Shen Yang Shi

Researchers are evaluating the use of three-dimensional magnetic resonance elastography (3D MRE) to measure the stiffness and adhesion of meningioma tumors before surgery. This study aims to see if these MRE measurements can predict what surgeons will find during tumor removal and how the tumor's characteristics relate to its behavior and pathology. The goal is to improve surgical planning and risk assessment for patients with meningioma, a common type of brain tumor. Participants will receive a standard brain MRI along with a 3D MRE scan using a 60 Hz vibration frequency to create detailed maps of tumor stiffness and adhesion. These imaging results will be shared with the surgical team to help guide the operation. During surgery, doctors will carefully assess the tumor's stiffness, adhesion, blood supply, and difficulty of removal using a standardized scale. The study will then compare these intraoperative findings with the MRE data and the tumor's pathology after surgery. About 300 patients scheduled for meningioma removal will take part. They will undergo imaging tests before surgery, and their tumors will be evaluated during and after surgery. Researchers will collect information on tumor characteristics, surgical challenges, and histological features. The study will analyze how well preoperative MRE predicts tumor behavior and surgical outcomes, aiming to support MRE as a noninvasive tool for better surgical decisions and improved patient care.

Researchers are investigating a new, non-invasive way to predict the hepatic venous pressure gradient (HVPG) to better manage portal hypertension in people with cirrhosis. This study focuses on comparing two imaging techniques: three-dimensional magnetic resonance elastography (3D-MRE) and two-dimensional magnetic resonance elastography (2D-MRE), aiming to establish a risk system to guide personalized treatment for portal hypertension associated with cirrhosis. Cirrhosis and portal hypertension pose significant health risks, and current gold standard diagnostic methods like HVPG are invasive and less practical for routine use. The study uses 3D-MRE and 2D-MRE imaging performed on a 3.0-Tesla MRI system to measure liver tissue properties. These imaging studies are done within one month before HVPG measurements, which are conducted by trained interventional radiologists following standard procedures. The goal is to see how well these imaging methods predict portal hypertension and cirrhosis severity compared to the invasive HVPG measurement. Participants will undergo both types of MRI elastography scans and HVPG testing. Researchers will assess the accuracy of 3D-MRE and 2D-MRE features over a 12-month period to determine their usefulness in evaluating portal hypertension. The study involves clinical evaluations, imaging assessments, and monitoring of patients' liver health to develop a reliable, less invasive tool for managing cirrhosis and portal hypertension.

Researchers are evaluating a new, non-invasive method using three-dimensional magnetic resonance elastography (3D-MRE) to predict hepatic venous pressure gradient (HVPG) for managing portal hypertension in cirrhosis and advanced chronic liver disease. This study addresses the need for a convenient and accurate alternative to invasive HVPG measurements, aiming to establish a risk stratification system and tailored management for patients with liver cirrhosis, which is a major health concern in China due to viral, alcoholic, and metabolic-related liver diseases. The study uses 3D-MRE imaging performed on a 3.0-T MRI system with a phased-array body coil to assess liver tissue properties. HVPG measurements are conducted by trained interventional radiologists following standard procedures. Participants undergo both 3D-MRE and HVPG assessments within one month to compare the methods and explore the mechanical properties of liver tissue as potential surrogates for cirrhosis and portal hypertension. Participants will be involved in imaging and pressure gradient evaluations to monitor portal hypertension. Researchers will collect data on the accuracy of 3D-MRE features in assessing portal hypertension over 12 months. The study includes various assessments such as liver imaging and HVPG measurement, focusing on safety and reliability of these diagnostic tools for better patient prognosis and management.

Researchers are conducting a prospective follow-up study on adult patients newly diagnosed with or relapsed Graves' disease at the Endocrinology Clinic of the First Affiliated Hospital of China Medical University. The study aims to determine the relapse and remission rates of Graves' disease treated with drugs, explore risk factors for relapse, and develop risk prediction software. It will also compare the effects of high and low doses of methimazole on remission rates and adverse reactions, investigate the role of TRAb in diagnosis and recurrence prediction, and analyze changes in serum alkaline phosphatase during treatment. The study involves treating participants with methimazole, adjusting doses based on the 2016 American Thyroid Association guidelines. Patients will undergo regular thyroid function, liver function, TRAb, and blood routine tests during outpatient follow-up visits to monitor treatment effects and guide medication use. The investigation focuses on evaluating side effects such as liver damage and leukopenia related to methimazole treatment. Participants will be followed prospectively over 30 years to monitor relapse and remission outcomes as well as adverse effects. Researchers will collect data on thyroid function, serum markers, and treatment safety throughout this period. The long-term monitoring includes assessments of liver side effects, leukopenia, and the dynamic changes of serum alkaline phosphatase in relation to thyroid function, ensuring comprehensive evaluation of the drug therapy for Graves' disease.

Researchers are evaluating anti-HER2-CAR-T cell therapy in patients aged 18 to 70 with HER2-positive locally advanced or metastatic solid tumors, including breast, gastric, colorectal, and pancreatic cancers. This Phase 1, single-center, open-label study aims to assess the safety and effectiveness of this treatment in patients who have not responded to or cannot tolerate conventional therapies. Participants must have measurable tumors, adequate organ function, and an expected survival of at least 12 weeks. Participants receive a single intravenous infusion of anti-HER2-CAR-T cells at doses of 1x10^6, 3x10^6, or 1x10^7 CAR-positive cells per kilogram. Additional infusions may be given at the investigator's discretion. Before treatment, patients undergo screening, peripheral blood mononuclear cell collection, possible bridging therapy, and lymphocyte clearance. The study follows a 3+3 dose escalation design to determine safe dosing. Throughout the study, participants are closely monitored for dose-limiting toxicities within 21 days after infusion. Researchers evaluate treatment safety and effectiveness by assessing tumor response, organ function, and adverse events. The study includes regular clinical assessments, laboratory tests, and imaging to track progress and ensure patient safety. Total participation length depends on treatment and follow-up schedules determined by the study team.

Researchers are evaluating the safety and effectiveness of a drug called B001 injection in patients who have neuromyelitis optica spectrum disorder (NMOSD) and test positive for aquaporin-4 antibodies. This study is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial designed to compare B001 with a placebo in this patient population. The goal is to assess whether B001 can reduce the time to the first NMOSD attack during the study period. Participants will receive either an intravenous dose of B001 or a matching placebo on Day 1 and Day 15 during the randomized controlled period (RCP). Both treatment groups follow the same dosing schedule to evaluate the effects of B001 compared to placebo over approximately 48 weeks. During the study, participants will be closely monitored through regular assessments to track any NMOSD attacks and overall health. Researchers will measure the time to the first NMOSD attack as the primary outcome. Safety and any side effects of the treatment will also be evaluated throughout the study period. Participants are expected to complete all required tests and follow study procedures as part of their involvement.

Researchers are evaluating the efficacy and safety of a drug called B007 compared to Cyclosporin in treating Primary Membranous Nephropathy, a kidney condition confirmed by biopsy. This study is a multicenter, randomized, controlled, open-label trial in phase II/III, focusing on patients aged 18 to 80 years with certain kidney function levels and proteinuria. Participants will receive either B007 via subcutaneous injections on days 1 and 15 or oral Cyclosporin capsules dosed at 3.5 mg per kg per day. The study includes screening to confirm eligibility, treatment administration, and monitoring for approximately two years to evaluate overall remission rates. Throughout the trial, participants will be monitored with laboratory tests to meet study standards and ensure safety. Researchers will assess kidney function, protein levels in urine, and remission rates over about two years. Safety will be followed closely, including checking for allergies, infections, and adherence to the treatment protocol.

Researchers are investigating HMPL-506, an oral drug, in a Phase 1 clinical study for patients with hematological malignancies such as relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and multiple myeloma (MM). The study has two phases: dose escalation and dose expansion, aiming to determine the safest and most effective dose. Approximately 60 to 132 patients are expected to participate, including those with specific genetic mutations or rearrangements related to these blood cancers. In the dose escalation phase, patients receive increasing doses of HMPL-506 orally once daily in 28-day cycles to identify the maximum tolerated dose and recommended Phase 2 dose. Initial doses start at 50 mg daily, with potential escalation based on safety and efficacy data. The dose expansion phase enrolls patients into three cohorts based on disease type and genetics, treating them with the recommended dose in 28-day cycles until disease progression, intolerable side effects, or other defined reasons to stop. Participants will undergo regular safety monitoring, including evaluation of dose-limiting toxicities, serious adverse events, and response to treatment. Tumor response is assessed every cycle for the first six cycles and then every two cycles thereafter, with follow-up lasting up to 42 months. Additional assessments include bone marrow biopsies, laboratory tests, and performance status evaluations. The study tracks participants until disease progression, withdrawal, or study completion to evaluate HMPL-506's safety and preliminary effectiveness.

Researchers are conducting an open, multicenter Phase I/II clinical trial evaluating the safety, tolerability, pharmacokinetics, and efficacy of HRS-8364 in adults with advanced solid tumors. The study includes three stages: dose escalation, dose expansion, and efficacy expansion, focusing on patients with tumors that have failed standard treatments or have no standard treatment available. The trial aims to determine the maximum tolerated dose, recommended dose for Phase II, and the incidence and severity of adverse events, as well as the objective response rate. Participants will receive HRS-8364 tablets as a monotherapy or combined treatment depending on the trial stage. The dose escalation stage tests increasing doses to find the maximum tolerated dose. The dose expansion stage further evaluates safety and efficacy in a larger group, including patients who have not previously received immuno checkpoint inhibitors. The efficacy expansion phase focuses on patients with measurable lesions and disease progression despite prior systemic treatments. Treatment is administered over approximately one year, with ongoing monitoring. Participants will be closely monitored from the start of treatment through about one year, with assessments including adverse event tracking, tumor response evaluations, and pharmacokinetic measurements. Follow-ups continue after treatment completion to evaluate safety and treatment effects. The study requires regular clinical visits for examinations, laboratory tests, and imaging to measure tumor changes and patient health status across the trial period.

This research aims to study hyperthyroidism in children by collecting detailed information on diagnosis, treatment, and long-term follow-up. It focuses on understanding the clinical features, treatment effects, side effects, remission, and recurrence after stopping antithyroid drugs. The study also investigates risk factors linked to adverse reactions from antithyroid medications. Children in this study receive methimazole, starting at a dose of 0.2 to 0.8 mg per kilogram per day. The dose is gradually reduced by 25% to 50% and adjusted to keep thyroid hormone levels normal, based on regular blood tests. This is an observational study without additional interventions beyond usual care. Participants are followed over time to track remission, defined as normal thyroid function without methimazole for at least 12 months, and to monitor any side effects such as low white blood cells, liver problems, rash, or muscle pain. The study collects clinical data to analyze treatment outcomes and safety. Follow-up lasts up to 10 years for remission and 1 year for side effect monitoring.