Browsing by Subject "Clinical study"
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Item ARDaC Common Data Model Facilitates Data Dissemination and Enables Data Commons for Modern Clinical Studies(IOS Press, 2024) Jin, Nanxin; Li, Zuotian; Kettler, Carla; Yang, Baijian; Tu, Wanzhu; Su, Jing; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public HealthModern clinical studies collect longitudinal and multimodal data about participants, treatments and responses, biospecimens, and molecular and multiomics data. Such rich and complex data requires new common data models (CDM) to support data dissemination and research collaboration. We have developed the ARDaC CDM for the Alcoholic Hepatitis Network (AlcHepNet) Research Data Commons (ARDaC) to support clinical studies and translational research in the national AlcHepNet consortium. The ARDaC CDM bridges the gap between the data models used by the AlcHepNet electronic data capture platform (REDCap) and the Genomic Data Commons (GDC) data model used by the Gen3 data commons framework. It extends the GDC data model for clinical studies; facilitates the harmonization of research data across consortia and programs; and supports the development of the ARDaC. ARDaC CDM is designed as a general and extensible CDM for addressing the needs of modern clinical studies. The ARDaC CDM is available at https://dev.ardac.org/DD.Item Chronic Heart Failure With Memory and Attention Dysfunction: Old Problem, Thinking Anew(Elsevier, 2018) Pressler, Susan J.; Jung, Miyeon; School of NursingItem In situ efficacy of an experimental toothpaste on enamel rehardening and prevention of demineralisation: a randomised, controlled trial(BMC, 2020) Creeth, Jonathan E.; Burnett, Gary R.; Souverain, Audrey; Gomez-Pereira, Paola; Zero, Domenick T.; Lippert, Frank; Hara, Anderson T.; Cariology, Operative Dentistry and Dental Public Health, School of DentistryBackground A novel sodium fluoride toothpaste containing lactate ion and polyvinylmethylether-maleic anhydride has been developed to promote enamel remineralisation and resistance to demineralisation. In this in situ study, we compared this toothpaste (‘Test’) with a stannous fluoride-zinc citrate (SnF2-Zn) toothpaste (‘Reference’) (both 1100–1150 ppm fluoride) and a fluoride-free toothpaste (‘Placebo’) using an enamel dental erosion-rehardening model. Methods In each phase of this randomised, investigator-blind, crossover study, participants wore palatal appliances holding bovine enamel specimens with erosive lesions. They brushed their natural teeth with either the Test, Reference or Placebo toothpastes, then swished the resultant slurry. Specimens were removed at 2 h and 4 h post-brushing and exposed to an in vitro acid challenge. Surface microhardness was measured at each stage; enamel fluoride uptake was measured after in situ rehardening. Surface microhardness recovery, relative erosion resistance, enamel fluoride uptake and acid resistance ratio were calculated at both timepoints. Results Sixty two randomised participants completed the study. Test toothpaste treatment yielded significantly greater surface microhardness recovery, relative erosion resistance and enamel fluoride uptake values than either Reference or Placebo toothpastes after 2 and 4 h. The acid resistance ratio value for Test toothpaste was significantly greater than either of the other treatments after 2 h; after 4 h, it was significantly greater versus Placebo only. No treatment-related adverse events were reported. Conclusions In this in situ model, the novel-formulation sodium fluoride toothpaste enhanced enamel rehardening and overall protection against demineralisation compared with a fluoride-free toothpaste and a marketed SnF2-Zn toothpaste.Item Orange/Red Fluorescence of Active Caries by Retrospective Quantitative Light-Induced Fluorescence Image Analysis(Karger, 2016-05) Gomez, G.F.; Eckert, G.J.; Ferreira Zandona, A.; Biostatistics, School of Public HealthThis retrospective clinical study determined the association of caries activity and orange/red fluorescence on quantitative light-induced fluorescence (QLF) images of surfaces that progressed to cavitation, as determined by clinical visual examination. A random sample of QLF images from 565 children (5-13 years) previously enrolled in a longitudinal study was selected. Buccal, lingual and occlusal surface images obtained after professional brushing at baseline and every 4 months over a 4-year period were analyzed for red fluorescence. Surfaces that progressed (n = 224) to cavitation according to the International Caries Detection and Assessment System (ICDAS 0/1/2/3/4 to 5/6 or filling), and surfaces that did not progress (n = 486) were included. QA2 image analysis software outputs the percentage increase of the red/green components as x0394;R and area of x0394;R (areax0394;R) at different thresholds. Mixed-model ANOVA was used to compare progressive and nonprogressive surfaces to account for correlations of red fluorescence (x0394;R and areax0394;R) between surfaces within a subject. The first analysis used the first observation for each surface or the first available visit if the surface was unerupted (baseline), while the second analysis used the last observation prior to cavitation for surfaces that progressed and the last observation for surfaces that did not progress (final). There was a significant (p < 0.05) association between red fluorescence and progression to cavitation at thresholds x0394;R0, x0394;R10, x0394;R20, x0394;R60, x0394;R70, x0394;R80, x0394;R90 and x0394;Rmax at baseline and for x0394;R0 and x0394;R10 at the final observation. Quantification of orange/red fluorescence may help to identify lesions that progress to cavitation. Future studies identifying microbiological factors causing orange/ red fluorescence and its caries activity are indicated.Item Pooled Phase 2 and 3 Efficacy and Safety Data on Budesonide Oral Suspension in Adolescents with Eosinophilic Esophagitis(Wolters Kluwer, 2023) Mukkada, Vincent A.; Gupta, Sandeep K.; Gold, Benjamin D.; Dellon, Evan S.; Collins, Margaret H.; Katzka, David A.; Falk, Gary W.; Williams, James; Zhang, Wenwen; Boules, Mena; Hirano, Ikuo; Desai, Nirav K.; Pediatrics, School of MedicineObjectives: The objective of this study was to evaluate the efficacy and safety of budesonide oral suspension (BOS) in adolescents with eosinophilic esophagitis (EoE). Methods: This post hoc analysis pooled data from two 12-week, randomized, double-blind, placebo-controlled studies of BOS 2.0 mg twice daily (b.i.d.) (phase 2, NCT01642212; phase 3, NCT02605837) in patients aged 11-17 years with EoE and dysphagia. Efficacy endpoints included histologic (≤6, ≤1, and <15 eosinophils per high-power field [eos/hpf]), dysphagia symptom (≥30% reduction in Dysphagia Symptom Questionnaire [DSQ] scores from baseline), and clinicopathologic (≤6 eos/hpf and ≥30% reduction in DSQ scores from baseline) responses at week 12. Change from baseline to week 12 in peak eosinophil counts, DSQ scores, EoE Histology Scoring System (EoEHSS) grade (severity) and stage (extent) total score ratios (TSRs), and total EoE Endoscopic Reference Scores (EREFS) were assessed. Safety outcomes were also examined. Results: Overall, 76 adolescents were included (BOS, n = 45; placebo, n = 31). Significantly more patients who received BOS than placebo achieved histologic responses (≤6 eos/hpf: 46.7% vs 6.5%; ≤1 eos/hpf: 42.2% vs 0.0%; <15 eos/hpf: 53.3% vs 9.7%; P < 0.001) and a clinicopathologic response (31.1% vs 3.2%; P = 0.003) at week 12. More BOS-treated than placebo-treated patients achieved a dysphagia symptom response at week 12 (68.9% vs 58.1%; not statistically significant P = 0.314). BOS-treated patients had significantly greater reductions in EoEHSS grade and stage TSRs ( P < 0.001) and total EREFS ( P = 0.021) from baseline to week 12 than placebo-treated patients. BOS was well tolerated, with no clinically meaningful differences in adverse events versus placebo. Conclusions: BOS 2.0 mg b.i.d. significantly improved most efficacy outcomes in adolescents with EoE versus placebo.