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Ofir Moreno Todd Butler Vanessa Zann Ashley Willson Pui Leung Alyson Connor 《Clinical therapeutics》2018,40(11):1855-1867
Purpose
ME-401 is a novel selective inhibitor of phosphatidylinositol 3 kinase p110δ, an enzyme often found overexpressed and overactive in B-cell malignancies. The current study was performed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending oral doses of ME-401 in healthy volunteers.Methods
This analysis was an open-label, nonrandomized study in healthy male volunteers. Three sequential groups were dosed. Each group received single doses of ME-401 on two occasions; the doses tested ranged from 10 to 150 mg. Blood was drawn at various time points to analyze plasma concentrations of ME-401 and inhibition of basophil activation, a marker of phosphatidylinositol 3 kinase p110δ inhibition.Findings
Fifteen subjects received a single dose of ME-401 on two occasions. Three adverse events that were considered possibly related to the study drug were reported: one event of pain, one event of headache, and one event of upper abdominal pain. ME-401 exhibited dose proportionality up to 60 mg, and supra-proportional increases in exposure were observed above doses of 60 mg. In addition, there was a dose-proportional increase in the inhibition of basophil activation up to 60 mg. Mean t1/2 ranged from 9.36 to 29.23 hours across the dose range. A 60 mg dose of ME-401 approached 90% inhibition of basophil activation, and thereafter no further increase to the percent inhibition of basophil activation was observed for higher doses. Once-daily dosing of 60 mg ME-401 was forecasted to result in trough plasma levels exceeding the concentration needed for 90% inhibition of basophil activation.Implications
This first-in-human study showed that ME-401 was well tolerated after single doses up to 150 mg. Pharmacologic activity was confirmed after administration of single ascending oral doses of 10 to 150 mg. ME-401 60 mg, administered once daily, was selected as the starting dose for patient studies. ClinicalTrials.gov identifier: NCT02521389. 相似文献123.
Kirstine Shrubsole Linda Worrall Emma Power Denise A. O&#x;Connor 《Archives of physical medicine and rehabilitation》2018,99(7):1413-1423.e24
Objective
To identify implementation priorities for poststroke aphasia management relevant to the Australian health care context.Data Sources
Using systematized searches of databases (CINAHL and MEDLINE), guideline and stroke websites, and other sources, evidence was identified and extracted for 7 implementation criteria for 13 topic areas relevant to aphasia management. These 7 priority-setting criteria were identified in the implementation literature: strength of the evidence, current evidence-practice gap, clinician preference, patient preference, modifiability, measurability, and health effect.Study Selection
Articles were included if they were in English, related to a specific recommendation requiring implementation, and contained information pertaining to any of the 7 prioritization criteria.Data Extraction
The scoping review methodology was chosen to address the broad nature of the topic. Evidence was extracted and placed in an evidence matrix. After this, evidence was summarized and then aphasia rehabilitation topics were prioritized using an approach developed by the research team.Data Synthesis
Evidence from 100 documents was extracted and summarized. Four topic areas were identified as implementation priorities for aphasia: timing, amount, and intensity of therapy; goal setting; information, education, and aphasia-friendly information; and constraint-induced language therapy.Conclusions
Closing the evidence-practice gaps in the 4 priority areas identified may deliver the greatest gains in outcomes for Australian stroke survivors with aphasia. Our approach to developing implementation priorities may be useful for identifying priorities for implementation in other health care areas. 相似文献124.
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McGinnis Kathleen A. Tate Janet P. Bryant Kendall J. Justice Amy C. O’Connor Patrick G. Rodriguez-Barradas Maria C. Crystal Stephen Cutter Christopher J. Hansen Nathan B. Maisto Stephen A. Marconi Vincent C. Williams Emily C. Cook Robert L. Gordon Adam J. Gordon Kirsha S. Eyawo Oghenowede Edelman E. Jennifer Fiellin David A. 《AIDS and behavior》2022,26(3):786-794
AIDS and Behavior - The timeline followback (TLFB) takes more resources to collect than the Alcohol Use Disorder Identification Test (AUDIT-C). We assessed agreement of TLFB and AUDIT-C with the... 相似文献
128.
Bajwa Farhan O’Connor Ryan Ananthasubramaniam Karthikeyan 《Heart failure reviews》2022,27(5):1471-1484
Heart Failure Reviews - Cardiac amyloidosis, once considered a rare disease, has garnered significant attention over the last few years due to three key reasons: first, increased... 相似文献
129.
Coakley G; Mok CC; Hajeer AH; Ollier WE; Turner D; Sinnott PJ; Hutchinson IV; Panayi GS; Lanchbury JS 《Rheumatology (Oxford, England)》1998,37(9):988-991
OBJECTIVE: To examine whether promoter polymorphisms associated with
variation in interleukin-10 (IL-10) production are relevant to the
development of rheumatoid arthritis (RA) or Felty's syndrome (FS). METHODS:
DNA was obtained from 44 FS patients, 117 RA patients and 295 controls. The
promoter region between -533 and - 1120 was amplified by polymerase chain
reaction, and polymorphisms detected by restriction enzyme digest or
sequence-specific oligonucleotide probing. RESULTS: We found no significant
difference in allele or haplotype frequencies between the groups.
CONCLUSION: There is no association between FS or RA and these recently
identified IL-10 promoter polymorphisms. Other genetic or environmental
factors could explain the alterations in IL-10 levels seen in these
conditions.
相似文献
130.