• Title/Summary/Keyword: phase II trial

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Supplementation of Dried Mealworm (Tenebrio molitor larva) on Growth Performance, Nutrient Digestibility and Blood Profiles in Weaning Pigs

  • Jin, X.H.;Heo, P.S.;Hong, J.S.;Kim, N.J.;Kim, Y.Y.
    • Asian-Australasian Journal of Animal Sciences
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    • v.29 no.7
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    • pp.979-986
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    • 2016
  • This experiment was conducted to investigate the effects of dried mealworm (Tenebrio molitor larva) on growth performance, nutrient digestibility and blood profiles in weaning pigs. A total of 120 weaning pigs ($28{\pm}3days$ and $8.04{\pm}0.08kg$ of body weight) were allotted to one of five treatments, based on sex and body weight, in 6 replicates with 4 pigs per pen by a randomized complete block design. Supplementation level of dried mealworm was 0%, 1.5%, 3.0%, 4.5%, or 6.0% in experimental diet as treatment. Two phase feeding programs (phase I from 0 day to 14 day, phase II from 14 day to 35 day) were used in this experiment. All animals were allowed to access diet and water ad libitum. During phase I, increasing level of dried mealworm in diet linearly improved the body weight (p<0.01), average daily gain (ADG) (p<0.01) and average daily feed intake (ADFI) (p<0.01). During phase II, ADG also tended to increase linearly when pigs were fed higher level of dried mealworm (p = 0.08). In addition, increasing level of dried mealworm improved the ADG (p<0.01), ADFI (p<0.05) and tended to increase gain to feed ratio (p = 0.07) during the whole experimental period. As dried mealworm level was increased, nitrogen retention and digestibility of dry matter as well as crude protein were linearly increased (p = 0.05). In the results of blood profiles, decrease of blood urea nitrogen (linear, p = 0.05) and increase of insulin-like growth factor (linear, p = 0.03) were observed as dried mealworm was increased in diet during phase II. However, there were no significant differences in immunoglobulin A (IgA) and IgG concentration by addition of dried mealworm in the growth trial. Consequently, supplementation of dried mealworm up to 6% in weaning pigs' diet improves growth performance and nutrient digestibility without any detrimental effect on immune responses.

Effects of the plane of nutrition for grower pigs on their grow-finish performance and meat quality in winter

  • Yang, Bo-Seok;Kim, Myeong Hyeon;Choi, Jung-Seok;Jin, Sang Keun;Park, Man-Jong;Song, Young-Min;Lee, Chul Young
    • Journal of Animal Science and Technology
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    • v.61 no.1
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    • pp.1-9
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    • 2019
  • Little is known about the effects of the plane of nutrition on growth performance and meat quality of grow-finish pigs under commercial production conditions. The present study was thus addressed to this virtually unanswered question. One hundred and two barrows and 102 gilts weighing approximately 24 kg were fed phase I and II grower diets with a high, medium, or low plane of nutrition (HP, MP, or LP) to approximately 43 and 70 kg, respectively, in 6 replicates (pens). Subsequently, the HP and MP groups were fed the HP and MP1 finisher diets, respectively, the LP group being fed a second MP (MP2) finisher diet (LP1 group). Moreover, 68 LP-grower-fed barrows and gilts were added to the feeding trial and fed the MP1 and LP finisher diets to approximately 95 kg and thereafter, respectively (LP2 group). All MP diets had the lysine:calorie ratios comparable to the RNC recommendations, with < 18% differences between those of the HP and LP diets. The finisher pigs were reared in 16 pens and slaughtered at approximately 115 kg. The gain:feed ratio, but not average daily gain (ADG), was greater for the HP group than for the MP and LP during the grower phase I whereas during the grower phase II, ADG was greater (p < 0.05) for the HP and LP groups vs. MP. During the finisher phase I, ADG was less for the LP (LP1 + LP2) group vs. HP and MP, with no difference between the HP and MP groups; the gain:feed ratio was less for the LP vs. MP group. Backfat thickness was greater for the LP vs. HP group. The water holding capacity of fresh longissimus dorsi muscle (LM) and the sensory juiciness score for cooked LM were greatest for the LP group, the sensory flavor and tenderness scores being greater for the LP group vs. MP. In conclusion, results suggest that compensatory growth occurred for the LP and MP groups during the grower phase II and finisher phase I, respectively, with fat deposition increased for the LP group and that meat quality could be improved by the use of LP.

Adjuvant Chemotherapy with or without Concurrent Radiotherapy for Patients with Stage IB Gastric Cancer: a Subgroup Analysis of the Adjuvant Chemoradiotherapy in Stomach Tumors (ARTIST) Phase III Trial

  • Kim, Youjin;Kim, Kyoung-Mee;Choi, Min Gew;Lee, Jun Ho;Sohn, Tae Sung;Bae, Jae Moon;Kim, Sung;Lee, Su Jin;Kim, Seung Tae;Lee, Jeeyun;Park, Joon Oh;Park, Young Suk;Lim, Ho Yeong;Kang, Won Ki;Park, Se Hoon
    • Journal of Gastric Cancer
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    • v.18 no.4
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    • pp.348-355
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    • 2018
  • Purpose: We aimed to discuss the roles of radiation and chemotherapy as adjuvant treatment in patients with staged IB GC who were enrolled in the adjuvant chemoradiotherapy in stomach tumors (ARTIST) trial. Materials and Methods: Among the 458 patients who were enrolled in the ARTIST trial, 99 had stage IB disease. The patients were randomly assigned to receive either adjuvant chemoradiotherapy with capecitabine plus cisplatin (XP, n=50) or chemoradiotherapy (XPRT, n=49). Survival analyses were performed in accordance with the AJCC 2010 staging system. Results: According to the AJCC 2010 system, stage migration from IB to II occurred in 71% of the patients; 98% of the T2 N0 cases were reclassified as T3 N0, and 42% of the T1 N1 cases were reclassified as T1 N2. When comparing survival outcomes between the XPRT and XP arms for stage IB cancer (AJCC 2002), no significant difference in 5-year disease-free survival (DFS) between the 2 arms was found. (median 5-year DFS, not reached, P=0.256). The patients classified as having stage IB cancer (AJCC 2002) and reclassified as having stage II cancer (AJCC 2010) exhibited worse prognoses than those who remained in stage IB, although the difference was not statistically significant (5-year DFS rate, 83% vs. 93%). When we compared 5-year DFS in 70 patients with stage II (AJCC 2010), the addition of radiotherapy to XP chemotherapy did not show better outcome than XP alone (P=0.137). Conclusions: The role of adjuvant chemoradiotherapy in the treatment of stage IB GC (AJCC 2002) warrants further investigation.

Comparative Growth Performance of the Selected and the Non-selected Red Sea Bream (Pagrus major) Lines (선발과 비선발 참돔 (Pagrus maior) 계통의 성장 양상 비교)

  • NOH Choong Hwan;HONG Kyung Pyo;OH Sung-Yong;CHOI Hee Jung;PARK Yong Joo;MYOUNG Jung Goo;KIM Jong Man
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.37 no.5
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    • pp.400-404
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    • 2004
  • Growth performances of the selected and the non-selected red sea bream (Pagrus major) lines were evaluated up to marketable size. The offspring were mass-produced either from the selected line (the fourth generation of broods from mass selection) or the non-selected line (the second generation of wild broods). Early (59 to 103 days old, trial I) and late growth performances (4 to 24 months old, trial II) were evaluated based on communal rearing in land-based tanks and sea cages, respectively. In trial I, the selected line exhibited significantly higher values in both weight gain (WG) and specific growth rate (SGR) when compared to those observed in the non-selected line (P<0.05). In trial II comprising of three growth phases (4-9, 9-16 and 16-24 months old), selected line showed only slightly improved in WG and SGR at the beginning two growth phases (4-9 and 9-16 months old) (P>0.05), however, displayed significantly higher values at the last growth phase (16-24 months old) (P<0.05). Overall WG and SGR throughout the experiment (4-24 months) were also significantly higher in the selected line than the non-selected line (P<0.05). Consequently, mean body weight of the selected line at 24 months old was 1.4-fold (40.8{\%}\;increased) as compared to that of the non-selected line. This present result indicates that mass selection of this species against the growth traits might be quite effective, and the present advance has important Implication in the productivity enhancement of red sea bream aquaculture.

Ongoing Clinical Trials of Vaccines to Fight against COVID-19 Pandemic

  • Chiranjib Chakraborty;Ashish Ranjan Sharma;Manojit Bhattacharya;Garima Sharma;Rudra P. Saha;Sang-Soo Lee
    • IMMUNE NETWORK
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    • v.21 no.1
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    • pp.5.1-5.22
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    • 2021
  • Coronavirus disease 2019 (COVID-19) has developed as a pandemic, and it created an outrageous effect on the current healthcare and economic system throughout the globe. To date, there is no appropriate therapeutics or vaccines against the disease. The entire human race is eagerly waiting for the development of new therapeutics or vaccines against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Efforts are being taken to develop vaccines at a rapid rate for fighting against the ongoing pandemic situation. Amongst the various vaccines under consideration, some are either in the preclinical stage or in the clinical stages of development (phase-I, -II, and -III). Even, phase-III trials are being conducted for some repurposed vaccines like Bacillus Calmette-Guérin, polio vaccine, and measles-mumps-rubella. We have highlighted the ongoing clinical trial landscape of the COVID-19 as well as repurposed vaccines. An insight into the current status of the available antigenic epitopes for SARS-CoV-2 and different types of vaccine platforms of COVID-19 vaccines has been discussed. These vaccines are highlighted throughout the world by different news agencies. Moreover, ongoing clinical trials for repurposed vaccines for COVID-19 and critical factors associated with the development of COVID-19 vaccines have also been described.

Review of Literatures for Development of Clinical Trial Guideline for Total Ankle Arthroplasty (인공발목관절의 임상시험 가이드라인 개발을 위한 문헌적 고찰)

  • Park, Jin Oh;Lee, Moses;Lee, Jin Woo;Lee, Soo Bin;Han, Seung Hwan
    • Journal of Korean Foot and Ankle Society
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    • v.18 no.4
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    • pp.195-201
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    • 2014
  • Purpose: The purpose of this study is to develop guidelines for clinical trial of the total ankle replacement system for premarket approval. Materials and Methods: We selected and analyzed nine peer-reviewed articles whose quality had been proven in a previous phase. Two investigators extracted parameters for guideline criteria, including number of cases, patient age, follow-up period, failure rate, radiographic osteolysis rate, residual pain rate, and percentage of satisfaction. In addition, the inclusion and exclusion criteria were analyzed and developed. Results: Eight level IV studies and one level II study were included. The average number of cases was 159 cases and the mean patient age was 63.5 years. The mean follow-up period was 4.2 years, ranging from two to nine. The average failure rate of total ankle replacement in mid- to long-term follow-up was approximately 13% (2%~32.3%). The rate of osteolysis was approximately 18%. Residual pain was common (21.4%~46%), but overall patient satisfaction was approximately 85.6% (67.5%~97%). Conclusion: The results could be used as criteria for designing the clinical studies, such as number of cases, patient age (over 60 years), and follow-up period (minimum two years). The clinical scoring system and 36-item short form health survey (SF-36) was the most commonly used method for clinical evaluation for total ankle arthroplasty. In addition, the overall results, including failure rate, osteolysis rate, and patient satisfaction, could be used as a parameter of guidelines for premarket approval.

Long-term cosmesis following a novel schedule of accelerated partial breast radiation in selected early stage breast cancer: result of a prospective clinical trial

  • Sayan, Mutlay;Hard, Daphne;Wilson, Karen;Nelson, Carl;Gagne, Havaleh;Rubin, Deborah;Heimann, Ruth
    • Radiation Oncology Journal
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    • v.35 no.4
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    • pp.325-331
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    • 2017
  • Purpose: There is controversy regarding the cosmetic outcome after accelerated partial breast radiation (APBR). We report the cosmetic outcome from a single-arm prospective clinical trial of APBR delivered using intensity-modulated radiation therapy (IMRT) in elderly patients with stage I breast cancer (BC), using a novel fractionation schedule. Materials and Methods: Forty-two patients aged ${\geq}65$, with Stage I BC who underwent breast-conserving surgery were enrolled in a phase I/II study evaluating a 2-week course of APBR. Thirty eligible patients received 40 Gy in 4 Gy daily fractions. Cosmetic outcome was assessed subjectively by physician/patient and objectively by using a computer program (BCCT.core) before APBR, during, and after completion of the treatment. Results: The median age was 72 years, the median tumor size was 0.8 cm, and the median follow-up was 50.5 months. The 5-year locoregional control in this cohort was 97% and overall survival 87%. At the last follow-up, patients and physicians rated cosmesis as 'excellent' or 'good' in 100% and 91 %, respectively. The BCCT.core program scored the cosmesis as 'excellent' or 'good' in 87% of the patients at baseline and 81% at the last follow-up. The median $V_{50}$ (20 Gy) of the whole breast volume (WBV) was 37.2%, with the median WBV $V_{100}$ (40 Gy) of 10.9%. Conclusion: An excellent rate of tumor control was observed in this prospective trial. By using multiple assessment techniques, we are showing acceptable cosmesis, supporting the use of IMRT planned APBR with daily schedule in elderly patients with early stage BC.

evaluation of PBAs packaging density in an ATM switching system (ATM 교환시스템의 PBA 실장밀도 평가와 예측)

  • 이명호;전용일;전병윤;박권철
    • Journal of the Korean Institute of Telematics and Electronics A
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    • v.33A no.3
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    • pp.55-64
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    • 1996
  • In this paper, we analyze packaging data of th eprinted board assemblies (PBAs) of an ATM switching system (the first network test bed) by statistical methods and discuss the relation between devices packaging area of a PBA and power consumption by a regression nalysis method. As a result, we evaluate the maximum power consumption of the PBA. And, this paper presents a forecasting mehtod of the packagable maximum power consumption per a PBA when TTL devices are replaced by ASIC or FPGA ones in a PBA. And, we forecast the possibility of packaging ATM switch circuit packs in the near future form a statistical viewpoint. These evaluation and forecasting results can reduce much development cost and time because trial nd error will not be made using these useful data when phase II ATM switching system will be realized in the near future.

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Optimal Scheme of Postoperative Chemoradiotherapy in Rectal Cancer : Phase III Prospective Randomized Trial (직장암의 근치적 수술 후 화학요법과 방사선치료의 순서)

  • Kim Young Seok;Kim Jong Hoon;Choi Eun Kyung;Ahn Seung Do;Lee Sang-Wook;Kim Kyoung-Ju;Lee Je Hwan;Kim Jin Cheon;You Chang Sik;Kim Hee Cheol
    • Radiation Oncology Journal
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    • v.20 no.1
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    • pp.53-61
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    • 2002
  • Purpose : To determine the optimal scheme of postoperative chemoradiotherapy in rectal cancer by comparing survival, Patterns of failure, toxicities in early and late radiotherapy groups using a Phase III randomized prospective clinical trial. Materials and Methods : From January 1996 to March 1999, 307 patients with curatively resected AJCC stage II and III rectal cancer were assigned randomly to an 'early (151 patients, arm 1)' or a 'late (156 patients, arm II)' and were administered combined chemotherapy (5-FU $375\;mg/m^2/day$, leucovorin $20\;mg/m^2$, IV bolus daily, for 3 days with RT, 5 days without RT, 8 cycles with 4 weeks interval) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Patients of arm I received radiation therapy from day 1 of the first cycle of chemotherapy and those of arm II from day 57 with a third cycle of chemotherapy. The median follow-up period of living patients was 40 months. Results : Of the 307 patients enrolled, fifty patients did not receive scheduled radiation therapy or chemotherapy. The overall survival rate and disease free survival rate at 5 years were $78.3\%\;and\;68.7\%$ in arm I, and $78.4\%\;and\;67.5\%$ in arm II. The local recurrence rate was $6.6\%\;and\;6.4\%$ (p=0.46) in arms I and II, respectively, no significant difference was observed between the distant metastasis rates of the two arms ($23.8\%\;and\;29.5\%$, p=0.16). During radiation therapy, grade 3 diarrhea or more, by the NCI common toxicity criteria, was observed in $63.0\%\;and\;58.2\%$ of the respective arms (p=N.S.), but most were controlled with supportive care. Hematologic toxicity (leukopenia) greater than RTOG grade 2 was found in only $1.3\%\;and\;2.6\%$ of patients in each respective arm. Conclusion : There was no significant difference in survival, patterns of failure or toxicities between the early and late radiation therapy arms. Postoperative adjuvant chemoradiation was found to be a relatively safe treatment but higher compliance is needed.