• Title/Summary/Keyword: Efficacy testing

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Monitoring of Clinical Trials: Issues and Recammendations

  • Fleming Thomas R.;Demets David L.
    • 대한예방의학회:학술대회논문집
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    • 1994.02b
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    • pp.270-284
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    • 1994
  • Interim analyses of randomized trials enable investigators to make more efficient use of limited research resources and to satisfy ethical requirements that a regimen be discontinued as soon as it has been established to have an inferior efficacy/toxicity profile. Unfortunately. the integrity and credibility of these trials can be compromised if inappropriate procedures are used in monitoring interim data. 'In this paper we discuss how group sequential designs provide useful guidelines that enable one to satisfy the valid objectives of interim monitoring while avoiding undesirable consequences, and we consider how flexible one can be in the way such designs are implemented. We also provide motivation for the role of data-monitoring committees in preserving study integrity and credibility in either government- or industry-sponsored trials. In our view. these committees should have multidisciplinary representation and membership limited to individuals free of apparent significant conflict of interest, and ideally should be the only individuals to whom the data analysis center provides interim results on relative efficacy of treatment regimens. Finally. we discuss some important practical issues such as estimation following group sequential testing, anal ysis of secondary outcomes after using a group sequential design applied to a primary outcome, early stopping of negative trials. and the role of administrative analyses.

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Evaluating Bleaching Effects of a Sodium Percarbonate in the Washing Process with Enzyme Containing Detergents (효소세제에 첨가한 과탄산나트륨이 세척효과에 미치는 영향)

  • 정혜원;유지혜;방종호
    • Journal of the Korean Society of Clothing and Textiles
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    • v.26 no.7
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    • pp.1085-1092
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    • 2002
  • Changes in laundering habits and the efficacy claims made for oxygen bleach added to detergents necessitate a deeper investigation into the testing of the washing efficacy of detergents and washing process. The effect of the addition of a sodium percarbonate and bleach activator TAED to an enzyme containing detergent on the soil removal and antimicrobial properties were investigated with the measuring of residual H$_2$O$_2$. The addition of sodium percarbonates to enzyme containing detergent lowered the soil removal of EMPA 116 cloth. But sodium percarbonates had greater effects on that of colored stained cloths such as EMPA 115 and artificially soiled with wine and red pepper while they were presoaked at 20$^{\circ}C$ or higher for So minutes or longer. Most of hydrogen peroxide was remained after washing. Over 99.9% of Staphylococcus aureus on the cotton cloth was removed in every washing solutions, but the cloth washed with enzyme containing detergent or detergent with oxygen bleach didn't show the antimicrobial property.

Clinical Trial to Evaluate the Hot Flush Relief Efficacy and Safety of Yiseontang-gami in Climacteric Women with Hot Flushes (갱년기 여성의 안면홍조에 대한 이선탕가미방(二仙湯加味方)의 증상완화 효과 및 안전성 평가를 위한 임상연구)

  • Jung, Su-Kyoung;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.21 no.3
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    • pp.75-89
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    • 2008
  • Purpose: To evaluate the hot flush relief efficacy of Yiseontang-gami in climacteric women with hot flushes, a vasomotor symptom. Methods: The 20 subjects who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine(Yiseontang-gami)during thirty-day. The evaluating indexes of this trial are hot flush VAS, hot flush frequency, hot flush consistence time, sweating VAS, palpitation VAS, sleep disturbance VAS, MRS, MENQOL, PGA. Results: The results were as follows 1. 4 subjects dropped out of the clinical trial and 16 subjects completed it. 2. After Yiseontang-gami treatment, hot flush VAS, hot flush frequent, sweating VAS. Palpitation VAS, sleep disturbance VAS improved significantly. 3. After Yiseontang-gami treatment, hot flush consistence time was not improved significantly. 4. After Yiseontang-gami treatment, blood test value were not different significantly. Conclusion: In this clinical trial we consider that Yiseontang-gami is suitable treatment for the hot flushes and related symptoms.

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Efficacy of Caffeine in Promoting Hair Growth by Enhancing Intracellular Activity of Hair Follicles

  • Kim, Sehyun;Kim, Su Na;Jeong, Gyusang;Hong, Min Jung;Lee, Yonghee;Shin, Seung Hyun;Park, Hyeokgon;Jung, Yu Chul;Kim, Eun Joo;Park, Byung Cheol;Kim, Hyoung-June
    • Korea Journal of Cosmetic Science
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    • v.1 no.1
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    • pp.11-18
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    • 2019
  • Caffeine is widely used in cosmetics and hair care products. Although its efficacy in stimulating hair growth has been confirmed in recent studies, its mechanism of action remains unelucidated. The present study aimed to determine the effects of caffeine on hair growth, with a focus on intracellular hair follicle activity. Experiments included in vitro and ex vivo tests, and a clinical study. Caffeine enhanced the cellular activity and potassium channel opening. It also promoted human hair follicle elongation. Immunohistochemical staining showed that the Ki-67 signal was significantly higher in cells treated with caffeine. These efficacies of caffeine were comprehensively demonstrated in clinical results, wherein caffeine-containing shampoo improved hair density after 24 weeks of testing. Collectively, the results of this study demonstrated that caffeine promoted hair growth and inhibited the progression of hair loss by enhancing intracellular activity of hair follicles.

Development and testing effectiveness of a simulation program to control COVID-19 infections in nursing students (간호대학생을 위한 COVID-19 감염관리 시뮬레이션 프로그램 개발 및 효과)

  • Kang, Kino;Im, Mihae;Jang, Miyoung;Lee, Jaewoon;Lee, Okjong
    • Journal of Korean Critical Care Nursing
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    • v.16 no.2
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    • pp.54-66
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    • 2023
  • Purpose : Developing infection control capabilities during the COVID-19 pandemic was critical. This study aimed to develop a simulation program to control patients with COVID-19 in nursing students and examine the effects on COVID-19 knowledge, COVID-19 nursing intention, self-efficacy learning, and clinical performance. Methods : The study used nonequivalent control group pretest-posttest design. Sixty nursing students were recruited from two different colleges using purposive sampling. For the intervention group(n=30), the pretest was administered before the simulation program, involving six sessions of online lectures and simulation practices. Immediately, the posttest was conducted following the program. Results : COVID-19 knowledge (t=9.87, p <.001), COVID-19 nursing intention (t=4.45, p <.001), learning self-efficacy (t=6.49, p <.001), and clinical performance (t=6.77, p <.001) increased significantly after the program, revealing the positive effect of the COVID-19 infection control simulation program in nursing students. Conclusion : The results of the study and the curriculum may be used as practical evidence for COVID-19 infection control in nursing schools and medical institutions.

Influential Factors of Digital Customer Experiences on Purchase in the 4th Industrial Revolution Era - Focusing on Moderated Mediating Effects of Digital Self Efficacy- (4차 산업혁명시대의 디지털 고객경험과 구매간 영향관계 - 디지털 자기효능감의 조절된 매개효과를 중심으로-)

  • Jung, Sang Hee;Chung, Byoung Gyu
    • Journal of Venture Innovation
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    • v.3 no.1
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    • pp.101-115
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    • 2020
  • In the era of the 4th Industrial Revolution customers living began to come out, not inside the purchase funnel. Due to the diversity of product selection and the increase in digital channels, the way customers search for information and purchase it is changing innovatively. So, the customer journey in the digital age is much more complicated than the traditional funnel model suggests. Unlike many previous studies, this study was conducted for 1,200 customers in four product groups of fashion, automobile, cosmetics, and online shopping malls. As a result of the study, we investigated how digital self-efficacy plays a role in purchasing in a series of processes in which digital experience affects customer satisfaction and finally affects purchase. As a theoretical implication, as a result of introducing and testing digital self efficacy as moderated mediation effect. the digital self-efficacy between customer satisfaction and customer loyalty were determined to play a moderated mediation effect role. As a practical implication, it was necessary to actively utilize digital marketing for customers with high digital self-efficacy, but it was suggested that customers with low digital self-efficacy need to be careful about digital marketing fatigue.

The Effect of Metacognition on Employees Agility: Focusing on the Serial Multiple Mediation of Role Breadth Self-efficacy and Learning Agility (메타인지가 구성원 민첩성에 미치는 영향: 역할확장 자기효능감과 학습민첩성의 직렬다중매개를 중심으로)

  • Kwon, Ki-Jung;Shin, Je-Goo
    • The Journal of the Korea Contents Association
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    • v.22 no.4
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    • pp.379-402
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    • 2022
  • The purpose of this study was to verify the effectiveness of the employee metacognition and it's positive effect on employee agility. Also it aims to investigate the mechanism through the cascading multi-mediating effect through the role breadth self-efficacy and learning agility in such a relationship. In order to solve the common-method bias, independent and dependent variables were measured with time lag, and the relationship between variables was clearly verified by applying the position and the length of time worked with the supervisor as control variables. In testing the hypothesis, 478 questionnaires collected from whom worked at the company has more than 300 office workers in various industries were analyzed. As the result, firstly metacognition had a significant positive(+) effect on employee agility. Second, role breadth self-efficacy was found to positively mediate the relationship between metacognition and employee agility. Third, learning agility was found to mediate metacognition and employee agility positively(+). Fourth, metacognition serially mediates role breadth self-efficacy and learning agility, and the positive(+) effect on employee agility was verified. In addition, metacognition had a greater effect on member agility when passing through role breadth self-efficacy and learning agility rather than the direct effect on employee agility.

Comparison of the Genetic Alterations between Primary Colorectal Cancers and Their Corresponding Patient-Derived Xenograft Tissues

  • Yu, Sang Mi;Jung, Seung-Hyun;Chung, Yeun-Jun
    • Genomics & Informatics
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    • v.16 no.2
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    • pp.30-35
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    • 2018
  • Patient-derived xenograft (PDX) models are useful tools for tumor biology research and testing the efficacy of candidate anticancer drugs targeting the druggable mutations identified in tumor tissue. However, it is still unknown how much of the genetic alterations identified in primary tumors are consistently detected in tumor tissues in the PDX model. In this study, we analyzed the genetic alterations of three primary colorectal cancers (CRCs) and matched xenograft tissues in PDX models using a next-generation sequencing cancer panel. Of the 17 somatic mutations identified from the three CRCs, 14 (82.4%) were consistently identified in both primary and xenograft tumors. The other three mutations identified in the primary tumor were not detected in the xenograft tumor tissue. There was no newly identified mutation in the xenograft tumor tissues. In addition to the somatic mutations, the copy number alteration profiles were also largely consistent between the primary tumor and xenograft tissue. All of these data suggest that the PDX tumor model preserves the majority of the key mutations detected in the primary tumor site. This study provides evidence that the PDX model is useful for testing targeted therapies in the clinical field and research on precision medicine.

A Nonparametric Multivariate Test for a Monotone Trend among k Samples

  • Hyun, Noo-Rie;Song, Hae-Hiang
    • The Korean Journal of Applied Statistics
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    • v.22 no.5
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    • pp.1047-1057
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    • 2009
  • The nonparametric bivariate two-sample test of Bennett (1967) is extended to the multivariate k sample test. This test has been easily modified for a monotone trend among k samples. Often in applications it is important to consider a set of multivariate response variables simultaneously, rather than individually, and also important to consider testing k samples altogether. Different approaches of estimating the null covariance matrices of the test statistics resulted in the same limiting form. The multivariate k sample test is applied to the non-normal data of a randomized trial conducted for a period of four weeks in mental hospitals. The purpose of the trial is to compare the efficacy of three different interventions for a relief of the frequently occurring problems of constipation, caused as a side effect of antipsychotic drugs during hospitalization. The bowel movement status of patient for a week is summarized into a single severity score, and severity scores of four weeks comprise a four-dimensional multivariate variable. It is desirable with this trial data to consider a multivariate testing among k samples.

Control Efficacy of Fungicide Injection on Oak Wilt in the Field (살균제 나무주사를 이용한 참나무 시들음병 방제 효과)

  • Son, Su-Yeon;Seo, Sang-Tae;Park, Ji-Hyun
    • Research in Plant Disease
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    • v.20 no.4
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    • pp.295-298
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    • 2014
  • Oak wilt caused by Raffaelea quercus-mongolicae was first noticed in South Korea in 2004 and, ever since, its distribution and damage have been increasing. To screen a fungicide effective for oak wilt control by tree injection, laboratory and field experiments were conducted. Ten fungicides and one antibiotic were examined in vivo for their effectiveness in restricting the growth of R. quercus-mongolicae and R. quercivora (Japanese oak wilt pathogen) isolates. To the Korean isolates of R. quercus-mongolicae, chlorothalonil showed the highest fungicidal effects, followed by benomyl and propiconazole. To the Japanese one, propiconazole was highest in the fungicidal effectiveness, followed by benomyl and bitertanol. Propiconazole was selected for field-testing of its control efficacy because it showed good fungicidal effects in vitro and systemic activity. The control efficacy in the field was 87.5% in the first year of injection and 66.7% in the second year, indicating the fungicidal effects last at least over one year.