Clinical trials

This study is a prospective, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of a photobiomodulation (PBM) patch (Super Vi PBM Patch - Soothing) and an enhanced PBM patch (Super Vi PBM Patch - Soothing EX), compared with a placebo patch, for postoperative pain relief following urological surgery, including nephroureterectomy with bladder cuff resection (NU+BCR) and adrenalectomy (ADRX).

This study investigates the effectiveness of immersive virtual reality (VR) training in stoma care on nurses' knowledge, skills, self-efficacy, and learning satisfaction. Using a mixed-method design with convenience sampling, 100 clinical nurses will be recruited and randomly assigned (1:1) to experimental and control groups. The experimental group will receive two VR training sessions one month apart, while the control group will attend a single traditional classroom session. Both groups will follow stoma care replacement procedures established by National Taiwan University Hospital. Data collection will include demographic information, knowledge/skill tests, and self-efficacy questionnaires administered at three time points: before training, immediately after training, and one month post-training. Learning satisfaction will be assessed immediately after training. Participants reporting adverse VR reactions or scoring below 4 on satisfaction will be invited to one-on-one semi-structured interviews.

Liver cancer is a significant malignancy in Taiwan. With the widespread implementation of antiviral therapies, hepatitis B and C-related liver cancer has gradually declined; however, metabolic dysfunction-associated liver cancer continues to increase, particularly among patients with type 2 diabetes mellitus (T2DM) who also present with significant liver fibrosis. Current clinical guidelines lack standardized recommendations for liver cancer screening in this specific population, and data from prospective randomized controlled trials remain scarce.This study is a prospective randomized controlled trial enrolling patients aged 18 years, diagnosed with T2DM, and with a FIB-4 \> 2.67. Participants will be randomly assigned to either the surveillance group or the standard-care group. The surveillance group will undergo blood tests every 6 months to monitor liver function, AFP, and PIVKA-II, alongside the calculation of the GAAD score. The standard-care group will receive liver function tests every 6 months according to routine clinical practice. Abdominal ultrasound or computed tomography (CT) scans will be arranged by clinicians when clinically indicated. All participants will undergo abdominal ultrasound at baseline and at the end of the third year, with blood samples and clinical data collected periodically. The primary endpoint of this study is the tumor size at the time of liver cancer diagnosis. Secondary endpoints include liver cancer staging, number of liver cancer tumors, liver cancer incidence, the proportion of patients receiving curative treatment, and the degree of liver fibrosis as reflected by changes in FIB-4. This study expects to clarify the clinical benefits of a GAAD score-based surveillance strategy compared to standard care in T2DM patients with high FIB-4 scores, thereby providing evidence-based support for future liver cancer screening strategies and clinical guidelines.

This study is a prospective, randomized, controlled clinical trial comparing the efficacy of a 24-month cyclic therapy regimen (6 months of Romosozumab followed by 6 months of Denosumab, repeated for two years) versus a traditional sequential treatment regimen (12 months of Romosozumab followed by 12 months of Denosumab). The goal is to determine which approach yields better therapeutic outcomes and to optimize drug strategies for osteoporosis patients.

The aim of this study is to evaluate the impact of artificial intelligence (AI) assistance during routine upper endoscopy on gastric cancer-specific mortality. We hypothesize that AI-assisted endoscopic interpretation can further reduce gastric cancer-related mortality through two mechanisms: (1) improved detection of H. pylori infection, facilitating timely eradication therapy and subsequent prevention of gastric carcinogenesis; and (2) earlier identification of premalignant gastric conditions, enabling appropriate surveillance endoscopy and earlier detection of gastric cancer. The primary endpoint is gastric cancer-specific mortality.

This study will discuss the impact of continuous glucose monitoring on maternal and infant's outcomes in gestational diabetes mellitus, and test the moderating effect of socioeconomic and cultural factors (dietary habits, socioeconomic status and income).

This study aims to develop and evaluate a peer-led training program specifically designed for Nurse Practitioners (NPs) to acquire Point-of-Care Ultrasound (POCUS) skills. POCUS, known for its non-invasive nature and real-time imaging capability, has been widely applied in clinical fluid status assessment and plays a pivotal role in enhancing diagnostic efficiency and quality of care. However, current POCUS training resources for NPs in Taiwan remain insufficient, limiting their clinical application and professional visibility. Using a quasi-experimental design, this study investigates the effectiveness of peer-led instruction in strengthening image interpretation, clinical reasoning, and self-efficacy among NPs. The ultimate goal is to establish an evidence-based, nursing-oriented POCUS education model to fill existing gaps in the training system and elevate the role of NPs in multidisciplinary care.

This groundbreaking human study on the ASD microbiome includes probiotic clinical trials, investigation of treatment biomarkers, machine learning/deep learning platform development for ASD classification and prediction, and identification of diagnostic biomarkers. Upon completion, the investigators anticipate publishing at least 12 SCI papers and/or patents and establishing an auxiliary diagnosis platform for both clinical and academic purposes. The findings will offer new insights into the pathogenetic mechanisms, improving early detection, diagnosis, and treatment, ultimately advancing precision medicine for ASD.

Shoulder joint orthoses are commonly used for patients with shoulder disorders to stabilize and protect shoulder joint after injury or surgery. These devices maintain proper anatomical alignment of the shoulder joint and surrounding soft tissues, reducing pain, facilitating proper recovery, and preventing further injury. Commonly used shoulder orthoses include shoulder sling, abduction brace, and figure-of-eight shoulder brace. The appropriate orthosis is selected based on patient's specific clinical needs, and it should be worn for an appropriate duration to avoid over or inadequate shoulder immobilization. When patients wear shoulder orthoses during daily activities, such as sit-to-stand, level walking, climbing stairs, or overcoming obstacles of a certain height, the immobilized shoulder reduces reciprocal arm swing, altering body's balance mechanism and potentially increasing the risk of falls. Different shoulder orthoses with various shoulder position affect human motor coordination and balance to varying degrees. Therefore, assessing the changes in body movements caused by shoulder immobilization with orthoses can provide crucial clinical information to aid in clinical decision-making. This study utilizes stereophotogrammetry to measure and analyze subjects' motion changes while their shoulders are immobilized with orthoses. It aims to understand the biomechanical changes when subjects participate in static balance tests and dynamic activities. Through corresponding biomechanical analyses, including kinematics, dynamics, and joint coordination, the study seeks to understand the extent of the impact of shoulder orthoses on human movements. This information would serve as important reference data for subsequent clinical decisions regarding whether to use orthoses or not, the duration of use, and the suitability of the orthoses for patients of different ages.

Atrial high-rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs) are associated with an increased risk of progression to clinical atrial fibrillation (AF), stroke, heart failure, and mortality. However, optimal management strategies for patients with AHREs lasting between 6 minutes and 24 hours remain uncertain. Current guidelines recommend risk factor modification, but the role of early rhythm-control therapy in preventing AHRE progression has not been well established. This prospective, randomized, open-label study aims to evaluate whether a rhythm-control strategy combined with optimal risk factor management can reduce progression to sustained AHREs (≥24 hours) or clinical AF compared with optimal risk factor management alone in patients with device-detected AHREs. Eligible participants with CIED-detected AHREs lasting 6 minutes to 24 hours and without prior clinical AF will be randomly assigned to either a rhythm-control group or a usual-care group. The primary endpoint is progression to AHRE duration ≥24 hours or documented clinical AF. Secondary endpoints include stroke, systemic embolism, heart failure hospitalization, cardiovascular death, and all-cause mortality.

The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.

The goal of this clinical trial is to determine whether tirzepatide can reduce atrial fibrillation (AF) burden after catheter ablation in overweight or obese patients with persistent AF. It will also evaluate the effects of tirzepatide on body weight, metabolic risk factors, and clinical outcomes, as well as its safety and tolerability in this population. The main questions it aims to answer are: 1. Does peri-procedural treatment with tirzepatide reduce AF burden at 3 months after de novo catheter ablation, as measured by 7-day continuous ECG patch monitoring? 2. Does tirzepatide lead to greater weight loss and improvement in metabolic parameters compared with standard care alone? 3. Does tirzepatide reduce AF recurrence and cardiovascular events during 12 months of follow-up? Researchers will conduct a multi-center, open-label, endpoint-blinded, randomized controlled trial in adults aged 18-80 years with persistent AF and body mass index ≥25 kg/m² who are scheduled for de novo catheter ablation. Participants will be randomized 1:1 to receive either tirzepatide plus standard peri-procedural and post-ablation care or standard care alone. Participants in the tirzepatide group will receive subcutaneous tirzepatide 2.5 mg once weekly starting about 4 weeks before ablation and continuing for 3 months afterward, for a total treatment duration of approximately 4 months. All participants will be followed at 1, 2, 3, 6, and 12 months after ablation, with detailed assessment of AF burden, AF recurrence, echocardiographic parameters, metabolic profile, quality of life by the AFEQT questionnaire, and safety events.

This study aims to evaluate the feasibility, safety, and acceptability of a newly developed artificial intelligence (AI)-assisted physiotherapy system for oromandibular and neck-shoulder range of motion (ROM) in patients who have undergone treatment for oral cancer. In this single-group, prospective, non-randomized pilot study, recruited participants will receive 4 to 6 weeks of AI-assisted physiotherapy. Participants will undergo a comprehensive clinical evaluation at baseline and post-intervention. During the intervention period, the AI system will perform a daily automated assessment to dynamically generate and adjust personalized exercise programs. Participants will perform these prescribed programs 4 to 6 times daily. Pre- and post-intervention changes, along with key feasibility parameters, acceptability, and safety metrics, will be statistically analyzed to inform future definitive trials.

Seasonal influenza causes morbidity in people with impaired immunity, including adults with elder ages and other comorbidities \[1\]. Standard-dose inactivated influenza vaccines (IIV) may induce lower hemagglutination inhibition (HAI) titers and more rapid waning in these groups. High-dose IIV could generate higher and more durable serological responses, including HAI, B-cell activation and antibody magnitude, which was demonstrated in randomized trials \[2,3\]. MF59-adjuvanted IIV further enhances innate immune activation and antigen presentation, potentially broadening and strengthening responses, particularly during antigenic drift seasons \[4\]. These enhanced platforms represent biologically distinct strategies to overcome reduced vaccine responsiveness. Influenza A/H3N2 was reported as the predominant circulating strain in Taiwan. Initial antigenic characterization suggested suboptimal match between some circulating A/H3N2 viruses (the subclade K variant) and the vaccine reference strain, whereas A/H1N1 viruses appeared consistency with the circulating and vaccine-containing strain \[5\]. As of February 2026, approximately 2,300 cases of severe influenza had been confirmed during the 2025-2026 season, representing the largest epidemic in the post-COVID-19 era. In the meanwhile, both MF59-adjuvanted and high-dose influenza vaccine were firstly introduced in Taiwan for elderly people \[5\]. Previous study had demonstrated that people living HIV (PWH) might have lower humoral immune responses compared with people without HIV, even among PWH with relatively higher (defined as ≥ 350 cells/mm3) CD4 counts \[6\]. In spite of the broad use of these novel influenza vaccines in older adults and other population with immunocompromised status such as the recipient of solid organ transplantation \[7\], evidence gap exists in PWH, where vaccine responses vary by CD4 count, viral suppression, immune activation, comorbidities, and prior vaccination history. High-dose influenza vaccination has shown improved serologic outcomes versus standard dose in PWH in randomized trials \[2\], while data of MF59-adjuvanted vaccines used for PWH are lacking. Moreover, comparative serological responses, durability or effectiveness between the two vaccines (MF59 adjuvant vs high-dose) was only conducted among participants with elder age, which showed that the seroconversion rate for H3N2 among those receiving MF59-adjuvanted vaccines did not meet noninferiority criteria compared with those receiving high-dose vaccines \[8\]. Nevertheless, such data on PWH remains unclear. In this study, we aimed to compare toe immunogenicity among PWH undergoing MF59-adjuvanted or high-dose seasonal influenza vaccine.

Background: Mycobacterium abscessus, one of the most common species of nontuberculous mycobacterium (NTM), poses a significant clinical challenge due to its natural resistance to antibiotics and high treatment failure rates, particularly in lung diseases. Among its subspecies, M. abscessus subspecies abscessus is especially prone to developing inducible resistance to Clarithromycin. This resistance mechanism is primarily due to the activation of the erm(41) gene,which inhibits Clarithromycin from effectively binding to the bacterial ribosome, diminishing its bactericidal efficacy. Rifabutin, an antibiotic widely used in treating tuberculosis and certain NTM infections, has been shown to inhibit the activation of the erm(41) gene by suppressing the whiB7 protein in M. abscessus, suggesting potential efficacy against inducible resistance. However,current evidence primarily stems from in vitro susceptibility studies and case reports, with a notable lack of systematic clinical trials.

Sleep problems are more common and more severe in children with epilepsy. The purpose of this study is to develop and evaluate the effect of a clinic-based and technology-supported sleep intervention for improving sleep and health in children with epilepsy and their parents.

The incidence of nontuberculous mycobacterial lung disease (NTM-LD) is increasing worldwide and in Eastern Asia. NTM-LD leads significant morbidity and mortality, around 25% within 5 years, but the treatment rate is low because the course of NTM-LD is indolent, especially in nodular-bronchiectatic (NB) form. However, there is no biomarker proven for predicting the progression in NB form of NTM-LD. Recently, it has been reported that the ratio of membrane-form programmed death-1 (PD-1) expressed T cells increased in patients with NTM-LD and it was associated with disease severity and progression. The mechanism has been speculated as a "immune exhaustion". In contrast to PD-1 expressed in cell membrane, soluble-form PD-1 is another biomarker that can be easily detected in serum. We recently reported that soluble PD-1 significantly correlated with cavitary lesion and disease progression in patients with NB-form NTM-LD in Taiwan. However, this has not been validated in other countries and ethnicities. Furthermore, the usefulness of soluble PD-1 in diagnosis and predicting mortality warrants further studies.

Patients with rectal cancer complicated by low anterior resection syndrome who undergo anal-preserving surgery may experience severe distress in daily life due to changes in bowel function, thus requiring significant post-discharge care support from healthcare professionals. This study is a multicenter, non-blinded randomized controlled trial. One hundred patients with rectal cancer complicated by low anterior resection syndrome are planned to be randomly assigned in a 1:1 ratio from the colorectal surgery outpatient clinics of National Taiwan University Hospital, its Cancer Center, and its Yunlin Branch. They will be divided into a control group receiving routine dietary education and an experimental group receiving both routine dietary education and the use of an artificial intelligence-based dietary care system application. The artificial intelligence-based dietary care system application will be used for approximately six months. Three questionnaires will be administered at one month post-surgery (before intervention), three months post-surgery, and six months post-surgery. The questionnaires will include: a demographic data sheet, a low anterior resection syndrome score, distress inventory from altered bowel functioning, and the European Organization for Research and Treatment of Cancer QLQ-30 Scale, to verify the effectiveness of the artificial intelligence-based dietary care system application in improving bowel disturbance and quality of life in patients with rectal cancer complicated by low anterior resection syndrome.

This study is a phase I dose escalation clinical trial aims to evaluate 161Tb-PSMA-I\&T, a new generation prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) using Terbium-161 to replace Lutetium-177, its safety, dosimetry, biodistribution, pharmacokinetics, and preliminary efficacy in Taiwanese men with metastatic castration-resistant prostate cancer, and to inform future clinical trials.

Colorectal cancer (CRC) is one of the most common cancers worldwide. These malignancies originate in the colon or rectum, and the majority evolve from pre-existing colonic adenomas (a type of colon polyp). Early detection, identification, and removal of these precancerous lesions can effectively reduce the morbidity and mortality of colorectal cancer. However, not all colonic polyps possess a significant risk of malignant transformation. Polyps can generally be subdivided into "neoplastic" and "non-neoplastic" lesions; major non-neoplastic polyps include inflammatory polyps, hamartomas, lymphoid polyps, mucosal prolapse polyps, and hyperplastic polyps. On the other hand, neoplastic polyps have the potential to develop into malignancies, primarily including adenomatous polyps and serrated polyps. Adenomatous polyps account for more than 50% of all colonic polyps and are the most common precancerous lesions for CRC. Clinically, they can be further classified into tubular, tubulovillous, or villous adenomas based on histological subtypes. As for serrated polyps, traditional serrated adenomas (TSAs) and sessile serrated lesions (SSLs) possess carcinogenic potential. During a colonoscopy, detecting colonic polyps is crucial, but it is equally important to identify which polyps have malignant potential. This allows for the accurate resection of true precancerous lesions while avoiding the procedural risks associated with unnecessary polypectomies. Furthermore, in rare instances, diminutive polyps may harbor cancer with deep submucosal invasion. Due to the risks of incomplete resection and lymph node metastasis, such lesions are not suitable for endoscopic resection. Therefore, achieving an accurate endoscopic diagnosis is a key step in determining the most appropriate management strategy for colonic polyps. To improve the diagnostic accuracy of endoscopy for colonic polyps, multiple modalities have been developed, including careful observation of lesion morphology, as well as various image-enhanced technologies and chromoendoscopy. Meanwhile, three-dimensional (3D) endoscopy, a novel technology, offers superior spatial resolution and depth perception compared to conventional two-dimensional (2D) endoscopy. Studies have confirmed that 3D endoscopy can improve the adenoma detection rate (ADR) due to its enhanced ability to detect flat and inconspicuous lesions. However, whether 3D colonoscopy can also enhance the endoscopic diagnostic accuracy for colonic polyps remains to be explored. Therefore, we designed a randomized controlled trial (RCT) to investigate whether 3D colonoscopy can improve the diagnostic accuracy of colonic polyps compared to conventional 2D colonoscopy.

This study aims to develop a low-cost, marker-free intelligent wound assessment system that can analyze wound photos taken with a standard smartphone. By comparing wound images over time, the system will generate a quantifiable Wound Progression Index (WPI) to provide objective feedback on whether a wound is improving, stable, or worsening. The long-term goal is to support early detection of wound deterioration and improve wound care in both clinical and home settings.

Perinatal anxiety and depression are common mental health concerns that may negatively affect maternal well-being, infant development, and family functioning. Mindfulness-based interventions have shown beneficial effects on reducing psychological distress during pregnancy; however, maintaining attention and engagement during mindfulness practice may be challenging for some pregnant women. This randomized controlled trial aims to evaluate the feasibility and effectiveness of an integrated virtual forest environment and mindfulness-based intervention for improving mental health in perinatal women. Pregnant women between 20 and 24 weeks of gestation will be randomly assigned to either an experimental group receiving virtual reality (VR)-based forest mindfulness intervention or a control group receiving conventional mindfulness intervention. Both groups will participate in a 9-week mindfulness program and receive app-based mindfulness practice. The experimental group will additionally receive immersive VR forest-based mindfulness sessions during prenatal visits. Outcomes including anxiety, depression, mindfulness awareness, physiological indicators, and intervention acceptability will be assessed during pregnancy and postpartum follow-up.

Upper digestive tract cancers are often preceded by pre-malignant lesions, but there is limited evidence regarding optimal risk prediction models and screening strategies for disease progression and cancer development. This prospective multicenter cohort study aims to establish a longitudinal database integrating clinical information, endoscopic findings, pathology, genetics, epigenetics, and gastrointestinal microbiota data from subjects undergoing upper digestive tract endoscopy. The study will develop explainable artificial intelligence (AI)-based risk prediction models to identify factors associated with disease progression, treatment response, and cancer development. Participants will be followed longitudinally to evaluate changes in lesion severity and clinical outcomes.

Improving Outcomes After AF Ablation in Obese Patients

Post-operative atrial fibrillation after coronary artery bypass grafting (CABG)