Clinical trials

Ischemic heart failure (IHF) is the final stage of coronary heart disease. Coronary revascularization is an important treatment method for IHF, but it has high perioperative risks and not all patients can benefit from it. Evaluation of viable myocardium is one of the important decision-making methods for IHF, but recent research results have raised doubts about its value. The clinical community urgently needs more precise and comprehensive non-invasive decision-making methods. Fibroblast activation protein inhibitor (FAPI) imaging can specifically identify activated fibroblasts and achieve non-invasive diagnosis of the early and reversible stage of myocardial injury. Previous studies have shown that FAPI imaging can identify more damaged myocardium in various heart diseases compared to existing imaging techniques, demonstrating good clinical application potential. This study aims to conduct a prospective cohort trial for IHF patients who have undergone revascularization, using 18F-FAPI and viable myocardium (18F-FDG) imaging to analyze the degree of improvement in left ventricular ejection fraction after revascularization and major adverse cardiovascular events, and to explore the independent or additive predictive value of 18F-FAPI imaging, in order to provide a more reliable non-invasive imaging decision-making method for the revascularization strategy of IHF patients.

The goal of this clinical trial is to learn whether using a reinforcing material called SIS (small intestinal submucosa) during bowel connection after rectal cancer surgery can help prevent anastomotic leakage-a serious complication where the connection between two parts of the intestine fails to heal properly. This study will focus on patients with mid-to-low rectal cancer who are scheduled for surgery. The main questions the study aims to answer are: Does using an SIS-reinforced connection reduce the rate of anastomotic leakage within 30 days after surgery compared to standard connection methods? Does it also reduce the need for a temporary stoma (an opening in the abdomen for waste removal)? Researchers will compare two groups: Intervention group: Patients who receive the SIS-reinforced connection during surgery. Control group: Patients who receive the standard connection without reinforcement. Participants in this study will: Be randomly assigned to either the intervention or control group. Undergo standard laparoscopic or robot-assisted rectal cancer surgery. Be followed up at 30 days, 90 days, and 12 months after surgery to check for complications, stoma status, and quality of life. This study is being conducted across multiple hospitals in China to ensure the results are reliable and widely applicable.

ECMO is widely used in patients with refractory respiratory and/or circulatory failure.The data shows that the incidence of bleeding and thrombotic events is still above 40%,and it is closely related to the increase in mortality rate.Therefore, optimizing ECMO anticoagulation management to reduce bleeding and thrombotic events is a key scientific issue that urgently needs to be addressed.

This study evaluates whether early administration of low-dose aspirin (100mg) at 2 hours post-intravenous thrombolysis, compared to the standard timing of 24 hours, improves functional outcomes in patients with acute ischemic stroke. Intravenous thrombolysis is effective for very early treatment of acute ischemic stroke. However, current guidelines recommend starting antiplatelet therapy 24 hours after thrombolysis to avoid symptomatic intracranial hemorrhage (SICH), a recommendation not based on prospective clinical studies. Early re-occlusion of recanalized arteries due to platelet aggregation occurs in 14-34% of cases and is associated with poor prognosis. The average incidence of SICH is 2.4%, with fatal SICH occurring in only 0.28%. Thus, the impact of re-occlusion on poor prognosis may outweigh the risk of SICH. In this prospective, randomized, open-label trial with blinded endpoint evaluation, participants are assigned to receive aspirin 100mg either at 2 hours (early group) or at 24 hours (standard group) after thrombolysis. The primary outcome is the proportion of patients with a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-2 at 3 months. Safety outcomes include the incidence of SICH and all-cause mortality at 3 months. This study will provide clinical evidence regarding the optimal timing for initiating antiplatelet therapy after thrombolysis in acute ischemic stroke.

The purpose of this observational study is to explore the incidence, risk factors, and relationship with therapeutic outcomes of VTE (venous thromboembolism) and ATE (arterial thromboembolism) associated with immune checkpoint inhibitors (ICIs) therapy. The primary questions it aims to address are: 1. What is the real-world incidence of VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors? 2. What are the risk factors and biomarkers for VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors? 3. What is the impact of VTE/ATE on the prognosis of lung cancer patients receiving immune checkpoint inhibitors? Researchers will compare the characteristics and biomarkers of patients with and without ICI-associated VTE/ATE to identify novel specific biomarkers for thrombotic events. Furthermore, they will construct a risk assessment model for thrombotic events to provide guidance for precision prevention and treatment in clinical practice.

This is a single-arm study to investigate the heterogeneity of glycemic response to Lactobacillus paracasei LC19 in patients with newly diagnosed type 2 diabetes. Participants will receive LC19 for 12 weeks, and changes in glycemic control will be evaluated.

To verify whether the transpulmonary pressure-guided mechanical ventilation strategy can reduce right ventricular involvement, especially the incidence of acute cor pulmonale (ACP), in patients with moderate to severe ARDS induced by pneumonia compared with the currently widely used right ventricular protective mechanical ventilation strategy.

Chronic obstructive pulmonary disease (COPD) is a major chronic respiratory condition with high prevalence of multimorbidity. COPD and comorbidities interact dynamically, contributing to symptom fluctuation, acute exacerbations, hospitalization, and long-term disease progression. The IMPACT COPD Cohort (China) is a multicenter prospective observational cohort designed to establish a real-world evidence base for integrative Chinese-Western medicine management of COPD with comorbidities. The cohort integrates conventional clinical assessments (symptoms, questionnaires, spirometry, imaging, and biomarkers) with continuous multisensor digital monitoring (e.g., heart rate, blood pressure, activity, sleep patterns, and other physiological and behavioral measures) and digital Traditional Chinese Medicine (TCM) phenotyping (e.g., tongue, pulse, and facial diagnostics). The study aims to characterize risk profiles of high-risk populations and patients with confirmed comorbidities, develop and validate prediction models for comorbidity risk and acute exacerbation events, and support evidence generation for long-term management strategies with early screening and risk warning capabilities across hospital, community, and home settings.

From 2003 when Severe Acute Respiratory Syndromes (SARS) appeared，many new types of respiratory viruses emerge in endlessly. Therefore, the epidemiology and the clinical character has changed quietly, especially severe pneumonia. This cohort study aim to obtain the contents of severe pneumonia patients in Respiratory Intensive Care Unit (RICU). Through the clinical data analysis, the investigators could get the information of the pneumonia caused by different reasons, such as morbidity and mortality, risk factors, clinical symptoms and radiographic changes, the respiratory support parameter and so on. The investigators hope the result could guide them do the clinical work of severe pneumonia better in the future.

This research study focuses on chronic airway diseases, such as Chronic Obstructive Pulmonary Disease (COPD) and asthma. These conditions make it difficult for patients to breathe, but breathing difficulty (dyspnea) is often perceived very differently. Some patients may feel severe distress with mild breathing problems, while others might not notice significant breathing issues even when lung function is poor. This difference in perception is termed "dyspnea perception." The main goal of this study is to understand how dyspnea perception varies among patients with chronic airway diseases. The investigators aim to determine if patients can be grouped into different subtypes based on the perception of breathing difficulties. The study will also investigate how these subtypes relate to other treatable characteristics, such as blood cell counts, allergy test results, and findings from lung function tests and brain scans. Approximately 800 patients with COPD or asthma and 150 healthy volunteers will participate. Participants will answer questionnaires, undergo lung function tests, provide blood samples, and a subset will undergo a special brain scan (functional MRI). No new treatments will be assigned; instead, these characteristics will be observed and measured over time. It is hoped that this study will help doctors better understand chronic airway diseases and lead to more personalized management strategies for patients in the future.

1. The goal of this clinical trial is to evaluate the efficacy and safety of hyperbaric oxygen (HBO)in stroke patients after endovascular treatment 2. The main questions it aims to answer is: Whether HBO can improve the prognosis of ischemic stroke patients after endovascular treatment? 3. Participants will: receive HBO (1.6 Atmosphere Absolute，1.6ATA)，Once a day, for 1 hour each time, for 5 days a week (it can be non-consecutive days), the total course of treatment is 10 times. undergo three scheduled face to face or telephone follow-up assessments during the 12-month period following HBO.

For obese individuals, semaglutide treatment was adopted. By using multi-omics techniques such as fecal metagenomic sequencing and based on in vitro strain screening platforms, the effects and specific mechanisms of semaglutide on the intestinal flora of obese patients were clarified.

Severe asthma is a complex and heterogeneous disease. Patients with severe asthma can present with different types of airway inflammation, and are often accompanied by a variety of comorbidities and risk factors. Identification of potentially modifiable factors affecting prognosis, that is, "treatable characteristics", and individualized bundle management based on these characteristics may help to improve the quality of life of patients with asthma and improve the level of asthma control. Through joint research, this project aims to evaluate the treatable characteristics of asthma in patients with severe asthma in tertiary hospitals across the country, including lung function, fractional exhaled nitric oxide, blood routine, allergen IgE, chest CT, and a detailed questionnaire. The distribution of treatable characteristics of patients with severe asthma and its impact on the quality of life or asthma control level of patients were investigated. For patients with severe asthma, multidisciplinary consultation and shared decision-making were used to establish an individualized bundle management model based on the treatable characteristics of severe asthma. A 6-month randomized parallel controlled clinical trial was conducted to determine whether this model was superior to conventional management in improving the quality of life or asthma control in patients with severe asthma. The implementation of this project will build a new model of individualized management of severe asthma based on treatable characteristics and improve the management level of severe asthma

Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a salvage treatment for severe acute respiratory distress syndrome (ARDS). With the large-scale implementation of VV-ECMO in critical care medicine departments in China, significant progress has been made in treating severe ARDS. However, the patient mortality rate remains high. The pathophysiological essence of ARDS is an imbalance between the body's oxygen supply and demand, causing tissue and cell hypoxia, organ dysfunction, and even death. The VV-ECMO treatment process still requires mechanical ventilation assistance. However, inappropriate mechanical ventilation settings can lead to ventilator-related lung injury (VILI). In recent years, mechanical power has gradually attracted everyone's attention and is considered the cause of VILI. The transpulmonary mechanical power is more accurate to the energy directly performed to the lung tissue. Transpulmonary mechanical energy has a specific value in judging the prognosis of mechanically ventilated patients, but its clinical significance in treating patients with VV-ECMO is unclear. This study aimed to explore the value of transpulmonary mechanical power in predicting the prognosis of patients with severe ARDS patients treated with VV-ECMO.

Over the last 20 years, extracorporeal membrane oxygenation (ECMO) has been used to support adult patients with respiratory or cardiac failure who are unlikely to survive conventional treatment methods. ECMO circuit, pump, and oxygenator technology improvements permit safer perfusion for extended periods. The prolonged use of an ECMO circuit increases the risk of membrane lung (ML) dysfunction. The ML is responsible for taking in oxygen and removing carbon dioxide. The non-biologic surface of the ML triggers inflammatory and coagulation pathways, resulting in the formation of blood clots, breakdown of fibrin, and activation of white blood cells, which ultimately leads to ML dysfunction. Coagulation and fibrinolysis activation can cause systemic coagulopathy or hemolysis, and the deposition of blood clots can block blood flow. Moreover, the accumulation of moisture in the gas phase and the buildup of protein and cellular debris in the blood phase may contribute to shunt and dead-space physiology, respectively, impairing the exchange of gases. These three categories-hematologic abnormalities, mechanical obstruction, and inadequate gas exchange-account for most ML exchanges. Worsening oxygenation during ECMO should prompt quantification of oxygen transfer. ML exchange is indicated when the ML can no longer meet the patient's oxygen demand. The partial pressure of Post-ML arterial oxygen less than 200 mmHg is the most important consideration in this decision. In some high-altitude regions of China, ECMO treatment is also routinely conducted. The experiences above are derived from low-altitude areas, and whether they apply in high-altitude regions is still being determined. This study aimed to explore the significantly lower membrane lung oxygen uptake in high-altitude regions compared to low-altitude areas.

Acute Respiratory Distress Syndrome (ARDS) is a syndrome characterized by respiratory distress and refractory hypoxemia caused by pulmonary and extra-pulmonary factors. Despite improvements in diagnosis and treatment in recent years, the mortality rate of severe ARDS is still around 40%. The distribution of lung lesions in ARDS patients is significantly gravity-dependent. Even with lung-protective ventilation strategies, tidal volume is concentrated in the ventral lung region, leading to ventilator-associated lung injury. Prone position ventilation can increase ventilation to the dorsal lung tissue and improve the ventilation-perfusion ratio, thus improving oxygenation. During prone position ventilation in ARDS patients, lung-protective ventilation strategies should be maintained, but with different respiratory mechanics from the supine position, requiring adjustment of ventilator parameters. Electrical Impedance Tomography (EIT) technology can be used for bedside monitoring of mechanically ventilated patients, providing real-time feedback on the patient's ventilation status and having great potential for clinical applications. Investigators believes that EIT monitoring during prone position ventilation in ARDS patients can individualize lung-protective ventilation strategies, minimize alveolar overdistension and collapse, improve the weaning success rate of invasive ventilation, and ultimately improve patient prognosis.

To explore the predictive value of Electroencephalography features in Perioperative Neurocognitive Disorders in patients undergoing cardiovascular surgery under general anesthesia

Through a randomized controlled trial (RCT) design, this study aiming to evaluated the efficacy and safety of rituximab lymph node injection combined with pulmonary vascular interventional therapy in treating fibrosing mediastinal pulmonary hypertension (FM-PH).Eligible participants were randomly assigned to either the combined treatment group, receiving both pulmonary vascular intervention and rituximab lymph node injection, or the interventional-only group, which received pulmonary vascular intervention alone. At 3, 6, and 12 months post-treatment, the efficacy was assessed based on symptom improvement, hemodynamic changes, lesion volume reduction, etc. Safety was mainly evaluated by comparing adverse event incidence between the two groups.

Pulmonary hypertension (PH) is a major global health concern, affecting approximately 1% of the world's population. With global aging and increased life expectancy, its incidence continues to rise. PH is a progressive and disabling disease, with studies showing its progression correlates with worsening symptoms and increased mortality. Even with targeted medications, the prognosis remains poor across PH subtypes, with PAH patients showing only a 49% 7-year survival rate. The 2022 ESC/ERS guidelines emphasize that PH management requires a comprehensive, multidisciplinary approach. Beyond pharmacological and surgical treatments, rehabilitation has demonstrated benefits in improving exercise capacity, quality of life, functional class, and peak oxygen consumption. However, research on specific and effective comprehensive pulmonary rehabilitation programs remains lacking.

Frailty refers to the age-related decline in physiological functions，that is associated with adverse outcomes. Frailty is a dynamic reversible state, that requires a comprehensive individualized management. Goal Attainment Scaling (GAS) is a structured, individualized method for setting and evaluating progress toward personalized goals. We conducted a randomized clinical trial of an individualized intervention program using GAS as evaluation method designed to improve physical functional in frailty elderly. A total of 160 individuals aged ≥60 years, who fulfill the Fried scale of frailty will be recruited from Beijing Chaoyang Hospital, Capital Medical University. All participants set personalized goals through GAS. Patients in the intervention group receive individualized interventions, implement tailored measures based on personalized goals to reverse the frailty state.The participants will be followed-up for 3 months and 24 months. This protocol would be established to examine the efficiency of targeted individualized intervention for frailty based on the GAS. If a positive consequence could be obtained, the results of this study will provide critical data for management of frailty in the elderly, that can be carried out in routine clinical practice.

This is a non-randomized, concurrent, parallel-controlled clinical trial. The objective of this trial is to determine the relationship between weight loss responsiveness to semaglutide in obese patients and their gut microbiota.

Periodontitis (gum disease) is an infection of the gums that can lead to tooth loss. In recent years, many types of dental lasers or other devices have been used for the non-surgical treatment of periodontal diseases. However, it remains unclear whether the combined application of laser and air polishing is effective as an adjuvant treatment for periodontitis. The purpose of this study is to compare the use of combined application of Er:YAG laser and sub-gingival air polishing powder, with the treatment of Er:YAG laser only, in periodontal diseases treatment in a Chinese population.

This is a randomized, double-blind, placebo-controlled clinical trial. The objective of this trial is to determine whether Lactobacillus paracasei LC19 supplementation has a positive effect on glucose lowering in patients with type 2 diabetes (T2D).

To determine whether high-intensity NPPV, compared with low-intensity NPPV, could have an effect on the subjective tolerance in patients with an AECOPD and hypercapnia.

Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.