A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Single-use Ring-shaped Pulmonary Artery Radiofrequency (RF) Ablation Catheter and Pulmonary Artery RF Ablation Generator for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure

It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.

Start Date14 Aug 2023

Sponsor / Collaborator

Pulnovo Medical (Wuxi) Co., Ltd.

[+32]

100 Clinical Results associated with Cangzhou Central Hospital

0 Patents (Medical) associated with Cangzhou Central Hospital

2,174

Literatures (Medical) associated with Cangzhou Central Hospital

01 Oct 2024·Hua xi kou qiang yi xue za zhi = Huaxi kouqiang yixue zazhi = West China journal of stomatology

A novel PAX9 variant in a Chinese family with non-syndromic oligodontia and genotype-phenotype analysis of PAX9variants.

Article

Author: Ma, Yongping ; Jin, Zhanyun ; Zhang, Hong ; Wang, Xiaoxue ; Meng, Lingqiang ; Wang, Jinmei ; Guo, Junjia ; Shen, Wenjing ; Ren, Jiabao ; Zhao, Ya ; Dou, Chenyun ; Yuan, Yunyun ; Yang, Ling ; Xiao, Zun-Sheng ; Li, Hui

OBJECTIVESThis study aimed to identifyPAX9variants in non-syndromic tooth agenesis families of China, as well as to analyze the genotype⁃phenotype of non-syndromic tooth agenesis caused by PAX9variants, which can provide a basis for the genetic diagnosis of tooth agenesis.METHODSWe collected the data of 44 patients with non-syndromic oligodontia who underwent treatment at Stomatological Hospital of Hebei Medical University between 2018 and 2023. Whole-exome sequencing was performed on the peripheral blood of the proband and its core family members, and the variants were verified by Sanger sequencing. Pathogenicity analysis and function prediction of the variants were performed using bioinformatics tools. The correlation between the genotype of PAX9 variant and its corresponding phenotype was examined by reviewing 55 publications retrieved from PubMed. The studies involved 232 tooth agenesis patients with PAX9 variants.RESULTSA novel PAX9 c.447delG (p.Pro150Argfs*62) and a reported PAX9 c.406C>T (p.Gln136*) were identified in two Chinese families. Through bioinformatics analysis and three-dimensional structural modeling, we postulated that the frameshift variant was pathogenic. The outcome was the premature cessation of PAX9 protein, which caused severe structural and functional deficiencies. Summarizing the PAX9 genotype-phenotype relationship revealed that patients carrying the PAX9 variant commonly led to loss of the second molars.CONCLUSIONSWe identified the novel PAX9 c.447delG (p.Pro150Argfs*62) in a Chinese family of non-syndromic oligodontia, expanding the known variant spectrum of PAX9. The most susceptible tooth position for PAX9 variants of tooth agenesis was the second molars and the deciduous molars during the deciduous dentition.

01 Oct 2024·Infection

Efficacy and safety of oral ibrexafungerp in Chinese patients with vulvovaginal candidiasis: a phase III, randomized, double-blind study

Article

Author: Shi, Hong ; Chen, Lihong ; Xu, Dabao ; Song, Weihua ; Liao, Qinping ; Zhang, Chun ; Wang, Wenying ; Wang, Xiaoli ; Li, Jingjing ; An, Ruifang ; Wu, Qiong ; Qiu, Jin ; Shi, Ling ; Li, Yingxiong ; Luo, Xiaowan ; Wang, Baojin ; Zhang, Chunlian ; Ye, Hong ; Ruan, Hongjie ; Patiman, Mijiti ; Wang, Gang ; Ruan, Qi ; Zhang, Songling ; Xu, Hongyan ; Wang, Xiaoqian ; Wang, Xu ; Li, Chuan ; Lu, Jing ; Jia, Wen ; Zhang, Bei ; Hu, Lina ; Lin, Jiajing ; Xue, Fengxia ; Qian, Sumin ; Wang, Shijin

AbstractPurposeTo evaluate the efficacy and safety of oral ibrexafungerp (HS-10366) versus placebo in Chinese patients with vulvovaginal candidiasis (VVC).MethodsA double-blind, placebo-controlled, randomized, multicenter phase III study was conducted in symptomatic VVC patients. Patients received (2:1) twice-daily oral ibrexafungerp 300 mg or matching placebo for 1 day. The primary endpoint was clinical cure (vulvovaginal signs and symptoms [VSS] score = 0) at test-of-cure (TOC) on day 11 ± 3. The secondary endpoints included mycological eradication, overall response, and clinical improvement (VSS score ≤ 1) at TOC, and vulvovaginal symptom resolution at follow-up on day 25 ± 4.ResultsIn total, 360 patients were included in the modified intention-to-treat set (defined as positive Candida cultured and receiving at least one study drug; 239 for ibrexafungerp, 121 for placebo). Compared with placebo, patients receiving ibrexafungerp had a significantly higher proportion of clinical cure (51.0% vs. 25.6%), mycological eradication (55.6% vs. 18.2%), overall response (33.9%, vs. 8.3%) at TOC and complete symptom resolution (74.5% vs. 39.7%, all P < 0.001) at follow-up. Subgroup analysis of clinical cure indicated that patients with C. albicans could benefit from ibrexafungerp over placebo. A similar benefit trend was also observed in those with non-albicans Candida by post-hoc analysis. Further analyses revealed similar efficacy of ibrexafungerp between patients with fluconazole non-susceptible C. albicans and fluconazole susceptible C. albicans regarding clinical cure and mycological eradication. Ibrexafungerp was generally well tolerated. Adverse events were primarily gastrointestinal and were mainly mild in severity.ConclusionsAs a first-in-class antifungal agent, ibrexafungerp demonstrated promising efficacy and favorable safety for VVC treatment in Chinese patients.Chinadrugtrials.org.cn registry numberCTR20220918.

27 Sep 2024·Medicine

Exploring the correlation among genetic variants, cholecystectomy and gut microbiome: A Mendelian randomization study

Article

Author: Yin, Yulai ; Zhang, Xiaoyu

This Mendelian randomization (MR) study aims to explore the relationship between gut microbiota and the occurrence of cholelithiasis, as well as the impact of cholecystectomy on the gut microbiota. This study leverages data on exposures and outcomes from the GWAS database, employing the inverse variance weighting (IVW) method to obtain primary causal estimates. Heterogeneity is assessed using Cochran Q and Rücker Q tests through both IVW and MR-Egger methods. Pleiotropy is evaluated using the Egger-intercept method, while sensitivity analyses are conducted via leave-one-out tests. Additionally, the F-statistic is calculated to assess the presence of weak instrument bias. Finally, the MR-PRESSO method is utilized to validate the findings concerning the relationship between gut microbiota and the incidence of cholelithiasis, as well as the impact of cholecystectomy on gut microbiota composition. The genera Butyricicoccus (ID: 2055), Solibacillus (ID: 11348), Anaerotruncus (ID: 2054), Allisonella (ID: 2174), and Howardella (ID: 2000) have been found to decrease the genetically predicted probability of cholelithiasis. Reverse MR analysis indicates that the occurrence of cholelithiasis reduces the levels of gut microbiota such as Blautia (ID: 1992), Anaerofilum (ID: 2053), Howardella (ID: 2000), Butyricicoccus (ID: 2055), Solibacillus (ID: 11348), Allisonella (ID: 2174), Anaerotruncus (ID: 2054), and Firmicutes (ID: 1672). Additionally, the genera Odoribacter (ID: 952), and Holdemanella (ID: 2157) increase the genetically predicted risk of cholecystectomy. Reverse MR results show that post-cholecystectomy reduces the levels of gut microbiota such as Blautia (ID: 1992), Butyricicoccus (ID: 2055), Alistipes (ID: 11296), Oxalobacteraceae (ID: 2966), and Ruminococcaceae UCG010 (ID: 11367). Conversely, post-cholecystectomy increases the levels of gut microbiota such as Odoribacter (ID: 952), an unknown family (ID: 1000001214), an unknown genus (ID: 1000001215), Aeromonadales (ID: 1591), Holdemanella (ID: 2157), Phascolarctobacteria (ID: 1589), and Eggerthella (ID: 819). All study results show no horizontal pleiotropy, and the MR-PRESSO validation results are consistent with the MR analysis findings. This study elucidates the relationship between gut microbiota and the occurrence of cholelithiasis, as well as the impact of cholecystectomy on the gut microbiota. These findings have clinical significance for diagnosing disease onset and understanding digestive function changes following gallbladder removal, providing theoretical support for further investigation into the molecular mechanisms underlying cholelithiasis.

100 Deals associated with Cangzhou Central Hospital

100 Translational Medicine associated with Cangzhou Central Hospital

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