Articles: human.
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Randomized Controlled Trial Multicenter Study
Persistence of immunity after vaccination with a capsular group B meningococcal vaccine in 3 different toddler schedules.
One schedule for the capsular group B meningococcal vaccine 4CMenB is 2 doses that are administered 2 months apart for children aged 12-23 months, with a booster dose 12-24 months later. Our objective was to provide data on persistence of human serum bactericidal antibody (hSBA) titres in children up to 4 years of age after initial doses at 12-24 months, and immunogenicity of a booster dose at 48 months of age compared with vaccine-naive children. ⋯ We found that waning of hSBA titres by 4 years of age occurred after 2 doses of 4CMenB vaccine administered at 12-24 months, and doses at 12-24 months have a priming effect on the immune system. A booster may be necessary to maintain hSBA titres of 1:5 or more among those children with increased disease risk. Trial registration: ClinicalTrials.gov, no. NCT01717638.
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Clin J Am Soc Nephrol · Sep 2017
Multicenter Study Comparative StudyFrailty Screening Tools for Elderly Patients Incident to Dialysis.
A geriatric assessment is an appropriate method for identifying frail elderly patients. In CKD, it may contribute to optimize personalized care. However, a geriatric assessment is time consuming. The purpose of our study was to compare easy to apply frailty screening tools with the geriatric assessment in patients eligible for dialysis. ⋯ All frailty screening tools are able to detect geriatric impairment in elderly patients eligible for dialysis. However, all applied screening tools, including the judgment of the nephrologist, lack the discriminating abilities to adequately rule out frailty compared with a geriatric assessment.
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Clin J Am Soc Nephrol · Sep 2017
Randomized Controlled Trial Multicenter Study Pragmatic Clinical TrialPragmatic Randomized, Controlled Trial of Patient Navigators and Enhanced Personal Health Records in CKD.
Patient navigators and enhanced personal health records improve the quality of health care delivered in other disease states. We aimed to develop a navigator program for patients with CKD and an electronic health record-based enhanced personal health record to disseminate CKD stage-specific goals of care and education. We also conducted a pragmatic randomized clinical trial to compare the effect of a navigator program for patients with CKD with enhanced personal health record and compare their combination compared with usual care among patients with CKD stage 3b/4. ⋯ We successfully developed a patient navigator program and an enhanced personal health record for the CKD population. However, there were no differences in eGFR decline and other outcomes among the study groups. Larger and long-term studies along with cost-effectiveness analyses are needed to evaluate the role of patient navigators and patient education through an enhanced personal health record in those with CKD.
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Clin J Am Soc Nephrol · Sep 2017
Multicenter StudyInitiation of Sevelamer and Mortality among Hemodialysis Patients Treated with Calcium-Based Phosphate Binders.
Prior studies have shown that sevelamer attenuates progression of arterial calcification and may reduce the risk of death compared with calcium-based phosphate binders. In clinical practice, however, sevelamer is used not only as an alternative but also as an add-on therapy in patients already being treated with calcium-based phosphate binders. We analyzed the Dialysis Outcomes and Practice Patterns Study (DOPPS) data to test the hypothesis that the initiation of sevelamer is associated with improved survival in patients on hemodialysis treated with calcium-based phosphate binders. ⋯ The use of sevelamer as an add-on or alternative therapy to calcium-based phosphate binders is associated with improved survival in patients on maintenance hemodialysis.
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Randomized Controlled Trial Multicenter Study
A pilot clinical trial of recombinant human angiotensin-converting enzyme 2 in acute respiratory distress syndrome.
Renin-angiotensin system (RAS) signaling and angiotensin-converting enzyme 2 (ACE2) have been implicated in the pathogenesis of acute respiratory distress syndrome (ARDS). We postulated that repleting ACE2 using GSK2586881, a recombinant form of human angiotensin-converting enzyme 2 (rhACE2), could attenuate acute lung injury. ⋯ GSK2586881 was well-tolerated in patients with ARDS, and the rapid modulation of RAS peptides suggests target engagement, although the study was not powered to detect changes in acute physiology or clinical outcomes.