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233
17 进行中
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进行中（未招募）
12
5.2%
已完成
155
66.5%
Enrolling By Invitation
2
0.9%
尚未招募
3
1.3%
招募中
34
14.6%
暂停
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0.4%
终止
7
3.0%
Unknown
10
4.3%
撤回
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3.9%
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- Neola Medical AB received FDA Breakthrough Device Designation for Neola®, a non-invasive, continuous lung monitoring device for preterm born babies. - The device aims to support timely detection of potentially life-threatening lung collapse, including pneumothorax, a severe pulmonary complication in neonatal intensive care. - The designation provides more frequent and interactive FDA communication and prioritized review of regulatory submissions, strengthening the company's U.S. regulatory pathway. - Neola® uses patented near-infrared light measurement technology developed at Lund University in Sweden, and the designation does not constitute market approval or authorization.
- Researchers at Lund University in Sweden utilized machine learning to identify a promising drug combination of statins and phenothiazines for treating aggressive neuroblastoma in children. - The computational analysis involved sifting through extensive datasets on genes and existing drugs to uncover effective treatments for this challenging pediatric cancer. - Experimental trials demonstrated that the statin-phenothiazine combination significantly slowed tumor growth and improved survival rates in preclinical models. - These findings suggest the potential for repurposing existing medications as a therapeutic approach for neuroblastoma patients, warranting further investigation.
- 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.
- A 13-week randomized trial of 384 patients with moderate to severe alcohol use disorder found that combining varenicline and bupropion produced approximately twice the effect of currently available medications. - The combination therapy significantly reduced alcohol consumption and cravings by targeting dopamine deficiency, which researchers hypothesize drives alcohol craving behavior. - Patients receiving the combination treatment experienced less nausea and shorter symptom duration compared to varenicline alone, potentially improving treatment completion rates. - The study provides pharmacological support for the dopamine deficiency hypothesis of alcohol use disorder and represents a significant advancement in addressing this condition that can reduce life expectancy by 25 years or more.
- NextCell Pharma has successfully completed treatment of all patients in the ProTrans-Young Phase II clinical trial, marking the completion of patient dosing in the company's largest clinical study to date. - The trial evaluates ProTrans, an allogeneic mesenchymal stromal cell therapy, in 66 pediatric and adolescent patients with recently diagnosed type 1 diabetes across three age cohorts. - One-year follow-up results from the 12-21 years age group showed a positive trend in preserved insulin production, with full study population data expected after summer 2026. - ProTrans is being developed as an off-the-shelf, single-dose infusion therapy aimed at modulating the immune system and preserving residual beta cell function in autoimmune diabetes.
- Hamlet BioPharma and Lund University researchers have discovered that Alpha1H, a bladder cancer drug candidate, targets the endoplasmic reticulum in tumor cells, causing it to collapse like a net around toxic components. - The mechanism explains Alpha1H's ability to kill cancer cells while sparing healthy tissue, as it prevents leakage of harmful substances from dying tumor cells into surrounding areas. - This breakthrough provides scientific validation for Alpha1H's efficacy and safety profile, strengthening its market position and potential applications in treating the 600,000 people affected by bladder cancer annually.
- Hockey players who suffered three or more concussions had twice the risk of depression symptoms compared to those without concussion history, according to new Swedish research. - The study revealed concussed athletes faced 3.5 times higher risk of burnout symptoms including exhaustion, stress, concentration difficulties, and sleep disturbances. - Both male and female hockey players showed equally strong links between concussion and mental health issues, challenging previous assumptions about gender differences in recovery.
- Researchers from Imperial College London and Lund University found that early combination therapy with statins and ezetimibe significantly reduces the risk of subsequent heart attacks and death in cardiac patients. - The study analyzed data from 36,000 heart attack patients, revealing that those receiving combination treatment within 12 weeks had better outcomes than patients receiving delayed treatment or statins alone. - Implementation of early combination therapy could prevent an estimated 133 heart attacks per 10,000 patients over three years, potentially saving 5,000 heart attacks in the UK over a decade.
- Swedish biotech Cantargia has enrolled the first patient in a Phase Ib/IIa trial investigating nadunolimab in combination with standard chemotherapy for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). - The US Department of Defense-funded study aims to enroll 40 patients and will assess safety, dosing recommendations, and efficacy measures including overall response rates and duration of response, with full recruitment expected by 2027. - This marks nadunolimab's first application in hematological malignancies, building on promising results in solid tumors and leveraging the discovery that leukemia stem cells express IL1RAP, the antibody's target protein.
