Yan Cheng Shi

Researchers are evaluating the dose-effect relationship of TQH3906 capsules compared to placebo in treating active Psoriatic Arthritis PsA. This Phase II, randomized, double-blind, placebo- and active drug-controlled clinical trial aims to measure the proportion of participants achieving a 20% improvement in arthritis symptoms by Week 12, using the American College of Rheumatology ACR20 criteria as the primary endpoint. Participants are randomly assigned to receive one of several oral treatments daily from Day 1 to Day 85 either 24 mg or 16 mg of TQH3906 capsules, placebo capsules matching TQH3906, or 5 mg tofacitinib citrate tablets. The treatments are administered in the morning while fasting, with tofacitinib also taken at bedtime. This study evaluates efficacy and safety across these groups over 12 weeks of treatment. During the study, participants are assessed at multiple timepoints for improvements in arthritis symptoms ACR20, ACR50, ACR70 and psoriasis severity PASI 75 and PASI 90. Blood samples are collected to evaluate drug levels and immune markers at baseline and Weeks 2, 4, 8, and 12. Safety is monitored continuously through adverse event reporting up to 28 days after the last dose. The total study duration per participant is approximately 12 weeks of treatment plus follow-up.

Researchers are comparing two treatment combinations for elderly patients with newly diagnosed multiple myeloma who are not planning to have a stem cell transplant initially. The study evaluates the safety and effectiveness of daratumumab, lenalidomide, and dexamethasone DRd versus a modified combination of bortezomib, lenalidomide, and dexamethasone VRd-lite. The main goals are to see which treatment better delays disease progression and achieves a negative minimal residual disease status. Participants can choose between the two treatments. Daratumumab is given through weekly intravenous infusions initially, then less frequently over several months, combined with oral lenalidomide and dexamethasone taken on specific days in 28-day cycles. The alternative group receives bortezomib injections weekly with the same oral medications on a similar schedule. After the initial treatment cycles, maintenance therapy continues with lenalidomide alone or combined with daratumumab or bortezomib based on risk assessment until disease progression or unacceptable side effects occur. During the study, participants will be regularly monitored for disease progression and safety, with evaluations including progression-free survival and minimal residual disease negativity measured at multiple timepoints over approximately five years. Additional response rates and overall survival will also be tracked. Safety assessments continue throughout the study to ensure participant well-being during treatment and follow-up.

Researchers are studying the safety and effectiveness of TQB2102 for injection in patients with HER2-positive biliary tract cancer. This includes patients with locally advanced or metastatic forms of the disease who have experienced failure of 1-2 prior systemic therapies. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. and spans phases 1 and 2 to evaluate dosing, safety, and immune response. Participants receive TQB2102, a HER2 dual-antibody-drug conjugate, by intravenous infusion every three weeks in cycles of 21 days. Treatment involves 6 to 8 cycles, with ongoing monitoring for adverse events and response to therapy. The study does not use masking or placebo controls. During the trial, participants undergo assessments for tumor response, disease control, survival, and side effects from the time of consent until 28 days after the last dose or the start of a new antitumor therapy. Follow-up includes evaluations up to 36 weeks for outcomes like progression-free and overall survival. Participants also provide tumor tissue samples for HER2 testing and are monitored for immune reactions and safety throughout the study.

Researchers are investigating acute aortic syndrome AAS, a serious and life-threatening heart condition where inflammation plays a significant role in its development and progression. This large observational study involves 20 cardiovascular centers in China collaborating to understand inflammatory responses and anti-inflammatory treatments in patients undergoing surgery for AAS. The study aims to assess how inflammation and anti-inflammatory strategies affect patient outcomes after surgery, including complications and survival. The study enrolls adult patients who have undergone surgery for AAS, which includes various types of aortic injuries such as dissection, penetrating ulcers, or hematomas. Participants may have received medical therapy, open surgery, endovascular repair, or hybrid procedures, sometimes combined with other cardiac surgeries. Data about their inflammatory responses and clinical results are collected through designed forms and analyzed using statistical software. This observational study began in 2016 and will continue enrolling patients until 2040. Participants will be followed over time to evaluate key outcomes like severe inflammatory reactions within 7 days after surgery and operative mortality within 30 days. Researchers will also monitor other complications such as organ dysfunction, stroke, kidney injury, infections, bleeding, and length of intensive care stay. The study gathers detailed information through clinical data collection and monitors these outcomes to better understand and improve management for patients with AAS over the long term.

Researchers are evaluating an allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell UCAR-T therapy targeting CD19 and BCMA to treat adults with refractory systemic lupus erythematosus SLE. This early phase 1 trial aims to understand the safety and effectiveness of this UCAR-T cell product, focusing on its impact on disease activity and remission outcomes in adults with difficult-to-treat SLE. Participants may receive lymphodepletion chemotherapy with fludarabine and cyclophosphamide if clinically needed before receiving a UCAR-T cell infusion delivered intravenously on Day 0. After infusion, participants will stay hospitalized for at least 7 days for close monitoring and remain within two hours of the treatment center for 28 days. Follow-up visits are scheduled at Day 14, Day 28, and at months 3, 6, 9, 12, 18, and 24 post-infusion to assess safety and treatment effects. During the study, researchers will monitor adverse events for up to two months after infusion and track dose-limiting toxicities within 28 days. They will also evaluate changes in disease activity scores, remission rates, and maintenance of drug-free remission over two years. Participants will undergo regular clinical assessments and safety monitoring throughout the study period, which can last up to two years after treatment.

Researchers are investigating the effects of amlodipine alone versus amlodipine combined with folic acid in Chinese adults aged 45 to 74 years who have H-type hypertension, specific MTHFR 677 genotypes CC or CT, elevated plasma homocysteine levels, and low serum folate. This large, multi-center, randomized, double-blind, double-dummy clinical trial aims to evaluate which treatment better reduces the risk of first ischemic stroke over five years. Participants are first screened and then enter a 2 to 4 week run-in period where they take amlodipine to assess tolerance and compliance. Afterward, eligible participants are randomized by genotype into two groups one receiving amlodipine 5mg daily with a placebo, and the other receiving amlodipine 5mg combined with 0.8mg folic acid daily with a placebo. Other blood pressure medications may be added as needed to reach target blood pressure goals. Follow-up visits occur every three months during the five-year treatment period with medication provided at each visit. Throughout the study, participants undergo interviews, clinical evaluations, and laboratory tests including genetic and blood analyses. Researchers monitor adherence, blood pressure, and cardiovascular health. The main outcome measured is the occurrence of first ischemic stroke by the end of five years. Secondary outcomes include other cardiovascular events and kidney function. Two interim analyses will be conducted during the study to assess progress and safety.

Researchers are evaluating the effects of different amlodipine-based treatments on the risk of first ischemic stroke in Chinese adults aged 45 to 74 years with hypertension and the MTHFR 677 TT genotype. This large, multi-center, randomized, double-blind, triple-dummy controlled trial aims to compare amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate over a 5-year period. The study focuses on preventing ischemic stroke as the primary outcome. Participants first undergo a screening period to confirm eligibility through interviews, clinical evaluations, and lab tests. Those who qualify enter a 2 to 4 week run-in phase with daily amlodipine to check treatment tolerance and compliance. Eligible participants are then randomly assigned to one of three daily oral treatment groups amlodipine alone, amlodipine folic acid, or amlodipine folic acid plus 5-MTHF. Additional antihypertensive medications may be added as needed to control blood pressure. Participants are followed every 3 months for drug distribution and monitoring. Throughout the study, participants will have regular clinical visits, interviews, and biological sample collections to monitor health and treatment effects. Researchers will track the incidence of first ischemic stroke and other cardiovascular and kidney outcomes over five years. Safety and treatment adherence are carefully observed, with two planned interim analyses during the trial. Total participation spans from initial screening through five years of treatment and follow-up.

This research aims to explore how 8 weeks of aerobic exercise with synchronized music at different intensities affects psychology, attention, and executive function among Chinese medical college students. It also focuses on validating the reliability and accuracy of Chinese versions of several questionnaires related to stress, life satisfaction, positive thinking, attention, procrastination, and executive function. This work provides a basis for understanding how aerobic exercise might improve cognitive and mental health in this population. Participants are divided into four groups three intervention groups receiving low-, moderate-, or high-intensity aerobic training combined with synchronous music, and a control group without intervention. Each intervention involves exercise sessions lasting 40 minutes, three times per week, for 8 weeks. The intensity of aerobic exercise is defined by MET values and adjusted through treadmill tests. Music tempo is matched to exercise intensity and delivered via headphones. The study design includes cross-sectional and randomized controlled trial parts. Participants will undergo psychological, attentional, and executive function assessments before and after the intervention using questionnaires, smartwatches, and brain imaging with functional near-infrared spectroscopy fNIRS. The study measures psychological function, attention, executive function, and brain connectivity up to 30 weeks. Data on positive thinking skills are also collected. Participation includes a total of 24 exercise sessions over 8 weeks, with ongoing monitoring of brain functional changes and mental health outcomes.

Researchers are evaluating whether adding a half-dose bolus of recombinant staphylokinase r-SAK, a clot-dissolving drug, immediately before primary percutaneous coronary intervention PCI can improve outcomes in patients with acute ST-segment elevation myocardial infarction STEMI treated within 120 minutes. This randomized, double-blind, placebo-controlled trial aims to assess the safety and efficacy of r-SAK in reducing major adverse cardiovascular events within 90 days after treatment. Participants are randomly assigned to receive either a single intravenous bolus of 5 mg r-SAK over 3 minutes or a placebo injection within 10 minutes after STEMI diagnosis. Following this, all patients undergo primary PCI within 30 to 120 minutes. The study is conducted across multiple centers and compares the effects of r-SAK versus placebo as adjunctive therapy before PCI. During the study, participants will be monitored for major adverse cardiovascular events up to 90 days, with additional assessments including cardiac and cerebrovascular events, blood biomarkers NT-proBNP, cardiac imaging by echocardiogram and cardiac magnetic resonance imaging CMR, and blood flow in coronary arteries immediately before and after PCI. Safety and efficacy will also be tracked up to one year. The total participation duration includes follow-up visits at days 7, 90, and 360 after treatment.

Researchers are evaluating the use of colistin in treating infections caused by carbapenem-resistant enterobacteriaceae CRE, specifically in patients with hospital-acquired pneumonia HAP or bloodstream infections in China. This study compares the effectiveness and safety of treatments with and without colistin to understand how well colistin works and its safety profile in these serious infections. The study follows good clinical practice and ethical guidelines, recruiting patients from 14 centers in China. Patients will be randomly assigned to one of two groups. One group will receive colistin-based therapy combined with other antibiotics such as meropenem, tigecycline, or amikacin. The colistin dose starts with a loading dose followed by maintenance doses given intravenously twice daily. The other group will receive the best available treatment without colistin, including combinations of antibiotics like ceftazidime-avibactam, tigecycline, meropenem, imipenem, or amikacin. Treatment duration and doses are specified for each drug. Participants will be monitored for outcomes including 14-day all-cause mortality, clinical cure rates, infection clearance, ICU-free days, and adverse events during and after treatment. The study includes follow-up assessments up to 90 days post-randomization to evaluate hospital and ICU mortality. Safety and efficacy will be measured through clinical evaluations, microbiological tests, and adverse event tracking. The total participation time varies depending on follow-up duration and clinical course.