Relationship Between Diaphragm Function and Sarcopenia Assessed by Ultrasound: A Cross-Sectional Study.

: The diaphragm is important for respiration, but the effects of age-related muscle loss and sarcopenia on diaphragm function are unclear. We evaluated the associations of sarcopenia and skeletal muscle mass (SMM) with diaphragm function. : This study was conducted at three Japanese hospitals from May 2023 to September 2024.

Mixture Disease Progression Model to Predict and Cluster the Long-Term Trajectory of Cognitive Decline in Alzheimer's Disease.

Background: Alzheimer's disease (AD) is a neurodegenerative disease for which many clinical trials failed to detect treatment effects, possibly due to the heterogeneity of disease progression among the patients. Predicting and clustering a long-term trajectory of cognitive decline from the short-term cognition data of individual patients would help develop therapeutic interventions for AD.

Methods: This study developed mixture disease progression model to predict and cluster the long-term trajectory of cognitive decline in the population.

Planning and Implementing Master Protocol Trials in Japan: Key Considerations of the Japanese Guideline.

The importance of master protocol trials, which encompass basket, umbrella, and platform trials, has been increasingly recognized worldwide for their efficiency in evaluating multiple drugs or diseases within a single trial. While the US Food and Drug Administration and European regulatory bodies have issued guidelines to facilitate such trials, Japan only recently introduced its own set of guidelines to address the unique challenges and opportunities within its regulatory and healthcare landscape. Our study elaborates on these newly issued Japanese guidelines, which were developed through a collaborative effort involving biostatisticians, physicians, clinical trialists, regulatory authorities, and industry representatives.

Modified oral antibiotics and mechanical bowel preparation (OAMBP) versus conventional OAMBP for sigmoid colon and rectal surgery: A multicenter randomized non-inferiority trial.

Aim: To evaluate whether the use of a laxative with reduced patient burden in oral antibiotics and mechanical bowel preparation (OAMBP) could prevent surgical site infection (SSI) in left-sided colon and rectal cancers.

Methods: This multicenter, non-blinded, randomized, non-inferiority trial included patients who underwent elective colorectal surgery for colorectal cancer in a university and community hospital in Japan from April 1, 2021 to March 31, 2023. We compared conventional OAMBP (polyethylene glycol, metronidazole, and kanamycin) (cOAMBP group) with modified OAMBP (sodium picosulfate hydrate, metronidazole, and kanamycin) (mOAMBP group).