• Title/Summary/Keyword: Clinical trial study

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Effect of Sa-am Acupuncture Method for Chronic Tension-type Headache;A Randomized Controlled Trial (만성 긴장성 두통 환자에 대한 사암침 치료효과의 Pilot 임상연구)

  • Hong, Kwon-Eui;Park, Yang-Chun;Jo, Jeong-Hyo;Jo, Hyun-Gyeong;Jeong, In-Cheol;Kang, Wee-Chang;Lee, Sang-Bong;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.24 no.1
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    • pp.13-28
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    • 2007
  • Objectives : Clinical character of chronic tension-type headache is bilateral, moderate intensity, persistent and chronic, repeating disease and CTTH is a common prevalent disease, but pathophysiology and likely mechanism remain unclear. It impedes subjective quality of life. The purpose of this research is to examine the effect of sa-am acupuncture method for chronic tension-type headache. Methods : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with sham acupuncture for the treatment of chronic tension-type headache. Volunteers who satisfied the requirements were enrolled in study. Evaluation of chronic tension-type headache was measured by VAS and Headache Disability Inventory(HDI), Six point Linkert Scale before and after treatments. Results : 26 subjects finished study. There were not difference between two groups on age, sex, weight, height, blood pressure, pulse, respiratory rate, Byeonjeung, sunrise of treatment. In change of VAS, there were not difference between two groups on before treatment. Before treatment per visit, VAS of 6th and 7th visit were significantly decreased in active acupuncture(each p=0.039, p=0.008) and were not decreased in sham acupuncture. In change of VAS on a withdrawing needling after treatment, VAS of 1st, 2nd, 6th and 7th visit were significantly decreased in active acupuncture (each p=0.001, 0.038, 0.035, 0.008) and VAS of 2nd, 4th and 5th, 6th visit were significantly decreased in sham acupuncture(each p=0.033, 0.032, 0.035, 0.031). In change of VAS on 2hrs after treatment, VAS of 4th and 5th, 6th visit were significantly decreased in active acupuncture(each p=0.014, 0.023, 0.027) and 5th visit were significantly decreased in sham acupuncture(each p=0.004, 0.009). In change of VAS on 4hrs after treatment, VAS of 4th and 5th, 6th visit were significantly decreased in active acupuncture(each p=0.018, 0.011, 0.015) and 5th, 6th visit were significantly decreased in sham acupuncture(each p=0.020, 0.015). In change of VAS on the next day after treatment, VAS of 3th and 4th and 5th, 6th visit were significantly decreased in active acupuncture(each p=0.032, 0.011, 0.005, 0.012) and 4th, 5th visit were significantly decreased in sham acupuncture(each p=0.001, 0.012). In change of VAS according to a current time(before treatment, after a withdrawing needling, 2hrs, 4hrs, the next day), total score of VAS was decreased more active acupuncture group than sham acupuncture group, but there were no statistical significance compared with sham acupuncture group. In change of HDI score, after treatment was decreased than before treatment in two group, but there were no statistical significance compared with two group. In change of Six point Linkert scale score, after treatment was decreased than before treatment in two group on 6th, 7th visit(active acupuncture 6th 7th each p=0.002, 0.003, sham acupuncture 6th 7th each 0.003, 0.009), but there were no statistical significance compared with tow group. Conclusion : Sa-am acupuncture treatment is effective to improve the symptoms and quality of life in patients with chronic tension-type headache.

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Study on the Safety of Firefly Luciferase in Human as a Transient Reporter Gene of Oncolytic Virotherapy (항암 바이러스 치료제의 보고유전자로써 반딧불이 루시퍼레이즈의 인체 내 안전성에 대한 연구)

  • Hong, Young Mi;Yoon, Woong Hee;Lee, You Ra;Kim, Soo Ji;Ngabire, Daniel;Narayanasamy, Badrinath;Ornella, Mefotse Saha Cyrelle;Kim, Myunghee;Cho, Euna;Lee, Bora;Hwang, Tae-Ho
    • Journal of Life Science
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    • v.31 no.11
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    • pp.1028-1036
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    • 2021
  • Firefly luciferase (FLuc) can function as an efficient marker in the gene and viral therapies. Nonetheless, its clinical translation has been unaccomplished with the concerns on its exogenous nature and the similarity with human fatty acyl-CoA synthetase. In this study, we aimed to show safety of FLuc by conducting a set of preclinical experiments and a human use. Initially, FLuc permeability across the plasma membrane was investigated by delivering the FLuc-carrying viral vector, OTS-412, or the FLuc recombinant protein. After in vitro infection of OTS-412 into different cancer cell lines, FLuc activity was detected only in the cell lysates, but not in culture media. In addition, recombinant FLuc protein further showed the impermeability against the plasma membrane. Similar result was also observed in the in vivo experiment. After being injected into the VX2 tumor-bearing rabbit, the FLuc exclusively resided within the tumor tissue without being detected in the blood plasma or other organs. Human cancer cell lines originated from various organs were lysed and treated to the FLuc, and none of the human substrates was reactive against the FLuc. As a final step, FLuc recombinant protein was intravenously injected into a human. The luciferase was degraded with the half-life of 20 to 30 minutes in blood, and was untraceable from 1.5 hr after the injection. In addition, the blood plasma was nonresponsive against the fatty acids. Hematological analysis was also comparable between the pre- and post-injection. Altogether, our study collectively demonstrates the safety of the firefly luciferase.

Status of Mixed Grain Diet by People with Diabetes in Jeollabuk-do and Sensory Evaluation of Different Composition of Mixed Grains (전라북도 지역 당뇨환자의 잡곡밥 섭취 실태 및 혼합비를 달리한 잡곡밥의 관능검사)

  • Jung, Eun-Sun;Shin, Dong-Hwa;Doo, Jae-Kyun;Chae, Soo-Wan;Kim, Young-Soo;Park, Young-Min
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.39 no.7
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    • pp.1049-1055
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    • 2010
  • This study investigated the status of mixed grain diet by 68 people with diabetes living in Jeollabuk-do and performed sensory evaluation of different composition of mixed grains to improve the sensory characteristics based on the investigation. BMI of all subjects were measured and found that 61.7% were overweight. 94.1% of them ate mixed grains and females ate more mixed grains than males (p<0.05). Most males and females answered that they ate mixed grains for their health. Females added more mixed grains than males (p<0.01). More females (47.1%) than males said they would continue to eat mixed grains (p<0.05). 59% of them said they had eaten mixed grains for more than 3 years. 46.0% of them said they purchased mixed grains at a small mart near their houses. The mostly added grain to rice was black soybean (76.5%). RMGD-50 is composed of six mixed grains excluding nonglutinous rice and has the mixing rate of 50%. RMGD-40 has the mixing rate of 40%. Sensory evaluation was performed and RMGD-50 got lower score ($3.33{\pm}0.68$, $3.50{\pm}0.81$) than RMGD-40 in the appearances and color. RMGD-40 with Control 1 that includes more glutinous grains and Control 2 that is polished rice were compared. RMGD-40 got lower score than Control 1 in its appearances, smell and color, although there wasn't a meaningful difference. For the people with diabetes who are accustomed to mixed grains, the polished rice got the lowest score in moisture amount, gumminess and overall taste ($3.26{\pm}0.82$, $3.48{\pm}0.85$, $3.19{\pm}0.70$). It showed meaningful difference from RMGD-40 and Control 1 (p<0.01). Consequently people with diabetes preferred mixed grains that include more glutinous grains that have lower mixed ratio. So it is necessary to educate the people with diabetes about eating grains for better blood sugar management. Continual study and development of mixed grains that can help people with diabetes to control their blood sugar are necessary.

The effect of Neurofeedback training on brain wave activity and cognitive performance in chronic stroke patients (뉴로피드백(Neurofeedback) 훈련이 만성 뇌졸중 환자의 뇌파활성도와 인지수행력에 미치는 효과)

  • Lee, Young-Sin;Kim, Sang-Yeob;Kim, Chan-Kyu;Jung, Dae-In;Kim, Kyung-Yoon
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.14 no.5
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    • pp.2329-2337
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    • 2013
  • This study was done objected to the chronic stroke patients in order to evaluate change in brain wave activity and cognitive performance when Neurofeedback training. The subjects were over 6 months ago in chronic stroke patients screened-test through the 20 patients, 10 persons in each group were randomly placed. This was carried out in 4 weeks in total, with control group(n=10) on general physical therapy and experimental group(n=10) on general physical therapy along with Neurofeedback training. The general physical therapy was applied 5 times a week, 30 minutes at once, Neurofeedback training was applied as equally as the general physical therapy, which makes 20 times in total. To learn about the effect before the training, after training, and 2 weeks after the training in electric physiological measurement method of the brain, electroencephalogram(EEG) to examine challenges by calculating the absolute spectrum power for standard EEG change(%), followed by evaluation with clinical assessment tool MMSE-K, Stroop Test, Digit Span Test. As a result of comparing the change in brain wave through EEG, after training and 2 weeks after training showed that absolute ${\alpha}$-power and absolute ${\beta}$-SMR power of experimental group have increased and absolute ${\theta}$-power decreased significantly compared to experimental group I. Moreover, the MMSE-K score in trial appraisal has increased significantly, and the error in Stroop Test and Digit Span Test has decreased significantly. such results, with the chronic stroke patient's brain wave control, Neurofeedback training was determined to improve the cognitive performance. this study suggests a new training possibility of stroke patients by identifying the training effects of Neurofeedback training that trains the brain directly with brain wave control.

Functional recovery after transplantation of mouse bone marrow-derived mesenchymal stem cells for hypoxic-ischemic brain injury in immature rats (저산소 허혈 뇌 손상을 유발시킨 미성숙 흰쥐에서 마우스 골수 기원 중간엽 줄기 세포 이식 후 기능 회복)

  • Choi, Wooksun;Shin, Hye Kyung;Eun, So-Hee;Kang, Hoon Chul;Park, Sung Won;Yoo, Kee Hwan;Hong, Young Sook;Lee, Joo Won;Eun, Baik-Lin
    • Clinical and Experimental Pediatrics
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    • v.52 no.7
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    • pp.824-831
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    • 2009
  • Purpose : We aimed to investigate the efficacy of and functional recovery after intracerebral transplantation of different doses of mouse mesenchymal stem cells (mMSCs) in immature rat brain with hypoxic-ischemic encephalopathy (HIE). Methods : Postnatal 7-days-old Sprague-Dawley rats, which had undergone unilateral HI operation, were given stereotaxic intracerebral injections of either vehicle or mMSCs and then tested for locomotory activity in the 2nd, 4th, 6th, and 8th week of the stem cell injection. In the 8th week, Morris water maze test was performed to evaluate the learning and memory dysfunction for a week. Results : In the open field test, no differences were observed in the total distance/the total duration (F=0.412, P=0.745) among the 4 study groups. In the invisible-platform Morris water maze test, significant differences were observed in escape latency (F=380.319, P<0.01) among the 4 groups. The escape latency in the control group significantly differed from that in the high-dose mMSC and/or sham group on training days 2-5 (Scheffe's test, P<0.05) and became prominent with time progression (F=6.034, P<0.01). In spatial probe trial and visible-platform Morris water maze test, no significant improvement was observed in the rats that had undergone transplantation. Conclusion : Although the rats that received a high dose of mMSCs showed significant recovery in the learning-related behavioral test only, our data support that mMSCs may be used as a valuable source to improve outcome in HIE. Further study is necessary to identify the optimal dose that shows maximal efficacy for HIE treatment.

Clinical Efficacy of Belotecan (CKD-602), Newly Developed Camptothecin Analog, in the 2nd Line Treatment of Relapsed Small Cell Lung Cancer (재발된 소세포폐암환자에서 이차 약제로 사용되는 Belotecan (CKD-602)의 임상적 효용성)

  • Ban, Hee-Jung;Oh, In-Jae;Kim, Kyu-Sik;Ju, Jin-Yung;Kwon, Yong-Soo;Kim, Yu-Il;Lim, Sung-Chul;Kim, Young-Chul
    • Tuberculosis and Respiratory Diseases
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    • v.66 no.2
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    • pp.93-97
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    • 2009
  • Background: Belotecan (Camtobell, CKD-602, Chongkundang Pharm., Korea), a camptothecin derivative, has anticancer effects by inhibiting topoisomerase I such as topotecan. This study observed the response, survival and toxicity of belotecan monotherapy after the failure of etoposide and platinum (EP). Methods: Forty nine small cell lung cancer (SCLC) patients (M/F=41/8; age, 64.5${\pm}$7.6 (mean${\pm}$SD) years), who failed in their first line chemotherapy were enrolled in this study. Twenty one SCLC patients showed relapsed lung cancer more than 90 days after their priorEP chemotherapy (sensitive relapse group, SR) and 28 patients relapsed within 90 days (refractory relapse group, RR). Results: The response rate was 25%. Eleven patients showed partial responses and 5 patients could not be checked. The response rate of the SR and RR patients was similar. The relative dose intensity was lower in the responders (78${\pm}$15%) than non-responders (83${\pm}$13%, p=0.03). The median survival time (MST) was 10.3 months (290 days). The MST of the non-responders and responders was 186 days (95% CI; 67-305) and 401 days (95% CI; 234-568, p=0.07), respectively. The median progression free survival (MPFS) was similar in the SR (79 days) and RR (67 days) patients. Grade 3-4 neutropenia, anemia, and thrombocytopenia were observed in 59.6%, 12.8% and 23.4% of patients, respectively. Conclusion: The efficacy and survival were demonstrated in the second-line setting. However, a randomized comparative trial with topotecan will be needed.

The Relation of BMI, Smoking and Drinking with Biomedical Parameters in 20s and 30s Men (20~30대 성인 남성에서 체질량지수, 흡연량 및 음주량과 혈액검사치의 관련성)

  • Kim, Chul-Gyu
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.12 no.10
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    • pp.4425-4433
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    • 2011
  • The purpose of this study was to explore the relation of BMI, smoking and drinking with biomedical parameters in 20s and 30s men. This was a retrospective exploratory study and the subjects were 603 men who participated in health check-up for clinical trial at a tertiary hospital between October 2006 and June 2011. RBC, hemoglobin(Hb), hematocrit(Hct), triglyceride(TG), uric acid(UA), ALT in obese group were significantly higher than those of normal weight group. WBC and Hb in smokers were significantly higher than those of nonsmokers, protein in smokers was significantly lower than that of nonsmokers. Platelet in moderate smokers who smoke 10~19 cigarettes a day was significantly higher than that of nonsmokers and light smokers who smoke below 10 cigarettes a day, albumin in moderate smokers was significantly lower than that of nonsmokers and light smokers. TG in moderate smokers was significantly higher than that of nonsmokers, and blood glucose(BG) in moderate smokers was significantly lower than that of nonsmokers. AST and ALT in drinkers who drink over 10g a day were significantly higher than those of nondrinkers. In regression, BMI was significant factors of increasing RBC, Hb, Hct, total cholesterol(TC), TG, BG, UA, AST and ALT. Smoking amount was significant factors of increasing WBC, Hb, Hct and TG, and was significant factors of decreasing BG and Ca. Smoking amount was significant factors of increasing TC, AST and ALT, and was significant factors of decreasing WBC. In conclusion, there was significant relations of BMI, smoking, and drinking with biomedical parameters such as Hb, TC, TG, and ALT in young-aged men. Therefore, practice of healthy lifestyle activities to include preventing obesity and heavy drinking, and quitting smoking needs to the 20s and 30s men for preventing lifestyle disease.

Effects of Fractionated Stereotactic Radiotherapy for Primary Hepatocellular Carcinoma (원발성 간암의 분할 정위방사선치료 효과)

  • Choi Byeong Ock;Kang Ki Mun;Jang Hong Seok;Lee Snag-wook;Kang Young Nam;Chai Gyu Young;Choi Ihl Bhong
    • Radiation Oncology Journal
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    • v.23 no.2
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    • pp.92-97
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    • 2005
  • Purpose : Reports on the outcome of curative radiotherapy for the primary hepatocellular carcinoma (HCC) are rarely encountered in the literature. in this study, we report our experience of a clinical trial where fractionated stereotactic radiotherapy (SRT) was used in treating a primary HCC. Materials and Methods : A retrospective analysis was peformed on 20 patients who had been histologically diagnosed as HCC and treated by fractionated SRT. The long diameter of tumor measured by CT was $2\~6.5$ cm (average: 3.8 cm). A single dose of radiation used in fractionated SRT was S or 10 Gy: each dose was prescribed based on the planning target volume and normalized to $85\~99\%$ isocenter dose. Patients were treated $3\~5$ times per week for 2 weeks, with each receiving a total dose of 50 Gy (the median dose: 50 Gy). The follow up period was $\~55$ months (the median follow up period: 23 months). Results : The response rate was $50\%$ (12 patients), with 4 patients showing complete response ($20%$), 8 patients showing partial response ($40\%$), and 8 patients showing stable disease ($40\%$). The 1-year and 2-year survival rates were $70.0\%$ and $43.1\%$, respectively, and the median survival time was 20 months. The 1-year and 2-year disease free survival rates were $65\%$ and $32.5\%$, respectively, and the median disease-free survival rate was 19 months. Some acute complications of the treatment were noted as follows: dyspepsia in 12 patients ($60\%$), nausea/emesis in 8 patients ($40\%$), and transient liver function impairment in 6 patients ($30\%$). However, there was no treatment related death. Conclusion : The study indicates that fractionated SRT is a relatively safe and effective method for treating primary HCC. Thus, fractionated SRT may be suggested as a local treatment for HCC of small lesion and containing a single lesion, when the patients are inoperable or operation is refused by the patients. We thought that fractionated SRT is a challenging treatment modality for the HCC.

3D analysis of soft tissue around implant after flap folding suture (Flap folding suture를 활용한 판막의 고정에 따른 임플란트 주변 연조직 3차원 부피 변화 관찰)

  • Jung, Sae-Young;Kang, Dae-Young;Shin, Hyun-Seung;Park, Jung-Chul
    • Journal of Dental Rehabilitation and Applied Science
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    • v.37 no.3
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    • pp.130-137
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    • 2021
  • Purpose: The various suture techniques can be utilized in order to maximize the keratinized tissue healing around dental implants. The aim of this study is to compare the soft tissue healing pattern between two different suture techniques after implant placement. Materials and Methods: 15 patients with 18 implants were enrolled in this study. Simple implant placement without any additional bone graft was performed. Two different suture techniques were used to tug in the mobilized flap near the healing abutment after paramarginal flap design. Digital intraoral scan was performed at baseline, post-operation, stitch out, and 3 months after operation. The scan data were aligned using multiple points such as cusp, fossa of adjacent teeth, and/or healing abutment. After subtracting scan data at baseline with other time-point results, closed space indicating volume increment of peri-implant mucosa was selected. The volume of the close space was measured in mm3. The volume between two suture techniques at three time-points was compared using nonparametric rank-based analysis. Results: Healing was uneventful in both groups. Both suture technique groups showed increased soft tissue volume immediately after surgery. The amount of volume increment significantly decreased after 3 months (P < 0.001). Flap folding suture group showed higher median of volume increment than interrupted suture group after 3 months without any statistical significance (P > 0.05). Conclusion: After paramarginal flap reflection, the raised flaps stabilized by flap folding suture showed relatively higher volume maintenance after 3-month healing period. However, further studies are warranted.

Efficacy evaluation dental plaque and halitosis removal of mouthwash containing sodium chloride (염화나트륨 함유 구중청량제의 치면세균막 및 구취 제거 효능평가)

  • Lee, Jong-Cheon;Cho, Ja-Won;Yoo, Hyun-Jun;Kim, Chan-Ho;Choe, Byeong-Gi
    • Journal of Dental Rehabilitation and Applied Science
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    • v.38 no.1
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    • pp.1-8
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    • 2022
  • Purpose: The purpose of this study was to evaluate the effects of mouthwash containing sodium chloride on dental plaque, gingival inflammation index, and bad breath through clinical trials. Materials and Methods: This trial was designed as 12 weeks and subjects were instructed to put an appropriate amount of the provided standard detergent on a toothbrush and brush their teeth 3 times a day. They were instructed to gargle a mouthwash provided to each group after brushiung. Efficacy was evaluated by performing gingival and periodontal-related index tests, dental plaque changes, and bad breath tests a total of 5 times. All data were statistically analyzed using 2-sample t-test, paired t-test to compare between groups at 95% significance level using IBM SPSS Statistics 24.0. Results: As a result of the PMA index measurement, the gingivitis improvement effect rate of the experimental group compared to the control group was 107.63% after 8 weeks and 73.08% after 12 weeks. As a result of the PHP index measurement, the plaque improvement effect rate of the experimental group compared to the control group was 79.37% after 8 weeks and 74.06% after 12 weeks. As a result of measuring volatile sulfur compounds using Oral Chroma, the effectiveness of improvement in bad breath in the experimental group was 65.06% after 8 weeks and 99.33% after 12 weeks, compared to the control group. Conclusion: As a result of this study, it was confirmed that effective gingivitis alleviation, plaque removal effect and bad breath removal effect can be expected when a mouthwash containing sodium chloride, green tea extract, and sodium monofluorophosphate is used.