Clinical trials

Atrial fibrillation (AF) is associated with both electrical and structural remodeling of the left atrium. While successful catheter ablation has been shown to reverse some aspects of atrial remodeling, the impact of pulsed-field ablation (PFA) - a non-thermal ablation technology that selectively targets cardiomyocytes while sparing surrounding structures - on atrial remodeling in patients with persistent AF undergoing extensive substrate modification remains unclear. This is a prospective, single-center, single-arm observational study conducted at Taipei Veterans General Hospital. The study will enroll 30 patients with persistent atrial fibrillation who undergo pulmonary vein isolation (PVI) and extensive substrate modification using the FARAWAVE / FARADRIVE Catheter and FARASTAR System. The primary objective is to evaluate left atrial structural remodeling following PFA, including changes in LA size, atrial strain, extent of atrial fibrosis, and atrial hemodynamic function. The secondary objective is to assess AF-free survival between 3 and 12 months after the procedure, and its relationship to atrial remodeling. All participants will be followed for 12 months, with an interim analysis conducted once all subjects complete their 6-month follow-up.

This multicenter randomized controlled trial evaluates the clinical and microbiological effects of inhaled 3% hypertonic saline in treatment-naïve patients with nontuberculous mycobacterial lung disease (NTM-LD). Participants are randomized in a 1:1 ratio to either early initiation of 3% hypertonic saline for 6 months or delayed initiation consisting of normal saline inhalation during the first 3 months followed by 3% hypertonic saline during the subsequent 3 months. The primary objective is to compare respiratory symptom improvement between hypertonic saline and normal saline at Month 3. Secondary objectives include evaluating sputum microbiological outcomes, radiographic changes, inflammatory markers, small airway function, treatment initiation, safety, and within-participant changes before and after switching from normal saline to hypertonic saline in the delayed-initiation arm. The first participant was enrolled on October 3, 2025.

The purpose of this study is to evaluate the effectiveness of a mobile application (app) in helping clinicians and dietitians provide personalized low-FODMAP diet (LFD) therapy for patients with Irritable Bowel Syndrome (IBS). The study also aims to explore the potential biological mechanisms behind the clinical outcomes of this dietary intervention. Participants diagnosed with IBS will be recruited and screened through clinical questionnaires. Eligible participants will receive dietary education from a dietitian and be randomly assigned to one of two groups: the AI-assisted LFDapp group or the LFD booklet group. The study consists of three main phases: Initial Intervention (4-6 weeks): Participants will follow their assigned diet intervention and complete assessments regarding gastrointestinal symptoms, psychological traits (such as anxiety and depression), and quality of life. Reintroduction Phase (12 weeks): Participants who respond well to the diet will enter a phase where specific foods are gradually reintroduced. Personalization \& Follow-up (4 weeks): A personalized diet will be established, followed by a final evaluation of bowel function and mental well-being. Researchers will use various standardized questionnaire to track changes in symptoms and overall well-being throughout the study period.

The purpose of this study is to investigate the differences in therapeutic efficacy of different deep TMS treatment coils and different brain stimulation targets on obsessive-compulsive symptoms, and to explore the neural mechanisms of obsessive-compulsive disorder using functional neuroimaging analysis. 1. Inclusion Criteria: Adults aged 18-65 years. Patients diagnosed with obsessive-compulsive disorder according to DSM-5 criteria. 2. Study Design: Double-blind, randomized assignment. 3. Number of Participants: Sham group: 32 participants Active H7 group: 32 participants Active H1 group: 32 participants Total: 96 participants 4. Study Procedures: \- Participant Screening and Baseline Assessment (Week 0) Determine eligibility for enrollment, including diagnostic confirmation, symptom assessment, screening for contraindications, and whether the participant has previously experienced adverse effects following TMS treatment. Participants with high suicide risk within the past year will be excluded. Develop a personalized symptom provocation procedure for obsessive-compulsive symptoms (Carmi et al., 2018). Complete baseline symptom severity assessments and brain positron emission tomography/magnetic resonance imaging (PET/MRI). Participants with structural brain abnormalities will be excluded. Participants will be randomly assigned (1:1:1) into three groups, with a planned total enrollment of 96 participants. Participants currently taking medication may continue their existing regimen, but no medication changes will be allowed during the study period. \- Treatment Phase (Week 1 to Week 6; duration: 6 weeks) Before each TMS session, participants will remove their shoes and socks, rest both hands flat on their thighs, keep their eyes looking straight ahead, and undergo measurement of resting motor threshold (RMT). Approximately 3-5 minutes before each TMS session, trained personnel with ERP experience will assist participants in symptom provocation and record the participant's subjective level of distress. The deep TMS treatment schedule consists of five sessions per week, one session per day, for six consecutive weeks. Adverse effects will be assessed and monitored at each session. After completing the first treatment session, participants will be asked to guess which group they were assigned to, in order to evaluate the effect of treatment expectations on outcomes. Symptom severity interviews will be conducted every two weeks. \- Post-treatment Assessment and Follow-up (Week 7 and after; duration: 2 weeks, then 6 months later) Within one week after completion of the deep TMS treatment course (within Week 7), participants will undergo follow-up brain PET/MRI. At the end of Week 8 (two weeks after treatment completion), symptom severity will be reassessed. Subsequent treatment plans will be discussed with participants, and outpatient follow-up will be arranged within six months. Subsequent treatment options may include cognitive behavioral therapy, pharmacotherapy, and figure-8 rTMS. 5. Statistical Analysis * Expected Outcomes: The H7 coil may improve obsessive-compulsive symptoms. Both the H7 and H1 coils may improve mood symptoms. \- Descriptive and Inferential Statistics: Analysis of covariance (ANCOVA) will be used to compare differences among the three groups in MADRS, Y-BOCS, HAM-A, HDRS, and CGI-S scores. The percentage of responders (% responders) will be calculated and compared among groups. Repeated-measures ANOVA will be used to examine within-group and between-group differences in symptom improvement before and after deep TMS treatment. Pearson correlation analysis will be used to assess the association between symptom improvement and changes observed in PET/MRI neuroimaging measures. \- PET/MRI Neuroimaging Analysis: Functional MRI analyses will include ROI-to-ROI functional connectivity and seed-based functional connectivity analyses. Changes in PET glucose uptake within specific regions of interest (ROIs) will also be examined to evaluate alterations in neural networks and brain function before and after deep TMS treatment.

Objectives: Our study is conducted to use the pre-treatment FCH PET/MR in breast cancer patients, to investigate whether the conventional PET/MR imaging markers (SUVmax, MR spectroscopy-derived choline analysis, dynamic contrast-enhanced MRI, ADC analysis), and FCH/MR radiomic features, deep learning (DL) analysis are associated with molecular subtypes, clinical outcomes, treatment response, survival, and which parameters are more accurate for prediction purposes. Primary study purposes: -To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with molecular subtypes of breast cancers, and to evaluate the diagnostic performance for prediction purpose. Secondary study purposes: \- To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with the factors related to clinical outcomes (histologic grade, prognosis) and to analyze which parameters are more accurate for prediction purposes. Test drug: Name: 18F- Fluorocholine (18F-FCH) Dosage form: N-(\[18F\]fluoromethyl)-2-hydroxy-N,N-dimethylethan-1-aminium Strength: 3-5 MBq/kg per patient (5-6 mCi/mL at time of injection (TOI)) Dosage and administration: Intravenous injection. Selection criteria: 1. Women aged 25-75 years old. 2. Women diagnosed as breast cancer by pathological diagnosis from core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy). 3. Women whose ECOG between 0-2 points and life expectancy ≧ 3 months.

The primary objective of this study is to evaluate the clinical efficacy of moderate-dose transcranial photobiomodulation (t-PBM) at different frequencies (10 Hz and 40 Hz) in patients with treatment-resistant depression (TRD). It further aims to explore the differential efficacy across various symptom subtypes, with a particular focus on the somatic symptom-dominant subtype. Additionally, this study will collect paired-pulse neurophysiological parameters (e.g., the ratio of cortical inhibition to excitation) to preliminarily explore the neural mechanisms underlying the modulation of cortical excitability by t-PBM intervention, and to analyze their correlation with the magnitude of clinical symptom improvement. The specific aims of this study are as follows: To evaluate the differential efficacy of t-PBM at varying frequencies (10 Hz vs. 40 Hz) in improving clinical depressive symptoms (as measured by scales such as HAM-D and MADRS). To investigate the therapeutic response to t-PBM in patients with the somatic symptom-dominant depression subtype, analyzing its potential suitability for targeting specific symptoms. To explore the changes in paired-pulse TMS parameters (e.g., SICI, ICF, and LICI) before and after t-PBM treatment, gaining preliminary insights into the potential association between its cortical modulatory effects and clinical outcomes.

The goal of this clinical trial is to develop and evaluate an Artificial Intelligence Assisted Prehabilitation Program (AI APP) for returning to work and cost-effectiveness analysis in patients with oral cancer (OC). The main questions it aims to answer are: * What kinds of needs are related to returning to work (RTW) in patients with OC from diagnosis to survival that we can incorporate into the development of AI APP to assist this population ? * How is the effect of the AI APP that based on findings from the first question for patients with OC on physical and psychological distress, fear of recurrence, self-efficacy in coping with cancer, communication, motor function, quality of life, and RTW? * How is the effect of the RTW AI prediction model to identify high-risk groups ? And how is the comprehensive cost effectiveness of benefits and quality of life of the AI APP for OC population? Researchers will compare patients without using AI APP to see if the AI APP works to assist with coping physical and psychological distress, communication, motor function, quality of life, and RTW issues for individuals with OC? Participants will: * Be asked to fulfill a structural questionnaire, or engage in a semi-structured one-by-one interview or a focus group to assess their physical, psychological, and social support needs in the first stage. * Be invited to participant the pilot testing of AI APP in the second stage. * Be provided and trained by 3-month AI APP for 3 months or cared as usual in the third stage. * Complete a structural questionnaire and follow up one year, including the baseline (before using the AI app) and at 1-2 weeks, 3 months, 6 months, 9 months, and 12 months after the baseline. * Engage in one-by-one interview or a focus group to assess user experiences of the AI APP.

The goal of this clinical trial is to learn whether statin therapy and vitamin D supplementation can modify disease activity in patients with active thyroid eye disease. The study will also evaluate the safety of these treatments. The main questions it aims to answer are: * Does statin therapy change disease activity, as measured by changes in the Clinical Activity Score (CAS) and proptosis? * Does vitamin D supplementation change disease activity in patients with active thyroid eye disease? * Does combined treatment with statin and vitamin D produce different effects compared with either treatment alone or standard care? * What adverse events occur during treatment? Researchers will compare four groups: standard care alone, statin therapy plus standard care, vitamin D supplementation plus standard care, and combined statin and vitamin D therapy plus standard care. Participants will: * Be randomly assigned to one of four treatment groups * Receive the assigned treatment for 24 weeks * Attend clinic visits for clinical assessments and blood tests at baseline and at 24 weeks * Be followed through medical record review for up to three years after completion of the intervention

During the immune checkpoint inhibitor therapy (ICIT), most of the patients stay at home, but there is lacking of the studies to explore their physical and psychological distress, financial toxicity, care needs, and quality of life. Therefore, the aims of this program are to (1) explore the immune-related adverse event (irAE) severity, distress, financial toxicity, and quality of life and examine the psychometric testing of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM); (2) establish the LINE group for assessing irAE severity and change trajectory of quality of life in one-year follow-up and (3) combined retrospective chart review and the finding in aim (2) to develop the risk prediction model in order to identify the high risk population.

Leptomeningeal metastasis (LM) is a complication of advanced non-small cell lung cancer (NSCLC). The incidence of LM in NSCLC patients is around 3-5 %, reaching 9.4 % of those with an epidermal growth factor receptor (EGFR) mutation. Generally, the efficacy of systemic treatment for LM is limited due to the blood-brain barrier. Osimertinib has a high central nervous system penetration rate, making it the preferred first-line treatment for EGFR-mutant NSCLC. Previous studies indicated that osimertinib had shown promising efficacy in pretreated patients harboring EGFR mutations and LM. However, intracranial disease progression eventually develops, and the prognosis of patients with LM progression after osimertinib is poor. Recently, intrathecal chemotherapy with pemetrexed (IP) was reported to be an alternative treatment in patients with NSCLC and LM. The results from a phase I/II trial examining the efficacy and safety of IP in patients with EGFR-mutant NSCLC after the failure of previous TKI, and 83% of study enrollees received osimertinib before IP. The clinical response rate was 84.6%, and the median overall survival was 9.0 months. Despite initial promising efficacy, further trials are needed to verify these results. Therefore, the investigators plan to conduct a prospective study to examine the safety and effectiveness of IP combined with EGFR-TKI for patients with EGFR mutant NSCLC after osimertinib failure.

This study aims to evaluate the feasibility and accuracy of a non-contact, camera-based physiological monitoring technology in a perioperative setting (including anesthesia induction, surgery, and recovery).Conventional vital sign monitoring tools-such as ECG leads, blood pressure cuffs, and pulse oximeters-require direct skin contact, which may pose risks of cross-infection or skin injury in vulnerable populations (e.g., newborns or elderly patients). This research utilizes remote Photoplethysmography (rPPG) technology to estimate vital signs, including heart rate, blood pressure, and blood oxygen saturation (SpO2), by analyzing facial video captured via standard camera devices (Logitech C930, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra).The primary goal is to assess the consistency and stability of this non-contact system compared to clinical gold-standard monitors (Masimo Root, SedLine O3, and Radical-7) during actual surgical procedures. The findings will serve as a foundation for developing non-invasive, supplementary monitoring tools in dynamic clinical environments.

Pneumonia is a leading cause of death and hospitalization among the elderly in Taiwan. High-quality home care is essential to recovery and reducing readmission, yet primary caregivers often lack the specific skills needed, such as airway clearance and safe feeding techniques. Traditional education, consisting of one-time verbal instructions and paper brochures, often lacks interactivity and real-time support. This study introduces "Pneumonia Care Helper," an interactive LINE chatbot designed to provide digital health education. The goal is to evaluate whether this digital tool is more effective than traditional paper-based education in improving the knowledge, attitudes, and caregiving practices of primary caregivers of elderly pneumonia patients. The study will compare the outcomes of caregivers using the chatbot versus those receiving standard paper-based instructions over a 5-day intervention period.

This study plans to investigate the effectiveness of six-week light exposure combined with an exercise training program on improving sleep-wake rhythm, physical and mental symptoms, quality of life, one-year recurrence rate, and one-year survival rate of patients with lung and esophageal cancer.

The goal of this clinical trial is to validate if temporal interference brain stimulation (TIBS) is safe in healthy volunteers aged 20 to 65. The main questions it aims to answer are: * Is it safe to apply TIBS intervention to the left hippocampus in healthy participants? * Is it safe to apply TIBS intervention to the left insula in healthy participants? * Is it safe to apply TIBS intervention to the left anterior cingulate cortex in healthy participants? * Is it safe to apply TIBS intervention to the right inferior frontal cortex in healthy participants? Participants will: * Be Randomly allocated to either sham-first group or treat first-group, stratified by stimulated brain region, following a crossover-controlled experimental design * Complete baseline cognitive evaluations and mental status assessments, and undergo a baseline MRI scan on the same day * Receive stimulation for 5 consecutive days, followed by a 2-days washout period, then complete the remaining 5 days of stimulation. * Complete post-intervention cognitive evaluations and mental status assessments, and undergo a post-intervention MRI scan on the same day

Paclitaxel-based drugs are commonly used adjuvant chemotherapy for gynecological cancer patients. Peripheral neuropathy, a side effect of this treatment, presents with symptoms such as numbness, tingling, decreased skin and reflex sensation, and impaired function in the hands and feet, thus affecting quality of life. Peripheral neuropathy is a side effect caused by the neurotoxicity of certain chemotherapeutic drugs, including paclitaxel and platinum-based drugs, resulting from the cumulative toxicity of specific drug doses. While numerous international studies have confirmed the preventative effects of hand and foot movement interventions, there is a lack of relevant literature in China. Therefore, this study aims to explore the effects of hand and foot movement interventions on elderly gynecological cancer patients undergoing chemotherapy.

This study is a prospective, open-label, randomized controlled trial designed to evaluate a new artificial intelligence (AI) tool for heart monitoring. Researchers will use an AI-enabled electrocardiography (ECG) system to screen patients before they undergo surgery. The main goal is to determine if this AI system can accurately detect pulmonary hypertension and related heart diseases in the preoperative setting. The study is being conducted at Taipei Veterans General Hospital.

This study aims to evaluate the effectiveness of an innovative inhaler training device, "Golden Rhino" (pMDI Practice Tool), in improving inhalation technique accuracy, dyspnea severity, and quality of life among elderly patients with chronic obstructive pulmonary disease (COPD). The device integrates a weighted valve and musical cues to guide patients in synchronizing their breath with proper pMDI inhalation technique. Participants will be randomly assigned to either standard nursing guidance or nursing guidance plus device-based training. Outcome measures include pMDI usage accuracy, dyspnea severity, and EQ-5D quality of life scores at baseline and follow-up.

This multicenter pragmatic randomized controlled trial evaluates whether AI-assisted interpretation of low-dose CT (LDCT) improves lung cancer screening performance compared with standard reading. Eligible participants are randomized to AI-assisted or conventional interpretation. The study assesses diagnostic accuracy, efficiency, lung cancer incidence, mortality, recurrence, and smoking cessation outcomes. Results will inform the clinical utility and potential implementation of AI-assisted LDCT in routine screening practice.

This study aims to analyze breath sounds during surgery by using electronic stethoscope sensors attached to patients under general anesthesia. The study will evaluate whether breath sound monitoring can provide useful information for respiratory management, assist anesthesiologists in early detection of abnormal breathing events, and support safer perioperative care. A total of 30 adult patients undergoing elective surgery under general anesthesia will be enrolled.

This is a non-randomized, open-label, dose-escalation and dose-expansion phase I/II clinical study to evaluate the safety, tolerability, and efficacy of HCB101 in combination with pembrolizumab in patients with platinum-refractory recurrent/metastatic HNSCC. The trial consists of two phases: the dose-escalation phase (I) and the dose-expansion phase (II). Subjects will receive a weekly single dose of HCB101 IV infusion over 60 (±10) minutes on Days 1, 8, and 15 in each 21-day cycle in combination with pembrolizumab (200 mg IV day 1; given every 21 days) until unacceptable AE(s), radiographic or clinically documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study whichever occurs first.

Focused ultrasound (FUS) has been shown to differentially lesion or modulate (excite and inhibit) brain circuit and neural activity across a broad range of acoustic stimulus parameters (intensity, duty cycle, pulse repetition frequency and pulse duration) for decades. From our previous study, FUS sonication may suppress the number of epileptic signal bursts observed in EEG recordings after the induction of acute epilepsy. The presence of the suppressive effect was found in terms of the number of epileptic EEG spikes from the analysis of the unfiltered and theta-band EEG activity, and further discontinue the seizure attacks. EEG activity has also been consistently reported to have a positive correlation with the level of epilepsy, and FUS-mediated reduction of epileptic EEG activity was most notably observed, no matter lesioning or modulating effects. The aims of this study are to demonstrate the safety and efficacy of FUS technology in epilepsy patients and to estimate the optimal parameters of focused ultrasound exposure that will be used in the case of epilepsy.

This pilot study evaluated the effectiveness of an AI health education assistant compared to case manager support in hypertension management. Key outcomes included changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), compliance with health behaviors, 722 goal achievement (monitoring, measurements, lifestyle improvements), and Technology Acceptance Model (TAM) metrics, including perceived usefulness (PU), perceived ease of use (PEU), and behavioral intention (BI). This study aims to examine whether the AI assistant group will achieve greater reductions in systolic and diastolic blood pressure compared to the case manager group. Additionally, it will evaluate whether the AI assistant group will demonstrate higher engagement in 722 goals and greater perceived ease of use. The results of this study are expected to provide further evidence supporting the potential of AI-driven interventions.

The goal of this clinical trial is to determine whether two different delivery methods of autologous platelet-rich plasma (PRP) can improve olfactory function in adults with persistent olfactory dysfunction lasting more than three months. The main questions it aims to answer are: 1. Does carrier-assisted topical application of PRP lead to comparable or better improvement in smell function than intranasal injection of PRP? 2. Which method provides greater patient comfort and fewer adverse effects? Researchers will compare carrier-assisted topical PRP application to intranasal PRP injection to see if one approach is more effective in restoring olfactory function. Participants will: 1. Receive a single PRP treatment delivered either by injection or via a PRP-soaked carrier placed into the olfactory cleft. 2. Continue daily olfactory training for three months following the intervention. 3. Undergo smell testing (Sniffin' Sticks) before and after treatment and complete quality-of-life questionnaires.

The investigators plan to enroll 60 patients from the outpatient clinics or inpatient wards of the Metabolism and Cardiology departments who, within the past three months, have undergone coronary angiography for the treatment of coronary artery disease, are currently using sodium-glucose cotransporter-2 (SGLT-2) inhibitors for glycemic control, and have not received glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy for more than three months. A randomized controlled clinical trial will be conducted, with 20 participants randomly assigned to receive semaglutide (a GLP-1 RA) at 1 mg once weekly for 6 months, another 20 participants to receive semaglutide at 0.5 mg once weekly for 6 months, and the control group (20 participants) to continue with standard treatment for 6 months. The effects after 6 months will be evaluated in terms of endothelial function, glycemic control indicators including glycemic variability assessed via continuous glucose monitoring (CGM), oxidative stress markers, and the incidence of symptomatic hypoglycemia. According to the treatment guidelines for type 2 diabetes, either GLP-1 receptor agonists or SGLT-2 inhibitors should be prioritized in patients with type 2 diabetes and coronary artery disease. Therefore, the medication choices in both the intervention and control groups in this study align with current treatment guidelines.

In this article, women were randomly assigned to the Breast Mask Containing Cabbage Leaves Extract group and Breast Mask without Cabbage Leaves Extract group, and the breast engorgement, pain, hardness, before and after each treatment were measured. At the end of the study breast mask user experience and continued breastfeeding were measured.