• 제목/요약/키워드: Multicenter clinical study

검색결과 182건 처리시간 0.024초

Radiosurgery Compared with External Radiation Therapy as a Primary Treatment in Spine Metastasis from Hepatocellular Carcinoma : A Multicenter, Matched-Pair Study

  • Sohn, Seil;Chung, Chun Kee;Sohn, Moon Jun;Kim, Sung Hwan;Kim, Jinhee;Park, Eunjung
    • Journal of Korean Neurosurgical Society
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    • 제59권1호
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    • pp.37-43
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    • 2016
  • Objective : The aim of this multicenter, matched-pair study was to compare the outcomes of stereotactic radiosurgery (SRS) and conventional external radiation therapy (RT) when used as a primary treatment in spine metastasis from hepatocellular carcinoma (HCC). Methods : From 2005 to 2012, 28 patients underwent SRS as the primary treatment in spine metastasis from HCC. Based on sex, age, number of spine metastasis, Child-Pugh classification, interval from original tumor to spine metastasis, and year of treatment, 28 patients who underwent RT were paired. Outcomes of interest were pain relief, progression free survival, toxicities, and further treatment. Results : The perioperative visual analog scale (VAS) decrease was larger in SRS group than in RT group, but the difference was not significant (3.7 vs. 2.8, p=0.13). When pain medication was adjusted, the number of patients with complete (n=6 vs.3) or partial (n=12 vs.13) relief was larger in SRS group than in RT group; however, the difference was not significant (p=0.83). There was no significant difference in progression free survival (p=0.48). In SRS group, 32.1% of patients had 1 or more toxicities whereas the percentage in RT group was 63.0%, a significant difference (p=0.04). Six SRS patients and 7 RT patients received further intervention at the treated segment. Conclusion : Clinical and radiological outcome were not significantly different between the two treatments. Toxicities, however, were more prevalent in the RT group.

Effect of Sihogayonggolmoryeo-Tang on Hwa-byung: A Multicenter, Randomized, Double-Blinded, Placebo-Control Trial

  • Choi, Woo-Chang;Lee, Hun-Soo;Kim, Ju-Yeon;Kang, Wee-Chang;Park, Yang-Chun;Kim, Geun-Woo;Kim, Jong-Woo;Jung, In Chul
    • 동의신경정신과학회지
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    • 제31권3호
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    • pp.135-147
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    • 2020
  • Objectives: Hwa-byung is a mental illness. It is also known as a Korean culture-related syndrome. In traditional Korean medicine, Sihogayonggolmoryeo-tang is used to treat Hwa-byung related neuropsychiatric symptoms. The purpose of this research was to examine the effect of Sihogayonggolmoryeo-tang on Hwa-byung. Methods: A multicenter, randomized, double-blinded, placebo-controlled study was performed for 160 patients with Hwa-byung. Patients were divided into a Sihogayonggolmoryeo-tang group and a placebo group. Treatment period was 8 weeks. Hamilton Rating Scale for Anxiety (HAM-A), Likert scale for major symptoms of Hwa-byung, Hwa-byung Scale (HBS), Korean Beck Depression Inventory (K-BDI), Korean State-Trait Anxiety Inventory (K-STAI), Korean State-Trait Anger Expression Inventory (K-STAXI), and Korean WHO Quality of Life Scale Abbreviated Version (WHOQOL-BREF) were used to evaluate the effect of Sihogayonggolmoryeo-tang on Hwa-byung. We also used an Instrument of Pattern Identification for Hwa-Byung to evaluate different responses for six patterns of patients. Results: Scores of all the measurements improved significantly for each group, showing no significant differences between the two groups. In the case of deficiency of both Qi and blood pattern, the Sihogayonggolmoryeo-tang group showed a significant decrease in the HAM-A score compared to the placebo group. Conclusions: The effect of Sihogayonggolmoryeo-tang on Hwa-byung did not exceed that of the placebo. Further studies involving more elaborate pattern identification are needed.

Chest wall perforator flaps for partial breast reconstruction: Surgical outcomes from a multicenter study

  • Soumian, Soni;Parmeshwar, Rishikesh;Chandarana, Mihir;Marla, Sekhar;Narayanan, Sankaran;Shetty, Geeta
    • Archives of Plastic Surgery
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    • 제47권2호
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    • pp.153-159
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    • 2020
  • Background Perforator artery flaps based on the branches of intercostal arteries and lateral thoracic artery can be used for reconstruction after breast-conserving surgery (BCS). Although described more than a decade ago, these have not been adopted widely in clinical practice. We report on short-term and long-term surgical outcomes of partial breast reconstruction using chest wall perforator flaps from a prospective multicenter audit. Methods All patients operated for BCS and partial breast reconstruction using intercostal artery perforator or lateral thoracic artery perforator flaps from January 2015 to October 2018 were included in the analysis. Oncoplastic breast surgeons with appropriate level of training performed all tumor excisions and reconstructions as a single-stage procedure. Patient characteristics, treatment details and surgical outcomes were noted. Specific outcomes recorded were margin re-excision and complication rates. Results One hundred and twelve patients underwent the procedure in the given study period. The median age was 54 years. Median specimen weight was 62.5 g and median volume of excision was 121.4 mL. Fifteen patients (13.39%) underwent a margin re-excision for close or positive margins without additional morbidity. One patient required a completion mastectomy. Eight patients (7.14%) had an early complication. None of the patients required a contralateral symmetrization procedure. The results were comparable across the participating centers. Conclusions Chest wall artery perforator-based flaps are an excellent option for lateral and inferior quadrant partial breast reconstructions. The short and long-term surgical outcomes are comparable across sites and can be performed with minimal morbidity. Patient-reported outcome measures need to be studied.

Self-Monitoring of Blood Pressure and Feed-back Using APP in TReatment of UnconTrolled Hypertension (SMART-BP): A Randomized Clinical Trial

  • Dong-Ju Choi;Jin Joo Park;Minjae Yoon;Sung-Ji Park;Sang-Ho Jo;Eung Ju Kim;Soo-Joong Kim;Sungyoung Lee
    • Korean Circulation Journal
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    • 제52권10호
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    • pp.785-794
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    • 2022
  • Background and Objectives: Self-monitoring of blood pressure (SMBP) is a reliable method used to assess BP accurately. However, patients do not often know how to respond to the measured BP value. We developed a mobile application-based feed-back algorithm (SMBP-App) for tailored recommendations. In this study, we aim to evaluate whether SMBP-App is superior to SMBP alone in terms of BP reduction and drug adherence improvement in patients with hypertension. Methods: Self-Monitoring of blood pressure and Feed-back using APP in Treatment of UnconTrolled Hypertension (SMART-BP) is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App compared with SMBP alone. Patients with uncomplicated essential hypertension will be randomly assigned to the SMBP-App (90 patients) and SMBP alone (90 patients) groups. In the SMBP group, the patients will perform home BP measurement and receive the standard care, whereas in the SMBP-App group, the patients will receive additional recommendations from the application in response to the obtained BP value. Follow-up visits will be scheduled at 12 and 24 weeks after randomization. The primary endpoint of the study is the mean home systolic BP. The secondary endpoints include the drug adherence, the home diastolic BP, home and office BP. Conclusions: SMART-BP is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App. If we can confirm its efficacy, SMBP-App may be scaled-up to improve the treatment of hypertension.

임상연구에서 사용되고 있는 NRS에 대한 분석 : 무작위대조군연구를 중심으로 (Analysis of the Numeric Rating Scale (NRS) Used in Clinical Studies Based on Randomized Controlled Studies)

  • 이찬;조임학;허기윤;강희경;김민화;한창우;김소연;최준용;박성하;윤영주;홍진우;권정남;이인
    • 대한한방내과학회지
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    • 제42권4호
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    • pp.510-531
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    • 2021
  • Objectives: The purpose of this study was to review the status of numeric rating scale (NRS) usage and suggest the potential for use in multicenter retrospective studies of various diseases. Methods: Articles published from 2011 to 2021 that used the keywords "NRS", "Multi-center", and "RCT" were identified in foreign databases, including EMBASE, PubMed, CENTRAL. The articles were analyzed according to their use of "NRS" by symptoms and by disease group using the major classifications of the Korean Standard Classification of Diseases (KCD-7). Results: Classification by symptom in a total of 288 articles illustrates that the NRS was not only commonly used in pain evaluation but also for non-pain symptoms. In usage with non-pain symptoms, chief complaint of patients was the most common at 79%, and other factors included treatment satisfaction, evaluation of daily life, and sleep quality. In disease classification according to the KCD-7, the NRS was commonly used in connection with musculoskeletal and connective tissue diseases but was also utilized in various other disease groups. Conclusions: This study confirms usage of the NRS in multi-center RCTs, as the NRS was widely used in all types of diseases and symptoms. Considering the result and the advantages of the NRS, it is recommended for use as a daily evaluation tool for the collection of common data in multicenter retrospective studies.

Optimal Duration of Dual Antiplatelet Therapy after Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms : A Prospective Randomized Multicenter Trial

  • Ban, Seung Pil;Kwon, O-Ki;Kim, Young Deok;Kim, Bum-Tae;Oh, Jae Sang;Kim, Kang Min;Kim, Chang Hyeun;Kim, Chang-Hyun;Choi, Jai Ho;Kim, Young Woo;Lim, Yong Cheol;Byoun, Hyoung Soo;Park, Sukh Que;Chung, Joonho;Park, Keun Young;Park, Jung Cheol;Kwon, Hyon-Jo;Korean NeuroEndovascular Society,
    • Journal of Korean Neurosurgical Society
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    • 제65권6호
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    • pp.765-771
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    • 2022
  • Objective : Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and short-term dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs). Methods : This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (long-term group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1 : 1 randomization. This study will involve 14 top-performing, high-volume Korean institutions specializing in coil embolization. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.

일개 응급센터에서 급속가압수액주입기의 사용경험 (Clinical Experience with using a Rapid Infuse at an Urban Emergency Department)

  • 홍종근;송형곤
    • Journal of Trauma and Injury
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    • 제19권1호
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    • pp.41-46
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    • 2006
  • Purpose: Hypovolemia is not uncommon among trauma patients in the emergency department (ED). Successful resuscitation of a hypovolemic patient often requires rapid intravenous administration of massive amounts of fluid. A rapid fluid infuser is used in the ED for this purpose, there have been no studies of their clinical uses and effectiveness. We studied clinical experience with a rapid fluid infuser at an urban university hospital in Seoul, Korea. Methods: We reviewed the medical records of 38 patients admitted to the ED with a history of application of a rapid fluid infuser from January 2004 to July 2005. Adult trauma patients older than 15 years of age were included in this study. Clinical data on the patients and the volume of fluid used to achieve a stable blood pressure were extracted from their medical records. Results: The total number of adult trauma patients with a history of application of a rapid fluid infuser from January 2004 to July 2005 in the ED was 16. The mean systolic blood pressure for deciding to apply the rapid fluid infuser was $74.9{\pm}12.7mmHg$. The mean time and volume used to achieve a stable blood pressure were 40.4 min and$2947.3{\pm}1339.2ml$, respectively. In all patients, the amount of fluid infused before using the rapid fluid infuser was between 500 ml and 10,000 ml, compared to 1,000 ml and 6,200 ml with the rapid fluid infuser. The mean amount of fluid per min. via the rapid fluid infuser was 85.5 ml. Vital signs were stabilized in 11 patients, 6 of the 11 were discharged alive. Conclusion: The mean amount of fluid delivered per min. via the rapid fluid infuser was much less than expected; thus, there should be clinical guidelines on volume resuscitation with a rapid fluid infuser in the ED. In the future, prospective, multicenter, clinical-data collection is needed for a more sophisticated study.

Characteristics, Management, and Clinical Outcomes of Patients with Hospital-Acquired and Ventilator-Associated Pneumonia: A Multicenter Cohort Study in Korea

  • Ko, Ryoung-Eun;Min, Kyung Hoon;Hong, Sang-Bum;Baek, Ae-Rin;Lee, Hyun-Kyung;Cho, Woo Hyun;Kim, Changhwan;Chang, Youjin;Lee, Sung-Soon;Oh, Jee Youn;Lee, Heung Bum;Bae, Soohyun;Moon, Jae Young;Yoo, Kwang Ha;Jeon, Kyeongman
    • Tuberculosis and Respiratory Diseases
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    • 제84권4호
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    • pp.317-325
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    • 2021
  • Background: Hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) are significant public health issues in the world, but the epidemiological data pertaining to HAP/VAP is limited in Korea. The objective of this study was to investigate the characteristics, management, and clinical outcomes of HAP/VAP in Korea. Methods: This study is a multicenter retrospective cohort study. In total, 206,372 adult patients, who were hospitalized at one of the 13 participating tertiary hospitals in Korea, were screened for eligibility during the six-month study period. Among them, we included patients who were diagnosed with HAP/VAP based on the Infectious Diseases Society of America (IDSA)/American Thoracic Society (ATS) definition for HAP/VAP. Results: Using the IDSA/ATS diagnostic criteria, 526 patients were identified as HAP/VAP patients. Among them, 27.9% were diagnosed at the intensive care unit (ICU). The cohort of patients had a median age of 71.0 (range from 62.0 to 79.0) years. Most of the patients had a high risk of aspiration (63.3%). The pathogen involved was identified in 211 patients (40.1%). Furthermore, multidrug resistant (MDR) pathogens were isolated in 138 patients; the most common MDR pathogen was Acinetobacter baumannii. During hospitalization, 107 patients with HAP (28.2%) had to be admitted to the ICU for additional care. The hospital mortality rate was 28.1% in the cohort of this study. Among the 378 patients who survived, 54.2% were discharged and sent back home, while 45.8% were transferred to other hospitals or facilities. Conclusion: This study found that the prevalence of HAP/VAP in adult hospitalized patients in Korea was 2.54/1,000 patients. In tertiary hospitals in Korea, patients with HAP/VAP were elderly and had a risk of aspiration, so they were often referred to step-down centers.

TESS 보고 양식을 활용한 대전 지역의 중독 양상 (The Toxic Exposure Patients of Daejon Province by Modified TESS Style)

  • 박정규;정성필;김승환;유인술;박준석;유진현;양영모;정시경
    • 대한임상독성학회지
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    • 제2권1호
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    • pp.1-6
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    • 2004
  • Purpose: A number of reports about the intoxicated patients have been introduced, but there were few multicenter studies. The purpose of this study was to analyse the patients with toxic exposure in the Daejon province. Methods: The patients who were presented to the four academic emergency departments in Daejon with toxic exposure were enrolled from January to June 2003. The collected variables were according to the form which modified from the Toxic Exposure Surveillance System (TESS) of the American Association of Poison Control Centers. Results: The toxic exposure patients were 362 cases which is $0.78\%$ of total patients presented to the emergency department. The most common exposure site was home ($84\%$). Eighteen percent of cases were exposed by two or more substances. The most common substance was the pesticides ($34.8\%$), and the non-prescription drugs ($32.6\%$) was followed. The suicidal attempt was the top reason for exposure ($67.1\%$). The route of exposure other than ingestion was $3.6\%$. Although the most patients left the hospital within a day, the average treatment period was 4.4 days. Thirty-one patients ($8.6\%$) were expired, and 22 among them were exposed to the paraquat. Conclusion: We reported the current status of toxic exposure in Daejon province by modified TESS style.

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Endoscopic mucosal resection using anchored snare Tip-in versus precut technique for small rectal neuroendocrine tumors

  • Seung Wook Hong;Dong-Hoon Yang;Yoo Jin Lee;Dong Hoon Baek;Jaeyoung Chun;Hyun Gun Kim;Sung Joo Kim;Seung-Mo Hong;Dae-Seong Myung
    • The Korean journal of internal medicine
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    • 제39권2호
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    • pp.238-247
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    • 2024
  • Background/Aims: Small rectal neuroendocrine tumors (NETs) can be treated with modified endoscopic mucosal resection (EMR). However, an optimal EMR method remains to be established. We aimed to assess the non-inferiority of Tip-in EMR versus precut EMR (EMR-P) for treating rectal NETs. Methods: This prospective, multicenter, randomized controlled trial enrolled patients with rectal NETs of < 10 mm in diameter. The patients were randomly assigned to EMR-P and Tip-in EMR groups in a 1:1 ratio. Primary outcome was margin-negative (R0) resection rate between the two methods, with a noninferiority margin of 10%. Results: Seventy-five NETs in 73 patients, including 64 eligible lesions (32 lesions in each, EMR-P and Tip-in EMR groups), were evaluated. In a modified intention-to-treat analysis, R0 resection rates of the EMR-P and Tip-in EMR groups were 96.9% and 90.6%, respectively, which did not demonstrate non-inferiority (risk difference, -6.3 [95% confidence interval: -18.0 to 5.5]). Resection time in the EMR-P group was longer than that in the Tip-in EMR group (p < 0.001). One case of intraprocedural bleeding was reported in each group. Conclusions: We did not demonstrate the non-inferiority of Tip-in EMR compared to EMR-P for treating small rectal NETs. However, the R0 resection rates for both techniques were high enough for clinical application.