Röderland-prösen, Germany

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.

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.

Comparison of Full Robotic Instrumentation and Assistant-Controlled Laparoscopic Instrumentation in Robotic Distal Gastrectomy

Comparison of Ropivacaine-Poloxamer 407 Hydrogel and TAP Block for Postoperative Pain Management in Laparoscopic/Robotic Gastrectomy

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.

DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes

This is a Phase 4, multicenter, randomized, open-label, parallel clinical trial

A Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2021 and BR2021-1

Efficacy and Safety of SPC1001 in Patients With Essential Hypertension

Efficacy and Safety of HANAROSTEN® HOT Plumber™ with Z-EUSIT™ for Pancreatic Pseudocyst Drainage

Detailed Description This prospective, single-center observational study aims to evaluate the safety and effectiveness of the HANAROSTEN HOT Plumber with Z-EUSIT for pancreatic pseudocyst drainage. The study will assess clinical success, defined as a reduction of at least 50% in pseudocyst size accompanied by symptom improvement, as well as technical success, device retention, lumen patency, and adverse events. Follow-up will continue until one month after stent removal. - Pancreatic pseudocysts develop due to pancreatic duct obstruction or damage caused by inflammation, resulting in fluid accumulation. Symptoms may include abdominal pain, gastric outlet obstruction, early satiety, and weight loss. Drainage is required when pseudocysts become symptomatic, infected, or increase in size. - Endoscopic ultrasound-guided transgastric or transduodenal drainage is the standard treatment for accessible pseudocysts. Compared to surgical or percutaneous methods, this approach is less invasive and promotes faster recovery. - The HANAROSTEN HOT Plumber with Z-EUSIT features an electrocautery-enhanced delivery system, eliminating the need for guidewire exchanges and tract dilation. The stent is made of nitinol wire with silicone coating and anti-migration bi-flanges, designed for easy placement and removal. Study Design - Type: Prospective, single-center, observational study - Device: HANAROSTEN HOT Plumber with Z-EUSIT - Target Enrollment: 20 adults aged 18 years or older - Procedure: Endoscopic ultrasound-guided transgastric or transduodenal drainage of pancreatic pseudocysts - Follow-Up: Until one month after stent removal Procedure Overview - Prior to the procedure, cross-sectional imaging (CT or MRI) will determine pseudocyst size and proximity to the gastrointestinal lumen, guiding stent selection. - Patients will receive prophylactic antibiotics and sedation with midazolam and pethidine according to institutional protocols. - Under EUS guidance, the pseudocyst will be punctured using the electrocautery-enhanced delivery system. The stent will be deployed to create a connection between the pseudocyst and the gastrointestinal lumen, allowing fluid drainage. - If direct puncture is not feasible, a 19-gauge needle will be used to access the pseudocyst, followed by guidewire placement and stent deployment. - Stent removal will occur after pseudocyst resolution, confirmed by follow-up imaging, and will be performed using forceps or a snare. Follow-Up and Safety Monitoring - Participants will be monitored for adverse events, including bleeding, infection, perforation, stent migration, tissue injury, and other complications. - Follow-up visits will occur within 30 or 60 days after the procedure, and one month after stent removal. - Safety monitoring will include clinical assessments, laboratory tests, and imaging studies as required. Data Collection and Statistical Analysis - Data will be summarized using descriptive statistics. Continuous variables will be reported as mean ± standard deviation or median (interquartile range), and categorical variables as frequencies and percentages. - Technical success rates will be calculated as the percentage of successful stent placements and removals. Clinical success rates will be reported as the percentage of participants with ≥50% pseudocyst size reduction and symptom improvement. - Adverse events will be classified according to severity and relationship to the device. The incidence of stent migration, retention, and lumen patency will also be reported. - Missing data will be handled using the last observation carried forward (LOCF) method. Ethical Considerations - The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. - All participants will provide written informed consent before enrollment. - Personal data will be anonymized and securely stored, accessible only to authorized study personnel. This study aims to provide clinical evidence supporting the safety and effectiveness of the HANAROSTEN HOT Plumber with Z-EUSIT for pancreatic pseudocyst drainage, potentially improving outcomes for patients with this condition.

Effect of Ezetimibe on Gut Microbiota

1. Study Period The clinical trial spans 12 weeks to analyze baseline data and changes after treatment. The study starts upon IRB approval, with participant recruitment concluding within 24 months and the entire study wrapping up within 48 months. 2. Study Design This is an investigator-initiated, prospective, single-center, open-label, randomized clinical trial. It involves 110 coronary artery disease (CAD) patients in need of lipid-lowering therapy, divided into two groups: Experimental Group (n=55): Moderate-intensity statin (Atorvastatin 20 mg) combined with Ezetimibe 10 mg. Control Group (n=55): High-intensity statin monotherapy (Atorvastatin 40 mg). Primary Outcome: Changes in gut microbiota composition. Secondary Outcomes: Changes in blood lipid levels and inflammatory biomarkers. 3. Methods 3.1. Screening and Enrollment Participants are screened for eligibility based on inclusion and exclusion criteria. After providing informed consent, participants are randomized into two groups (1:1 ratio) using a permuted block randomization method. For those on prior statin or Ezetimibe therapy, a 2-week washout period is required before enrollment. 3.2. Study Medication Participants receive their assigned treatment for 12 weeks, with medications administered orally once daily at consistent times, irrespective of meals: High-Intensity Statin Group: Atorvastatin 40 mg. Combination Therapy Group: Atorvastatin 20 mg + Ezetimibe 10 mg. 3.3. Follow-Up Baseline data, including demographic details, blood tests, and stool samples, are collected at enrollment. After 12 weeks of treatment, follow-up includes clinical evaluations, blood tests, and stool sample collection for post-treatment analysis. 4. Efficacy Evaluation 4.1. Primary Endpoint Gut Microbiota Analysis: Stool samples are analyzed using 16S rRNA sequencing. Statistical tests compare microbiota differences: Between groups at baseline (T-test or Mann-Whitney test). Pre- and post-treatment within groups (Paired t-test or Wilcoxon test). Intergroup changes over time (ANOVA test). 4.2. Secondary Endpoint Similar statistical methods are applied to assess changes in blood lipid levels and inflammatory biomarkers. 4.3. Subgroup Analysis Specific subgroups undergo additional analysis: Subgroup 1: Low-risk CAD patients (10-year ASCVD risk <7.5%). Subgroup 2: Patients with poor response to therapy (LDL >70 mg/dL after 12 weeks). Subgroup 3: Recurrent CAD patients despite optimal therapy. Subgroup stool samples are analyzed using shotgun metagenomic sequencing for detailed microbial insights.