and in KRAS in 2720 stage III cancer samples , collected prospectively from patients participating in an adjuvant chemotherapy trial ( NCCTG N0147 ) .", "Tumors deficient or proficient in DNA mismatch repair ( MMR ) were identified based on detection of MLH1 , MSH2 , and MSH6 proteins and methylation of the MLH1 promoter .", "Findings were validated using tumor samples from a separate set of patients with stage III cancer ( n = 783 ) .", "Association with 5-year disease-free survival was evaluated using Cox proportional hazards models .", "Tumors were categorized into 5 subtypes based on MMR status and detection of BRAF or KRAS mutations which were mutually exclusive .", "Three subtypes were MMR proficient : those with mutations in BRAF ( 6.9 % of samples ) , mutations in KRAS ( 35 % ) , or tumors lacking either BRAF or KRAS mutations ( 49 % ) .", "Two subtypes were MMR deficient : the sporadic type ( 6.8 % ) with BRAF mutation and/or or hypermethylation of MLH1 and the familial type ( 2.6 % ) , which lacked BRAF ( V600E ) or hypermethylation of MLH1 .", "A higher percentage of MMR-proficient tumors with BRAF ( V600E ) were proximal ( 76 % ) , high-grade ( 44 % ) , N2 stage ( 59 % ) , and detected in women ( 59 % ) , compared with MMR-proficient tumors without BRAF ( V600E ) or KRAS mutations ( 33 % , 19 % , 41 % , and 42 % , respectively ; all P < .0001 ) .", "A significantly lower proportion of patients with MMR-proficient tumors with mutant BRAF ( hazard ratio = 1.43 ; 95 % confidence interval : 1.11-1 .85 ; Padjusted = .0065 ) or mutant KRAS ( hazard ratio = 1.48 ; 95 % confidence interval : 1.27-1 .74 ; Padjusted < .0001 ) survived disease-free for 5 years compared with patients whose MMR-proficient tumors lacked mutations in either gene .", "Disease-free survival rates of patients with MMR-deficient sporadic or familial subtypes was similar to those of patients with MMR-proficient tumors without BRAF or KRAS mutations .", "The observed differences in survival rates of patients with different tumor subtypes were validated in an independent cohort .", "We identified subtypes of stage III colon cancer , based on detection of mutations in BRAF ( V600E ) or KRAS , and MMR status that show differences in clinical and pathologic features and disease-free survival .", "Patients with MMR-proficient tumors and BRAF or KRAS mutations had statistically shorter survival times than patients whose tumors lacked these mutations .", "The tumor subtype found in nearly half of the study cohort ( MMR-proficient without BRAF ( V600E ) or KRAS mutations ) had similar outcomes to those of patients with MMR-deficient cancers ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "This paper is embedded in a randomised controlled trial ( Alcohol and Employment ) that investigated whether welfare-to-work schemes combined with alcohol treatment were more effective than welfare-to-work schemes alone for helping unemployed welfare recipients with alcohol problems get back to employment and reduce their alcohol problems .", "The implementation of Alcohol and Employment turned out to be challenging , and fewer welfare recipients than expected were enrolled .", "The aim of this paper was to identify and investigate obstacles to the implementation of Alcohol and Employment .", "Our main objective was to study the job consultants ' role in the implementation process as they were key personnel in conducting the trial .", "The process evaluation was conducted in four Danish municipalities in 2011-2012 .", "Data for identifying factors important for the implementation were collected through observations and focus group interviews with job consultants .", "Data were analysed thematically and thoroughly discussed among members of the project team ; emerging themes were then grouped and read again repeatedly until the themes were consistent .", "Three themes emerged as the main factors influencing the degree of implementation of Alcohol and Employment : ( 1 ) The job consultants ' personal attitudes toward alcohol were an important factor .", "The job consultants generally did not consider a high alcohol intake to be an impediment to employment , or they thought that alcohol problems were only symptoms of more profound problems .", "( 2 ) The job consultants ' perception of their own roles and responsibilities in relation to the welfare recipients was a barrier : they felt that addressing alcohol problems and at the same time sustaining trust with the welfare recipient was difficult .", "Also , they did not consider alcohol problems to be their responsibility .", "( 3 ) Shortage of time and resources among the job consultants was determined to be an influential factor .", "We identified important factors at the individual level among the job consultants who threatened the implementation of Alcohol and Employment .", "Future studies in similar settings can take advantage of these findings when preparing interventions that are implemented by job consultants or similar professionals .", "ClinicalTrials.gov ID : NCT01416103 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "We designed a continuing medical education ( CME ) program to teach primary care physicians ( PCP ) how to engage in cancer risk communication and shared decision making with patients who have limited health literacy ( HL ) .", "We evaluated whether training PCPs , in addition to audit-feedback , improves their communication behaviors and increases cancer screening among patients with limited HL to a greater extent than only providing clinical performance feedback .", "Four-year cluster randomized controlled trial .", "Eighteen PCPs and 168 patients with limited HL who were overdue for colorectal/breast/cervical cancer screening .", "Communication intervention PCPs received skills training that included standardized patient ( SP ) feedback on counseling behaviors .", "All PCPs underwent chart audits of patients ' screening status semiannually up to 24 months and received two annual performance feedback reports .", "PCPs experienced three unannounced SP encounters during which SPs rated PCP communication behaviors .", "We examined between-group differences in changes in SP ratings and patient knowledge of cancer screening guidelines over 12 months ; and changes in patient cancer screening rates over 24 months .", "There were no group differences in SP ratings of physician communication at baseline .", "At follow-up , communication intervention PCPs were rated higher in general communication about cancer risks and shared decision making related to colorectal cancer screening compared to PCPs who only received performance feedback .", "Screening rates increased among patients of PCPs in both groups ; however , there were no between-group differences in screening rates except for mammography .", "The communication intervention did not improve patient cancer screening knowledge .", "Compared to audit and feedback alone , including PCP communication training increases PCP patient-centered counseling behaviors , but not cancer screening among patients with limited HL .", "Larger studies must be conducted to determine whether lack of changes in cancer screening were due to clinic/patient sample size versus ineffectiveness of communication training to change outcomes ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To investigate the safety and short term outcome of high dose recombinant human erythropoietin ( rhEpo ) given shortly after birth and subsequently over the first 2 days for neuroprotection to very preterm infants .", "Randomized , double masked phase II trial .", "Preterm infants ( gestational age 26 0/7 -31 6/7 weeks ) were given rhEpo ( nt = 229 ; 3000 U/kg body weight ) or NaCl 0.9 % ( nc = 214 ) intravenously at 3 , 12-18 , and 36-42 hours after birth .", "There were no relevant differences between the groups for short-term outcomes such as mortality , retinopathy of prematurity , intraventricular hemorrhage , sepsis , necrotizing enterocolitis , and bronchopulmonary dysplasia .", "At day 7-10 , we found significantly higher hematocrit values , reticulocyte , and white blood cell counts , and a lower platelet count in the rhEpo group .", "Early high-dose rhEpo administration to very premature infants is safe and causes no excess in mortality or major adverse events .", "ClinicalTrials.gov : NCT00413946 ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "Delayed graft function , which is reported in up to 50 % of kidney-transplant recipients , is associated with increased costs and diminished long-term graft function .", "The effect that targeted mild hypothermia in organ donors before organ recovery has on the rate of delayed graft function is unclear .", "We enrolled organ donors ( after declaration of death according to neurologic criteria ) from two large donation service areas and randomly assigned them to one of two targeted temperature ranges : 34 to 35C ( hypothermia ) or 36.5 to 37.5 C ( normothermia ) .", "Temperature protocols , which were initiated after authorization was obtained for the organ to be donated and for the donor 's participation in the study , ended when organ donors left the intensive care unit for organ recovery in the operating room .", "The primary outcome was delayed graft function in the kidney recipients , which was defined as the requirement for dialysis during the first week after transplantation .", "Secondary outcomes were the rates of individual organs transplanted in each treatment group and the total number of organs transplanted from each donor .", "The study was terminated early , on the recommendation of an independent data and safety monitoring board , after the interim analysis showed efficacy of hypothermia .", "At trial termination , 370 organ donors had been enrolled ( 180 in the hypothermia group and 190 in the normothermia group ) .", "A total of 572 patients received a kidney transplant ( 285 kidneys from donors in the hypothermia group and 287 kidneys from donors in the normothermia group ) .", "Delayed graft function developed in 79 recipients of kidneys from donors in the hypothermia group ( 28 % ) and in 112 recipients of kidneys from donors in the normothermia group ( 39 % ) ( odds ratio , 0.62 ; 95 % confidence interval , 0.43 to 0.92 ; P = 0.02 ) .", "Mild hypothermia , as compared with normothermia , in organ donors after declaration of death according to neurologic criteria significantly reduced the rate of delayed graft function among recipients .", "( Funded by the Health Resources and Services Administration ; ClinicalTrials.gov number , NCT01680744 . )" ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Antipsychotics are commonly used for management of behavioural symptoms in dementia , among people in residential care .", "This continues to occur despite their modest effectiveness , potential harms including increased risk of death and stroke , and absence of detrimental effect when people with dementia were randomised to antipsychotic withdrawal .", "This study aims to test the hypothesis that the multifaceted REducing Anti-Psychotic use in residential care-Huntington Disease ( REAP-HD ) programme is more effective than standard staff education ( SSE ) in reducing antipsychotic use for people with HD in residential care facilities ( RCF ) .", "this is a cluster randomised controlled trial with blinded outcome assessment .", "The study population is healthcare professionals looking after people with HD in individual RCF , in the state of New South Wales .", "Each RCF will be centrally randomised to the REAP-HD programme or the comparator , SSE .", "Blinded outcome assessment will be performed by examining drug charts and using the Neuropsychiatric Inventory-Q ( NPI-Q ) .", "Primary outcome is the proportion of people with HD who have had a reduction in antipsychotic use 4 months after the intervention .", "Secondary outcome measures are ( 1 ) change in severity of behavioural symptoms , as measured by the NPI-Q at 4 months ( to ensure antipsychotic reduction has not lead to worsening behavioural symptoms ) , and ( 2 ) proportion of people with HD who have had a reduction in antipsychotic dosage at 4 months for each strategy , compared to 4 months prior to enrolment ( to capture the possibility that both arms reduced antipsychotic use ) .", "Analysis will be by Intention-To-Treat and take into account the clustering .", "Recruitment is ongoing , as of July 2014 .", "This protocol has been approved by the Western Sydney Local Health District Human Research Ethics Committee , trial registration ACTRN12614000083695 .", "Study results will be disseminated through peer-reviewed publication in an anonymous manner .", "ACTRN12614000083695 , the Australian New Zealand Clinical Trials Registry ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "BACKGROUND", "BACKGROUND", "BACKGROUND" ]

[ "The objective of this study was to investigate the association of spirometry and pulmonary CT biomarkers with cardiovascular events .", "In this lung cancer screening trial 3,080 male participants without a prior cardiovascular event were analysed .", "Fatal and non-fatal cardiovascular events were included .", "Spirometry included forced expiratory volume measured in units of one-second percent predicted ( FEV1 % predicted ) and FEV1 divided by forced vital capacity ( FVC ; FEV1/FVC ) .", "CT examinations were quantified for coronary artery calcium volume , pulmonary emphysema ( perc15 ) and bronchial wall thickness ( pi10 ) .", "Data were analysed via a Cox proportional hazard analysis , net reclassification improvement ( NRI ) and C-indices .", "184 participants experienced a cardiovascular event during a median follow-up of 2.9 years .", "Age , pack-years and smoking status adjusted hazard ratios were 0.992 ( 95 % confidence interval ( CI ) 0.985-0 .999 ) for FEV1 % predicted , 1.000 ( 95 % CI 0.986-1 .015 ) for FEV1/FVC , 1.014 ( 95 % CI 1.005-1 .023 ) for perc15 per 10 HU , and 1.269 ( 95 % CI 1.024-1 .573 ) for pi10 per 1 mm .", "The incremental C-index ( < 0.015 ) and NRI ( < 2.8 % ) were minimal .", "Coronary artery calcium volume had a hazard ratio of 1.046 ( 95 % CI 1.034-1 .058 ) per 100 mm ( 3 ) , an increase in C-index of 0.076 and an NRI of 16.9 % ( P < 0.0001 ) .", "Pulmonary CT biomarkers and spirometry measurements were significantly associated with cardiovascular events , but did not contain clinically relevant independent prognostic information for cardiovascular events .", "Pulmonary CT biomarkers and spirometry are associated with cardiovascular events These pulmonary measurements do not contain clinically relevant independent prognostic information Only coronary calcium score improved cardiovascular risk prediction above age and smoking ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Effective and safe management of oral anticoagulant treatment ( OAT ) requires a high level of patient knowledge and adherence .", "The aim of this study was to assess patient knowledge about OAT and factors associated with patient knowledge .", "This is a baseline survey of a cluster-randomized controlled trial in 22 general practices with an educational intervention for patients or their caregivers .", "We assessed knowledge about general information on OAT and key facts regarding nutrition , drug-interactions and other safety precautions of 345 patients at baseline .", "Participants rated their knowledge about OAT as excellent to good ( 56 % ) , moderate ( 36 % ) or poor ( 8 % ) .", "However , there was a discrepancy between self-rated knowledge and evaluated actual knowledge and we observed serious knowledge gaps .", "Half of the participants ( 49 % ) were unaware of dietary recommendations .", "The majority ( 80 % ) did not know which non-prescription analgesic is the safest and 73 % indicated they would not inform pharmacists about OAT .", "Many participants ( 35-75 % ) would not recognize important emergency situations .", "After adjustment in a multivariate analysis , older age and less than 10 years education remained significantly associated with lower overall score , but not with self-rated knowledge .", "Patients have relevant knowledge gaps , potentially affecting safe and effective OAT .", "There is a need to assess patient knowledge and for structured education programs .", "Deutsches Register Klinischer Studien ( German Clinical Trials Register ) : DRKS00000586.Universal Trial Number ( UTN U1111-1118-3464 ) ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "The optimal second-line regimen for treating advanced gastric cancer ( AGC ) remains unclear .", "While irinotecan ( CPT-11 ) plus cisplatin ( CDDP ) combination therapy and CPT-11 monotherapy have been explored in the second-line setting , the superiority of second-line platinum-based therapies for AGC patients initially treated with S-1 monotherapy has not yet been evaluated ; therefore , we aimed to examine the survival benefit of CPT-11 / CDDP combination over CPT-11 monotherapy .", "AGC patients showing progression after S-1 monotherapy for advanced cancer or recurrence within 6 months after completion of S-1 adjuvant therapy were randomly allocated to CPT-11 / CDDP ( CPT-11 , 60 mg/m ( 2 ) ; CDDP , 30 mg/m ( 2 ) , q2w ) or CPT-11 ( 150 mg/m ( 2 ) , q2w ) .", "Sixty-eight advanced and 95 recurrent cases were evaluated .", "The median overall survivals were 13.9 ( 95 % confidence interval [ CI ] : 10.8-17 .6 ) and 12.7 ( 95 % CI : 10.3-17 .2 ) months for CPT-11 / CDDP and CPT-11 , respectively ( hazard ratio : 0.834 ; 95 % CI : 0.596-1 .167 , P = 0.288 ) .", "No significant differences were observed in the secondary end-points , including progression-free survival ( 4.6 [ 95 % CI : 3.4-5 .9 ] versus 4.1 [ 95 % CI : 3.3-4 .9 ] months ) and response rate ( 16.9 % [ 95 % CI : 8.8-28 .3 ] versus 15.4 % [ 95 % CI : 7.6-26 .5 ] ) .", "The incidences of grade 3-4 anaemia ( 16 % versus 4 % ) and elevated serum lactate dehydrogenase levels ( 5 % versus 0 % ) were higher for CPT-11 / CDDP than for CPT-11 .", "Exploratory subgroup analysis revealed that CPT-11 / CDDP was significantly more effective for intestinal-type AGC , compared with CPT-11 ( overall survival : 15.8 versus 14.0 months ; P = 0.019 ) .", "No survival benefit was observed upon adding CDDP to CPT-11 after S-1 monotherapy failure ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Postoperative delirium is the most common postoperative complication in the elderly .", "The purpose of this study was to evaluate the safety and effectiveness of the preventive administration of low-dose haloperidol on the development of postoperative delirium after abdominal or orthopedic surgery in elderly patients .", "A total of 119 patients aged 75 years or older who underwent elective surgery for digestive or orthopedic disease were included in this study .", "Patients were divided into those who did ( intervention group , n = 59 ) and did not ( control group , n = 60 ) receive 2.5 mg of haloperidol at 18:00 daily for 3 days after surgery ; a randomized , open-label prospective study was performed on these groups .", "The primary endpoint was the incidence of postoperative delirium during the first 7 days after the operation .", "The incidence of postoperative delirium in all patients was 37.8 % .", "No side effects involving haloperidol were noted ; however , the incidences of postoperative delirium were 42.4 and 33.3 % in the intervention and control groups , respectively , which were not significantly different ( p = 0.309 ) .", "No significant effect of the treatment was observed on the severity or persistence of postoperative delirium .", "The preventive administration of low-dose haloperidol did not induce any adverse events , but also did not significantly decrease the incidence or severity of postoperative delirium or shorten its persistence ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "There are insufficient data to guide perioperative implantable cardioverter-defibrillator ( ICD ) management for patients undergoing surgical procedures using electrocautery .", "We conducted a multicenter randomized controlled trial of patients with ICDs undergoing surgery with monopolar electrocautery .", "Subjects were randomized to an `` Off '' group ( ICD therapy programmed off , then postoperatively programmed on ) or a `` Magnet '' group ( ICD therapy suspended with a magnet and no immediate postoperative ICD interrogation ) .", "Also , a registry was maintained of ICD patients with procedures within 6 inches of the ICD ( all programmed off ) .", "The primary endpoint was ICD off time with secondary endpoints being caregiver handoffs and incidence of electromagnetic interference ( EMI ) .", "All patients ( n = 80 ) had pectoral ICDs .", "Subject demographics were well matched in each group , and duration of electrocautery was similar ( 80 minutes vs 64 minutes , P = 0.58 ) .", "The mean `` excess '' ICD off time ( ICD off time - electrocautery time ) was significantly higher in the Off group than the Magnet group ( 115 minutes vs 28 minutes , P < 0.001 ) .", "Mean number of caregiver handoffs were higher in the Off group ( 6.6 vs 5.5 , P < 0.001 ) .", "There was no EMI in any lower abdominal or lower extremity procedures .", "Neither group had arrhythmic events or device reset .", "A magnet protocol simplifies perioperative ICD management for procedures using electrocautery more than 6 inches from the ICD .", "This protocol results in significantly shorter time with ICD therapy off , fewer provider handoffs , no risk of inadvertently discharging patients home with ICD therapies off , and no device reset ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "This phase 2 study examined the efficacy and tolerability of edivoxetine , a highly selective norepinephrine reuptake inhibitor , as an adjunctive treatment for patients with major depressive disorder ( MDD ) who have a partial response to selective serotonin reuptake inhibitor ( SSRI ) treatment .", "Study design consisted of double-blind , 10-week therapy of adjunctive edivoxetine ( 6-18 mg once daily ) or adjunctive placebo with SSRI .", "Inclusion/entry criteria included partial response to current SSRI by investigator opinion and a GRID 17-item Hamilton Rating Scale for Depression ( HAMD17 ) total score 16 .", "The primary efficacy measure was the Montgomery-Asberg Depression Rating Scale ( MADRS ) .", "Safety measures included treatment-emergent adverse events ( TEAE ) and vital signs .", "For the primary evaluable population ( n = 63 for adjunctive edivoxetine and n = 68 for adjunctive placebo ) , the treatment groups did not differ significantly on the primary outcome of change from baseline to week 8 in the MADRS total score ; the effect size of edivoxetine treatment was 0.26 .", "Significant treatment differences , favoring adjunctive edivoxetine ( p. 05 ) , were shown for improvements in role functioning and the functional impact of fatigue .", "For the adjunctive edivoxetine randomized group ( N = 111 ) , the most frequent TEAEs were hyperhidrosis ( 7.2 % ) , nausea ( 7.2 % ) , erectile dysfunction ( 6.3 % ) and testicular pain ( 6.3 % ) .", "Hemodynamic changes were observed in blood pressure and pulse rate between treatment groups .", "Study was underpowered for an alpha 2-sided 0.05 significance level for the primary outcome .", "For patients with MDD who had a partial response to SSRIs , adjunctive edivoxetine treatment was not statistically superior to adjunctive placebo on the primary outcome measure .", "However , pending further study , improved functioning and remission rate suggest a potential role for edivoxetine for patients with depression ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "We assessed the effectiveness of the Luoghi di Prevenzione-Prevention Grounds school-based smoking prevention programme .", "We undertook a cluster randomized controlled trial of 989 students aged 14-15 years in 13 secondary schools located in Reggio Emilia , Italy .", "The intervention consisted of the `` Smoking Prevention Tour '' ( SPT ) out-of-school workshop , one in-depth lesson on one Smoking Prevention Tour topic , a life-skills peer-led intervention , and enforcement surveillance of school antismoking policy .", "Self-reported past 30-day smoking of 20 or 1-19 days of cigarette smoking ( daily or frequent smoking , respectively ) was recorded in 2 surveys administered immediately before and 18 months after the beginning of the programme .", "Analysis was by intention to treat .", "The effect of the intervention was evaluated using random effects logistic regression and propensity score-matching analyses .", "Past 30-day smoking and daily cigarette use at eighteen months follow-up were 31 % and 46 % lower , respectively , for intervention students compared to control students .", "Taking into account non-smokers at baseline only , daily smoking at eighteen months follow-up was 59 % lower in intervention students than in controls .", "Past 30-day smoking in school areas was 62 % lower in intervention students compared to controls .", "The Luoghi di Prevenzione-Prevention Grounds programme was effective in reducing daily smokers and in reducing smoking in school areas ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To assess the efficacy of dapagliflozin , a sodium-glucose cotransporter 2 inhibitor , for the treatment of individuals with type 2 diabetes mellitus ( T2DM ) and preexisting cardiovascular disease ( CVD ) .", "Randomized , double-blind , age-stratified ( < 65 and 65 ) , 24-week clinical trial with a 28-week extension .", "One hundred seventy-three centers in 10 countries .", "Individuals ( N = 964 ) with T2DM , glycosylated hemoglobin ( HbA1c ) of 7.0 % to 10.0 % , and documented CVD .", "Dapagliflozin 10 mg/d or placebo was added to usual care .", "Participants receiving insulin had their total daily insulin dose reduced by 25 % at randomization .", "Two equal primary end points : change from baseline in HbA1c and proportion of participants achieving a three-item end point ( reduction of 0.5 % in HbA1c , 3 % in body weight , and 3 mmHg in systolic blood pressure ) at 24 weeks .", "Forty-seven percent were aged 65 and older , 7.7 % were aged 75 and older , mean duration of T2DM was 13 years , mean baseline HbA1c was 8.1 % , and approximately 60 % were taking insulin .", "The placebo-corrected change in HbA1c with dapagliflozin was -0.4 % at 24 weeks .", "Significantly more participants achieved the three-item end point with dapagliflozin ( 10.0 % ) than with placebo ( 1.9 % ) .", "The placebo-corrected percentage change in body weight for dapagliflozin was -1.9 % ( -1.8 kg ) .", "Similar results were observed in both age strata , and changes were maintained over 52 weeks .", "More than one-quarter ( 28.2 % ) of participants receiving dapagliflozin and 25.3 % of those receiving placebo experienced hypoglycemia .", "More participants receiving dapagliflozin had vulvovaginitis , balanitis , or urinary tract infection .", "When added to a usual background regimen in an older population with advanced T2DM and preexisting comorbid CVD , dapagliflozin improved glycemic control without an increase in hypoglycemic risk , promoted weight loss , and was well tolerated ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "A recent international , multicenter , double-blinded , randomized trial shows delayed-enhanced magnetic resonance imaging ( DE-MRI ) using contrast doses of 0.2 mmol/kg is effective in the detection and assessment of myocardial infarction ( MI ) , and 0.1 mmol/kg is not enough ; intermediate doses between 0.1 and 0.2 mmol/kg have not been tested .", "The aim of this study was to prospectively test the performance of DE-MRI using 0.15 mmol/kg of contrast agent for the detection of MI .", "A total of 31 consecutive patients with chronic MI underwent DE-MRI at 3.0 T using both 0.15 mmol/kg and 0.2 mmol/kg of contrast agent in random order and on separate days .", "Infarction segment and infarction size were compared on DE-MRI images using a 17-segment model .", "Bland-Altman analysis was used to analyze correlation and agreement between global infarct sizes .", "DE-MRI showed enhanced myocardium in all the 31 patients with chronic MI .", "There was no significant difference between the 0.15 mmol/kg and 0.2 mmol/kg images in all 31 patients based on the infarction segment ( 7.872.72 vs. 7.812.64 , respectively ; p = 0.33 ) .", "There was no significant difference between the infarction size obtained from 0.15 mmol/kg acquisition and that from 0.2 mmol/kg acquisition ( 16.37.8 % vs. 16.47.9 % , respectively ; p = 0.87 ) .", "A strong correlation between the infarction size obtained from 0.15 mmol/kg acquisition and that from 0.2 mmol/kg acquisition was indicated through Bland-Altman analysis .", "DE-MRI at 3.0 T using 0.15 mmol/kg of contrast agent is effective for the assessment of MI ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "A sudden gain is defined as a large and stable individual improvement occurring between two consecutive treatment sessions .", "Sudden gains have been shown to predict better long-term improvement in several treatment studies , including cognitive behavioural therapy for depression and anxiety disorders , but have not been studied in the treatment of health anxiety or any form of internet-based cognitive behavioural therapy .", "The aim of this study was to investigate the role of sudden gains in internet-based cognitive behavioural therapy for severe health anxiety .", "We examined the occurrence and significance of sudden gains in measures of health anxiety in 81 participants receiving internet-based cognitive behavioural therapy .", "We compared patients with sudden gains , patients without sudden gains , and patients with gradual gains .", "Thirteen participants ( 16 % ) experienced one sudden gain in health anxiety with individual sudden gains distributed across the treatment .", "As expected , patients with a sudden gain showed larger improvements than patients without a sudden gain at post-treatment ( d = 1.04 ) and at one-year follow-up ( d = 0.91 ) on measures of health anxiety .", "Consistent with previous studies , sudden gains in internet-based cognitive behavioural therapy are associated with significantly larger and stable treatment effects up to one-year follow-up ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Same-sex attracted young adults have been found to experience higher rates of mental health problems and greater difficulties in accessing specialist mental health care services compared to their heterosexual peers .", "Internet-based mental health interventions have the potential to be more engaging and accessible to young adults compared to those delivered face-to-face .", "However , they are rarely inclusive of lesbian women and gay men .", "Thus , the current study aims to evaluate the effectiveness of an online mental health and wellbeing program , Out & Online ( http://www.outandonline.org.au ) , in comparison to a wait-list control group , for reducing anxiety and depressive symptoms in same-sex attracted young adults aged between 18 and 25 years .", "We are recruiting , through media and community organisations , 200 same-sex attracted young adults with anxiety and/or depressive symptoms and mild to moderate psychological distress ( Kessler-10 score between 16 to 21 ) .", "Participants will be randomly allocated to the intervention ( the online program ) or the wait-list control group based on a permuted blocked randomisation method to allow for stratification by gender .", "Participants in the intervention group will receive a tailored program for up to three types of mental health difficulties simultaneously .", "The primary outcome of anxiety and/or depressive symptoms , and secondary outcomes related to psychological distress , wellbeing and health behaviour will be measured at pre-intervention ( 0 week ) , post-intervention ( 8 weeks ) and at a 3-month follow-up ( 20 weeks ) .", "This online mental health and wellbeing program will be one of the first online interventions to be designed specifically to be relevant for same-sex attracted individuals .", "If the program is found to be effective it will improve access to specialist same-sex attracted-relevant mental health services for young adults and will facilitate wellbeing outcomes for these individuals .", "This program will also be a significant development in the delivery of tailored interventions that target multiple types of mental health conditions simultaneously .", "Australian New Zealand Clinical Trials Registry : ACTRN12611000700932 .", "Date registered : 7 July 2011 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "Endometriosis affects fertility negatively .", "The study aims to evaluate whether laparoscopic surgery combined with oral contraceptive or herbs were more effective than laparoscopic alone in improving fecundity and pelvic pain in women with minimal/mild endometriosis .", "A randomized controlled trial ( RCT ) was conducted in 156 infertile women with minimal/mild endometriosis .", "After laparoscopic surgery , patients were randomized to three groups : in Group A ( n = 52 ) oral contraceptive ( OC ) was administered one pill a day , continuous for 63days without intervals , in Group B ( n = 52 ) OC was administered as above and then Dan ' e mixture was added 30g/day for the latter 30days , and in control Group C ( n = 52 ) patients tried to get pregnant after surgery without complementary treatment .", "The follow-up periods were 12months in Group C and 14months in complementary medical treatment Group A and B.", "The pregnant women were further followed up , and labor and pregnancy outcomes were assessed .", "Primary outcome was pregnancy rate ( PR ) and live birth rate ( LBR ) .", "Secondary outcomes included changes of pelvic pain visual analog scale scores and side effects .", "Analyses were done as intention-to-treat .", "The PR was 46.80 % ( 73/156 ) , and the LBR was 69.86 % ( 51/73 ) .", "Of the 73 pregnancies , 60 occurred within 12months of follow-up and 7 of the remaining 13 patients underwent assisted reproductive technology for > 1year .", "No significant difference was observed in PR and LBR among the three groups .", "Patients given medical treatment ( OCs or OCs plus herbal medicine ) had significantly decreased pain scores compared with the laparoscopy alone group .", "Combination of laparoscopy with OCs or OCs and herbal medicine does not have more advantages than laparoscopy alone in improving fertility of women with minimal/mild endometriosis .", "ChiCTR-TRC-11001820 ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "To explore the effect of continuous nursing intervention guided by chronotherapeutics so as to provide the easy , noninvasive , effective and acceptable intervention for older hypertensive patients in the community .", "Many researchers studied the effect of administration at different times on blood pressure control and circadian rhythm .", "However , the individual administrative time was set ambiguously in previous studies .", "A semi-experimental study .", "In the study , 90 eligible patients were recruited and separated into three groups randomly , which were the control group , intervention group A ( behaviour and chronotherapy intervention ) and intervention group B ( behaviour intervention ) .", "At 6 and 12months after the study , the intervention groups were measured 24-hour ambulatory blood pressure monitoring .", "There were significant differences in ambulatory blood pressure monitoring parameters of the two intervention groups at different measurement times , and there were interaction between measurement time and different groups .", "The number of patients with dipper increased and reverse dipper decreased in group A as the intervention applied .", "There were statistical differences between two groups .", "The number of patients with morning surge in group A decreased more , and there were statistical differences between two groups at six months after the intervention .", "The behaviour and chronotherapy intervention based on the patients ' ambulatory blood pressure monitoring can control casual blood pressure much better and last longer , which can also improve patients ' indexes of ambulatory blood pressure monitoring better than behaviour intervention only .", "The behaviour and chronotherapy intervention can increase patients ' nocturnal blood pressure drop , increase the number of patients with dipper and decrease reverse dipper , and improve blood pressure surge in the morning .", "Nurses can use continuous nursing intervention guided by chronotherapeutics to help improve hypertension of older patients better in the community ." ]

[ "OBJECTIVE", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To test the impact of the method of administration ( MOA ) on score level , reliability , and validity of scales developed in the Patient Reported Outcomes Measurement Information System ( PROMIS ) .", "Two nonoverlapping parallel forms each containing eight items from each of three PROMIS item banks ( Physical Function , Fatigue , and Depression ) were completed by 923 adults with chronic obstructive pulmonary disease , depression , or rheumatoid arthritis .", "In a randomized crossover design , subjects answered one form by interactive voice response ( IVR ) technology , paper questionnaire ( PQ ) , personal digital assistant ( PDA ) , or personal computer ( PC ) and a second form by PC , in the same administration .", "Method equivalence was evaluated through analyses of difference scores , intraclass correlations ( ICCs ) , and convergent/discriminant validity .", "In difference score analyses , no significant mode differences were found and all confidence intervals were within the prespecified minimal important difference of 0.2 standard deviation .", "Parallel-forms reliabilities were very high ( ICC = 0.85-0 .93 ) .", "Only one across-mode ICC was significantly lower than the same-mode ICC .", "Tests of validity showed no differential effect by MOA .", "Participants preferred screen interface over PQ and IVR .", "We found no statistically or clinically significant differences in score levels or psychometric properties of IVR , PQ , or PDA administration compared with PC ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Prospective randomized study .", "This study aimed to prospectively compare the surgical results of the open - and French-door laminoplasty .", "Cervical laminoplasty is a common surgical procedure for the treatment of cervical compressive myelopathy .", "These procedures are primarily classified as either open - or French-door laminoplasties .", "Only few prospective studies comparing the surgical results of the 2 procedures are available .", "A total of 92 patients with cervical compressive myelopathy who underwent cervical laminoplasty were prospectively enrolled and randomized into the following 2 groups according to the type of laminoplasty : open-door and French-door groups .", "A single attending spine surgeon performed all surgical procedures .", "The following factors were evaluated : surgical duration , blood loss , perioperative complications , neurological assessment using the Japanese Orthopedic Association score , and recovery rate .", "Radiological evaluations included assessment of the cervical lordotic angle and cervical range of motion .", "In addition , the ratio of postoperative spinal lamina opening was evaluated by magnetic resonance imaging .", "There were no differences in perioperative complications and neurological outcomes between the 2 groups .", "The mean reduction in cervical lordotic angle after surgery was significantly greater in the open-door group than the French-door group ( 3.0 vs. 5.6 ) .", "Postoperative cervical range of motion significantly decreased in the open-door group than in the French-door group ( 19.3 vs. 26.0 ) .", "Postoperative cervical lordotic angle in the extension position significantly diminished in the open-door group than in the French-door group ( 7.9 vs. 14.1 ) .", "The ratio of opening of the spinal lamina after surgery was significantly larger in the open-door group than in the French-door group .", "The 2 laminoplasty methods showed almost the same neurological recovery as well as perioperative complications .", "In cases of open-door laminoplasty , postoperative cervical alignment became more kyphotic and cervical range of motion was more restricted than that in French-door laminoplasty cases after surgery .", "French-door laminoplasty is preferable to open-door laminoplasty for postoperative cervical alignments .", "1 ." ]

[ "METHODS", "OBJECTIVE", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "METHODS" ]

[ "Burnout is a very prevalent type of stress among health professionals .", "It affects their well-being , performance , and attitude toward patients .", "This study assessed the effectiveness of a training program for primary health care professionals designed to reduce burnout and mood disturbance , increase empathy , and develop mindfulness .", "Pragmatic randomized controlled trial with pre - and postintervention measurements of 68 primary health care professionals ( 43 in the intervention and 25 in the control group ) in Spain .", "The intervention consisted of presentations of clinically relevant topics , mindfulness-based coping strategies , mindfulness practice , yoga , and group discussions ( 8 sessions of 2.5 hours per week plus a 1-day session of 8 hours ) .", "Outcome measures included the Maslach Burnout Inventory , Profile of Mood States , Jefferson Scale of Physician Empathy , Baer 's Five Facets Mindfulness Questionnaire , and a questionnaire on changes in personal habits and mindfulness practice .", "Measurements were performed at baseline and after 8 weeks .", "The intervention group improved in the 4 scales measured .", "The magnitude of the change was large in total mood disturbance ( difference between groups -7.1 ; standardized effect-size [ SES ] 1.15 ) and mindfulness ( difference between groups 11 ; SES 0.9 ) and moderate in the burnout ( difference between groups -7 ; SES 0.74 ) and empathy scales ( difference between groups 5.2 ; SES 0.71 ) .", "No significant differences were found in the control group .", "Our study supports the use of mindfulness-based programs as part of continuing professional education to reduce and prevent burnout , promote positive attitudes among health professionals , strengthen patient-provider relationships , and enhance well-being ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Anogenital warts are a common disorder associated with significant physical and mental distress and a substantial cause of health care costs .", "To assess the efficacy of the topical application of nitric oxide delivered using acidified nitrite .", "A multicenter , randomized , controlled , dose-ranging clinical trial was conducted in European genitourinary medicine clinics between December 20 , 2001 , and January 14 , 2003 .", "Analysis was by intent to treat for all individuals initiating therapy .", "Participants included male and female volunteers older than 18 years with between 2 and 50 external anogenital warts .", "A total of 299 individuals from 40 centers were randomized to a control arm and a treatment arm that received 3 doses of acidified nitrite applied topically for 12 weeks with an additional 12 weeks of follow-up , with the final follow-up visit on January 14 , 2003 .", "Placebo nitrite cream and placebo citric acid cream were applied twice daily .", "Active treatment was divided as low dose ( sodium nitrite , 3 % , with citric acid , 4.5 % , creams applied twice daily ) , middle dose ( sodium nitrite , 6 % , with citric acid , 9 % , creams applied once daily at night , with placebo applied in the morning ) , and high dose ( sodium nitrite , 6 % , with citric acid , 9 % , creams applied twice daily ) .", "The primary outcome was proportion of patients with complete clinical clearance of target warts ; secondary outcomes were reduction in target wart area and safety .", "Complete clinical clearance at 12 weeks occurred in 10 of 74 patients ( 14 % ; 95 % CI , 6 % -21 % ) with placebo ; 11 of 72 ( 15 % ; 95 % CI , 7 % -24 % ) with low-dose treatment ; 17 of 74 ( 23 % ; 95 % CI , 13 % -33 % ) with middle-dose treatment ; and 22 of 70 ( 31 % ; 95 % CI , 21 % -42 % ) with high-dose treatment ( P = .01 ) .", "Reduction in target wart area , time to clearance , and patient and investigator assessments supported the superiority of the high-dose therapy vs placebo .", "There were no systemic or serious adverse events associated with treatment .", "However , there was a dose-related increase in itching , pain , edema , and staining of the anogenital skin associated with the active treatment .", "Overall , 21 patients withdrew from active treatment because of adverse events compared with none using placebo .", "Use of sodium nitrite , 6 % , with citric acid , 9 % , twice daily is more effective than placebo in the treatment of anogenital warts .", "Treatment was associated with local irritant adverse effects .", "clinicaltrials.gov Identifier : NCT02015260 ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Noncardiac chest pain ( NCCP ) is seen more frequently in young population and in these patients loss of function is evolving in social and professional areas .", "The aim of the study is to evaluate the levels of anxiety and somatic perception in patients with chest pain presenting to cardiology clinic .", "Fifty-one patients with noncardiac chest pain and 51 healthy controls were included in the study .", "All participants performed self-report based health anxiety inventory ( HAI ) , somatosensory amplification scale ( SAS ) , and Toronto alexithymia scale ( TAS ) .", "The patient group had significantly higher scores on the SAS , HAI-1 , and HAI-T scales compared to controls ( P < 0.001 , P = 0.006 , and P = 0.038 , resp . )", "SAS , HAI-1 , and HAI-T scores were significantly higher in female patients than male ( P = 0.002 , 0.036 , and 0.039 , resp . )", "There were significant differences in all TAS subscale scores between two groups .", "Patients , who had total TAS score more than 50 , also presented higher levels of health anxiety ( P = 0.045 ) .", "Anxiety , somatic symptoms , and the exaggerated sense of bodily sensations are common in patients with NCCP .", "These patients unnecessarily occupy the cardiology outpatient clinics .", "These negative results can be eliminated when consultation-liaison psychiatry evaluates these patients in collaboration with cardiology departments ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To compare the differences in the clinical efficacy on Alzheimer 's disease between acupuncture and medicine .", "One hundred and forty-one patients were randomized into an acupuncture group ( 72 cases ) and a medicine group ( 69 cases ) .", "In the acupuncture group , the needling technique for benefiting qi , promoting blood circulation , regulating mind and improving intelligence was used at Shenting ( GV 24 ) , Baihui ( GV 20 ) , Fengchi ( GB 20 ) , Wangu ( GB 12 ) , Danzhong ( CV 17 ) , Zhangwan ( CV 12 ) , Qihai ( CV 6 ) , Xuehai ( SP 10 ) and Zusanli ( ST 36 ) .", "The supplementary acupoints were selected according to the symptoms and physical signs .", "Acupuncture was given once a day and 6 treatments were required for a week .", "In the medicine group , the choline sterase inhibitor , donepezil ( aricept ) was prescribed for oral administration , 1 tablet ( 5 mg ) each time , once every night .", "Four weeks later , the dose was increased to 2 tablets ( 10 mg ) each time .", "In the two groups , the treatment of 4 weeks made one session and 4 sessions were required .", "The changes of scores before and after treatment in the minimum mental state examination ( MMSE ) , the activity of daily living scale ( ADL ) , Alzheimer 's disease assessment scale-cognition ( ADAS-cog ) and the digit span ( DS ) were observed .", "After treatment , scores of MMSE and DS were increased as compared with those before treatment ( both P < 0.05 ) and scores of ADL and ADAS-cog were reduced as compared with those before treatment .", "The score differences in MMSE , ADL , ADAS-cog and DS before and after treatment were significant in the two groups ( all P < 0.01 ) .", "The needling technique for benefiting qi , promoting blood circulation , regulating mind and improving intelligence significantly improves the overall function , cognition and activity of daily life in the patients of Alzheimer 's disease and the efficacy is better than donepezil ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "There is little evidence available on the use of robot-assisted therapy in subacute stroke patients .", "A randomized controlled trial was carried out to evaluate the short-time efficacy of intensive robot-assisted therapy compared to usual physical therapy performed in the early phase after stroke onset .", "Fifty-three subacute stroke patients at their first-ever stroke were enrolled 307days after the acute event and randomized into two groups , both exposed to standard therapy .", "Additional 30 sessions of robot-assisted therapy were provided to the Experimental Group .", "Additional 30 sessions of usual therapy were provided to the Control Group.The following impairment evaluations were performed at the beginning ( T0 ) , after 15 sessions ( T1 ) , and at the end of the treatment ( T2 ) : Fugl-Meyer Assessment Scale ( FM ) , Modified Ashworth Scale-Shoulder ( MAS-S ) , Modified Ashworth Scale-Elbow ( MAS-E ) , Total Passive Range of Motion-Shoulder/Elbow ( pROM ) , and Motricity Index ( MI ) .", "Evidence of significant improvements in MAS-S ( p = 0.004 ) , MAS-E ( p = 0.018 ) and pROM ( p < 0.0001 ) was found in the Experimental Group .", "Significant improvement was demonstrated in both Experimental and Control Group in FM ( EG : p < 0.0001 , CG : p < 0.0001 ) and MI ( EG : p < 0.0001 , CG : p < 0.0001 ) , with an higher improvement in the Experimental Group .", "Robot-assisted upper limb rehabilitation treatment can contribute to increasing motor recovery in subacute stroke patients .", "Focusing on the early phase of stroke recovery has a high potential impact in clinical practice ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "In advanced gastric cancer ( AGC ) , no globally accepted prognostic scoring system has been developed .", "Therefore , we explored baseline prognostic factors in Japanese AGC patients using the data from a randomized controlled trial , Japan Clinical Oncology Group ( JCOG ) 9912 , which investigated the efficacy of systemic chemotherapy as a first-line treatment .", "Prognostic factors and prognostic indices for overall survival were screened and evaluated in patients enrolled in JCOG9912 using the Cox proportional hazard model .", "The Royal Marsden Hospital prognostic model was also applied to the JCOG9912 trial .", "A total of 650 ( 92.3 % ) of the 704 patients randomized in the JCOG9912 trial , for whom complete data were available for multivariate analyses , was included in the present study ( 5-fluorouracil arm , n = 215 ; irinotecan plus cisplatin arm , n = 216 ; S-1 arm , n = 219 ) .", "The median survival time ( MST ) for all patients was 11.8 months .", "To construct a prognostic index , we selected four risk factors by multivariate analysis : performance status 1 , number of metastatic sites 2 , no prior gastrectomy , and elevated alkaline phosphatase .", "MSTs were 17.0 months for patients categorized into the low-risk group , who had zero or one risk factor ( n = 225 ) ; 10.4 months for patients in the moderate-risk group , who had two or three risk factors ( n = 368 ) ; and 5.0 months for patients in the high-risk group , who had all four risk factors ( n = 57 ) .", "In the present study , we propose a new prognostic index for patients with AGC .", "This can be used for more appropriate patient stratification in future clinical trials ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Treatment of food allergy essentially consists of food avoidance , but immunotherapy with food is emerging as a new therapeutic option .", "To evaluate clinical improvement and immunological changes in patients with peach allergy following sublingual immunotherapy ( SLIT ) with a Prup3 quantified peach extract .", "A randomized , double-blind , placebo-controlled clinical trial with peach SLIT was conducted .", "We assessed clinical efficacy after 6 months of treatment by means of double-blind , placebo-controlled oral challenges with peach and also evaluated immunological changes ( basophil activation test [ BAT ] and determination of sulphidoleukotriene production ) following stimulation with peach peel and pulp , rPrup3 , rMald 1 , and rMal d 4 stimulation .", "We also measured specific IgE and IgG4 to Pru p3 .", "After 6 months of SLIT ( T6 ) , the active group showed a 3-fold improvement in tolerance to Prup3 and a significant increase in IgE to rPrup3 and in sLT production following stimulation with peach peel and rPrup3 .", "There was also a significant increase in BAT results after stimulation with rPrup3 at 1 month of SLIT ( T1 ) .", "Statistically significant between-group differences were only observed for BAT with peach peel and pulp at T1 and T6 and for BAT with rPru p3 at T6 .", "No changes were observed in BAT with rMal d 1 or rMal d 4 or in IgG4 levels to nPrup3 .", "SLIT with a Pru p 3 quantified peach extract is clinically effective and leads to an increase in basophil activation and sulphidoleukotriene production following stimulation with rPru p3 and peach peel in the first months of treatment ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Pharmacogenetics ( PGx ) promises to optimize patient response to therapy .", "However , the public 's acceptance of PGx is not well known , notably when this applies to children .", "Our objective was to explore perceptions of PGx testing among individuals , who differ from each other by either parental status or educational exposure to PGx , and to explore parents ' views between PGx testing for oneself and PGx testing for their children .", "An exploratory survey was conducted among parents and other adults .", "Surveys P and C were completed by parents , survey NP by middle-aged nonparents , and survey MS by medical students .", "Proper explanation before PGx testing appeared to be the most important issue to the respondents ( eg , P = 1.55 10 ( -38 ) for survey NP ) .", "Respondents who were more knowledgeable about PGx were also more comfortable with PGx testing ( eg , P = 2.53 10 ( -7 ) in case of mild disease ) .", "When PGx testing was for one 's child , parents valued their own understanding more than their child 's assent ( P = 1.57 10 ( -17 ) ) .", "The acceptability of PGx testing , either for oneself or for one 's child , seemed to depend on baseline PGx knowledge , but not on parenthood ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Dilatation and curettage ( D&C ) is a common day-care procedure in obstetrics and gynecology , with patients discharged after a brief hospital stay on the same day of the surgery .", "Although it has a short duration , severe pain occurs during the procedure .", "Therefore , this surgical procedure requires an anesthetic to provide adequate analgesia , rapid onset , and rapid recovery .", "The main objective of the present study was to compare the analgesic effectiveness and safety of tramadol with those of fentanyl during D&C .", "The study comprised 100 women with American Society of Anesthesiologists classification I-II who were scheduled for a D&C procedure .", "Baseline anesthesia was maintained with 1mg/kg propofol , and the patients were then randomly allocated to receive tramadol 1mg/kg ( Group T , n = 50 ) or fentanyl 1g/kg ( Group F , n = 50 ) .", "Hemodynamic variables , sedation , pain , the Aldrete recovery score , and side-effects were recorded .", "SpO levels in Group F in the 5th min and at the end of the procedure were significantly lower than those in Group T ( P = 0.024 and 0.021 , respectively ) .", "Tramadol provides similar analgesic efficacy to fentanyl .", "Furthermore , tramadol may provide better respiratory stability in patients undergoing a D&C procedure ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Based on current recommendations , 30 + pack-years of smoking are required for eligibility for low-dose CT ( LDCT ) lung cancer screening ; former smokers must have quit within 15 years .", "We investigated whether current smokers with 20 to 29 pack-years have similar lung cancer risks as eligible former smokers and also whether they have a different demographic profile .", "The Prostate , Lung , Colorectal , and Ovarian Cancer Screening Trial ( PLCO ) was a randomly assigned screening trial of subjects age 55 to 74 years with chest radiographs ( CXR ) used for lung cancer .", "Subjects completed a baseline questionnaire containing smoking history questions .", "Cox proportional hazards models , adjusted for age and sex , were utilized to estimate hazard ratios ( HRs ) for various smoking history groups .", "Next , we utilized the National Health Interview Survey ( NHIS ) , which inquired about smoking history and race/ethnicity , to analyze the demographic profiles of various high-risk smoking history categories .", "All statistical tests were two-sided .", "The PLCO cohort included 18 114 former and 12 243 current LDCT-eligible smokers , plus 2283 20 - to 29-pack-year current smokers .", "The hazard ratio for 20 - to 29-pack-year current smokers compared with eligible ( 30 + pack-year ) former smokers was 1.07 ( 95 % confidence interval [ CI ] = 0.75 to 1.5 ) .", "Based on the NHIS , 10 million persons in the United States are currently LDCT eligible ; an additional 1.6 million ( 16 % , 95 % CI = 13.6 % to 19.0 % ) are 20 - to 29-pack-year current smokers .", "The percentage increase in eligibles if 20 - to 29-pack-year current smokers were included was substantially greater for women than men ( 22.2 % , 95 % CI = 17.9 % to 26.7 % ; vs 12.2 % , 95 % CI = 9.3 % to 15.3 % , P < .001 ) and for minorities than non-Hispanic whites ( 30.0 % , 95 % CI = 24.2 % to 36.0 % ; vs 14.1 % , 95 % CI = 11.1 % to 17.0 % , P < .001 ) .", "The potential benefits and harms of recommending LDCT screening for 20 to 29-pack-year current smokers should be assessed ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Progression-free survival ( PFS ) in metastatic castration-resistant prostate cancer ( mCRPC ) trials has been inconsistently defined and poorly associated with overall survival ( OS ) .", "A reproducible quantitative definition of radiographic PFS ( rPFS ) was tested for association with a coprimary end point of OS in a randomized trial of abiraterone in patients with mCRPC .", "rPFS was defined as two new lesions on an 8-week bone scan plus two additional lesions on a confirmatory scan , two new confirmed lesions on any scan 12 weeks after random assignment , and/or progression in nodes or viscera on cross-sectional imaging , or death .", "rPFS was assessed by independent review at 15 % of deaths and by investigator review at 15 % and 40 % of deaths .", "rPFS and OS association was evaluated by Spearman 's correlation .", "A total of 1,088 patients were randomly assigned to abiraterone plus prednisone or prednisone alone .", "At first interim analysis , the hazard ratio ( HR ) by independent review was 0.43 ( 95 % CI , 0.35 to 0.52 ; P < .001 ; abiraterone plus prednisone : median rPFS , not estimable ; prednisone : median rPFS , 8.3 months ) .", "Similar HRs were obtained by investigator review at the first two interim analyses ( HR , 0.49 ; 95 % CI , 0.41 to 0.60 ; P < .001 and HR , 0.53 ; 95 % CI , 0.45 to 0.62 ; P < .001 , respectively ) , validating the imaging data assay used .", "Spearman 's correlation coefficient between rPFS and OS was 0.72 .", "rPFS was highly consistent and highly associated with OS , providing initial prospective evidence on further developing rPFS as an intermediate end point in mCRPC trials ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Rehabilitation care is an important part of comprehensive care for MS patients .", "Little is known about the number of physiatry residents who are interested in providing care to individuals with multiple sclerosis [ MS ] .", "This study examines factors that influence physiatry residents ' interest in providing care to MS patients .", "We randomly sampled half of all Accreditation Council for Graduate Medical Education-certified physical medicine and rehabilitation residency programs in the continental United States and Puerto Rico .", "Surveys were received from 74 % of programs ( Stage 1 response rate ) and from 221 residents ( 45 % Stage 2 response rate ) .", "Residents expressing interest in providing MS care were more likely to be female , Asian , and to select statements emphasizing multidisciplinary care approaches and a community of dedicated professional colleagues as positive features of MS patient care .", "Residents interested in teaching and with more education debt were marginally more likely to express interest in MS care .", "Medical education should emphasize the need for physical medicine and rehabilitative care among individuals with MS , the ability of physiatrists to improve the functional status and quality of life for MS patients , and the team-based nature of MS care ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Lysine requirements of well-nourished children from developing regions have been found to be similar to those of children from developed regions ( 33.5 mgkgd ) .", "However , intestinal parasites have been shown to increase lysine requirements in undernourished adults , and it is not known if a similar phenomenon occurs in undernourished children from poor and unsanitary environments .", "Our objective was to measure the lysine requirement of moderately undernourished school-aged Indian children by the indicator amino acid oxidation technique before and after successful treatment for intestinal parasites .", "Twenty-one undernourished school-aged children ( 8 y of age ) with z scores between -2 SD and -3 SD for height-for-age or weight-for-age , who tested positive for intestinal parasites , were studied before and after successful antiparasite treatment .", "Children were fed any 2 of 7 levels of lysine intakes ( 5 , 15 , 25 , 35 , 50 , 65 , and 80 mgkgd ) in random order .", "The lysine requirement was determined by applying a 2-phase linear regression crossover analysis on the fractional oxidation rate of the tracer L - [ 1-C ] phenylalanine in response to the graded lysine intakes .", "The lysine requirement of undernourished children with intestinal parasite infestations was determined to be 42.8 mgkgd ( 95 % CI : 32.6 , 53.1 mgkgd ) , and after successful antiparasitic treatment it was determined to be 35.5 mgkgd ( 95 % CI : 25.5 , 45.5 mgkgd ) .", "The results were significantly different ( P < 0.05 ) , although the 95 % CIs overlapped .", "The lysine requirement in undernourished children is similar to that of well-nourished children , and intestinal parasitic infestation increased the lysine requirement by 20 % ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To compare the efficacy and side effects of low-dose amitriptyline ( AMT ) with proton pump inhibitor treatment in patients with globus pharyngeus .", "Thirty-four patients who fulfilled the Rome III criteria for functional esophageal disorders were included in this study .", "Patients were randomly assigned to receive either 25 mg AMT before bedtime ( AMT group ) or 40 mg Pantoprazole once daily for 4 wk ( conventional group ) .", "The main efficacy endpoint was assessed using the Glasgow Edinburgh Throat Scale ( GETS ) .", "The secondary efficacy endpoints included the Medical Outcomes Study 36-item short form health survey [ social functioning ( SF ) -36 ] and the Pittsburgh Sleep Quality Index .", "Treatment response was defined as a > 50 % reduction in GETS scores .", "All patients entering this study recorded side effects at days 1 , 8 , 15 , 22 and 29 using a visual analogue scale .", "Thirty patients completed the study .", "After 4 wk of treatment , the AMT group had a greater response than the conventional group ( 75 % vs 35.7 % , P = 0.004 ) .", "At day 3 , the AMT group showed significantly more improvement than the Conventional group in GETS score ( 3.69 1.14 vs 5.64 1.28 , P = 0.000 ) .", "After 4 wk of treatment , the AMT group showed significantly greater improvement in GETS score and sleep quality than the Conventional group ( 1.25 1.84 vs 3.79 2.33 , 4.19 2.07 vs 8.5 4.97 ; P < 0.01 for both ) .", "Additionally , the AMT group was more likely than the Conventional group to experience improvement in the SF-36 , including general health , vitality , social functioning and mental health ( P = 0.044 , 0.024 , 0.049 and 0.005 ) .", "Dry mouth , sleepiness , dizziness and constipation were the most common side effects .", "Low-dose AMT is well tolerated and can significantly improve patient symptoms , sleep and quality of life .", "Thus , low-dose AMT may be an effective treatment for globus pharyngeus ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Up to now , all tested Ebola virus vaccines have been based on the virus strain from the Zaire outbreak in 1976 .", "We aimed to assess the safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine expressing the glycoprotein of the 2014 epidemic strain .", "We did this randomised , double-blind , placebo-controlled , phase 1 clinical trial at one site in Taizhou County , Jiangsu Province , China .", "Healthy adults ( aged 18-60 years ) were sequentially enrolled and randomly assigned ( 2:1 ) , by computer-generated block randomisation ( block size of six ) , to receive placebo , low-dose adenovirus type-5 vector-based Ebola vaccine , or high-dose vaccine .", "Randomisation was pre-stratified by dose group .", "All participants , investigators , and laboratory staff were masked to treatment allocation .", "The primary safety endpoint was occurrence of solicited adverse reactions within 7 days of vaccination .", "The primary immunogenicity endpoints were glycoprotein-specific antibody titres and T-cell responses at day 28 after the vaccination .", "Analysis was by intention to treat .", "The study is registered with ClinicalTrials.gov , number NCT02326194 .", "Between Dec 28 , 2014 , and Jan 9 , 2015 , 120 participants were enrolled and randomly assigned to receive placebo ( n = 40 ) , low-dose vaccine ( n = 40 ) , or high-dose vaccine .", "Participants were followed up for 28 days .", "Overall , 82 ( 68 % ) participants reported at least one solicited adverse reaction within 7 days of vaccination ( n = 19 in the placebo group vs n = 27 in the low-dose group vs n = 36 in the high-dose group ; p = 00002 ) .", "The most common reaction was mild pain at the injection site , which was reported in eight ( 20 % ) participants in the placebo group , 14 ( 35 % ) participants in the low-dose group , and 29 ( 73 % ) participants in the high-dose vaccine group ( p < 00001 ) .", "We recorded no statistical differences in other adverse reactions and laboratory tests across groups .", "Glycoprotein-specific antibody titres were significantly increased in participants in the low-dose and high-dose vaccine groups at both day 14 ( geometric mean titre 4214 [ 95 % CI 2497-7113 ] and 8205 [ 5989-11240 ] , respectively ; p < 00001 ) and day 28 ( 6827 [ 4243-10985 ] and 13057 [ 9701-17572 ] , respectively ; p < 00001 ) .", "T-cell responses peaked at day 14 at a median of 4650 spot-forming cells ( IQR 1800-12025 ) in participants in the low-dose group and 7650 cells ( 4000-14600 ) in those in the high-dose group .", "21 ( 18 % ) participants had mild fever ( n = 9 in the placebo group , n = 6 in the low-dose group , and n = 6 in the high-dose group ) .", "No serious adverse events were recorded .", "Our findings show that the high-dose vaccine is safe and robustly immunogenic .", "One shot of the high-dose vaccine could mount glycoprotein-specific humoral and T-cell response against Ebola virus in 14 days .", "China National Science and Technology , Beijing Institute of Biotechnology , and Tianjin CanSino Biotechnology ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "To evaluate the thermal antinociceptive effects and duration of action of buprenorphine hydrochloride after IM administration to American kestrels ( Falco sparverius ) .", "12 healthy 3-year-old American kestrels .", "Buprenorphine hydrochloride ( 0.1 , 0.3 , and 0.6 mg/kg ) and a control treatment ( saline [ 0.9 % NaCl ] solution ) were administered IM in a randomized crossover experimental design .", "Foot withdrawal response to a thermal stimulus was determined 1 hour before ( baseline ) and 1.5 , 3 , and 6 hours after treatment administration .", "Agitation-sedation scores were determined 3 to 5 minutes before each thermal stimulus .", "Adverse effects were monitored for 6 hours after treatment administration .", "Buprenorphine hydrochloride at 0.1 , 0.3 , and 0.6 mg/kg , IM , increased thermal threshold for 6 hours , compared with the response for the control treatment .", "There were no significant differences among buprenorphine treatments .", "A mild sedative effect was detected at a dose of 0.6 mg of buprenorphine/kg .", "At the doses tested , buprenorphine hydrochloride resulted in thermal antinociception in American kestrels for at least 6 hours , which suggested that buprenorphine has analgesic effects in this species .", "Further studies with longer evaluation periods and additional forms of noxious stimuli , formulations , dosages , and routes of administration are needed to fully evaluate the analgesic effects of buprenorphine in American kestrels ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Patellofemoral pain syndrome ( PFPS ) is a common musculoskeletal condition , particularly among women .", "Patients with PFPS usually experience weakness in the gluteal muscles , as well as pain and impaired motor control during activities of daily living .", "Strengthening the hip muscles is an effective way of treating this disorder .", "Neuromuscular training has also been identified as a therapeutic tool , although the benefits of this intervention in patients with PFPS patients remain inconclusive .", "This is a protocol of randomized controlled trial with a blind assessor .", "Thirty-four women with a clinical diagnosis of PFPS participated .", "These participants were allocated into two groups ( experimental and control ) .", "The experimental group performed twelve sessions to strengthen the knee extensors , hip abductor and lateral rotator muscles in association with neuromuscular training of the trunk and lower extremities .", "The control group performed the same number of sessions to strengthen the muscles of the hip and knee .", "The primary outcome was functional capacity ( Anterior Knee Pain Scale - AKPS ) at 4weeks .", "Pain intensity , muscle strength and kinematic changes were also measured during the step down test after four weeks of intervention .", "Follow up assessments were conducted after three and six months to assess functional capacity and pain .", "The effects of the treatment ( i.e. between-group differences ) were calculated using mixed linear models .", "The present study was initiated on the 1st of April 2013 and is currently in progress .", "The results of this study may introduce another effective technique of conservative treatment and could guide physical therapists in the clinical decision-making process for women with PFPS .", "Current Controlled Trials NCT01804608 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "The objective of this study was to evaluate the effect of nasal packing , septal suture technique and vacuum sealing drainage ( VSD ) after septoplasty .", "Ninety patients of nasal septal deviation in Combination with outfracture of the inferior turbinates who had received septoplasty were selected in this study .", "The patients were allocated into three groups , with thirty in each : for packing group , marcel materials were used for nasal packing after septoplasty ; for suturing group , septal suture technique was performed after septoplasty ; for VSD group , one drainage tube was used for negative pressure sucking after septoplasty without nasal packing .", "Postoperative signs and symptoms were compared between three groups .", "The comfort degree assessment included headache and nasal obstruction were evaluated by using visual analogue scale ( VAS ) at the 12th hour and 24 hour after operation .", "The edema in nasal cavity , hemorrhage .", "abscess , adhesive and healing rates after operation were compared among three groups .", "The VAS score of headache and nasal obstruction and the severity of patient 's conditions were significantly less in septal suture group and VSD group than that in packing group at the 12th and 24th hour after operation .", "The mucosa edema of nasal cavity was significantly slighter in septal suture group and VSD group than that in packing group at the third day after operation .", "The healing rates and number of complications are better in septal suture group and VSD group than those in packing group at the 7th day after operation .", "There were no hemorrhage or abscess in VSD group .", "Septal suture technique and VSD after septoplasty can significantly relieve the distress of patients and reduce the healing time of mucosa in nasal cavity without increasing the risk of complications ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To investigate baseline predictors of month 24 best-corrected visual acuity ( BCVA ) and central foveal thickness ( CFT ) in patients with diabetic macular edema ( DME ) treated monthly with ranibizumab or sham .", "Post hoc analysis of DME patients in 2 identical phase 3 studies .", "Patients randomized to ranibizumab ( n = 502 ) or sham ( n = 257 ) .", "Multivariate regression on predictors with P < 0.20 in univariate logistic regression using backward selection to retain predictors with P < 0.05 .", "Patient characteristics correlating with month 24 BCVA in Early Treatment Diabetic Retinopathy Study letter score 70 ( 20/40 ) or 50 ( 20/100 ) , gain or loss from baseline BCVA of 15 , or CFT 250 m.", "Baseline predictors of BCVA 20/40 in ranibizumab-treated patients were good BCVA , submacular fluid , no cardiovascular disease , no scatter photocoagulation , and male gender , whereas in sham-treated patients , they were mild increase in CFT , presence of hard exudates in center subfield , and absence of renal disease .", "Predictors of improvement in BCVA letter score 15 in ranibizumab-treated patients were poor BCVA , submacular fluid , young age , and short diabetes duration , and those in sham-treated patients were poor BCVA , young age , and mild increase in CFT .", "Predictors of resolution of edema ( CFT 250 m ) in ranibizumab-treated patients were mild foveal thickening and prominent subfoveal fluid , and those in sham-treated patients were poor BCVA , mild foveal thickening , and statin usage .", "Month 24 BCVA 20/100 was predicted by poor baseline BCVA in ranibizumab-treated patients , and by poor baseline BCVA , large intraretinal cystoid spaces , renal disease , and absence of hypercholesterolemia in sham-treated patients .", "Loss of BCVA 15 letters was predicted in sham-treated patients by submacular fluid , intraretinal cystoid spaces , and renal disease .", "Patients with DME and submacular fluid , intraretinal cysts , severe thickening , or renal disease respond poorly when untreated and respond well to ranibizumab treatment .", "Elimination of submacular fluid , intraretinal cysts , and severe thickening are important goals of DME treatment , and in patients with renal disease , treatment should be very aggressive , with a goal of eliminating all macular fluid ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "This study included 54-month-old children with a history of institutional care .", "Our goal was to : ( 1 ) examine differences in indiscriminate social behaviors in children with a history of institutional care compared with home-reared children ; ( 2 ) test whether foster care reduces indiscriminate social behaviors in a randomized controlled trial ; and ( 3 ) examine early predictors of indiscriminate behaviors .", "Participants were 58 children with a history of institutional care and 31 never-institutionalized control ( NIG ) subjects enrolled in a randomized controlled trial of foster care for institutional care , assessed from toddlerhood to 54 months .", "Indiscriminate social behaviors were measured naturalistically by using the Stranger at the Door procedure .", "In the Stranger at the Door procedure , children with a history of institutional care left with a stranger at higher rates than NIG subjects ( 33 % vs. 3.5 % ; P < .001 ) .", "Children in the care as usual group left more than NIG subjects ( 41.9 % vs. 3.6 % ; P .001 ) .", "The differences between the foster care group ( 24.1 % ) and the care as usual group and between foster care group and NIG were not significant .", "In a logistic regression , early disorganized attachment behaviors , baseline developmental quotient , and caregiving quality after randomization contributed to variance at 54 months .", "In the same analysis using only children with a history of institutional care , only disorganized attachment contributed significantly to 54-month indiscriminate social behaviors ( Exp [ B ] = 1.6 [ 95 % confidence interval : 1.1-2 .5 ] ) .", "Observed socially indiscriminate behaviors at 54 months were associated with prolonged exposure to institutional care .", "Young children raised in conditions of deprivation who fail to develop organized attachments as toddlers are at increased risk for subsequent indiscriminate behaviors ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "One goal of guideline-based asthma therapy is minimal use of short-acting agonist ( SABA ) medications .", "Inner-city children with asthma are known to have high SABA use .", "To examine factors associated with high SABA use in inner-city children with asthma .", "One hundred inner-city children with persistent asthma were enrolled into a randomized controlled trial of an emergency department ( ED ) and home intervention .", "All children underwent serologic allergen specific IgE and salivary cotinine testing at the ED enrollment visit .", "Pharmacy records for the past 12 months were obtained .", "Number of SABA fills during the past 12 months was categorized into low - to moderate - vs high-use groups .", "SABA groups were compared by the number of symptom days and nights , allergen sensitization , and exposures .", "Regression models were used to predict high SABA use .", "Mean number of SABA fills over 12 months was 3.12 .", "Unadjusted bivariate analysis showed that high SABA users were more than 5 times more likely to have an asthma hospitalization , almost 3 times more likely to have an asthma intensive care unit admission , and more than 3 times more likely to have prior specialty asthma care or positive cockroach sensitization than low to moderate SABA users .", "In the final regression model , for every additional inhaled corticosteroid fill , a child was 1.4 times more likely and a child with positive cockroach sensitization was almost 7 times more likely to have high SABA use when controlling for prior intensive care unit admission , receipt of specialty care , child age , and income .", "Providers should closely monitor SABA and controller medication use , allergen sensitization , and exposures in children with persistent asthma .", "ClinicalTrials.gov , identifier NCT01981564 ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "To compare the cardiopulmonary effects of intravenous ( IV ) and intramuscular ( IM ) medetomidine and butorphanol with or without MK-467 .", "Prospective , randomized experimental cross-over .", "Eight purpose-bred beagles ( two females , six males ) , 3-4 years old and weighing 14.5 1.6 kg ( mean SD ) .", "All dogs received four different treatments as follows : medetomidine 20 g kg ( -1 ) and butorphanol tartrate 0.1 mg kg ( -1 ) IV and IM ( MB ) , and MB combined with MK-467 ,500 g kg ( -1 ) ( MBMK ) IV and IM .", "Heart rate ( HR ) , arterial blood pressures ( SAP , MAP , DAP ) , central venous pressure ( CVP ) , cardiac output , respiratory rate ( fR ) , rectal temperature ( RT ) were measured and arterial blood samples were obtained for gas analysis at baseline and at 3 , 10 , 20 , 30 , 45 and 60 minutes after drug administration .", "The cardiac index ( CI ) , systemic vascular resistance index ( SVRI ) and oxygen delivery index ( DO2 I ) were calculated .", "After the follow-up period atipamezole 50 g kg ( -1 ) IM was given to reverse sedation .", "HR , CI and DO2 I were significantly higher with MBMK after both IV and IM administration .", "Similarly , SAP , MAP , DAP , CVP , SVRI and RT were significantly lower after MBMK than with MB .", "There were no differences in fR between treatments , but arterial partial pressure of oxygen decreased transiently after all treatments .", "Recoveries were uneventful following atipamezole administration after all treatments .", "MK-467 attenuated the cardiovascular effects of a medetomidine-butorphanol combination after IV and IM administration ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To evaluate adherence to therapy in acne patients using mobile phones and Short Message Service ( SMS ) to communicate .", "160 patients were randomly assigned to two groups : the SMS group received 2 text messages twice a day for a period of 12 weeks ; the control group did not receive any messages .", "Before and after 12 weeks , the following evaluations were performed in all patients : digital photographs , the Global Acne Grading System , the Dermatology Life Quality Index , the Cardiff Acne Disability Index , the doctor-patient relationship evaluated through the Patient-Doctor Depth-of-Relationship Scale , and the adherence to treatment evaluated by asking patients how many days a week they had followed the therapy .", "For statistical analysis we used Student 's t test .", "The SMS group had a better improvement of all parameters compared to the control group .", "Adherence and compliance are higher for patients who are included in a strategy of control ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]

[ "Ondansetron , sometimes combined with acustimulation at PC6 ( Neiguan ) , is commonly used for preventing postoperative nausea and vomiting , but PC6 is not the only point that can be used for this purpose .", "To evaluate the combined effects of ondansetron and ST36 ( Zusanli ) acupuncture point injection on postoperative vomiting ( POV ) after laparoscopic surgery .", "A randomised , patient and assessor-blinded , placebo-controlled clinical study was conducted .", "One hundred and sixty patients undergoing laparoscopic surgery were randomly assigned to one of four groups : ( 1 ) group P ( placebo-control ) : intravenous normal saline + bilateral non-acupuncture point injection of vitamin B1 ( n = 40 ) ; ( 2 ) group O ( ondansetron ) : intravenous ondansetron + bilateral ST36 sham injection ( n = 40 ) ; ( 3 ) group A ( acupuncture point injection ) : intravenous normal saline + bilateral acupuncture point injection at ST36 of vitamin B1 ( n = 40 ) ; ( 4 ) group C ( combination ) : intravenous ondansetron + bilateral acupuncture point injection at ST36 of vitamin B1 ( n = 40 ) .", "Interventions were made on arrival at the postanaesthesia care unit .", "The primary outcome was the incidence of POV within 24 h after the operation .", "Secondary outcomes included severity of vomiting , incidence of rescue treatment , patients ' satisfaction and the first anal exsufflation time 24 h after the operation .", "The incidence of POV within 24 h postoperative period in each group was P 33 % ; O 11 % , A 9 % and C 6 % .", "Outcomes for all intervention groups were significantly better than that for placebo ( p < 0.01 ) .", "For the three interventions compared with placebo , the numbers needed to treat ( NNTs ) were O , NNT = 5 ; A , NNT = 5 and C , NNT = 4 .", "The secondary outcomes also demonstrated greater benefits of the combined regimen , with improvement seen in all the measures .", "Ondansetron , acupuncture , and ondansetron and acupuncture combined are effective prophylaxis for POV ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "The impact of sugar-sweetened beverages ( SSB ) on lipid metabolism when consumed in moderate amounts by normal weight subjects is debated .", "The objective of the study was to investigate the effect of different types of sugars in SSB on fatty acid metabolism ( ie , fatty acid synthesis and oxidation ) in healthy young men .", "Thirty-four normal-weight men were studied in a randomized crossover study .", "Four isocaloric 3-week interventions with SSB were performed in random order : medium fructose ( MF ; 40 g/d ) ; high fructose ( HF ; 80 g/d ) , high sucrose ( HS ; 80 g/d ) , and high glucose ( HG ; 80g/d ) .", "Fasting total plasma fatty acid composition was measured after each intervention .", "Acylcarnitines were measured in the fasting state and after a euglycemic hyperinsulinemic clamp in nine subjects .", "The relative abundance of palmitate ( 16:0 ) and the molar fatty acid ratio of palmitate to linoleic acid ( 16:0 to18 :2 ) as markers of fatty acid synthesis were increased after HF [ relative abundance of palmitate : 22.97 % 5.51 % ( percentage of total fatty acids by weight SD ) ] and MF ( 26.1 % 1.7 % ) compared with HS ( 19.40 % 2.91 % , P < .001 ) , HG ( 19.43 % 3.12 % , P < .001 ) , or baseline ( 19.40 % 2.79 % , P < .001 ) .", "After HS and HG , the relative abundance of palmitate was equal to baseline .", "Fasting palmitoylcarnitine was significantly increased after HF and HS ( HF and HS vs. HG : P = .005 ) , decreasing after inhibition of lipolysis by insulin in the clamp .", "When consumed in moderate amounts , fructose but not sucrose or glucose in SSB increases fatty acid synthesis ( palmitate ) , whereas fasting long-chain acylcarnitines are increased after both fructose and sucrose , indicating an impaired - oxidation flux ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Little is known about global patterns of critical care unit ( CCU ) care and the relationship with outcomes in patients with acute decompensated heart failure ( ADHF ) .", "Whether a ward or a CCU admission is associated with better outcomes is unclear .", "Patients in the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure ( ASCEND-HF ) trial were initially hospitalized in a ward or CCU ( coronary or intensive care unit ) .", "Sites were geographically classified : Asia-Pacific ( AP ) , Central Europe ( CE ) , Latin America ( LA ) , North America ( NA ) , and Western-Europe ( WE ) .", "The primary outcome of 30-day all-cause mortality or all-cause hospital readmission was adjusted using a two-stage multivariable logistic regression model with a generalized estimated equation that took sites within each country as a nested random factor .", "Overall , 1944 ( 38.2 % ) patients were admitted to a CCU and 3150 ( 61.8 % ) to a ward , and this varied by region : 50.6 % AP , 63.3 % CE , 60.7 % WE , 22.1 % LA , and 28.6 % NA .", "The 30-day death or readmission rate was 15.2 % in ward patients and 17.0 % in CCU patients ( risk-adjusted Odds Ratio [ OR ] 1.44 : 95 % CI , 1.14-1 .82 ) .", "Compared with CCU patients in NA ( 24.1 % 30-day event rate ) , the primary outcomes were : AP ( 10.4 % , Odds Ratio [ OR ] 0.63 ; 95 % confidence Interval [ CI ] , 0.35 to 1.15 ) , CE ( 10.4 % , OR 0.56 : 95 % CI , 0.31 to 1.02 ) , LA ( 22.4 % , OR 0.60 : 95 % CI , 0.11 to 3.32 ) , and WE ( 11.2 % , OR 0.63 , 95 % CI , 0.25 to 1.56 ) .", "No regional differences in 30-day mortality were observed ; however , 30-day readmission rates were highest in NA sites .", "Management of patients with ADHF varies significantly , and after adjustment , CCU care was associated with higher risk of early mortality , not explained by international differences .", "These findings may help to improve the early decisions regarding risk stratification of patients hospitalized with ADHF ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Hand-foot syndrome ( HFS ) is a frequently occurring adverse event associated with anticancer drugs .", "This study compares a newly introduced ointment containing several antioxidants and exhibiting high radical protection factor , which has been available on the German market since 2011 , with urea cream for prevention of HFS in patients treated with capecitabine .", "Patients with GI tumors or breast cancer treated with capecitabine were included in this randomized phase III study .", "The primary end point was prevention of HFS of any grade within 6 weeks of treatment as indicated by a standardized patient diary .", "The study had 80 % power to show a 20 % reduction of the incidence of HFS with the new ointment .", "Secondary end points included time to development of HFS greater than grade 1 , evaluation of capecitabine dose intensity , and quality of life analyses .", "A total of 152 patients were evaluable .", "In total , 47 of 152 patients experienced HFS ( 30.9 % ) , 39.5 % with the new ointment and 22.4 % in the urea arm ( stratified odds ratio , 2.37 ; P = .02 ) .", "Time to HFS greater than grade 1 was comparable , but time to any-grade HFS was significantly longer in the urea group ( P = .03 ) .", "Capecitabine dose intensity , time under study , and percentage of days with correct administration of study medication were identical , as were adverse events except for HFS .", "Skin-related quality of life was significantly worse in the group treated with the new ointment at the end of study treatment .", "This trial demonstrated that 10 % urea cream was superior to the new ointment at preventing HFS over the first 6 weeks of treatment with capecitabine ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Atrial fibrillation ( AFib ) is common in heart failure ( HF ) with preserved ejection fraction ( HFpEF ) .", "Current AFib stroke risk prediction models include the presence of HF but do not specifically include HFpEF as a risk factor .", "Whether a history of AFib should be used to identify patients with HFpEF who are at risk has not been established .", "Baseline characteristics and outcomes of patients with HFpEF in the Irbesartan in Heart Failure with Preserved Ejection Fraction Trial were analyzed in relation to AFib .", "At baseline , 1209 ( 29.3 % ) had a history of AFib .", "Of these 557 ( 13.5 % ) had history of AFib alone , whereas 670 ( 16.2 % ) had both a history and AFib on ECG ; 2901 ( 70.3 % ) had neither .", "There were no significant differences in the risk of stroke between the 2 groups with a history of AFib who did or did not have AFib present on baseline ECG .", "During a median follow-up of 53 months , a fatal or nonfatal stroke occurred in 6.5 % ( 79/1209 ) patients with history of AFib compared with 3.9 % ( 114/2901 ) with no AFib .", "Having a history of AFib was independently associated with higher risk of stroke ( hazard ratio , 2.2 ; 95 % confidence interval , 1.6-3 .2 ; P < 0.0001 ) compared with those with no history of AFib .", "In patients with HFpEF , a history of AFib was common and independently associated with increased risk of stroke , regardless of whether AFib was present on ECG .", "Patients with HFpEF and a history of AFib should be considered at risk .", "Further studies are needed to determine whether this risk can be safely reduced .", "http://www.clinicaltrials.gov .", "Unique identifier : NCT000095238 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "Selective kappa opioid receptor antagonism is a promising experimental strategy for the treatment of depression .", "The kappa opioid receptor antagonist , LY2456302 , exhibits ~ 30-fold higher affinity for kappa opioid receptors over mu opioid receptors , which is the next closest identified pharmacology .", "Here , we determined kappa opioid receptor pharmacological selectivity of LY2456302 by assessing mu opioid receptor antagonism using translational pupillometry in rats and humans .", "In rats , morphine-induced mydriasis was completely blocked by the nonselective opioid receptor antagonist naloxone ( 3mg/kg , which produced 90 % mu opioid receptor occupancy ) , while 100 and 300 mg/kg LY2456302 ( which produced 56 % and 87 % mu opioid receptor occupancy , respectively ) only partially blocked morphine-induced mydriasis .", "In humans , fentanyl-induced miosis was completely blocked by 50mg naltrexone , and LY2456302 dose-dependently blocked miosis at 25 and 60 mg ( minimal-to-no blockade at 4-10mg ) .", "We demonstrate , for the first time , the use of translational pupillometry in the context of receptor occupancy to identify a clinical dose of LY2456302 achieving maximal kappa opioid receptor occupancy without evidence of significant mu receptor antagonism ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To compare the efficacy of an acupuncture regimen for persistent allergic rhinitis ( PER ) , aimed at improving a patient 's mind or Shen in Traditional Chinese Medicine , to that of a second-generation Hi-receptor antagonist , cetirizine hydrochloride .", "This multicenter , randomized , controlled clinical trial on PER will be conducted at three institutions in China .", "The total study period will be 9 weeks .", "After a 1-week preparatory screening period , 240 eligible participants with PER will be randomized to receive acupuncture or pharmacotherapy ( 1:1 ) for 4 weeks with a 4-week follow-up .", "The primary outcome will be changes in 7-day average total nasal symptom score .", "Secondary outcome measures include rhinoconjunctivitis quality of life questionnaire score and total non-nasal symptom score .", "The presence and seriousness of psychological and emotional impairments should be considered in therapeutic programs for allergic rhinitis .", "No clinical trial for treating allergic rhinitis via acupuncture regulation of psychological and emotional activities has been reported .", "The findings of the trial will allow us to determine the effects of the mind ( Shen ) - regulation treatment approach .", "We will also be able to confirm if the effects of acupuncture are equivalent to those of the conventional drug cetirizine hydrochloride ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Probiotics are microbial supplements that have shown efficacy in a wide range of applications .", "To assess the safety and effects of enteral probiotics in critically ill neonates .", "A double-blind , randomized controlled trial was conducted in 100 full-term infants with critical illness according to scores of neonatal acute physiology .", "Fifty neonatal intensive care patients were randomly assigned to receive probiotics three times daily after birth for 8 days , and fifty patients were not given probiotics , but who received a placebo .", "The incidence of sepsis , multiple organ dysfunction syndrome ( MODS ) , nosocomial pneumonia , and necrotizing enterocolitis were recorded .", "The prognosis of probiotic treatment was determined based on the rate of recovery and hospital days .", "Serum IgA , IgG , and IgM concentrations were measured on days 4 and 8 .", "Infants in the probiotics group showed a significantly reduced rate of nosocomial pneumonia ( 18 % versus 36 % ) and multiple organ dysfunction syndrome ( 6 % versus 16 % ) compared with the placebo group ( p < 0.05 ) .", "Significant results were demonstrated in favour of the probiotics for days of hospital stay ( 13 3.5 d versus 15.8 5.3 d ) ( p < 0.05 ) .", "However , there were no significant differences in the occurrence of sepsis , necrotizing enterocolitis , and recovery rate .", "Patients given probiotics had significantly greater levels of IgA than those in the placebo group ( p < 0.05 ) .", "No serious adverse effects in the study population were noted .", "Supplements of probiotics to critically ill neonates could enhance immune activity , decrease occurrence of nosocomial pneumonia and MODS , and reduce days in hospital ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Recently , there have been investigations that have targeted improving the relatively poor validity and reliability of attentional bias measures .", "These studies have demonstrated that individuals show elevated attentional bias to stimuli associated with their drinking history , although to date , the predictive utility of these measures has yet to be assessed .", "The current study aimed to investigate the predictive value of an individualised alcohol Stroop task compared to that of an alcohol Stroop task with general alcohol-related words in a sample of non-dependent undergraduate drinkers .", "48 undergraduate social drinkers completed questionnaire measures of alcohol consumption and hazardous drinking which were combined to get an alcohol involvement measure .", "Participants also completed three blocked format Stroop tasks , a control Stroop ( containing soft drink-related words ) , a general alcohol Stroop ( containing a mixture of alcohol-related words ) and an individualised Stroop that contained words relating to the participants ' favourite alcoholic drink .", "Although there was no significant difference in participants ' performance across the three different Stroop tasks , only performance on the individualised Stroop was associated with alcohol involvement .", "Notably , the individualised Stroop predicted variance in drinking after controlling for demographics and general alcohol Stroop performance .", "This study indicates that adopting individualised stimuli into attentional bias tasks may increase their predictive validity ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Following acute coronary syndrome ( ACS ) , the risk for future cardiovascular events is high and is related to levels of low-density lipoprotein cholesterol ( LDL-C ) even within the setting of intensive statin treatment .", "Proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) regulates LDL receptor expression and circulating levels of LDL-C .", "Antibodies to PCSK9 can produce substantial and sustained reductions of LDL-C .", "The ODYSSEY Outcomes trial tests the hypothesis that treatment with alirocumab , a fully human monoclonal antibody to PCSK9 , improves cardiovascular outcomes after ACS .", "This Phase 3 study will randomize approximately 18,000 patients to receive biweekly injections of alirocumab ( 75-150 mg ) or matching placebo beginning 1 to 12 months after an index hospitalization for acute myocardial infarction or unstable angina .", "Qualifying patients are treated with atorvastatin 40 or 80 mg daily , rosuvastatin 20 or 40 mg daily , or the maximum tolerated and approved dose of one of these agents and fulfill one of the following criteria : LDL-C 70 mg/dL , non-high-density lipoprotein cholesterol 100 mg/dL , or apolipoprotein B 80 mg/dL .", "The primary efficacy measure is time to first occurrence of coronary heart disease death , acute myocardial infarction , hospitalization for unstable angina , or ischemic stroke .", "The trial is expected to continue until 1613 primary end point events have occurred with minimum follow-up of at least 2 years , providing 90 % power to detect a 15 % hazard reduction .", "Adverse events of special interest include allergic events and injection site reactions .", "Interim analyses are planned when approximately 50 % and 75 % of the targeted number of primary end points have occurred .", "ODYSSEY Outcomes will determine whether the addition of the PCSK9 antibody alirocumab to intensive statin therapy reduces cardiovascular morbidity and mortality after ACS ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS" ]

[ "Intrauterine growth restriction may be reduced by supplementing maternal diets during pregnancy , but few studies have assessed the impact of combined prenatal and postnatal interventions on child growth .", "We tested a hypothesis that provision of small-quantity lipid-based nutrient supplements ( SQ-LNSs ) to mothers in pregnancy and 6 mo postpartum and to their infants from 6 to 18 mo of age would promote infant and child growth in the study area in rural Malawi .", "We enrolled 869 pregnant women in a randomized trial in Malawi .", "During pregnancy and 6 mo thereafter , the women received daily 1 capsule of iron-folic acid ( IFA ) , 1 capsule containing 18 micronutrients ( MMN ) , or one 20-g sachet of SQ-LNS [ lipid-based nutrient supplements ( LNS ) , containing 21 MMN , protein , carbohydrates , essential fatty acids , and 118 kcal ] .", "Children in the IFA and MMN groups received no supplementation ; children in the LNS group received SQ-LNSs from 6 to 18 mo. .", "Primary outcome was child length at 18 mo. .", "At 18 mo , the mean length in the IFA , MMN , and LNS groups was 77.0 , 76.9 , and 76.8 cm ( P = 0.90 ) , respectively , and the prevalence of stunting was 32.7 % , 35.6 % , and 37.9 % ( P = 0.54 ) , respectively .", "No intergroup differences were found in the mean weight , head circumference , or midupper arm circumference or the proportions with low z scores for these variables ( P > 0.05 ) .", "Covariate adjustment did not change the analysis results , and the associations between the intervention and child length were not modified by maternal parity , age , or nutritional status ( P > 0.10 ) .", "The findings do not support a hypothesis that provision of SQ-LNSs to women in pregnancy and postpartum and to children from 6 to 18 mo of age would promote child growth in this Malawian study area .", "This trial was registered at clinicaltrials.gov as NCT01239693 ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Femoral nerve block ( FNB ) with varying concentrations of bupivacaine is often used for postoperative analgesia after anterior cruciate ligament ( ACL ) reconstruction .", "To determine whether FNB using 0.25 % or 0.5 % bupivacaine provided better analgesia with less effect on quadriceps strengths after ACL reconstruction .", "One hundred patients were randomized to receive FNB with 20 mL of 0.25 % or 0.5 % bupivacaine .", "Data regarding demographic , effectiveness of FNB , time to first pain , time to first analgesic , pain scores , morphine use , and recovery of sensory and motor function were recorded .", "Median time to first morphine requirement was 12 hours in 0.5 % bupivacaine group and 10 hours in 0.25 % bupivacaine group ( p = 0.048 ) .", "Pain score at 18 hours was lower in 0.5 % bupivacaine group compared with 0.25 % bupivacaine group ( p = 0.001 ) .", "When specify to the patellar tendon graft subgroup , the patients requiring morphine were 70 % in 0.5 % bupivacaine group and 90 % in 0.25 % bupivacaine group ( p = 0.03 ) .", "No differences were found in demographic data , effectiveness of FNB , time to first pain , morphine consumption , and recovery of sensorimotor function .", "FNB with 0.5 % bupivacaine provided longer time to first analgesic and lower narcotic requirements after patellar tendon graft ACL reconstruction when compared to 0.25 % bupivacaine .", "Both concentrations showed similar effect on quadriceps strengths ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To establish a preoperative deep venous thrombosis predictor score for patients with fresh lower extremity fractures by statistical analysis .", "From January 2011 to December 2012 , 1 705 patients with fresh lower extremity fractures were admitted to department of orthopaedic trauma , Beijing Jishuitan Hospital .", "They were randomly divided into two groups , the group 1 ( n = 879 ) was used to screen risk factors and derived a predictive models based on logistic regression , the group 2 ( n = 826 ) validated the models .", "Among the patients , there were 1 106 male and 599 female patients , with an average age of ( 50 18 ) years.Variables related to preoperative deep venous thrombosis were age , length of time before surgery , cause of injury , low/high-energy injury , location of injury , history of cardiovascular and cerebrovascular diseases , and D-Dimer .", "The scores based on OR were : age 35 years : 1 point , > 35 - < 65 years : 4 points , 65 years : 6 points ; length of time before surgery , < 8 days :1 point , 8 days :2 points ; low-energy injury :1 point , high energy injury :3 points ; location of injury , foot and ankle :1 point , calf :3 points , around the knee : 5 points , femoral diaphysis and proximal femur :7 points , pelvis and acetabulum :4 points , 2 sites :6 point ; history of cardiovascular and cerebrovascular diseases , yes :2 points , no :1 point .", "D-Dimer < 600 g/L :1 point , 600 g/L :3 points .", "Area under receiver operating characteristic curve was 0.79 , critical point 15.5 points , sensitivity was 77.00 % , specificity was 68.17 % .", "The score can predict the preoperative deep venous thrombosis for patients with fresh lower extremity fractures , but limited ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To investigate if baseline depression moderated response to Media Smart , an 8-lesson school-based program previously found to achieve a long-term risk reduction effect in young adolescents .", "540 Grade 8 students ( M age = 13.62 years , SD = .37 ) from 4 schools participated with 11 classes receiving the Media Smart program ( 126 girls ; 107 boys ) and 13 comparison classes receiving their normal lessons ( 147 girls ; 160 boys ) .", "Shape and weight concern , media internalization , body dissatisfaction , dieting , ineffectiveness , and perceived pressure were the outcome variables .", "Moderation was indicated by significant interaction effects for group ( Media Smart ; Control ) moderator ( high depression ; low depression ) time ( post-program ; 6-month follow-up ; 2.5-year follow-up ) , with baseline entered as a covariate .", "Such effects were found for shape and weight concern , media internalization , body dissatisfaction , ineffectiveness and perceived pressure .", "Post-hoc testing found high depression Media Smart participants scored significantly lower than their control counterparts at post-program on shape and weight concern , media internalization and dieting , whereas low depression Media Smart participants scored significantly lower on shape and weight concern at 2.5-year follow-up .", "Media Smart achieved a reduction in eating disorder risk factors for high-depression participants and a reduced rate of growth in risk factor scores for low-depression participants .", "Trial registry name : Australian New Zealand Clinical Trials Registry .", "URL : http://www.anzctr.org.au .", "Registration identification number : ACTRN12608000545369 ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The purpose of this study was to determine the effects of early outpatient exercise on muscle mass , function , and fractional synthetic rate in severely burned children .", "Forty-seven children with 40 % total body surface area burn performed a 12-wk standard of care rehabilitation ( SOC , n = 23 ) or rehabilitative exercise training ( RET , n = 24 ) immediately after hospital discharge .", "Dual-energy x-ray absorptiometry was used to assess lean body mass ( LBM ) at discharge , posttreatment , and 12 months post-burn .", "Muscle function was evaluated with a Biodex Isokinetic Dynamometer , and peak aerobic fitness ( VO2peak ) was measured using a modified Bruce treadmill protocol posttreatment .", "Stable isotope infusion studies were performed in a subset of patients ( SOC , n = 13 ; RET , n = 11 ) at discharge and posttreatment to determine mixed-muscle fractional synthetic rate .", "Relative peak torque ( RET , 138 9 Nmkg , vs SOC , 106 9 Nmkg ) and VO2peak ( RET , 32 1 mLkgmin , vs SOC , 28 1 mLkgmin ) were greater at posttreatment with RET compared with those with SOC .", "In addition , RET increased whole-body ( 9 % 2 % ) and leg ( 17 % 3 % ) LBM compared with SOC .", "Furthermore , the percentage change in whole-body ( 18 % 3 % ) and leg ( 31 % 4 % ) LBM from discharge to 12 months post-burn was greater with RET compared to SOC .", "Muscle fractional synthetic rate decreased from discharge to posttreatment in both groups ( 6.9 % 1.1 % per day vs 3.4 0.4 % per day ) ; however , no differences were observed between treatment groups at each time point .", "Early outpatient exercise training implemented at hospital discharge represents an effective intervention to improve muscle mass and function after severe burn injury ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "This study compared generalized complex fractionated atrial electrograms ( CFAE ) ablation versus a selective CFAE ablation strategy targeting areas of continuous electric activity .", "Subjects with symptomatic , persistent/high-burden paroxysmal atrial fibrillation ( AF ) were enrolled at 6 centers ( n = 86 ) and randomized to 1 of 2 arms .", "For group I , all CFAE regions with an interval confidence level > 7 were ablated followed by pulmonary vein isolation ( PVI ) .", "For group II , only CFAE sites with continuous electric activity were ablated followed by PVI .", "For PVI , all 4 PV antra were isolated with confirmed entrance block .", "Subjects were followed for 1 year with a visit , ECG , and 48-hour Holter every 3 months .", "Symptoms were confirmed by loop recording .", "The primary end point was freedom from arrhythmia > 30 seconds at 1 year .", "For both group I and II , CFAE ablation prolonged AF cycle length ( 2533 versus 2333 ms ; P = 0.78 ) and resulted in similar rates of AF termination ( 37 % versus 28 % ; P = 0.42 ) .", "Radiofrequency duration during CFAE ablation was significantly less in group II ( 2320 versus 3820 minutes ; P = 0.002 ) .", "At 1-year follow-up , freedom from AF/atrial flutter/atrial tachycardia recurrence was significantly higher in group I versus group II after 1 procedure ( 50 % versus 28 % ; P = 0.03 ) .", "There were also significantly fewer repeat procedures in group I ( 13 % versus 36 % ; P = 0.021 ) .", "Continuous electric activity ablation + PVI result in a similar incidence of acute AF termination with significantly less radiofrequency time .", "However , incidence of repeat procedures and long-term recurrence of AF/atrial flutter/atrial tachycardia are significantly lower using generalized CFAE ablation + PVI .", "Clinical Trial Registration - URL : http://www.clinicaltrials.gov .", "Unique identifier : NCT00926783 ." ]

[ "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To determine if the use of a Bakri balloon at cesarean delivery ( CD ) for placenta previa is associated with a reduced need for additional surgical or pharmacologic measures and less blood loss than usual practices .", "In a randomized controlled trial , 52 women undergoing CD for placenta previa were randomly allocated 1:1 into an intervention arm ( prophylactic Bakri balloon immediately following placental delivery ) or a control arm ( use of any usual surgical/pharmacologic measures to achieve hemostasis ) .", "The primary outcomes were a clinician 's decision to undertake further intervention to control bleeding , and the difference between preoperative and postoperative hemoglobin levels .", "Although fewer women in the intervention group required additional measures to achieve hemostasis during CD , the difference between the groups was not significant ( relative risk 0.54 ; 95 % confidence interval , 0.19-1 .57 ) .", "The change in hemoglobin level among women in the intervention arm was also similar to that among controls ( 2.3 g/dL ; 95 % confidence interval , -4.4 to 8.9 ) .", "The prophylactic use of a Bakri balloon at CD for placenta previa tended to be of benefit , with no evidence of harm or patient dissatisfaction , but the need for additional medical/surgical measures to control blood loss was not significantly reduced .", "Australian New Zealand Clinical Trials Registry : ACTRN12613000348752 ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Exercise training is recommended for chronic heart failure ( HF ) patients to improve functional status and reduce risk of adverse outcomes .", "Elevated plasma levels of amino-terminal pro-brain natriuretic peptide ( NT-proBNP ) , high-sensitivity C-reactive protein ( hs-CRP ) , and cardiac troponin T ( cTnT ) are associated with increased risk of adverse outcomes in this patient population .", "Whether exercise training leads to improvements in biomarkers and how such improvements relate to clinical outcomes are unclear .", "Amino-terminal pro-brain natriuretic peptide , hs-CRP , and cTnT levels were assessed at baseline and 3 months in a cohort of 928 subjects from the HF-ACTION study , a randomized clinical trial of exercise training versus usual care in chronic HF patients with reduced left ventricular ejection fraction ( < 35 % ) .", "Linear and logistic regressions were used to assess 3-month biomarker levels as a function of baseline value , treatment assignment ( exercise training vs usual care ) , and volume of exercise .", "Linear regression and Cox proportional hazard modeling were used to evaluate the relations between changes in biomarker levels and clinical outcomes of interest that included change in peak oxygen consumption ( peak VO2 ) , hospitalizations , and mortality .", "Exercise training was not associated with significant changes in levels of NT-proBNP ( P = .10 ) , hs-CRP ( P = .80 ) , or detectable cTnT levels ( P = .83 ) at 3 months .", "Controlling for baseline biomarker levels or volume of exercise did not alter these findings .", "Decreases in plasma concentrations of NT-proBNP , but not hs-CRP or cTnT , were associated with increases in peak VO2 ( P < .001 ) at 3 months and decreased risk of hospitalizations or mortality ( P .04 ) , even after adjustment for a comprehensive set of known predictors .", "Exercise training did not lead to meaningful changes in biomarkers of myocardial stress , inflammation , or necrosis in patients with chronic HF .", "Only improvements in NT-proBNP translated to reductions in peak VO2 and reduced risk of clinical events ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Biofortification is a strategy to relieve vitamin A ( VA ) deficiency .", "Biofortified maize contains enhanced provitamin A concentrations and has been bioefficacious in animal and small human studies .", "The study sought to determine changes in total body reserves ( TBRs ) of vitamin A with consumption of biofortified maize .", "A randomized , placebo-controlled biofortified maize efficacy trial was conducted in 140 rural Zambian children .", "The paired ( 13 ) C-retinol isotope dilution test , a sensitive biomarker for VA status , was used to measure TBRs before and after a 90-d intervention .", "Treatments were white maize with placebo oil ( VA - ) , orange maize with placebo ( orange ) , and white maize with VA in oil [ 400 g retinol activity equivalents ( RAEs ) in 214 L daily ] ( VA + ) .", "In total , 133 children completed the trial and were analyzed for TBRs ( n = 44 or 45/group ) .", "Change in TBR residuals were not normally distributed ( P < 0.0001 ) ; median changes ( 95 % CI ) were as follows : VA - , 13 ( -19 , 44 ) mol ; orange , 84 ( 21 , 146 ) mol ; and VA + , 98 ( 24 , 171 ) mol .", "Nonparametric analysis showed no statistical difference between VA + and orange ( P = 0.34 ) ; both were higher than VA - ( P = 0.0034 ) .", "Median ( 95 % CI ) calculated liver reserves at baseline were 1.04 ( 0.97 , 1.12 ) mol/g liver , with 59 % > 1 mol/g , the subtoxicity cutoff ; none were < 0.1 mol/g , the deficiency cutoff .", "The calculated bioconversion factor was 10.4 g - carotene equivalents/1 g retinol by using the middle 3 quintiles of change in TBRs from each group .", "Serum retinol did not change in response to intervention ( P = 0.16 ) but was reduced with elevated C-reactive protein ( P = 0.0029 ) and -1 - acid glycoprotein ( P = 0.0023 ) at baseline .", "- Carotene from maize was efficacious when consumed as a staple food in this population and could avoid the potential for hypervitaminosis A that was observed with the use of preformed VA from supplementation and fortification .", "Use of more sensitive methods other than serum retinol alone , such as isotope dilution , is required to accurately assess VA status , evaluate interventions , and investigate the interaction of VA status and infection .", "This trial was registered at clinicaltrials.gov as NCT01814891 ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Submassive pulmonary embolism ( PE ) has a low mortality rate but can degrade functional capacity .", "The present study aims to provide rationale , methodology , and initial findings of a multicentre , randomised trial of fibrinolysis for PE that used a composite end-point , including quality of life measures .", "This investigator-initiated study was funded by a contract between a corporate partner and the investigator 's hospital ( the prime site ) .", "The investigator was the Food and Drug Administration ( FDA ) sponsor .", "The prime site subcontracted , indemnified , and trained consortia members .", "Consenting , normotensive patients with PE and right ventricular strain ( by echocardiography or biomarkers ) received low-molecular-weight heparin and random assignment to a single bolus of tenecteplase or placebo in double-blinded fashion .", "The outcomes were : ( i ) in-hospital rate of intubation , vasopressor support , and major haemorrhage , or ( ii ) at 90 days , death , recurrent PE , or composite that defined poor quality of life ( echocardiography , 6 min walk test and surveys ) .", "The planned sample size was n = 200 .", "Eight sites enrolled 87 patients over 5 years .", "The ratio of patients screened for each enrolled was 7.4 to 1 , equating to 11 h screening time per patient enrolled .", "Primary barrier to enrolment was the cost of screening .", "Two patients died ( 2.5 % , 95 % CI [ 0-8 % ] ) , one developed shock , but 18 ( 22 % , 95 % CI : [ 13-30 % ] ) had a poor quality of life .", "An investigator-initiated , FDA-regulated , multicentre trial of fibrinolysis for submassive PE was conducted , but was limited by screening costs and a low mortality rate .", "Quality of life measurements might represent a more important patient-centred end-point ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Crashes are the leading cause of death for teens , and parent-based interventions are a promising approach .", "We assess the effectiveness of Steering Teens Safe , a parent-focused program to increase safe teen driving .", "Steering Teens Safe aimed to improve parental communication with teens about safe driving using motivational interviewing techniques in conjunction with 19 safe driving lessons .", "A randomized controlled trial involved 145 parent-teen dyads ( 70 intervention and 75 control ) .", "Intervention parents received a 45-minute session to learn the program with four follow-up phone sessions , a DVD , and a workbook .", "Control parents received a standard brochure about safe driving .", "Scores were developed to measure teen-reported quantity and quality of parental communication about safe driving .", "The main outcome measure was a previously validated Risky Driving Score reported by teens .", "Because the Score was highly skewed , a generalized linear model based on a gamma distribution was used for analysis .", "Intervention teens ranked their parent 's success in talking about driving safety higher than control teens ( p = 0.035 ) and reported that their parents talked about more topics ( non-significant difference ) .", "The Risky Driving Score was 21 % lower in intervention compared to control teens ( 85 % CI = 0.60 , 1.00 ) .", "Interaction between communication quantity and the intervention was examined .", "Intervention teens who reported more successful communication had a 42 % lower Risky Driving Score ( 95 % CI = 0.37 , 0.94 ) than control parents with less successful communication .", "This program had a positive although not strong effect , and it may hold the most promise in partnership with other programs , such as Driver 's Education or Graduated Driver 's License policies .", "ClinicalTrials.gov NCT01014923 .", "Registered Nov. 16 , 2009 ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "Deep molecular response ( MR ( 4.5 ) ) defines a subgroup of patients with chronic myeloid leukemia ( CML ) who may stay in unmaintained remission after treatment discontinuation .", "It is unclear how many patients achieve MR ( 4.5 ) under different treatment modalities and whether MR ( 4.5 ) predicts survival .", "Patients from the randomized CML-Study IV were analyzed for confirmed MR ( 4.5 ) which was defined as 4.5 log reduction of BCR-ABL on the international scale ( IS ) and determined by reverse transcriptase polymerase chain reaction in two consecutive analyses .", "Landmark analyses were performed to assess the impact of MR ( 4.5 ) on survival .", "Of 1,551 randomly assigned patients , 1,524 were assessable .", "After a median observation time of 67.5 months , 5-year overall survival ( OS ) was 90 % , 5-year progression-free-survival was 87.5 % , and 8-year OS was 86 % .", "The cumulative incidence of MR ( 4.5 ) after 9 years was 70 % ( median , 4.9 years ) ; confirmed MR ( 4.5 ) was 54 % .", "MR ( 4.5 ) was reached more quickly with optimized high-dose imatinib than with imatinib 400 mg/day ( P = .016 ) .", "Independent of treatment approach , confirmed MR ( 4.5 ) at 4 years predicted significantly higher survival probabilities than 0.1 % to 1 % IS , which corresponds to complete cytogenetic remission ( 8-year OS , 92 % v 83 % ; P = .047 ) .", "High-dose imatinib and early major molecular remission predicted MR ( 4.5 ) .", "No patient with confirmed MR ( 4.5 ) has experienced progression .", "MR ( 4.5 ) is a new molecular predictor of long-term outcome , is reached by a majority of patients treated with imatinib , and is achieved more quickly with optimized high-dose imatinib , which may provide an improved therapeutic basis for treatment discontinuation in CML ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To compare the efficacy and safety of endoscopic dacryocystorhinostomy ( En-DCR ) with different stent materials for lacrimal sac intubation in primary nasolacrimal ductal obstructions .", "Randomized controlled study with three parallel groups .", "Level of evidence is 1b .", "A total of 91 patients ( five bilateral ) with primary nasolacrimal duct obstruction ( NLDO ) at a tertiary referral center scheduled for En-DCR were to allocated into three stent groups with a sealed envelope and were randomized into three treatments : silicone , Prolene ( polypropylene ) , and otologic T-tube .", "Ophthalmology and otolaryngology clinics evaluated the patients preoperatively and postoperatively with endoscopes , lacrimal system syringing , and dacryocystography .", "The success of the stents was evaluated 12 months after surgery with symptom relief and ostial patency .", "Complications were also noted .", "The overall success rate of the En-DCR in the stent groups was 78.1 % ( 75/96 ) ; specifically , 87.5 % ( 28/32 ) with silicone , 84.4 % ( 27/32 ) with Prolene , and 62.5 % ( 20/32 ) with T-tube .", "The efficacy of the procedures with the T-tube was significantly lower than that of the Prolene and silicone ( p = .031 , ( 2 ) test ) .", "There were no significant differences between the silicone and Prolene ( p = .718 , ( 2 ) test ) .", "Prolene was found to be related with orbital complications .", "Spontaneous loss is a particular complication of otologic T-tube and highly portends to failure .", "The results of our study suggest that efficacy , defined as anatomic and functional success , is equally high for silicone and Prolene stents and lower for otologic T-tube in En-DCR ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Little is known about the longer-term effects of adjunctive benzodiazepines on symptom response during treatment in patients with bipolar disorders .", "The study sample consisted of 482 patients with bipolar I or II disorder enrolled in a 6-month , randomized , multi-site comparison of lithium - and quetiapine-based treatment .", "Changes in clinical measures ( BISS total and subscales , CGI-BP , and CGI-Efficacy Index ) were compared between participants who did and did not receive benzodiazepine treatment at baseline or during follow-up .", "Selected outcomes were also compared between patients who did and did not initiate benzodiazepines during follow-up using stabilized inverse probability weighted analyses .", "Significant improvement in all outcome measures occurred within each benzodiazepine exposure group .", "Benzodiazepine users ( at baseline or during follow-up ) experienced significantly less improvement in BISS total , BISS irritability , and CGI-BP scores than did benzodiazepine non-users .", "There were no significant differences in these measures between patients who did and did not initiate benzodiazepines during follow-up in the weighted analyses .", "There was no significant effect of benzodiazepine use on any outcome measure in patients with comorbid anxiety or substance use disorders .", "This is a secondary analysis of data from a randomized effectiveness trial that was not designed to address differential treatment response according to benzodiazepine use .", "Adjunctive benzodiazepines may not significantly affect clinical outcome in lithium - or quetiapine-treated patients with bipolar I or II disorder over 6 months , after controlling for potential confounding factors ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Most patients with diabetic kidney disease ( DKD ) experience disease progression despite receiving standard care therapy .", "Oxidative stress is associated with DKD severity and risk of progression , but currently approved therapies do not directly attenuate the pathologic consequences of oxidative stress .", "GS-4997 is a once daily , oral molecule that inhibits Apoptosis Signal-regulating Kinase 1 ( ASK1 ) , which is a key mediator of the deleterious effects of oxidative stress .", "We describe the rationale and design of a Phase 2 placebo-controlled clinical trial investigating the effects of GS-4997 in patients with T2DM and stage 3/4 DKD receiving standard of care therapy .", "Approximately , 300 subjects will be randomized in a stratified manner , based on the estimated glomerular filtration rate ( eGFR ) and urine albumin to creatinine ratio , to one of four arms in this dose-ranging study .", "The primary endpoint is change in eGFR at 48 weeks , and the key secondary endpoint is change in albuminuria .", "Guided by the biology of oxidative stress signaling through ASK1 , the biology of DKD pathogenesis , and solid statistical methods , the decisions made for this Phase 2 study regarding delineating study population , efficacy outcomes , treatment period and statistical methods represent innovative attempts to resolve challenges specific to DKD study design ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "CONCLUSIONS" ]

[ "Adherence to medication is often low .", "Pharmacists may improve adherence , but a one-size-fits-all approach will not work : different patients have different needs .", "Goal of the current study is to assess the effectiveness of a patient-tailored , telephone-based intervention by a pharmacist at the start of pharmacotherapy aimed at improving medication adherence , satisfaction with information and counselling and the beliefs about medicines .", "A cluster randomized controlled intervention trial in 30 Dutch pharmacies , randomly assigned to 1 of 2 intervention groups .", "Each group consists of an intervention arm and an usual care arm .", "The intervention arm in the first group is the usual care arm in the second group and vice versa .", "One intervention arm focuses on patients starting with antidepressants or bisphosphonates and the other on antilipaemic drugs or renin angiotensin system ( RAS ) - inhibitors .", "The intervention consists of a telephone call by a pharmacist 2 or 3 weeks after a new prescription .", "A random sample of pharmacies will send questionnaires 3 months after the first prescription .", "This contains socio-demographic questions , a measure of beliefs about medicines ( BMQ ) , satisfaction with information received ( SIMS , abbreviated ) and frequency of pharmacy counselling ( Consumer Quality Index , CQI , abbreviated ) .", "The primary outcome measure will be medication adherence calculated from dispensing records retrieved 12 months after the intervention .", "Patients ' beliefs on medication , perception of the quality of information received and pharmacy counselling are secondary outcomes .", "The TelCIP study will determine the effectiveness of telephone counselling to improve adherence in patients initiating a new treatment .", "By measuring satisfaction with information and counselling and beliefs about medication the study will also give clues for the reason of a potential increase in adherence .", "Finally the study will provide information on which patients are most likely to benefit from this intervention .", "The trial is registered at http://www.trialregister.nl under the identifier NTR3237 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "The purpose of this study was to examine the effects of including female athletes ' weights in athletic event programs on female spectators ' body image , eating disorder symptoms , self-esteem , and affective state and to investigate whether the magnitude of the athletes ' reported weights had differential effects on female spectators ( i.e. , do female spectators who view heavier athletes respond differently than those who view less heavy athletes ? )", "We used an experimental design to examine hypotheses derived from competing theories to determine whether exposure to female athletes of varying weight would adversely or beneficially impact female undergraduates ( N = 152 ) who served as athletic event spectators .", "Analyses indicated that in this simulated study , female spectators ' body image , eating disorder symptoms , self-esteem , and affective states were not impacted by the presence or by the magnitude of female athletes ' weights in athletic event programs .", "The results imply that including athletes ' weights in game-day programs at women 's athletic events does not affect female spectators on an individual level ." ]

[ "OBJECTIVE", "METHODS", "RESULTS", "CONCLUSIONS" ]

[ "Approximately 20 % of patients are not satisfied with the outcome of total knee replacement , great volumes of which are carried out yearly .", "Physiotherapy is often provided by the NHS to address dysfunction following knee replacement ; however the efficacy of this is unknown .", "Although clinically it is accepted that therapy is useful , provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year .", "No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improving the one year outcomes .", "We are also investigating whether the structure of the physiotherapy provision itself influences outcomes .", "The study is a multi-centre prospective randomised controlled trial ( RCT ) of patients undergoing primary total knee replacement , with treatment targeted at those deemed most susceptible to gain from it .", "Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review , and recruit only those deemed to be recovering slowly.We aim to recruit 440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy .", "The intervention will be either ` intensive ' involving both hospital and home-based functional exercise rehabilitation , or ` standard of care ' consisting of home exercises .", "Patients will be randomised to either group using a web-based system .", "Both groups will receive pre and post-intervention physiotherapy review .", "Patients will be followed-up to one year post-operation .", "The primary outcome measure is the Oxford Knee Score .", "Secondary outcomes are patient satisfaction , functional ability , pain scores and cost-effectiveness .", "Current Controlled Trials ISRCTN23357609 .", "ClinicalTrials.gov NCT01849445 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "BACKGROUND", "BACKGROUND" ]

[ "In developing countries , mortality in children with very severe pneumonia is high , even with the provision of appropriate antibiotics , standard oxygen therapy , and other supportive care .", "We assessed whether oxygen therapy delivered by bubble continuous positive airway pressure ( CPAP ) improved outcomes compared with standard low-flow and high-flow oxygen therapies .", "This open , randomised , controlled trial took place in Dhaka Hospital of the International Centre for Diarrhoeal Disease Research , Bangladesh .", "We randomly assigned children younger than 5 years with severe pneumonia and hypoxaemia to receive oxygen therapy by either bubble CPAP ( 5 L/min starting at a CPAP level of 5 cm H2O ) , standard low-flow nasal cannula ( 2 L/min ) , or high-flow nasal cannula ( 2 L/kg per min up to the maximum of 12 L/min ) .", "Randomisation was done with use of the permuted block methods ( block size of 15 patients ) and Fisher and Yates tables of random permutations .", "The primary outcome was treatment failure ( ie , clinical failure , intubation and mechanical ventilation , death , or termination of hospital stay against medical advice ) after more than 1 h of treatment .", "Primary and safety analyses were by intention to treat .", "We did two interim analyses and stopped the trial after the second interim analysis on Aug 3 , 2013 , as directed by the data safety and monitoring board .", "This trial is registered at ClinicalTrials.gov , number NCT01396759 .", "Between Aug 4 , 2011 , and July 17 , 2013 , 225 eligible children were recruited .", "We randomly allocated 79 ( 35 % ) children to receive oxygen therapy by bubble CPAP , 67 ( 30 % ) to low-flow oxygen therapy , and 79 ( 35 % ) to high-flow oxygen therapy .", "Treatment failed for 31 ( 14 % ) children , of whom five ( 6 % ) had received bubble CPAP , 16 ( 24 % ) had received low-flow oxygen therapy , and ten ( 13 % ) had received high-flow oxygen therapy .", "Significantly fewer children in the bubble CPAP group had treatment failure than in the low-flow oxygen therapy group ( relative risk [ RR ] 027 , 997 % CI 007-099 ; p = 00026 ) .", "No difference in treatment failure was noted between patients in the bubble CPAP and those in the high-flow oxygen therapy group ( RR 050 , 997 % 011-229 ; p = 0175 ) .", "23 ( 10 % ) children died .", "Three ( 4 % ) children died in the bubble CPAP group , ten ( 15 % ) children died in the low-flow oxygen therapy group , and ten ( 13 % ) children died in the high-flow oxygen therapy group .", "Children who received oxygen by bubble CPAP had significantly lower rates of death than the children who received oxygen by low-flow oxygen therapy ( RR 025 , 95 % CI 007-089 ; p = 0022 ) .", "Oxygen therapy delivered by bubble CPAP improved outcomes in Bangladeshi children with very severe pneumonia and hypoxaemia compared with standard low-flow oxygen therapy .", "Use of bubble CPAP oxygen therapy could have a large effect in hospitals in developing countries where the only respiratory support for severe childhood pneumonia and hypoxaemia is low-flow oxygen therapy .", "The trial was stopped early because of higher mortality in the low-flow oxygen group than in the bubble CPAP group , and we acknowledge that the early cessation of the trial reduces the certainty of the findings .", "Further research is needed to test the feasibility of scaling up bubble CPAP in district hospitals and to improve bubble CPAP delivery technology .", "International Centre for Diarrhoeal Disease Research , Bangladesh , and Centre for International Child Health , University of Melbourne ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Blood Pressure related disease affected 118 million people in India in the year 2000 ; this figure will double by 2025 .", "Around one in four adults in rural India have hypertension , and of those , only a minority are accessing appropriate care .", "Health systems in India face substantial challenges to meet these gaps in care , and innovative solutions are needed .", "We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare .", "This intervention will be implemented as a stepped wedge , cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged 40 years at high cardiovascular disease event risk ( approximately 15,000 people ) .", "Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension 's region-specific risk charts .", "Cluster randomisation will occur at the level of the primary health centres .", "Outcome analyses will be conducted blinded to intervention allocation .", "The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period .", "Secondary outcomes include mean reduction in blood pressure levels ; change in other cardiovascular disease risk factors , including body mass index , current smoking , reported healthy eating habits , and reported physical activity levels ; self-reported use of blood pressure and other cardiovascular medicines ; quality of life ( using the EQ-5D ) ; and cardiovascular disease events ( using hospitalisation data ) .", "Trial outcomes will be accompanied by detailed process and economic evaluations .", "The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served populations in low and middle income country settings .", "Clinical Trial Registry India CTRI/2013/06 / 003753 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "CONCLUSIONS", "BACKGROUND" ]

[ "To observe the effect of external application of Zhuangshenling Recipe ( ZR ) combined with Western medicine ( WM ) on the heart function of chronic heart failure ( CHF ) patients of Xin-Shen yang deficiency , interior retention of water-fluid syndrome ( XSYDIRWFS ) .", "Totally 140 CHF patients of XSYDIRWFS were randomly assigned to two groups , the treatment group and the control group , 70 in each group .", "All patients received WM therapy .", "Those in the treatment group were applied with ZR at Xinshu ( BL15 ) and Shenshu ( BL23 ) , while those in the control group were applied with placebos at Xinshu ( BL15 ) and Shenshu ( BL23 ) .", "The therapeutic course for all was 12 weeks .", "The integrals of TCM syndrome , grading of cardiac function , brain natriuretic polypeptide ( BNP ) , and 6 min walking distance were observed before and after treatment .", "After twelve weeks of treatment , the effective rate of improved grading of cardiac function , the total effective rate of TCM syndrome efficacy , and the BNP level were obviously better in the treatment group ( P < 0.05 ) .", "There was no statistical difference in 6 min walking distance between the two groups ( P > 0.05 ) .", "External application of ZR combined with WM could improve the heart function of CHF patients of XSYDIRWFS ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "High levels of circulating fibroblast growth factor 23 ( FGF23 ) are associated with chronic kidney disease ( CKD ) progression and high mortality .", "In the Phosphate Reduction Evaluation of FGF23 in Early CKD Treatment ( PREFECT ) study , we assessed the effect of reducing intestinal phosphate absorption using lanthanum carbonate on FGF23 levels in normophosphatemic patients with CKD stage 3 .", "Thirty-five individuals were randomized to lanthanum carbonate 3000 mg/day ( n = 23 ) or placebo ( n = 12 ) for 12 weeks .", "Levels of intact FGF23 ( iFGF23 ) , C-terminal FGF23 , serum and urinary phosphate and calcium , intact parathyroid hormone and 1,25-dihydroxyvitamin D were assessed .", "The median age was 65 years in the lanthanum group and 73 years in the placebo group ; 58.8 % and 41.7 % were men , respectively .", "No significant difference was seen in mean iFGF23 between groups at week 12 .", "There was , however , a transient reduction from baseline in iFGF23 in the lanthanum group at week 1 , from 70.5 pg/ml to 51.9 pg/ml , which was not seen in the placebo group ; this between-group difference in percentage change from baseline was significant in post hoc analyses ( p = 0.0102 ) .", "Urinary phosphate decreased after 1 week of lanthanum treatment and remained low at week 12 .", "Reducing intestinal phosphate absorption with lanthanum carbonate did not lead to sustained reductions in iFGF23 in patients with CKD stage 3 , although phosphaturia decreased .", "This suggests that factors other than phosphate burden may be responsible for driving increases in circulating FGF23 in patients with CKD .", "ClinicalTrials.gov NCT01128179 , 20 May 2010 ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "This study sought to compare the efficacy of drug-eluting balloons ( DEB ) with that of everolimus-eluting stents ( EES ) in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) .", "Treatment of patients with ISR remains a challenge .", "This was a prospective , multicenter , randomized trial comparing DEB with EES in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) .", "The primary endpoint was the minimal lumen diameter at 9 months ' follow-up .", "A total of 189 patients with BMS-ISR from 25 Spanish sites were included ( 95 were allocated to DEB and 94 to EES ) .", "Procedural success was achieved in all patients .", "At late angiography ( median 249 days ; 92 % of eligible patients ) , patients in the EES arm had a significantly larger minimal lumen diameter ( 2.36 0.6 mm vs. 2.01 0.6 mm , p < 0.001 ; absolute mean difference : 0.35 mm ; 95 % confidence interval [ CI ] : 0.16 to 0.53 ) and a lower percent of diameter stenosis ( 13 17 % vs. 25 20 % , p < 0.001 ) .", "However , late loss ( 0.04 0.5 mm vs. 0.14 0.5 mm , p = 0.14 ) and binary restenosis rate ( 4.7 % vs. 9.5 % , p = 0.22 ) were very low and similar in both groups .", "Clinical follow-up ( median 365 days ) was obtained in all ( 100 % ) patients .", "Occurrences of the combined clinical outcome measure ( cardiac death , myocardial infarction , and target vessel revascularization ; 6 % vs. 8 % ; hazard ratio [ HR ] : 0.76 ; 95 % CI : 0.26 to 2.18 , p = 0.6 ) and the need for target vessel revascularization ( 2 % vs. 6 % ; HR : 0.32 : 95 % CI : 0.07 to 1.59 , p = 0.17 ) were similar in the 2 groups .", "In patients with BMS-ISR , both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences .", "However , compared with DEB , EES provide superior late angiographic findings .", "( Restenosis Intra-stent of Bare Metal Stents : Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [ RIBS V ] ; NCT01239953 ) ." ]

[ "OBJECTIVE", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Irregularity measures have been suggested as risk indicators in patients with atrial fibrillation ( AF ) ; however , it is not known to what extent they are affected by commonly used rate-control drugs .", "We aimed at evaluating the effect of metoprolol , carvedilol , diltiazem , and verapamil on the variability and irregularity of the ventricular response in patients with permanent AF .", "Sixty patients with permanent AF were part of an investigator-blind cross-over study , comparing 4 rate-control drugs ( diltiazem , verapamil , metoprolol , and carvedilol ) .", "We analyzed five 20-minute segments per patient : baseline and the 4 drug regimens .", "On every segment , heart rate ( HR ) variability and irregularity of RR series were computed .", "The variability was assessed as standard deviation , pNN20 , pNN50 , pNN80 , and rMSSD .", "The irregularity was assessed by regularity index , approximate ( ApEn ) , and sample entropy .", "A significantly lower HR was obtained with all drugs , the HR was lowest using the calcium channel blockers .", "All drugs increased the variability of ventricular response in respect to baseline ( as an example , rMSSD : baseline 171 47 milliseconds , carvedilol 229 58 milliseconds ; P < 0.05 vs. baseline , metoprolol 226 66 milliseconds ; P < 0.05 vs. baseline , verapamil 228 84 ; P < 0.05 vs. baseline , diltiazem 256 87 milliseconds ; P < 0.05 vs. baseline and all other drugs ) .", "Only - blockers significantly increased the irregularity of the RR series ( as an example , ApEn : baseline 1.86 0.13 , carvedilol 1.92 0.09 ; P < 0.05 vs. baseline , metoprolol 1.93 0.08 ; P < 0.05 vs. baseline , verapamil 1.86 0.22 ns , diltiazem 1.88 0.16 ns ) .", "Modification of AV node conduction by rate-control drugs increase RR variability , while only - blockers affect irregularity ." ]

[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Among patients with quiescent ulcerative colitis ( UC ) , lower fecal concentrations of calprotectin are associated with lower rates of relapse .", "We performed an open-label , randomized controlled trial to investigate whether increasing doses of mesalamine reduce concentrations of fecal calprotectin ( FC ) in patients with quiescent UC .", "We screened 119 patients with UC in remission on the basis of Simple Clinical Colitis Activity Index scores , FC > 50 g/g , and intake of no more than 3 g/day mesalamine .", "Participants taking mesalamine formulations other than multimatrix mesalamine were switched to multimatrix mesalamine ( 2.4 g/day ) for 6 weeks ; 52 participants were then randomly assigned ( 1:1 ) to a group that continued its current dose of mesalamine ( controls , n = 26 ) or a group that increased its dose by 2.4 g/day for 6 weeks ( n = 26 ) .", "The primary outcome was continued remission with FC < 50 g/g .", "Secondary outcomes were continued remission with FC < 100 g/g or < 200 g/g ( among patients with pre-randomization values above these levels ) .", "The primary outcome was achieved by 3.8 % of controls and 26.9 % of the dose escalation group ( P = .0496 ) .", "More patients in the dose escalation group reduced FC to below 100 g/g ( P = .04 ) and 200 g/g ( P = .005 ) .", "Among the patients who were still in remission after the randomization phase , clinical relapse occurred sooner in patients with FC > 200 g/g compared with those with FC < 200 g/g ( P = .01 ) .", "Among patients with quiescent UC and increased levels of FC , increasing the dose of mesalamine by 2.4 g/day reduced fecal concentrations of calprotectin to those associated with lower rates of relapse .", "Clinicaltrials.gov number : NCT00652145 ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Despite standard statin therapy , a majority of patients retain a high `` residual risk '' of cardiovascular events .", "The aim of this study was to evaluate the effects of ezetimibe plus atorvastatin versus atorvastatin monotherapy on the lipid profile and coronary atherosclerosis in Japanese patients who underwent percutaneous coronary intervention ( PCI ) .", "This trial was a prospective , randomized , controlled , multicenter study .", "Eligible patients who underwent PCI were randomly assigned to atorvastatin alone or atorvastatin plus ezetimibe ( 10 mg ) daily .", "Atorvastatin was uptitrated with a treatment goal of low-density lipoprotein cholesterol ( LDL-C ) < 70 mg/dl .", "Serial volumetric intravascular ultrasound was performed at baseline and again at 9 to 12 months to quantify the coronary plaque response in 202 patients .", "The combination of atorvastatin/ezetimibe resulted in lower levels of LDL-C than atorvastatin monotherapy ( 63.2 16.3 mg/dl vs. 73.3 20.3 mg/dl ; p < 0.001 ) .", "For the absolute change in percent atheroma volume ( PAV ) , themean difference between the 2 groups ( -1.538 % ; 95 % confidence interval [ CI ] : -3.079 % to 0.003 % ) did not exceedthe pre-defined noninferiority margin of 3 % , but the absolute change in PAV did show superiority for the dual lipid-lowering strategy ( -1.4 % ; 95 % CI : -3.4 % to -0.1 % vs. -0.3 % ; 95 % CI : -1.9 % to 0.9 % with atorvastatin alone ; p = 0.001 ) .", "For PAV , a significantly greater percentage of patients who received atorvastatin/ezetimibe showed coronary plaque regression ( 78 % vs. 58 % ; p = 0.004 ) .", "Both strategies had acceptable side effect profiles , with a low incidence oflaboratory abnormalities and cardiovascular events .", "Compared with standard statin monotherapy , the combination of statin plus ezetimibe showed greater coronary plaque regression , which might be attributed to cholesterol absorption inhibition-induced aggressive lipid lowering .", "( Plaque Regression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound [ PRECISE-IVUS ] ; NCT01043380 ) ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]