Efficacy, safety, and health-related quality of life in transplant-ineligible newly diagnosed multiple myeloma patients receiving bortezomib maintenance therapy: a study of the Korean Multiple Myeloma Working Party (KMMWP-174 study).

Not available.

Effectiveness of the Human Papillomavirus Vaccine in Extended Age Groups: A Real-World Analysis Based on the Korean HPV Cohort Study.

Background/objectives: This study evaluated the real-world effectiveness of prophylactic Human Papillomavirus (HPV) vaccination in Korean women aged over 26 years, focusing on its impact on persistent HPV infection and disease progression.

Methods: This multicenter prospective study analyzed data from the Korea HPV Cohort (2010-2021). After applying exclusion criteria, the final analytical cohort included 1,231 women aged ≥ 27 years with cytologic findings of atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesions and HPV infection.

Correction: Participant Adherence in Repeated-Dose Clinical Studies Using Video-Based Observation: Retrospective Data Analysis.

[This corrects the article DOI: 10.2196/65668.].

Quantification of Total and Unbound Selinexor Concentrations in Human Plasma by a Fully Validated Liquid Chromatography-Tandem Mass Spectrometry Method.

Selinexor is a selective nuclear-export inhibitor approved for hematologic malignancies, characterized by extensive plasma protein binding (>95%). However, a validated analytical method to accurately measure the clinically relevant unbound fraction of selinexor in human plasma has not yet been established. This study aimed to develop a fully validated bioanalytical assay for simultaneous quantification of total and unbound selinexor concentrations in human plasma.

Fractures incidence and its association on mortality in multiple myeloma patients: a nationwide cohort study (CAREMM-2105 study).

Multiple myeloma (MM) is known to compromise bone integrity, leading to an increased risk of fractures, which compromise the quality of life and increase mortality rates. This study investigated the incidence of fractures in MM patients and explored the association between fractures after MM diagnosis and mortality using the Korean National Health Insurance Service database. Fracture incidence was compared between MM patients (n = 9365) and 1:1 matched control group from general population.

Automated protocol templates with efficient schedule of activities table generation for healthy volunteer trials.

Background: The writing of clinical trial protocols that conform to relevant guidelines is a labor- and time-intensive endeavor. An automated clinical trial protocol template generation system for healthy volunteer trials and a web-based schedule of activities (SoA) generator were developed in this study.

Materials And Methods: was applied as the primary template development tool to automate the creation of a clinical trial protocol template that adheres to the International Council for Harmonization (ICH) M11 guidelines by enabling the adjustment of dynamic variables and facilitating the standardized presentation of relevant data using associated R packages.

Cost-Effectiveness Analysis of Daratumumab Monotherapy and Subsequent Therapies in Heavily Treated Relapsed/Refractory Multiple Myeloma: A Feasible Methodology using a Korean Nationwide Population Cohort.

Purpose: High-cost novel therapies for multiple myeloma (MM) require evaluation of efficacy and cost-effectiveness.

Materials And Methods: This study developed a methodology to assess cost-effectiveness using nationwide data from 11,450 newly diagnosed MM patients. A novel algorithm was applied to identify lines of therapy (LoT).

Participant Adherence in Repeated-Dose Clinical Studies Using Video-Based Observation: Retrospective Data Analysis.

Background: Maintaining accurate medication records in clinical trials is essential to ensure data validity. Traditional methods such as direct observation, self-reporting, and pill counts have shown limitations that make them inaccurate or impractical. Video-based monitoring systems, available as commercial or proprietary mobile applications for smartphones and tablets, offer a promising solution to these traditional limitations.

Risk factors and predictive models about false-negative urine dipstick results in albuminuria patients: population-based study from Korea National Health and Nutrition Examination Survey 2019 to 2022.

Background: Chronic kidney disease prognosis is determined based on glomerular filtration rate and albuminuria categories. However, the albumin-to-creatinine ratio (ACR) test is not performed on all patients as a screening test. The purpose of this study was to identify risk factors for patients with albuminuria confirmed by a urine dipstick negative and develop a model to predict underestimated patients.

Global burden of antidepressant-associated seizures from 1967 to 2023: A comparative analysis of the international pharmacovigilance database.

Background: Although antidepressants have been implicated in seizure risk, comprehensive safety data examining this risk across different antidepressants remains limited.

Methods: Data from Vigibase, an international pharmacovigilance database, encompassing 131,255,418 reports from 1967 to 2023, was analyzed. Reporting odds ratio (ROR) and information component (IC) were calculates to identify disproportionate associations between 17 antidepressants and seizures.

Rapid Differentiation of False Positives of Galactomannan Related to Contaminated Intravenous Fluids via a Pharmacokinetics Model and Innovative Web-Based Tool.

This study developed a pharmacokinetic model and web-based tool to distinguish true invasive aspergillosis from false positives caused by contaminated fluids. By analyzing galactomannan kinetics, false positives were identified within 24 hours, improving diagnostic accuracy and aiding clinicians in early decision making while minimizing unnecessary interventions.

Videofluoroscopic swallowing study predicts clinical outcomes in critically Ill children with dysphagia: a retrospective observational study.

Background: This retrospective observational study aimed to investigate the features of acute dysphagia observed during videofluoroscopic swallowing study (VFSS) in critically ill children and their potential to anticipate clinical outcomes.

Methods: Administrative healthcare data of children aged 1-18 were analyzed. Data were collected from the pediatric intensive care unit (PICU) of a single tertiary medical center in South Korea between March 2019 and December 2022.

Mathematical modelling for vaccine efficacy trials during the future epidemics of emerging respiratory infections.

Assessing vaccine efficacy (VE) during emerging epidemics is challenging due to unpredictable disease transmission dynamics. We aimed to investigate the impact of vaccine randomized controlled trials (RCTs) timing on estimates of VE and sample sizes during future epidemics of emerging respiratory diseases. We developed an age-structured susceptible-exposed-infected-asymptomatically infected-removed (SEIAR) compartment models using 2022 Korean population, and COVID-19 and 2009 A/H1N1 pandemic influenza parameters.

Deciphering risk factors for severe postherpetic neuralgia in patients with herpes zoster: an interpretable machine learning approach.

Introduction: Postherpetic neuralgia (PHN) is a common complication of herpes zoster (HZ). This study aimed to use a large real-world electronic medical records database to determine the optimal machine learning model for predicting the progression to severe PHN and to identify the associated risk factors.

Methods: We analyzed the electronic medical records of 23,326 patients diagnosed with HZ from January 2010 to June 2020.

Efficacy and Safety of Bispecific T-Cell Engagers in Relapsed/Refractory Multiple Myeloma: A Real-World Data-Based Case-Controlled Study.

Although bispecific T-cell engager (BiTE) is a promising treatment for relapsed/refractory multiple myeloma (RRMM), it needs to be evaluated in a real-world setting. This study aimed to evaluate the efficacy and safety of BiTEs compared with a synthetic standard of care (SOC). From a multicenter registry database of 474 patients with RRMM who received third- or more advanced-line treatments between January 2021 and October 2023, 1:1 propensity score-matched BiTE cohort (n = 71) and SOC cohort (n = 71) were established.

Dementia Incidence in Survivors of Multiple Myeloma: A National Case-Control Study Conducted in Korea (The CAREMM-2106 Study).

Background: Dementia, a growing global health issue, affects older adults and specific groups like long-term cancer survivors. The link between cancer survival and dementia is debated. Multiple myeloma (MM), a common blood cancer in older adults, is often linked with cognitive issues.

Major cardiovascular events in long-term multiple myeloma survivors: a Korean case-control study (the CAREMM-2105 study).

Purpose: Despite improvements in multiple myeloma (MM) survival rates, data on cardiovascular outcomes in long-term survivors remain lacking.

Methods: This retrospective case-control study utilized the Korean National Health Insurance Service database (2009-2020) to compare the incidence of cardiovascular disease (CVD) between patients with MM and a matched control group, focusing on long-term (> 5 years) survivors. A preliminary case cohort (n = 15,402 patients with MM) and a matched control cohort (n = 123,216 patients without MM) were established based on birth year and sex.

Risk of Secondary Malignancies After Multiple Myeloma: A Nationwide Case-Control Cohort Study.

Introduction: In light of improved survival rates among multiple myeloma (MM) survivors, we sought to assess their risk of secondary malignancies compared to the general population.

Materials And Methods: This nationwide population-based case-control cohort study utilized the Korea National Health Insurance Service (KNHIS) database incorporating data from 2009 to 2020. We analyzed a total of 7348 patients diagnosed with MM in the case cohort.

Quantitative risk factor analysis of prior disease condition and socioeconomic status with the multiple myeloma development: nationwide cohort study.

Early diagnosis and following management are important determinants of the prognosis of multiple myeloma (MM). However, screening for MM is not routinely performed because it is rare disease. In this study, we evaluated the association of prior disease condition and socioeconomic status (SES) with MM diagnosis and developed a simple predictive model that can identify patients at high risk of developing MM who may need screening using nationwide database from South Korea.

Pharmacokinetic properties of a new sustained-release pregabalin tablet in subjects with reduced renal function.

Unlabelled: A new sustained-release (SR) pregabalin tablet, YHD1119, was formulated for once-daily dosing. In the current study, we aimed to evaluate the pharmacokinetics of YHD1119 tablets in patients with reduced renal function. Subjects were grouped by creatinine clearance: > 60 mL/min/1.

A multicenter, retrospective comparison of pregnancy outcomes between groups of preterm labor nulliparous mothers treated with atosiban vs. ritodrine in singleton and multiple pregnancies.

Objective: To evaluate the safety and efficacy of atosiban and ritodrine in pregnant women who were hospitalized for threatened preterm labor (TPL).

Materials And Methods: Diagnosis records of preterm labor and subsequent pregnancy-related records and medical records of newborns were extracted from the Clinical Data Warehouse of the Catholic Medical Center's affiliated hospital. Since 2009, cases of preterm labor diagnosed before 34 weeks of pregnancy for first-time mothers who delivered at any one of three hospitals and who received drug treatment for more than 2 days to delay delivery were included in the dataset.

Establishing Rationale for the Clinical Development of Cell Therapy Products: Consensus between Risk and Benefit.

Despite long-term research achievements, the development of cell therapy (CT) products remains challenging. This is because the risks experienced by the subject and therapeutic effects in the clinical trial stage are unclear due to the various uncertainties of CT when administered to humans. Nevertheless, as autologous cell products for systemic administration have recently been approved for marketing, CT product development is accelerating, particularly in the field of unmet medical needs.

Pharmacokinetic Model Based on Stochastic Simulation and Estimation for Therapeutic Drug Monitoring of Tacrolimus in Korean Adult Transplant Recipients.

Background: Tacrolimus shows high variability in inter- and intraindividual pharmacokinetics (PK); therefore, it is important to develop an appropriate model for accurate therapeutic drug monitoring (TDM) procedures. This study aimed to develop a pharmacokinetic model for tacrolimus that can be used for TDM procedures in Korean adult transplant recipients by integrating published models with acquired real-world TDM data and evaluating clinically meaningful covariates.

Methods: Clinical data of 1829 trough blood samples from 269 subjects were merged with simulated data sets from published models and analyzed using a nonlinear mixed-effect model.