Dongying

Mechanical ventilation is often necessary for critically ill patients with acute brain injury, but how certain ventilator strategies like positive end-expiratory pressure PEEP and lung recruitment maneuvers affect brain function is not fully understood. This study aims to evaluate changes in brain electrical activity and cerebral blood flow during these ventilator interventions in neurocritical care patients. It investigates the relationship between ventilator settings and cerebral physiology to better understand brain-lung interactions in this population. Participants will undergo clinically indicated recruitment maneuvers and PEEP adjustments as part of their respiratory management. During these interventions, continuous monitoring using scalp electroencephalography EEG, transcranial Doppler ultrasound, invasive arterial blood pressure, end-tidal carbon dioxide, and other clinical variables will be performed. The study will record physiological data during baseline, intervention, and recovery periods lasting about 30 minutes to assess cerebral and systemic responses. Throughout the study, researchers will analyze EEG signals to assess cortical activity changes and measure cerebral blood flow velocity and neurovascular coupling. They will also monitor systemic hemodynamics and respiratory parameters to explore how ventilator-induced changes influence brain function. This comprehensive monitoring aims to inform future individualized ventilation strategies for patients with acute brain injury, with study participation lasting for the duration of these ventilator interventions and monitoring sessions.

Acute ischemic stroke is a leading cause of death worldwide, and intravenous thrombolysis with recombinant tissue plasminogen activator rt-PA within 4.5 hours of symptom onset is the most effective treatment currently available. However, some patients experience stroke progression and early reocclusion after thrombolysis, which can worsen neurological outcomes. This trial evaluates whether early antiplatelet therapy with oral aspirin, given soon after thrombolysis, can improve recovery without increasing bleeding risks. The study randomly assigns patients to receive either early oral aspirin within 3 hours of starting intravenous thrombolysis or a placebo, alongside the best medical care based on current guidelines. Aspirin is administered as a 300 mg dose, either chewed or given via nasogastric tube if swallowing is difficult. The trial includes a control group receiving placebo under similar conditions to compare outcomes. This is a Phase 3, multicenter, quadruple-blind, randomized clinical trial. During the study, participants will be closely monitored for neurological status and functional recovery using the modified Rankin scale at 30 and 90 days after stroke, as well as other assessments like NIH Stroke Scale scores within the first week. Researchers will track early neurological changes and safety outcomes such as intracranial hemorrhage. Follow-up will include evaluations at multiple time points up to 90 days post-stroke to determine the effects of early antiplatelet treatment on stroke recovery.

Researchers are evaluating first-line treatments for adults aged 18 to 75 with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma that cannot be removed by surgery or has spread to distant sites. This Phase II, randomized, open-label, multicenter trial compares a combination of Disitamab Vedotin, Sintilimab, and S-1 with Trastuzumab plus chemotherapy, with or without Sintilimab, to better understand their effects in this condition. Participants will receive either the experimental combination of Disitamab Vedotin 2.5 mgkg IV every 3 weeks, Sintilimab 200 mg IV every 3 weeks, and S-1 40-60 mg twice daily for 14 days every 3 weeks, or the active comparator treatment of Trastuzumab initial dose 8.0 mgkg, then 6.0 mgkg IV every 3 weeks plus chemotherapy drugs such as Oxaliplatin, Capecitabine, 5-FU, or Cisplatin, with or without Sintilimab. Treatments will continue as per the study schedule to assess their effectiveness and safety. During the trial, participants will be monitored for tumor response at 6 months, progression-free survival, overall survival, duration of relief, and disease control rate up to 12 months after the last participant joins. Safety and adverse events will be observed for up to about 2 years. Regular assessments will include clinical exams and imaging to measure tumor changes and treatment effects. The total duration of participation varies based on treatment and follow-up schedules.

Researchers are evaluating the safety and effectiveness of combining two drugs, iparomlimab and tuvonralimab QL1706, with chemotherapy to treat adults with HER2-negative, low PD-L1 expressing, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. This phase II trial focuses on patients whose cancer cannot be removed by surgery or has spread to other parts of the body. The study aims to understand how well this combination works and its safety profile in this specific group of patients. Participants will receive iparomlimab and tuvonralimab at a dose of 5 mgkg by intravenous drip on the first day of each 3-week cycle until disease progression or unacceptable side effects occur. They will also receive XELOX chemotherapy, which includes oxaliplatin given intravenously at 130 mgm2 on day 1 of each 3-week cycle for the first 6 cycles, and capecitabine tablets taken orally twice daily from days 1 to 14 of each cycle. This treatment continues until disease progression or intolerable toxicity. The study is a single-arm trial, meaning all participants receive this combination treatment. During the trial, researchers will monitor participants for progression-free survival over 12 months after the last participant joins, along with overall survival, response rates, duration of response, disease control rate, and safety through adverse event tracking for up to about 2 years. Participants will undergo regular assessments to measure tumor response and side effects. The total study period includes these follow-up evaluations to understand the treatments impact and safety profile comprehensively.

Researchers are studying patients who have had an acute ischemic stroke caused by a blockage in a large blood vessel in the brain. The trial focuses on the safety and effectiveness of remote ischemic conditioning RIC as an additional treatment to improve recovery after endovascular thrombectomy, a procedure that removes the blockage. This research addresses the challenge that even when blood flow is restored, many patients still have poor outcomes or die, possibly due to brain injury during and after the procedure. The study compares three groups one receiving only endovascular thrombectomy and best medical care, a second group receiving thrombectomy plus RIC treatment for 14 days, and a third group receiving thrombectomy plus RIC for 30 days. RIC is a noninvasive device treatment where a cuff on the upper arm inflates and deflates in cycles, applied once before thrombectomy and twice daily afterward. Best medical management follows clinical guidelines for all groups. Participants will be monitored closely for 90 days after stroke. Researchers will assess recovery using the modified Rankin Scale to measure functional independence and will record neurological improvements, brain infarct size, adverse events, and quality of life. The study includes imaging, neurological exams, and safety checks at multiple time points, including 24 hours, 14 days, 72 hours, and 90 days post-treatment to evaluate the impact of RIC on stroke outcomes.

Atrial fibrillation AF is a common heart rhythm disorder with a significant chance of returning after catheter ablation treatment. This trial studies adults aged 18 to 75 who have persistent AF and obstructive sleep apnea OSA to see if using continuous positive airway pressure CPAP therapy after ablation reduces AF recurrence. The trial is a randomized, open-label study conducted at multiple centers in China to evaluate the effect of CPAP on AF outcomes over 12 months. Participants are randomly assigned to either the CPAP group, which uses a CPAP device for 12 months with treatment settings adjusted by pressure titration, or the usual care group, which receives standard AF treatment and education about OSA without CPAP provided. CPAP adherence is monitored through device data, and participants in both groups receive guideline-based medical therapy for AF. Additional OSA treatments outside the study may be used and recorded. Throughout the 12 months, participants will wear ambulatory ECG monitors for seven days at 3, 6, 9, and 12 months to detect arrhythmia recurrence. Follow-up visits occur at 1, 3, 6, and 12 months in person or by phone to check health status and treatment progress. Researchers will measure freedom from atrial arrhythmia recurrence as the primary outcome and assess other factors like arrhythmia patterns, medication use, quality of life, and psychological health.

Researchers are studying patients with osteoporotic fractures to find better prevention and treatment methods for refractures. This project involves registering patients for follow-up studies to collect epidemiological data and conducting prospective treatment studies. It aims to explore effective treatment strategies through randomized controlled trials and to develop warning models using biomarkers and new imaging technologies to predict osteoporotic refractures. Participants receive either denosumab alone or a sequential treatment starting with teriparatide followed by denosumab. Denosumab is given as a 60mg subcutaneous injection every six months for 24 months. Teriparatide is administered as a daily 20ug subcutaneous injection for either 6 or 12 months before switching to denosumab, which continues until the 24th month. These treatment plans are part of a multicenter randomized controlled trial. During the study, participants will be monitored for new vertebral fractures and changes in bone mineral density BMD at the lumbar spine, total hip, and femoral neck over 12 and 24 months. Blood tests will measure biomarkers related to bone turnover at several time points. Researchers will also track patients adherence to treatment and assess cost-effectiveness. Follow-up includes evaluation of new fractures at various sites and safety monitoring throughout the 24-month treatment period.

This research aims to evaluate the effect of two different treatments on gastrointestinal bleeding in patients with acute coronary syndrome ACS who have undergone percutaneous coronary intervention PCI and require dual antiplatelet therapy DAPT for at least six months. The study focuses on patients infected with Helicobacter pylori Hp, a known risk factor for gastrointestinal bleeding, which occurs commonly in these patients. Experts in China have recommended Hp detection and eradication therapy alongside DAPT, but evidence is lacking. This trial investigates whether Vonoprazan-based dual eradication therapy is not inferior to standard proton pump inhibitor PPI treatment in preventing bleeding events. The study enrolls 2600 patients randomized into two groups. One group receives a 14-day dual eradication therapy with Vonoprazan 20 mg twice daily and amoxicillin 1 g three times daily, followed by monitoring for six months. The other group receives pantoprazole 40 mg daily for six months as the control treatment. All patients continue their DAPT regimen, which includes aspirin and either clopidogrel or ticagrelor, as decided by their doctors. Hp infection is confirmed before enrollment using breath tests and antibody detection. Participants will be closely monitored throughout the six-month follow-up period. Assessments include repeat Hp testing after treatment completion and tracking any gastrointestinal bleeding or major cardiovascular events. Safety visits record any adverse reactions or incomplete treatments. The primary outcome measured is the incidence of gastrointestinal bleeding over six months, with additional outcomes including cardiovascular events and complex gastrointestinal events. This comprehensive monitoring aims to provide clear evidence on managing Hp infection in ACS patients undergoing DAPT.