• Journal of Korean Neurosurgical Society
• /
• 제65권6호
• /
• pp.772-778
• /
• 2022

Objective : Endovascular treatment of large, wide-necked intracranial aneurysms by coil embolization is often complicated by low rates of complete occlusion and high rates of recurrence. A flow diverter device has been shown to be safe and effective for the treatment of not only large and giant unruptured aneurysms, but small and medium aneurysms. However, in Korea, its use has only recently been approved for aneurysms <10 mm. This study aims to compare the safety and efficacy of flow diversion and coil embolization for the treatment of unruptured aneurysms ≥7 mm. Methods : The participants will include patients aged between 19 and 75 years to be treated for unruptured cerebral aneurysms ≥7 mm for the first time or for recurrent aneurysms after initial endovascular coil embolization. Participants assigned to a flow diversion cohort will be treated using any of the following devices : Pipeline Flex Embolization Device with Shield Technology (Medtronic, Minneapolis, MN, USA), Surpass Evolve (Stryker Neurovascular, Fremont, CA, USA), and FRED or FRED Jr. (MicroVention, Tustin, CA, USA). Participants assigned to a coil embolization cohort will undergo traditional endovascular coiling. The primary endpoint will be complete occlusion confirmed by cerebral angiography at 12 months after treatment. Secondary safety outcomes will evaluate periprocedural and post-procedural complications for up to 12 months. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes the aim and design of a multi-center, randomized, open-label trial to compare the safety and efficacy of flow diversion versus traditional endovascular treatment for unruptured cerebral aneurysms ≥7 mm.

• Nuclear Engineering and Technology
• /
• 제55권3호
• /
• pp.1015-1020
• /
• 2023

A multi-layer design is applied to mitigate single event effect (SEE) in a 28 nm System-on-Chip (SoC). It depends on asymmetric multiprocessing (AMP), redundancy and system watchdog. Irradiation tests utilized 70 and 90 MeV proton beams to examine its performance through comparative analysis. Via examining SEEs in on-chip memory (OCM), compared with the trial without applying the multi-layer design, the test results demonstrate that the adopted multi-layer design can effectively mitigate SEEs in the SoC.

• Journal of the Ergonomics Society of Korea
• /
• 제26권4호
• /
• pp.1-7
• /
• 2007

Navigation system or way finding in Wearable computer help disabled and impaired persons and it is impossible to be safe and efficient for drivers as well as pedestrian. Wearable computing situation must be multi-tasking simultaneously and users need minimal attention. In this paper, we used virtual environment as real way-finding similarly. The direction cues of navigation system are investigated as visual only, visual & auditory, and visual & speech. In the paper, the trial demonstrates the difference of performance in detection of directing and performance of motor and subjective satisfaction of user.

• Journal of the Korean Data and Information Science Society
• /
• 제27권2호
• /
• pp.499-510
• /
• 2016

It is very important to select relevant variables in regression models for survival analysis. In this paper, we introduce a penalized variable-selection procedure in multi-level frailty models based on the "frailtyHL" R package (Ha et al., 2012). Here, the estimation procedure of models is based on the penalized hierarchical likelihood, and three penalty functions (LASSO, SCAD and HL) are considered. The proposed methods are illustrated with multi-country/multi-center bladder cancer survival data from the EORTC in Belgium. We compare the results of three variable-selection methods and discuss their advantages and disadvantages. In particular, the results of data analysis showed that the SCAD and HL methods select well important variables than in the LASSO method.

• Archives of Plastic Surgery
• /
• 제42권6호
• /
• pp.721-728
• /
• 2015

Background We conducted this clinical study to compare the efficacy and safety between Neuramis Deep and Restylane in the correction of nasolabial folds. Methods In this phase III, randomized, multi-center, double-masked, matched-pairs, active-controlled trial (ClinicalTrials.gov Identifier: NCT01585220), we evaluated a total of 67 subjects (n=67). All the subjects underwent Neuramis Deep treatment on one side and Restylane on the contralateral side of the bilateral nasolabial folds at a ratio of 1:1. To compare the efficacy of Neuramis Deep and Restylane, we evaluated the Wrinkle Severity Rating Scale scores and those of the Global Aesthetic Improvement Scale. In addition, we compared the safety of Neuramis Deep and Restylane based on adverse events, physical examination, and clinical laboratory tests. Results Neuramis Deep was not inferior in improving the nasolabial folds as compared with Restylane. In addition, there was no significant difference in the efficacy between Neuramis Deep and Restylane. There were no significant differences in safety parameters between Neuramis Deep and Restylane. Conclusions In conclusion, our results indicate that Neuramis Deep may be a safe, effective material for improving the nasolabial folds. However, further studies are warranted to compare the tolerability of Neuramis Deep and Restylane based on histopathologic findings.

• Communications for Statistical Applications and Methods
• /
• 제25권3호
• /
• pp.321-328
• /
• 2018

In clinical trials with repeated measurements, the time-averaged difference (TAD) may provide a more powerful evaluation of treatment efficacy than the rate of changes over time when the treatment effect has rapid onset and repeated measurements continue across an extended period after a maximum effect is achieved (Overall and Doyle, Controlled Clinical Trials, 15, 100-123, 1994). The sample size formula has been investigated by many researchers for the evaluation of TAD in two treatment groups. For the evaluation of TAD in multi-arm trials, Zhang and Ahn (Computational Statistics & Data Analysis, 58, 283-291, 2013) and Lou et al. (Communications in Statistics-Theory and Methods, 46, 11204-11213, 2017b) developed the sample size formulas for continuous outcomes and count outcomes, respectively. In this paper, we derive a sample size formula to evaluate the TAD of the repeated binary outcomes in multi-arm trials using the generalized estimating equation approach. This proposed sample size formula accounts for various correlation structures and missing patterns (including a mixture of independent missing and monotone missing patterns) that are frequently encountered by practitioners in clinical trials. We conduct simulation studies to assess the performance of the proposed sample size formula under a wide range of design parameters. The results show that the empirical powers and the empirical Type I errors are close to nominal levels. We illustrate our proposed method using a clinical trial example.

• Journal of Gastric Cancer
• /
• 제12권1호
• /
• pp.7-12
• /
• 2012

More than ten years have passed since the sentinel node (SN) concept for gastric cancer surgery was first discussed. Less invasive modified surgical approaches based on the SN concept have already been put into practice for malignant melanoma and breast cancer, however the SN concept is not yet placed in a standard position in gastric cancer surgery even after two multi-institutional prospective clinical trials, the Japan Clinical Oncology Group trial (JCOG0302) and the Japanese Society for Sentinel Node Navigation Surgery (SNNS) trial. What is the problem in the clinical application of the SN concept to gastric cancer surgery? There is no doubt that we need reliable indicator(s) to determine with certainty the absence of metastasis in the lymph nodes in order to avoid unnecessary lymphadenectomy. There are several matters of debate in performing the actual procedure, such as the type of tracer, the site of injection, how to detect and harvest, how to detect metastases of SNs, and learning period. These issues have to be addressed further to establish the most suitable procedure. Novel technologies such as indocyanine green (ICG) fluorescence imaging and one-step nucleic acid amplification (OSNA) may overcome the current difficulties. Once we know what the problems are and how to tackle them, we can pursue the goal.

• Journal of the Korean housing association
• /
• 제19권4호
• /
• pp.79-87
• /
• 2008

Snoezelen, multi-sensory stimulation, provides stimulation through the visual, aural, tactile, olfactory, gustatory and proprioceptive senses. Its aim is to be a relaxing, feeling of safety, novelty and stimulation with no expectations for performance. Agitated behavior of people with dementia causes significant problems and distress for cares. The objective of this research study was to test the effects of Snoezelen room on physical and verbal agitated behaviors of people with dementia. Four patients participated five sessions in Snoezelen room of 'F' dementia care facility in Sweden. Assessment instrument was basically used Cohen-Mansfield Agitation Inventory-Short Form to be rated by caregivers on a 5-point frequency scale. Pre-trial and post-trial assessments were carried out during $27^{th}$ Aug.-$27^{th}$ Sept. 2007. Result shows that Snoezelen room has some short-term positive effect on agitated behavior even though there was a considerable variation individuals responded. This result adds to the increasing evidence that Snoezelen could be a therapeutic environment for the elderly with dementia. Further research study, with larger number of participation, and a control group is required to establish more scientific evidence of Snoezelen effects on health outcome.

• Journal of Gastric Cancer
• /
• 제16권3호
• /
• pp.177-181
• /
• 2016

Purpose: The International Organization for Standardization-5fluorouracil (FU) 10 trial found that bolus 5-FU and l-leucovorin was not inferior to S-1 in the treatment of gastric cancer (GC). Continuous 5-FU and the rapid injection of 5-FU have different anti-cancer effects. Thus, bolus 5-FU and l-leucovorin treatment might be useful for oral FU-resistant GC. Materials and Methods: We retrospectively analyzed the medical records of all patients with S-1 or capecitabine-resistant, unresectable, or recurrent GC treated with bolus 5-FU and l-leucovorin between January 2010 and December 2015 at Hokkaido University Hospital. The bolus 5-FU and l-leucovorin regimen consisted of intravenous l-leucovorin ($250mg/m^2/2h$) and bolus 5-FU ($600mg/m^2$) administered once weekly followed by a 2-week rest period; each cycle was repeated every 8 weeks. Results: A total of 14 patients were identified. The disease control rate was 35.7%. The median progression-free survival was 1.6 months (95% confidence interval [CI], 1.3~2.0 months), and the median overall survival was 6.3 months (95% CI, 4.7~7.9 months). No patient died from treatment-related causes. The most common severe adverse event associated with bolus 5-FU and l-leucovorin was neutropenia, which occurred in 21.4% of patients. Conclusions: Bolus 5-FU and l-leucovorin treatment might be useful for oral FU-resistant GC. We are planning a multi-center prospective phase II trial to evaluate the efficacy and safety of bolus 5-FU and l-leucovorin treatment for pre-treated unresectable or recurrent GC to confirm the results of this limited, retrospective study.

• Journal of Preventive Medicine and Public Health
• /
• 제44권3호
• /
• pp.101-110
• /
• 2011

Objectives: Screening for colorectal cancer is considered cost effective, but is underutilized in the U.S. Information on the efficiency of "tailored interventions" to promote colorectal cancer screening in primary care settings is limited. The paper reports the results of a cost effectiveness analysis that compared a survey-only control group to a Centers for Disease Control (CDC) web-based intervention (screen for life) and to a tailored interactive computer-based intervention. Methods: A randomized controlled trial of people 50 and over, was conducted to test the interventions. The sample was 1224 partcipants 50-70 years of age, recruited from Kelsey-Seybold Clinic, a large multi-specialty clinic in Houston, Texas. Screening status was obtained by medical chart review after a 12-month follow-up period. An "intention to treat" analysis and micro costing from the patient and provider perspectives were used to estimate the costs and effects. Analysis of statistical uncertainty was conducted using nonparametric bootstrapping. Results: The estimated cost of implementing the web-based intervention was $40 per person and the cost of the tailored intervention was $45 per person. The additional cost per person screened for the web-based intervention compared to no intervention was $2602 and the tailored intervention was no more effective than the web-based strategy. Conclusions: The tailored intervention was less cost-effective than the web-based intervention for colorectal cancer screening promotion. The web-based intervention was less cost-effective than previous studies of in-reach colorectal cancer screening promotion. Researchers need to continue developing and evaluating the effectiveness and costeffectiveness of interventions to increase colorectal cancer screening.