Qian Dong Nan Miao Zu Dong Zu Zi Zhi Zhou

Researchers are evaluating a new tuberculosis preventive treatment among adolescents and school staff who have been in close contact with active TB cases. This study compares a novel 1-month ultra-short regimen called 1H3P3 with the standard 3-month 3HR regimen, aiming to prevent latent TB infection from progressing to active tuberculosis. The trial is a phase 3, multi-center, open-label, cluster randomized controlled study conducted in school settings in China, with the goal of improving TB prevention strategies for adolescents. Participants are randomly assigned to receive either the 12-dose 1H3P3 regimen of isoniazid and rifapentine taken three times a week for one month, or the 3HR regimen of isoniazid and rifampicin taken once daily for three months. Close contacts of TB cases are screened using blood tests, chest X-rays, sputum testing, and symptom checks to rule out active TB before enrollment. The treatment period lasts either one or three months depending on the group, followed by two years of follow-up to monitor for TB development. During the study, participants will undergo regular assessments including monitoring for active tuberculosis through clinical and laboratory tests, adverse events, treatment adherence, and drug resistance if active TB occurs. The main measurement is the cumulative incidence of active TB over 24 months after treatment begins. Safety and treatment completion rates are tracked throughout. Participation involves screening, treatment administration, and periodic follow-up visits over two years to evaluate outcomes and overall TB prevention effectiveness.

Researchers are studying the rate of Mycobacterium tuberculosis MTB infection among students who have been in close contact with active tuberculosis ATB patients at school. The study also aims to identify risk factors related to tuberculosis infection and evaluate the health economics of the screening strategy. This observational study is sponsored by Huashan Hospital and focuses on school contacts of ATB patients aged 13 years and older. Participants will undergo the QuantiFERON-TB Gold QFT test to determine if they have been infected with MTB. Those who test positive will have further assessments including sputum Xpert MTBRIF testing, physical examination, chest CT scan, and if necessary, sputum culture to differentiate latent TB infection from active tuberculosis. For participants over 15 years old with a positive QFT result, a chest X-ray scan may also be performed. During the study, participants will provide baseline information including age, sex, vaccination history, contact patterns, and medical history through checklists. Researchers will monitor the prevalence of tuberculosis infection at baseline and collect other relevant data. The study is observational, meaning no treatment is provided, and participants will be followed to understand the infection status and related factors. The total study duration extends until the end of 2025.

Primary aldosteronism PA is a common cause of secondary hypertension, and its diagnosis and treatment pose significant challenges. This research investigates adrenal venous sampling AVS, which is considered the best method to distinguish between different types of PA. The study aims to address clinical, technical, and methodological questions about AVS and to understand how AVS-guided management influences long-term health and biochemical results to improve patient care. Participants with PA will undergo adrenal venous sampling through either the antecubital or femoral vein to identify whether aldosterone overproduction is unilateral or bilateral. This observational study evaluates the AVS procedure itself and its clinical outcomes, refining protocols and standardizing practices to optimize treatment decisions and patient prognosis. Throughout the study, researchers will monitor major cardiovascular events one year after AVS. They will also assess procedure success rates, complications, medication changes, blood pressure, heart and kidney function, and clinical outcomes over multiple years. The follow-up includes assessments at 1, 3, 6, 12, 18 months, and up to 10 years, enabling comprehensive evaluation of long-term effects and safety.

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.

The trial investigates treatment options for patients with rifampicin-resistant tuberculosis RR-TB, including those resistant or susceptible to fluoroquinolones. It compares seven different 9-month oral drug combinations to the current 9-month standard of care for fluoroquinolone-susceptible RR-TB, and a 9-month bedaquiline-containing regimen to a 20-month conventional regimen for fluoroquinolone-resistant RR-TB. This Phase 3, randomized, controlled, open-label study aims to evaluate if these new shorter treatments are as effective and safe as existing therapies. Participants susceptible to fluoroquinolones receive one of several oral regimens combining drugs like bedaquiline, linezolid, fluoroquinolones moxifloxacin or levofloxacin, cycloserine, clofazimine, and pyrazinamide. Treatment lasts 9 months, with possible extension by 2 months for certain conditions. For fluoroquinolone-resistant participants, the experimental regimen includes bedaquiline, cycloserine, clofazimine, linezolid, and pyrazinamide for 9 months, compared to a 20-month standard regimen. Drug resistance is tested at baseline to adjust medications accordingly. During the study, participants undergo assessments including sputum culture tests and safety evaluations up to 21 months after randomization. Researchers monitor treatment outcomes such as cure rates, time to culture conversion, adverse effects severity, mortality, and specific drug-related side effects. Participants are followed closely with clinical and laboratory tests to evaluate the effectiveness and safety of these regimens throughout the treatment and follow-up period.

Researchers are evaluating the safety and effectiveness of JX10 compared to a placebo in adults aged 18 to 90 who have experienced an acute ischemic stroke and present for care between 4.5 to 24 hours after stroke onset. The study aims to determine if JX10 improves functional outcomes measured by the modified Rankin Scale and to assess the risk of symptomatic intracranial hemorrhage. This is a multicenter, double-blind, randomized, placebo-controlled study sponsored by Corxel Pharmaceuticals, conducted in phases 2 and 3. Participants in Part 1 are randomly assigned to receive either JX10 at doses of 1 mgkg or 3 mgkg, or a placebo. In Part 2, participants receive the optimal JX10 dose selected from Part 1 or a placebo. The treatment involves intravenous administration of a thrombolytic agent, JX10, designed to improve blood flow by dissolving clots. The study uses a quadruple masking design to ensure unbiased results. Throughout the study, participants will be monitored and assessed for functional recovery using the modified Rankin Scale at 90 days, with safety evaluations including the incidence of symptomatic intracranial hemorrhage within 36 hours post-treatment. Additional assessments include adverse events, serious adverse events, and major bleeding occurrences within 24 hours and up to 14 days after treatment. Total participation spans at least 90 days, during which clinical and radiographic evaluations will be conducted to track progress and safety.

Tuberculosis TB remains a leading infectious disease worldwide, with treatment challenges including poor adherence to long and complex regimens. Researchers are evaluating high-dose rifapentine regimens to treat rifampicin-sensitive pulmonary tuberculosis with the aim of shortening treatment duration and reducing side effects and economic burden. This multicenter, prospective, randomized controlled study focuses on assessing the safety, effectiveness, and pharmacokineticspharmacodynamics of these regimens compared to the standard treatment. The study includes four treatment groups three experimental groups receiving rifapentine at doses of 10mgkg, 15mgkg, or 20mgkg combined with isoniazid, pyrazinamide, and moxifloxacin during an 8-week intensive phase, followed by a continuation phase of 9 weeks with rifapentine, isoniazid, and moxifloxacin and one comparator group receiving the World Health Organizations standard 26-week regimen with rifampicin, isoniazid, pyrazinamide, and ethambutol. The continuation phase may be extended up to 18 weeks if certain treatment response criteria are not met. Participants will be monitored through treatment and follow-up lasting up to 108 weeks after randomization. Researchers will evaluate treatment success rates, culture conversion at various time points, relapse rates, and adverse events throughout the study period. Safety assessments will include laboratory tests and clinical evaluations to monitor tolerability and drug effects, ensuring thorough observation during and after treatment completion.

Researchers are evaluating and comparing the effects of total intravenous anesthesia using remimazolam versus propofol in patients at moderate to high risk undergoing major elective noncardiac surgery under general anesthesia. This randomized controlled trial aims to determine if remimazolam can increase the number of days patients are alive and out of the hospital within 30 days after surgery. The study is conducted by Nanfang Hospital, Southern Medical University and is classified as a phase 4 trial. Participants receive either remimazolam or propofol as anesthesia. Remimazolam is given intravenously at 6-12 mgkgh for induction and 1.0-2.0 mgkgh for maintenance, adjusted to keep the Bispectral Index between 40 and 60. Propofol is administered intravenously at 1.5-2.5 mgkg for induction and 4-12 mgkgh for maintenance, also titrated to maintain the same Bispectral Index range. These dosing strategies help monitor and control anesthesia depth during surgery. During the study, participants will be closely monitored for outcomes including days alive and out of hospital at 30 days after randomization, all-cause mortality within 30 days, length of hospital stay, unplanned re-hospitalizations, postoperative complications, and quality of recovery on the first day after surgery. The trial involves double-blind randomization and includes follow-up assessments at 30 days to gather comprehensive data on recovery and safety.

Researchers are evaluating whether injecting nicardipine directly into the cerebrospinal fluid improves outcomes for patients with cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage. This multi-center, prospective, double-blinded, randomized controlled trial compares two methods of delivering nicardipine through extraventricular drainage EVD or lumbar drainage LD. The study aims to determine which approach leads to a better prognosis for affected patients. Participants in the treatment group receive intrathecal nicardipine injections via EVD or LD catheters. The process involves withdrawing 6 ml of cerebrospinal fluid, injecting 4 ml 4 mg of nicardipine hydrochloride, followed by 2 ml of saline, then clamping the catheter for 2 hours. This dosing is done twice daily. The control group undergoes a simulated procedure without receiving the drug. The drainage tubes remain open as clinically needed between doses. During the study, participants are monitored for outcomes using multiple scales, including the Modified Rankin Scale at 90 and 365 days, Glasgow Outcome Score, MMSE, NIH Stroke Scale, and rates of complications like infections or hemorrhage. Safety is assessed through adverse event tracking. Follow-up visits occur up to one year after treatment. The entire study period spans from the start of treatment to long-term outcome evaluations.