Clinical trials

Exploring the safety and efficacy of the therapy combining immune checkpoint inhibitors (anti-PD-L1 monoclonal antibody, ASC22) and pegylated interferon alfa (Peg-IFNα) in patients with CHB. Exploring new combination therapeutic schemes for hepatitis B cure, and raising the overall clinical cure rate to more than 50% without screening specific advantageous groups.

This multicenter, prospective, cohort study is designed to investigate how metabolic disorders (such as obesity, diabetes, and high cholesterol) influence the progression of liver disease in patients with compensated advanced chronic liver disease (cACLD). Chronic liver disease often progresses silently for many years before serious complications like liver failure, cancer, or variceal bleeding develop. While it is known that metabolic problems can accelerate liver damage, current tools for predicting individual risk remain limited. This study aims to enroll approximately 4,307 adults with cACLD from six major medical centers across China. Participants will undergo regular follow-up every 3 to 6 months for up to 5 years, during which routine clinical assessments, non-invasive imaging (including MRI elastography), metabolic health indicators, and biological samples will be collected. No experimental treatments are provided; participants receive standard medical care as determined by their physicians. The primary goal is to determine whether metabolic abnormalities are linked to serious liver-related events including ascites, variceal bleeding, hepatic encephalopathy, liver cancer, liver failure, and liver-related death. The study will also evaluate how advanced imaging techniques predict these complications and develop a comprehensive risk prediction model integrating metabolic factors, imaging results, and traditional liver function tests. By better understanding the role of metabolic health in liver disease progression, this research may help identify new intervention targets and improve the ability to predict which patients are most likely to develop serious complications, ultimately leading to more personalized care and better outcomes for individuals with chronic liver disease.

Study population: Patients with liver cirrhosis complicated by sepsis Observation indicators: Fluid resuscitation strategy, early dynamic indicators such as MAP Observation endpoint: 28-day all-cause mortality Study design: Retrospective cohort study

This prospective, single-center, single-arm study will evaluate the feasibility and safety of 4DCT ventilation functional imaging-guided functional lung avoidance radiotherapy (FLAR) in patients with lung malignancies receiving IMRT radiotherapy. All participants will undergo 4DCT simulation as part of routine radiotherapy preparation. A ventilation map will be generated from 4DCT data, and the top 80% ventilation region will be defined as the high-function lung. This structure will be imported into the treatment planning system to create an FLAR plan that prioritizes sparing of high-function lung while maintaining target coverage (PTV D95%) and meeting standard dose constraints for organs at risk. A conventional anatomic plan (without functional guidance) will also be created for paired, within-patient dosimetric comparison. The primary outcome is improvement in dosimetric sparing of the high-function lung (V10, V20, V30, and mean lung dose). Secondary outcomes include the incidence of grade ≥2 radiation pneumonitis (CTCAE v5.0), changes in pulmonary function (e.g., FEV1 and DLCO), and lung-related quality-of-life scores. Assessments will be performed mid-treatment (after 15 fractions), at the end of radiotherapy (after 30 fractions), and at 1, 3, 6, and 12 months after radiotherapy. The study plans to enroll 100 participants and follow each participant for 12 months.

Transjugular intrahepatic portosystemic shunt (TIPS) is a critical therapeutic approach for managing esophagogastric variceal bleeding and refractory ascites in decompensated cirrhosis patients. To date, hepatic encephalopathy (HE) remains one of the most common complications following TIPS procedures, and prediction and prevention of post-TIPS HE have always been a hotspot in the field of hepatology. However, no reliable clinical studies have confirmed that any drug or intervention can effectively prevent the occurrence of HE episodes following TIPS, including lactulose and rifaximin. Underdilated strategy (UDS) was reported as an development technique proposed in recent years for TIPS procedures, which involves using a small-diameter balloon to dilate the puncture tract and subsequently implanted standard-diameter covered stent (e.g., 8 mm). This allows the stent to maintain a smaller diameter shortly after release, thereby reducing the incidence of hepatic encephalopathy during the postoperative period. Over time, the stent gradually dilates to its normal diameter within months. This period coincides with the higher incidence risk of post-TIPS HE, most commonly occurring within 6 months, especially within the first 3 months after TIPS. Therefore, theoretically, UDS can reduce the occurrence of post-TIPS HE. In terms of clinical research, however, there were still no high quality studies reported the advantages of this technique. Current reported clinical studies were all non-randomized controlled trials or retrospective studies, with low-quality evidence and sometimes contradictory findings. The aim of this prospective randomized controlled clinical study is to evaluate whether administration of underdilated technology during TIPS can improve postoperative hepatic encephalopathy, without compromising the therapeutic efficacy of portal hypertension complications.

Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of HBV treatment. However, HBsAg loss can be achieved in less than 10% of chronic hepatitis B (CHB) patients treated with current available antiviral drug interferon (IFNα) or nucleos(t)ide analogues (NAs) monotherapy. With the support of the national major special funding for infectious diseases from "11th Five-Year Plan" to "13th Five-Year Plan", we have implemented a pioneer clinical study of sequential combination of IFNα therapy on NAs to treat NAs-treated CHB patients (ie. New Switch Study). This is the world's first clinical trial aiming to functional cure, which increased the rate of HBsAg loss to 15% in the overall population in our study, and to 30-50% among those with lower baseline HBsAg levels. How to further improve the HBsAg loss rate is an urgent issue for us. The key point of achieving functional cure is to reverse the HBV-specific T cell exhaustion and establish the long-term immune control against HBV infection. (Programmed death-1) PD-1/programmed death-ligand 1 (PD-L1) axis blockade has been demonstrated to reinvigorate exhausted CD8+ T cells, and would be a potential strategy to treat chronic HBV infection. In this study, a large multicenter prospective study will be performed to explore the safety and efficacy of a novel combination strategy involving immune checkpoint inhibitor (anti-PD-1 antibody) and IFNα in CHB patients, observe the HBsAg loss rate in NA-treated CHB patients receiving this combination strategy, evaluate the potential of breaking immune tolerance by this strategy, and further assess its efficacy to further improve the clinical cure rate on the basis of New Switch Study. Based on New Switch Study, this study further attempts to reverse T cell exhaustion in CHB patients, explore a novel platform of combination therapy development for clinical cure, and ultimately increase the HBsAg loss rate to higher than 50% in overall patients. The implementation of the project is expected to reduce the burden of HBV infection in China and contribute to the goal of global elimination of hepatitis B and C by 2030 (WHO 2030).

Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of HBV treatment. However, HBsAg loss can be achieved in less than 10% of chronic hepatitis B (CHB) patients treated with current available antiviral drug interferon (IFNα) or nucleos(t)ide analogues (NAs) monotherapy. With the support of the national major special funding for infectious diseases from "11th Five-Year Plan" to "13th Five-Year Plan", we have implemented a pioneer clinical study of sequential combination of IFNα therapy on NAs to treat NAs-treated CHB patients (ie. New Switch Study). This is the world's first clinical trial aiming to functional cure, which increased the rate of HBsAg loss to 15% in the overall population in our study, and to 30-50% among those with lower baseline HBsAg levels. How to further improve the HBsAg loss rate is an urgent issue for us. The key point of achieving functional cure is to reverse the HBV-specific T cell exhaustion and establish the long-term immune control against HBV infection. Programmed death-1 (PD-1)/ programmed death-ligand 1 (PD-L1) axis blockade has been demonstrated to reinvigorate exhausted CD8+ T cells, and would be a potential strategy to treat chronic HBV infection. In this study, a large multicenter prospective study will be performed to explore the safety and efficacy of a novel combination strategy involving immune checkpoint inhibitor (anti-PD-1 antibody) in CHB patients, observe the HBsAg loss rate in NA-treated CHB patients receiving this combination strategy, evaluate the potential of breaking immune tolerance by this strategy, and further assess its efficacy to further improve the clinical cure rate on the basis of New Switch Study. Based on New Switch Study, this study further attempts to reverse T cell exhaustion in CHB patients, explore a novel platform of combination therapy development for clinical cure, and ultimately increase the HBsAg loss rate to higher than 50% in overall patients. The implementation of the project is expected to reduce the burden of HBV infection in China and contribute to the goal of global elimination of hepatitis B and C by 2030 (WHO 2030).

This study aims to investigate the factors influencing the risk of postoperative visceral pain in patients undergoing abdominal surgery. The goal is to develop and validate a predictive model for assessing the risk of postoperative visceral pain, in order to guide individualized preoperative interventions and pain management strategies.

Patients who met the criteria and needed to undergo elective surgery via arterial and venous puncture were included in this center. They were randomly divided into three time periods (8:00-9:00, 12:00-13:00, 16:00-17:00) and were exposed to green light (experimental group) and transparent light (control group) respectively. The effects of green light exposure on acute perioperative pain in patients were observed at different times.

This is a prospective observational study. To investigate the effect of serum calcium levels on postoperative pain in patients undergoing abdominal surgery, and to determine whether changes in serum calcium levels are a risk factor for postoperative pain.

The goal of this clinical trial is to evaluate the efficacy and safety of liposomal Bupivacaine administered by paravertebral block for the treatment of acute and chronic pain after video-assisted thoracoscopic lobectomy.

1. A predictive model for NARDS was established based on perinatal risk factors. Multivariate Logistic regression analysis was used to screen the independent prenatal risk factors for NARDS. A Logistic regression model was constructed using the above independent risk factors and quantified in a nomogram to construct a visualization model for prenatal prediction of NARDS. 2. The role of ACS in the prevention and treatment of ARDS in near-term/full-term infants. For neonates with a probability greater than 80% in the prediction model of ARDS, at least one ACS was given before the termination of pregnancy. The GC level of cord blood (taken at birth) and the mRNA levels of α-ENaC, Na-K-atpase and SGK1 in nasal epithelium were measured within 2 hours and 1 day after birth in the ACS intervention group and the control group. The occurrence and severity of pulmonary edema, the occurrence and severity of ARDS, and the mortality rate of NARDS were evaluated by lung ultrasound. The indexes of the two groups were compared horizontally and longitudinally.

In this project, volunteers will be recruited to cool the superficial skin of the axillary brachial plexus away from the puncture point, resulting in local peripheral nerve cooling, and observe its impact on the pain of arterial puncture.To explore the local peripheral nerve cooling treatment can produce controllable and reversible analgesic effect even if away from the wound, and provide a new nonpharmaceutical analgesic mode for clinical.

This study aimed to assess the effectiveness of Coenzyme Q10 in preventing both acute and chronic pain following thoracoscopic surgery, with a focus on its potential benefits in reducing the incidence and severity of pain.

This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, Observe changes in patients' biochemical and imaging indicators, liver stiffness values, fecal microbiota, and metabolites before and after the use of sulfasalazine.

This study want to observe the effects of remimazolam and propofol for general anesthesia on postoperative rhythm and cognitive function. The observation group was given remimazolam for general anesthesia, and the control group was given propofol for general anesthesia. Both drugs are commonly used as intravenous anesthetics for general anesthesia and have been shown to be safe for use in general anesthesia. The investigators hope can understand the effects of remimazolam and propofol for general anesthesia on rhythm status and cognitive function through this study, further reduce the occurrence of postoperative cognitive function impairment, and enable subjects to better recover.

To compare the efficacy and safety of traditional inflatable laryngeal mask, i-gel non-inflatable laryngeal mask and GMA-TULIP non-inflatable laryngeal mask in surgeries with lateral position under general anesthesia, so that providing evidence for the selection of laryngeal mask in surgeries with lateral position.

This project aims to compare the application effects of traditional inflatable BlockBuster laryngeal mask, i-gel non-inflatable laryngeal mask and GMA-TULIP non-inflatable laryngeal mask in laparoscopic surgeries with trendelenburg position under general anesthesia, in order to explore which laryngeal mask is best for reducing postoperative throat pain of patients and improving patient comfort and satisfaction.

Surgical pain is a common complication after surgery, affecting patient recovery and treatment quality. \>20% of patients suffer from chronic postoperative pain. China has \>70 million surgeries yearly. Nerve block manages postoperative pain, with developing nerve block needles now used in clinics. Developed needles may have better pain management effects than non-developed ones, but their effect on reducing chronic pain remains unclear. This study aims to explore the effect of developed nerve block needles on postoperative pain and compare them to non-developed needles, providing new ideas and methods for pain management.

Use huawei wristwatch to record maternal rhythm status and record the VAS score after cesarean section under combined spinal-epidural anesthesia. Based on this study the investigators intend to explore the correlation between maternal circadian rhythm status and postoperative pain after cesarean section.

Electrical/pharmacological cardioversion improves structural remodeling of left atrium. We hypothesize that persistent atrial fibrillation (AF) patients with more significant left atrial size reduction after cardioversion have lower AF recurrence rates following radiofrequency ablation. The aim is to evaluate the relationship between changes in left atrial size 3 to 6 months after cardioversion and the recurrence rate of atrial fibrillation following radiofrequency ablation.