Douliu City

The key role of gut microbiota in keeping local and systemic homeostasis is termed the "Microbiota-gut-brain axis", which is a complex bidirectional communication system between the gastrointestinal tract and the brain. The hypothalamic-pituitary adrenal (HPA) axis takes part to this bidirectional communication by releasing corticotrophin-releasing factor (CRF), which facilitates the release of adenocorticotrophin hormone (ACTH) from the pituitary, which enters systemic circulation to lead to the release of cortisol from the adrenal glands. Many reports indicating that this hormonal cascade has a significant role in the adjustment of several functions like gastrointestinal transit, visceral sensation and permeability of the intestinal wall. The etiology of intestinal FDG uptake without pathologic lesions is not fully understood. Tohihara et al. reported physiologic bowel FDG activity at the delayed phase was more than that at the early phase in dual-time images, and postulated FDG secretion was the major cause of physiologic uptake. Franquet et al. reported that physiologic bowel FDG uptake was inhibited by antibiotics, such as rifaximin. Some studies proposed that a specific type of bacteria in the lumen plays a role in gathering FDG, and it explain individual differences in physiologic bowel FDG activity. Previous studies debated about if FDG transfer from the blood to the bowel lumen through a transcellular or paracellular pathways. The GLUT transporters are known to export glucose from mucosal cells to the blood, but it is doubtful they can also transport in the opposite direction. If bowel FDG uptake is associated to intestinal permeability, FDG is likely to migrate through a paracellular pathway because intestinal permeability is adjusted by paracellular tight junction. There is strong evidence that microbial strains may generate neuroactive molecules such as neurotransmitters, which may interfere with gut and brain functions. Furthermore, gut microbiota compositional changes may affect pathogenesis in patients with Parkinson's disease (PD). A previous hypothesis of PD pointed disease originates in the enteric nervous system and spreads via autonomic neurons to the brain, eventually causing PD. Besides, several studies support the clinical use of Tc-99m TRODAT-1 SPECT in assessing the neurodegenerative status of PD. To date, no radionuclide imaging studies for correlation between physiologic bowel FDG uptake and dopamine transporter degeneration have been elucidated. The investigators hope to have insight into pathophysiology of PD by investigating the association between the pattern of intestinal FDG activity and Tc-99m TRODAT-1 SPECT images. In addition, research in this field opens the possibility to use neuroactive molecule-producing probiotics as new potential therapeutic tools for patients with PD.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are investigating how a modified Pap test might improve participation in cervical cancer screening among women aged 25 and older. The study expands on prior pilot research by conducting a multicenter randomized controlled trial to test whether adding a brief, non-painful step at the end of the Pap smear reduces recalled pain and encourages more women to participate in screening. This approach is based on the peak-end theory and aims to provide a practical, low-cost way to increase screening rates. Participants are randomly assigned to receive either the traditional Pap test or the modified Pap test. The modified test includes an additional 15-second step where the speculum is gently held in place after specimen collection, without causing pain. The procedures before and after this step are standardized and performed behind a privacy curtain by trained operators. Both groups undergo the same Pap smear process up to specimen preparation. The study is conducted across multiple hospitals within the NTUH Healthcare System in 2026. During the study, participants provide consent and undergo interviews to collect personal and medical information, including lifestyle factors, anxiety and stress levels, and medical history. Researchers measure body metrics and blood pressure, and use standardized scales to assess psychological stress and anxiety. The primary outcome measured is participation in cervical cancer screening over three years. The study also monitors pain recall and employs blinded analysis to ensure unbiased results.

Researchers are conducting a randomized, prospective, multicenter clinical trial to compare rigid and non-rigid interbody fusion devices in anterior cervical discectomy and fusion (ACDF) surgery for adults with cervical degenerative disc disease. The study involves patients with one or two levels affected between C3 and C7, who have symptoms like radiculopathy or myeloradiculopathy and meet certain diagnostic and functional criteria. The trial aims to evaluate outcomes such as overall success, neck disability, pain levels, and fusion rates over two years following surgery. The study compares a rigid PEEK interbody fusion device with a non-rigid Titanium Alloy Z-Brace device, both used with an artificial bone graft made of hydroxyapatite and tricalcium phosphate. A total of 180 patients were randomized in a 2:1 ratio to receive one of the devices during ACDF surgery at 11 clinical sites. Patients receive the assigned device during surgery and are followed regularly with evaluations before surgery, then at 1 month and at 3, 6, 12, 18, and 24 months after surgery. Participants undergo assessments including the Neck Disability Index, pain scores for neck and arm, range of motion near the treated area, patient satisfaction, anxiety levels, and imaging to check fusion and device subsidence. Safety is monitored through tracking complications and any additional surgeries during the follow-up period. The primary endpoint combines clinical improvement with absence of major complications and further surgeries, ensuring thorough evaluation over the 24-month follow-up.

Autism spectrum disorder (ASD) affects social communication and behavior, impacting many children worldwide, including about 1% of children in Taiwan. This research evaluates the effectiveness of Naturalistic Developmental Behavioral Interventions (NDBIs) for autistic preschoolers. The study focuses on comparing group-based NDBI programs involving caregivers versus traditional one-on-one NDBI settings, aiming to improve autistic symptoms, social communication, play skills, group behaviors, adaptation, and reduce parenting stress. Participants will receive either group-based NDBIs or one-on-one NDBIs. Both interventions use NDBI-Fi fidelity criteria to guide treatment. The group-based model is designed to be intensive and includes caregiver involvement to enhance feasibility and benefits in community or school settings. The study includes diagnostic evaluations through Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS) for confirming autism diagnosis. During the study, children will be assessed with several measures such as the Autism Treatment Evaluation Checklist, Mullen Early Scale Learning, Structured Play Assessment, and Vineland Adaptive Behavior Scales. Parents will also complete questionnaires like the Autism Parenting Stress Index and Family Empowerment Scale. These assessments evaluate improvements in behavior, social skills, adaptation, and parent stress. The study is a randomized controlled trial involving children aged 2 to 6 years and their caregivers.

Researchers are evaluating the effectiveness of in-situ simulation (ISS) training compared to off-site simulation (OSS) training for adult non-trauma cardiac arrest resuscitation teams. This study uses a two-group non-randomized pre-post design over one year at the National Taiwan University Hospital Yunlin Branch. The goal is to improve teamwork and non-technical skills in emergency care by applying the A-C-L-S (Airway-Circulation-Leadership-Support) teamwork model. The study also aims to establish evidence-based education models, strengthen institutional teaching and research capacity, and develop systematic data collection for quality improvement. Participants are emergency department resuscitation teams assigned to two campuses: the ISS group trains in the real clinical environment at the Douliu campus, while the OSS group trains at a dedicated simulation center at the Huwei campus. Both training types include a 20-minute briefing, a 10-minute high-fidelity simulation exercise, and a 30-minute structured debriefing following the A-C-L-S model. The ISS training occurs directly in the clinical setting to enhance realistic team training, whereas OSS training takes place in a controlled off-site simulation environment. Throughout the study, team performance is assessed using the Team Emergency Assessment Measure (TEAM) scale focused on non-technical skills, with blinded evaluations by external ACLS-qualified experts reviewing recorded sessions. Secondary outcomes include the resuscitation process, CPR quality, and patient outcome indicators. The study monitors participants over an average of one year, aiming to improve resuscitation team efficiency and patient outcomes through standardized assessment and training transfer.

Researchers are evaluating the effectiveness of ultrasound-guided femoral nerve blocks performed by emergency physicians for pain control in patients with hip fractures aged 20 years and older. This prospective before-and-after study compares the nerve block method with traditional intravenous or intramuscular pain medication given in the emergency department. The main goal is to assess how quickly pain relief occurs, with fewer side effects and less need for additional pain medication, along with patient satisfaction and any adverse effects from the different pain control methods. The study involves two treatments: the ultrasound-guided femoral nerve block, where local anesthetic is injected around the femoral nerve using ultrasound guidance, and standard intravenous or intramuscular pain medication. Pain severity is measured on a 0 to 10 numeric scale at various times before and after treatment. Patients must stay in the emergency department for at least two hours during the observation period. Participants will have their pain levels assessed every 30 minutes before and after receiving pain management. Researchers will also monitor for complications, side effects, and patient satisfaction with the pain relief methods. The primary measure is the time to achieve pain relief, and secondary measures include patient experience and adverse effects. The total study involvement covers the emergency department stay and pain evaluations during this time.

Researchers are evaluating the efficacy and safety of combining gedatolisib with fulvestrant and CDK4/6 inhibitors for treating patients with locally advanced or metastatic hormone receptor positive, HER2-negative (HR+/HER2-) advanced breast cancer. This Phase 3, open-label, randomized trial focuses on patients whose cancer progressed during or within 12 months of adjuvant endocrine therapy and who have not received prior systemic therapy for advanced breast cancer. The trial separates participants into groups based on PIK3CA mutation status and compares the investigational treatment to standard care. Participants receive either the investigational treatment of intravenous gedatolisib once weekly for three weeks followed by a week off, combined with oral palbociclib or ribociclib taken on days 1-21 of each 28-day cycle plus intramuscular fulvestrant every 2 weeks during the first cycle and then every 4 weeks, or the standard-of-care treatment of oral palbociclib or ribociclib with intramuscular fulvestrant on the same schedules without gedatolisib. The study includes a safety run-in phase to determine dosing of gedatolisib with ribociclib before randomization. Throughout the study, participants will undergo assessments to monitor progression-free survival, which is measured from randomization until death from any cause for up to approximately 48 months. Evaluations include tumor tissue or liquid biopsies for PIK3CA status, imaging to assess measurable disease, and monitoring of bone marrow, liver, kidney, and coagulation functions. Safety and efficacy are closely followed with ongoing clinical evaluations, and participants must have an expected life expectancy greater than six months for enrollment.

Osteoporosis is a lifelong chronic condition requiring long-term management. Conventional first-line anti-resorptive therapies often yield slow BMD improvement and may plateau after years of treatment. Recent AACE/ACE guidelines recommend anabolic agents as initial therapy in patients with severe osteoporosis or very high fracture risk; however, even anabolic monotherapy may be insufficient, with many patients failing to reach a T-score ≥ -2.5. To address this unmet need, we propose a pilot study exploring cyclic treatment using romosozumab combined with denosumab, compared with standard denosumab monotherapy. In addition to monitoring biochemical bone markers and BMD, we will incorporate imaging feature extraction from X-rays and AI-based radiomic analysis to identify imaging biomarkers that may support precision treatment strategies. This single-center, open-label, 6-month, randomized pilot trial will enroll 90 postmenopausal women with osteoporosis (T-score ≤ -2.5) at NTUH Yunlin Branch, randomized 1:1:1 into three arms: denosumab alone, romosozumab alone, or combined therapy. The primary endpoint is percent change in lumbar spine BMD at 6 months; secondary outcomes include hip and femoral neck BMD, bone turnover markers (CTX, P1NP), fracture incidence, and adverse events. Results will estimate effect size and synergy to inform future large-scale RCTs and clinical application.