Young Kang City, Taiwan
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Gemini Trial
This study will last for a period of up to 21 months. An 18-month screening period is planned for evaluating patients that are not currently experiencing flares of GPP, and will be re-evaluated every 6 months, or upon experiencing a flare. Once the patient is in flare, he or she may begin the screening period (Part 2) to continue the journey towards the study treatment day. During the treatment period, there are 8 visits over a 3-month period. Visits take approximately 1 to 3 hours each, except for the screening visit of part 2 that may take up to 4 hours. Several blood samples will be collected on Day 1, Day 3, Week 1, Week 2, Week 4, Week 8 and Week 12. During the study visits, a physical evaluation of your GPP and overall health will be done by the study team. Non-invasive tape stripping to collect surface skin tissue samples will also be performed, and photography of your lesions will be conducted. You may be offered to take part in another optional aspect of the trial, which includes additional blood draws and skin biopsies of your GPP lesions. For the biopsy portion, there will be a total of three punch biopsies. At the end of the study, participants may be eligible to participate in the subsequent long term extension study, which may allow participants to receive the study treatment as a monthly injection under the skin, regardless of what they received during the first study. More information will be made available to you should you be interested. For more information and to register to the study, please visit the study page: https://gpptrial.com/
Phase
2Span
Sponsor
Anaptys BioTaipei City
Recruiting
Digital Sleep Program for College Students with Insomnia
This is a parallel-group, randomized controlled trial (RCT). 90 participants who experiencing insomnia for at least 3 months with college students will be enrolled. Eligible participants who complete the baseline measurements will be randomly allocated to a digital-based multimodal sleep management program group (N = 45) and a waitlist control group (N = 45). The primary outcome is insomnia severity, assessed using the Insomnia Severity Index (ISI). The secondary outcomes include daytime sleepiness, objective sleep parameters, sleep reactivity, resilience, anxiety, and depression, which will be examined using the Epworth Sleepiness Scale (ESS), a wearable sleep tracker, the Ford Insomnia Response to Stress Test (FIRST), the Brief Resilience Scale (BRS), the State-Trait Anxiety Inventory (STAI), and the Beck Depression Index II (BDI-II), respectively. Additionally, chronotype will be assessed using the Morningness-Eveningness Questionnaire (MEQ) as a moderating role to be tested in this study. All outcomes will be measured at three time points: T0 (baseline assessment), T1 (immediately after the 4-week intervention period), and T2 (4 weeks after the intervention period).
Phase
N/ASpan
171 weeksSponsor
Taipei Medical UniversityTaipei
Recruiting
Healthy Volunteers
Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis
Cholelithiasis (gallstones) is a common disease of digestive tract in adults. It has been reported that 5-10% or 2 million of Taiwanese adults have gallstones according to National Health Insurance Administration. Laparoscopic cholecystectomy is deemed a surgical standard of care for its safety, effectiveness, and benefits: less post-operative pain, faster recovery, shorter hospital stay, and better cosmesis. However, the advantages of da Vinci surgical system include enhanced vision, wristed instruments, and dexterity of control. Robotic cholecystectomy by single-port SP system is associated with shorter operation time, shorter dissection time, and less post-operative pain. Further improvement in robotic cholecystectomy with CBDE regarding cosmesis and patient satisfaction could be made by adopting da Vinci SP system which preserves enhanced vision and instrument dexterity with only one access port. So far there is no published data on robotic cholecystectomy with CBDE using da Vinci SP. Current study is set forth to evaluate technical feasibility and clinical outcome of robotic biliary surgery using da Vinci SP Surgical System for patients with complex cholelithiasis.
Phase
N/ASpan
106 weeksSponsor
National Taiwan University HospitalTaipei
Recruiting
Early vs. Late Referral for Scapular Exercises in Shoulder Function After Neck Dissection
This study will recruit 30 head and neck cancer patients with spinal accessory nerve shoulder dysfunction based on the timing of referral, which will be divided into early (within 2 months post-surgery) and late (after 2 months post-surgery) referral groups. Both groups will receive conventional physical therapy (e.g., shoulder joint mobility training, electrical stimulation, or laser therapy for pain relief) and scapular-focused exercises. Scapular-focused exercise primarily targets the trapezius muscle, 60 minutes each session, once a week for 12 weeks.
Phase
N/ASpan
45 weeksSponsor
National Taiwan University HospitalTaipei
Recruiting
A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters
Phase
N/ASpan
44 weeksSponsor
National Yang Ming Chiao Tung UniversityTaipei
Recruiting
Healthy Volunteers
Prospective Study Between Polysomnography (PSG) and Novel Ultrasonic Jaw Tracking Device in Patients with Sleep Apnea
Phase
N/ASpan
50 weeksSponsor
Taipei Medical University WanFang HospitalTaipei
Recruiting
Healthy Volunteers
Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials
Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)is an improved diagnostic standard derived from Non-Alcoholic Fatty Liver Disease (NAFLD), emphasizing the correlation between fatty liver and metabolic dysfunction. Compared to NAFLD, which requires the exclusion of various conditions for diagnosis, the diagnostic criteria for MASLD can enhance the homogeneity of study subjects. It also addresses various groups with coexisting liver diseases, aiding in the efficiency and applicability of new drug development. MASLD has a prevalence rate of approximately one-fourth of the global population. If left untreated and worsens, it may lead to liver fibrosis, cirrhosis, or even liver cancer. Due to the significant medical burden associated with MASLD and the lack of FDA-approved treatments, the development of therapeutic methods for MASLD is an urgent issue. Past literature indicates that diet and gut microbiota play crucial roles in the progression of MASLD. The composition of the diet affects gut microbiota and intestinal barrier function. In cases of dysbiosis, harmful substances produced by gut microbiota, including pathogen-associated molecular patterns (PAMPs) and microbiota-dependent metabolites (MDMs), enter the liver through the portal vein via the leaky gut, resulting in toxicity. The pathogenic pathways exacerbating MASLD through gut microbiota dysbiosis, collectively termed the gut-liver axis, are not fully understood. Some animal studies have found dietary supplements to regulate gut microbiota beneficial for improving MASLD. Although most lack clinical evidence, incorporating food components that regulate gut microbiota and immune function into the diet indeed holds potential for treating MASLD. Next-generation probiotics have been found in past studies to improve liver lipid metabolism and regulate gut microbiota. They may slow the progression of MASLD by modulating the gut-liver axis. Previous studies by our team applied the pasteurized Akkermansia muciniphila strain NTUH_Amuc03 (pAKK NTUH_Amuc03), in preclinical animal studies to alleviate fatty liver disease progression. In experiments with mice induced with high-fat, high-fructose, high-cholesterol diets, pAKK NTUH_Amuc03 trended to reduce the body weight, improve abnormal blood lipids in mice, NASLD activity score, and HOMA-IR. These results indicate the potential of pAKK NTUH_Amuc03 to slow the progression of MASLD. Therefore, this project aims to further evaluate the efficacy and safety of pAKK NTUH_Amuc03 in MASLD patients through clinical trials.
Phase
N/ASpan
102 weeksSponsor
National Taiwan University HospitalTaipei
Recruiting
Different Re-training Durations in BLS Training Among Non-Professionals
In this study, participants first underwent compression-only CPR and AED training. Before training, they completed a questionnaire on their perspectives on BLS retraining and basic demographic information. Knowledge tests, skill assessments, and attitude and confidence questionnaires were conducted both before and after training. During the skill assessment, two cameras recorded the process from different angles: one positioned from the feet towards the head of the manikin and the other from the left chest towards the right chest. Instructors, blinded to group allocation, later reviewed the recordings and assessed participants' performance using an evaluation form. Additionally, chest compressions were recorded using a computerized manikin (SkillReporter Resusci Anne®, Laerdal, Stavanger, Norway). Participants were then randomly assigned to one of three groups based on different retraining durations: 1. 45-minute retraining sessions 2. 60-minute retraining sessions 3. 75-minute retraining sessions All three groups underwent skill assessments and knowledge tests every three months before their respective retraining sessions. The retraining skill assessments followed the same procedure as the initial training. Each retraining session began with a 15-minute comprehensive review, followed by hands-on practice. Each participant practiced for approximately five minutes per cycle, which included two minutes of chest compressions, one minute of AED application, one minute of feedback, and one minute for role-switching. Based on this structure, participants in the 45-minute group completed two practice cycles, those in the 60-minute group completed three cycles, and those in the 75-minute group completed four cycles. Both the initial training and retraining followed the American Heart Association (AHA) Heartsaver® CPR+AED course guidelines, with a participant-to-manikin ratio of 3:1 and a maximum of six participants per instructor. One year after the initial training, before the final skill assessment, participants completed the knowledge test and the attitude and confidence questionnaire. After the final skill assessment, they completed the CPR retraining perspectives questionnaire.
Phase
N/ASpan
100 weeksSponsor
National Taiwan University HospitalTaipei
Recruiting
Healthy Volunteers
Physiological and QoL Benefits of Qi-Gong in Post-acute Sequelae of Covid-19
Phase
N/ASpan
18 weeksSponsor
POCHIWUTaipei
Recruiting