• Title/Summary/Keyword: Non-clinical trial

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Improvement of FK506 Production in the High-Yielding Strain Streptomyces sp. RM7011 by Engineering the Supply of Allylmalonyl-CoA Through a Combination of Genetic and Chemical Approach

  • Mo, SangJoon;Lee, Sung-Kwon;Jin, Ying-Yu;Suh, Joo-Won
    • Journal of Microbiology and Biotechnology
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    • v.26 no.2
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    • pp.233-240
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    • 2016
  • FK506, a widely used immunosuppressant, is a 23-membered polyketide macrolide that is produced by several Streptomyces species. FK506 high-yielding strain Streptomyces sp. RM7011 was developed from the discovered Streptomyces sp. KCCM 11116P by random mutagenesis in our previous study. The results of transcript expression analysis showed that the transcription levels of tcsA, B, C, and D were increased in Streptomyces sp. RM7011 by 2.1-, 3.1-, 3.3-, and 4.1-fold, respectively, compared with Streptomyces sp. KCCM 11116P. The overexpression of tcsABCD g enes in Streptomyces sp. RM7011 gave rise to approximately 2.5-fold (238.1 μg/ml) increase in the level of FK506 production compared with that of Streptomyces sp. RM7011. When vinyl pentanoate was added into the culture broth of Streptomyces sp. RM7011, the level of FK506 production was approximately 2.2-fold (207.7 μg/ml) higher than that of the unsupplemented fermentation. Furthermore, supplementing the culture broth of Streptomyces sp. RM7011 expressing tcsABCD genes with vinyl pentanoate resulted in an additional 1.7-fold improvement in the FK506 titer (498.1 μg/ml) compared with that observed under non-supplemented condition. Overall, the level of FK506 production was increased approximately 5.2-fold by engineering the supply of allylmalonyl-CoA in the high-yielding strain Streptomyces sp. RM7011, using a combination of overexpressing tcsABCD genes and adding vinyl pentanoate, as compared with Streptomyces sp. RM7011 (95.3 μg/ml). Moreover, among the three precursors analyzed, pentanoate was the most effective precursor, supporting the highest titer of FK506 in the FK506 high-yielding strain Streptomyces sp. RM7011.

The Case Study of Oriental Medicine Music Therapy's Effect on Improving Middle Aged Woman's Self-Esteem Inventory & Anger Expression and Depression (중년여성에게 실행한 한방음악치료 전후(前後) 자아존중감 및 분노와 우울증상 개선에 대한 1례(例))

  • Lee, Seung-Hyun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.27 no.3
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    • pp.175-188
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    • 2014
  • Objectives: The study was implemented to observe how Oriental Medicine Music Therapy (Korean Medicine Music Therapy) influences on curing the symptoms of anger and depression. Methods: Study conducted an experiment with an age of 43 female who usually suffers from headache and dizziness, and frequently gets angry at her daughter. The Study was conducted for an hour, 1 times a week. In the present study, the whole program consisted of 7 sessions. Other than the Oriental Medicine Music Therapy, the patient had never been cured by other treatments. Results: 1. According to the result of STAXI analysis, the patient with anger scale of 36 (before treatment) became to have anger scale of 31 after the treatment, indicating that the therapy had positive effect on curing the anger symptom. 2. Moreover, the analysis result of BDI showed that the patient with depression scale of 17 (before treatment) turned out to be non-depression state, which he had the depression scale of 8. Regarding the results above, it was observed that the treatment cured the depression symptom. 3. Based on the result of SEI analysis, the patient with a SEI score of 139 (higher the SEI score, more the self-esteem one has) became to have score of 142 after the treatment. Conclusions: From the research, it was observed that Korean Medicine Music Therapy has positive influence on improving one's anger or depression control and self-esteem. Clinical trial is needed to verify statistical significance.

Effects of a low-FODMAP enteral formula on diarrhea on patients in the intensive care unit

  • Bae, Eunjoo;Kim, Jiyoon;Jang, Jinyoung;Kim, Junghyun;Kim, Suyeon;Chang, Youngeun;KIM, MI YEON;Jeon, Mira;Kang, Seongsuk;Lee, Jung Keun;Kim, Tae Gon
    • Nutrition Research and Practice
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    • v.15 no.6
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    • pp.703-714
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    • 2021
  • BACKGROUND/OBJECTIVES: A dietary restriction on the intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) has been reported to be effective in the treatment of gastrointestinal (GI) tract complications. Enteral nutrition (EN) is widely used for patients who cannot obtain their nutritional requirements orally, but many studies have reported EN complications, especially diarrhea, in up to 50% of patients. SUBJECTS/METHODS: We performed a single-center, non-randomized, controlled trial to determine the effects of a low-FODMAP enteral formula on GI complications in patients in intensive care units (ICUs). Patients in the ICU who needed EN (n = 66) were alternately assigned to the low-FODMAP group (n = 33) or the high-FODMAP group (n = 33). RESULTS: Anthropometric and biochemical parameters were measured, and stool assessment was performed using King's Stool Chart. We excluded patients who received laxatives, GI motility agents, proton pump inhibitors, antifungal agents, and antibiotics other than β-lactams. There were no differences in GI symptoms during 7 days of intervention, including bowel sound, abdominal distension, and vomiting between the 2 groups. However, diarrhea was more frequent in the high-FODMAP group (7/33 patients) than the low-FODMAP group (1/33 patients) (P = 0.044). CONCLUSIONS: Our results suggest that a low-FODMAP enteral formula may be a practical therapeutic approach for patients who exhibit enteral formula complications. Our study warrants further randomized clinical trials and multicenter trials.

Effects of dynamic myofascial release on trunk mobility and standing balance in persons with chronic nonspecific low back pain

  • Lee, Dong-Woo;Shin, Hwa-Kyung;Kim, Kwang-Su
    • Physical Therapy Rehabilitation Science
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    • v.8 no.2
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    • pp.74-78
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    • 2019
  • Objective: Myofascial release (MFR) is used to restore tissue extensibility of the fascia tissue and is considered to be useful in a number of clinical settings, such as low back pain (LBP). Dynamic myofascial release (DMFR) is the manual therapy, which combined the conventional MFR with the joint mobilization. The purpose of this study was to investigate the effects of the DMFR on trunk mobility, and furthermore, whether the increase of trunk mobility can carry over the improvement of dynamic standing balance in persons with chronic nonspecific LBP. Design: Randomized controlled trial. Methods: Thirty persons with chronic non-specific LBP participated in the study and were randomly assigned to the DMFR group (n=15) or the control group (n=15). DMFR was performed for two sessions (15 minutes/session) per week for four weeks for the treatment group. Both the DMFR and control groups were allowed to perform low-intensity physical activities during the treatment period. The Modified-modified $Sch{\ddot{o}}ber$ test (MMST) for trunk mobility and the Functional Reach Test (FRT) for dynamic standing balance were measured before and after the treatment period in both the DMFR group and the control group. Results: The MMST value of DMFR group increased significantly in all trunk range of motion (flexion, extension, lateral flexion, and rotation) after treatment, compared with the control group (p<0.05). Additionally, the FRT value of the DMFR group improved significantly after treatment, compared with the control group (p<0.05). Conclusions: We suggest that DMFR have a positive effect on trunk mobility and standing balance in persons with chronic LBP.

Liquid Biopsy: Current Status and Future Perspective in Gastric Cancer and Helicobacter Infection (액체 생검(Liquid Biopsy): 위암 및 헬리코박터 감염증에서 적응과 전망)

  • Kang, Eun A;Han, Young Min;Park, Jong Min;Yoo, In Kyung;Hong, Sung Pyo;Hahm, Ki Baik
    • The Korean journal of helicobacter and upper gastrointestinal research
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    • v.18 no.3
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    • pp.150-156
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    • 2018
  • Precision medicine stands for 4Ps - precise, preventive, participatory, and personal; in which "precision" is important because the current modern medicine starts from "trial and error," and "one does not fit all". Current targeted therapies for cancer have changed treatment approaches and led the precision medicine; however, clinical use of liquid biopsy, using blood or other liquid specimens to characterize circulating tumor cells (CTC) or tumor genes instead of biopsies of tumor tissues, still awaits availability of more information regarding non-invasive cancer detection and characterization, prediction of treatment response, monitoring the disease course and relapse possibilities, identification of mechanisms of drug resistance, and newer pathogenesis. In this review, we will introduce the basic concept of CTC, circulating cell free DNA, and exosomes and their possible application for gastric cancer relevant with Helicobacter pylori infection.

Comparison of postoperative pain intensity after using reciprocating and continuous rotary glide path systems: a randomized clinical trial

  • Adiguzel, Mehmet;Yilmaz, Koray;Tufenkci, Pelin
    • Restorative Dentistry and Endodontics
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    • v.44 no.1
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    • pp.9.1-9.9
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    • 2019
  • Objectives: The aim of this study was to compare postoperative pain intensity after root canal treatment with One G (OG) vs. R-Pilot (RP) files used for glide path preparation. Materials and Methods: Ninety-three single-canaled mandibular premolar teeth with asymptomatic non-vital pulp were randomly assigned into 3 groups (n = 31): OG, RP, or without glide path (WGP). After creating the glide path, the root canals were prepared using sequential Mtwo rotary files to size 30/0.05. One endodontic specialist carried out single-visit endodontic treatment. The patients were asked to rate the severity of postoperative pain on a visual analogue scale at 24, 48, and 72 hours after the visit. They were also asked to record their intake of prescribed analgesics taken. The data were analyzed using the ${\chi}^2$, Friedman, Kruskal-Wallis, and Mann-Whitney U tests. Results: In all 3 groups, postoperative pain decreased significantly at each time interval (p < 0.05). At 24 hours, the OG group had less postoperative pain than the WGP group (p < 0.05). However, no significant difference was found between the RP group and the others. No statistically significant difference was found among the WGP, OG, and RP groups in postoperative pain intensity at 48 or 72 hours or in analgesic tablet intake at the 3 assessed time intervals. Conclusions: The OG group had less postoperative pain than the WGP group in the first 24 hours. The OG and RP systems were similar regarding postoperative pain intensity and analgesic intake.

Comparative evaluation of the effectiveness of two innovative methods in the management of anxiety in a dental office: a randomized controlled trial

  • Panchal, Jay;Panda, Anup;Trivedi, Krishna;Chari, Deepika;Shah, Rushita;Parmar, Binny
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.4
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    • pp.295-304
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    • 2022
  • Background: The first dental experience is vital in molding a child's attitude towards dentistry and dental outcomes. The cooperation of a child during dental treatment is essential to render successful and high-quality treatment. Dental anxiety is common in children undergoing dental treatment. The success of pediatric dental treatments and patient comfort depends on controlling the levels of patient anxiety in clinical settings. This study aimed to compare the effectiveness of the recorded maternal voice and virtual cognitive tool (Roogies application) in the management of pediatric dental patients. Methods: The study was carried out with children aged of 4-7 years [n = 80, (40 male and 40 female)], without any past dental history, and were randomly allocated into two groups. After informed consent was obtained, the entire procedure was explained to the parents. Anxiety was assessed pre-, during, and post-treatment by measuring pulse rate, and recording Venham Picture Test (VPT) scores. Group A [n = 40; 20 boys and 20 girls)] was provided with a headphone that played a recorded maternal voice. Group B [n = 40; 20 boys and 20 girls)] was administered the virtual cognitive tool. After conditioning the children, oral prophylaxis was performed for both groups. A comparative evaluation was conducted for each treatment session. Results: The intra-group comparison of VPT scores and heart rate for patients assigned to the recorded maternal voice showed a statistically significant difference in dental anxiety (P-value ≤0.001). Conclusion: This study demonstrated that a reduction in dental anxiety with the help of recorded maternal voice forms an important component of non-pharmacological behavior management. Alternatively, the use of a virtual cognitive tool as an anxiety-reducing technique can also be advocated.

Effects of Bojungikgi-tang and its modifications for Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (빈혈에 대한 보중익기탕 및 그 가미방의 효과: 체계적 문헌고찰과 메타분석)

  • Mikyung Kim;Chang-ho Han
    • The Journal of Korean Medicine
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    • v.44 no.2
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    • pp.181-200
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    • 2023
  • Objectives: This study aimed to evaluate the efficacy and safety of Bojungikgi-tang (BJIG) and its modifications for patients with anemia. Methods: The subject of analysis of this study was a parallel design randomized controlled trial in which BJIG or its modifications was administered orally to patients who met the World Health Organization's anemia criteria and the efficacy and safety were prospectively measured. Electronic databases were searched to retrieve eligible literature published from 1 January 2000 to 12 February 2023. A meta-analysis was conducted, and the risk of bias (RoB) and level of evidence of the included studies was assessed using the Cochrane RoB 2 tool and GRADE method, respectively. Results: Five studies were included in the meta-analysis. When BJIG or its modifications was administered to anemia patients receiving conventional treatment, additional benefits compared to the non-administered group were found in terms of an increase in red blood cell count (mean difference (MD) 0.46 × 1012/L, 95% confidence interval (CI) 0.17 to 0.74), hemoglobin concentration (MD 9.28 g/L, 95% CI 6.06 to 12.51), hematocrit (MD 2.57%, 95% CI 1.76 to 3.38), total effective rate (odds ratio 5.29, 95% CI 2.05 to 13.68), and traditional Chinese medicine symptom scores (standardized MD -1.51, 95% CI -2.79 to -0.24). Conclusions: This study demonstrated the clinical potential of BJIG and its modifications to provide additional benefits to patients with anemia receiving conventional treatment.

Development and Evaluation of Evidence-Based Nursing Protocol for Extracorporeal Membrane Oxygenation to Critically Ill Patients (체외막산소화장치 적용 중환자를 위한 근거기반 간호 프로토콜 개발 및 효과 평가)

  • Kim, Soomi;Kim, Chul-Gyu
    • Journal of Korean Academy of Nursing
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    • v.53 no.3
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    • pp.275-294
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    • 2023
  • Purpose: This study aimed to develop an evidence-based extracorporeal membrane oxygenation (ECMO) nursing protocol for critically ill patients receiving ECMO treatment by using an adaptation process, and to verify the effects of the protocol. Methods: The protocol was developed according to the adaptation guidelines. A non-randomized controlled trial was conducted to test the protocol's effects. Data were collected between April 2019 and March 2021. The differences in physiological indicators and complication rates between the two groups were investigated using a chart review to evaluate patient outcomes. The nurses' outcome variables were evaluated using a questionnaire. Results: First, after reviewing 11 guidelines by appraisal of the guidelines for research and evaluation collaboration II, 5 guidelines with a standardization grade of over 50 points were selected. An ECMO nursing protocol was developed based on these guidelines. Second, there were no statistically significant differences in physiological indicators between the two groups of patients. However, the experimental group showed a statistically significant decrease in the infection rate (p = .026) and pressure injury rates (p = .041). The levels of satisfaction with ECMO nursing care, and empowerment and performance of the nurses who used the ECMO nursing protocol were higher than those of nurses who did not (p < .001). Conclusion: This protocol may help prevent infections and pressure injuries in patients, and improve nurses' satisfaction and empowerment. The nursing protocol developed for critically ill patients receiving ECMO treatment can be utilized in evidence-based nursing practice.

Treat-to-Target Strategy for Asian Patients with Early Rheumatoid Arthritis: Result of a Multicenter Trial in Korea

  • Song, Jason Jungsik;Song, Yeong Wook;Bae, Sang Cheol;Cha, Hoon-Suk;Choe, Jung-Yoon;Choi, Sung Jae;Kim, Hyun Ah;Kim, Jinseok;Kim, Sung-Soo;Lee, Choong-Ki;Lee, Jisoo;Lee, Sang-Heon;Lee, Shin-Seok;Lee, Soo-Kon;Lee, Sung Won;Park, Sung-Hwan;Park, Won;Shim, Seung Cheol;Suh, Chang-Hee;Yoo, Bin;Yoo, Dae-Hyun;Yoo, Wan-Hee
    • Journal of Korean Medical Science
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    • v.33 no.52
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    • pp.346.1-346.11
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    • 2018
  • Background: To evaluate the therapeutic benefits of the treat-to-target (T2T) strategy for Asian patients with early rheumatoid arthritis (RA) in Korea. Methods: In a 1-year, multicenter, open-label strategy trial, 346 patients with early RA were recruited from 20 institutions across Korea and stratified into 2 groups, depending on whether they were recruited by rheumatologists who have adopted the T2T strategy (T2T group) or by rheumatologists who provided usual care (non-T2T group). Data regarding demographics, rheumatoid factor titer, anti-cyclic citrullinated peptide antibody titer, disease activity score of 28 joints (DAS28), and Korean Health Assessment Questionnaire (KHAQ) score were obtained at baseline and after 1 year of treatment. In the T2T group, the prescription for disease-modifying antirheumatic drugs was tailored to the predefined treatment target in each patient, namely remission (DAS28 < 2.6) or low disease activity (LDA) ($2.6{\leq}DAS28$ < 3.2). Results: Data were available for 163 T2T patients and 162 non-T2T patients. At the end of the study period, clinical outcomes were better in the T2T group than in the non-T2T group (LDA or remission, 59.5% vs. 35.8%; P < 0.001; remission, 43.6% vs. 19.8%; P < 0.001). Compared with non-T2T, T2T was also associated with higher rate of good European League Against Rheumatism response (63.0% vs. 39.8%; P < 0.001), improved KHAQ scores (-0.38 vs. -0.13; P = 0.008), and higher frequency of follow-up visits (5.0 vs. 2.0 visits/year; P < 0.001). Conclusion: In Asian patients with early RA, T2T improves disease activity and physical function. Setting a pre-defined treatment target in terms of DAS28 is recommended.