Kai Feng Shi

Researchers are evaluating the effectiveness and safety of TQB2102 injection compared to a combination of docetaxel, trastuzumab, and pertuzumab in treating adults with HER2 positive recurrent or metastatic breast cancer. This Phase III, randomized, open-label, multicenter trial aims to compare these treatments in patients who have not received systemic anti-tumor therapy during their recurrence or metastasis stage, except for limited first-line endocrine therapy. Participants must have HER2 positive invasive breast cancer confirmed by pathology and measurable lesions. Participants are randomly assigned to one of two treatment groups in equal numbers. One group receives TQB2102, a next-generation HER2 Antibody-Drug Conjugate, while the other group receives docetaxel combined with trastuzumab and pertuzumab as a positive control. The study monitors the patients during treatment and collects data on tumor response and progression. During the study, participants undergo regular assessments including imaging to measure tumor size and progression according to RECIST 1.1 criteria. Researchers track the objective response rate and progression-free survival for up to approximately 30 months. Safety and adverse events are monitored throughout the trial, and participants must have good compliance and major organ function to continue. The study includes long-term follow-up to assess treatment outcomes and tolerability.

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 evaluating the real-world effectiveness of Repatha® combined with standard of care (SOC) compared to SOC alone in reducing major cardiovascular events. The study focuses on people with established atherosclerotic cardiovascular disease (ASCVD) who are treated according to local clinical practice. The goal is to see how these treatments affect the risk of cardiovascular death, heart attacks, stroke, hospitalization for unstable angina, or coronary revascularization. Participants will either be prescribed Repatha® in addition to their existing SOC treatment or continue with SOC alone. The study follows these participants over time to observe outcomes. Treatments are given according to local guidelines and approved labels, reflecting real-world medical care. During the study, researchers will monitor participants for the time until the first occurrence of any major cardiovascular event listed above, for up to 72 months. Participants will undergo regular assessments to track their health status and treatment effects. Safety and effectiveness are observed through ongoing real-world data collection in this prospective, observational study.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the efficacy and safety of Antiwei granules for treating the common cold, specifically the wind-cold syndrome type. This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to assess how well Antiwei granules work and how safe they are for adults aged 18 to 65 who have had a recent onset of the common cold. Participants will be randomly assigned to receive either Antiwei granules or a placebo. Both groups will take oral doses of 1 sack (6g) three times daily for a total of 9 sacks over a 3-day treatment period. The study compares the effects of the active granules versus placebo on cold symptoms. During the trial, participants will be monitored closely with assessments focusing on the cure rate after 3 days of treatment. Researchers will track symptoms and safety throughout the short treatment period. The total study duration for each participant is about 3 days, during which the effectiveness and any side effects of the treatment will be recorded and analyzed.

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 effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are studying the importance of new-onset atrial fibrillation (NOAF) that occurs during acute myocardial infarction (AMI). This study aims to confirm previous findings that a higher burden of NOAF after AMI is linked to worse outcomes. The study will also identify factors that influence how NOAF progresses after a heart attack and develop a model to predict risk in these patients. Additionally, researchers will explore how NOAF burden can help guide blood-thinning treatment decisions. Patients admitted for AMI who develop NOAF during their hospital stay will be enrolled from nine medical centers in Shanghai, Henan, and Zhejiang provinces. All patients will undergo at least 5 days of continuous electronic heart rhythm monitoring to measure NOAF burden, which is the total duration of atrial fibrillation divided by the total monitoring time. Other characteristics like AF pattern, frequency, symptoms, and longest episode duration will also be recorded. Data collected will include demographics, cardiovascular risks, lab tests, heart imaging, angiography, and medications. After discharge, patients will be followed for at least two years to track cardiovascular outcomes, including death from any cause for up to one year. Researchers will use the collected data to better understand the impact of NOAF burden on health and to improve risk assessment. This study involves continuous monitoring, clinical data collection, and long-term follow-up to provide insights into managing patients with NOAF after AMI.

Primary aldosteronism (PA) is a common cause of secondary high blood pressure, but its best diagnosis and treatment methods are still difficult to establish. This research thoroughly evaluates adrenal venous sampling (AVS), focusing on important clinical, technical, and methodological questions. The goal is to understand how AVS-guided care affects long-term health and biochemical results to improve patient outcomes and management. The study involves patients with PA undergoing adrenal venous sampling through either the antecubital or femoral vein to identify whether aldosterone overproduction is coming from one side or both sides of the adrenal glands. This procedure helps classify the subtype of PA, which guides treatment decisions including potential adrenalectomy. The study also aims to refine AVS protocols and standardize clinical practice. Participants will be monitored for major adverse cardiovascular events (MACE) for one year after the AVS procedure. Researchers will assess clinical and biochemical outcomes to better understand the impact of AVS-guided management on patient prognosis. The study collects detailed information to optimize diagnosis, treatment decisions, and long-term care for individuals with primary aldosteronism.

Researchers are conducting the China Cognition and Aging Study (China COAST), a large national research project in China aiming to better understand dementia and its subtypes, including mild cognitive impairment (MCI), sporadic and familial Alzheimer's disease (AD), vascular dementia (VaD), and other dementias. The study seeks to clarify the epidemiology, genetic factors, disease characteristics, diagnosis, and treatment status of these conditions. It will also explore risk and protective factors, discover new genes related to dementia, study biomarkers, and evaluate the effectiveness of non-pharmacological treatments over an average of two years. The study involves collecting comprehensive data from community and hospital populations, including demographic information, clinical evaluations, neuropsychological tests, imaging, and biological samples such as blood and cerebrospinal fluid. Genetic analyses like exome sequencing and genome-wide association studies will be performed. Participants will undergo regular follow-ups every 2 to 3 years to update prevalence and incidence rates, assess disease progression, and evaluate lifestyle and non-drug interventions. Randomized controlled trials will be conducted to assess non-pharmacological treatments including exercise, diet, cognitive training, and risk factor control. Participants will be assessed using standardized neuropsychological scales and undergo imaging and laboratory tests to monitor cognitive function and disease progression. Researchers will collect data on genetic markers, biomarkers, and clinical symptoms to develop early diagnostic tools and prediction models. The study also includes education efforts to raise awareness about dementia and investigates stigma and discrimination affecting patients and caregivers. Overall participation may extend over several years with detailed evaluations and follow-up assessments.