Clinical trials

An open-label study will evaluate effects of Tezepelumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis

The goal of this clinical trial is to compare two commonly used opioid pain medications-alfentanil and remifentanil-during general anesthesia for surgery, and to find out whether alfentanil is as good as (not worse than) remifentanil in keeping patients stable (steady blood pressure and heart rate) and adequately pain-free during the operation. The study will enroll adults aged 18-65 years who are in good to fair health (ASA class I-III) and are scheduled for elective non-cardiac, non-brain surgery lasting 1 to 4 hours with expected blood loss under 500 mL. The main questions it aims to answer are: How often do patients need extra painkillers or blood-pressure medications during surgery (a "rescue event") when receiving alfentanil compared with remifentanil? How quickly do patients wake up, breathe on their own, and get discharged from the recovery room after the operation? Do patients experience differences in pain levels, nausea, vomiting, or thinking/memory problems in the days after surgery? If there is a comparison group: Researchers will compare the alfentanil group with the remifentanil group to see if the rate of rescue events with alfentanil is not more than 8% higher than with remifentanil (the non-inferiority margin). Both groups will receive the same standard anesthetic (propofol and muscle relaxants) and the same postoperative pain management; only the study opioid differs. Participants will: Sign an informed consent form and undergo screening tests, including blood work, physical exam, and medical history review. Be randomly assigned (like a coin flip) to receive either alfentanil or remifentanil during their operation, with the drug given through an IV. Neither the patient nor the care team will know which drug is given until after the study is completed. Have their blood pressure, heart rate, breathing, and brain activity (using BIS monitors to measure depth of anesthesia) continuously tracked during surgery. After surgery, be followed for up to 3 days, during which they will be asked to rate their pain (using a simple 0-10 scale) and complete a short memory/thinking test (MMSE) at set times. Provide small blood samples before, right after, and 24 hours after surgery to measure stress hormones and inflammation markers. This study will involve about 990 patients across multiple hospitals and will take about 2 years to complete. The results will help doctors choose the best opioid for safer, smoother surgeries and faster recovery.

This study aims to evaluate the safety, tolerability, and preliminary efficacy of ZR001, a novel chemogenetic gene therapy product, in patients with moderately advanced Parkinson's disease (PD). ZR001 is administered via stereotactic injection into the bilateral substantia nigra, followed by postoperative ultra-low-dose clozapine to activate the transduced direct pathway, with the goal of improving motor symptoms of Parkinson's disease.

This multicenter bidirectional cohort study aims to develop and externally validate a machine learning model for predicting the risk of acute exacerbation within 1 year in patients with allergic bronchopulmonary aspergillosis (ABPA) during the stable phase, and further to evaluate the model's practical value in risk stratification and clinical decision-making. All patients diagnosed with ABPA according to the ISHAM 2024 criteria will be assigned to either the acute exacerbation group or the non-exacerbation group based on whether they experience an acute exacerbation within 1 year. Enrolled participants will be randomly divided into a training set and an internal validation set. During the feature selection phase, univariate analysis, collinearity diagnostics, feature importance ranking derived from nine machine learning algorithms, and expert consensus are comprehensively applied, ultimately leading to the development of 12 independent machine learning models. Model performance is assessed using the receiver operating characteristic (ROC) curve and its area under the curve (AUC), sensitivity, specificity, F1-score, calibration curve, and decision curve analysis. In addition, external validation further enhances the credibility of the model. To improve clinical interpretability, the SHAP method is employed to quantify the contribution of each feature, and an interactive nomogram is constructed to facilitate clinical application. All participants will be followed up for 12 months, during which regular clinical and laboratory evaluations will be performed.

This multicenter bidirectional cohort study aims to investigate the clinical characteristics and prognostic outcomes of patients with allergic bronchopulmonary aspergillosis (ABPA) stratified by fungal microbiological status in sputum or bronchoalveolar lavage fluid (BALF). Patients diagnosed with ABPA according to the ISHAM 2024 criteria will be classified into fungal-positive and fungal-negative groups based on results from fungal culture, galactomannan (GM) testing, and metagenomic next-generation sequencing (mNGS) of sputum or BALF samples. The study will compare baseline clinical features, laboratory findings, radiological characteristics, treatment response, and long-term outcomes, including acute exacerbation rate and time to first exacerbation, between the two groups. All participants will be followed for up to 12 months with serial clinical and laboratory assessments.

This multicenter, prospective, randomized controlled trial aims to evaluate whether a novel multifunctional oropharyngeal airway (MOPA) reduces the incidence of hypoxemia in 1,518 adult patients (ASA I-II, aged 18-80 years) undergoing elective sedated gastrointestinal endoscopy. Patients are randomized 1:1 to receive either the MOPA (which integrates oxygen delivery, PETCO₂ monitoring, and airway support) or conventional nasal cannula with standard mouthpiece. The primary endpoint is the incidence of hypoxemia (75% ≤ SpO₂ \< 90% for \<60 seconds) during the procedure. Secondary outcomes include severe hypoxemia, hypercapnia, PETCO₂ monitoring success, airway interventions, adverse events, and satisfaction scores. The study is conducted across 29 centers in China, with centralized randomization via an EDC system, blinded outcome assessment, and statistical analysis using a two-sided alpha of 0.05 (power 90%). Results are expected to provide high-level evidence for optimizing airway management during sedated endoscopy.

To develop and externally validate a machine learning model for predicting the 1-year risk of relapse in patients with stable ABPA, and to further evaluate its value in risk stratification and clinical decision-making.

Postoperative delirium (POD) is a common acute and transient form of brain dysfunction in elderly patients following surgery that can lead to serious adverse clinical outcomes and even death. Although existing studies have preliminarily investigated the effects of opioid-free anaesthesia (OFA) on POD, high-quality evidence on these effects for elderly patients undergoing gastrointestinal surgery remains limited. This study aims to investigate the effects of OFA on the development of POD in elderly patients following gastrointestinal surgery. This single-centre, prospective, randomized controlled trial will be conducted at the First Affiliated Hospital of Shandong First Medical University, China. A total of 654 patients aged 65 years or older who are scheduled for elective gastrointestinal surgery will be randomly allocated to receive either opioid-free anaesthesia (OFA; dexmedetomidine, esmolol, and esketamine) or conventional opioid-based anaesthesia (OBA). The primary outcome is the incidence of POD 7 days after surgery. The secondary outcomes are all-cause mortality within 30 days after surgery, intraoperative haemodynamic changes, the 15-item quality of recovery (QoR-15) scores at 24 h, 48 h, and 72 h after surgery, complications during postoperative hospitalization, pain numerical rating scale (NRS) score at 72 h after surgery, incidence of nausea and vomiting at 72 h after surgery, morphine milligram equivalent for analgesics at 72 h after surgery, duration of anaesthesia (from induction to discontinuation), duration of surgery (from skin incision to the last suture), duration of post-anaesthesia care unit (PACU) stay, and length of hospital stay. The results of this study may shed light on the effects of OFA on POD in elderly patients undergoing gastrointestinal surgery. The study is designed on the basis of the following key hypothesis: the use of opioid drugs for anaesthesia may increase the risk of POD through mechanisms such as blood-brain barrier destruction, neuroinflammatory responses, and central nervous system depression. Through the single-centre and prospective design of this randomized controlled trial, this study will directly analyse differences in the effects of OFA and conventional OBA on the incidence of POD, haemodynamic stability and long-term cognitive function in elderly patients.

An open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis

To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.

Background: According to GLOBOCAN 2022 statistics, colorectal cancer has become the third most common cancer disease worldwide, and also the second leading cause of death. The incidence rate of rectal cancer is particularly prominent. Radiotherapy is one of the important methods for comprehensive treatment of rectal cancer, but the radiation damage caused by radiotherapy cannot be ignored. During radiotherapy for rectal cancer, the skin of the anal canal will be damaged by radiation, resulting in acute radiation dermatitis, which is characterized by redness, pain, and ulcers. The main symptom of patients is anal pain. As the radiation dose accumulates, the skin damage to the anal canal becomes increasingly severe, and the patient's anal pain becomes more severe, which seriously affects the patient's quality of life. Mepilex Lite Dressings can absorb the exudate, keep it moist, promote the healing of radioactive dermatitis, and relieve pain. However, when inserting into the anal canal, the patient reported significant pain that was difficult to tolerate. Therefore, indomethacin suppositories were administered rectally before inserting the dressing, which has been proven to have a reliable analgesic effect by research. In summary, the main objective of this study is to determine the effectiveness of Mepilex Lite Dressings combined with indomethacin suppositories in the treatment of acute radiation dermatitis of anal canal skin in patients with rectal cancer undergoing radiotherapy. Method: The research plan will be a prospective randomized controlled trial. Participants were randomly divided into an experimental group (n=137) and a control group (n=137) using a simple randomization method. The control group received indomethacin suppositories and routine nursing measures, while the experimental group received the same treatment as the control group and received insertion of Meipile Lite Dressing into the anal canal. The primary outcome measure was the effective rate of treatment for acute radiation dermatitis of the anal canal skin on the 14th day after intervention, and the secondary outcome measure was the effective rate of treatment for acute radiation dermatitis of the anal canal skin on the 7th and 21st days after intervention. At the same time, a questionnaire survey was conducted using the Digital Pain Assessment Scale, Anxiety and Depression Scale, Pittsburgh Sleep Quality Index, and Skin Disease Patient Quality of Life Scale at baseline and on the 7th, 14th, and 21st days after intervention.

This is a prospective, multicenter, real-world observational study to evaluate the impact of perioperative parenteral nutrition (PN) with fish oil-containing lipid emulsion on outcomes in adult patients with constipation undergoing elective colon surgery. The study will compare two clinical nutrition strategies: (1) PN with fish oil-containing lipid emulsion started before surgery and continued after surgery, and (2) PN with fish oil-containing lipid emulsion started only after surgery. Eligible participants are adults (18-75 years) with slow-transit constipation (STC) or megacolon who are scheduled for elective colon surgery and have nutritional risk (NRS2002 score \>=3). The primary objective is to compare the incidence of postoperative complications between these two PN timing strategies. Secondary objectives include comparison of perioperative nutritional status, postoperative inflammatory status, prognosis, and safety outcomes. This study will collect and analyze clinical data, laboratory indicators, perioperative recovery outcomes, follow-up assessments, and safety information in routine clinical practice. Outcomes include postoperative complication rates, changes in nutritional and inflammatory markers, bowel function recovery, length of hospital stay, constipation-related symptoms, quality of life, and adverse events. No experimental intervention will be assigned as part of this observational study. The planned sample size is 306 participants. The findings may help optimize perioperative nutritional support strategies for patients with constipation undergoing surgery.

To evaluate the efficacy and safety of bronchoscopic airway clearance and amphotericin B spraying in the treatment of allergic bronchopulmonary aspergillosis

This study conducted a comprehensive evaluation of commonly used neuroprotective agents in acute ischemic stroke, assessing their real-world value across six dimensions: safety, efficacy, cost-effectiveness, innovativeness, appropriateness, and accessibility. Employing a prospective observational design, it primarily investigates the association of edaravone and dexrazoxane with clinical outcomes in patients with mild-to-moderate stroke, with subgroup analyses performed according to Trial of Org 10172 in Acute Stroke Treatment （TOAST ）classification.

In total knee arthroplasty (TKA), the use of a tourniquet and controlled hypotension is common. However, ischemia-reperfusion injury induced by the tourniquet and inappropriate controlled hypotension can lead to cardiac and cerebral damage in patients. Consequently, maintaining hemodynamic stability, ensuring adequate cerebral perfusion, and achieving controlled blood pressure during the perioperative period are critical factors influencing patient outcomes. Postoperatively, patients typically experience moderate to severe pain. Severe postoperative pain can result in prolonged hospital stays, increased readmission rates, elevated opioid consumption, and associated nausea and vomiting. Therefore, exploring effective multimodal postoperative pain management strategies is essential. Nalbuphine, an opioid analgesic acting as a full kappa-receptor agonist and a partial mu-receptor antagonist, is considered to provide analgesic efficacy equivalent to morphine while potentially offering advantages in maintaining hemodynamic stability. This study aims to investigate the effects of administering equivalent doses of nalbuphine at different perioperative time points on analgesia and hemodynamics in elderly patients undergoing knee arthroplasty.

The goal of this clinical trial is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of remimazolam (CNS 70754) in healthy adult participants. The main questions it aims to answer are: What are the key pharmacokinetic parameters of remimazolam, including peak concentration (Cmax), time to peak concentration (Tmax), area under the curve (AUC), and elimination half-life (T1/2)? What is the effect of remimazolam on consciousness, as measured by the MOAA/S scale and Narcotrend monitoring during anesthesia? Researchers will compare the pharmacokinetic and pharmacodynamic effects of remimazolam to see if the drug provides consistent and predictable sedation without significant adverse effects. Participants will: Receive continuous Infusion of Remimazolam. Have blood samples taken at various time points to measure plasma concentrations and calculate PK parameters. Be monitored for consciousness and sedation levels using the MOAA/S scale and Narcotrend. Undergo safety assessments, including laboratory tests, vital signs monitoring, and physical examinations throughout the study. This study will help determine the drug's behavior in the body and its impact on sedation, providing valuable information for its future clinical use in anesthesia and other medical applications. Last updated on December 22, 2024

This study is a single-arm, multicenter clinical trial evaluating the efficacy and safety of radiotherapy combined with TAS-102 monotherapy in elderly patients with locally advanced esophageal cancer. Treatment Phase: The treatment phase is divided into a Phase I stage and a Phase II stage. The Phase I stage aims to explore the maximum tolerated dose (MTD) of TAS-102 in elderly esophageal cancer patients. A total of 9 subjects were enrolled, and the dose was escalated from 30 mg/m² in 5 mg/m² increments up to 40 mg/m². The MTD was defined as the highest drug dose at which no dose-limiting toxicity (DLT) was observed in more than 40% of treated patients during the first two weeks of combined radiotherapy and TAS-102 administration. The Phase II stage aims to investigate the efficacy of radiotherapy combined with TAS-102 at the MTD in elderly esophageal cancer patients, with 36 subjects enrolled. Consolidation Phase: Following the treatment phase, subjects had a 3-4 week rest period. This was followed by consolidation therapy with TAS-102 monotherapy at a dose of 35 mg/m², administered twice daily on days 1-5 of a 28-day cycle for two cycles. Subsequently, patients entered the efficacy and safety follow-up phase until the study endpoints were reached or after a full 2-year follow-up period.

This study aims to investigate whether preoperative NLR (Neutrophil-to-Lymphocyte Ratio) serves as a biomarker for PONV (Postoperative Nausea and Vomiting). It also examines the impact of erector spinae plane block on NLR and PONV. Furthermore, the research explores the effect of erector spinae plane block on postoperative pain relief in spinal surgery and its influence on the usage of opioid medications.

Non-intubated Thoracoscopic surgery (NITS) is a newly emerging minimally invasive surgical technique in recent years . Compared with traditional intubation general anesthesia, it has the advantages of less trauma, faster recovery and fewer complications . This surgical method allows patients to perform under local anesthesia or regional block and moderate sedation, providing a physiologic ventilation method , reducing the intervention on the respiratory system and conducive to rapid postoperative recovery. The importance of sedative drugs in non-intubated thoracoscopic surgery Successful implementation of non-intubated thoracoscopic surgery requires sound regional block, airway management, and rational use of intravenous sedation and analgesics . In addition, sedative drugs need to have less respiratory and circulatory inhibition and fewer side effects. Propofol, as the most commonly used sedative drug, has a high incidence of adverse reactions such as injection pain and respiratory and circulatory inhibition. A large number of meta-analyses and systematic reviews have compared the sedative effects of remazolam and propofol, proving that Remazolam, as a new sedative, has advantages such as short half-life, rapid onset, rapid recovery, and light respiratory and circulatory inhibition.Compared with traditional benzodiazepines, Remazolam has a shorter half-life, which is conducive to rapid postoperative wakeup and reduces the risk of discomfort and cognitive dysfunction in patients. In addition, remazolam has little influence on the respiratory system and is relatively stable on the circulatory system ，which is an ideal sedation option for non-intubated thoracoscopic surgery that retains spontaneous respiration. Afentanil mainly acts on μ opioid receptors , and its analgesic intensity is about 15 times that of morphine, which has the advantages of rapid onset, short duration of action, rapid recovery, high safety, and few adverse reactions . Afentanil has a short half-life , mild respiratory depression, low incidence of cough, postoperative nausea and vomiting . Remazolam combined with afentanil is widely used in various surgeries or examinations that preserve spontaneous breathing, such as gastroenteroscopy, ERCP, hysteroscopy, short-term plastic surgery and fiberbronchoscopy, and has shown the advantage of light respiratory circulation inhibition . We speculate that remazolam combined with afentanil may have certain advantages in non-intubated thoracoscopic surgery that retains spontaneous breathing. At present, the application of remazolam combined with afentanil in non-intubated thoracoscopic surgery is still lacking. The purpose of this study was to observe the safety and effectiveness of remazolam combined with afentanil in non-intubated thoracoscopic surgery, and to provide a better choice of sedation drugs for non-intubated thoracoscopic surgery.

This study aims to reveal the immune and inflammatory regulatory molecular mechanisms related to the progression of allergic bronchopulmonary aspergillosis (ABPA), and to build a precision typing based on inflammation and identify the biomarkers of typing, and to explore the clinical outcomes of different inflammatory phenotypes.

This is a single-arm, multi-center, exploratory study evaluating the efficacy and safety of iparomlimab and tuvonralimab (QL1706) in combination with bevacizumab for the treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic colorectal cancer. Eligible participants who meet the inclusion and exclusion criteria will provide written informed consent and receive QL1706 at 5.0 mg/kg and bevacizumab at 7.5 mg/kg on Day 1 of every 3-week cycle (Q3W), until disease progression or completion of 2 years of treatment. The primary endpoint of this study is objective response rate (ORR). Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), PFS and OS rates at 6, 12, and 24 months, and safety.

Background Postoperative delirium (POD) is a common acute and transient form of brain dysfunction in elderly patients following surgery that can lead to serious adverse clinical outcomes and even death. Although existing studies have preliminarily investigated the effects of opioid-free anaesthesia (OFA) on POD, high-quality evidence on these effects for elderly patients undergoing gastrointestinal surgery remains limited. This study aims to investigate the effects of OFA on the development of POD in elderly patients following gastrointestinal surgery. Methods and analysis: This single-centre, prospective, randomized controlled trial will be conducted at the First Affiliated Hospital of Shandong First Medical University, China. A total of 406 patients aged 65 years or older who are scheduled for elective gastrointestinal surgery will be randomly allocated to receive either opioid-free anaesthesia (OFA; dexmedetomidine, esmolol, and esketamine) or conventional opioid-based anaesthesia (OBA). The primary outcome is the incidence of POD 7 days after surgery. The secondary outcomes are all-cause mortality within 30 days after surgery, intraoperative haemodynamic changes, the 15-item quality of recovery (QoR-15) scores at 24 h, 48 h, and 72 h after surgery, complications during postoperative hospitalization, pain numerical rating scale (NRS) score at 72 h after surgery, incidence of nausea and vomiting at 72 h after surgery, morphine milligram equivalent for analgesics at 72 h after surgery, duration of anaesthesia (from induction to discontinuation), duration of surgery (from skin incision to the last suture), duration of post-anaesthesia care unit (PACU) stay, and length of hospital stay. Discussion: The results of this study may shed light on the effects of OFA on POD in elderly patients undergoing gastrointestinal surgery. The study is designed on the basis of the following key hypothesis: the use of opioid drugs for anaesthesia may increase the risk of POD through mechanisms such as blood-brain barrier destruction, neuroinflammatory responses, and central nervous system depression. Through the single-centre and prospective design of this randomized controlled trial, this study will directly analyse differences in the effects of OFA and conventional OBA on the incidence of POD, haemodynamic stability and long-term cognitive function in elderly patients. gastrointestinal surgery.

The main purpose of this study is to investigate whether long-term oral administration of Staphylococcus albicans tablets can significantly reduce the number of acute exacerbations in patients with bronchiectasis. Secondary objective is to explore whether long-term oral administration of Staphylococcus albicans tablets can reduce the risk of hospitalization in patients with bronchiectasis and whether it can improve the quality of life of patients. Other purpose is to explore the regulatory effect of long-term oral administration of Staphylococcus albicans tablets on the immune function of patients with bronchiectasis.

This study is a multicenter, prospective, observational study aimed at investigating the efficacy and safety of triple targeted drug therapy in patients with arterial pulmonary hypertension (PAH) who are not at low risk and are receiving initial treatment. The prognosis of arterial pulmonary hypertension is explored.

The management of serum potassium in maintenance hemodialysis（MHD ）patients is one of the hot topics at present. In order to control hyperkalemia in dialysis patients, the use of hypokalemic dialysate is the most important measure to reduce potassium. This measure effectively reduces serum potassium, but increases the risk of hypokalemia after dialysis, which increases the risk of all-cause death in patients. Hyperkalemia and hypokalemia during and at the end of dialysis are important factors for arrhythmia and death in MHD patients. Due to the intermittent nature of hemodialysis treatment, MHD patients often experience frequent fluctuations in serum potassium, which is a potential risk factor for poor prognosis of MHD patients. Serum potassium variability can better reflect the potassium homeostasis in MHD patients. In addition to hyperkalemia and hypokalemia, serum potassium variability is a potential risk factor affecting the prognosis of MHD patients. At present, there are few studies on the effect of improving serum potassium variability on cardiovascular complications, especially multi-center randomized controlled trials. In this study, sodium zirconium cyclosilicate was used to control hyperkalemia before dialysis and increase potassium concentration in dialysate, so as to reduce the risk of hypokalemia after dialysis, and to verify whether improving serum potassium variability can reduce myocardial injury in hemodialysis patients.