The purpose of this study is to find out if reSET, an FDA authorized mobile therapeutic, is effective in treating stimulant use disorder and helping keep HIV viral load suppression stable among men who have sex with men who are living with HIV and have a stimulant use disorder.

开始日期2025-01-21

申办/合作机构

University of Miami

[+1]

NCT05862519

/ Active, not recruitingN/A

A Single-Group, Open-Label Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy

This study is to evaluate the efficacy of four supplements designed to help participants get ready for sexual intimacy through improving digestion, weight management, sexual drive and stamina, and physical endurance during workouts and overall mood and quality of life. This study will be conducted as a single group, virtual trial, in which all participants will take all four supplements and complete online questionnaires. Participants will take the indicated supplements for the indicated amounts of time over 12 weeks. Questionnaires will be completed at baseline, and then at indicated times throughout the trial.

开始日期2023-03-14

申办/合作机构-

NCT05451589

/ RecruitingN/AIIT

Improving Physical and Psychosocial Functioning in Underserved Older Adults During the COVID-19 Pandemic: A Community Health Worker-Led Intervention

The heightened vulnerability to COVID-19 of African American older adults in Detroit, Michigan and other marginalized communities is linked to systemic racism experienced over the life course. Structural inequities also magnify the pandemic's impact on older adults' physical and psychosocial functioning. Many older adults in Detroit, burdened by poor health even before the pandemic, face a downward spiral of increased distress, reduced physical and social activity, and physical deconditioning. RESET (Re-Engaging in Self-care, Enjoying Today) is a self-management and resilience-building intervention led by community health workers (CHWs) at the Detroit Health Department (DHD). The central hypothesis of this study is that RESET, with components that include group telephone calls, a podcast series, and activity trackers, will improve psychosocial and physical functioning at 2 and 8 months. Specific aims are: 1) With input from a Community Advisory Board, modify RESET for group delivery and refine content after testing in a mini-pilot (n=10). 2) Conduct a randomized, controlled trial to assess the impact of RESET (compared to a one-time /telephone wellness check) on PROMIS-29 Psychosocial Score (a weighted combination of distress, fatigue, pain, social participation and sleep) among 456 primarily African American older adults age 50 and over who are at elevated risk of poor functioning. 3) Collect qualitative (interview) data from participants and other stakeholders, and use this data to better understand trial results, as well as to assess community impact and inform a dissemination toolkit.

开始日期2023-03-01

申办/合作机构

University of Michigan

[+1]

100 项与茴拉西坦相关的临床结果

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100 项与茴拉西坦相关的转化医学

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100 项与茴拉西坦相关的专利（医药）

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项与茴拉西坦相关的文献（医药）

2025-05-01·Journal of Industrial and Engineering Chemistry

ZnO/Organic superlattice with phase composite structure for enhanced thermoelectric performance at low temperature

作者: Kim, Chaerim ; Palani, Indirajith ; Sung, Myung Mo ; Mo Sung, Myung ; Ji, Hyeonseok ; Park, Jaeyoung ; Giang Pham, Hoang ; Pham, Hoang Giang ; Cho, Sangho

Semiconducting metal oxides, such as zinc oxide (ZnO), are gaining recognition for thermoelec. applications due to their temperature stability, availability, eco-friendliness, and cost-effectiveness.However, ZnO faces challenges in achieving high ZT value due to its low carrier concentration and high thermal conductivityTraditional methods, like doping and defect engineering, have shown limited success in overcoming these challenges.In this study, we introduce a unique superlattice structure with a phase-composite composition that significantly decreases thermal conductivity through enhanced phonon scattering while maintaining the power factor by inducing new resonant conducting states near the mobility edge.By optimizing nanolayer thickness and doping concentration, we achieved a remarkable power factor of 14.6 μW cm^-1 K^-2 and reduced thermal conductivity to ∼1.97 W m^-1 K^-1 at room temperature in samples with 6 nm-thick ZnO nanolayers fabricated at 100 °C.This leads to a ZT value of ∼0.22 at 300 K, the highest among metal oxide thermoelec. materials at low temperatures, which further increases to ∼0.55 at 510 K.These findings demonstrate the potential of hybrid superlattices for efficient low-temperature thermoelec. applications.

2025-02-01·Chinese Journal of Chemistry

Enabling Access to 3‐gem‐Difluorovinyl Lactams via Zn‐Mediated Sequential Single Electron Reductive Hydrodehalogenation

作者: Yin, Jiawen ; Liu, Xuran ; Zhang, Juanjuan ; Li, Shuaikang ; Hu, Weigao ; Zheng, Jia

Comprehensive SummaryHerein, we describe a direct route for the synthesis of 3‐gem‐difluorovinyl lactams through Zn‐mediated reductive hydrodehalogenation. Importantly, by using inexpensive deuterium oxide (D2O), the high value‐added vicinal dideuterated gem‐difluoroalkenes with excellent deuterium (D) incorporation were prepared. Mechanism studies indicated a successive single electron transfer process: the reaction initially undergoes hydrodechlorination to give the intermediate α‐trifluoromethylidene lactams, which are then activated by the in‐situ generated zinc cations and reduced to the desired product via hydrodefluorination.

2024-12-01·Chemical Engineering Journal

An injectable extracellular matrix-mimicking conductive hydrogel for sequential treatment of ischemic stroke

作者: Zhang, Wen ; Guo, Wen ; Wu, Dongdong ; Wang, Zhicun ; Hu, Cheng ; Wang, Yue ; Kwong Cheng, Chak ; Wang, Yunbing ; Bai, Long ; Luo, Qiuhao

Ischemic stroke (IS), the primary health and life threat, frequently results in significant neurol. impairment.Current research on IS treatment concentrates mainly on modulating the inflammatory microenvironment, often overlooking the significance of elec. fields in brain tissue regeneration.Developing microenvironment-responsive conductive hydrogel strategies for IS treatment presents a considerable challenge.Achieving a balance between ensuring hydrogel stability for sustained conductivity and a swift response to inflammation is a complex tradeoff.In this work, we innovatively grafted polyaniline-aminobenzene sulfonic acid-aminophenyl boronic acid onto gelatin (GM), which allows GM to engage in crosslinking reactions, forming a stable, multi-conductive hydrogel network.To enhance microenvironmental regulation and sequential treatment, pluronic F-127 grafted with lipoic acid was used to encapsulate aniracetam into PSA NPs, which were then embedded into the HA/GM/PSA hydrogel.Within the inflammatory microenvironment, boronate bonds break, releasing PSA NPs that reshape the environment while the hydrogel maintains its conductivityPhys. and electrochem. characterizations of the hydrogels revealed that they closely match the modulus (1-1.3 kPa) and conductivity (0.93 mS/cm) of brain tissue.Moreover, both in vitro and in vivo studies demonstrated that the hydrogels provide excellent antioxidant effects, anti-inflammatory functions, promote vascular regeneration, and mitigate neuronal apoptosis.Collectively, this strategy advances brain tissue repair following IS by synergistically enhancing long-term conductivity and rapid microenvironment remodeling.

项与茴拉西坦相关的新闻（医药）

2024-03-18

·佰傲谷BioValley

数字疗法企业裁员、卖身

近日，美国的数字疗法企业Better Therapeutics宣布将缩减业务、裁员，并为公司剩余资产寻找买家。公司目前处于退市的边缘，但是上周公司董事会没有选择推出重新遵守股市交易规则的计划，而是要求其退市。此消息放出后，公司的股票当天暴跌80%。数字疗法于2010年在美国有了雏形，通过软件程序来向患者提供基于治疗措施或干预措施。据《2022年全球数字疗法产业报告》，2020年全球数字疗法市场规模已达35亿美元。Better成立于2015年，公司使用经临床验证的、FDA监管的软件来改变导致心脏代谢疾病的行为，以改善生活治疗，较少持续的药物需求，并降低成本。2021年，Better借助“数字疗法第一股”Pear Therapeutics上市的东风上市。但是成于此，败也此。2023年4月，Pear Therapeutics申请破产并关闭运营，Bette也将很快步其后尘。2021年12月，Pear以110亿人民币的价格登陆纳斯达克，被业内誉为“数字疗法第一股”。但是上市一年后，百一估值就化为泡影。在申请破产保护之前，Pear共有三款数字疗法产品获批上市，分别针对药物使用障碍（ReSET）、阿片类药物使用障碍（ReSET-O）和慢性失眠（Somryst）。2017年，Pear推出的首款数字疗法产品ReSET通过FDA审批，成为官方认证的“世界上第一款数字疗法”。但是上市后，就开始走下坡路。2022年度，Pear营业亏损为1.234亿美元，收入仅为1270万美元。股价也从9美元左右跌至不足2美元。截止申请破产前，Pear的股价从9美元跌至0.22美元，市值蒸发一百多亿。与Pear相比，Better的情况更加艰难，目前还没有上市的产品。Better目前的产品线包括4款产品——针对治疗2型糖尿病的BT-001、针对高血压的BT-002、针对高脂血症的BT-003和针对非酒精性脂肪肝的BT-004。目前只有BT-001管线处于关键性临床阶段，BT-002和BT-003仍在试点研究阶段，BT-004处于发现阶段。2023年7月，公司的AspyreRx项目获得FDA新的临床许可，为高血糖患者提供数字疗法，同时一项临床研究表明，该项目改善了患者的血压、体重和生活质量。此外，今年2月份，Better的另一项针对晚期肝病的数字疗法获得了FDA的突破性疗法认证。但是随着行业龙头Pear的前车之鉴，Better似乎也开始不被看好，关门卖身可能是迫不得已的选择。参考来源：1.https://www.fiercebiotech.com/medtech/digital-diabetes-app-maker-better-therapeutics-shutters-operations-lays-staff2.https://www.bettertx.com/pipeline/本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处·····

财报突破性疗法加速审批高管变更

2023-04-13

·生物制药小编

“数字疗法第一股”Pear Therapeutics申请破产

在宣布将开始寻找战略替代方案不到一个月后，数字疗法先驱Pear Therapeutics决定走项破产之路。根据该公司最近向美国证券交易委员会提交的文件中披露，包括首席执行官Corey McCann在内的几乎所有员工(总共170人，占92%)都将被解雇，剩下的15名员工在法院的监督下，负责进行公司资产的出售交易。Pear于2013年成立，是一家基于软件的数字疗法平台提供商，致力于处方数字疗法（PDT）的研发工作。Pear已经向市场成功推出了三种处方数字疗法。2017年，Pear推出的首款数字疗法ReSET通过FDA审批，成为官方认证的“世界上第一款数字疗法”。2018年，Pear推出其第二款数字疗法reSET-O，用于治疗阿片类药物使用障碍症。2020年推出用于治疗慢性失眠的数字疗法Somryst。此外，Pear旗下还有14个在研产品，覆盖精神病学、神经病学、胃肠、肿瘤学和心血管等多个领域。因为在数字疗法领域的领先地位，Pear成立之后备受资本青睐，先后完成8轮融资，获得了包括软银、淡马锡等知名风投机构的支持，2021年12月，Pear通过SPAC形式登陆纳斯达克，被业内誉为“数字疗法第一股”。而在闯过了艰难的监管关卡后，处方数字疗法面临的最大挑战则是商业规模化。一方面，数字疗法很像药品，有着较为严格的临床要求，需要有类似药品的功效才能获得市场的认可。但另一方面，处方类数字疗法的有效性受到医生投入的精力、病人的依从性和医疗制度本身的完善性等诸多因素的影响，任一环节的缺失，都会使得整个产品的疗效很难体现，最终无法说服用户继续使用。Corey McCann也表示很难让客户（保险公司）为其产品买单是导致Pear破产的关键原因。Pear在一份证监会的文件中提到，目前美国医疗保险并未把处方数字疗法涵盖在内。2022年，Pear的数字疗法产品开出了4.5万张处方，但只有约一半付费，而且公司仅能收取其中41%的费用。2022年度，Pear营业亏损1.234亿美元，收入仅为1270万美元。为了控制成本，去年Pear进行了两轮裁员，分别裁掉了25人和59人，以期节约超过1000万美元的成本。不过，两番裁员也没能让Pear摆脱困境，在2022年生物科技资本寒冬之下，数字疗法的艰难推广让公司也无力支撑下去，Pear的现金流已经宣告枯竭，截至2022年底，Pear的现金和现金等价物总计4830万美元。今年3月17日，Pear寻求战略性解决方案（strategic alternatives），包括潜在的合并、出售、资产剥离或者额外融资。而在申请破产保护前，Pear委托的的投资银行MTS Health Partners已经接触了140多家潜在买家，其中24家公司准备签署保密协议。不过，在评估所有选项后，Pear最终还是选择申请了破产保护。参考出处：https://www.sec.gov/ix?doc=/Archives/edgar/data/1835567/000183556723000018/pear-20221231.htmhttps://xueqiu.com/S/PEAR/247063450https://xueqiu.com/4171822787/244884657https://endpts.com/digital-therapeutics-maker-pear-files-for-bankruptcy-lays-off-170-staffers-including-ceo/

抗体药物偶联物财报生物类似药

2023-02-27

·BioSpace

Pear Therapeutics to Participate in 43rd Annual Cowen Healthcare Conference

BOSTON--(BUSINESS WIRE)-- Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced the Company will participate in the 43rd Annual Cowen Healthcare Conference being held March 6-8, 2023 in Boston. Corey McCann, M.D., Ph.D., President and CEO, will represent the Company in an analyst-led fireside chat on Monday, March 6 at 9:10 a.m. Eastern Time. A live audio webcast can be accessed by clicking here and will be made available in the Investors section of Pear’s website at . A replay of the webcast will be available on Pear’s website for up to 30 days following the live presentation. About Pear Therapeutics Pear Therapeutics, Inc., which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs). Pear aims to redefine care through the widespread use of clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst® for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at .

突破性疗法

100 项与茴拉西坦相关的药物交易

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