NCT05538962已完成不适用
Longitudinal Monitoring of Inflammation in Cirrhosis
Hunter Holmes Mcguire Veteran Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2022年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
Longitudinal monitoring of inflammation using skin devices may help predict outcomes compared to traditional blood draws
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •Inclusion Criteria:
- •Age >18 years
- •Able to give consent
排除标准
- •Unable/unwilling to consent
- •Chronic diseases
- •Unable to come in daily or be available daily for 3 days.
- •Outpatients with Cirrhosis:
- •Inclusion criteria:
- •Age >18 years
- •Able to give consent
- •Cirrhosis defined by any one of the following
- •Cirrhosis on liver biopsy or transient wave elastography
- •Nodular liver on imaging
- •Endoscopic or radiological evidence of varices in a patient with chronic liver disease
- •Platelet count <150,000/mm3 and AST/ALT ratio >1 in a patient with chronic liver disease
- •Patients with frank decompensation (ascites, HE, variceal bleeding, hepato-pulmonary syndrome)
- •Exclusion criteria:
- •Unable/unwilling to consent
- •Unclear diagnosis of cirrhosis
- •Unable to come in daily or be available daily for 3 days.
- •Inflammatory bowel disease or other diseases that require immunosuppressive therapy use
- •Inpatients with Cirrhosis:
- •Inclusion criteria:
- •Age >18 years
- •Able to give consent
- •Cirrhosis defined by any one of the following
- •Cirrhosis on liver biopsy or transient wave elastography
- •Nodular liver on imaging
- •Endoscopic or radiological evidence of varices in a patient with chronic liver disease
- •Platelet count <150,000/mm3 and AST/ALT ratio >1 in a patient with chronic liver disease
- •Patients with frank decompensation (ascites, HE, variceal bleeding, hepato-pulmonary syndrome)
- •Exclusion criteria:
- •Unable/unwilling to consent
- •Unclear diagnosis of cirrhosis
- •Unable to be seen daily or able to come in daily for 3 days (if discharged in between)
- •Inflammatory bowel disease or other diseases that require immunosuppressive therapy use
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 3 days
We will study whether subjects have any issues or adverse events related to the sensor
次要结局
- Ability to detect inflammatory markers (TNF, IL-1b, IL-6 and CRP) using skin sensor compared to blood values(3 days)
- Linkage of skin inflammatory markers (TNF, IL-6, IL-1b and CRP) with quality of life(3 days)
- Linkage of inflammatory markers (TNF, IL-6, IL-1b and CRP) with cognitive testing(3 days)
- Linkage of inflammatory markers with MELD score(3 days)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
Capsule & Omics for pRedicting Exacerbation of Crohn's DiseaseCrohn's DiseaseNCT06362174Sheba Medical Center62
撤回
不适用
Non-endoscopic Tracking of Disease Activity in Eosinophilic EsophagitisEosinophilic EsophagitisNCT03834298University of Colorado, Denver
进行中（未招募）
不适用
Pilot Study of the Physiological Effects of an Integrative Medicine Approach in Irritable Bowel SyndromeIrritable Bowel SyndromeNCT03370614Thomas Jefferson University50
已完成
不适用
Identification of Microcirculation and Inflammation After Minimal-invasive Osteosynthesis of the Proximal FemurLevel of PainNCT01264172RWTH Aachen University50
招募中
不适用
Predictive Biomarker for Endoscopic Therapy in Chronic PancreatitisChronic PancreatitisNCT06267365NYU Langone Health100