Huai An Shi

Hepatitis B virus (HBV) infection is a major global health concern, with chronic infection increasing the risk of liver cirrhosis, liver cancer, and death. Researchers aim to better understand which factors influence the long-term outcomes of chronic HBV infection in a broad group of Chinese patients. This study is an observational cohort designed to collect detailed data on epidemiology, clinical status, biology, virology, immune response, and treatments to identify these important factors. Participants with chronic HBV infection, defined by positive hepatitis B surface antigen (HBsAg) for at least 6 months, will be included in this real-life cohort. There are no specific treatment interventions or experimental therapies involved, as the study focuses on observing and collecting comprehensive patient data over time. During the study, researchers will track patient health outcomes for up to 20 years, including loss of viral antigens (HBeAg and HBsAg), development of liver cirrhosis, liver failure, liver cancer (hepatocellular carcinoma), and mortality. The long-term follow-up will involve monitoring clinical and laboratory parameters to understand disease progression and outcomes in this patient population.

Researchers are evaluating the safety, tolerability, and preliminary effectiveness of the ZRMT regimen (Zanubrutinib, Rituximab, Methotrexate, Temozolomide) with or without autologous stem cell transplantation (ASCT) followed by zanubrutinib maintenance in treating newly diagnosed primary central nervous system lymphoma (PCNSL), a rare and aggressive form of diffuse large B-cell lymphoma. PCNSL has a poor prognosis with current treatments, and this study aims to find a low-toxicity, effective therapy for patients, including those who may not be eligible for ASCT due to age or frailty. Participants will receive the ZRMT induction treatment consisting of zanubrutinib 160 mg twice daily orally, rituximab 375 mg/m2 intravenously on day 7, methotrexate 3-3.5 g/m2 intravenously on day 1, and temozolomide 100 mg orally on days 1 to 5. This will be administered over 6 to 8 cycles. Patients who respond with partial response or better may choose to undergo ASCT if eligible. After transplantation or if ASCT is not performed, participants will continue zanubrutinib monotherapy at 160 mg twice daily for up to two years or until disease progression, death, or intolerable side effects. During the study, participants will be monitored for overall response rate, complete response, duration of response, progression-free survival, and overall survival over one year from treatment start. Researchers will assess safety, tolerability, and treatment effects through clinical visits, laboratory tests, and imaging. The total participation period includes induction treatment, possible ASCT, and long-term maintenance with zanubrutinib, with close monitoring to evaluate treatment outcomes and patient well-being.

Researchers are evaluating the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) injection for treating upper limb spasticity in adults with unilateral hemiplegia caused by stroke. This randomized, double-blind, multi-center phase II/III study focuses on adults aged 18 to 75 years who have experienced at least 3 months since stroke onset and exhibit functional impairments in hygiene, dressing, limb position, or pain due to spasticity. Participants will receive a single intramuscular injection of either Recombinant Botulinum Toxin Type A (YY001) at doses between 200 to 400 units, BOTOX® at 200 units, or a placebo prepared with 0.9% Sodium Chloride. The study monitors effects at 4 weeks after treatment, comparing the changes in muscle tone using the Modified Ashworth Scale among the groups. During the study, participants' disability levels, treatment adherence, and any side effects will be assessed. Oral antispasticity medication and physical or occupational therapy, if ongoing, must be stable before enrollment. Safety monitoring includes exclusion of individuals with allergies to study drugs, recent botulinum toxin use, fixed limb contractures, or other medical conditions that increase risk. The study spans screening, treatment, and follow-up to ensure thorough evaluation of outcomes and safety.

Researchers are studying stroke patients with large vessel blockage in the brain to see if a simpler imaging method can effectively select patients for a procedure called thrombectomy. This trial compares the usual detailed imaging approach using CT perfusion or MRI with a simpler method using only NCCT and CTA scans. The goal is to find out if this simpler imaging is as good as the standard method in helping patients achieve favorable outcomes after treatment. Participants will be randomly assigned to one of two groups. One group will be screened using the simplified imaging strategy involving NCCT and CTA scans, while the other group will undergo the standard screening that includes NCCT-ASPECTS, CTA, and CT perfusion imaging. Both approaches are used to decide eligibility for endovascular treatment to remove the blood clot. The study includes patients arriving within 24 hours of stroke onset and uses imaging to guide treatment decisions. During the study, patients will be assessed for clinical outcomes 90 days after the thrombectomy procedure to determine treatment success. Researchers will monitor stroke severity, functional recovery, and safety. Follow-up evaluations will ensure data on patient progress and any complications are collected. Participation involves initial imaging screening, treatment if eligible, and follow-up visits lasting at least 90 days post-treatment to measure results and recovery.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are conducting an open-label, multicenter Phase III clinical trial to study the long-term safety and effectiveness of multiple treatments using recombinant botulinum toxin type A (YY001) injections in adults with upper limb spasticity. This condition mainly affects adults who have unilateral hemiplegia caused by stroke occurring at least three months before joining the study. Participants must have a certain level of disability in one of the functional areas such as hygiene, dressing, limb position, or pain. The trial involves intramuscular injections of recombinant botulinum toxin type A (YY001) prepared by mixing a powder with 0.9% sodium chloride. Each treatment dose ranges from 200 to 400 units. Multiple treatments will be administered over the study period to evaluate the sustained effects and safety of the drug. Participants will be closely monitored for up to 48 weeks to track any adverse or serious adverse events. Researchers will assess safety and efficacy through regular evaluations during this time. The study includes adults aged 18 to 75 years with upper limb spasticity after stroke, and it excludes individuals with certain medical conditions or prior treatments that could affect the study results or participant safety.

Researchers are evaluating the effectiveness and safety of efgartigimod given through intravenous infusion in adults with primary immune thrombocytopenia (ITP), a condition characterized by low platelet counts. This Phase 3 trial includes participants who have had ITP for over a year and have previously received treatments like corticosteroids or immunoglobulins but had insufficient responses. The study aims to measure disease control by tracking the number of weeks during which platelet counts remain at or above 50 x 10^9/L over a 24-week treatment period. After a screening period of up to 2 weeks, participants are randomly assigned in a 2:1 ratio to receive either efgartigimod IV or a placebo IV during a 24-week double-blinded treatment period. Following this, all participants enter a 52-week open-label treatment phase where everyone receives efgartigimod IV. Those who complete this phase may continue for an additional 52 weeks in a second open-label treatment period. After finishing these treatment phases, participants undergo an approximately 8-week follow-up period without the study drug. Throughout the study, participants will have their platelet counts regularly monitored to assess the extent of disease control. Researchers will also evaluate safety and monitor participants for any medical conditions that might affect the study results or their well-being. The total duration of participation can be up to 138 weeks, including screening, treatment, and follow-up periods.

Researchers are comparing the effectiveness of two treatments for participants with stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC) who have PD-L1 expression of 1% or higher. This phase 3, randomized, open-label study focuses on first-line treatment options and aims to evaluate overall survival over up to five years for participants with PD-L1 levels between 1% and 49%. The trial involves participants with measurable disease and good performance status who have not received prior systemic therapy for advanced disease. The study compares a combination of Nivolumab and Relatlimab plus chemotherapy against Pembrolizumab plus chemotherapy. Chemotherapy drugs include Carboplatin, Pemetrexed, and Cisplatin, administered at specified doses on scheduled days. Participants are randomly assigned to receive either the Nivolumab and Relatlimab combination with chemotherapy or Pembrolizumab with chemotherapy as their initial treatment. Treatment schedules and doses are defined but not detailed here. Participants will be closely monitored throughout the study, which may last up to five years. Researchers will assess overall survival as the primary outcome, along with regular imaging tests like CT or MRI to measure disease status. Eligibility screening includes assessing PD-L1 levels, performance status, and other health factors. Safety monitoring and follow-up will continue to evaluate treatment effects and participant well-being during and after treatment.

Researchers are investigating the safety and effectiveness of several new treatments, with or without pembrolizumab and chemotherapy, for adults with advanced esophageal squamous cell carcinoma who have previously received PD-1/PD-L1 based therapies. This Phase 1/2 multicenter, randomized, open-label study focuses on participants whose cancer has progressed after one prior standard treatment including a platinum agent and PD-1/PD-L1 immune therapy. The study aims to better understand how these investigational agents perform in this specific patient group. Participants may receive different combinations of treatments including intravenous infusions of pembrolizumab, MK-4830, paclitaxel, irinotecan, and sacituzumab tirumotecan, as well as oral lenvatinib daily. The dosages and schedules vary, for example, paclitaxel is given on days 1, 8, and 15 every 28 days, while irinotecan is administered every 14 days. Supportive care and medications such as antihistamines, corticosteroids, and acetaminophen are allowed to manage side effects. Some arms of the study involving pembrolizumab plus MK-4830 with paclitaxel/irinotecan or lenvatinib are no longer enrolling. During the study, participants will be monitored for adverse events and dose-limiting toxicities, especially during an initial safety lead-in phase of about three weeks. Researchers will also track treatment discontinuation due to side effects and measure the tumor response over up to 48 months. Assessments include clinical evaluations, imaging, and tissue sample analyses. The study is designed to gather detailed safety and efficacy data to inform future treatment options for esophageal cancer patients.