Efficacy of combined administration of Baekhogainsam-Tang and low-dose pilocarpine on frequent intractable xerostomia: Study protocol for a randomized controlled trial.

Background: Intractable xerostomia is defined as the subjective perception of dry mouth and persistent salivary gland hypofunction. Pilocarpine is an approved salivary sialagogue that is frequently prescribed for the treatment of intractable xerostomia; however, it often exhibits more side effects at high-doses and limited effectiveness at low-doses. Baekhogainsam-Tang (BIT) is a common herbal formula used by patients complaining of sore throats and thirst.

Association between Tumor Size at the Time of Disease Progression and Survival Outcomes.

Purpose: This study evaluates the prognostic significance of tumor size at disease progression (PD) and depth of response (DOR) in cancer patients.

Materials And Methods: We performed post hoc analysis using data from six prospective clinical trials conducted by the Korean Cancer Study Group. Patients with tumor size at PD was categorized into 'Mild PD' and 'Significant PD' based on the cutoff values of relative change from baseline using maximally selected rank statistics.

Simple and robust LC-MS/MS method for quantification of colistin methanesulfonate and colistin in human plasma for therapeutic drug monitoring.

A rapid, simple, and robust LC-MS/MS method was developed and validated for the quantitation of colistin and colistin methanesulfonate (CMS) in human plasma. The method also prevented overestimation of colistin concentration by establishing the stability of CMS under sample preparation conditions, including blood and plasma storage conditions. Polymyxin B1 was used as an internal standard, and positive-ion electrospray ionization in multiple reaction monitoring mode was used for quantification.

Application of critical pathway of integrative medical service for lumbar herniated nucleus pulposus: A protocol for single-centered prospective observational study.

Background: Lumbar herniated nucleus pulposus (L-HNP) is a condition in which fibroblasts escape due to degenerative changes or external forces in the intervertebral disc, causing neurological symptoms by compressing the dura mater or nerve root.

Objectives: The purpose of this study is to analyze and compare the effectiveness, economic feasibility, and safety of using an integrated medical service critical pathway (CP) in L-HNP patients.

Methods: This single-center prospective observational study will be performed at Kyung Hee University Medicine Hospital and Kyung Hee University Korean Medicine Hospital.

Effects of three-dimensional image based insole for healthy volunteers: a pilot clinical trial.

Unlabelled: Insoles are used to treat various foot diseases, including plantar foot, diabetic foot ulcers, and refractory plantar fasciitis. In this study, we investigated the effects of 3-dimensional image-based (3-D) insole in healthy volunteers with no foot diseases. Additionally, the comfort of the 3-D insole was compared with that of a custom-molded insole.

A clinical trial on anti-diabetic efficacy of submerged culture medium of Ceriporia lacerata mycelium.

Background: Increased glucose level and insulin resistance are major factors in Type 2 diabetes mellitus (T2M), which is chronic and debilitating disease worldwide. Submerged culture medium of Ceriporia lacerata mycelium (CLM) is known to have glucose lowering effects and improving insulin resistance in a mouse model in our previous studies. The main purpose of this clinical trial was to evaluate the functional efficacy and safety of CLM in enrolled participants with impaired fasting blood sugar or mild T2D for 12 weeks.

Pharmacokinetic Comparison of Ginsenosides between Fermented and Non-Fermented Red Ginseng in Healthy Volunteers.

Fermentation of red ginseng (RG) produces fermented red ginseng (FRG), thereby increasing the relative amount of downstream ginsenosides, including compound Y (CY), F2, Rh2, compound K (CK), compound O, protopanaxadiol (PPD), and protopanaxatriol (PPT). These downstream ginsenosides have beneficial pharmacological effects, and are easily absorbed by the human body. Based on these expectations, a randomized, single-dose, two-period, crossover clinical trial was planned to compare the pharmacokinetic characteristics of seven types (Rb1, CY, F2, CK, Rh2, PPD, and PPT) of ginsenoside components after FRG and RG administration.

Application of Machine Learning Classification to Improve the Performance of Vancomycin Therapeutic Drug Monitoring.

Bayesian therapeutic drug monitoring (TDM) software uses a reported pharmacokinetic (PK) model as prior information. Since its estimation is based on the Bayesian method, the estimation performance of TDM software can be improved using a PK model with characteristics similar to those of a patient. Therefore, we aimed to develop a classifier using machine learning (ML) to select a more suitable vancomycin PK model for TDM in a patient.

Effect of multimodal intervention care on cachexia in patients with advanced cancer compared to conventional management (MIRACLE): an open-label, parallel, randomized, phase 2 trial.

Background: Cancer cachexia (CC) is a multifactorial process characterized by progressive weight loss, muscle mass, and fat tissue wasting, which adversely affects the quality of life and survival of patients with advanced stages of cancer. CC has a complex and multifactorial pathophysiology, and there is no established standard treatment. Therefore, it is often irreversible and a single treatment modality is unlikely to suppress its progression.

Development and Validation of Open-Source R Package HMCtdm for Therapeutic Drug Monitoring.

Most therapeutic drug monitoring (TDM) packages are based on the maximum a posteriori (MAP) estimation. In this study, HMCtdm, a new TDM package, was developed using a Hamiltonian Monte Carlo (HMC) simulation. The estimation process of HMCtdm for the drugs amikacin, vancomycin, theophylline, and phenytoin was based on the R package Torsten.

A Pharmacokinetic Study of Ephedrine and Pseudoephedrine after Oral Administration of Ojeok-San by Validated LC-MS/MS Method in Human Plasma.

A sensitive and reproducible liquid chromatography-tandem mass spectrometry (LC-MS/MS) system was developed and fully validated for the simultaneous determination of ephedrine and pseudoephedrine in human plasma after oral administration of the herbal prescription Ojeok-san (OJS); 2-phenylethylamine was used as the internal standard (IS). Both compounds presented a linear calibration curve ( ≥ 0.99) over a concentration range of 0.

Model-Based Approach for Designing an Efficient Bioequivalence Study for Highly Variable Drugs.

The statistical procedures as outlined by the European Medicines Agency (EMA) and United States Food and Drug Administration (FDA) guidelines for bioequivalence testing of highly variable drugs (HVDs) are complex. Additionally, the sample size is affected by clinical study designs or practical real-world problems, such as dropout rate or study budget. To overcome these difficulties, we propose a model-based approach for the selection of a study design with a sample size that satisfies the bioequivalence criteria using simulation studies based on a pharmacokinetic (PK) model.

Pharyngeal reflux episodes in patients with suspected laryngopharyngeal reflux versus healthy subjects: a prospective cohort study.

Purpose: This study aimed to analyze pharyngeal reflux episodes in patients with suspected LPR versus healthy subjects using 24-h MII-pH monitoring.

Methods: One hundred twenty-one patients who visited our clinic with a chief complaint of LPR-related symptoms and underwent 24-h MII-pH monitoring were enrolled prospectively. Also, 27 healthy subjects were enrolled and underwent 24-h MII-pH monitoring during the same period.

Ginsenoside Absorption Rate and Extent Enhancement of Black Ginseng (CJ EnerG) over Red Ginseng in Healthy Adults.

Red ginseng (RG) and black ginseng (BG, CJ EnerG) were prepared from fresh ginseng using one and nine cycles of steaming and drying, respectively. This process reduces the molecular weight (MW) of ginsenoside-active compounds in ginseng by removing sugar moieties from their dammaranes. We compared the pharmacokinetic characteristics of ginsenosides between BG comprising mainly low-MW ginsenosides (Rg3, Rg5, Rk1, and Rh1) and RG that predominantly contains high-MW ginsenosides (Rb1, Rb2, Rc, Rd, Re, and Rg1).

Clinical Implications of Cancer Stem Cell Markers and ABC Transporters as a Predictor of Prognosis in Colorectal Cancer Patients.

Background/aim: Cancer stem cells (CSCs) and ABC transporters are associated with treatment resistance and outcomes of cancer patients. We aimed to investigate the prognostic implications of CSC markers and ABC transporters in colorectal cancer (CRC) patients.

Materials And Methods: We collected 331 CRC samples and evaluated 3 CSC markers (SOX2, LGR5, and ALDH1) and 3 ABC transporters (ABCC2, ABCC3, and ABCG2) by immunohistochemistry.

Cognition enhancing effect of panax ginseng in Korean volunteers with mild cognitive impairment: a randomized, double-blind, placebo-controlled clinical trial.

This study aimed to investigate the cognition-enhancing effect of Panax ginseng. A randomized, double-blind, placebo-controlled clinical trial was conducted to address the cognition-enhancing effects of Panax ginseng. A total of 90 Korean volunteers with mild cognitive impairment participated in this study.

Enhanced Moisture Stability by Butyldimethylsulfonium Cation in Perovskite Solar Cells.

Many organic cations in halide perovskites have been studied for their application in perovskite solar cells (PSCs). Most organic cations in PSCs are based on the protic nitrogen cores, which are susceptible to deprotonation. Here, a new candidate of fully alkylated sulfonium cation (butyldimethylsulfonium; BDMS) is designed and successfully assembled into PSCs with the aim of increasing humidity stability.

Diagnostic accuracy of SOX11 immunohistochemistry in mantle cell lymphoma: A meta-analysis.

SOX11 is a transcription factor that is normally expressed in the fetal brain and has also been detected in some malignant tumors, including mantle cell lymphoma (MCL). MCL is a mature B-cell lymphoma that characteristically expresses cyclin D1, which has been used as a diagnostic tumor marker. SOX11 has also recently emerged as a tumor marker for MCL, particularly in cyclin D1-negative MCLs and to distinguish between MCLs and other cyclin D1-positive lymphomas.