EUCTR2020-004132-22-SE进行中（未招募）1 期
Double-blind randomized acetazolamide trial in normal pressure hydrocephalus - DRAI
ppsala University Hospital0 个研究点目标入组 56 人开始时间: 2020年11月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of idiopathic normal pressure hydrocephalus according to international guidelines
- •2. Age =50 years and = 82 years
- •3. Cognitive function with Mini-Mental State Examination > 20 points or cognitive domain of the iNPH scale =30 points
- •4. MRI image for iNPH defined as callosal angle <95 degrees and dilated lateral ventricles or image as in disproportionately subarachnoid space hydrocephalus (DESH)
- •5. Signed informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 56
排除标准
- •1. Exclusion criteria for MRI examination
- •2. Participation in another medical trial
- •3. Other disease likely to impact the symptoms of the patient
- •4. Wheelchair bound or in need of support when walking
- •5. Reduced kidney function with creatinine GFR < 50
- •6. Reduced liver function: Prothrombin complex > 1.2 or increased alanine transaminase concentrations in plasma 1.5 times above the upper reference value (women > 1.125 mkat/L; men > 1.65 mkat/L).
- •7. Known heart failure
- •8. Low concentrations of electrolytes in blood plasma, or other illness or treatment that may cause significant lowering of electrolyte concentrations according to the investigator
- •9. Angle-closure glaucoma
- •10. Allergy to acetazolamide, sulfonamides, or sulfonamide derivatives
- •11. Treatment with phenytoin, valproate, carbamazepine, lithium, thiazide-diuretics > 25mg/day, acetylsalicylic acid > 100 mg/day, daily use of NSAID or furosemide > 20 mg/day
- •12. Inability to swallow capsules of the same size as the investigational medicinal products (will be tested using empty capsules when the patient is asked to participate in the study)
- •13. Average walking time for the three walking tests <10.5 seconds for men and <11.5 seconds for women
- •14. Average walking time for the three walking tests > 50 seconds
- •15. Inability to comply with the study treatment independently, and a concurrent lack of individuals to help the patient comply with the treatment during the study period
- •16. Females who are not infertile or females of childbearing potential who do not use highly effective birth control. For females of childbearing potential a negative pregnancy test will be documented before inclusion
研究者
相似试验
尚未招募
2 期
Comparative search between HIV medicines in Covid-19COVID-19C01.925.937RBR-6wgwxsyHospital das Clínicas da Universidade Federal de Pernambuco
已完成
不适用
Evaluation of Allium ampeloprasum cream effect for the management of hemorrhoids symptomshemorrhoids.Unspecified haemorrhoids with other complicationsIRCT2014010816143N1Shiraz University of Medical Sciences75
已完成
不适用
Can attention training improve sleep, anxiety, and mood?Mental Health - AnxietyMental Health - DepressionMental Health - Other mental health disordersInsomniaAnxietyDepressionACTRN12616000346471St Vincent's Hospital Sydney66
已完成
不适用
Randomized double-blind controlled trial of patient-controlled epidural analgesia after gynecological abdominal surgery with levobupivacaine 0.125% or ropivacaine 0.2%postoperative painJPRN-UMIN000026931Toho University120
进行中（未招募）
不适用
Effect of deep muscle relaxation on surgical conditions during gastric pull-upoesophageal carcinomaEUCTR2014-002147-18-NLAcademic Medical Center60