Beaufort-sur-gervanne, France
Complications of Midline Catheter in Surgical Children
Phase
N/ASpan
150 weeksSponsor
Seoul National University HospitalSeoul
Recruiting
Validation of the Prognostic Impact of a Retinal Photograph-based Cardiovascular Disease Risk Stratification System in de Novo HFrEF
"Study Methods 1. Eligible participants will be approached during outpatient visits or hospitalization. The purpose and procedures of the study will be explained in detail, and informed consent will be obtained prior to data collection. Even after initial enrollment, participants will undergo continuous re-confirmation of consent at each subsequent visit. 2. All data will be collected in accordance with clinical guideline of heart failure in Korea (published from KHFS). This includes demographic characteristics, clinical history, echocardiographic parameters, laboratory findings, and cardiovascular outcomes. These data will be documented in a dedicated case report form. 3. Participants will undergo assessments during the first year following enrollment, with a target total follow-up duration of at least five years to evaluate long-term clinical outcomes. 4. All study data will be stored on password-protected computers with restricted access. No personal identifiers will be included and only de-identified, coded data will be used for analysis to ensure data confidentiality. This study will not involve development or modification of a deep learning algorithm. Instead, we will apply a pre-existing, validated retinal-based cardiovascular risk classification algorithm to newly diagnosed heart failure patients. Prognostic analyses will be conducted to determine whether algorithm-derived risk stratification is associated with differences in clinical outcomes during follow-up."
Phase
N/ASpan
313 weeksSponsor
Yonsei UniversitySeoul
Recruiting
Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease
Background and Theoretical Basis 1. Necessity of Exercise Intervention in Patients with Nontuberculous Mycobacterial Pulmonary Disease NTM (Nontuberculous Mycobacteria) includes all mycobacterial species except for tuberculosis and leprosy bacteria. It is commonly found in water and soil, and the lungs are the most frequent infection site. NTM pulmonary disease is increasing globally and in Korea, where its incidence has risen almost fivefold from 11.4 per 100,000 in 2010 to 56.7 per 100,000 in 2021, surpassing the incidence of tuberculosis (52.1 per 100,000) in 2021. Economic Impact: Direct medical expenditures related to NTM pulmonary disease in Korea rapidly increased to 20.9 billion KRW in 2021, a 5.8-fold increase compared to 2010. Studies in Canada have shown that the average annual medical cost per NTM patient is $11,541, with higher costs associated with inpatient care prior to death. Reducing hospital admissions through improved prognosis via exercise interventions can be economically beneficial. Demographic Considerations: The incidence and mortality of NTM pulmonary disease are higher in those over 65 years old, with the prevalence rate being significantly higher in this age group (163.1 per 100,000 in 2021). With Korea's rapidly aging population, the prevalence and associated medical costs of NTM pulmonary disease are expected to increase. Clinical Considerations: NTM pulmonary disease has a long treatment period with frequent treatment failures and relapses. There is a need for adjunctive therapies beyond pharmacological treatment to improve patient prognosis. Studies have shown a correlation between muscle deterioration measured indirectly by CT and increased mortality in NTM patients, suggesting that exercise interventions to improve muscle quality could enhance patient outcomes. Conclusion: Developing an exercise intervention program as an adjunctive therapy may contribute to improving prognosis and quality of life for NTM pulmonary disease patients. 2. Recent Research Trends Existing Research: There are few studies analyzing the effects of exercise interventions in NTM pulmonary disease patients. Two small-scale studies have been conducted on inpatient exercise interventions and chest physical therapy (using positive expiratory pressure devices or cough training). However, there is no large-scale study on outpatient exercise interventions. Research Gaps: There is a lack of descriptive epidemiological studies on physical activity levels or muscle strength in NTM pulmonary disease patients, which are essential for setting appropriate exercise intervention goals. Existing studies on conditions frequently associated with NTM pulmonary disease, such as bronchiectasis or chronic obstructive pulmonary disease (COPD), have shown that exercise interventions can improve exercise capacity and quality of life. Conclusion: Given the positive outcomes of exercise interventions in related conditions, further research on the effects of exercise interventions in NTM pulmonary disease patients is warranted. 4. Research Design (1) Study Design 1. design 1) Prospective, single-center, randomized, open-label, two-group clinical study 2) Patients eligible for the study are randomly assigned 1:1 2. group 1. arm 1 : immediate exercise intervention group Exercise intervention will begin immediately after randomization. 2. arm 2 : delayed intervention group : Exercise intervention will begin 6 weeks after randomization. 3. intervention 1. 6-week exercise program : one-day hospital-based education, 5-day home-based exercise A structured exercise regimen tailored to each patient's physical capacity, including aerobic, resistance, and flexibility training, conducted over a 6-week period 4. Participants : 1. Incluison patients with nontuberculous mycobacterial pulmonary disease - 40-80 years old - culture positive within 6months - with respiratory symptoms 2. exclusion Patients with severe comorbid conditions, recent surgery, or those unable to participate in exercise programs 5. Procedure - Baseline Assessment: All participants will undergo initial assessments, including medical history, physical examination, 6MWT, QOL, body composition, handgrip, and pulmonary function tests. - Randomization: Participants will be randomly assigned to either the intervention group (immediate exercise group) or the control group (delayed exercise group) stratified by BACES score (low BACES (0/1) vs moderate to severe BACES (2-5)) - intervention : 6-week exercise program : one-day hospital-based education, 5-day home-based exercise A structured exercise regimen tailored to each patient's physical capacity, including aerobic, resistance, and flexibility training, conducted over a 6-week period - Follow-up: Assessments will be repeated after 6-week program and 6 months later to evaluate the impact of the exercise intervention in the intervention group (immediate exercise program). Assessments will be repeated after 6-week baseline examination, before exercise program and 6 months later to evaluate the impact of the exercise intervention in the control group (delayed exercise group) Data Analysis: Statistical analyses will be performed to compare the outcomes between the intervention and control groups. 5. Ethical Considerations Informed Consent: All participants will provide written informed consent before participation. Ethical Approval: The study protocol was reviewed and approved by the institutional review board (IRB). 6. Outcome measure 1. primary outcome : VO2 max 2. secondary outcome : 6MWT, quality of life, pulmonary function, body composition, inflammatory marker
Phase
N/ASpan
141 weeksSponsor
Yonsei UniversitySeoul
Recruiting
Binaural Sound for Remimazolam Maintenance
Phase
N/ASpan
33 weeksSponsor
Gangnam Severance HospitalSeoul
Recruiting
A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)
Phase
1/2Span
211 weeksSponsor
Merck Sharp & Dohme LLCSeoul
Recruiting
Effects of Inspiratory Muscle Training and Abdominal Drawing-In Maneuver on Balance, Gait and Pulmonary Function in Stroke Patients
This study investigates the effects of Inspiratory Muscle Training (IMT) and Abdominal Drawing-In Maneuver (ADIM) on stroke rehabilitation. IMT involves resistance-based breathing exercises to strengthen the inspiratory muscles and improve pulmonary function, while ADIM focuses on activating the deep abdominal muscles, particularly the transversus abdominis, to enhance trunk stability and postural control. Participants in the intervention group perform IMT using a threshold resistance device, starting at 30% of MIP and progressively increasing to 60% MIP over four weeks. ADIM exercises are conducted with verbal and manual guidance to ensure proper engagement of core muscles. Sessions are held five times per week for four weeks, with each session lasting 40 minutes (20 minutes for each intervention). The control group receives conventional rehabilitation without resistance-based inspiratory training. The study utilizes TIS, BBS and TUG to assess balance, FGA to evaluate gait performance, and MIP and MEP to measure respiratory function. Assessments are conducted before and after the intervention to evaluate changes resulting from the treatment. Eligible participants are individuals with subacute stroke (onset within 1-6 months), an MMSE-K score of 24 or higher, and the ability to walk at least 6 meters with or without an assistive device. Exclusion criteria include conditions prohibiting the Valsalva maneuver (e.g., glaucoma, aneurysm, pulmonary hypertension), acute respiratory infections, severe cognitive or language impairments, prior inspiratory muscle training within the past six months, unstable medical conditions, and neurological or musculoskeletal disorders affecting gait and balance. This study aims to determine whether the combined application of IMT and ADIM enhances functional recovery, improves postural control, and promotes better respiratory health in stroke patients. The findings may contribute to the development of more effective rehabilitation strategies for improving quality of life in individuals recovering from stroke.
Phase
N/ASpan
19 weeksSponsor
Sahmyook UniversitySeoul
Recruiting
Comparison of Ropivacaine-Poloxamer 407 Hydrogel and TAP Block for Postoperative Pain Management in Laparoscopic/Robotic Gastrectomy
Phase
N/ASpan
61 weeksSponsor
Gangnam Severance HospitalSeoul
Recruiting
Comparison of Full Robotic Instrumentation and Assistant-Controlled Laparoscopic Instrumentation in Robotic Distal Gastrectomy
Phase
N/ASpan
61 weeksSponsor
Gangnam Severance HospitalSeoul
Recruiting
Trastuzumab Deruxtecan vs Endocrine Therapy in Low-HER2 HR+ Advanced Breast Cancer
Study Design: Randomized phase II, two-arm, randomized, open label study - The Hormone receptor (HR)-positive HER2-low advanced breast cancer patients (HER2 IHC 1+ or 2+ & ISH negative, n=141) who progressed on first-line endocrine + CDK4/6 inhibitor therapy for advanced disease will be enrolled in this study. Patients will be 2:1 randomized to experimental and control treatment arms by stratification factors below Stratification factor 1. Visceral metastasis (with visceral metastasis versus without visceral metastasis) 2. Progression-free survival on prior CDK4/6 inhibitor therapy (< 6 months versus ≥ 6 months) - In the experimental treatment arm (n=94), patients receive trastuzumab deruxtecan (T-Ddx) 5.4mg/kg intravenous infusion every 3 weeks. In the control treatment arm (n=47), patients receive endocrine therapy of physicians' choice (TPC: fulvestrant, fulvestrant + alpelisib, exemestane, exemestane + everolimus, or tamoxifen; fulvestrant + alpelisib can be selected in PIK3CA activating mutation positive patients). The study treatment will continue until disease progression by RECIST 1.1, unacceptable toxicity, end of study, or death. - This study both enrolls pre- and post-menopausal patients, and pre-menopausal patients should receive ovarian function suppression treatment (GnRH agonist injection or surgical bilateral oophorectomy) while receiving fulvestrant or aromatase inhibitor treatment in the control arm. - The endocrine TPC is pre-selected by investigator in screening period before randomization. The regimens that the patient received for advanced disease before cannot be selected. The regimen that the patients received for (neo)adjuvant therapy for breast cancer before cannot be selected unless the recurrence of disease was diagnosed > 1 year after the completion of the (neo)adjuvant therapy. - The evaluation of tumor response by computed tomography or magnetic resonance imaging of the chest, abdomen, and pelvis will be performed every 9 weeks from the date of randomization for 54 weeks and performed every 12 weeks after then until objective (RECIST 1.1 defined) disease progression. - Mandatory baseline tissue and ctDNA collection followed by three on-treatment ctDNA samples (Day 1 of Cycle 2, Cycle 3, and Cycle 6) will be collected. The post-treatment ctDNA (mandatory) and tumor tissues (optional) will be also collected - The patient samples will be evaluated to identify predictive biomarkers including copy number aberration (CNA), mutations, molecular subtype, or HRD status on LP-WGS ctDNA analysis.
Phase
2Span
157 weeksSponsor
Yonsei UniversitySeoul
Recruiting
Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography
CCTA is an accurate, noninvasive alternative to invasive coronary angiography. CCTA can provide detailed information about the characteristics of coronary artery plaques, such as their composition, morphology, and distribution. Various CCTA-detected plaque characteristics indicative of plaque quantity and quality have been identified as high-risk features independently predicting clinical events, including the presence of positive remodeling, low attenuation plaque, spotty calcification, and napkin ring sign. Currently, the treatment for CCTA-detected high-risk plaque has been receiving increasing interest. The current study aimed to prove the efficacy of PCSK9 inhibitors in addition to the background LMT, as compared with placebo plus background LMT in patients with CCTA-detected high-risk plaques. Hypothesis: PCSK9 inhibitors in addition to background LMT will show a superior event rate, compared with placebo plus background LMT, in terms of major adverse cardiac and cerebrovascular events (MACCEs) at 24 months after the last patient's randomization in patients with high-risk coronary plaques assessed by CT Angiography.
Phase
N/ASpan
422 weeksSponsor
Second Affiliated Hospital, School of Medicine, Zhejiang UniversitySeoul
Recruiting