• Integrative Medicine Research
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• v.6 no.3
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• pp.317-324
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• 2017

Background: Bu-Zhong-Yi-Qi-Tang (BZYQT) has long been used for the treatment of severe weakness caused by general fatigue, loss of appetite, or indigestion. The aim of this feasibility study is to assess the effectiveness and safety of BZYQT for the treatment of functional dyspepsia (FD) with spleen qi deficiency. Methods: This study will be conducted at a single center as a prospective, nonrandomized, nonblinded, single-arm feasibility study. A total of 30 participants diagnosed with FD in accordance with the Rome III criteria will be enrolled. All patients will receive BZYQT for 4 weeks. The primary outcome is the change in the Nepean Dyspepsia Index-Korean version (NDI-K) scores between the baseline and 4-week images. The secondary outcomes include the tongue coating thickness, blood parameters, and BZYQT Questionnaire score. The NDI-K score will be acquired four times, at Weeks 0 (baseline), 2 (during treatment), 4 (after treatment), and 8 (after follow-up). Written informed consent will be obtained from all study participants prior to enrollment. This study has been approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital. This study protocol is registered with the national clinical trial registry of the World Health Organization International Clinical Trials Registry Platform. Results will be published in a journal and will be disseminated both electronically and in print. Discussion: The results of this study may serve as a guide for researchers seeking to effectively evaluate the effects of BZYQT.

• Journal of Gastric Cancer
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• v.16 no.2
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• pp.93-97
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• 2016

Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospective study evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japanese institutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints are overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. The UMIN Clinical Trials Registry number is UMIN000017155.

• Journal of mucopolysaccharidosis and rare diseases
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• v.1 no.1
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• pp.2-4
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• 2015

Though the rate of incidence of each rare disease, including mucopolysaccharidosis (MPS), is low, this is not the case if they are taken as a whole. Rare diseases often have genetic causes and vary in type. However, the signs and symptoms vary greatly by disease, making it difficult to make accurate diagnoses and conduct necessary research, which is why we believe it is a field that deserves more attention and research. It is important to establish an infrastructure of experts in each country and promote cooperation within the Asia-Pacific region in order to improve specialist training and communication. Given the need for a system of cooperation, the Asia Pacific MPS Network (APMN) was established by several MPS experts in South Korea, Japan, and Taiwan in January 2013. Thereafter, the Asia Pacific MPS Registry (APMR), an electronic remote data system, was established by the APMN. Then, the Association for Research of MPS & Rare Diseases (ARMRD), an academic society that supports research on MPS and other rare diseases, was established by President Dong-Kyu Jin in April in 2015. The main task of the ARMRD is to support APMN-related work. The ARMRD published a uniform guideline that reflects the characteristics and circumstances of local patients through the Korean MPS Expert Council. Now, the APMN, APMR, and the annual Korean MPS Symposium are supported by ARMRD. Organizations like the APMN and APMR are necessary because international cooperation and collaboration are needed to conduct clinical trials on those diseases. ARMRD members hope to encourage the interest of experts and researchers of MPS & rare diseases as well as active participation in the research and treatment of patients suffering from rare diseases, including MPS, to ultimately improve the quality of life of the patients as well as their families.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.9
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• pp.5043-5047
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• 2013

Background: This is a part of a larger effort to characterize the effects on socio-economic factors (SEFs) on cancer outcome. Surveillance, Epidemiology and End Result (SEER) bone and joint sarcoma (BJS) data were used to identify potential disparities in cause specific survival (CSS). Materials and Methods: This study analyzed SEFs in conjunction with biologic and treatment factors. Absolute BJS specific risks were calculated and the areas under the receiver operating characteristic (ROC) curve were computed for predictors. Actuarial survival analysis was performed with Kaplan-Meier method. Kolmogorov-Smirnov's 2-sample test was used to for comparing two survival curves. Cox proportional hazard model was used for multivariate analysis. Results: There were 13501 patients diagnosed BJS from 1973 to 2009. The mean follow up time (SD) was 75.6 (90.1) months. Staging was the highest predictive factor of outcome (ROC area of 0.68). SEER stage, histology, primary site and sex were highly significant pre-treatment predictors of CSS. Under multivariate analysis, patients living in low income neighborhoods and rural areas had a 2% and 5% disadvantage in cause specific survival respectively. Conclusions: This study has found 2-5% decrement of CSS of BJS due to SEFs. These data may be used to generate testable hypothesis for future clinical trials to eliminate BJS outcome disparities.

• Journal of Korean Neurosurgical Society
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• v.55 no.1
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• pp.1-4
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• 2014

Objective : The case fatality rate of nonlesional intracerebral hemorrhage (n-ICH) was high and not changed. Knowing the causes is important to their prevention; however, the reasons have not been studied. The aims of this study were to determine the cause of death, to improve the clinical outcomes. Methods : We retrospectively analyzed consecutive cases of nonlesional intracerebral hemorrhage in a prospective stroke registry from January 2010 to December 2010. Results : Among 174 patients ($61.83{\pm}13.36$, 28-90 years), 29 patients (16.7%) died during hospitalization. Most common cause of death was initial neurological damage (41.4%, 12/29). Seventeen patients who survived the initial damage may then develop various potentially fatal complications. Except for death due to the initial neurological sequelae, death associated with immobilization (such as pneumonia or thromboembolic complication) was the most common in eight cases (8/17, 47.1%). However, death due to early rebleeding was not common and occurred in only 2 cases (2/17, 11.8%). Age, initial Glasgow Coma Scale, and diabetes mellitus were statistically significant factors influencing mortality (p<0.05). Conclusion : Mortality of n-ICH is still high. Initial neurological damage is the most important factor; however, non-neurological medical complications are a large part of case fatality. Most cases of death of patients who survived from the first bleeding were due to complications of immobilization. These findings have implications for clinical practice and planning of clinical trials. In addition, future conduct of a randomized study will be necessary in order to evaluate the benefits of early mobilization for prevention of immobilization related complications.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.10
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• pp.4591-4597
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• 2016

Purpose: Decisions as to whether to provide adjuvant treatment in older breast cancer patients remains challenging. Side effects of chemotherapy have to be weighed against life expectancy, comorbidities, functional status, and frailty. To aid decision-making, we retrospectively analyzed 110 women with breast cancer treated with a curative intention from 2006 to 2012. Survival data with clinical and pathological parameters were evaluated to address the role of adjuvant chemotherapy in this study population. Method: A total of 110 elderly (>70 years) patients that received mastectomy at two hospitals in Taiwan were observed retrospectively for a medium of 51 months. After mastectomy, patients received conservative treatment or adjuvant chemotherapy, or hormone therapy following clinical guidelines or physician's preference. Data were collected from the cancer registry system. Results: Median age at diagnosis was 75.7 years. Thirty-five percent of patients received adjuvant chemotherapy, these having a significantly younger age ($mean=74.0{\pm}5.3$ vs $77.5{\pm}5.3$, p<0.001) and higher tumor staging (p=0.003) compared with their non-chemotherapy counterparts.Five-year overall survival was non-significantly higher in patients who received adjuvant chemotherapy (with chemotherapy 64.2% vs without chemotherapy 62.6%, p=0.635), while five-year recurrence free survival was non-significantly lower (with chemotherapy 64.1% vs without chemotherapy 90.5%, p=0.80). Conclusions: In this analysis, adjuvant chemotherapy tended to be given to patients with a younger age and higher tumor staging at our institute. It was not associated with any statistically significant improvement in survival and recurrence rate. Until age specific recommendations are available, physicians must use their clinical judgment and assess the tumor biology with the patient's comorbidities to make the best choice. Clinical trials focusing on this critical issue are warranted.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.2
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• pp.697-702
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• 2016

Background: The Asia-Pacific Breast Initiatives (APBI) I and II registries were established to collect safety data for patients with early stage breast cancer receiving adjuvant docetaxel-based regimens in the Asia-Pacific region. Materials and Methods: Data from the two registries were combined to perform a safety analysis. Participants in the registry were women with early stage operable breast cancer with an intermediate or high risk of recurrence. These women received adjuvant chemotherapy that included docetaxel between 2006 and 2011. Adverse events (AEs) were recorded and analyzed. Results: Data were collected from 3,224 patients from 13 countries. The mean dose intensity of docetaxel was 24.1, 22.7, $25.1mg/m^2/week$ among patients receiving docetaxel-based monotherapy, combination therapy and sequential therapy, respectively. Granulocyte colony-stimulating factor (G-CSF) was given with docetaxel to 41.8% of women and 20.6% of women receiving prophylactic antibiotics. Adverse events were reported in 86% of patients (anthracycline-containing regimens vs. non-anthracycline regimens; 87% vs. 80%). The most common adverse events were alopecia, nausea, neutropenia, vomiting, and myalgia. Adverse events NCI CTCAE ${\geq}$Grade 3 were reported in 45.4% of patients. Serious adverse events were reported in 13% of patients, of which 2.5% led to study discontinuation. Forty-six deaths (1.4%) were reported, with no significant difference between regimens. Conclusions: The safety parameters of adjuvant docetaxel therapy used to treat sequential Asian women were comparable to those reported in clinical trials evaluating the role of adjuvant docetaxel. No unusual adverse events linked to Asia-Pacific region patients were observed.

• Clinical and Experimental Pediatrics
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• v.57 no.3
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• pp.135-139
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• 2014

Purpose: Adult Korean patients on chronic dialysis have a 9-year survival rate of 50%, with cardiovascular problems being the most significant cause of death. The 2011 annual report of the North American Pediatric Renal Trials and Collaborative Studies group reported 3-year survival rates of 93.4% and relatively poorer survival in younger patients. Methods: In this study, we have reviewed data from Korean Pediatric Chronic Kidney Disease Registry from 2002 to 2010 to assess survival rates and causes of death in Korean children on chronic dialysis. Results: The overall estimated patient survival rates were 98.4%, 94.4%, and 92.1% at 1, 3, and 5 years, respectively. No significant difference was observed in survival rates between patients on peritoneal dialysis and those on hemodialysis. Patients for whom dialysis was initiated before 2 years of age (n=40) had significantly lower survival rates than those for whom dialysis was initiated at 6-11 years of age (n=140). In all, 26 patients had died; the mortality rate was 19.9 per 1,000 patient years. The most common causes of death were infections and comorbidities such as malignancy and central nervous system (CNS) or liver diseases. Conclusion: The outcomes observed in this study were better than those observed in adults and comparable to those observed in pediatric studies in other countries. To improve the outcomes of children on chronic dialysis, it is necessary to prevent dialysis-related complications such as infection, congestive heart failure, or CNS hemorrhage and best control treatable comorbidities.

• Journal of Gynecologic Oncology
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• v.29 no.6
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• pp.92.1-92.9
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• 2018

Objective: To evaluate the effectiveness of the pulmonary recruitment maneuver (PRM) at the end of the operation to decrease laparoscopy-induced abdominal or shoulder pain after gynecological oncologic surgery. Methods: In total, 113 women undergoing laparoscopic surgery for malignant or premalignant gynecological lesions were assigned randomly to two groups: the PRM group (the patient was placed in the Trendelenburg position ($30^{\circ}$) and the PRM, consisting of two manual pulmonary inflations to a maximum pressure of $40cmH_2O$) (n=54) and the control group (n=52). Postoperative shoulder and abdominal pain was assessed 12, 24, and 48 hours later using a visual analog scale (0-10). In addition, the incidence of post-discharge nausea and vomiting was recorded until 48 hours after discharge. Results: Postoperative shoulder pain at 12 and 24 hours was significantly less severe in the PRM group ($2.2{\pm}0.5$ and $2.0{\pm}0.4$) than in the control group ($4.0{\pm}0.5$ and $3.9{\pm}0.4$; both p<0.001). The PRM significantly reduced the severity of upper abdominal pain at 12 and 24 h compared with the control group ($3.1{\pm}0.4$ and $2.9{\pm}0.4$ vs. $2.9{\pm}0.5$ and $4.9{\pm}0.5$; both p<0.001). The analgesic requirement during the postoperative period was similar in the two groups (control group, 78.8%; PRM group, 75.9%; p=0.719). Conclusion: The PRM effectively and safely reduced postoperative shoulder and upper abdominal pain levels in patients undergoing laparoscopic gynecological oncologic surgery. Trial registry at ClinicalTrials.gov, NCT01940042.

• Proceedings of the Korean Society for Information Management Conference
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• 2017.08a
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• pp.104-104
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• 2017

연구 데이터란 과학적 연구에서 사용된 일차 자료와 연구자에 의해 직접 작성된 연구의 결과로서 수치, 문자, 이미지, 음성 등의 사실적 기록을 의미한다. 이 연구의 주제 분야인 의학은 잠재적 가치와 활용 가능성이 높고 공익적 성격을 가지고 있는 학문 분야로 의학 연구 데이터의 종류와 관리의 필요성을 통해서 그 가치와 공유 의미를 찾아보고자 한다. 또한 연구 데이터의 대표적인 임상 시험 기록과 연구 논문의 발표와 공유 현황에 대해서도 살펴보고 그 안에서 도서관의 역할이 어떤 것인가를 짚어보고자 한다. 의학 연구 데이터는 환자 진료기록, 건강 검진 기록, 임상 기록, 사망 기록, 임상 시험 기록, 유전체 정보, 연구 논문 등 그 종류와 형태가 다양하며 대용량인 경우가 많다. 의학 연구는 개인 정보보호와 윤리적인 문제 등 연구 수행 과정에서 어려운 점이 많은 성격을 가지고 있으나 질병 치료나 예방 나아가 인류의 건강과 직접적으로 관련된 학문 분야로 의학 연구 데이터의 보존과 공개, 공유를 위한 관리는 큰 의미가 있다. 의학 연구 데이터관리는 새로운 연구의 밑받침이 될 뿐만 아니라 중 저개발 국가의 연구자들에게도 큰 기회를 부여하여 세계적인 의학 발전에 기여할 수 있다. 또한 임상 시험 결과에 대한 은폐와 거짓 연구 방지에도 의미가 있어 미국뿐만 아니라 전세계적으로 학술 연구 논문 발표에 사용된 데이터는 등록하도록 규정하고 있다. 임상 시험 등록으로 공인된 사이트는 NIH의 ClinicalTrials.gov, ICTRP의 Primary Registry 등이 있으며, 우리나라에도 질병관리본부 국립보건연구원에서 관리하는 CRIS 등이 있다. 의학 연구자들은 연구의 시작부터 연구 데이터를 수집, 사용, 보존, 공유의 문제를 고려해야 하나 시간적 물리적인 문제 등으로 어려움을 겪고 있으며, 이를 지원하는 서비스는 도서관에서도 관심이 높아지고 있는 분야로 Virginia Commonwealth 대학 도서관과 Emory 대학 도서관 등에서 시도되고 있다. 이 서비스는 연구 과정에서 사서의 지원이 가능한 새로운 기회로 연구자의 데이터관리를 위한 단계별 스토리를 조직하고 DMP 작성 지원 및 교육 등을 통해서 학술 커뮤니케이션에서 새로운 역할자로 자리잡을 수 있을 것이다.