Clinical trials

Trauma causes at least 5.8 million deaths worldwide annually, accounting for 1 in 10 of all global deaths. Uncontrolled bleeding within 24 hours after trauma is the leading cause of death in trauma patients, and about one-third of patients present with trauma-induced coagulopathy on admission. Fatal severe traumatic hemorrhage is the most common preventable factor contributing to death. Tranexamic acid (TXA), a synthetic lysine derivative, competitively inhibits plasminogen activation, preventing fibrin clot breakdown and thereby enhancing hemostasis and reducing blood loss. Randomized controlled trials such as CRASH-2 have confirmed that TXA significantly reduces mortality in patients with severe traumatic bleeding. TXA has therefore become a cornerstone of traumatic hemorrhage treatment, with current international guidelines recommending 1 g intravenous bolus (over \>10 minutes) plus 1 g intravenous maintenance infusion (over 8 hours). However, severe traumatic hemorrhage is typically managed in high-pressure, chaotic battlefield or emergency settings, where this complex, time-sensitive, multi-step divided regimen is difficult to fully execute in real-world practice. The omission rate of the second maintenance infusion is particularly high, reaching up to 67% during prehospital-to-hospital handover. Rowell et al. showed that even with a strict research protocol, completion of the planned 8-hour in-hospital maintenance infusion was only about 70%. Previous pharmacokinetic studies found that without the second maintenance dose, 21% of patients receiving an initial 1 g dose had already failed to achieve effective plasma concentrations at hospital admission (approximately 1.5 hours post-dose). Thus, the inherent difficulty of fully executing the divided regimen may prevent patients from receiving the full benefits of TXA. To address this, a simplified regimen of a single 2 g loading dose without maintenance infusion has been recommended in recent expert consensus statements, especially for prehospital or battlefield settings. However, these recommendations were mainly based on the 2020 Rowell et al. randomized controlled study, whose exploratory analysis suggested potential mortality reduction with the simplified regimen. That study enrolled patients with traumatic brain injury and had limited statistical power, so evidence on the efficacy and safety of the simplified regimen in patients with severe traumatic hemorrhage remains lacking. Based on the pharmacokinetic study by Grassin-Delyle et al., a single 2 g loading dose is hypothesized to maintain effective concentrations during the peak fibrinolytic period (within 3 hours post-injury), while the transient peak plasma concentration remains well below the toxicity threshold of 500 μg/mL. We therefore hypothesize that, in patients with severe traumatic hemorrhage, the simplified TXA regimen is non-inferior to the divided regimen in efficacy, including bleeding control. However, the primary limitation of a large randomized controlled trial to verify this hypothesis is that safety concerns regarding the simplified regimen due to higher transient plasma concentrations compared with the divided regimen have not been clearly resolved. Previous systematic reviews concluded that safety events such as thrombosis and seizures are dose-dependent, and that a total daily dose not exceeding 2 g is safe. Previous pharmacokinetic studies also suggest that the transient peak concentration of the simplified regimen should be well below the toxicity threshold. Although expert consensus has recommended the simplified regimen, suggesting it can be considered safe, studies directly comparing the two regimens are lacking, particularly regarding whether the simplified regimen increases safety risks when the total dose is identical. Before conducting a larger, more definitive efficacy trial, it is also important to evaluate recruitment rates, protocol adherence, accurate sample size estimation, and other potential barriers. For these reasons, we designed this pilot study, primarily to evaluate the safety of the simplified TXA regimen compared with the divided regimen in patients with traumatic hemorrhagic shock, and the feasibility of a subsequent randomized controlled trial.

The goal of this retrospective observational study is to evaluate the effectiveness of retrobulbar glucocorticoid injection in patients with retinal photo-injury. The main questions it aims to answer are: Does retrobulbar glucocorticoid injection improve visual outcomes in patients with retinal photo-injury? Does retrobulbar glucocorticoid injection promote recovery of retinal structural and microvascular changes assessed by optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA)? Patients with retinal photo-injury will be retrospectively identified and grouped according to the treatment they received. Clinical and ophthalmic data collected before treatment and during follow-up for up to 6 months will be reviewed, including best-corrected visual acuity (BCVA), fundus photography, spectral-domain OCT (SD-OCT), and OCTA. Visual and retinal imaging outcomes will be compared between the two groups to evaluate the potential effectiveness of retrobulbar glucocorticoid treatment.

Clinical Trial Abstract Nasal bone fracture is the most common traumatic disease in otorhinolaryngology, which adversely affects nasal appearance and physiological function. Traditional closed reduction relies merely on visual observation and palpation without objective intraoperative evaluation, often leading to insufficient reduction in comminuted, overlapping, or severely swollen fractures and residual nasal deformity. Musculoskeletal ultrasound features real-time dynamic imaging, radiation-free performance, and convenient operation, enabling visualized and precise fracture reduction. However, conventional ultrasound imaging for nasal bones is compromised by air interference due to the protruding nasal structure. This study aims to determine the optimal scanning parameters and suitable coupling agents for high-quality nasal bone imaging by enrolling healthy volunteers and fracture patients. Furthermore, it compares operative duration, postoperative CT scores, and physician and patient satisfaction between traditional reduction and ultrasound-assisted reduction groups. This study intends to establish a standardized intraoperative ultrasound-assisted nasal bone reduction protocol to improve reduction accuracy and clinical satisfaction.

This clinical trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with social anxiety disorder (SAD). The study addresses the following key research questions: * Does taVNS demonstrate preliminary clinical efficacy in the treatment of SAD? * What adverse events may occur during taVNS treatment, and what is the treatment compliance of the subjects?

In the management of locally advanced esophageal squamous cell carcinoma, the outcomes associated with surgical resection, whether conducted alone or supplemented with postoperative adjuvant radiotherapy and chemotherapy, have been suboptimal. Immune checkpoint inhibitors (ICIs) have shown potential in enhancing the immune system's capacity to target and eliminate cancer cells. Evidence suggests that the concurrent administration of JAK inhibitors with ICIs may improve anti-cancer efficacy, increase patient response rates, and prolong progression-free survival compared to ICIs alone. This prospective, exploratory study aims to assess the efficacy of combining camrelizumab, chemotherapy, and Ivarmacitinib in neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma, with the objective of broadening therapeutic options for this malignancy.

In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. It is recommended that a treatment strategy be employed that integrates surgery with radiotherapy, chemotherapy, or immunotherapy, in order to enhance overall survival by improving local-regional tumor control and addressing microscopic metastases. Clinical research indicates that combining anti-PD-1/L1 and anti-VEGF antibodies enhances anti-tumor effects in esophageal squamous cell carcinoma. Ivonescimab, a humanized bispecific monoclonal antibody targeting PD-1/VEGF. This single-arm, prospective, exploratory study is planned to evaluate the combination of ivonescimab and chemotherapy in neoadjuvant therapy for resectable esophageal squamous cell carcinoma, with the aim of providing new therapeutic options for this condition.

The goal of this clinical trial is to learn whether Chinese herbal acupoint application, when added to standard three-drug anti-nausea treatment, can prevent nausea and vomiting caused by chemotherapy in people with breast cancer. The study will also evaluate the safety of the Chinese herbal acupoint application. The main questions it aims to answer are: * Does Chinese herbal acupoint application help participants have less nausea during the first 5 days after chemotherapy? * Does it reduce vomiting and the need for additional anti-nausea medicine? * Does it affect the impact of chemotherapy-related nausea and vomiting on daily life? * What medical problems or side effects occur with the Chinese herbal acupoint application? Researchers will compare Chinese herbal acupoint application with a sham application. Both groups will receive standard three-drug anti-nausea treatment. The sham application looks and feels similar to the herbal application but does not contain the active herbal ingredients. Participants will: * Receive one cycle of planned chemotherapy and standard three-drug anti-nausea treatment. * Receive either the Chinese herbal acupoint application or sham application before chemotherapy. The application will be placed on selected acupuncture points for 4 to 6 hours. * Record nausea, vomiting, and use of additional anti-nausea medicine during the first 5 days after chemotherapy. * Complete a questionnaire about how nausea and vomiting affect daily life. * Have safety follow-up for about 2 weeks after chemotherapy.

Malignant bone tumors often lead to skeletal complications, known as skeletal related events (SRE). These complications mainly include pathological fractures, severe pain, and spinal cord compression. Typically, SRE reduces overall survival rates and is associated with loss of mobility and social functioning, decreased quality of life, and significantly increased healthcare costs. Surgical resection is an important means of treating malignant bone tumors. The main goal of surgical treatment is to maintain the patient's function and mobility by relieving pain, preventing impending fractures and/or nerve compression, or stabilizing pathological fractures. Surgery for malignant bone tumors often requires extensive exploration, osteotomy, and prosthetic reconstruction. The surgery involves significant trauma and excessive bleeding from the wound. Therefore, there is a significant risk of perioperative blood loss and transfusion during surgery for malignant bone tumors. However, blood transfusion also brings transfusion related risks to patients, increases the incidence of postoperative complications, and increases the healthcare burden on patients and society. Acute normovolemic hemodilution (ANH) may help reduce allogeneic red blood cell transfusion. However, There is a lack of high-quality evidence to support the use of ANH in bone cancer surgery.

The TOP-MDRVAP trial will test whether inhaled tobramycin can safely prevent pneumonia caused by multidrug-resistant bacteria in adults who need a breathing machine. Tobramycin is an antibiotic. Multidrug-resistant bacteria are bacteria that resist treatment with several types of antibiotics. Pneumonia that develops in patients receiving breathing support through a breathing tube is called ventilator-associated pneumonia (VAP). This study will evaluate tobramycin as a preventive treatment, rather than as treatment for existing VAP. The study plans to enroll 574 adults aged 18 years or older in intensive care units (ICUs) at several hospitals. Participants must have received breathing support through a tube for 72 to 96 hours and be expected to need this support for at least another 72 hours. They must have at least one risk factor for infection with multidrug-resistant bacteria and must not have suspected or confirmed VAP when entering the study. Participants will be assigned by chance to one of two groups, with an equal chance of entering either group. One group will receive tobramycin inhalation solution, 300 mg in 5 mL, twice daily for 3 consecutive days. The other group will receive 5 mL of 0.9% saline, a saltwater solution containing no antibiotic, on the same schedule. A nebulizer will turn the solution into a fine mist delivered through the breathing tube. Both groups will receive standard measures to prevent VAP. Participants, their representatives, the healthcare professionals providing their direct care, and the researchers assessing outcomes will not know which study treatment each participant receives. The main question is whether fewer participants develop VAP caused by multidrug-resistant bacteria within 28 days after assignment to a study group. Researchers will also compare the occurrence of VAP from any cause, antibiotic use, time receiving breathing support, time spent in the ICU and hospital, and deaths within 28 and 90 days. Participants will be monitored for possible side effects, including kidney problems, narrowing of the airways, and complications involving the breathing tube or equipment. Samples will be tested for bacteria and antibiotic resistance. Follow-up will continue for up to 90 days after assignment, using hospital records or telephone contact to assess survival and recovery milestones, including discharge and the end of breathing support.

This is a single-center, prospective observational study. We aim to evaluate the performance of transdermal glomerular filtration rate (TGFR) compared with baseline estimated glomerular filtration rate (eGFR) for early prediction of contrast-associated acute kidney injury (CA-AKI) in emergency patients scheduled for contrast-enhanced CT. Eligible participants are adult emergency patients with baseline eGFR between 15 and 120 mL/min/1.73m². TGFR monitoring will be performed during the peri-contrast CT period. We will collect clinical and laboratory data and follow up renal function after contrast exposure to analyze the predictive value of TGFR for CA-AKI. No extra therapeutic interventions will be applied in this study.

The goal of this clinical trial is to determine the effect of pre-operative dexmedetomidine on periprocedural myocardial injury in patients having percutaneous coronary intervention (PCI). The specific research hypothesis is that intranasal administration of 100 μg dexmedetomidine (DEX) reduces the incidence of periprocedural myocardial injury within 48 hours after PCI, as compared with normal saline. Participants will be randomly assigned in a 1:1 ratio to two groups: the dexmedetomidine group and the placebo group.

This multicenter, prospective, observational, real-world clinical study aims to evaluate the efficacy and safety of Aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) by prospectively observing changes in symptoms, biomarkers, imaging findings, and adverse reactions, etc. It will also record the dosing regimens at which individual patients achieve steady state, and explore the treatment patterns of Aficamten in Chinese patients with symptomatic nHCM.

Acute ischemic stroke may result in substantial disability despite timely reperfusion therapy because ischemic and reperfusion-related brain injury can continue before, during, and after restoration of blood flow. This investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate whether a protocolized Stimulation-Temperature-Oxygen-Positioning (STOP) multimodal neuroprotective strategy added to guideline-based reperfusion therapy and stroke-unit care improves 90-day functional outcome compared with standard care alone. A total of 380 adults with acute ischemic stroke treated with intravenous thrombolysis and/or endovascular therapy within 24 hours of symptom onset or last known well will be randomized in a 1:1 ratio to the STOP strategy plus standard care or standard care alone. The STOP strategy comprises transcutaneous auricular vagus nerve stimulation, protocolized normothermia targeting a body temperature of 37.5 °C or lower, high-flow normobaric oxygen, and dynamic head positioning according to reperfusion treatment and recanalization status. The primary outcome is the ordinal distribution of modified Rankin Scale scores at 90 days after randomization. Blinded assessors will evaluate functional outcomes, and a blinded central imaging core laboratory will adjudicate imaging outcomes. Among participants with anterior-circulation large-vessel occlusion who undergo endovascular therapy, eligible and consenting participants may additionally enter an embedded randomized substudy evaluating selective intra-arterial infusion of 4 °C isotonic saline during thrombectomy.

The goal of this clinical trial is to evaluate whether AI-assisted workflows improve physicians' admission diagnosis and management planning performance on standardized simulated inpatient cases, among practicing internal medicine and surgery physicians across all seniority levels and across three tiers of the Chinese healthcare system. The main questions it aims to answer are: * Does the Agent-assisted workflow yield better structured admission diagnosis and management planning scores than standalone LLM assistance? * Does the Agent-assisted workflow outperform the traditional workflow without AI tools? Researchers will compare three parallel groups (traditional workflow group, LLM-assisted group, Agent-assisted group) to determine whether the Agent tool can improve diagnostic accuracy and efficiency. The goal of this clinical trial is to evaluate whether AI-assisted workflows improve physicians' admission diagnosis and management planning performance on standardized simulated inpatient cases, among practicing internal medicine and surgery physicians across all seniority levels and across three tiers of the Chinese healthcare system. The main questions it aims to answer are: * Does the Agent-assisted workflow yield better diagnosis and management planning scores than the LLM-assisted workflow? * Does the Agent-assisted workflow yield better diagnosis and management planning scores than the conventional workflow without AI assistance? Researchers will compare three parallel groups (traditional workflow group, LLM-assisted group, Agent-assisted group) to determine whether the agent tool can improve diagnostic and management planning performance and efficiency. Participants will: * Be recruited from 15 hospitals in China and participate remotely under video proctoring * Be randomly assigned to one of the three fixed workflows, with randomization stratified by hospital tier, specialty and seniority * Work through 6 anonymized simulated HIS admission cases and complete as many as they can. * Submit structured answers for each case covering principal diagnosis, secondary diagnoses, differential diagnoses, diagnostic justification, next diagnostic or therapeutic steps, consultation and referral decisions, and diagnostic confidence. * Have their operation logs and time consumption recorded automatically by the study platform. * Complete a post-session questionnaire after submitting all cases.

This study is a multicenter, single-arm, open-label Phase II exploratory clinical trial designed to evaluate whether prophylactic use of leucogen can reduce the incidence of Grade 3 or higher neutropenia in early-stage HR+/HER2- breast cancer patients receiving ribociclib combined with endocrine therapy. The study plans to enroll 97 patients using a Simon two-stage design, with the primary endpoint being the incidence of severe neutropenia within 4 treatment cycles (4 months) after initiation. Secondary endpoints include the incidence of all-grade neutropenia, febrile neutropenia, ribociclib treatment intensity, and safety. The study will systematically assess the preventive efficacy and safety of leucogen to provide a basis for subsequent Phase III randomized controlled trials.

Acute ST-segment elevation myocardial infarction (STEMI) is a life-threatening emergency requiring immediate intervention. The incidence of premature coronary artery disease (PCAD) is rising rapidly in China; its long-term prognosis remains poor and it frequently progresses to acute myocardial infarction, necessitating high-risk therapies such as primary percutaneous coronary intervention (PCI) or coronary artery bypass grafting, thereby imposing enormous economic and psychological burdens on patients and their families. Moreover, the cumulative 6-year rate of death or myocardial infarction after implantation of the latest-generation drug-eluting stents still reaches 15%, and management of stent failure is extremely challenging. Drug-coated balloon (DCB) angioplasty-representing the "leave-nothing-behind" paradigm-is a highly promising option in young subjects. Accumulating clinical evidence demonstrates that DCB provides favorable efficacy across a broad spectrum of lesions, including small-vessel and large-vessel de novo disease, bifurcation lesions, and in-stent restenosis. Nevertheless, high-quality data on the impact of DCB angioplasty in de novo large-vessel disease and in the setting of acute STEMI are still lacking.

Clinical Study Abstract (Ethics Application) Hereditary hemorrhagic telangiectasia (HHT) is a rare autosomal dominant vascular disorder characterized by recurrent intractable epistaxis and multi-organ arteriovenous malformations. Moderate-to-severe patients often develop refractory anemia with severely impaired quality of life. Current stepwise therapeutic strategies have substantial limitations, including frequent adverse reactions of thalidomide, high recurrence rates after electrocoagulation, and severe surgical trauma, resulting in a lack of safe and individualized treatment options. Our preliminary clinical practice has verified the promising efficacy and long-term benefits of bevacizumab in severe HHT-related epistaxis. However, obvious interindividual variability and occasional adverse events exist, and the underlying mechanism remains unclear. This study aims to systematically evaluate the efficacy and safety of bevacizumab for severe HHT-associated epistaxis, explore the influences of baseline clinical and genetic factors on prognosis, and investigate the mechanism of treatment heterogeneity, so as to optimize individualized therapeutic strategies and provide clinical evidence for precise management of HHT in China.

This is a prospective, single-arm, single-center phase I/II clinical trial evaluating the safety, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of simultaneous integrated boost accelerated hyperfractionated radiotherapy in patients with high-proliferation non-small cell lung cancer (NSCLC).

This is a single arm, multi-center clinical trial. The goal of this clinical trial is to evaluate the efficacy, safety and biomarkers of Tafolecimab combined with Sintilimab and Chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). Tafolecimab is a recombinant fully humanized monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK-9), which can reduce low-density lipoprotein-C levels and increase the expression level of major histocompatibility complex class I (MHC-I) on tumor cells. Sintilimab is a fully humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1).

This study is a prospective cohort study aimed at exploring the baseline characteristics and treatment patterns of the Chinese population with hypertrophic cardiomyopathy (HCM) in real-world settings. The objective is to assess the real-world treatment approaches and longitudinal outcomes in this population.

The purpose of this study was to evaluate the efficacy and safety of fexofenadine hydrochloride on the basis of standard treatment after PCI in STEMI patients.

A large number of patients undergoing radiotherapy and chemotherapy are suffering from dry mouth. Due to reduced saliva secretion, patients may experience symptoms such as difficulty chewing and swallowing. In severe cases, they may also experience pain and burning sensation in the oral mucosa, decreased taste, ulcers, which seriously affect the quality of life of patients. However, radiation-induced dry mouth lacks early objective predictive indicators (molecular biomarkers) and the mechanism is unclear. Only when patients experience clinical symptoms will symptomatic treatment be taken to alleviate them. Therefore, elucidating the mechanism of radiation-induced dry mouth syndrome (RIX) and achieving early prediction, detection, and intervention of RIX are crucial in improving the prognosis and quality of life of radiotherapy patients. It is urgent to seek early and precise detection targets in clinical practice to predict dry mouth caused by irreversible damage to salivary gland tissue. This study aims to collect blood samples from patients with severe dry mouth before and after radiotherapy and chemotherapy in clinical practice. Multiple omics techniques will be used to search for predictive molecular biomarkers for RIX, construct a predictive model, and verify the sensitivity and specificity of the biomarkers. The goal is to predict the occurrence of RIX early in clinical practice, intervene in advance, greatly improve the prognosis of radiotherapy and chemotherapy patients, and enhance their quality of life.

Generalized anxiety disorder (GAD) is a common mental disorder characterized by persistent excessive worry, which seriously affects patients' quality of life. Electroacupuncture (EA) has been widely used in the clinical treatment of anxiety disorders, but the optimal stimulation parameters remain unclear. This study will adopt a randomized controlled trial (RCT) design to systematically compare the clinical efficacy of three different EA stimulation parameters (2 Hz continuous wave, 100 Hz continuous wave, and 2 Hz/100 Hz dense-disperse wave) in patients with GAD. Multidimensional outcome assessment tools will be used to comprehensively evaluate the therapeutic effects of different stimulation modes. The results of this study are expected to provide evidence-based reference for the selection of electroacupuncture parameters in the treatment of GAD, so as to optimize the clinical treatment regimen and improve the therapeutic effect.

This study is aimed to explored the safety and efficacy of 7×19-THEMIS CAR-T cell therapy for large B-cell lymphoma and to conduct an exploratory comparison of the 3-month objective response rate (ORR) and complete remission rate (CR rate) between the experimental cohort and the historical control cohort (NCT04833504).

Most patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed with locally advanced disease. While cisplatin-based chemoradiotherapy remains the standard-of-care treatment for this patient population, it is still associated with a high rate of disease recurrence. Given the relatively high mutational burden of HNSCC, immunotherapy has emerged as a promising therapeutic strategy. The addition of PD-1 inhibitors to induction chemotherapy has been shown to improve antitumor responses without increasing treatment-related toxicity. In addition, radiotherapy can further potentiate systemic antitumor immune responses. Sintilimab, a PD-1 monoclonal antibody, has demonstrated robust antitumor activity across multiple solid malignancies. Early clinical evidence indicates a synergistic antitumor effect when combined with hypofractionated radiotherapy. Nevertheless, clinical data regarding the combination of sintilimab with chemoradiotherapy in locally advanced HNSCC remain limited. Accordingly, we designed a multicenter, single-arm phase II trial to evaluate the efficacy and safety of sintilimab in combination with definitive chemoradiotherapy for patients with locally advanced HNSCC.