• Korean Journal of Biological Psychiatry
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• v.19 no.4
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• pp.153-158
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• 2012

Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

• The korean journal of orthodontics
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• v.44 no.4
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• pp.168-176
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• 2014

Objective: The aim of this randomized controlled clinical trial was to compare oral health-related quality of life (OHRQoL) of patients treated with conventional, active self-ligating (ASL), and passive self-ligating (PSL) brackets in different therapeutic phases. Methods: Sixty patients (mean age 18.3 years; 29 males and 31 females) requiring orthodontic treatment were randomly and equally assigned to receive conventional (Victory Series), ASL (In-Ovation R), or PSL (Damon 3MX) brackets. OHRQoL was measured with a self-administered modified 16-item Malaysian version of the Oral Health Impact Profile for immediate (soon after the visit) and late (just before the subsequent visit) assessments of the bonding and activation phases. Data were analyzed with the Kruskal-Wallis and chi-square tests. Results: The PSL and ASL groups showed more immediate and late impacts in the bonding phase, respectively; the conventional group was affected in both the assessments. The first activation phase had similar impacts in the groups. After the second activation, the conventional group showed more immediate impacts, whereas the PSL and ASL groups had more late impacts. The commonly affected domains were "physical disability," "functional limitation," "physical pain," and "psychological discomfort." No significant differences in the prevalence and severity of immediate and late impacts on OHRQoL of the patients were noted in any therapeutic phase. Conclusions: No bracket system seems to ensure superior OHRQoL. This information could be useful for explaining the therapeutic phases, especially the initial one, and selecting the optimal bracket system based on the patient's preference.

• Biomedical Science Letters
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• v.28 no.2
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• pp.67-82
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• 2022

The prevalence of SARS-CoV-2 led to inconsistent public health policies that resulted in COVID-19 containment failure. These factors resulted in increased hospitalization and death. To prevent viral spread and achieve herd immunity, the only safe and effective measure is to provide to vaccinates. Ever since the release of the SARS-CoV-2 nucleotide sequence in January of 2020, research centers and pharmaceutical companies from many countries have developed different types of vaccines including mRNA, recombinant protein, and viral vector vaccines. Prior to initiating vaccinations, phase 3 clinical trials are necessary. However, no vaccine has yet to complete a phase 3 clinical trial. Many products obtained "emergency use authorization" from governmental agencies such as WHO, FDA etc. The Korean government authorized the use of five different vaccines. The viral vector vaccine of Oxford/AstraZeneca and the Janssen showed effectiveness of 76% and 66.9%, respectively. The mRNA vaccine of Pfizer-BioNTech and Moderna showed effectiveness of 95% and 94.1%, respectively. The protein recombinant vaccine of Novavax showed an effectiveness of 90.4%. In this review, we compared the characteristics, production platform, synthesis principles, authorization, protective effects, immune responses, clinical trials and adverse effects of five different vaccines currently used in Korea. Through this review, we conceptualize the importance of selecting the optimal vaccine to prevent the COVID-19 pandemic.

• The Journal of Internal Korean Medicine
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• v.43 no.4
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• pp.582-595
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• 2022

Objectives: To investigate the effects of acupuncture at GV20 and EX-HN1 on cerebral blood flow (CBF) velocity and cerebrovascular reactivity (CVR) in the middle cerebral arteries (MCA) and anterior cerebral arteries (ACA) and to compare the effects to acupuncture at GV20. Methods: The study was a randomized, crossover trial that included 10 healthy men aged 20 to 29 years who underwent acupuncture treatment four times with a washout period of one week. The CBF velocity and CVR were measured by transcranial Doppler sonography (TCD) on both MCAs at the first and second visits, and both ACAs at the third and fourth visits. Participants were randomly assigned to one of two groups (A and B) before the first and third visits. Group A received two phases of acupuncture intervention at a single GV20 point and a combination of GV20 and EX-HN1 acupoints. Group B received the same interventions, but in the reverse order. Results: The increase in CO₂ reactivity was significantly higher for the combination acupoints of GV20 and EX-HN1 than for the GV20 single acupoint in both MCAs (Right: 136 to 178, p=0.017; Left: 127 to 191, p=0.017) and ACAs (Right: 133 to 158, p=0.013; Left: 122 to 168, p=0.025). No significant change was noted in the corrected velocity at PETCO₂ 40 mmHg, blood pressure, or heart rate. Conclusions: The findings suggest that improvement of the CBF in the MCA and ACA after GV20 acupuncture increases when acupuncture is also performed at EX-HN1. These results clinically support the combined use of EX-HN1 and GV20 to treat disorders of MCA and ACA circulation.

• Physical Therapy Rehabilitation Science
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• v.5 no.2
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• pp.63-69
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• 2016

Objective: To evaluate the effects of sit-to-stand (STS) imagery group training (IGT) on STS movement and balance performance for chronic hemiparetic stroke. Design: Randomized controlled trial. Methods: A total of 30 people with chronic hemiparetic stroke (15 for STS-IGT group and 15 for control) were recruited in this study. The STS-IGT group participated in a videotape-based STS-IGT for 30 minutes a day, five days a week for six weeks, while the control group watched a documentary on television for the same period. The STS-IGT focused on a five-stage protocol. Specifically, external imagery was used during the four phases of the STS movement from the seat of the chair to standing up. All of the participants also participated in a regular rehabilitation program. STS movement and balance performance were assessed using three clinical measures. Results: After training, time to perform the 5-repetition STS test significantly increased in the STS-IGT group (change value, $4.0{\pm}2.0$ sec) compared with the control group (change value, $0.9{\pm}0.7$ sec) (p<0.05). There was a greater improvement in Berg balance scale scores in the STS-IGT group (change value, $0.2{\pm}4.1$ points) compared with the control group (change value, $0.3{\pm}0.9$ points) (p<0.05). There was a greater improvement in Timed Up and Go scores in the STS-IGT group (change value, $2.6{\pm}1.5$ sec) compared with the control group (change value, $0.9{\pm}1.0$ sec) (p<0.05). Conclusions: STS-IGT can be considered as a useful option for restoration of STS movement and balance performance for individuals with chronic hemiparetic stroke who are unable to fully participate in physical activities.

• Journal of Acupuncture Research
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• v.25 no.3
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• pp.139-162
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• 2008

Objectives : Korean tradithional acupuncture Theory, Sa-am's 5 phases acupuncture method was originated in 1644-1742, in the middle of the Cho Sun dynasty. This study was to vertify the effect of Sa-am Acupuncture Treatment on Primary dysmenorrhea of Women. Methods : The subjects were 80 volunteers who was suffering for dysmenorrhea, employed using Measure of Menstrual Pain (MMP) questionnaire. Subjects were divided into two groups including Sa-am acupuncture treatment group(n=25), minimal acupuncture treatment group(n=22). They had agreed to take part in this experiment, with didn't take any anodyne drugs. In the acupuncture group, subjects were stimulated at G41, $SI_3$, B66, $SI_2$(Small intestine jung-guk), $SP_6$, $CV_6$ and one points were inserted additionally depending the symptoms among $ST_{36}$ or $LI_2$. In the control group, subjects were needled at 5 non-acupuncture points have any effect on Dysmenorrhea. A total of 8 acupuncture sessions were performed for each patient depending on the individual menstruation cycle The MMP score by using 7 questions and the Menstrual Symptom Severity List(MSSL-D) was measured before and after menstruation cycle. Collected data were analyzed as frequency, percentage, paired t-test, independent t-test using SPSS 10.0 WIN Program. Results : Acupuncture treatment produced a significant decreasing the symptom of Primary dysmenorrhea in two groups, but a statistically significant difference was not shown in the acupuncture group compare to control group. Conclusions : Based on the above results, it was verified that Acupuncture Treatment was effective in decreasing the symptom of Primary Dysmenorrhea.

• Journal of Acupuncture Research
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• v.24 no.3
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• pp.63-79
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• 2007

Objectives : Korean traditional acupuncture Theory, Sa-am's 5 phases acupuncture method was originated in 1644-1742, in the middle of the Cho Sun dynasty. This study was to verify the effect of Sa-am Acupuncture Treatment on dysmenorrhea of Women. Methods : The subjects were 49 volunteers who were suffering for dysmenorrhea, employed using Measure of Menstrual Pain (MMP) questionnaire. Subjects were divided into two groups including Sa-am acupuncture treatment group(n=23) and minimal acupuncture treatment group(n=26). They had agreed to take part in tIris experiment, with didn't take any anodyne drugs. In the acupuncture group, subjects were stimulated at $GB_{41}$, $SI_3$, $GL_{66}$, $SI_2$(Small intestine jung-guk) and $SP_6$. In the control group, subjects were needled at $L_{10}$, $S_{40}$, $P_5$, $G_{40}$ points have any effect on dysmenorrhea. A total of 5 acupuncture sessions were performed for each patient depending on the individual menstruation cycle. The MMP score by using 7 questions and the Menstrual Symptom Severity List(MSSL-D) were measured before and after menstruation cycle. Collected data were analyzed as frequency, percentage, paired t-test, independent t-test using SPSS 10.0 WIN Program. Results : Acupuncture treatment produced a significant improvement on dysmenorrhea in two groups, but a statistically significant difference was not shown in the acupuncture group compare to control group. Conclusions : Based on the above results, it was verified that Acupuncture Treatment was effective in decreasing the symptom of Dysmenorrhea.

• Journal of Gastric Cancer
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• v.17 no.2
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• pp.120-131
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• 2017

Purpose: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. Materials and Methods: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). Results: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. Conclusions: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).

• Asian-Australasian Journal of Animal Sciences
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• v.21 no.9
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• pp.1312-1317
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• 2008

The objective of the present trial was to determine the effect of a thermostable probiotic containing Bacillus licheniformis and B. subtilis on health and production parameters of fattening rabbits from weaning until slaughter. In a rabbitry with average post-weaning mortality of 5-9%, 1,680 rabbits were supplied with: a) a basic feed, or b) the same basic feed supplemented with probiotic from the 4th day postweaning (41st day of age) up to 88th day of age. Clinical signs, microbiological status and growth performance were recorded for two distinct fattening periods, growing and finishing. A significant decrease in mortality of probiotic-treated rabbits when compared to the controls was observed during the growing and entire fattening periods. Within these periods, E. coli and C. perfringens - but not P. multocida - were isolated at a lower frequency from probiotic-treated rabbits (p<0.05). Compared to the control animals, probiotic-treated rabbits were 54 g and 123 g heavier at the end of the growing and finishing phases, respectively, and had significantly higher average daily gain and better feed conversion ratio (p<0.05).

• Journal of Dental Anesthesia and Pain Medicine
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• v.20 no.6
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• pp.397-402
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• 2020

Background: Inferior alveolar nerve block (IANB) is the most common, painful, and anxiety-provoking procedure involving needle insertion for anesthetic solution deposition. DentalVibeⓇ (DV) delivers vibration at a sustained frequency as a counter-stimulation to the site of injection, thereby alleviating pain. The aim of this study was to evaluate and compare the effectiveness of DV and lignocaine hydrochloride 2% gel (Lox 2% jelly) in pain reduction during IANB in children. Methods: A split-mouth randomized clinical trial was designed with a sample of 60 children (age, 6 to 12 years) requiring bilateral IANB for various dental procedures; DV was used while administering IANB and Lox 2% jelly was used as the topical anesthetic before administering IANB at subsequent appointments. During both appointments, pain perception was measured using the sound, eye, motor (SEM) scale and Wong-Baker faces pain rating scale (WBFPRS); oxygen saturation (SpO2) and pulse rate were measured using a pulse oximeter before, during, and after the IANB procedure. The obtained values were tabulated and subjected to statistical analysis. Wilcoxon test was used for intergroup comparison, and Friedman test, for intragroup comparison of measured variables at different treatment phases. Results: The medians and interquartile ranges of the WBFPRS scores recorded during the IANB procedure for DV and Lox 2% jelly were 2 (2-4) and 2 (0-2), respectively (P < 0.05). The SEM scale scores, mean SpO2, and pulse rate did not show any significant differences during the IANB procedure between both treatments. Conclusion: Both DV and Lox 2% jelly were found to be effective in pain reduction during IANB in children.