• Title/Summary/Keyword: Clinical trial center

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The Short Term Effects of the Decompression (KNX $7000^{(R)}$) and Traction Device on Pain in Patients with Chronic Low Back Pain with or without Radicular Pain (만성 요통 및 하지방사통 환자에서 감압치료(KNX $7000^{(R)}$)와 견인치료의 단기 치료 효과)

  • Park, So-Hyun;Kim, Chul-Seoung;Lee, Dong-Gyu;Ahn, Sang-Ho
    • The Journal of Korean Physical Therapy
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    • v.23 no.5
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    • pp.29-34
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    • 2011
  • Purpose: The purpose of this study is to evaluate the short term effects of the traction and decompression device, which is a newly developed domestic medical device, on pain and functional activity in patients with chronic low back pain with or without radicular pain. Methods: Forty patients with chronic low back pain were included and allocated to decompression (n=20) and traction groups (n=20). They received decompression or traction therapy for 20 minutes a day, 3 days per week for two weeks. For evaluating pain and functional activity, a visual analogue scale (VAS) for low back pain and the Oswestry back pain disability index (ODI) were obtained on pre-treatment, and at 6, 12 and 15 days after treatment. Patients'satisfaction levels were measured 15 days after treatment. Results: VAS was significantly decreased at 12 days and 15 days post-treatment compared to pre-treatment in both groups (p<0.05). ODI was significantly decreased at 12 days and 15 days post-treatment compared to pre-treatment in the decompression group (p<0.05). However, there was no significant difference between the two groups in the VAS and ODI scales (p>0.05). Patients' satisfaction levels were significantly higher in the decompression group than in the traction group (p<0.05). Conclusion: These findings suggest that decompression therapy might be effective for increasing functional activity in patients with low back pain and could provide patients with higher satisfaction than traction therapy. This study provided validity data for the therapeutic effects of the decompression device in patients with low back pain and it will be useful for medical cost development and patient education of this device.

Efficacy of Inhalation Therapy using Zizyphus jujuba var. spinosa Blended Oil and Spa Therapy on Stress : A Double-blind, Randomized, Single center Clinical Trial (산조인 복합오일을 이용한 향기건식 흡입요법과 스파 프로그램이 스트레스에 미치는 효과 : 이중맹검, 무작위배정, 단일기관 임상시험)

  • Oh, Seo Young;Kang, Jae Hui;Jang, Tae Soo;Choi, Hee Jeong;Ahn, Taek Won
    • Journal of Haehwa Medicine
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    • v.26 no.1
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    • pp.49-57
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    • 2017
  • Objectives : The purpose of this study was to investigate the efficacy of inhalation therapy using Zizyphus jujuba var. spinosa blended oil and spa therapy on stress in adults. Methods : The study design was a double blind, randomized, single center clinical trial. A total of 30 volunteers who were highly stressed and were over 9 points on POMS(profile of mood states) participated in this study. Inhalation therapy using Zizyphus jujuba var. spinosa blended oil and spa therapy were applicate for the experimental group and Jojoba oil inhalation and spa therapy was given for the control group. During the 2 weeks, the participants were treated about inhalation and spa therapy twice a week. The treatment sequence is spa therapy after inhalation therapy. Result : The improvement of stress was evaluated by POMS, HRV(Heart Rate Variability), EEG(Electroencephalography), PSQI(Pittsburgh Sleep Quality Index), salivary cortisol. After treatment, POMS was significantly decreased between the experimental group and the control group. In other measurement(HRV, EEG, PSQI, salivary cortisol) except POMS, there were not significant. Overall, however, they showed a tendency to alleviate stress in the experimental group. Conclusions : We suggest that inhalation therapy using Zizyphus jujuba var. spinosa blended oil and spa therapy might be effective on stress.

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Effect of Korean Red Ginseng in individuals exposed to high stress levels: a 6-week, double-blind, randomized, placebo-controlled trial

  • Baek, Ji Hyun;Heo, Jung-Yoon;Fava, Maurizio;Mischoulon, David;Choi, Kwan Woo;Na, Eun Jin;Cho, Hana;Jeon, Hong Jin
    • Journal of Ginseng Research
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    • v.43 no.3
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    • pp.402-407
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    • 2019
  • Background: To investigate the neurobiological evidence supporting the adaptogenic effects of Korean Red Ginseng in reducing the harmful consequences of stress using a double-blind, placebo-controlled trial. Method: Sixty-three subjects with high stress levels were randomized to receive an orally administered, double-blind, 6-week treatment with Korean Red Ginseng (n = 32) or placebo (n = 31). All participants underwent a comprehensive psychological evaluation using Beck Depression Inventory and Stress Response Inventory, cognitive evaluation using the continuous performance test, biological evaluation by measuring blood levels of lipids, catecholamines, inflammation markers, and heart rate variability at baseline and after 6 weeks. Results: At baseline, both groups showed no significant differences in age, sex, years of education, Beck Depression Inventory, and Stress Response Inventory. After 6 weeks, triglyceride levels were significantly increased within the normal limit in the Korean Red Ginseng group (F = 4.11, p = 0.048), and the epinephrine level was decreased in this group (F = 4,35, p = 0.043). The triglyceride increase was significantly associated with epinephrine decrease (B = 0.087, p = 0.041), suggesting that Korean Red Ginseng may stabilize the sympathetic nervous system. In addition, we detected a significant group by time effect in the visually controlled continuous performance test, suggesting positive effects of Korean Red Ginseng on cognition. Conclusion: Korean Red Ginseng might help to stabilize the sympathetic nervous system and improve cognition in individuals with high stress.

Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: preliminary results of a randomized controlled trial

  • Aghili, Mahdi;Khalili, Nastaran;Khalili, Neda;Babaei, Mohammad;Farhan, Farshid;Haddad, Peiman;Salarvand, Samaneh;Keshvari, Amir;Fazeli, Mohammad Sadegh;Mohammadi, Negin;Ghalehtaki, Reza
    • Radiation Oncology Journal
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    • v.38 no.2
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    • pp.119-128
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    • 2020
  • Purpose: Colorectal cancer is becoming an increasing concern in the middle-aged population of Iran. This study aimed to compare the preliminary results of short-course and long-course neoadjuvant chemoradiotherapy treatment for rectal cancer patients. Materials and Methods: In this clinical trial we recruited patients with rectal adenocarcinoma located from 5 cm to 15 cm above the anal verge. Patients in group I (short-course) received three-dimensional conformational radiotherapy with a dose of 25 Gy/5 fractions in 1 week plus concurrent XELOX regimen (capecitabine 625 mg/㎡ from day 1-5 twice daily and oxaliplatin 50 mg/㎡ on day 1 once daily). Patients in group II (long-course) received a total dose of 50-50.4 Gy/25-28 fractions for 5 to 5.5 weeks plus capecitabine 825 mg/㎡ twice daily. Both groups underwent consolidation chemotherapy followed by delayed surgery at least 8 weeks after radiotherapy completion. The pathological response was assessed with tumor regression grade. Results: In this preliminary report on complications and pathological response, 66 patients were randomized into two study groups. Mean duration of radiotherapy in the group II (long-course) was 5 ± 1 days (range, 5 to 8 days) and 38 ± 6 days (range, 30 to 58 days). The median follow-up was 18 months. Pathological complete response was achieved in 32.3% and 23.1% of patients in the shortcourse and long-course groups, respectively (p = 0.558). Overall, acute grade 3 or higher treatment-related toxicities occurred in 24.2% and 22.2% of patients in group I and II, respectively (p = 0.551). No acute grade 4 or 5 adverse events were observed in either group except one grade 4 hematologic toxicity that was seen in group II. Within one month of surgery, no significant difference was seen regarding grade ≥3 postoperative complications (p = 0.333). Conclusion: For patients with rectal cancer located at least 5 cm above the anal verge, short-course radiotherapy with concurrent and consolidation chemotherapy and delayed surgery is not different in terms of acute toxicity, postoperative morbidity, complete resection, and pathological response compared to long-course chemoradiotherapy.

Clinical research methodology for Traditional Korean Medicine treatment of lung cancer : Evidence-based approach (폐암(肺癌)의 한방치료 임상연구 방법론)

  • Kim, Kyung-Suk;Kim, Sme-Hyun;Eo, Wan-Kyu;Cheon, Seong-Ha;Eom, Seok-Ki;Jo, Hak-Jun
    • Journal of Korean Medical classics
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    • v.23 no.4
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    • pp.39-62
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    • 2010
  • Background : I investigated clinical research methodology of Traditional Korean Medicine(TKM) for treatment of lung cancer with Evidence Based Medicine(EBM) approach. Methods : I conducted the internet search of National Central Library, the National Assembly Library, Korea Education & Research Information Service, Korea Institute of Science and Technology Information for Korean theses and papers, and MEDLINE for the outside articles. Conclusion : In addition to outcomes of clinical trial, abundant clinician's experience and patients' preference are also considered. Pragmatic trials and quasi-experimental trials are better than clinical trials to plan clinical design of TKM for lung cancer and appropriate endpoints includes overall survival, disease-free survival, patient reporting outcome.

Review of Randomized Controlled Trials using Herbal Remedies on Cancer Patients (한약물을 이용한 암 치료 관련 무작위 배정 임상시험에 대한 고찰)

  • Park, Bong-Ky;Wang, Jing-Hua;Cho, Jung-Hyo;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.31 no.5
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    • pp.12-32
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    • 2010
  • Objective: This study aimed to review herbal remedy-based RCTs on cancer patients in order to produce helpful information for clinical study of herbal medicine in the future. Methods: We collected all RCTs using herbal remedies on cancer patients from Pubmed and Cochrane databases until November 1st, 2009. Elementary information such as nation where performed, clinical question, design, randomization, double-blinding and allocation concealment were analyzed. Results: 153 RCTs were finally selected. 119 RCTs were conduced in China while only 2 were done in Korea. The most frequent targeted cancer was lung cancer as 29 RCTs. The main clinical questions included improvement of quality of life, elongation of survival rate and regression of tumor being 83, 62 and 55 respectively. 112 RCTs used herbal remedies with western therapy. Adequate methods for randomization and allocation concealment were found in 37% and 10% of trials respectively. Conclusions: We found that herbal remedies are used on cancer patients in aspects of both caring for the human body and tumor treatment itself. The study might provide us useful data for cancer-related clinical study using herbal remedies in the future.

A Study on Safety, Performance and Clinical effectiveness Test Guideline of Versatile Ophthalmic Laser System (다목적 안과용 레이저 시스템 안전성 성능평가 및 임상적 유효성평가 가이드라인 수립을 위한 연구)

  • Kim, You Rim;Yu, Woo Jin;Park, Ho Joon;Jang, Won Seuk
    • Journal of Biomedical Engineering Research
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    • v.40 no.6
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    • pp.250-259
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    • 2019
  • Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

Antimicrobial Effects of the Extract of Galla rhois on the Long-term Swine Clinical Trial (양돈 임상 연구에 의한 천연물 오배자 추출물의 항균.항바이러스 효과 규명)

  • Lee, Hyun-A;Hong, Sun-Hwa;Han, Sang-Jun;Kim, Ok-Jin
    • Journal of Veterinary Clinics
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    • v.28 no.1
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    • pp.1-6
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    • 2011
  • We are aim to evaluate antimicrobial effects of the extract of Galla rhois (GR) on the health status and performance of growing and finishing pigs. This study was conducted on the growing and finishing pigs (n = 200) for 130 days in a swine husbandry. The animals were divided with two groups; GR treated group (n = 100) and commercial diet feeding group (n = 100). GR treated animals had provided with commercial diet adding the extract of GR as 0.2%. During the study period, we compared clinical signs, weight increase rate, diet consumption amount, fecal scores, gross findings, necropsy findings, histopathological findings between the treated group and non treated group. After necropsy, bacteria isolation and PCR analysis were conducted with the clinical samples. As the results of this long-term clinical trial, GR showed the antimicrobial effects on respiratory disease and diarrhea. We were identified that GR had the anti-bacterial and anti-viral effects.

Visceral fat and body weight are reduced in overweight adults by the supplementation of Doenjang, a fermented soybean paste

  • Cha, Youn-Soo;Yang, Ji-Ae;Back, Hyang-Im;Kim, Soo-Ran;Kim, Min-Gul;Jung, Su-Jin;Song, Won O;Chae, Soo-Wan
    • Nutrition Research and Practice
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    • v.6 no.6
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    • pp.520-526
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    • 2012
  • Various forms of fermented soybean products are well documented for their health benefits. The efficacy of anti-obesogenic effect of Doenjang, one of the most commonly used seasonings in Korean cuisine, has been reported only in animal models; thus, an evaluation of Doenjang needs to be conducted in human studies. We aimed to test the hypothesis that Doenjang supplementation reduces body weight and changes body composition in overweight adults. A total of 51 overweight adults participated in this study. A group of males with BMI ${\geq}23kg/m^2$ and waist to hip ratio (WHR) ${\geq}$ 0.90, and a group of females with BMI ${\geq}23kg/m^2$ and WHR ${\geq}$ 0.85 were randomly assigned to either a Doenjang supplement (9.9 g dry/day) group or a placebo group for a 12-week randomized, double-blind and placebo-controlled study. Anthropometric parameters, abdominal fat distribution by computerized tomography (CT) and blood components were measured before and after the intervention period. After the 12-week study, the Doenjang supplementation group had significant reductions in body weight (kg), body fat mass (kg) and body fat (%) compared to the placebo group, the supplementation of Doenjang resulted in a significant reduction in visceral fat ($cm^2$), although no changes were observed in total and subcutaneous fat are as ($cm^2$), serum lipid profiles and dietary intakes. The present study demonstrated that daily supplementation of 9.9 g dry/day of Doenjang for 12 weeks reduces body weight and visceral fat in overweight adults.