Lianyungang

Researchers are evaluating the effectiveness, safety, and tolerability of elecoglipron alone or combined with dapagliflozin compared with a placebo in adults with type 2 diabetes mellitus T2DM who are not adequately controlled by lifestyle management alone or who are on other background glucose-lowering medications. This Phase III study aims to understand how these treatments impact blood sugar control and related health factors. Participants will be randomly assigned to one of four groups elecoglipron at dose level 1 with dapagliflozin-matched placebo, elecoglipron at dose level 2 with dapagliflozin-matched placebo, a combination of elecoglipron at one of the studied doses with dapagliflozin, or matching placebos for both drugs. All treatments are taken orally once daily. The study uses a quadruple-blind design to compare these options over a treatment period lasting up to 40 weeks. During the study, participants will have their blood sugar levels measured by changes in Hemoglobin A1c HbA1c from baseline to week 40. Other assessments include body weight, blood pressure, and the time to start any additional rescue medication. Participants will attend regular visits for monitoring and safety evaluations throughout the study duration, which extends until the primary completion date in July 2028.

Researchers are evaluating the real-world effectiveness and safety of Trastuzumab Deruxtecan T-DXd in patients with unresectable or metastatic HER2-positive or HER2-low breast cancer. This observational study focuses on patients who have previously received anti-HER2 treatments or systemic therapy and aims to understand treatment outcomes, patient characteristics, and tolerability over time. The study is sponsored by Daiichi Sankyo and collects detailed clinical and patient-reported data to provide insights into treatment patterns and safety. Participants are grouped into two cohorts those with HER2-positive breast cancer who have had one or more anti-HER2 regimens, and those with HER2-low breast cancer who have received prior systemic therapy or experienced early recurrence after adjuvant chemotherapy. All participants are starting or have recently started T-DXd treatment according to approved labeling in China. The study observes these patients from the start of treatment until study end, death, withdrawal, loss to follow-up, or closure. During the study, researchers will track time to next treatment or death, treatment duration, dosing changes, safety events, and patient-reported tolerability using questionnaires and symptom diaries. Follow-up lasts up to 36 months with ongoing data collection on clinical characteristics, treatment patterns, and safety management. This design allows for a comprehensive view of how T-DXd performs in routine clinical practice for this patient population.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

Researchers are studying the safety, tolerability, and preliminary effectiveness of a drug called HB0025 combined with chemotherapy in patients with advanced solid tumors, including non-squamous and squamous non-small cell lung cancer NSCLC and advanced endometrial cancer EC. This multicenter Phase IbII clinical trial involves dose escalation to find the maximum safe dose and dose expansion to evaluate the drugs effects. The study aims to understand how well HB0025 works with chemotherapy in these patients, particularly those who have limited treatment options or have experienced disease progression after previous therapies. The trial has two main phases Phase Ib focuses on dose escalation using a 33 method to determine the maximum tolerated dose and dose-limiting toxicities of HB0025 combined with fixed doses of chemotherapy drugs, including pemetrexed, carboplatin, and paclitaxel. After initial evaluation, patients may continue multiple cycles of combined treatment followed by maintenance therapy with HB0025 alone or combined with pemetrexed, depending on their cancer type. Phase II expands the study with multiple cohorts receiving specific doses of HB0025 combined with chemotherapy to further assess safety and preliminary efficacy, with approximately 40 subjects per cohort. Participants will undergo treatment cycles every three weeks, with evaluations including tumor assessments, laboratory tests, and monitoring for side effects. Researchers will measure outcomes such as objective response rate, disease control, overall survival, progression-free survival, and treatment-related adverse events over up to 24 months. Safety and response will be closely monitored throughout the trial, with treatment continuing until disease progression, unacceptable toxicity, withdrawal, or study completion. This study provides ongoing follow-up to evaluate the drugs impact and tolerability in advanced cancer patients.

Researchers are evaluating the safety and effectiveness of the J-VALVE Transcatheter Aortic Valve Replacement TAVR compared to traditional Surgical Aortic Valve Replacement SAVR in patients aged 65 and older with severe aortic regurgitation Grade 3. This study aims to determine which method better manages this heart valve condition, focusing on important health outcomes such as survival and hospital readmissions. Participants will be randomly assigned to receive either the J-VALVE Transfemoral Aortic Valve system through a catheter-based procedure or a commercially available surgical biological aortic valve replacement device through open-heart surgery. Both approaches are performed by specialized heart teams, and treatment suitability is assessed carefully before enrollment. During the study, participants will be closely monitored for up to 12 months to track outcomes like mortality, stroke, and unplanned cardiac hospitalizations. Additional assessments within 30 days will include heart rhythm changes, valve function via echocardiography, quality of life questionnaires, and hospitalization length. Follow-up visits and evaluations will ensure comprehensive safety and effectiveness data collection throughout the trial 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 studying a new targeted CAR-T cell therapy called RD06-05 for adults with active autoimmune diseases including systemic lupus erythematosus SLE, systemic sclerosis SSc, ANCA-associated vasculitis AAV, idiopathic inflammatory myopathies IIM, neuromyelitis optica spectrum disorder NMOSD, multiple sclerosis MS, and myasthenia gravis MG. This early-phase clinical trial aims to evaluate the safety, tolerability, how the body processes the therapy, and its effects in these patients. The study is sponsored by Nanjing Bioheng Biotech Co., Ltd. Participants will receive RD06-05 CAR-T cell injections given intravenously after a preparatory lymphodepleting treatment with fludarabine and cyclophosphamide. The study includes careful monitoring over a two-year period to observe adverse events and other outcomes related to the treatment. The trial does not use placebo or masking, and all participants receive the experimental therapy. During the study, patients will undergo regular assessments including laboratory tests for liver, kidney, blood, and coagulation function, oxygen saturation, and heart function via echocardiography. Women of childbearing potential will have pregnancy tests and must use effective contraception. Researchers will track treatment safety by recording adverse events and will evaluate clinical disease activity using established criteria specific to each autoimmune condition. Participant involvement may last at least two years to monitor long-term effects and safety.

Researchers are studying TQC2731 injection, a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin TSLP to block its pathway and reduce inflammation. This clinical trial focuses on patients with chronic rhinosinusitis with nasal polyps CRSwNP to evaluate the safety and effectiveness of TQC2731 injection. Participants will receive either TQC2731 injection or a placebo in treatment cycles lasting 4 weeks. The study is randomized, double-blind, and placebo-controlled, with repeated treatment cycles. The effects on nasal polyp size and nasal congestion will be assessed over a 24-week period, with additional measures taken up to 60 weeks. During the trial, participants will undergo nasal endoscopy to score nasal polyps and congestion, complete symptom questionnaires, and have blood and nasal tissue samples collected at various points. Safety monitoring includes tracking adverse events and immune response tests. The study duration extends to 60 weeks to evaluate long-term outcomes and treatment impact.

The trial investigates the occurrence of cough caused by opioid drugs during the induction of general anesthesia in patients planned for tracheal intubation. It compares two drugs, Tegilerdine and Sufentanil, to understand their effects on triggering coughs shortly after administration. This randomized, controlled study aims to provide insight into opioid-induced cough reactions in this surgical context. Participants are randomly assigned to receive either Tegilerdine at doses of 20-50 gkg or Sufentanil at doses of 0.2-0.4 gkg intravenously before anesthesia induction. Routine monitoring such as blood pressure, ECG, and oxygen saturation is conducted before drug administration. Cough episodes are recorded two minutes after the study drug injection, and anesthesia proceeds thereafter. The study uses a double-blind approach to ensure unbiased results. During the trial, participants are monitored for their cough response graded by frequency and duration. Blood pressure and heart rate are measured at multiple timepoints before and after drug injection and intubation. Adverse reactions are also recorded two minutes after drug administration. The primary outcome measures the incidence of cough 2 minutes after drug injection. The total participation timeframe includes the anesthesia induction period and immediate monitoring post-administration.