Zhaoqing

Researchers are evaluating a combined screening and follow-up management approach for gastrointestinal tumors. This study aims to explore and assess the feasibility and cost-effectiveness of screening for esophagus, stomach, and colorectal cancers in a population-based, multicenter setting. The trial includes participants aged 45 to 70 years and will observe outcomes over a 10-year follow-up period. Participants are divided into groups undergoing different screening methods. Group one receives gastroscopy, colonoscopy, fecal occult blood test FIT, Helicobacter pylori antigen test, RNF180 and SEPTIN9 gene methylation tests, along with an investigation of various risk factors such as past diseases, lifestyle habits, family cancer history, and reproductive status. Group two undergoes risk factor investigation, FIT, and Helicobacter pylori antigen stool test if positive, further gene methylation tests and possibly colonoscopy are conducted. Control groups matched by spouse or sibling undergo only risk factor investigations. During the study, participants provide information on medical history, lifestyle habits, and family cancer history. Screening tests including endoscopies, stool tests, and gene methylation analyses are performed as specified. Researchers will monitor the detection of cancer or precancerous lesions over 10 years, tracking health outcomes and the effectiveness of combined screening. Safety and adherence are observed throughout the follow-up.

The trial investigates the use of MI078 capsules to treat postpartum depression in women aged 18 to 45 years. It is a multicenter, randomized, double-blind, placebo-controlled study aiming to assess the efficacy and safety of MI078 for this condition. Participants must have a diagnosis of major depressive disorder with onset during late pregnancy or early postpartum, and a certain level of depression severity as measured by the Hamilton Depression Rating Scale. Participants are randomly assigned to two groups one receiving MI078 capsules and the other receiving a matching placebo. The treatment is taken for 3 days during the treatment period. The study includes a screening phase lasting up to 14 days before treatment, a 4-day treatment period, and a follow-up period lasting until day 31 after treatment begins. During the study, participants will undergo clinical assessments including depression rating scales such as the HAM-D17 and other mood and anxiety scales. Researchers will monitor changes from baseline in depression scores and record safety information throughout the follow-up period. Participants are expected to comply with study requirements, lifestyle restrictions, and attend scheduled visits for evaluations over approximately one month.

Researchers are conducting a multicenter, randomized controlled trial to evaluate a new screening approach for gastrointestinal cancers in adults aged 45 to 74. The study aims to see if an active screening method using a combined model of blood and stool tests can reduce deaths from these cancers compared to routine observation. This trial also seeks to validate novel biomarkers and identify factors affecting screening outcomes to help improve prevention strategies. Participants will be randomly assigned to one of two groups. The intervention group will undergo a combined screening test including multi-target blood methylation, fecal FIT, and fecal calprotectin. Those with positive results will have a standard gastrointestinal endoscopy immediately, while those with negative results will continue with routine observation. The control group will only receive routine observation and follow-up. The study follows participants for 5 years to monitor outcomes. During the 5-year follow-up, researchers will collect data on gastrointestinal cancer incidence and mortality through regular contact and medical record review. They will assess differences in cancer-specific death rates between the groups as the main outcome. Additional measures include cancer incidence, test accuracy, all-cause mortality, detection rates of precancerous and early cancers, and endoscopy-related complications. Participants may expect scheduled check-ins and monitoring over this period to support study goals.

Researchers are conducting an observational study to describe clinical characteristics, treatment patterns, and biomarkers in Chinese adults with asthma. The study aims to identify different asthma types phenotypes and endotypes linked to varying outcomes, which may help develop personalized treatment strategies in the future. Approximately 80 healthy participants and various groups of asthmatics with mild, moderate, or severe disease are included. Participants are grouped into cohorts healthy individuals, mild asthmatics using low dose inhaled corticosteroids ICS with formoterol or short-acting beta-2 agonists SABA, moderate to severe asthmatics on low or medium dose ICS with long-acting beta-2 agonists LABA or high dose ICS alone or with LABA, and asthmatics experiencing protocol defined exacerbations. No study drug or intervention is administered, as this is an observational research study. Participants undergo assessments at baseline including lung function tests such as FEV1, Forced Vital Capacity FVC, Maximal Mid Expiratory Flow MMEF, airway remodeling evaluation, gas trapping analysis, and computed tomography CT scans. Biomarker levels and clinical characteristics are collected and analyzed. The study tracks statistical associations between biomarkers and clinical outcomes over time from 2023 to 2025. Participation lasts until the study completion date in October 2026.

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 evaluating the use of absorbable and moldable skull base support plates in patients undergoing extended endoscopic endonasal transsphenoidal surgery for sellar region tumors. The study aims to compare the incidence of cerebrospinal fluid CSF rhinorrhea within one month after surgery between patients receiving standard sellar floor repair combined with the support plate and those receiving standard repair alone. This phase II, randomized, controlled trial also assesses intracranial infection rates, surgery duration, hospital stay length, and safety, including nasal complications. Participants will be randomly assigned to one of two groups. The experimental group will receive a skull base repair that includes the use of a shaped and trimmed absorbable and moldable support plate placed during surgery, covered with nasal septal mucosa and stabilized with gelatin sponge. The control group will undergo the standard multi-layer sellar floor repair without the support plate but with similar packing and mucosal coverage. The trial follows a 11 parallel design and plans to enroll approximately 126 patients. During the study, participants will be monitored for CSF rhinorrhea and intracranial infections within the first month after surgery using clinical symptoms, imaging, and nasal endoscopy. Researchers will also record surgery duration and hospital stay length. Safety will be assessed by tracking treatment-related adverse events, especially nasal complications. Follow-up includes face-to-face visits for patients returning for reexamination and telephone follow-ups for those who cannot. Data will be analyzed using established statistical methods to evaluate the outcomes and safety over the study period.

Researchers are conducting a multi-center observational study to develop and assess the accuracy of fecal multi-marker panels for screening gastrointestinal cancers, specifically gastric and colorectal cancers. The study aims to evaluate the sensitivity and specificity of stool-based biomarker testing compared to baseline endoscopic screening. This research will help determine how well these stool tests can identify gastrointestinal cancers early. Participants scheduled for gastroscopy and colonoscopy will provide a stool sample before their endoscopic procedures. These samples will undergo qualitative and quantitative Fecal Immunochemical Tests FIT along with novel biomarker testing. After the initial endoscopic screening, participants will be followed for two years to monitor outcomes and assess the screening tests performance. During the study, participants will have stool samples collected before their endoscopy appointments. Data from these tests will be compared to the results of their endoscopic examinations conducted about two weeks later. Researchers will focus on measuring the sensitivity and specificity of the fecal biomarker tests for cancer screening. The two-year follow-up will provide additional information on the tests effectiveness and participants health outcomes throughout this period.

Researchers are investigating how changes in multigene methylation levels in the blood relate to treatment responses in people with esophageal cancer. The study aims to understand if these methylation changes correspond with objective response rates seen in imaging scans and serum tumor markers. Secondary goals include examining how methylation patterns relate to progression-free survival, comparing methylation to standard biomarkers, and exploring if methylation can guide treatment adjustments. Participants are grouped based on their treatment approach surgery alone, surgery after neoadjuvant therapy, active surveillance after neoadjuvant therapy, or definitive chemoradiotherapy with or without immunotherapy. All participants undergo regular blood tests for multigene methylation during follow-up, with specific timing depending on their treatment group. The study involves multiple assessments through pre-scheduled timepoints extending up to five years post-treatment. Throughout the study, participants will have blood samples taken at various intervals up to five years to measure methylation levels. Additional evaluations include tumor marker tests, imaging scans such as contrast-enhanced CT, PETCT, ultrasound, X-rays, MRI, and endoscopies following a set schedule based on the treatment group. Researchers will monitor these results to evaluate treatment response and disease progression over time, ensuring comprehensive long-term follow-up and safety monitoring.

Researchers are evaluating a new chemotherapy drug called JSKN003 in people with recurrent or metastatic breast cancer that is HER2-low and cannot be removed by surgery. This phase III clinical trial compares JSKN003 to chemotherapy drugs chosen by doctors in patients who have already tried and not responded to one or two previous chemotherapy treatments. The study aims to assess the safety and effectiveness of JSKN003 in this group of patients. Participants are randomly assigned to one of two groups one group receives JSKN003 alone given by intravenous infusion, while the other group receives one chemotherapy drug selected by their doctor from options like capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The choice of the chemotherapy drug for the control group is made before randomization. Treatment schedules follow the study protocol at multiple centers. During the study, participants will have regular assessments including scans to measure tumor progression and other tests to evaluate response and overall survival, monitored for up to about three years after enrollment. Researchers will track progression-free survival as the main outcome, along with overall survival, response rate, and duration of response. Safety and side effects will also be closely monitored throughout the study.

Researchers are evaluating the safety and effectiveness of combining orelabrutinib with the standard R-CHOP chemotherapy regimen as a first treatment for patients with CD5-positive diffuse large B-cell lymphoma DLBCL. This phase II, multicenter trial focuses on patients who have not received prior treatment. The study aims to understand if adding orelabrutinib improves patient outcomes compared to historical data. Participants will receive up to 8 cycles of treatment over several months. The first cycle uses R-CHOP alone, with orelabrutinib tablets 150 mg daily added starting from the second cycle. After 6 cycles of combination therapy, patients receive 2 more cycles of rituximab plus orelabrutinib. If a complete remission is achieved after these 8 cycles, patients will continue taking orelabrutinib as maintenance therapy. During the study, researchers will monitor participants closely with assessments to track disease progression, response to treatment, and side effects. They will measure outcomes such as event-free survival over 2 years, complete response rate, disease-free survival, and overall survival. Safety will be evaluated by recording adverse events throughout the study. The total participation period may last around 2 years, including follow-up to assess long-term effects.