Yan An Shi

Researchers are evaluating the diagnostic accuracy of 68Ga-PSMA PET scans compared with enhanced CT scans in detecting metastatic lesions in patients with locally advanced and advanced renal cell carcinoma. The study also aims to determine whether the use of 68Ga-PSMA PET can influence treatment decisions for these patients. This is a prospective, multicenter study focusing on patients with stage III or IV renal cell carcinoma as defined by the 2017 AJCC TNM staging system. Participants will undergo 68Ga-PSMA PET / CT imaging within 6 weeks after their renal cell carcinoma diagnosis. This diagnostic test is being studied for its potential impact on clinical decision-making in renal cancer management. The trial aims to assess the additional diagnostic value of 68Ga-PSMA PET compared to standard CT imaging. During the study, patients will be monitored over a 2-year period to evaluate the diagnostic effectiveness of the 68Ga-PSMA PET. Researchers will collect data on imaging results and observe any changes in treatment plans based on PET findings. Safety and kidney function will also be considered, especially since renal impairment or ongoing hemodialysis are exclusion factors. Participants will provide informed consent before joining the study.

Researchers are investigating the prognostic value of initial staging using prostate-specific membrane antigen (PSMA) positron emission tomography (PET) in men with newly diagnosed, untreated prostate cancer. This study aims to develop a prognostic tool called the PSMA-VISION score to predict progression-free survival (PFS), and to compare this tool with existing prognostic models. The study addresses the current need for clear risk assessment specifically in treatment-nafve patients, as earlier studies included mixed patient groups with varied disease stages and treatment histories, which may limit accuracy. Participants will undergo PSMA PET imaging as part of their initial cancer staging before starting any treatment. The study will collect baseline PSMA PET parameters, such as lesion counts and metastatic stage, alongside clinical and pathological information. These data will be used to create and validate the PSMA-VISION score. The study will follow patients for at least two years to track progression-free survival and overall survival, comparing the new score to established tools like the NCCN risk categories and PPP nomograms. During the study, data will be collected repeatedly every 3 to 6 months and securely stored in a central database. Researchers will monitor progression-free survival over two years and evaluate the predictive accuracy of the PSMA-VISION score. Additional analyses will explore correlations with clinical features and early disease progression. This study plans to enroll approximately 1000 men and will use statistical methods to validate the prognostic value of PSMA PET imaging in this specific patient group.

Cerebral microbleeds (CMBs) are caused by microvascular lesions in the brain, which is a subclinical deposition of hemosiderin after the damage of microvascular. Antithrombotic drug are widely used in the secondary prevention of patients with ischemic stroke. Studies have shown that antithrombotic drug can increase the incidence of intracranial hemorrhage in ischemic stroke patients with cerebral microbleeds. For such patients, how to carry out effective and safe antithrombotic therapy is still unclear. We will study from two aspects: 1) We designed a cohort registration study to observe the prognosis and progress of CMBs in ischemic stroke patients one year after using various antithrombotic drugs. 2) Data independent acquisition quantitative proteomics (DIA quantitative proteomics) will be used to screen serum protein markers that may affect the prognosis of ischemic stroke patients with CMBs.

Researchers are evaluating whether delayed PSMA PET imaging improves the detection of clinically significant prostate cancer (csPCa) compared with standard imaging in men suspected of having newly diagnosed prostate cancer. This prospective, multicenter study focuses on treatment-nafve patients and aims to compare the diagnostic accuracy of delayed imaging taken 2-3 hours after injection with standard imaging taken about 60 minutes post-injection. The study addresses the need for more evidence on the added value of delayed imaging in this group of patients. All participants undergo a dual-phase imaging protocol with [^68Ga]Ga-PSMA PET/CT. The first phase is a whole-body scan approximately 60 minutes after the radiotracer injection. The second phase is a delayed pelvic PET-only scan performed 2-3 hours after injection, using the CT data from the first scan for image correction. Each patient acts as their own control, with diagnostic performance compared between the standard and delayed images. Biopsy is performed after imaging to confirm cancer presence and grade. Participants will undergo prostate biopsy using a 12-core systematic approach with additional targeted biopsy as needed. The study measures include comparing the area under the curve (AUC) for maximum standardized uptake values (SUVmax) between delayed and standard imaging to assess which is better at detecting csPCa. Secondary outcomes include defining optimal diagnostic thresholds, evaluating biopsy avoidance potential, assessing changes in clinical management, and exploring performance in patient subgroups. Data monitoring ensures study integrity, and the total participation involves imaging and biopsy procedures.

Researchers are evaluating the effectiveness and safety of two drugs, Sivelestat sodium and dexamethasone, in treating patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS). The study aims to determine whether Sivelestat sodium or dexamethasone works better than a placebo in this condition. This is a prospective, multicenter, double-blind, randomized controlled pilot study involving adult patients diagnosed with moderate-to-severe ARDS who require mechanical ventilation within 72 hours of disease onset. Participants will be randomly assigned to receive either Sivelestat sodium, dexamethasone, or corresponding placebos. Sivelestat sodium is given as a continuous intravenous infusion at a dose of 4.8 mg/kg per day for up to 14 days or until ICU discharge, whichever comes first. Dexamethasone is administered intravenously at 10 mg once daily for up to 5 days or until extubation. The study uses a double-mock design to maintain blinding. During the study, participants will be closely monitored for ventilator-free days within 28 days post-randomization, consent rates, recruitment rates, protocol adherence, and completion of follow-up visits up to 90 days after randomization. Researchers will assess safety and treatment compliance throughout the study duration. The total follow-up period includes multiple evaluations of patient outcomes and adherence to study protocols.

Researchers are evaluating the effects of fenofibrate on liver enzyme levels and safety in patients with primary biliary cholangitis (PBC) who have compensated cirrhosis and did not respond adequately to ursodeoxycholic acid (UDCA). This multi-center, randomized, placebo-controlled study aims to assess fenofibrate's impact on a composite biochemical endpoint, focusing on serum alkaline phosphatase levels over 48 weeks in this patient population. Participants will be randomly assigned to receive either fenofibrate 200 mg daily or a placebo, both in combination with UDCA dosed at 13-15 mg/kg per day. The treatment period lasts for 12 months. This study includes both a fenofibrate treatment group and a placebo group, with all patients continuing their UDCA therapy during the trial. During the study, participants will undergo biochemical monitoring to evaluate their liver enzyme responses and assess safety over the 48-week treatment period. Researchers will measure the percentage of patients achieving a biochemical response. The study includes careful safety monitoring to track any adverse effects and ensure participant well-being throughout the trial.

Researchers are studying how changes in circulating multigene methylation levels relate to treatment responses in people with esophageal cancer. The goal is to see if these methylation changes correlate with objective response rates measured by contrast-enhanced CT or MRI scans and serum tumor markers. The study also aims to explore the relationship between methylation patterns and progression-free survival, compare methylation indices with traditional biomarkers, and assess if methylation thresholds can guide changes in therapy. Participants will undergo multi-gene methylation testing through blood samples during follow-up visits. There are four groups based on treatment types and timing: preoperative, pre-neoadjuvant therapy, post-neoadjuvant therapy, and pre- and post-definitive chemoradiotherapy. Each group will have scheduled methylation testing at multiple time points from baseline up to five years after treatment. During the study, participants will have blood tests to measure methylation levels at various intervals, along with imaging scans and serum marker evaluations to monitor treatment response. Researchers will track methylation changes over time and relate them to clinical outcomes like progression-free survival. The follow-up lasts up to five years, allowing close observation of long-term treatment effects and disease status.

Researchers are evaluating a plasma exosome RNA signature to diagnose clinically significant prostate cancer. This study focuses on men suspected of having this condition, aiming to improve diagnostic methods through a liquid biopsy approach. The main goal is to assess how well plasma exo-RNA can detect clinically significant prostate cancer at the time of prostate biopsy. Participants will undergo a plasma exoRNA-based liquid biopsy as part of the diagnostic process. Men with elevated prostate-specific antigen (PSA) levels and clinical suspicion of prostate cancer through symptoms, digital rectal exam, ultrasound, or MRI are included. The study requires willingness to undergo a prostate biopsy to confirm diagnosis. During the study, researchers will collect blood samples for plasma exoRNA analysis and compare the results to prostate biopsy findings. The primary outcome is the diagnostic accuracy of the plasma exo-RNA panel in detecting clinically significant prostate cancer. Participants will be monitored for safety, and data will be collected at the time of biopsy to evaluate the test's performance.

Researchers are evaluating a new blood test that uses plasma exosomal RNA to predict bone metastasis in men with prostate cancer. This study aims to develop and validate this test as a reliable way to rule out bone metastasis compared to the current standard, PSMA PET imaging, which is expensive and not widely available. The goal is to provide a non-invasive, accurate test that can reduce unnecessary imaging and radiation exposure for low-risk patients. The study is conducted in four phases. Phase 1 involves discovering candidate RNAs through high-throughput sequencing in 250 patients. Phase 2 tests these candidates with a special PCR method in 300 patients to develop a predictive model. Phase 3 validates the model in another 300 patients reflecting typical disease rates, focusing on achieving at least 95% sensitivity. Phase 4 externally validates the model in 150 patients from multiple centers. Blood samples are collected before any prostate cancer treatment or biopsy to avoid contamination. Participants provide blood samples, undergo PSMA PET imaging, and may have prostate biopsies if needed. Researchers analyze RNA levels, imaging results, and clinical data to measure how well the test predicts bone metastasis. The main measure is the test's ability to correctly identify patients without bone metastasis while maintaining high sensitivity. Additional analyses explore correlations with tumor characteristics and clinical outcomes. Participants' data are securely stored and monitored throughout the study.

This research aims to evaluate the safety and effectiveness of YZJ-1139 tablets in adults aged 18 to under 65 years who have insomnia disorder. The study focuses on measuring both objective and subjective sleep parameters to see how YZJ-1139 affects sleep quality and patterns over a 28-day period. It is a Phase 3, randomized, double-blind, active-controlled, parallel-group clinical trial comparing YZJ-1139 with zolpidem. Participants will receive either YZJ-1139 20mg tablets or zolpidem 10mg tablets, both taken once daily in the evening. The treatment period lasts 28 days, during which sleep and related measures will be closely monitored. The study uses objective sleep assessments such as polysomnography and sleep diaries to evaluate sleep latency, efficiency, total sleep time, and wake after sleep onset. During the study, participants will undergo sleep assessments at baseline, Day 1/Day 2, and Day 27/Day 28 to track changes in key sleep parameters. Researchers will collect data on sleep latency, wake after sleep onset, sleep efficiency, and total sleep time to evaluate treatment effects. Participants will be monitored for safety and compliance throughout the study period, which includes regular visits and assessments.