• Korean Journal of Adult Nursing
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• v.25 no.1
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• pp.53-61
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• 2013

Purpose: The purpose of the study was to identify the levels of anxiety, depression and uncertainty of patients who participated in the clinical trials for anticancer drug, and to identify correlations among these variables. Methods: Cross-sectional survey used the Symptom Check List-90-Revision and the Mishel Uncertainty in Illness Scale from 106 subjects in 2011. The data were analyzed using descriptive statistics, t-test, ANOVA, Pearson correlation coefficients. Results: The mean score of anxiety was 2.06, that of depression 2.35, and that of uncertainty 2.61. Anxiety and depression (r=.70), anxiety and uncertainty (r=.44), depression and uncertainty (r=.60) were significantly correlated each other. The levels of anxiety, depression and uncertainty were different in various characteristics of the subjects, such as education, recurrence, and economic burden. Conclusion: The results of the study indicate that when implementing psychosocial interventions for cancer patients who participate in clinical trial, factors such as education, economic burden, and recurrence should be integrated into the intervention. Further studies applying theoretical model would be helpful to identify directional relationships among the variables that are important in psychosocial well-being of cancer patients undergoing clinical trial.

• Structural Engineering and Mechanics
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• v.29 no.3
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• pp.289-300
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• 2008

The use of metric trial functions to represent the real stress field in what is called the unsymmetric finite element formulation is an effective way to improve predictions from distorted finite elements. This approach works surprisingly well because the use of parametric functions for the test functions satisfies the continuity conditions while the use of metric (Cartesian) shape functions for the trial functions attempts to ensure that the stress representation during finite element computation can retrieve in a best-fit manner, the actual variation of stress in the metric space. However, the issue of how to handle situations where there is locking along with mesh distortion has never been addressed. In this paper, we show that the use of a consistent definition of the constrained strain field in the metric space can ensure a lock-free solution even when there is mesh distortion. The three-noded Timoshenko beam element is used to illustrate the principles. Some significant conclusions are drawn regarding the optimal strategy for finite element modelling where distortion effects and field-consistency requirements have to be reconciled simultaneously.

• The Journal of KAIRB
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• v.5 no.1
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• pp.14-20
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• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• Journal of Korean Ophthalmic Optics Society
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• v.11 no.3
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• pp.217-223
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• 2006

The purpose of this study is to provide improvements and standards of trial lens, in a situation that there is a lack of standards of trial lens set that have been used for self-conscious refraction test after helm refraction test at about 5,000 opticians, ophthalmologic clinics and hospitals, and contact-lens shops, that there is a lot of discrepancies between refraction specified and the actual power, and that there is no regulation of optical tolerance error. For the study, opticians who have used Trial lens set were asked to participate in a questionnaire survey through continuing education, and divided into those who have used domestic lens and those who have used imported lens, 5 opticians each for less than 5 years, 5 to 10 years, more than 10 years. The measurement of both refraction specified and the actual diopter was compared to Japan Industrial Standards(JIS T4402). As a result of comparative analysis, more than 80% of respondents have had reliability on the refraction of trial lens they had used, indicating that they have never measured the refraction specified and the actual diopter after buying them. Besides, Korean Industrial Standards(KS P4402) has been imperfect in diopter range since it was legislated in 1979. More than 95% of respondents have been unsatisfied with optometry. Also, it has indicated that refraction error is more frequent in long-term-used trial lens. The conclusion is that it is necessary to standardize trial lens set and that it is required to add lens to lens set provided under KS P4402. Moreover, it is necessary to have supervisory agency for a standardization of trial lens. I hope that both domestic lens and imported lens, as in German and Japan, will be tested to find whether they meet optical tolerance error and standard trial lens will be distributed. Good optic inspection is required for the improvement and management of eye health and optical function, and the same standard trial lens set should be used. whoever is tested. Also, I hope that trial lens set will be specified within standards and tolerance error.

• Journal of Ginseng Research
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• v.48 no.5
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• pp.504-510
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• 2024

Background: As a physiological function of body, immunity can maintain health by identifying itself and excluding others. With economic development and increasingly fierce social competition, the number of sub-healthy population is gradually increasing, and the most basic problem exposed is human hypoimmunity. Hypoimmunity can be manifested as often feeling tired, catching colds, mental depression, etc. In order to enhance immunity, eating healthy foods with the effect of enhancing immunity may become an effective choice. KRG has pharmacological effects of enhancing immunity. Because the screening and evaluation method of immune population are not unified, there are relatively few KRG immunity tests for sub-health population. It is of great significance to study the effect of KRG on people with hypoimmunity to improve sub-health status. Methods: This was a 180-day, randomized, double-blind, placebo-controlled clinical trial. According to the trial scheme design, 119 qualified subjects were included and randomly divided into the test group taking KRG and the placebo control group. Subjects need to check safety indicators (blood pressure and heart rate, blood routine, liver and kidney function, urine routine and stool routine) and efficacy indicators (main and secondary) inspection at baseline, efficacy indicators inspection during the mid-term of the test (90th days of administration), safety and efficacy indicators inspection after the test (180th days of administration). Results: After the test, the safety indicators of placebo control group and KRG test group were basically within the normal range, and there is no significant difference in fireness score between the two groups. Through follow-up interviews, it was found that the subjects in the test group and the control group had no adverse reactions and allergic reactions such as nausea, flatulence, diarrhea, and abdominal pain during the test period. Self-comparison of the test group, the results of the main efficacy indicators: (1) immune related health scores were significantly improved in the mid-term and after the test (P < 0.01), (2) CD3 and CD4/CD8 increased significantly after the test (P < 0.05), (3) IgG, IgA, IgM and WBC increased significantly in the mid-term and after the test (P < 0.01); the results of the secondary efficacy indicators: (1) TNF-α decreased significantly in the midterm (P < 0.05), IFN-γ decreased significantly in the mid-term (P < 0.01), (2) NK increased significantly in the mid-term and after the test (P < 0.05), (3) monocyte increased significantly in the mid-term and after the test (P < 0.01). Inter-group comparison of the test group and the control group, the results of the main efficacy indicators: (1) immune related health scores were higher than that of the control group in the mid-term and after the test (P < 0.01), (2) IgA of the test group was higher than that of the control group in the mid-term and after the test (P < 0.05); the results of the secondary efficacy indicators: (1) WBC of the test group was higher than that of the control group in the mid-term (P < 0.05); (2) monocytes of the test group were higher than that of the control group in the mid-term and after the test (P < 0.05), neutrophils of the test group were higher than that of the control group in the mid-term (P < 0.05). Conclusion: Taking KRG has no adverse effects on the health of the subjects. According to the standard of clinical trial scheme, the immune related health scores and IgA in the main efficacy indicators were positive, which shows that KRG is helpful in enhancing human immunity.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.46 no.1
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• pp.41-48
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• 2020

Objectives: One of the most common complications of bilateral sagittal split ramus osteotomy (BSSRO) is neurosensory impairment of the inferior alveolar nerve (IAN). Accurate preoperative determination of the position of the IAN canal within the mandible using cone-beam computed tomography (CBCT) is recommended to prevent IAN dysfunction during BSSRO and facilitate neurosensory improvement after BSSRO. Materials and Methods: This randomized clinical trial consisted of 86 surgical sites in 43 patients (30 females and 13 males), including 21 cases (42 sides) and 22 controls (44 sides). Panoramic and lateral cephalographs were obtained from all patients. In the experimental group, CBCT was also performed from both sides of the ramus and mandibular body. Neurosensory function of the IAN was subjectively assessed using a 5-point scale preoperatively and 7 days, 1 month, 3 months, 6 months, and 12 months post-surgery. Data were analyzed using Fisher's test, Spearman's test, t-test, linear mixed-model regression, and repeated-measures ANCOVA (α=0.05, 0.01). Results: Mean sensory scores in the control group were 1.57, 2.61, 3.34, 3.73, and 4.20 over one year and were 1.69, 3.00, 3.60, 4.19, and 4.48 in the CBCT group. Significant effects were detected for CBCT intervention (P=0.002) and jaw side (P=0.003) but not for age (P=0.617) or displacement extent (P=0.122). Conclusion: Preoperative use of CBCT may help surgeons to practice more conservative surgery. Neurosensory deficits might heal faster on the right side.

• Preventive Nutrition and Food Science
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• v.20 no.2
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• pp.126-132
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• 2015

This study investigated the anti-amnesic effect of fermented Ganoderma lucidum water extracts (GW) on scopolamine- induced memory impairment in rats. GW were fermented by the lactic acid bacterium Bifidobacterium bifidum (FGWB), followed by Lactobacillus sakei LI033 (FGWBL). To induce amnesia, scopolamine (1 mg/kg) was intraperitoneally injected into rats 30 min before the behavioral tests. Step-through latencies of rats treated with primary fermented extracts (300 mg/kg, FGWB) and secondary fermented extracts (300 mg/kg, FGWBL) were significantly longer than those of rats treated with GW (300 mg/kg) in the retention trial of the multiple trial passive avoidance test. In the Morris water maze task, FGWBL significantly shortened escape latencies in training trials. Furthermore, swimming times within the target zone during the probe trial with FGWBL were significantly higher than the GW and FGWB treatments. In addition, acetylcholinesterase activities were lower in the brains of scopolamine-treated rats treated with FGWBL. These results suggest that FGWBL could be useful to enhance learning memory and cognitive function via cholinergic dysfunction.

• Korean Journal of Veterinary Research
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• v.36 no.3
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• pp.731-741
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• 1996

ELISA kit for cortisol was developed and then evaluated. Polyclonal antihydrocortisone-3-(o-carboxymethyl)oxime BSA rabbit serum was used to coat the 96-well microplates. The minimum detection limit of the kit was 250pg of cortisol per milliliter. The within-run variation and the day to day variation of the ELISA system were 2.0 and 5.9 at maximum, respectively. The kit was used to determine whether salivary cortisol concentration could replace blood cortisol concentration in dexamathasone suppression test of dogs. Changes of cortisol concentration were measured in serum or saliva after intravenous administration of 0.01mg of dexamethasone per kilogram of body weight. Blood alone, saliva alone or both were collected at 0, 30, 60, 120, 240, and 360 minutes after injection of dexamethasone. The change in blood cortisol concentration was found to be suitable in dexamathasone suppression test of dogs, but the change in salivary cortisol concentration was not. The kit was also used to determine whether salivary cortisol concentration could be a stress index as well as blood cortisol concentration in dogs. Two types of trial were performed to estimate the stress either by blood or salivary cortisol concentration. The first trial was stress experiment by intravenous injection of 0.2IU of PZI-insulin per kilogram body weight. Either blood alone or saliva alone was collected at 0, 30, 60, and 90 minutes after insulin administration. Both blood and salivary cortisol concentration were found to be suitable index in estimating stress from hypoglycemia by injection of insulin. The second trial was stress experiment by electrical irritation. The dogs were irritated with anti-bark device for 10 seconds. Blood was collected before and at 2 and 5 minutes after electrical irritation. Saliva was collected before and at 3 and 6 minutes after electrical irritation. The blood cortisol concentration, but not the salivary cortisol concentration was found to be suitable index in estimating stress from electrical irritation. Cushing syndrome in a dog was also successfully diagnosed with this kit.

• Journal of Physiology & Pathology in Korean Medicine
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• v.18 no.1
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• pp.93-100
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• 2004

This study was carried out for analyzing pathological and epidemiological factors of osteoporosis and doing pilot test using trial compounds of tuna bone and oriental herbs based on the factors. Osteoporosis is originated from osteoblast, osteoclast, organic and inorganic factors etc. Therefore the pathology of osteoporosis is not simple because the cytokine, growth factors and hormones of the components are various a lot. Taking a view of epidemiological factors of type I osteoporosis, ageㆍmenarcheㆍcholesterolㆍBMI etc. have definite relation to them. So we can approach to aging or consumptive disease in oriental medicine, specifically differential diagnosis of blood depletion with deficiency of qi, deficiency of kidney, deficiency of yin, bony weakness etc. And it should be considered together with rules for maintaining good health or habit concomitantly. Therefore IL1ㆍ6 or TNF αㆍβ are generally used as molecular biological index for osteoblast and osteoclast because the most important index is bone mineral density and strength, but the factors like collagen and noncollagen protein must be accounted as biomarkers. Trial compounds generally showed favorable effects on accompanying subjective symptoms of osteoporosis in the pilot test for menopausal woman. But if she didn't have specific symptoms of osteoporosis there wasn't any specific change. And osteocalcin was increased in case of being under standard level, but wasn't changed in case of normal level. Therefore these trial compounds can be used as a funcdonal diet for type I osteoporotic patients or preventive measures.

• Proceedings of the Ginseng society Conference
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• 1984.09a
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• pp.215-223
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• 1984

Panax ginseng has often been suggested as a geriatric restorative. This study is a double blind crossover trial to test whether ginseng can improve function in subjects with the depression and reduced abilities associated with senescence. 49 screened subjects were given 1500 mg Korean Red ginseng and identical placebo each for ten days, with a washout period in between the dosages. Standard tests of mental function, neuromuscular reflexes, responsiveness, mood and well being were used. The subjects were somewhat better at the co-ordination and speed test ('number copying') but tests of concentration and memory ('Concentration', 'Paired Association', 'Digit Span' and 'Object Learning') gave equivocal results. There were small improvements in mood and well being ('Life Satisfaction' and 'General Health Questionnaire') while the subjects indicated increased energy, alertness and less sleep, but also less happiness on the daily analogue scales. The major result was a highly significant improvement in reactivity, speed and co-oridnation at the tapping test, and the visual, auditory and disjunctive reaction timer. These are the most objective and accurate tests used in this trial. It is therefore concluded that ginseng can increase function in senile individuals. This effect is most easily visualisable in objective psychophysical tests, rather than the more subjective memory and concentration tests.