Zhang Jia Kou Shi

Researchers are collecting data on 10,000 patients aged 12 years and older with primary headache disorders and medication-overuse headache in the China HeadAche DIsorders RegiStry (CHAIRS). The study examines biomarkers, brain imaging features, cognitive abilities, genetic characteristics, social and demographic details, medical history, treatments used, and outcomes related to headache disorders, with planned long-term follow-up. Participants include groups with episodic migraine, chronic migraine, medication-overuse headache, new daily persistent headache, and other primary headache types. Some participants receive behavioral follow-up, while others using medications like Yangxue Qingnao Granules or biological treatments such as eptinezumab or erenumab are observed during a 12-week period where treatment decisions and dosing are made by their physicians as part of routine care. Throughout the study, participants undergo assessments including headache frequency, brain MRI changes, cognitive tests like the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Exam (MMSE), genetic analysis, and evaluations of disability, anxiety, and depression over long-term periods up to 10 years. Short-term outcomes such as pain relief two hours after medication are also measured. Follow-up visits may continue annually after the initial 24 months, with data collected during routine clinical visits.

Researchers are conducting a multicenter, open-label, Phase II clinical trial to evaluate the safety and effectiveness of TQH2722 injection for treating seasonal allergic rhinitis. This study aims to enroll between 200 and 300 adults aged 18 to 75 who have a history of poor symptom control or dissatisfaction with symptom management during previous pollen seasons and have confirmed sensitivity through allergen testing. The study intervention involves administering TQH2722 injection, a humanized monoclonal antibody targeting the interleukin-4 receptor alpha (IL-4Rα), combined with background therapy. Participants will receive this drug during the study period, with close monitoring for safety and efficacy outcomes. Participants will be assessed for adverse events from baseline up to 4 weeks, including regular symptom scoring and compliance checks. The study includes evaluations of symptom control using standardized scores, stability of any comorbid asthma, and adherence to contraceptive measures. Safety monitoring and data collection will be conducted throughout the study duration to understand the treatment's impact.

Researchers are evaluating the effectiveness and safety of TQC2731 injection, a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP) to block its pathway and reduce inflammation. The study focuses on adults aged 18 to 75 years with chronic rhinosinusitis and nasal polyps (CRSwNP), a condition involving persistent nasal symptoms and polyps in both nostrils. This is a Phase III clinical trial designed to assess improvements in nasal polyp size and nasal congestion over 24 weeks. Participants will be randomly assigned to receive either TQC2731 injection or a placebo. The study involves monitoring the nasal polyp score (NPS) and nasal congestion score (NCS) from baseline through 24 weeks to evaluate changes. Both groups will continue using a stable dose of intranasal corticosteroids during the study. The trial is double-blind and placebo-controlled, ensuring that neither participants nor researchers know which treatment is given. During the study, participants will undergo nasal endoscopy to assess polyp size and daily or weekly symptom scoring for nasal congestion. Researchers will track adherence to nasal spray use and symptom recording through electronic diaries. Safety will be monitored throughout, and participants will be followed for 24 weeks to measure changes in nasal polyp and congestion scores as primary outcome measures.

This research investigates the impact of having had an induced termination of pregnancy (abortion) on future pregnancy complications and outcomes. The study is designed as a prospective multicenter cohort, focusing on women who have experienced an early pregnancy abortion (before 12 weeks of gestation). The goal is to understand how prior induced abortions might affect reproductive health and abortion-related outcomes. Participants include women who have undergone induced termination of pregnancy, which is defined as voluntarily ending a pregnancy through medical or surgical methods to prevent live birth. The study observes these women over time to evaluate any complications or outcomes in subsequent pregnancies. During the study, participants will be monitored and followed up to assess adverse pregnancy outcomes. Researchers will collect information through follow-up investigations and assess the effects of prior induced abortion on pregnancy health. The study involves obtaining informed consent and maintaining contact with participants, with the total study duration covering the time needed for pregnancy outcome evaluation.

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 efficacy and safety of Yangxinshi tablets in patients with coronary heart disease complicated by cardiac dysfunction. This Phase 4 randomized controlled trial aims to determine whether adding Yangxinshi tablets to conventional treatment can reduce ischemic or heart failure-related clinical events, improve exercise tolerance, and enhance quality of life and mental health in these patients. The study includes 2708 patients aged 40 to 80 years with specific heart conditions and symptoms. Participants are randomly divided into two groups: one group receives conventional treatment plus Yangxinshi tablets (3 tablets, three times daily), while the control group receives only conventional treatment without additional tablets. Conventional treatment includes drugs such as aspirin, beta-blockers, statins, and others aimed at improving outcomes and relieving symptoms. The treatment continues until the expected number of endpoint events occurs or the study ends. During the study, participants are monitored for ischemic events or heart failure-related clinical events, including death, stroke, myocardial infarction, and hospital readmissions. The average follow-up period is about three years. Researchers assess exercise tolerance, quality of life, and mental health, while monitoring safety and overall health status throughout the study.

Chronic kidney disease (CKD) is a serious health concern, with primary glomerulonephritis being a leading cause in 50% to 60% of cases. This research aims to evaluate the safety and effectiveness of Huaiqihuang Granule, a traditional Chinese herbal medicine, in treating patients with stage 3 CKD caused by primary glomerulonephritis. The study is a phase 4, multicenter, randomized, double-blind, positive-drug controlled trial conducted across about 40 top hospitals in China. Participants will be randomly assigned to receive either Huaiqihuang Granules or Valsartan capsules. The Huaiqihuang group will take 2 bags of granules three times daily, while the Valsartan group will take 80 mg capsules once daily, with each group receiving a simulant of the other drug to maintain blinding. All medications are taken orally over a treatment period of 48 weeks, with follow-up visits scheduled at weeks 0, 8, 16, 24, 32, 40, and 48. During the study, participants will be monitored through regular visits to assess kidney function and overall health. The main outcome measured is the rate of change in estimated glomerular filtration rate (eGFR) from the start to week 48. The study also tracks safety and adherence, ensuring participants meet the eligibility requirements and receive ongoing evaluation throughout the nearly one-year participation period.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.