• Title/Summary/Keyword: Multicenter study

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A MULTICENTER RETROSPECTIVE STUDY OF OUTPATIENT INTRAVENOUS SEDATION FOR DENTAL TREATMENTS (치과 치료를 위한 외래 정주진정 법에 대한 다기관 후향적 임상연구)

  • Jung, Se-Hwa;Baik, Sang-Hyun;Roh, Hyun-Ki;Kang, Na-Ra;Im, Jae-Jung;Lee, Byung-Ha;Jeon, Jae-Yoon;Hwang, Kyung-Gyun;Shim, Kwang-Sup;Park, Chang-Joo
    • Maxillofacial Plastic and Reconstructive Surgery
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    • v.31 no.5
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    • pp.394-400
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    • 2009
  • Purpose : On outpatient facilities, our sedation protocol focuses on the intermittent bolus injections of midazolam intravenously, according to patient's and operator's needs during the dental treatment. This multicenter retrospective study was aimed to prove the efficiency and safety of our sedation protocol. Patients and Methods : In three centers using the same outpatient sedation protocol for dental treatment (Division of Oral and Maxillofacial Surgery/Department of Dentistry in Hanyang University Medical Center, S-plant Dental Hospital. and Grand Oral and Maxillofacial Surgery), total 937 patients had various dental treatments under intravenous conscious sedations with independent patient monitoring from March 2006 to March 2009. By reviewing charts, we analyzed the results of sedation and dental treatment, retrospectively. Results : Our sedation protocol had no severe postoperative complications requiring admission. while showing good compatibility with almost all dental treatments, with acceptable satisfaction of both patients and operators. Conclusion : We assure that our sedation protocol can be used efficiently and safely on routine outpatient basis. We also hope that this study will provide the concrete concepts to common dental practitioners, who desire to perform sedation for dental treatment.

Prevalence and Risk Factors of Functional Dyspepsia in Health Check-up Population: A Nationwide Multicenter Prospective Study

  • Kim, Sung Eun;Kim, Nayoung;Lee, Ju Yup;Park, Kyung Sik;Shin, Jeong Eun;Nam, Kwangwoo;Kim, Hyeon Ju;Song, Hyun Joo;Joo, Young-Eun;Myung, Dae-Seong;Seo, Ji-Hyun;Jo, Hyun Jin;Kim, Seon Mie;Lim, Seon Hee;Kim, Hyun Jin;Baik, Gwang Ho;Choi, Sang Hyeon;Choi, Suck Chei
    • Journal of Neurogastroenterology and Motility
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    • v.24 no.4
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    • pp.603-613
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    • 2018
  • Background/Aims Functional dyspepsia (FD) is one of the most common gastrointestinal disorders, and FD imposes social and economic burden worldwide. The aim of this study is to identify the prevalence and risk factors of FD in health check-up population in tertiary centers in Korea. Methods A nationwide multicenter prospective study was performed at 9 tertiary healthcare centers in Korea between September 2016 and June 2017. A total of 2525 subjects were investigated based on endoscopic findings and questionnaires with the Rome III criteria, and Helicobacter pylori serology (IgG). Results A total of 1714 subjects without organic disease were enrolled. The mean (${\pm}SD$) age was 51.5 (${\pm}12.7$) years, and 917 patients (53.5%) were female. The proportion of H. pylori seropositivity was 51.0% (874/1714). The prevalence of FD was 10.3% (176/1714), and the subtypes of postprandial distress syndrome alone, epigastric pain syndrome alone, and postprandial distress syndromeepigastric pain syndrome overlap were 4.8%, 3.0%, and 2.5%, respectively. Multivariate analysis showed that female gender (OR, 1.58; 95% CI, 1.14-2.21) and education below college level (OR, 1.45; 95% CI, 1.01-2.07) were related to FD. Multivariate analysis based on age 60 showed female gender as a significant (OR, 2.90; 95% CI, 1.06-7.94) factor in the group ${\geq}60$ years. Conclusions The prevalence of FD was 10.3% in the health check-up population in Korea. Female sex and education below college level were risk factors for FD. Female sex is a risk factor for FD in old age, underscoring the need for close attention in this age group.

Extended Use of Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Retrospective Multicenter Study

  • Kim, Won-Young;Park, SeungYong;Kim, Hwa Jung;Baek, Moon Seong;Chung, Chi Ryang;Park, So Hee;Kang, Byung Ju;Oh, Jin Young;Cho, Woo Hyun;Sim, Yun Su;Cho, Young-Jae;Park, Sunghoon;Kim, Jung-Hyun;Hong, Sang-Bum
    • Tuberculosis and Respiratory Diseases
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    • v.82 no.3
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    • pp.251-260
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    • 2019
  • Background: Beyond its current function as a rescue therapy in acute respiratory distress syndrome (ARDS), extracorporeal membrane oxygenation (ECMO) may be applied in ARDS patients with less severe hypoxemia to facilitate lung protective ventilation. The purpose of this study was to evaluate the efficacy of extended ECMO use in ARDS patients. Methods: This study reviewed 223 adult patients who had been admitted to the intensive care units of 11 hospitals in Korea and subsequently treated using ECMO. Among them, the 62 who required ECMO for ARDS were analyzed. The patients were divided into two groups according to pre-ECMO arterial blood gas: an extended group (n=14) and a conventional group (n=48). Results: Baseline characteristics were not different between the groups. The median arterial carbon dioxide tension/fraction of inspired oxygen ($FiO_2$) ratio was higher (97 vs. 61, p<0.001) while the median $FiO_2$ was lower (0.8 vs. 1.0, p<0.001) in the extended compared to the conventional group. The 60-day mortality was 21% in the extended group and 54% in the conventional group (p=0.03). Multivariate analysis indicated that the extended use of ECMO was independently associated with reduced 60-day mortality (odds ratio, 0.10; 95% confidence interval, 0.02-0.64; p=0.02). Lower median peak inspiratory pressure and median dynamic driving pressure were observed in the extended group 24 hours after ECMO support. Conclusion: Extended indications of ECMO implementation coupled with protective ventilator settings may improve the clinical outcome of patients with ARDS.

Efficacy and safety of losartan in childhood immunoglobulin A nephropathy: a prospective multicenter study

  • Hyesun Hyun;Yo Han Ahn;Eujin Park;Hyun Jin Choi;Kyoung Hee Han;Jung Won Lee;Su Young Kim;Eun Mi Yang;Jin Soon Suh;Jae Il Shin;Min Hyun Cho;Ja Wook Koo;Kee Hyuck Kim;Hye Won Park;Il Soo Ha;Hae Il Cheong;Hee Gyung Kang;Seong Heon Kim
    • Childhood Kidney Diseases
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    • v.27 no.2
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    • pp.97-104
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    • 2023
  • Purpose: Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers (ARBs) are frequently employed to counteract the detrimental effects of proteinuria on glomerular diseases. However, the effects of ARBs remain poorly examined in pediatric patients with immunoglobulin A (IgA) nephropathy. Herein, we evaluated the efficacy and safety of losartan, an ARB, in pediatric IgA nephropathy with proteinuria. Methods: This prospective, single-arm, multicenter study included children with IgA nephropathy exhibiting proteinuria. Changes in proteinuria, blood pressure, and kidney function were prospectively evaluated before and 4 and 24 weeks after losartan administration. The primary endpoint was the difference in proteinuria between baseline and 24 weeks. Results: In total, 29 patients were enrolled and received losartan treatment. The full analysis set included 28 patients who received losartan at least once and had pre- and post-urinary protein to creatinine ratio measurements (n=28). The per-protocol analysis group included 22 patients who completed all scheduled visits without any serious violations during the study period. In both groups, the mean log (urine protein to creatinine ratio) value decreased significantly at 6 months. After 24 weeks, the urinary protein to creatinine ratio decreased by more than 50% in approximately 40% of the patients. The glomerular filtration rate was not significantly altered during the observation period. Conclusions: Losartan decreased proteinuria without decreasing kidney function in patients with IgA nephropathy over 24 weeks. Losartan could be safely employed to reduce proteinuria in this patient population. ClinicalTrials.gov trial registration (NCT0223277)

Safety and Effectiveness of Passeo-18 Lux Drug-Coated Balloon Catheter in Infrainguinal Endovascular Revascularization in the Korean Population: A Multicenter Post-Market Surveillance Study

  • Tae Won Choi;Je Hwan Won;Hwan Jun Jae;Yong Sun Jeon;Sang Woo Park;Gi-Young Ko;Nam Yeol Yim;Jong Yun Won;Chang Won Kim;Jinoo Kim
    • Korean Journal of Radiology
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    • v.25 no.6
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    • pp.565-574
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    • 2024
  • Objective: To evaluate the safety and clinical outcomes of the Passeo-18 Lux drug-coated balloon (DCB) in endovascular revascularization procedures under real-world conditions in a Korean population with atherosclerotic disease of the infrainguinal arteries, including below-the-knee (BTK) arteries. Materials and Methods: Eight institutions in the Republic of Korea participated in this prospective, multicenter, single-arm, post-market surveillance study. Two hundred patients with Rutherford class 2-5 peripheral arterial disease and infrainguinal lesions suitable for endovascular treatment were competitively enrolled. Data were collected at baseline, the time of intervention, discharge, and 1-, 6-, 12-, and 24-month follow-up visits. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months (except when limiting the time frame for procedure- or device-related mortality to within 30 days), and the primary effectiveness endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) within 12 months after the procedure. Results: A total of 197 patients with 332 target lesions were analyzed. Two-thirds of the patients had diabetes mellitus, and 41.6% had chronic limb-threatening ischemia. The median target lesion length was 100 mm (interquartile range: 56-133 mm). Of the target lesions, 35.2% were occlusions, and 14.8% were located in the BTK arteries. Rate of freedom from MAE was 97.9% at 6 months, and the rate of freedom from CD-TLR was 95.0% and 92.2% at 12 and 24 months, respectively. Subgroup analysis of 43 patients and 49 target lesions involving the BTK arteries showed rate of freedom from MAE of 92.8% at 6 months and rates of freedom from CD-TLR of 88.8% and 84.4% at 12 and 24 months, respectively. Conclusion: The results of the present study, including the BTK subgroup analysis, showed outcomes comparable to those of other DCB studies, confirming the safety and effectiveness of Passeo-18 Lux DCB in the Korean population.

Long-Term Survival Outcomes of Elderly Patients Treated With S-1 or Capecitabine Plus Oxaliplatin for Stage II or III Gastric Cancer: A Multicenter Cohort Study

  • Choi, Seohee;Min, Jae-Seok;Jeong, Sang-Ho;Yoo, Moon-Won;Son, Young-Gil;Oh, Sung Jin;Kim, Jong-Han;Park, Joong-Min;Hur, Hoon;Jee, Ye Seob;Hwang, Sun-Hwi;Jin, Sung-Ho;Lee, Sang Eok;Lee, Young-Joon;Seo, Kyung Won;Park, Sungsoo;Lee, Chang Min;Kim, Chang Hyun;Jeong, In Ho;Lee, Han Hong;Choi, Sung Il;Lee, Sang-Il;Kim, Chan-Young;Chae, Hyundong;Son, Myoung-Won;Pak, Kyung Ho;Kim, Sungsoo;Lee, Moon-Soo;Kim, Hyoung-Il
    • Journal of Gastric Cancer
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    • v.22 no.1
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    • pp.67-77
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    • 2022
  • Purpose: Tegafur/gimeracil/oteracil (S-1) and capecitabine plus oxaliplatin (CAPOX) are standard adjuvant chemotherapies (ACs) administered after gastrectomy to patients with stage II or III gastric cancer. However, the efficacy of AC in elderly patients remains unclear. The objective of this retrospective multicenter cohort study was to compare the efficacies of S-1 and CAPOX AC in patients aged ≥70 years. Materials and Methods: Nine hundred eighty-three patients who were treated with AC using S-1 (768 patients) or CAPOX (215 patients) were enrolled in this study. Each patient underwent AC after curative gastrectomy for stage II or III gastric cancer at one of 27 hospitals in the Republic of Korea between January 2012 and December 2013. Relapse-free survival (RFS) and overall survival (OS) were analyzed according to AC regimen and age group. Results: Of the 983 patients, 254 (25.8%) were elderly. This group had a similar RFS (P=0.099) but significantly poorer OS (p=0.003) compared with the non-elderly group. Subgroup analysis of the non-elderly group revealed no AC-associated differences in survival. Subgroup analysis of the elderly group revealed significantly better survival in the S-1 group than in the CAPOX group (RFS, P<0.001; OS, P<0.001). Multivariate analysis revealed that the CAPOX regimen was an independent poor prognostic factor for RFS (hazard ratio [HR], 1.891; 95% confidence interval [CI], 1.072-3.333; P=0.028) and OS (HR, 2.970; 95% CI, 1.550-5.692; P=0.001). Conclusions: This multicenter observational cohort study found significant differences in RFS and OS between S-1 and CAPOX AC among patients with gastric cancer aged ≥70 years.

Prospective Multicenter Surveillance Study of Surgical Site Infection after Spinal Surgery in Korea : A Preliminary Study

  • Jeong, Tae Seok;Yee, Gi Taek
    • Journal of Korean Neurosurgical Society
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    • v.61 no.5
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    • pp.608-617
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    • 2018
  • Objective : This study aimed to investigate the rates, types, and risk factors of surgical site infection (SSI) following spinal surgery using data from a Korean SSI surveillance system that included diagnoses made by surgeons. Methods : This was a prospective observational study of patients who underwent spinal surgeries at 42 hospitals in South Korea from January 2017 to December 2017. The procedures included spinal fusion, laminectomy, discectomy, and corpectomy. Univariate and multivariate logistic regression analyses were performed. Results : Of the 3080 cases included, 30 showed infection, and the overall SSI rate was 1.0% (an incidence of 1.2% in spinal fusion and 0.6% in laminectomy). Deep incisional infections were the most common type of SSIs (46.7%). Gram-positive bacteria caused 80% of the infections, and coagulase-negative staphylococci, including Staphylococcus epidermidis, accounted for 58% of the gram-positive bacteria. A longer preoperative hospital stay was significantly associated with the incidence of SSI after both spinal fusion and laminectomy (p=0.013, p<0.001). A combined operation also was associated with SSI after laminectomy (p=0.032). Conclusion : An SSI surveillance system is important for the accurate analysis of SSI. The incidence of SSI after spinal surgery assessed by a national surveillance system was 1.0%. Additional data collection will be needed in future studies to analyze SSI in spinal surgery.

Prospective Multicenter Surveillance Study of Surgical Site Infection after Intracranial Procedures in Korea : A Preliminary Study

  • Jeong, Tae Seok;Yee, Gi Taek
    • Journal of Korean Neurosurgical Society
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    • v.61 no.5
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    • pp.645-652
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    • 2018
  • Objective : This study aimed to investigate the rates, types, and risk factors of surgical site infection (SSI) following intracranial neurosurgical procedures evaluated by a Korean SSI surveillance system. Methods : This was a prospective observational study of patients who underwent neurosurgical procedures at 29 hospitals in South Korea from January 2017 to June 2017. The procedures included craniectomy, craniotomy, cranioplasty, burr hole, and ventriculoperitoneal shunt. Univariate and multivariate logistic regression analyses were performed. Results : Of the 1576 cases included, 30 showed infection, for an overall SSI rate of 1.9%. Organ/space infection was the most common, found in 21 out of the 30 cases (70%). Staphylococcus aureus was the most common (41%) of all bacteria, and Serratia marcescens (12%) was the most common among gram-negative bacteria. In univariate analyses, the p-values for age, preoperative hospital stay duration, and over T-hour were <0.2. In a multivariate analysis of these variables, only preoperative hospital stay was significantly associated with the incidence of SSI (p<0.001), whereas age and over T-hour showed a tendency to increase the risk of SSI (p=0.09 and 0.06). Conclusion : Surveillance systems play important roles in the accurate analysis of SSI. The incidence of SSI after neurosurgical procedures assessed by a national surveillance system was 1.9%. Future studies will provide clinically useful results for SSI when data are accumulated.

Consumption of Alcohol, Cigarettes, and Drugs in Patients with Posttraumatic Stress Disorder-Korean Multicenter Hospital Samples (외상후 스트레스장애 환자군의 알코올, 담배 및 약물 사용-다기관 병원 대상 연구)

  • Lee, Ju-Young;Lee, Ha-Min;Seo, Ho-Jun;Woo, Young-Seob;Kim, Tae-Suk;Chae, Jeong-Ho
    • Anxiety and mood
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    • v.3 no.1
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    • pp.41-45
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    • 2007
  • Objective : The present study investigates patterns of consumption of alcohol, cigarettes, and over the counter drugs (OTC) in Korean patients with PTSD and psychiatric patient controls and healthy controls from multicenter hospital samples. Method : Data were collected from 18 hospitals nationwide. Patients with PTSD were compared with nonpsychotic psychiatric disorders control and healthy control subjects on psychometric measures of consumption of alcohol, cigarettes, and OTC drugs. Result : Ninety-three patients with PTSD, 73 patients with psychiatric disorders control, and 88 healthy control subjects were enrolled. There were significant differences in the frequency of alcohol drinking among the three groups ($X^2$=12.93, df=6, p=0.044). Only 3.2% of healthy control subjects drank alcohol more than 4 times a week, but 43.9% of PTSD group and 46.5% of mental disorder controls drank alcohol more than 4 times a week, respectively. Regarding cigarette smoking, there were no differences among the three groups. There were significant differences in uses of OTC drugs among the three groups; 16.7 % in the PTSD group, 14.9% in the psychiatric control group and 1.3% in the heath control group, respectively ($X^2$=11.31, df=2, p=0.004). Conclusion : In this study, patients with PTSD showed significant differences in the frequency of consumption of alcohol and OTC drugs, as compared with healthy controls. However, there were no differences between the PTSD and psychiatric patient control groups. Since all subjects were enrolled from hospital based sample, results may differ in the community samples. Further studies will be needed for the evaluation of substance uses in these groups.

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Clinical Efficacy and Safety of Gyebutang Granules Combined with Acupuncture for the Treatment of Knee Osteoarthritis: Protocol for a Multicenter, Randomized, Assessor-blinded, 2-armed Parallel, Controlled Trial

  • Lee, Cham-Kyul;Kang, Ha-Ra;Lee, Yeon-Sun;Sung, Won-Suk;Lim, Chi-Yeon;Jung, Chan-Yung;Kim, Eun-Jung;Seo, Byung-Kwan;Baek, Yong-Hyeon;Kim, Kyung-Ho;Lee, Eun-Young
    • Journal of Acupuncture Research
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    • v.37 no.2
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    • pp.102-109
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    • 2020
  • Background: Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods: A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results: The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion: The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.