Ka Shi Di Qu

Researchers are studying the gut microbiome in people with several serious chronic diseases in China, including various cancers, hypertension, epilepsy, and kidney disease. The study aims to better understand the differences and similarities in gut microbiome patterns linked to these diseases and different regions, and how these patterns affect microbiome-based diagnostic tests. This work is important because past research has shown links between microbial imbalances and disease, but variability between studies has made it hard to draw clear conclusions. This observational study will recruit 500 patients diagnosed with each target disease and 500 healthy control participants matched by age and sex. Researchers will collect detailed information about participants' demographics, lifestyle, diet, medications, and health status. Biological samples including feces, saliva, urine, and blood will be collected for analysis. There is no active treatment or intervention; the study focuses on characterizing the microbiome and related health data. Participants will undergo assessments of their medical history and lifestyle, with sample collections to analyze microbiome and biochemical markers. Researchers will measure the baseline microbiome to identify disease-associated signatures. The study requires participants to be aged 18 to 75 and to have lived in the hospital's province for at least three years. Safety monitoring is observational, with no study treatments given. The total participant involvement includes data and sample collection for cross-sectional analysis.

Researchers are evaluating the effectiveness and safety of BGB-16673 compared to the investigator's choice of treatment (either bendamustine plus rituximab or high-dose methylprednisolone plus rituximab) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with covalent Bruton tyrosine kinase inhibitors. CLL and SLL are blood cancers that cause enlarged lymph nodes, spleen, or liver and symptoms such as night sweats, weight loss, and fever, leading to a shorter life expectancy. Participants will be randomly assigned to receive either oral BGB-16673 or the investigator's choice of intravenous bendamustine plus rituximab or high-dose methylprednisolone plus rituximab. About 150 participants in Mainland China and Taiwan will take part in this Phase 3, open-label, randomized study. During the study, researchers will measure how long participants live without their disease worsening, known as progression-free survival, over approximately 23 months. Participant health and disease status will be monitored through imaging, laboratory tests, and clinical assessments to evaluate treatment effects and safety.

People with end stage kidney disease (ESKD) who require dialysis have a much higher risk of developing cardiovascular disease compared to the general population, with heart problems causing over half of the deaths in this group. This trial is studying whether taking low dose aspirin daily can safely reduce cardiovascular events in these dialysis patients. The study is a Phase 4, multi-center, randomized controlled trial designed to provide clear evidence about aspirin's benefits and risks in this specific population, where existing data is limited. Participants will be randomly assigned to receive either a daily 100 mg aspirin tablet or a matching placebo. The trial uses the Chinese peritoneal dialysis and hemodialysis registry to efficiently screen and recruit patients and collect data during routine dialysis care. Follow-up visits occur every six months as part of regular clinical care, and the study will continue until enough cardiovascular events have occurred, expected to take about five years. During the study, participants will have their health monitored through routine clinic visits every six months, with data collected on cardiovascular events and safety. The main outcome measured is the number of participants experiencing major cardiovascular events over the study period. An independent board will oversee safety and study progress. The trial uses intention-to-treat analysis and aims to minimize participant burden by integrating study procedures into usual care.

Researchers are investigating the occurrence of dyspeptic symptoms in patients infected with Helicobacter pylori and monitoring how these symptoms improve after the infection is treated. This multicenter, prospective, observational study aims to provide useful information to guide clinical diagnosis and treatment for patients with H. pylori infection and related dyspepsia. Patients confirmed to have H. pylori infection through breath tests and/or endoscopic examination will complete an epidemiological questionnaire and a Functional Dyspepsia Symptom Diary (FDSD). Those who have dyspepsia and successfully undergo eradication treatment for H. pylori will be followed up after 2 months and again after 6 months to evaluate relief from dyspeptic symptoms. Participants will provide baseline information and symptom assessments at the start. Researchers will track the incidence of dyspepsia when the questionnaires and diaries are completed and then measure symptom remission at follow-up visits. This study includes monitoring safety and symptom changes over time in patients between 18 and 80 years old who have not previously been treated for H. pylori infection.

Researchers are evaluating the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells (MSCs) therapy for patients with decompensated cirrhosis, a serious liver condition with high mortality. This phase 2 clinical trial addresses the challenges of liver transplantation, such as donor shortages, high costs, and rejection, by studying MSCs as an alternative treatment to improve liver function and outcomes. The trial compares three intravenous doses of MSCs given on days 1, 8, and 15 with placebo infusions on the same schedule. A total of 140 patients will be randomly assigned to receive either MSCs plus standard care or placebo plus standard care. This randomized, double-blind, multicenter study aims to validate MSC therapy’s effects on liver health and function. Participants will be monitored for changes in their Model for End-Stage Liver Disease (MELD) score from the start of treatment to day 28. Throughout the study, they will undergo clinical assessments, laboratory tests, and imaging to evaluate liver status and safety. The study also ensures close monitoring for adverse effects, with follow-up visits to assess patient health and treatment impact over time.

Researchers are conducting a large study called the IDEAL study to evaluate the use of an artificial intelligence (AI) model in detecting intracranial aneurysms using head CT angiography (CTA) scans. The study will enroll over 6450 adult patients scheduled for head CTA across 21 hospitals in more than 10 provinces in China. The main goal is to compare how well the AI-assisted diagnosis detects aneurysms compared to a control group, focusing on sensitivity and specificity. The study will also examine patient prognosis and outcomes related to aneurysm detection and treatment. Participants will be randomly assigned to one of two groups: the True-AI group using a deep-learning AI model with high sensitivity and specificity for aneurysm detection, or the Sham-AI group which uses a similar system but with very low sensitivity and comparable specificity. Neither patients nor radiologists will know which group they are in. The study includes follow-up procedures such as repeat imaging at 12 months and tracks clinical outcomes, hospitalizations, treatments, and quality of life. Cost-effectiveness and workload impact of the AI system will also be evaluated. During the study, patients will undergo head CTA scans as part of routine clinical care. Researchers will collect and analyze diagnostic accuracy data, resource use, and clinical follow-up information. They will monitor aneurysm-related events, repeat imaging results, and patient quality of life. The study aims to assess both short- and long-term effects of integrating AI into routine aneurysm diagnosis, with a total monitoring period of at least 12 months post-imaging.

Researchers are investigating the safety, tolerability, and preliminary effectiveness of VUM02 Injection, an allogeneic cell therapy made from human umbilical cord tissue-derived mesenchymal stem cells, in patients with idiopathic pulmonary fibrosis (IPF). This Phase I, open-label, dose-escalation clinical trial follows a "3+3" design to carefully evaluate different dose levels from low to high. The study involves adult participants aged 40 to 75 years who have stable IPF as defined by specific lung function criteria and previous standard treatments. The trial includes three dose groups: low dose (5 x 10^7 cells), medium dose (1 x 10^8 cells), and high dose (2 x 10^8 cells) per person per administration. Each participant receives VUM02 Injection intravenously every 3 days for a total of 3 doses. Initial safety assessments are conducted after the first dose, including monitoring symptoms, physical exams, vital signs, ECG, and laboratory tests. Dose escalation decisions are made by a Safety Monitoring Committee based on these safety data, with enrollment proceeding sequentially through dose groups. Participants undergo multiple evaluations, including lung function tests and various laboratory tests, to track treatment effects and safety. The study measures the incidence and severity of treatment-related adverse events and determines the maximum tolerated dose within 28 days. The trial also monitors longer-term safety and tolerability, with careful oversight to ensure participant well-being throughout the study period.

Researchers are developing a standardized approach and quality assessment system for confocal enteroscopy, a technology that allows real-time microscopic examination of small bowel mucosa. This technique, combined with double-balloon enteroscopy, aims to improve targeted biopsy, early diagnosis, and staging of small bowel diseases such as inflammatory bowel disease and tumors. Although confocal endoscopy is used for upper and lower gastrointestinal tract diseases, its application to small bowel conditions is still limited, making this study important for establishing diagnostic frameworks and quality standards. The study plans to enroll 200 patients undergoing confocal small-bowel endoscopy along with 400 control cases split into exploratory and validation groups. During single- or double-balloon enteroscopy, suspected lesions and normal mucosa will be examined using confocal laser endomicroscopy (CLE). Data collected will include mucosal barrier assessments, inflammation activity scores, and AI-assisted image recognition to aid lesion detection. The exploratory arm will help create a diagnostic model for small-bowel inflammatory bowel disease, which will be tested in the validation arm. Additionally, quality control indicators such as procedural success, diagnostic accuracy, adverse events, and image quality will be developed and applied. Participants will undergo detailed endoscopic examination with CLE during their procedures, and data on procedure times, scope handling, bowel preparation, and specimen processing will be recorded. Researchers will analyze factors affecting quality and build a quality control system. The study includes clinical assessments, pathology comparisons, and AI evaluation to measure diagnostic success within 14 days. Ongoing internal audits will ensure continuous improvement of the quality system throughout the study.

Researchers are investigating the effects of thrombus aspiration (TA) in patients experiencing ST-segment Elevation Myocardial Infarction (STEMI) who have a high thrombus burden, indicated by a TIMI thrombus grade of 3 or higher. This prospective, multicenter, open-label, randomized controlled trial aims to compare outcomes between patients treated with or without manual thrombus aspiration during primary percutaneous coronary intervention (PPCI) performed within 12 hours of symptom onset. The goal is to assess if TA reduces major cardiovascular events including cardiovascular death, recurrent heart attacks, stent thrombosis, target vessel revascularization within 180 days, or stroke within 30 days. Participants are randomly assigned in a 1:1 ratio to receive either primary PCI with manual thrombus aspiration or PCI alone without thrombus aspiration. Both procedures are performed as part of the treatment for STEMI patients with high thrombus burden. The study evaluates the safety and efficacy of adding thrombus aspiration to the standard PCI process. During the study, patients will be monitored for up to 180 days to track the occurrence of major adverse cardiovascular events. Researchers will collect data on cardiovascular death, recurrent myocardial infarction, stent thrombosis, need for target vessel revascularization, and stroke. Follow-up evaluations will help determine the overall impact of thrombus aspiration on patient outcomes after STEMI treatment.