Healthy Control Population für PAIS-ME/CFS: Studie Zur Evaluation möglicher Biomarker Und Untersuchungsmethoden für Die PAIS-ME/CFS-Diagnostik Bei Gesunden Probanden
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Personal data
研究概览
简要总结
Using the data from the HelP study, the underlying processes of the diseases ME/CFS and PAIS are to be researched and elucidated. The comparison of affected patients with healthy controls is intended to identify disease-specific patterns that could be related to the development or progression of the disease. The aim is to find a suitable biomarker for diagnostics and to develop therapeutic approaches.
详细描述
The underlying pathomechanisms of the diseases PAIS and ME/CFS are to be investigated and elucidated in more detail. The aim is to establish a cohort of healthy controls at our MRI Chronic Fatigue Center (MCFC). Within this cohort, the measurement instruments used so far in ME/CFS diagnostics will be validated. In addition, data material from this pool should be used for the statistical evaluations of various case-control studies of our center and our cooperation partners in order to find and develop a suitable biomarker for diagnostics and therapeutic approaches for PAIS and ME/CFS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy control subjects without a known medical diagnosis, except: asthma, allergies, neurodermatitis, if this does not require regular medication (self-disclosure)
- •Age: 10 - 25 years
- •Written declaration of consent or, in the case of minors, written declaration of consent from the participants and their legal representatives
排除标准
- •Acute illnesses (e.g. infections) or major injuries
- •Known chronic diseases (including psychological diagnoses) other than those mentioned above
- •Surgery or blood transfusion in the last 3 months
- •No intake of on-demand medication (e.g. painkillers) in the last 7 days before the date of the examination
- •Pregnancy; Breastfeeding
- •Limited legal capacity
结局指标
主要结局
Personal data
时间窗: Measurement is taken at a single time point right after enrollment
Name, date of birth, contact details
Clinical data
时间窗: Measurement is taken at a single time point right after enrollment
Sex, vaccination status, level of education, occupation, smoking and alcohol behavior, other addictive behavior, competitive sports
Physical assessment
时间窗: Measurement is taken at a single time point right after enrollment
weight and height will be combined to report BMI in kg/m\^2
Heart rate
时间窗: Measurement is taken at a single time point right after enrollment
beats per minute
Blood pressure
时间窗: Measurement is taken at a single time point right after enrollment
in mmHg
Questionnaire data
时间窗: Measurement is taken at a single time point right after enrollment
Following questionnaires are rated on a scale: MBSQ, Chalder Fatigue Scale, PedsQL Fatigue, Bell Score, DSQ-PEM, SF-36, PedsQL, EQ5D, PHQ4, Compass31
YSR questionnaire
时间窗: Measurement is taken at a single time point right after enrollment
Open questions and questions to be rated on a scale
Imaging
时间窗: Measurement is taken at a single time point right after enrollment
OCT-A: Imaging of ocular fundus
Full blood count
时间窗: Measurement is taken at a single time point right after enrollment
CRP, Ferritin, Creatinin, GPT and Immunglobuline
Deformability Cytometer
时间窗: Measurement is taken at a single time point right after enrollment
Cell-deformation
Virology
时间窗: Measurement is taken at a single time point right after enrollment
EBV, CMV, HSV1, HSV2 and Sars CoV2 antibodies
Immunology
时间窗: Measurement is taken at a single time point right after enrollment
ANA, Cystatin C, dsDNA Ak
Endocrinology
时间窗: Measurement is taken at a single time point right after enrollment
TPO antibodies
B-cell phenotyping
时间窗: Measurement is taken at a single time point right after enrollment
Analysis of surface antigens using cytometry by time of flights (CyTOF)
Pain threshold
时间窗: Measurement is taken at a single time point right after enrollment
Measuring pressure tolerancy in Newton by means of an algometer at the iliotibial tract, phalanx distalis III, trapezius muscle in triplicates
Orthostasic Tolerance
时间窗: Measurement is taken at a single time point right after enrollment
blood pressure and heart rate are measured during the 10-minute standing test to determine orthostasic tolerance
Grip strength
时间窗: Measurement is taken at a single time point right after enrollment
Hand dynamometer test to assess grip strength in Newton
Smell test
时间窗: Measurement is taken at a single time point right after enrollment
Recognition of different substances
次要结局
未报告次要终点