Yan Cheng Shi

Researchers are evaluating the safety and effectiveness of MC2-01 cream in treating Chinese adults aged 18 years and older with plaque psoriasis affecting the body (trunk and/or limbs). This phase 3, multi-center, randomized, investigator-blinded study compares MC2-01 cream to both calcipotriol and betamethasone dipropionate gel and a vehicle cream. The study includes screening, treatment, and safety follow-up periods to thoroughly assess the treatment's impact. Participants receive one of three treatments: MC2-01 cream (containing calcipotriene and betamethasone dipropionate), CAL/BDP gel (calcipotriol and betamethasone dipropionate gel), or a vehicle cream without active ingredients. Treatments are applied during the treatment period following the study protocol. The design allows comparison of MC2-01 cream’s efficacy and safety against the gel and vehicle. During the study, participants undergo evaluations including physician assessments using the Physician's Global Assessment (PGA) to measure treatment success on the body after 8 weeks. Researchers monitor safety and treatment response through scheduled visits covering screening, treatment, and follow-up phases. Participation involves completing visits as required by the protocol to ensure comprehensive data collection over the study duration.

Researchers are evaluating the effectiveness and safety of two treatment combinations for elderly patients newly diagnosed with multiple myeloma who are not planning to undergo stem cell transplant initially. The study compares daratumumab, lenalidomide, and dexamethasone (DRd) with a modified regimen of bortezomib, lenalidomide, and dexamethasone (VRd-lite). The main goals are to measure how long patients survive without disease progression and the rate of minimal residual disease negativity. Participants can choose between the two treatment options. Daratumumab is given intravenously weekly for the first 8 weeks, then every two weeks for 16 weeks, and finally every 4 weeks in later cycles. Bortezomib is administered by injection once a week during each 28-day cycle for 8 cycles. Both groups receive lenalidomide orally for 21 days of each cycle and dexamethasone twice a week. After initial treatment, all participants continue lenalidomide maintenance until the disease worsens or side effects become unacceptable. During the study, participants undergo regular evaluations including tests for disease progression and minimal residual disease status at various time points up to approximately 5 to 8 years. Safety is monitored throughout. The study involves ongoing assessments such as laboratory tests and clinical evaluations to track treatment response, side effects, and overall health during and after therapy.

Researchers are evaluating the safety and effectiveness of TQB2102 for injection, a HER2 dual-antibody-drug conjugate, in treating patients with HER2-positive biliary tract cancer. This study focuses on patients aged 18 to 75 years who have advanced or metastatic biliary tract cancer confirmed by specific tests and who have failed 1-2 prior systemic therapies. The trial is conducted in Phase 1 and Phase 2 stages to determine the recommended dose and assess adverse events. Participants receive TQB2102 injections as part of the treatment. This study includes a screening period to confirm eligibility, followed by treatment cycles where participants are monitored closely. Women of reproductive age and men must agree to use effective contraception during and for six months after the study. The study also excludes patients with certain medical conditions, recent treatments, or prior anti-HER2 therapies depending on the stage. During the study, participants undergo tumor evaluations, safety assessments, and laboratory tests to monitor the drug's effects and side effects. Researchers collect data on adverse events from the time participants consent until 28 days after the last dose or start of new antitumor therapy. The study period includes up to 24 weeks to establish the recommended dose and long-term monitoring to ensure participant safety and treatment adherence.

Acute Aortic Syndrome (AAS) is a serious and life-threatening condition where inflammation significantly affects its development and progression, leading to high rates of death and complications. This research focuses on understanding how inflammation and anti-inflammatory treatments impact patients with AAS, particularly those undergoing surgery. The study is a large, long-term observational registry involving 20 cardiovascular centers in China, enrolling adult patients from 2016 through 2040 to investigate early and late outcomes related to inflammation. Participants in the study have undergone various treatments for AAS, including medical therapy, open surgery, endovascular repair, or hybrid procedures. The research collects detailed clinical data using specially designed forms and statistical analysis software to explore the role of inflammation and anti-inflammatory strategies alongside surgical repair. The registry also includes patients who had additional cardiac surgeries like coronary artery bypass or carotid artery replacement during their AAS treatment. During the study, researchers assess patients for severe inflammatory responses and organ function within the first week after surgery, and track outcomes such as mortality within 30 days, stroke, kidney injury, infections, bleeding, blood transfusions, and time spent in intensive care. The study aims to provide insights over 15 years on how inflammation affects recovery and long-term prognosis in AAS patients, helping to guide improved treatment strategies and reduce residual cardiovascular risks.

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 study aims to assess the safety and effectiveness of the UCAR-T cell product, focusing on adverse events and optimal dosing, as well as measuring disease activity and remission outcomes in participants. Participants may receive lymphodepletion chemotherapy with fludarabine and cyclophosphamide if clinically needed, followed by a resting period on Days -2 and -1. On Day 0, they receive the UCAR-T cell infusion intravenously. After infusion, participants are hospitalized for at least 7 days for close safety monitoring and must stay within 2 hours of the treatment center for at least 28 days. Follow-up visits occur on Day 14, Day 28, and at months 3, 6, 9, 12, 18, and 24 post-infusion. During the study, researchers will monitor the incidence of dose-limiting toxicities up to 28 days after infusion and track adverse events for up to 2 months after UCAR-T injection. Disease activity and remission rates will also be evaluated over time. Participants undergo clinical assessments, lab tests, and safety monitoring throughout the 24-month follow-up period to gather comprehensive data on treatment effects and patient well-being.

Researchers are evaluating the effects of two treatments in people with H-type hypertension who have specific genetic types (MTHFR 677 CC or CT), elevated plasma homocysteine levels, and low serum folate. This large, phase 4 clinical trial involves 32,000 Chinese men and women aged 45 to 74 years. The study aims to compare the risk of first ischemic stroke over a five-year period between the two treatment groups. Participants will be divided into groups based on their MTHFR genotype and randomly assigned to receive either amlodipine tablets (5mg once daily) or amlodipine combined with folic acid tablets (5.8mg once daily). The study includes a screening period, a 2 to 4-week run-in phase to check tolerance and compliance to amlodipine, and a five-year randomized treatment phase. Additional blood pressure medications may be added if needed to maintain target blood pressure levels. During the study, participants will have visits every three months for drug distribution and monitoring. Researchers will collect blood samples, conduct clinical evaluations, and gather data on medication adherence and health outcomes. The primary outcome measured is the first occurrence of ischemic stroke by the end of five years. Safety and efficacy will be assessed, with two interim analyses planned at years three and four.

Researchers are studying the effects of three different treatment approaches on the risk of first ischemic stroke in Chinese men and women with hypertension and a specific genetic type called MTHFR 677 TT genotype. This large, phase 4 clinical trial will include 24,000 participants aged 45 to 74, and will compare the impact of amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate (5-MTHF). The goal is to evaluate which treatment strategy might better prevent the first ischemic stroke over five years. The study has three main periods: screening, run-in, and randomized treatment. During screening, participants provide consent and undergo interviews, clinical evaluations, and lab tests to confirm eligibility. The run-in period lasts 2 to 4 weeks, where participants take amlodipine (5 mg once daily) to assess tolerance and compliance. After this, eligible participants are randomly assigned to one of three groups: amlodipine only, amlodipine plus folic acid, or amlodipine plus folic acid and 5-MTHF. Treatments are taken orally once daily for five years. Additional antihypertensive medications may be added as needed to keep blood pressure controlled. Participants will visit the research centers every three months for follow-up, medication distribution, and monitoring. Researchers will check blood pressure, collect biological samples, and assess compliance and safety throughout the five-year treatment. The study’s main outcome is the occurrence of a first ischemic stroke by the end of the fifth year. Two interim analyses are planned at years three and four to evaluate ongoing results while maintaining study integrity.

Researchers are studying the effects of an 8-week aerobic exercise program combined with synchronized music on psychological, attentional, and executive functions in Chinese medical students. The research also aims to validate several Chinese versions of psychological and cognitive assessment scales to provide a basis for how aerobic exercise might improve mental health and cognitive function in this population. The study includes up to 134 participants who will be randomly assigned to intervention or control groups. The intervention involves three groups performing aerobic exercise at different intensities—low, moderate, and high—each combined with synchronous music tailored to the exercise intensity. Each group will exercise three times a week for 8 weeks, with each session lasting 40 minutes. The control group does not receive any intervention. Music tempos correspond to exercise intensities and are delivered through headphones, with exercise intensity adjusted using treadmill testing. Participants will be assessed before and after the intervention on psychological function, attention, executive function, and brain functional connectivity using questionnaires, smartwatches, and brain imaging technology called functional near-infrared spectroscopy (fNIRS). The study measures will include psychological and cognitive changes over up to 30 weeks. Participants' adherence and response to the exercise and music intervention will be monitored throughout the study period.

This research evaluates whether giving a half-dose bolus of recombinant staphylokinase (r-SAK) before primary percutaneous coronary intervention (PCI) improves outcomes in patients experiencing acute ST-segment elevation myocardial infarction (STEMI). STEMI is a serious heart condition caused by blocked coronary arteries leading to heart muscle damage. Early reperfusion treatment can reduce heart damage and improve prognosis, but it is unclear if adding thrombolytic therapy immediately before PCI within 120 minutes benefits patients. The study is a multicenter, randomized, double-blind, placebo-controlled Phase 4 trial comparing r-SAK to placebo in patients undergoing PCI within 120 minutes. Participants are randomly assigned to receive either an intravenous half-dose bolus of r-SAK or placebo within 10 minutes after STEMI diagnosis. The study focuses on facilitating PCI by potentially improving blood flow in blocked arteries through r-SAK's clot-dissolving action. The trial addresses challenges such as delays in transferring patients to PCI-capable hospitals and the risk of complications from high thrombus burden during stent placement. During the study, researchers will monitor participants for major adverse cardiovascular events (MACE) within 90 days. Assessments include clinical evaluations, ECGs, and safety monitoring to observe heart function and adverse effects. The total participation involves initial treatment and follow-up visits to track health status and treatment impact over three months.

Researchers are evaluating the safety and effectiveness of colistimethate sodium (colistin) in treating infections caused by carbapenem-resistant enterobacteriaceae (CRE) in patients with hospital-acquired pneumonia (HAP) or bloodstream infections. This study is conducted in China across 14 centers and aims to compare treatment outcomes between patients receiving colistin-based therapies and those receiving other best available treatments without colistin. The trial follows good clinical practice and ethical guidelines, focusing primarily on 14-day all-cause mortality along with other clinical and microbiological outcomes. Participants are randomly assigned to one of two groups: one receiving colistin combined with metroperan, imipenem, tigecycline, or aminoglycosides (amikacin), and the other receiving best available treatments without colistin, such as ceftazidime-avibactam or combinations of tigecycline with other antibiotics. Treatments are administered in intensive care units, and patients are closely monitored throughout the study period. During the study, patients undergo clinical assessments including culture tests from respiratory or blood samples collected before randomization to confirm CRE infection. Researchers track several outcomes such as mortality rates at 14 and 28 days, clinical cure, microbiological cure, adverse events, and ICU-free days. Safety follow-up and evaluation of treatment effects are conducted as part of the trial, which includes patients aged 18 to 85 years who meet specific diagnostic and health criteria.