UI14SDF100CW is a chewable tablet of sildenafil citrate, which was developed to improve compliance through convenience of administration. The purpose of this study was to compare the pharmacokinetic (PK) properties of sildenafil citrate chewable tablets (UI14SDF100CW) and conventional sildenafil citrate film-coated tablets ($Viagra^{(R)}$, Pfizer). A randomized, open-label, single dose, two-treatment, two-period, two-way crossover study was conducted in 60 healthy male volunteers. In each period, the subjects received a single oral dose of UI14SDF100CW or $Viagra^{(R)}$ (both tablets contain 140.45 mg of sildenafil citrate, which is equivalent to 100 mg of sildenafil). Serial blood samples were collected up to 24 h post-dose for PK analysis. The plasma concentration of sildenafil was determined using a validated HPLC-MS/MS assay. PK parameters of sildenafil were calculated using non-compartmental methods. The plasma concentration-time profiles of sildenafil in both formulations were similar. For UI14SDF100CW, the $C_{max}$ and $AUC_{last}$ of sildenafil were $1068.69{\pm}458.25$ (mean${\pm}$standard deviation) mg/L and $3580.59{\pm}1680.29h{\cdot}mg/L$, and the corresponding values for $Viagra^{(R)}$ were $1146.84{\pm}501.70mg/L$ and $3406.35{\pm}1452.31h{\cdot}mg/L$, respectively. The geometric mean ratios (90% confidence intervals) of UI14SDF100CW to $Viagra^{(R)}$ for $C_{max}$ and $AUC_{last}$ were 0.933 (0.853-1.021) and 1.034 (0.969-1.108), respectively, which met the bioequivalence criteria of Korean regulatory agency. In conclusion, UI14SDF100CW and $Viagra^{(R)}$ showed similar PK properties. Therefore, UI14SDF100CW can be an alternative to sildenafil for the treatment of erectile dysfunction, providing better compliance.
The occurrence and intensity of wildfires are increasing with climate change. Emissions from forest fire smoke are recognized as one of the major causes affecting air quality and the greenhouse effect. The use of satellite product and machine learning is essential for detection of forest fire smoke. Until now, research on forest fire smoke detection has had difficulties due to difficulties in cloud identification and vague standards of boundaries. The purpose of this study is to detect forest fire smoke using Level 1 and Level 2 data of Geostationary Environment Monitoring Spectrometer (GEMS), a Korean environmental satellite sensor, and machine learning. In March 2022, the forest fire in Gangwon-do was selected as a case. Smoke pixel classification modeling was performed by producing wildfire smoke label images and inputting GEMS Level 1 and Level 2 data to the random forest model. In the trained model, the importance of input variables is Aerosol Optical Depth (AOD), 380 nm and 340 nm radiance difference, Ultra-Violet Aerosol Index (UVAI), Visible Aerosol Index (VisAI), Single Scattering Albedo (SSA), formaldehyde (HCHO), nitrogen dioxide (NO2), 380 nm radiance, and 340 nm radiance were shown in that order. In addition, in the estimation of the forest fire smoke probability (0 ≤ p ≤ 1) for 2,704 pixels, Mean Bias Error (MBE) is -0.002, Mean Absolute Error (MAE) is 0.026, Root Mean Square Error (RMSE) is 0.087, and Correlation Coefficient (CC) showed an accuracy of 0.981.
Boram, Lee;Sookjin, Pyo;Ae-Ran, Kim;Eunbin, Kwag;Jang-Gi, Choi;Hwaseung, Yoo;Hwan-Suck, Chung;Jongkwan, Jo
Herbal Formula Science
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v.30
no.4
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pp.241-248
/
2022
Objective : The purpose of this trial is to observe the preliminary effects of Salvia plebeia (SP) extract on quality of life in patients with solid cancer. Methods : This is a prospective, open-label, single-arm, and single-dose clinical trial. Twenty participants who have been diagnosed with solid cancer between the ages of 20 and 65 will be included. All participants will be administered SP granules for 12 weeks. Data will be collected at 4, 8, and 12 weeks after enrollment. The primary outcome is quality of life, using the Korean version of the Functional Assessment Cancer Therapy-General questionnaire. Secondary outcomes include tumor markers in blood tests for each cancer type, soluble programmed death-ligand 1, the percentage of natural killer cells among lymphocytes, ratio of T-helper and T-suppressor cells, ratio of total T, T-helper, T-suppressor, and B cells in lymphocytes, level of C-reactive protein, and tumor size via radiology examination. Safety will be assessed by clinical laboratory tests and monitoring of adverse events. Discussion : This study aims to observe the effects of an oral administration of SP preparations in patients with solid cancer on changes in quality of life and an improvement in immune function. It is expected to provide objective evidence of the effect and safety of SP for patients with solid cancer. Trial registration: KCT0007315 (Clinical Research Information Service)
Boram Lee;Min-Jin Cho;Young-Eun Choi;Ojin Kwon;Mi Young Lim;Seok-Jae Ko;So-yeon Kim;Yongjoo Kim;Donghyun Nam;Dong-Jun Choi;Jun-Hwan Lee;Jae-Woo Park;Hojun Kim
The Journal of Internal Korean Medicine
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v.43
no.6
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pp.1105-1121
/
2022
Objectives: The purpose of this study is to explore the effectiveness and safety of frequently used clinical herbal medicines (Yijung-tang [Lizhong-tang, LJT], Pyeongwi-san [Pingwei-san, PWS], and Shihosogan-tang [Chaihu Shugan-tang, SST]) in patients with functional dyspepsia (FD) when administered according to herbal medicine and Korean medicine pattern identification. The results of this study will be used to standardize the diagnostic instrument used in Korean medicine and to investigate biomarkers of Korean medicine pattern identification. Methods: This study will be a randomized, assessor-blind, 3-arm, parallel, open-label, multi-center clinical trial. A total of 300 FD participants will be recruited from 3 Korean medical hospitals and assigned to the LJT (n=100), PWS (n=100), and SST (n=100) groups according to FD pattern identification. The patients will take the medication for 8 weeks, 3 times a day, before or between meals. The primary outcome will be total dyspepsia symptom (TDS) and the secondary outcomes will be adequate relief (AR) for dyspepsia, overall treatment effect (OTE), visual analogue scale (VAS), functional dyspepsia-related quality of life (FD-QoL), gastrointestinal symptom score (GIS), and pattern identification questionnaires. For the exploratory outcomes, we will analyze blood and fecal metabolome profiles, microbiota from fecal and saliva samples, single nucleotide polymorphism (SNP), and results of Korean medicine diagnosis device measurements (heart rate variability, and tongue, pulse, and abdominal diagnosis). Conclusions: The results of this study will prove objectivity for Korean medicine pattern identifications, and the effectiveness and safety of herbal medicines for the population with FD.
The different social reflections about the benefits and the potential risks of genetically modified (GM) crops have evolved with .different reactions in different countries. Many countries including Korea are working toward setting down new guidelines. Korea requires companies to label all food that contains more than 3% GM ingredients. One of the rapid and convenient detection methods of GM ingredients is amplification of the introduced DNAs by polymerase chain reaction (PCR). Many PCR kits for this purpose are commercially available. The objective of this study was to evaluate performance of commercialized GM crop detection kits. The results showed that 6 out of 15 kits tested did not meet the requirements even purposed by the manufacturers themselves in terms of stability, reproducibility, and detection limits, suggesting a potential quality control problem in their design stage or production line. The evaluation also suggests that, although the duplex and triplex detection kits allowed unambiguous detection in a single PCR reaction, the monoplex detection kits were the most sensitive to the detection of GM ingredients. The detection limits also differ between soybean and corn. Results from this study will be useful in the development of sound qualitative tracking systems of GM ingredients for monitoring throughout the cultivation of GM crops, their trans-boundary movement, and food production using GM grains as well as for complying with government guidelines associated with GM crops.
Objectives: Use of dietary supplements containing vitamins and minerals is growing in Korean adults, especially in pregnant and lactating women. Vitamin and mineral supplements are available in different composition and in a wide range of contents. The purposes of the study were to examine nutrient composition and content of vitamin and mineral supplements for pregnant and lactating women and assess their appropriateness as dietary supplements. Methods: Information on the name, manufacturer, nutrient composition, and usage of vitamin and mineral supplements for pregnant and lactating women were obtained from the homepage of the Food Safety Information Portal managed by the Ministry of Food and Drug Safety, and Korean Index of Medical Specialties. A total of 264 products were identified. Results: Among 264 products, 26.1% were single nutrient products, and 73.9% were multinutrient products. The most commonly included nutrient was iron (70.1%), folic acid (66.3%), vitamin $B_{12}$ (45.8%), vitamin C (38.6%), and vitamin $B_6$ (38.6%). Although more than 50% of products contained nutrients less than 150% of Recommended Nutrient Intakes or Adequate Intakes for daily use, some products contained inappropriately high amounts of nutrients. When a maximum daily dose of supplements was taken as described on the label, iron in 73 products (39.5%), folic acid in 14 products (8.0%) were likely to be consumed in amounts greater than Tolerable Upper Intake Levels. Most products were assessed as inappropriate for pregnant women due to the possibility of excessive intake of vitamins or minerals when compared with Dietary Reference Intakes. Conclusions: Pregnant and lactating women need to carefully select dietary supplements containing adequate amounts of vitamins and minerals. Nutritionists should provide guidelines regarding selection of appropriate vitamin and mineral supplements for pregnant and lactating women.
Surface plasmon resonance (SPR) which is utilized in thin film refractometry-based sensors has been concerned on measurement of physical, chemical and biological quantities because of its high sensitivity and label-free feature. In this paper, an application of SPR to detection of alcohol content in wine and liquor was investigated. The result showed that SPR sensor had high potential to evaluate alcohol content. Nevertheless, food industry may need SPR sensor with higher sensitivity. Herein, we introduced a nano-technique into fabrication of SPR chip to enhance SPR sensitivity. Using Langmuir-Blodgett (LB) method, gold film with nano-structured surface was devised. In order to make a new SPR chip, firstly, a single layer of nano-scaled silica particles adhered to plain surface of gold film. Thereafter, gold was deposited on the template by an e-beam evaporator. Finally, the nano-structured surface with basin-like shape was obtained after removing the silica particles by sonication. In this study, two types of silica particles, or 130 nm and 300 nm, were used as template beads and sensitivity of the new SPR chip was tested with ethanol solution, respectively. Applying the new developed SPR sensor to a model food of alcoholic beverage, the sensitivity showed improvement of 95% over the conventional one.
Kim, Nam Kyun;Park, Chang-Soo;Kim, Hong Kook;Hur, Jin Ook;Lim, Jeong Eun
The Journal of the Acoustical Society of Korea
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v.40
no.5
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pp.479-487
/
2021
In this paper, we propose an Sound Event Detection (SED) model using self-training based on a noisy student model. The proposed SED model consists of two stages. In the first stage, a mean-teacher model based on an Residual Convolutional Recurrent Neural Network (RCRNN) is constructed to provide target labels regarding weakly labeled or unlabeled data. In the second stage, a self-training-based noisy student model is constructed by applying different noise types. That is, feature noises, such as time-frequency shift, mixup, SpecAugment, and dropout-based model noise are used here. In addition, a semi-supervised loss function is applied to train the noisy student model, which acts as label noise injection. The performance of the proposed SED model is evaluated on the validation set of the Detection and Classification of Acoustic Scenes and Events (DCASE) 2020 Challenge Task 4. The experiments show that the single model and ensemble model of the proposed SED based on the noisy student model improve F1-score by 4.6 % and 3.4 % compared to the top-ranked model in DCASE 2020 challenge Task 4, respectively.
The Journal of The Korea Institute of Intelligent Transport Systems
/
v.20
no.2
/
pp.95-111
/
2021
As the population decreases in an aging society, the average age of drivers increases. Accordingly, the elderly at high risk of being in an accident need autonomous-driving vehicles. In order to secure driving safety on the road, several technologies to respond to various obstacles are required in those vehicles. Among them, technology is required to recognize static obstacles, such as poor road conditions, as well as dynamic obstacles, such as vehicles, bicycles, and people, that may be encountered while driving. In this study, we propose a deep neural network algorithm capable of simultaneously detecting these two types of obstacle. For this algorithm, we used 1,418 road images and produced annotation data that marks seven categories of dynamic obstacles and labels images to indicate road damage. As a result of training, dynamic obstacles were detected with an average accuracy of 46.22%, and road surface damage was detected with a mean intersection over union of 74.71%. In addition, the average elapsed time required to process a single image is 89ms, and this algorithm is suitable for personal mobility vehicles that are slower than ordinary vehicles. In the future, it is expected that driving safety with personal mobility vehicles will be improved by utilizing technology that detects road obstacles.
Objective: 68Ga-NGUL is a novel prostate-specific membrane antigen (PSMA)-targeting tracer based on Glu-Urea-Lys derivatives conjugated to a 1,4,7-triazacyclononane-N,N',N''-triacetic acid (NOTA) chelator via a thiourea-type short linker. This phase I clinical trial of 68Ga-NGUL was conducted to evaluate the safety and radiation dosimetry of 68Ga-NGUL in healthy volunteers and the lesion detection rate of 68Ga-NGUL in patients with prostate cancer. Materials and Methods: We designed a prospective, open-label, single-arm clinical trial with two cohorts comprising six healthy adult men and six patients with metastatic prostate cancer. Safety and blood test-based toxicities were monitored throughout the study. PET/CT scans were acquired at multiple time points after administering 68Ga-NGUL (2 MBq/kg; 96-165 MBq). In healthy adults, absorbed organ doses and effective doses were calculated using the OLINDA/EXM software. In patients with prostate cancer, the rates of detecting suspicious lesions by 68Ga-NGUL PET/CT and conventional imaging (CT and bone scintigraphy) during the screening period, within one month after recruitment, were compared. Results: All 12 participants (six healthy adults aged 31-32 years and six prostate cancer patients aged 57-81 years) completed the clinical trial. No drug-related adverse events were observed. In the healthy adult group, 68Ga-NGUL was rapidly distributed, with the highest uptake in the kidneys. The median effective dose coefficient was calculated as 0.025 mSv/MBq, and cumulative activity in the bladder had the highest contribution. In patients with metastatic prostate cancer, 229 suspicious lesions were detected using either 68Ga-NGUL PET/CT or conventional imaging. Among them, 68Ga-NGUL PET/CT detected 199 (86.9%) lesions and CT or bone scintigraphy detected 114 (49.8%) lesions. Conclusion: 68Ga-NGUL can be safely applied clinically and has shown a higher detection rate for the localization of metastatic lesions in prostate cancer than conventional imaging. Therefore, 68Ga-NGUL is a valuable option for prostate cancer imaging.
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