• Title/Summary/Keyword: Clinical trial center

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Should Cerebral Angiography Be Avoided within Three Hours after Subarachnoid Hemorrhage?

  • An, Hong;Park, Jaechan;Kang, Dong-Hun;Son, Wonsoo;Lee, Young-Sup;Kwak, Youngseok;Ohk, Boram
    • Journal of Korean Neurosurgical Society
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    • v.62 no.5
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    • pp.526-535
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    • 2019
  • Objective : While the risk of aneurysmal rebleeding induced by catheter cerebral angiography is a serious concern and can delay angiography for a few hours after a subarachnoid hemorrhage (SAH), current angiographic technology and techniques have been much improved. Therefore, this study investigated the risk of aneurysmal rebleeding when using a recent angiographic technique immediately after SAH. Methods : Patients with acute SAH underwent immediate catheter angiography on admission. A four-vessel examination was conducted using a biplane digital subtraction angiography (DSA) system that applied a low injection rate and small volume of a diluted contrast, along with appropriate control of hypertension. Intra-angiographic aneurysmal rebleeding was diagnosed in cases of extravasation of the contrast medium during angiography or increased intracranial bleeding evident in flat-panel detector computed tomography scans. Results : In-hospital recurrent hemorrhages before definitive treatment to obliterate the ruptured aneurysm occurred in 11 of 266 patients (4.1%). Following a univariate analysis, a multivariate analysis using a logistic regression analysis revealed that modified Fisher grade 4 was a statistically significant risk factor for an in-hospital recurrent hemorrhage (p=0.032). Cerebral angiography after SAH was performed on 88 patients ${\leq}3$ hours, 74 patients between 3-6 hours, and 104 patients >6 hours. None of the time intervals showed any cases of intra-angiographic rebleeding. Moreover, even though the DSA ${\leq}3$ hours group included more patients with a poor clinical grade and modified Fisher grade 4, no case of aneurysmal rebleeding occurred during erebral angiography. Conclusion : Despite the high risk of aneurysmal rebleeding within a few hours after SAH, emergency cerebral angiography after SAH can be acceptable without increasing the risk of intra-angiographic rebleeding when using current angiographic techniques and equipment.

Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocol

  • Kim, Jihye;Kim, Hyunho;Kim, Keun Ho
    • Integrative Medicine Research
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    • v.6 no.3
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    • pp.317-324
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    • 2017
  • Background: Bu-Zhong-Yi-Qi-Tang (BZYQT) has long been used for the treatment of severe weakness caused by general fatigue, loss of appetite, or indigestion. The aim of this feasibility study is to assess the effectiveness and safety of BZYQT for the treatment of functional dyspepsia (FD) with spleen qi deficiency. Methods: This study will be conducted at a single center as a prospective, nonrandomized, nonblinded, single-arm feasibility study. A total of 30 participants diagnosed with FD in accordance with the Rome III criteria will be enrolled. All patients will receive BZYQT for 4 weeks. The primary outcome is the change in the Nepean Dyspepsia Index-Korean version (NDI-K) scores between the baseline and 4-week images. The secondary outcomes include the tongue coating thickness, blood parameters, and BZYQT Questionnaire score. The NDI-K score will be acquired four times, at Weeks 0 (baseline), 2 (during treatment), 4 (after treatment), and 8 (after follow-up). Written informed consent will be obtained from all study participants prior to enrollment. This study has been approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital. This study protocol is registered with the national clinical trial registry of the World Health Organization International Clinical Trials Registry Platform. Results will be published in a journal and will be disseminated both electronically and in print. Discussion: The results of this study may serve as a guide for researchers seeking to effectively evaluate the effects of BZYQT.

Fermented Laminaria japonica improves working memory and antioxidant defense mechanism in healthy adults: a randomized, double-blind, and placebo-controlled clinical study

  • Kim, Young-Sang;Reid, Storm N.S.;Ryu, Jeh-Kwang;Lee, Bae-Jin;Jeon, Byeong Hwan
    • Fisheries and Aquatic Sciences
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    • v.25 no.8
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    • pp.450-461
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    • 2022
  • A randomized, double-blind, and placebo-controlled clinical study was used to determine the cognitive functions related to working memory (WM) and antioxidant properties of fermented Laminaria japonica (FLJ) on healthy volunteers. Eighty participants were divided into a placebo group (n = 40) and FLJ group (n = 40) that received FLJ (1.5 g/day) for 6 weeks. Memory-related blood indices (brain-derived neurotrophic factor, BDNF; angiotensin-converting enzyme; human growth hormone, HGH; insulin-like growth factor-1, IGF-1) and antioxidant function-related indices (catalase, CAT; malondialdehyde, MDA; 8-oxo-2'-deoxyguanosine, 8-oxo-dG; thiobarbituric acid reactive substances, TBARS) were determined before and after the trial. In addition, standardized cognitive tests were conducted using the Cambridge Neuropsychological Test Automated Batteries. Furthermore, the Korean Wechsler Adult Intelligence Scale (K-WAIS)-IV, and the Korean version of the Montreal Cognitive Assessment (MoCA-K) were used to assess the pre and post intake changes on WM-related properties. According to the results, FLJ significantly increased the level of CAT, BDNF, HGH, and IGF-1. FLJ reduced the level of TBARS, MDA, and 8-oxo-dG in serum. Furthermore, FLJ improved physical activities related to cognitive functions such as K-WAIS-IV, MoCA-K, Paired Associates Learning, and Spatial Working Memory compared to the placebo group. Our results suggest that FLJ is a potential candidate to develop functional materials reflecting its capability to induce antioxidant mechanisms together with WM-related indices.

A Literature Review on the Application of the Propensity Score Matching Method in the Field of Asian Oncology (한의 종양학 연구 분야에서의 Propensity Score Matching Method 적용에 대한 문헌 고찰)

  • Dong-hyeon, Kim;Jong-hee, Kim;Hwa-seung, Yoo;So-jung, Park
    • Journal of Korean Traditional Oncology
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    • v.27 no.1
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    • pp.25-36
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    • 2022
  • The Randomized Control Trial (RCT) is the most well-established and widely used statistical methodology in clinical research; however, applying thorough RCT to cancer patients presents challenges such as ethical concerns, high costs, short clinical periods, and limitations in collecting various side effects. To address this issue, the propensity score matching method, which takes advantage of the benefits of observational research while compensating for the drawbacks of randomized control trials, is used in a variety of fields. In recent years, 28 studies on the effectiveness of Korean medicine on tumors have been conducted abroad using the Propensity Score Matching Method, but none have been conducted in Korea. The majority of studies have focused on liver cancer, colon cancer, lung cancer, and stomach cancer, with endpoints such as survival time, incidence rate, quality of life, and treatment outcomes revealing statistical differences in how Korean medicine intervention affects treatment outcomes. As a result, well-established studies using the propensity matching score methodology should be useful in evaluating the impact of Korean medicine in oncology treatments.

The Impact of Fractional Flow Reserve on Clinical Outcomes after Coronary Artery Bypass Grafting: A Meta-analysis

  • Yoonjin, Kang;Heeju, Hong;Suk Ho, Sohn;Myoung-jin, Jang;Ho Young, Hwang
    • Journal of Chest Surgery
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    • v.55 no.6
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    • pp.442-451
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    • 2022
  • Background: This meta-analysis was conducted to evaluate the effect of fractional flow reserve (FFR) on clinical outcomes after coronary artery bypass grafting (CABG). Methods: Five online databases were searched for studies that (1) enrolled patients who underwent isolated CABG or CABG with aortic valve replacement and (2) demonstrated the effect of an FFR-guided strategy on major adverse cardiac events (MACE) after surgery based on a randomized controlled trial or adjusted analysis. MACE included cardiac death, acute myocardial infarction (MI), and repeated revascularization. The primary outcomes were all MACE outcomes and a composite of all-cause death and MI, and the secondary outcomes were the individual MACE outcomes. Publication bias was assessed using a funnel plot and the Egger test. Results: Six articles (3 randomized and 3 non-randomized studies: n=1,027) were selected. MACE data were extracted from 4 studies. The pooled analyses showed that the risk of MACE was not significantly different between patients who underwent FFR-guided CABG and those who underwent angiography-guided CABG (hazard ratio [HR], 0.80; 95% CI, 0.57-1.12). However, the risk of the composite of death or MI was significantly lower in patients undergoing FFR-guided CABG (HR, 0.62; 95% CI, 0.41-0.94). The individual MACE outcomes were not significantly different between FFR-guided and angiography-guided CABG. Conclusion: FFR-guided CABG might be beneficial in terms of the composite outcome of death or MI compared with angiography-guided CABG although data are limited.

A Clinical Study of Acupuncture with Aromatherapy on Poststroke Depression Patients (중풍후우울증 환자에 대한 향기침요법의 임상적 연구)

  • Chung, Sae-Yun;Hwang, Jae-Woong;Kim, Seok-Min;Jung, Jae-Han;Choi, Chang-Min;Jung, Woo-Sang;Moon, Sang-Kwan;Cho, Ki-Ho;Kim, Young-Suk;Sun, Jong-Joo
    • The Journal of Internal Korean Medicine
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    • v.27 no.2
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    • pp.480-487
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    • 2006
  • Objectives : In this study we investigated BDI(Beck Depression Inventory) improvement of poststroke depression Patients who took the acupuncture with aromatherapy, in order to examine its capacity as a new treatment and to establish a primary data for further studies of developments of diverse Practical acupunctures. Methods : Physicians applied the acupuncture with aromatherapy every day for two weeks. We had evaluated baseline characteristics and BDI of all Patients, and revaluated BDI and examined the side effects two weeks later. The qualified Patients were classified into two groups, depression group (more than 10 points and 10 in BDI) and non-depression group (less than 10 points in BDI) according to the baseline BDI. Results : The study was completed with 27stroke patients. The acupuncture with aroma therapy was applied in 18 post-stroke depression patients and 9 non-depression patients for 2 weeks. And the result showed that the BDI scores in the depression group decreased to $16.5{\pm}11.1$ after the treatment (compared to $24.4{\pm}11.5$ before the treatment). so proved the significant effect on post-stroke depression of the acupuncture. On the other hand. the scores in the non-depression group increased to $9.2{\pm}9.5$ (compared to $3.3{\pm}3.0$). Conclusions : The acupuncture with aromatherapy applied on post-stroke depression patients showed the effect of BDI improvement. Further researches are needed to evaluate the distinct functional mechanism of acupuncture with aromatherapy, and to estimate its effectiveness by well-designed randomized controlled trial.

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$H_2$ Receptor Antagonists and Gastric Cancer in the Elderly: A Nested Case-Control Study (노인 인구에서 $H_2$ Receptor Antagonist와 위암과의 관련성: 코호트 내 환자-대조군 연구)

  • Kim, Yoon-I;Heo, Dae-Seog;Lee, Seung-Mi;Youn, Kyoung-Eun;Koo, Hye-Won;Bae, Jong-Myon;Park, Byoung-Joo
    • Journal of Preventive Medicine and Public Health
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    • v.35 no.3
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    • pp.245-254
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    • 2002
  • Objective : To test if the intake of $H_2$ receptor antagonists ($H_2$-RAs) increases the risk of gastric cancer in the elderly. Methods : The source population for this study was drawn from the responders to a questionnaire survey administered to the Korea Elderly Pharmacoepidemiological Cohort (KEPEC), who were beneficiaries of the Korean Medical Insurance Corporation, were at least 65 years old, and residing in Busan in 1999. The information on $H_2$-RAs exposure was obtained from a drug prescription database compiled between inn. 1993 and Dec. 1994. The cases consisted of 76 gastric cancer patients, as confirmed from the KMIC claims data, the National Cancer Registry and the Busan Cancer Registry. The follow-up period was from Jan. 1993 to Dec. 1998. Cancer free controls were randomly selected by 1:4 individual matching, which took in to consideration the year of birth and gender. Information on confounders was collected by a mail questionnaire survey. The odds ratios, and their 95% confidence intervals, were calculated using a conditional logistic regression model. Results : After adjusting for a history of gastric ulcer symptoms, medication history, and body mass index, the adjusted OR (aOR) was 4.6 (95% CI=1.72-12.49). The odds ratio of long term use (more than 7 days) was 2.3 (95% CI=1.07-4.82). The odds ratio of short term use was 4.6 (95% CI=1.26-16.50). The odds ratio of parenteral use was 4.4 195% CI=1.16-17.05) and combination use between the oral and parenteral routes (aOR, 16.8; 95% CI=1.21-233.24) had the high risk of gastric cancer. The aOR of cimetidine was 1.7 (95% CI=1.04-2.95). The aOR of ranitidine was 2.0 (95% CI=1.21-3.40). The aOR of famotidine was 1.7 (95% CI=0.98-2.80). Conclusion : The intake of $H_2$-RAs might increase the risk of gastric cancer through achlorhydria in the elderly.

An Analysis of Clinical Prognosis Factors of Peripheral Facial Palsy and the Effects of Electrodiagnostic Test (말초성 안면신경마비 경과에 대한 임상적 예후인자 및 신경생리검사의 유용성 분석)

  • Ahn, Chang-Beohm;Yoon, Hyun-Min;Jang, Kyung-Jun;Kim, Cheol-Hong;Jung, Kyoung-Keun;Min, Young-Kwang;Kim, Soo-Min;Kim, Jeong-Eun;Cho, Beohm-Gyu
    • Journal of Acupuncture Research
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    • v.24 no.4
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    • pp.209-223
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    • 2007
  • Objectives : Facial Nerve Paralysis is one kind of common diseases and it can be treated by natural therapy and the efficiency of treatment is relatively high. In clinical trial, it is not difficult to find patients who were not completely recovered from Facial Nerve Paralysis, so the symptoms are fixed permanently. This leads many doctors and patients to have interests in the progress and prognosis of the disease, so this study was to analyze clinical prognosis factors and verify the effects of Electrodiagnostic Test. Methods : The 378 subjects were chosen from 987 patients who were suffering from Peripheral Facial Palsy, diagnosed with Bell's palsy and Ramsay Hunt Syndrome and had admission treatment. They got Oriental-Western Medicine Treatment within two weeks after outbreaks of the disease and treated at least over 3 weeks using Oriental-Western Medicine Treatment. Results : 1. There was a significant difference in the results of treatment according to gender, age, types of Facial Palsy, existence of Post Auricular Pain, existence of Labyrinth Symptom, HBGS, and existence of onsets of recovery as clinical prognosis factors of Peripheral Facial Palsy, However, a statistically significant difference was not shown in the results of treatment according to the position of Facial Palsy(left or right), existence of a relapse, and diabetes, hypertension. 2. As a result of overall treatment, 77.2% of patients were recovered almost entirely and 22.8% were not, and the quelae of incomplete recovery were Synkinesis, facial contracture, facial spasm, crocodile tears and scheroma in order of frequency. 3. The results of electrodiagnostic test represented useful correlation to predict the final effects of treatment. Conclusion : Based on the above results, the prognosis factors, the degree of recovery, and the sequelae of incomplete recovery were analysed and the effects of electrodiagnostic test was verified.

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Preoperative short course radiotherapy with concurrent and consolidation chemotherapies followed by delayed surgery in locally advanced rectal cancer: preliminary results

  • Aghili, Mahdi;Sotoudeh, Sarvazad;Ghalehtaki, Reza;Babaei, Mohammad;Farazmand, Borna;Fazeli, Mohammad-Sadegh;Keshvari, Amir;Haddad, Peiman;Farhan, Farshid
    • Radiation Oncology Journal
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    • v.36 no.1
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    • pp.17-24
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    • 2018
  • Purpose: This study aimed to assess complications and outcomes of a new approach, that is, combining short course radiotherapy (SRT), concurrent and consolidative chemotherapies, and delayed surgery. Materials and Methods: In this single arm phase II prospective clinical trial, patients with T3-4 or N+ M0 rectal adenocarcinoma were enrolled. Patients who received induction chemotherapy or previous pelvic radiotherapy were excluded. Study protocol consisted of three-dimensional conformal SRT (25 Gy in 5 fractions in 1 week) with concurrent and consolidation chemotherapies including capecitabine and oxaliplatin. Total mesorectal excision was done at least 8 weeks after the last fraction of radiotherapy. Primary outcome was complete pathologic response and secondary outcomes were treatment related complications. Results: Thirty-three patients completed the planned preoperative chemoradiation and 26 of them underwent surgery (24 low anterior resection and 2 abdominoperineal resection). Acute proctitis grades 2 and 3 were seen in 11 (33.3%) and 7 (21.2%) patients, respectively. There were no grades 3 and 4 subacute hematologic and non-hematologic (genitourinary and peripheral neuropathy) toxicities and perioperative morbidities such as anastomose leakage. Grade 2 or higher late toxicities were observed among 29.6% of the patients. Complete pathologic response was achieved in 8 (30.8%) patients who underwent surgery. The 3-year overall survival and local control rates were 65% and 94%, respectively. Conclusion: This study showed that SRT combined with concurrent and consolidation chemotherapies followed by delayed surgery is not only feasible and tolerable without significant toxicity but also, associated with promising complete pathologic response rates.

A Comparison Study of Postural Control Measures Between Before and After Applying Temporomandibular Joint Balance Appliance-Golf (TBA-G) Using Balance Master System (Balance Master를 이용한 TBA-G 착용 전후 균형능력 평가 비교 연구)

  • Doo, Kyeong-Hee;Lee, Ji-Hyun;Lee, Dong-Hyuk;Kim, Soo-Kyung;Cho, Seung-Yeon;Park, Jung-Mi;Ko, Chang-Nam;Bae, Hyung-Sup;Park, Seong-Uk
    • The Journal of Korean Medicine
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    • v.35 no.1
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    • pp.50-57
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    • 2014
  • Objectives: The purpose of this study was to examine whether Temporomandibular Joint Balance Appliance-Golf (TBA-G) can improve postural control ability of healthy adults. Methods: Twenty participants (10 male, 10 female) aged 20 to 39 years were involved. Postural control ability of all participants was assessed before and after applying TBA-G with Balance $Master^{(R)}$ system. Modified clinical test sensory interaction on balance (mCTSIB), unilateral stance, weight bearing and rhythmic weight shift were used to evaluate postural control ability. Results: After applying TBA-G, mCTSIB on a firm plate with eyes open increased from 0.2 to 0.23 (p<0.05) but directional control was improved in slow and moderate velocity of front/back rhythmic weight shift test (P<0.05). In two cases with postural imbalance, most of the postural control measures improved after applying TBA-G. Conclusions: The results suggest that TBA-G could improve balance control ability. A larger controlled trial is needed to determine more accurately the effect of TBA-G on balance control ability.