• Title/Summary/Keyword: Trial Intention

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Effect of dietary salicylic acid supplementation on performance and blood metabolites of sows and their litters

  • Serge, Muhizi;Sungbo, Cho;Thanapal, Palanisamy;In Ho, Kim
    • Journal of Animal Science and Technology
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    • v.64 no.4
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    • pp.707-716
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    • 2022
  • The core intention to undertake this experiment for a period of 21 days is to evaluate the effect of salicylic acid (SA) supplemented diet on the performance and blood metabolites of sows and their litters. Sows weighing 208.5 ± 18.34kg and their neonates were used. From day 114 of gestation to 21st day of lactation(weaning), ten multiparous sows (n = 5/treatment) (Landrace × Yorkshire) were assigned randomly into one of two treatments: CON (basal diet) and TRT (CON + 0.05% SA). There was no significant difference in the body weight, backfat thickness, backfat loss, and body condition score in SA treated sows compared to sows fed the CON diet. However, the bodyweight of sow was dramatically reduced by an average of 16kg from farrowing to weaning time. The dietary inclusion of SA in the sow diet slightly improved the survival rate (p = 0.065) and showed a higher body weight (p = 0.009) in piglets. However, there was no significant difference in red blood cell, Fe, Hematocrit, and Hb concentrations between CON and TRT sows' groups, but the total iron-binding capacity (TIBC) was significantly reduced in sows from the TRT group compared with the CON group from the beginning to weaning. The outcome of this trial shows that dietary addition of SA on sows diet from early lactation could increase the birth weight and TIBC of neonates at the end of the trial.

Sample Size Calculations with Dropouts in Clinical Trials (임상시험에서 중도탈락을 고려한 표본크기의 결정)

  • Lee, Ki-Hoon
    • Communications for Statistical Applications and Methods
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    • v.15 no.3
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    • pp.353-365
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    • 2008
  • The sample size in a clinical trial is determined by the hypothesis, the variance of observations, the effect size, the power and the significance level. Dropouts in clinical trials are inevitable, so we need to consider dropouts on the determination of sample size. It is common that some proportion corresponding to the expected dropout rate would be added to the sample size calculated from a mathematical equation. This paper proposes new equations for calculating sample size dealing with dropouts. Since we observe data longitudinally in most clinical trials, we can use a last observation to impute for missing one in the intention to treat (ITT) trials, and this technique is called last observation carried forward(LOCF). But LOCF might make deviations on the assumed variance and effect size, so that we could not guarantee the power of test with the sample size obtained from the existing equation. This study suggests the formulas for sample size involving information about dropouts and shows the properties of the proposed method in testing equality of means.

Comparison of the Suicide Attempt Characteristics Associated with Mixed and Non-Mixed Depression in Koreans

  • Choi, Hyeon-Seok;Kim, Sung-Jin;Nam, Sang-Hun;Jung, Do-Un;Moon, Jung-Joon;Kim, Yeon-Sue;Oh, Min-Kyung;Jeon, Dong-Wook;Ahn, Yong Min
    • Korean Journal of Psychosomatic Medicine
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    • v.29 no.2
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    • pp.199-206
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    • 2021
  • Objectives : This study aimed to compare the characteristics of suicide attempts among Korean patients with mixed and non-mixed depression. Methods : Patients who visited the emergency room due to a suicide attempt and participated in the Korean Cohort for the Model Predicting a Suicide and Suicide-related Behavior study were included. Using the Montgomery-Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS), 111 patients were classified into the mixed depression (n=46) and non-mixed depression groups (n=65). The Koukopoulos Mixed Depression Rating Scale (KMDRS) score was calculated using the MADRS and YMRS scores. Suicide attempt characteristics were evaluated using the Columbia Suicidal Severity Rating Scale (C-SSRS) and Suicide Intent Scale (SIS). Results : In the mixed depression group, the reason item among the ideation intensity score of the C-SSRS was higher, and the deterrent item score was lower. Scores on the timing and suicide note items of the SIS were higher, and scores for overt communication items were lower in the mixed depression group. The KMDRS score was positively correlated with the C-SSRS ideation intensity and total SIS score. After adjusting for additional variables, the KMDRS scores had a significant effect on the C-SSRS ideation intensity and total SIS scores. Conclusions : The mixed depression group showed a difference in the intensity of suicidal ideation and suicidal intention compared to those in the non-mixed depression group. The overall suicidal ideation intensity and suicidal intention increased according to the degree of mixed depression.

Job Stress and Turnover of Fashion Designers and Fashion Merchandisers (어패럴업계 전문직 종사자의 직무스트레스와 이직에 관한 연구)

  • 하유선;정성지
    • Journal of the Korean Society of Clothing and Textiles
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    • v.24 no.8
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    • pp.1103-1114
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    • 2000
  • The purpose of the study was to investigate the level and the major causes of job stress, and the causes of the high level of job turnover rate of fashion merchandisers and fashion designers. The study also examined the correlations among the major causes of job stress, job results and job turnover rate. A part of the questionnaire consisted of questions on major causes of job stress, job result, and intention and trial to leave a job. The subjects were to rate on 5 point Likert-type scales. The other part included the questions on demographic and individual characteristics of the subjects and their company characteristics. For the survey, the subjects were 99 fashion merchandisers and 128 fashion designers who are employed by mens or womens wear manufacturers. The SAS PC+ package was used to calculate frequency, Cronbach $\alpha$, multiple regressions. The results of the study were as follows: 1. The high degree of the job results were resulted from the high degree of specialties in their job characteristics, high contentment in human relations, career development and income, and low role conflict. 2. Stronger intentions and more trials to leave their job were correlated to better task performance in the workplace, lower commitment to their job, and lower job satisfaction. 3. Higher level of job stress caused by interpersonal relationship in the organization and contentment in career development and income affected stronger intentions and more trials to leave their job.

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Estimation of Willingness To Pay for Health Forecasting Services (건강예보 서비스 제공에 대한 지불의사금액 추정)

  • Oh, Jin-A;Park, Jong-Kil;Oh, Min-Kyung
    • Journal of Environmental Science International
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    • v.20 no.3
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    • pp.395-404
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    • 2011
  • Weather forecasting is one of the key elements to improve health through the prevention and mitigation of health problems. Health forecasting is a potential resource creating enormous added value as it is effectively used for people. The purpose of this study is to estimate 'Willingness to Pay' for health forecasting. This survey was carried out to derive willingness to pay from 400 people who lived in Busan and Kyungnam Province and over 30 years of age during the period of July 1-31, 2009. The results showed that a 47.50% of people had intention to willingness to pay for health forecasting, and the pay was 7,184.21 won per year. Willing to pay goes higher depending on 'tax burden as to benefit of weather forecasting', 'importance of the weather forecasting in the aspect of health', 'satisfaction to the weather forecasting', and 'frequency of health weather index check'. This study followed the suggestion of the Korea Meteorological Administration generally and the values derived through surveys could be reliable. It can be concluded that a number of citizens who are willing to pay for health forecasting are high enough to meet the costs needed to provide health forecasting.

The change of the Pre-Post a maximal exercise on the Physiological Variable in the athletics children runners (소년체전 육상선수들의 최대 운동부하 전.후 혈중 생리적 변인 변화에 관한 연구)

  • Koo, Sung-Wan;Park, Han-Su
    • Journal of Korean Physical Therapy Science
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    • v.11 no.1
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    • pp.5-13
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    • 2004
  • The purpose of this study was to the Pre-Post maximal exercise for analyze the Physiological Variable(Lactate, LDH, Glucose) in the runners. The subjects were 12 volunteers 6 sprinters and 6 distance runners who agreed to intention of this study. Subjects performed until possible all-out trials. Blood samples were taken from a median cubital vein Pre-Post exercise and every rest 5min during the all-out trial. The results obtained were summarized as follow ; 1) Lactate of Pre-Post exercise in treadmill test showed no significant difference between sprinters and distance runners, but showed significant in sprinters and distance respectively 2) LDH of Pre-Post exercise in treadmill test showed no significant difference between sprinters and distance runners, and that showed no significant in sprinters and distance respectively 3) Glucose of Pre-Post exercise in treadmill test showed no significant difference between sprinters and distance runners, and showed no significant in distance, but showed significant in sprinters therefor, since the runners has an intermittent characteristic which includes a frequent momentary change, it needs the fitness training that being consisted of various training, in the training method, it needs the training process which is from the whole fitness to specific fitness to improve general physical ability.

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The clinical effects of a hydroxyapatite containing toothpaste for dentine hypersensitivity (민감성 치아에 대한 수산화인회석 함유 치약의 임상적 효과)

  • Kim, Su-Hwan;Park, Jun-Beom;Lee, Chul-Woo;Koo, Ki-Tae;Kim, Tae-Il;Seol, Yang-Jo;Lee, Yong-Moo;Ku, Young;Chung, Chong-Pyung;Rhyu, In-Chul
    • Journal of Periodontal and Implant Science
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    • v.39 no.1
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    • pp.87-94
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    • 2009
  • Purpose: The aim of this study was to compare the effectiveness of hydroxyapatite containing toothpaste with positive control toothpastes in reducing dentine hypersensitivity. Materials and methods: This clinical trial was a double-blind, randomized, parallel group comparison of two, namely hydroxyapatite containing toothpaste and strontium chloride containing toothpaste. A total of 55 subjects were included in this study. The subjects were given randomly assigned one of the two toothpastes after received tooth brushing instruction at baseline. Some clinical indices(PI, GI, PD), verbal rating score(VRS) for sensitivity to stimulus, the effect in relieving sensitivity and visual analogue scale(VAS) for sensitivity at baseline, week 2, week 4 and week 8 were assessed. All data were evaluated by intention-to-treat analysis. Results: Overall, PI and GI scores were significantly reduced compare baseline in all groups(p<0.05). In addition, there was significant difference in PI at 4 weeks and in GI at 4, 8 weeks between groups. The proportions of subjects relieved sensitivity were 70.4% in experimental group and 57.1% in control group at 8 weeks respectively. The VRS for sensitivity to three kinds of stimuli and VAS for sensitivity decreased according to time, there was no overall difference between two groups(p>0.05). Conclusion: This study demonstrated that the new hydroxyapatite containing toothpaste was similarly effective in reducing dentine hypersensitivity with pre-existing benchmark toothpaste.

A randomized controlled trial of an individualized nutrition counseling program matched with a transtheoretical model for overweight and obese females in Thailand

  • Karintrakul, Sasipha;Angkatavanich, Jongjit
    • Nutrition Research and Practice
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    • v.11 no.4
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    • pp.319-326
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    • 2017
  • BACKGROUND/OBJECTIVE: Effective weight reduction remains a challenge throughout the world as the prevalence of obesity and its consequences are increasing. This study aimed to determine the effects of an individualized nutrition counseling program (IC) matched with a transtheoretical model (TTM) for overweight and obese subjects. SUBJECTS/METHODS: Fifty overweight and obese subjects aged 19-60 years with a body mass index ${\geq}23kg/m^2$ were enrolled in the weight reduction study. They were randomized into two groups: Intervention group received an IC matched with a TTM; control group received an educational handbook. Body weight (BW), body fat (BF), waist circumference (WC), waist to height ratio (WHtR), stages of change (SOC), processes of change (POC), food intake, and physical activity (PA) were assessed at baseline and at 4, 8, and 12 weeks after program initiation in both groups. All data were analyzed by intention-to-treat, using SPSS software for hypothesis testing. RESULTS: Forty-five female subjects were included in the 12-week trial at Ramkhamhaeng Hospital, Bangkok, Thailand. The results showed significant weight loss ($1.98{\pm}1.75kg$; 3% loss of initial weight) in the intervention group at 12 weeks, compared to a $0.17{\pm}1.67kg$ loss in the control group. There were significant differences between intervention and control groups in BF mass ($-1.68{\pm}1.78$, $-0.04{\pm}1.62kg$); percentage BF ($-1.54{\pm}2.11$, $0.08{\pm}2.05$); WC ($-5.35{\pm}3.84$, $0.13{\pm}3.23cm$); WHtR ($-0.0336{\pm}0.02$, $-0.0004{\pm}0.02$), and energy consumption ($-405.09{\pm}431.31$, $-74.92{\pm}499.54kcal/day$) in the intervention and control groups, respectively. Intragroup SOC was improved in both groups. The POC for the weight management action (WMA) process was significantly different with POC scores increasing by $16.00{\pm}11.73$ and $7.74{\pm}14.97$ in the intervention and the control groups, respectively. PA level did not change in either group. CONCLUSIONS: The IC matched with a TTM resulted in reductions in BW, BF, and WC, thus reducing likely health risks by decreasing energy intake and inducing positive behavior changes while enhancing the WMA process.

Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05 Randomized Clinical Trial

  • Hwang, Sun-Hwi;Park, Do Joong;Kim, Hyung-Ho;Hyung, Woo Jin;Hur, Hoon;Yang, Han-Kwang;Lee, Hyuk-Joon;Kim, Hyoung-Il;Kong, Seong-Ho;Kim, Young Woo;Lee, Han Hong;Kim, Beom Su;Park, Young-Kyu;Lee, Young-Joon;Ahn, Sang-Hoon;Lee, In-Seob;Suh, Yun-Suhk;Park, Ji-Ho;Ahn, Soyeon;Han, Sang-Uk
    • Journal of Gastric Cancer
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    • v.22 no.2
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    • pp.94-106
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    • 2022
  • Purpose: Laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a function-preserving procedure performed for treating upper early gastric cancer (EGC). However, few studies have compared the outcomes of LPG-DTR with those of laparoscopic total gastrectomy (LTG). This study aimed at comparing the short-term outcomes of LPG-DTR between LTG and upper EGC. Materials and Methods: For upper-third EGC, a multicenter, prospective, randomized trial was performed to compare those who underwent LPG-DTR with those who underwent LTG. Short-term outcomes, including clinicopathologic results, morbidity, mortality, and postoperative courses, were evaluated using a full analysis set based on the intention-to-treat principle and the per-protocol set. Results: Of the patients, 138 who fulfilled the criteria were randomized to each group. One patient in the LPG-DTR group withdrew consent. Sixty-eight patients underwent LPG-DTR and 69 underwent LTG. The operative time (LPG-DTR=219.4 minutes; LTG=201.8 minutes; P=0.085), estimated blood loss (LPG-DTR=76.0 mL; LTG=66.1 mL; P=0.413), and the morbidity rate (LPG-DTR=23.5%; LTG=17.4%; P=0.373) between the groups were not significantly different. No mortality occurred in either of the study groups. Two weeks post operation, the Visick scores for postprandial symptoms, including reflux symptoms, were not significantly different between the groups (P=0.749). Laboratory findings on postoperative day 5 were not significantly different between the groups. Conclusions: The short-term outcomes of LPG-DTR for upper EGC were comparable to those of LTG.

No-Touch vs. Conventional Radiofrequency Ablation Using Twin Internally Cooled Wet Electrodes for Small Hepatocellular Carcinomas: A Randomized Prospective Comparative Study

  • Yun Seok Suh;Jae Won Choi;Jeong Hee Yoon;Dong Ho Lee;Yoon Jun Kim;Jeong Hoon Lee;Su Jong Yu;Eun Ju Cho;Jung Hwan Yoon;Jeong Min Lee
    • Korean Journal of Radiology
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    • v.22 no.12
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    • pp.1974-1984
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    • 2021
  • Objective: This study aimed to compare the efficacy between no-touch (NT) radiofrequency ablation (RFA) and conventional RFA using twin internally cooled wet (TICW) electrodes in the bipolar mode for the treatment of small hepatocellular carcinomas (HCC). Materials and Methods: In this single-center, two-arm, parallel-group, prospective randomized controlled study, we performed a 1:1 random allocation of eligible patients with HCCs to receive NT-RFA or conventional RFA between October 2016 and September 2018. The primary endpoint was the cumulative local tumor progression (LTP) rate after RFA. Secondary endpoints included technical conversion rates of NT-RFA, intrahepatic distance recurrence, extrahepatic metastasis, technical parameters, technical efficacy, and rates of complications. Cumulative LTP rates were analyzed using Kaplan-Meier analysis and the Cox proportional hazard regression model. Considering conversion cases from NT-RFA to conventional RFA, intention-to-treat and as-treated analyses were performed. Results: Enrolled patients were randomly assigned to the NT-RFA group (37 patients with 38 HCCs) or the conventional RFA group (36 patients with 38 HCCs). Among the NT-RFA group patients, conversion to conventional RFA occurred in four patients (10.8%, 4/37). According to intention-to-treat analysis, both 1- and 3-year cumulative LTP rates were 5.6%, in the NT-RFA group, and they were 11.8% and 21.3%, respectively, in the conventional RFA group (p = 0.073, log-rank). In the as-treated analysis, LTP rates at 1 year and 3 years were 0% and 0%, respectively, in the NT-RFA group sand 15.6% and 24.5%, respectively, in the conventional RFA group (p = 0.004, log-rank). In as-treated analysis using multivariable Cox regression analysis, RFA type was the only significant predictive factor for LTP (hazard ratio = 0.061 with conventional RFA as the reference, 95% confidence interval = 0.000-0.497; p = 0.004). There were no significant differences in the procedure characteristics between the two groups. No procedure-related deaths or major complications were observed. Conclusion: NT-RFA using TICW electrodes in bipolar mode demonstrated significantly lower cumulative LTP rates than conventional RFA for small HCCs, which warrants a larger study for further confirmation.