Jiao Zuo Shi

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are conducting a prospective, multi-center observational study in China to better understand drug-induced liver injury DILI. The study aims to explore the clinical features, identify the drugs or herbs causing DILI, assess patient outcomes, and discover new serum markers. The goal is to develop and validate a prognostic model incorporating these novel markers to improve prediction of patient prognosis in China. Participants will be grouped into a modeling group to help build a predictive model for DILI outcomes, and a validation group to test the accuracy of this model. The study collects long-term data to establish and verify these prognostic tools. No experimental treatments are given as this is an observational cohort study. During the study, researchers will monitor participants for key outcomes such as death, liver transplantation, and acute liver failure over one year, as well as chronic DILI and recovery over two years. Data will be collected through regular clinical assessments and laboratory tests. This long-term follow-up will help improve understanding of DILI prognosis and validate new serum biomarkers. Participants will be involved over extended periods to ensure comprehensive outcome measurement.

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 long-term effectiveness and safety of drug-coated balloon DCB strategies, including DCB alone or combined with drug-eluting stents DES, compared to DES-only treatment in patients with chronic total occlusion CTO of coronary arteries after successful reopening. This multicenter randomized controlled trial aims to fill the gap in direct comparative data between DCB and DES treatments for CTO, with the goal of optimizing treatment strategies, reducing stent use, lowering complication risks, and improving patient outcomes. Participants will be randomly assigned to either the DCB group, which involves balloon angioplasty with drug coating and possible provisional DES implantation if needed hybrid strategy, or the DES-only group receiving standard drug-eluting stent placement. Both groups receive standard medical therapy including at least 12 months of dual antiplatelet therapy DAPT. The study includes a 9-month primary endpoint assessment and a 36-month follow-up period to monitor long-term outcomes. During the study, patients will undergo angiographic evaluation for late lumen loss at 9 months, assessed by an independent laboratory using quantitative coronary angiography. Clinical events such as target lesion failure, cardiac death, myocardial infarction, and repeat revascularization will be monitored up to 36 months. Patient-reported outcomes like angina status and quality of life, as well as intravascular imaging and safety parameters, will also be collected. Overall participation spans over three years with regular follow-up visits to assess treatment effects and safety.

Researchers are evaluating TQB6411 Injection in adults with recurrent or metastatic Esophageal Cancer who have previously not responded to PD-1PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. The study includes Phase Ib to assess tolerance and safety, and Phase II to evaluate the effectiveness of TQB6411 Injection in this participant group. Participants will receive TQB6411 Injection administered in treatment cycles of either 21 or 28 days. The study follows a single group model where all participants receive the investigational drug. The research aims to determine the recommended dose for Phase II, monitor adverse events, and assess progression-free survival over 24 months. Participants will be involved in treatment and regular assessments including laboratory tests, tumor measurements according to RECIST v1.1, and biomarker analysis using tumor tissue samples. The study measures include response rates, survival outcomes, and drug concentration in plasma. Safety monitoring continues for up to 24 months, and participants must comply with study procedures and contraception requirements during and after the study.

Researchers are evaluating the efficacy and safety of oral minocycline in patients who have experienced an acute spontaneous intracerebral hemorrhage within 48 hours of onset. This prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial aims to improve patient outcomes and explore the effects of minocycline on venous neuroinflammation in this condition. Participants will be randomly assigned to receive either minocycline or a matching placebo for 5 days alongside standard medical care. The minocycline group will take an initial dose of 200 mg immediately after randomization, followed by 100 mg every 12 hours for a total of 10 doses. Those with swallowing difficulties may receive the medication through a nasal feeding tube. The trial includes screening, treatment, and follow-up phases with visits scheduled at screening, 72 hours, 7 days, 90 days, and 180 days after randomization. During the study, participants will undergo assessments including neurological evaluations and imaging at specified time points. Researchers will measure outcomes such as the modified Rankin Scale score at 90 days, changes in neurological scores, inflammation markers, and stroke recurrence. Safety and efficacy will be monitored through these evaluations, with total participation lasting up to 180 days post-randomization.

Researchers are evaluating the efficacy, safety, and tolerability of a subcutaneous drug called lunsekimig compared to placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease COPD with an eosinophilic phenotype. This Phase 2b3 study aims to better understand how lunsekimig might affect COPD symptoms and exacerbations in this specific group. Participants will be randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. All treatments are given by subcutaneous injection during a 48-week intervention period. The study includes a screening period up to 4 weeks before treatment and an approximately 8-week follow-up after the intervention, for a total duration of up to 60 weeks. During the study, participants will have regular assessments including lung function tests and symptom questionnaires. Researchers will monitor the annual rate of moderate-to-severe COPD exacerbations as the primary outcome. Secondary measures include changes in lung function and quality of life scores, along with safety evaluations such as monitoring adverse events and laboratory tests. Blood samples will be collected to measure drug levels and antibody responses. Participants are observed throughout the treatment and follow-up periods to assess the effects and tolerability of lunsekimig.

Researchers are evaluating treatment options for patients infected with Helicobacter pylori HP, a common stomach infection. This prospective, multicenter study enrolls 200 patients who test positive for HP through rapid urease tests or 13C urea breath tests. The study aims to assess the success rate of HP eradication, side effects, patient compliance, antibiotic resistance, and how these factors impact treatment outcomes. Participants will receive one of two experimental treatments a high-dose dual therapy consisting of Vonoprazan, a potassium competitive acid blocker, and Amoxicillin, an antibiotic or a minocycline-containing quadruple therapy including Bismuth Potassium Citrate for stomach protection, along with Minocycline and Metronidazole antibiotics. Patients will undergo HP culture and drug sensitivity tests before treatment. The study is non-randomized and does not use blinding. Throughout the study, patients will be monitored for HP eradication six weeks after finishing therapy. Researchers will also track adverse effects and treatment compliance within seven days following therapy completion. Participation involves informed consent and ongoing assessments to evaluate treatment effectiveness and safety. The total participation period extends at least six weeks after therapy to assess outcomes and side effects.

Researchers are conducting a multicenter, prospective observational study across 200 hospitals in China to examine current treatment patterns for chronic hepatitis B CHB. The study aims to compare patient outcomes under different treatment regimens to provide evidence-based data that can improve CHB treatment strategies and follow-up care, ultimately advancing efforts toward a functional cure for chronic hepatitis B. Participants include those receiving or planned to receive treatments such as entecavir ETV, tenofovir disoproxil fumarate TDF, tenofovir alafenamide fumarate TAF, tenofovir amibufenamide TMF, or peginterferon alpha-2b injection. The study observes real-world clinical practice without assigning treatments, capturing data on these therapies over an extended period. During the study, researchers will monitor outcomes including the percentage of patients developing HBsAg-associated hepatocellular carcinoma HCC, incidence of HCC, rates of HBsAg seroclearance and seroconversion, changes in HBsAg levels, HBV DNA levels, liver fibrosis improvement, and liver-related complications. Data collection spans from week 4 up to week 240, with continuous follow-up to assess treatment effects and patient status over time.

Researchers are conducting a phase II clinical trial to evaluate the safety and effectiveness of RC1416 injection in adults aged 40 to 85 with moderate to severe chronic obstructive pulmonary disease COPD. The study is randomized, double-blind, and placebo-controlled, aiming to better understand treatment options for patients with this lung condition. The trial is sponsored by Nanjing RegeneCore Biotech Co., Ltd. Participants will receive either the RC1416 drug or a placebo through subcutaneous injections every two weeks for a year. The study focuses on two doses of RC1416 and compares them against placebo to assess impacts on COPD exacerbations and lung function. Treatment continues for 52 weeks under close medical supervision. Throughout the study, participants will undergo regular assessments including lung function tests such as forced expiratory volume in 1 second FEV1, and measurements of biomarkers like FeNO, total IgE, eosinophil count, and TARC levels. Safety, tolerability, pharmacokinetics, and immunogenicity will also be monitored. The trials total duration for treatment and evaluation is one year, with careful tracking of participants health and response to the study drug.