Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT07050550
Eligibility Criteria:
Inclusion Criteria:
* 1\) Aged between 18 and 80 years old; 2) Clinically diagnosed with liver damage (combined with medical history and laboratory tests, manifested as changes in liver enzymes, abnormal bilirubin metabolism, dysfunction of substance synthesis, and decreased biodegradation function, including indicators such as ALT, AST, ALP, GGT, albumin (Alb), TBil, and DBil); 3) Clinically diagnosed with liver failure (liver failure is a severe liver damage caused by multiple factors, resulting in severe dysfunction or decompensation of its synthesis, detoxification, excretion, and biotransformation functions, and a group of clinical syndromes with coagulation dysfunction, jaundice, hepatic encephalopathy, ascites, etc. as the main manifestations. Key points for the diagnosis of liver failure (a) Extreme fatigue, and severe gastrointestinal symptoms such as anorexia, vomiting, and abdominal distension; (b) Progressive deepening of jaundice (serum TBil ≥171μmol/L or daily increase ≥17.1μmol/L); (c) Bleeding tendency, plasma prothrombin activity (PTA≤40% or international normalized ratio (INR ≥ 1.5; (d) hepatic encephalopathy (grade II or above) or other complications.); 4) informed consent and able to accept follow-up, can understand and comply with the requirements of the study
Exclusion Criteria:
* 1\) Patients with serious primary diseases of the heart, brain, kidney and hematopoietic system (i.e. Weber heart function grade D; hemoglobin (Hb) \<10 g/dL, white blood cells (WBC) \<3×109/L, platelets (PLT) \<90×109/L; creatinine clearance (CrCl) \<40 mL/min); 2) Patients with mental disorders or primary affective disorders; 3) Patients who cannot understand, follow the study protocol or sign the informed consent form; 4) Patients with contraindications to PET imaging (including pregnant women, breastfeeding women, women of childbearing age who have plans to have children in the near future, etc.); 5) Patients with allergies to imaging agents; 6) Patients who cannot cooperate with PET scanning due to hypoglycemia, severe pain or tremor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07050550
Study Brief:
Protocol Section:
NCT07050550