• Title/Summary/Keyword: Multicenter clinical studies

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

  • Lee, Chan;Cho, Im-hak;Heo, Gi-yoon;Kang, Hee-kyung;Kim, Min-hwa;Han, Chang-woo;Kim, So-yeon;Choi, Jun-yong;Park, Seong-ha;Yun, Young-ju;Hong, Jin-woo;Kwon, Jung-nam;Lee, In
    • The Journal of Internal Korean Medicine
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    • v.42 no.4
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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.

Factors Associated with Gastric and Duodenal Neuroendocrine Tumor Development

  • Kwangwoo Nam;Su Youn Nam
    • Journal of Digestive Cancer Research
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    • v.12 no.1
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    • pp.1-5
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    • 2024
  • The incidence and prevalence of upper gastrointestinal neuroendocrine tumors (NETs), including gastric NETs (GNETs) and duodenal NETs (DNETs), have been gradually increasing. These trends may be associated with the increased use of health checkups, which includes upper endoscopy, in conjunction with better disease recognition. However, the clinical factors associated with GNETs and DNETs remain unknown; previous studies revealed discrepancies. Recently, metabolic disorders have been indicated as potential factors that are associated with GNETs and DNETs. This review summarizes the results of previous studies and briefly introduces the results of a recent Korean multicenter study on the factors associated with GNETs and DNETs.

Clinical predictors of therapeutic laparotomy in anterior abdominal stab injuries: a multicenter study from low-income institutions in Ethiopia

  • Segni Kejela;Abel Hedato;Yeabsera Mekonnen Duguma;Meklit Solomon Gebremariam
    • Journal of Trauma and Injury
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    • v.37 no.2
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    • pp.140-146
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    • 2024
  • Purpose: Despite the high incidence of abdominal stab injuries, the rate of nontherapeutic laparotomies and the predictors of therapeutic laparotomies have rarely been studied in low-income settings. Methods: This multicenter retrospective study involved three of the largest academic medical centers in central Ethiopia. All patients who sustained an anterior abdominal stab injury and underwent exploratory laparotomy, regardless of the intraoperative findings, were included over the 3-year course of the study. Results: Of the 117 patients who underwent exploratory laparotomy, 35 patients (29.9%) underwent nontherapeutic laparotomies. Three factors predicted therapeutic laparotomy: hollow viscus evisceration (adjusted odds ratio [AOR], 5.77; 95% confidence interval [CI], 1.16-28.64; P=0.032), localized and generalized peritonitis (AOR, 4.77; 95% CI, 1.90-11.93; P=0.001), and white blood cell count ≥11,500/mm3 (AOR, 2.77; 95% CI, 1.002-7.650; P=0.049). The overall positive predictive value of the therapeutic predictors was 80.2%, while the negative predictive value of all predictor-negative patients was 58.1%. The predictors would have prevented 51.4% of the nontherapeutic laparotomies. Conclusions: Close to one-third of the patients had a nontherapeutic laparotomy. The clinical predictors of therapeutic laparotomy were shown to have a high positive predictive value despite a lower negative predictive value. Further prospective studies that involve all patients who sustain anterior abdominal stab injuries are needed to potentially improve on the negative predictive value of the predictors suggested by our study.

Analysis on Research Trend of Studies Related with Scutellariae Radix in Korea (황금(黃芩)에 관한 국내 연구 동향에 관한 소고)

  • Kim, Kang-San;Kim, Lae-Hee;Rhee, Yun-Jin;Lee, Su-Hyoun;Choi, Ji-Hye;Ko, Ha-Neul
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.25 no.6
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    • pp.1095-1101
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    • 2011
  • Scutellariae Radix has been used as a traditional medicine for anti-oxidant, anti-inflammatory, anti-allergic function. But most study methods were restricted to in vitro and in vivo. Therefore to perform for clinical trials further for a new natural drug development is necessary and this study will be used as a basis for it. The studies selected from domestic academic database included the following key words; '황금', '黃芩', 'skullcap', 'Scutellariae Radix', 'scutellaria baicalensis' and considered were those published from 1990 to July, 2011. All 1080 studies were found to include the keywords related to the study subjects either in their title of contents or abstracts. and 298 studies were finally selected as subjects for this study. 243 studies among 293 studies were published between 2000 to 2011. Classification was proceeded according to study subjects as followed; anti-Inflammatory effect and antiallergic and antihistamin effect(66), antibacterial and antivirus effect(61), antioxidant effect(51), neuronal cell apoptosis and neuronal cell protective effect(22), liver cell protective effect(20). According to method type of study, 194 studies practicing in vitro, 60 studies practicing in vivo, 37 studies practicing in both. and 5 studies on documentary records. Most study methods were restricted in vitro and in vivo. For developmenting of function of anti-inflammatory effect and antiallergic, antihistamin effect & atopic dermatitis effect, antibacterial and antivirus effect, antioxidant effect, case report on various fields and multicenter clinical trials is necessary.

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

  • Park Jung Kyoo;Jeong Sung Phil;Kim Seung Hwan;Yoo In Sui;Park Joon Seok;Yoo Jin Hyun;Yang Yeong Mo;Jeong Si Kyung
    • Journal of The Korean Society of Clinical Toxicology
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    • v.2 no.1
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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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The Association of Circumcision and Prostate Cancer: A Meta-Analysis

  • Li, Yu-dan;Teng, Yang;Dai, Yu;Ding, Hui
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.8
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    • pp.3823-3827
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    • 2016
  • Background: To investigate the association circumcision with prostate cancer. Materials and Methods: We searched PubMed, EMBASE, the Cochrane Library, and Chinese biomedicine literature database up to August 2015. All case-control studies were identified in which investigated the association circumcision with prostate cancer. Three authors independently assessed study quality and extracted data. All data were analyzed using RevMan 5.3 and STATA version 11.0. Results: Six case-control studies met the inclusion criteria. The pooled meta-analysis showed that there was a lower incidence of circumcision in prostate cancer patients compared with control (OR=0.90, 95% confidence interval [CI] 0.82-0.98, P=0.01). The results of meta-analysis also showed that no significant difference was found between circumcision and less aggressive prostate cancer (OR=0.93, 95% CI 0.83-1.04, P=0.19); however, there was a lower incidence of circumcision in more aggressive prostate cancer compared with control (OR =0.84, 95% CI 0.72-0.97, P=0.02). The Egger's results did not show any evidence of publication bias(P=0.798). Conclusions: In summary, within the limits of available data, male with circumcision appears to have a lower incidence of prostate cancer. In the future, high-quality multicenter studies are needed to thoroughly verify the outcome.

A cross-sectional survey of clinical factors that influence the use of traditional Korean medicine among children with cerebral palsy

  • Lee, Hye-Yoon;Yun, Young-Ju;Yu, Sun-Ae;Park, Yo-Han;Park, Byung-Wook;Kim, Bu-Young;Hwang, Man-Suk
    • Integrative Medicine Research
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    • v.7 no.4
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    • pp.333-340
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    • 2018
  • Background: Traditional Korean medicine (TKM) is widely used to treat children with cerebral palsy (CP) in Korea; however, studies investigating factors that influence the use of TKM are scarce. Thus, we investigated the clinical factors that might influence the use of TKM. Methods: A population-based, cross-sectional, multicenter survey was performed from August 2014 to May 2016. The history of TKM use, type and severity of CP, current treatment characteristics, presence of accompanying disabilities or other health problems not directly related to CP, and monthly cost for the treatment of CP were surveyed. Results: In total, 182 children were recruited, and 78 children (42.9%) had used TKM. Among these 78 children, 50 (64.1% of the TKM-use group) had used both acupuncture and herbal medication, 15 (19.2%) had used acupuncture only, and 13 (16.7%) had used herbal medication only. Children with non-typical CP, accompanying disabilities and general health problems tended to use TKM. The monthly cost of treatment for CP was significantly higher in the TKM-use group than that in the no-TKM-use group, suggesting that economically disadvantaged children may have difficulty in accessing TKM. Dietary supplements, conventional pharmacological treatments, and rehabilitation therapies did not affect TKM use. Conclusion: Children with non-typical symptoms or those with poor overall health status are likely to use TKM. Additionally, TKM use leads to increased treatment costs. Studies investigating the motivation for starting or ceasing TKM therapy, socioeconomic factors and the attitude of parents towards complementary and alternative medicine should be performed.

The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP- (소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.1
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

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
    • Journal of Oriental Neuropsychiatry
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    • v.31 no.3
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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.

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

  • Hong, Chong Kun;Song, Hyoung Gon
    • Journal of Trauma and Injury
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    • v.19 no.1
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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.