Clinical Research Directory

Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension

The investigators propose a prospective, observational study to determine the impact of OSA and associated physiological parameters on clinical outcomes in patients with pulmonary hypertension. The prevalence, phenotypes, and predictors of OSA in the setting of pulmonary hypertension will also be investigated. Adult patients diagnosed with pulmonary hypertension by right heart catheterization are eligible. Recruited patients will undergo an overnight cardiorespiratory study using a Level III portable device before hospital discharge. The cardiorespiratory tracings during sleep will be analyzed and audited by a certified sleep physician. The patients will be divided into two groups based on the apnea-hypopnea index (AHI): OSA (AHI ≥ 5) and non-OSA (AHI\<5) groups. Hypoxemic parameters such as time percentage spent with oxygen saturation below 90% and nadir oxygen saturation were all collected. Baseline clinical characteristics, such as the Epworth sleepiness scales, were also obtained. The primary endpoint of this study was clinical worsening (CW), defined as the composite event of a reduction in exercise capacity, worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension, or all-cause mortality. Secondary endpoints include individual outcomes of clinical worsening and all-cause mortality.

Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures

The aim of this study is to assess the clinical value of 5 transcriptomic signatures prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate (ORR) of first-line (L1). Chemotherapy regimen (FOLFIRINOX vs Gem-nabP) will be selected based on transcriptomic signatures applied to the pre-therapeutic liver biopsy of newly diagnosed PDAC patients.

Clinical Value of CT Perfusion in Peripheral Artery Disease

Peripheral artery disease (PAD) affects millions worldwide and can lead to serious complications such as leg ulcers, gangrene, and amputation. Current imaging methods mainly evaluate large blood vessels but do not measure microcirculation in the foot. Computed tomography perfusion (CTP) is a new technique that can assess blood flow in small vessels. The purpose of this study is to see whether combining CTP measurements with standard CT angiography images and patient clinical information can help predict which PAD patients are more likely to have poor outcomes after surgery to restore blood flow (revascularization). Poor outcomes include death or major limb problems such as amputation or need for another procedure. This is an observational study. Researchers will collect data from about 200 adult PAD patients who are scheduled to undergo revascularization. Participants will receive routine care including CT scans before and after surgery. No experimental drugs or devices are given. Researchers will follow participants for up to 2 years after surgery through medical records and phone calls to track their recovery and any complications. The results may help doctors identify high-risk patients earlier and improve treatment decisions.

Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast: A Randomized Controlled Trial

Phyllodes tumor (PT) of the breast is a rare fibroepithelial neoplasm, and the role of postoperative radiotherapy (PORT) remains controversial. Our team has previously established a molecular subtyping system for PT, classifying patients into four subtypes. Among them, the malignant novel 1/2 (MN1/MN2) subtypes exhibit extremely high risk of local recurrence, and retrospective data suggest that PORT may significantly improve local control in these subtypes. This study aims to evaluate the efficacy and safety of molecular subtype-guided postoperative radiotherapy (PORT) in patients with MN-subtype phyllodes tumor of the breast. This prospective, multicenter, open-label, randomized controlled trial plans to enroll 160 patients with molecularly confirmed MN1 or MN2 subtype who have undergone R0 resection. Patients will be randomized in a 1:1 ratio to either the PORT group or the observation-only group, with stratification by negative margin width (\<1 cm vs. ≥1 cm) and molecular subtype (MN1 vs. MN2). The primary endpoint is 2-year local recurrence-free survival (LRFS). Secondary endpoints include distant metastasis-free survival (DMFS), disease-free survival (DFS), overall survival (OS), and the incidence of acute and late radiotherapy-related toxicities. By using an innovative molecular subtyping system to precisely select the target population, this study seeks to assess the benefit and safety of PORT in MN-subtype phyllodes tumors. The results are expected to provide the highest level of evidence for this specific subgroup, advance treatment strategies toward "molecular subtype-guided precision radiotherapy," improve patient outcomes, and inform future clinical guidelines.

Breast Phyllodes Tumors: Based on 20-year Real-world Data From China

Phyllodes tumor (PT) is a rare type of breast tumor made up of both connective tissue (stroma) and gland tissue (epithelium). It accounts for less than 1% of all breast tumors. The main symptom is a fast-growing, painless lump. Based on its appearance under a microscope, the World Health Organization (WHO) classifies PT into three grades: benign (non-cancerous), borderline (intermediate), and malignant (cancerous). The chance of the tumor coming back after treatment (recurrence) is about 7%, 17%, and 25% for each grade, respectively. The average age when patients are diagnosed is between 36 and 55 years, and the typical tumor size ranges from about 4 to 11 cm. Malignant PT can spread to other parts of the body (metastasis) in up to 6% to 62% of cases, most often to the lungs or bones through the bloodstream. Because PT is rare, large studies on its causes, diagnosis, treatment, and long-term outlook are very limited. PT can grow very quickly. Delaying diagnosis and treatment may allow the tumor to become so large that surgery is no longer an option. Standard imaging tests (ultrasound, mammogram, MRI) have limited ability to tell the difference between benign and malignant PT. Also, since these tumors are often large and vary from one area to another, a small needle biopsy may not show the whole picture. An accurate grade is usually only possible after the whole tumor is removed and examined by a pathologist. PT does not respond well to radiation or chemotherapy. Therefore, the main treatment is complete surgical removal with clear margins. The role of newer therapies such as targeted therapy or immunotherapy is still being studied. Although the WHO grade gives some idea of how the patient might do, some benign PT can come back many times or even turn malignant, while some malignant PT stay stable for a long time. The current grading system does not fully explain why individual outcomes differ. In recent years, most prediction models for PT have been built using Western patient data (for example, from the SEER database). These models have not been tested in Asian populations. They are usually based on small, single-center studies with dozens to a few hundred patients, and many have only been checked inside the same database without outside (external) validation. Most studies focus on symptoms, imaging findings, how to tell benign from malignant PT, or comparing different types of surgery. Few have looked closely at patterns of recurrence and metastasis, or risk factors for rare events like multiple recurrences, distant spread, or death. To fill these gaps, we plan to conduct a large, multi-center, retrospective (looking back at past medical records) study across 8 top hospitals in China. We will use real-world data from about 3,500 patients with breast PT diagnosed between 2001 and 2023. The main goals are to describe the clinical and pathological features, treatment patterns, and long-term outcomes of Chinese PT patients. The main outcomes we will measure are local recurrence, distant metastasis, and overall survival. Secondary outcomes include disease characteristics and current treatment practices. This study aims to provide evidence from the Chinese population to help guide personalized treatment and future updates to clinical guidelines.

Dynamic Trajectories of Pupillary Light Reflex Parameters and Prognosis in Critically Ill Patients: A Multicenter Prospective Cohort Study

This multicenter prospective observational cohort study aims to investigate the association between early dynamic trajectories of pupillary light reflex parameters and clinical outcomes in critically ill patients admitted to emergency intensive care units. Quantitative pupillometry will be performed during the first 7 days after EICU admission. Constriction velocity will be the primary parameter for trajectory analysis, while dilation velocity, pupil diameter, constriction percentage, maximum constriction velocity, and latency will be analyzed as supplementary parameters. The study will evaluate whether these dynamic pupillary trajectories are associated with discharge outcome and 90-day functional outcome assessed by the Glasgow Outcome Scale-Extended.

Tumor Deposits in Colorectal Cancer and Its Prognostic Value in Survival and Metastasis

This study aims to evaluate the tumor deposits in colorectal cancer and its prognostic value in survival and metastasis

Spatiotemporal Evolution of Traditional Chinese Medicine Mechanisms in Acute Ischemic Stroke Treated With Dengzhan Xixin and Dengzhan Shengmai

To integrate large-scale RCT data on clinical symptoms, TCM syndromes, prognosis, and multi-omics profiles, construct a spatiotemporal dynamic network for disease-syndrome evolution of acute ischemic stroke (AIS) in the acute and recovery phases, evaluate the efficacy and safety of sequential treatment with Erigeron breviscapus-Dengzhan Shengmai for AIS, and provide evidence for precise syndrome differentiation and individualized therapy.Secondary Objective:To investigate the optimal time window and key intervention targets of sequential treatment with Erigeron breviscapus-Dengzhan Shengmai for AIS.

Sentinel Lymph Node Sampling for Patients With Middle-high Risk Endometrial Cancer Confined to the Uterus

Aim To investigate the effect of sentinel lymph node (SLN) sampling on the prognosis of patients with middle-high risk endometrial cancer obviously confined to the uterus before surgery.

Antimicrobial Therapy for Difficult-to-treat Pseudomonas Aeruginosa

The primary objective of the ADDICT study is to assess and compare the clinical efficacy of available options for antimicrobial therapy (new beta-lactam/beta-lactamase inhibitor combination, cefiderocol or older agents such as aminoglycosides and colistin) in unselected patients with infection due to difficult-to-treat P. aeruginosa.

Stratified Blood Pressure Management After Endovascular Treatment for Acute Ischemic Stroke

The RESCUE-BP is a multi-centered, prospective, randomized, open label, blinded endpoint (PROBE) phase III trial. In patients with acute ischemic stroke who have undergone endovascular treatment and achieved successful recanalization, the evaluation will compare a stratified blood pressure management strategy based on the collateral circulation status with the guideline-recommended conventional blood pressure management strategy. Within each stratum, participants will be randomized in a 1:1 ratio to either the stratified blood pressure management strategy group or the guideline-recommended conventional blood pressure management group. The goal is to determine whether this can improve good functional outcomes at 90 days (90-day Modified Rankin Scale \[mRS\] score 0-2). The study consists of four visits including the day of randomization, 24±4 hours after randomization, 7±1 days after randomization and 90±7 days after randomization. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment, neurological function rating scale will be recorded during the program. The primary outcome is the modified Rankin Scale (mRS) score of 0 to 2 at 90±7 days after randomization. The primary safety outcome is the incidence of sICH within 24±4 hours after randomization.

Cardiac Magnetic Resonance-Clinical Prediction Model-Dilated Cardiomyopathy

Dilated cardiomyopathy (DCM) is a common and serious heart disease characterized by left ventricular enlargement and impaired pumping function, with adverse prognosis (including heart failure, arrhythmia, heart-related hospitalization, and death) being a major concern for patients. Currently, a critical gap exists in accurately predicting which DCM patients are at high risk of these severe outcomes, limiting targeted clinical care. This observational, non-invasive study aims to develop and validate a clinical prediction model for early risk warning of adverse prognosis in DCM patients. The model integrates multi-parameter stress perfusion cardiac magnetic resonance (MP stress perfusion CMR)-a safe, high-resolution imaging technique that assesses cardiac structure, function, blood perfusion, and tissue damage under mild stress-and standard clinical data (e.g., age, gender, blood pressure, and routine heart test results). The model will be trained and tested using follow-up data from hundreds of DCM patients, with the analysis identifying patterns in CMR and clinical data associated with adverse outcomes. Once validated for accuracy, the model will provide doctors with personalized risk scores to prioritize care for high-risk patients (e.g., early intervention, close monitoring) and avoid over-treatment for lower-risk individuals. Beyond clinical application, the study will enhance understanding of DCM progression, laying the groundwork for improved diagnostic tools, more effective treatments, and better strategies to prevent DCM-related complications, ultimately improving patient quality of life and reducing mortality.

Validation of RCC Predicting Model With Emulated-target Trial

This single-center study utilizes real-world data (2012-2024) from 4700 renal cell carcinoma (RCC) patients at Peking University Third Hospital to: (1) Develop and validate a prognostic prediction model specifically for RCC patients, including those with venous tumor thrombus (VTT); (2) Compare the performance of this new model against existing RCC prediction models in both the overall RCC cohort and the VTT subgroup; (3) Employ an emulated target trial (ETT) methodology to evaluate whether risk-stratified treatment based on the prediction model (grouping patients as high/medium/low risk) improves survival outcomes .

NEURO - Prognostication Using Late Somatosensory Evoked - Potentials

The main aim of this study is to develop a new technique for the passive diagnosis of cognitive-motor dissociation, with the detection of motor intention in a comatose patient by analysing the EEG signal and in particular the ERD/ERS amplitudes in the motor cortex after stimulation of the median nerve.

Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

To investigate the role of preoperative serum FGF19 level in the prognosis of biliary atresia.

Fertility Outcomes In Young Breast Cancer Patients And Their Prognosis And Offspring Health

The goal of this observational study is to clarify the fertility status of young breast cancer patients, verify the independent impact of fertility behavior on the prognosis of patients with different molecular types, and evaluate the association between treatment regimens and offspring health.

Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis

The recent validation of thrombectomy in addition to thrombolysis with intravenous administration of alteplase suggests a major revolution in the management of acute strokes. This treatment option also opens up a new field of research, making possible the analysis of the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the thrombectomy procedure makes it possible to retrieve either partially or completely the clot. Previous studies have analyzed the correlation between the composition of the thrombus and the etiology of stroke. Their discordant results do not yet make it possible to distinguish a particular profile of thrombus according to etiology. Other studies have shown a correlation between the proportion of red blood cells in a thrombus and the likelihood that it is visible in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between the presence of lymphocytes in the thrombus and an atheromatous etiology. The main limitations of these studies are the small number of patients included, the high variability of conservation protocols and the absence of plasma data, which does not allow for research on the correlation between clot composition and plasma biomarkers.

Application of Multimodal MRI in Histological Grading and Prognostic Assessment of Rectal Cancer

Rectal cancer (RC) is among the most prevalent gastrointestinal cancers \[1\], characterized by significant tumor heterogeneity \[2\]. Neoadjuvant chemoradiotherapy followed by total mesorectal excision is a standard treatment for locally advanced rectal cancer \[3\]. Although the locoregional recurrence rate has decreased due to this treatment, distant metachronous metastases still occur in over 20-30% of cases \[4,5\]. The varying biological characteristics of rectal cancer may result in different treatment responses and prognoses \[6\]. Patients who are diagnosed with the same tumor-node-metastasis (TNM) stage of RC frequently exhibit vastly different clinical outcomes, despite receiving the same therapeutic interventions \[7\]. While the TNM staging system remains the predominantly used framework for directing treatment choices and forecasting prognosis, it is crucial to take into account additional pathological elements, such as tumor budding, lymphovascular invasion (LVI), perineural invasion, and extramural venous invasion \[8-10\]. A recent investigation has highlighted that LVI, rather than the traditionally prioritized extent of tumor invasion, serves as a significant risk factor for metastasis in early-stage RC \[11\]. Patients exhibiting LVI+ demonstrate a considerably worse prognosis and overall survival when compared to those with LVI -. Identifying LVI before surgery is crucial for informing treatment strategies in RC \[12\]. LVI offers important information regarding the tumor's biological behavior and its likelihood of metastasizing, thus improving the precision of disease staging. This information enables clinicians to tailor treatment approaches, which helps prevent overtreatment in patients with LVI -. In cases where LVI is present, it may be essential to adopt more aggressive treatment methods, such as postoperative chemotherapy, radiotherapy, or more extensive surgical resections, to reduce the chances of recurrence and metastasis. In summary, LVI serves as a crucial prognostic factor, providing essential insights into the tumor's potential for metastasis and recurrence, which has significant clinical implications for predicting postoperative outcomes, including recurrence, metastasis, and disease-free survival. Therefore, a preoperative non-invasive assessment of LVI, particularly in patients with LVI +, may be instrumental in guiding clinical practice. Conventional magnetic resonance imaging (MRI) is particularly effective in observing large blood vessels and has moderate sensitivity and high specificity to distinguish LVI \[13\]. However, it can noninvasively and accurately assess extramural vascular invasion with a diameter greater than 3 mm. In contrast, it is challenging to evaluate vascular invasion with a diameter less than 3 mm, as well as intramural vascular and lymphatic infiltration, due to the limitations in resolution \[14,15\]. In addition, pathological biopsy is the gold standard for preoperative diagnosis. However, this invasive approach may not reflect the LVI status of the entire tumor due to possible sample errors \[16\]. Therefore, effectively assessing LVI in RC via preoperative imaging remains a significant challenge. Intravoxel incoherent motion (IVIM) is a functional imaging method that can display the diffuse movement of water molecules and blood flow, microcirculation perfusion, thereby improving the diagnostic accuracy of RC \[17,18\]. The IVIM model has the potential to identify perfusion effects using multiple b-value samples and biexponential curve fit analysis \[19\], which can lead to three parameters, namely the true diffusion coefficient (D), the pseudo-diffusion coefficient (D\*), and the perfusion fraction (f). Li et al \[20\]. discovered that the D value obtained from IVIM of LVI+ patients was significantly higher than that of LVI- patients with RC, but only 42 patients were included in this study, making it more difficult to accurately assess the feasibility of IVIM. In another study, Kan et al \[21\]. revealed that the D value was helpful to assess the prognostic factor related to RC, while the AUC of the D value for evaluating LVI was only 0.646. Currently, studies utilizing conventional IVIM quantitative parameters have demonstrated a relatively low diagnostic efficiency in detecting LVI, with AUC values ranging from 0.629 to 0.646 \[22,23\]. Tumor heterogeneity has emerged as a significant biomarker for tumor staging and prognosis \[24\]. Sub-region analysis, an innovative imaging post-processing technique, has demonstrated its potential in exploring intratumor heterogeneity in recent years. Prior research has underscored the importance of sub-region analysis derived from either single-modality or multiparametric MRI in the investigation of intratumor heterogeneity in RC \[25-27\]. However, to our knowledge, the application of sub-region analysis based on IVIM-MRI to evaluate LVI status and prognosis in patients with RC has not been reported. Thus, this study aimed to assess the fe

PBC Long-term Outcomes Study

Primary biliary cholangitis (PBC) is an autoimmune liver disease predominantly affecting middle-aged women. While historically it was deemed rare, advancements in specific auto-antibody tests have led to increased recognition of PBC. The long-term survival of PBC patients in China is not yet fully understood. Several studies have investigated the prognosis of PBC in China. While these studies provide valuable insights into the disease characteristics and prognostic factors of PBC in China, they are all single-center studies with limitations. They lack consideration of the impact of symptoms, varying disease stages, and second-line treatments on prognosis. Therefore, there is a pressing need for multicenter and large-scale studies to further elucidate the characteristics and long-term survival of PBC patients in China. Biochemical response to ursodeoxycholic acid (UDCA) is an independent factor associated with long-term survival. Unfortunately, approximately 30-40% of PBC patients demonstrate insufficient biochemical response to UDCA. In our cohort, we reported a higher nonresponse rate, with about 44% according to the Paris I criteria. These patients remain at risk for disease progression to advanced stages and may benefit from additional second-line drug therapies. With significant advancements in the development of new drugs for PBC, a comprehensive understanding of patients with suboptimal responses to UDCA-including long-term prognosis, the distribution of different disease stages, and the prevalence of pruritus-will provide a basis for individualized treatment strategies. Additionally, fatigue and pruritus are prevalent symptoms for PBC patients and fluctuates independently of disease activity or stage, which significantly diminishing health-related quality of life. However, the incidence and impact of fatigue and pruritus on long-term outcomes for PBC patients in China need further clarification. Therefore, we would like to conduct this multicenter study to estimate the prevalence of PBC in China and to evaluate the symptomatic burden, treatment, and long-term outcomes among PBC patients in China.

Impact of Erector Spinae Plane Block on Chronic Postsurgical Pain in Breast Cancer Patients

Chronic postsurgical pain (CPSP) has an incidence of 46% in patients after breast cancer surgery, which seriously affects patients' physiological and psychological function, as well as quality of life. Acute pain is an independent risk factor for persistent pain after surgery. Erector spinae plane block (ESPB) provided excellent perioperative analgesia in patients undergoing breast surgery. Dexmedetomidine as an adjuvant of local anesthetics prolongs the duration of peripheral nerve block and decreases the requirements of postoperative analgesia. The investigators hypothesize that, for breast cancer patients undergoing mastectomy, ESPB (with a combination of 0.5% ropivacaine 35 ml and dexmedetomidine 1 microgram/kg) can reduce the occurrence of CPSP. The purpose of this randomized controlled trial is to investigate the impact of ESPB with adjuvant dexmedetomidine on the incidence of CPSP in breast cancer patients after mastectomy. We will also observe the impact of ESPB on long-term survival in these patients.

Effect of Bone Augmentation Simultaneous to Implant Removal on the Prognosis of Reimplantation at the Same Site

The aim of this study was to investigate the effect of bone augmentation simultaneous to implant removal on the prognosis of reimplantation at the same sites, providing recommendations for management strategies after failed implant removal.

Using Cardiac MRI to Predict Outcomes in Patients With STEMI

This prospective, multicenter observational study aims to evaluate the prognostic value of a comprehensive set of cardiac magnetic resonance (CMR) imaging parameters in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The study integrates advanced artificial intelligence (AI) techniques to extract and analyze high-dimensional imaging features from multiple CMR sequences-including cine, strain mapping, and functional sequences-going beyond traditional measures such as infarct size or microvascular obstruction. The primary objective is to identify novel prognostic markers from routinely acquired CMR images that reflect myocardial structure, function, and mechanical deformation (strain), and to assess their association with long-term clinical outcomes. In addition to standard parameters, the study includes a detailed evaluation of left and right ventricular systolic and diastolic volumes, ejection fractions, and biventricular strain components (including longitudinal, circumferential, and radial strain), as well as left and right atrial volumes, emptying fractions, and reservoir/conduit/booster strain indices. Approximately 1000 STEMI patients will undergo CMR scanning within one week after PCI. The imaging data will be subjected to AI-based feature extraction and dimensionality reduction algorithms to uncover latent patterns associated with adverse outcomes. Patients will be followed for up to three years for the occurrence of major adverse cardiovascular events (MACE), including cardiovascular death, recurrent myocardial infarction, and heart failure hospitalization. The central hypothesis is that comprehensive CMR functional and strain-derived parameters, when analyzed using AI-driven models, offer independent and incremental prognostic value beyond conventional clinical risk factors. This study seeks to establish a data-driven, multimodal imaging framework for personalized risk stratification in STEMI patients, potentially enabling more precise post-infarction management strategies. No investigational treatment is involved. All imaging and clinical data are collected as part of routine care and analyzed retrospectively for outcome prediction.

Prognostic Value of Isolated and Combined Score Aspects in Acute Ischemic Stroke

This study, called TARGET-ASPECT, looks at patients who had a type of stroke called acute ischemic stroke and were treated with clot-busting medicine and a procedure to remove the clot. Even with these treatments, about half of patients don't fully recover. The study aims to see if certain brain imaging scores, especially when combined, can better predict how well patients will recover 90 days after their stroke and if their blood vessels reopen successfully. The study will include 152 patients and last about 9 months. The goal is to find easy and reliable tools that doctors can use to make better treatment decisions.

Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological Response

We are using a tool called QtNGS (quantitative targeted amplicon-based next-generation sequencing ) to measure the abundance of local pathogens in patients with ventilator-associated lower respiratory tract infections. We hypothesize that changes in pathogen abundance before and after treatment are related to patient outcomes. This study aims to evaluate the effectiveness of the tool by analyzing the changes in pathogen abundance and exploring the relationship between these changes and clinical outcomes.