Mao Ming Shi

Researchers are evaluating the safety and effectiveness of AND017 in adults with transfusion-dependent and non-transfusion dependent beta-thalassemia. This phase II, randomized, double-blind, placebo-controlled study aims to assess AND017 alongside optimal supportive care, such as blood transfusions and iron removal, tailored by the clinician's judgment. Participants receive either AND017 capsules or matching placebo capsules once daily. The study includes patients who have different transfusion histories, with treatment and monitoring extending up to 24 weeks or until early discontinuation. Supportive care continues throughout the study based on usual clinical practice. During the study, researchers monitor safety and tolerability from baseline to Week 24 or end of treatment. Participants' transfusion records, hemoglobin levels, and liver function are evaluated. The study measures adverse events and clinical responses to treatment over time to understand the effects of AND017 in managing beta-thalassemia.

This research aims to accurately evaluate pseudoprogression after immunotherapy in patients with rectal cancer by using multiple MRI features over time, blood biomarkers, and clinical indicators. The study focuses on patients with rectal cancer confirmed by biopsy and clinical stage II-IV, who are planned to receive immunotherapy with PD-1/PD-L1 inhibitors alone or combined with CTLA-4 inhibitors, without previous treatments. The goal is to distinguish true progression from pseudoprogression using advanced imaging and clinical data. Participants undergo multiparametric MRI scans before immunotherapy, and again at 6 and 12 weeks after treatment. Blood tests measuring IL-8, NLR, LDH, and S100, along with clinical indicators such as KPS score, CEA level, and T-stage, are also collected at these time points. Follow-up CT or MRI data are used to evaluate treatment response according to specific criteria or pathology results after surgery, when applicable. This comprehensive approach helps monitor the effects of immunotherapy and identify pseudoprogression. During the study, researchers analyze MRI images and clinical data from the start of treatment to the preoperative MRI. They assess the accuracy of various models in predicting pseudoprogression by measuring the area under the curve (AUC) of receiver operating characteristic (ROC) curves. Participants are followed closely with imaging and blood tests, and those showing signs of disease progression undergo biopsy or surgical pathology to confirm diagnosis. The study requires informed consent and tracks survival beyond three months while monitoring for safety and treatment complications.

Researchers are studying the use of amide proton transfer-weighted imaging (APTWI) to predict how rectal cancer responds to neoadjuvant therapy before surgery. This observational study focuses on patients with locally advanced rectal cancer who have received pre-surgery treatment. The key question is whether APTWI can help assess cancer response accurately as part of regular MRI examinations. Participants undergo amide proton transfer-weighted imaging during their routine MRI scans before surgery. The study includes patients who have had neoadjuvant therapy and complete surgical removal of the rectal cancer, followed by pathological examination. This imaging technique is evaluated to see if it can predict a complete pathological response, which could inform treatment decisions. Throughout the study, researchers will analyze imaging results from baseline MRI to preoperative MRI within 12 months. They will measure the accuracy of APTWI by examining the area under the curve (AUC) of receiver operating characteristic (ROC) curves to predict tumor response. Patient consent and follow-up are part of the study process, and those unable to complete MRI or follow-up are excluded.

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 evaluating how using an amino acid peritoneal dialysis solution affects blood sugar control in diabetic patients undergoing peritoneal dialysis. This single-center, open, prospective, self-controlled clinical study focuses on adults aged 18 to 75 years with type I or II diabetes who have been stable on peritoneal dialysis for at least three months. The study aims to observe changes in glycosylated hemoglobin (HbA1c) levels from baseline to 90 days after starting the amino acid dialysis solution. Participants will use one 2-liter bag of amino acid (15) peritoneal dialysis solution daily after breakfast, followed by treatment with glucose peritoneal dialysis solution containing lactate. This treatment regimen is integrated into their ongoing peritoneal dialysis routine, which includes using 3 to 5 bags of dialysis solution each day. The study includes a 90-day treatment period during which the effects of this dialysis solution on blood sugar levels are monitored. During the study, participants will have their HbA1c levels measured at the start (Day 0) and after 90 days of treatment to assess changes. Researchers will also monitor hemoglobin concentrations, medication stability, and dietary intake to ensure consistent conditions. Safety and eligibility criteria will be closely observed throughout the study to maintain participant health and data integrity.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating the effect of absorbable and moldable skull base support plates in patients with sellar region tumors undergoing extended endoscopic endonasal transsphenoidal surgery. This phase II, multicenter, randomized, controlled trial aims to compare the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month after surgery between the group receiving standard sellar floor repair combined with the support plates and the group receiving only standard sellar floor repair. The study also assesses secondary outcomes including intracranial infection rates, surgery duration, hospital stay length, and safety, particularly nasal complications. Participants will be randomly assigned to one of two groups: one group will have the standard sellar floor repair plus the absorbable and moldable skull base support plate used during the skull base repair phase, while the other group will receive standard sellar floor repair alone. The support plate is trimmed and shaped to fit the skull base defect and positioned securely under bone edges to prevent gaps. Approximately 126 participants, aged 1 to 80 years, will be enrolled with a 1:1 allocation to each group. During the study, participants will be monitored for signs of CSF rhinorrhea and intracranial infection within 1 month following surgery through clinical symptoms, imaging, and nasal endoscopy. Surgery duration and hospital stays will be recorded. Safety assessments will include monitoring for adverse events and nasal complications. Follow-up will be conducted face-to-face or by telephone for those unable to return for reexamination. Statistical analysis will be performed to compare outcomes between groups with significance set at P < 0.05.

Researchers are evaluating the efficacy and safety of SR1375 in adult patients hospitalized with community-acquired pneumonia (CAP). This is a phase 2 randomized, double-blind, placebo-controlled study involving about 240 eligible adults aged 18 to 85 years. The study will compare different doses of SR1375 (0.3 mg, 1 mg, and 3 mg) against a placebo, alongside standard treatments for CAP. The goal is to assess improvements using the National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale up to day 28. Participants will be randomly assigned to receive one of the three SR1375 doses or a placebo once daily by mouth for 56 days, together with their regular pneumonia treatments. The study includes a screening period, followed by the 8-week double-blind treatment phase. After completing treatment, participants will undergo a 14-day safety follow-up to monitor any side effects or health changes. Everyone involved in the study, including participants and researchers, will be unaware of which treatment is given to ensure unbiased results. During the study, participants will be closely monitored with regular assessments including their oxygen levels, chest CT scans, and clinical evaluations. Researchers will track health status and treatment effects throughout the treatment and follow-up periods. The total participation time for each patient is up to 10 weeks, during which safety and efficacy data will be collected to help understand how well SR1375 works and how safe it is for hospitalized CAP patients.

This trial focuses on patients with transfusion-dependent thalassemia undergoing haploidentical or matched unrelated donor hematopoietic stem cell transplantation. Researchers are evaluating whether adding recombinant humanized anti-CD25 monoclonal antibody to the standard prevention treatment can reduce the occurrence of graft-versus-host disease (GVHD), a serious complication that affects treatment success and quality of life. The study also aims to assess the safety of this antibody and monitor participants' quality of life over two years. Participants are randomly assigned in a 2:1 ratio to either an intervention group receiving recombinant humanized anti-CD25 monoclonal antibody plus standard GVHD prevention, or a control group receiving only the standard prevention. The antibody is given as four doses at 1 mg/kg on days 7, 14, 28, and 42 after transplantation. Both groups will be observed to compare the rates of GVHD after their stem cell transplant. During the study, participants will be regularly monitored for the development of severe acute GVHD within 100 days after transplantation. Researchers will assess safety, medical issues, and quality of life for up to two years. The study includes evaluations of physical condition and clinical outcomes to understand the antibody's effects and any side effects. Overall participation involves follow-up visits and assessments to track the study outcomes and participant health.

Researchers are evaluating the safety and effectiveness of the WeFlow-EndoSeal Aorta Vascular Plug System, a new device designed to treat dissecting aneurysms of the descending thoracic aorta that occur after aortic dissection repair. This prospective, single-center, first-in-man study focuses on patients aged 18 to 80 years old who meet specific medical criteria related to their aortic condition. The study uses the Aorta Vascular Plug System, which includes a vascular plug and an adjustable bend conveyor to enter the false lumen of the aorta through tears in arteries. The plug is pre-installed on a steel cable to facilitate delivery. The study monitors outcomes such as adverse events, mortality, false lumen thrombosis, and aortic dissection progression at 30 days, 6 months, and 12 months after the operation. Participants will be closely followed with regular assessments to evaluate safety and treatment effects. Researchers will track serious adverse events, overall survival, and specific aortic-related outcomes. The study aims to ensure no major adverse events occur within 30 days post-operation and to observe the control of aortic dissection progression and false lumen thrombosis during one year of follow-up.