NL-OMON22233招募中不适用
FESS Effectiveness Study: a multi-centre randomised controlled trial studying the effectiveness of functional endoscopic sinus surgery (FESS) in adult patients with chronic rhinosinusitis/nasal polyps unresponsive to medical therapy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- one
- 入组人数
- 160
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Males or females aged 18 years old can participate.
- •2.Diagnosis CRS with/without NP (definition according to EPOS)
- •3.Prior treatment as defined in the treatment scheme of the protocol for at least 12 weeks
- •4.No prior sinus surgery
- •5.Indication for FESS, both criteria must be met:
- •-RSOM-31 (add score of magnitude of questions 1,2,4,22 result > 9)
- •-CT score > 3 on 1 side at least, judged on a CT-scan made prior to visit 1 and made less than 4 months ago; Lund/Mackay scoring;
- •6. Written informed consent.
排除标准
- •1. Cystic fibrosis;
- •2. Gross immunodeficiency (congenital or acquired);
- •3. Congenital mucociliary problems e.g. primary ciliary dyskinesia (PCD);
- •4. Non-invasive fungal balls and invasive fungal disease;
- •5. Systemic vasculitis and granulomatous diseases;
- •6. Patients who have any serious or unstable concurrent disease;
- •7. Any structural nasal abnormalities (other than polyps or chronic sinusitis), e.g. severe nasal septum deviation;
- •8. Rhinosurgery during the past 6 weeks;
- •9. Systemic steroids 4 weeks before the study;
- •10. Medication affecting nasal mucosa (cyclosporine, ß-blocker, ACE inhibitors, NSAIDs, reserpine, guanethidinge, phenolomine, methyldopa, alfa-adrenoceptor antagonist and chlorpromazine);
- •11. Medication other than trial medication;
- •12. Females who are pregnant or lactating;
- •13. Inability to follow the instructions within this protocol or known inability to attend ALL clinical visits within the intervals stated.
研究者
相似试验
已完成
不适用
FES: FESS Effectiveness Study: a multi-centre randomised controlled trial studying the effectiveness of functional endoscopic sinus surgery (FESS) in adult patients with chronic rhinosinusitis/nasal polyps unresponsive to medical therapyChronic rhinosinusitis (CRS), nasal polyps (NP)Ear, Nose and Throat1. Chronic sinusitis 2. Nasal polypISRCTN87577685Academic Medical Centre (AMC) (Netherlands)160
进行中（未招募）
不适用
A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy StudyMultiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK.EUCTR2005-005751-18-GBCL Biomedicine R&D Unit100
尚未招募
不适用
Multicenter randamized study for evaluating the effect of dantrolene aganst heart failure and arrhythmiaheart failureJPRN-UMIN000022756Yamaguchi University Graduate School of Medicine100
进行中（未招募）
1 期
STUDY TO OPTIMIZE IMMUNOSUPPRESSIVE MEDICATION AS A RESULT OF TWO MARKERS IN PATIENTS WHO RECEIVE A RENAL TRANSPLANTATION OF A LIVE DONORPROPHYLAXIS OF REJECTION AFTER KIDNEY TRANSPLANTATIONMedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disordersEUCTR2017-002293-39-NLORIOL BESTARD164
进行中（未招募）
1 期
STUDY TO OPTIMIZE IMMUNOSUPPRESSIVE MEDICATION AS A RESULT OF TWO MARKERS IN PATIENTS WHO RECEIVE A RENAL TRANSPLANTATION OF A LIVE DONOREUCTR2017-002293-39-ESORIOL BESTARD