DRKS00024906招募中1 期
Clinical outcome and Quality of Life of multimodal treatment of venous malformations of the body - ARTEMIS
Klinikum der Universität München, Campus Großhadern0 个研究点目标入组 300 人开始时间: 2021年7月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 4 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Age: > 4 years, < 70 years
- •- Patients with simple peripheral (=extracranial) venous malformations according to the ISSVA (International Society for the Study of Vascular Anomalies) classification. Each patient and the corresponding diagnosis, is discussed in an interdisciplinary board for vascular anomalies before initiation of treatment.
- •Patients with combined vascular malformations and venous malformations associated with other anomalies according to the ISSVA (International Society for the Study of Vascular Anomalies) classification
- •- Patients with first line therapy or patients with previous alternative therapies in whom the previous treatments did not lead to durable symptom improvement
- •- Previous surgery or sclerotherapy are not an exclusion criterion, but these patients will only be included in case of a therapy-free interval of 12 months
- •- Adults and children will be similarly included
排除标准
- •Patients with VM located in the central nervous system
- •- Patients with VM located in abdominal parenchymal organs and the gastrointestinal tract
- •- Patients with other high-flow vascular anomalies (e. g. vascular tumors) - Patients who have been previously treated by surgery or sclerotherapy within the last 12 months
- •- Patients with concomitant life-limiting diseases (such as cancer)
- •- Patients with acute inflammatory diseases
- •- Patients with contraindications for invasive treatments
- •o Patients with contrast agent intolerance or renal insufficiency (GFR>30ml/min)
- •o Patients with impaired coagulation status:- Platelet count <50.000 / µl
- •- aPTT > 50s
- •- INR > 1,5
- •o Poor general condition with ECOC performance > 1
- •- Pregnant or breast-feeding women
- •- Inability to access the VM lesion due to anatomical or pathoanatomical reason
- •- Inability of the patient/parents to understand or follow the study protocol e.g. due to impaired mental health status
- •- Patients/parents who refuse to give informed consent
研究者
相似试验
招募中
1 期
Clinical outcome and Quality of Life of multimodal treatment of arteriovenous malformations of the bodyQ87Other specified congenital malformation syndromes affecting multiple systemsDRKS00021019Klinikum der Universität München, Campus Großhadern148
已完成
不适用
Effectiveness and mechanisms of a multimodal treatment for low back pain: a pragmatic matched cohort studyM54DorsalgiaDRKS00030389Bundesinstitut für Sportwissenschaft316
进行中（未招募）
不适用
Patient-reported and functional outcomes following ReActiv8 implantable neurostimulatioACTRN12622000555752BackSpace Clinics Pty Ltd.50
已完成
不适用
Assessing the the Efficacy of Multimodal Interventions on Knowledge, Symptoms, Quality of life and Health seeking behavior, among Menopausal age women in selected Institutions of Kottayam District.CTRI/2021/01/030747Jolly Joseph78
已完成
不适用
Observational study on the efficacy of multimodal complex therapy and Viscum album extract in the treatment of patients with advanced lung cancerC34Malignant neoplasm of bronchus and lungDRKS00022891Forschungsinstitut Havelhöhe gGmbH101