• Title/Summary/Keyword: Trial registration

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Laparoscopy Assisted versus Open Distal Gastrectomy with D2 Lymph Node Dissection for Advanced Gastric Cancer: Design and Rationale of a Phase II Randomized Controlled Multicenter Trial (COACT 1001)

  • Nam, Byung Ho;Kim, Young-Woo;Reim, Daniel;Eom, Bang Wool;Yu, Wan Sik;Park, Young Kyu;Ryu, Keun Won;Lee, Young Joon;Yoon, Hong Man;Lee, Jun Ho;Jeong, Oh;Jeong, Sang Ho;Lee, Sang Eok;Lee, Sang Ho;Yoon, Ki Young;Seo, Kyung Won;Chung, Ho Young;Kwon, Oh Kyoung;Kim, Tae Bong;Lee, Woon Ki;Park, Seong Heum;Sul, Ji-Young;Yang, Dae Hyun;Lee, Jong Seok
    • Journal of Gastric Cancer
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    • v.13 no.3
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    • pp.164-171
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    • 2013
  • Purpose: Laparoscopy-assisted distal gastrectomy for early gastric cancer has gained acceptance and popularity worldwide. However, laparoscopy-assisted distal gastrectomy for advanced gastric cancer is still controversial. Therefore, we propose this prospective randomized controlled multi-center trial in order to evaluate the safety and feasibility of laparoscopy assisted D2-gastrectomy for advanced stage gastric cancer. Materials and Methods: Patients undergoing distal gastrectomy for advanced gastric cancer staged cT2/3/4 cN0/1/2/3a cM0 by endoscopy and computed tomography are eligible for enrollment after giving their informed consent. Patients will be randomized either to laparoscopyassisted distal gastrectomy or open distal gastrectomy. Sample size calculation revealed that 102 patients are to be included per treatment arm. The primary endpoint is the non-compliance rate of D2 dissection; relevant secondary endpoints are three-year disease free survival, surgical and postoperative complications, hospital stay and unanimity rate of D2 dissection evaluated by reviewing the intraoperative video documentation. Discussion: Oncologic safety is the major concern regarding laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Therefore, the non-compliance rate of clearing the N2 area was chosen as the most important parameter for the technical feasibility of the laparoscopic procedure. Furthermore, surgical quality will be carefully reviewed, that is, three independent experts will review the video records and score with a check list. For a long-term result, disease free survival is considered a secondary endpoint for this trial. This study will offer promising evidence of the feasibility and safety of Laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Trial Registration: NCT01088204 (international), NCCCTS-09-448 (Korea).

'Neulchan', a Middle-seed, Disease-resistant, and High-yield Soybean Cultivar for Soy-paste and Tofu (중립 내병 다수성 장류·두부용 콩 '늘찬')

  • Kim, Hyun Tae;Ko, Jong Min;Baek, In Youl;Han, Won Young;Yun, Hong Tai;Lee, Byoung Won;Shin, Sang Ouk;Seo, Jeong Hyun;Kim, Hong Sik;Kwak, Do Yeon
    • Korean Journal of Breeding Science
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    • v.51 no.4
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    • pp.475-481
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    • 2019
  • The soybean cultivar 'Neulchan' was developed for production of soy-paste and tofu. SS91501-9-1-1 and SS96205 (F2) were crossed in 1998, and F3 to F7 were selected by the pedigree method. A preliminary yield trial (PYT) and an advanced yield trial (AYT) were conducted from 2006 to 2008, and a regional yield trial (RYT) in nine regions was conducted from 2009 to 2011. In the RYT, 'Neulchan' was stable in variable environments and generated high yield. 'Neulchan' was determinate with white flower, light brown pod color, yellow spherical seed, and yellow hilum. Its flowering date and maturity date were Jul. 30 and Oct. 9, respectively. The plant height was shorter than that of 'Daewonkong' (a standard cultivar). 'Neulchan' had the same node number (14), higher first-pod height (12 cm), and lighter seed weight (21.7 g/100-seed weight) than those of 'Daewonkong' (14, 11, and 24.2 g/100-seed weight, respectively). 'Neulchan' had high resistance to bacterial pustule, and its resistance to soybean mosaic virus was similar to that of 'Daewonkong'. The yield and color of 'Neulchan' tofu were similar to those of 'Daewonkong' tofu, but the hardness was lower than that of 'Daewonkong' tofu. The soybean malt scent, fermented soybean yield, and γ-polyglutamic acid (γ-PGA) of 'Neulchan' were 3, 215%, and 24.6 mg/g, respectively. Its yield in adaptable regions was 307 kg/10a, higher than that of 'Daewonkong'. 'Neulchan' was expected to be cultivated and used widely for soy-paste and tofu production. (Registration No. 4904).

Influences of Demographic, Smoking, and Smoking Cessation Factors on Smoking Cessation Success in Adolescent Smokers (인구학적, 흡연 및 금연관련 요인이 청소년 흡연자의 금연성공에 미치는 영향)

  • Yi, Yeo-Jin;Lee, Kun-Ja;Kim, Young-Sook
    • The Journal of the Korea Contents Association
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    • v.11 no.4
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    • pp.303-311
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    • 2011
  • This study aimed to identify success factors of smoking cessation for 6 months in Adolescent smokers. Data were collected from January to December, 2008. The 925 adolescent smokers were registered smoking cessation clinic at public health center in Incheon. Data(demographic, smoking, smoking cessation) were analyzed by logistic regression. Major factors are attempting to quit smoking(no trial, OR=9.48), alcohol drinking(yes, OR=4.61), information source for registration(family, friends's ask, OR=3.94), cessation methods(cognitive+behavior+ nicotine alternative therapy, OR=2.45), gender(male, OR=1.78), grade in school(high schooler, OR=1.65), expiration CO concentration (OR=0.95), and nicotine dependency(OR=0.76). Therefore, smoking cessation policy for adolescence should be emphasized on smoking prevention as well as smoking cessation. We have to help the adolescent to succeed in smoking cessation when they attempt to quit smoking at first time. Female student smokers and middle school smokers should be given advice for smoking cessation motives and more times of counselling for smoking cessation. If adolescent smokers have high expiration CO concentration and high nicotine dependency, they should not only take cognitive-behavior therapy but also nicotine alternative therapy.

Comparison of Pesticide Residue Amounts in Apple Trees Applied by Different Sprayers and Spray Volumes (살포기 종류별 살포물량별 사과 중 농약 잔류량의 비교)

  • Moon, Seong-Hwan;Kwon, Hyeyoung;Hong, Su-Myeong;Kim, Sang-Su;Son, Kyung-Ae;Lim, Chi-Hwan
    • The Korean Journal of Pesticide Science
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    • v.20 no.3
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    • pp.264-270
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    • 2016
  • This study was conducted to compare of the pesticide residue amounts in fruit trees applied by different sprayers and spray volumes. Apple tree was used as a sample tree, and speed sprayer, power sprayer and knapsack motorized sprayer were tested. For similar sprayer and spray volume, the concentration of fluquinconazole and flusilazole in apple leaves were obtained respectively, for speed sprayer 8.33 and 2.15 mg/kg, for power sprayer 4.56 and 1.10 mg/kg, and for knapsack 4.55 and 1.12 mg/kg. The results showed that the treatment using speed sprayer had highest efficiency. The pesticide residues in apple leaves sprayed by 3 different spray volumes (560, 336 and 230 L/10a) using speed sprayer were 10.76 mg/kg, 8.32 mg/kg, 6.04 mg/kg on fluqinconazle and 3.04 mg/kg, 2.14 mg/kg and 1.47 mg/kg on flusilazole, respectively, indicating that the higher the volume, the higher the residues. The results from this study can be used as scientific basis for evaluating the field trial data for pesticide registration and the spray volume setting for fruit trees in Korea.

Design and Development of Middleware for Clinical Trial System based on Brain MR Image (뇌 MR 영상기반 임상연구 시스템을 위한 미들웨어 설계 및 개발)

  • Jeon, Woong-Gi;Park, Kyoung-Jong;Lee, Young-Seung;Choi, Hyun-Ju;Jeong, Sang-Wook;Kim, Dong-Eog;Choi, Heung-Kook
    • Journal of Korea Multimedia Society
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    • v.15 no.6
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    • pp.805-813
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    • 2012
  • In this paper, we have designed and developed a middleware for an effectively approaching database to the existed brain disease clinical research system. The brain disease clinical research system was consisted of two parts i.e., a register and an analyzer. Since the register collects the registration data the analyzer yields a statistical data which based on the diverse variables. The middleware has designed to database management and a large data query processing of clients. By separating the function of each feature as a module, the module which was weakened connectivity between functionalities has been implemented the re-use module. And image data module used a new compression method from image to text for an effective management and storage in database. We tested the middleware system using 700 actual clinical medical data. As a result, the total data transmission time was improved maximum 115 times faster than the existing one. Through the improved module structures, it is possible to provide a robust and reliable system operation and enhanced security functionality. In the future, these middleware importances should be increased to the large medical database constructions.

Late-term effects of hypofractionated chest wall and regional nodal radiotherapy with two-dimensional technique in patients with breast cancer

  • Yadav, Budhi Singh;Bansal, Anshuma;Kuttikat, Philip George;Das, Deepak;Gupta, Ankita;Dahiya, Divya
    • Radiation Oncology Journal
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    • v.38 no.2
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    • pp.109-118
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    • 2020
  • Purpose: Hypofractionated radiotherapy (RT) is becoming a new standard in postoperative treatment of patients with early stage breast cancer after breast conservation surgery. However, data on hypofractionation in patients with advanced stage disease who undergo mastectomy followed by local and regional nodal irradiation (RNI) is lacking. In this retrospective study, we report late-term effects of 3 weeks post-mastectomy hypofractionated local and RNI with two-dimensional (2D) technique in patients with stage II and III breast cancer. Methods: Between January 1990 and December 2007, 1,770 women with breast cancer who were given radical treatment with mastectomy, systemic therapy and RT at least 10 years ago were included. RT dose was 35 Gy/15 fractions/3 weeks to chest wall by two tangential fields and 40 Gy in same fractions to supraclavicular fossa (SCF) and internal mammary nodes (IMNs). SCF and IMNs dose was prescribed at dmax and 3 cm depth, respectively. Chemotherapy and hormonal therapy was given in 64% and 74% patients, respectively. Late-term toxicities were assessed with the Radiation Therapy Oncology Group (RTOG) scores and LENT-SOMA scales (the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales). Results: Mean age was 48 years (range, 19 to 75 years). Median follow-up was 12 years (range, 10 to 27 years). Moderate/marked arm/shoulder pain was reported by 254 (14.3%) patients. Moderate/marked shoulder stiffness was reported by 219 (12.3%) patients. Moderate/marked arm edema was seen in 131 (7.4%) patients. Brachial plexopathy was not seen in any patient. Rib fractures were noted in 6 (0.3%) patients. Late cardiac and lung toxicity was seen in 29 (1.6%) and 23 (1.3%) patients, respectively. Second malignancy developed in 105 (5.9%) patients. Conclusion: RNI with 40 Gy/15 fractions/3 weeks hypofractionation with 2D technique seems safe and comparable to historical data of conventional fractionation (ClinicalTrial.gov Registration No. NCT04175821).

Records of the Prosecutor's Office at Gyeongseong District Court(京城地方法院檢事局) and Set up the Department of Ideology(思想部) (경성지방법원 검사국 기록과 '사상부(思想部)'의 설치)

  • Jung, Byung Wook
    • The Korean Journal of Archival Studies
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    • no.40
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    • pp.95-130
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    • 2014
  • Three frequently used documents by researchers on the Japanese colonial period-Classified Police Records of the Japanese Government-General of korea on the Anti-Japanese Movement 舊 朝鮮總督府 警務局 抗日獨立運 動關係 秘密記錄, Trial Records of Gyeongseong District Court 京城地方法院 裁判記錄 and Filed Documents of Gyeongseong District Court 京城地方法院 編綴文書(while the latter two were collected by the National Institute of Korean History, the former was collected by Asiatic Research Institute of Korea University)-are among the same records group that the Prosecutor's Office of Gyeongseong District Court produced through registration and compilation. As contents related to ideology suppression and thought control were numerous, it could be assumed that most of the materials were produced by the 'Department of Ideology' of the Prosecutor's Office. By examining the administrative records of the 1920's within this group, the process of how the 'Department of Ideology' was formed is clearly shown. As ideological movements for Korea's independence and revolution grew, execution of regulations was further expanded by the Prosecutor's Office. Since the mid-1920's, information on ideology had been separated from general information, was routinely collected heavily, and was considered more valuable than the general information. By the end of the 1920's, the term Ideology Prosecutor 思想係 檢事(meaning a prosecutor who specializes in ideology verification) and the named 'Department of Ideology'(思想部) emerged on the records.

Efficacy and safety of losartan in childhood immunoglobulin A nephropathy: a prospective multicenter study

  • Hyesun Hyun;Yo Han Ahn;Eujin Park;Hyun Jin Choi;Kyoung Hee Han;Jung Won Lee;Su Young Kim;Eun Mi Yang;Jin Soon Suh;Jae Il Shin;Min Hyun Cho;Ja Wook Koo;Kee Hyuck Kim;Hye Won Park;Il Soo Ha;Hae Il Cheong;Hee Gyung Kang;Seong Heon Kim
    • Childhood Kidney Diseases
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    • v.27 no.2
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    • pp.97-104
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    • 2023
  • Purpose: Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers (ARBs) are frequently employed to counteract the detrimental effects of proteinuria on glomerular diseases. However, the effects of ARBs remain poorly examined in pediatric patients with immunoglobulin A (IgA) nephropathy. Herein, we evaluated the efficacy and safety of losartan, an ARB, in pediatric IgA nephropathy with proteinuria. Methods: This prospective, single-arm, multicenter study included children with IgA nephropathy exhibiting proteinuria. Changes in proteinuria, blood pressure, and kidney function were prospectively evaluated before and 4 and 24 weeks after losartan administration. The primary endpoint was the difference in proteinuria between baseline and 24 weeks. Results: In total, 29 patients were enrolled and received losartan treatment. The full analysis set included 28 patients who received losartan at least once and had pre- and post-urinary protein to creatinine ratio measurements (n=28). The per-protocol analysis group included 22 patients who completed all scheduled visits without any serious violations during the study period. In both groups, the mean log (urine protein to creatinine ratio) value decreased significantly at 6 months. After 24 weeks, the urinary protein to creatinine ratio decreased by more than 50% in approximately 40% of the patients. The glomerular filtration rate was not significantly altered during the observation period. Conclusions: Losartan decreased proteinuria without decreasing kidney function in patients with IgA nephropathy over 24 weeks. Losartan could be safely employed to reduce proteinuria in this patient population. ClinicalTrials.gov trial registration (NCT0223277)

Birth and Infant Death Reporting System via Computer Network (출생 및 영아사망 신고체계 및 전산정보체계 개발)

  • Park, Jung-Han;Lee, Young-Sook;Rhee, Jung-Ae;Cho, Hyun;Chung, Young-Hae;Park, Soon-Woo;Jun, Hae-Ri
    • Health Policy and Management
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    • v.8 no.2
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    • pp.125-148
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    • 1998
  • Accurate vital statistics are essential for a national health planning and evaluation. Among various vital statistics, birth and death rates, and infant and matemal mortality rates together with the causes of death are the very basic ones for above purposes as well as for the maternal and child health management. These statistics are based on the birth and death reports. It is required by law to report every birth and death within one month after its occurrence. However, in case of a neonatal death occurring prior to the birth report, most of the birth and death are not reported. Thus accurate infant and maternal mortality rates are not available yet in Korea. The main objective of this study is to develop a birth and infant death reporting system via computer network. We designed a new birth report form based on the current form and data from the analysis of medical record forms of 14 hospitals. A new form is basically addition of essential medical information to the current birth report form. Since a revision of the rules and regulations related wtih the birth report is necessary to use a new form, we kept the current from intact to make it acceptable to the government office for a field trial. We also developed computer programs for data input for birth and death reports at a medical faciltiy, data processing for production of maternal and child health indices at a health center, and management of maternal and child health services including immunization and postantal care at health center. The birth certificate and birth report can be printed out at a medical facility. The computer packages were programmed by Borland Delphi 3.0 and can be run under Windows 95 system. We proposed a new birth and death reporting system via computer network after a field trial for data input, transmission, and processing. The medical and demographic data o birth and death at medical facilities will be sent to health centers directly via computer network. The health center will retain the medical data for analysis and forward only the data for birth and death reports required by current regulations to the Dong, Up, or Myun Office. Once the birth or death is reported via computer network to the Dong Office, then the Dong Office will notify the baby's mother of the birth report and request to submit the baby's name by mail. When the baby's name its submitted. the Dong Office will forward the birth reports to the Common Court and Statistics Agency in the same way as the current system, Upon the completion of birth registration of the Common Court, the court will issue the birth certificate to mother which will be used in lieu of the family record. The advantages of proposed birth and death reporting system via computer network ar as follows ; I) The accuracy, timing, and completeness of reporting will be improved and more accurate maternal and child health indices can be obtained, ii) The maternal and child health services of health center will be obtained, iii) Epidemiologic data for pregnancy and birth can be obtained, iv) Manpower for birth and death reporting will be saved.

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Status of the Constitutional Court Records Management and Improvement (헌법재판소 기록관리현황과 개선방안)

  • Lee, Cheol-Hwan;Lee, Young-Hak
    • The Korean Journal of Archival Studies
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    • no.38
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    • pp.75-124
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    • 2013
  • This study aims, by paying attention to the special values of records of Constitutional Court, to discuss the characteristics of them and figuring out their present state, and to suggest some measures for improvement in the records management. First of all, I defined the concept of the records of Constitutional Court and its scope, and made an effort to comprehend their types and distinct features, and on the basis of which I tried to grasp the characteristics of the records. Put simply, the records of Constitutional Court are essential records indispensible to the application of Constitutional Court's documentation strategy of them, and they are valuable particularly at the level of the taking-root of democracy and the guarantee of human rights in a country. Owing to their characteristics of handling nationally important events, also, the context of the records is far-reaching to the records of other constitutional institutions and administrations, etc. In the second place, I analyzed Records Management Present State. At a division stage, I grasped the present state of creation, registration, and classification system of records. At an archives repository stage, I made efforts to figure out specifically the perseveration of records and the present of state of using them. On the basis of such figuring-outs of the present situation of records of Constitutional Court, I pointed at problems in how to manage them and suggested some measures to improve it in accordance with the problems, by dividing its process into four, Infrastructure, Process, Opening to the public and Application. In the infrastructure process, after revealing problems in its system, facilities, and human power, I presented some ways to improve it. In terms of its process, by focusing on classification and appraisal, I pointed out problems in them and suggested alternatives. In classification, I suggested to change the classification structure of trial records; in appraisal, I insisted on reconsidering the method of appropriating the retention periods of administration records, for it is not correspondent with reality in which, even in an file of a event, there are several different retention periods so it is likely for the context of the event worryingly to be segmented. In opening to the public and application, I pointed at problems in information disclosure at first, and made a suggestion of the establishment of a wide information disclosure law applicable to all sort of records. In application, I contended the expansion of the possibility of application of records and the scope of them through cooperation with other related-institutions.