Pu Tian Shi

Researchers are evaluating an artificial intelligence (AI) system to assist in classifying the depth of invasion in early esophageal squamous cell carcinoma using endoscopic ultrasound. This study aims to support preoperative T staging and improve diagnosis and treatment decisions for patients with early esophageal cancer and related precancerous lesions. The study design is a multicenter, prospective, randomized cohort trial comparing the AI-assisted method to conventional grading techniques. Participants who meet the inclusion criteria are randomly assigned to either the AI group or the conventional group, with about 100 patients in each group. The AI system helps determine the invasion depth of early esophageal squamous cell carcinoma under endoscopic ultrasound. Randomization is managed centrally, and the study is blinded so that the operating physicians follow protocols labeled as A or B without knowing the group assignments. During the study, researchers evaluate the accuracy of grading the invasion depth over a 2-year period, comparing the AI-assisted assessments with pathological findings. Participants undergo endoscopic ultrasound examinations, and their clinical and pathological data are recorded in detail. The study monitors the consistency between grading judgment and pathology to assess the AI system's performance in assisting clinical decision-making.

Researchers are evaluating the pain-relieving effects of wrist-ankle acupuncture in patients who experience different types of pain after perianal surgery. This prospective clinical observation study includes 60 patients aged 18 to 75 years with a postoperative pain level of 4 or higher on the Visual Analog Scale (VAS). The study aims to assess how effective and applicable wrist-ankle acupuncture is for managing postoperative pain, and also explores how pain influences the occurrence of urinary retention after surgery. All patients receive standard postoperative care, which includes intravenous flurbiprofen infusions, traditional Chinese medicine sitz baths, and pain education. When a patient's pain reaches a certain threshold (Verbal Rating Scale score of 4 or higher), wrist-ankle acupuncture treatment is given once daily. This treatment involves inserting sterile needles just under the skin at specific points on both lower limbs and keeping them in place for 30 minutes to 1 hour. The treatment course is adjusted based on symptom relief, and if pain remains high 30 minutes after acupuncture, additional pain medication is provided. Participants are monitored through multiple assessments including pain scores before and after acupuncture, the frequency of additional pain medication use over 3 days post-surgery, and urinary retention scores within 24 hours after surgery. Researchers collect data on pain reduction at 5 and 30 minutes following treatment and compare results between two groups of patients experiencing different pain types. The study involves close observation during hospitalization to evaluate how wrist-ankle acupuncture affects postoperative pain and related outcomes.

Cervical precancerous lesions, specifically Cervical Intraepithelial Neoplasia grade 2 (CIN2), pose significant risks to the health and fertility of young women. This research evaluates how the integration of Human Papillomavirus (HPV) DNA affects the progression and prognosis of CIN2 in women aged 45 and below. The study also explores the relationship between HPV integration status, vaginal flora diversity, and cervical cytology findings to improve understanding of disease outcomes. The study follows 300 women diagnosed with CIN2 confirmed by biopsy, recruiting them from multiple hospitals in China. Participants undergo comprehensive testing, including HPV viral integration tests, HPV genotyping, cervical cytology (ThinPrep tests), and vaginal secretion analysis at baseline and at 3, 6, 9, and 12 months. Colposcopy and biopsies are performed at the 6- and 12-month visits to assess lesion progression. No surgical or medication treatments are given unless the disease progresses during the 12-month observation. Participants will attend scheduled visits for sample collection and testing throughout the year-long follow-up. Researchers will perform various laboratory analyses, including HPV integration and genotyping, cervical cytology, and 16SrRNA sequencing of vaginal secretions. These assessments aim to monitor disease progression, understand HPV's role in CIN2 outcomes, and evaluate changes in vaginal flora. The study's comprehensive data collection supports a detailed evaluation of prognostic factors and disease management in young women with CIN2.

Researchers are evaluating the safety and effectiveness of neoadjuvant adebrelimab combined with chemotherapy in patients with locally advanced esophageal squamous cell carcinoma (ESCC). This exploratory, single-arm Phase 2 study focuses on patients whose cancer has been confirmed by tissue or cell analysis and aims to measure the rate of complete cancer response four weeks after surgery. Participants in the study will receive adebrelimab intravenously at a dose of 1200 mg or 20 mg/kg every three weeks. Alongside this, chemotherapy includes nanoparticle albumin-bound paclitaxel given at 100 mg/m² on days 1 and 8 every three weeks, and cisplatin at 75 mg/m² on days 1, 2, and 3 every three weeks. After completing neoadjuvant therapy, participants are planned to undergo surgical removal of the tumor. During the study, participants will be monitored through clinical assessments including performance status and organ function tests. Researchers will evaluate pathological complete response rate four weeks post-surgery. The study also involves safety monitoring for adverse effects and requires compliance with follow-up visits. The trial includes adults aged 18 to 75 years with no prior anti-tumor therapy for esophageal cancer and adequate organ function.

Researchers are evaluating the safety and effectiveness of a combination treatment using zanidatamab, tislelizumab, and chemotherapy before surgery in patients with HER2-positive muscle-invasive bladder cancer (MIBC) at stages cT2-4aN0-1M0. This phase II, open-label, multicenter study aims to assess whether this neoadjuvant therapy can lead to bladder preservation through selective treatment strategies. Participants will receive four cycles of zanidatamab (dosed by weight), tislelizumab, and chemotherapy every three weeks. After this neoadjuvant therapy, their disease status will be reassessed. Those who achieve a clinical complete response (cCR) may continue maintenance therapy with zanidatamab and tislelizumab for additional cycles as part of bladder preservation. Patients without cCR may undergo radiotherapy or partial cystectomy followed by maintenance therapy, or proceed directly to radical cystectomy followed by adjuvant tislelizumab. Throughout the study, participants will be closely monitored with clinical evaluations to measure the clinical complete response rate at the end of neoadjuvant therapy cycles. Safety and disease status assessments will guide subsequent treatment decisions. The study includes detailed follow-up for maintenance therapy and possible surgical interventions, with overall participation spanning multiple treatment phases to observe long-term outcomes.

Researchers are studying the effects of normobaric oxygen (NBO) therapy on patients who have experienced an acute ischemic stroke (AIS) and are transferred for endovascular thrombectomy (EVT). The goal is to assess the safety and effectiveness of NBO in improving functional outcomes three months after stroke. Stroke is a major cause of death and disability worldwide, and while treatments like mechanical thrombectomy can improve blood flow, less than half of patients with large vessel occlusion achieve good recovery. NBO offers potential brain protection by improving oxygen delivery to affected areas and reducing damage through multiple mechanisms. Participants will receive either inhaled 100% oxygen (NBO) or best medical care without NBO. The study focuses on patients transferred for EVT who meet specific stroke severity and imaging criteria. NBO treatment is delivered through oxygen inhalation, aiming to increase oxygen availability to the brain before reperfusion. The study is conducted in a Phase 3 setting and compares outcomes between those receiving NBO and those receiving standard care. During the study, participants will be monitored for disability levels using the modified Rankin scale at 90 days and one year after treatment. Assessments include neurological exams and imaging to confirm stroke details and severity. Researchers will also track safety and functional outcomes to evaluate the impact of NBO therapy. Participants are followed for at least three months after randomization to observe recovery and potential benefits.

Researchers are investigating the clinical and molecular characteristics of cervical neuroendocrine tumors by collecting and analyzing data from 300 women diagnosed with this rare type of cervical cancer. The study aims to evaluate the prognosis and survival outcomes of these patients through detailed clinical information such as age, biopsy results, HPV genotyping, cancer staging, and follow-up data. Additionally, the study includes molecular analysis to better understand the protein features and potential prognostic markers of this cancer type. The research involves gathering paraffin tissue samples from 100 cases of cervical neuroendocrine tumors across multiple centers in China. These samples are processed to measure protein concentration and perform proteomic analyses to identify molecular characteristics that may correlate with patient outcomes. The study does not include specific treatment interventions but focuses on diagnostic and molecular data collection. Participants will be involved through data review and tissue sample analysis, with clinical follow-up information recorded to assess survival and disease progression over three years after surgery. The outcomes measured include mortality rates and disease-free survival within this timeframe. The study establishes a follow-up database to facilitate ongoing evaluation of clinical and molecular data to explore the clinical application of these findings.

Researchers are investigating the prevalence, disease burden, and prognosis of chronic obstructive pulmonary disease (COPD) in patients aged 40 years or older with three types of cardiovascular diseases (CVD): coronary heart disease (CHD), atrial fibrillation (AF), and chronic heart failure (CHF). This multi-center, prospective, and interventional study aims to describe how common COPD is among these CVD patients and to observe how combined cardiopulmonary management affects their short-term prognosis. The study plans to enroll approximately 3,000 subjects, divided evenly among the three disease cohorts. The study involves a guideline education and implementation intervention delivered at both the investigator and patient levels. Investigators will receive education about COPD and CVD about four weeks before enrolling subjects. After enrollment, cardiologists and pulmonologists will provide patients with disease education every four weeks and collaborate on treatment management. Participants will be followed up every four weeks throughout the study period to monitor their health and treatment progress. Participants will undergo assessments including spirometry testing and questionnaires evaluated by investigators to confirm cognitive ability. Researchers will measure the number and percentage of COPD cases among subjects with CVD at baseline. Follow-up visits every four weeks will support ongoing treatment management and monitoring. The study duration and detailed timelines align with the intervention and follow-up schedules, ensuring comprehensive observation of patient outcomes and safety.