• Title/Summary/Keyword: Multicenter study

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Treat-to-Target Strategy for Asian Patients with Early Rheumatoid Arthritis: Result of a Multicenter Trial in Korea

  • Song, Jason Jungsik;Song, Yeong Wook;Bae, Sang Cheol;Cha, Hoon-Suk;Choe, Jung-Yoon;Choi, Sung Jae;Kim, Hyun Ah;Kim, Jinseok;Kim, Sung-Soo;Lee, Choong-Ki;Lee, Jisoo;Lee, Sang-Heon;Lee, Shin-Seok;Lee, Soo-Kon;Lee, Sung Won;Park, Sung-Hwan;Park, Won;Shim, Seung Cheol;Suh, Chang-Hee;Yoo, Bin;Yoo, Dae-Hyun;Yoo, Wan-Hee
    • Journal of Korean Medical Science
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    • v.33 no.52
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    • pp.346.1-346.11
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    • 2018
  • Background: To evaluate the therapeutic benefits of the treat-to-target (T2T) strategy for Asian patients with early rheumatoid arthritis (RA) in Korea. Methods: In a 1-year, multicenter, open-label strategy trial, 346 patients with early RA were recruited from 20 institutions across Korea and stratified into 2 groups, depending on whether they were recruited by rheumatologists who have adopted the T2T strategy (T2T group) or by rheumatologists who provided usual care (non-T2T group). Data regarding demographics, rheumatoid factor titer, anti-cyclic citrullinated peptide antibody titer, disease activity score of 28 joints (DAS28), and Korean Health Assessment Questionnaire (KHAQ) score were obtained at baseline and after 1 year of treatment. In the T2T group, the prescription for disease-modifying antirheumatic drugs was tailored to the predefined treatment target in each patient, namely remission (DAS28 < 2.6) or low disease activity (LDA) ($2.6{\leq}DAS28$ < 3.2). Results: Data were available for 163 T2T patients and 162 non-T2T patients. At the end of the study period, clinical outcomes were better in the T2T group than in the non-T2T group (LDA or remission, 59.5% vs. 35.8%; P < 0.001; remission, 43.6% vs. 19.8%; P < 0.001). Compared with non-T2T, T2T was also associated with higher rate of good European League Against Rheumatism response (63.0% vs. 39.8%; P < 0.001), improved KHAQ scores (-0.38 vs. -0.13; P = 0.008), and higher frequency of follow-up visits (5.0 vs. 2.0 visits/year; P < 0.001). Conclusion: In Asian patients with early RA, T2T improves disease activity and physical function. Setting a pre-defined treatment target in terms of DAS28 is recommended.

A prospective multicenter clinical study on the efficiency of detachable ball- and spring-retained implant prosthesis

  • Min-Jung Kim;Won-Tak Cho;Su-Hyun Hwang;Ji-Hyeon Bae;Eun-Bin Bae;June-Sung Shim;Jong-Eun Kim;Chang-Mo Jeong;Jung-Bo Huh
    • The Journal of Advanced Prosthodontics
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    • v.15 no.4
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    • pp.202-213
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    • 2023
  • PURPOSE. This prospective clinical study was conducted to evaluate the clinical usefulness of the freely detachable zirconia ball- and spring-retained implant prosthesis (BSRP) through a comparative analysis of screw- and cement-retained implant prosthesis (SCRP). MATERIALS AND METHODS. A multi-center, randomized, prospective clinical study evaluating the clinical usefulness of the detachable zirconia ball- and spring-retained implant prostheses was conducted. Sixty-four implant prostheses in 64 patients were examined. Periodic observational studies were conducted at 0, 3, 6, and 12 months after delivery of the implant prosthesis. Factors such as implant success rate, marginal bone resorption, periodontal pocket depth, plaque and bleeding index, and prosthetic complications were evaluated, respectively. RESULTS. During the 1-year observation period, all implants survived without functional problems and clinical mobility, showing a 100% implant success rate. Marginal bone resorption was significantly higher in the SCRP group than in the BSRP group only at the time of implant prosthesis delivery (P = .043). In all observation periods, periodontal pocket depth was slightly higher in the BSRP group than in the SCRP group, but there was no significant difference (P > .05). The modified plaque index (mPI) scores of both groups were moderate. Higher ratio of a score 2 in modified sulcus bleeding index (mBI) was observed in the BSRP group in the 6- and 12-months observation. CONCLUSION. Within the limitations of this study, the newly developed zirconia ball- and spring-retained implant prosthesis could be considered as an applicable and predictable treatment method along with the existing screw- and cement-retained prosthesis.

Artificial Intelligence-Based Identification of Normal Chest Radiographs: A Simulation Study in a Multicenter Health Screening Cohort

  • Hyunsuk Yoo;Eun Young Kim;Hyungjin Kim;Ye Ra Choi;Moon Young Kim;Sung Ho Hwang;Young Joong Kim;Young Jun Cho;Kwang Nam Jin
    • Korean Journal of Radiology
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    • v.23 no.10
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    • pp.1009-1018
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    • 2022
  • Objective: This study aimed to investigate the feasibility of using artificial intelligence (AI) to identify normal chest radiography (CXR) from the worklist of radiologists in a health-screening environment. Materials and Methods: This retrospective simulation study was conducted using the CXRs of 5887 adults (mean age ± standard deviation, 55.4 ± 11.8 years; male, 4329) from three health screening centers in South Korea using a commercial AI (Lunit INSIGHT CXR3, version 3.5.8.8). Three board-certified thoracic radiologists reviewed CXR images for referable thoracic abnormalities and grouped the images into those with visible referable abnormalities (identified as abnormal by at least one reader) and those with clearly visible referable abnormalities (identified as abnormal by at least two readers). With AI-based simulated exclusion of normal CXR images, the percentages of normal images sorted and abnormal images erroneously removed were analyzed. Additionally, in a random subsample of 480 patients, the ability to identify visible referable abnormalities was compared among AI-unassisted reading (i.e., all images read by human readers without AI), AI-assisted reading (i.e., all images read by human readers with AI assistance as concurrent readers), and reading with AI triage (i.e., human reading of only those rendered abnormal by AI). Results: Of 5887 CXR images, 405 (6.9%) and 227 (3.9%) contained visible and clearly visible abnormalities, respectively. With AI-based triage, 42.9% (2354/5482) of normal CXR images were removed at the cost of erroneous removal of 3.5% (14/405) and 1.8% (4/227) of CXR images with visible and clearly visible abnormalities, respectively. In the diagnostic performance study, AI triage removed 41.6% (188/452) of normal images from the worklist without missing visible abnormalities and increased the specificity for some readers without decreasing sensitivity. Conclusion: This study suggests the feasibility of sorting and removing normal CXRs using AI with a tailored cut-off to increase efficiency and reduce the workload of radiologists.

The Prevalence and Histopathologic Characteristics of Oral Minor Salivary Gland Tumors in Korean Patients (한국인의 구강내 소타액선 종양의 발생 빈도와 조직병리학적 특성)

  • Ryu, Mi-Heon
    • Journal of dental hygiene science
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    • v.8 no.3
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    • pp.207-214
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    • 2008
  • The present study was based on the multicenter study and retrospective method of 200 patients with intraoral minor salivary gland tumors which were received at the Yonsei university dental hospital, Soonchunhyang Bucheon hospital and Yonsei university Severance hospital from 1990 to 2006. In this study, 61.5% of the cases were benign tumor and 38.5% were malignant tumor. Of the benign tumors, pleomorphic adenoma was the most common benign tumor (n=104) and Warthin's tumor, lymphangioma, myoepithelioma and basal cell adenoma were followed. Of the malignant tumors, adenoid cystic carcinoma was the most common malignant tumor (n=32) and mucoepidermoid carcinoma, adenocarcinoma, carcinoma ex pleomorphic adenoma, metastatic adenocarcinoma and acinic cell carcinoma were followed. The most common primary tumor location was palate. The result of this study was compared with other previous reviews and showed some differences.

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Recent Epidemiologic Trends on Stroke Patients Admitted to Department of Acupuncture & Moxibustion, Oriental Medical Hospital, Kyung Hee University (침구과에 입원한 뇌졸중 환자의 최근 역학적 동향)

  • Hong, Jang-mu;Kang, Mi-kyeong;Kim, Jong-deog;Yin, Chang-sik;Kang, Jung-won;Park, Sang-min;Seo, Byung-kwan;Chung, In-tae;Koh, Hyung-kyun
    • Journal of Acupuncture Research
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    • v.21 no.4
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    • pp.19-29
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    • 2004
  • Objective : The purpose of this study is to present the epidemiological data on patients with a stroke admitted to Department of Acupuncture & Moxibustion, Oriental Medical Hospital Kyung Hee University and to investigate the difference between preceding diseases of stroke. Methods : We reviewed medical records of 700 patients with a stroke admitted to Department of Acupuncture & Moxibustion, Oriental Medical Hospital, Kyung Hee University. Results: The incidence of cerebral infarction was 6.7 times that of cerebral hemorrhage. The incidence in males was 1.28 times of that in females. The incidence of stroke increased with aging and more cerebral hemorrhage occured in lower age group than cerebral infarction. There was higher morbidity in October, during the changing of the seasons, than any other months. Hypertension was the most common preceding disease followed by diabetis mellitus, heart disease, hyperlipidemia, and according to Odds's ratio for Male/Female, the probability of having preceding diseases was higher in females than males. In cerebral infarction, MCA territory was the most frequent lesion sites. Of the cerebral hemorrhage, basal ganglia (60%) was the most commonly involved site which was followed by thalamus(33.3%), cortex (3.3%) and subcortex (2.2%). The most common symptom accompanied by stroke was motor dysfunction which was followed by verbal disturbance, urination disorder and dysphagia. Conclusion : This study showed the trends of stroke in Oriental medical center. We expects that Multicenter cooperative and prospective study including Oriental Medicine will be inspired by this study for establishing more accurate chacteristics of stroke in Korea in the future.

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Reliability and Data Integration of Duplicated Test Results Using Two Bioelectrical Impedence Analysis Machines in the Korean Genome and Epidemiology Study

  • Park, Bo-Young;Yang, Jae-Jeong;Yang, Ji-Hyun;Kim, Ji-Min;Cho, Lisa-Y.;Kang, Dae-Hee;Shin, Chol;Hong, Young-Seoub;Choi, Bo-Youl;Kim, Sung-Soo;Park, Man-Suck;Park, Sue-K.
    • Journal of Preventive Medicine and Public Health
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    • v.43 no.6
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    • pp.479-485
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    • 2010
  • Objectives: The Korean Genome and Epidemiology Study (KoGES), a multicenter-based multi-cohort study, has collected information on body composition using two different bioelectrical impedence analysis (BIA) machines. The aim of the study was to evaluate the possibility of whether the test values measured from different BIA machines can be integrated through statistical adjustment algorithm under excellent inter-rater reliability. Methods: We selected two centers to measure inter-rater reliability of the two BIA machines. We set up the two machines side by side and measured subjects' body compositions between October and December 2007. Duplicated test values of 848 subjects were collected. Pearson and intra-class correlation coefficients for inter-rater reliability were estimated using results from the two machines. To detect the feasibility for data integration, we constructed statistical compensation models using linear regression models with residual analysis and R-square values. Results: All correlation coefficients indicated excellent reliability except mineral mass. However, models using only duplicated body composition values for data integration were not feasible due to relatively low $R^2$ values of 0.8 for mineral mass and target weight. To integrate body composition data, models adjusted for four empirical variables that were age, sex, weight and height were most ideal (all $R^2$ > 0.9). Conclusions: The test values measured with the two BIA machines in the KoGES have excellent reliability for the nine body composition values. Based on reliability, values can be integrated through algorithmic statistical adjustment using regression equations that includes age, sex, weight, and height.

A Clinical Analysis of Patients Who Visited Emergency Department due to Chemical Incident Occurred at Industrial Place: A Retrospective Study (산업장 화학 사고로 응급실에 내원한 환자의 임상적 고찰: 일개병원의 후향적 연구)

  • Shin, Hee Jun;Oh, Se Kwang;Yoo, Byeong Dai;Jun, Duck Ho;Lee, Dong Ha;Woo, Kuck Hyeun;Yoon, Seong Yong;Choi, Sung Yong
    • Journal of The Korean Society of Clinical Toxicology
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    • v.13 no.2
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    • pp.78-86
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    • 2015
  • Purpose: The purpose of this study is to understand what kinds of chemical substances have been used annually and to investigate incidents that occurred due to chemical hazard release and to analyze statistically clinically chemical injury patients who visited one regional emergency medical center in Gumi city with documented references review. Methods: Annual chemical waste emission quantity (Kg/Year) (Cwep) was reproduced using national web site data governed by the Ministry of Environment and 5 years (from 1 .Jan. 2010 to 31. Dec. 2014) of medical records of chemical injury patients who visited our emergency department were reviewed retrospectively. By applying exclusion criteria, 446 patients of 460 patients were selected. Results: Dichloromethane, Toluene, Trichloroethylene, and Xylene were always included within Top 5 of Cweq. Six cases of chemical incidents were reported and in 3 of 6 cases involving Hydrogen fluoride were included during the study period. Male gender and twenties were the most prevalent group. Injury evoking chemicals were Hydrogen fluoride, unknown, complex chemicals (over 2 substances) in sequence. The most frequent site of wounds and injuries was the respiratory tract. Gas among status, intoxication among diagnosis, and discharge among disposition was most numerous in each group. Conclusion: There have been no uniform clinical protocols for chemical wounds and injuries due to various kinds of chemicophysical properties and ignorance of antidotes. Therefore conduct of a multicenter cohort study and experiments for ruling out chemicals according to chemicophysical priority as well as development of antidotes and clinical protocols for chemical injury patients is needed.

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Gefitinib in Selected Patients with Pre-Treated Non-Small-Cell Lung Cancer: Results from a Phase IV, Multicenter, Non-Randomized Study (SELINE)

  • Lee, Kwan-Ho;Lee, Kye-Young;Jeon, Young-June;Jung, Maan-Hong;Son, Choonhee;Lee, Min-Ki;Ryu, Jeong-Seon;Yang, Sei-Hoon;Lee, Jae-Cheol;Kim, Young-Chul;Kim, Sun-Young
    • Tuberculosis and Respiratory Diseases
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    • v.73 no.6
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    • pp.303-311
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    • 2012
  • Background: This study was designed to analyze the efficacy of gefitinib as a second-line therapy, according to the clinical characteristics in Korean patients with non-small-cell lung cancer (NSCLC). Methods: In this Phase IV observational study, we recruited patients, previously failed first-line chemotherapy, who had locally advanced or metastatic NSCLC, and who were found to be either epidermal growth factor receptor (EGFR) mutation-positive or satisfied 2 or more of the 3 characteristics: adenocarcinoma, female, and non-smoker. These patients were administered with gefitinib 250 mg/day, orally. The primary endpoints were to evaluate the objective response rate (ORR) and to determine the relationship of ORRs, depending on each patient's characteristics of modified intent-to-treat population. Results: A total of 138 patients participated in this study. One subject achieved complete response, and 42 subjects achieved partial response (ORR, 31.2%). The subgroup analysis demonstrated that the ORR was significantly higher in patients with EGFR mutation-positive, compared to that of EGFR mutation-negative (45.8% vs. 14.0%, p=0.0004). In a secondary efficacy variable, the median progression-free survival (PFS) was 5.7 months (95% confidence interval, 3.9~8.4 months) and the 6-month PFS and overall survival were 49.6% and 87.9%, respectively. The most common reported adverse events were rash (34.4%), diarrhea (26.6%), pruritus (17.5%), and cough (15.6%). Conclusion: Gefitinib was observed in anti-tumor activity with favorable tolerability profile as a second-line therapy in these selected patients. When looking at EGFR mutation status, EGFR mutation-positive showed strong association with gefitinib by greater response and prolonged PFS, compared with that of EGFR mutation-negative.

A Multicenter Noncomparative Clinical Study on Midface Rejuvenation Using a Nonabsorbable Polypropylene Mesh: Evaluation of Efficacy and Safety

  • Pak, Chang Sik;Chang, Lan Sook;Lee, Hobin;Jeong, Jae Hoon;Jeong, Jinwook;Yoon, Eul-Sik;Heo, Chan Yeong
    • Archives of Plastic Surgery
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    • v.42 no.5
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    • pp.572-579
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    • 2015
  • Background Facial rejuvenation can be achieved using a variety of techniques. Since minimally invasive procedures for face lifting have become popular because of their convenience and short operating time, numerous minimally invasive surgical procedures have been developed. In this study, a nonabsorbable polypropylene mesh is introduced as a new face lifting instrument, with the nasolabial fold as the main target area. In this paper, we report the efficacy and safety of a polypropylene mesh in midface rejuvenation. Methods Thirty-three subjects with moderate-to-severe nasolabial folds were enrolled from two medical institutions for a noncomparative single-sample study. A mesh was inserted above the superficial muscular aponeurotic system layer, reaching the nasolabial folds through a temporal scalp incision. After 3 weeks, the temporal end of the mesh was pulled to provide a lifting effect. Then, the mesh was fixed to the deep temporal fascia using nonabsorbable sutures. To evaluate efficacy, we compared the scores on the Wrinkle Severity Rating Scale and a visual analog scale for patient satisfaction between the baseline and 7 weeks postoperatively. In addition, we evaluated safety based on the incidence of adverse events. Results The treatment was deemed effective at improving wrinkles in 23 of 28 cases, and patient satisfaction improved significantly during the study period. There were seven cases of skin or subcutaneous tissue complications, including edema and erythema, but there were no suspected serious adverse events. Conclusions Face lifting using a nonabsorbable mesh can improve nasolabial folds without serious adverse effects. Thus, this technique is safe and effective for midface rejuvenation.

Protocol of a Nationwide Observational Study among Patients with Nontuberculous Mycobacterium Pulmonary Disease in South Korea (NTM-KOREA)

  • Kwak, Nakwon;Choi, Hongjo;Jeon, Doosoo;Jhun, Byung Woo;Jo, Kyung-Wook;Kang, Young Ae;Kwon, Yong-Soo;Lee, Myungsun;Mok, Jeongha;Shim, Tae-Sun;Shin, Hong-Joon;Whang, Jake;Yim, Jae-Joon
    • Tuberculosis and Respiratory Diseases
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    • v.83 no.2
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    • pp.141-146
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    • 2020
  • Background: The burden of nontuberculous mycobacterial (NTM) pulmonary disease (PD) is increasing globally. To understand the treatment outcomes and prognosis of NTM-PD, a unified registry is needed. In this project, we aim to construct a multicenter prospective observational cohort with NTM-PD in South Korea (NTM-KOREA). Methods: The primary objective of this study is to analyze treatment outcomes according to the species. In addition, recurrence rate, adverse events, the impact of each drug on treatment outcomes as well as the impact of characteristics of mycobacteriology will be analyzed. The inclusion criteria for the study are as follows: fulfilling the criteria for NTM-PD having one of the following etiologic organisms: Mycobacterium avium complex, M. abscessus subspecies abscessus, M. abscessus subspecies massiliense, or M. kansasii; receiving the first treatment for NTM-PD after enrollment; age >20 years; and consenting to participate in the study. Seven institutions will participate in patient enrollment and about 500 patients are expected to be enrolled. Participants will be recruited from 1 March 2020 until 19 March 2024 and will be observed through 19 March 2029. During the follow-up period, participants' clinical course will be tracked and their clinical data as well as NTM isolates will be collected. Conclusion: NTM-KOREA will be the first nationwide observational cohort for NTM-PD in South Korea. It will provide the information to optimize treatment modalities and will contribute to deeper understanding of the treatment outcomes and long-term prognosis of patients with NTM-PD in South Korea.