Clinical trials

Modifiable risk factors, including smoking, alcohol consumption, and diet, play critical roles in cancer progression and patient prognosis. In patients diagnosed with lung cancer, these risk factors not only directly modulate host metabolism and immune regulation, but also exert indirect effects by altering the internal milieu, such as the gut microbiota-potentially exerting a profound impact on long-term clinical trajectories. Leveraging a well-characterized, longitudinally followed cohort of confirmed lung cancer patients, this study systematically assesses habitual dietary intake, emotional well-being, lifestyle behaviors, and related variables using validated instruments, including the Food Frequency Questionnaire (FFQ). Furthermore, the study integrates multidimensional biomarker profiling across tumor tissue, blood, urine, and fecal samples. By linking exposure profiles, multi-omics data, and long-term clinical follow-up records, this project aims to: 1. Evaluate Prognostic Associations: Investigate the relationships between exposure profiles (e.g., dietary patterns) and long-term clinical outcomes in lung cancer patients, including progression-free survival (PFS), overall survival (OS), and recurrence risk. 2. Elucidate Biological Mechanisms: Unravel the underlying mechanisms by which the "exposure profile-multi-omics" axis mediates lung cancer progression, and identify candidate biomarkers with predictive value for clinical prognosis. Ultimately, this study aims to establish evidence-based healthy lifestyle recommendations for patients and provide healthcare professionals with translational insights to inform precision nutrition and targeted intervention strategies across the continuum of lung cancer care.

The purpose of this multicenter pragmatic randomized controlled trial is to determine whether AI-assisted interpretation of multiphasic liver contrast-enhanced computed tomography (CE-CT) is non-inferior to standard radiology reporting with respect to missed clinically significant malignant focal liver lesions, \*\*with the non-inferiority margin prespecified in the statistical analysis plan before enrollment\*\*, and whether it improves lesion detection, diagnostic characterization, downstream clinical management, and reporting efficiency. On AI-assisted center-days, AI results will be revealed only after the first-line radiologist has saved an unaided initial assessment and may be used to revise the final report. On control center-days, examinations will be interpreted using the standard radiology workflow without access to AI tools.

This clinical trial aims to investigate whether the combination of high-frequency sacral nerve root magnetic stimulation and bladder-directed ultrasound therapy can effectively improve detrusor overactivity (involuntary bladder contractions) and related voiding dysfunctions in patients with spinal cord injury. The main questions it seeks to answer are: What is the effect of high-frequency sacral nerve root magnetic stimulation on detrusor overactivity and bladder function in patients with spinal cord injury? What is the effect of bladder-directed ultrasound therapy on detrusor overactivity and bladder wall compliance in patients with spinal cord injury? Is the combination of these two treatment modalities superior to magnetic stimulation alone?

The goal of this observational study is to evaluate whether increased lower extremity muscle tone can serve as an independent predictor of neurogenic detrusor overactivity (NDO) in adult patients (aged 18-80 years) with upper sacral spinal cord injury . The main questions it aims to answer are: Is increased lower extremity muscle tone independently associated with the presence of detrusor overactivity after adjusting for age, sex, injury level, injury type, and injury cause? Does the predictive value of muscle tone for detrusor overactivity differ across subgroups defined by injury level, injury severity, and time since injury? Researchers will compare patients with lower extremity hypertonia (Modified Ashworth Scale ≥ 1) to patients with normal muscle tone (Modified Ashworth Scale = 0) to see if muscle tone elevation independently predicts detrusor overactivity. Participants will not be asked to do anything beyond their routine clinical care, as this is a retrospective study that only collects data from existing medical records, including neurological examination results, Modified Ashworth Scale scores, and urodynamic study reports.

This study aims to investigate the rehabilitative effects and synergistic potential of combining Fastigial Nucleus Stimulation (FNS) with Sling Exercise Training (SET) on motor function in patients with post-stroke hemiplegia. Hemiplegia after stroke often results in unilateral motor impairment, balance dysfunction, and decreased proprioception. Although traditional rehabilitation methods can improve certain functions, they are often limited by insufficient central targeting and inadequate activation of deep core muscles, making it difficult to fundamentally repair damaged motor control circuits. FNS, as a non-invasive neuromodulation technique, can precisely target the fastigial nucleus-a critical hub for motor coordination and balance control-thereby modulating neuroplasticity and promoting regional cerebral blood flow to optimize cortical function. SET, on the other hand, utilizes an unstable sling system to efficiently activate deep core muscles (such as the transversus abdominis and multifidus), enhance proprioceptive input, and promote neural reorganization. Based on the concept of "central regulation-peripheral enhancement," this study hypothesizes that the combination of FNS and SET can create a bidirectional intervention pathway, breaking the vicious cycle between central damage and peripheral dysfunction, and achieving a "1+1\>2" therapeutic effect. This study employs a randomized, double-blind, sham-controlled design and plans to enroll 54 eligible patients with post-stroke hemiplegia (aged 18-70 years, within 6 months of onset). Participants will be randomly assigned to three groups: Group A (FNS + sham SET), Group B (sham FNS + SET), and Group C (FNS + SET). FNS will be delivered using high-precision electrodes placed over the bilateral mastoid regions, with a stimulation frequency of 180 Hz and an intensity of 2 mA (sham stimulation at 0.1 mA) for 20 minutes per session. SET will include supine and prone bridging exercises for 30 minutes per session, while sham SET involves suspension without active movement. All patients will be assessed before and after the intervention using the Berg Balance Scale, Fugl-Meyer Assessment, three-dimensional gait analysis, trunk control test, and proprioceptive measurement instruments. The sample size was calculated based on previous data for lower extremity Fugl-Meyer scores (effect size f = 0.502), with an estimated 20% dropout rate, resulting in a target of 54 participants. The innovation of this study lies in its first-time combination of FNS-a more targeted neuromodulation approach-with SET-a high-intensity sensorimotor integration training-and the use of sham controls to precisely quantify the individual contributions of each intervention and validate the synergistic effect of central-peripheral co-stimulation. Potential risks will be strictly managed: FNS may cause localized tingling or mild headache, which can be addressed by adjusting or pausing stimulation; SET will be conducted under the supervision of trained therapists with individualized intensity adjustments to prevent muscle soreness or falls. All adverse events will be documented and managed promptly. The findings of this study are expected to provide an effective, non-invasive central-peripheral synergistic rehabilitation strategy for post-stroke hemiplegia and offer evidence-based guidance for clinical practice and future research.

The goal of this study is to investigate the value of noninvasive evaluation of multimodal magnetic resonance imaging in diagnosis and treatment of diabetic kidney disease (DKD). We aim to explore the feasibility of multimodal magnetic resonance imaging in the staging diagnosis of DKD, and establish a non-invasive method for evaluating the progression of DKD disease by combining imaging and biochemical indicators. Multimodal magnetic resonance examinations will be performed on diabetic patients with different stages as well as regular follow-up during treatment, in order to investigate the relationship between imaging findings and pathophysiological changes of the kidneys.

This study is a prospective observational cohort study aimed at developing a clinical model based on dynamic changes in anti-Müllerian hormone (AMH) to predict ovarian reserve in perimenopausal women with hormone receptor-positive breast cancer. The study will enroll approximately 300 women aged 45-55 years with perimenopausal status confirmed by menstrual history and hormone levels (FSH 10-40 IU/L, E2 \>20 pg/mL). Participants will be stratified by treatment regimen: (A) chemotherapy plus endocrine therapy, (B) chemotherapy plus targeted therapy plus endocrine therapy, and (C) endocrine therapy alone. Blood samples will be collected at seven time points to measure AMH, FSH, E2, and LH. Menstrual patterns and menopausal symptoms will be recorded prospectively. The primary outcome is the association between dynamic AMH changes and the occurrence of menopause. A predictive model will be constructed using LASSO regression and Cox proportional hazards models, with internal validation by bootstrap resampling. The goal is to develop a clinically applicable tool to guide endocrine therapy decisions-including the duration of ovarian function suppression (OFS), choice between tamoxifen and aromatase inhibitors (AIs), and selection of CDK4/6 inhibitors-as well as to provide individualized fertility preservation counseling for perimenopausal breast cancer patients.

Hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer constitutes approximately 70% of all breast cancer cases. Although early-stage patients generally have favorable outcomes following standard surgery and adjuvant endocrine therapy, long-term follow-up data reveal a distinct "bimodal" or "long-tail" recurrence pattern, with risks persisting for decades. Recent landmark trials (e.g., NATALEE, MonarchE) have established that combining CDK4/6 inhibitors with endocrine therapy significantly improves invasive disease-free survival (iDFS) in high-risk populations. However, the stringent enrollment criteria of these randomized controlled trials may not fully capture the heterogeneity of real-world patients. Reliance on binary cut-off values (e.g., nodal status alone) risks misclassifying biologically high-risk individuals with low anatomical burden, leading to either undertreatment or overtreatment. There is an urgent clinical need for a multidimensional, individualized risk assessment tool to guide escalated therapy decisions.

The investigators aim to build a predictive tool for Adverse Outcome of Acute Pulmonary Embolism by Artificial Intelligence System Based on CT Pulmonary Angiography.

This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission to predict adverse outcomes within 30 days after admission into hospital.

How to construct a non-invasive, accurate, and convenient method to evaluate the severity of liver fibrosis (LF) is an important general problem in the management of patients with chronic hepatitis B (CHB). We plan to investigate the ability of magnetic resonance elastography (MRE) to grade fibrosis in chronic hepatitis B and apply to clinical longitudinal follow-up.

This prospective single-center study aims to evaluate the feasibility and clinical utility of three-dimensional magnetic resonance elastography (3D MRE) in assessing tumor stiffness and adhesion in patients with meningioma undergoing surgical resection. By correlating preoperative MRE-derived stiffness and adhesion maps with intraoperative findings and histopathological features, the study seeks to determine whether MRE can serve as a noninvasive imaging biomarker for surgical planning, risk stratification, and prediction of tumor behavior.

In spinal cord tumors requiring surgical intervention, the resection difficulty is determined by two significant factors: tumor stiffness and adhesion to surrounding tissue. The stiffness of the tumor dictates the complexity of removal, while strong adhesion presents additional challenges during the surgical procedure. This clinical trial aims to assess the clinical utility of magnetic resonance elastography (MRE), in evaluating the stiffness and adhesion of spinal cord tumors and guiding surgical planning to selecting the most appropriate surgical approach for patients with spinal cord tumors.

Chronic Kidney Disease (CKD) is a major public health issue, leading to high mortality and the necessity for renal replacement therapy. Kidney fibrosis, resulting from chronic damage to kidney tissue, significantly determines CKD outcomes. Kidney biopsy, the gold standard for assessing fibrosis, is invasive and limited in its ability to reflect the heterogeneous nature of fibrosis. Consequently, there is growing interest in noninvasive methods, particularly Magnetic Resonance Elastography (MRE). MRE, which evaluates tissue stiffness, has shown potential for assessing kidney fibrosis. This study aims to use multifrequency MRE to assess renal fibrosis, focusing particularly on the early stages of CKD, to enhance understanding of its progression and relationship to clinical outcomes.

How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of hepatic venous pressure gradient (HVPG) is an important general problem in the management of portal hypertension in cirrhosis. We plan to compare the ability of three demensional-magnetic resonance elastography (3D-MRE) to two demensional-magnetic resonance elastography (2D-MRE) to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis.

How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of hepatic venous pressure gradient (HVPG) is an important general problem in the management of portal hypertension in cirrhosis or advanced chronic liver disease. We plan to investigate the ability of three demensional-magnetic resonance elastography (3D-MRE) to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis or advanced chronic liver disease.

Globally, approximately 750,000 cases of infantile meningitis occur annually\[1\]. Clinical data show infantile postmeningitis subdural fluid collection (IPSFC) is the most common complication of infantile bacterial meningitis (IBM), with a progression rate of 30-60% (39% in standardized treatment cohorts)\[2\]. Pathogens, predominantly Escherichia coli and Streptococcus pneumoniae, account for 70% of IPSFC cases\[3\]. IPSFC progresses to subdural empyema (IPSE) in 3.7-17.6% of cases, with 87.1% of IPSE cases occurring in infants \<1 year old\[4\]. Collectively termed infantile postmeningitis subdural space lesions (IPSSL), these conditions impose the highest burden in Sub-Saharan Africa's "Meningitis Belt" and Southeast Asia\[5\]. IPSE progresses rapidly in infants, with a mortality rate of 18% and 50% of survivors developing neurological sequelae (e.g., epilepsy, motor/intellectual disability, sensory impairment)\[6\]. While spontaneously resolved IPSFC shows no significant sequelae, prolonged IPSE disrupts brain development, requires extended treatment, and incurs substantial familial burdens. Causes of IPSFC secondary to IBM include increased subdural capillary permeability (with plasma exudation), cerebrospinal fluid (CSF) circulation/absorption disturbance, immature infantile blood-brain barrier (BBB), and underdeveloped arachnoid granulations\[7\]. IPSFC typically develops on days 7-10 of IBM and is staged by fluid thickness: Stage I (\<0.3 mm), Stage II (3-8 mm), Stage III (\>8 mm)\[8\]. Uncontrolled IBM infection, due to inappropriate antibiotics, inadequate dosage, delayed treatment, or infantile immunocompromise, e.g., preterm infants, allows pathogens to invade and proliferate in the subdural space, inducing local secondary infection, inflammatory cell infiltration, and accumulation of pathogen metabolites/necrotic tissue-ultimately progressing to IPSE\[9\]. Fibrinogen exudation and fibroblast activation may further form subdural fibrous cords, septa, purulent plaques, inflammatory pseudomembranes, and other fibro-inflammatory proliferative lesions (FIPLs)\[10\]. IPSE causes more severe mass/toxic effects, requiring aggressive surgical intervention. Cranial MRI shows empyema cavity rim enhancement, heterogeneous internal signals due to fluid collection septa, and dural thickening. The progression rate of IPSFC to IPSE ranges from 3.7% to 17.6%, influenced by IBM pathogen types, therapeutic intervention, and host immunity\[11\]. However, large-scale cohort studies on risk factors for this progression remain lacking. Early adequate antibiotic therapy reduces IPSFC incidence by nearly 50%, whereas delayed intervention may accelerate IPSFC onset (day 3-7) via unremitting meningeal permeability\[12\]. Inadequate antibiotic courses may promote persistent IPSFC progression with FIPLs formation. Some pediatric neurosurgeons advocate extending antibiotic therapy beyond 21 days for IPSFC to prevent progression to IPSE\[13\]. Despite early antibiotic therapy reducing IBM mortality, IPSSL management remains challenging. A clinical study showed 22.4% of IPSFC cases required surgery, but occult inflammation in infants can prolong IPSFC up to 2 months\[14\]. Infantile unclosed fontanelles and cranial elasticity increase neurosurgical complication risks. Current consensus suggests asymptomatic/small-volume fluid collections (thickness \<5 mm) often resolve spontaneously, obviating intervention\[15\]. Ultrasound-guided subdural puncture (US-SP-AF) is the first-line invasive treatment, curing about 50% of infants acutely but with a 30-50% recurrence rate. Whether US-SP-AF reduces IPSFC-to-IPSE progression remains controversial. For US-SP-AF-resistant cases, minimally invasive burr hole irrigation (BHID) with silicone tube drainage (3-5 days) is used; BHID shows higher cure rates than US-SP-AF but still has a 20-33% recurrence rate in small cohorts\[16\]. Neuroendoscopic technique allows rigid endoscope entry into the subdural space for visualized resection of pathological tissues, management of multiloculated cavities, adhesion lysis, and FIPLs irrigation. This approach directly targets the pathological substrate under vision, reducing residual lesions and recurrence rates compared to traditional methods. In adult cohorts, 6-month postoperative fluid collection recurrence rates are only 8% with neuroendoscopy, versus 33% with BHID\[17\]. However, neuroendoscopic exploration is technically demanding and equipment-dependent. The Ommaya reservoir offers advantages in postoperative management of cerebrospinal fluid-related disorders, including precise drainage, dynamic monitoring of disease progression, and local drug administration. However, it may be prone to catheter obstruction by pathological components\[18\]. Severe IPSSL causes intracranial hypertension and neurodevelopmental impairment, requiring comprehensive pediatric neurosurgical and pharmacologic strategies. Treatment selection depends on IPSFC/IPSE pathological features. Current stu

this study will investigate the relationship between tumor stiffness and adhesion in gliomas using MRE. By utilizing preoperative MRE and Intraoperative neuronavigation, followed by comprehensive molecular pathology analysis, we aim to explore the correlation of tumor stiffness and adhesion with molecular and genetic characteristics of gliomas. Additionally, the predictive value of MRE in terms of pathological staging and prognosis will be determined. This research may pave the way for improved clinical decision-making, personalized treatment approaches, and more accurate clinical trials for glioma patients.

The primary objective of this clinical trial is to investigate the efficacy of motor imagery-based brain-computer interface (MI-BCI) technology in improving motor function among patients with spinal cord injury (SCI), as well as its impact on cortical motor area function across varying states. To achieve this, the study will implement MI-BCI intervention in SCI patients, evaluate post-treatment motor function improvements, and assess changes in cortical motor area oxygen metabolism (via functional near-infrared spectroscopy, fNIRS) and neural activity (via electroencephalography, EEG). The ultimate goal is to establish a novel rehabilitation strategy for SCI. Specifically, the trial aims to: (1) determine whether MI-BCI effectively enhances motor function in SCI patients; and (2) clarify the differential effects of MI-BCI on cortical motor area function under distinct states (e.g., resting vs. task-performing) in this population. Participants will be randomly assigned to one of two groups: the experimental group will undergo MI-BCI training, while the control group will receive active cycling training (as a conventional rehabilitation control). Both interventions will be structured as 20-minute sessions, administered 5 days per week, over a total of 4 weeks.Pre- and post-treatment assessments will include: lower limb motor function (measured by the Lower Limb Motor Score), activities of daily living (evaluated via the Modified Barthel Index), walking capacity (quantified using the Spinal Cord Injury Walking Index), and cortical motor activity (captured through fNIRS and EEG measurements).

The objective of this study is to evaluate the efficacy and safety of chemotherapy plus toripalimab, with or without JS004,as neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). TNBC patients were randomly assigned in a 2:2:1 ratio to receive either JS004 plus toripalimab plus chemotherapy, toripalimab plus chemotherapy, or chemotherapy alone.Surgery will be performed within 5 weeks after the last dose of neoadjuvant treatment.

The purpose of this clinical trial is to understand whether threshold pressure load respiratory muscle training combined with iTBS can effectively improve the respiratory function of SCI patients. The main questions it aims to answer are: * The impact of threshold pressure load respiratory muscle training on the respiratory function of SCI patients. * The impact of iTBS treatment at the cortical projection point of the diaphragm on the respiratory function of SCI patients. * Whether the combination of the above two treatment techniques is superior to single treatment.

The purpose of this study is to dynamically observe the dynamic changes of serum IGF-1 after intracerebral hemorrhage, explore the impact and correlation of serum IGF-1 with the severity of the patient's condition and prognosis, and provide a reference for clinical treatment timing.

The objective of this clinical trial is to investigate whether intelligent visual feedback-based lower limb motor control training is more effective than conventional rehabilitation training in promoting walking ability recovery among stroke patients with hemiplegia. The trial aims to address the primary question of the impact of intelligent visual feedback motor control training on the walking function of stroke patients with hemiplegia, and uses three-dimensional gait analysis for precise quantitative evaluation of therapeutic effects. Functional near-infrared spectroscopy (fNIRS) will be employed to explore patients' cerebral functional connectivity and cortical activation, and to analyze the correlation between fNIRS data and walking function scores (such as those from three-dimensional gait analysis), providing effective methods and a reliable reference basis for rehabilitation training of post-stroke hemiplegic patients. Participants will be randomly divided into two groups: the experimental group receiving intelligent visual feedback motor control training, and the control group receiving Bobath ball training, 20 minutes per day, 5 days per week, for a total of four weeks. Before and after the treatment, indicators including fNIRS brain functional imaging, three-dimensional gait analysis, and Fugl-Meyer Assessment will be evaluated.

The goal of this study is to investigate the value of MR elastography-based SII as a means of detecting HGP noninvasively in patients with pathology-proven CRLM. MRE will provide a direct measure of tumor-liver adhesion to investigate the relationship between imaging findings and pathophysiological changes in the Liver.

To construct a novel, non-invasive, accurate, and convenient method to achieve the degree of liver damage is an important general problem in the management of patients with chronic liver disease. The investigators would like to develop non invasive advanced Magnetic Resonance Imaging (MRI) techniques (MR elastography, MRI-PDFF) to assess the degree of liver damage in patients with chronic liver disease. These techniques could reach high diagnostic performance for detection of liver fibrosis, inflammation and liver fat content; and could decrease the number of liver biopsies, which have risks and sample only a small portion of the liver.