Clinical trials

Patients with severe brain injury may develop impaired respiratory drive, diaphragm dysfunction, prolonged mechanical ventilation, and difficulty recovering spontaneous breathing. Epidural spinal cord stimulation may activate preserved spinal respiratory circuits and improve respiratory muscle activity. This prospective, single-center, non-randomized, single-arm exploratory study will enroll 10 patients with stroke or traumatic brain injury who have impaired consciousness and require invasive mechanical ventilation. Participants will undergo epidural spinal cord stimulation in addition to standard clinical care. Diaphragmatic electrical activity, respiratory function, diaphragm ultrasound findings, diaphragm electromyography, duration of mechanical ventilation, pulmonary infection, length of stay, mortality, safety events, and 6-month neurological outcome will be assessed. The study aims to evaluate the safety and preliminary efficacy of epidural spinal cord stimulation for improving respiratory function after brain injury.

1\. Project Rationale Benign prostatic hyperplasia (BPH) is one of the most prevalent urological disorders among middle-aged and elderly men, and it represents a common chronic condition in the male population. Its incidence increases from 8% in men aged 31-40 years to over 80% in men aged over 80 years. With the intensification of global population aging, the prevalence of BPH and the corresponding burden on global public healthcare systems have been increasing continuously. BPH not only impairs patients' micturition function and reduces their quality of life, but also may lead to multiple complications involving the urinary system, such as urinary tract infection, bladder calculi and renal function impairment. Although the exact etiology of BPH remains incompletely elucidated, existing studies have confirmed that multiple factors including age, altered hormone levels, genetic background and lifestyle are associated with its pathogenesis. The global number of prevalent BPH cases increased from 51 million in 2000 to 94 million in 2019, representing a 70.5% growth in global prevalence during this period. Driven by population aging, changes in lifestyle and the popularization of screening methods such as prostate-specific antigen (PSA) detection, the number of prevalent BPH cases in China increased from 10.2 million in 2000 to 20.3 million in 2019, with a 99.0% growth in prevalence over the period, which exceeds the global average growth rate. Data from the 7th National Population Census of China in 2021 shows that the population aged 60 years and above in China reaches approximately 264 million, accounting for 18.70% of the total population, which is 5.44 percentage points higher than the data from the 6th National Population Census in 2010, and this figure is projected to exceed 400 million by 2050. The intensification of population aging and the corresponding growth in BPH prevalence indicate that BPH has evolved from a common urological disease to a major public health issue that poses a substantial threat to the health of Chinese men. Transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP) are routine surgical interventions for BPH, which can effectively reduce prostate volume and improve micturition function in patients. However, persistent lower urinary tract symptoms (LUTS) such as urinary frequency, urgency and dysuria after surgery still negatively affect patients' quality of life. Approximately 30% of patients with pre-operative urological symptoms experience persistent symptoms after surgery. Due to symptom persistence, up to 27% of male patients receive pharmacological intervention for LUTS after TURP. This poses a great challenge to patients' physical and mental health, and effective intervention strategies are urgently needed. Currently, the management of post-TURP LUTS mainly relies on conservative interventions such as Pelvic Floor Muscle Training (PFMT) and pharmacological therapy. However, these interventions are typically initiated after urinary catheter removal, which cannot meet the demand for immediate urinary continence after catheter withdrawal. In addition, the therapeutic effect of PFMT requires long-term persistence, which generally leads to poor patient adherence, and the most critical limitation is the lagged intervention timing. Similar issues including delayed intervention and unsatisfactory efficacy also exist in pharmacological therapy. Currently, medications for LUTS secondary to BPH include α-adrenergic receptor blockers, 5-α reductase inhibitors, anticholinergics, β-3 adrenergic receptor agonists and phytotherapy. These agents are routinely used for the management of BPH and BPH-related LUTS, and are widely applied to alleviate persistent or new-onset LUTS after BPH surgery. Although these drugs are generally adopted as standard interventions for post-BPH surgery LUTS, multiple studies have demonstrated that there are no significant differences in objective indicators including symptom score, quality of life index and post-void residual volume between patients receiving these medications after BPH surgery and patients receiving placebo. Currently, there is still a lack of effective and widely accepted intervention regimens for LUTS after BPH surgery. Against the background that existing treatment modalities cannot meet clinical demand, this study proposes early post-operative electroacupuncture as an innovative and scientifically sound intervention strategy. Acupuncture is not merely a simple "alternative therapy", but an effective "non-invasive peripheral neuromodulation technique" validated by modern medical research. Existing studies have shown that acupuncture exerts a certain therapeutic effect on relieving BPH-related LUTS. For example, in a study conducted by Chen Chao et al., clear conclusions were drawn by comparing the efficacy of acupuncture and α-adrenergic receptor blockers in the treatment of 64 patients with BP

Objective: To investigate the correlation of PyroEVs and PLIN3 with the severity and prognosis of sepsis patients. Participants: Sepsis patients meeting the Sepsis 3.0 diagnostic criteria admitted to the Intensive Care Unit of Zhongda Hospital affiliated with Southeast University, as well as healthy volunteers. Inclusion Criteria: 1. Presence of confirmed or suspected infection; 2. Sequential Organ Failure Assessment (SOFA) score increase ≥ 2 points from baseline; 3. Signed informed consent. Exclusion Criteria: Age \< 18 or \> 80 years, pregnancy, cancer patients, and individuals with diseases potentially complicated by vascular endothelial cell injury. Primary outcome: 28-day mortality, SOFA score

This multicenter, single-arm exploratory IIT evaluates epidural spinal cord electrical stimulation (ESCES) in 20 adults with C1-C5 SCI and respiratory failure. Participants receive ESCES plus standard care; electrodes are implanted at C3-C5 with daily individualized stimulation. Primary outcomes: Edi peak, change of Edi peak and frequency. Secondary: tidal volume, maximal inspiratory pressure, NVE, NME, diaphragm ultrasound, cough strength, 90-day ventilator-free days, ICU stay, and survival. This is the first systematic ESCES study for SCI-related respiratory failure, aiming to provide preliminary safety/efficacy data for future RCTs.

Study Overview Atopic dermatitis (AD), commonly known as eczema, is a chronic inflammatory skin condition characterized by intense itching and skin barrier damage. While researchers know that the immune system is overactive in AD, it is difficult to measure the exact level of "damage" or "inflammation" happening deep within the skin using only a physical exam. The Purpose of This Study This study investigates a specific "danger signal" called circulating cell-free DNA (cfDNA). When skin cells are damaged or die due to inflammation, they release tiny fragments of DNA into the bloodstream. The investigators believe these fragments might act as a trigger for the immune system, worsening the disease. What the Study Involves Researchers will collect blood samples and small skin biopsies from patients with AD and healthy volunteers. The study aims to: Compare the levels of cfDNA in the blood of AD patients versus healthy individuals. Determine if higher levels of cfDNA correlate with more severe skin symptoms (measured by scores like SCORAD and EASI). Examine how immune cells in the skin (macrophages) respond to these DNA fragments through a specific biological switch called the STING pathway. Potential Impact By understanding this "damage-signal" loop, this research may lead to new ways for doctors to monitor AD severity through simple blood tests and could identify new targets for future anti-inflammatory treatments.

By comparing the diagnostic accuracy of spectral CT and conventional CT in evaluating treatment response efficacy after TACE, this study aims to investigate the diagnostic performance of spectral CT in assessing treatment response following TACE for hepatocellular carcinoma.

The goal of this multicenter retrospective cohort study aimed to explore the effect of BPV during anesthesia induction and surgery on the occurrence of postoperative AKI in non-cardiac surgery patients.

Previous study findings suggest that the efficacy limitations of the neoadjuvant treatment regimen combining docetaxel with androgen deprivation therapy are associated with protein synthesis. Homoharringtonine (HHT) is currently the only small-molecule translation elongation inhibitor approved by the U.S. Food and Drug Administration (FDA). Building on this foundation, we plan to conduct a prospective interventional study aimed at validating whether the intensified quadruple regimen, formed by adding darolutamide and homoharringtonine (HHT) to the standard regimen, can further significantly enhance the depth of pathological response and improve patient outcomes through multi-mechanism synergy.

This multicenter, physiological, observational study hypothesizes that in moderate to severe ARDS, trunk inclination unloads the chest wall, but its impact on lung mechanics depends on PEEP levels and lung recruitability.

The goal of this clinical trial is to learn if electroacupuncture at the Zusanli (ST-36) can assist in the treatment of diabetic foot ulcers. The main question it aims to answer is: Can electroacupuncture at the Zusanli (ST-36) promote wound healing in patients with diabetic foot ulcers? Researchers will compare outcomes between participants receiving electroacupuncture plus standard treatment and those receiving standard treatment alone to assess the effect of Zusanli (ST36) stimulation on wound healing in patients with diabetic foot ulcers. Participants will: Receive standard diabetes treatment (including diabetes education, dietary control, insulin combined with oral hypoglycemic agents to manage blood glucose, and effective antibiotics to control infection. For patients with foot ulcers, the wound will be cleaned with saline; abscesses will be drained if present; daily dressing changes.) Participants in the electroacupuncture group will receive electroacupuncture at Zusanli(ST-36) every day; 6 sessions constitute one treatment course, for a total of 4 courses. Visit the hospital for examinations before treatment and after each treatment course to measure the ankle-brachial index (ABI), assess diabetic foot Wagner grade, and evaluate hemodynamic parameters.

This observational study will explore the effects of PEEP and position on regional lung ventilation-perfusion mismatch by electrical impedance tomography (EIT) in moderate-to-severe ARDS patients with different lung recruitability.

The aim of this study is to explore the safety and efficacy of endoscopic surgery in the treatment of extraluminal growing stromal tumors

Propranolol, a non-selective adrenergic beta-receptor blocker, is conventionally used to treat arrhythmias. However, recent studies have demonstrated its therapeutic efficacy in breast cancer, prostate cancer, neonatal hemangioma, and neonatal facial rhabdomyoma. Given the significant potential of neoadjuvant therapy in prostate cancer, we designed a multicenter, single-arm clinical study. This trial evaluates neoadjuvant propranolol combined with novel endocrine therapy and androgen deprivation therapy (ADT) in high-risk prostate cancer patients prior to radical prostatectomy, aiming to achieve superior curative outcomes.

Previous clinical observations of potential benefit from Roxadustat in this complex patient population prompted this investigation Therefore, the investigators designed this retrospective, observational study to thoroughly investigate the effects of Roxadustat on heart failure treatment and ventricular remodelling in this specific patient population, aiming to provide new insights for patients management.

The purpose of this trial is to investigate whether sigh ventilation strategy, combining sigh breaths, low tidal volume, and moderate PEEP levels, protects against major pulmonary complications within the first 7 postoperative days after cardiac surgery, as compared with conventional ventilation strategy with low tidal volume, and moderate PEEP levels.

The goal of this clinical trial is to evaluate the efficacy and safety of combining endovascular denervation (EDN) with transarterial chemoembolization/ hepatic arterial infusion chemotherapy (TACE/HAIC) plus second-line immune-targeted therapy in patients with locally advanced hepatocellular carcinoma (HCC) who have progressed after first-line systemic therapy and present with portal vein tumor thrombus (PVTT). The main questions this study aims to answer are: Does the addition of EDN to standard TACE/HAIC and immune-targeted therapy improve intrahepatic progression-free survival (hPFS) based on RECIST 1.1 criteria? What is the safety profile of the combined treatment, including device-related adverse events? Researchers will compare the experimental group (EDN + TACE/HAIC + immune-targeted therapy) with the control group (TACE/HAIC + immune-targeted therapy alone) in a 1:1 randomized design. A total of 62 participants will be enrolled across 8 centers, with an expected enrollment period of 12 months and a 12-month follow-up period. Participants will: Undergo screening assessments including imaging (CT/MRI), blood tests, and ECG within specified time windows. Receive assigned interventions (EDN procedure or control) during the baseline visit (Day 0). Attend follow-up visits at 1 month (±7 days), 3 months (±14 days), 6 months (±30 days), 9 months (±30 days), and 12 months (±30 days) for repeated imaging, laboratory tests, and safety evaluations. Have their tumor response, survival outcomes, and adverse events monitored throughout the study.

Unresectable hepatocellular carcinoma (uHCC) constitutes a significant health burden in the Asia-Pacific (APAC) region, particularly in China, where it is frequently associated with hepatitis B virus (HBV) infection and diagnosed at advanced stages. Transarterial chemoembolization (TACE) remains the standard treatment for intermediate-stage hepatocellular carcinoma (HCC), though its effectiveness diminishes in unresectable HCC (uHCC) with intermediate-to-high tumor burden. The IMbrave150 trial established atezolizumab plus bevacizumab (Atezo+Bev) as a superior alternative to sorafenib, demonstrating significant survival advantages in uHCC. Given the marked heterogeneity of intermediate-stage HCC, TACE may not benefit all patients equally. The TALENTACE study investigated on-demand TACE combined with Atezo+Bev versus TACE alone in treatment-naïve uHCC patients with intermediate-to-high tumor burden across China and Japan. Results revealed a statistically significant and clinically meaningful improvement in the primary endpoint, TACE- progression-free survival (PFS), though overall survival (OS) remained immature at the time of analysis. This situation establishes a critical and unmet need for randomized controlled trials (RCTs) combined with extensive real-world evidence (RWE) to facilitate the assessment of individualized treatment heterogeneity and provide precise treatment recommendations in China and select Asia-Pacific regions.

This study intends to conduct a multi-center, large-sample clinical trial, aiming at using multi-channel near-infrared spectroscopy to detect the characteristics of brain Oxy-Hb changes over time during cognitive activation in patients with depression before treatment and in the gender - and age-matched control group, and using eye tracking technology to detect the eye movement characteristics of patients with depression before treatment and in the gender - and age-matched control group. The sensitivity and specificity of fNIRS spectrum and eye movement index in objective diagnosis of patients with depressive disorder were calculated, and according to the HAMD reduction rate, depression patients after 2 weeks of treatment were divided into remission group and non-remission group. fNIRS imaging and eye movement indexes in depression group and normal control group were compared, fNIRS imaging and eye movement indexes in depression remission group before and after treatment, fNIRS imaging and eye movement indexes in depression remission group and non-remission group were compared at baseline to verify the biomarkers of fNIRS spectrum and eye movement indexes in predicting antidepressant efficacy. Finally, it provides reliable scientific evidence for the important role of fNIRS imaging and eye tracking technology in the diagnosis and treatment of depression.

To assess the efficacy and safety of Saccharomyces boulardii combined with triple therapy containing minocycline in the initial eradication of Helicobacter pylori (H. pylori) infection

To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma

Tumor-draining lymph nodes play an important role in anti-tumor immune responses. In patients with hepatocellular carcinoma (HCC), however, the relationship between regional lymph node metastasis (LNM) and immunotherapy-based efficacy is unclear. This study aimed to evaluate whether extrahepatic LNM is associated with worse survival outcomes as compared to other metastatic sites in patients with advanced HCC.

This study focused on the longitudinal tumor burden profile (tumor macro features, histopathological types and imaging features, etc.), liver function, health status, tumor biomarkers, and serological indicators of patients with unresectable biliary malignancies before chemotherapy combined with immunotherapy to build a dynamic prediction model. Based on this model, risk stratification of BTC patients was realized to explore which specific populations could safely initiate combination therapy. By constructing a risk stratification model, it can help clinicians to screen the best treatment population and provide a basis for safe treatment of high-risk patients.

This study focused on exploring new comprehensive treatment strategies for patients with unresectable combined hepatocellular-cholangiocarcinoma, classifying patients with CHC subtypes based on the combination of artificial intelligence and multi-omics, and exploring the optimal treatment strategies for patients with different subtypes, helping clinicians to screen the most beneficial groups of various treatment schemes, and providing new ideas for safe treatment of high-risk patients.

Patients who met the inclusion criteria were treated with endovascular radiofrequency ablation and desympathetic nerve surgery. After enrollment, endovascular radiofrequency ablation and desympathetic surgery were performed. After radiofrequency ablation, the safety and efficacy of follow-up treatment will be carried out every 1 month or so, including blood routine, liver and kidney function, tumor indicators, abdominal CT/magnetic resonance, etc.

Hepatocellular carcinoma (HCC) patients with Vp4 \[main trunk\] portal vein tumor thrombosis (PVTT) face a significantly poor prognosis, and current treatment options provide limited benefits. We aimed to assess the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with immune checkpoint inhibitors (ICIs) plus molecular targeted therapy (MTT) after irradiation stent placement (ISP) as first line treatment for HCC patients with Vp4 PVTT.