Clinical trials

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Condition / disease
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Status: Not yet recruiting

Mechanistic Study of PK2 Pathway in Alleviating Perioperative Neurocognitive Disorders by Improving Neurometabolic Uncoupling

The term perioperative neurocognitive disorders (PND) is derived from postoperative cognitive dysfunction (POCD), and has been renamed as PND in recent years in accordance with the latest international consensus. PND specifically refers to changes in mental, social and cognitive abilities in patients following surgery; in severe cases, personality changes and reduced social functioning may also occur. As a serious complication affecting the central nervous system (CNS), apart from surgical trauma, advanced age is widely recognized as a critical factor contributing to the development and progression of PND. Its adverse effects represent a major challenge for the rapidly growing elderly population worldwide. It is currently believed that the decline in cognitive functions such as memory and attention observed in some patients after surgery may be associated with inflammatory responses in the brain. Surgical stress may activate supporting cells in the brain, such as astrocytes. When these cells are abnormally activated, they may fail to maintain normal neuronal function, thereby disrupting brain homeostasis and leading to cognitive impairment. Recent studies have shown that these glial cells exert distinct effects on neurons under different phenotypes: some phenotypes promote neural repair and protection, whereas others exacerbate neural injury. Evidence suggests that in multiple neurological disorders, the pro-inflammatory phenotype of glial cells is closely associated with cognitive impairment. Prokineticin-2 (PK2) is an endogenous signaling molecule involved in the regulation of diverse physiological processes, including inflammatory responses, energy metabolism, and neuroprotection. Previous studies have demonstrated that PK2 exerts protective effects in various neurological disease models, improving neuronal function and alleviating cognitive or motor deficits. Our preliminary animal experiments revealed reduced brain PK2 levels, especially in memory-related regions, in mice with postoperative cognitive dysfunction. Exogenous supplementation of PK2 significantly restored brain cell function and improved cognitive performance in these mice, suggesting that PK2 may play an important role in maintaining cerebral function after surgery. However, it remains unclear whether changes in PK2 levels in clinical patients correlate with the occurrence and severity of postoperative cognitive dysfunction. This study aims to investigate changes in circulating PK2 levels and explore their association with postoperative cognitive alterations, so as to provide evidence for the improved prevention and identification of PND. We plan to enroll elderly patients undergoing hip replacement surgery at Nanjing First Hospital. By analyzing PK2 expression levels and dynamic changes, combined with postoperative neuropsychological scale assessments, we will evaluate the correlation between serum PK2 levels and the clinical incidence of PND, and further verify the intrinsic link between PK2 levels and the pathogenesis of PND.

Participants needed: 40
Trial details
Age: 65-80Biological sex: AllType: ObservationalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Jun 16, 2026
Eligibility criteria

Age ≥ 65 years and ≤ 80 years [+2]

Mini-Mental State Examination (MMSE) score ≤ 24 [+6]

Status: Not yet recruiting

PCI With GDMT Versus GDMT Alone for Patients With Ischemic Cardiomyopathy and Reduced LVEF

To evaluate whether percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) combined with guideline-directed medical therapy (GDMT), compared to GDMT alone, reduces the time to first occurrence of major adverse cardiovascular events (MACE) during a median follow-up of at least 24 months, measured at the time the last enrolled patient reaches 12 months, in patients with ischemic cardiomyopathy and left-ventricular ejection fraction (LVEF) ≤40%. MACE is a composite of cardiovascular \[CV\] death, myocardial infarction (MI), heart failure (HF) related rehospitalization, heart transplantation, requirement for durable left ventricular assist device \[LVAD\] implantation, or worsening heart failure treated as an out-patient requiring treatment with intravenous medications.

Participants needed: 1,154
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: May 28, 2026Locations: 1
Eligibility criteria

Age ≥18 years at screening. [+5]

Class III or IV angina requiring revascularization. [+13]

Status: Not yet recruiting

Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction

To assess the impact of PADN combined with guideline-directed medical therapy (GDMT) versus a sham procedure with GDMT on clinical outcomes in heart failure (HF) patients with preserved left ventricular ejection fraction (LVEF\>40%). Outcomes include cardiovascular death, HF-related rehospitalization, requirement for heart transplantation or need of valvular treatment or LVAD or pacemaker implantation, and worsening in outpatients (defined as requirement for intravenous therapy or diuretic intensification, including increasing the types or dose of diuretics).

Participants needed: 310
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: May 27, 2026Locations: 1
Eligibility criteria

Age <50 years: BNP >100 pg/mL or NT-proBNP >450 pg/mL [+7]

Hospitalization for HF within 7 days prior to screening. [+24]

Status: Not yet recruiting

STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism

This study aims to compare the effectiveness and safety of three treatment strategies (Anticoagulation, Thrombolysis, and Mechanical Thrombectomy) for patients with intermediate-high risk acute pulmonary embolism (PE) in a real-world setting. Approximately 1,300 patients will be enrolled across multiple centers in China. Patients will be followed for 90 days to assess mortality, heart function recovery, bleeding risks, and quality of life. The results will help guide personalized treatment decisions and healthcare policy.

Participants needed: 1,300
Trial details
Biological sex: AllType: ObservationalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: May 22, 2026Locations: 1
Eligibility criteria

Age unlimited (reflecting real-world population). [+6]

Already received thrombolysis or mechanical thrombectomy for the current episode... [+2]

Status: Recruiting

IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus

Intravascular ultrasound (IVUS) serves as a beneficial instrument during percutaneous coronary intervention (PCI) procedures, affording insight into lesion characteristics and stent implantation. The ULTIMATE trial recently evidenced that IVUS-guided Drug-Eluting Stent (DES) implantation notably ameliorated clinical outcomes in all-comers, especially in patients who underwent an optimal procedure defined by IVUS, as opposed to angiography guidance, resonating with findings from the IVUS-XPL study, OCTOBER trial, and RENOVATE COMPLEX PCI trial, further confirmed by more recent IVUS-ACS trial. Optical coherence tomography (OCT) has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI. Regrettably, a dearth of prospective, randomized, multicenter trials exists that scrutinize the benefits of IVI-guided as opposed to angiography-guided PCI in patients suffering from diabetes mellitus. However, several trials have presented subgroup analyses reporting the reduction of clinical events by IVUS but not OCT guidance in patients with diabetes mellitus, which served as the foundation for the design of this trial.

Participants needed: 1,332
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: May 19, 2026Locations: 1
Eligibility criteria

Age between 18 ~ 80 years old, [+3]

Cardiogenic shock [+10]

Status: Recruiting

Coronary and Myocardial Evaluation by Cardiac CT for Acute Myocardial Infarction

Acute myocardial infarction (AMI) remains a major cause of mortality and morbidity worldwide. Although percutaneous coronary intervention (PCI) combined with guideline-directed medical therapy has substantially improved survival, many patients continue to experience adverse cardiovascular events after revascularization, including recurrent ischemic events, heart failure, and malignant arrhythmias. Therefore, accurate risk stratification after PCI is essential for optimizing clinical management and improving long-term outcomes. However, currently available risk prediction tools are limited by suboptimal predictive performance or restricted clinical accessibility. Cardiac imaging plays a central role in post-AMI evaluation. Echocardiography is routinely recommended after PCI to assess cardiac structure and function and to exclude early mechanical complications. Nevertheless, its ability to predict subsequent ventricular remodeling and long-term clinical outcomes is limited. Cardiac magnetic resonance imaging (CMR) is considered the reference standard for myocardial tissue characterization and provides important prognostic markers such as infarct size, microvascular obstruction, and intramyocardial hemorrhage. However, the routine use of CMR in patients with AMI is constrained by limited availability, high cost, and relatively long examination time. In addition, CMR does not directly evaluate coronary artery anatomy or plaque characteristics, which are important determinants of recurrent ischemic events. Recent advances in cardiac computed tomography (CT) have enabled comprehensive assessment of coronary artery disease. Beyond evaluating coronary stenosis, coronary CT angiography can identify high-risk plaque features associated with plaque vulnerability. Furthermore, emerging CT-based techniques allow simultaneous assessment of coronary physiology, perivascular inflammation, myocardial structure and function, and myocardial tissue characteristics. CT-derived fractional flow reserve (CT-FFR) enables noninvasive functional assessment of coronary lesions, while the fat attenuation index (FAI) reflects pericoronary inflammatory activity. In addition, delayed iodine enhancement and dual-energy CT techniques allow evaluation of myocardial injury and fibrosis, and CT-derived extracellular volume fraction (ECV) provides quantitative assessment of myocardial fibrosis. These advances suggest that multimodal cardiac CT may provide an integrated imaging approach for comprehensive risk assessment after AMI. The COMET-AMI study (Coronary and Myocardial Evaluation by Multimodal Cardiac CT in Acute Myocardial Infarction) is a prospective, multicenter cohort study designed to evaluate the prognostic value of multimodal cardiac CT in patients with AMI after PCI. A total of 1,000 patients with AMI undergoing successful PCI will be prospectively enrolled. All participants will undergo multimodal cardiac CT within 7 days after PCI to assess coronary plaque characteristics, coronary physiology, pericoronary adipose tissue inflammation, cardiac structure and function, and myocardial tissue features. A subset of participants will also undergo cardiac magnetic resonance imaging for validation of CT-derived myocardial tissue parameters. Comprehensive clinical information, including demographic characteristics, cardiovascular risk factors, medication history, laboratory biomarkers, and procedural data, will be collected. Quantitative and qualitative analyses of coronary plaques will be performed using dedicated software to assess plaque burden, plaque composition, remodeling characteristics, and high-risk plaque features. Additional CT-derived parameters such as CT-FFR, myocardial strain, pericoronary fat attenuation index, and extracellular volume fraction will also be analyzed. Participants will be followed longitudinally through outpatient visits, telephone interviews, and electronic medical record review for up to five years after PCI. The primary outcomes include composite thrombotic events (cardiac death, recurrent myocardial infarction, and urgent or clinically driven revascularization). Secondary outcomes include heart failure and major arrhythmic events such as new-onset heart failure, sustained ventricular arrhythmia, implantable cardioverter-defibrillator implantation, sudden cardiac death, or resuscitated cardiac arrest. All clinical events will be independently adjudicated by a blinded clinical events committee. Using multimodal cardiac CT-derived imaging biomarkers in combination with clinical and laboratory data, machine learning-based predictive models will be developed to identify key determinants of adverse outcomes after PCI in patients with AMI. The results of this study may provide a novel imaging-based risk stratification strategy and facilitate personalized management for patients with AMI after PCI.

Participants needed: 1,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Apr 17, 2026Locations: 2Duration: 5 Years
Eligibility criteria

Age ≥18 years [+5]

Contraindications to cardiac CT (eGFR <30 mL/min/1.73 m² or iodine contrast alle... [+5]

Status: Recruiting

Improving Blood Lipid Management in Symptomatic Intracranial Atherosclerotic Stenosis on Clinical Outcome

sICASBLM is a prospective controlled trial, to asses the impact of improving blood lipid management on clinical outcome of moderate to severe symptomatic intracranial atherosclerotic stenosis patients (LDL-C\>1.8mmol/L) without endovascular therapy.

Participants needed: 180
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Apr 15, 2026Locations: 2
Eligibility criteria

Age ≥18 years [+5]

Contraindications to statins [+6]

Status: Recruiting

Circulating Non-coding RNA in Acute Ischemic Stroke (AISRNA)

AISRNA is to analyze the expression pattern of circular RNA (circRNA), micro-RNA (miRNA) and long non-coding RNA (lncRNA) by next-generation sequencing in patients with acute ischemic stroke and healthy control. The candidate circRNA/miRNA/lncRNA will be verified as biomarkers for the detection and prognosis of acute ischemic stroke.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Apr 15, 2026Locations: 1Duration: 90 Days
Eligibility criteria

Aged 18 years or older [+4]

Status: Recruiting

Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulation of Gut Microbiota.

The Role of Gut Microbiota in the Mechanism of Helicobacter pylori Eradication-Induced Amelioration of Metabolic Syndrome-Related Parameters Study Sponsor: Nanjing First Hospital Principal Investigator: Dr. Wanli Liu Department: Gastroenterology Study Duration: February 2025 - August 2025 Key Information for Patients and Families 1. What is this study about? This study aims to understand how treating a common stomach infection caused by Helicobacter pylori (Hp) might improve metabolic health issues like high blood sugar, cholesterol problems, or obesity (collectively called metabolic syndrome). Specifically, it explores whether adding probiotics (good bacteria) or a natural compound called berberine (BBR) to standard Hp treatment can enhance these benefits by improving gut bacteria balance. 2. Who can participate? Patients: Adults aged 18-65 with both Helicobacter pylori infection (confirmed by a breath test) and newly diagnosed metabolic syndrome (based on waist size, blood sugar, cholesterol, or blood pressure). Healthy Volunteers: Adults aged 18-65 with no Hp infection and normal metabolic health (to compare results). Exclusions: Allergy to study medications (e.g., penicillin). Previous Hp treatment, recent antibiotic/steroid use, pregnancy, or serious medical conditions (e.g., liver/kidney disease). 3. What will participants do? Treatment Groups: Group A: Take two medications (vonoprazan + amoxicillin) for 14 days. Group B: Take the two medications + probiotics (Bifidobacterium tablets). Group C: Take the two medications + berberine (a plant-based supplement). Tests: Before treatment: Breath test, blood tests (blood sugar, cholesterol, inflammation markers), stool sample analysis (gut bacteria), and body measurements (weight, waist size). After treatment (1 month): Repeat tests to check Hp eradication and metabolic improvements. 4. Possible Benefits and Risks Benefits: Free Hp treatment and metabolic health monitoring. Potential improvement in blood sugar, cholesterol, or weight. Contribution to future treatments for metabolic syndrome. Risks: Mild side effects (e.g., nausea, diarrhea, stomach pain) from medications. Discomfort from blood draws or stool sample collection. 5. How are participants protected? All treatments are FDA-approved or widely used in clinical practice. Ethical review ensures participant safety. You can withdraw at any time without affecting your regular care. Information for Health Care Providers 1. Study Design Type: Prospective, single-center, open-label, randomized controlled trial. Population: 140 participants (120 Hp+ patients with metabolic syndrome; 20 Hp- healthy controls). Intervention: Group A: Vonoprazan (20 mg bid) + amoxicillin (1 g tid) for 14 days. Group B: Group A + Bifidobacterium tetragenous probiotic (3 tablets tid). Group C: Group A + berberine (3 tablets tid). Primary Outcomes: Hp eradication rate (confirmed by urea breath test). Changes in metabolic parameters (fasting glucose, HbA1c, lipid profile). Gut microbiota composition (16S rRNA sequencing). Secondary Outcomes: Multi-omics analysis (inflammation markers, endotoxins, short-chain fatty acids, bile acids). 2. Scientific Rationale Hp and Metabolic Syndrome: Epidemiological evidence links Hp infection to metabolic dysfunction, possibly via chronic inflammation. Eradication may partially reverse insulin resistance and dyslipidemia. Gut Microbiota as Mediator: Hp eradication alters gut microbiota, which regulates metabolic homeostasis through metabolites (e.g., SCFAs), bile acid metabolism, and inflammatory pathways. Probiotics/BBR may enhance these effects. 3. Methodology Randomization: Block randomization (block size = 4) using SAS 9.4. Assessments: Metabolic Parameters: Fasting glucose, HbA1c, lipid profile, BMI. Microbiome: 16S rRNA sequencing (α/β diversity, taxa abundance). Multi-omics: ELISA (TNF-α, IL-6), GC-MS (SCFAs), UPLC-MS (bile acids). Statistical Analysis: Microbiome: QIIME2, LEfSe, PICRUSt2. Multi-omics: limma, SparCC, sPLS-DA. Clinical data: ANOVA, χ² tests (SPSS v25.0). 4. Clinical Implications Clarify whether probiotics or BBR add value to Hp eradication in improving metabolic health. Identify gut microbiota-driven mechanisms linking Hp eradication to metabolic benefits. Resources for Participants Study Flowchart: Screening: Breath test, blood/stool tests (1 week). Treatment: 14 days of medication. Follow-up: Repeat tests at 1 month. Contact Information: Dr. Wanli Liu: +86-18951670222 Nanjing First Hospital Gastroenterology Department. FAQ Sheet: Can I take my regular medications? Yes, unless they interfere with Hp treatment (e.g., PPIs). What if I miss a dose? Contact the study team immediately. Ethical Compliance Approved by the Institutional Review Board of Nanjing First Hospital. Complies with the Declaration of Helsinki and China's ethical guidelines. Informed consent required for participation.

Participants needed: 120
Trial details
Phase: Phase 4Age: 18-65Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Apr 13, 2026Locations: 1
Eligibility criteria

Aged 18-65 years; [+7]

Hypersensitivity to study drugs (e.g., penicillin, amoxicillin, vonoprazan); [+10]

Status: Recruiting

Different Treatment Strategies on Prognosis of Acute Ischemic Stroke(AISDTS)

AISDTS is a prospective registry study, in which clinical information, examination and imaging data of patients with acute ischemic stroke receiving different treatment strategies were collected, grouped and statistically analyzed, and corresponding clinical prediction models were constructed to explore the role of clinical biological indicators in the occurrence and development of stroke.

Participants needed: 5,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Apr 9, 2026Locations: 1
Eligibility criteria

A) ≥18 years of age; B) hospital admission for ischemic stroke; C) Signed inform...

A) patients with incomplete clinical information; B) hospitalization observation...

Status: Recruiting

Circulating Non-coding RNA in Acute Ischemic Stroke With Endovascular Treatment (EVTRNA)

EVTRNA is to analyze the differentiated expression pattern of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA) by next-generation sequencing in acute ischemic stroke patients before and/or after endovascular treatment. The candidate circRNA/lncRNA/miRNA will be verified as the biomarker and regulator for progression and prognosis of acute ischemic stroke with endovascular treatment. Further, the candidate non-coding RNA will be used to evaluate the effect of endovascular treatment on both peripheral and central immune after stroke.

Participants needed: 300
Trial details
Age: 18-90Biological sex: AllType: ObservationalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Apr 9, 2026Locations: 1Duration: 90 Days
Eligibility criteria

Aged 18 years or older [+4]

a history of hemorrhagic infarction, chronic kidney/liver diseases, peripheral a...

Status: Not yet recruiting

Jianpi Lishi Jiedu Granules for Prevention of Postoperative Recurrence in Colorectal Advanced Adenomas

This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of Jianpi Lishi Jiedu Granules in preventing postoperative recurrence of colorectal advanced adenoma. A total of 376 patients aged 18-80 years with endoscopically resected advanced adenoma and diagnosed with Spleen Deficiency and Dampness Toxin syndrome will be enrolled and randomly assigned to receive either Jianpi Lishi Jiedu Granules or placebo for 3 months. The primary endpoint is the adenoma recurrence rate at 1 year post-treatment, assessed by colonoscopy and pathological examination. Secondary endpoints include malignant transformation rate, TCM syndrome improvement, quality of life, gastrointestinal symptoms, and exploratory analyses of gut microbiota and inflammatory cytokines.

Participants needed: 376
Trial details
Phase: Phase 3Age: 18-80Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Apr 1, 2026
Eligibility criteria

Aged between 18 and 80 years, male or female [+3]

Patients with diseases such as familial polyposis, inflammatory bowel disease, s... [+8]

Status: Recruiting

Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions

this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions

Participants needed: 78
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Mar 10, 2026Locations: 3
Eligibility criteria

Age > 18 years and < 80 years [+8]

Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogen... [+7]

Status: Not yet recruiting

Ultrasound-guided Non-invasive Simulation in Anesthesia Residency Training

Study Aim: This trial evaluates if a novel non-invasive, AI-assisted simulation training improves ultrasound-guided needle visualization skills in anesthesia residents. Design: Trainees were randomized into two groups: Intervention: AI-based, non-invasive simulated needle puncture training. Control: Conventional ultrasound teaching. Key Outcomes: The primary outcome is objective needle tip visibility. Secondary outcomes include anatomical identification, correct view acquisition, operator confidence, and overall scanning performance. Assessment: Outcomes are measured via blinded expert evaluation and theoretical tests. The goal of this randomized controlled clinical trial is to determine whether an ultrasound-guided non-invasive simulated needle puncture training technique can improve ultrasound-guided needle visualization skills in anesthesiology residents undergoing standardized residency training. The study is conducted in anesthesiology residents enrolled in a standardized residency training program. The main questions it aims to answer are: 1. Does non-invasive simulated needle puncture training improve objective needle tip visibility during ultrasound-guided peripheral nerve block procedures? 2. Does this training method improve anatomical structure identification, acquisition of correct block views, operator confidence, and overall scanning performance compared with conventional ultrasound teaching? Researchers will compare a non-invasive simulated needle puncture training group with a conventional ultrasound teaching group to see if the simulated training technique leads to superior needle visualization and procedural performance. Participants will: Receive standardized theoretical instruction on ultrasound- guided peripheral nerve blocks; Be randomly assigned to either non-invasive simulated needle puncture training using an artificial intelligence-assisted system or conventional ultrasound scanning training; Perform ultrasound scanning and simulated or conventional practice on healthy volunteers; Undergo theoretical examinations and blinded expert assessments of ultrasound scanning performance and needle visualization outcomes.

Participants needed: 30
Trial details
Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Feb 4, 2026Locations: 1
Eligibility criteria

Residents with prior experience in performing nerve block procedures. [+1]

Status: Not yet recruiting

Thyroid Cartilage Plane VS Superior Laryngeal Nerve Space Block in Awake Tracheal Intubation

The aim of this clinical trial is to compare the effectiveness and safety of ultrasound-guided thyroid cartilage plane approach with the superior laryngeal nerve space approach for superior laryngeal nerve block in awake tracheal intubation. Patients were randomized into the thyroid cartilage plane block group (T group) or the superior laryngeal nerve space block group (C group). In Group T, bilateral thyroid cartilage plane block was performed under ultrasound with thyroid cartilage as the landmark, and local anesthetic was injected on the surface of the thyroid cartilage. In Group C, local anesthetic was injected into the space between the thyrohyoid membrane and muscle groups above. We aim to evaluate whether the thyroid cartilage plane approach is not inferior to the superior laryngeal nerve space approach for ultrasound-guided superior laryngeal nerve block in awake tracheal intubation

Participants needed: 94
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Feb 9, 2026Locations: 1
Eligibility criteria

Patients scheduled for awake tracheal intubation under general anesthesia. [+4]

Cardiovascular dysfunction or arterial aneurysms. [+7]

Status: Not yet recruiting

Effects of Esketamine and Bilateral Lower Limb Elevation on Hemodynamic Stability During Induction of General Anesthesia in Elderly Patients Undergoing Thoracic Surgery

Video-assisted thoracoscopic surgery (VATS) is widely used in thoracic surgery due to small incisions, low stress response, and high patient tolerance. Compared with open thoracotomy, VATS has fewer complications, shorter hospital stays, and better postoperative quality of life. Despite being minimally invasive, VATS can cause severe postoperative pain via pleural/lung parenchyma damage, intercostal nerve traction, and chest tube stimulation. This pain impairs patient mobility (e.g., turning over, getting out of bed), increasing risks of atelectasis and pulmonary infections. Approximately 78% of patients experience moderate-to-severe postoperative pain, and 50% receive inadequate analgesia \[3\]. Effective postoperative pain management is critical for recovery and reducing pulmonary infections. In recent years, combined general anesthesia with regional nerve blocks has been recommended to enhance postoperative comfort and accelerate recovery, as regional blocks alleviate pain and reduce general anesthetic dosage. Thoracic paravertebral block (TPVB), an effective regional anesthesia technique, is commonly used for postoperative analgesia in VATS. TPVB involves injecting local anesthetics near thoracic spinal nerves exiting the intervertebral foramen, blocking ipsilateral somatic and sympathetic nerves. It is mainly used for analgesia after rib fractures, breast surgery, and thoracic surgeries (open or VATS). However, preoperative TPVB blocks both thoracic nerves and sympathetic nerves. Sympathetic inhibition reduces myocardial contractility, heart rate, and peripheral vascular resistance. Additionally, rapid administration of multiple drugs during general anesthesia induction further increases hypotension risk. Esketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has stronger sedative/analgesic effects and fewer adverse events than ketamine. Studies show sub-anesthetic doses (0.15-0.3 mg/kg) reduce induction hypotension, opioid-induced cough, and other adverse events via sympathetic stimulation, analgesia, and NMDA receptor antagonism. The passive leg raising (PLR) test assesses fluid responsiveness in acute circulatory failure by shifting \~300 mL of venous blood from lower limbs to the right heart. Its hemodynamic effects are reversible, avoiding fluid overload. Based on this, lower limb elevation during anesthesia induction rapidly and transiently increases venous return, reducing hypotension. Bilateral elevation enhances venous return, increases cardiac preload, improves cardiac output, and stabilizes blood pressure. General anesthesia induction is a period of frequent hemodynamic fluctuations. Elderly patients, often with comorbidities and reduced physiological reserve, are more susceptible to induction-related hemodynamic disturbances (40% incidence). Sustained/severe hypotension causes inadequate organ perfusion/ischemia, increasing postoperative complications (myocardial injury, ischemic stroke, acute kidney injury). Preventing post-induction hypotension in the elderly is clinically valuable. Opioids, propofol, and muscle relaxants induce hypotension via arterial dilation and reduced peripheral resistance. TPVB-induced sympathetic block further increases hypotension risk. This study hypothesizes that esketamine administration or lower limb elevation during induction reduces hypotension incidence in elderly VATS patients with TPVB.

Participants needed: 292
Trial details
Age: 60-80Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Jan 28, 2026
Eligibility criteria

Aged 60-80 years old [+3]

Allergy to the drugs used in this study [+9]

Status: Not yet recruiting

Combined Mitral and Tricuspid Versus Isolated Mitral Transcatheter Edge-to-Edge Repair for Mitral Regurgitation With Tricuspid Regurgitation (DUAL-TEER Trial)

This study aims to investigate the efficacy and safety of combined mitral and tricuspid transcatheter edge-to-edge repair (TEER) versus isolated mitral TEER in the treatment of patients with mitral regurgitation (MR) combined with tricuspid regurgitation (TR). The expected objective is to provide a more precise treatment strategy for patients with MR combined with TR, reduce surgical risks, improve survival rates and quality of life, and offer evidence for clinical practice. The main research content involves enrolling 404 patients with severe MR combined with TR, who will be randomly assigned to either the group receiving simultaneous mitral and tricuspid TEER or the group receiving isolated mitral TEER. The primary endpoint is the composite endpoint at one year postoperatively, including death during the one-year follow-up, mitral and/or tricuspid surgery or intervention due to mitral and/or tricuspid dysfunction, rehospitalization for heart failure, and an increase of \<15 points in the KCCQ score.

Participants needed: 404
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Jan 20, 2026
Eligibility criteria

Age ≥ 18 years [+17]

Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericardit... [+24]

Status: Recruiting

Colchicine Treatment for Non-Flow-Limiting Coronary Plaque by Coronary CTA: A Randomized Controlled Trial

This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate whether an anti-inflammatory medication can help improve heart health in patients with stable coronary artery disease. 1. Research Question \& Hypothesis We aim to determine whether adding low-dose colchicine (0.5 mg once daily) to standard medical treatment can further reduce the risk of major cardiovascular events in patients with chronic coronary syndromes (CCS), especially those with non-flow-limiting coronary plaques detected by coronary CT angiography (CCTA). We hypothesize that colchicine, by reducing vascular inflammation, may help prevent future heart attacks, strokes, and the need for coronary revascularization. 2. Study Population \& Design Design: A rigorously designed, prospective, multicenter, randomized (1:1), controlled superiority trial. Population: Adults (\>18 years) diagnosed with CCS, identified by CCTA as having at least one coronary artery with ≥50% narrowing but without significant impact on blood flow (CT-FFR \> 0.80). Intervention: Intervention Group: Standard guideline-directed medical therapy (GDMT) + colchicine 0.5 mg once daily Control Group: GDMT alone Sample Size: Approximately 3,826 participants, accounting for a 5% dropout rate. 3. Study Endpoints Primary Endpoint: The occurrence of major adverse cardiovascular or cerebrovascular events (MACCE), including:Cardiovascular death; Ischemic stroke; Non-fatal myocardial infarction; Any coronary revascularization. Assessed for 12 months after the last patient is enrolled. Secondary Endpoints:Occurrence of MACCE over 36 months. Incidence and time to first occurrence of each event category at 12, 24, and 36 months. Safety Endpoint: Side effects related to colchicine (e.g., gastrointestinal upset, liver or kidney abnormalities, blood disorders, muscle-related reactions).

Participants needed: 3,826
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Jan 20, 2026Locations: 1
Eligibility criteria

The subject (or legal guardian) understands the trial requirements and treatment... [+3]

Unable or unwilling to provide informed consent; [+18]

Status: Recruiting

Intravascular Imaging-Guided Versus Angiography- Guided PCI in Patients With DES-ISR

This study aimed to compare the clinical and angiographic outcomes of patients with DES-ISR who underwent repeat PCI with intravascular imaging or angiographic guidance.

Participants needed: 1,500
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Dec 22, 2025Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma

The goal of this clinical trial is to evaluate the diagnostic efficacy of somatostatin receptor and norepinephrine transporter targeted imaging (including 18F-MFBG, 123I-MIBG, 131I-MIBG, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE, 68Ga-DOTA-TOC, and other radiolabeled somatostatin analogues) in the diagnosis and staging of neuroblastoma and pheochromocytoma/paraganglioma patients aged 1-70 years. The main questions it aims to answer are: Can molecular targeted imaging using various norepinephrine transporter tracers (18F-MFBG, 123I/131I-MIBG) and somatostatin receptor tracers (68Ga-DOTA-peptides series) accurately detect primary tumors and metastatic lesions in neuroblastoma/pheochromocytoma patients? What is the comparative diagnostic performance (sensitivity, specificity, accuracy) of different molecular imaging techniques compared to histopathological diagnosis as the gold standard? Researchers will compare the imaging findings from multiple tracer types with surgical pathology results to assess diagnostic accuracy and clinical staging precision. Participants will: * Undergo screening assessments including medical history, physical examination, and laboratory tests * Receive intravenous injection of selected tracers (18F-MFBG, 68Ga-DOTA-NOC/TATE, or other appropriate agents) at standardized doses followed by PET-CT/MRI imaging at optimal time points * Undergo histopathological examination within 2 months post-imaging * Complete safety follow-up for 6 months to monitor for any adverse reactions to the imaging agents

Participants needed: 30
Trial details
Age: 6+Biological sex: AllType: ObservationalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Sep 26, 2025Locations: 1Duration: 6 Months
Eligibility criteria

Age: ≥6 months (pediatric and adult). [+6]

Pregnant or breastfeeding; breastfeeding participants unwilling to follow tracer... [+6]

Status: Recruiting

Local Anaesthetic Spread and Sensory Block Range of the Retro-superior Costotransverse Ligament Space Block

The aim of this clinical trial is to investigate the effects of local anesthetic diffusion range and sensory block range during retro-SCTLB(retro superior costotransverse ligament space block) and TPVB(thoracic paravertebral block) in patients undergoing CT-guided lung nodule localization. The main issue of the study is to determine the differences in the diffusion range and sensory block range of local anesthetics between the retro-SCTLB and TPVB nerve block methods.

Participants needed: 50
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Sep 16, 2025Locations: 2
Eligibility criteria

aged 18-80 years [+2]

Allergy to the study drug or local anesthetic; [+4]

Status: Recruiting

Laser-assisted Ultrasound-guided Peripheral Vein Cannulation in Cardiac Surgery

The aim of this clinical trial is to investigate the advantages of single-operator laser-assisted ultrasound-guidance comparing with traditional ultrasound guidance in peripheral venous catheterization.The primary question addressed is whether single-operator laser-assisted ultrasound-guidance could improve the first-attempt success rate of peripheral venous catheterization compared with traditional ultrasound guidance.

Participants needed: 100
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Sep 12, 2025Locations: 1
Eligibility criteria

aged 18-80 years [+2]

infection or hematoma at the puncture site [+2]

Status: Not yet recruiting

Huazhi Rougan Granule as an Add-On Therapy for H. Pylori Infection With Metabolic-associated Steatohepatitis

This study employed a double-blind, randomized, placebo-controlled design. Eligible treatment-naïve patients with Helicobacter pylori (Hp) infection complicated by metabolic-associated steatohepatitis (MASH) (dampness-heat accumulation syndrome) were enrolled and randomly assigned to either the experimental group or the placebo control group. Both groups received a 2-week Hp eradication regimen consisting of vonoprazan (20 mg twice daily) and amoxicillin (1000 mg three times daily). The experimental group additionally received active Huazhi Rougan Granule (taken orally three times daily, one sachet each time, with a 6-day medication followed by a 1-day drug holiday per cycle), while the placebo control group received an identical matching placebo on the same schedule. The study aims to evaluate the synergistic therapeutic efficacy of Huazhi Rougan Granule in combination with the vonoprazan-amoxicillin dual therapy.

Participants needed: 286
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Sep 8, 2025
Eligibility criteria

Aged 18-65 years; [+3]

Individuals with fatty liver caused by chronic heart failure, malnutrition, or p... [+11]

Status: Recruiting

Determination of the Optimal Volume of Liposomal Bupivacaine in Adductor Canal Block for Knee Joint Surgery

Building on Bayesian design methodologies from volume optimization studies of ropivacaine in shoulder surgery, this study pioneers the application of a seamless dose-finding strategy in knee ACB. Utilizing advanced statistical models (BOIN/BOP2 design), we aim to systematically evaluate the volume-effect relationship of liposomal bupivacaine, providing precise dosing recommendations to advance personalized and optimized analgesic protocols for knee surgery.

Participants needed: 63
Trial details
Phase: Phase 4Age: 18-85Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Sep 8, 2025Locations: 1
Eligibility criteria

Patients undergoing elective general anesthesia for unilateral knee joint surger... [+4]

Femoral neuropathy. [+6]