Clinical Research Directory

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.

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.

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.

Development and 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 (Overall Survival, Recurrence-Free Survival) and health economic outcomes (Quality-Adjusted Life-Years, Incremental Cost-Effectiveness Ratio), compared to non-stratified treatment group.

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.

Risk Model for Metastasis Detection of Neuroblastoma

Neuroblastoma (NB) is the most common extracranial solid tumor in children, accounting for about 15% of tumor-related mortality. NB patients in high-risk group are prone to bone marrow and/or bone metastases with low five-year overall survival rate. The artificial intelligence (AI) and deep learning technologies have potential to identifying morphological characteristics of bone marrow cytology in clinical practice. In this study, the investigators construct and evaluate the bone marrow cytology-based AI model for detection and prognosis of NB. The main questions of the study as follows: The question 1: Dose bone marrow cytology-based AI model work for prediction of bone marrow metastasis in NB? The question 2: Dose bone marrow cytology-based AI model work for prediction of bone metastasis in NB? The question 3: Dose bone marrow cytology-based AI model have potential to assist doctors in making individualized predictions of survival outcome? The investigators will retrospectively obtain the participants with NB between January 2019 and June 2024. The follow-up date ended on June 30, 2024. The internal cohort including participants from Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. The independent external cohorts including participants form Children's Hospital, Zhejiang University School of Medicine and Shenzhen Children's Hospital. The investigators collect the clinical data of enrolled participants at the time of the patients' initial admission to the hospital, prior to receiving treatment. The clinical information including age, gender, primary tumor location, tumor grade, bone marrow metastasis state, bone metastasis state, genetic aberrations (MYCN amplification, Chromosome 1p deletion, Chromosome 11q deletion) and lab variables (peripheral blood cell count, bone marrow cytology indicators, the serum concentration of lactate dehydrogenase, neuron specific enolase). This study is a non-interventional observational study, there is no risk to the participants and investigators. Participants get these benefits: 1. Early Detection: The model helps in early risk identification and personalize treatment. 2. Convenience: Because the model relies on general lab tests, it is easy to carry out can reduce invasive diagnostic procedures. 3. Cost-Effective: Using existing clinical data from routine tests can make the prediction process more cost-effective. 4. Data-Driven Decisions: The AI model improve diagnostic efficiency and support the medical decision.

Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery. Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).

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.

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

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.

Profiling the Intratumoral Microbiome of Pancreatic Ductal Adenocarcinoma Based on EUS-FNB Tissue Samples and Exploring Its Impact on Tumor Diagnosis and Prognosis.

The goal of this observational study is to use endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) to investigate the intratumoral microbiome profile in patients with pancreatic ductal adenocarcinoma (PDAC) and to evaluate its potential impact on tumor diagnosis and prognosis. PDAC is the most common and lethal type of pancreatic cancer, accounting for over 85% of all pancreatic cancer cases. Given that most patients are diagnosed at an advanced stage when surgery is no longer an option, EUS-FNB serves as a crucial and minimally invasive method for accessing and analyzing the microbiome within the tumor. The main questions this study aims to answer are: Can EUS-FNB reliably and accurately detect the microbiome within PDAC tumors? Researchers will analyze tissue samples obtained through EUS-FNB to confirm its ability to accurately capture the diversity and composition of the tumor microbiome. Are there specific microbes or metabolites within the PDAC tumor microbiome that are linked to patient prognosis or response to chemotherapy? The study will screen for and identify key microbial species or metabolites associated with treatment outcomes and patient survival in PDAC. To ensure the reliability of the EUS-FNB results, researchers will systematically compare microbiome data obtained from EUS-FNB samples with those from surgical biopsies of pancreatic cancer tissue. This comparison will help validate the consistency and accuracy of the two methods in identifying the microbiome diversity and composition, confirming the clinical and research utility of EUS-FNB. Participant Requirements: Participants will be patients diagnosed with PDAC who require EUS-FNB as part of their clinical assessment and treatment pathway. During the EUS-FNB procedure, researchers will use the remaining tissue after rapid on-site evaluation (ROSE) to conduct microbiome sequencing, ensuring sample quality. All participants will provide informed consent, allowing the use of leftover tissue for microbiome analysis, and their privacy will be strictly protected throughout the study. Study Procedures: Participants will undergo a standard EUS-FNB procedure as part of their routine clinical care, with no additional procedures required for the study. Researchers will compare the microbiome characteristics from EUS-FNB samples with those from surgical biopsy samples to verify consistency. The study will utilize 2bRAD-M metagenomic sequencing technology, which is cost-effective and suitable for low-biomass, host-contaminated, and degraded microbiome samples. This method generates an accurate species-level taxonomic profile for analysis. By identifying key microbial components or metabolites linked to patient prognosis or treatment response, this study aims to provide scientific evidence for early detection strategies and effective treatment plans for PDAC patients, potentially bringing significant clinical benefits.

Metabolism Imaging-genomics for Predicting the Surgical Outcomes of Colorectal Cancer

In this study, the investigators constructed an imaging-metabolism prediction model for colorectal cancer by analysing the imaging and metabolomics features of colorectal cancer, in order to further adjust and guide the treatment plan.

Evaluation of the Levels of Calcitonin Gene-related Peptide and Substance P

In cases of meningitis caused by external ventricular catheters (EVDs), which are the most commonly placed intracranial catheters that can lead to central nervous system infection through contamination/colonisation, the diagnosis may not be differentiated by either clinical signs and symptoms or conventional cerebrospinal fluid (CSF) tests. Therefore, due to the limitations in diagnosis and prognostic prediction of EVD-induced meningitis and the high mortality/morbidity rates of the disease, markers with high sensitivity and specificity in post-operative meningitis are needed. Calcitonin gene-related peptide (CGRP), a neuropeptide, has been shown to increase when C or Aδ sensory fibres are damaged or in the presence of inflammation in tissues adjacent to the fibres. CGRP is localised in nociceptive nerve terminals together with another neuropeptide, substance P, which has similar biological effects. There are very few studies investigating how CGRP levels in CSF and serum change in bacterial meningitis. Although it is thought that nociception and neuroimmune interactions affect meningeal antibacterial host defence, that nociceptors signal via CGRP to meningeal immune cells during infection, and that this neuroimmune axis exacerbates bacterial meningitis by weakening host defence, it is not yet clear how CGRP and substance P levels affect disease prognosis. This study will evaluate the utility of CGRP and substance P levels as biomarkers to assess diagnosis and treatment response in patients with post-operative meningitis followed in the intensive care unit.

Predictive Value of Combining AccuIMR and AccuFFR in Patients With STEMI

Patients with acute myocardial infarction were enrolled retrospectively. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were analyzed, and the relationship between FFR and IMR and the prognosis of patients with acute myocardial infarction was analyzed

The Impact of Colorectal Cancer Screening on Surgical Outcomes

This study aims to investigate the pathological characteristics and surgical outcomes of stage III CRC patients detected through screening. Data extracted from the database included the following patient information: age at diagnosis, gender, tumor location, neoadjuvant therapy, surgical procedures, histologic type, differentiation, vascular invasion, perineural invasion, pathological T stage, pathological N stage, and survival outcomes.

A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes

The aims of this study are to 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.