Luo He Shi

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 whether stopping oral anticoagulant medication after a successful atrial fibrillation ablation can lower bleeding risks without increasing the chances of death or blood clots. This randomized, open-label trial involves adults aged 18 to 80 years who are between 60 and 365 days post-ablation, have a specific risk score of 2 or higher, no prior stroke or embolism, continuous use of certain anticoagulants, and no signs of recurring atrial arrhythmia. Participants are randomly assigned to either stop their anticoagulant medication immediately or continue taking it according to guidelines. All participants undergo close heart rhythm monitoring using a smartwatch capable of single-lead ECG and scheduled Holter or ECG patch monitoring at least every six months, with encouraged monitoring every two months. If any recurrence of atrial arrhythmia is detected, participants exit the trial. Study visits occur at months 3 and 6 after randomization, then every six months, with additional follow-ups every two months. Throughout the study, researchers collect data on serious outcomes including death, stroke, systemic embolism, and bleeding events for up to 48 months. They also assess quality of life, anxiety, depression, and atrial fibrillation recurrence through questionnaires. The study includes a planned 4,100 participants and is sponsored by Beijing Anzhen Hospital, aiming to provide detailed safety and effectiveness information on anticoagulation management after atrial fibrillation ablation.

Researchers are evaluating the traditional Chinese medicine Yufeng Ningxin for its potential to lower blood pressure in patients with hypertension. This randomized, double-blind, placebo-controlled trial aims to rigorously assess the effectiveness and safety of Yufeng Ningxin tablets in adults aged 18 to 65 years with newly diagnosed or treated hypertension. The study is led by Beijing Anzhen Hospital and will provide important data to better understand this treatment. Participants will be randomly assigned to receive either Yufeng Ningxin tablets or a placebo. Both groups will take 5 tablets per dose, three times daily, for 8 weeks. Yufeng Ningxin tablets contain 0.28 g per tablet. The study includes a comparison of these two groups over the treatment period to determine the effects on blood pressure and other health measures. During the trial, participants will have their blood pressure measured in the office and by 24-hour ambulatory monitoring at the start and after 8 weeks of treatment. Researchers will also assess headache impact, gut microbiota changes, blood lipid levels, blood sugar, and safety outcomes including hospitalizations and adverse events. The total participation time is about 8 weeks of treatment with monitoring throughout this period.

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 evaluating Shuxuening injection, a multi-target neuroprotective agent, to see its effects when added to intravenous thrombolysis therapy in patients with acute ischemic stroke. This large, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness and safety of Shuxuening injection in improving outcomes after stroke. Intravenous thrombolysis with rt-PA is the current standard treatment, but many patients still experience significant disability, so neuroprotective agents like Shuxuening may help reduce brain cell death. Participants will be randomly assigned to one of two groups one group will receive Shuxuening injection combined with intravenous thrombolysis, and the other will receive a placebo combined with intravenous thrombolysis. Both treatments involve a daily intravenous drip of 20 ml Shuxuening or placebo plus 250 ml of 0.9% sodium chloride for 10 to 14 days. The study plans to enroll 1380 patients within 6 hours of stroke onset from 50 centers across China. During the study, participants will be monitored closely with assessments including the modified Rankin Scale mRS score at 90 days to measure functional recovery, along with safety monitoring for adverse events over 90 days. Other evaluations include neurological function scores, quality of life surveys, and various safety outcomes. The trial will last for at least 90 days after treatment, with data collected on disability, recovery, and any side effects experienced.