JPRN-jRCTs051230023招募中Unknown
A prospective, single-group, exploratory study on the efficacy and safety of combined methotrexate and betamethasone eye drops for scleritis
Matsumiya Wataru0 个研究点目标入组 10 人开始时间: 2023年5月19日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •(1) Patients aged between 18 and 70 at the time of informed consent
- •(2) Patients with active inflammation in the sclera
- •Patients with idiopathic non-necrotizing scleritis with a scleritis score of 1 or higher who have a history of steroid eye drops for 2 weeks or more and subsequently have recurrence or prolonged inflammation
- •(3) Males and females who agree to use contraception before and during administration of this drug and for 3 months after discontinuation of this drug, or males and females who are medically judged to be infertile
- •(4) Patients who have shown the consent of agreement with the written informed consent by their own free will after receiving a sufficient explanation for participating in this study.
排除标准
- •Patients who correspond to any of the following are excluded from the study.
- •1. Patients with only posterior or episcleritis of scleritis
- •2. Patients with infectious scleritis
- •3. Patients with severe renal dysfunction (judged by following states)
- •Patients receiving dialysis or glomerular filtration rate (GFR) <30 mL/min/1.73m2
- •4. Patients already taking immunosuppressants or corticosteroids at the time of enrollment
- •5. Patients who appear to be immunosuppressed (e.g., congenital immune deficiency, HIV infection, etc)
- •6. Patients who are pregnant, lactating, or may be pregnant
- •7. Patients with malignant tumors
- •8. Patients who have undergone intraocular surgery or glaucoma surgery in the past, excluding cataract surgery, or who are expected to require surgery during this clinical study
- •9. Patients who have a history of hypersensitivity to methotrexate or betamethasone eye drop
- •10. Patients with significant hematological/lymphatic disorders
- •(1) Patients have a history of myelodysplastic syndrome, aplastic anemia, or blood-cell aplasia
- •(2) Patients have been diagnosed or treated for lymphoproliferative disease within the past 5 years
- •(3) Patients with leukopenia or thrombocytopenia: following criteria should be used for the judgment, and the presence of other complications should be also considered: 1) White blood cell count < 3,000/mm3, 2) Platelet count < 50,000/mm3
- •11. Patients with liver dysfunction
- •(1) Hepatic dysfunction AST>60 (U/L) or ALT>84 (U/L)
- •(2) Complication of acute/chronic active viral hepatitis B or C
- •(3) Liver cirrhosis
- •(4) Other severe liver dysfunction.
- •12. Patients with severe respiratory disorders (refer to the following criteria for judgment)
- •(1) Presence of hypoxemia SpO2<93% in room air (equivalent to PaO2<70 Torr)
- •(2) Restrictive disorder with % VC < 80% in pulmonary function test
- •(3) Presence of advanced pulmonary fibrosis in chest X-ray imaging
- •13. Patients with severe infections
- •14.In addition to the above, the drug is contraindicated for target diseases (systemic diseases: myelosuppression, pleural effusion, ascites. ocular diseases: corneal epithelial erosion or ulcer, viral conjunctival corneal disease, tuberculous eye disease, fungal eye disease, or purulent eye disease, ocular tuberculosis.)
- •15. Other patients who are judged to be inappropriate as research subjects by the principal investigator or co-investigator
研究者
相似试验
招募中
1 期
A single-center, single-group exploratory study to investigate whether one-time administration of mixture of RI colloid and dye is as tolerable as standard separate administration of the two drugs for sentinel lymph node navigation in gastric cancer surgeryGastric cancerJPRN-jRCTs031230237Matsumoto Yasunori10
招募中
4 期
An open-label, single-center, exploratory study of the safety and efficacy of avalglucosidase alfa in patients with non-classic Pompe disease aged >= 5 years.glycogen storage disease type II or acid maltase deficiency10027424Pompe diseaseNL-OMON56788Erasmus MC, Universitair Medisch Centrum Rotterdam6
进行中（未招募）
不适用
The psychosocial impact of haematopoietic stem cell donation on adult related donorsHaematopoietic stem cell donationPsychosocial distressUnmet needsQuality of lifePublic Health - Health service researchBlood - Haematological diseasesMental Health - Studies of normal psychology, cognitive function and behaviourACTRN12617000407392niversity of Queensland41
进行中（未招募）
1 期
The effect of 20 mg ambroxol on artificially induced coughacute cough assouciated with URTIMedDRA version: 20.0 Level: LLT Classification code 10066522 Term: Acute cough System Organ Class: 100000004855EUCTR2017-003980-36-GBHull and East Yorkshire Hospitals NHS Trust14
招募中
不适用
A prospective, explorative cohort study to assess the value of an ex vivo radiosensitivity assay as a BIOmarker of treatment Response in Oropharyngeal Cancer (BIO-ROC).throat cancer10027655oropharyngeal cancerNL-OMON52756Erasmus MC, Universitair Medisch Centrum Rotterdam200