Dupnitsa, Bulgaria

AZD0486 as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of AZD0486 monotherapy administered as an intravenous (IV) infusion in participants with relapsed or refractory B-NHL. The purpose of this study is to determine the efficacy and safety of AZD0486 administered at the RP2D in adults 18 to 80 years of age with relapsed or refractory B-NHL.

Phase 1 Single Ascending Dose Study

Phase 1, double-blind, placebo-controlled, single-centre, single ascending dose escalation study to assess safety and tolerability of a monoclonal antibody, NM-101 in healthy volunteer subject and multiple system atrophy (MSA) patients.

Validation of the Efficacy of Air Purifiers in Indoor Environment and Allergic Symptoms in Allergic Rhinitis Patients

This study targets adult patients between the ages of 19 and 60 who were diagnosed with allergic rhinitis caused by indoor inhalation antigens. Patients with moderate to severe and persistent allergic rhinitis who continue to require medication such as antihistamines and nasal spray steroids for allergic rhinitis are the subjects of this study. Patients who participate in the study will install air purifiers for a certain period of time and observe the objective and subjective improvement of rhinitis symptoms. The study is conducted on two separate occasions for four weeks, and there is a two-week period between the two periods of no use of air purifiers. There are two types of air purifiers: 1)It is an air purifier with a HEPA filter and a VOC filter, and 2) a fake air purifier without air cleaning function. Subjects are divided into Group A and Group B. Group A will receive a fake air purifier, and Group B will be assigned an air purifier with a HEPA + VOC collecting filter. After using the assigned air purifier for the first four weeks, you will have a period of not using it for two weeks, and then replace the air purifiers with each other and use it again for four weeks. When you first assign an air purifier, you will receive an air purifier with a certain filter It is randomly assigned without knowing whether both the researcher and the patient will receive a regular period. During the study period, patients need to visit three times, including when registering for the study, and the study period is screened It will take about 5 months from the end of the air purifier operation A detailed chronological overview of the study is as follows 1. Screening and Baseline Visits (Visit 1) Before the process of the study begins, the study subjects are fully explained about the entire research process and checked whether they meet the selection and exclusion criteria. If the selection criteria are met, a written consent form will be written, basic demographic information (gender, age, medical history (including allergic disease-related and surgical history), and drug administration history (four weeks before registration). We will conduct a survey on subjective symptoms of allergic rhinitis, drug use scores, subjective score indicators, and quality of life evaluation indicators, and double-check the drugs currently being taken by the study subjects. If you have previously used drugs for allergic rhinitis, you can maintain the medication without change and prescribe additional relief drugs if necessary. 2. Installation of air purifier and Study I after randomization Randomization is a method that is divided into groups A and B and is assigned based on a randomized list (random table) with statistician advice at a ratio of 1:1 respectively. The first study (Study I) will run for four weeks. During this period, the air purifier will continue to operate, and no indoor ventilation will be performed for these four weeks to reduce other factors that may affect indoor air quality. After four weeks, the air purifier will be remotely controlled, and indoor air quality information will be continuously collected in the filter replacement. 3. Interim Visit (Visit 2) The subject of the study will visit the hospital with a journal written about the changes in symptoms and the use of drugs after the first operation of the purifier (Study I). During the first and second visits, the symptoms will be checked for differences and whether relief drugs have been used, and additional relief drugs will be prescribed if necessary, along with retraining on the next visit schedule. 4. Study II progress and end visit after replacement of air purifier filter (Visit 3) To proceed with the second study (Study II), LG Electronics installers revisit each home and install Dual Defense Filter (HEPA + VOC capture filter) in Group A. Conversely, Group B will remove the Dual Defense filter and attach void labels again each. Study II will also run for four weeks, during which the air purifier is continuously running and there is no indoor ventilation. The subject of the study should visit the hospital with symptoms and drug use log even at the end of the visit, and the change in symptoms and the use of relief drugs will be confirmed. At the end of the study, we will disclose which group the study subjects were assigned to.

South Korean Study to Prevent Frailty and Aging-related Diseases Through Lifestyle Intervention

The physical exercise program will comprise aerobic exercise, balance-improving exercises, flexibility-enhancing activities, and strength-building exercises targeting major muscle groups through a mobile app . Customized cognitive training, performed using a mobile app, targets the cognitive domains of prospective memory and executive function. Nutritional intervention will be performed to treat frailty symptoms and disease related to frailty through a mobile app. Education and management of disease related to frailty will be done through a mobile app.

Pharmacokinetics and Safety of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers

Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)

In 2024, it is estimated that there will be over 1 million individuals aged 65 and older with dementia in South Korea, with national dementia care costs exceeding approximately 17 trillion KRW (0.9% of GDP). South Korea is experiencing rapid population aging, leading to a projected significant increase in both the number of patients and the associated socio-economic costs. Alzheimer's disease (AD) is the most common cause of dementia and cognitive impairment in the elderly, characterized by the abnormal accumulation of amyloid beta (Aβ) and tau proteins in the brain. Research has shown that beta-amyloid protein begins to accumulate in the brain over 20 years before the onset of memory impairment symptoms. Consequently, Alzheimer's disease progresses through a prolonged asymptomatic stage of normal cognitive function (cognitively unimpaired, CU) to subjective cognitive decline, mild cognitive impairment, and dementia. In May 2024, the Korean Ministry of Food and Drug Safety approved lecanemab for the treatment of Alzheimer's disease. Recent advancements have been made in the development of new treatments and diagnostic methods for Alzheimer's disease, with some already approved for use in South Korea or anticipated to receive approval soon. These developments are expected to significantly impact the management of dementia and cognitive impairment patients in the near future. Among the new treatments, monoclonal antibody injections targeting the core pathological mechanism of Alzheimer's disease, which is the removal of beta-amyloid protein (e.g., lecanemab, donanemab), currently lack long-term efficacy data, providing only 1-2 years of investigatory data in clinical trials. Such medications may have side effects, including amyloid-related imaging abnormalities (ARIA) such as brain edema or microbleeding and infusion-related adverse reactions. For the advancement of precise treatments for Alzheimer's disease, it is essential to monitor long-term effects and side effects of these drugs in clinical practice to collect and analyze more extensive clinical data to establish additional clinical evidence. Moreover, the phase 3 clinical trial data for lecanemab suggests that the drug's effectiveness and side effects may vary by ethnicity. Recently, a diagnostic technique that measures Elecsys beta-amyloid 42 (Aβ42) and Elecsys Phospho-Tau181 (ptau181) in cerebrospinal fluid (CSF) has received approval from the Korean Ministry of Food and Drug Safety for the diagnosis of Alzheimer's disease. Additionally, there is a strong potential for new diagnostic methods that measure proteins such as ptau217, ptau181, and Aβ42 in blood to be commercialized in clinical practice. Future advancements through real-world data collection on these new diagnostic methods will be necessary. The Alzheimer's Association (AA) and researchers in the United States have initiated a registry study named the Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) to collect real-world data on new treatments and diagnostic methods for Alzheimer's disease. Longitudinal studies to investigate the long-term effectiveness and safety of new treatments and diagnostic methods in Alzheimer's patients are also being established in countries such as Japan, Australia, the Netherlands, and Europe. In response to these changes in Alzheimer's disease management, the researchers aim to contribute to the precision of Alzheimer's treatment and the enhancement of new diagnostic methods by collecting real-world data from Korean Alzheimer's patients regarding the long-term effectiveness and safety of new therapies.

Exploratory Biomarker Analysis of Neoadjuvant Chemoimmunotherapy Followed by Pulmonary Resection in Stage II-III Non-Small Cell Lung Cancer

1. Construction of a neoadjuvant chemoimmuntherapy cohort of resectable stage 2-3 lung cancer patients and acquisition of clinical-pathological-radiological data. 2. Plasma from individual patient will be collected at preneoadjuvant and postneoadjuvant stages and ctDNA analysis will be performed.

A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy subjects.

Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea

Prospective Observational Study On The Impact Of Nebilet In Blood Pressure Control In Hypertensive Patients (HYIMPACT)

Introduction. Hypertension remains one of the leading risk factors for cardiovascular morbidity and mortality worldwide, contributing significantly to the burden of stroke, heart failure, and other cardiovascular diseases. Despite advancements in antihypertensive therapies, real-world data on long-term blood pressure control, treatment adherence, and patient-reported outcomes remain insufficient, particularly in diverse populations across Asia. While clinical trials have established the efficacy of various antihypertensive agents, the applicability of these findings to routine clinical practice remains unclear. Beta-blockers, particularly nebivolol, a third-generation β1-selective adrenergic antagonist with nitric oxide-mediated vasodilatory properties, have demonstrated favorable hemodynamic effects, improved vascular function, and better tolerability compared to traditional beta-blockers. However, there is a lack of robust real-world evidence assessing its long-term impact on blood pressure control and cardiovascular outcomes. The HYIMPACT study is a multinational, multicenter, observational, longitudinal study designed to evaluate the real-world effectiveness, safety, and adherence of Nebilet® (nebivolol) in hypertensive patients across seven Asian countries. This study will provide insights into the clinical utility of Nebilet® in achieving sustained blood pressure control over time, while also assessing the influence of cardiovascular risk factors on treatment outcomes. By systematically collecting data from patients in routine clinical settings, HYIMPACT aims to bridge the gap between controlled clinical trials and real-world practice, offering valuable evidence to optimize hypertension management strategies. Study Objectives. HYIMPACT aims to assess the impact of Nebilet®-based treatment on systolic and diastolic blood pressure control from baseline to 12, 24, and 36 months. The study will determine the proportion of patients achieving target blood pressure levels (<140/90 mmHg) and evaluate adherence using the Morisky 8-Item Medication Adherence Scale (MMAS). Additionally, the study will compare the effectiveness of Nebilet® monotherapy versus combination therapy in achieving blood pressure control. Patient-reported outcomes will be analyzed using the SF-36 and MINICHAL questionnaires, providing insights into the impact of treatment on quality of life. The study will also assess the correlation between home and office blood pressure measurements and investigate the association between Nebilet® use and major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and cardiovascular mortality. Study Design and Population. HYIMPACT is an observational, prospective, longitudinal study enrolling approximately 5,000 hypertensive patients across Malaysia, Indonesia, the Philippines, Korea, Vietnam, Thailand, and Taiwan. Eligible patients will be adults aged 18 years or older with newly diagnosed or uncontrolled hypertension, defined as an office systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg at screening. Patients may be included if they have either been newly prescribed Nebilet® or have been on Nebilet®-based treatment for no more than two weeks prior to enrollment. Individuals with recent major cardiovascular events within the last three months, severe heart failure classified as NYHA Class IV, or contraindications to Nebilet® as per the Summary of Product Characteristics will be excluded. The study will involve 300 to 500 physicians, ensuring representation across a wide range of real-world clinical settings. Variables to be Collected. The study will systematically collect patient demographic and clinical data, including medical history, cardiovascular risk factors such as diabetes, obesity, and hypercholesterolemia, and medication use. Blood pressure measurements will be recorded at baseline and at each follow-up visit, with additional data collected on prescription patterns, dose adjustments, and patient adherence. Laboratory parameters, including lipid profiles, glycated hemoglobin (HbA1c), and renal function markers, will be documented when available. Cardiovascular outcomes such as MACE, including myocardial infarction, stroke, and cardiovascular mortality, will be monitored throughout the study. Follow-Up and Data Collection. Patients will be evaluated at baseline and followed up at 12, 24, and 36 months. Blood pressure will be measured at each visit using standardized protocols, and home blood pressure readings will be encouraged to assess their correlation with office measurements. Patient-reported quality of life and adherence assessments will be conducted using validated questionnaires. Any adverse events, including treatment-emergent and serious adverse events, will be documented. Data will be recorded in an electronic case report form (eCRF) using the CLINYTICS platform, ensuring consistency and standardization across study sites. Quality Control Measures. To ensure high data quality, the study will implement standardized definitions and data collection procedures across all sites. Investigators will receive training on study protocols, and automated validation checks within the eCRF system will help identify inconsistencies. Regular site audits will be conducted to monitor compliance, and periodic investigator meetings will be held to review study progress. Ethics committee approvals will be obtained in each participating country, and all data will be handled in compliance with Good Clinical Practice (GCP) guidelines and local data protection regulations. Statistical Analysis. Continuous variables such as blood pressure values will be summarized as means with standard deviations, while categorical variables will be presented as frequencies and percentages. Changes in systolic and diastolic blood pressure over time will be analyzed using paired t-tests and repeated measures ANOVA, with non-parametric alternatives applied when normality assumptions are not met. The effectiveness of Nebilet® monotherapy versus combination therapy will be assessed using logistic regression for categorical outcomes and ANOVA for continuous variables. Cox proportional hazards models will evaluate the association between Nebilet® treatment and cardiovascular outcomes. Pearson correlation coefficients will be used to analyze the relationship between home and office blood pressure measurements, and structural equation modelling (SEM) will be applied to address potential regression dilution bias. Study Governance and Data Ownership. HYIMPACT is an investigator-led study with data collection coordinated through a centralized electronic data management system. Each participating physician retains ownership of individual patient data, while consolidated and anonymized study results will be used for scientific analysis and publication. Patient confidentiality will be strictly maintained through secure data storage, anonymization, and regulatory compliance with local data protection laws. The findings from HYIMPACT will provide valuable insights into the long-term real-world effectiveness of Nebilet® in managing hypertension. By analyzing treatment adherence, quality of life, and cardiovascular outcomes over time, this study will contribute to optimizing hypertension treatment strategies and improving patient care across diverse healthcare settings.