• Title/Summary/Keyword: Phase I Trial

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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.

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.

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.

EFFECTS OF PROTEIN LEVEL AND EXTRUSION PROCESSING OF SOYBEAN MEAL ON THE PERFORMANCE OF GROWING PIGS

  • Paik, I.K.;Um, J.S.;Lee, S.H.;Chung, M.S.
    • Asian-Australasian Journal of Animal Sciences
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    • v.8 no.2
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    • pp.129-133
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    • 1995
  • A feeding trial was conducted to evaluate the effects of crude protein concentration (44% vs 48%) and extrusion processing of soybean meal (SBM) on the performance of weanling and growing pigs. One hundred and ninety two (96 pigs of each sex) 3 way crossed (Landrace ${\times}$ Hampshire ${\times}$ Duroc) weaned pigs were allotted to 12 pens each of 16 pigs (8 pigs of each sex). Three pens were assigned to each of the 4 treatment; $T_1$; 44% SBM diet, $T_2$; extruded 44% SBM diet, $T_3$; 48% SBM diet and $T_4$; extruded 48% SBM diet. The 44% SBM diet was formulated to have 18% CP for the starter phase (5-10 wk of age) and 15% CP for the grower phase (10-15 wk of age). The other treatments used equivalent amount of each SBM, replacing the 44% SBM. Chemical assay showed that extrusion processing generally decreased amino acid content especially total lysine and available lysine. Extrusion increased Hunterlab color +a value and decreased the urease activity index. The body weight gains for the $T_3$ and $T_4$ pigs were significantly(p < 0.05) greater than for those on $T_1$ and $T_2$ for the starter phase, but not the grower phase. Extrusion processing did not improve weight gain. Feed intake for the overall period was significantly(p < 0.05) different among treatments. The feed conversion ratios were not significantly different among treatments. An economic analysis showed that the high protein (48%) SBM diet was more cost effective than the low protein(44%) SBM diet, for the starter phase.

Histone Deacetylase in Carcinogenesis and Its Inhibitors as Anti-cancer Agents

  • Kim, Dong-Hoon;Kim, Min-Jung;Kwon, Ho-Jeong
    • BMB Reports
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    • v.36 no.1
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    • pp.110-119
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    • 2003
  • The acetylation state of histone is reversibly regulated by histone acetyltransferase (HAT) and deacetylase (HDAC). An imbalance of this reaction leads to an aberrant behavior of the cells in morphology, cell cycle, differentiation, and carcinogenesis. Recently, these key enzymes in the gene expression were cloned. They revealed a broad use of this modification, not only in histone, but also other proteins that involved transcription, nuclear transport, and cytoskeleton. These results suggest that HAT/HDAC takes charge of multiple-functions in the cell, not just the gene expression. HDAC is especially known to play an important role in carcinogenesis. The enzyme has been considered a target molecule for cancer therapy. The inhibition of HDAC activity by a specific inhibitor induces growth arrest, differentiation, and apoptosis of transformed or several cancer cells. Some of these inhibitors are in a clinical trial at phase I or phase II. The discovery and development of specific HDAC inhibitors are helpful for cancer therapy, and decipher the molecular mode of action for HDAC.

Investigation on the modified continual reassessment method in phase I clinical trial (1상 임상실험에서 수정된 CRM에 대한 연구)

  • 강승호
    • The Korean Journal of Applied Statistics
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    • v.15 no.2
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    • pp.323-336
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    • 2002
  • In this paper we consider the modified continual reassessment method in which a cohort consists of three patients. Simulation has been a main research tool in the investigation of CRM. In this paper we propose complete enumeration as an alternative of simulation. Using new method we show that the expected toxicity rate at the MTD converges to the target toxicity rate well as the sample size increases.

CONSISTENCY AND ASYMPTOTIC NORMALITY OF A MODIFIED LIKELIHOOD APPROACH CONTINUAL REASSESSMENT METHOD

  • Kang, Seung-Ho
    • Journal of the Korean Statistical Society
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    • v.32 no.1
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    • pp.33-46
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    • 2003
  • The continual reassessment method (CRM) provides a Bayesian estimation of the maximum tolerated dose (MTD) in phase I clinical trials. The CRM has been proposed as an alternative design of the standard design. The CRM has been modified to improve practical feasibility and, recently, the likelihood approach CRM has been proposed. In this paper we investigate the consistency and asymptotic normality of the modified likelihood approach CRM in which the maximum likelihood estimate is used instead of the posterior mean. Small-sample properties of the consistency is examined using complete enumeration. Both the asymptotic results and their small-sample properties show that the modified CRML outperforms the standard design.

Development and Clinical Evaluation of Dendritic Cell Vaccines for HPV Related Cervical Cancer - a Feasibility Study

  • Ramanathan, Priya;Ganeshrajah, Selvaluxmy;Raghanvan, Rajalekshmi Kamalalayam;Singh, Shirley Sundar;Thangarajan, Rajkumar
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.14
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    • pp.5909-5916
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    • 2014
  • Human papillomavirus infection (HPV) and HPV related immune perturbation play important roles in the development of cervical cancer. Since mature dendritic cells (DCs) are potent antigen-presenting cells (APC), they could be primed by HPV antigens against cervical cancers. In this study we were able to generate, maintain and characterize, both phenotypically and functionally, patient specific dendritic cells in vitro. A randomized Phase I trial with three arms - saline control (arm I), unprimed mature DC (arm II) and autologous tumor lysate primed mature DC (arm III) and fourteen patients was conducted. According to WHO criteria, grade 0 or grade one toxicity was observed in three patients. One patient who received tumor lysate primed dendritic cells and later cis-platin chemotherapy showed a complete clinical response of her large metastatic disease and remained disease free for more than 72 months. Our findings indicate that DC vaccines hold promise as adjuvant sfor cervical cancer treatment and further studies to improve their efficacy need to be conducted.

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 Dietary Coconut Oil as a Medium-chain Fatty Acid Source on Performance, Carcass Composition and Serum Lipids in Male Broilers

  • Wang, Jianhong;Wang, Xiaoxiao;Li, Juntao;Chen, Yiqiang;Yang, Wenjun;Zhang, Liying
    • Asian-Australasian Journal of Animal Sciences
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    • v.28 no.2
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    • pp.223-230
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    • 2015
  • This study was conducted to investigate the effects of dietary coconut oil as a medium-chain fatty acid (MCFA) source on performance, carcass composition and serum lipids in male broilers. A total of 540, one-day-old, male Arbor Acres broilers were randomly allotted to 1 of 5 treatments with each treatment being applied to 6 replicates of 18 chicks. The basal diet (i.e., R0) was based on corn and soybean meal and was supplemented with 1.5% soybean oil during the starter phase (d 0 to 21) and 3.0% soybean oil during the grower phase (d 22 to 42). Four experimental diets were formulated by replacing 25%, 50%, 75%, or 100% of the soybean oil with coconut oil (i.e., R25, R50, R75, and R100). Soybean oil and coconut oil were used as sources of long-chain fatty acid and MCFA, respectively. The feeding trial showed that dietary coconut oil had no effect on weight gain, feed intake or feed conversion. On d 42, serum levels of total cholesterol, low-density lipoprotein cholesterol, and low-density lipoprotein/high-density lipoprotein cholesterol were linearly decreased as the coconut oil level increased (p<0.01). Lipoprotein lipase, hepatic lipase, and total lipase activities were linearly increased as the coconut oil level increased (p<0.01). Abdominal fat weight/eviscerated weight (p = 0.05), intermuscular fat width (p<0.01) and subcutaneous fat thickness (p<0.01) showed a significant quadratic relationship, with the lowest value at R75. These results indicated that replacement of 75% of the soybean oil in diets with coconut oil is the optimum level to reduce fat deposition and favorably affect lipid profiles without impairing performance in broilers.