Qi Qi Ha Er Shi

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 safety and effectiveness of two antibiotic treatments, omadacycline and moxifloxacin, in Chinese adults with community-acquired bacterial pneumonia (CABP). This Phase 3b study is designed as a bridging trial to confirm whether omadacycline works as well as moxifloxacin in this specific population, building on results from a global CABP trial. Participants will receive either omadacycline or moxifloxacin through intravenous or oral routes. The treatments are given as a course, with details on dosing schedules not specified. The study compares these two drugs directly to assess their clinical efficacy and safety in treating CABP. During the study, participants will be monitored and evaluated for their clinical response at 18 months after therapy. Researchers will assess symptoms, vital signs, and overall health related to pneumonia to determine treatment success. Safety and efficacy data collected throughout the study will help understand how well each drug performs in this patient group.

Stroke is the second leading cause of death worldwide, with ischemic stroke being the most common type. The current best treatment for acute ischemic stroke is intravenous thrombolysis using recombinant tissue plasminogen activator (rt-PA) given within 4.5 hours of symptom onset. However, some patients experience stroke progression or early blood vessel reocclusion after thrombolysis, which worsens neurological function and outcomes. This is believed to be caused by increased platelet activation after thrombolysis, which peaks within the first 2 hours. This clinical trial is testing whether starting oral aspirin early after intravenous thrombolysis can improve functional outcomes without causing more bleeding problems. Patients are randomly assigned to receive either 300 mg aspirin tablets or matching placebo tablets as soon as possible after enrollment. If swallowing is difficult, tablets can be crushed and given through a nasogastric tube. Both groups receive best medical management according to guidelines. The study is a Phase 3, multicenter, randomized, placebo-controlled trial. Participants will be followed for 90 days after stroke to measure their functional recovery using the modified Rankin scale (mRS). Researchers will check if patients have a good outcome defined as an mRS score of 0 or 1 at 90 days. During the study, patients undergo assessments including neurological exams and imaging to confirm eligibility and monitor safety. The trial aims to determine if early aspirin treatment after thrombolysis is safe and can help prevent neurological decline and improve recovery.

Researchers are evaluating the efficacy, safety, and tolerability of lunsekimig compared with a placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3 study focuses on patients with COPD who have specific lung function criteria, prior exacerbations, and blood eosinophil counts, aiming to better manage their condition using a new subcutaneous treatment. Eligible participants will receive subcutaneous injections of either lunsekimig or a matching placebo during a randomized intervention period lasting approximately 48 weeks. The study includes a screening period of up to 4 weeks before treatment and a follow-up period of about 8 weeks after treatment, making the total study duration up to 60 weeks. Participants remain in one of three study arms throughout this timeline. During the study, participants will be monitored regularly to measure the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will assess safety, tolerability, lung function, and other health outcomes. The study collects data on participants' lung function, exacerbation frequency, and blood markers, along with adherence to treatment and safety follow-up over the entire study period.

Researchers are evaluating the efficacy and safety of orelabrutinib in adults with systemic lupus erythematosus (SLE) who are already receiving standard care treatments. This phase IIb, randomized, double-blind, placebo-controlled, multicenter study aims to better understand how different doses of orelabrutinib work in managing SLE symptoms and improving patient outcomes. Participants will be randomly assigned to receive either a low dose or a high dose of orelabrutinib, or a placebo, all taken orally once daily along with their standard of care therapy. The study compares these different treatment groups to assess the effects of the drug over time while maintaining current SLE treatments. The treatment phase includes ongoing oral administration of the assigned intervention combined with standard care. During the study, participants will undergo various assessments including measurement of the SLE Responder Index (SRI) at week 48 to evaluate treatment response. Researchers will monitor safety and efficacy through clinical evaluations and laboratory tests. The total participation period includes screening, treatment, and follow-up, allowing detailed observation of the drug's impact and participant health over several months.

Researchers are conducting a phase 2, double-blind, randomized, placebo-controlled, multi-center study to evaluate the effectiveness and safety of Kylo-11 in people with atherosclerotic cardiovascular disease (ASCVD) who have elevated lipoprotein(a) levels. The study aims to find the appropriate dose of Kylo-11, which is given as a subcutaneous injection, compared to a placebo. Elevated lipoprotein(a) is a type of lipoprotein disorder that may contribute to cardiovascular risks. Participants will receive either Kylo-11 or a matched placebo by subcutaneous injection. The study is designed to find the best dose by comparing different amounts of the drug against placebo over the treatment period. The treatments are administered in a blinded manner, meaning neither the participants nor the researchers know who receives the active drug or placebo. During the study, researchers will monitor participants' lipoprotein(a) levels to measure the percent change from baseline over weeks 8 through 26. Participants will undergo various safety and efficacy assessments throughout the trial to evaluate Kylo-11's effects. The total age range for participants is from 18 to 80 years old, and safety monitoring will ensure participants meet the study criteria and do not experience adverse effects.

Researchers are evaluating the efficacy and safety of TQC2731 injection in adults with severe asthma that is not well controlled. This is a Phase III, multicenter, randomized, double-blind, placebo-controlled trial involving 660 participants aged 18 to 75 years. The study focuses on those who have had asthma diagnosed for at least a year and have experienced multiple asthma exacerbations in the past year despite using high-dose inhaled corticosteroids and other asthma medications. Participants are randomly assigned in equal numbers to receive either TQC2731 injection at a dose of 420 mg every four weeks or a placebo injection with no active drug. Both treatments are given by subcutaneous injection. The study treatment lasts for 52 weeks, during which the effects of blocking the Thymic Stromal Lymphopoietin (TSLP) protein by TQC2731 are assessed. Throughout the study, participants will be monitored for asthma exacerbations and other health outcomes. Researchers will regularly evaluate safety and treatment effects over the full 52-week period. The primary outcome measured is the annual rate of asthma exacerbations from the first day of dosing through completion. Participants' medication use, symptom control, and adverse events will also be tracked to assess treatment impact and safety.

Researchers are evaluating treatments for adults with acute spontaneous supratentorial intracerebral hemorrhage (ICH) of 20 mL or more. The study compares early minimally invasive surgery combined with thrombolysis (eMIST) against the best medical management. This multicenter trial is designed to adaptively assess outcomes using a randomized, open-label approach with blinded evaluation of results. The main goal is to improve functional recovery measured by a utility-weighted modified Rankin Scale at 180 days after treatment. Participants are randomly assigned to one of two groups: one receiving early minimally invasive catheter evacuation surgery along with up to ten doses of urokinase administered through the catheter placed in the hemorrhage area, and the other receiving the best available medical care without surgery. The intervention must start within 4 hours after randomization, which itself must occur within 8 hours of stroke symptom onset or the last known well time. The study includes an adaptive design to reassess sample size after 250 patients complete 180-day follow-up. Throughout the study, patients undergo assessments including head CT scans before randomization to confirm eligibility. Functional improvement is tracked using the utility-weighted modified Rankin Scale at 180 days. Safety and effectiveness of treatments are monitored during the trial, which includes long-term follow-up to evaluate outcomes. Participants or their legal representatives provide informed consent prior to enrollment.