• Title/Summary/Keyword: Clinical trial center

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The Current Status of Utilization of Palliative Care Units in Korea: 6 Month Results of 2009 Korean Terminal Cancer Patient Information System (말기암환자 정보시스템을 이용한 우리나라 암환자 완화의료기관의 이용현황)

  • Shin, Dong-Wook;Choi, Jin-Young;Nam, Byung-Ho;Seo, Won-Seok;Kim, Hyo-Young;Hwang, Eun-Joo;Kang, Jina;Kim, So-Hee;Kim, Yang-Hyuck;Park, Eun-Cheol
    • Journal of Hospice and Palliative Care
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    • v.13 no.3
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    • pp.181-189
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    • 2010
  • Purpose: Recently, health policy making is increasingly based on evidence. Therefore, Korean Terminal Cancer Patient Information System (KTCPIS) was developed to meet such need. We aimed to report its developmental process and statistics from 6 months data. Methods: Items for KTCPIS were developed through the consultation with practitioners. E-Velos web-based clinical trial management system was used as a technical platform. Data were collected for patients who were registered to 34 inpatient palliative care services, designated by Ministry of Health, Welfare, and Family Affairs, from $1^{st}$ of January to $30^{th}$ of June in 2009. Descriptive statistics were used for the analysis. Results: From the nationally representative set of 2,940 patients, we obtained the following results. Mean age was $64.8{\pm}12.9$ years, and 56.6% were male. Lung cancer (18.0%) was most common diagnosis. Only 50.3% of patients received the confirmation of terminal diagnosis by two or more physicians, and 69.7% had an insight of terminal diagnosis at the time of admission. About half of patients were admitted to the units on their own without any formal referral. Average and worst pain scores were significantly reduced after 1 week when compared to those at the time of admission. 73.4% faced death in the units, and home-discharge comprised only 13.3%. Mean length of stay per admission was $20.2{\pm}21.2$ days, with median value of 13. Conclusion: Nationally representative data on the characteristics of patients and their caregiver, and current practice of service delivery in palliative care units were obtained through the operation of KTCPIS.

Safety and Efficacy of the Mandibular Advancement Device 'Bioguard' for the Treatment of Obstructive Sleep Apnea : A Prospective, Multi-Center, Single Group, and Non-Inferiority Trial (폐쇄성 수면무호흡증의 치료에 사용되는 하악전방이동장치-'바이오가드'의 안전성과 유효성 검증을 위한 전향적, 다기관, 단일군 및 비열등성 연구)

  • Kim, Hyoung Wook;Hwang, Chungpoong;Eun, Hun Jeong
    • Sleep Medicine and Psychophysiology
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    • v.23 no.2
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    • pp.84-92
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    • 2016
  • Objectives: The purpose of this study was to estimate the safety and efficacy of a mandibular advancement device (MAD), 'Bioguard,' for the treatment of obstructive sleep apnea (OSA). Methods: In this 5-week prospective, multi-center, single group, and non-inferiority trial, patients who chose 'Bioguard' as their treatment option were evaluated using both questionnaires (Pittsburgh Sleep Quality Index (PSQI), Epworth sleepiness scale (ESS)) and polysomonography (PSG) (apnea hypopnea index (AHI), oxygen saturation). All patient data, including clinical records, PSG studies (both pre- and post-treatment), and adverse events (AEs), were reviewed and analyzed. Results: Results were obtained for 59 of 62 patients (95.16%). No significant difference in success rate was found between the MAD treatment and surgical treatment (95% CI). AHI, PSQI, ESS and oxygen saturation demonstrated significant improvement (p < 0.001) after MAD treatment, and 39 of 62 patients (62.9%) reported 85 AEs. 79 of the 85 AEs (91.8%) were mild cases, and there were no severe AEs related to the MAD treatment. Conclusion: The MAD 'Bioguard' should be considered as an alternative treatment option for OSA patients.

The Effectiveness of Moxibustion Treatment for Primary Dysmenorrhea: A Systematic Review and Meta-Analysis (원발성 월경곤란증의 뜸 치료에 대한 체계적 문헌고찰 및 메타분석)

  • Lee, Hye-In;Baek, Seon-Eun;Lee, Ho-Jung;Park, Kyoung-Sun;Lee, Jin-Moo;Yoo, Jeong-Eun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.30 no.2
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    • pp.107-119
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    • 2017
  • Objectives: The purpose of this study is to investigate the effectiveness of moxibustion for primary dysmenorrhea (PD). Methods: We searched 10 electronic databases (CNKI, WANFANG, VIP, AMED, CiNii, Embase, PubMed, Cochrane, OASIS, Korea Traditional Knowledge Portal) to identify eligible studies published before November 2016. We included randomized controlled clinical trials (RCTs) using moxibustion for primary dysmenorrhea. The methodological quality of each RCT was assessed by the Cochrane risk of bias tool. Results: Ten RCT studies were eligible in our review. The overall risk of bias was evaluated as unclear. The meta-analysis of 4 trials indicated that favorable results for the use of moxibustion. Conclusions: This systematic review and meta-analysis of clinical trials suggests that moxibustion can achieve good efficacy for PD patients. However, because of studies included analysis was biased due to unclear risk of bias and unreliable study design, future high-quality RCT studies are needed to determine the association moxibustion with PD.

A Clinical Study to Assess the Safety of GyoGam-Dan (교감단의 안정성과 임상적 적용에 대한 연구)

  • Kang, Hyung-Won;Kim, Ji-Hwon;Kim, Jin-Heong;Lee, Chung-Sik;Lee, Sang-Eon;Kim, Tae-Heon;Kim, Tae-Heon
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.3
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    • pp.195-203
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    • 2008
  • Objective: 'GyoGam-Dan' is known as a medicine to cure depression in Donguibogam (traditional Korean oriental medicine book). GyoGam-dan which is composed of Cyperi Rhizoma L. and Poria cum Radix pini has been used by basic prescription of asymptom related to all kinds of Qi(氣) disease. Although it has been clinically used for a long time, its safety have never been proved till now. Methods: We had collected data of 610 cases of patients taking 'GyoGam-Dan' at Wonkwang univ. oriental medical center for a period of three years (2005.3.09-2008.04.30). On the patients' blood, the levels of LFT and RFT were examined and the residual levels of heavy metals and pesticides were measured. Results: There were 610 patients who had taken GyoGam-Dan for about three years. In the patients, the most common diseases is depression, followed by palpitation, and then insomnia. Among the patients' estimations on its effectiveness, there were many of positive ones. The blood analyses of patients who had taken GyoGam-Dan did not show any problems and moreover there was not any problems in the levels of residual heavy metals and agricultural pesticides. Taken together, GyoGam-Dan was proved to be a safe medicine for health. Conclusions: Our clinical and chemical studies show that GyoGam-dan has the anti-stress effect and is a safe medicine of which side effect does not exist. Hereafter, Nigorous clinical trial on GyoGam-dan is required.

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Preliminary Study to Develop the Instrument on Pattern Identifications for Insomnia (불면증 변증도구 개발을 위한 기초 연구)

  • Lee, Hun-Soo;Kim, Hwan;Yun, Yong-Gi;Lee, Sujin;Jeon, Ju-Hyun;Kim, Bo-Kyung;Lee, Eun Jung;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.27 no.4
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    • pp.223-234
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    • 2016
  • Objectives: This study was carried out to develop a standard tool of pattern identifications for insomnia in Korean Medicine. Methods: The advisory committee for this study was organized by 17 Korean Medicine neuropsychiatry professors who were faculty members of different Korean Medicine colleges. The pattern identifications and symptoms for this tool were extracted from published Korean and Chinese literature. The Instrument on Pattern Identifications for Insomnia was developed following discussions among internal experts and after consultations with members of the advisory committee. Results: 1) Five pattern identifications were set for the tool. 2) The mean weights which represent the importance of each symptom and scored on a hundred-point scale were obtained. 3) The Instrument on Pattern Identifications for insomnia was designed in the self-reporting format composed of 47 questions. Conclusions: An Instrument on Pattern Identifications for Insomnia was created in this study. However, owing to any clinical trials has not been set yet. Therefore its validity and reliability were not confirmed. To make up for this limitation, the further clinical study would be performed in the near future.

Pulmonary stenosis and pulmonary regurgitation: both ends of the spectrum in residual hemodynamic impairment after tetralogy of Fallot repair

  • Yoo, Byung Won;Park, Han Ki
    • Clinical and Experimental Pediatrics
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    • v.56 no.6
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    • pp.235-241
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    • 2013
  • Repair of tetralogy of Fallot (TOF) has shown excellent outcomes. However it leaves varying degrees of residual hemodynamic impairment, with severe pulmonary stenosis (PS) and free pulmonary regurgitation (PR) at both ends of the spectrum. Since the 1980s, studies evaluating late outcomes after TOF repair revealed the adverse impacts of residual chronic PR on RV volume and function; thus, a turnaround of operational strategies has occurred from aggressive RV outflow tract (RVOT) reconstruction for complete relief of RVOT obstruction to conservative RVOT reconstruction for limiting PR. This transformation has raised the question of how much residual PS after conservative RVOT reconstruction is acceptable. Besides, as pulmonary valve replacement (PVR) increases in patients with RV deterioration from residual PR, there is concern regarding when it should be performed. Regarding residual PS, several studies revealed that PS in addition to PR was associated with less PR and a small RV volume. This suggests that PS combined with PR makes RV diastolic property to protect against dilatation through RV hypertrophy and supports conservative RVOT enlargement despite residual PS. Also, several studies have revealed the pre-PVR threshold of RV parameters for the normalization of RV volume and function after PVR, and based on these results, the indications for PVR have been revised. Although there is no established strategy, better understanding of RV mechanics, development of new surgical and interventional techniques, and evidence for the effect of PVR on RV reverse remodeling and its late outcome will aid us to optimize the management of TOF.

A Systematic Review from the Journals of the Korean Oriental Medical Society. (대한한의학회지 및 대한한의학회 산하 정회원 학회의 학술진흥재단 등재지에 대한 천식 임상연구의 체계적 고찰)

  • Choi, Jun-Yong;Bang, Ji-Hyung;Shen, Feng-Yan;Jung, Hee-Jae;Jung, Sung-Ki
    • The Journal of Korean Medicine
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    • v.31 no.1
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    • pp.14-22
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    • 2010
  • Objectives: This study aimed to evaluate any clinical research regarding asthma published by the Korean Oriental Medical Society and its sub-societies for future rigorous clinical research. Methods: Every article relevant to asthma was initially obtained from journals in the Korean Oriental Medical Society and its sub-societies by electronic search at journal web sites or manual search. Journals were limited to those registered by the Korea Research Foundation. From initial findings, two independent reviewers selected clinical articles and these articles were further analyzed separately into predefined criteria according to prospective and retrospective studies. For prospective studies, quality assessment was also conducted. Results: From 99 articles initially obtained, 19 were finally analyzed. 14 were prospective whereas 5 were retrospective. Among the prospective articles, there were no randomized controlled trials and the non-randomized studies had no control groups, with several problems of quality regarding pre-calculated study size and unbiased assessment. None of the retrospective studies described asthma diagnosis objectively and outcome measures were either non-relevant to asthma or non-validated. Conclusions: Well-designed randomized controlled studies for asthma are needed and more rigorous non-randomized controlled studies should be conducted.

A clinical study for effect of a supplement(Bee Larva) in subjects with tinnitus (벌유충 분말 서플리먼트의 이명에 대한 임상적 연구)

  • Kang, Da-Hae;O, Min-Ji;Kim, Hee-Taek
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.25 no.2
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    • pp.20-37
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    • 2012
  • Objectives : The primary purpose of present study is to evaluate the effect of a supplement of Bee Larva on tinnitus. the second is to comparatively evaluate safety of this supplement. Methods : Among those patients who visited Semyung Oriental Medical Center from January 11st, 2010 to February 20th, 2010, we screened 45 patients considered suitable for this study after some examinations and consent of the patients. they were devided into 2 groups. Group A took 5 tablets of this supplement everyday for 4 weeks, group B, placebo, in the same way. for 4 weeks, we checked changes in intensity, duration, extent of tinnitus on daily life and sleep and THI(Tinnitus Handicap Inventory) score. to evaluate safety of this supplement, adverse events, assessment of vital sign, hematologic examination were recorded. Result : Through 4 weeks of the clinical trial, we found that this supplement is effective on tinnitus and it improves intensity, duration and extent (its influence on daily life) of tinnitus, influence of tinnitus on sleep and THI score more effectively than the placebo drug. Also, in the assessment of the safety of the study the supplement of bee Larva and placebo drug, there were no adverse events and side effects over the average which need treatment for it. Moreover, there were not any abnormal findings in change of blood pressure and hematologic examination. Conclusion : According to this experiment, we confirmed that the supplement of bee Larva can be used effectively and safely on tinnitus.

The Comorbidity of Anxiety Disorder in Depressed Patients : A CRESCEND(Clinical Research Center for Depression in Korea) Cohort Study (우울증 환자에서 불안장애의 동반이환 : 우울증 임상연구센터 코호트연구)

  • Sakong, Jeong-Kyu;Lee, Do-Yun;Suh, Ho-Suk;Sung, Hyung-Mo;Kim, Jung-Bum;Jung, Young-Eun;Lee, Min-Soo;Kim, Jae-Min;Jo, Sunjin
    • Mood & Emotion
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    • v.9 no.1
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    • pp.30-36
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    • 2011
  • Purpose : Anxiety disorder and depressive disorder are often comorbid with each other, and the comorbidity is associated with poorer psychiatric outcome, resistance to treatment, increased risk for suicide, greater chance for recurrence. We aimed to investigate the comorbidity of anxiety disorder in Korea. Method : Subjects were total of 867 depressed patients recruited CRESCEND-K multicenter trial. We used SCID (Structured Clinical Interview for DSM - IV) to find comorbidity of anxiety disorders in depressed patient. Results : Of 867 patients, total 8.2% had anxiety disorder. Proportion of anxiety disorder Not Otherwise Specified was 3.5%, panic disorder was 1.7%, generalized anxiety disorder was 1.1%, post traumatic stress disorder was 0.9%, obsessive compulsive disorder was 0.6%, social phobia was 0.4%. Conclusion : In this study, anxiety disorder in depression were measured at a low comorbidity rate in compare to previous studies. Selection bias, use of antidepressants at registration, severity of depression symptoms, and point of SICD administration seems to have affected these results. It is probable that comorbidity evaluation would be more precise if shorter, structured interviews such as M. I.N.I.-Plus were used during first clinical interview for depression diagnosis.

Clinical Study for Visual Application of Circle Pattern with 3G Color on Attention Deficit/Hyperactivity Disorder Patients (주의력결핍-과잉행동장애 (ADHD) 환아에 대한 집중력 개선과 심리적 안정을 위한 3G 색과 원문양의 시각적 활용의 효과 연구)

  • Choi, Hyeon;Kim, Jeong-Sin;Lee, Eun-Hye
    • The Journal of Korean Medicine
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    • v.31 no.1
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    • pp.47-56
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    • 2010
  • Objective: Many drug or non-drug therapies are reported to be effective in reducing the severity of attention deficit/hyperactivity disorder (ADHD). The aim of this study was to assess the effect of color and pattern on the severity of ADHD in young ADHD patients. Method: We randomly assigned 30 children into two groups and had them participate in 15-minute block play sessions once in a week. The experimental group used blocks with green (3G, Munsell color system) circle patterns on them, while the control group played with plain white blocks. We also provided a set of playing cards with the corresponding patterns. This trial continued for 4 weeks and 29 children (96.7%) completed. The primary outcome measurement was the ADHD rating scale-IV and was evaluated on every visit. Results: After the trial, ADHD score decreased in both groups but not significantly ($34.4{\pm}8.0$ to $30.0{\pm}4.3$; $34.0{\pm}6.0$ to $30.3{\pm}3.2$). However, there were significant differences in 4 items of ADHD rating scale between the two groups. These consisted of 3 inattention (Q3, Q7, Q15) and 1 hyperactivity-impulsivity (Q12) items and the reduction between the first and final visits was significant (p=0.0240, p=0.0498, p=0.0237 and p=0.0012 respectively). Conclusion: Repeated exposure to a green circle pattern might not influence the total score of ADHD rating scale but reduced 3 inattention items and 1 hyperactivity-impulsivity significantly in children with ADHD. Proper visual stimuli are partially helpful for pediatric ADHD.