• 제목/요약/키워드: Clinical trial center

검색결과 704건 처리시간 0.028초

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

  • 이헌수;김환;윤용기;이수진;전주현;김보경;이은정;정인철
    • 동의신경정신과학회지
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    • 제27권4호
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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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    • 제56권6호
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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.

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

  • 최준용;방지현;심봉암;정희재;정승기
    • 대한한의학회지
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    • 제31권1호
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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.

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

  • 강다혜;오민지;김희택
    • 한방안이비인후피부과학회지
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    • 제25권2호
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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.

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

  • 사공정규;이도윤;서호석;성형모;김정범;정영은;이민수;김재민;조선진
    • 우울조울병
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    • 제9권1호
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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.

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

  • 최현;김정신;이은혜
    • 대한한의학회지
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    • 제31권1호
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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.

Evaluation of the alignment efficiency of nickel-titanium and copper-nickel-titanium archwires in patients undergoing orthodontic treatment over a 12-week period: A single-center, randomized controlled clinical trial

  • Aydin, Burcu;Senisik, Neslihan Ebru;Koskan, Ozgur
    • 대한치과교정학회지
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    • 제48권3호
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    • pp.153-162
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    • 2018
  • Objective: The aim of this trial was to compare the alignment efficiency and intermaxillary arch dimension changes of nickel-titanium (NiTi) or copper-nickel-titanium (CuNiTi) round archwires with increasing diameters applied sequentially to the mandibular arch. Methods: The initial alignment phase of fixed orthodontic treatment with NiTi or CuNiTi round archwires was studied in a randomly allocated sample of 66 patients. The NiTi group comprised 26 women, 10 men, and the CuNiTi ($27^{\circ}C$) group comprised 20 women, 10 men. The eligibility criteria were as follows: anterior mandibular crowding of minimum 6 mm according to Little's Irregularity Index (LII), treatment requiring no extraction of premolars, 12 to 18 years of age, permanent dentition, skeletal and dental Class I malocclusion. The main outcome measure was the alignment of the mandibular anterior dentition; the secondary outcome measure was the change in mandibular dental arch dimensions during 12 weeks. Simple randomization (allocation ratio 1:1) was used in this single-blind study. LII and mandibular arch dimensions were measured on three-dimensional digital dental models at 2-week intervals. Results: No statistically significant difference was observed between NiTi and CuNiTi according to LII (p > 0.05). Intercanine and intermolar arch perimeters increased in the CuNiTi group (p < 0.001). Inter-first premolar width showed a statistically significant interaction in week ${\times}$ diameter ${\times}$ application (p < 0.05). Conclusions: The effects of NiTi and CuNiTi round archwires were similar in terms of their alignment efficiency. However, the intercanine and intermolar arch perimeters, and the inter-first premolar width changes differed between groups.

$Doxycycline(Vibramycin^{\circledR})$의 호흡기감염증(呼吸器感染症)에 대(對)한 임상적(臨床的) 효과(效果) (Clinical Evaluation of $Doxycycline(Vibramycin^{\circledR})$ in Respiratory Tract Infection)

  • 임정규;김명석;신상구;윤효인;홍사악
    • 대한약리학회지
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    • 제11권2호
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    • pp.47-53
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    • 1975
  • Pan-Korean multi-center trial of doxycycline in the treatment of upper and lower respiratory infection was carried out in the summer(from May to October) of 1975. A total of 204 patients between the ages of 3 and 75 was treated by 37 physicians including the internal medicine, pediatrics and ENT specialist in 17 general hospitals and 2 private clinics all-over the country. The dosage recommended was 200 mg on the first day of therapy followed by 100 mg daily thereafter. The pediatric dosage was 4 mg/kg on the first day and then 2mg/kg on each successive day. The subjective and objective signs of respiratory infection such as temperature, cough, sputum, pain and associated inflammatory symptoms were assessed using the carefully designed protocols and it showed rapid improvement by the fifth day (80%) of therapy. Only minor side-effects were reported and these were mild and mainly limited to gastrointestinal tract. The overall evaluation of the trial showed that 170 patients(83.3%) had a very good or good result, 13 patients (6.4%) a moderate and another 13 patients (6.4%) a negative result.

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Effects of Korean Red Ginseng on Cognitive and Motor Function: A Double-blind, Randomized, Placebo-controlled Trial

  • Yeo, Hye-Bin;Yoon, Ho-Kyoung;Lee, Heon-Jeong;Kang, Seung-Gul;Jung, Ki-Young;Kim, Leen
    • Journal of Ginseng Research
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    • 제36권2호
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    • pp.190-197
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    • 2012
  • Ginseng has a long history of use for health enhancement, and there is some evidence from animal studies that it has a beneficial effect on cognitive performance. The purpose of this study was to investigate the effect of Korean red ginseng on cognitive performance in humans. A total of 15 healthy young males with no psychiatric or cognitive problems were selected based on an interview with a board-certified psychiatrist. The subjects were randomly assigned to receive a daily dose of 4,500 mg red ginseng or placebo for a 2-week trial. There were 8 subjects in the red ginseng group and 7 subjects in the placebo group. All of the subjects were analyzed with the Vienna test system and a P300 event-related potential (ERP) test. There were no significant differences in the Vienna test system scores between the red ginseng group and the placebo group. In the event-related potential test, the C3 latency of the red ginseng group tended to decrease during the study period (p=0.005). After 2 wk, significant decreases were observed in the P300 latencies at Cz (p=0.008), C3 (p=0.005), C4 (p=0.002), and C mean (p=0.003) in the red ginseng group. Our results suggest that the decreased latency in ERP is associated with improved cognitive function. Further studies with a higher dosage of ginseng, a larger sample size, and a longer follow-up period are necessary to confirm the clinical efficacy of Korean red ginseng.

An R package UnifiedDoseFinding for continuous and ordinal outcomes in Phase I dose-finding trials

  • Pan, Haitao;Mu, Rongji;Hsu, Chia-Wei;Zhou, Shouhao
    • Communications for Statistical Applications and Methods
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    • 제29권4호
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    • pp.421-439
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    • 2022
  • Phase I dose-finding trials are essential in drug development. By finding the maximum tolerated dose (MTD) of a new drug or treatment, a Phase I trial establishes the recommended doses for later-phase testing. The primary toxicity endpoint of interest is often a binary variable, which describes an event of a patient who experiences dose-limiting toxicity. However, there is a growing interest in dose-finding studies regarding non-binary outcomes, defined by either the weighted sum of rates of various toxicity grades or a continuous outcome. Although several novel methods have been proposed in the literature, accessible software is still lacking to implement these methods. This study introduces a newly developed R package, UnifiedDoseFinding, which implements three phase I dose-finding methods with non-binary outcomes (Quasi- and Robust Quasi-CRM designs by Yuan et al. (2007) and Pan et al. (2014), gBOIN design by Mu et al. (2019), and by a method by Ivanova and Kim (2009)). For each of the methods, UnifiedDoseFinding provides corresponding functions that begin with next that determines the dose for the next cohort of patients, select, which selects the MTD defined by the non-binary toxicity endpoint when the trial is completed, and get oc, which obtains the operating characteristics. Three real examples are provided to help practitioners use these methods. The R package UnifiedDoseFinding, which is accessible in R CRAN, provides a user-friendly tool to facilitate the implementation of innovative dose-finding studies with nonbinary outcomes.