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Translation - English AAA is a new compound of protease obstruction medicine.
Effectiveness in postoperative reflux esophagitis is expected due to strong obstruction
action for digestive enzymes especially trypsin and Kimotoripshin.
For basic research, dose dependent improvement showed in postgastrectomy reflux
esophagitis models of rat and dogs. For clinical, initial phaseⅡtrial shows improvement in
subjective symptoms and endoscope findings.
In this trial, there is an additional objective to conduct double-blinded comparative study for
postgastrectomy reflux esophagitis to determine clinically optimal dose for three dosage
50mg, 100mg, and 200mg per/day.
As a result, 50mg per/day was enough dosage for efficacy in subject symptoms for
postgastrectomy reflux esophagitis. However, 100mg or more per/day shows better
improvement rates in endoscopic findings and final overall improvement factor. To ensure a
definite effect, 100mg or more was appropriate dosage.
English to Japanese: Clinical Study protocol
Source text - English • Study Objective – To verify the safety and efficacy of XXX for two-week PRS
in daily wear in patients with myopia and mild myopic astigmatism needing
vision correction.
In a recent single-group clinical trial conducted in Japan, in which the Control device
(XXX lens) was used on a daily wear modality with 2-week PRS, 15.46% of patients
reported corneal epithelial staining at one month. A one-month validation trial on the
investigational device as daily wear was also carried out, although with monthly
replacement schedule, in the US. From this trial, the incidence rate of epithelial staining
for XXX lens was estimated to be 43.28%.
Translation - Japanese 目的–近視および軽度の近視性乱視を有する患者に対し1 枚のレンズの使用期間を2 週間までとしたPRS 用本被験機器XXX 終日装用レンズの安全性と
有効性を確認する。
● Work experience :Clinical Research Associate :Clinical research & regulatory for Gov.authorities such as PMDA&FDA: Cardiology,Ophthalmology
-Clinical Coordinator:Us hospital (Gynecology, Reproductive)
-Licened therapist :Eastern Medicine, sports medicine other physical and massage therapies.
Past Translation project: expertise including( but not limited to)
-Medical device: (Device manuals, speck sheet, marketing brochure, package insert, data
sheet,medical gernals, study reports)
Cardiac device ( Pacemaker, stent, ICD),
Orthopedic device (cement, screws, and other implants)
Ophthalmic device ( Contactlens, lens solution, drops, surgical instruments,intraocular lens)
Respiratory device (Ventilator)
Other devices: Irrigation fluid warming system, electrical toothbrush,etc
-Clinical research and regulatory documents( Study protocol,reports, datas,patient forms, insurance and other documents for condacting a research)
-Statistical Analysis
- Quality assurance, ISO, Pharmaceutical law
-Good clinical research practice(Law)
-Academic seminar materials
-Acanthamoeba species study
-Gynecology related drug study phase 3
Expertise