Da Zhou Shi

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the efficacy and safety of a combination budesonide and albuterol metered dose inhaler (MDI) compared with an albuterol sulfate MDI in symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter, event-driven study aims to reduce the risk of severe asthma exacerbations in this population. The study will enroll approximately 790 participants who meet specific asthma-related eligibility criteria. The study includes three periods: a screening period of 14 to 28 days, a treatment period lasting at least 24 weeks and up to 52 weeks, and a safety follow-up period occurring about two weeks after the final visit. Participants will be randomly assigned to one of two treatment groups, receiving either the budesonide/albuterol MDI or the albuterol sulfate MDI as needed for asthma symptoms or before exercise, alongside their usual maintenance therapy. Participants will undergo assessments including lung function tests, asthma control questionnaires, and monitoring of severe asthma exacerbations throughout the treatment period. Researchers will track the time to the first severe asthma exacerbation as the primary outcome. Safety will be monitored during the follow-up period, and participants must demonstrate the ability to use the inhaler correctly and comply with study procedures throughout the trial.

Researchers are collecting data on 10,000 patients aged 12 years and older with primary headache disorders and medication-overuse headache in the China HeadAche DIsorders RegiStry (CHAIRS). The study examines biomarkers, brain imaging features, cognitive abilities, genetic characteristics, social and demographic details, medical history, treatments used, and outcomes related to headache disorders, with planned long-term follow-up. Participants include groups with episodic migraine, chronic migraine, medication-overuse headache, new daily persistent headache, and other primary headache types. Some participants receive behavioral follow-up, while others using medications like Yangxue Qingnao Granules or biological treatments such as eptinezumab or erenumab are observed during a 12-week period where treatment decisions and dosing are made by their physicians as part of routine care. Throughout the study, participants undergo assessments including headache frequency, brain MRI changes, cognitive tests like the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Exam (MMSE), genetic analysis, and evaluations of disability, anxiety, and depression over long-term periods up to 10 years. Short-term outcomes such as pain relief two hours after medication are also measured. Follow-up visits may continue annually after the initial 24 months, with data collected during routine clinical visits.

Researchers are conducting a Phase III randomized, open-label, multi-center trial to compare the effectiveness and safety of two treatments, TQB2102 Injection and trastuzumab emtansine, in patients with HER2-positive advanced breast cancer. This study focuses on patients with unresectable, locally advanced, or metastatic invasive breast cancer confirmed to be HER2-positive according to specific testing guidelines. The primary goal is to evaluate progression-free survival as assessed by an independent review committee over a period of up to 30 months. Participants are randomly assigned in a 1:1 ratio to receive either TQB2102 Injection, a HER2 bispecific antibody-drug conjugate, or trastuzumab emtansine, a HER2-targeting antibody-drug conjugate. Both drugs are given by injection, and the study compares their impact on disease progression and safety in eligible patients who have previously received anti-HER2 monoclonal antibody and taxane drugs. During the study, patients will be closely monitored for treatment response and progression through regular assessments, including imaging to identify measurable lesions. Safety and adverse effects will be evaluated throughout the trial. The study includes participants aged 18 to 75 years with good performance status and expected survival exceeding three months. Researchers will follow patients for up to 30 months to assess progression-free survival and overall treatment outcomes.

Hepatocellular carcinoma (HCC) is a common and deadly cancer in China, with early recurrence and long-term outcomes closely linked to how aggressive the tumor is. Microvascular invasion (MVI), where tumor cells are found in small blood vessels near the liver, indicates more aggressive cancer behavior and is strongly connected to early recurrence after surgery. Currently, MVI can only be definitively diagnosed after surgery through pathological examination, and reliable methods to assess it before surgery are lacking. Previous attempts to predict MVI using imaging before surgery have faced challenges like poor general use, limited clarity, and difficulty adapting across different centers. This research is developing and testing a computer-aided diagnosis (CAD) system that uses advanced artificial intelligence techniques combined with preoperative multiphase CT scans and clinical knowledge to predict MVI in HCC patients before surgery. The system integrates features automatically extracted by deep neural networks, predefined radiomics features related to tumor shape and texture, and expert-defined imaging traits such as tumor margin clarity and its relationship with nearby blood vessels. It uses a hybrid model combining convolutional neural networks, Transformer modules, and graph neural networks to capture detailed textures, long-range connections, and tumor-vascular relationships. The system also provides prediction confidence and visual maps to help doctors interpret the results. Participants will be observed prospectively across multiple clinical centers, with data collected before surgery and model predictions compared blindly to postoperative pathology results. The study will measure accuracy and other diagnostic metrics within one month after surgery and observe how the model affects risk assessment and surgical planning. The goal is to confirm the CAD system's performance, generalizability, and usefulness in real-world clinical practice without influencing patient treatment, which will continue as standard care.

Researchers are investigating the safety and effectiveness of neuroendoscopic surgery compared to traditional craniotomy for treating large intracerebral hemorrhage. Previous studies suggest that neuroendoscopic surgery may reduce operation time and blood loss while improving recovery and quality of life, but there is a lack of prospective randomized trials to confirm these benefits. This multicenter, randomized controlled trial aims to provide clear evidence to guide surgical treatment decisions for this brain condition. Participants will be randomly assigned to receive either neuroendoscopic surgery or craniotomy, followed by standard medical care. Both surgeries target patients with large supratentorial cerebral hemorrhages requiring emergency intervention, with treatment occurring within 24 hours of diagnostic CT scanning. The study compares these two surgical methods directly to assess their impact on recovery outcomes. Throughout the trial, patients will be monitored for neurological recovery using the Modified Rankin Scale at 180 days after treatment. Researchers will evaluate functional outcomes, neurological status, and safety measures to determine the proportion of patients achieving favorable recovery scores. The study includes assessments during and after hospitalization, with follow-up visits to track long-term effects and overall patient progress over several months.

Researchers are evaluating the safety and effectiveness of low-dose tenecteplase in elderly patients who have experienced an acute ischemic stroke. This prospective, multicenter, randomized controlled Phase 4 trial focuses on patients aged 70 years and older who receive treatment within 4.5 hours of stroke onset. The study aims to compare low-dose tenecteplase with the standard dose to understand its impact on stroke recovery in aging patients. Participants are randomly assigned to one of two groups: a low-dose group receiving tenecteplase at 0.175 mg/kg (up to 17.5 mg per patient) or a standard-dose group receiving tenecteplase at 0.25 mg/kg (up to 25 mg per patient). Treatment is administered intravenously as thrombolysis. The trial monitors patients closely to assess how these dosing strategies affect recovery and safety. During the study, researchers will evaluate neurological function using the Modified Rankin Scale 90 days after treatment, measuring the percentage of participants who achieve a score of 0 or 1, indicating no symptoms or no significant disability. Patients will undergo neurological assessments and safety monitoring throughout the trial. The study ensures informed consent and collects relevant clinical data to support its findings on tenecteplase use in elderly stroke patients.

Researchers are conducting a randomized, blinded, active-controlled Phase I trial to evaluate the safety and initial immune response of a combined Diphtheria-Tetanus-acellular Pertussis vaccine (DTacP) in children aged 2 months to 6 years. The study focuses on monitoring adverse events shortly after vaccination and up to 12 months post-immunization, as well as measuring antibody levels against diphtheria, tetanus, pertussis, and poliovirus to assess immune response. The trial is organized in three stages based on age groups: children (6 years), toddlers (18-24 months), and infants (2-3 months). Participants receive different vaccines including DTacP, DT, DTaP, and Pentaxim, administered by injection in either the deltoid muscle or anterolateral midthigh according to specific schedules. The study uses dose escalation and random assignment to compare vaccines and injection sites. Intervention duration varies by group, with children and toddlers receiving a single dose and infants receiving either a 2- or 4-month vaccination schedule. Participants will be closely observed for adverse events immediately and for up to 30 days after each dose, with serious events monitored for 12 months. Safety is assessed through diaries, phone calls, and visits. Laboratory tests and blood samples are taken before and after vaccination to monitor health and immune response. Antibody levels are measured before vaccination, 30 days after, and in infants again around 12 months after primary vaccination. Each participant's involvement lasts approximately 12 to 16 months depending on age and immunization schedule.

Researchers are evaluating the usefulness of chest X-rays (CXR) for large-scale screening of thoracic diseases like lung, pleural, and heart conditions in adults. This prospective, multicenter study aims to provide real-world evidence on how well CXR can detect early-stage thoracic abnormalities and support public health efforts to improve early medical care. The study will measure how often confirmed thoracic diseases are detected through CXR screening and examine the accuracy and consistency of these findings across multiple centers. Adult participants coming for routine health exams will receive digital chest X-rays. If any abnormalities are suspected on the X-rays, they will be confirmed using a gold standard such as chest CT scans or clinical follow-up. The study will track the detection rate of thoracic diseases over about one year, alongside secondary outcomes like sensitivity, specificity, false-positive rates, and reading agreement between centers. Participants will undergo screening and any necessary follow-up imaging or clinical evaluations. Researchers will collect data on the accuracy of the chest X-rays in detecting thoracic diseases and the overall yield of the screening process. Safety and consistency will be monitored throughout the study, which is expected to last roughly one year from enrollment to outcome measurement.

Researchers are evaluating the safety and effectiveness of atorvastatin in adults aged 18 to 80 years who have experienced spontaneous intracerebral hemorrhage (ICH). This multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study plans to enroll 264 patients who arrive within 3 to 24 hours after symptom onset. The goal is to see if atorvastatin can improve recovery compared to standard medical treatment alone. Participants will be randomly assigned to one of two groups: one group will receive best medical treatment according to current ICH guidelines, and the other will receive the same treatment plus atorvastatin at a dose of 20 mg once daily for 21 days. Treatment is started within 48 hours of symptom onset or last known well time. The study focuses on patients with hematomas in the supratentorial brain region, with specific volume and coma scale criteria. During the study, participants will be monitored for functional outcomes, with the primary measure being the proportion of patients who have poor functional recovery at about 90 days, defined by a modified Rankin Scale score of 4 to 6. The study includes assessments through imaging to confirm diagnosis and careful tracking of symptoms and clinical status throughout the treatment and follow-up periods to evaluate safety and efficacy.