Optimizing Measures for Clinical Trials in Covert Hepatic Encephalopathy
隐性肝性脑病临床试验的优化措施
基本信息
- 批准号:10132309
- 负责人:
- 金额:$ 19.4万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-07-01 至 2023-03-31
- 项目状态:已结题
- 来源:
- 关键词:Abdominal MusclesAddressAdrenergic beta-AntagonistsAdverse eventAlbuminsAmericanAmmoniaAreaAscitesBilirubinBloodBrainCalibrationCaloriesCatabolic ProcessCessation of lifeChronicCirrhosisClinicalClinical TrialsClinical Trials DesignCodeComaComplicationComputersConfusionDataData AnalysesDevelopmentDiagnosisDietDietary InterventionDisorientationElectronic MailEnrollmentExecutive DysfunctionExerciseExposure toFall preventionFeasibility StudiesFocus GroupsGoalsGoldGrantHandHemorrhageHepatic EncephalopathyHospitalizationInpatientsInterventionInterviewInvestigationKnowledgeLethargiesMalnutritionMaster&aposs DegreeMeasuresMentorshipMethodologyMethodsModelingMuscleMuscle functionNutritionalOnline SystemsOutcomeOutpatientsPathway interactionsPatient Outcomes AssessmentsPatient SelectionPatientsPersonal SatisfactionPharmaceutical PreparationsPhysical FunctionPortal HypertensionPositioning AttributeProspective cohortProteinsPublishingRandomized Controlled TrialsResearchResearch PersonnelRetrospective cohortRiskRisk FactorsSeveritiesStructureTalentsTestingText MessagingTimeTrainingTraining ProgramsVoiceWorkabdominal CTarmauthoritybasecareerchronic liver diseaseclinical investigationclinical predictorscognitive changecognitive functioncohortcostdaily functioningdisabilityexecutive functionexercise interventionfallsgrasphealth care service utilizationhealth related quality of lifehigh riskimprovedinattentioninsightmodifiable riskmortalityneurocognitive testneuropsychiatrynovelnutritionpatient orientedpoint of carepredictive modelingpreventprospectiverandomized trialresistance exerciseresponserisk predictionrisk stratificationsarcopeniasuccesstherapeutic targettherapy designtoolvehicular accidentwasting
项目摘要
Optimizing Measures for Clinical Trials in Covert Hepatic Encephalopathy
PI: Elliot B. Tapper, MD
Among all complications of cirrhosis, none is more devastating than hepatic encephalopathy (HE). Although it
will afflict up to 40% of patients with cirrhosis, HE has few dedicated researchers. A spectrum of
neuropsychiatric disability, HE ranges in severity from covert (deficits in executive function) to overt (confusion,
even coma). Even covert HE – the earliest stage – is independently associated with repeated hospitalization,
falls, motor vehicle accidents and death. Unfortunately, strategies to prevent the development HE are limited.
Furthermore, investigations of potential therapies are complicated by limited knowledge of both the clinical
predictors of HE and impact on patient well-being and daily functions. This grant proposes to close these gaps.
The training program aims to prepare the applicant for a career vested in identifying risk factors for HE, and in
designing interventions to prevent HE and to improve patient well-being. A master's degree in clinical
investigation with targeted additional courses will provide training in clinical trial design, calibration of patient
reported measures for clinical trials, and longitudinal data analysis to develop clinical predictive models. The
mentorship team assembled is diverse and talented, including Dr. Anna Lok (a clinical trialist and content
expert), Dr. Jasmohan Bajaj (an authority on HE and clinical trials), Dr. Noelle Carlozzi (a neuropsychologist
with expertise in mixed-methodology), and Dr. Susan Murphy (a trialist with a focus on interventions for frail
patients). In research aim 1, we will determine the most important domains of health related quality of life
(HRQOL) for patients with covert HE. In Aim 2, we will analyze a cohort of 300 cirrhosis patients without HE
followed for up to 4 years to determine the modifiable risk factors for HE and to develop predictive models for
HE and falls. In Aim 3, we will launch a pilot intervention aimed at the improvement of HRQOL and prevention
of falls in patients with covert HE using a web-based platform that co-ordinates a combination of text-message,
email and interactive-voice response to deliver structured encouragement to meet nutritional and exercise
goals aimed at improving sarcopenia. By the conclusion of the K23, the applicant will be positioned for
academic success with a niche in an important complication of cirrhosis and providing necessary preliminary
data for an R01 supporting a larger, randomized trial.
隐匿性肝性脑病临床试验的优化措施
PI:Elliot B.马里兰州塔珀
在肝硬化的所有并发症中,没有一种比肝性脑病(HE)更具破坏性。虽然
将折磨高达40%的肝硬化患者,HE几乎没有专门的研究人员。的光谱
神经精神残疾,HE的严重程度从隐性(执行功能缺陷)到显性(混乱,
甚至昏迷)。即使是隐性HE -最早期-也与反复住院独立相关,
福尔斯、机动车事故和死亡。不幸的是,防止HE发展的策略是有限的。
此外,对潜在疗法的研究由于对临床和病理学的知识有限而变得复杂。
HE的预测因素以及对患者健康和日常功能的影响。这笔赠款旨在弥补这些差距。
该培训计划旨在为申请人的职业生涯做好准备,以确定HE的风险因素,
设计干预措施以预防HE并改善患者健康。临床医学硕士学位
有针对性的额外课程的调查将提供临床试验设计,患者校准
报告临床试验的措施和纵向数据分析,以开发临床预测模型。的
导师团队成员多元化,才华横溢,包括安娜洛克博士(临床试验和内容
专家),Jasmohan Bajaj博士(HE和临床试验的权威),Noelle Carlozzi博士(神经心理学家
具有混合方法学方面的专业知识)和Susan Murphy博士(一位专注于脆弱人群干预的试验者)
患者)。在研究目标1中,我们将确定健康相关生活质量的最重要领域
(HRQOL),用于隐性HE患者。在目标2中,我们将分析300名无HE的肝硬化患者队列
随访长达4年,以确定HE的可改变风险因素,并建立预测模型,
他和福尔斯。在目的3方面,我们会推行一项先导计划,以改善健康相关生活质量和预防
的福尔斯在隐性肝性脑病患者使用基于网络的平台,
电子邮件和交互式语音响应,提供结构化的鼓励,以满足营养和锻炼
目的是改善肌肉减少症。到K23结束时,申请人将定位于
学术上的成功与一个小生境的重要并发症肝硬化,并提供必要的初步
R 01的数据支持更大的随机试验。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Elliot Tapper其他文献
Elliot Tapper的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Elliot Tapper', 18)}}的其他基金
Optimizing Measures for Clinical Trials in Covert Hepatic Encephalopathy
隐性肝性脑病临床试验的优化措施
- 批准号:
10382474 - 财政年份:2019
- 资助金额:
$ 19.4万 - 项目类别:
相似海外基金
Rational design of rapidly translatable, highly antigenic and novel recombinant immunogens to address deficiencies of current snakebite treatments
合理设计可快速翻译、高抗原性和新型重组免疫原,以解决当前蛇咬伤治疗的缺陷
- 批准号:
MR/S03398X/2 - 财政年份:2024
- 资助金额:
$ 19.4万 - 项目类别:
Fellowship
CAREER: FEAST (Food Ecosystems And circularity for Sustainable Transformation) framework to address Hidden Hunger
职业:FEAST(食品生态系统和可持续转型循环)框架解决隐性饥饿
- 批准号:
2338423 - 财政年份:2024
- 资助金额:
$ 19.4万 - 项目类别:
Continuing Grant
Re-thinking drug nanocrystals as highly loaded vectors to address key unmet therapeutic challenges
重新思考药物纳米晶体作为高负载载体以解决关键的未满足的治疗挑战
- 批准号:
EP/Y001486/1 - 财政年份:2024
- 资助金额:
$ 19.4万 - 项目类别:
Research Grant
Metrology to address ion suppression in multimodal mass spectrometry imaging with application in oncology
计量学解决多模态质谱成像中的离子抑制问题及其在肿瘤学中的应用
- 批准号:
MR/X03657X/1 - 财政年份:2024
- 资助金额:
$ 19.4万 - 项目类别:
Fellowship
CRII: SHF: A Novel Address Translation Architecture for Virtualized Clouds
CRII:SHF:一种用于虚拟化云的新型地址转换架构
- 批准号:
2348066 - 财政年份:2024
- 资助金额:
$ 19.4万 - 项目类别:
Standard Grant
The Abundance Project: Enhancing Cultural & Green Inclusion in Social Prescribing in Southwest London to Address Ethnic Inequalities in Mental Health
丰富项目:增强文化
- 批准号:
AH/Z505481/1 - 财政年份:2024
- 资助金额:
$ 19.4万 - 项目类别:
Research Grant
ERAMET - Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
ERAMET - 快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
- 批准号:
10107647 - 财政年份:2024
- 资助金额:
$ 19.4万 - 项目类别:
EU-Funded
BIORETS: Convergence Research Experiences for Teachers in Synthetic and Systems Biology to Address Challenges in Food, Health, Energy, and Environment
BIORETS:合成和系统生物学教师的融合研究经验,以应对食品、健康、能源和环境方面的挑战
- 批准号:
2341402 - 财政年份:2024
- 资助金额:
$ 19.4万 - 项目类别:
Standard Grant
Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
- 批准号:
10106221 - 财政年份:2024
- 资助金额:
$ 19.4万 - 项目类别:
EU-Funded
Recite: Building Research by Communities to Address Inequities through Expression
背诵:社区开展研究,通过表达解决不平等问题
- 批准号:
AH/Z505341/1 - 财政年份:2024
- 资助金额:
$ 19.4万 - 项目类别:
Research Grant