Jiao Zuo Shi

Researchers are conducting a prospective, multi-center, non-interventional cohort study across China to investigate Drug-induced Liver Injury (DILI). The study aims to explore the clinical characteristics, responsible drugs or herbs, patient outcomes, and risk factors associated with DILI. An important goal is to identify new serum markers that could help predict the prognosis of this condition. The study also seeks to develop and validate a prognostic model incorporating these novel serum markers to improve patient care in China. Participants will be followed in a nationwide standardized cohort with long-term monitoring to collect detailed prognostic data on DILI. The study does not involve experimental treatments but focuses on observation and data collection to help understand DILI better. No specific interventions are delivered as part of this research. During the study, participants will undergo evaluations to confirm diagnosis and monitor their liver health over time. Researchers will measure primary outcomes including death or liver transplantation within one year and the occurrence of acute liver failure within one year. The study involves ongoing assessments to gather clinical data and validate the prognostic model based on novel serum biomarkers, aiming to enhance future management of DILI.

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 long-term safety and effectiveness of drug-coated balloon (DCB) strategies compared to drug-eluting stent (DES) only treatment in patients with chronic total occlusion (CTO) of the coronary arteries after successful reopening of the artery. This study aims to provide high-quality evidence by directly comparing DCB alone or combined with DES (hybrid strategy) against DES-only treatment. The goal is to improve treatment strategies, reduce the use of stents, lower complication risks, and enhance patient outcomes for these complex heart artery blockages. The trial involves two groups: one receiving DCB angioplasty with possible provisional DES implantation if necessary, and the other receiving standard DES implantation. Both treatments use devices sized to the vessel diameter and cover the blocked segment plus surrounding healthy areas. DCB balloons are inflated to deliver medication, while stents are deployed with appropriate pressure to ensure vessel support. All patients receive standard medical therapy including at least 12 months of dual antiplatelet therapy and are followed for 36 months after the procedure. Participants will undergo assessments including angiographic imaging to measure late lumen loss at 9 months by a blinded core lab, as well as monitoring for clinical outcomes such as cardiac events, repeat procedures, and quality of life. An independent committee adjudicates clinical events. The study uses intention-to-treat analysis to compare safety and efficacy between groups. This comprehensive follow-up and evaluation plan aims to provide valuable insights into optimizing CTO treatment.

Researchers are evaluating the safety and effectiveness of TQB6411 Injection in adults aged 18 to 75 years with recurrent or metastatic esophageal cancer who have not responded to previous treatment with PD-1/PD-L1 inhibitors combined with platinum-based chemotherapy. This study includes Phase Ib to assess tolerance and safety, and Phase II to evaluate how well the treatment works in this patient group. TQB6411 Injection is an antibody-drug conjugate targeting EGFR and c-Met. Participants receive TQB6411 Injection administered as part of the study treatment. The trial includes a dose-finding phase to determine the recommended Phase 2 dose over 3 months, followed by ongoing treatment and observation for up to 24 months. During this time, researchers monitor adverse events and progression-free survival to assess safety and efficacy. Throughout the study, participants undergo regular evaluations including laboratory tests, tumor assessments based on measurable lesions, and biomarker analysis from tumor tissue samples. Safety is closely monitored with attention to adverse events and treatment compliance. The total study duration for each participant may be up to 24 months to capture long-term outcomes and side effects.

Primary liver cancer, particularly hepatocellular carcinoma (HCC) at BCLC stage C, is a common and serious cancer where many patients are not eligible for surgery due to advanced disease. Researchers are evaluating the effectiveness and safety of two treatments: drug-eluting bead transarterial chemoembolization (DEB-TACE) alone versus DEB-TACE followed by hepatic artery infusion chemotherapy (HAIC). This study aims to see if combining these treatments provides better outcomes for patients with unresectable advanced liver cancer. The trial compares two groups: one receiving DEB-TACE alone and the other receiving DEB-TACE followed by sequential HAIC using a FOLFOX-based chemotherapy regimen. DEB-TACE uses drug-loaded beads to block tumor blood supply and release chemotherapy slowly, while HAIC delivers chemotherapy directly into the liver artery. This combination is designed to enhance the anti-tumor effect while potentially reducing side effects. Treatment is administered in a multi-center setting with careful monitoring. Participants will be monitored from the first DEB-TACE treatment up to 36 months or until disease progression or death. Assessments include imaging scans to evaluate tumor response according to mRECIST criteria, laboratory tests, and safety evaluations. Researchers will measure progression-free survival, which is the time without tumor growth or death. Participants must cooperate with treatment, complete scheduled visits, and provide informed consent, with an estimated life expectancy of at least 3 months.

The study population are patients with acute anterior circulation large vessel occlusion stroke and planned to undergo endovascular treatment. All participants are randomly assigned in a 1:1 ratio to the tocilizumab group or the placebo group. In tocilizumab group, participants will receive tocilizumab combined endovascular treatment. And in placebo group, participants will receive placebo combined endovascular treatment. All participants will be visited immediately postoperatively, at 24 hours, 7 days, and 90 days after randomization.

Researchers are investigating the effectiveness and safety of oral minocycline compared to placebo in patients who have experienced an acute spontaneous intracerebral hemorrhage within 48 hours of symptom onset. This phase III clinical trial is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled study aiming to improve recovery outcomes in this patient population. An additional goal is to assess the impact of minocycline on markers of venous neuroinflammation at various times after the hemorrhage. A total of 1192 participants will be randomly assigned in equal numbers to receive either minocycline capsules containing 50 mg of minocycline hydrochloride or matching placebo capsules for five days. All participants will also receive standard medical care based on current guidelines. The study includes three phases: screening and baseline, treatment, and follow-up. Participants will be evaluated at several time points including screening/baseline, 72 ±12 hours, 7 ±1 days, 90 ±7 days, and 180 ±7 days after randomization, as well as during any relevant events. Researchers will measure the primary outcome of disability and functional status using the modified Rankin Scale score (mRS) at 90 days post-randomization, aiming for scores between 0 and 3. Throughout the study, assessments and interviews will monitor safety, efficacy, and treatment adherence.

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous lunsekimig compared to a placebo in adults aged 40 to 80 years with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3, parallel, 3-arm study focuses on participants who have a history of COPD with an eosinophilic profile and have not achieved control with current treatments. Eligible participants will receive either lunsekimig or a matching placebo through subcutaneous injections over a randomized treatment period of approximately 48 weeks. The study involves three periods: an initial screening period lasting up to 4 weeks, followed by the 48-week treatment period, and finally an 8-week follow-up period. The total study duration may last up to 60 weeks. During the study, participants will be regularly assessed for the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will monitor safety, tolerability, and treatment effects through various evaluations throughout the treatment and follow-up periods. Participant involvement includes completing assessments and receiving scheduled injections as part of the study protocol.

This research aims to evaluate and compare treatments for people infected with Helicobacter pylori, a type of bacteria that can cause stomach problems. It is a Phase 4 multicenter prospective study including 200 patients confirmed positive for H. pylori by rapid urease test or 13C urea breath test. The study will follow ethical guidelines and obtain informed consent from all participants before enrollment. Researchers will assess factors such as antibiotic resistance, success rates, adverse reactions, and patient compliance during treatment. Participants will receive either a high-dose dual therapy or a quadruple therapy containing minocycline and other medications. The drugs studied include vonoprazan (a potassium competitive acid blocker), amoxicillin, bismuth potassium citrate (which protects the stomach lining and fights H. pylori), and a combination of minocycline and metronidazole antibiotics. All patients will undergo H. pylori culture and drug sensitivity testing to guide therapy. During the study, researchers will monitor the eradication rate of H. pylori six weeks after therapy completion. They will also observe adverse reactions and patient adherence to treatment. The study includes careful follow-up and assessments to measure treatment outcomes and antibiotic resistance impact. The total participation period and further follow-up details are guided by study protocols to ensure comprehensive evaluation of therapies.

Researchers are conducting a multicenter, prospective, observational real-world study across 200 hospitals in China to examine treatment patterns for chronic hepatitis B (CHB). The study aims to compare patient outcomes under various therapies to provide evidence-based data that can help optimize CHB treatment and follow-up, with the ultimate goal of advancing a functional cure for chronic hepatitis B. The focus includes monitoring the incidence of hepatocellular carcinoma (HCC) associated with hepatitis B. Participants receive treatments including entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF), or Peginterferon α-2b injection. The study follows both patients currently on these therapies and those initiating or re-initiating Peginterferon α-2b therapy. These treatments are assessed in routine clinical practice settings without intervention from the study team. Throughout the study, patients are monitored from week 4 up to week 240 for the development of HBsAg-associated hepatocellular carcinoma (HCC) and overall HCC incidence. Researchers collect data on treatment effectiveness and safety as part of the observational follow-up. Participants provide informed consent and are observed under real-world conditions to evaluate long-term outcomes and risks associated with chronic hepatitis B and its treatments.