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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
Geometric-Based Handwriting Intervention: Development, Feasibility and Randomized Clinical Trial
Phase
N/ASpan
288 weeksSponsor
National Taiwan University HospitalTaipei
Recruiting
Pregnancy Weight Management Health Literacy Questionnaire
This study will use a multiphase prospective longitudinal design. While developing the items of the instrument based on the review of the literature, five content experts will be invited to participate in the study for examining the appropriateness of the generated items. Upon the approval of the Institutional Review Board, a convenience sample will be recruited to establish face validity. Then the instrument will be refined according to the report derived from the pretesting. The content experts will then review the revised instrument again, and another 330 primigravida women will be enrolled in the study for assessing the psychometric properties. The validity and reliability of the instrument will be examined through evaluating the internal consistency reliability, split-half reliability, concurrent validity, and predictive validity. Health practitioners can use this newly developed instrument to assess pregnant women's health literacy to help manage their weight gain during pregnancy. By utilizing this instrument, health practitioners can provide individually tailored nursing care to improve the effectiveness of their weight management.
Phase
N/ASpan
46 weeksSponsor
Chao-Hui, LeeTaipei
Recruiting
Healthy Volunteers
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Phase
3Span
276 weeksSponsor
Jazz PharmaceuticalsTaipei
Recruiting
The Effect of Adaptogen Elixir on Sleep Improvement
Phase
N/ASpan
53 weeksSponsor
TCI Co., Ltd.Taipei
Recruiting
Healthy Volunteers
Taipei
Recruiting
3D Visualization System in Highly Myopic Cataract Operation
The objective of this study is to compare the surgical outcomes and parameters between cataract surgeries performed using the NGENUITY® 3D Visualization System (Alcon, TX, USA), a 3D imaging system, and the current standard binocular microscope in highly myopic patients. The focus is on evaluating the differences in depth of field and their impact on intraoperative parameters and outcomes. This prospective randomized controlled trial aims to enroll patients with both high myopia and cataracts requiring surgical intervention. Participants will be randomly assigned to undergo cataract surgery using the current standard binocular microscope (control group) or the NGENUITY® 3D Visualization System (Alcon, TX, USA) (study group). The study will compare intraoperative parameters, surgical outcomes, and the incidence of potential complications, including the frequency of microscope adjustments during surgery, total distance of adjustments during surgery, distance needed to achieve clear focus from the corneal surface to the posterior capsule, surgical duration, cumulative ultrasound energy during surgery, and occurrence of surgical complications.
Phase
N/ASpan
78 weeksSponsor
National Taiwan University HospitalTaipei
Recruiting
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
Phase
3Span
122 weeksSponsor
SanofiTaipei
Recruiting
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Phase
3Span
278 weeksSponsor
GlaxoSmithKlineTaipei
Recruiting