相关临床试验
671
71 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1883
进行中（未招募）
49
7.3%
Approved For Marketing
1
0.1%
已完成
408
60.8%
Enrolling By Invitation
9
1.3%
No Longer Available
1
0.1%
尚未招募
13
1.9%
招募中
113
16.8%
暂停
1
0.1%
终止
43
6.4%
Unknown
4
0.6%
撤回
29
4.3%
暂无批准数据
- A study published in Cell Reports Medicine found that indigo light (419–446 nm) completely prevented myopia development in tree shrews, an animal model with human-like eyes. - The research suggests modern white LED lighting lacks indigo wavelengths, which may contribute to the global "myopia boom" affecting children and adolescents. - Researchers developed a new metric, the μ-opic, to quantify how effectively different light wavelengths protect against myopia. - A UAB startup, Electric Indigo, is developing eyewear with LEDs that emit indigo light, with future clinical studies planned in daycare settings.
- An oral live-attenuated Shigella sonnei vaccine candidate, WRSs2, achieved 89% protection against shigellosis in a phase 2 controlled human infection trial published in The Lancet Infectious Diseases. - Only 3 of 34 vaccinated participants developed shigellosis compared with 21 of 26 placebo recipients, with just 3% experiencing severe symptoms versus 69% in the placebo group. - The trial enrolled 108 healthy adults aged 18–49, and no vaccine-related serious adverse events were reported, supporting a favorable safety profile. - Researchers emphasize further optimization is needed, including studies in children in endemic regions, as Shigella causes hundreds of thousands of deaths annually worldwide with no licensed vaccine currently available.
- The phase 2 DEGAS trial found dupilumab significantly reduced stomach eosinophil counts and improved endoscopic and histologic outcomes in patients with eosinophilic gastritis over 12 weeks, with benefits sustained through 36 weeks. - The 11-center study, published in The Lancet Gastroenterology & Hepatology, involved 41 adolescents and adults and was conducted by the NIH-supported CEGIR consortium led by Cincinnati Children's. - No FDA-approved medications currently exist for EoG, a rare inflammatory food-allergic disease affecting an estimated 5 to 7 per 100,000 people, leaving patients reliant on strict food-elimination diets. - Researchers say the findings merit pursuing FDA approval and may serve as a model for repurposing already-approved therapies across the more than 7,000 rare diseases lacking effective treatments.
- A multi-center prospective cohort study (CHICKADEE) will enroll 300 children aged 4–16 years, 4–12 years after their first cardiac surgery requiring cardiopulmonary bypass, to characterize the natural history of hypertension and kidney disease in congenital heart disease. - The study integrates 24-hour ambulatory blood pressure monitoring, novel glomerular and tubular biomarkers, proteomics, and genetic characterization to detect subclinical kidney injury and identify risk factors beyond traditional measures. - Prior data show hypertension (12%–17%), albuminuria (8%), and chronic kidney disease (21%–30%) emerge in childhood after cardiac surgery, yet only 4% of affected children are evaluated by a pediatric nephrologist. - Recruitment began March 1, 2025, with data collection expected to conclude by December 2027 and results anticipated by June 2028.
- The Renal Activity Index for Lupus (RAIL), a six-biomarker urine-based score, demonstrated strong accuracy in identifying complete renal response in lupus nephritis patients, with AUC values of 0.83–0.85. - In an exploratory analysis of the phase III ALLURE trial involving 240 patients, RAIL outperformed eGFR and showed improved discrimination compared to UPCR after adjusting for baseline characteristics. - Higher RAIL scores at a given visit were associated with nonresponse at the subsequent visit, indicating the score's longitudinal predictive value for disease course. - The findings support RAIL as a noninvasive tool to assess disease activity and anticipate treatment response, though generalizability may be limited to clinical trial populations.
- BioOra and Cincinnati Children's Hospital Medical Center have formed a strategic partnership to advance Atla-cel, a third-generation CD19-directed CAR-T therapy, into clinical development for children with relapsed or refractory B-cell acute lymphoblastic leukemia. - Atla-cel demonstrated markedly reduced neurotoxicity in adult trials from the ENABLE programme, positioning it as a compelling candidate for pediatric investigation where neurotoxicity carries heightened developmental risks. - The proposed global clinical programme will enroll patients across the United States, New Zealand, and potentially Australia, with Cincinnati Children's leading trial management and Dr. Stella Davies serving as principal investigator. - The collaboration aims to address the significant unmet need for safer CAR-T therapies in children, potentially enabling outpatient delivery and reducing the prolonged inpatient stays currently required with approved therapies.
- BrioHealth Solutions achieved a significant milestone with the 100th implantation of its investigational BrioVAD System across 34 US clinical trial sites since launching in November 2024. - The FDA granted conditional approval for the Brio4Kids Trial, marking the first expansion of the BrioVAD System evaluation into pediatric patients with advanced heart failure. - The compact pump design with thin driveline and lightweight components may address critical unmet needs in pediatric heart failure treatment where durable LVAD options remain limited. - Initial pediatric trial enrollment is expected to begin mid-2026 with preliminary data anticipated in the fourth quarter of 2026.
- Baylor College of Medicine will lead cardiac innovation for DATAMAP, a $21 million ARPA-H funded project developing AI-driven models to predict drug-induced cardiotoxicity and hepatotoxicity. - The initiative aims to create FDA-qualified in silico organ toxicity models that integrate artificial intelligence with physiology-based mathematical modeling to predict human drug toxicity for small molecules. - Baylor's team will develop state-of-the-art human heart slice culture systems using multi-electrode array technology and optical strain analysis to generate critical validation data. - The project addresses a major clinical challenge, as liver and heart toxicity are the organs most often implicated in clinical trial failures due to adverse drug reactions.
- AJOVY (fremanezumab) achieved FDA approval in August 2025 for preventing episodic migraine in children and adolescents aged 6-17 years weighing 45 kg or more, making it the first CGRP antagonist indicated for both pediatric and adult migraine prevention. - The pivotal SPACE trial demonstrated that AJOVY significantly reduced monthly migraine days by 2.5 days compared to 1.4 days with placebo, with 47.2% of patients achieving a ≥50% reduction in monthly migraine days versus 27.0% with placebo. - Real-world evidence from the PEARL study reinforced AJOVY's long-term effectiveness over 24 months in adults, with over 66% of episodic migraine patients and 51.6% of chronic migraine patients achieving ≥50% reduction in monthly migraine days during the first 6 months. - The safety profile remained consistent across pediatric and adult populations, with injection site reactions being the most common adverse event and high treatment adherence rates of approximately 90% maintained throughout studies.
- Researchers at Cincinnati Children's Hospital Medical Center, in collaboration with Roche, have developed a next-generation human liver organoid microarray platform that integrates patient-specific genetics and immune responses to predict idiosyncratic drug-induced liver injury. - The platform successfully recreated immune-mediated liver injury from the antibiotic flucloxacillin in carriers of the HLA-B*57:01 risk gene, reproducing T cell activation, cytokine secretion, and hepatocyte damage that matches what occurs in susceptible patients. - This breakthrough addresses a critical gap in drug safety testing, as standard lab tests and animal models cannot reproduce the complex, patient-specific immune mechanisms that cause rare but severe liver injuries. - The CuSTOM Accelerator team plans to automate organoid assays for high-throughput screening across genetically diverse populations, moving closer to predicting individual patient responses before treatments reach clinical trials.
