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OBJECTIVE | The study sought to determine changes in total body reserves ( TBRs ) of vitamin A with consumption of biofortified maize . |
METHODS | A randomized , placebo-controlled biofortified maize efficacy trial was conducted in 140 rural Zambian children . |
METHODS | 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 . |
METHODS | 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 + ) . |
RESULTS | In total , 133 children completed the trial and were analyzed for TBRs ( n = 44 or 45/group ) . |
RESULTS | 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 . |
RESULTS | Nonparametric analysis showed no statistical difference between VA + and orange ( P = 0.34 ) ; both were higher than VA - ( P = 0.0034 ) . |
RESULTS | 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 . |
RESULTS | 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 . |
RESULTS | 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 . |
CONCLUSIONS | - 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 . |
CONCLUSIONS | 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 . |
CONCLUSIONS | This trial was registered at clinicaltrials.gov as NCT01814891 . |
###24224521 | null |
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 . |
###25082132 | null |
BACKGROUND | Crashes are the leading cause of death for teens , and parent-based interventions are a promising approach . |
BACKGROUND | We assess the effectiveness of Steering Teens Safe , a parent-focused program to increase safe teen driving . |
METHODS | Steering Teens Safe aimed to improve parental communication with teens about safe driving using motivational interviewing techniques in conjunction with 19 safe driving lessons . |
METHODS | A randomized controlled trial involved 145 parent-teen dyads ( 70 intervention and 75 control ) . |
METHODS | Intervention parents received a 45-minute session to learn the program with four follow-up phone sessions , a DVD , and a workbook . |
METHODS | Control parents received a standard brochure about safe driving . |
METHODS | Scores were developed to measure teen-reported quantity and quality of parental communication about safe driving . |
METHODS | The main outcome measure was a previously validated Risky Driving Score reported by teens . |
METHODS | Because the Score was highly skewed , a generalized linear model based on a gamma distribution was used for analysis . |
RESULTS | 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 ) . |
RESULTS | The Risky Driving Score was 21 % lower in intervention compared to control teens ( 85 % CI = 0.60 , 1.00 ) . |
RESULTS | Interaction between communication quantity and the intervention was examined . |
RESULTS | 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 . |
CONCLUSIONS | 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 . |
BACKGROUND | ClinicalTrials.gov NCT01014923 . |
BACKGROUND | Registered Nov. 16 , 2009 . |
###24297946 | null |
OBJECTIVE | 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 . |
OBJECTIVE | It is unclear how many patients achieve MR ( 4.5 ) under different treatment modalities and whether MR ( 4.5 ) predicts survival . |
METHODS | 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 . |
METHODS | Landmark analyses were performed to assess the impact of MR ( 4.5 ) on survival . |
RESULTS | Of 1,551 randomly assigned patients , 1,524 were assessable . |
RESULTS | 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 % . |
RESULTS | The cumulative incidence of MR ( 4.5 ) after 9 years was 70 % ( median , 4.9 years ) ; confirmed MR ( 4.5 ) was 54 % . |
RESULTS | MR ( 4.5 ) was reached more quickly with optimized high-dose imatinib than with imatinib 400 mg/day ( P = .016 ) . |
RESULTS | 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 ) . |
RESULTS | High-dose imatinib and early major molecular remission predicted MR ( 4.5 ) . |
RESULTS | No patient with confirmed MR ( 4.5 ) has experienced progression . |
CONCLUSIONS | 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 . |
###25590323 | null |
OBJECTIVE | To compare the efficacy and safety of endoscopic dacryocystorhinostomy ( En-DCR ) with different stent materials for lacrimal sac intubation in primary nasolacrimal ductal obstructions . |
METHODS | Randomized controlled study with three parallel groups . |
METHODS | Level of evidence is 1b . |
METHODS | 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 . |
METHODS | Ophthalmology and otolaryngology clinics evaluated the patients preoperatively and postoperatively with endoscopes , lacrimal system syringing , and dacryocystography . |
METHODS | The success of the stents was evaluated 12 months after surgery with symptom relief and ostial patency . |
METHODS | Complications were also noted . |
RESULTS | 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 . |
RESULTS | The efficacy of the procedures with the T-tube was significantly lower than that of the Prolene and silicone ( p = .031 , ( 2 ) test ) . |
RESULTS | There were no significant differences between the silicone and Prolene ( p = .718 , ( 2 ) test ) . |
RESULTS | Prolene was found to be related with orbital complications . |
RESULTS | Spontaneous loss is a particular complication of otologic T-tube and highly portends to failure . |
CONCLUSIONS | 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 . |
###24751304 | null |
BACKGROUND | Little is known about the longer-term effects of adjunctive benzodiazepines on symptom response during treatment in patients with bipolar disorders . |
METHODS | 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 . |
METHODS | 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 . |
METHODS | Selected outcomes were also compared between patients who did and did not initiate benzodiazepines during follow-up using stabilized inverse probability weighted analyses . |
RESULTS | Significant improvement in all outcome measures occurred within each benzodiazepine exposure group . |
RESULTS | 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 . |
RESULTS | There were no significant differences in these measures between patients who did and did not initiate benzodiazepines during follow-up in the weighted analyses . |
RESULTS | There was no significant effect of benzodiazepine use on any outcome measure in patients with comorbid anxiety or substance use disorders . |
CONCLUSIONS | 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 . |
CONCLUSIONS | 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 . |
###25531162 | null |
BACKGROUND | Most patients with diabetic kidney disease ( DKD ) experience disease progression despite receiving standard care therapy . |
BACKGROUND | 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 . |
BACKGROUND | 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 . |
METHODS | 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 . |
METHODS | 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 . |
METHODS | The primary endpoint is change in eGFR at 48 weeks , and the key secondary endpoint is change in albuminuria . |
CONCLUSIONS | 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 . |
###24885317 | null |
BACKGROUND | Adherence to medication is often low . |
BACKGROUND | Pharmacists may improve adherence , but a one-size-fits-all approach will not work : different patients have different needs . |
BACKGROUND | 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 . |
METHODS | A cluster randomized controlled intervention trial in 30 Dutch pharmacies , randomly assigned to 1 of 2 intervention groups . |
METHODS | Each group consists of an intervention arm and an usual care arm . |
METHODS | The intervention arm in the first group is the usual care arm in the second group and vice versa . |
METHODS | One intervention arm focuses on patients starting with antidepressants or bisphosphonates and the other on antilipaemic drugs or renin angiotensin system ( RAS ) - inhibitors . |
METHODS | The intervention consists of a telephone call by a pharmacist 2 or 3 weeks after a new prescription . |