Ka Shi Di Qu

People with end stage kidney disease ESKD who require dialysis face a much higher risk of cardiovascular disease compared to the general population, with cardiac issues causing 58% of deaths in this group. However, while aspirin is known to reduce cardiovascular problems in the general population, there is limited evidence about its effects in dialysis patients. The ASPIrin to Reduce Event in Dialysis ASPIRED trial aims to study whether taking low-dose aspirin can safely improve cardiovascular outcomes in people with ESKD receiving dialysis. This study is a multi-center, double-blind, randomized controlled trial that will compare daily low-dose aspirin 100 mg to a placebo pill in patients undergoing dialysis. The trial uses an existing dialysis registry platform to screen, recruit, and collect data during routine clinical care, minimizing participant burden and study costs. Randomization is managed through a secure web-based system, and follow-up visits occur every six months as part of regular clinic visits. The trial is expected to last approximately five years and includes oversight by an independent safety and monitoring board. Participants will be involved in regular six-monthly clinic visits where their health will be monitored as part of their usual dialysis care. Researchers will track the occurrence of major cardiovascular events, including heart attacks, strokes, vascular complications, and deaths, throughout the study period. Data will be collected from routine clinical procedures and the dialysis registry to evaluate outcomes. Safety and efficacy will be closely monitored, and the study will follow participants for up to five years to assess the long-term effects of aspirin use in this population.

Researchers are conducting a multicenter, prospective observational study to investigate how often patients with Helicobacter pylori infection experience dyspeptic symptoms, such as indigestion. The study also aims to follow these patients after they undergo treatment to eradicate H. pylori to see how their dyspeptic symptoms improve over time. This research intends to guide better diagnosis and treatment strategies for patients with H. pylori infection and related digestive discomfort. Participants diagnosed with H. pylori infection confirmed by breath tests or gastroscopy will complete an epidemiological questionnaire and a Functional Dyspepsia Symptom Diary FDSD to record their symptoms. Patients who have dyspepsia and successfully clear the infection will be followed up at 2 months and again at 6 months to assess if their symptoms have improved. The study does not involve any experimental drugs or treatments but focuses on observation and symptom tracking. During the study, patients will provide basic health information and record their digestive symptoms in the diary. Researchers will track the occurrence of dyspepsia at the start and monitor symptom relief after treatment. The follow-up periods at 2 and 6 months after eradication therapy will help measure symptom changes. Participants may be involved for several months, contributing to a better understanding of the natural history of H. pylori-related dyspepsia and treatment outcomes.

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 a high death rate. Liver transplantation remains the most effective treatment, but challenges like limited donor availability, high costs, and rejection restrict its use. Given these issues, this study aims to explore MSCs as a potential alternative therapy through a phase 2, multicenter, randomized, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive either three intravenous doses of MSCs or a placebo at days 1, 8, and 15, alongside standard care. The trial will include 140 patients with decompensated cirrhosis, split evenly between the MSC treatment group and the placebo group. The study treatments are given through IV transfusions, and the trial will be conducted at multiple centers to assess both safety and treatment effects. During the trial, patients will undergo regular assessments including laboratory tests, clinical evaluations, and quality-of-life questionnaires over a period of up to 24 months. The main outcome measured is the change in the Model for End-Stage Liver Disease MELD score from baseline to day 28. Secondary outcomes include longer-term changes in MELD scores, incidence of complications, liver transplant-free survival, liver function tests, and monitoring of treatment-emergent adverse events. This comprehensive monitoring will help determine the potential benefits and risks of MSC therapy for this condition.

Researchers are conducting the IDEAL study, a large, multicenter, prospective, double-blind randomized controlled trial, to evaluate the impact of an artificial intelligence AI model on diagnosing intracranial aneurysms using head CT angiography CTA. The study aims to compare the diagnostic sensitivity and specificity of this AI-assisted approach against a sham AI method, while also assessing patient prognosis and various clinical outcomes. Over 6450 patients scheduled for head CTA will be enrolled across 21 hospitals in China. Participants will be randomly assigned to one of two groups the True-AI group, where radiologists use a deep-learning AI model with high sensitivity to assist in diagnosing intracranial aneurysms, and the Sham-AI group, where radiologists use a similar AI model with very low sensitivity but comparable specificity. Both groups will undergo their usual head CTA scans and diagnoses. The study includes a 12-month follow-up to monitor repeat imaging, clinical follow-up, treatment, and patient outcomes. During the study, patients will have their head CTA images interpreted with either the True-AI or Sham-AI assistance, without knowledge of group assignment by patients or radiologists. Researchers will assess diagnostic accuracy, detection rates of intracranial lesions, workload of CTA interpretation, resource use, hospitalization rates, quality of life measures, functional outcomes, and safety indicators at 3, 6, and 12 months. The primary outcomes focus on diagnostic sensitivity and specificity at 6 months, with secondary outcomes covering broader clinical and patient-centered measures over the follow-up period.

Researchers are investigating the use of confocal technology, also known as optical biopsy, combined with double-balloon enteroscopy to improve real-time cellular-level examination of the small bowel. This study aims to establish a diagnostic framework for small bowel tumors and non-neoplastic lesions, as confocal endoscopy is currently used mainly for upper and lower gastrointestinal tract diseases. The project is focused on developing a quality assessment system for confocal enteroscopy procedures to enhance early diagnosis and staging of small bowel diseases such as inflammatory bowel disease and hereditary neoplastic syndromes. This project will create a multi-center cohort with 200 confocal small-bowel endoscopy cases and 400 gastrointestinal control cases divided equally into exploratory and validation arms. Patients with suspected small-bowel diseases who require endoscopy will be included. During single- or double-balloon enteroscopy, suspected areas and adjacent normal mucosa will be examined with confocal laser endomicroscopy CLE, and conventional enteroscopic findings will be recorded. CLE will assess various mucosal and inflammatory activity scores, supported by AI image-recognition systems. The exploratory arm will identify diagnostic parameters to build a new confocal enteroscopy model for small-bowel inflammatory bowel disease, which will then be tested in the validation arm. Quality-control indicators covering pre-, intra-, and post-procedure phases will also be developed and validated. Participants will undergo confocal small-bowel endoscopy with data collection on procedural success, diagnostic accuracy, complication rates, and image quality. The study will assess factors impacting quality control throughout the workflow, including preparation, procedure timing, scope handling, specimen management, and recovery. Regular audits will ensure continuous improvement. The primary outcome is procedural success rate within 14 days, with secondary outcomes including diagnostic accuracy and complication rates. The study will last until June 2028, involving adult participants aged 18 to 70 years.

Researchers are evaluating the use of manual thrombus aspiration TA during primary percutaneous coronary intervention PPCI in patients who have experienced an ST-segment Elevation Myocardial Infarction STEMI with a high thrombus burden. The study aims to determine if including TA can reduce major adverse cardiovascular events such as cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days, or stroke within 30 days. This is a prospective, multicenter, open-label, randomized controlled trial. Participants are randomly assigned to one of two groups one receiving upfront manual thrombus aspiration followed by PCI, and the other undergoing PCI without the use of manual thrombus aspiration. The treatment is delivered during the primary PCI procedure within 12 hours of symptom onset. The study compares these two approaches to assess their impact on patient outcomes. Throughout the study, participants will be monitored for major adverse cardiovascular events up to 180 days after treatment, with additional tracking of stroke occurrences up to 30 days and composite adverse cardiocerebrovascular events up to one year. Researchers will collect data on safety and efficacy as part of the follow-up period. The trial is led by Guangdong Provincial Peoples Hospital and does not include blinding, with a planned end date in February 2026.