Clinical significance of the preoperative prognostic nutritional index in patients with resectable non-small cell lung cancer: a multicenter study.

Purpose: To validate the clinical impacts of the prognostic nutritional index (PNI), an immune-nutritional blood marker, in patients with resectable non-small cell lung cancer (NSCLC) using multicenter cohort data.

Methods: The subjects of this retrospective multicenter study, involving 11 hospitals, were patients who underwent curative lung resection for pathological stage IA-IIIA NSCLC. We analyzed the relationship between the preoperative PNI and postoperative outcomes.

Potential Bias Models With Bayesian Shrinkage Priors for Dynamic Borrowing of Multiple Historical Control Data.

When multiple historical controls are available, it is necessary to consider the conflicts between current and historical controls and the relationships among historical controls. One of the assumptions concerning the relationships between the parameters of interest of current and historical controls is known as the "Potential biases." Within the "Potential biases" assumption, the differences between the parameters of interest of the current control and of each historical control are defined as "potential bias parameters.

Rationale and Design of Prospective, Multicenter, Double-Arm Clinical Trial to Investigate the Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus (TOP-HFPEF Trial).

Background: Recent large clinical trials have revealed that sodium-glucose cotransporter 2 (SGLT2) inhibitors improve cardiovascular outcomes not only in patients with heart failure with reduced ejection fraction, but also in patients with heart failure with mildly reduced or preserved ejection fraction (HFpEF). However, the effect of SGLT2 inhibitors on left ventricular (LV) diastolic function is still controversial.

Methods And Results: The TOP-HFPEF trial (Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus) is a multicenter, double-arm, open-label, confirmatory, investigator-initiated clinical study to investigate the effect of SGLT2 inhibitor on LV diastolic function in patients with HFpEF and type 2 diabetes mellitus.

Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event Data.

Background: Progression-free survival (PFS) is used to evaluate treatment effects in cancer clinical trials. Disease progression (DP) in patients is typically determined by radiological testing at several scheduled tumor-assessment time points. This produces a discrepancy between the true progression time and the observed progression time.

The inter-laboratory validation study of EpiSensA for predicting skin sensitization potential.

The Epidermal Sensitization Assay (EpiSensA) is a reconstructed human epidermis (RhE)-based gene expression assay for predicting the skin sensitization potential of chemicals. Since the RhE model is covered by a stratified stratum corneum, various kinds of test chemicals, including lipophilic ones and pre-/pro-haptens, can be tested with a route of exposure akin to an in vivo assay and human exposure. This article presents the results of a formally managed validation study of the EpiSensA that was carried out by three participating laboratories.