Clinical trials

In today's medical environment, laparoscopic cholecystectomy is a common procedure for treating gallbladder diseases, offering advantages such as smaller incisions and faster recovery. However, patients often experience significant preoperative anxiety and uncertainty when facing general anesthesia. This is mainly due to unfamiliarity with the anesthesia process, concerns about potential risks, and uncertainty regarding the overall experience. Excessive anxiety and uncertainty can not only affect the patient's emotional stability and cooperation but may also prolong postoperative recovery time and negatively impact the overall quality of medical care. Virtual Reality (VR) is an emerging innovative technology characterized by its immersive, interactive, and highly realistic features. It has been widely applied in fields such as education, psychotherapy, and healthcare education. By simulating the surgical environment and anesthesia process through VR technology, patients can gain visual and psychological adaptation before undergoing anesthesia. This helps enhance their understanding and sense of control over the medical procedure, thereby reducing feelings of unease and anxiety. The purpose of this study is to explore the effects of a virtual reality (VR) intervention on preoperative anxiety and uncertainty in patients undergoing laparoscopic cholecystectomy under general anesthesia. This experimental study recruited a total of 142 patients scheduled for surgery at a medical center, who were randomly assigned to either the experimental group or the control group. Patients in the experimental group, in addition to receiving standard printed preoperative education materials, experienced a VR video the day before surgery. The video introduced the operating room environment and anesthesia procedures. The control group received only the printed educational materials. Research instruments included measures of anxiety (Amsterdam Preoperative Anxiety and Information Scale \[APAIS\], Anxiety Visual Analogue Scale \[VAS\]), uncertainty (Uncertainty Visual Analogue Scale, Intolerance of Uncertainty Scale), and neuro-autonomic feedback indicators. Assessments were conducted before and after the intervention to evaluate its effectiveness. This study anticipates that the virtual reality (VR) intervention will effectively reduce patients' pre-anesthesia anxiety and uncertainty, thereby enhancing their adaptation to the general anesthesia process and improving psychological stability. The findings may provide clinical anesthesia nursing staff with evidence-based support for incorporating emerging technologies into pre-anesthesia education. Furthermore, the results can serve as a reference for developing diversified patient education models in the future.

Anxiety and depressive disorders, referred to as emotional disorders, have high rates of prevalence, recurrence, and functional impairment. Transdiagnostic psychotherapy targeting shared features of these disorders has recently emerged. Dialectical behavior therapy (DBT) for the transdiagnostic treatment of emotional disorders is a promising approach, as results of preliminary studies for use in a broad range of mental disorders are encouraging. Since there is a lack of research on transdiagnostic psychotherapy in Taiwan, the investigators thus propose this 3-year randomized controlled trial to test the efficacy of a modified DBT for the treatment of transdiagnostic emotional disorders and to further evaluate whether the efficacy of modified DBT differs in the specific emotional disorders. The investigators expect that patients with emotional disorders receiving modified DBT are more likely to improve clinical outcomes, functioning, and quality of life.

We use generative AI to make personalized books for young children about going to the eye doctor. We want to see if reading these stories helps kids feel more comfortable and improves their overall experience at the clinic.

The goal of this study is to learn if Dialectical behavior therapy Skills Training for Adolescents (DBT-A-ST) works on emotional disorders in adolescents. The main questions it aims to answer are: Does DBT-A-ST produce faster improvements (i.e., steeper slopes), compared to ASG, on primary and secondary outcome measures during treatment and 3-month follow-up? Does DBT-A-ST produce greater improvements, compared to SBG, on primary and secondary outcome measures? Participants is: Randomly assigned to (a) a culturally adapted DBT-A-ST or (b) Satir-based group (SBG). Received five assessments before the start of the trial (T1), after 4, 8 sessions (T2, T3), at post-intervention (T4), and 3-month follow-up (T5).

This is a two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis. All participants remain on background darbepoetin alfa therapy throughout the study. The study compares add-on vadadustat plus background darbepoetin alfa with background darbepoetin alfa alone, with each treatment period lasting 8 weeks and separated by a 4-week washout period. Monthly laboratory assessments and dialysis adequacy measurements will be performed to evaluate anemia control, quality of life, inflammation, and dialysis adequacy.

Depression is common among older adults and is often associated with declines in physical and oral health. Non-pharmacological, community-based interventions are needed to support both mental and physical well-being. This study examines the effects of a program combining group-based reading activities and oral exercises in community-dwelling older adults. Participants are randomly assigned to either an intervention group, which receives the six-week program, or a control group receiving general oral health education. The study evaluates whether the intervention can improve physical and oral function, enhance psychological resilience (grit), and reduce depressive symptoms.

This study aims to evaluate the effectiveness of a virtual reality (VR)-based transitional care program for adult survivors of intensive care unit (ICU) care. ICU survivors frequently experience relocation stress, anxiety, pain, and physiological instability after transfer from the ICU to general wards, which may increase the risk of unplanned ICU readmission. Participants will be randomly assigned to receive either standard transitional care or additional VR-based intervention sessions during their ICU stay. The VR intervention is designed to provide psychological support, environmental orientation, and stress reduction. Primary outcomes include short-term physiological indicators within 48 hours after ICU transfer. Secondary outcomes include pain, relocation stress, and unplanned ICU readmission within 7 days.

The goal of this three-year mixed-methods observational study with an embedded randomized controlled trial is to develop and validate a frailty risk prediction model and evaluate an artificial intelligence-based voice emotion detection-guided counselling intervention in adults with congenital heart disease (ACHD). The main questions it aims to answer are: Are symptom clusters associated with frailty and psychological outcomes in adults with congenital heart disease? Can symptom clusters and psychosocial factors be used to predict frailty risk over time in ACHD patients? Does an AI-based voice emotion detection-guided counselling intervention improve psychological outcomes, fatigue, and quality of life among high-risk ACHD patients? Researchers will compare ACHD patients receiving AI-based voice emotion detection-guided counselling with those receiving usual care to determine whether the intervention reduces depression, anxiety, sleep disturbance, fatigue, and frailty risk, and improves grit and quality of life. Participants will: Complete longitudinal assessments of symptom clusters, frailty, and psychological status at baseline and follow-up time points Participate in qualitative interviews to explore lived experiences related to symptoms and frailty Receive AI-based voice emotion detection-guided counselling (intervention group only in Year 3)

The nurse-patient communication environment in pediatric care is characterized by high uncertainty and complexity. Due to children's limited language development and emotional regulation abilities, coupled with parents' high level of involvement, nursing students often experience anxiety, lack of confidence, and avoidance behaviors, which negatively affect their clinical learning outcomes and the establishment of therapeutic relationships. Therefore, providing effective communication support strategies is essential in pediatric nursing education. This study aims to implement an instructional scaffolding model using artificial intelligence (AI)-generated empathy maps to enhance the communication skills, empathy performance, and grit of nursing students during pediatric clinical practicums when encountering communication challenges. A mixed-methods research design was adopted, and the participants were third-year nursing students enrolled in a pediatric nursing practicum course. The teaching intervention included AI-assisted generation of age-appropriate communication strategies, the construction of a grit-oriented empathy map, small group scenario-based exercises, and the application of learned strategies in clinical settings. Quantitative data were collected using pre- and post-intervention assessments, including an empathy scale, a communication skills scale, and a grit scale, to evaluate changes in learning outcomes. Qualitative data, including reflective journals, clinical observations, and focus group interviews, were analyzed to explore students' learning processes and strategy adaptations. Triangulation was applied to strengthen the validity of the findings. It is anticipated that this teaching model will enhance students' understanding of pediatric patients' emotional needs, strengthen their communication strategy application and clinical interaction quality, and promote persistence and adaptability in challenging situations. Through evidence-based teaching practice, this study is expected to provide a feasible and scalable innovative instructional model that supports the effective integration of AI into clinical nursing education, thereby improving pediatric nursing competence and the quality of care for children.

This randomized, placebo-controlled pilot study aims to evaluate the effects of probiotic supplementation on sperm quality in male patients diagnosed with infertility. Male infertility accounts for approximately 40% of all infertility cases and is closely related to abnormalities in sperm count, motility, and morphology. Factors such as oxidative stress, inflammation, and DNA fragmentation are known to impact sperm function and subsequent fertilization potential negatively. Probiotics are microorganisms that confer health benefits by improving the intestinal microenvironment and regulating immunity. Emerging research suggests that probiotics may reduce oxidative stress and DNA fragmentation in men with asthenozoospermia; however, clinical data on human sperm remains limited. This study seeks to determine whether specific probiotic strains can improve sperm parameters and function in patients with unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia. The study will enroll 60 male participants aged 20 to 45 who meet specific inclusion criteria, including a sperm concentration of less than 50 million/mL, motility less than 40%, and normal morphology (Kruger) less than 4%. Participants will be randomly assigned to either an experimental group receiving probiotics or a control group receiving a placebo for approximately 100 days. Semen samples will be collected and analyzed at three time points: before the intervention (Day 0), during the intervention (Day 60), and at the end of the study (Day 100). The primary objective is to assess changes in sperm concentration, motility, and morphology using the Computer-Aided Sperm Analysis (CASA) system. Secondary objectives include evaluating sperm DNA integrity using the Sperm Chromatin Structure Assay (SCSA) by flow cytometry and assessing sperm function via the acrosome reaction assay. The results of this pilot study will help determine the potential therapeutic role of probiotics in the management of male infertility.

Epidemiology studies showed that the burden of cardiogenic shock (CS) persistently high, with increasing annual medical expenses and steady prevalence. In-hospital and one-year mortality reduce annually. Hence, there are increasing number of patients who survive to hospital discharge but they will face further challenges in the subacute stage after hospital discharge. However, there are still insufficient studies focusing on this issue. Establishment of a healthcare neatwork to help hospital survivors of CS return society safely is critical.

Multimedia birth prediction intervention helps mothers and their spouses reduce the number of trips to the hospital, reduce anxiety, and increase self-confidence. A total of 83 couples were accepted for cases, with a 10% attrition rate. so, A total of 95 couples were admitted and divided into the experimental group and the intervention measures were implemented Experimental group. Fill out basic demographic and obstetric variables, self-confidence visual analog scale, situational-trait anxiety scale-situational anxiety part at 37 weeks of pregnancy, at the first visit to the hospital, and one hour after admission to the hospital for delivery

This is a qualitative and quantitative mixed-methods, open-label study, will involve 12 participants and their caregivers. Participants will also undergo blood exams and gait analysis, while caregivers will complete qualitative interviews and quantitative questionnaires on autistic symptoms, stress, anxiety, and quality of life. After the baseline assessments, participants will receive Lactobacillus plantarum for 8 weeks, followed by further evaluations at end point.

Heart failure (HF) is a clinical complication. About half of HF patients have heart failure with normal systolic fraction (HFpEF), and most of them are elderly women. The other type is systolic heart failure, characterized by a left ventricular ejection fraction of less than 40 (LVEF\<40). The clinical symptoms of HFpEF are very similar to those of low systolic fraction heart failure (HFrEF) with abnormal left ventricular ejection fraction. Generally speaking, the morbidity and severity of HFrEF are higher, and the survival rate is lower. HFpEF is generally difficult to diagnose, so it is critical to find a method to accurately diagnose HFpEF. HFpEF is most commonly diagnosed by echocardiography and biomarkers. In a cardiac ultrasound examination, it is impossible to diagnose HFpEF based on a single parameter of the results. We need multiple examination parameters to gather enough evidence to confirm the existence of HFpEF. These parameters include the mitral inflow velocity pattern, the pulmonary vein flow pattern, changes in flow velocity from the left atrium to the left ventricle, tissue Doppler measurements, and M-mode ultrasound measurements. We train artificial intelligence to distinguish between normal and abnormal cardiac ultrasound images, measure or evaluate all the above parameters, and analyze all the data. We hope that, with the help of artificial intelligence, we can improve the prediction and diagnosis rate of HFpEF. Simply diagnosing HFrEF requires an LVEF of less than 40%. Diagnosing HFpEF poses significant clinical challenges because no single tool or method can reliably confirm the condition or predict associated hospitalizations. Consequently, diagnosis depends heavily on physician judgment, requiring the synthesis of considerable clinical data and information. Recognizing the heterogeneity of the HFpEF phenotype, phenomapping integrates comprehensive data (clinical history, physiological measurements, biomarkers, ECG, echocardiographic parameters) to stratify patients into distinct subtypes, thereby optimizing classification for improved prognostic prediction. It can be seen from this that HF will rely heavily on artificial intelligence in the future to assist in patient data management and classification diagnosis and further develop clinical prediction models. This research project will implement a multi-center design to collect ultrasound images from patients with heart failure and perform relevant analyses using artificial intelligence.

To investigates the effects of solifenacin or mirabegron with local estrogen versus combination treatment with solifenacin and mirabegron in women with overactive bladder

To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.

Hypotension prediction index (HPI) was applied in various types of non-cardiac surgery with convincing benefits of preventing hypotensive events and clinical sequelae. Although HPI was validated in cardiac surgery, its clinical benefits are not proven yet. We aim to evaluate its effects on intraoperative hypotension and postoperative adverse events in cardiac surgery. In this randomized, single-blind trial, we will enroll adults scheduled for elective primary cardiac surgery under general anesthesia. Participants will be randomly assigned to intraoperative HPI-guided or non-HPI-guided hemodynamic management. The primary endpoint is the time-weighted average intraoperative hypotension below a mean arterial pressure threshold of 65 mmHg. The secondary endpoints are postoperative complications.

To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.

The definition of Genitourinary Syndrome of Menopause (GSM) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems. Estrogen and other hormones production decrease after menopause because the ovaries lose their effectiveness, leading to mucosal atrophy, reduced vaginal moisture, dysuria, urgency, recurrent infection, burning, pruritus and dyspareunia. The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet rich plasma, etc. Observational cohort study will be used for study design, and questionnaire, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used for evaluation of the effectiveness and side effects.

Caesarean section is one of the most frequent surgeries causing severe postoperative pain. Poor management of acute pain can contribute to postoperative complications, late recovery and the development of chronic pain. Moreover, it had been demonstrated that the intensity of postpartum pain is associated with depression. It is imperative to find out appropriate methods of postpartum pain alleviation. Currently, a lot of analgesic drugs and methods have been developed and used in clinical practice, such as patient-controlled analgesia, extended-release analgesics and multimodal analgesia. This prospective cohort study is aimed to investigate the outcome of each postoperative analgesic method used in caesarean section.

The purpose of this study is to explore Effect of Auricular Acupressure on Improving Sleep Quality in Nurses. Adopting a quasi-experimental research design and convenience sampling, nursing staff from a northern medical center who scored 5 or higher on the Pittsburgh Sleep Quality Scale were selected as research subjects. Eligible participants were assigned to either the experimental group (auricular acupoint sticking) or the control group (no intervention).Pittsburgh Sleep Quality Scale were measured on the day of application, as well as during the fourth and eighth weeks. The collected data were analyzed using SPSS 29.0 for Windows.

Fabry disease (FD) is a rare X-linked lysosomal storage disorder caused by deficient activity of the enzyme α-Gal A resulting from mutations affecting the GLA gene. It is characterized by severe multi-systemic involvement that leads to major organ failure and premature death in affected men and in some women. The α-Gal A deficiency results in progressive accumulation of un-degraded glycosphingolipids, predominantly globotriaosylceramide (Gb3), within cell lysosomes throughout the body.1 In patients at the fourth to fifth decade, left ventricular hypertrophy occur usually, and myocardial infarction and heart failure develops disease progress. Life-threatening renal, cardiac, and cerebrovascular diseases are added in later decades.2,3 Fabry disease is treatable with enzyme replacement therapy (ERT). Early recognition of symptoms and diagnosis of patients at a potentially reversible stage of the disease is therefore important. To date, plasma Lyso-Gb3 is useful in the diagnosis of Fabry disease. All male with classical Fabry disease could be discerned by an elevated plasma Lyso-GL-3; All adult female patients have elevated plasma Lyso-GL-3 above normal range.4 Other study also indicated that higher lyso-Gb3 concentrations at first visit were associated with a higher event rate in the past. Men with classical FD have higher Lyso-GL-3 values compared with patients with non-classical FD and women along with an increased risk of developing complications, more severe cardiac and renal disease.5 According to a publication from Taiwan society of cariology (TSOC) expert consensus, several cardiac biomarkers including N terminal pro B type natriuretic peptide (NT-proBNP) and cardiac troponin I/T (cTNI/cTNT) have been proposed to be alternative surrogate markers of cardiac involvement in FD.6However, there is no study to analyze the relationship between all these biomarkers including lyso-Gb3 and FD cardiac manifestation or improvement of cardiac damage outcomes under ERT yet. There is a high prevalence of the cardiac variant (IVS4+919G→A) (\~1 in 1600 males) of FD in Taiwan as revealed by newborn screening programs7,8 and patients with idiopathic HCM.9 FD patients with cardiac variant need to fulfill at least two indicators as stated in "cardiac function assessment indicators of Fabry's disease cardiac variant type" with cardiac biopsy confirmed GL3 or lyso-Gb3 lipid accumulation to get local reimbursement for treatment. Cardiac biopsy is an invasive and relative dangerous procedure that some patients would refuse to take this procedure and could not get local reimbursement resulting in delay in treatment. Therefore in the present study the investigators are aiming to identify candidate biomarkers to establish a scoring algorithm for evaluating Fabry disease progression status or treatment response and the investigators could stage patient who with more correlated biomarkers at baseline would have higher risk to develop sever clinical outcome and initiate early therapy.

This household-based prospective cohort study aims to stablish the household transmission of Respiratory syncytial virus and S. pneumoniae especially in the elderly and infants/children as well as inter-relationship between S. pneumoniae and Respiratory syncytial virus.