• Title/Summary/Keyword: Trial Division

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Effect of coadministration of enriched Korean Red Ginseng (Panax ginseng) and American ginseng (Panax quinquefolius L) on cardiometabolic outcomes in type-2 diabetes: A randomized controlled trial

  • Jovanovski, Elena;Smircic-Duvnjak, Lea;Komishon, Allison;Au-Yeung, Fei (Rodney);Sievenpiper, John L.;Zurbau, Andreea;Jenkins, Alexandra L.;Sung, Mi-Kyung;Josse, Robert;Li, Dandan;Vuksan, Vladimir
    • Journal of Ginseng Research
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    • v.45 no.5
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    • pp.546-554
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    • 2021
  • Background: Diabetes mellitus and hypertension often occur together, amplifying cardiovascular disease (CVD) risk and emphasizing the need for a multitargeted treatment approach. American ginseng (AG) and Korean Red Ginseng (KRG) species could improve glycemic control via complementary mechanisms. Additionally, a KRG-inherent component, ginsenoside Rg3, may moderate blood pressure (BP). Our objective was to investigate the therapeutic potential of coadministration of Rg3-enriched Korean Red Ginseng (Rg3-KRG) and AG, added to standard of care therapy, in the management of hypertension and cardiometabolic risk factors in type-2 diabetes. Methods: Within a randomized controlled, parallel design of 80 participants with type-2 diabetes (HbA1c: 6.5-8%) and hypertension (systolic BP: 140-160 mmHg or treated), supplementation with either 2.25 g/day of combined Rg3-KRG + AG or wheat-bran control was assessed over a 12-wk intervention period. The primary endpoint was ambulatory 24-h systolic BP. Additional endpoints included further hemodynamic assessment, glycemic control, plasma lipids and safety monitoring. Results: Combined ginseng intervention generated a mean ± SE decrease in primary endpoint of 24-h systolic BP (-3.98 ± 2.0 mmHg, p = 0.04). Additionally, there was a greater reduction in HbA1c (-0.35 ± 0.1% [-3.8 ± 1.1 mmol/mol], p = 0.02), and change in blood lipids: total cholesterol (-0.50 ± 0.2 mmol/l, p = 0.01), non-HDL-C (-0.54 ± 0.2 mmol/l, p = 0.01), triglycerides (-0.40 ± 0.2 mmol/l, p = 0.02) and LDL-C (-0.35 ± 0.2 mmol/l, p = 0.06) at 12 wks, relative to control. No adverse safety outcomes were observed. Conclusion: Coadministration of Rg3-KRG + AG is an effective addon for improving BP along with attaining favorable cardiometabolic outcomes in individuals with type 2 diabetes. Ginseng derivatives may offer clinical utility when included in the polypharmacy and lifestyle treatment of diabetes. Clinical trial registration: Clinicaltrials.gov identifier, NCT01578837;

Effects of Neuromuscular Electrical Stimulation on Muscle Wasting with Cancer Patient: A Systematic Review (신경근전기자극치료가 암 환자의 근육 손실에 미치는 영향: 체계적 문헌고찰)

  • Eun Soo Park;Jong Hee Kim;Soo Dam Kim;Dong Hyun Kim;Eun Jung Lee;Min Seok Oh;Hwa Seung Yoo
    • Journal of Korean Medicine Rehabilitation
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    • v.33 no.4
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    • pp.15-29
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    • 2023
  • Objectives The purpose of this study is to systematically review the effects of Neuromuscular Electrical Stimulation treatment on muscle wasting in cancer patients. Methods Randomized controlled trials (RCTs) were searched from seven online databases (PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure, Oriental Medicine Advanced Searching Integrated System, Korean studies Information Service System, Research Information Sharing Service. The selected RCTs were evaluated for methodological quality through the Cochrane RoB. Results A total of 126 articles were identified, and 4 randomized controlled trials were selected for systematic review. In one study, it was found that there were statistically significant improvements in the Health-Related Quality of Life (FACTH&N total score, p<0.001). Additionally, significant effects were observed in measurements that represented the size of the quadriceps muscle (cross-sectional area of Vastus lateralis and Rectus femoris, p=0.004), maximum muscle strength, the twitch response of resistance muscles, and voluntary activation (p<0.001). However, no significant differences were observed between the intervention and control groups in terms of quadriceps muscle strength in two other studies (p>0.05). Lastly, while one study showed no significant differences in muscle fiber characteristics between the two groups, it did report significant improvements in measurements related to mitochondria within muscle tissue and muscle strength in the intervention group (p<0.05). Conclusions Neuromuscular electrical stimulation can be a method used to improve muscle strength in muscle wasting of cancer patients, but it is difficult to see its effects as significant compared to other treatments.

Developing Measurement Items for the Service Quality of Clinical Trials based on the Brady & Cronin Model (Brady & Cronin의 모델에 기반한 임상시험 서비스 질 측정 문항 개발)

  • Go-Eun Lee;Sanghee Kim;Sue Kim;Sang Hui Chu;Jeong-Ho Seok;So Yoon Kim
    • The Journal of KAIRB
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    • v.6 no.1
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    • pp.17-31
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    • 2024
  • Purpose: This study aims to develop preliminary items for measuring the perceived service quality of clinical trials among participants and to verify content validity. Methods: This study was designed as a methodological study. A conceptual framework was established based on Brady and Cronin's hierarchical model, and preliminary items were prepared through translation-back-translation, a review of existing instruments, and in-depth interviews with clinical trial participants and clinical research coordinators. The final items were completed through content validity testing by experts and a review of items by clinical trial participants for the prepared preliminary items. Results: Through this study, a set of 58 items across four domains (quality of interaction with researchers, the physical environment, performance procedures, and performance results) and 9 components (information·education·communication, trust, respect for participant preferences, securing facilities and space, accessibility, comfortability, informed consent, coordination of care, subjective understanding of clinical trials) on the service quality of clinical trials were completed. The scale content validity index of all preliminary items was 0.96, meeting the recommended standards. The individual-item content validity index also meets the recommended criteria for most items, excluding four items. Conclusion: This study holds significance in developing items to measure the quality of clinical trial execution from the perspective of participants. By verifying the reliability and validity of these items through subsequent research, it is expected that they can be utilized as a valuable instrument to devise strategies for improving the quality of clinical trials.

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A Case Report of Concurrent Korean Herbal Medicine Treatment, Cognitive Behavior Therapy, and Person-centered Counseling Therapy for Anorexia Nervosa (신경성 식욕부진증에 대한 한약치료, 인지행동치료 및 인간중심상담치료 병행 1예 보고)

  • Her, Misuk;Kim, Hwan;Seo, Young-Kyung;Yang, Changsop;Lee, Mi-Young;Jang, Ik-Soon;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.3
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    • pp.195-206
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    • 2017
  • Objectives: To evaluate the effects of concurrent therapy with cognitive behavior therapy and person-centered counseling in addition to general Korean herbal medicine treatment for a patient with anorexia nervosa. Methods: A patient diagnosed with anorexia nervosa was treated with Korean herbal medicine treatment, cognitive behavior therapy, and person-centered treatment. The results were evaluated through a feeding interview, self-checklist, beck depression inventory (BDI) and InBody test. Results: After the treatment period, the treatment effects such as improvement of dietary restriction and elimination behavior, weight gain, and reduced depression were confirmed. Conclusions: This study suggests that concurrent therapy together with cognitive behavior therapy, person-centered counseling, and general Korean herbal medicine treatment is effective on patients with anorexia nervosa.

Effects of Dietary Scutellaria baicalensis Extract on Growth, Feed Utilization and Challenge Test of Olive Flounder (Paralichthys olivaceus)

  • Cho, S.H.;Jeon, G.H.;Kim, H.S.;Kim, D.S.;Kim, C.
    • Asian-Australasian Journal of Animal Sciences
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    • v.26 no.1
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    • pp.90-96
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    • 2013
  • Effects of dietary Scutellaria baicalensis extract (SBE) on growth, feed utilization and challenge test of olive flounder (Paralichthys olivaceus) were determined. Six hundred thirty fish averaging 5.0 g were distributed into 18, 180-L tanks. Six experimental diets were prepared in triplicate: SBE-0, SBE-0.5, SBE-1, SBE-2, SBE-3 and SBE-5 diets containing SBE at the concentrations of 0, 0.5, 1, 2, 3 and 5%, respectively. Fish were hand-fed to apparent satiation twice a day for 8 wks. At the end of 8-wk feeding trial, ten fish from each tank were infected by Edwardsiella tarda for challenge test. Survival and weight gain of fish were not affected by dietary concentrations of SBE. However, specific growth rate of fish fed the SBE-2 diet was higher than that of fish fed the SBE-0, SBE-1, SBE-3 and SBE-5 diets. Neither feed efficiency nor serum chemical composition of fish was affected by dietary concentrations of SBE. The cumulative mortality of fish fed the SBE-0 diet was 100% at 96 h after E. tarda infection, but 77 to 87% for fish fed the other diets. Dietary inclusion of 2% SBE appears to be recommendable to improve specific growth rate of fish and SBE had the potential to mitigate mortality of fish at E. tarda infection.

Pharmacokinetics of Astromicin Following a Single Intravenous Infusion in Healthy Korean Subjects (정상성인 한국인에서 아스트로마이신 1회 점적 주사후 약물동태학적 평가)

  • Bok, Hae Sook;Choi, Kyung Eob;Kim, Yeon Hwa;Peck, Kyong Ran;Song, Jae Hoon
    • Korean Journal of Clinical Pharmacy
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    • v.13 no.2
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    • pp.55-58
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    • 2003
  • Astromicin is an aminoglycoside antiviotic that is structually different from conventional aminoglycosides. Astromicin has been shown to be active against aerobic Gram-negative bacilli. The pharmacokinetics of astromicin were determined in 12 healthy volunteers ($65.5\pm5.23\;kg$ of body weight) following a 30-min continuous intravenous infusion at a dose of 200 mg. The plasma and urine samples were collected up to 24 h and drug concentrations were measured by a bioassay using Bacillus subtilis. Pharmacokinetic parameters were calculated by fitting individual concentration-time curve to a one-exponential decay model. The plasma levels were $16.9\pm1.68\;and\;1.05\pm0.346\l{\mu}g/ml$ at 0 h and 8 h after the infusion, respectively. The elimination half-life of astromicin was $1.86\pm0.360\;h$ The volume of distribution was $0.182\pm0.0164\;L/kg$, and the total body clearance was $5.25\pm1.74\;L/h$. These pharmacokinetic parameters were similar to these of gentamicin, tobramycin, and amikacin. Therefore, it is recommended that therapeutic drug monitoring of astromicin could be conducted in a similar fashion as the other aminoglycosides.

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Iodine Supplementation of Leucaena leucocephala Diet for Goats. I. Effects on Nutrient Utilization

  • Rajendran, D.;Pattanaik, A.K.;Khan, S.A.;Bedi, S.P.S.
    • Asian-Australasian Journal of Animal Sciences
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    • v.14 no.6
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    • pp.785-790
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    • 2001
  • Twelve indigenous male goats, comprising of six intact and six castrated (2.5-3 years; $24.4{\pm}0.62kg$) were assigned evenly into two dietary treatments, viz. $I_0$ and $I_{100}$ and were used to study the effect of supplementation of iodine on the nutrient utilization when their diet contained Leucaena leaf meal. They were offered a conventional concentrate mixture along with Leucaena leucocephala leaf meal, the latter to meet 50% of their crude protein (CP) requirements, and supplemented with either no iodine ($I_0$) or 0.1 mg of iodine ($I_{100}$)/day/animal as potassium iodide for a period of 105 days. Wheat straw given ad libitum was the sole source of roughage. A metabolism trial of 8 days duration was conducted after 90 days of experimental feeding. It was observed that the overall dry matter (DM) intake during experimental period was higher (p<0.05) in $I_{100}$ group as compared to $I_0$ group (508.6 vs. $443.7g\;d^{-1}$). The intake of CP, digestible crude protein (DCP) and metabolisable energy (ME), although non-significant, tended to be higher in the iodine supplemented group, $I_{100}$. Digestibility of dry matter, organic matter (OM), CP, ether extract and crude fiber (CF) did not differ (p>0.05) between the treatments. However, nitrogen retention was higher (p<0.01) in $I_{100}$ than $I_0$ with the values being 2.63 and $1.70g\;d^{-1}$, respectively. No difference (p>0.05) was evident in the retention of calcium and phosphorus between the two groups. The castrated animal exhibited lower DM intake concurrent with higher digestibility of DM and crude fibre (p<0.05), and organic matter and total carbohydrates (p<0.01) when compared to intact ones. It was concluded that supplementation of iodine to leucaena based ration may help in improving the DM intake and nitrogen utilization by goats.

The Marine Safety Judgment Management System for Scientific Investigation and Analysis of Marine Accidents (해양사고의 과학적인 수사 및 분석을 위한 해양안전심판관리 시스템)

  • Kim, Jeong-Rok;Jong, Jae-Yong;Im, Nam-Kyun;Kim, Chol-Seong
    • Proceedings of KOSOMES biannual meeting
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    • 2006.11a
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    • pp.9-13
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    • 2006
  • In the marine accidents judgment, investigation of truth of matters is one of important process to find out the reason of ship collision accidents. In this paper, reproduce system of ship collision accidents using ship manoeuvirng simulator technique will be introduced with which marine accidents can be easily reproduced in visual display at the case of marine accidents trial. In this system if the users select the type of ship and location of accidents, the process of ship collision will be provided in 2D and 3D display. The system also provides environmental visualizationdisplay such as fog whether and day-night view including various view angle that can be helpful to find out the reason of accidents.

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Effect of Selective Consumption on Intake, Diet Selectivity and Passage Kinetics of Wheat Straw by Barbari Goats

  • Biswal, B.;Hasan, Q.Z.;Sharma, K.;Dutta, N.
    • Asian-Australasian Journal of Animal Sciences
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    • v.13 no.7
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    • pp.913-917
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    • 2000
  • Sixteen adult Barbari bucks were divided into 4 homogeneous groups, each group was offered wheat straw (WS) at levels 75, 100, 125 and 150 per cent of ad libitum intake in a factorial randomized complete block design. All goats were uniformly fed a supplement ($13.5g\;DM/kg\;W^{0.75}$) to fulfill their requirement for protein at maintenance level. The experimental feeding of goats at different levels for 21 days was followed by a digestion trial of 6 days and determination of rate of passage of digesta for 144 h duration, respectively. Intake ($g/kg\;W^{0.75}$) of dry matter (DM), organic matter (OM), digestible DM and digestible OM increased with increase in amount of WS offered. The levels of WS refusals for obtaining upper limit of intake was found to be above 30% of DMO. Concentration of ADF and lignin was significantly lower and CP was higher (p>0.05) in food ingested relative to food offered or refused in response to increasing allowance of WS. Dietary means of particulate rate of passage from rumen, transit time and total mean retention time ranged from 0.032 to 0.036/h, 19.10 to 21.72/h and 58.61 to 61.53/h respectively and did not show significant differences (p>0.05) irrespective of dietary level of WS. The results suggest that DMI and quality of ingested WS would improve with higher rates of offer and refusals (${\geq}30%$ of DMO) without any pronounced effect on passage kinetics of digesta, because of the greater opportunity afforded to goats for selective feeding.

Evaluation of a Visible Implant Fluorescent Elastomer Tag in the Greenling Hexagrammos otakii

  • Park, In-Seok;Kim, Young Ju;Gil, Hyun Woo;Kim, Dong-Soo
    • Fisheries and Aquatic Sciences
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    • v.16 no.1
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    • pp.35-39
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    • 2013
  • The aim of this study was to assess visible implant fluorescent elastomer (VIE) tagging in greenling Hexagrammos otakii. The experiental fish were anesthetized individually and marked with orange, yellow, red, and green elastomer at the following five body locations, respectively: the adipose eyelid, the surface of the dorsal fin base, the inside surface of the pectoral fin base, the inside surface of the pelvic fin base, and the surface of the anal fin base. Control fish were anesthetized but not marked. During the 20-month trial, fish growth and retention, underwater visibility, and readability of the tags were determined. After 20 months, body length of marked greenling ($43.2{\pm}3.5cm$, mean ${\pm}$ standard deviation [SD]) did not differ from that of the control ($41.4{\pm}3.7cm$). Additionally, the body weight of marked greenling ($527.4{\pm}39.8g$, mean ${\pm}$ SD) did not differ from that of the controls ($505.9{\pm}31.7g$). Greenling retained >90% of the tags at the surface of the dorsal fin base. The anal fin base showed a higher tag retention rate than the inside surfaces of the pectoral fin and the pelvic fin bases (P < 0.05). Red and orange tags were identified more easily underwater than green and yellow tags. Green and yellow tags emitted fluorescence in response to a narrower range of light wavelengths. Thus, the VIE mark was easy to apply to greenling (< 1 min per fish) and was readily visible when viewed under an ultraviolet lamp.