A Model-Based Trial Design With a Randomization Scheme Considering Pharmacokinetics Exposure for Dose Optimization in Oncology.

The primary purpose of an oncology dose-finding trial for novel anticancer agents has been shifting from determining the maximum tolerated dose to identifying an optimal dose (OD) that is tolerable and therapeutically beneficial for subjects in subsequent clinical trials. In 2022, the FDA Oncology Center of Excellence initiated Project Optimus to reform the paradigm of dose optimization and dose selection in oncology drug development and issued a draft guidance. The guidance suggests that dose-finding trials include randomized dose-response cohorts of multiple doses and incorporate information on pharmacokinetics (PK) in addition to safety and efficacy data to select the OD.

Safety and efficacy of viltolarsen treatment in patients with Duchenne muscular dystrophy: A retrospective study with 3-year follow-up.

Background: Duchenne muscular dystrophy (DMD) is a hereditary neuromuscular disorder characterized by severe, progressive muscle wasting. Viltolarsen, a formulation consisting of exon 53-skipping antisense oligonucleotides of the dystrophin gene, has been indicated for some patients with DMD. However, reports describing the efficacy and safety of viltolarsen treatment in patients with DMD, particularly those comparing patients receiving viltolarsen with age- and time-period-matched controls, are limited.

Comparative analysis of image quality and diagnostic performance among SS-EPI, MS-EPI, and rFOV DWI in bladder cancer.

Purpose: To compare image quality and diagnostic performance among SS-EPI diffusion weighted imaging (DWI), multi-shot (MS) EPI DWI, and reduced field-of-view (rFOV) DWI for muscle-invasive bladder cancer (MIBC).

Materials And Methods: This retrospective study included 73 patients with bladder cancer who underwent multiparametric MRI in our referral center between August 2020 and February 2023. Qualitative image assessment was performed in 73; and quantitative assessment was performed in 66 patients with maximum lesion diameter > 10 mm.

Lenvatinib treatment strategy for thyroid carcinoma with malignant pleurisy: a case report.

Background: Although lenvatinib is effective for unresectable thyroid carcinoma, it may cause adverse events owing to rapid tumor shrinkage or necrosis. Pneumothorax during lenvatinib therapy is rare. However, once it occurs, it can become a refractory and fatal complication.

Adaptor protein 3BP2 regulates gene expression in addition to the ubiquitination and proteolytic activity of MALT1 in dectin-1-stimulated cells.

Dectin-1, a C-type lectin, plays important roles in the induction of antifungal immunity. Caspase recruitment domain-containing protein 9 (CARD9) is essential for the dectin-1-induced production of cytokines through the activation of NF-κB. However, the molecular mechanisms underlying the dectin-1-mediated activation of CARD9 have not been fully elucidated.

Comprehensive genomic profiling for advanced hepatocellular carcinoma in clinical practice.

Aim: Although several therapeutic agents show efficacy in advanced hepatocellular carcinoma (HCC), biomarkers such as comprehensive genomic profiling (CGP) for the selection of second-line treatments after immunotherapy have not been established. We evaluated the value of CGP for the treatment decision in patients with HCC.

Methods: We retrospectively studied 52 patients with advanced HCC who received CGP tests at three tertiary hospitals between February 2022 and November 2023.

Combined Treatment With Inverted Internal Limiting Membrane Flap and Subretinal Injection of Balanced Salt Solution to Repair Chronic Macular Holes.

To present a surgical technique that combines an inverted internal limiting membrane (ILM) flap and subretinal injection of balanced salt solution for the closure of chronic macular holes (MH). Two cases are presented. A 74-year-old man and a 63-year-old woman presented with decreased visual acuity (VA) of 20/600 and 20/200, respectively, resulting from a chronic MH.

Efficacy of endovascular therapy in short-term two-stage operation for thrombosed giant cerebral aneurysm.

Background: Giant cerebral aneurysms have a high rupture rate, are often difficult to treat, and have a poor prognosis. We report two cases in which good results were achieved with a short, two-stage operation using a combination of endovascular treatment (EVT) and direct surgery.

Case Description: Case 1 - A 50-year-old man had become immobile due to truncal ataxia after nausea.

Association of anemia with hyperadiponectinemia in oldest-old Japanese women who resided at home alone without wheelchair use.

The association of anemia with hyperadiponectinemia (HAN) (≥ 20 μg/mL) was studied in 95 Japanese women aged 65-74 (young-old), 175 women aged 75-84 (old-old), and 51 women aged over 85 (oldest-old) who resided at home alone without wheelchair use. The prevalence of anemia was 21.5% overall and increased with aging stepwise (9.

Cities beyond proximity.

The concept of 'proximity-based cities' has gained attention as a new urban organizational model. Most prominently, the 15-minute city contends that cities can function more effectively, equitably and sustainably if essential, everyday services and key amenities are within a 15-minute walk or cycle. However, focusing solely on travel time risks overlooking disparities in service quality, as the proximity paradigm tends to emphasize the mere presence of an element in a location rather than bringing up more complex questions of identity, diversity, quality, value or relationships.

Bactericidal effect of far ultraviolet-C irradiation at 222 nm against bacterial peritonitis.

Far ultraviolet-C irradiation at 222 nm has potent bactericidal effects against severe infections such as peritonitis, with minimal cytotoxicity. Bacterial peritonitis due to bowel perforation is a serious condition with high mortality despite current treatments. This study investigated the safety and efficacy of intraperitoneal far ultraviolet-C irradiation at 222 nm.

Complete suspension culture of human induced pluripotent stem cells supplemented with suppressors of spontaneous differentiation.

Human induced pluripotent stem cells (hiPSCs) are promising resources for producing various types of tissues in regenerative medicine; however, the improvement in a scalable culture system that can precisely control the cellular status of hiPSCs is needed. Utilizing suspension culture without microcarriers or special materials allows for massive production, automation, cost-effectiveness, and safety assurance in industrialized regenerative medicine. Here, we found that hiPSCs cultured in suspension conditions with continuous agitation without microcarriers or extracellular matrix components were more prone to spontaneous differentiation than those cultured in conventional adherent conditions.

SOX17 expression in ovarian clear cell carcinoma.

Recent studies have revealed that the Sry-related HMG box gene 17 (SOX17) plays an important role in ovarian carcinogenesis. Unlike other types of ovarian cancer, ovarian clear cell carcinoma (OCCC) has a distinct pathobiological phenotype, often harboring an AT-rich interaction domain 1 A (ARID1A) mutation. In the present study, to determine the SOX17 in OCCC cells, we immunohistochemically examined SOX17 expression in 47 whole-tissue specimens of OCCC.

Longitudinal association between posterior occlusal contact and dementia development in a large retrospective cohort study using a Japanese claims database.

This study examines the association between posterior occlusal contact and the risk of dementia development in the Japanese population, utilizing Eichner classification to evaluate occlusal status. Data from Japanese health insurance claims were analyzed for the period from April 2016 to March 2022. Participants had undergone specific health checkups, had no prior history of dementia, and were classified according to their dental occlusal contact.

Comparison of effects of intra-articular diclofenac etalhyaluronate and hyaluronic acid in a monoiodoacetate rat osteoarthritis model.

Diclofenac etalhyaluronate (DF-HA) sustained diclofenac release with the effects of hyaluronic acid (HA), offering long-term analgesia in osteoarthritis. In this study, the effects of DF-HA on pain improvement and osteoarthritis were evaluated in a rat knee monoiodoacetate-induced osteoarthritis model compared to HA. Eight rats per group had been injected with monoiodoacetate (2.

Myosteatosis Evaluated Based on Intramuscular Adipose Tissue Content Is a Risk Factor for Postoperative Complications in Crohn's Disease.

Background: Crohn's disease causes acute and chronic inflammation that often make the preoperative evaluation of surgical risks difficult. Myosteatosis is used for the evaluation of muscle quality to assess sarcopenia. However, data on the relationship between myosteatosis and surgical outcomes in patients with Crohn's disease are lacking.

L-Cysteine-Bonded Polymeric Monolithic Stationary Phase for Enantioseparation of Dansyl Amino Acids in Capillary Liquid Chromatography.

A chiral monolith stationary phase was fabricated by modifying the monolith surface using L-cysteine through a thiol-epoxy click reaction. L-cysteine-bonded polymer monolith was characterized by scanning electron microscopy/energy-dispersive X-ray and attenuated total reflectance Fourier-transformed infrared. The monomer content and modification temperature were carefully optimized to create a polymer monolith with excellent mechanical stability and permeability.

Efficacy and safety of endoscopic hemostasis with a self-assembling peptide solution in patients with colonic diverticular bleeding: a multicenter pilot study (with video).

Background And Aims: PuraStat (3-D Matrix, Tokyo, Japan) is an absorbent localized hemostatic agent that uses self-assembling peptide technology. In this multicenter pilot study, we evaluated the efficacy and safety of endoscopic hemostasis using PuraStat in patients with colonic diverticular bleeding (CDB).

Methods: This study involved patients who had CDB with stigmata of recent hemorrhage (SRH) and underwent endoscopic hemostasis with PuraStat monotherapy or combination therapy comprising PuraStat with endoscopic band ligation (EBL) or clipping (group A).

Development and accuracy of an artificial intelligence model for predicting the progression of hip osteoarthritis using plain radiographs and clinical data: a retrospective study.

Background: Predicting the progression of hip osteoarthritis (OA) remains challenging, and no reliable predictive method has been established. This study aimed to develop an artificial intelligence (AI) model to predict hip OA progression via plain radiographs and patient data and to determine its accuracy.

Methods: This retrospective study utilized anteroposterior pelvic radiographs of consecutive patients with hip OA who underwent primary unilateral total hip arthroplasty.

Predictors of Emergency Interventions in Acute Airway Obstructive Diseases: A Retrospective Single-Center Observational Study.

Background: The factors related to emergency intervention for internal medicine conditions leading to airway obstruction are not clear.

Objective: We aimed to identify factors associated with emergency interventions in acute airway obstructive diseases (AAODs).

Methods: This is a retrospective observational single-center study.