• Title/Summary/Keyword: International registry

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The Current State of Registration of Interventional Clinical Trials for Children and Adolescents with Precocious Puberty (성조숙증 소아 대상 중재 임상시험의 등록 현황 보고 -Clinicaltrial.gov, WHO ICTPR, CRIS를 중심으로-)

  • Shim, Soo Bo;Seo, Hyun Sik;Lee, Hyun Hee;Lee, Hye Lim
    • The Journal of Pediatrics of Korean Medicine
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    • v.36 no.3
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    • pp.1-18
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    • 2022
  • Objectives The purpose of this study was to investigate the current status of interventional clinical trial registration for children with precocious puberty and to secure basic data for the design of clinical trials for traditional Korean medicine treatment of precocious puberty. Methods The following resources were used to search for data: Clinicaltrial.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), and Clinical Research Information Service (CRIS), using the search terms, 'Precocious puberty', 'child'. All clinical trials which were registered as of June 2022 were used. Results For the intervention and clinical trial design, gonadotropin releasing hormone (GnRH) analog was reported in 41.7% of trials, and single group assignment was performed in 66.7% of the studies. Prior consent had not been reported in 50% of the studies. Tanner stage and GnRH stimulation tests were reported by multiple trials as inclusion criteria, and prior treatment experiences for trial drugs were reported as exclusion criteria. The peak serum concentration of luteinizing hormone following GnRH stimulation test was used as a primary outcome in 45.8% of clinical trials, and other growth-related indicators such as growth rate, height, and predicted adult height were also reported. Conclusions In consideration of the design, eligibility criteria, and outcome measurement of the existing clinical trials identified in this study, it should be referred to in the design of clinical trials for traditional Korean medicine treatment of precocious puberty.

Analysis of Registration Information of Randomized Controlled Clinical Trials on Suicide Attempters Based on WHO-ICTRP (자살시도자에 대한 무작위대조군연구의 등록 현황 분석: WHO-ICTRP를 중심으로)

  • Min-Ryeong Park;Ji-Won Lee;In-Jun Hwang;Chan-Young Kwon
    • Journal of Oriental Neuropsychiatry
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    • v.34 no.3
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    • pp.213-234
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    • 2023
  • Objectives: To investigate current status of randomized controlled clinical trial (RCT) registration for suicide attempters. Methods: The World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) was used to search for data using 'suicide' as a search term. All registration information of RCTs registered up to April 2023 were collected. Results: Among a total of 68 RCTs registered, the United States ranked the highest in terms of quantity in this field (n=30, 46.15%), whereas Asia had only six (8.82%). A total of 62 (91.18%) RCTs involved individual interventions, while nine (13.24%) RCTs involved group interventions. Among individual interventions, 11 (16.18%) and 54 (79.41%) RCTs were on pharmacotherapy and psychotherapy, respectively. Within psychotherapy, there were a total of 17 (25%) studies utilizing digital media, with cognitive behavioral therapy (CBT) via phone being the most common approach. Among non-digital media-based studies, CBT was used the most frequently (n=11, 16.18%), followed by attempted suicide short intervention program (n=6, 8.82%). There were no studies using interventions from East Asian traditional medicine, including Korean medicine (KM). The most frequently used main outcome was the Beck scale for suicidal ideation. Conclusions: Studies on suicide attempts in Asia, especially in South Korea, are very scarce. Despite vigorous psychotherapeutic research in this field, KM psychotherapy has not been used. Thus, KM clinical trial for suicide attempters might be planned in the future based on our findings.

The Analysis of Registration Status of Interventional Clinical Trials for Children and Adolescents with Tension-Type Headache - Focused on WHO ICTRP - (소아 청소년 긴장성 두통 대상 중재 임상시험의 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Choi Seo Yeon;Jeong Yoon Kyoung;Han Ju Hui;Bang Miran;Lee Sun Haeng;Chang Gyu Tae;Lee Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.3
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    • pp.13-28
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    • 2024
  • Objectives This study aimed to analyze registrations in the World Health Organization International Clinical Trials Registry Platform for children and adolescents with tension-type headaches. Methods We collected and analyzed information on the basic and clinical characteristics of patients who participated in related clinical trials. All relevant clinical trials registered on or before July 2, 2024 were included in this study. Results Twenty clinical trials were selected for the analysis. Behavioral therapy was the most common intervention (60%), followed by drug, device, and manual therapies. The type of headache was the most frequently mentioned inclusion criteria, noted in 70% of the patients. Outcome indicators included headache frequency and intensity, quality of life, daily functioning, and mood. Conclusions Further clinical trials should require informed consent, an appropriate research design, suitable controls, and clear presentation of diagnostic criteria for more accurate and ethical studies.

The Significance of Registration Convention and its Future Challenges in Space Law (등록협약의 우주법상 의의와 미래과제에 관한 연구)

  • Kim, Han-Taek
    • The Korean Journal of Air & Space Law and Policy
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    • v.35 no.2
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    • pp.375-402
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    • 2020
  • The adoption and entering into force of the Registration Convention was another achievement in expanding and strengthening the corpus iuris spatialis. It was the fourth treaty negotiated by the member states of the UNCOPUOS and it elaborates further Articles 5 and 8 of the Outer Space Treaty(OST). The Registration Convention also complements and strengthens the Article 11 of the OST, which stipulates an obligation of state parties to inform the UN Secretary-General of the nature, conduct, locations, and results of their space activities in order to promote international cooperation. The prevailing purposes of the Registration Convention is the clarification of "jurisdiction and control" as a comprehensive concept mentioned in Article 5 8 of the OST. In addition to its overriding objective, the Registration Convention also contributes to the promotion and the exploration and use of outer space for peaceful purposes. Establishing and maintaining a public register reduces the possibility of the existence of unidentified space objects and thereby lowers the risk such as, for example, putting the weapons of mass destruction secretly into orbit. And furthermore it could serve for a better space traffic management. The Registration Convention is a treaty established to implement Article 5 of OST for the rescue and return of astronaut in more detail. In this respect, if OST is a general law, the Registration Convention would be said to be in a special law. If two laws conflict the principle of lex specialis will be applied. Countries that have not joined the Registration Convention will have to follow the rules concerning the registration of paragraph 7 of the Declaration by the United Nations General Assembly resolution 1721 (X V I) in 1961. UN Resolution 1721 (XVI) is essentially non-binding, but appears to have evolved into the norm of customary international law requiring all States launching space objects into orbit or beyond to promptly provide information about their launchings for registration to the United Nations. However, the nature and scope of the information to be supplied is left to the discretion of the notifying State. The Registration Convention is a treaty created for compulsory registration of space objects by nations, but in reality it is a treaty that does not deviate from existing practice because it is based on voluntary registration. With the situation of dealing with new problems due to the commercialization and privatization of the space market, issues related to the definition of a 'space object', including matter of the registry state of new state that purchased space objects and space debris matter caused by the suspension of space objects launched by the registry state should be considered as matters when amendments, additional protocols or new Registration Convention are established. Also the question of registration of a flight vehicle in the commercial space market using a space vehicle traveling in a sub-orbital in a short time should be considered.

International Liability for Damage Caused by Space Debris (우주잔해 손해에 대한 국제책임)

  • Kim, Dong-Uk
    • The Korean Journal of Air & Space Law and Policy
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    • v.23 no.2
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    • pp.173-205
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    • 2008
  • Space debris have frequently caused damage to space objects like satellites in orbits and sometimes have fallen on the earth. Such increase in space debris will lead to the high possibility of threatening space activities of mankind. However, it is not so easy for the damage caused both by identified and by unidentified space debris to be recovered since in the regime of the current international law, there is no legislation of prescribing the damage done by space debris. For overcoming the limitation it seems desirable that either the Liability Convention should partly be amended or new international law regime should be established. For instance, 'space debris' should be included in the new definition of 'space object' and the range of launching should also be defined clearly by making the concept of 'launching' somewhat more specified. Moreover, the subject of international liability for damage caused by space debris should be divided into two classes: the subject before and after registration. While in case of before-registration launch states should be held liable for any damage jointly or individually, in case of after-registration 'the state of registry' or 'owner' of the space debris should be. In the event of damage being caused elsewhere than on the surface of the earth to a space object of other State, 'fault-based liability' is currently applied. But it needs to be changed into 'absolutely liability'. In this paper, 'Liability Pool', 'Insurance', 'Market-Share Liability' are presented as aid devices of the damages resulting from unidentified space debris. They should be defined through the amendment of the Liability Convention or another international treaty. Some day there comes a time when our country shall possess many of the astronomical price of satellites. It means that we can't be free from the damage by the increasing number of space debris. Provided that our satellites are damaged by such space debris, it will do the satellites damage and cause impaired functioning or troubles in operation. As a result, if we are not paid for the damage by space debris, we will be confronted with tremendous economic loss because it is necessarily connected with the excess burden of taxation. Thus, an international agreement regarding the measures of the compensation for space debris damage must be made very soon.

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Patterns of Esophageal Cancer in the National Cancer Institute at the University of Gezira, in Gezira State, Sudan, in 1999-2012

  • Gasmelseed, Nagla;Abudris, Daffalla;Elhaj, Ahmed;Eltayeb, Elgaylani A;Elmadani, Ahmed;Elhassan, Moawia M;Mohammed, Khadiga;Elgaili, Elgaili M;Elbalal, Moawia;Schuz, Joachim;Leon, Maria E
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.15
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    • pp.6481-6490
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    • 2015
  • Background: Esophageal cancer (EC) is among the most common malignancies in Eastern Africa, but the occurrence of EC in Sudan has rarely been described in the scientific literature. This paper reports the results of a consecutive case series of all EC patients who visited one of the two public cancer treatment centers in the country in 1999-2012, providing a first description of this disease in a treatment center located in central Sudan. Materials and Methods: Clinical and demographic data for all EC patients who visited the Department of Oncology of the National Cancer Institute at the University of Gezira (NCI-UG) from 1999 to the end of 2012 were abstracted and tabulated by sex, tumor type and other characteristics. Results: A total of 448 EC patients visited NCI-UG in 1999-2012, and the annual number of EC cases increased steadily from 1999. Squamous cell carcinoma (SCC) was the predominant EC tumor type (90%), and adenocarcinoma (ADC) was reported in 9.4% of the EC cases. The overall male-to-female ratio for EC was 1:1.8, but the ratio was tumor type-dependent, being 1:2 for SCC and 2:1 for ADC. Only 20% of EC patients reported having ever used tobacco and/or alcohol, and the vast majority of these patients were male. At the time of EC diagnosis, 47.3% of the patients resided in Gezira State. Some EC patients from Gezira State seek out-of-state treatment in the national capital of Khartoum instead of visiting NCI-UG. Conclusions: The annual number of EC patients visiting NCI-UG has increased in recent years, approximately half of these patients being from Gezira State. Although this consecutive series of EC patients who visited NCI-UG was complete, it did not capture all EC patients from the state. A populationbased cancer registry would provide more complete data required to better understand EC patterns and risk factors.

Clinical Significance of Restless Legs Syndrome in Patients with Late Life Depression (노년기 우울증 환자의 하지불안증후군의 임상적 중요성)

  • Song, Jae Min;Park, Joon Hyuk;Kang, Ji Eon;Lee, Chang In
    • Korean Journal of Biological Psychiatry
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    • v.21 no.3
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    • pp.107-113
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    • 2014
  • Objectives Restless legs syndrome (RLS) is a sleep disorder characterized by uncomfortable and unpleasant sensations in the legs and an urge to move the legs, usually at night. The aim of this study is to investigate the incidence of RLS in patients with late life depression and its influence on various clinical outcomes such as severity of depression, sleep quality, cognitive function, and quality of life and accordingly, to elucidate the clinical significance of RLS in patients with late life depression (LLD). Methods This study enlisted 170 depressive patients aged 65 years or older from an outpatient clinic. Structured diagnostic interviews were performed using the Korean version of the Mini-International Neuropsychiatric Interview. All patients completed the questionnaires, including the International RLS Severity Scale, the Korean version of Short-Form 36-Item Health Survey (SF-36), and the Pittsburgh Sleep Quality Index (PSQI). The severity of depression was evaluated by the Korean form of the Geriatric Depression Scale (KGDS) and the level of global cognition was assessed by the Mini-Mental State Examination in the Korean version of The Consortium to Establish a Registry for Alzheimer's Disease Assessment Packet (MMSE-KC). Results The incidence of RLS was 17.6% in LLD patients. RLS was more prevalent among the subjects with major depressive disorder (MDD) than those with minor depressive disorder or subsyndromal depressive disorder. The RLS group showed higher score in the KGDS than the Non-RLS group but the difference did not reach the statistical significance (p = 0.095, Student t-test). The mean PSQI score was significantly higher in the RLS group than in the Non-RLS group (p = 0.001, Student t-test). The MMSE-KC score was also lower in the RLS group than in Non-RLS group (p = 0.009, analysis of covariance). But, there was no difference in the score of SF-36 between the RLS group and the Non-RLS group. Conclusions RLS is common in LLD patients, especially in the patients with MDD and is associated with poor sleep quality and cognitive dysfunction, indicating that RLS is clinically significant in patients with LLD. Therefore, RLS should be considered as an important clinical issue in the management of LLD.

Clinical Characteristics of Haenyeo with Depressive Disorders (해녀 우울장애 환자의 임상적 특징)

  • Park, Joon Hyuk;Jun, Byoung Sun;Lee, Chang In;Kim, Moon-Doo;Jeong, Ji Woon;Jung, Young-Eun
    • Korean Journal of Biological Psychiatry
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    • v.23 no.2
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    • pp.63-68
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    • 2016
  • Objectives Haenyeo are Korean professional women breath-hold divers in Jeju island. The aim of this study was to investigate the clinical characteristics of depressed Haenyeo group, compared to non-Haenyeo depressed group. Methods This study included 75 Haenyeo and 340 non-Haenyeo with depressive disorders recruited from the Dementia Early Detection Program in Jeju island. Structural diagnostic interviews were performed using the Korean version of Mini International Neuropsychiatric Interview. All patients completed the questionnaires, including the Subjective Memory Complaints Questionnaire (SMCQ), the Patient Health Questionnaire-15 (PHQ-15), and the Blessed dementia scale. Depression was evaluated by the Korean version of short form the Geriatric Depression Scale (K-SGDS) and cognition was assessed by the Korean version of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) assessment packet. Results Although the mean scores of the K-SGDS were similar between Haenyeo and non-Haenyeo depressed groups, the Haenyeo group showed a higher mean score on the PSQ-15 (p < 0.001, ANCOVA adjusting for age, the K-SGDS and education). The Haenyeo group showed poorer performance on the Korean Version of Frontal Assessment Batter (p < 0.001), the Mini-Mental State Examination in the Korean version of the CERAD Assessment Packet (p < 0.018), the word fluency test (p < 0.001), and the word list memory test (p = 0.012) in ANCOVA adjusting for age and education. The mean SMCQ score was higher in the Haenyeo depressed group than in the non-Haenyeo depressed group. Conclusions The Haenyeo depressed group shows cognitive dysfunction, especially frontal lobe dysfunction, compared to the non-Haenyeo depressed group, indicating the Haenyeo depressed group may have more severe frontolimbic dysfunction due to chronic exposure to hypoxia. The Haenyeo depressed group suffers more somatic symptoms than the non-Haenyeo depressed group.

A Study of Acute Stroke Patients (hospitalized at the oriental internal disease ward of Kyungwon University In-cheon Oriental Medical Hospital) according to the TOAST Classification (Trial of Org 10172 in Acute Stroke Treatment) (TOAST 분류에 의한 급성기 중풍(뇌중풍) 입원 환자 분석 (경원인천한방병원))

  • Jung, Ki-Yong;Go, Ho-Yeon;Jeong, Seung-Min;Hsia, Yu-Chun;Jung, Hee;Choi, You-Kyung;Kim, Dong-Woo;Han, Chang-Ho;Cho, Ki-Ho;Park, Jong-Hyung;Jun, Chan-Yong
    • The Journal of Internal Korean Medicine
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    • v.27 no.4
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    • pp.905-914
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    • 2006
  • Background and Purpose : The purpose of this study was to classify according to the TOAST classification (Trial of Org 10172 in Acute Stroke Treatment) acute stroke patients (first-ever stroke) treated at the Department of Internal Medicine of Kyungwon University In-cheon Oriental Medical Hospital. Methods : In the time period Oct. 2005 to Oct. 2006. 101 patients with a first-ever stroke admitted to the Department of Internal Medicine of Kyungwon University In-cheon Oriental Medical Hospital were included. Patients were hospitalized within 14 days after the onset of stroke. They had neurological deficits for a time more than 24 hours. We classified patients according to the original TOAST classification (Trial of Org 10172 in Acute Stroke Treatment) Results : The incidence in males was 54.4%, in females was 45.6%. Ischemic stroke (86.l%) was more common than hemorrhagic stroke (13.9%). The results of TOAST classification in this study were as follows: small-vessel occlusion, 72.4% large-artery atherosclerosis. 14.9 % cardioembolism, 4.6% stroke of other determined etiology, 4.6%: stroke of undetermined etiology, 3.5%. Patients in the small-vessel occlusion subgroup in this study were the most frequent. The result of this study is that Korean stroke registry is not in accordance with western medicine. Conclusions : The TOAST classification system is the most widely accepted tool to categorize stroke subtypes in western medicine, but in oriental medicine, it is not yet widely accepted. The authors suggest the general use of the TOAST classification to determine adequate management for stroke patients, to predict the prognosis and recurrence of stroke and to develop a Korean standard of stroke in oriental medicine.

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The Effects of Tacrolimus versus Cyclosporine on Acute Graft Rejection Episode and Acute Renal Dysfunction Following Pancreas Transplantation (췌장이식환자에서 Tacrolimus와 Cyclosporine이 급성거부반응과 신장장애에 미치는 영향)

  • Oh, Jung Mi;Klassen, David
    • Korean Journal of Clinical Pharmacy
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    • v.9 no.2
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    • pp.81-87
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    • 1999
  • 췌장이식의 성공률은 지난 10년 동안 상당히 상승되었다. International Pancreas Transplant Registry에 따르면 1995년 이래 미국에서만 매년 1,000건 이상의 췌장이식이 실시되고 있다. 장기이식후 나타나는 급성 거부반응은 이식 후 6개월 이내에 가장 높은 빈도수로 나타난다. 췌장이식환자에서는 신장을 이식한 것보다 두배나 높은 거부반응을 나타나며 이로 인한 입원율의 증가 항림프제(antilyinphocyte) 사용과 감염의 증가로 이환율이 높다. 더구나 Cyclosporine (CsA)을 기초로 한 면역억제제요법의 사용은 높은 급성 거부반응률(acute graft rejection)을 초래하여 이식한 장기의 조직손실이 문제가 되고 있다. 새로운 면역억제제인 Tacrolimus (FK506)의 사용은 이식환자에서의 거부반응을 감소시켜 생존율을 증가시키는 것으로 알려져 있다. Tacrolimus는 neutral macrolide로 cyclic peptide인 CsA과는 화학 구조는 매우 다르나 비슷한 면역억제 효과를 보인다. 하지만 Tacrolimus의 사용시 신경독성, 신독성, 특히 고혈당증의 발생률이 높아 일부 이식센터에서는 장기 이식 후에 사용하기를 꺼리기도 한다. 하지만 여러 연구논문에서 간과 신장 이식 후 급성 거부반응 예방에 Tacrolimus는 CsA에 비해 이점이 있는 결과를 발표하였다. 결과적으로, 현재 췌장이식 후 Tacrolimus를 기초로 한 면역억제의 효과에 대한 연구가 활발히 진행중이다. 따라서 본 연구에서는 1994-1996년 사이에 Tacrolimus 또는 CsA를 기초로 한 면역억제요법을 투여 받은 췌장이식환자 101명을 후향적으로 조사하여 Tacrolimus (n=54)와 CsA(n=57)의 급성 거부반응 예방 효과와 신부전 발생률을 비교하였다. 모든 환자는 항림프구 약물, Azathioprine, Prednisone을 이식 후 면역억제제로 투여 받았다 기준선으로부터 $20\%$ 이상의 혈청 creatinine의 상승이 있는 환자에서는 급성 신부전으로 정의하였고 신장생검법으로 거부반응을 진단하였다 Matched-pair analysis에 따르면 췌장이식환자의 6개월 생존율은 CsA군에서 $97\%$, Tacrolimus군에서 $96\%$로 별다른 차이가 없었으며 (p=0.57), 6개월간의 이식한 췌장의 보존율은 CsA군에서는 $88\%, Tacrolimus에서 $91\%$. 유의한 차이는 없었다(p=0.29). 췌장이식 후 6개월 동안 Tacrolimus의 사용은 생검으로 증명되는(biopsy-proven) 급성 거부반응의 발생빈도는 CsA보다 유의하게 낮았을 뿐만 아니라 (p<0.05) 거부반응 증상의 심각도 또한 감소시켰다 (p=0.03). 급성거부반응 발생빈도의 감소로 Tacrolimus군에서 antilymphocyte 치료가 유의하게 줄어들었다(p=0.01). CsA군에서 Tacrolimus보다 신부전의 발생률이 높았으나 통계학적 차이는 없었다. 췌장이식후의 최적의 면역억제요법의 결정하기 위해서는 향후 Tacrolimus와 CsA을 비교하는 전향적 무작위 연구가 필요하다.

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