• Korean Journal of Clinical Pharmacy
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• v.16 no.1
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• pp.40-45
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• 2006

In clinical trials, it is important to have well designed case report forms (CRF) in order to obtain good quality of data. If CRF design at the first stage of your study goes wrong, after all efforts have been made, you may find practical difficulties in data analysis at the final stage of your study because of incomplete or wrong information. In this paper, the following rules fundamental to CRF design are introduced: rules in general, rules of format or style, categorized responses, forms with multiple records per subject, and international studies. Investigators are well aware of research goals, however sometimes they do not know how to express it on CRF. If they understand the rules fundamental to CRF design, time for CRF development will be saved and CRF completeness will be enhanced.

• The korean journal of orthodontics
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• v.44 no.4
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• pp.168-176
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• 2014

Objective: The aim of this randomized controlled clinical trial was to compare oral health-related quality of life (OHRQoL) of patients treated with conventional, active self-ligating (ASL), and passive self-ligating (PSL) brackets in different therapeutic phases. Methods: Sixty patients (mean age 18.3 years; 29 males and 31 females) requiring orthodontic treatment were randomly and equally assigned to receive conventional (Victory Series), ASL (In-Ovation R), or PSL (Damon 3MX) brackets. OHRQoL was measured with a self-administered modified 16-item Malaysian version of the Oral Health Impact Profile for immediate (soon after the visit) and late (just before the subsequent visit) assessments of the bonding and activation phases. Data were analyzed with the Kruskal-Wallis and chi-square tests. Results: The PSL and ASL groups showed more immediate and late impacts in the bonding phase, respectively; the conventional group was affected in both the assessments. The first activation phase had similar impacts in the groups. After the second activation, the conventional group showed more immediate impacts, whereas the PSL and ASL groups had more late impacts. The commonly affected domains were "physical disability," "functional limitation," "physical pain," and "psychological discomfort." No significant differences in the prevalence and severity of immediate and late impacts on OHRQoL of the patients were noted in any therapeutic phase. Conclusions: No bracket system seems to ensure superior OHRQoL. This information could be useful for explaining the therapeutic phases, especially the initial one, and selecting the optimal bracket system based on the patient's preference.

• Journal of Acupuncture Research
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• v.35 no.3
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• pp.120-128
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• 2018

Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using acupuncture for AC. Methods: Thirty participants with AC were randomly assigned to acupuncture (A) or sham acupuncture (SA) groups. The participants received 15 acupuncture sessions over 6 weeks, and follow-up occurred for an additional 4 weeks thereafter. The primary clinical outcome was the numeric rating scale (NRS) for shoulder pain 6 weeks from the baseline. Secondary outcomes included range of motion (ROM) in the shoulder, the shoulder pain and disability index (SPADI), the EuroQol-5 dimensions (EQ-5D), the Pittsburgh sleep quality index (PSQI), and the patient global impression of change (PGIC). Results: Thirty participants were enrolled out of 37 screened individuals. Recruitment was conducted between August 2014 until May 2015. A total of 28 participants (93%) completed the 6-week intervention, and 26 participants (87%) completed the study. NRS, ROM, SPADI, EQ-5D, PSQI, and PGIC scores improved in both the experimental group and the sham group after 6 weeks, but the difference between the groups was not statistically significant. Adverse events were reported by 12 participants, although these events were not associated with acupuncture. Conclusion: A future RCT for AC may be feasible with some modifications to the recruitment plan and the secondary outcome measurement methods.

• Clinical and Experimental Reproductive Medicine
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• v.49 no.2
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• pp.135-141
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• 2022

Objective: This study investigated the impact of two stimulation protocols using highly purified human menopausal gonadotropin (HP-hMG) on the endocrine profile, follicular fluid soluble Fas levels, and outcomes of intracytoplasmic sperm injection (ICSI) cycles. Methods: This prospective clinical trial included 100 normal-responder women undergoing ovarian stimulation for ICSI; 55 patients received concomitant follicle-stimulating hormone (FSH) plus HP-hMG from the start of stimulation, while 45 patients received FSH followed by HP-hMG during mid/late follicular stimulation. The primary outcome was the number of top-quality embryos. The secondary outcomes were the number and percentage of metaphase II (MII) oocytes and the clinical pregnancy rate. Results: The number of MII oocytes was significantly higher in the concomitant protocol (median, 13.0; interquartile range [IQR], 8.5-18.0 vs. 9.0 [8.0-13.0] in the consecutive protocol; p=0.009); however, the percentage of MII oocytes and the fertilization rate were significantly higher in the consecutive protocol (median, 90.91; IQR, 80.0-100.0 vs. 83.33 [75.0-93.8]; p=0.034 and median, 86.67; IQR, 76.9-100.0 vs. 77.78 [66.7-89.9]; p=0.028, respectively). No significant between-group differences were found in top-quality embryos (p=0.693) or the clinical pregnancy rate (65.9% vs. 61.8% in the consecutive vs. concomitant protocol, respectively). The median follicular fluid soluble Fas antigen level was significantly higher in the concomitant protocol (9,731.0 pg/mL; IQR, 6,004.5-10,807.6 vs. 6,350.2 pg/mL; IQR, 4,382.4-9,418.4; p=0.021). Conclusion: Personalized controlled ovarian stimulation using HP-hMG during the late follicular phase led to a significantly lower response, but did not affect the quality of ICSI.

• Therapeutic Science for Rehabilitation
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• v.9 no.2
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• pp.27-38
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• 2020

Introduction : This review aims to introduce an intention-to-treat analysis(ITT) method and demonstrate the importance of rigorous utilization of this method to researchers in Korea. Discussion : ITT analysis includes all data as results in randomized control trials (RCT). Thereby the result of RCT is high validated to adapt in the real-world so that the result should be expected at clinical practice. Therefore, many RCT quality assessment tools include the question of the utilization of ITT analysis in individual trials. However, many researchers omit to report ITT, not utilize ITT or use ITT incorrectly. Conclusion : Through this review, more Korean researchers may understand and utilize ITT which is expected to enhance the quality of RCT papers.

• Journal of Oriental Neuropsychiatry
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• v.20 no.2
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• pp.143-152
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• 2009

Objectives : Hwabyung is one of well-known mental health problems like depression in Korea and it's concept is generated from oriental medicine. We suggest that clinical practice guideline should reflect the Hwabyung's characteristics, clinical environment and Oriental medical doctor's need. Methods : We use the general development method of clinical practice guideline and also apply the oriental medicine's properties. Results : We need to refer to the western psychiatric field, especially the clinical guideline of depression. And we should base on the clinical survey and trial with the selected core subject considering oriental medicine's character. Conclusions : From this development, we expect the application of proper clinical decision by medical team, the objectification of oriental medicine, and the improvement of medical quality in the clinical field of oriental medicine.

• The Journal of Korean Academic Society of Nursing Education
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• v.22 no.4
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• pp.559-566
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• 2016

Purpose: This study aimed to examine the communication styles and nursing service satisfaction of clinical research nurses perceived by clinical subjects. Methods: The data were collected with self-administrated questionnaires after receiving consents from 200 clinical trial subjects. The data were analysed with descriptive statistics, t-test, ANOVA, Pearson's correlation coefficients and stepwise multiple regression analysis using SPSS 21.0 statistic program. Result: Clinical subjects perceived that clinical research nurses used the informative, affective, and non-authoritative communication styles. The study identified factors influencing the nursing service satisfaction, and they were the informative communication styles (${\beta}$=.34, p<.001) and affective communication styles (${\beta}$=.35, p<.001, $R^2$=37%) by multiple linear regression. Conclusion: If educational programs on communication are developed to help clinical research nurses use the informative and affective communication styles according to the characteristics of subjects and applied to the field of practice, they will be able to increase the nursing service satisfaction and contribute to the higher quality of clinical trials.

• Journal of Korean Medicine Rehabilitation
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• v.33 no.4
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• pp.15-29
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• 2023

Objectives The purpose of this study is to systematically review the effects of Neuromuscular Electrical Stimulation treatment on muscle wasting in cancer patients. Methods Randomized controlled trials (RCTs) were searched from seven online databases (PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure, Oriental Medicine Advanced Searching Integrated System, Korean studies Information Service System, Research Information Sharing Service. The selected RCTs were evaluated for methodological quality through the Cochrane RoB. Results A total of 126 articles were identified, and 4 randomized controlled trials were selected for systematic review. In one study, it was found that there were statistically significant improvements in the Health-Related Quality of Life (FACTH&N total score, p<0.001). Additionally, significant effects were observed in measurements that represented the size of the quadriceps muscle (cross-sectional area of Vastus lateralis and Rectus femoris, p=0.004), maximum muscle strength, the twitch response of resistance muscles, and voluntary activation (p<0.001). However, no significant differences were observed between the intervention and control groups in terms of quadriceps muscle strength in two other studies (p>0.05). Lastly, while one study showed no significant differences in muscle fiber characteristics between the two groups, it did report significant improvements in measurements related to mitochondria within muscle tissue and muscle strength in the intervention group (p<0.05). Conclusions Neuromuscular electrical stimulation can be a method used to improve muscle strength in muscle wasting of cancer patients, but it is difficult to see its effects as significant compared to other treatments.

• Journal of the Korean Society of Food Science and Nutrition
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• v.43 no.8
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• pp.1197-1206
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• 2014

This study compared and analyzed the physiochemical and quality characteristics of young radish kimchi made with YR-FNC or YR-GC cultivated by organic farming as well as kimchi made with young radish cultivated by chemical composting/general farming (YR-Control). YR-Control showed higher contents of water and crude protein than YR-FNC and YR-GC kimchi but lower contents of crude ash, dietary fiber, and vitamin C. YR-FNC and YR-GC kimchi also showed higher contents of P and Cu than YR-Control but lower contents of N, K, Ca, Mg, Fe, and Zn. YR-Control fermentation progressed faster than that of YR-FNC or YR-GC after 24 days, and YR-Control more rapidly reached an appropriate pH. On the other hand, YR-FNC and YR-GC kimchi fermentation progressed slow and did not reach a pH level below 5.3. For period of fermentation, YR-Control and YR-FNC kimchi showed no significant difference in reducing sugar content, whereas that of YR-GC kimchi decreased significantly after 24 days of fermentation (P<0.002). YR-FNC and YR-GC kimchi showed 1.5~3 times higher total polyphenol and flavonoid contents than YR-Control at the beginning of fermentation, whereas YR-Control and YR-FNC kimchi showed a significant increase in total polyphenol and flavonoid contents during the fermentation period. By day 7 of fermentation, YR-FNC kimchi showed higher contents of lactic acid bacteria and total microbes than YR-Control. In the sensory evaluation, YR-FNC and YR-GC kimchi showed higher preference values than YR-Control. Therefore, kimchi made from young radish cultivated by organic farming has a longer freshness period than control kimchi and is characterized by excellent sensory quality, increased physiological contents, and improved beneficial health effects.

• 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.