This randomized open label clinical trial will evaluate the effect of continued denosumab alone over 18 months versus denosumab with added abaloparatide for 18 months. 70 postmenopausal women will be enrolled over a period of 18 months. The co-primary outcomes will be group differences in bone mineral density (BMD) of the total hip and lumbar spine at 18 months. Secondary outcomes will include group differences in bone mineral density (BMD) at the femoral neck, trochanter and wrist sites at 6, 12 and 18 months, spine and total hip bone mineral density (BMD) at 6 and 12 months and trabecular bone score (TBS) at 18 months. Secondary outcomes will also include within group changes from baseline for each of these variables. Bone turnover markers will also be measured to demonstrate that PINP levels will increase with administration of abaloparatide even in the setting of ongoing denosumab, while CTX levels will remain low.

开始日期2021-02-01

申办/合作机构

Hospital for Special Surgery

[+2]

NCT04517682

/ CompletedN/A

SARS -CoV-2 Detection in Saliva Samples: A Test Validation Protocol

This study aims to validate the use of human saliva as a substrate for an assay to detect SARS-CoV-2 and define accuracy, analytical sensitivity and specificity of the TaqPath RT-PCR test.

开始日期2020-05-21

申办/合作机构

Ambry Genetics Corp.

[+3]

NCT03734471

/ Unknown status临床3期IIT

Use of a Novel Chest Tube Insertion Device for Urgent Thoracostomy in an Emergency Department Setting

Tube thoracostomy is commonly performed in the emergency department for patients suffering from traumatic hemo- or pneumo-thorax. The procedure involves the use of a scalpel incision at the skin followed by blunt dissection through tissue, penetration into the thoracic cavity, dilation of a tract for tube placement, exploration of the thoracic cavity with a gloved finger, and finally insertion of a sterile tube into the intrathoracic space. The procedure is considered extremely painful despite the routine provision of systemic analgesics and local anesthetics.
Cadaver and animal studies have demonstrated the use of the Reactor chest tube device, a squeeze-activated thoracostomy trochar with placement of a clear sheath for chest tube insertion, to decrease procedure time, incision size, and blood loss. Case series and observational reports suggest lower rates of procedural complication and failure as well as increased patient satisfaction due to pain reduction.

开始日期2019-01-01

申办/合作机构

Crozer-Keystone Health System

100 项与 Prospect Medical Holdings, Inc. 相关的临床结果

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项与 Prospect Medical Holdings, Inc. 相关的文献（医药）

2025-03-04·Expert Opinion on Drug Safety

A drug safety evaluation of dapagliflozin for diabetic nephropathies in patients with cardiovascular risk

Review

作者: Vyas, Apurva V. ; Sawhney, Aanchal ; Gupta, Rahul ; Borokhovsky, Benjamin ; Sood, Aayushi

INTRODUCTIONDiabetic nephropathy is a significant concern for patients with cardiovascular disease. Dapagliflozin, an SGLT2 inhibitor, has emerged as a promising therapeutic approach to managing diabetic nephropathy and reducing cardiovascular risk.AREAS COVEREDThis review encompasses the research and literature search methodology, including clinical trials and real-world evidence, assessing the safety profile of Dapagliflozin in patients with diabetic nephropathy and cardiovascular risk.EXPERT OPINIONDapagliflozin, an SGLT2 inhibitor, has redefined patient-centric care by simultaneously improving glycemic control, cardiovascular health, and renal outcomes in individuals with type 2 diabetes, cardiovascular disease, and nephropathy.

2025-03-01·Mayo Clinic Proceedings

Impact of Lipid-Lowering Combination Therapy With Statins and Ezetimibe vs Statin Monotherapy on the Reduction of Cardiovascular Outcomes: A Meta-analysis

Article

作者: Jaiswal, Vikash ; Ang, Song Peng ; Deb, Novonil ; Reiner, Zeljko ; Amarenco, Pierre ; Gaita, Dan ; Pećin, Ivan ; Toth, Peter P ; Lavie, Carl J ; Penson, Peter E ; Banach, Maciej ; Sawhney, Aanchal

OBJECTIVETo evaluate the efficacy of combination lipid-lowering therapy (LLT) compared with statin monotherapy for low-density lipoprotein cholesterol (LDL-C) reduction, associated adverse events, and outcomes.METHODSA systematic literature search was conducted using PubMed, Embase, and ClinicalTrials.gov to identify relevant articles published from inception until the end of June 2024. The outcomes were assessed using pooled odds ratios (ORs) for categorical data and mean difference for continuous data, with corresponding 95% CIs.RESULTSA total of 14 studies (11 randomized controlled trials and 3 cohort studies) with 108,373 very high-risk patients were included in the final analysis. The mean age of the patients in the combination LLT group and the statin monotherapy group was 67.31 and 67.89 years, respectively. Pooled analysis revealed that combination LLT significantly more effectively reduced the LDL-C level from baseline (mean difference, -12.96 mg/dL; 95% CI, -17.27 to -8.65; P<.001) and significantly reduced all-cause mortality (OR, 0.81; 95% CI, 0.67 to 0.97; P=.02), major adverse cardiovascular events (OR, 0.82; 95% CI, 0.69 to 0.97; P=.02), and stroke incidence (OR, 0.83; 95% CI, 0.75 to 0.91; P<.001), with an insignificant effect on cardiovascular mortality (OR, 0.86; 95% CI, 0.65 to 1.12; P=.26) when compared with statin monotherapy. The risk of adverse events and the therapy discontinuation rate were comparable between groups.CONCLUSIONCombination LLT was associated with an overall greater reduction in LDL-C, the same risk of adverse effects, and significantly lower risk of all-cause mortality, major adverse cardiovascular events, and stroke compared with statin monotherapy. Forthcoming guidelines should consider the lipid-lowering combination therapy as early as possible, preferably up-front, for more effective LDL-C goal achievement and significant reduction of cardiovascular disease outcomes and mortality in high- and very high-risk patients.

2025-02-01·Stroke

Abstract TP13: Effectiveness and safety of direct oral anticoagulation vs. warfarin for primary prevention of stroke and bleeding risk among patients with atrial fibrillation.

作者: Kalra, Kriti ; Hanif, Muhammad ; Jaiswal, Akash ; Shrestha, Abhigan ; Patel, Nirmit ; Jaiswal, Vikash ; Ang, Song Peng ; Sawhney, Aanchal ; Rajak, Kripa ; Danisha, FNU ; Shama, Nishat

Background: Atrial fibrillation (AF) patients carry a high risk of stroke, and treatment related bleeding complications. Evidence for the safety and efficacy of anticoagulation remains sparse with conflicting results. Objective: We sought to investigate the effectiveness and safety of direct oral anticoagulant (DOAC) versus warfarin in atrial fibrillation patients. Methods: We performed a systematic literature search on PubMed, EMBASE, and ClinicalTrials.gov for relevant randomized controlled trials (RCTs) from inspection until July 30th, 2024, without any language restrictions. Odds ratios (OR) and 95% confidence intervals (CI) were pooled using a random-effect model, and a p-value of <0.05 was considered statistically significant. Results: A total of 7 RCTs with 79,001 patients were included (46069 in DOAC and 32932 in the warfarin group) in the analysis. The mean age of the patients in DOAC and the warfarin groups was 72.8 and 72.9 years, respectively. Pooled analysis of primary and secondary endpoints showed that DOAC significantly reduced the risk of stroke or systemic embolism by 18% (OR, 0.82(95%CI: 0.75-0.91), P<0.01), stroke by 19% (OR, 0.81(95%CI: 0.68-0.97), P=0.02), and hemorrhagic stroke by 57% (OR, 0.43(95%CI: 0.33-0.56), P<0.01) when compared with warfarin. However, the risk of ischemic stroke (OR, 0.96(95%CI: 0.78-1.18), P=0.69), major bleeding (OR, 0.84(95%CI: 0.67-1.06), P=0.14) and myocardial infarction (OR, 1.07(95%CI: 0.89-1.28), P=0.45) was comparable between DOAC and the warfarin group of patients. The use of DOACs was associated with lower odds of all-cause mortality (OR, 0.91(95%CI: 0.85-0.97), P<0.01) when compared with the warfarin group of patients. Conclusion: In this comprehensive analysis of randomized controlled trials data, the use of DOACs was associated with reduction in stroke or systemic embolism, hemorrhagic stroke, and all cause mortality, compared with warfarin therapy. Major bleeding risk was comparable between both groups of patients.

项与 Prospect Medical Holdings, Inc. 相关的新闻（医药）

2025-01-16

·医药健闻

GE医疗精准医疗国产化实践基地落户成都；亚虹医药任命徐瑛为首席商务官；百济神州预计今年将盈利 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态 GE医疗精准医疗国产化实践基地暨GE医疗中国先进制造中心授牌仪式1月15日在成都高新区举行。该项目位于成都天府国际生物城，是GE医疗在中国西部打造精准医疗产业集群的又一动作。根据规划，GE医疗下一步计划在川加强人才、技术、规模的投入，将产线从回旋加速器拓展至整个核医学影像链，并加速建设制造中心、供应链中心等项目，进一步推广GE医疗先进制造技术在精准医疗产业链中的应用，打造GE医疗供应链生态圈。 GE医疗宣布与Sutter Health签署了一项为期七年、金额约为10亿美元的合作协议，将为该非营利医疗系统提供人工智能（AI）驱动的医疗技术和软件升级。这是自两年前该公司从通用电气公司（General Electric Co.）分拆以来，医疗技术公司获得的最大订单。这项名为Care Alliance的协议预计将在合作期间产生10亿美元的收入。亚虹医药宣布，任命徐瑛为亚虹医药首席商务官，全面负责公司商业化事务，直接汇报于公司创始人、董事长兼CEO潘柯博士。徐瑛在医药行业拥有超过30年的从业经验，曾任职于辉瑞、葛兰素史克、罗氏、辉凌医药等多家跨国药企，以及绿叶、海正等国内企业。加入亚虹医药之前，徐瑛为意大利阿尔法西格玛集团（Alfasigma）中国区总经理。百济神州首席执行官欧雷强在第43届摩根大通年度医疗健康大会上表示，预计将实现2025年全年经营利润为正，即营业收入大于营业成本、销售费用、管理费用及研发费用之总和。由于创新药研发的“烧钱”属性，百济神州长期处于亏损状态。百济神州业绩的增长目前主要得益于两款已经商业化的肿瘤药物，PD-1肿瘤药替雷利珠单抗（商品名：百泽安）以及BTK抑制剂泽布替尼（商品名：百悦泽）。保诺-桑迪亚(BioDuro)宣布，其位于中国上海张江研发中心的全自动固相肽合成放大实验室正式启用。新的实验室进一步增强了公司的多肽合成能力，以满足全球合作伙伴对高效和可扩展性的多肽开发日益增长的需求。新的公斤级多肽实验室配备了全自动固相肽合成仪、裂解仪和冻干设备，支持高达800毫摩尔的多肽固相合成。它可以支持多种多肽的合成及纯化服务，包括线性多肽、环状多肽和偶联肽（PDC）等。美国最大医院业主的主要租户Prospect Medical Holdings已申请破产，此前多个州监管机构就这家医院运营商的财务困境和旗下设施状况对其施加了压力。这家总部位于洛杉矶的连锁医院表示，将利用破产保护程序重新将重点放在加州的医院运营上，同时继续为其在罗德岛州和宾夕法尼亚州的其他设施寻找买家。产业动态礼来治疗中度至重度活动性克罗恩病的药物已获得美国食品药品管理局(FDA)的批准。克罗恩病是一种炎症性肠病，可导致慢性腹痛。这款由该公司开发、品牌名称为Omvoh的药物目前已在美国获准用于治疗两种类型的炎症性肠病。该药此前已于2023年10月获准用于治疗成人溃疡性结肠炎。礼来（Eli Lilly）将与风险投资公司安德森-霍洛维茨（a16z）联手成立一只新的5亿美元生物技术基金，旨在为潜在的颠覆性科学和行业领导者提供资金支持。礼来和a16z没有具体说明该基金将重点关注哪些疾病领域，只是表示将寻找“治疗平台和尖端技术公司”。该基金将把a16z的采购能力与礼来在研发方面的专业知识和资金结合起来。信达生物宣布其抗紧密连接蛋白18.2（CLDN18.2）抗体-依喜替康偶联物（ADC）IBI343已被中国国家药品监督管理局（NMPA）药品评审中心（CDE）纳入突破性治疗药物（BTD）品种名单，拟定适应症为至少接受过一种系统性治疗的CLDN18.2表达阳性的晚期胰腺导管腺癌。 Stämm宣布，其在德国、瑞士和阿根廷进行的单克隆抗体生产专用连续生物反应器试点研究取得了突破性成果。实现了体积生产率提升至少15倍，并预计将在2025年达到最高50倍。此外，在细胞密度和单位生产率方面持续表现出最高4倍的提升。Bioprocessor是一种即插即用型台式生物反应器，相较于传统的流加补料式系统成本更低，能在减少停机时间的同时保证产品质量，适用于贴壁和悬浮细胞培养。上海市科学技术委员会印发《上海市脑机接口未来产业培育行动方案（2025-2030年）》。其中提出，到2030年前，实现高质量控脑，脑机接口产品全面实现临床应用，打造全球脑机接口产品创新高地，产业链核心环节实现自主可控。系列侵入式、半侵入式脑机接口产品进入医疗器械注册审批阶段，帮助失明患者，部分恢复视觉能力；帮助瘫痪患者，部分恢复全身的触觉感知与运动能力；为难治性癫痫、重度抑郁症等脑疾病，提供新型治疗手段。美国斯坦福大学的科学家利用5000万张标准医学图像和超10亿篇病理学相关文本训练出一种AI模型，命名为马斯克（MUSK），它可以高准确率地预测哪些癌症患者能从免疫疗法中受益，确定癌症复发概率，生存率等。科学家称，马斯克的独特之处在于可将未来更多种数据纳入预训练，这大大增加了数据规模，这将是人工智能帮助医生改善患者能力的重大进步。联系美通社 +86-10-5953 9500 info@prnasia.com

高管变更多肽偶联药物

2024-10-21

·BioSpace

Zai Lab Announces Participation in November and December Investor Conferences

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company’s senior management team will participate in the following investor conferences in November and December 2024: Goldman Sachs APAC Healthcare Corporate Day 2024 Time: November 5-8, 2024 Location: Hong Kong, Hong Kong Jefferies London Healthcare Conference Fireside Chat: Tuesday, November 19, 2024,1:30 p.m. GT Location: Aldwych, London Citi’s 2024 Global Healthcare Conference Time: December 3-5, 2024 Location: Miami, Florida About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide. For additional information about Zai Lab, please visit or follow us at . Contacts Investor Relations: Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (415) 317-7255 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com

2024-09-19

·mobihealthnews

Health tech company Fabric acquires TeamHealth VirtualCare

Healthcare technology and enablement company Fabric announced it has acquired virtual care provider TeamHealth VirtualCare, a virtual care provider that is part of physician practice group TeamHealth. Fabric is a care-enablement company that uses conversational AI to help identify patients' symptoms, then navigate them to the ideal care setting, such as urgent or virtual care and helping schedule primary care visits. The union of Fabric's technology and TeamHealth VirtualCare's provider network will allow Fabric to "deliver operational efficiency, clinical capacity and expanded access for health systems and payers," the company said in a statement. Former health systems that were part of TeamHealth VirtualCare will make the switch to Fabric and become the benefactors of an increased technology offering meant to improve multichannel patient experiences and increase efficiency across virtual and in-person care. Fabric's technology will help to reduce provider work time in virtual settings, lower call center volume and fast-track ER visits by minimizing length of stay. In addition, payers, employers and health systems will have a pathway to Fabric's 50-state network that features virtual behavioral and urgent care options. "This strategic addition expands our reach across payers, employers, and provider organizations," Aniq Rahman, chief executive officer and founder of Fabric, said in a statement. "In conjunction with the acquisition of TeamHealth's virtual care service line, we are now expanding our medical group with additional highly skilled physicians and advanced practice providers with multi-specialty experience, including cardiology, sports medicine, OB/GYN, family medicine, and emergency medicine. Our versatile technology suite and expanded provider network advance our mission to deliver boundless care across client initiatives and clinical business lines." Dr. Jody Crane, chief medical officer for TeamHealth, is optimistic about expanding the long-term partnership with Fabric. "Combining Fabric's technology with our more than 40-year history as the nation's leading physician practice will allow us to advance exceptional innovations in patient care and clinical outcomes," Crane said in a statement. Fabric's acquisition of TeamHealth VirtualCare is the company's fourth in the past 18 months. Other acquisitions include on-demand and asynchronous virtual care company Zipnosis, AI and patient engagement solution firm GYANT and payer and employer solutions provider MeMD, which was previously owned by Walmart. THE LARGER TREND In June, Fabric acquired Walmart's telehealth platform MeMD, a company that provides virtual medical and behavioral health services. Fabric will grow its employer and payer offerings and boost its behavioral health initiatives. The company will also integrate its clinical intelligence and automation products into MeMD. In February, Fabric announced $60 million in Series A funding led by General Catalyst. Also participating in the round were Thrive Capital, GV (Google Ventures), Salesforce Ventures, Vast Ventures, Box Group and Atento Capital. The funding came in the wake of Fabric’s acquisition of GYANT. Also in February, TeamHealth created TeamACO, an ACO that addresses the healthcare requirements of more than 17,000 post-acute care patients in the U.S. In 2022, TeamHealth expanded its presence in the Dallas-Fort Worth area by acquiring Acute Care Transitions, an emergency medicine and advanced care at home telehealth provider. That same year, Crozer Health, a healthcare provider in Delaware County, Pennsylvania, partnered with TeamHealth to include a wide-range of services at Crozer-Chester Medical Center in Upland, Taylor Hospital in Ridley Park, and Delaware County Memorial Hospital in Drexel Hill. As a result of the partnership, patients will benefit from care from TeleHealth hospitalists in the ER or as inpatients. The HIMSS Healthcare Cybersecurity Forum is scheduled to take place October 31-November 1 in Washington, D.C. Learn more and register.

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