Zhang Jia Kou Shi

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are conducting a large observational study called the China HeadAche Disorders Registry CHAIRS to better understand primary headaches and medication-overuse headaches MOH in patients aged 12 years and older. The study aims to collect detailed information including biomarkers, brain imaging, cognitive and genetic data, as well as social, demographic, medical, and treatment-related data. Long-term follow-up is planned to observe outcomes related to headache disorders over many years. Participants include those with various types of primary headaches such as migraine, tension-type headache, new daily persistent headache, and MOH. The study includes behavioral follow-up visits at multiple time points monthly for the first 18 months, then at 24 months, and annually thereafter. Some participants are observed during routine clinical use of treatments like Yangxue Qingnao Granules, Erenumab, and Eptinezumab, with treatment decisions made by their physicians and outcomes tracked over 12 weeks or longer. Throughout the study, participants undergo periodic assessments including MRI scans, cognitive tests like the Montreal Cognitive Assessment MoCA and Mini-Mental State Exam MMSE, and questionnaires evaluating headache impact, anxiety, depression, quality of life, sleep quality, and fatigue. Data on headache frequency, severity, medication use, and biological samples are collected. Follow-up can extend up to 10 years, allowing researchers to monitor long-term changes and outcomes related to headache disorders and treatments.

Researchers are evaluating the safety and efficacy of TQH2722 injection combined with background therapy in people with seasonal allergic rhinitis. This multicenter, open-label, Phase II clinical trial aims to enroll 200 to 300 adults aged 18 to 75 who have seasonal allergic rhinitis with poor symptom control or dissatisfaction with symptom management during the previous pollen season. Participants will receive TQH2722 injection, a humanized monoclonal antibody targeting interleukin-4 receptor alpha, administered in treatment cycles lasting two weeks. The study is single-arm and open-label, meaning all participants receive the injection combined with their background treatment without placebo comparison. The treatment period is followed by assessments at baseline, 2 weeks, and 4 weeks to monitor nasal and ocular symptoms, quality of life, and laboratory tests. During the study, participants will be monitored for adverse events, serious adverse events, and changes in laboratory indicators up to 4 weeks after baseline. Nasal and ocular symptom scores will be recorded daily and retrospectively assessed at 2 and 4 weeks. Blood tests for eosinophil counts, immunoglobulin E levels, and lung function tests for those with asthma will be conducted up to 12 weeks. Participants must comply with study visits, symptom diaries, and safety evaluations throughout the trial, which continues until March 2027.

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.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

This research aims to evaluate how previous induced termination of pregnancy affects complications and outcomes in later pregnancies. It is a prospective multicenter cohort study focused on reproductive health and abortion. The study seeks to understand the relationship between early pregnancy terminations and future pregnancy risks to improve knowledge in this area. Participants are women who have experienced an induced abortion within the first 12 weeks of pregnancy. The study observes these women over time without providing any experimental treatment, focusing on medical or surgical termination of pregnancy as the prior event. There are no intervention groups as this is an observational study. During the study, participants will be monitored for complications and adverse pregnancy outcomes. Researchers will collect data through follow-up investigations and evaluate pregnancy progress and health status. The primary outcome is adverse pregnancy outcomes reviewed by June 2028, with complications also tracked. Participation includes providing informed consent and cooperating with follow-ups over the study period.

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 safety and effectiveness of Yangxinshi tablets in patients with coronary heart disease combined with cardiac dysfunction. This study aims to determine if adding Yangxinshi tablets to standard treatment can reduce heart-related events, enhance exercise capacity, and improve quality of life and mental health. The trial includes 2708 patients and is a Phase 4 randomized controlled study sponsored by SPH Qingdao Growful Pharmaceutical Co., Ltd. Participants are randomly assigned to one of two groups one group receives conventional treatment plus Yangxinshi tablets 3 tablets taken orally three times a day, while the control group receives conventional treatment alone. Conventional treatment includes drugs such as aspirin, beta-blockers, statins, and others for symptom relief and improving heart outcomes. The treatment continues until a set number of heart-related events occur or the study ends. Throughout the study, participants undergo regular assessments including measurements of heart events, exercise tolerance, heart function tests, blood markers, and mental health questionnaires over an average of three years. Additional evaluations at 24 and 48 weeks include depression and anxiety scales, echocardiography, and exercise testing. The research team closely monitors safety, quality of life, and heart function throughout the study period.

Researchers are evaluating the safety and effectiveness of Qishen Yiqi Dripping Pills for treating adults aged 18 to 80 with chronic heart failure characterized by reduced ejection fraction due to coronary heart disease, specifically involving Qi deficiency with blood stasis syndrome. This phase 3 trial aims to compare these pills with a placebo to understand their impact on this condition. Participants will receive either Qishen Yiqi Dripping Pills or a matching placebo, both taken orally as 2 bags three times a day, half an hour after meals, over a 12-week period. The study uses a randomized, parallel design with quadruple masking to assess the effects. During the 12 weeks, participants will be monitored through various assessments including the 6-minute walk test, echocardiographic measurements, heart failure symptom evaluations, laboratory tests for biomarkers like NT-proBNP, and quality of life questionnaires. Researchers will track changes from baseline at weeks 4, 8, and 12 to evaluate exercise capacity, symptom improvement, heart function, and safety outcomes throughout the study.