Clinical trials

As Taiwan transitions into a super-aged society, rising dementia rates have severely strained long-term care systems. Although current daycare centers provide multi-modal programs, they remain limited to behavioral training, lacking precise interventions targeting brain function and neuroplasticity or integrated non-invasive neuromodulation technologies. Furthermore, urban-rural disparities in resources, staffing allocation, and tech experience hinder practical deployment, with empirical research remaining scarce. Addressing this gap, this study investigates a smart brain health promotion model combining personalized gamma music stimulation and cognitive training for mild cognitive impairment and dementia, while evaluating its feasibility across diverse care settings.

Add-on dostarlimab to chemoradiation with etoposide and cisplatin and radiotherapy can improve progression-free survival (PFS) compared with historical controls who were treated with chemoradiation alone in SCNECC

Animal studies have shown that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, human studies using 40 Hz auditory stimulation alone remain limited. Therefore, this study will use a randomized, double-blind, placebo-controlled design to investigate the effects of 40 Hz auditory stimulation on cognitive function, EEG activity, sleep quality, and quality of life in older adults with mild cognitive impairment (MCI) or mild dementia.

The goal of this observational study is to evaluate the effectiveness and impact of Enhanced Recovery After Surgery (ERAS) on patients with pituitary gland tumors.

Ovarian cancer remains the deadliest gynecologic malignancy, with poor survival rates largely due to late-stage diagnosis. Early detection is crucial, yet no universally accepted screening method exists. Current imaging techniques and biomarkers, such as CA-125, have limitations in specificity and sensitivity. This study aims to develop and evaluate a deep learning-based computer-aided diagnosis tool (CAT-OV), for ovarian cancer detection using CT imaging. The system integrates a Body Part Regression (BPR) model for pelvic localization and a Multiple Instance Learning (MIL) ensemble classifier for cancer prediction. The model was trained and validated using retrospective datasets from Taiwan, the United States, and a nationwide real-world cohort. Stringent preprocessing and quality control measures were implemented to enhance model accuracy. Results highlight the potential of AI-driven CT screening in improving early detection, though further validation is needed for clinical adoption.

Acute ischemic stroke caused by blockage of a large brain artery can lead to severe disability. Endovascular thrombectomy is a catheter-based procedure used to remove the blood clot and restore blood flow. It can benefit selected patients treated 6 to 24 hours after stroke onset, but some patients remain disabled even when the blocked artery is successfully reopened. Ongoing injury to brain tissue, small blood vessels, and the blood-brain barrier may contribute to this incomplete recovery. This multicenter randomized clinical trial will evaluate whether Cerebrolysin, given after successful extended-window endovascular thrombectomy, can reduce brain tissue injury and support recovery. The study will enroll 100 adults aged 18 to 80 years at three stroke centers in Taiwan. Participants will be randomly assigned, after successful reperfusion has been confirmed, to receive either Cerebrolysin 30 mL or a matched normal saline placebo by intravenous infusion once daily for 10 consecutive days. The first infusion will begin within 36 hours of stroke onset. All participants will also receive standard stroke care and rehabilitation. The primary outcome is final infarct volume measured by diffusion-weighted magnetic resonance imaging on Day 7 to Day 10. Other outcomes include functional recovery at 3 and 12 months, neurological improvement, symptomatic intracranial hemorrhage, cerebral edema, recurrent stroke, mortality, cognition, language, and mood. The study will also examine blood-brain barrier injury using computed tomography perfusion, dynamic contrast-enhanced magnetic resonance imaging, and serial plasma Claudin-5 measurements. This study will determine whether Cerebrolysin shows evidence of reducing postreperfusion brain injury after successful thrombectomy and will help guide the design of a larger trial focused on clinical outcomes.

The goal of this observational study is to learn about the impact of sarcopenia (muscle loss) on the efficacy of regional nerve blocks and postoperative recovery in patients undergoing upper extremity surgery. The main questions it aims to answer are: 1. Does sarcopenia affect the onset time and success rate of peripheral nerve blocks? 2. How does sarcopenia influence postoperative pain control and opioid consumption compared to patients receiving pure general anesthesia? Participants will undergo a preoperative muscle assessment, which includes a chair stand test and a brief ultrasound of the thigh muscle. Researchers will then observe and record their nerve block onset time (if applicable), postoperative pain scores, and recovery metrics during their hospital stay up to postoperative day 2.

This project adopts a prospective study design. It is scheduled to enroll 60 participants diagnosed with Head and Neck cancer in this hospital, of which 30 are in the experimental group and 30 are in the control group. The purpose of this research is to analyze the skeletal muscle mass changes on images in Head and Neck cancer patients after exercise training and the association with systemic inflammatory markers. Investigators would like to know whether these images and biomarkers predict the prognosis of Head and Neck cancer. Subjects enrolled in the trial will receive 36 times of exercise training after concurrent chemoradiotherapy. Before and after the completion of exercise training, investigators will arrange (1) dual energy X-ray absorptiometry (DXA) to measure the whole-body skeletal muscle mass and appendicular skeletal muscle mass and (2) blood tests for markers of systemic inflammation. In addition to DXA, computed tomography (CT) is another image modality for skeletal muscle mass evaluation. Positron emission tomography - CT or whole-body CT for cancer staging are considered as baseline studies. The routine follow-up CT images are used to analyze the changes after exercise training. If magnetic resonance imaging is also performed during the follow-up period, images will also be collected and assessed as an alternative.If the experimental group can maintain or even improve skeletal muscle mass and can be reflected in blood tests and prognosis, the result may be able to apply on cancer treatment and disease followup.

This prospective, multicenter study compares the efficacy and functional outcomes of three surgical treatments for symptomatic Goligher Grade III internal hemorrhoids: Laser Hemorrhoidoplasty (LHP), Hemorrhoid Energy Therapy (HET), and conventional closed hemorrhoidectomy (Ferguson technique). Due to strong patient preferences in hemorrhoidal surgery, this study utilizes a pragmatic, preference-tolerant design. Eligible patients will undergo standardized counseling and select their preferred treatment arm. The study aims to evaluate whether minimally invasive energy-based therapies offer superior postoperative pain relief and faster functional recovery compared to conventional hemorrhoidectomy

Study Objectives： Atezolizumab (anti-programmed death-ligand 1; anti-PD-L1) combined with bevacizumab (anti-vascular endothelial growth factor; anti-VEGF) or Durvalumab (anti-programmed death-ligand 1; anti-PD-L1) combined with tremelimumab (anti-cytotoxic T-lymphocyte-associated protein 4; anti-CTLA4) have recently been established as a standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). However, its objective response rate (ORR) is only less than 27% (1, 2), and the majority of patients died of HCC progression and liver failure. Therefore, there is an urgent need to develop a novel combination treatment strategy to overcome resistance to immunotherapy and improve patient outcomes. Transarterial chemoembolization (TACE) remains the standard treatment for patients with intermediate-stage hepatocellular carcinoma (HCC) (3, 4). However, in our previous retrospective study (5-7), the investigators consistently observed that this combination not only improves therapeutic responses but also significantly prolongs patient survival. The tumor necrosis caused by TACE may enhance the efficacy of systemic therapies by promoting the release of neoantigens, thereby stimulating immune responses (8-14). This concept has been substantiated in two recent trials involving intermediate-stage HCC (15, 16), where the addition of immune checkpoint inhibitors to TACE resulted in improved clinical outcomes. Nevertheless, this promising approach has yet to replace the decades-old standard treatment protocols, underscoring the need for further proof-of-concept studies. Both immunotherapy (atezolizumab/bevacizumab or durvalumab/tremelimumab) and transarterial chemoembolization (TACE) are approved treatment modalities for unresectable hepatocellular carcinoma (HCC) by the U.S. and Taiwan Food and Drug Administration (FDA). This phase II non-randomized trial is designed to prospectively evaluate the therapeutic efficacy, safety, and immunological responses in patients with unresectable HCC treated with a combination of immunotherapy and TACE. A particular focus of this study is to explore the potential immune-boosting effects of TACE, including its ability to enhance antigen presentation and stimulate anti-tumor immune responses.

Pancreatic ductal adenocarcinoma (PDAC) carries one of the worst prognoses among solid tumors. Even after curative-intent resection, 70-80% of patients recur within two years. Current post-operative surveillance relies on computed tomography (CT) imaging and the serum tumor marker CA 19-9, but both have limited sensitivity for detecting microscopic residual disease. This single-center, prospective observational study evaluates the use of the K-4CARE Lite platform-a tumor-informed plus tumor-agnostic circulating tumor DNA (ctDNA) assay with a limit of detection of 0.005%-for dynamic monitoring of minimal residual disease (MRD) in patients with resected PDAC. Thirty adult patients who have undergone R0 or R1 (margin \<1 mm) resection at Linkou Chang Gung Memorial Hospital will be enrolled over 24 months. Each participant will provide one baseline tumor tissue sample (formalin-fixed paraffin-embedded) and three serial blood samples at three pre-specified study timepoints: Timepoint 1 (Week 4 to Week 10 after surgery, before adjuvant chemotherapy); Timepoint 2 (12 weeks after Timepoint 1, approximately 3 months into adjuvant chemotherapy); and Timepoint 3 (at completion of adjuvant chemotherapy, approximately Month 6 after surgery). A fourth long-term follow-up phase (Timepoint 4) collects results from patient-funded ctDNA testing performed as part of routine care. The primary outcome is the cumulative MRD detection rate across the three pre-specified post-surgical timepoints (Timepoint 1, Timepoint 2, and Timepoint 3). Secondary outcomes include the association between ctDNA status and disease-free survival (DFS) and overall survival (OS), molecular clearance rate at Timepoint 3, lead time of molecular relapse over imaging, and platform performance. ctDNA results are reported back to the treating physician for reference but do not mandate treatment changes-all clinical decisions remain at the physician's discretion per standard guidelines. This study aims to generate the prospective evidence base needed to design future ctDNA-guided interventional trials in pancreatic cancer.

Anterior cruciate ligament (ACL) reconstruction surgery is a common procedure performed by orthopedic surgeons. Postoperatively, patients often experience pain, muscle tension, and concerns about their ability to return to sports. These factors influence the recovery and return to sports capabilities of ACL patients. According to research, only 64% of patients are able to recover to their pre-injury level after surgery, and the success rate for returning to competitive sports is only 56%. Psychological factors during the recovery process may explain this disparity. ACL injury is associated with anxiety, pain reaction, and emotional disorders, with fear of re-injury being the most common obstacle to returning to sports, accounting for 19%. A study by Lentz et al. (2015) also found no significant differences in pain assessments between individuals who were afraid of re-injury and those who were able to return to sports at six months and one year after surgery. This suggests that fear of pain may limit activity and increase the risk of unsuccessful return to sports. Mindfulness intervention is a psychological approach that involves non-judgmental awareness and focus on moment to moment. Mindfulness practice is known to reduce stress in athletes, promote recovery, enhance athletic performance, and improve sleep quality. Good sleep quality contributes to emotional stability and physical recovery. Even short daytime naps can be beneficial for athletes. A review of 37 studies of moderate quality found that daytime napping can improve physical and cognitive performance, psychological state, and nighttime sleep. Therefore, investigators hypothesize that integrating mindfulness practice into daytime napping may lead to improved spirit upon waking, reduce sleep inertia, and over time, potentially increase the rate of return to sports after ACL reconstruction.

This project aims to build up the comprehensive health database of geriatric medicine for middle-aged and elderly people in Taiwan.

This study is testing new imaging and analysis methods to improve how doctors predict treatment response in rectal cancer patients receiving chemoradiotherapy. Current MRI scans sometimes miss complete tumor response, which can lead to unnecessary surgery. To address this, researchers will use a special MRI technique called hyperpolarized carbon-13 MRI, along with blood and tissue analysis (metabolomics) and advanced image feature analysis (radiomics). These tools can track how cancer cells use energy and how metabolism changes during treatment. The study will follow 30 rectal cancer patients at Chang Gung Memorial Hospital over 3 years. Patients will undergo standard MRI, colonoscopy, and advanced metabolic imaging before and after treatment. Results will compare patients whose tumors completely respond to therapy with those who do not. The goal is to see if metabolic changes detected by hyperpolarized MRI and metabolomics can predict treatment outcomes earlier and more accurately. This may help doctors avoid unnecessary surgery and provide more personalized care for rectal cancer patients.

Umbilical cord care is an essential component of newborn care, but the optimal method remains controversial. This randomized controlled trial aims to compare routine alcohol cord care with natural dry cord care in healthy newborns. A total of 210 mother-infant dyads will be randomly assigned to either routine alcohol cord care or natural dry cord care. The primary outcome is the incidence of umbilical cord infection. Secondary outcomes include umbilical cord separation time, bacterial colonization, and healthcare resource utilization for umbilical cord care. The findings of this study will provide evidence to support optimal umbilical cord care practices for healthy newborns.

Stroke survivors often experience persistent unmet needs during long-term recovery. Young and middle-aged stroke survivors may face additional challenges in balancing rehabilitation with work and family responsibilities. Although digital health interventions have the potential to improve access to education and self-management support, existing programs are often provider-driven, provide limited peer support, and have short follow-up periods. This study aims to evaluate the effectiveness of a patient-centered digital education and peer support intervention co-designed with young and middle-aged stroke survivors. Participants will be randomly assigned to either the intervention group or the usual care group. The intervention will be delivered through LINE communities and Google collaborative platforms over a 12-month period. The primary outcome is unmet needs. Secondary outcomes include stroke self-efficacy, depressive symptoms, quality of life, activities of daily living, instrumental activities of daily living, and return-to-work status.

Conventional imaging methods, such as CT and MRI, are limited in evaluating GIST response to imatinib, as they mainly reflect tumor size and fail to capture early metabolic or molecular changes. This study investigates GISTs from a metabolic perspective by integrating hyperpolarized (HP) 13C-MRI, metabolomics, and radiomics. HP 13C-MRI enables real-time monitoring of metabolic flux in vivo, while NMR-based metabolomics provides systemic insights. In this single-center, prospective observational cohort study, 30 GIST patients receiving imatinib will undergo pre-treatment CT, HP 13C-MRI, metabolomics, and biopsy. Early response will be assessed at one month, with routine evaluation at four months. Patients will be categorized as responders or non-responders, and multi-omics data will be analyzed using machine learning. The study hypothesizes that metabolic changes detected by HP 13C-MRI can predict treatment response, offering reproducible, quantifiable metrics to improve evaluation and patient care.

This study aims to evaluate whether personalized gamma-frequency auditory stimulation enhances cognitive function and brain synchronization. While 40 Hz auditory stimulation has been widely studied, recent evidence suggests optimal frequencies vary by individual. Using a cross-over design with 20 healthy adults, the research compares "optimal" versus "non-optimal" frequencies over one-month intervention periods. Effectiveness is measured through EEG recordings and executive function tasks. The goal is to determine if personalized sensory intervention provides a more effective, non-invasive strategy for enhancing cognitive performance.

This study evaluates the safety and preliminary efficacy of Bletilla formosana (BF), a traditional herbal medicine, in adults with prediabetes. Prediabetes is a high-risk condition where blood sugar levels are elevated, often leading to type 2 diabetes. While lifestyle changes are the standard treatment, researchers are exploring herbal supplements as a complementary way to support metabolic health. Preclinical research has shown that BF possesses anti-inflammatory properties and may help regulate blood glucose. Participants in this study will be randomly assigned to receive either a high dose of BF, a low dose of BF, or a placebo (an inactive substance) for 12 weeks. The total study duration is approximately 24 weeks, involving four clinic visits for blood tests and safety monitoring to see how BF affects blood sugar markers and inflammation.

Background and Purpose: Vertigo is common in emergency and outpatient settings, yet standard oculomotor testing usually requires dedicated equipment and exam rooms. This study evaluates whether nystagmus examinations performed with wearable augmented-reality (AR) glasses are equivalent to conventional examination-room testing for classifying central vs. peripheral vertigo. The investigators also assess diagnostic accuracy, patient tolerability, and the reliability of AR-based interpretation (test-retest and inter-rater). Study Design: Prospective, single-center, within-subject randomized equivalence study at Kaohsiung Chang Gung Memorial Hospital. Each participant completes both AR-based and conventional oculomotor testing in a randomized order during the same visit, separated by a 30-minute washout. The study uses an evaluator-blind approach: de-identified trajectories are reviewed offline by independent experts who are masked to test modality. A follow-up visit (\~1 week) captures adverse events and patient experience. Participants: Adults (≥18 years) presenting with vertigo who can tolerate the AR headset and provide consent. Key exclusions include conditions that prevent reliable eye-tracking (e.g., corrected visual acuity \<20/40), recent use of vestibular suppressants (within 24 hours), and other factors limiting cooperation or safety. Interventions and Procedures: The AR system records eye movements and presents standardized visual stimuli. Conventional testing follows current clinical standards (e.g., Frenzel/oculomotor exam). All recordings are stored securely for blinded review. Outcomes: Primary endpoint: Equivalence of diagnostic agreement (central vs. peripheral) between AR-based and conventional methods, quantified by Cohen's kappa (κ) with a predefined equivalence margin. Secondary endpoints: (1) Diagnostic accuracy of the AR method in a clinically-indicated imaging subgroup (MRI preferred; CT as needed) using a sequential evaluation strategy; (2) Patient discomfort/tolerability using VAS and CSQ-VR, compared between modalities; (3) Test-retest reliability of AR-based classifications; (4) Inter-rater reliability between independent evaluators, with a third reader adjudicating discordant cases; (5) prespecified subgroup analyses by age, medical history, and vestibular function. Sample Size and Duration: Approximately 200 participants will be enrolled (target \~180 evaluable after \~10% attrition). Total study duration is \~2 years, including enrollment, follow-up, and analysis. Risks and Benefits: Both tests are non-invasive. Potential transient discomfort (e.g., eye strain or cybersickness) will be monitored. There may be no direct benefit to participants; however, results could support broader, more accessible, and standardized vertigo assessment. Data Security and Privacy: All data are de-identified, stored on secure platforms with role-based access and audit trails. Safety events are monitored and graded, and protocol deviations are handled per Good Clinical Practice.

This clinical trial investigates the safety, side effects, and effectiveness of combining an immunotherapy drug called dinutuximab-beta with standard induction chemotherapy for patients newly diagnosed with high-risk neuroblastoma. Dinutuximab-beta is an antibody designed to target specific molecules on the surface of neuroblastoma cells. In this pilot study, enrolled patients will receive dinutuximab-beta as a continuous intravenous infusion alongside a standard 6-cycle induction chemotherapy regimen. The primary goals of this study are to monitor how well patients tolerate the new combination treatment closely and to determine how effectively tumors shrink before patients proceed to the next phase of their standard consolidation therapy.

This study aims to study the relationships between obesity, circadian rhythm, and aging. The investigators set up a prospective cohort registry for morbid obesity, obesity, and normal subjects with annual follow-up. The cohort aims to investigate the pathophysiological, molecular, genetic, and cellular aspects of the relationships between obesity, circadian deregulation, and impacts on aging. Clinical data, questionnaires, biological material, and molecular signatures will be collected and investigated.

The primary objective of this study is to prospectively determine and precisely estimate the incidence of Internal Anal Sphincter (IAS) Injury at 12 months following colectomy with Transrectal NOSE.

This clinical trial aims to investigate the mechanisms of brain reorganization underlying motor recovery following end-effector (EE) and exoskeleton (Exo) robot-assisted hand training in individuals with stroke. Using functional near-infrared spectroscopy (fNIRS), the study will (1) investigate brain activation patterns during EE and Exo robot-assisted hand movements in healthy adults and individuals with stroke and (2) examine longitudinal changes in brain activation and motor recovery over a 6-week intervention. For Part 1, a cross-sectional observational study will be conducted to examine brain activation using fNIRS while participants perform EE and Exo robot-assisted movements. Healthy adults and individuals with stroke will each perform one session of each type of robot-assisted movement. For Part 2, an evaluator-blinded randomized controlled design will be used. Participants will be stratified based on the level of motor impairment and the side of the brain lesion and then randomly assigned to either the EE or Exo robot-assisted training group. Both groups will receive training 3 times per week, with each session lasting 60 minutes, for a total of 6 weeks. Each session will include 40 minutes of robot-assisted therapy and 20 minutes of functional training. Outcome assessments will be conducted at four time points: prior to the intervention (baseline), mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up. These assessments will be used to evaluate motor recovery and longitudinal changes in brain function.

Methods: This three-year experimental study is divided into two phases. In the first phase, a mixed-methods approach will be used. During this phase, a mobile application based on the Career Planning Model will be developed, followed by a pilot study to perform user testing and evaluate usability. The second phase will employ a prospective, double-blind randomized controlled trial (RCT) design, utilizing the nursing career planning application developed in the first phase for a six-month intervention study. A total of 108 senior-year nursing students (54 in the intervention group and 54 in the control group) will be invited to participate inthe study.