Da Zhou Shi

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the safety and effectiveness of BGB-16673 compared to pirtobrutinib in adults with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with a covalent Bruton tyrosine kinase inhibitor cBTKi. The study is a phase 3, open-label, randomized trial sponsored by BeOne Medicines, aiming to assess treatment options for these patients. Participants are randomly assigned to receive either BGB-16673 or pirtobrutinib, both taken orally. This parallel assignment design compares these two drugs directly. The treatments continue with monitoring up to approximately three years to observe progression-free survival and other outcomes. The study began in September 2025 and is expected to complete in April 2028. During the trial, participants will undergo regular assessments including imaging scans to measure disease status, quality of life questionnaires, and monitoring for adverse events. Outcomes such as overall survival, response rates, duration of response, and time to next treatment are tracked. Safety and quality of life will be evaluated throughout the study period, which may last up to about three years for each participant.

Researchers are evaluating the efficacy and safety of two inhalers, BDA MDI budesonide and albuterol and AS MDI albuterol sulfate, in reducing severe asthma attacks among symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter study involves about 1000 participants who have been diagnosed with asthma and continue to experience symptoms despite maintenance therapy. Participants will be randomly assigned to receive either BDA MDI 160180 mcg two puffs of 8090 mcg or AS MDI 180 mcg two puffs of 90 mcg as needed to relieve asthma symptoms or before exercise. The study includes a screening period lasting 14 to 28 days, followed by a treatment period of at least 24 weeks and up to 52 weeks, and concludes with a safety follow-up about two weeks after the last treatment visit. During the trial, participants will attend regular visits to monitor their asthma control and lung function. Researchers will assess the time to the first severe asthma exacerbation, the rate of exacerbations, steroid use, and responses to asthma control questionnaires. Safety will be carefully followed during and after treatment, with the total participation lasting up to approximately one year.

Researchers are conducting a large observational study called the China HeadAche Disorders Registry CHAIRS to better understand primary headaches and medication-overuse headaches MOH in patients aged 12 years and older. The study aims to collect detailed information including biomarkers, brain imaging, cognitive and genetic data, as well as social, demographic, medical, and treatment-related data. Long-term follow-up is planned to observe outcomes related to headache disorders over many years. Participants include those with various types of primary headaches such as migraine, tension-type headache, new daily persistent headache, and MOH. The study includes behavioral follow-up visits at multiple time points monthly for the first 18 months, then at 24 months, and annually thereafter. Some participants are observed during routine clinical use of treatments like Yangxue Qingnao Granules, Erenumab, and Eptinezumab, with treatment decisions made by their physicians and outcomes tracked over 12 weeks or longer. Throughout the study, participants undergo periodic assessments including MRI scans, cognitive tests like the Montreal Cognitive Assessment MoCA and Mini-Mental State Exam MMSE, and questionnaires evaluating headache impact, anxiety, depression, quality of life, sleep quality, and fatigue. Data on headache frequency, severity, medication use, and biological samples are collected. Follow-up can extend up to 10 years, allowing researchers to monitor long-term changes and outcomes related to headache disorders and treatments.

This trial studies patients with HER2-positive advanced breast cancer who have unresectable, locally advanced, or metastatic invasive breast cancer. Researchers are comparing two drug treatments, TQB2102 injection and trastuzumab emtansine injection, to evaluate their effects on progression-free survival. This is a randomized, open-label, phase III clinical trial designed to assess the efficacy and safety of these treatments in this patient population. Participants are randomly assigned to receive either TQB2102 or trastuzumab emtansine by intravenous infusion. TQB2102 is given at a dose of 6 mgkg every 3 weeks, while trastuzumab emtansine is given at 3.6 mgkg every 3 weeks. Each infusion cycle lasts 3 weeks, and treatment continues according to the protocol. The trial includes multiple centers and uses positive drug control design. During the study, participants will be monitored for progression-free survival assessed by an Independent Review Committee over 30 months. Additional evaluations include overall survival, duration and rate of response, clinical benefit rate, and safety assessments of adverse events. Antibody levels and immune responses will be measured at various cycles. Follow-up for survival outcomes may continue up to 5 years. Participants will have regular visits for assessments, safety monitoring, and laboratory tests throughout the trial duration.

Hepatocellular carcinoma HCC is a common and serious liver cancer in China with a high death rate. Early recurrence of the cancer is closely linked to how aggressive the tumor is. Microvascular invasion MVI, which means cancer cells are found in small blood vessel branches near the tumor, is an important sign of aggressive disease and is linked to early return of cancer after surgery. Currently, MVI can only be definitively diagnosed after surgery, and there are no reliable methods to predict it before surgery. This research aims to create and test an advanced computer-aided diagnosis CAD system using artificial intelligence and detailed CT images taken before surgery to predict MVI in patients with HCC. The CAD system combines multiple types of imaging features including deep learning-extracted patterns, specific tumor characteristics like shape and texture, and expert-defined factors such as tumor edge clarity and blood vessel relationships. It uses a hybrid model combining convolutional neural networks, Transformer modules, and graph neural networks to analyze tumor details and surrounding areas. The system also provides confidence levels and visual outputs to help doctors understand and trust the predictions. This study will observe its performance across multiple hospitals by comparing the systems predictions with actual pathology results after surgery. Participants are adults aged 18 and older who are scheduled for surgical removal of HCC and have preoperative multiphase CT scans and pathological evaluation data available. Researchers will collect imaging, clinical, and pathology data to evaluate how accurately the CAD system predicts MVI compared to standard pathology. The main measures include the systems accuracy and the area under the receiver operating characteristic curve AUC within one month after surgery. Additional measures include sensitivity, specificity, and calibration. The study will also examine how the systems predictions might influence surgical decision-making and risk assessment in real-world practice.

Researchers are evaluating the safety and effectiveness of neuroendoscopic surgery compared to traditional craniotomy for treating large intracerebral hemorrhage. This trial addresses the lack of prospective randomized studies on surgical methods for this condition, aiming to provide clearer guidance for treatment decisions. Previous studies suggest neuroendoscopic surgery may reduce surgery time and blood loss while improving recovery and quality of life. Participants will be randomly assigned to one of two groups one receiving neuroendoscopic surgery to remove the brain hematoma, and the other undergoing craniotomy for the same purpose. Both groups will receive standard medical care after surgery. The trial is conducted across multiple centers and includes a single-blinded design. During the study, participants will be monitored for several outcomes, including neurological recovery using the Modified Rankin Scale at 180 days, mortality rates at 30, 90, and 180 days, cognitive function with the Mini-Mental State Examination, and quality of life assessments. Researchers will also track hospital and ICU stay lengths, operation duration, and bleeding during surgery. Follow-up assessments will occur up to 180 days after treatment to evaluate safety and effectiveness.

Researchers are evaluating the safety and effectiveness of low-dose tenecteplase in elderly patients aged 70 and older who have experienced an acute ischemic stroke. This multicenter, randomized controlled trial focuses on treatment within 4.5 hours of stroke onset to assess how this therapy may improve neurological outcomes compared to a standard dose. Participants are randomly assigned to receive either a low dose 0.175 mgkg, up to 17.5 mg or a standard dose 0.25 mgkg, up to 25 mg of tenecteplase given intravenously. The study is designed as a parallel-group trial comparing these two dosing regimens to understand which may be more beneficial and safe for elderly stroke patients. Participants will be monitored for recovery and safety through neurological assessments using scales such as the Modified Rankin Scale and the National Institutes of Health Stroke Scale up to 90 days after treatment. Outcomes like neurological improvement, functional independence, quality of life, and any bleeding events will be closely measured. The trial will continue until December 2028, with follow-up visits planned to evaluate participants progress and overall health.

Researchers are conducting a randomized, single-blind, active-controlled phase I clinical trial to evaluate the safety and early immune response of a combined Diphtheria-Tetanus-acellular Pertussis DTacP vaccine in children aged 2 months to 6 years. The study aims to assess adverse events shortly after vaccination and up to 12 months later, as well as measure antibody levels to various components of the vaccine. The trial includes infants, toddlers, and children, with careful monitoring of immune response and safety outcomes. The trial is divided into three stages by age groups children aged 6 years, toddlers aged 18-24 months, and infants aged 2 to 3 months. Participants are randomly assigned to receive either the DTacP vaccine or other vaccines such as DT, DTaP, or Pentaxim in different dosing schedules and injection sites. Children and toddlers receive a single injection on Day 0, while infants receive three doses over 2 to 4 months following specific immunization schedules. Safety reviews occur after each stage to decide progression. Participants will be monitored closely for adverse events through diaries, phone calls, and face-to-face visits for up to 12 months after vaccination. Blood, urine, and other lab tests will be performed before and after vaccination to assess safety and immune responses. Antibody levels against diphtheria, tetanus, pertussis, and poliovirus will be measured before vaccination, 30 days after, and for infants, again at 12 months. The study duration varies by group but may last up to 16 months for infants.

Researchers are evaluating the use of chest X-ray CXR in a large-scale study to screen for thoracic diseases in adults. This observational study involves participants who come for routine health exams and aims to confirm suspected abnormalities with more precise methods like chest CT scans or clinical follow-up. The goal is to determine how well CXR works in detecting early lung, pleural, and heart problems and to provide evidence for its cost-effectiveness and feasibility in public health screening. Participants will undergo digital chest X-rays during their health examinations. When abnormalities are suspected, these findings will be verified using a gold standard reference such as a chest CT scan or through clinical follow-up procedures. The study gathers data across multiple centers to assess detection rates, diagnostic accuracy, false positives, and reading consistency among centers over an average period of one year. During the study, participants will have their chest X-rays analyzed and may be asked to undergo further scans or follow-ups if needed. Researchers will measure the overall detection rate of thoracic diseases, diagnostic performance metrics, and consistency across different centers. The study tracks participants for about one year to monitor these outcomes and better understand the benefits and limitations of using chest X-rays for disease screening.