Introduction Despite the high response rates seen with Chimeric Antigen Receptor (CAR) T-cell therapy for relapsed/refractory Large B-cell lymphoma (R/R LBCL), post-therapy relapse remains a key challenge. To date, no...
Introduction Despite the high response rates seen with Chimeric Antigen Receptor (CAR) T-cell therapy for relapsed/refractory Large B-cell lymphoma (R/R LBCL), post-therapy relapse remains a key challenge. To date, no study has evaluated the comparative efficacy and safety of experimental CAR T-cell products versus currently approved CAR T-cell therapies. Objective To indirectly compare the efficacy and safety of novel, experimental CAR T-cell products against the first FDA-approved CAR T-cell construct, Axicabtagene ciloleucel (Yescarta). Methods In compliance with the PRISMA guidelines, we performed a systematic review, which identified 16 independent, early-phase clinical trials consisting of 193 LBCL patients with individual patient data (IPD). We categorized eight pooled populations based on the target antigens (CD19, CD20), co-stimulatory domains (CD28, 4-1BB), and CAR T-cells administered with or without concomitant autologous stem cell transplant (ASCT). The pooled populations were categorized as follows: (1) dual targeting strategies, such as tandem ***20, n = 28; (2) co-infusion of CD19 and CD20 CARs, n = 21; (3) third-generation CARs, n = 26; (4) CD19 CARs with modified constructs for reduced toxicity, including ***.86, n = 21; and (5) ***828Z, n = 14; (6) CD19. 4-1BB.S manufactured in China, n = 24; (7) concomitant ASCT and ***28, n = 45; and (8) CD20 CARs with a 4-1BB co-stimulatory domain, n = 14. A Matching Adjusted Indirect Comparison (MAIC) statistical technique was applied to account for heterogeneity in the study population across trials. Estimates for the experimental CAR T-cell trials were adjusted using patient-level data to match the ZUMA-1 (Yescarta, n = 108) study population based on mutually reported key baseline covariates, including age, disease stage, histology, refractoriness, number of prior lines of therapy, and extranodal disease. The study endpoints for this study included progression-free survival (PFS), cytokine r
BackgroundClostridioides difficileinfection (CDI) may be life-threatening, and individuals aged ≥ 65 years are at increased risk. CDI burden among Medicare fee-for-service enrollees and nursing home residents in the ...
Background
Clostridioides difficile
infection (CDI) may be life-threatening, and individuals aged ≥ 65 years are at increased risk. CDI burden among Medicare fee-for-service enrollees and nursing home residents in the United States have been characterized previously. The present study aimed to describe the incidence of CDI among Medicare Advantage Enrollees (MAEs), who account for 34% of all Medicare beneficiaries with enrollment increasing annually since 2004.
Methods
De-identified claims data for this retrospective cohort study were collected from the Optum® Clinformatics® Data Mart and included MAEs aged ≥ 65 years with continuous enrollment for ≥ 1 year before January 1, 2016, followed through death or disenrollment. CDI incidence was defined using the International Classification of Diseases 9th Revision diagnosis code of 008.45 or 10th Revision code of A04.7 (other than admitting diagnosis) or by treatment with nontopical metronidazole, oral vancomycin, or fidaxomicin within 14 days of CDI test. Incident CDI cases were identified from January 1 to December 31, 2016, and required that no CDI occurred within the previous 60 days in 2016. Incidence in 2016 was calculated as CDI cases and CDI patients per 100,000 person-years (PY) of observation time.
Results
Of 2,542,341 MAEs analyzed, 15,201 patients (0.6%) experienced a total of 18,842 incident CDI episodes. Overall, incidence rates were 762.8 CDI cases and 616.5 CDI patients per 100,000 PY. Incidence increased with age (539.6, 847.3, and 1259.6 cases per 100,000 PY in patients aged 65‒74 years, 75‒84 years, and ≥ 85 years, respectively). Most episodes (50.9%) were community acquired; the remaining 37.7% and 11.4% of episodes were hospital acquired and indeterminate, respectively. CDI patients were more likely than non-CDI patients to be older (mean age, 78.3 vs. 76.1 years,
P <
0.0001), be women (64.5% vs. 58.1%,
P <
0.0001), or have comorbidities (mean Charlson comorbidity index score, 4.5 vs. 1.8,
P
< 0.0001
We propose a new class of distribution-based clustering algorithms, called k-groups, based on energy distance between samples. The energy distance clustering criterion assigns observations to clusters according to a m...
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In this study, the effect of practical courses (especially robotics) on students' success is evaluated using fuzzy cognitive maps. This study particularly focuses on how practical courses increase the learning ach...
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ISBN:
(纸本)9781509007790
In this study, the effect of practical courses (especially robotics) on students' success is evaluated using fuzzy cognitive maps. This study particularly focuses on how practical courses increase the learning achievements in vocational schools. For this purpose, students and academicians were chosen as stakeholders for this study. Student were selected from departments of machine, electronic and computer. In total views of 30 students were taken and evaluated using fuzzy cognitive maps before the study. Students were studied on three projects within this study. These projects are autonomous cleaning robot, chameleon robot and sumo wrestler robot. Each robot was developed by a group consisting of ten students. Three main outputs determined to be gained by students in the robot development process as sensor calibration, improvement of mechanical systems and software optimization. These outputs are also among the output concepts of the fuzzy cognitive map. Sensor calibration, improvement of the mechanical systems and optimization of the software are the critical tasks respectively for the student groups of electronics, machine and computer. Each student group shared students of their departments homogeneously. Academicians were selected as one from each department. Fuzzy cognitive maps' survey applied to 15 academicians. After the design and development processes of robots, students and academicians views re-evaluated. It was observed clearly from the comparison of the results that, learning achievement, desire to learn, desire to interdisciplinary collaboration, self-confidence, interest in robotic technologies, satisfaction and desire to give priority to practical training in other subjects are increased by %45, %63, %42, %74, %85, %88 and %76 respectively.
Cardiovascular event trials can be designed to allow adaptation based on interim results. In this article, we first discuss a strategy either to accept noninferiority at an interim analysis or to continue the study to...
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