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METHODS Patients were randomly assigned to receive 20 mg of lidocaine either as lidocaine 2 % gel ( 1 ml ) or as lidocaine 4 % unpreserved eyedrops ( 0.5 ml ) before clear corneal phacoemulsification . |
METHODS Aqueous samples were taken to measure lidocaine intraocular levels . |
METHODS Intraoperative pain was quantified a few minutes after surgery using a 0 to 10 visual analog scale . |
METHODS Patients were asked to grade the degree to which they were bothered by tissue manipulation . |
METHODS The surgeon graded patients ' cooperation . |
METHODS The anesthesiologist recorded any increase in pulse or blood pressure and the need for supplemental topical anesthesia or intravenous sedation . |
METHODS Duration of surgery and intraoperative complications were also recorded . |
RESULTS In the gel group intracameral lidocaine levels were significantly higher ( P < 0.001 ) and patient-reported intraoperative pain scores were significantly lower ( P = 0.026 ) . |
RESULTS Patients in the gel group were bothered by tissue manipulation to a lesser extent ( P = 0.028 ) , and their cooperation was better ( P = 0.002 ) . |
RESULTS Increases in blood pressure were more frequent in the eyedrops group . |
RESULTS Supplemental anesthesia was required in two cases ( 3.70 % ) in the gel group versus eight cases in the eyedrops group ( 15.09 % ) . |
RESULTS No correlation between intracameral lidocaine levels and intraoperative pain scores was found ( r = -0.026 , P = 0.789 ) . |
CONCLUSIONS If administered by means of gel , the same amount of lidocaine gives significantly higher intracameral levels of lidocaine , better analgesia , better patient cooperation , and less need for intraoperative supplemental anesthesia . |
CONCLUSIONS Lower pain scores do not correlate with intracameral lidocaine levels . |
###23435350 |
BACKGROUND Psychosocial stress profoundly impacts long-term cardiovascular health through adverse effects on sympathetic nervous system activity , endothelial dysfunction , and atherosclerotic development . |
BACKGROUND Recreational Music Making ( RMM ) is a unique stress amelioration strategy encompassing group music-based activities that has great therapeutic potential for treating patients with stress-related cardiovascular disease . |
METHODS Participants ( n = 34 ) with a history of ischemic heart disease were subjected to an acute time-limited stressor , then randomized to RMM or quiet reading for one hour . |
METHODS Peripheral blood gene expression using GeneChip Human Genome U133A 2.0 arrays was assessed at baseline , following stress , and after the relaxation session . |
RESULTS Full gene set enrichment analysis identified 16 molecular pathways differentially regulated ( P < 0.005 ) during stress that function in immune response , cell mobility , and transcription . |
RESULTS During relaxation , two pathways showed a significant change in expression in the control group , while 12 pathways governing immune function and gene expression were modulated among RMM participants . |
RESULTS Only 13 % ( 2/16 ) of pathways showed differential expression during stress and relaxation . |
CONCLUSIONS Human stress and relaxation responses may be controlled by different molecular pathways . |
CONCLUSIONS Relaxation through active engagement in Recreational Music Making may be more effective than quiet reading at altering gene expression and thus more clinically useful for stress amelioration . |
###18848141 |
OBJECTIVE The goal of this study was to determine whether azimilide , as compared with placebo , will reduce the number of emergency department ( ED ) visits and hospitalizations caused by arrhythmias or cardiac events in patients with an implantable cardioverter-defibrillator ( ICD ) . |
BACKGROUND Patients with an ICD may require ED visits and hospitalizations because of arrhythmias , which trigger ICD therapies . |
BACKGROUND The effect of adjunctive antiarrhythmic therapy on these outcomes is not known . |
METHODS A total of 633 patients with an ICD were randomized in the SHIELD ( SHock Inhibition Evaluation with AzimiLiDe ) trial , a blinded , placebo-controlled randomized trial of the investigational class III antiarrhythmic azimilide ( 75 and 125 mg/day ) , and , prospectively , cardiac and arrhythmic ED visits and hospitalization data were collected over 1 year . |
RESULTS All patients had symptomatic sustained ventricular tachycardia ( 72 % ) or ventricular fibrillation ( 28 % ) before study entry . |
RESULTS Overall , 44 % ( n = 276 ) experienced at least 1 cardiac ED visit or hospitalization . |
RESULTS Among 214 patients assigned to placebo , 38.3 % had at least 1 arrhythmic-related ED visit or hospitalization compared with 21.8 % of 220 patients assigned to 75-mg azimilide ( p < 0.001 ) and 27.6 % of 199 patients assigned to 125 mg azimilide ( p < 0.05 ) . |
RESULTS Symptomatic ventricular tachycardia treated by antitachycardia pacing , shocks , and shocks plus symptomatic arrhythmias were significant predictors of cardiac-related ED visits or hospitalizations ( relative risk : 2.0 , 3.0 , and 3.1 , respectively ) . |
RESULTS In a stepwise logistic regression model , the presence of congestive heart failure ( New York Heart Association functional class II/III ) was the only additional independent predictor of cardiac ED visits or hospitalizations . |
CONCLUSIONS Azimilide significantly reduces the number of ED visits and hospitalizations in patients with an ICD at high risk of arrhythmias . |
###8475955 |
OBJECTIVE Our aim was to test the hypothesis that acetylsalicylate ( aspirin ) treatment reduces the incidence or severity of pregnancy-associated hypertension . |
METHODS Patients were nulliparous , healthy , and with a singleton gestation at between 20 and 22 weeks ' gestation . |
METHODS A sample size of 600 patients was calculated on the basis of p < or = 0.05 and 90 % power of observation . |
METHODS A 2-week placebo-controlled `` run-in '' was used to select compliant patients . |
METHODS Randomization occurred at 24 weeks , with 60 mg of aspirin or placebo treatment from randomization to delivery . |
RESULTS Follow-up was maintained on 99 % of the patients . |
RESULTS The randomized patients had a 94 % pill compliance index . |
RESULTS At randomization , serum thromboxane medians were similar in both groups . |
RESULTS Thromboxane B2 levels in the aspirin group decreased significantly from baseline at 29 to 31 weeks , 34 to 36 weeks , and at delivery as compared with an overall increase in the placebo group . |
RESULTS Preeclampsia developed in five of 302 women ( 1.7 % ) who received aspirin versus 17 of 302 ( 5.6 % ) who received the placebo ( p = 0.009 ) . |
RESULTS Preeclampsia was severe in one aspirin and in six placebo recipients ( p = 0.06 ) . |
CONCLUSIONS Daily ingestion of 60 mg of aspirin beginning at 24 weeks ' gestation significantly reduced the occurrence of preeclampsia . |
###18021533 |
OBJECTIVE To assess the efficacy and safety of interferon-alpha ( IFN-alpha ) in children with Hepatitis B e antigen-positive chronic hepatitis B virus infection . |
METHODS PubMed and Chinese Biomedical Database were searched from the beginning of operation of the databases to April 2006 , and the references of eligible studies were manually screened . |
METHODS Randomized controlled trials ( RCTs ) published in the English and Chinese literature comparing interferon-alpha with non-antiviral interventions ( placebo or no treatment ) in children with hepatitis B e antigen-positive chronic hepatitis B virus infection were eligible for inclusion . |
METHODS Studies were included if patients were treated for at least 3 months and followed-up for at least 6 months after cessation of therapy . |
METHODS Two investigators independently assessed the quality and extracted the data . |
METHODS The methodological quality of trails was assessed by the Jadad-scale plus allocation concealment . |
METHODS Heterogeneity was examined by Chi-square test . |
METHODS Fixed effects model or random effects model were used to pool the data . |
METHODS Sensitivity analyses were used for the treatment course . |
RESULTS Ten randomized controlled studies with a total of 542 children chronic HBV carriers who were positive for hepatitis B surface antigen ( HBsAg ) and hepatitis B e antigen ( HBeAg ) were identified . |
RESULTS It was found by the meta-analysis that , compared with the control , at the end of the follow-up period , IFN-alpha could still significantly clear HBeAg [ 31.1 % vs. 12.4 % , odds ratio ( OR ) : 3.17 , 95 % CI ( 2.00 , 5.02 ) , P < 0.000 01 ] , clear HBV-DNA [ 33.9 % vs. 16.2 % , OR : 2.59 , 95 % CI ( 1.70 , 3.96 ) , P < 0.0001 ] , clear HBsAg [ 5.5 % vs. 1.2 % , OR : 3.44 , 95 % CI ( 1.20 , 9.89 ) , P = 0.02 ] , normalize ALT [ 43.0 % vs. 27.7 % , OR : 1.99 , 95 % CI ( 1.16 , 3.42 ) , P = 0.01 ] , and achieve HBeAg seroconversion [ 30.4 % vs. 12.8 % , OR : 2.90 , 95 % CI ( 1.56 , 5.39 ) , P = 0.0008 ] , but was not effective in HBsAg seroconversion [ 1.9 % vs. 0 , 95 % CI ( 0.42 , 18.13 ) , P = 0.29 ] . |
CONCLUSIONS Interferon-alpha might be efficacious in clearance of HBeAg , HBV-DNA and HBsAg , normalization of ALT , and achievement of HBeAg seroconversion in children with chronic hepatitis B. Little evidence is available on HBsAg seroconversion . |
CONCLUSIONS Further RCTs of high-quality and sufficient number of cases are needed for confirmation of the clinical efficacy of IFN-alpha in chronic hepatitis B in children . |
###24224521 |
BACKGROUND Submassive pulmonary embolism ( PE ) has a low mortality rate but can degrade functional capacity . |
OBJECTIVE 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 . |
METHODS This investigator-initiated study was funded by a contract between a corporate partner and the investigator 's hospital ( the prime site ) . |
METHODS The investigator was the Food and Drug Administration ( FDA ) sponsor . |
METHODS The prime site subcontracted , indemnified , and trained consortia members . |
METHODS 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 . |
METHODS 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 ) . |
METHODS The planned sample size was n = 200 . |
RESULTS Eight sites enrolled 87 patients over 5 years . |
RESULTS The ratio of patients screened for each enrolled was 7.4 to 1 , equating to 11 h screening time per patient enrolled . |
RESULTS Primary barrier to enrolment was the cost of screening . |
RESULTS 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 . |
CONCLUSIONS 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 . |
CONCLUSIONS Quality of life measurements might represent a more important patient-centred end-point . |
###15119720 |
OBJECTIVE To compare in vivo bitewing film quality using the holder versus the paper loop technique . |
METHODS Four bitewing films were taken from the right and left premolar and molar regions of 45 dental students using both the bitewing holder and paper loop techniques . |
METHODS A total of 360 films were taken and assessed by an experienced practitioner not apprised of the bitewing technique used . |
METHODS Of interest were : ( 1 ) the number of overlaps and the percentage of teeth showing the alveolar crest ; ( 2 ) proper film positioning ; and ( 3 ) the percentage of cone cutting . |
METHODS A Poisson regression using generalized estimating equations ( GEEs ) was used to estimate the difference in overlap between the two techniques . |
METHODS For proper positioning and cone cutting , logistic regressions using GEEs were used . |
RESULTS The average number of horizontal overlaps for the loop and holder techniques at the right premolar , right molar , left premolar , and left molar were 1.64 , 2.11 , 2.16 , 2.78 , and 1.64 , 2.00 , 2.00 , 2.18 , respectively . |
RESULTS The loop technique was 1.11 times more likely to cause overlapping than the holder technique . |
RESULTS The highest percentage of teeth showing the alveolar crest by the loop technique was 97.8 % in the mandibular second premolar and first molar . |
RESULTS With respect to film positioning , the loop technique was 1.12 times more likely to cause improper positioning than the holder technique . |
RESULTS Both techniques demonstrated minimal cone cutting ( 1 in the loop versus 0 in the holder ) . |
CONCLUSIONS The quality of bitewing films taken by the loop and holder techniques was not significantly different . |
###1388878 |
OBJECTIVE To evaluate clinical efficacy and toxicity of low-dose oral natural human interferon-alpha ( nHuIFN alpha ) on CD4 + lymphocyte counts and clinical symptoms in patients with HIV-1 infection . |
METHODS Double-blind , randomized , placebo-controlled trial with crossover . |