Luo He 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.

Primary liver cancer, particularly hepatocellular carcinoma (HCC) at BCLC stage C, is a common and serious cancer where many patients are not eligible for surgery due to advanced disease. Researchers are evaluating the effectiveness and safety of two treatments: drug-eluting bead transarterial chemoembolization (DEB-TACE) alone versus DEB-TACE followed by hepatic artery infusion chemotherapy (HAIC). This study aims to see if combining these treatments provides better outcomes for patients with unresectable advanced liver cancer. The trial compares two groups: one receiving DEB-TACE alone and the other receiving DEB-TACE followed by sequential HAIC using a FOLFOX-based chemotherapy regimen. DEB-TACE uses drug-loaded beads to block tumor blood supply and release chemotherapy slowly, while HAIC delivers chemotherapy directly into the liver artery. This combination is designed to enhance the anti-tumor effect while potentially reducing side effects. Treatment is administered in a multi-center setting with careful monitoring. Participants will be monitored from the first DEB-TACE treatment up to 36 months or until disease progression or death. Assessments include imaging scans to evaluate tumor response according to mRECIST criteria, laboratory tests, and safety evaluations. Researchers will measure progression-free survival, which is the time without tumor growth or death. Participants must cooperate with treatment, complete scheduled visits, and provide informed consent, with an estimated life expectancy of at least 3 months.

Researchers are investigating the safety and effects of stopping oral anticoagulation treatment after successful catheter ablation in adults with atrial fibrillation or atrial flutter. The study enrolls adults aged 18 to 80 years who are between 60 and 365 days post-ablation, have a CHA2DS2-VA score of 2 or higher, no history of stroke or embolism, and no recurrence of atrial tachyarrhythmia. The goal is to evaluate whether stopping anticoagulation reduces bleeding risk without increasing the risk of death, stroke, or systemic embolism. Participants will be randomly assigned to one of two groups: either to stop their non-vitamin K antagonist oral anticoagulant (NOAC) medication immediately or to continue standard NOAC therapy. All participants will use intensified rhythm monitoring with a smartwatch that records single-lead ECGs and scheduled Holter or ECG patch monitoring at least every six months, with encouragement for every two months. If atrial tachyarrhythmia recurrence is detected, participants will exit the study follow-up. During the study, participants will have structured visits at months 3 and 6 after randomization, then every six months, alongside additional rhythm and anticoagulation follow-up every two months. Researchers will monitor for outcomes including all-cause death, ischemic stroke, systemic embolism, and major or clinically relevant bleeding events over 48 months. The study plans to enroll about 4,100 participants to assess safety and outcomes of the anticoagulation discontinuation strategy.

Researchers are conducting a multicenter, prospective, observational real-world study across 200 hospitals in China to examine treatment patterns for chronic hepatitis B (CHB). The study aims to compare patient outcomes under various therapies to provide evidence-based data that can help optimize CHB treatment and follow-up, with the ultimate goal of advancing a functional cure for chronic hepatitis B. The focus includes monitoring the incidence of hepatocellular carcinoma (HCC) associated with hepatitis B. Participants receive treatments including entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF), or Peginterferon α-2b injection. The study follows both patients currently on these therapies and those initiating or re-initiating Peginterferon α-2b therapy. These treatments are assessed in routine clinical practice settings without intervention from the study team. Throughout the study, patients are monitored from week 4 up to week 240 for the development of HBsAg-associated hepatocellular carcinoma (HCC) and overall HCC incidence. Researchers collect data on treatment effectiveness and safety as part of the observational follow-up. Participants provide informed consent and are observed under real-world conditions to evaluate long-term outcomes and risks associated with chronic hepatitis B and its treatments.

Researchers are evaluating the efficacy and safety of Shuxuening injection as an additional treatment to intravenous thrombolysis in patients with acute ischemic stroke. This multicenter, randomized, double-blind, placebo-controlled phase 3 trial involves patients aged 18 to 100 years who have experienced an ischemic stroke and can be treated within 6 hours of symptom onset. The study aims to improve functional outcomes by reducing brain cell death after stroke using this multi-target neuroprotective agent alongside the standard clot-busting therapy. Participants are randomly assigned in a 1:1 ratio to receive either Shuxuening injection or a placebo. Both groups receive a daily intravenous drip of 20 ml of the study drug or placebo combined with 250 ml of 0.9% sodium chloride injection for 10 to 14 days. The treatment starts as soon as possible after intravenous thrombolysis therapy, and the study compares these two groups to assess differences in recovery and safety. During the trial, researchers will monitor participants for 90 days after randomization. They will assess the primary outcome by measuring the proportion of patients achieving a modified Rankin Scale (mRS) score of 0 to 1, indicating good functional recovery. Safety will be evaluated by tracking adverse events over the same 90-day period. Participants will be closely followed with clinical evaluations to understand the effects and tolerability of Shuxuening injection in stroke recovery.