English to Chinese: CSR/CSP EN CN
General field: Medical
Detailed field: Medical: Pharmaceuticals | |
Source text - English
1. A Phase I, Randomized, Double
Blind, Placebo Controlled, Parallel Group Study to Assess
the Safety, Tolerability and Pharmacokinetics of Avibactam Alone and in Combination with Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Chinese
Subjects
2. The incidence and character of adverse events in patients taking any medications likely to alter the rate pressure product (e.g., beta blockers, calcium channel blockers) on the day of dosing despite the request to preferent ially withhold these medications, or taking sublingual nitroglycerin despite the specific prohibition of nitroglycerin within 2 hours of either the initial or randomized study, was compared to that in patients who did not take these medications
on the day of dosing.
3. If, at a given time point, 50% or fewer of the plasma concentrations are NQ (non quantifiable), the mean, SD, gmean, gmean±SD, and CV will be calculated by substituting the limit of quantification (LOQ) for values which are NQ. If the calcula tion of the geometric mean minus SD results in a value less than the LOQ, NQ will be displayed.
| Translation - Chinese
1.
关于阿维巴坦单独应用和与头孢他定联合应用在健康中国受试者中进行单次或多次静脉注射的安全性、耐受性和药代动力学情况的 I 期随机、双盲、安慰剂平行对照研究。
2.
研究将两组患者副反应的发生率和特性进行了对照：一组患者包括那些尽管有医嘱建议不应服用但仍在用药当天服用了有可能改变心率或血压的药物（如 β 受体阻滞剂、钙 通道阻滞剂）的患者，以及尽管明令禁用硝酸甘油但仍在预实验或随机试验前后 2 小时内舌下含服了硝酸甘油的患者；另一组为用药当天未使用以上药物的患者。
3.
如果在某一指定时间点上，等于或低于 50% 的血浆浓度为 NQ （不可量化），则用 NQ 值替换最低定量限（ LOQ ）来计算平均数、 SD 、 gmean 、 gmean±SD 和 CV 。如果几何平均数减去 SD 的计算结果值小于 LOQ ，则显示 NQ 。（译注： SD ，标准差 gmean ，几何平均数CV ，变异系数)
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English to Chinese: CMC EN CN
General field: Medical
Detailed field: Medical: Pharmaceuticals | |
Source text - English
1. Rosuvastatin calcium is categorised as ‘highly soluble’ under the Biopharmaceutical Classification System (BCS) and combined with low to moderate proposed doses. This has meant that the desired characteristics of complete and rapid release of the drug substance
from the tablet have been readily achieved. However, some control of particle size is important to ensure a consistent material for pharmaceutical processing and, particularly, to ensure tablet content uniformity where drug concentration in a tablet formulation is low (eg , 2.5 mg and 5 mg tablets). Rosuvastatin calcium drug substance is therefore milled.
2. It was demonstrated that material with a range of 2.6% to 9.8% retained on a 250 μm sieve produced tablets with satisfactory content uniformity and dissolution characte ristics, with no
effect on the flow properties of the powder blends or on the tablet compression performance. It is therefore proposed that a limit of not more than 10% retained on a 250 μm sieve is an appropriate particle size control specification for ro suvastatin calcium. This value is consistent with the mean plus 3 times the standard deviation (9.7%). | Translation - Chinese
1.
在生物药剂学分类系统 ( 中，瑞舒伐他汀钙被归类为 高度可溶 ””，并建议按低至中度剂量联合应用。这意味着正如治疗所需，该药很容易就能快速、完全地从片剂中释放。不过，为了确保药品加工的用料稳定性，尤其是为了确保药物浓度较低的情况下（如 2.5mg 每片或 5mg 每片的片剂）片剂中药物含量的均匀性 ，在一定程度上控制药物颗粒的尺寸很重要。因此，瑞舒伐他汀钙制药过程中要经过碾磨。
2.
结果表明，在 250 μm 粒径的筛网（译注： 60 目）上保留 2.6% 9.8% 的物料，所生产出的片剂具有令人满意的含量均匀性和溶解特性，且不会对混合粉剂的流动性能或药物的压片性能产生影响。因此，建议在 250μm 的筛网上保留不超过 10% 的物料，此限值作为瑞舒伐他汀钙颗粒尺寸的控制指标较为合适。该数值等于平均数加 3 倍标准差 (9.7) |
English to Chinese: Abstract
General field: Medical
Detailed field: Medical: Dentistry | |
Source text - English
Abstract
Purpose: To compare the prosthodontic success, implant success, implant survival and patient centered outcomes of patients restored with mandibular two implant retained overdentures (2-IRODs) supported by either Locator or Novaloc retentive systems.
Methods: This study was designed as an open, prospective, randomized, intra-subject crossover clinical trial on 20 mandibular edentulous patients over follow up period of 2 x 6 months. Prosthodontic restoration was carried on 2 intraforaminal bone level tapered implants 2 months after implantation with full acrylic dentures using either Locator or Novaloc attachment systems. Switch-over between groups was carried out at 6 months.
The primary outcome was the prosthodontic success. Secondary outcomes included prosthodontic retention, mechanical wear, implant survival rate, Oral health related quality of life, perceived general health, patient satisfaction and patient preference.
Results: The implant survival rate over the study duration in both groups was 100%. Prosthetic survival rates were 55.0% and 70.0% in the Locator and Novaloc groups respectively with the difference being non-statistically significant (p=0.3240). Qualitative differences in the success rate and type of prosthodontic adverse events were observed. No differences in any of the patient centered outcomes were detected.
Conclusions: The results of this study indicate that both tested attachment systems represent predictable and successful candidates for the prosthodontic retention of 2-IRODs. Implant survival was 100% independent of the retentive system used. The influence of material combinations of the retentive system between the tested systems on treatment outcome remain inconclusive and require further investigations.
| Translation - Chinese
摘要
目的：比较由Locatorator和Novaloc系统固位的下颌双种植体支持覆盖义齿（2-IROD）修复的修复成功率、种植手术成功率、植体存留率和以患者为中心的结果。
方法：本研究是一项前瞻性随机开放体内交叉临床研究，研究对20名下颌无牙患者进行了2×6个月的跟踪随访。种植术后2个月，在牙槽骨内骨水平的2个锥形种植体上使用Locator或Novaloc附着系统结合全树脂义齿进行牙列修复。在6个月时进行组间切换。
主要结果为修复成功。次要结果包括义齿固位、机械磨损、种植体存留率、与口腔健康相关的生活质量、总体健康状况、患者满意度和患者偏好。
结果：研究期间两组种植体的存留率均为100%。Locator组和Novaloc组的修复成功率分别为55.0%和70.0%，差异无统计学意义（P=0.3240）。研究中观察到两组的成功率和修复不良事件类型存在质的差异。在以患者为中心的治疗结果中未发现任何差异。
结论：研究结果表明，经测试的两种附着系统对2-IRODs的义齿固位效果可以预知也很成功。种植体的存留率与所使用的固位系统100%无关。两组测试系统之间固位系统的用物组合对治疗结果的影响尚无定论，需要进一步研究。
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English to Chinese: New SiHy materials
General field: Medical
Detailed field: Medical: Instruments | |
Source text - English
New silicone hydrogel (SiHy) materials continue to be developed and each contains a unique set of properties. SiHy lenses provide superior oxygen transmissibility over contact lenses made with conventional hydrogel materials. The objective of the DD T2 Contact Lens clinical investigations is to evaluate the performance of DD T2 Contact Lenses when used as intended for daily disposable wear for the optical correction of refractive myopia in persons with non-diseased eyes. In consideration of this, the Sponsor believes that the investigational product, DD T2 Contact Lenses, is a non-significant risk device and the intended use for daily disposable wear in clinical studies in human subjects constitutes non-significant risk device studies. This medical device complies with all legal requirements apart from those requirements that clinical investigations are intended to fulfill. All reasonable precautions have been taken to ensure the health and safety of all study subjects.
In the USA, the FDA has classified soft contact lenses worn for daily wear vision correction as Class II non-significant risk medical devices [21 CFR 886.5925 (b) (1)]; and per 21 CFR 812, non-significant risk device studies using Class II medical devices are subject to ethics committee approval by an IRB prior to study initiation, but not FDA pre-approval.
| Translation - Chinese
新型硅水凝胶（SiHy）材料不断被开发出来，每一种材料都有其独特的性能。与传统水凝胶材料制成的隐形眼镜相比，SiHy镜片具有优越的透氧性。DD T2隐形眼镜临床研究的目的是评估DD T2隐形眼镜在作为日抛镜使用时对无眼病人士的屈光性近视进行光学矫正的性能。鉴于此点，申请人认为，研究产品DD T2隐形眼镜是一种无重大风险的器械，在临床研究中作为日抛镜在人类受试者中使用为非重大风险的器械研究。该医疗产品在符合临床研究要求的同时，还符合各项法律法规。为确保所有实验对象的健康和安全，研究已采取所有合理的预防措施，
在美国，FDA已将日常佩戴矫正视力的软性角膜接触镜归为II类非重大风险医疗器械[21 CFR 886.5925 (b) (1)]；依据21 CFR 812，使用II类医疗器械进行的非重大风险器械研究必须在研究开始之前获得IRB伦理委员会的批准，但无需FDA预先批准。
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