• Journal of The Korean Society of Integrative Medicine
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• v.10 no.3
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• pp.27-36
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• 2022

Purpose : This study was aimed to analyze the effects of cosmetics containing Persicaria perfoliata water extract (PPWE) on the skin moisturizing and improvement of skin condition in clinical trials. Methods : Clinical trial was conducted for five weeks after IRB approval at Dong-Eui University. Out of a total of 64 people, 15 people each were assigned to four groups as follows; control group A, B, C and the experimental group A that using cosmetic containing PPWE. Skin condition was measured two times, before and after clinical trial, by a professional skin analyzer, SDM (skin diagnosis system). Moisture and oil value of participants was analyzed twice, each morning and evening, using a portable device on their cheeks. In addition, the survey was investigated subjective satisfaction on change in skin condition and the satisfaction on the use of cosmetics. Result : The experimental group exhibited subjectively significant changes before and after clinical trials on skin its dryness (p=.039), blush (p=.017), and redness (p<.001). In addition, subjective evaluation was also the highest satisfaction in aspects of number of application (p=.003), amount of application (p=.002), moisture maintenance, and skin scratching frequency. The satisfaction on the use of cosmetics was the highest in the intention to repurchase (p=.045), recommendation willingness to others (p=.020), and intention to use various products (p=.001). Skin moisture of the clinical trial participants using the SDM, moisture level and elasticity of the experimental group increased by 12.94 and 10.28. Moisture level, which was measured by a portable device, was the most potently increased in the experimental group. Conclusion : Consequently, PPWE containg cosmetics exhibited the effects of moisturization and attenuated skin dryness in clinical trials, which might be utilized as a fundamental data to develop numerous lines of cosmetics.

• The Korean Journal of Applied Statistics
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• v.27 no.1
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• pp.13-20
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• 2014

Phase I Clinical Trials estimate a Maximum Tolerated Dose(MTD). In this paper, an MTD estimation method applied stopping rule is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the Continual Reassessment Method(CRM) method using a Monte Carlo simulation study.

• The Journal of the Korean dental association
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• v.45 no.3 s.454
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• pp.169-181
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• 2007

In this second part of series report on evidence-based dentistry, the level of evidence and the methods for critical appraisal are discussed. The epidemiologic studies, namely clinical studies have some bias per se, and the degree of bias is somewhat predetermined by the study design. The level of evidence can be defined as the reliability of the clinical study and it is dependent on the degree of bias. Thus, it is important to determine the type of the study and to understand its structure before critically appraising them. Systematic reviews of primary studies, randomized controlled trials, nonrandomized clinical trials, cohort studies, case-control studies, and case reports / series constitute the clinical studies and the level of evidence follows the order of the studies listed above. Critical appraisal is the most important procedure in evidence-based dentistry. It is done to determine the credibility of research papers and their usefulness in the clinician s own practice. Critical appraisal is consisted of multiple questions that are helpful for evaluating validity and usefulness of the studies concerning therapy, diagnosis, prognosis, and causation.

• IMMUNE NETWORK
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• v.22 no.5
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• pp.37.1-37.16
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• 2022

Autoimmune diseases are caused by a dysfunction of the acquired immune system. In a subset of autoimmune diseases, B cells escaping immune tolerance present autoantigen and produce cytokines and/or autoantibodies, resulting in systemic or organ-specific autoimmunity. Therefore, B cell depletion with monoclonal Abs targeting B cell lineage markers is standard care therapy for several B cell-mediated autoimmune disorders. In the last 5 years, genetically-engineered cellular immunotherapies targeting B cells have shown superior efficacy and long-term remission of B cell malignancies compared to historical clinical outcomes using B cell depletion with monoclonal Ab therapies. This has raised interest in understanding whether similar durable remission could be achieved with use of genetically-engineered cell therapies for autoimmunity. This review will focus on current human clinical trials using engineered cell therapies for B cell-associated autoimmune diseases.

• Biomolecules & Therapeutics
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• v.32 no.1
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• pp.13-24
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• 2024

Cytokines influence the overall cancer immune cycle by triggering tumor antigen expression, antigen presenting, immune cell priming and activation, effector immune cell recruitment and infiltration to cancer, and cancer killing in the tumor microenvironment (TME). Therefore, cytokines have been considered potential anti-cancer immunotherapy, and cytokine-based anti-cancer therapies continue to be an active area of research and development in the field of cancer immunotherapy, with ongoing clinical trials exploring new strategies to improve efficacy and safety. In this review, we examine past and present clinical developments for major anticancer cytokines, including interleukins (IL-2, IL-15, IL-12, IL-21), interferons, TGF-beta, and GM-CSF. We identify the current status and changes in the technology platform being applied to cytokine-based immune anti-cancer therapeutics. Through this, we discuss the opportunities and challenges of cytokine-based immune anti-cancer treatments in the current immunotherapy market and suggest development directions to enhance the clinical use of cytokines as immuno-anticancer drugs in the future.

• The Korean journal of internal medicine
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• v.39 no.2
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• pp.205-214
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• 2024

Hypertension remains a global health concern because of suboptimal blood pressure control despite advancements in antihypertensive treatments. Chronotherapy, defined as evening or bedtime administration of medication based on biological rhythms, is emerging as a potential strategy to improve blood pressure control and treatment outcomes. Clinical trials have investigated the potential effects of nighttime administration of antihypertensive medication in the improvement of 24 hours blood pressure control and reduction of cardiovascular risk. Implementing chronotherapy in clinical practice could have significant implications in enhancing blood pressure control and improving clinical outcomes in patients with hypertension, particularly those with resistant hypertension. However, recent trials have reported contradictory results, causing confusion in real-world practice. Herein we review, analyze, and critique the current evidence and propose suggestions regarding the clinical application and future directions of chronotherapy.

• Journal of Gastric Cancer
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• v.5 no.2
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• pp.79-88
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• 2005

Quality assurance may be defined as the complete set of systemic actions that is required to achieve a better treatment result by standardizing treatment and by using various audit programs. In general, application of a quality assurance program in surgery is considered to be more difficult than it is in chemotherapy or radiotherapy. However, recently, the importance of quality assurance in the surgical field has been emphasized in clinical trials comparing different surgical procedures and evaluating the role of postoperative adjuvant therapy. In the case of gastric cancer surgery, excellent quality assurance programs have rarely been applied in most large prospective clinical trials. Although the quality assurance in Dutch trial was conducted very systemically and strictly, the situation is quite different from ours. On the other hand, several quality assurance programs in Japanese trials comparing D2 and D2 plus para-arotic lymph node dissection seem to be applicable to Korean clinical trials. Several factors, including selection of appropriate surgeons based on personal experience and annual number of operations, standardization of surgical procedures by education and consensus, development of a unified database program, application of standardized perioperative management, and standardization of pathologic examination, are required to guarantee a successful multi-institutional prospective clinical trial. In contrast, one needs to realize that protocols that are too strict and sophisticated can make the enrollment of patients and surgeons more difficult and can promote protocol violation during the clinical trials. (J Korean Gastric Cancer Assoc 2005;5:79-88)

• 한국데이터정보과학회:학술대회논문집
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• 2005.04a
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• pp.200-201
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• 2005

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.21 no.2
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• pp.94-101
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• 2008

Objectives : To discuss the types of control groups in randomized controlled trials (RCTs) of herbal medicine, and to provide suggestions for improving the design of control group in future clinical trials. Methods : We reviewed the 8 articles about clinical trial design of Chinese herbal preparation which were published from 2005 through 2008. We selected those articles from CNKI(中國知識基礎施設工程(http://www.cnki.net)). Results : It is necessary to have control group in randomized controlled trials(RCTs) of Korean herbal preparation. But there are problems in the selection of appropriate control group drug. This paper lists several problems about the choice of control drug and puts forward some proposals and countermeasures. There are problems such as ethics and manufacturing matching placebo and positive control herbal drug. Conclusion : To improve the quality of control group design, we introduce standard drug plus placebo drug method and add-on research for placebo control group design, double dummy technique, using negative control drug or composite control drug for active control group design.

• Journal of Acupuncture Research
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• v.28 no.1
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• pp.109-115
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• 2011

Objectives : This review is to summarize and assess the effects of acupuncture on parasympathetic nervous system(PNS). Methods and Materials : We searched two electronic databases (CNKI, PubMed) for the articles published until Oct. 2010. The randomized clinical trials (RCTs) and uncontrolled clinical trials (UCTs) were considered to be reviewed. We selected four RCTs, seven UCTs and one article which conducted both RCT and UCT, and reviewed them. The quality of RCTs was also assessed with Cochrane criteria. Results : There were four RCTs which reported acupuncture enhanced PNS, and one RCT reported acupuncture reduced PNS. Four UCTs reported acupuncture enhanced PNS, three UCTs reported acupuncture reduced PNS and one UCT reported there was no remarkable change of PNS after acupuncture. Conclusions : Although the majority of reviewed articles showed acupuncture enhance PNS, it is hard to conclude clearly how acupuncture affects PNS due to insufficient quality of trials. Therefore, more trials with strict condition need to be conducted to obviously identify the effects of acupuncture on PNS.