This project is an open, single-center, prospective study aimed at developing high-sensitivity, high-specificity enrichment SERS chips using femtosecond laser processing technology. It involves extracting information from blood samples of ovarian cancer patients and normal controls, specifically identifying cancer and non-cancer signals. The study will construct a statistical algorithm model for the early diagnosis of ovarian cancer, enabling early identification and intervention for ovarian cancer patients.

开始日期2025-01-01

申办/合作机构

安徽省立医院（中国科学技术大学附属第一医院）

NCT06531915 / Not yet recruitingN/AIIT

Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic Bronchoscopy: a Study Protocol for a Single-center, Double-blind, Randomized Controlled Trial

Both ciprofol and remimazolam have been found to be potential alternatives to propofol (a commonly used anesthesia) during fiberoptic bronchoscopy, while the efficacy and safety between ciprofol and remimazolam have not been reported. This study aims to compare the efficacy and safety between ciprofol and remimazolam in patients undergoing fiberoptic bronchoscopy.

开始日期2024-12-01

申办/合作机构

安徽省立医院（中国科学技术大学附属第一医院）

NCT06664021 / Recruiting临床2期IIT

Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma：A Prospective, Multicenter, Single-arm Phase II Clinical Study

Evaluating the efficacy and safety of treatment with Tislelizumab in combination with S-1 in patients with high-risk recurrent intrahepatic cholangiocarcinoma after radical surgery

开始日期2024-11-10

申办/合作机构

安徽省立医院（中国科学技术大学附属第一医院）

100 项与安徽省立医院（中国科学技术大学附属第一医院）相关的临床结果

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0 项与安徽省立医院（中国科学技术大学附属第一医院）相关的专利（医药）

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项与安徽省立医院（中国科学技术大学附属第一医院）相关的文献（医药）

2024-10-01·Annals of Hematology

Improved efficacy and safety of zanubrutinib versus ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) in China: a subgroup of ALPINE

Article

作者: Wang, Liping ; Sun, Zimin ; Yu, Kang ; Weng, Jianyu ; Li, Ping ; Qiu, Lugui ; Xu, Wei ; Li, Fei ; Fu, Lina ; Yan, Dongmei ; Liu, Peng ; Zhu, Xiongpeng ; Hu, Jianda ; Zhang, Wei ; Jing, Hongmei ; Feng, Ru ; Zhang, Huilai ; Wang, Tingyu ; Pan, Ling ; Liu, Zhougang ; Salmi, Tommi ; Gao, Sujun ; Jin, Jie ; Zhou, Keshu ; Wang, Zhao ; Hu, Yu ; Wu, Kenneth

AbstractChronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) has different epidemiology in Chinese vs. Western patients, but there are few studies of CLL/SLL in large populations of Chinese patients. ALPINE is a global phase 3 trial investigating Bruton tyrosine kinase inhibitors zanubrutinib vs. ibrutinib to treat relapsed/refractory (R/R) CLL/SLL. Here we report results from the subgroup of Chinese patients. Adults with R/R CLL/SLL were randomized 1:1 to receive zanubrutinib (160 mg twice-daily) or ibrutinib (420 mg once-daily) until disease progression or unacceptable toxicity. Endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Data were analyzed descriptively. Ninety patients were randomized in China (zanubrutinib, n = 47; ibrutinib, n = 43). Baseline characteristics were balanced between groups, with fewer male patients in the zanubrutinib vs. ibrutinib group (55.3% vs. 69.8%). Median age was 60.5 years, 11% had del(17p) mutation, and 32% had tumor protein 53 (TP53) mutation. With median 25.3 months follow-up, ORR was 80.9% with zanubrutinib vs. 72.1% with ibrutinib. PFS was improved with zanubrutinib vs. ibrutinib (HR = 0.34 [95% CI, 0.15, 0.77]), and the HR for OS was 0.45 (95% CI, 0.14, 1.50). Rates of Grade ≥ 3 treatment-emergent adverse events (TEAEs; 64.4% vs. 72.1%), AEs leading to discontinuation (6.4% vs. 14.0%), and serious TEAEs (35.6% vs. 51.2%) were lower with zanubrutinib vs. ibrutinib. Zanubrutinib demonstrated improved ORR, PFS, and OS vs. ibrutinib and a more favorable safety profile in patients with R/R CLL/SLL in China. These results are consistent with the full global population of ALPINE. ClinicalTrials.gov: NCT03734016, registered November 7, 2018.

2024-09-16·BMC gastroenterology

Association between lipid accumulation products and gallstones: an analysis of the National Health and Nutrition Examination Survey 2017-2020.

Article

作者: Wang, Huimin ; Feng, Xiaojia ; Zheng, Xiaowei ; Huang, Qihui

AIMSThe aim of the research was to look into the connection between the occurrence of gallstones in adult US citizens and lipid accumulation products (LAP).METHODSWe conducted a cross-sectional study of 3,582 U.S. adults with relevant indicators collected from the 2017-2020 National Health and Nutrition Examination Survey (NHANES) database. Multifactorial logistic regression was used to investigate the linear relationship between LAP and gallstone incidence, while smoothed curve fitting was used to describe the nonlinear relationship, and subgroup and interaction analyses were used to evaluate the potential differences between groups.RESULTSAmong the 3582 participants aged ≥ 20 years included, there was a positive association between LAP and gallstones. Following adjustments for all covariates, the likelihood of getting gallstones rose by 29% for each unit rise in log2-LAP (OR = 1.29, 95% CI: 1.13‒1.49). Compared to those in the lowest tertile, those in the highest LAP tertile had a significantly higher risk of developing gallstones (OR = 1.97, 95% CI: 1.31‒2.95). Subgroup analyses indicated that the association between LAP and gallstones was not affected by the stratification of the variables examined.CONCLUSIONGallstones and LAP exhibited a positive association in our investigation, indicating that LAP may be utilized as a clinical indicator to determine the occurrence of gallstones.

2024-08-01·Rheumatology and Therapy

Rapid and Sustained Effect of Ixekizumab on Patient Global, Spinal Pain, Stiffness, and Fatigue in Chinese Patients with Radiographic Axial Spondyloarthritis

Article

作者: Sun, Lingyun ; Yan, Yan ; Liu, Dongzhou ; Dou, Guanshen ; Xiao, Zhengyu ; Li, Jingyang ; Dai, Lie ; Li, Xiaomei ; Zhu, Xiaoxia ; Sun, Yuzi ; Hu, Jiankang ; Li, Zhijun ; Tan, Chunyu ; Wu, Huaxiang ; Zou, Hejian

INTRODUCTIONIxekizumab, an interleukin 17A (IL-17A) inhibitor, has demonstrated rapid and sustained improvement in the signs and symptoms in patients with active radiographic axial spondyloarthritis (r-axSpA) in global and Chinese populations. We studied the effect of ixekizumab on patient-reported outcomes (PROs) (including patient global, spinal pain, stiffness, and fatigue) and overall health-related quality of life (HRQoL) of ixekizumab in the phase 3 study in China.METHODSIn this Chinese phase 3, randomized, double-blind, placebo-controlled study, patients with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W; starting dose 160 mg) or placebo for 16 weeks. At week 16, patients receiving placebo were switched to IXEQ4W, and those receiving IXEQ4W continued, until week 52. Data for patient global, spinal pain, spinal pain at night, stiffness, and fatigue were collected through week 52. Minimally clinical important differences (MCIDs) were determined for spinal pain and spinal pain at night. The subgroup analyses by baseline disease duration since diagnosis and baseline C-reactive protein (CRP) level were conducted post hoc.RESULTSCompared with placebo, patients treated with IXEQ4W reported significantly greater improvement with a rapid onset in changes from baseline of PROs (patient global, spinal pain, spinal pain at night, stiffness, and fatigue) through week 16. Improvements were maintained through week 52. A similar trend of improvement was also observed in MCID response in spinal pain and spinal pain at night. The improvement in overall HRQoL was supported by EQ-5D-5L assessment. Subgroup analyses demonstrated that IXEQ4W provided significantly greater efficacy at week 16 compared with placebo, irrespective of baseline disease duration or baseline CRP level.CONCLUSIONIXEQ4W provided rapid and sustained improvement in clinically relevant PROs and overall HRQoL through 1-year treatment in Chinese patients with r-axSpA. Regardless of the baseline disease duration or baseline CRP level, consistent efficacy was observed.TRIAL REGISTRATIONClinicalTrials.gov identifier NCT04285229.

100 项与安徽省立医院（中国科学技术大学附属第一医院）相关的药物交易

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