Development of an External Control Arm Using Electronic Health Record-Based Real-World Data to Evaluate the Efficacy of COVID-19 Treatment.

To protect people from severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) infection, tremendous research efforts have been made toward coronavirus disease 19 (COVID-19) treatment development. Externally controlled trials (ECTs) may help reduce their development time. To evaluate whether ECT using real-world data (RWD) of patients with COVID-19 is feasible enough to be used for regulatory decision making, we built an external control arm (ECA) based on RWD as a control arm of a previously conducted randomized controlled trial (RCT), and compared it to the control arm of the RCT.

Comparison of hepatotoxicity of tegoprazan, a novel potassium-competitive acid blocker, with proton pump inhibitors using real-world data: A nationwide cohort study.

Background: Proton pump inhibitors (PPIs) are acid suppressants that are frequently prescribed in many countries to reduce heartburn. A potassium-competitive acid blocker (P-CAB; tegoprazan) was launched relatively recently that also inhibits gastric acid secretion. This study aimed to compare the hepatotoxicity of the six existing PPIs with P-CAB.

Long-term taxonomic and functional stability of the gut microbiome from human fecal samples.

Appropriate storage of fecal samples is a critical step for unbiased analysis in human microbiome studies. The purpose of this study was to evaluate the stability of the fecal microbial community for up to 18 months. Ten healthy volunteers provided fecal samples at the Jeonbuk National University Hospital.

Treatment outcomes of oral doxycycline versus intravenous azithromycin in adults hospitalized with scrub typhus: A retrospective study using inverse probability treatment weighting (IPTW) propensity analysis.

Objective: Only a few well-designed studies that have investigated the effectiveness of azithromycin in treating adult patients hospitalized with scrub typhus are currently available. The purpose of our study was to compare the effects of intravenous azithromycin administration with those of oral doxycycline, and to evaluate cardiovascular death associated with intravenous azithromycin in adult patients hospitalized with scrub typhus.

Methods: This retrospective study investigated Korean National Infectious Disease Cohort Collaborative-registered scrub typhus-infected patients who were hospitalized between January 1, 2013, and December 31, 2021, and who were ≥18 years old.

Occlusion type and posterior communicating artery patency may predict favorable outcome after endovascular thrombectomy in selective basilar top occlusion.

Introduction: The top of the basilar artery is a five-branched junction, consisting of two superior cerebellar arteries (SCAs), two posterior cerebellar arteries (PCAs), and the basilar artery itself. This study aimed to investigate prognostic factors in patients with selective acute basilar top occlusion managed with mechanical thrombectomy, focusing on occlusion type and posterior communicating artery (PCoA) patency.

Methods: Eligible patients who underwent endovascular treatment (EVT) for acute basilar top occlusion were reviewed.

Changes of Atherosclerotic Plaque in Cerebral Artery Stenosis According to High-Resolution MR Imaging.

Atherosclerosis can affect multiple arteries, and result in stroke and heart disease. Clinical and conventional imaging is insufficient to predict the progression of atherosclerosis. This study investigates risk factors that rely on high-resolution magnetic resonance imaging (HR-MRI).

Clinical characteristics of medication-overuse headache according to the class of acute medication: A cross-sectional multicenter study.

Objective: To characterize the clinical features of patients with medication-overuse headache (MOH) according to the class of acute medications being overused.

Background: MOH is a common global health problem, severely disabling the majority of the patients affected. Although various medications can cause MOH, whether clinical features differ according to the overused medication type remains unclear.

Treatment Patterns of Type 2 Diabetes Assessed Using a Common Data Model Based on Electronic Health Records of 2000-2019.

Background: Real-world data analysis is useful for identifying treatment patterns. Understanding drug prescription patterns of type 2 diabetes mellitus may facilitate diabetes management. We aimed to analyze treatment patterns of type 2 diabetes mellitus using Observational Medical Outcomes Partnership Common Data Model based on electronic health records.

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy: Results of the Korean South West Oncology Group (KSWOG) Study.

Purpose: Data on the efficacy of olanzapine in patients receiving moderately emetogenic chemotherapy (MEC) are limited. This study aimed to evaluate and compare the efficacy of olanzapine versus placebo in controlling nausea and vomiting in patients receiving MEC.

Materials And Methods: We conducted a randomized, double-blind, placebo-controlled study to determine whether olanzapine can reduce the frequency of chemotherapy-induced nausea and vomiting (CINV) and improve the quality of life (QOL) in patients receiving palonosetron and dexamethasone as prophylaxis for MEC-induced nausea and vomiting.

Clinical Phenotype of Diabetic Peripheral Neuropathy and Relation to Symptom Patterns: Cluster and Factor Analysis in Patients with Type 2 Diabetes in Korea.

Objectives: Patients with diabetic peripheral neuropathy (DPN) is the most common complication. However, patients are usually suffering from not only diverse sensory deficit but also neuropathy-related discomforts. The aim of this study is to identify distinct groups of patients with DPN with respect to its clinical impacts on symptom patterns and comorbidities.

Effects of Double Active Layer and Acetic Acid Stabilizer on the Electrical Properties of a Solution-Processed Zinc Tin Oxide Thin-Film Transistor.

We investigated the effects of a double active layer (DAL) and acetic acid stabilizer on zinc tin oxide (ZTO) thin-film transistors (TFTs) fabricated using a solution process. The DAL was composed of two layers created by a ZTO solution doped with the same or different percentiles of an atomic Sn concentration (30 at.%, 60 at.

Improvement in the Electrical Performance of Ge-Doped InZnO Thin-Film Transistor.

We fabricated amorphous oxide semiconductor thin-film transistors (TFTs) using Ge-doped InZnO (Ge-IZO) thin films as active-channel layers. The Ge-IZO thin films were deposited at room temperature by radio-frequency (RF) magnetron co-sputtering system, and then annealed in air for 1 h at 300 °C. Some processing parameters such as sputtering oxygen partial pressure [O2/(Ar + O2)] and sputtering power for GeO2 target were changed to investigate what was the optimal amount of Ge in the Ge-IZO active layer.

An assessment of the pharmacokinetics of a sustained-release formulation of a tramadol/acetaminophen combination in healthy subjects.

Purpose: To provide consistent pain relief and improve convenient sustained release (SR), a fixed-dose combination tramadol/acetaminophen tablet was formulated. This study aimed to evaluate the pharmacokinetic profiles of an SR 75-mg tramadol/650-mg acetaminophen formulation after a single dose compared with an immediate release (IR) 37.5-mg tramadol/325-mg acetaminophen formulation after 2 doses and at steady state and to assess the effect of food on the pharmacokinetic SR formulation profile after a single dose.

Pharmacokinetic properties of isosorbide-5-mononitrate under fasting and fed conditions in healthy male subjects.

Objective: This study was performed to compare the pharmacokinetic properties and relative bioavailability of two isosorbide-5-mononitrate (5-ISMN) sustained-release drugs in healthy Korean subjects under fasting and fed conditions.

Methods: A total of 60 healthy volunteers (30 each in the fasting and fed arms of the study) were enrolled in the study and were randomized to treatment. After the administration of a single dose of one of the investigational products, blood samples were collected at specific time intervals from 0 to 36 hours.

Pharmacokinetic comparison study of a combination containing 500 mg of Naproxen and 20 mg of Esomeprazole: a randomized, single-dose, 2-way crossover, open-label study in healthy Korean men.

Purpose: Nonsteroidal anti-inflammatory drugs have been used for analgesic, anti-inflammatory, and antithrombotic effects, but they carry a risk of major gastrointestinal damage. This risk can be greatly reduced by the coadministration of inhibitors of gastric acid secretion, such as proton pump inhibitors. This study was performed for the subsequent marketing of a combination drug that contained 500 mg of naproxen and 20 mg of esomeprazole in Korea.

Pharmacokinetic properties of two erlotinib 150 mg formulations with a genetic effect evaluation in healthy Korean subjects.

Background And Objective: Erlotinib is a drug used to treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. It is a reversible tyrosine kinase inhibitor that acts on the epidermal growth factor receptor and inhibits cell proliferation, growth, migration, invasion and survival. This study was performed for the subsequent marketing of a test erlotinib formulation in Korea.

The validities and efficiencies of korean ADHD rating scale and korean child behavior checklist for screening children with ADHD in the community.

Objective: The purpose of this study is to examine the validity of primary screening tools for attention deficit hyperactivity disorder (ADHD) in a community-based sample of children using the Korean version of the Child Behavior Checklist (K-CBCL) and the Korean version of the ADHD Rating Scale (K-ARS).

Methods: A large-scale community-based study for ADHD screening was conducted in the Jeollabuk province in the Republic of Korea. In 2010-2011, we surveyed a total of 49,088 first- and fourth-grade elementary school students.

Pharmacokinetics of a new orally soluble film formulation of sildenafil administered without water.

Objective: To compare the pharmacokinetic profiles and to assess bioequivalence of a newly developed orally soluble film formulation of sildenafil, taken without water, with those of a conventional formulation of sildenafil.

Methods: This study was conducted in a population of healthy subjects as an open-label, randomized sequence, two-period, two-formulation, single-dose, crossover design. The subjects were randomly assigned to 1 of 2 sequences of the two formulations: an orally soluble film (OSF) of 50 mg sildenafil as the test drug and a film-coated tablet (FCT) of 50 mg sildenafil as the reference drug.

Comparison of the pharmacokinetics, safety, and tolerability of vitamin D3 in DP-R206 (150-mg ibandronate/24,000-IU vitamin D3 tablet) and as monotherapy (24,000 iu) in healthy male Korean adults.

Background: Combined treatment with a bisphosphonate and vitamin D has been proposed for postmenopausal osteoporosis. A new, fixed-dose combination tablet of ibandronate plus vitamin D3 has been developed for monthly administration to treat postmenopausal osteoporosis.

Objectives: The main objective of the present study was to compare the pharmacokinetics of vitamin D3 administered in 2 forms: a newly developed ibandronate 150-mg/vitamin D3 24,000-IU tablet (DP-R206, test drug) and a stand-alone vitamin D3 24,000-IU tablet (reference drug).

Continuous long-term entecavir therapy in naïve chronic hepatitis B patients showing partial virologic response.

Background/aims: We investigated the efficacy of continuous long-term entecavir 0.5 mg treatment in naïve chronic hepatitis B patients showing a partial virologic response (PVR).

Methods: A total of 227 patients were included.

Pharmacokinetic comparisons between two formulations containing 100 mg of miglitol in healthy male Korean volunteers: a randomized, open-label, single-dose, two-period, two-sequence crossover bioequivalence study.

Background: Miglitol is an α-glucosidase inhibitor (AGI) used as an antihyperglycemic agent in the treatment of type 2 diabetes mellitus. The mechanism is that miglitol binds to and inhibits the α-glucosidase reversibly in the proximal intestine. Thus, carbohydrates not digested in the upper small intestine are transported to the lower intestine where they are eventually digested.

Pharmacokinetic properties and bioequivalence of olmesartan medoxomil/hydrochlorothiazide in healthy Korean male subjects.

Unlabelled: Olmesartan medoxomil inhibits the vasoconstrictor effects of angiotensin II. Hydrochlorothiazide (HCTZ) promotes sodium excretion, resulting in a reduction of plasma volume and peripheral resistance. A combination of these agents is known to have a greater effect for the treatment of hypertension than monotherapy with either one of these components.

Development and validation of an LC-MS/MS method for determination of compound K in human plasma and clinical application.

A rapid, sensitive and selective analytical method was developed and validated for the determination of compound K, a major intestinal bacterial metabolite of ginsenosides in human plasma. Liquid-liquid extraction was used for sample preparation and analysis, followed by liquid chromatography tandem spectrometric analysis and an electrospray-ionization interface. Compound K was analyzed on a Phenomenex Luna C18 column (100×2.

Pharmacokinetic properties and bioequivalence of candesartan cilexetil in Korean healthy volunteers.

Candesartan is a long-acting and selective nonpeptide AT1 subtype angiotensin II receptor antagonist. The aim of this study was to compare the pharmacokinetics and to evaluate the bioequivalence of two candesartan cilexetil 16 mg formulations. Forty healthy volunteers were randomly assigned into two groups.

Validation of the Korean version of the Eppendorf Schizophrenia Inventory as a screening measure to detect adolescents at ultra-high risk for psychosis.

Aim: No validated self-report scale is available for use as a screening tool to detect non-help-seeking adolescents at ultra-high risk (UHR) for psychosis in a community setting. The study aims to examine the reliability and validity of the Korean version of the Eppendorf Schizophrenia Inventory (K-ESI) for assessing adolescents at UHR for psychosis in a community setting.

Methods: In the first study, to confirm the reliability and discriminant validity of the K-ESI, community sample (782 adolescents, 281 young adults, 122 early and middle-aged adults) and outpatients with schizophrenia (109) were recruited.