• 한국임상약학회지
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• 제34권2호
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• pp.134-139
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• 2024

Background: Increasing numbers of studies and research about artificial intelligence (AI) and machine learning (ML) have led to their application in clinical trials. The purpose of this study is to analyze computer-based new technologies (AI/ML) applied on clinical trials registered on ClinicalTrials.gov to elucidate current usage of these technologies. Methods: As of March 1st, 2023, protocols listed on ClinicalTrials.gov that claimed to use AI/ML and included at least one of the following interventions-Drug, Biological, Dietary Supplement, or Combination Product-were selected. The selected protocols were classified according to their context of use: 1) drug discovery; 2) toxicity prediction; 3) enrichment; 4) risk stratification/management; 5) dose selection/optimization; 6) adherence; 7) synthetic control; 8) endpoint assessment; 9) postmarketing surveillance; and 10) drug selection. Results: The applications of AI/ML were explored in 131 clinical trial protocols. The areas where AI/ML was most frequently utilized in clinical trials included endpoint assessment (n=80), followed by dose selection/optimization (n=15), risk stratification/management (n=13), drug discovery (n=4), adherence (n=4), drug selection (n=1) and enrichment (n=1). Conclusion: The most frequent application of AI/ML in clinical trials is in the fields of endpoint assessment, where the utilization is primarily focuses on the diagnosis of disease by imaging or video analyses. The number of clinical trials using artificial intelligence will increase as the technology continues to develop rapidly, making it necessary for regulatory associates to establish proper regulations for these clinical trials.

• 한방안이비인후피부과학회지
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• 제32권2호
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• pp.24-58
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• 2019

Objectives : The purpose of this study is to confirm the Efficacy and Safety of "Functional cosmetics containing Humulus japonicus Extract" on dry skin due to mild atopic dermatitis. Methods : A total of 48 patients who visited Semyung Oriental Medical Center from March 20th, 2018 to July 5th, 2018 were included in the study. In this study, the patients were treated with Functional cosmetics containing Humulus japonicus Extract and positive control group. For 6 weeks of gross examination, instrumental assessment were made before and after the study to evaluate how well the products for treatment group with positive control products for control group in recovering the dry skin barriers by mild atopic dermatitis. Results : 1. In the primary endpoint, Skin Hydration showed a statistically significant increase and Transepidermal Water Loss(TEWL) showed a statistically significant decrease in treatment group between Baseline and 6 weeks. 2. In the secondary endpoint, Skin Hydration showed a statistically significant increase in treatment group between Baseline and 3 weeks, but TEWL showed no statistical significance. 3. In the secondary endpoint, Skin Hydration showed a statistically significant increase in treatment group between 3 weeks and 6 weeks, but TEWL showed no statistical significance. 4. In the secondary endpoint, Change of Skin Hydration and TEWL between treatment and control group showed a statistical significance in 6 weeks. 5. In the secondary endpoint, Change of Skin Hydration of 1cm below the medial aspect of the elbow between treatment and control group showed a statistical significance in 3 weeks. 6. In the secondary endpoint, Change of Skin Hydration between treatment and control group showed a statistical significance in 3 weeks and 6 weeks except Center between the medial aspect of the elbow and the wrist in 3 weeks, and Change of TEWL between treatment and control group showed a statistical significance in 6 weeks. 7. To evaluate the safety of the products for the human body, Adverse events, EASI Score, Itching Symptoms Assessment, vital sign check were conducted; There were no severe adverse events during this study. And both experimental group and control group showed no abnormal level. Therefore, it is suggested that products, if used for certain period, should be safe for the human body. Conclusions : According to the above experiments, it is suggested that "Functional cosmetics containing Humulus japonicus Extract" should be effective for dry skin due to mild atopic dermatitis.

• Nutrition Research and Practice
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• 제16권4호
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• pp.450-463
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• 2022

BACKGROUND/OBJECTIVES: Adolescents who skip breakfast have an increased prevalence of chronic diseases. Thus, we aimed to evaluate whether the intake of rice-based breakfast had positive effects on blood glucose indices and to determine the possibility of diabetes prevalence in Korean youths who habitually skip breakfast. SUBJECTS/METHODS: In this randomized parallel-group controlled trial, 81 subjects who were suitable for compliance among 105 middle-and high-school students aged 12-18 years who usually skipped breakfast were included in this study (rice-meal group [RMG], n = 26; wheat-meal group [WMG], n = 29; general-meal group [GMG], n = 26). The RMG and WMG received a rice-based breakfast and a wheat-based breakfast for 12 weeks, respectively. The anthropometric indices, blood glucose indices, and metabolites were measured at baseline and the endpoint, respectively. RESULTS: The mean body weights in the RMG, WMG, and GMG groups at the endpoint were 62.44 kg, 61.80 kg, and 60.28 kg, respectively, and the mean body weights of the WMG and GMG groups at the endpoint were significantly higher than that at baseline (P < 0.05). The levels of fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR) values were significantly decreased in the RMG group at the endpoint compared to baseline (P < 0.05, P < 0.05, respectively). The levels of tryptophan and tyrosine in the WMG group at the endpoint were significantly higher than that those at baseline (P < 0.01, P < 0.05, respectively). CONCLUSIONS: Rice-based breakfast has positive effects on fasting insulin levels and HOMA-IR in Korean adolescents who skip breakfast. Additionally, it was found that a skipping breakfast could increase the prevalence of diabetes in adolescents who skip breakfast. Therefore, in addition to reducing breakfast skipping, it is vital to develop a rice-based menu that fits teenage preferences to prevent chronic diseases such as diabetes.

• Toxicological Research
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• 제18권1호
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• pp.99-106
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• 2002

The United States Environmental Protection Agency (EPA) characterized the cancer hazard of di(2-ethylhexyl)-phthalate (DEHP) as a B2 group (probable human carcinogen) and proposed "Guide-lines for Carcinogen Risk Assessment". This guidelines proposed alternative methods for analyzing carcinogen dose-response data and for extrapolating the effects of observed at high dose to predict that might occur at lower doses relevant to human exposure. This proposed guidelines state that "If in a particular case, the evidence indicated a threshold, as in the case of carcinogenicity being secondary to another toxicity that has a threshold, the margin of exposure analysis for toxicity is the same as is done for a non-cancer endpoint". DEHP is excellent candidate for reconideration under the new guidelines for carcinogen risk assessment (John Doull et al., 1998). This study is conducted about risk assessment for infant exposure on DEHP in powdered milk wing methodology in EPA's new guideline on carcinogenic risk assessment. Estimated cancer risk of DEHP in powdered milk and cow milk is 2.83$\times$$10^5$ (using cancer potency: 1.4$\times$$10^2$/ (mg/kg/day)) as mean and MOE is 12075 (using selected NOEL 20 mg/kg/day) as mean. mg/kg/day) as mean.

• 한방안이비인후피부과학회지
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• 제32권3호
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• pp.23-36
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• 2019

Objectives : The purpose of this study is to confirm the efficacy and safety of "Functional cosmetics containing peptide Scolopendrasin-I isolated from the Scolopendra subspinipes mutilans" on dry skin due to mild atopic dermatitis. Methods : A total of 24 patients who visited Semyung Oriental Medical Center from November 1st, 2018 to December 20th, 2018 were included in the study. In this study, the patients were treated with Functional cosmetics containing peptide Scolopendrasin-I isolated from the Scolopendra subspinipes mutilans. For 4 weeks of gross examination, instrumental assessment were made before and after the study to evaluate how well the products for treatment group in recovering the dry skin barriers by mild atopic dermatitis. Results : 1. In the primary endpoint, Skin Hydration showed a statistically significant increase in treatment group in baseline, 2 weeks and 4 weeks. 2. In the primary endpoint, Transepidermal Water Loss(TEWL) showed a statistically significant decrease in treatment group between Baseline and 4 weeks. 3. In the secondary endpoint, Skin pH showed a statistically significant decrease in treatment group between baseline and 4 weeks. 4. To evaluate the safety of the products for the human body, Adverse events, SCORAD Index Assessment were conducted; There were no severe adverse events during this study. And SCORAD Index showed a statistically significant decrease in treatment group in baseline, 2 weeks and 4 weeks. Therefore, it is suggested that products, if used for certain period, should be safe for the human body. Conclusions : According to the above experiments, it is suggested that "Functional cosmetics containing peptide Scolopendrasin-I isolated from the Scolopendra subspinipes mutilans" should be effective for dry skin due to mild atopic dermatitis.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• 제25권2호
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• pp.89-94
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• 2014

Objectives : This study was conducted naturalistically in order to observe the long-term effects of attention-deficit hyperactivity disorder (ADHD) medications on growth rates among Korean school-aged boys with ADHD. Methods : Participants in the study were boys with ADHD aged 6 to 11 years who have taken ADHD medication, methylphenidate (extended release) or atomoxetine. They attended scheduled visits monthly or bimonthly for clinical assessment with measurement of height and weight. In this study, 35 boys with ADHD (mean age at baseline=$7.90{\pm}1.77$ years ; mean age at endpoint= $12.54{\pm}1.91$ years) were included, with a mean follow-up period of 4.64 years (${\pm}1.62$ years), ranging from 2 to 9.7 years. Height, weight, and body mass index (BMI) measurements were converted to "age-corrected Z-scores" using data from Growth Charts provided by the Korean Center for Disease Control and Prevention from 2007. Results : Age-corrected endpoint growth parameters (height, weight, BMI Z-scores) did not differ significantly from the baseline values (height t=0.027 ; weight t=-0.61 ; BMI t=-1.86, in paired t-test). Especially high correlation was observed between the baseline and endpoint height Z-scores (r=0.876, p<.001), for which the coefficient of determination $r^2$ was 0.767, meaning that the amount of variability in endpoint height Z-scores explained by the baseline height Z-scores was 76.7%. Conclusion : Our results suggested that the long-term effects of ADHD medications on growth parameters to be tolerable in Korean school-aged boys with ADHD.

• 한국지하수토양환경학회지:지하수토양환경
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• 제20권6호
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• pp.1-7
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• 2015

The most critical health effect of lead exposure is the neurodevelopmental effect to children caused by the increased blood lead level. Therefore, the endpoint of the risk assessment for lead-contaminated sites should be set at the blood lead level of children. In foreign countries, the risk assessment for lead-contaminated sites is conducted by estimating the increased blood lead level of children via oral intake and/or inhalation (United States Environmental Protection Agency, USEPA), or by comparing the estimated oral dose to the threshold oral dose of lead, which is derived from the permissible blood lead level of children (Dutch National Institute for Public Health and the Environment, RIVM). For the risk assessment, USEPA employs Integrated-Exposure-Uptake-Biokinetic (IEUBK) Model to check whether the estimated portion of children whose blood lead level exceeds 10 µg/dL, threshold blood lead level determined by USEPA, is higher than 5%, while Dutch RIVM compares the estimated oral dose of lead to the threshold oral dose (2.8 µg/kg-day), which is derived from the permissible blood lead level of children. In Korea, like The Netherlands, risk assessment for lead-contaminated sites is conducted by comparing the estimated oral dose to the threshold oral dose; however, because the threshold oral dose listed in Korean risk assessment guidance is an unidentified value, it is recommended to revise the existing threshold oral dose described in Korean risk assessment guidance. And, if significant lead exposure via inhalation is suspected, it is useful to employ IEUBK Model to derive the risk posed via multimedia exposure (i.e., both oral ingestion and inhalation).

• 대한예방한의학회지
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• 제17권3호
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• pp.129-141
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• 2013

Objectives : Anorexia is the primary symptom impinging cancer patients' Quality of Life. It is usually accompanied by gastrointestinal symptoms(GI symptoms). Thus, to measure anorexia symptom precisely, assessing anorexia and GI symptoms together is recommended. This study was designed to analyze cancer-related anorexia assessment tools, extract GI symptoms included in these tools and investigate usefulness of instruments in clinical trials. Methods : Instruments were selected by searching PubMed, PROQOLID database. We analyzed instruments by number of items, assessment method, type of question, GI symptoms. Results : 9 instruments were selected to assess cancer-related anorexia symptom. Most tools adopt Likert scale as response scale and 'during past week' as recall period. Assessment method of all 9 instruments is the self-administration. Questions measuring anorexia are able to be sorted into 3 forms (frequency, severeness, distress of anorexia symptom). Among the GI symptoms, nausea is included in all 9 instruments. In clinical trials of cancer-related anorexia, Edmonton Symptom Assessment Scale(ESAS) and Functional Assessment of Anorexia/Cachexia Therapy Questionnaire(FAACT) were selected as endpoint measure. Conclusions : The result showed that FAACT is the only specialized tool to assess cancer-related anorexia. To measure cancer-related anorexia precisely, the need to develop new instrument exists.

• 한방안이비인후피부과학회지
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• 제23권3호
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• pp.138-153
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• 2010

Purposes : The object of present study is to detect the Effects of Snail Secretion Filtrate and Hyaluronic acid on the skin barrier's recovery of the Atopic dermatitis. Methods : A total of 20 patients who visited Semyung Hanny Oriental Medical Center from september 1st, 2009 to August 31th, 2010 were included in this study. In this study, they were treated with Snail Secretion Filtrate(experimental group) and Hyaluronic acid(control group). For 4 weeks gross examination, hematological examination and instrumentation through skin-ANBT equipment were made before and after the experiments to see how well the products for experimental group act against those for control group in recovering the damaged skin barriers by Atopic dermatitis. Results : 1. In the primary endpoint, SCORAD Index showed a statistically significant decline in both the control group and the experimental group. However, the experimental group showed greater statistical significance than the control group. 2. In the secondary endpoint index of skin hydration, both the control group and the experimental group did not show a statistically significant increase. However, the degree of skin hydration in the experimental group is greater than in the control group. 3. In global assessment of efficacy, it was higher in the experimental group than in the control group for both the subjects and the researchers. 4. To evaluate the safety of the products for the human body, hematological examination and hematological biochemical examination were conducted; both the control group and the experimental group showed no abnormal level. Therefore, the safety of the products, if used for so long a time, proved to be safe for the human body. 5. Product satisfaction was higher in the experimental group than in the control group. Conclusions : According to above experiments, Snail Secretion Filtrate was effective on the Atopic dermatitis.

• The Korean journal of internal medicine
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• 제39권2호
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• pp.338-346
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• 2024

Background/Aims: Systemic lupus erythematosus (SLE) responder index (SRI)-4 response has been achieved with belimumab treatment in patients with moderate disease activity in cornerstone clinical trials and following studies. However, most studies involved patients treated with a mean prednisolone-equivalent dose of approximately 10 mg/d and focused on the steroid-sparing effect of belimumab. We aimed to identify the effect of belimumab in patients with mild-to-moderate SLE who were treated with low-dose or no corticosteroids. Methods: We retrospectively reviewed the electronic medical records of patients treated with belimumab for at least 6 months between May 2021 and June 2022. The primary endpoint was SRI-4 response at 6 months. Results: Thirty-one patients were included (13 low dose- and 18 steroid non-users). The mean age was 39.2 ± 11.4 years, and 90.3% of patients were female. The baseline Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score was 6.0 (4.0-9.0). The primary endpoint was achieved in 32.3% (10/31) of patients. Significant improvements in anemia, C4 levels, and SELENA-SLEDAI score were observed during treatment. Univariate analysis showed that the baseline SELENA-SLEDAI and arthritis were significantly associated with SRI-4 response at 6 months, and only the SELENA-SLEDAI remained significant (p = 0.014) in multivariate analysis. Conclusions: This cohort study is the first to report the efficacy of belimumab after minimizing the effect of corticosteroids. Belimumab showed efficacy in improving the SELENA-SLEDAI score, anemia, and low C4 in patients who did not receive corticosteroids or received only low doses.