• Title/Summary/Keyword: Multicenter clinical studies

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Analysis of Factors Affecting the Hospitalization of Patients Visited the Emergency Department after Deliberate Self-poisoning (의도적 음독후 응급실에 내원한 환자의 입원과 관련된 요인 분석)

  • Noh, Woo Sik;Kim, Hye Jin
    • Journal of The Korean Society of Clinical Toxicology
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    • v.18 no.2
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    • pp.102-109
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    • 2020
  • Purpose: This study examined factors associated with the hospitalization of patients who visited the emergency department (ED) after deliberate self-poisoning. Methods: The medical records of the patients, who visited the ED at a tertiary teaching hospital after deliberate self-poisoning between March 2017 and December 2019, were reviewed retrospectively. Results: Fifty-seven in the hospitalization and 236 in the discharge group patients were included. The mean age in the hospitalization and discharge group was 48.8±20.4 and 41.8±19.1, respectively (p=0.020). Univariate analysis revealed statistically significant differences in age (p=0.020), mental status (p<0.001), request for help (p=0.046), chronic disease (p=0.036), substance ingested (p<0.001), and risk rescue-rating scale (p<0.001) between the two groups (hospitalization group and discharge group). In multiple logistic regression analysis for predicting the hospitalization of patients after deliberate self-poisoning, the Risk-Rescue Rating Scale (RRRS) was identified (OR=1.493, 95% confidential interval=1.330-1.675, p<0.001). Receiver operating characteristics analysis of RRRS for the decision to hospitalize showed a cut-off value of 38.9, with a sensitivity, specificity, and area under the curve of 96.4%, 77.0%, and 0.949, respectively. Conclusion: The RRRS can be used to determine the hospitalization for patients who visited the ED after deliberate self-poisoning. Nevertheless, multicenter prospective studies will be needed to determine the generalisability of these results.

Safety and Efficacy of Flow Diverter Therapy for Unruptured Intracranial Aneurysm Compared to Traditional Endovascular Strategy : A Multi-Center, Randomized, Open-Label Trial

  • Kim, Junhyung;Hwang, Gyojun;Kim, Bum-Tae;Park, Sukh Que;Oh, Jae Sang;Ban, Seung Pil;Kwon, O-Ki;Chung, Joonho;Committee of Multicenter Research, Korean Neuroendovascular Society,
    • Journal of Korean Neurosurgical Society
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    • v.65 no.6
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    • pp.772-778
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    • 2022
  • Objective : Endovascular treatment of large, wide-necked intracranial aneurysms by coil embolization is often complicated by low rates of complete occlusion and high rates of recurrence. A flow diverter device has been shown to be safe and effective for the treatment of not only large and giant unruptured aneurysms, but small and medium aneurysms. However, in Korea, its use has only recently been approved for aneurysms <10 mm. This study aims to compare the safety and efficacy of flow diversion and coil embolization for the treatment of unruptured aneurysms ≥7 mm. Methods : The participants will include patients aged between 19 and 75 years to be treated for unruptured cerebral aneurysms ≥7 mm for the first time or for recurrent aneurysms after initial endovascular coil embolization. Participants assigned to a flow diversion cohort will be treated using any of the following devices : Pipeline Flex Embolization Device with Shield Technology (Medtronic, Minneapolis, MN, USA), Surpass Evolve (Stryker Neurovascular, Fremont, CA, USA), and FRED or FRED Jr. (MicroVention, Tustin, CA, USA). Participants assigned to a coil embolization cohort will undergo traditional endovascular coiling. The primary endpoint will be complete occlusion confirmed by cerebral angiography at 12 months after treatment. Secondary safety outcomes will evaluate periprocedural and post-procedural complications for up to 12 months. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes the aim and design of a multi-center, randomized, open-label trial to compare the safety and efficacy of flow diversion versus traditional endovascular treatment for unruptured cerebral aneurysms ≥7 mm.

Non-atrophic gastric mucosa is an independently associated factor for superficial non-ampullary duodenal epithelial tumors: a multicenter, matched, case-control study

  • Azusa Kawasaki;Kunihiro Tsuji;Noriya Uedo;Takashi Kanesaka;Hideaki Miyamoto;Ryosuke Gushima;Yosuke Minoda;Eikichi Ihara;Ryosuke Amano;Kenshi Yao;Yoshihide Naito;Hiroyuki Aoyagi;Takehiro Iwasaki;Kunihisa Uchita;Hisatomi Arima;Hisashi Doyama
    • Clinical Endoscopy
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    • v.56 no.1
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    • pp.75-82
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    • 2023
  • Background/Aims: The etiology of superficial non-ampullary duodenal epithelial tumors (SNADETs) remains unclear. Recent studies have reported conflicting associations between duodenal tumor development and Helicobacter pylori infection or endoscopic gastric mucosal atrophy. As such, the present study aimed to clarify the relationship between SNADETs and H. pylori infection and/or endoscopic gastric mucosal atrophy. Methods: This retrospective case-control study reviewed data from 177 consecutive patients with SNADETs who underwent endoscopic or surgical resection at seven institutions in Japan over a three-year period. The prevalence of endoscopic gastric mucosal atrophy and the status of H. pylori infection were compared in 531 sex- and age-matched controls selected from screening endoscopies at two of the seven participating institutions. Results: For H. pylori infection, 85 of 177 (48.0%) patients exhibited SNADETs and 112 of 531 (21.1%) control patients were non-infected (p<0.001). Non-atrophic mucosa (C0 to C1) was observed in 96 of 177 (54.2%) patients with SNADETs and 112 of 531 (21.1%) control patients (p<0.001). Conditional logistic regression analysis revealed that non-atrophic gastric mucosa was an independent risk factor for SNADETs (odds ratio, 5.10; 95% confidence interval, 2.44-8.40; p<0.001). Conclusions: Non-atrophic gastric mucosa, regardless of H. pylori infection status, was a factor independently associated with SNADETs.

Risk factors for overcorrection of severe hyponatremia: a post hoc analysis of the SALSA trial

  • Huijin Yang;Songuk Yoon;Eun Jung Kim;Jang Won Seo;Ja-Ryong Koo;Yun Kyu Oh;You Hwan Jo;Sejoong Kim;Seon Ha Baek
    • Kidney Research and Clinical Practice
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    • v.41 no.3
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    • pp.298-309
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    • 2022
  • Background Hyponatremia overcorrection can result in irreversible neurologic impairment such as osmotic demyelination syndrome. Few prospective studies have identified patients undergoing hypertonic saline treatment with a high risk of hyponatremia overcorrection. Methods We conducted a post hoc analysis of a multicenter, prospective randomized controlled study, the SALSA trial, in 178 patients aged above 18 years with symptomatic hyponatremia (mean age, 73.1 years; mean serum sodium level, 118.2 mEq/L). Overcorrection was defined as an increase in serum sodium levels by >12 or 18 mEq/L within 24 or 48 hours, respectively. Results Among the 178 patients, 37 experienced hyponatremia overcorrection (20.8%), which was independently associated with initial serum sodium level (≤110, 110-115, 115-120, and 120-125 mEq/L with 7, 4, 2, and 0 points, respectively), chronic alcoholism (7 points), severe symptoms of hyponatremia (3 points), and initial potassium level (<3.0 mEq/L, 3 points). The NASK (hypoNatremia, Alcoholism, Severe symptoms, and hypoKalemia) score was derived from four risk factors for hyponatremia overcorrection and was significantly associated with overcorrection (odds ratio, 1.41; 95% confidence interval, 1.24-1.61; p < 0.01) with good discrimination (area under the receiver-operating characteristic [AUROC] curve, 0.76; 95% CI, 0.66-0.85; p < 0.01). The AUROC curve of the NASK score was statistically better compared with those of each risk factor. Conclusion In treating patients with symptomatic hyponatremia, individuals with high hyponatremia overcorrection risks were predictable using a novel risk score summarizing baseline information.

Immune Checkpoint Inhibitor Score Predicts Survival Benefit of Immunotherapy in Patients with Non-small Cell Lung Cancer

  • Da Hyun Kang;Chang-Min Choi;Cheol-Kyu Park;In-Jae Oh;Young-Chul Kim;Seong Hoon Yoon;Yoonjoo Kim;Jeong Eun Lee
    • Tuberculosis and Respiratory Diseases
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    • v.87 no.4
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    • pp.483-493
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    • 2024
  • Background: The use of immune checkpoint inhibitors (ICIs) in patients with advanced lung cancer is increasing. Despite ongoing studies to predict the efficacy of ICIs, its use in clinical practice remains difficult. Thus, we aimed to discover a predictive marker by analyzing blood cell characteristics and developing a scoring system for patients treated with ICIs. Methods: This was a prospective multicenter study in patients with advanced non-small cell lung cancer (NSCLC) who received ICIs as second-line treatment from June 2021 to November 2022. Blood cell parameters in routine blood samples were evaluated using an automated hematology analyzer. Immune checkpoint inhibitor score (IChIS) was calculated as the sum of neutrophil count score and immature granulocyte score. Results: A total of 143 patients from four institutions were included. The treatment response was as follows: partial response, 8.4%; stable disease, 37.1%; and progressive disease, 44.8%. Median progression-free survival and overall survival after ICI treatment was 3.0 and 8.3 months, respectively. Median progression-free survival in patients with an IChIS of 0 was 4.0 months, which was significantly longer than 1.9 months in patients with an IChIS of 1 and 1.0 month in those with an IChIS of 2 (p=0.001). The median overall survival in patients with an IChIS of 0 was 10.2 months, which was significantly longer than 6.8 and 1.8 months in patients with an IChIS of 1 and 2, respectively (p<0.001). Conclusion: Baseline IChIS could be a potential biomarker for predicting survival benefit of immunotherapy in NSCLC.

Possible different genotypes for human papillomavirus vaccination in lower middle-income countries towards cervical cancer elimination in 2030: a cross-sectional study

  • Tofan Widya Utami;Andrijono Andrijono;Andi Putra;Junita Indarti;Gert Fleuren;Ekaterina Jordanova;Inas Humairah;Ahmad Utomo
    • Clinical and Experimental Vaccine Research
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    • v.11 no.2
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    • pp.141-148
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    • 2022
  • Purpose: Human papillomavirus (HPV) genotype and age distribution of HPV infection were crucial for the national vaccination and screening program planning. However, there was a limited study providing these data in the normal cervix population. This study aimed to explore the HPV genotypes profile of women with clinically normal cervix based on Visual Inspection of Acetic Acid (VIA) test. Materials and Methods: A 7-year cross-sectional study was conducted from 2012 to 2018 in private and public health care centers in Jakarta. Subjects were recruited consecutively. Data were collected by anamnesis, VIA, and HPV DNA test using the polymerase chain reaction (PCR; SPF10-DEIA-LiPA25) method. HPV genotyping procedures include DNA extraction, PCR (SPF10-DEIA-LiPA25) using the HPV XpressMatrix kit (PT KalGen DNA, East Jakarta, Indonesia), and hybridization. The IBM SPSS ver. 20.0 (IBM Corp., Armonk, NY, USA) were used to analyze the data. Results: A total of 1,397 subjects were collected. Positive HPV-DNA tests were found in 52 subjects (3.7%); 67% were single and 33% were multiple HPV infections. HPV 52 was the most frequently detected HPV genotype, followed by HPV 39, 16, 18 74, 44, 31, 54, and 66, respectively. The highest HPV infections in this population were in the 31-40 and 41-50 years old group. Conclusion: This study suggested beneficial screening for women aged 31-50 years old. Instead of "original" nonavalent (HPV 16, 18, 6, 11, 31, 33, 45, 52, 58), the different "nonavalent" formula for HPV vaccines protecting against HPV 16, 18, 6, 11, 31, 39, 44, 52, 74 might be useful for Indonesian population. However, further multicenter studies with a huge sample size are still needed.

Nationwide Multicenter Study of Eosinophilic Esophagitis in Korean Children

  • Lee, Kunsong;Choe, Byung-Ho;Kang, Ben;Kim, Seung;Kim, Jae Young;Shim, Jung Ok;Lee, Yoo Min;Lee, Eun Hye;Jang, Hyo-Jeong;Ryoo, Eell;Yang, Hye Ran
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.23 no.3
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    • pp.231-242
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    • 2020
  • Purpose: In East Asian countries, there are only a few epidemiologic studies of eosinophilic esophagitis (EoE) and no studies in children. We investigated the incidence and compared the clinical characteristics of EoE and eosinophilic gastroenteritis involving the esophagus (EGEIE) in Korean children. Methods: A total of 910 children, who had symptoms of esophageal dysfunction, from 10 hospitals in Korea were included. EoE was diagnosed according to diagnostic guidelines and EGEIE was diagnosed when there were >15 eosinophils in the esophagus per high power field (HPF) and >20 eosinophils per HPF deposited in the stomach and duodenum with abnormal endoscopic findings. Results: Of the 910 subjects, 14 (1.5%) were diagnosed with EoE and 12 (1.3%) were diagnosed with EGEIE. Vomiting was the most common symptom in 57.1% and 66.7% of patients with EoE and EGEIE, respectively. Only diarrhea was significantly different between EoE and EGEIE (p=0.033). In total, 61.5% of patients had allergic diseases. Exudates were the most common endoscopic findings in EoE and there were no esophageal strictures in both groups. The median age of patients with normal endoscopic findings was significantly younger at 3.2 years, compared to the median age of 11.1 years in those with abnormal endoscopic findings (p=0.004). Conclusion: The incidence of EoE in Korean children was lower than that of Western countries, while the incidence of EGEIE was similar to EoE. There were no clinical differences except for diarrhea and no differences in endoscopic findings between EoE and EGEIE.

Epidemiology and Clinical Severity of the Hospitalized Children with Viral Croup (바이러스성 크루프로 입원하는 소아 환자의 역학적 특성과 임상적 중증도 평가)

  • Jeon, In Soo;Cho, Won Je;Lee, Jeongmin;Kim, Hwang Min
    • Pediatric Infection and Vaccine
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    • v.25 no.1
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    • pp.8-16
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    • 2018
  • Purpose: In this study, the clinical and epidemiological characteristics of patients admitted for viral croup were analyzed to evaluate disease severity based on the organism that caused the infection. Methods: We retrospectively reviewed the medical records of 302 patients who were admitted to the Department of Pediatrics at the Wonju Severance Hospital between May 2013 and December 2016 for viral croup. Patients who showed positive results on multiplex polymerase chain reaction were subsequently diagnosed with respiratory virus infection. The Westley scoring system was used to evaluate the severity of viral croup. Results: Of the 302 patients, 149 were admitted due to severe viral croup, including 88 boys and 61 girls, with a boy-to-girl ratio of 1.44:1. About 110 cases of parainfluenza virus infection have been reported, which accounted for almost half of the total cases. The other identified viruses included influenza virus, human rhinovirus, and respiratory syncytial virus. Analysis of the association between severe viral croup and causative pathogen revealed that only parainfluenza type 2 virus showed a significantly high risk. Parainfluenza type 2 virus did not show an age-based difference in frequency but showed relatively a higher frequency of infections during the summer and fall. Conclusions: In this study, parainfluenza virus type 2 was the only virus associated with severe viral croup. To facilitate proper preventive management, treatment, and prognosis evaluation of viral croup, prospective and multicenter studies should assess the additional variables and the severity of the virus. Additionally, further studies should be conducted to assess age-dependent influences, as well as the regional and seasonal incidence of viral infection.

Prevalence of Inflammatory Bowel Disease Unclassified, as Estimated Using the Revised Porto Criteria, among Korean Pediatric Patients with Inflammatory Bowel Disease

  • Sung Hee Lee;Minsoo Shin;Seo Hee Kim;Seong Pyo Kim;Hyung-Jin Yoon;Yangsoon Park;Jaemoon Koh;Seak Hee Oh;Jae Sung Ko;Jin Soo Moon;Kyung Mo Kim
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.27 no.4
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    • pp.206-214
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    • 2024
  • Purpose: Few studies have reported the prevalence of inflammatory bowel disease unclassified (IBDU) among Korean pediatric IBD (PIBD) population. To address this gap, we used two tertiary centers and nationwide population-based healthcare administrative data to estimate the prevalence of Korean pediatric IBDU at the time of diagnosis. Methods: We identified 136 patients aged 2-17 years with newly diagnosed IBD (94 Crohn's disease [CD] and 42 ulcerative colitis [UC]) from two tertiary centers in Korea between 2005 and 2017. We reclassified these 136 patients using the revised Porto criteria. To estimate the population-based prevalence, we analyzed Korean administrative healthcare data between 2005 and 2016, which revealed 3,650 IBD patients, including 2,538 CD and 1,112 UC. By extrapolating the reclassified results to a population-based dataset, we estimated the prevalence of PIBD subtypes. Results: Among the 94 CD, the original diagnosis remained unchanged in 93 (98.9%), while the diagnosis of one (1.1%) patient was changed to IBDU. Among the 42 UC, the original diagnosis remained unchanged in 13 (31.0%), while the diagnoses in 11 (26.2%), 17 (40.5%), and one (2.4%) patient changed to atypical UC, IBDU, and CD, respectively. The estimated prevalences of CD, UC, atypical UC, and IBDU in the Korean population were 69.5%, 9.4%, 8.0%, and 13.1%, respectively. Conclusion: This study is the first in Korea to estimate the prevalence of pediatric IBDU. This prevalence (13.1%) aligns with findings from Western studies. Large-scale prospective multicenter studies on PIBDU are required to examine the clinical features and outcomes of this condition.

Effectiveness of alendronate as an adjunct to scaling and root planing in the treatment of periodontitis: a meta-analysis of randomized controlled clinical trials

  • Chen, Jin;Chen, Qian;Hu, Bo;Wang, Yunji;Song, Jinlin
    • Journal of Periodontal and Implant Science
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    • v.46 no.6
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    • pp.382-395
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    • 2016
  • Purpose: Alendronate has been proposed as a local and systemic drug treatment used as an adjunct to scaling and root planing (SRP) for the treatment of periodontitis. However, its effectiveness has yet to be conclusively established. The purpose of the present meta-analysis was to assess the effectiveness of SRP with alendronate on periodontitis compared to SRP alone. Methods: Five electronic databases were used by 2 independent reviewers to identify relevant articles from the earliest records up to September 2016. Randomized controlled trials (RCTs) comparing SRP with alendronate to SRP with placebo in the treatment of periodontitis were included. The outcome measures were changes in bone defect fill, probing depth (PD), and clinical attachment level (CAL) from baseline to 6 months. A fixed-effect or random-effect model was used to pool the extracted data, as appropriate. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Heterogeneity was assessed using the Cochrane ${\chi}^2$ and $I^2$ tests. Results: After the selection process, 8 articles were included in the meta-analysis. Compared with SRP alone, the adjunctive mean benefits of locally delivered alendronate were 38.25% for bone defect fill increase (95% CI=33.05%-43.45%; P<0.001; $I^2=94.0%$), 2.29 mm for PD reduction (95% CI=2.07-2.52 mm; P<0.001; $I^2=0.0%$) and 1.92 mm for CAL gain (95% CI=1.55-2.30 mm; P<0.001; $I^2=66.0%$). In addition, systemically administered alendronate with SRP significantly reduced PD by 0.36 mm (95% CI=0.18-0.55 mm; P<0.001; $I^2=0.0%$) and increased CAL by 0.39 mm (95% CI=0.11-0.68 mm; P=0.006; $I^2=6.0%$). Conclusions: The collective evidence regarding the adjunctive use of alendronate locally and systemically with SRP indicates that the combined treatment can improve the efficacy of non-surgical periodontal therapy on increasing CAL and bone defect fill and reducing PD. However, precautions must be exercised in interpreting these results, and multicenter studies evaluating this specific application should be carried out.