• Title/Summary/Keyword: Trial Division

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Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial

  • Nam, Tae-Hyun;Kang, Sung-Yoon;Lee, Sang Min;Kim, Tae-Bum;Lee, Sang Pyo
    • Tuberculosis and Respiratory Diseases
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    • v.85 no.1
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    • pp.25-36
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    • 2022
  • Background: Only a few studies directly compared the therapeutic efficacy and safety of two pressurized metered-dose inhalers (pMDIs) in asthma. We analyzed the asthma treatment outcomes, safety, and patient preferences using formoterol/beclomethasone (FORM/BDP), a pMDI with extra-fine particles, compared with formoterol/budesonide (FORM/BUD), another pMDI with non-extra-fine particles. Methods: In this randomized, double-blind, double-dummy parallel group study, 40 adult asthmatics were randomized to FORM/BDP group (n=18; active FORM/BDP and placebo FORM/BUD) or FORM/BUD group (n=22; active FORM/BUD and placebo FORM/BDP). During the two visits (baseline and end of 8-week treatment), subjects were asked to answer questionnaires including asthma control test (ACT), asthma control questionnaires (ACQ), and Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA). Lung function, compliance with inhaler, and inhaler-handling skills were also assessed. Results: Ten subjects in the FORM/BDP group and 14 in the FORM/BUD group completed follow-up visits. ACT, ACQ, QLQAKA (a primary outcome), and adverse events did not differ between two groups. We found that the increase in forced expiratory volume in 1 second/forced vital capacity and forced expiratory flow at 25% to 75% of the pulmonary volume in the FORM/BDP group was higher than in the FORM/BUD group. Regarding preference, subjects responded that the flume velocity of FORM/BDP was higher, but more adequate than that of FORM/BUD. They also answered that FORM/BDP reached the trachea and bronchus and irritated them significantly more than FORM/BUD. Conclusion: The use of pMDI with extra-fine particles may relieve small airway obstruction more than the one with non-extra-fine particles despite no significant differences in overall treatment outcomes. Some asthmatics have a misconception about the adequacy of high flume velocity of pMDIs.

Evaluation of the equation for predicting dry matter intake of lactating dairy cows in the Korean feeding standards for dairy cattle

  • Lee, Mingyung;Lee, Junsung;Jeon, Seoyoung;Park, Seong-Min;Ki, Kwang-Seok;Seo, Seongwon
    • Animal Bioscience
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    • v.34 no.10
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    • pp.1623-1631
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    • 2021
  • Objective: This study aimed to validate and evaluate the dry matter (DM) intake prediction model of the Korean feeding standards for dairy cattle (KFSD). Methods: The KFSD DM intake (DMI) model was developed using a database containing the data from the Journal of Dairy Science from 2006 to 2011 (1,065 observations 287 studies). The development (458 observations from 103 studies) and evaluation databases (168 observations from 74 studies) were constructed from the database. The body weight (kg; BW), metabolic BW (BW0.75, MBW), 4% fat-corrected milk (FCM), forage as a percentage of dietary DM, and the dietary content of nutrients (% DM) were chosen as possible explanatory variables. A random coefficient model with the study as a random variable and a linear model without the random effect was used to select model variables and estimate parameters, respectively, during the model development. The best-fit equation was compared to published equations, and sensitivity analysis of the prediction equation was conducted. The KFSD model was also evaluated using in vivo feeding trial data. Results: The KFSD DMI equation is 4.103 (±2.994)+0.112 (±0.022)×MBW+0.284 (±0.020)×FCM-0.119 (±0.028)×neutral detergent fiber (NDF), explaining 47% of the variation in the evaluation dataset with no mean nor slope bias (p>0.05). The root mean square prediction error was 2.70 kg/d, best among the tested equations. The sensitivity analysis showed that the model is the most sensitive to FCM, followed by MBW and NDF. With the in vivo data, the KFSD equation showed slightly higher precision (R2 = 0.39) than the NRC equation (R2 = 0.37), with a mean bias of 1.19 kg and no slope bias (p>0.05). Conclusion: The KFSD DMI model is suitable for predicting the DMI of lactating dairy cows in practical situations in Korea.

Fecal microbiome shifts by different forms of copper supplementations in growing pigs

  • Kim, Minji;Cho, Jae Hyoung;Seong, Pil-Nam;Jung, Hyunjung;Jeong, Jin Young;Kim, Sheena;Kim, Hyeri;Kim, Eun Sol;Keum, Gi Beom;Guevarra, Robin B.;Kim, Hyeun Bum
    • Journal of Animal Science and Technology
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    • v.63 no.6
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    • pp.1386-1396
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    • 2021
  • Copper is an essential mineral for pigs, thus it is used as a feed additive in the forms of copper sulfate. Therefore, this study aimed at characterizing the fecal microbiota shifts in pigs as fed by different forms of copper supplementation. 40 growing pigs aged 73 ± 1 days with an average weight of 30.22 ± 1.92kg were randomly divided into 5 groups. The control group (CON) fed with basal diet, while treatment groups were fed a basal diet supplemented with 100 ppm/kg of copper sulfate (CuSO4), Cu-glycine complex (CuGly), Cu-amino acid complex (CuAA), and Cu-hydroxy(4methylthio)butanoate chelate complex (CuHMB) for 28 days of trial, respectively. The data presented the comparison between inorganic and organic copper supplementation through gut microbiota in growing pigs. Alpha and Beta diversity anaylsis resulted in copper supplementation did shifted gut microbioal community structure. At the phylum level, Firmicutes and Bacteroidetes were the most abundant phyla at all times regardless of treatment. At the genus level, the relative abundances of Prevotella, Lactobacillus, Megasphaera, and SMB53 of the CuGly and CuHMB groups were significantly higher than those of copper sulfate and basal diet groups. Overall, this study may provide the potential role of organic copper replacing inorganic copper, resulting in increased beneficial bacteria in the pig gut.

A pilot study on estimating the biomass of chub mackerel and jack mackerel in the northwestern sea of Jeju Island using trawl survey and frequency characteristics (트롤 조사와 주파수특성을 이용한 제주도 서북 해역의 고등어와 전갱이 생물량 추정에 관한 예비 연구)

  • KANG, Myounghee;MIN, Eunbi;KIM, Byung-Yeob;LEE, Changheon;KANG, Taejong;OH, Taegeon;LIM, Byeonggwon;HWANG, Doojin
    • Journal of the Korean Society of Fisheries and Ocean Technology
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    • v.58 no.1
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    • pp.49-58
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    • 2022
  • In September and October 2020, combined acoustic and trawl surveys were conducted in the northwestern sea of Jeju Island. In the survey area, a region, so called Jeju region, was designated to esimate the biomass of chub mackerel and jack mackerel using a trawl survey method and frequency difference method. In the September survey, the weight ratios of jack mackerel and chub mackerel to the total catch were 24.6% and 2.8%, respectively, and in the October survey, those ratios were 24.9% and 20.7%, which were used to calculate their biomass (trawl survey). Using the frequency difference range (-8 to -3dB) corresponding to two species in 120 and 200 kHz, their biomass was estimated (frequency difference method). As a result, the biomass of two species from the trawl method was 3252.3 tons in September and 5777.0 tons in October. The estimated biomass by the frequency difference method was 4926.6 tons in September and 7521.5 tons in October. It was the first trial to estimate the biomass of two species using the trawl and frequency differencing methods in South Korea although there were some differences between two methods. In addition, horizontal distributions of acoustic backscattering strength over the entire survey area were mapped.

Prospective Targets for Colon Cancer Prevention: from Basic Research, Epidemiology and Clinical Trial

  • Shingo Miyamoto;Masaru Terasaki;Rikako Ishigamori;Gen Fujii;Michihiro Mutoh
    • Journal of Digestive Cancer Research
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    • v.4 no.2
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    • pp.64-76
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    • 2016
  • The step-wise process of colorectal carcinogenesis from aberrant crypt foci, adenoma to adenocarcinoma, is relatively suitable for chemopreventive intervention. Accumulated evidences have revealed that maintaining an undifferentiated state (stemness), inflammation, and oxidative stress play important roles in this colon carcinogenesis process. However, appropriate molecular targets that are applicable to chemopreventive intervention regarding those three factors are still unclear. In this review, we summarized appropriate molecular targets by identification and validation of the prospective targets from a comprehensive overview of data that showed colon cancer preventive effects in clinical trials, epidemiological studies and basic research. We first selected a study that used aspirin, statins and metformin from FDA approved drugs, and epigallocatechin-gallate and curcumin from natural compounds as potential chemopreventive agents against colon cancer because these agents are considered to be promising chemopreventive agents. Experimental and observational data revealed that there are common target molecules in these potential chemopreventive agents: T-cell factor/lymphoid enhancer factor (TCF/LEF), nuclear factor-&B (NF-κB) and nuclear factor-erythroid 2-related factor 2(NRF2). Moreover, these targets, TCF/LEF, NF-κB and NRF2, have been also indicated to suppress maintenance of the undifferentiated state, inflammation and oxidative stress, respectively. In the near future, novel promising candidate agents for colon cancer chemoprevention could be identified by integral evaluation of their effects on these three transcriptional activities.

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Effects of the Various Dietary Additives on Growth and Tolerance of Abalone Haliotis discus hannai against Stresses (다양한 사료첨가제 공급에 따른 전복의 성장과 스트레스에 대한 내성 효과)

  • Cho, Sung-Hwoan;Kim, Chung-Il;Cho, Young-Jin;Lee, Bom-Sok;Park, Jung-Eun;Yoo, Jin-Hyung;Lee, Sang-Min
    • Journal of Aquaculture
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    • v.21 no.4
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    • pp.309-316
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    • 2008
  • Effects of the various dietary additives on growth and tolerance of abalone Haliotis discus hannai to the stresses were determined in the 16-week feeding trial. Seventy juvenile (an initial body weight of 4.2 g) abalone per container were randomly distributed into 21, 50 L plastic rectangular containers each. The six kinds of experimental diets were prepared: control (CON) with no additive, by-product of green tea (BPG), extract of figs (EF), extract of green tea (EG), commercially available product of Hearok (PH), and Haematococcus (HC). In addition, dry sea tangle (ST) was prepared to compare the efficiency of the experimental diets. Fishmeal, soybean meal and shrimp head meal were used as the protein source, and dextrin, sea tangle powder and wheat flour, and soybean oil and fish oil were used as the carbohydrate and lipid sources, respectively in the experimental diets. The experimental diets were fed to abalone once a day at a satiation level with a little leftover. The feeding trial lasted for 16 weeks. At the end of the 16-week feeding trial, abalone was exposed to the different types of stresses (air exposure, and sudden changes of rearing temperature and salinity). Survival of abalone fed the sea tangle was highest. However, weight gain of abalone fed the EF, EG and PH diets was significantly (P<0.05) higher than that of abalone fed the BPG diet or dry sea tangle. Shell length of abalone fed the all experimental diets was significantly (P<0.05) higher than that of abalone fed the dry sea tangle. Accumulated mortality of abalone fed the sea tangle was low when exposed to the different types of stresses. Also, relatively low mortality was achieved in abalone fed the HC and EF diets. In considering these results, it can be concluded that the various sources of additives is effective to improve production of abalone, and Haematococcus and extract of figs can be considered as dietary additives to improve resistance of abalone against the different types of stresses.

Hypoglycemic Effect of Smallanthus sonchifolius (Yacon) Extracts on Animals with Streptozotocin-induced Diabetes (야콘 추출물이 Streptozotocin으로 유도된 당뇨 동물모델에서 혈당강하에 미치는 효과)

  • Oh, Hong-Geun;Kang, Young-Rye;Kim, Jung-Hoon;Moon, Dea-In;Seo, Min-Young;Park, Sang-Hoon;Choi, Kwang-Ho;Kim, Chang-Ryong;Kim, Sang-Hyun;Oh, Ji-Hyun;Kim, Sun-Young;Kim, Min-Gul;Chae, Soo-Wan;Kim, Ok-Jin;Lee, Hak-Yong
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.41 no.6
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    • pp.759-765
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    • 2012
  • This study was performed to investigate improvements in diabetes mellitus by extracts of yacon in streptozotocin (STZ)-induced diabetic rats. Fifty rats were divided into a normal group and four experimental groups. STZ (45 mg/kg) was injected intraperitoneally to induce type I diabetes in the four experimental groups. Yacon extracts were administered for 5 weeks. Forty-five ICR mice were also divided into one positive control group and four experimental groups for the oral glucose tolerance test (OGTT) after fed yacon extract. The control group did not eat any yacon extracts, while Group 1 (GI) was fed 125 mg/kg of yacon extracts, Group 2 (GII) was fed 250 mg/kg of yacon extracts, and Group 3 (GIII) was fed 500 mg/kg of yacon extracts. After treatment for 5 weeks, blood glucose in GIII group showed decreased tendency at the 5 week. In OGTT by glucose, the glucose level of yacon treatment group in diabetic rats was significantly decreased compared to the glucose level of the control group, but there was no difference in OGTT by maltose. In ICR mice, the glucose level of the experimental group in OGTT by maltose was significantly decreased compared to the control group. The area of the islets of Langerhans was increased by yacon treatment in a dose-dependent manner on diabetic rats. Insulin concentration of the GIII group was also decreased compared to the control group, while the concentration of fructosamine, total cholesterol, and triglycerides in serum showed no difference. OGTT by glucose or maltose in ICR mice or diabetic rats, area of the Islets of Langerhans, and insulin concentration improved. Yacon treatment may be a useful therapeutic and preventive strategy for diabetes mellitus.

Administration of Yijung-tang, Pyeongwi-san, and Shihosogan-tang for Standardization of Korean Medicine Pattern Identification for Functional Dyspepsia: A Study Protocol of a Randomized, Assessor-blind, 3-Arm, Parallel, Open-label, Multicenter Clinical Trial (기능성 소화불량 한의 변증 표준화를 위한 이중탕, 평위산 및 시호소간탕 투여 : 무작위 배정, 평가자 눈가림, 3군 비교, 평행 설계, 공개, 다기관 임상시험 프로토콜)

  • Boram Lee;Min-Jin Cho;Young-Eun Choi;Ojin Kwon;Mi Young Lim;Seok-Jae Ko;So-yeon Kim;Yongjoo Kim;Donghyun Nam;Dong-Jun Choi;Jun-Hwan Lee;Jae-Woo Park;Hojun Kim
    • The Journal of Internal Korean Medicine
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    • v.43 no.6
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    • pp.1105-1121
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    • 2022
  • Objectives: The purpose of this study is to explore the effectiveness and safety of frequently used clinical herbal medicines (Yijung-tang [Lizhong-tang, LJT], Pyeongwi-san [Pingwei-san, PWS], and Shihosogan-tang [Chaihu Shugan-tang, SST]) in patients with functional dyspepsia (FD) when administered according to herbal medicine and Korean medicine pattern identification. The results of this study will be used to standardize the diagnostic instrument used in Korean medicine and to investigate biomarkers of Korean medicine pattern identification. Methods: This study will be a randomized, assessor-blind, 3-arm, parallel, open-label, multi-center clinical trial. A total of 300 FD participants will be recruited from 3 Korean medical hospitals and assigned to the LJT (n=100), PWS (n=100), and SST (n=100) groups according to FD pattern identification. The patients will take the medication for 8 weeks, 3 times a day, before or between meals. The primary outcome will be total dyspepsia symptom (TDS) and the secondary outcomes will be adequate relief (AR) for dyspepsia, overall treatment effect (OTE), visual analogue scale (VAS), functional dyspepsia-related quality of life (FD-QoL), gastrointestinal symptom score (GIS), and pattern identification questionnaires. For the exploratory outcomes, we will analyze blood and fecal metabolome profiles, microbiota from fecal and saliva samples, single nucleotide polymorphism (SNP), and results of Korean medicine diagnosis device measurements (heart rate variability, and tongue, pulse, and abdominal diagnosis). Conclusions: The results of this study will prove objectivity for Korean medicine pattern identifications, and the effectiveness and safety of herbal medicines for the population with FD.

Direct Switch from Tiotropium to Indacaterol/Glycopyrronium in Chronic Obstructive Pulmonary Disease Patients in Korea

  • Lee, Sang Haak;Rhee, Chin Kook;Yoo, Kwangha;Park, Jeong Woong;Yong, Suk Joong;Kim, Jusang;Lee, Taehoon;Lim, Seong Yong;Lee, Ji-Hyun;Park, Hye Yun;Moon, Minyoung;Jung, Ki-Suck
    • Tuberculosis and Respiratory Diseases
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    • v.84 no.2
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    • pp.96-104
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    • 2021
  • Background: Many chronic obstructive pulmonary disease (COPD) patients receiving monotherapy continue to experience symptoms, exacerbations and poor quality of life. This study aimed to assess the efficacy and safety of direct switch from once-daily tiotropium (TIO) 18 ㎍ to indacaterol/glycopyrronium (IND/GLY) 110/50 ㎍ once daily in COPD patients in Korea. Methods: This was a randomized, open-label, parallel group, 12-week trial in mild-to-moderate COPD patients who received TIO 18 ㎍ once daily for ≥12 weeks prior to study initiation. Patients aged ≥40 years, with predicted post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥50%, post-bronchodilator FEV1/forced vital capacity <0.7 and smoking history of ≥10 pack-years were included. Eligible patients were randomized in a 1:1 ratio to either IND/GLY or TIO. The primary objective was to demonstrate superiority of IND/GLY over TIO in pre-dose trough FEV1 at week 12. Secondary endpoints included transition dyspnea index (TDI) focal score, COPD assessment test (CAT) total score, and rescue medication use following the 12-week treatment, and safety assessment. Results: Of the 442 patients screened, 379 were randomized and 347 completed the study. IND/GLY demonstrated superiority in pre-dose trough FEV1 versus TIO at week 12 (least squares mean treatment difference [Δ], 50 mL; p=0.013). Also, numerical improvements were observed with IND/GLY in the TDI focal score (Δ, 0.31), CAT total score (Δ, -0.81), and rescue medication use (Δ, -0.09 puffs/day). Both treatments were well tolerated by patients. Conclusion: A direct switch from TIO to IND/GLY provided improvements in lung function and other patient-reported outcomes with an acceptable safety profile in patients with mild-to-moderate airflow limitation.