Chen Zhou Shi

Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This prospective, multi-center, single-arm study will recruit about 1000 participants from approximately 50 centers across China, focusing on patients suitable for stent angioplasty. The study will last from December 2022 to December 2030, aiming to observe real-world outcomes with this stent system. Participants will receive the NOVA stent, a sirolimus-eluting device designed specifically for intracranial artery stenosis and delivered with a rapid exchangeable balloon. The study includes ten visits: preoperative screening, operation day, and follow-ups at 30 days, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. These visits will monitor the safety and performance of the stent over both the short and long term. During the study, participants will undergo assessments including digital subtraction angiography to confirm artery stenosis, and will be monitored for stroke, death, and any need for further artery procedures. Researchers will carefully track any ischemic strokes or revascularizations related to the treated artery up to one year after the operation. Follow-up visits will continue for five years to ensure thorough observation of outcomes and safety measures.

Researchers are investigating whether Extract of Ginkgo Biloba Leaves Tablets can help improve thinking and memory in people aged 55 years and older who have had an ischemic stroke, which is caused by a blocked blood vessel in the brain. This phase 4 clinical trial is designed to assess both the effectiveness and safety of this treatment when added to the usual care for stroke recovery. Participants must have had a mild stroke confirmed by an MRI scan and show signs of cognitive impairment. The study takes place at multiple hospitals across China. Participants will be randomly assigned to one of two groups: one group will receive Extract of Ginkgo Biloba Leaves Tablets at a dose of 240 mg daily, divided into three doses of two 40 mg tablets each, along with their standard post-stroke care for 52 weeks. The other group will receive only the standard care recommended by the Chinese Stroke Association. The trial is open-label, meaning both the researchers and participants know which treatment is given. Throughout the year-long study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and testing. Researchers will evaluate changes in cognitive function using tests such as the Montreal Cognitive Assessment, Trail Making Test, Symbol Digit Modalities Test, and Verbal Fluency Test. They will also monitor neurological impairment and any new stroke events. Follow-up phone calls will occur at 12 and 38 weeks to support ongoing monitoring and safety assessments.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Researchers are evaluating the effectiveness and safety of Sodium Oligomannate (GV-971) in treating mild to moderate Alzheimer's disease. This Phase 4, multi-center, randomized, double-blind, placebo-controlled study aims to confirm how GV-971 works in the body, identify known side effects from long-term use, and watch for any new adverse reactions to guide clinical use. Participants in the study will receive either GV-971 or a placebo, both taken orally, over a period of 36 weeks. The study measures changes from the beginning in cognitive function using the ADAS-cog/12 score and daily living activities using the ADCS-ADL23 score. During the trial, participants will undergo brain MRI scans to confirm Alzheimer's diagnosis and will be monitored through various assessments including cognitive and functional tests. Researchers will track safety and side effects throughout the 36 weeks to better understand the treatment's impact and tolerability.

Stroke is the second leading cause of death worldwide, with ischemic stroke being the most common type. The current best treatment for acute ischemic stroke is intravenous thrombolysis using recombinant tissue plasminogen activator (rt-PA) given within 4.5 hours of symptom onset. However, some patients experience stroke progression or early blood vessel reocclusion after thrombolysis, which worsens neurological function and outcomes. This is believed to be caused by increased platelet activation after thrombolysis, which peaks within the first 2 hours. This clinical trial is testing whether starting oral aspirin early after intravenous thrombolysis can improve functional outcomes without causing more bleeding problems. Patients are randomly assigned to receive either 300 mg aspirin tablets or matching placebo tablets as soon as possible after enrollment. If swallowing is difficult, tablets can be crushed and given through a nasogastric tube. Both groups receive best medical management according to guidelines. The study is a Phase 3, multicenter, randomized, placebo-controlled trial. Participants will be followed for 90 days after stroke to measure their functional recovery using the modified Rankin scale (mRS). Researchers will check if patients have a good outcome defined as an mRS score of 0 or 1 at 90 days. During the study, patients undergo assessments including neurological exams and imaging to confirm eligibility and monitor safety. The trial aims to determine if early aspirin treatment after thrombolysis is safe and can help prevent neurological decline and improve recovery.

Researchers are evaluating the effectiveness and safety of orelabrutinib in adults with chronic primary immune thrombocytopenia (ITP) who have had the condition for at least 12 months. This phase III study compares orelabrutinib with a placebo in patients who have not responded well to or cannot tolerate standard first-line treatments like glucocorticoids or intravenous immunoglobulin. Participants will receive either orelabrutinib or a placebo once daily. The study is randomized, double-blind, and placebo-controlled to ensure unbiased results. The treatment period includes monitoring for response durability over an average of six months. During the study, participants will be regularly assessed for treatment response and safety. Researchers will measure the durable response rate, which reflects sustained improvement over the study period. Monitoring includes clinical evaluations and laboratory tests to ensure participant safety and to track the drug's effects.

Researchers are studying the effect of oral immunonutrition on reducing acute esophagitis in patients with lung cancer who are receiving thoracic radiotherapy. This phase 3 clinical trial includes patients with non-small cell and small cell lung cancer. The goal is to explore the safety and effectiveness of this dietary supplement in preventing esophagitis, a common side effect during radiotherapy treatment of the chest area. Participants are randomly assigned to receive oral immunonutrition, specifically Oral Impact® by Nestlé, which is taken as two 250 ml bottles daily starting on the first day of radiotherapy and continuing for three weeks after treatment ends. The radiotherapy dosing is based on standard prescriptions targeting the tumor area near the esophagus. The study is open-label and controlled, allowing researchers to compare outcomes with usual care. During the study, participants undergo regular assessments including monitoring for the incidence of grade 2 or higher acute esophagitis within three months after radiotherapy. Researchers also evaluate lung radiation exposure, patient performance status, blood counts, and biochemical markers to ensure safety. The study requires participants to be able to eat normally and have an expected survival of over three months. Safety and treatment effects are closely tracked throughout the treatment and follow-up periods.

Researchers are evaluating the effectiveness and safety of adding low-dose radiotherapy to chemoimmunotherapy as a first treatment for patients with nasopharyngeal carcinoma that has spread to the liver. This phase 2 study focuses on patients aged 18 to 70 with confirmed nonkeratinizing nasopharyngeal carcinoma and liver metastasis. The goal is to understand if this combined approach can improve progression-free survival within the liver. The treatment involves delivering low-dose radiotherapy (1.4 Gy daily for 5 days) targeted to liver metastases before starting chemoimmunotherapy. The chemoimmunotherapy regimen includes gemcitabine given on days 1 and 8, cisplatin on day 1, and penpulimab on day 1. This combination aims to assess the safety and therapeutic response in this specific cancer setting. Participants will undergo regular assessments including imaging to measure tumor response, blood tests to monitor organ function and blood counts, and evaluation for side effects. The main outcome measured is intrahepatic progression-free survival at one year. The study includes careful monitoring of safety and drug effects throughout treatment, with follow-up visits to track disease control and patient well-being.

Researchers are investigating the effectiveness and safety of PM8002, a bispecific antibody targeting PD-L1 and VEGF, combined with Paclitaxel as a second-line treatment for small cell lung cancer (SCLC). This phase III, open-label, randomized study compares this combination to standard chemotherapy options, including Topotecan or Paclitaxel, in patients whose cancer has progressed after first-line platinum-containing chemotherapy. The study aims to improve outcomes for patients with advanced SCLC. Participants will be randomly assigned to receive either PM8002 with Paclitaxel or the investigator's choice of chemotherapy (Topotecan or Paclitaxel). Paclitaxel is given as a 175 mg/m2 intravenous infusion on Day 1 every three weeks, while Topotecan is administered as 1.25 mg/m2 per day via intravenous infusion on Days 1 through 5 every three weeks. PM8002 dosing follows a predefined schedule. The study involves multiple centers and evaluates these treatments as second-line therapy. During the study, participants will undergo regular assessments to monitor overall survival for up to approximately 32 months from the first patient enrolled. Researchers will evaluate safety and treatment effects through clinical examinations, tumor measurements following RECIST v1.1 criteria, and tests of organ function. The study also includes monitoring for adverse events and ensures participants have a life expectancy of at least 12 weeks, adequate organ function, and an ECOG performance score of 0 or 1 to participate.