• 제목/요약/키워드: Trial Division

검색결과 620건 처리시간 0.03초

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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    • 제85권1호
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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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    • 제34권10호
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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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    • 제63권6호
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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.

트롤 조사와 주파수특성을 이용한 제주도 서북 해역의 고등어와 전갱이 생물량 추정에 관한 예비 연구 (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)

  • 강명희;민은비;김병엽;이창헌;강태종;오태건;임병권;황두진
    • 수산해양기술연구
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    • 제58권1호
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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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    • 제4권2호
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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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다양한 사료첨가제 공급에 따른 전복의 성장과 스트레스에 대한 내성 효과 (Effects of the Various Dietary Additives on Growth and Tolerance of Abalone Haliotis discus hannai against Stresses)

  • 조성환;김충일;조영진;이범석;박정은;유진형;이상민
    • 한국양식학회지
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    • 제21권4호
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    • pp.309-316
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    • 2008
  • 사료내 다양한 사료 첨가제 공급에 따른 전복의 성장과 스트레스(공기중 노출, 급격한 온도 변화 및 급격한 염분 변화)에 대한 전복의 내성에 미치는 영향을 조사하였다. 21개의 직사각형 50 L 플라스틱 용기에 각각 70 마리의 치패(시작시 무게 4.2 g)를 수용하여 3개의 1.3톤 raceway에 분산 수용하였다. 다양한 원료의 사료첨가제를 이용하여 6종류의 실험사료 [대조구 (CON), 녹차부산물 첨가(BPC), 무화과엑기스 첨가(EF), 녹차엑기스 첨가(EG), 시판용 해록상품 첨가(PH) 및 Haematococcus 첨가(HC)]를 제조하였으며, 이들 실험사료의 유용성을 평가하기 위하여 건조 다시마(ST)를 공급하는 실험구와 비교하였다. 실험사료는 어분, 대두박 및 새우머리분을 주요 단백질원으로 공급하였으며, 덱스트린, 다시마분말 및 소맥분을 주요 탄수화물원으로 공급하였으며, 대두유와 어유를 주요 지질원으로 공급하여 주었다. 전복은 1일 1회 사료가 조금씩 남아서 만복시까지 먹게끔 충분한 양의 사료를 공급하여 주었다. 각 실험구는 3반복구를 두었으며, 총 사육기간은 16주간이었다. 16주간의 사육실험 종료후, 각 실험 구에서 생존한 전복은 10마리씩 무작위로 추출하여 공기노출, 급격한 온도 변화 및 급격한 염분변화의 스트레스를 주어서 이들의 누적폐사율을 조사하였다. 16주간의 사육실험 종료시 전복의 생존율은 다시마를 공급한 실험구에서 가장 높았다. 그러나 전복의 체중증가는 무화과엑기스, 녹차엑기스 및 해록상품을 첨가한 실험사료를 공급한 실험구에서 녹차부산물 첨가한 시험구 또는 다시마를 공급한 실험구에 비하여 유의적으로 높게 나타났다. 전복의 각장은 다시마를 공급한 실험구에 비하여 실험용 사료를 공급한 모든 실험구에서 유의적으로 높게 나타났다 다양한 형태의 스트레스에 노출시 전복의 누적폐사율은 다시마를 공급한 실험 구에서 낮게 나타났으며, Haematococcus 첨가구 및 무화과엑기스 첨가구에서도 비교적 낮은 전복의 폐사율을 보였다. 이상의 결과를 고려할 때, 본 실험에 이용된 다양한 사료첨가제는 전복의 성장을 개선시키는데 효과적이며, 특히 Haematococcus와 무화과엑기스는 다양한 형태의 스트레스의 내성을 개선시키는 사료 첨가제로서 이용 가능한 것으로 판단된다.

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

  • 오홍근;강영례;김정훈;문대인;서민영;박상훈;최광호;김창용;김상현;오지현;김선영;김민걸;채수완;김옥진;이학용
    • 한국식품영양과학회지
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    • 제41권6호
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    • pp.759-765
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    • 2012
  • 본 연구에서는 5주간 야콘 추출물을 경구투여 하여 STZ에 의한 제1형 당뇨모델에서 주간혈당, 경구 당부하 검사, 랑게르한스섬의 크기 및 혈중 내 인슐린 농도를 관찰함으로써 당뇨 개선에 대한 평가를 하였다. 7주령 SD rats은 normal군, control군(STZ), GI(STZ+125 mg/kg 야콘), GII(STZ+250 mg/kg 야콘)와 GIII(STZ+500 mg/kg 야콘)으로 군 구성을 하였다. 주간 체중은 군간 차이가 없었으며, 주간 혈당은 5주차의 control군에 비하여 GIII군에서 감소하는 경향이 나타났으나 통계학적인 유의성은 없었다. 경구당부하 검사 결과는 STZ으로 유도된 동물모델에서 glucose 투여에 의한 혈당변화는 유의하게 감소하였고 maltose 투여에 의한 혈당변화는 감소하는 경향은 나타났으나 유의한 차이는 없었다. 또한 ICR계 mice에서의 경구 당부하 검사에서 maltose에 의한 혈당변화는 control군에 비하여 GIII군에서 유의하게 감소하였다. 더욱이 STZ에 의해 감소한 랑게르한스섬의 크기가 유의하게 증가되었으며, 비슷한 결과로 혈중 인슐린 농도가 증가되었다. 그러나 혈중 fructosamine, total cholesterol 및 triglyceride의 농도는 유의한 차이를 관찰할 수 없었다. 본 연구에서는 5주간의 야콘 추출물 섭취가 경구당부하 검사, 췌장조직 내 랑게르한스섬의 크기 및 혈중 인슐린 농도를 개선시킴으로써 당뇨 개선에 도움을 줄 것으로 생각된다.

기능성 소화불량 한의 변증 표준화를 위한 이중탕, 평위산 및 시호소간탕 투여 : 무작위 배정, 평가자 눈가림, 3군 비교, 평행 설계, 공개, 다기관 임상시험 프로토콜 (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)

  • 이보람;조민진;최영은;권오진;임미영;고석재;김소연;김용주;남동현;최동준;이준환;박재우;김호준
    • 대한한방내과학회지
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    • 제43권6호
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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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    • 제84권2호
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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.