Huang Gang Shi

Researchers are evaluating the safety and immune response of a new 24-valent pneumococcal conjugate vaccine called PCV24 in children aged 2 months to 5 years. This phase 2 clinical trial is randomized, double-blind, and compares PCV24 to an existing vaccine, Prevenar13, to better understand its effects in young children. The study is sponsored by Sinovac Life Sciences Co., Ltd and aims to gather important data on this vaccines performance in the pediatric population. Participants will be randomly assigned to receive either the Sinovac PCV24 vaccine or the Prevenar vaccine. Both vaccines are given as 0.5 mL injections into the muscle, following age-appropriate immunization schedules. The trial includes different age groups within the 2 months to 5 years range, ensuring the vaccine is assessed across a broad pediatric population. During the study, children will be monitored for immune response by measuring pneumococcal serotype-specific antibodies 30 days after vaccination. Safety is also closely observed, tracking any adverse reactions within 30 days and serious events up to six months after the last dose. Guardians will be required to follow study procedures and maintain contact throughout the trial, which will continue until December 2027.

Researchers are studying the safety and effectiveness of early use of tirofiban in patients who have acute ischemic stroke and are treated with tenecteplase. This study is exploring whether adding tirofiban soon after tenecteplase can reduce the risk of blood clot re-blockage in the brain, which happens in some patients after initial treatment. The study is a phase 3 trial aiming to improve stroke outcomes by preventing this reocclusion. Participants first receive tenecteplase intravenously for stroke treatment. Those who meet the study criteria are then randomly assigned to receive either tirofiban or a placebo. Tirofiban or placebo is given intravenously starting as soon as possible after randomization, initially as a higher dose for 30 minutes, followed by a continuous lower dose infusion for nearly 48 hours. After 24 hours, patients receive aspirin andor clopidogrel or their placebos, then after 44 hours, antiplatelet therapy with aspirin andor clopidogrel continues until the 90-day follow-up. During the study, participants undergo assessments including neurological exams and monitoring for bleeding or other adverse events. The main outcome measured is excellent functional recovery 90 days after randomization. Other outcomes include disability levels, neurological improvement, quality of life, bleeding events, and mortality. Safety and serious adverse events are tracked through the 90-day period to evaluate treatment effects and risks.

Researchers are studying whether switching from solid fuels to liquefied petroleum gas LPG and improving kitchen ventilation can reduce household air pollution and improve heart and lung health. This clinical trial aims to find out if using LPG, ventilation, or both together lowers pollution levels, improves cardiopulmonary function, reduces clinical events, and is cost-effective and sustainable. The study is randomized and includes multiple groups to compare these interventions.

Researchers are evaluating the safety and effectiveness of low-dose tenecteplase in elderly patients aged 70 and older who have experienced an acute ischemic stroke. This multicenter, randomized controlled trial focuses on treatment within 4.5 hours of stroke onset to assess how this therapy may improve neurological outcomes compared to a standard dose. Participants are randomly assigned to receive either a low dose 0.175 mgkg, up to 17.5 mg or a standard dose 0.25 mgkg, up to 25 mg of tenecteplase given intravenously. The study is designed as a parallel-group trial comparing these two dosing regimens to understand which may be more beneficial and safe for elderly stroke patients. Participants will be monitored for recovery and safety through neurological assessments using scales such as the Modified Rankin Scale and the National Institutes of Health Stroke Scale up to 90 days after treatment. Outcomes like neurological improvement, functional independence, quality of life, and any bleeding events will be closely measured. The trial will continue until December 2028, with follow-up visits planned to evaluate participants progress and overall health.

Researchers are evaluating a new treatment regimen called MAAZA, which combines mitoxantrone hydrochloride liposomes with cytarabine and azacitidine, for adults newly diagnosed with primary Acute Myeloid Leukemia AML. This study compares the MAAZA regimen with the traditional DAAZA chemotherapy regimen to assess their effectiveness and safety in improving treatment outcomes for AML patients. The trial is a prospective, multicenter, randomized controlled study aiming to provide high-quality clinical evidence to improve AML treatment and prognosis. Participants are randomly assigned to one of two treatment groups. The MAAZA group receives mitoxantrone hydrochloride liposome 24 mgm2 intravenously on day 1 every 4 weeks, cytarabine 100 mgm2 intravenously every 12 hours for 7 days, and azacitidine 100 mg subcutaneously once daily for 7 days. The comparison group receives daunorubicin 60 mgm2 intravenously once daily for 3 days, cytarabine 100 mgm2 intravenously every 12 hours for 7 days, and azacitidine 100 mg subcutaneously once daily for 7 days. Each treatment cycle lasts 28 days. During the study, participants undergo evaluations including complete remission rates 2 to 3 weeks after the first treatment cycle. Researchers also monitor adverse events, remission rates, survival times, and mortality up to 100 months after randomization. Regular assessments include blood tests and physical health evaluations. The study lasts for multiple cycles and includes long-term follow-up to assess the overall impact of the treatments on patient survival and disease progression.

Researchers are studying upper tract urothelial carcinoma UTUC, a condition with a poor outlook when treated with conventional chemotherapy regimens. This trial focuses on patients with HER2 2-3 UTUC and aims to evaluate the effectiveness and safety of combining Trastuzumab Rezetecan, an anti-HER2 antibody-drug conjugate, with gemcitabine. This phase II study explores a new treatment approach due to limitations of traditional cisplatin-based chemotherapy. Participants will receive intravenous infusions of gemcitabine followed by Trastuzumab Rezetecan every 21 days. The treatment includes four cycles of neoadjuvant therapy before surgery. After surgery, patients who do not achieve a complete pathological response will receive two additional cycles of adjuvant therapy. Those with suboptimal pathological downstaging after surgery may also receive immune checkpoint inhibitors as a combination therapy. During the neoadjuvant period, side effects will be closely monitored. Participants will undergo regular imaging and follow-up assessments to track disease recurrence and progression. The main outcome measured is the pathological complete response rate shortly after surgery. Secondary outcomes include adverse events during neoadjuvant therapy, event-free survival, and overall survival. The total study duration extends until August 2029.

Researchers are evaluating two different neoadjuvant treatment strategies for adults with muscle-invasive bladder cancer MIBC that expresses the HER2 protein. The study aims to compare disitamab vedotin RC48 combined with gemcitabine versus disitamab vedotin combined with toripalimab before surgery, focusing on the rate of complete tumor removal confirmed by pathology. This is a Phase 3 trial designed to assess if the two treatment approaches are similarly effective in this setting. Participants will be randomly assigned to one of two groups one receives disitamab vedotin plus gemcitabine, and the other receives disitamab vedotin plus toripalimab. Both treatments are given intravenously every two weeks for 3 to 6 cycles, depending on tumor response seen in imaging after the initial 3 cycles. After completing neoadjuvant therapy, all patients undergo radical cystectomy with pelvic lymph node dissection within four weeks. Those eligible will then receive additional adjuvant therapy with disitamab vedotin plus toripalimab for 6 cycles, followed by up to one year of toripalimab maintenance therapy. During the study, participants will have regular imaging scans of the abdomen, pelvis, and chest every 3 to 6 months after surgery, or cystoscopy and imaging if bladder-sparing treatment is chosen. Study staff will contact participants every 3 months to track imaging results and symptoms such as hematuria or respiratory issues, and to document any cancer recurrence or progression. The primary outcome is the pathological complete response rate measured shortly after surgery. Safety is monitored through tracking treatment-related adverse events during neoadjuvant therapy. The total study duration is up to 3 years from start to completion.

Researchers are evaluating normobaric hyperoxia NBO as a treatment for patients who have experienced an acute ischemic stroke and are transferred for endovascular thrombectomy EVT. The study aims to assess the effectiveness and safety of NBO in improving functional outcomes at 3 months after stroke. Stroke is a leading cause of death and disability, and although reperfusion treatments like thrombectomy improve blood flow, less than half of patients achieve favorable recovery. NBO is thought to protect the brain by rescuing hypoxic tissue and reducing damage processes, with advantages such as low cost and easy use. Participants will be randomly assigned to receive either NBO, which involves inhaling 100% oxygen alongside the best medical care, or best medical care alone. The study compares these two groups to see if NBO provides additional benefits. The treatment is given during the acute phase before or during transfer for EVT. The study includes a single-blind design and follows patients for outcomes over time. During the study, participants will have their disability level measured using the modified Rankin Scale at 90 days and one year after randomization. Other assessments include neurological function scores, imaging scans, infarct volume changes, and quality of life questionnaires at various time points. Safety and recovery progress are closely monitored throughout, with follow-up visits to track long-term effects. The total participation duration includes initial treatment and follow-up through one year.

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.

Researchers are evaluating an artificial intelligence-based multimodal cognitive screening system to identify mild cognitive impairment MCI related to diabetes early in patients with type 2 diabetes mellitus T2DM. This observational study follows participants for 3 to 5 years to assess the systems accuracy and feasibility. The study also explores how diabetic metabolic indicators, such as glycemic variability and HbA1c levels, relate to changes in cognitive function, aiming to improve early detection and intervention for cognitive decline in T2DM patients. Participants are observed without additional interventions over the 3 to 5 years of follow-up. The study includes groups of participants with normal cognition and those with mild cognitive impairment. Cognitive status data are collected at the beginning and end of the study period, with no study drug or treatment administered. During the study, participants undergo cognitive assessments and monitoring of diabetic metabolic factors. Researchers measure the accuracy of the AI screening system in early detection and track the rate of cognitive decline over the follow-up period. The study also evaluates the predictive value of combining multiple types of data. Participants remain under observation with regular assessments, helping to understand the relationship between diabetes and cognitive changes over time.