Beitou District

Researchers are evaluating the safety and tolerability of a drug called EBC-129, used alone and with pembrolizumab, in patients with advanced solid tumors. This open-label, phase 1ab study is divided into four parts to identify safe dosing levels and to explore the drugs effects in different patient groups. It aims to find the maximum tolerated dose and recommended phase 2 dose for EBC-129 alone and combined with pembrolizumab, targeting patients who have limited treatment options due to advanced cancer. The study includes four parts Part A tests escalating doses of EBC-129 alone to find safe dosing Part B tests escalating doses of EBC-129 combined with pembrolizumab Part C expands on Part A using the recommended dose of EBC-129 alone in more patients and Part D evaluates dosing schedules in patients with cancer types showing early responses. EBC-129 is given intravenously on Day 1 of each 21-day cycle in Parts A, B, and C, with varying dosing schedules in Part D. Pembrolizumab is administered every 21 days at a fixed dose. Participants will undergo monitoring for adverse events and treatment responses over several cycles, with assessments including tumor response rates and drug concentration measurements. The study tracks serious and treatment-emergent adverse events from before treatment until 30 days after the last dose, with outcome measures extending up to approximately 3.3 years. This includes evaluating tumor control, duration of response, progression, survival rates, and drug levels in the blood to understand the safety and effects of the treatments.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

This research aims to evaluate the effects of a six-week bright-light exposure combined with a specific exercise training program on patients with lung and esophageal cancer. The study focuses on improving sleep-wake rhythm, physical and mental symptoms, quality of life, and assessing one-year recurrence and survival rates. It is a randomized, double-blind clinical trial conducted at a single center in Taiwan involving participants with thoracic cancer. Participants are randomly assigned to one of two groups. The experimental group undergoes a rehabilitation program consisting of daily morning bright-light exposure for 36 minutes and tailored moderate-intensity walking sessions three times per week for six weeks, with weekly exercise consultations via a communication app. The control group participates in a six-week stretching exercise program involving four movements, lasting 10 minutes per session, three times a week. Both groups receive instruction through manuals, videos, and online resources. During the study, participants will be assessed five times before the intervention, at the 6th and 12th weeks, and at the 6th and 12th months. Researchers will measure sleep-wake rhythm changes, subjective and objective sleep quality, anxiety and depression levels, quality of life, and track cancer recurrence and survival rates. The study includes long-term follow-up to evaluate outcomes over one year.

Researchers are studying limited-stage small cell lung cancer LS-SCLC patients to evaluate the safety and effectiveness of toripalimab alone or combined with tifcemalimab as follow-up consolidation therapy. This Phase 3, randomized, double-blind, placebo-controlled, multi-regional trial enrolls patients who have completed chemoradiotherapy without disease progression. Tifcemalimab targets B and T lymphocyte attenuator BTLA, while toripalimab targets the programmed death protein-1 PD-1, and neither drug is yet approved for this condition. Participants are randomly assigned to one of three groups one receiving tifcemalimab 200 mg IV plus toripalimab 240 mg IV every three weeks, another receiving toripalimab 240 mg IV with a placebo for tifcemalimab, and a third group receiving placebos for both drugs. The investigational treatments are administered intravenously as consolidation therapy after chemoradiotherapy. Treatment continues according to the study schedule, with follow-up assessments planned to monitor outcomes. Throughout the study, participants will undergo evaluations including overall survival and progression-free survival measurements for up to three and two years, respectively. Researchers will also assess response rates, disease control, duration of response, and safety through monitoring adverse events and laboratory tests. The study involves regular visits for treatment and assessments, with close monitoring to understand the effects of the therapies over time.

Researchers are evaluating the TipTraQ device, a new wearable sleep screening tool developed by PranaQ, designed to detect Sleep Breathing Disorders such as obstructive sleep apnea-hypopnea syndrome OSAHS. The study aims to validate this device by comparing its performance with the traditional polysomnography PSG test, which is the current standard for sleep disorder diagnosis but is complex and requires specialist interpretation. This research seeks to make sleep disorder screening more accessible and easier for patients. Participants will wear the TipTraQ device on their fingertip during an in-lab PSG sleep study at a sleep center. The TipTraQ device uses photoplethysmography and an accelerometer to monitor physiological sleep parameters. Data collected by TipTraQ will be analyzed using an artificial intelligence system on a cloud server. The study plans to enroll 125 subjects who will use the device alongside a mobile app, with the goal of comparing the AI-generated results to expert PSG annotations. During the study, participants will undergo a single PSG study lasting between 4 to 10 hours while simultaneously using the TipTraQ device. Researchers will measure key outcomes including the Oxygen Desaturation Index, Apnea Hypopnea Index, and Total Sleep Time. Participants can withdraw at any time. The studys duration for each participant is limited to the time of the sleep study, with no long-term follow-up specified.

Researchers are studying how vestibular problems and thinking abilities like attention and mental flexibility relate in older adults. The study focuses on how performing a balance task and a thinking task simultaneously affects their performance. Two groups will be compared healthy older adults and those who have experienced dizziness or falls in the past two years. The aim is to help design future assessment and training programs to reduce balance problems and falls in this population. Participants will complete questionnaires and simple cognitive tests while seated. They will then perform standing balance tasks on a portable force platform under various conditions, repeating some cognitive tasks simultaneously. Next, participants will walk on a treadmill wearing motion sensors, both with and without added thinking tasks such as serial subtraction and digit reordering. The total testing time is about 90 minutes. During the study, participants will be assessed with various measures including gait speed, stride length, step width, cadence, and trunk movement using wearable inertial sensors. Cognitive and balance confidence scales will also be used. The study includes a single baseline laboratory visit to collect these data. The results will help understand balance and cognitive function in older adults and inform future rehabilitation strategies.