Zao Zhuang Shi

Researchers are evaluating the safety and effectiveness of a drug called B001 injection in patients who have neuromyelitis optica spectrum disorder (NMOSD) and test positive for aquaporin-4 antibodies. This study is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial designed to compare B001 with a placebo in this patient population. The goal is to assess whether B001 can reduce the time to the first NMOSD attack during the study period. Participants will receive either an intravenous dose of B001 or a matching placebo on Day 1 and Day 15 during the randomized controlled period (RCP). Both treatment groups follow the same dosing schedule to evaluate the effects of B001 compared to placebo over approximately 48 weeks. During the study, participants will be closely monitored through regular assessments to track any NMOSD attacks and overall health. Researchers will measure the time to the first NMOSD attack as the primary outcome. Safety and any side effects of the treatment will also be evaluated throughout the study period. Participants are expected to complete all required tests and follow study procedures as part of their involvement.

Researchers are evaluating the safety, effectiveness, and how the body processes YL201 combined with serplulimab, with or without platinum-based chemotherapy, in adults with advanced solid tumors such as nasopharyngeal carcinoma (NPC), small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), and others. This phase 1, open-label study is conducted in China and is designed to find the best tolerable dose and assess treatment benefits in this patient group. The study has two parts: Part 1 focuses on gradually increasing doses of YL201 combined with serplulimab (at 4.5 mg/kg every three weeks), with or without platinum chemotherapy (70 mg/m2 every three weeks), to evaluate safety and determine the maximum tolerated dose or recommended dose. Part 2 expands on this by assessing the treatment’s effectiveness using the optimal dose found in Part 1. Treatment schedules occur every three weeks. Participants will undergo evaluations including tumor measurements using RECIST v1.1 criteria, providing tumor tissue samples, and regular checks of organ and bone marrow function. Researchers will monitor side effects, measure tumor response rates, and study how the drugs behave in the body over roughly 36 months. Participants must be able to follow study visits and procedures and have an expected survival of at least 3 months. Safety follow-up and efficacy assessments are included throughout the study duration.

Bladder cancer, primarily bladder uroepithelial cancer, is a common genitourinary tumor with a high recurrence rate, especially for non-muscle-invasive bladder cancer (NMIBC), which accounts for about 75% of cases. This research evaluates how drug sensitivity testing using patient-derived bladder cancer organoids can guide individualized bladder perfusion chemotherapy to improve treatment selection and reduce recurrence. The study is designed as a multicenter cohort study and aims to compare recurrence-free survival rates among patients receiving organoid-sensitive chemotherapy, organoid-non-sensitive chemotherapy, and BCG therapy. Patients undergo organoid culture from tumor tissue collected during surgery to test sensitivity to several chemotherapeutic agents including gemcitabine, piroxicam, epirubicin, mitomycin, and doxorubicin. Based on organoid drug sensitivity results, patients are assigned to either an organoid-sensitive drug perfusion group or an organoid-non-sensitive drug perfusion group. Chemotherapy regimens include induction perfusion weekly for 4 weeks starting 4 to 8 weeks post-surgery, followed by maintenance perfusion monthly for 11 months. The BCG group receives a series of infusions over one year including induction, booster, and maintenance doses. Participants are closely followed with regular cystoscopy based on their risk level to monitor tumor recurrence and progression over one and three years. Assessments include clinical efficacy evaluations using established criteria and survival analysis to compare recurrence rates. Safety and adverse events are recorded, and data management and quality control measures are applied. The study duration includes treatment, follow-up, and outcome measurement periods up to three years to explore the value of organoid-guided therapy in precision bladder cancer treatment.

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.

This trial studies patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. It is a randomized, double-blind, phase III clinical study designed to compare the effectiveness and safety of the drug AK112 against a placebo as a consolidation treatment. The goal is to evaluate the potential benefits of AK112 in improving outcomes for these patients. Participants receive either AK112 at a dose of 20 mg/kg or a placebo, both administered intravenously every three weeks (Q3W). The treatment is given as consolidation therapy following initial chemoradiation, aiming to maintain disease control. The study involves two groups: one receiving AK112 and the other receiving placebo, with both treatments delivered under double-blind conditions. Throughout the trial, researchers monitor participants for up to approximately six years, focusing on progression-free survival and overall survival as primary outcomes. Patients undergo regular assessments to track disease status and safety, including blinded independent center reviews. The long-term follow-up ensures comprehensive evaluation of treatment effects and participant safety over time.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are evaluating the effects of two treatments in people with H-type hypertension who have specific genetic types (MTHFR 677 CC or CT), elevated plasma homocysteine levels, and low serum folate. This large, phase 4 clinical trial involves 32,000 Chinese men and women aged 45 to 74 years. The study aims to compare the risk of first ischemic stroke over a five-year period between the two treatment groups. Participants will be divided into groups based on their MTHFR genotype and randomly assigned to receive either amlodipine tablets (5mg once daily) or amlodipine combined with folic acid tablets (5.8mg once daily). The study includes a screening period, a 2 to 4-week run-in phase to check tolerance and compliance to amlodipine, and a five-year randomized treatment phase. Additional blood pressure medications may be added if needed to maintain target blood pressure levels. During the study, participants will have visits every three months for drug distribution and monitoring. Researchers will collect blood samples, conduct clinical evaluations, and gather data on medication adherence and health outcomes. The primary outcome measured is the first occurrence of ischemic stroke by the end of five years. Safety and efficacy will be assessed, with two interim analyses planned at years three and four.

Researchers are studying the effects of three different treatment approaches on the risk of first ischemic stroke in Chinese men and women with hypertension and a specific genetic type called MTHFR 677 TT genotype. This large, phase 4 clinical trial will include 24,000 participants aged 45 to 74, and will compare the impact of amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate (5-MTHF). The goal is to evaluate which treatment strategy might better prevent the first ischemic stroke over five years. The study has three main periods: screening, run-in, and randomized treatment. During screening, participants provide consent and undergo interviews, clinical evaluations, and lab tests to confirm eligibility. The run-in period lasts 2 to 4 weeks, where participants take amlodipine (5 mg once daily) to assess tolerance and compliance. After this, eligible participants are randomly assigned to one of three groups: amlodipine only, amlodipine plus folic acid, or amlodipine plus folic acid and 5-MTHF. Treatments are taken orally once daily for five years. Additional antihypertensive medications may be added as needed to keep blood pressure controlled. Participants will visit the research centers every three months for follow-up, medication distribution, and monitoring. Researchers will check blood pressure, collect biological samples, and assess compliance and safety throughout the five-year treatment. The study’s main outcome is the occurrence of a first ischemic stroke by the end of the fifth year. Two interim analyses are planned at years three and four to evaluate ongoing results while maintaining study integrity.

Double-balloon enteroscopy is a new endoscopic method used to diagnose and treat diseases in the small intestine by allowing deep intubation and full visualization of the small intestinal lining, known as total enteroscopy. Achieving total enteroscopy is challenging, and currently, endoscopists cannot accurately predict the difficulty of the procedure before it begins, leading to less optimal preparation and strategy. Researchers have developed and validated a predictive model to assess the difficulty of total enteroscopy before the procedure. This study is a multicenter randomized controlled trial designed to evaluate the impact of using this predictive model on the total enteroscopy rate during double-balloon enteroscopy. Endoscopists will obtain a predictive model score for each patient before performing the procedure. The study will compare outcomes such as total enteroscopy rate, positive findings during the procedure, procedural time, and occurrence of adverse events. Participants will be adults aged 18 to 80 years undergoing double-balloon enteroscopy for suspected small-bowel disease, with a recent CT scan of the abdomen. Researchers will monitor and record procedure-related data and safety outcomes over an 8-month period, focusing primarily on the total enteroscopy rate. The study aims to understand whether the predictive model can improve procedure success and inform better preoperative planning.

This research investigates the impact of having had an induced termination of pregnancy (abortion) on future pregnancy complications and outcomes. The study is designed as a prospective multicenter cohort, focusing on women who have experienced an early pregnancy abortion (before 12 weeks of gestation). The goal is to understand how prior induced abortions might affect reproductive health and abortion-related outcomes. Participants include women who have undergone induced termination of pregnancy, which is defined as voluntarily ending a pregnancy through medical or surgical methods to prevent live birth. The study observes these women over time to evaluate any complications or outcomes in subsequent pregnancies. During the study, participants will be monitored and followed up to assess adverse pregnancy outcomes. Researchers will collect information through follow-up investigations and assess the effects of prior induced abortion on pregnancy health. The study involves obtaining informed consent and maintaining contact with participants, with the total study duration covering the time needed for pregnancy outcome evaluation.