• Title/Summary/Keyword: Multicenter study

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RETROSPECTIVE MULTICENTER STUDY OF CSM ENDOSSEOUS DENTAL IMPLANT

  • Park, Eun-Young
    • The Journal of Korean Academy of Prosthodontics
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    • v.45 no.3
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    • pp.321-328
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    • 2007
  • Statement of problem. To work the economic limitation of dental implant usage, some types of domestic implant have been developing. But, there have been seldom reported about the clinical success rate of them as yet. Purpose. The aim of this retrospective multicenter study was to evaluate the performance of CSM implants(CSM company, Daegu, Korea). Material and methods. Thirty-five patients were rehabilitated with 150 CSM implants in this multicenter study. Results. The success rate was 96.2%. CSM Titanium fixtures can obtain slightly higher success rate when a cover screw was not used for implant installation than when used. However it doesn't show significant difference(p=.7615, Fisher's Exact test). Conclusion. This multicenter retrospective study demonstrated the efficacy of the CSM implant in the treatment of variety of clinical manifestation of tooth loss. And it can be assumed that whether a cover screw is used or not should no influence on the osseointegration.

Occupational exposure to polycyclic aromatic hydrocarbons and lung cancer risk : a multicenter study in Europe (국외논문정보 - 직업적인 PAHs 노출과 폐암 위험 : 유럽의 multicenter 연구를중심으로)

  • Olsson, Ann C.; Fevotte, Joelle;Fletcher, Tony;Cassidy, Adrian;Mannetje, Andrea't;Zaridze, David;Szeszenia-Dabrowska, Neonila;Rudnai, Peter;Lissowska, Jolanta;Fabianova, Eleonora;Mates, Dana;Bencko, Vladimir;Foretova, Lenka;Janout, Vladimir;Brennan, Paul;Boffetta, Paolo
    • 월간산업보건
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    • s.265
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    • pp.44-51
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    • 2010
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Harmonization of laboratory results by data adjustment in multicenter clinical trials

  • Lee, Sang Gon;Chung, Hee-Jung;Park, Jeong Bae;Park, Hyosoon;Lee, Eun Hee
    • The Korean journal of internal medicine
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    • v.33 no.6
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    • pp.1119-1128
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    • 2018
  • Background/Aims: In multicenter clinical trials, laboratory tests are performed in the laboratory of each center, mostly using different measuring methodologies. The purpose of this study was to evaluate coefficients of variation (CVs) of laboratory results produced by various measuring methods and to determine whether mathematical data adjustment could achieve harmonization between the methods. Methods: We chose 10 clinical laboratories, including Green Cross Laboratories (GC Labs), the central laboratory, for the measurement of total cholesterol, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), serum triglycerides, creatinine, and glucose. The serum panels made with patient samples referred to GC Labs were sent to the other laboratories. Twenty serum samples for each analyte were prepared, sent frozen, and analyzed by each participating laboratory. Results: All methods used by participating laboratories for the six analytes had traceability by reference materials and methods. When the results from the nine laboratories were compared with those from GC Labs, the mean CVs for total cholesterol, HDL-C, LDL-C, and glucose analyzed using the same method were 1.7%, 3.7%, 4.3%, and 1.7%, respectively; and those for triglycerides and creatinine analyzed using two different methods were 4.5% and 4.48%, respectively. After adjusting data using Deming regression, the mean CV were 0.7%, 1.4%, 1.8%, 1.4%, 1.6%, and 0.8% for total cholesterol, HDL-C, LDL-C, triglyceride, creatinine, and glucose, respectively. Conclusions: We found that more comparable results can be produced by laboratory data harmonization using commutable samples. Therefore, harmonization efforts should be undertaken in multicenter trials for accurate data analysis (CRIS number; KCT0001235).

Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol

  • Eom, Bang Wool;Yoon, Hong Man;Min, Jae Seok;Cho, In;Park, Ji-Ho;Jung, Mi Ran;Hur, Hoon;Kim, Young-Woo;Park, Young Kyu;Nam, Byung-Ho;Ryu, Keun Won;Sentinel Node Oriented Tailored Approach (SENORITA) Study Group
    • Journal of Gastric Cancer
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    • v.19 no.2
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    • pp.157-164
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    • 2019
  • Purpose: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD. Materials and Methods: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications. Conclusions: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.

Association Between Insomnia and Constipation: A Multicenter Three-year Cross-sectional Study Using Shift Workers' Health Check-up Data

  • Yun, Byung-Yoon;Sim, Juho;Yoon, Jin-Ha;Kim, Sung-Kyung
    • Safety and Health at Work
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    • v.13 no.2
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    • pp.240-247
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    • 2022
  • Background: Although insomnia and constipation are highly prevalent worldwide, studies examining a possible association between them are lacking. We examined the relationship between insomnia and constipation in shift workers who have a high prevalence of insomnia and other diseases. Methods: This study had a multicenter cross-sectional design and conducted using health examination data including self-reported questionnaires. In total, 12,879 and 4,650 shift workers were enrolled in Severance Hospital and Wonju Severance Hospital, respectively, during 2015-2017. Multivariate logistic regression models and subgroup analysis were performed in each center with the same protocol, using a common data model. Results: The mean age of the total population was 44.35 (standard deviation = 8.75); the proportion of males was 56.9%. Female sex, being underweight and non-smoker were strongly associated with an increased risk of constipation symptom (p < 0.001). Pooled odds ratios (ORs) were calculated using ORs of both centers with weights; there was a significant dose-response relationship (sub-threshold 1.76 [95% confidence interval [CI] 1.62-1.91]; moderate 2.28 [95% CI 2.01-2.60]; severe 4.15 [95% CI 3.18-5.41] in the final model, p for trend < 0.001). Subgroup analysis performed by stratifying sex and pooled ORs showed a similar trend to that of the entire group. Conclusion: We observed a strong correlation between insomnia and constipation in this population. Our findings may help in formulating guidelines and policies to improve quality of life in shift workers through the management of sleep quality and proper bowel function. This study is the first to report this relationship among people working in shifts.

Methodologic Lessons Learned from Multicenter, Randomized, Controlled Clinical Trial of Acupuncture for Hot Flashes in Peri- and Postmenopausal Women (갱년 및 폐경 후 여성의 안면홍조에 대한 침 치료 다기관 임상연구 : 수행보고 및 방법론적 교훈)

  • Kim, Kun-Hyung;Kim, Dong-Il;Hwang, Deok-Sang;Lee, Jin-Moo;Kim, Hyung-Jun;Yoon, Hyun-Min;Jung, Hee-Jung;Kang, Kyung-Won;Lee, Myeong-Soo;Choi, Sun-Mi
    • The Journal of Korean Obstetrics and Gynecology
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    • v.23 no.1
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    • pp.42-52
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    • 2010
  • Purpose: This report aims to administer methodologic issues around recently conducted multicenter study for evaluating the effects of acupuncture on menopusal hot flashes and discuss practical issues for further implementation of acupuncture clinical trial for hot flashes. Methods: Study process were mentioned, and issues related to avoiding risk of bias, designing appropriate control group, optimal outcome measurement, potential different effects of menopausal status on study outcomes, and suggestions for developing future clinical trials are discussed. Results: Shortcomings of our multicenter study include lack of allocation concealment and assessor blinding, subjective outcome measurement, short-term follow-up, and fixed acupuncture regimen despite pragmatic purpose of this study. Improving trial design, using objective or validated outcomes, assessing long-term effects of acupuncture, and individualizing acupuncture regimen are needed in future clinical trials. Conclusion: We expect these practical discussions to enable researchers to plan and develop future well-designed clinical trials for evaluating the effects of acupuncture on hot flashes or other women's health issues.

The characteristics of zoster-associated prodromal symptoms in Korea (한국의 대상 포진 관련 전구 증상의 특징)

  • Kim, Yeon-dong;Lee, Gong-heui;Lee, Cheolhyeong
    • Journal of the Korea Convergence Society
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    • v.12 no.8
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    • pp.327-333
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    • 2021
  • Zoster-associated pain (ZAP) in patients with herpes zoster (HZ) may persist for a long time, occurring even years after the rash has healed. In this case, the patient is diagnosed as having postherpetic neuralgia (PHN). Prodromal symptoms can present with constant or intermittent pain, and are often accompanied by other symptoms, resulting in misdiagnosis and/or inappropriate treatment. The aim of this study is to investigate the characteristics of the prodromal symptoms of ZAP through a multicenter study in Korea.

Treatment of Unruptured Intracranial Aneurysms in South Korea in 2006 : A Nationwide Multicenter Survey from the Korean Society of Cerebrovascular Surgery

  • Kim, Jeong-Eun;Lim, Dong-Jun;Hong, Chang-Ki;Joo, Sung-Pil;Yoon, Seok-Mann;Kim, Bum-Tae
    • Journal of Korean Neurosurgical Society
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    • v.47 no.2
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    • pp.112-118
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    • 2010
  • Objective : There have been no clinical studies regarding the epidemiology and treatment outcome for unruptured intracranial aneurysm (UIA) in South Korea yet. Thus, The Korean Society of Cerebrovascular Surgery (KSCVS) decided to evaluate the clinical and epidemiological characteristics, and outcome of the treatment of UIA in 2006, using the nationwide multicenter survey in South Korea. Methods : A total of 1,696 cases were enrolled retrospectively over one year at 48 hospitals. The following data were obtained from all patients : age, sex, presence of symptoms, location and size of the aneurysm, treatment modality, presence of risk factors for stroke, and the postoperative 3D-day morbidity and mortality. Results : The demographic data showed female predominance and peak age of seventh and sixth decades. Supraclinoid internal carotid artery was the most common site of aneurysms with a mean size of 5.6 mm. Eight-hundred-forty-six patients (49.9%) were treated with clipping, 824 (48.6%) with coiling, and 26 with combined method. The choice of the treatment modalities was related to hospital (p=0.000), age (p=0.000), presence of symptom (p=0.003), and location of aneurysm (p=0.000). The overall 30-day morbidity and mortality were 7.4% and 0.3%, respectively. The 30-day mortality was 0.4% for clipping and 0.2% for coiling, and morbidity was 8.4% for clipping and 6.3% for coiling. Age (p=0.010), presence of symptoms (p=0.034), size (p=0.000) of aneurysm, and diabetes mellitus (p=0.000) were significant prognostic factors, while treatment modality was not. Conclusion : This first nation-wide multicenter survey on UIAs demonstrates the epidemiological and clinical characteristics, outcome and the prognostic factors of the treatment of UIAs in South Korea. The 30-day postoperative outcome for UIAs seems to be reasonable morbidity and mortality in South Korea.

An Overview on the Construction of Korea Constitutional Multicenter Bank for Sasang Constitutional Medicine (체질정보은행 구축현황에 관한 소고)

  • Baek, Young-Hwa;Jin, Hee-Jeong;Kim, Ho-Seok;Jang, Eun-Su;Lee, Si-Woo
    • Journal of Sasang Constitutional Medicine
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    • v.24 no.2
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    • pp.47-53
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    • 2012
  • 1. Objectives : The aim of the present study was to describe the Korea Constitutional Multicenter Bank (KCMB), which was various clinical data bank for scientific advancement of constitutional diagnosis and treatment. 2. Methods and Results : The KCMB is based on the 28 multi-institute cooperative clinical research networks including domestic and international institute. Since the KCMB was founded in 2006, data have been accumulated from 10,412 subjects. The KCMB consists of three parts: The clinical constitutional data, the measurement data, and the biological data. The method of data entry is via web based electronic Case Report From (eCRF). The eCRF has been developed and programed to ensure the efficient entry of data. We also developed coding manual, ongoing quality control assessment to obtain high-quality data. 3. Conclusions : The KCMB with various data contribute to providing the scientification of Sasang Constitutional Medicine.

COVID-19 and Cancer: Questions to Be Answered

  • Hong, Young Seon
    • Journal of Hospice and Palliative Care
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    • v.24 no.1
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    • pp.66-68
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    • 2021
  • The World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) outbreak to be a pandemic on March 12, 2020. In Korea, there have been 24,027 confirmed cases of COVID-19 and 420 deaths as of October 3, 2020. The clinical spectrum of COVID-19 ranges from asymptomatic infection to death. Cancer care in this pandemic has radically changed. The literature was reviewed. The COVID-19 pandemic has made it urgently necessary to profoundly re-organize cancer patients' care without compromising cancer outcomes. Several important questions in regard to COVID-19 infection in cancer patients have emerged. Are patients with cancer at a higher risk of COVID-19 infection? Are they at an increased risk of mortality and severe illness when infected with COVID-19? Does anticancer treatment affect the course of COVID-19? Based on the existing research, cancer patients with immunosuppression are vulnerable to COVID-19 infection, and cancer patients are more likely to experience severe COVID-19. However, chemotherapy and major surgery do not seem to be predictors of hospitalization or severe disease. Korean background data on patients with cancer and COVID-19 are lacking. Prospective multicenter studies on the outcomes of patients with cancer and COVID-19 should be conducted.