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METHODS | 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 . |
METHODS | The primary efficacy measure is time to first occurrence of coronary heart disease death , acute myocardial infarction , hospitalization for unstable angina , or ischemic stroke . |
METHODS | 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 . |
METHODS | Adverse events of special interest include allergic events and injection site reactions . |
METHODS | Interim analyses are planned when approximately 50 % and 75 % of the targeted number of primary end points have occurred . |
CONCLUSIONS | ODYSSEY Outcomes will determine whether the addition of the PCSK9 antibody alirocumab to intensive statin therapy reduces cardiovascular morbidity and mortality after ACS . |
###25926413 | null |
BACKGROUND | 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 . |
OBJECTIVE | 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 . |
METHODS | We enrolled 869 pregnant women in a randomized trial in Malawi . |
METHODS | 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 ] . |
METHODS | Children in the IFA and MMN groups received no supplementation ; children in the LNS group received SQ-LNSs from 6 to 18 mo. . |
METHODS | Primary outcome was child length at 18 mo. . |
RESULTS | 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 . |
RESULTS | 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 ) . |
RESULTS | 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 ) . |
CONCLUSIONS | 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 . |
CONCLUSIONS | This trial was registered at clinicaltrials.gov as NCT01239693 . |
###25265770 | null |
BACKGROUND | Femoral nerve block ( FNB ) with varying concentrations of bupivacaine is often used for postoperative analgesia after anterior cruciate ligament ( ACL ) reconstruction . |
OBJECTIVE | To determine whether FNB using 0.25 % or 0.5 % bupivacaine provided better analgesia with less effect on quadriceps strengths after ACL reconstruction . |
METHODS | One hundred patients were randomized to receive FNB with 20 mL of 0.25 % or 0.5 % bupivacaine . |
METHODS | 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 . |
RESULTS | 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 ) . |
RESULTS | Pain score at 18 hours was lower in 0.5 % bupivacaine group compared with 0.25 % bupivacaine group ( p = 0.001 ) . |
RESULTS | 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 ) . |
RESULTS | No differences were found in demographic data , effectiveness of FNB , time to first pain , morphine consumption , and recovery of sensorimotor function . |
CONCLUSIONS | 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 . |
CONCLUSIONS | Both concentrations showed similar effect on quadriceps strengths . |
###25908281 | null |
OBJECTIVE | To establish a preoperative deep venous thrombosis predictor score for patients with fresh lower extremity fractures by statistical analysis . |
METHODS | From January 2011 to December 2012 , 1 705 patients with fresh lower extremity fractures were admitted to department of orthopaedic trauma , Beijing Jishuitan Hospital . |
METHODS | 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 . |
RESULTS | 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 . |
RESULTS | 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 . |
RESULTS | D-Dimer < 600 g/L :1 point , 600 g/L :3 points . |
RESULTS | Area under receiver operating characteristic curve was 0.79 , critical point 15.5 points , sensitivity was 77.00 % , specificity was 68.17 % . |
CONCLUSIONS | The score can predict the preoperative deep venous thrombosis for patients with fresh lower extremity fractures , but limited . |
###24342265 | null |
OBJECTIVE | 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 . |
METHODS | 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 ) . |
METHODS | Shape and weight concern , media internalization , body dissatisfaction , dieting , ineffectiveness , and perceived pressure were the outcome variables . |
RESULTS | 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 . |
RESULTS | Such effects were found for shape and weight concern , media internalization , body dissatisfaction , ineffectiveness and perceived pressure . |
RESULTS | 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 . |
CONCLUSIONS | 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 . |
CONCLUSIONS | Trial registry name : Australian New Zealand Clinical Trials Registry . |
CONCLUSIONS | URL : http://www.anzctr.org.au . |
CONCLUSIONS | Registration identification number : ACTRN12608000545369 . |
###24824900 | null |
OBJECTIVE | 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 . |
METHODS | 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 . |
METHODS | Dual-energy x-ray absorptiometry was used to assess lean body mass ( LBM ) at discharge , posttreatment , and 12 months post-burn . |
METHODS | Muscle function was evaluated with a Biodex Isokinetic Dynamometer , and peak aerobic fitness ( VO2peak ) was measured using a modified Bruce treadmill protocol posttreatment . |
METHODS | 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 . |
RESULTS | 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 . |
RESULTS | In addition , RET increased whole-body ( 9 % 2 % ) and leg ( 17 % 3 % ) LBM compared with SOC . |
RESULTS | 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 . |
RESULTS | 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 . |
CONCLUSIONS | Early outpatient exercise training implemented at hospital discharge represents an effective intervention to improve muscle mass and function after severe burn injury . |
###24425420 | null |
BACKGROUND | This study compared generalized complex fractionated atrial electrograms ( CFAE ) ablation versus a selective CFAE ablation strategy targeting areas of continuous electric activity . |
RESULTS | Subjects with symptomatic , persistent/high-burden paroxysmal atrial fibrillation ( AF ) were enrolled at 6 centers ( n = 86 ) and randomized to 1 of 2 arms . |
RESULTS | For group I , all CFAE regions with an interval confidence level > 7 were ablated followed by pulmonary vein isolation ( PVI ) . |
RESULTS | For group II , only CFAE sites with continuous electric activity were ablated followed by PVI . |
RESULTS | For PVI , all 4 PV antra were isolated with confirmed entrance block . |
RESULTS | Subjects were followed for 1 year with a visit , ECG , and 48-hour Holter every 3 months . |
RESULTS | Symptoms were confirmed by loop recording . |
RESULTS | The primary end point was freedom from arrhythmia > 30 seconds at 1 year . |
RESULTS | 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 ) . |
RESULTS | Radiofrequency duration during CFAE ablation was significantly less in group II ( 2320 versus 3820 minutes ; P = 0.002 ) . |
RESULTS | 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 ) . |
RESULTS | There were also significantly fewer repeat procedures in group I ( 13 % versus 36 % ; P = 0.021 ) . |
CONCLUSIONS | Continuous electric activity ablation + PVI result in a similar incidence of acute AF termination with significantly less radiofrequency time . |
CONCLUSIONS | However , incidence of repeat procedures and long-term recurrence of AF/atrial flutter/atrial tachycardia are significantly lower using generalized CFAE ablation + PVI . |
CONCLUSIONS | Clinical Trial Registration - URL : http://www.clinicaltrials.gov . |
CONCLUSIONS | Unique identifier : NCT00926783 . |
###24262684 | null |
OBJECTIVE | 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 . |
METHODS | 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 ) . |
METHODS | The primary outcomes were a clinician 's decision to undertake further intervention to control bleeding , and the difference between preoperative and postoperative hemoglobin levels . |
RESULTS | 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 ) . |
RESULTS | 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 ) . |
CONCLUSIONS | 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 . |
CONCLUSIONS | Australian New Zealand Clinical Trials Registry : ACTRN12613000348752 . |
###24439980 | null |
BACKGROUND | Exercise training is recommended for chronic heart failure ( HF ) patients to improve functional status and reduce risk of adverse outcomes . |
BACKGROUND | 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 . |
BACKGROUND | Whether exercise training leads to improvements in biomarkers and how such improvements relate to clinical outcomes are unclear . |
RESULTS | 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 % ) . |
RESULTS | 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 . |
RESULTS | 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 . |
RESULTS | 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 . |
RESULTS | Controlling for baseline biomarker levels or volume of exercise did not alter these findings . |
RESULTS | 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 . |
CONCLUSIONS | Exercise training did not lead to meaningful changes in biomarkers of myocardial stress , inflammation , or necrosis in patients with chronic HF . |
CONCLUSIONS | Only improvements in NT-proBNP translated to reductions in peak VO2 and reduced risk of clinical events . |
###25411289 | null |
BACKGROUND | Biofortification is a strategy to relieve vitamin A ( VA ) deficiency . |
BACKGROUND | Biofortified maize contains enhanced provitamin A concentrations and has been bioefficacious in animal and small human studies . |