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Found 7 Actively Recruiting clinical trials
Actively Recruiting
Researchers are conducting a Phase I trial to study BB-1705, a drug made of an engineered antibody linked to a cancer-fighting agent, in adults with locally advanced or metastatic solid tumors that have not responded to standard treatments. The study aims to evaluate the safety, tolerability, the maximum tolerated dose (MTD), maximum administered dose (MAD), recommended Phase 2 dose (RP2D), pharmacokinetics, and preliminary anti-tumor activity of BB-1705. The study includes two parts: Phase Ia dose escalation and Phase Ib cohort expansion. During Phase Ia, participants receive increasing doses of BB-1705 to identify the safest and most effective dose. Phase Ib involves giving one or more recommended doses to additional patients to further assess safety and early treatment effects. Treatment cycles last 21 days, and dosing frequency is based on these cycles. Participants will undergo regular assessments including monitoring for side effects and serious adverse events for up to two years. Researchers will track dose-limiting toxicities during the first 21-day cycle. Evaluations include safety tests, blood samples for drug levels, tumor measurements, and questionnaires about health status. The study monitors patients closely through all treatment cycles and follows them for long-term safety and response.
Actively Recruiting
Heat stroke is a serious condition caused by an imbalance between heat production and heat loss, often due to exposure to hot, humid environments or intense exercise. It is characterized by a core body temperature above 40°C, central nervous system problems, and multiple organ dysfunction. The extent of damage depends on how high the temperature rises and how long it lasts. Quickly lowering the core temperature can stop cell damage, reverse organ issues, and improve recovery. Early recognition and rapid cooling are therefore critical to prevent permanent harm or death. However, there is currently no standardized protocol for emergency medical staff to manage body temperature effectively in heat stroke patients. To address this, a new early in-hospital temperature management protocol was developed based on expert advice and evidence. The temperature management protocol focuses on early identification of heat stroke, choosing the best cooling techniques for rapid temperature reduction, managing target temperatures precisely, and continuous monitoring. This systematic approach aims to improve outcomes for heat stroke patients by controlling their body temperature effectively during their hospital stay. Participants admitted to the emergency department with heat stroke will be monitored for their cooling rate and body temperature at 0.5 hours to evaluate the protocol's effectiveness. The study will assess how quickly the core temperature decreases and track patient progress during treatment. This research will provide evidence on the feasibility and effectiveness of the protocol to guide clinical practice in managing heat stroke patients.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of the Lifetech Concave Supra-arch Branched Stent-Graft System for treating aortic arch diseases such as aortic arch aneurysms and penetrating aortic ulcers. The study focuses on patients aged 18 to 80 years who need endovascular intervention with the stent securely anchored in a specific zone of the aorta. This prospective, single-group clinical trial aims to assess clinical treatment success and monitor complications within the first year after surgery. Participants will receive the Concave Supra-arch Branched Stent-Graft System as the treatment device. The procedure involves placing the stent-graft through arteries to treat the aortic arch condition. The study requires careful adherence to the clinical protocol, with any emergencies or protocol changes subject to approval by an Ethics Committee. The device's anatomical suitability includes specific measurements of the aorta and branch vessels, and patients must be considered high-risk for traditional surgery. During the study, participants will be closely monitored through follow-up visits up to 12 months post-surgery. Researchers will track the incidence of key clinical endpoints within 30 days after surgery and evaluate the overall treatment success rate within a year. Assessments include imaging, clinical evaluations, and safety monitoring to ensure proper device function and patient well-being throughout the study period.
Actively Recruiting
Researchers are comparing two heart procedures — a modern, imaging- and physiology-guided percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) — in people with type 2 diabetes who have significant disease in three heart arteries but not the left main artery. This study focuses on patients with diabetes and three-vessel coronary artery disease to determine which treatment approach results in better outcomes over two years. One group receives PCI guided by advanced imaging techniques like intravascular ultrasound or optical coherence tomography and physiological measurements such as fractional flow reserve or instantaneous wave-free ratio. They are treated with modern drug-eluting stents and receive optimal medical therapy including high-dose statins, advanced antiplatelet regimens, and anti-diabetic medications like SGLT-2 inhibitors or GLP-1 agonists. The other group undergoes standard coronary artery bypass surgery (CABG). Both treatments aim to restore blood flow in the affected arteries. Participants are followed for two years to monitor major adverse cardiac or cerebrovascular events. The study includes clinical follow-ups and assessments to evaluate the safety and effectiveness of the procedures combined with medical therapy. Patients must consent to the study protocol and follow-up schedule. This research helps understand the best revascularization strategy for diabetic patients with complex coronary artery disease.
Actively Recruiting
Researchers are evaluating Clifutinib compared to salvage chemotherapy in Chinese adults with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML). This Phase III, multicenter, open-label study aims to assess overall survival and the complete remission or complete remission with partial hematologic recovery (CR/CRh) rates in these patients. Participants who are 18 years or older will be randomly assigned in a 2:1 ratio to receive either Clifutinib tablets orally or one of several pre-selected salvage chemotherapy regimens, including low-dose cytarabine, azacitidine, decitabine, Ara-C±IDA, or FLAG±IDA. Treatments are given in continuous 28-day cycles. Before starting treatment, a screening period of up to 28 days is conducted, and randomization is stratified by response to first-line therapy and the chosen chemotherapy. During the study, participants will have an end-of-treatment visit within 7 days after stopping treatment, followed by a 30-day safety follow-up. Long-term follow-up visits will occur every 90 days to monitor outcomes. Researchers will assess overall survival for up to 5 years from randomization and measure CR/CRh rates with at least 4 months of follow-up for all subjects. Safety and efficacy data will be collected throughout the study.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of a chemotherapy drug called JSKN003 compared to other chemotherapy treatments chosen by doctors for adults with HER2-low, unresectable, or metastatic breast cancer. This study focuses on patients whose cancer has returned or spread and who have already tried one or two previous chemotherapy treatments without success. It is a phase III, open-label, randomized study conducted at multiple centers. Participants will be randomly assigned to one of two groups: one group will receive JSKN003 given through an intravenous infusion according to the study plan, while the other group will receive one of several chemotherapy drugs selected by their doctor before joining the study. These options include capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. Treatment is given as a single drug in both groups. During the study, participants will be monitored for up to about three years to see how long they live without their cancer worsening. Researchers will conduct imaging scans, lab tests, and other evaluations to track disease progression and overall health. Safety and side effects will be carefully observed, and participants' tumor samples will be analyzed to confirm HER2 status. The study aims to enroll 408 subjects and includes follow-up assessments to ensure continued monitoring of treatment outcomes.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the effectiveness and safety of GP681 tablets compared to placebo for preventing influenza infection in household members of patients diagnosed with influenza. This Phase III study focuses on households where the first patient diagnosed with influenza (index patient) has started symptoms within 48 hours and household contacts have not received an influenza vaccine in the past six months and test negative for influenza at screening. Index patients eligible for treatment receive anti-influenza drugs if their symptoms began within 48 hours of screening. Eligible households are then randomized to receive either GP681 tablets, given as two 20 mg tablets taken orally, or placebo tablets matching GP681. The study monitors participants for up to 10 days, collecting multiple respiratory swabs from household contacts and assessing symptoms to evaluate infection rates. Participants will be closely monitored through respiratory tests and symptom assessments during the 10-day period. Researchers measure the proportion of household members who become infected with influenza, confirmed by lab testing and symptom severity. Safety and adherence to study procedures are also tracked, with participants and guardians providing consent and completing health diaries throughout the study.