• Title/Summary/Keyword: Multicenter clinical studies

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Assessing Abdominal Aortic Aneurysm Progression by Using Perivascular Adipose Tissue Attenuation on Computed Tomography Angiography

  • Shuai Zhang;Hui Gu;Na Chang;Sha Li;Tianqi Xu;Menghan Liu;Ximing Wang
    • Korean Journal of Radiology
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    • v.24 no.10
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    • pp.974-982
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    • 2023
  • Objective: Recent studies have highlighted the active and potential role of perivascular adipose tissue (PVAT) in atherosclerosis and aneurysm progression, respectively. This study explored the link between PVAT attenuation and abdominal aortic aneurysm (AAA) progression using computed tomography angiography (CTA). Materials and Methods: This multicenter retrospective study analyzed patients with AAA who underwent CTA at baseline and follow-up between March 2015 and July 2022. The following parameters were obtained: maximum diameter and total volume of the AAA, presence or absence of intraluminal thrombus (ILT), maximum diameter and volume of the ILT, and PVAT attenuation of the aortic aneurysm at baseline CTA. PVAT attenuation was divided into high (> -73.4 Hounsfield units [HU]) and low (≤ -73.4 HU). Patients who had or did not have AAA progression during the follow-up, defined as an increase in the aneurysm volume > 10 mL from baseline, were identified. Kaplan-Meier and multivariable Cox regression analyses were used to investigate the association between PVAT attenuation and AAA progression. Results: Our study included 167 participants (148 males; median age: 70.0 years; interquartile range: 63.0-76.0 years), of which 145 (86.8%) were diagnosed with AAA accompanied by ILT. Over a median period of 11.3 months (range: 6.0-85.0 months), AAA progression was observed in 67 patients (40.1%). Multivariable Cox regression analysis indicated that high baseline PVAT attenuation (adjusted hazard ratio [aHR] = 2.23; 95% confidence interval [CI], 1.16-4.32; P = 0.017) was independently associated with AAA progression. This association was demonstrated within the patients of AAA with ILT subcohort, where a high baseline PVAT attenuation (aHR = 2.23; 95% CI, 1.08-4.60; P = 0.030) was consistently independently associated with AAA progression. Conclusion: Elevated PVAT attenuation is independently associated with AAA progression, including patients of AAA with ILT, suggesting the potential of PVAT attenuation as a predictive imaging marker for AAA expansion.

Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05 Randomized Clinical Trial

  • Hwang, Sun-Hwi;Park, Do Joong;Kim, Hyung-Ho;Hyung, Woo Jin;Hur, Hoon;Yang, Han-Kwang;Lee, Hyuk-Joon;Kim, Hyoung-Il;Kong, Seong-Ho;Kim, Young Woo;Lee, Han Hong;Kim, Beom Su;Park, Young-Kyu;Lee, Young-Joon;Ahn, Sang-Hoon;Lee, In-Seob;Suh, Yun-Suhk;Park, Ji-Ho;Ahn, Soyeon;Han, Sang-Uk
    • Journal of Gastric Cancer
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    • v.22 no.2
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    • pp.94-106
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    • 2022
  • Purpose: Laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a function-preserving procedure performed for treating upper early gastric cancer (EGC). However, few studies have compared the outcomes of LPG-DTR with those of laparoscopic total gastrectomy (LTG). This study aimed at comparing the short-term outcomes of LPG-DTR between LTG and upper EGC. Materials and Methods: For upper-third EGC, a multicenter, prospective, randomized trial was performed to compare those who underwent LPG-DTR with those who underwent LTG. Short-term outcomes, including clinicopathologic results, morbidity, mortality, and postoperative courses, were evaluated using a full analysis set based on the intention-to-treat principle and the per-protocol set. Results: Of the patients, 138 who fulfilled the criteria were randomized to each group. One patient in the LPG-DTR group withdrew consent. Sixty-eight patients underwent LPG-DTR and 69 underwent LTG. The operative time (LPG-DTR=219.4 minutes; LTG=201.8 minutes; P=0.085), estimated blood loss (LPG-DTR=76.0 mL; LTG=66.1 mL; P=0.413), and the morbidity rate (LPG-DTR=23.5%; LTG=17.4%; P=0.373) between the groups were not significantly different. No mortality occurred in either of the study groups. Two weeks post operation, the Visick scores for postprandial symptoms, including reflux symptoms, were not significantly different between the groups (P=0.749). Laboratory findings on postoperative day 5 were not significantly different between the groups. Conclusions: The short-term outcomes of LPG-DTR for upper EGC were comparable to those of LTG.

Effect of Non-contact Korean Medical Treatment for Patients Recovering at Home with Positive Coronavirus Disease 2019 Diagnostic Test Results at a Local Public Health Center: A Retrospective Chart Review (지역 보건소에서 시행한 코로나 바이러스 감염증-19 진단 검사상 양성인 재택치료 환자의 비대면 한의진료 효과: 후향적 차트 리뷰)

  • Jeon, Chaeheun;Choi, Daejun;Kim, Gyeongmuk;Kim, Hyejin;Leem, Jungtae;Chi, Gyoo-yong
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.36 no.4
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    • pp.130-137
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    • 2022
  • Due to the coronavirus disease 2019 (COVID-19) pandemic, appropriate management of sequelae and treatment of infectious symptoms became increasingly important healthcare issues. Although the practice guidelines and treatment cases based on the East Asian traditional medicine have been reported, there are rare studies on the use of Korean medicine in Korea. Therefore, this study aimed to present the progress of non-contact Korean medical treatment for infected patients at a local public health center using retrospective chart review. A total of 18 patients were prescribed with 5 days of herbal decoction and medicine extract covered by the national health insurance. With the questionnaire form, the progression and improvement of symptoms before and after treatment were evaluated using the numerical rating scale (NRS), and the treatment satisfaction and opinions were obtained. The symptoms such as cough (5.56±2.23 to 2.89±2.14), sputum (6.11±1,75 to 3.28±2.47), sore throat (6.06±2.70 to 1.47±1.62), anorexia (5.56±2.63 to 1.94±2.21), nausea (3.75±1.71 to 1.17±1.11), diarrhea (3.40±2.63 to 1.50±1.51), chest tightness (4.93±2.46 to 2.29±2.30) and fatigue (6.44±1.79 to 2.67±1.88) all improved according to the NRS, and the satisfaction with herbal medicine treatment on a 5-point Likert scale was 4.24±0.90. No side effects and adverse reactions were reported. Thereupon non-contact Korean medical treatment can be concluded that it effectively reduces the COVID-19 infection mild symptoms in restrictive extent. Since the retrospective data does not include a control group, the more confirmative data is needed by multicenter and large-scale controlled clinical study afterwards.

Development and Validation of AI Image Segmentation Model for CT Image-Based Sarcopenia Diagnosis (CT 영상 기반 근감소증 진단을 위한 AI 영상분할 모델 개발 및 검증)

  • Lee Chung-Sub;Lim Dong-Wook;Noh Si-Hyeong;Kim Tae-Hoon;Ko Yousun;Kim Kyung Won;Jeong Chang-Won
    • KIPS Transactions on Computer and Communication Systems
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    • v.12 no.3
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    • pp.119-126
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    • 2023
  • Sarcopenia is not well known enough to be classified as a disease in 2021 in Korea, but it is recognized as a social problem in developed countries that have entered an aging society. The diagnosis of sarcopenia follows the international standard guidelines presented by the European Working Group for Sarcopenia in Older People (EWGSOP) and the d Asian Working Group for Sarcopenia (AWGS). Recently, it is recommended to evaluate muscle function by using physical performance evaluation, walking speed measurement, and standing test in addition to absolute muscle mass as a diagnostic method. As a representative method for measuring muscle mass, the body composition analysis method using DEXA has been formally implemented in clinical practice. In addition, various studies for measuring muscle mass using abdominal images of MRI or CT are being actively conducted. In this paper, we develop an AI image segmentation model based on abdominal images of CT with a relatively short imaging time for the diagnosis of sarcopenia and describe the multicenter validation. We developed an artificial intelligence model using U-Net that can automatically segment muscle, subcutaneous fat, and visceral fat by selecting the L3 region from the CT image. Also, to evaluate the performance of the model, internal verification was performed by calculating the intersection over union (IOU) of the partitioned area, and the results of external verification using data from other hospitals are shown. Based on the verification results, we tried to review and supplement the problems and solutions.

Serotypes and Antimicrobial Susceptibility of Streptococcus pneumoniae (폐구균의 혈청형 분포와 항생제 감수성에 관한 연구)

  • Choi, Kyoung-Min;Kim, Jeong-Hyun;Shin, Kyoung-Mi;Yeon, Soo-In;Shin, Jeon-Soo;Yong, Dong-Eun;Lee, Kyoung-Won;Kim, Dong-Soo
    • Pediatric Infection and Vaccine
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    • v.10 no.2
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    • pp.159-166
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    • 2003
  • Purpose : Streptococcus pneumoniae is part of the normal flora but is also responsible for causing many invasive diseases such as pneumonia, meningitis, and sepsis in addition to noninvasive diseases such as otitis in children. Multi-drug resistant strains has raised a lot of concern worldwide and thus the importance of prevention has been emphasized. We have analyzed the current serotypes and antibiotic sensitivity of each serotype as a baseline study to estimate the efficacy of the pneumococcal vaccine in Korean children. Methods : One hundred sixteen cases of pneumococcus cultured at Yonsei Medical Center from September 2001 to January 2003 were analyzed. The serotyping was done with the Quellung reaction and penicillin resistance was tested using the oxacillin disc diffusion method. Results : Pneumococcus were cultured from the sputum in 76 cases(65.5%), from the blood in 13 cases(11.2%), from the ear discharge in 12 cases(10.3%), from the throat in 7 cases(6.0%), from the nasal cavity in 2 cases(1.7%), and one case(0.9%) each from the cerebrospinal fluid, eye discharge, peritoneal fluid, post-operational wound, brain abscess, and catheter tip. Serotyping was possible with 98 cases and the following serotypes were found; 15 cases of type 19F(15.3%), 11 cases of 19A(11.2%), 8 cases of 11A(8.2%), 7 cases each of 6A, 14 and 3(7.1%), 6 cases each of 35, 6B and 23F(6.1%). Eighty two cases(70.7%) out of 116 cases were penicillin resistant and serotypes 19F, 19A, 11A, 23F, 6A, 9V constituted the majority, 48 cases(59.8%). These serotypes showed resistance to cotrimoxazole (74.4%), tetracycline(69.5%), and erythromycin(90.3%) as well. In the 22 cases cultured from children, 19A and 19F were found in 25.0%, 6A, 6B, and 23F in 10.0%, 11A, 14, 19, and 29 in 5.0%. Fifty percent(10/20) of the clinical isolates were represented in the current 7-valent pneumococcal protein conjugate vaccine, and 85%(17/20) when the cross-reacting serotypes were included. Penicillin resistance was found in 86.4%(19/22). Conclusion : The percentage of serotypes included in the 7 valent pneumococcal protein conjugate vaccine found in our study was 40.8% which was less than other prior studies. In anticipation of a change of pneumococcal serotypes, a nationwide multicenter study is needed before the initiation of pneumococcal vaccines in Korea.

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A Randomized, Double-Blind Study to Assess the Efficacy and Safety of Oral LB20304 (Gemifloxacin) at Doses of 160mg or 320mg (Equivalent to 200mg or 400mg of the Mesylate Salt) Once Daily for 7 Days for the Treatment of Acute Exacerbations of Chronic Bronchitis (AECB) in Korean Adult Population (한국인에서 만성기관지염의 급성악화를 치료하기 위한 LB20304(Gemifloxacin) 160mg 또는 320mg 1일 1회 7일간 투여의 유효성과 안전성에 대한 연구)

  • Kim, Young Whan;Shim, Young-Soo;Kim, Won Dong;Shim, Tae Sun;Kang, Hong Mo;Choi, ByoungWhui;Kim, Jae-Yeol;Kwon, O Jung;Kim, Hojoong;Kim, Ju Ock;Jung, Ki-Suck;Hyeon, In Gyou;Mo, Eun Kyung;Lee, Seung-Joon;Nam, Gui Hyun;Lee, Kye Young;Park, Jae Seuk
    • Tuberculosis and Respiratory Diseases
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    • v.55 no.1
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    • pp.69-87
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    • 2003
  • Background : LB20304(gemifloxacin) is a new fluoroquinolone antibacterial agent with excellent activity against both Gram-negative and Gram-positive organisms. In vitro studies using clinical isolates have shown gemifloxacin to be highly active against penicillin-resistant strains of S. pneumoniae and in contrast to other reference quinolones, gemifloxacin retained good activity against clinical isolates of S. pneumoniae that were resistant to other members of the quinolone class. Therefore, gemifloxacin is thought to be effective in treating acute bacterial exacerbation of chronic bronchitis(AECB). The objective of this study was to evaluate the efficacy and safety of oral gemifloxacin at doses of 160mg or 320mg once daily for 7 days for the treatment of AECB in Korean adult population. Methods : This was a randomized, multicenter, double-blind, parallel group Phase II study to assess the clinical and antibacterial efficacy and safety of oral gemifloxacin for the treatment of AECB. Treatment Group A (67 patients) took oral gemifloxacin 160mg once daily for seven days and treatment Group B (70 patients) took oral gemifloxacin 320mg once daily for seven days. Results : The demographic profiles of the two treatment groups were similar. The clinical response at follow-up was 84.2% in the gemifloxacin 160-mg group, and 88.7% in the gemifloxacin-320 mg group, showing no statistically significant difference between two treatment groups(p=0.49). The clinical response at the end of therapy was 96.5% in the 160-mg group, and 96.4% in the 320-mg group. The bacteriological response at the end of therapy and follow-up were 81.8% and 78.9%, respectively, in the 160-mg group, and 86.4% and 84.2%, respectively, in the 320-mg group, showing no statistically significant difference between two treatment groups(p=0.68 and 0.68, respectively). S. pneumoniae(12 isolates) and H. influenzae(10 isolates) were the most prevalent pathogens. The MICs were lower for gemifloxacin than other quinolones against these key pathogens, and for S. pneumoniae, the MICs for gemifloxacin were considerably lower(${\leq}0.03$ ug/mL) than those for other quinolones, beta-lactams and macrolides. In the period on-therapy plus 30 days post-therapy, a total of 18 patients(26.9%) in the gemifloxacin 160mg group and 22 patients(31.4%) in the 320mg group reported at least one adverse event(AE). The most frequently reported AE was abdominal pain(3/67 patients, 4.5%) in the gemifloxacin 160mg group and increased level of hepatic enzyme(5/70 patients, 7.1%) in the 320mg group. The overall AE profiles for the two treatment groups were similar. Two out of 67 patients(3.0%) in the gemifloxacin 160mg group and 1/70 patients(1.4%) in the 320mg group reported at least one serious AE, however, none of which was considered by the investigator to be of suspected or probable relationship to study medication. Conclusion : The results of this study showed that gemifloxacin at doses of 160mg or 320mg once daily for 7 days in the treatment of acute exacerbations of chronic bronchitis(AECB) in adult Koreans was a very effective and safe treatment both clinically and bacteriologically.