Zao Zhuang Shi

Researchers are evaluating the effectiveness and safety of B001 injection in patients who have neuromyelitis optica spectrum disorder NMOSD and test positive for aquaporin-4 antibodies. This condition involves recurrent attacks affecting the nervous system. The study is a multicenter, randomized, double-blind, placebo-controlled trial conducted in phases II and III to understand how well B001 works and how safe it is for these patients. Participants will receive intravenous doses of either B001 or a placebo on Day 1 and Day 15 during the randomized controlled period. The study includes two groups one receiving B001 injections and the other receiving placebo injections matching B001s schedule. The trial will extend over several years, monitoring patients closely for disease relapse and treatment side effects. During the study, participants will be regularly assessed for the time to their first NMOSD attack, changes in disability status, vision acuity, and opticospinal function. Researchers will also observe the annual relapse rate and document any adverse events. The trial includes safety monitoring for about three years to ensure comprehensive data collection on treatment impact and participant health.

Bladder cancer is a common and serious tumor that originates from the bladders lining, with the majority being non-muscle invasive bladder cancer NMIBC. NMIBC has a high recurrence rate even after initial treatment, making postoperative bladder perfusion chemotherapy important to prevent tumor return. This research evaluates the use of patient-derived bladder cancer organoids to test drug sensitivities and guide individualized chemotherapy, aiming to improve treatment effectiveness and reduce recurrence for bladder cancer patients. The study involves preparing bladder cancer organoids from tumor tissue collected during surgery. Researchers perform drug sensitivity testing on these organoids with various chemotherapeutic agents, including gemcitabine, pirenzolubicin, epirubicin, mitomycin, and doxorubicin. Based on organoid sensitivity results, patients receive bladder perfusion chemotherapy with either sensitive or non-sensitive drugs, or receive BCG vaccine infusions. Treatment schedules include induction perfusion weekly for 4 weeks and maintenance perfusion monthly for 11 months, or BCG infusions following an induction and maintenance regimen over one year. Participants undergo regular clinical assessments including cystoscopy, urine cytology, and imaging as needed to monitor tumor recurrence and progression over up to three years. Researchers analyze one-year and three-year tumor recurrence-free and progression-free survival rates among groups. The study monitors patient compliance, adverse events, and clinical outcomes to assess the value of organoid drug sensitivity testing in guiding personalized bladder cancer perfusion chemotherapy.

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 AK112, a PD-1VEGF bispecific antibody, as a consolidation treatment for patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. This phase III, randomized, double-blind study aims to compare the effectiveness and safety of AK112 against a placebo in this specific patient group. Participants will receive either AK112 or a placebo intravenously every three weeks as consolidation therapy following their initial chemoradiation. The study includes two groups one receiving AK112 at a dose of 20 mgkg every three weeks, and the other receiving a matching placebo on the same schedule. Treatment continues under close monitoring to assess outcomes. Throughout the study, participants will undergo regular assessments including scans and evaluations to monitor progression-free survival and overall survival over approximately six years. Additional outcome measures include response rates and disease control rates assessed by both independent review and investigators, along with safety monitoring for adverse events. This long-term follow-up helps researchers understand how the treatments perform and their impact on patient health.

Researchers are evaluating a new medicine called YL201 compared to the standard chemotherapy chosen by doctors in people with locally advanced or metastatic esophageal squamous cell carcinoma who have stopped responding to first-line treatment. The goal is to see if YL201 works better and is safer. The study is a large, randomized phase III trial involving multiple hospitals and also investigates how YL201 is processed in the body, immune reactions it might cause, and whether certain biological markers can predict its effects. Participants will be assigned to one of two groups one group receives YL201 alone, given as an intravenous infusion on the first day of each 3-week cycle. The other group receives a chemotherapy drug chosen by their doctor, which may be paclitaxel, docetaxel, or irinotecan, each given intravenously on specific schedules every 3 weeks. The study treatment continues as planned, with monitoring throughout the treatment period. During the study, participants will undergo regular evaluations including scans and laboratory tests to measure how well the treatments are working and to monitor side effects. The main outcome researchers will track is overall survival for up to about 36 months. They will also assess progression-free survival, response rates, duration of response, and adverse events during this time. The study will last until the end of 2028, with ongoing monitoring and data collection.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

Researchers are investigating the effects of amlodipine alone versus amlodipine combined with folic acid in Chinese adults aged 45 to 74 years who have H-type hypertension, specific MTHFR 677 genotypes CC or CT, elevated plasma homocysteine levels, and low serum folate. This large, multi-center, randomized, double-blind, double-dummy clinical trial aims to evaluate which treatment better reduces the risk of first ischemic stroke over five years. Participants are first screened and then enter a 2 to 4 week run-in period where they take amlodipine to assess tolerance and compliance. Afterward, eligible participants are randomized by genotype into two groups one receiving amlodipine 5mg daily with a placebo, and the other receiving amlodipine 5mg combined with 0.8mg folic acid daily with a placebo. Other blood pressure medications may be added as needed to reach target blood pressure goals. Follow-up visits occur every three months during the five-year treatment period with medication provided at each visit. Throughout the study, participants undergo interviews, clinical evaluations, and laboratory tests including genetic and blood analyses. Researchers monitor adherence, blood pressure, and cardiovascular health. The main outcome measured is the occurrence of first ischemic stroke by the end of five years. Secondary outcomes include other cardiovascular events and kidney function. Two interim analyses will be conducted during the study to assess progress and safety.

Researchers are evaluating the effects of different amlodipine-based treatments on the risk of first ischemic stroke in Chinese adults aged 45 to 74 years with hypertension and the MTHFR 677 TT genotype. This large, multi-center, randomized, double-blind, triple-dummy controlled trial aims to compare amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate over a 5-year period. The study focuses on preventing ischemic stroke as the primary outcome. Participants first undergo a screening period to confirm eligibility through interviews, clinical evaluations, and lab tests. Those who qualify enter a 2 to 4 week run-in phase with daily amlodipine to check treatment tolerance and compliance. Eligible participants are then randomly assigned to one of three daily oral treatment groups amlodipine alone, amlodipine folic acid, or amlodipine folic acid plus 5-MTHF. Additional antihypertensive medications may be added as needed to control blood pressure. Participants are followed every 3 months for drug distribution and monitoring. Throughout the study, participants will have regular clinical visits, interviews, and biological sample collections to monitor health and treatment effects. Researchers will track the incidence of first ischemic stroke and other cardiovascular and kidney outcomes over five years. Safety and treatment adherence are carefully observed, with two planned interim analyses during the trial. Total participation spans from initial screening through five years of treatment and follow-up.

Researchers are conducting a nationwide, multicenter observational study to establish and improve a hospital-based clinical surveillance and early warning system for respiratory syndrome pathogens. The study will include patients with respiratory syndrome from various hospital settings across seven regions in China. It aims to monitor pathogen trends, support risk assessment, and provide evidence for prevention and control strategies over several years. Participants diagnosed with respiratory syndrome will have clinical data collected every two weeks, including demographics, symptoms, diagnoses, lab tests, medications, oxygen therapy, hospital stays, ICU admissions, and outcomes. For those meeting specific diagnostic criteria, respiratory and other biospecimens will undergo a range of tests including routine pathogen tests, multiplex PCR, targeted and metagenomic sequencing, antibody and cytokine testing, and exploratory multi-omics analyses. During the study, data and specimens will be collected routinely from participants receiving clinical care. Researchers will generate national and regional surveillance reports to support early warnings and prevention efforts. The main outcomes measured include detection rates and types of respiratory pathogens and immune responses after infection or vaccination, tracked over three years. Participation involves regular data reporting through secure channels without additional treatment interventions.

Researchers are evaluating a predictive model designed to improve the total enteroscopy rate during double-balloon enteroscopy, a technique used to diagnose and treat small intestinal diseases. This study aims to see if using the model before the procedure can help endoscopists better prepare and plan, potentially increasing the chance of detecting positive lesions. The trial is a randomized controlled study led by Shandong University. Participants will be randomly assigned to one of two groups one where endoscopists receive the predictive model scores before performing double-balloon enteroscopy, and a control group where they do not. The study will compare outcomes such as total enteroscopy rate, diagnostic yield, procedure time, and any adverse events. The procedure will be performed either orally or anally, depending on the patient. During the study, participants will undergo double-balloon enteroscopy after a recent abdominal CT scan. Researchers will monitor how often complete small intestine visualization is achieved, findings from the procedure, duration of the procedure, and any complications over an 8-month period. The study will include adults aged 18 to 80 years and exclude those with certain conditions or risks, including pregnancy and inability to consent.