Clinical trials

The goal of this observational study is to establish the protocol of systemic analysis of the causes of non-traumatic cardiac arrest in young patients. The main questions it aims to answer are: * Whether the protocolized classification of cardiac arrest minimizes the proportion of unknown causes and mis-classification in young cardiac arrest patients? * Whether the incorporation of genetic tests in the identification protocol of arrest cause helps the recognition of sudden arrhythmic death syndrome in young cardiac arrest patients? Participants will be asked to received serial examinations including genetic analysis to explore the cause of cardiac arrest.

Optic nerve sheath diameter (ONSD) had been proved to be associated with increased intracranial pressure and can be used as one of the prognostic factors in cardiac arrest patients. It is simple, quick and can be measured repeatedly. Carotid duplex and transcranial duplex(TCD) provide rapid, noninvasive, real-time measures of cerebrovascular function. It can be used to assess the vascular territory by measuring blood flow, and to evaluate factors include brain perfusion, plaque morphology, and patency of intracranial collaterals. Hence, it could act as a crucial role in neuroprognosis in post-arrest patients. In this study, the investigator aimed to analyze the ONSD diameters, ONSD/external transverse diameter (ETD) ratio, carotid duplex and transcaranial duplex parameters in different stages of post-cardiac arrest care, demographic characteristics and resuscitation information with the neurological outcome of post-cardiac arrest patients. The ONSD diameter, and ONSD/ETD ratio were compared with age-, and sex-matched normal volunteers.

Sudden cardiac arrest (SCA) remains one of the major challenges in clinical care. Although improvements in resuscitation quality have increased the likelihood of return of spontaneous circulation (ROSC), most patients still fail to survive to hospital discharge, and neurological injury is the leading determinant of poor outcome. Hypoxic-ischemic encephalopathy caused by global cerebral hypoxia during cardiac arrest is a key contributor to long-term disability, and even survivors often experience substantial functional impairment, placing a significant burden on families and society. Targeted temperature management (TTM) has long been regarded as a cornerstone neuroprotective strategy; however, TTM and TTM2 trials reported no significant neurological difference between lower and higher temperature targets. However, these studies predominantly enrolled patients with relatively mild illness severity, and multiple real-world observational cohorts suggest that, among more severely ill resuscitated patients, lower target temperatures may still confer benefit. Consequently, the optimal temperature strategy in higher-risk subgroups remains uncertain. Seizures are another common manifestation of brain injury after cardiac arrest, occurring in approximately 20-30% of resuscitated patients and contributing to secondary neurological damage. Earlier trials evaluating prophylactic anti-seizure medication (ASM) (thiopental or diazepam/magnesium) did not demonstrate neurological benefit; however, these studies primarily focused on neuroprotection rather than seizure prevention, leaving a substantial evidence gap. Patients with moderate to severe disease severity-those at the highest risk of both cerebral injury and seizure occurrence-have never been specifically studied to determine whether personalized temperature selection or early short-term prophylactic ASM (e.g., valproic acid or levetiracetam) may provide clinical benefit. Accordingly, identifying the most appropriate temperature target for higher-risk patients and determining whether short-term prophylactic antiepileptic therapy can reduce seizure-related injury represent important unresolved questions in post-resuscitation care. The aim of this study is to conduct a prospective, multicenter, randomized clinical trial to evaluate whether, among comatose patients with moderate to severe risk after ROSC, specific TTM temperature strategies combined with early short-term prophylactic ASM can reduce postresuscitation seizure incidence and improve neurological outcomes. By addressing a population underrepresented in prior clinical trials-those at highest risk and most likely to benefit-this study aims to generate clinically meaningful evidence to guide temperature selection and prophylactic ASM after cardiac arrest. Evaluating these interventions in combination may provide a more comprehensive understanding of whether they reduce seizure burden, mitigate brain injury, and improve functional recovery.

Primary Endpoint: * Early detection rate in Atrial Arrhythmia (AA) burden * Data transmission success rate for overall number of atrial burden collection during the monitoring period Secondary Endpoints: * Atrial burden occurrence at 3/6/12 months post-aATP * Incidence of arrhythmia * Safety: Immediate (\< 24 hours), in-hospital, 3 months, 6 months and 12 months adverse events

There is substantial evidence confirming that identifying and removing colorectal adenomas during colonoscopy helps prevent the development of colorectal cancer. Among the quality indicators for colonoscopy, adenoma detection rate (ADR) is the most important, as it is closely related to the patient's future risk of colorectal cancer. Recent studies have further demonstrated that improving ADR can reduce future mortality from colorectal cancer. Notably, non-polypoid lesions (such as flat or depressed lesions) are more likely to be missed during traditional colonoscopy, making these lesions a leading cause of post-colonoscopy interval colorectal cancer. In a prospective trial conducted by our team comparing the ADR of 3D colonoscopy with standard 2D colonoscopy, we found that 3D colonoscopy significantly improved overall ADR and the detection rate of non-polypoid adenomas. According to current international guidelines, after an index colonoscopy, patients are recommended to undergo surveillance colonoscopy 1 to 10 years later, depending on their findings at index colonoscopy. Since these patients represent the majority in clinical practice, increasing the ADR during surveillance colonoscopy not only allows for more precise recommendations for the timing of the next colonoscopy but also effectively reduces the risk of post-colonoscopy colorectal cancer (PCCRC). Therefore, this multicenter, prospective, randomized trial aims to compare the clinical performance of 3D colonoscopy and standard 2D colonoscopy in the context of surveillance colonoscopy.

Background: Adenoma detection rate is one of the most quality indicator: an accumulating body of evidence has shown that detection and resection of pre-cancerous adenoma by colonoscopy could effectively prevent colorectal cancer (CRC) and its related mortality1,2. Among various colonoscopy quality indicators, such as cecal intubation rate, withdrawal time, and adenoma detection rate (ADR), ADR is the most important one and most closely associated with the subsequent risk of CRC3,4. A recent study further demonstrated the improvement of ADR could reduce subsequent risk of CRC5. Equipment and technique to improve ADR: To be noted, among all colorectal neoplasm, non-polypoid lesions, such as flat or depressed lesions, carries higher likelihood to be overlooked during conventional colonoscopy and these overlooked lesions were the main etiology of post-colonoscopy colorectal cancer (PCCRC)6. Nowadays, several colonoscopy technologies had been developed to enhance the detection of colorectal adenoma such as using digital or dye-spray chromoendoscopy7 or add-on device such as Cap/Endocuff/third eye/FUSE-assisted endoscopy8. Among them, some had showed the potential to enhance the detection of non-polypoid lesion, for example, the next-generation NBI9 or iSCAN10. Application of 3D endoscopy on GI disease: 3D endoscopy is a new technology that using image processing technique to offer more information on tissue depth in comparison with conventional 2D endoscopy. The utility of 3D endoscopy on GI tract was mainly from upper GI tract and it was proved to enhance the diagnostic accuracy on superficial gastric tumors11 and shortened the procedure time during performing gastric endoscopic submucosal dissection (ESD)12. However, few is known that whether 3D colonoscopy could enhance the ADR, especially for non-polypoid lesion detection, during colonoscopy examination. Positive fecal immunochemical test(FIT) group Among subjects who receive colonoscopy examination, higher advanced adenoma or invasive caners were found in FIT positive group. However, still about half of positive FIT subjects who received colonoscopy exam, have negative colonoscopy result. Non polypoid lesions could be overlooked during the colonoscopy. Therefore, we tried to use this prospective, multicenter, randomized control study to demonstrate the efficacy of 3D colonoscopy on adenoma detection in comparison with conventional 2D colonoscopy in this kind of high risk group.

This study aims to verify whether high-intensity pulsed electromagnetic fields (HI-PEMF) can be effectively applied to postoperative total hip arthroplasty patients. Using pain and function as the primary assessment indicators, the study explores the effects of HI-PEMF on postoperative total hip arthroplasty to confirm its effectiveness in relieving pain and improving daily living functions. Simultaneously, it combines physical therapy with exercise training to simulate a clinical environment, comprehensively understanding the feasibility of future clinical applications of magnetic field therapy. It is hoped that by exploring the potential benefits of magnetic field intervention in improving the postoperative condition of these high-needs patients, new clinical evidence can be provided for postoperative management.

Our project is going to enroll patients with stage IV NSCLC with EGFR mutation and evaluate whether primary tumor resection after receiving the afatinib can prolong survival. This project is supposed to establish a new treatment protocol for stage IV NSCLC with EGFR mutation.

There are more than 7000 known genetic disorders, and the number of affected is estimated to be about 6-10% of the population. Around 30 to 40% of genetic disorders have physical changes in the face and skull such as Down's syndrome or Fragile X syndrome. Therefore, the known facial phenotype of many genetic disorders is highly informative to clinical diagnosis. Since a large number of genetic diseases are associated with special facial phenotypes that are difficult to remember, automated facial analysis such as Face2Gene and GestaltMatcher can assist in the identification and diagnosis of facial phenotypes related to various genetic diseases. Although the current advances in whole exome sequencing (whole exome sequencing) or whole genome sequencing (whole genome sequencing) have greatly improved the diagnostic rate of genetic diseases, about half of the patients are still undiagnosed. For patients with special facial phenotypes, the investigators believe that by combining automated facial analysis and whole exome sequencing data, it should be possible to provide a fast and accurate diagnostic model of genetic mutations for genetic diseases. GestaltMatcher Database is a medical imaging database of rare diseases developed by Professor Peter Krawitz of the University of Bonn, Germany. The database's artificial intelligence module will infer a patient's possible diagnosis based on the patient's photo, age, gender, race, and clinical description. The database will be open to medical researchers in related fields to improve the diagnosis of rare diseases. The investigators will use GestaltMatcher to assist in the diagnosis of patients, and compare the accuracy and significant differences in facial deformities between Taiwanese patients and patients from different countries. And use Eye Tracker to analyze how doctors diagnose patients through facial photos, and compare whether there are significant differences between foreign patients and Taiwanese patients in the diagnosis literature of Taiwanese doctors. The project will also analyze how genetic doctors at the University of Bonn in Germany diagnose patients, and compare it with Taiwanese doctors to better understand the differences in the process of doctors diagnosing patients and ethnic backgrounds.

This study will focus on grade I to III knee osteoarthritis by randomized controlled trials which comparing the effectiveness between placebo, autologous platelet rich plasma and autologous platelet lysate injections.

Evaluate short- and long-term biomarker, motor function, respiratory function and safety with avalglucosidase alfa in IOPD and LOPD patients who switched from other ERT.

The purpose of this study is to compare the efficacy and safety between EUS-HGAS and EUS-HGS. We hypothesized that EUS-HGAS provides lower recurrent biliary obstruction (RBO) rate but with a comparable safety profile to EUS-HGS.

Extrapulmonary small cell carcinoma (EPSCC) or neuroendocrine carcinoma (NEC) is a rare but fatal disease. The prognosis of patients with advanced EPSCC or NEC failed platinum-etoposide chemotherapy is poor with median overall survival ranged 6 to 9 months. High expression levels of DLL3 has been demonstrated in many EPSCC or NEC. As tarlatamab, a bispecific T-cell engager with dual affinity for DLL3 on tumor cells and CD3 on T cells, has demonstrated clinically meaningful activity for patients with advanced small cell lung cancer. We thus hypothesize that tarlatamab also has clinically activity for patients with advanced EPSCC and NECs.

The goal of this study is to establish the ICP and CPP monitoring process and analyze the results in post-arrest patients, to validate the correlation between direct and non-invasive ICP monitoring indicators, to establish a protocol of management of elevated ICP and insufficient CPP in post-arrest care, to establish a protocol for personalizing CPP and MAP optimization, and to analyze its impact on neuroprognosis. Participants will receive ICP monitoring within 12 hours post-ROSC if meet all inclusion and exclusion criteria.

The goal of this clinical trial is to investigate the efficacy and safety of sacituzumab govitecan in patients with advanced esophageal squamous cell carcinoma.

The study aims to identify potential urine marker metabolites as predictive or prognostic markers for treatment outcomes in patients with prostate cancer.

Parkinson's disease (PD) is commonly associated with impaired motor learning and reduced motivation, both of which can negatively influence rehabilitation outcomes. Prior cross-sectional evidence suggests that providing individuals with PD self-controlled access to training parameters enhances motor learning, increases motivation, and facilitates cognitive processing. However, the effects of self-controlled practice implemented across repeated training sessions remain underexplored. Moreover, given that dysfunction of fronto-striatal circuits in PD may limit the neuroplastic response to motor training alone, adjunctive neuromodulatory priming approaches such as repetitive transcranial magnetic stimulation (rTMS) may be required to optimize therapeutic efficacy. To date, it remains unclear whether rTMS priming combined with self-controlled motor training yields superior clinical benefits, and whether stimulation of different cortical targets produces differential effects. In particular, the dorsolateral prefrontal cortex (DLPFC), a key region involved in cognitive control and motivation, may offer distinct therapeutic effects compared with stimulation of the primary motor cortex (M1). This study aims to investigate the effects of rTMS priming over the DLPFC or M1, followed by self-controlled motor training, in individuals with PD, and to compare these effects with a sham stimulation condition. This single-blinded, randomized control trial will recruit 90 individuals with PD, who will be matched into 45 pairs and randomly assigned to one of three stimulation conditions: DLPFC, M1, or sham. Within each pair, one participant will be allocated to a self-controlled practice condition, and the other to a yoked (paired-control) condition that receives identical training content determined by their matched counterpart. Each participant will undergo 12 intervention sessions. In each session, rTMS will be applied first as a priming intervention, followed immediately by 45 minutes of standardized physical therapy-based motor training. For the DLPFC group, stimulation will target the left DLPFC; for the M1 group, stimulation will be applied over the M1 contralateral to the more affected limb; and for the sham condition, the coil will be rotated 90 degrees to mimic stimulation without effective cortical activation. During the training phase, participants in the self-controlled condition will be allowed to select aspects of their practice content, whereas yoked participants will follow the corresponding selections made by their matched partner. The primary outcome measure is the Unified Parkinson's Disease Rating Scale (UPDRS). Secondary outcomes include assessments of cognitive function, apathy, non-motor symptoms, gait performance, balance, functional mobility, falls efficacy, and quality of life. Neurophysiological outcomes will be assessed using single- and paired-pulse TMS to evaluate corticospinal excitability and cortico-cortical connectivity, particularly between DLPFC and M1 networks. All assessments will be conducted in the medication-on state by blinded evaluators at baseline, immediately post-intervention, and at one-month follow-up. Data will be analyzed using mixed-effects repeated-measures ANOVA to examine group-by-time interactions and intervention effects. This study seeks to determine whether rTMS priming over cognitive-control versus motor networks differentially enhances the efficacy of self-controlled motor training, and whether such combined interventions can induce sustained improvements in motor and non-motor outcomes in PD.

Visuomotor processing is the ability to integrate visual information into motor plans and movement correction, which is highly required in daily activities such as writing and walking. As visual impairments have been reported in people with Parkinson's disease (PD), it is likely that those impairments may affect visuomotor processing ability and subsequently impair motor performance. Furthermore, people with PD and freezing of gait (FOG) have exhibited poorer visual perception than those without FOG, yet the differences of visuomotor control have not been well investigated. Additionally, little did the studies apply neurophysiological assessment to investigate the associated neural mechanisms. This study aims to investigate behavioral and neurophysiological differences in visuomotor control among people with PD and FOG (freezers), without FOG (non-freezers), and age-matched healthy controls. Sixty-three participants, 21 freezers, 21 non-freezers, and 21 age-matched healthy controls, will be enrolled in this study. Behavioral assessments, including a manual control task and visual perception tests will be used to evaluate visuomotor and visual perceptual abilities. Neurophysiological correlates, including corticomotor excitability and corticocortical connectivity between V1-M1 and PPC-M1, will be examined using transcranial magnetic stimulation. It is hypothesized that freezers will demonstrate the greatest visuomotor impairments and disrupted corticocortical connectivity compared to non-freezers and controls. By integrating behavioral and neurophysiological outcomes, this study seeks to unravel the mechanisms linking visual and motor impairments to FOG, ultimately providing insights into targeted interventions to improve visuomotor processing and motor performance in PD.

Diabetes mellitus

This study aims to establish a cohort of individuals with metabolic syndrome and prediabetes to enable long-term follow-up of risk factors, disease progression, and the development of obesity-related complications. The study will also monitor changes in nutritional status and physical function over time, in order to identify key prognostic determinants influencing clinical outcomes. Metabolic syndrome and prediabetes are chronic multisystem disorders, and poor long-term control is closely associated with the development of various complications. Moreover, malnutrition and functional decline are common comorbid conditions that further impair quality of life and impose a substantial burden on healthcare resources.

This study implemented a personalized 6-month diet and exercise program to promote weight loss. Participants were recruited from outpatient clinics at the Department of Family Medicine, National Taiwan University Hospital. Overweight and obese adults were eligible, defined as follows: overweight (BMI 24-27 kg/m²), mild obesity (BMI 27-30 kg/m²), moderate obesity (BMI 30-35 kg/m²), and severe obesity (BMI ≥ 35 kg/m²). Exclusion criteria included recent weight changes exceeding 3%, a history of bariatric surgery, untreated psychiatric disorders, or medications affecting body weight. Study design: Of the 171 subjects screened, 29 were excluded due to BMI criteria, leaving 142 participants for baseline body composition and biochemical analysis. Of these, 98 joined the 6-month weight loss program, while 44 remained in the control group. Participants were divided into two groups: one followed a standard diet and exercise program, while the other used a wearable device and AI apps alongside the same program. The wearable device tracked steps, heart rate, and estimated calories burned. Outpatient visits occurred at weeks 0, 12, and 24, with additional diet and exercise education. Phone consultations at weeks 2, 4, and 8 provided 10-minute guidance sessions from case managers. Weight loss medications were not permitted during the study. Data collection: Weight, height, and blood pressure were measured using standard scales and sphygmomanometers. Waist circumference was measured by a trained operator, and bioelectrical impedance analysis was used to assess skeletal muscle, fat mass, and body fat percentage. Blood samples were collected after an 8-hour fast to measure glucose, cholesterol, and triglycerides. Insulin levels were measured, and HOMA-IR was used to assess insulin resistance. Galectin-1 levels were measured using an ELISA kit. Measurements were taken at baseline and at the end of the intervention (week 24). Diet and exercise intervention: All participants followed a standard diet and exercise program. Those opting for the wearable device aimed for 7,500 steps per day, following World Health Organization recommendations for 150 minutes of moderate aerobic activity per week. Dietary education included caloric intake calculations and Mediterranean diet principles. Participants using wearable devices logged daily steps and food intake, which was uploaded to a health management platform. Case managers provided lifestyle coaching through the platform.

To address workforce shortages and increasing workloads in nursing, technological solutions and AI-powered robots for ward navigation have been introduced. However, limitations remain in their application to clinical care. This study aims to develop and test a programming framework for an AI-assisted nursing care robot ("E-Nursing Assistant") to reduce nurses' workload and improve the efficiency and quality of care.

Based on the high levels of emotional distress, burnout, and turnover intentions among clinical oncology nursing staff, this study will provide a multimedia "Mind-Body Support" Line platform and ACT workshop courses as intervention measures for oncology nursing staff. The study aims to explore the effectiveness of these interventions in alleviating their psychological and physical distress, utilizing both qualitative and quantitative research methods to achieve the research objectives.

Osimertinib is a standard first-line treatment for patients with metastatic non-small cell lung cancer harboring an epidermal growth factor receptor exon 19 deletion or exon 21 L858R mutation. Although osimertinib can provide effective disease control, most patients eventually experience disease progression, and the primary lung tumor may remain an important site of treatment resistance. This multicenter, randomized, open-label phase III trial will evaluate whether surgical removal of the primary lung tumor, in addition to continued osimertinib treatment, prolongs progression-free survival in patients with EGFR-mutated oligometastatic non-small cell lung cancer. All participants will initially receive osimertinib 80 mg orally once daily for 12 weeks. Participants who have a partial response or stable disease according to RECIST version 1.1 and remain suitable for surgery will be randomly assigned in a 1:1 ratio to continue osimertinib alone or to undergo primary lung tumor resection followed by resumption of osimertinib. The study will also evaluate overall survival, safety, pathologic response, quality of life, patterns of disease progression, and changes in molecular biomarkers.

Bile duct blockage caused by cancer near the liver hilum (where the bile ducts join) leads to jaundice and infection. The standard treatment is to place a plastic stent (a small tube) through an endoscope to drain the bile. Conventionally, the stent is placed across the papilla, the opening between the bile duct and the intestine, with one end inside the intestine. An alternative method places the stent entirely inside the bile duct, above the papilla, which may reduce bacterial contamination from the intestine and help the stent stay open longer. However, previous studies have shown inconsistent results. This multicenter randomized trial will compare these two stent placement methods in patients with unresectable malignant hilar biliary obstruction. About 70 participants will be randomly assigned (50:50) to receive either a suprapapillary (above the papilla) or a transpapillary (across the papilla) plastic stent during the same standard endoscopic procedure (ERCP). Both stents are approved, commonly used medical devices. The main question is which method keeps the bile duct open longer before re-blockage. Participants will be followed with regular clinic visits, and safety will be monitored throughout the study.