Clinical trials

This study is designed as a prospective, randomized, open-label, phase II clinical trial to systematically evaluate the efficacy and safety of durvalumab combined with GEMOX/GC chemotherapy followed by lenvatinib, compared with capecitabine monotherapy, as adjuvant therapy for biliary tract cancer (BTC) after curative-intent resection.The primary objective is to determine whether the combination regimen can significantly improve the 1-year recurrence-free survival (RFS) rate. Secondary objectives include assessment of overall survival (OS) and the incidence of treatment-related adverse events. The overall aim is to identify a more effective and safer treatment strategy for postoperative adjuvant therapy in BTC.

The REALVENT trial is designed to evaluate whether a real-time, algorithm-driven ventilation feedback strategy can improve lung-protective ventilation (LPV) achievement rates in critically ill patients receiving invasive mechanical ventilation. This multicentre randomised controlled trial will compare real-time respiratory waveform monitoring with automated feedback against standard ICU care. The primary endpoint is the LPV achievement rate over the first 72 hours.

This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low biliary tract cancer. The primary objective is the objective response rate (ORR). Key secondary objectives include efficacy endpoints-progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DoR)-and safety assessments comprising adverse events (AEs), serious adverse events (SAEs), vital signs, and laboratory findings.

The goal of this observational study is to explore the spatial multi-omics mechanism of cachexia in pancreatic cancer and construct a high-precision multimodal intelligent early warning model for its early diagnosis in pathologically confirmed pancreatic ductal adenocarcinoma patients aged ≥18 years with an expected survival of ≥1 month. The main questions it aims to answer are: 1) Can spatial transcriptomics/metabolomics reveal the interaction mechanism between tumor microenvironment and metabolism in pancreatic cancer cachexia? 2)Can a multimodal AI early warning model be built to achieve accurate early identification of pancreatic cancer cachexia? Researchers will compare the surgical cohort and advanced cohort to see the differences in cachexia incidence and progression rules among different subgroups. Participants will complete baseline questionnaires on physical and mental state, nutrition and muscle strength, undergo imaging examinations and provide biological samples (blood, feces, tissue etc.), and receive regular follow-ups for updated questionnaires, imaging rechecks and supplementary biological sample collection until death, loss to follow-up or voluntary withdrawal.

The goal of this clinical trial is to learn whether a study drug called Compound Betamethasone (also known as Diprospan) works to treat pulmonary sarcoidosis in people with early-stage disease (stage I or II). It will also learn about its safety compared to the standard treatment, prednisone. The main questions it aims to answer are: * How much does the study drug improve lung function (measured by a test called FVC%) after 24 weeks of treatment? * How does it compare to prednisone in controlling symptoms, reducing chest lymph node swelling, and preventing relapse? Researchers will compare Compound Betamethasone injections (given once every 4 weeks) to prednisone pills (taken daily with a gradual dose reduction). Participants will: * Receive either the study drug injection or prednisone pills for 24 weeks * Visit the clinic for checkups and lung function tests at weeks 6, 12, and 24 * Have chest CT scans and blood tests to monitor their condition and any side effects * Be followed up for additional 24 weeks (up to week 48) to see if the disease comes back after treatment stops

The goal of this observational study is to learn about pulmonary hypertension crisis (PHC) - a severe, and often fatal complication - in patients with pulmonary hypertension (PH). The main questions this study aims to answer are: What are the clinical and hemodynamic features of PHC, and what underlying pathophysiological mechanisms cause it to develop? Can these features be used to diagnostic PHC, predict who is at risk of developing it or dying from it, and develop targeted prevention and treatment of PHC? A multi-center registry platform and biobank will be established to enroll and follow up patients with PH. Clinical data, hemodynamic measurements, and biological specimen will be collected. Risk prediction and early warning tools of PHC will be developed.

Keloids are often described as benign dermal fibroproliferative lesions characterized by increased growth beyond the boundaries of the original wound margin.Fibroblasts are considered to be the key cellular mediators of fibrogenesis in keloid scars. Thus this prospective study is going to investigate whether 68Ga-RGD PET/CT may provide evidence for diagnosis and evaluate the effectiveness of treatment.

The study is to evaluate the efficacy and safety of lenalidomide in the treatment of oral ulcers in adult patients with refractory mucosal Behcet's syndrome.

The goal of this clinical trial is to evaluate the safety and efficacy of PUMCH-E111 injection in subjects with RLBP1 related Inherited Retinal Dystrophy.

1. wAIHA Treatment Regimen: Group A (50mg group): Orelabrutinib 50 mg, orally, once daily. After 4 weeks of treatment, if still transfusion-dependent or hemoglobin increase is \< 20 g/L, the dose may be increased to 100 mg qd. Treatment can be discontinued if ineffective at 12 weeks. Group B (100mg group): Orelabrutinib 100 mg, orally, once daily. The treatment course is at least 12 weeks. Treatment can be discontinued if ineffective at 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety. 2. cAIHA Treatment Regimen: Group C (150mg group): Orelabrutinib 150 mg, orally, once daily. The treatment course is at least 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety.

The goal of this clinical trial is to see if a new pain medicine called Tegileridine is at least as effective as morphine (the standard treatment) for pain relief after spinal surgery in teenagers with scoliosis. This type of study is called a "non-inferiority" trial. The study will also carefully compare the safety of both medicines. The main questions it aims to answer are: Is Tegileridine no worse than morphine at controlling pain in the first 24 hours after surgery? How do the side effects (like sleepiness or nausea) of Tegileridine compare to those of morphine? Researchers will compare two different doses of Tegileridine against morphine. Neither the participants nor the doctors assessing them will know which medicine is being given. Participants in this study will: Receive one of the three pain medicine options through a pump (called a PCA pump) that they can control themselves after surgery. Use the pump for up to 48 hours. Regularly rate their pain levels using a simple number scale. Have their health closely monitored by the study team during this time.

A multicentre, prospective, cluster-randomised, parallel-controlled real-world effectiveness study evaluating whether a rare-disease diagnostic large language model can improve diagnostic quality, efficiency, and health-economic outcomes for physicians managing patients with suspected rare or diagnostically unresolved disease.

This is a prospective, multicenter real-world study evaluating the effectiveness and safety of hexaminolevulinate photodynamic therapy (HAL-PDT) in patients with cervical intraepithelial neoplasia grade 2 (CIN2). Treatment is guided by colposcopic response: patients receive 2, 3, or 4 sessions of HAL-PDT based on lesion persistence at Day 60 and Day 90 assessments. The primary endpoint is histopathological regression rate at 6 months after first treatment. Secondary endpoints include histopathological regression at 12 months, HPV clearance at 6 and 12 months, and safety. A total of 500 patients will be enrolled.

This study prospectively observes changes in critical closing pressure (Pcc) and derived hemodynamic parameters in mechanically ventilated distributive shock patients when clinically indicated norepinephrine dose reduction is performed by the attending physician. Pcc is measured before and 30 minutes after dose reduction using a stepwise inspiratory hold maneuver via PiCCO monitoring.

This study aims to compare the efficacy and safety of recombinant human thrombopoietin (rhTPO) + cyclosporine (CsA) and CsA monotherapy in the treatment of lower-risk myelodysplastic neoplasms with thrombocytopenia.

This is a prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial designed to evaluate the efficacy and safety of PCSK9 inhibitor combined with statin therapy compared to statin monotherapy in reversing asymptomatic intracranial atherosclerosis, assessed using high-resolution magnetic resonance imaging of the intracranial vessel walls.

This multicenter real-world study assesses the efficacy and safety of adjuvant therapies in postoperative intrahepatic cholangiocarcinoma (ICC) patients with high-risk recurrence factors. 90 eligible patients will be assigned to: Cohort 1: GP (gemcitabine/cisplatin) + adebrelimab Cohort 2: Apatinib + adebrelimab Cohort 3: S-1 (tegafur/gimeracil/oteracil) + adebrelimab Outcomes will be compared against historical real-world controls receiving standard chemotherapy.

In this 24-week, single center, randomized, double-blind, placebo-controlled study, the efficacy and safety of lyophilised oral fecal microbiota transplantation in patients with active refractory rheumatoid arthritis will be evaluated.

Primary aldosteronism (PA) is the most common cause of secondary hypertension. Liquid chromatography - tandem mass spectrometry (LC-MS/MS) is more accurate than the traditional radioimmunoassay in measuring aldosterone. This study aims to establish a more precise diagnostic threshold for the oral sodium loading test (OSLT) by using LC-MS/MS to measure urinary aldosterone levels. We will combine the biochemical results of OSLT and other data from healthy volunteers and suspected PA patients to determine a new 24-hour urinary aldosterone threshold. We expect to improve the diagnostic accuracy of PA, helping clinicians identify this curable cause of hypertension earlier and more accurately, and achieving precise treatment.

A multicentre, randomised diagnostic accuracy study to evaluate whether the rare disease-specific AI can improve diagnostic accuracy and efficiency for physicians managing real-world clinical cases.

Acquired immunodeficiency syndrome (AIDS) remains a severe global infectious disease, with over 38 million people living with HIV and around 35 million cumulative deaths worldwide by 2023; approximately 1.24 million HIV-positive individuals and 100,000 new infections are reported annually in China. Widespread use of HAART has prolonged HIV patients' survival and reduced AIDS-related mortality, yet non-AIDS comorbidities dominated by chronic liver disorders, particularly metabolic dysfunction-associated fatty liver disease (MAFLD), have become a major challenge in long-term HIV management. Triggered by elevated blood lipids from lifestyle, antiretroviral agents and inherited metabolic factors, MAFLD initiates with hepatic steatosis and may progress to NASH, liver fibrosis, cirrhosis and even hepatocellular carcinoma (HCC) without timely intervention. HIV-positive patients develop more severe MAFLD progression than HIV-negative counterparts; existing biopsy data shows 91% of ART-treated HIV patients have NAFLD, among whom 65% suffer from NASH complicated with liver fibrosis. Fatty liver prevalence keeps rising with younger onset age in China, which highlights the necessity of early screening. Liver biopsy, the historical diagnostic gold standard for liver injury grading, is restricted by invasiveness, bleeding risks and poor reproducibility. Transient elastography (TE), a novel non-invasive ultrasonic technique, quantifies hepatic steatosis via the ultrasound attenuation parameter (UAP) and liver fibrosis via liver stiffness measurement (LSM), and has been validated and guideline-endorsed for multiple chronic liver diseases globally. Published foreign data report 35%, 42% and 22% prevalence of NAFLD, NASH and fibrosis in PLWH, while domestic evidence on HIV-associated MAFLD is limited, especially liver-related discrepancies among varied ART regimens. With the implementation of China's new medical insurance policy, numerous patients are shifting from non-INI regimens to once-daily single-tablet INSTI STR regimens, whose hepatic and lipid impacts remain unclear. This study targets early detection of HIV patients with concomitant fatty liver to optimize management strategies and improve clinical outcomes. Our preliminary cohort at Peking Union Medical College Hospital included 188 virologically suppressed HIV patients on ART, 56.9% (107/188) of whom developed fatty liver (mild:27.1%, moderate:19.7%, severe:10.1%). Liver fibrosis (LSM≥7.3 kPa) was found in 12.8% (24/188) subjects, with 1.1% having advanced cirrhosis, and no significant inter-group difference in fatty liver incidence was noted between INSTI and NNRTI recipients. These findings lay a foundation for early diagnosis and follow-up intervention of metabolic liver disease among HIV-infected populations.

This single-center prospective cohort study is designed to evaluate whether preoperative physical activity measured by a wearable accelerometer is associated with cardiovascular autonomic function and whether it can help predict post-induction hypotension in elderly patients undergoing elective non-cardiac surgery. Patients aged 65 years or older scheduled for general anesthesia with tracheal intubation will undergo preoperative physical activity monitoring using an ActiGraph wearable accelerometer. Activity-related parameters, including sedentary time, light-, moderate-, and vigorous-intensity activity, daily step count, and sleep duration, will be recorded. Cardiovascular autonomic function will be assessed perioperatively using noninvasive continuous hemodynamic monitoring, with baroreflex sensitivity-related indices derived from continuous blood pressure and beat-to-beat timing data. The primary outcome is post-induction hypotension. Secondary outcomes include early intraoperative hypotension, postoperative complications, and 30-day mortality. This study aims to clarify the relationship between habitual physical activity and autonomic regulation in older surgical patients and to provide evidence supporting future prehabilitation strategies.

Hypertriglyceridemia-induced acute pancreatitis (HTG-AP) is associated with a high risk of recurrence despite standard lipid-lowering therapy and lifestyle modification. The goal of this clinical trial is to evaluate whether GLP-1 receptor agonist therapy can reduce the recurrence of HTG-AP in adults with a history of HTG-AP and hypertriglyceridemia. The main questions this study aims to answer are: * Whether GLP-1 receptor agonist therapy reduces the recurrence rate of HTG-AP. * Whether GLP-1 receptor agonist therapy improves triglyceride control, body weight, and metabolic parameters. * Whether GLP-1 receptor agonist therapy is safe and well tolerated in this patient population. Researchers will compare GLP-1 receptor agonist therapy plus standard care with standard care alone to determine whether GLP-1 receptor agonist therapy provides additional benefit in preventing recurrent HTG-AP. Participants will: * Receive either GLP-1 receptor agonist therapy plus standard care or standard care alone. * Undergo regular clinical follow-up visits and laboratory assessments. * Receive monitoring of triglyceride levels, recurrence events, metabolic outcomes, and adverse events during the study period.

The purpose of this study is to develop a high-performance machine learning model combining dynamic baroreflex sensitivity (BRS) metrics and multi-dimensional static clinical features to predict the risk of post-induction hypotension (PIH) in elderly patients undergoing elective non-cardiac surgery under general anesthesia.

The purpose of this study is to integrate millimeter-wave radar technology to investigate the dynamic movement characteristics of the pelvic floor muscles in patients with different Body Mass Index (BMI) and stress urinary incontinence. Based on this, a large database of pelvic floor movement parameters for Chinese women will be constructed, and a multi-subgroup standard atlas of pelvic floor muscle movement will be established to promote the standardized application of this technology in obstetrics and gynecology clinical assessments. This study also aims to explore the clinical value of pelvic floor movement assessment within the pelvic floor evaluation system, providing directions and insights for establishing a systematic evaluation system and standardizing the diagnosis and treatment of pelvic floor disorders.