• 생물정신의학
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• 제14권1호
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• pp.48-54
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• 2007

Objectives : This study aimed to examine the relationship between behavioral and psychological symptoms of dementia(BPSD) and patient and caregiver QOL in Alzheimer's disease(AD). Methods : Fifty-one AD patients and their caregivers participated. Measures about patients were Neuropsychiatric Inventory(NPI), Korean version of QOL-Alzheimer's Disease(KQOL-AD), Activities of Daily Living(ADL), Clinical Dementia Rating(CDR), and Korean version-Mini Mental State Examination(K-MMSE). Caregiver QOL was assessed with KQOL-AD and General Health Questionnaire/Quality of Life-12(GHQ/QOL-12). Results : Patient QOL-AD on patient ratings was negatively correlated with appetite/eating change and NPI scores. Patient QOL-AD on caregiver ratings was negatively correlated with hallucinations, depression/dysphoria, and NPI scores. Caregiver QOL assessed by the GHQ/QOL-12 was negatively correlated with agitation/aggression, depression/dysphoria, and NPI scores and was negatively correlated with distress related to agitation/aggression, depression/dysphoria, and NPI scores. Conclusion : BPSD of AD patients was associated with low QOL of both patients and caregivers. Thus, interventions of BPSD were needed to improve both patient and caregiver QOL.

• 한방안이비인후피부과학회지
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• 제30권1호
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• pp.17-28
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• 2017

Objectives : The aim of this study is reviewing the literature to extracting the key parameter and finding the calibration parameter for the clinical study with economical assessment protocol on atopic dermatitis. Methods : Literature search is performed using PUBMED for literature published from Janurary 2000 to December 2016. We included randomized controlled trials(RCTs) with economic assessment in which human participants. Results : Among the articles published from January 2000 to December 2016, The 1464 articles were found. After reviewing the title, abstract and full text, the five articles were selected. Selected articles are classified 3 CEA(cost effective analysis)study, 1 CMA(cost minimizing analysis)study and 1 cost analysis study. Conclusions : We found highly reliable key parameters and calibration parameters, which might be necessary factors for developing research protocol of economic evaluation alongside clinical trial about atopic dermatitis patients.

• Allergy, Asthma & Immunology Research
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• 제10권6호
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• pp.686-697
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• 2018

Purpose: Several markers for eosinophilic inflammation have been proposed to predict response to asthma treatment. However, definitive criteria for treatment decisions have not yet been established. We investigate a potentially useful relatively non-invasive biomarker, eosinophil-derived neurotoxin (EDN), to predict favorable responses to budesonide or montelukast, common treatment for children with asthma. Methods: Young children (1 to 6 years old) were enrolled in this randomized, parallel, 2-group, open-label trial. Criteria for eligibility included: 1) being symptomatic during the run-in period; and 2) having a serum EDN (sEDN) level ${\geq}53ng/mL$, with positive specific immunoglobulin E to house dust mite. Eligible patients were randomly placed into 2 groups: the BIS group received budesonide inhalation suspension (BIS) 0.5 mg once daily; the MONT group received montelukast 4 mg once daily. Ineligible patients were invited to receive montelukast 4 mg once daily (OBS group). Treatment period was 12 weeks. Results: Asthma control days increased significantly in the BIS and MONT groups (P < 0.000) over the 12-week study period. There was no significant change in sEDN in the BIS group but there was a significant decrease in the MONT group (P < 0.000). Patients in the OBS group with high EDN levels (> 53 ng/mL) showed a significant decrease due to MONT treatment (P = 0.023). Rescue medication usage significantly decreased in the BIS and MONT groups (P < 0.000). Conclusions: EDN is a useful relatively non-invasive biomarker for predicting responses to montelukast and budesonide treatment of preschool children with beta2-agonist responsive recurrent wheeze and multiple-trigger wheeze (Trial registry at UMIN Clinical Trials Registry, UMIN000008335).

• 대한한방내과학회지
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• 제45권1호
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• pp.1-10
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• 2024

Objectives: This study investigated the pattern identification (PI) and clinical index of Parkinson's disease (PD) for personalized diagnosis and treatment. Methods: This prospective observational multi-center study recruited 100 patients diagnosed with PD from two Korean medicine hospitals. To cluster new subtypes of PD, items on a PI questionnaire (heat and cold, deficiency and excess, visceral PI) were evaluated along with pulse and tongue analysis. Gait analysis was performed and blood and feces molecular signature changes were assessed to explore biomarkers for new subtypes. In addition, unified PD rating scale II and III scores and the European quality of life 5-dimension questionnaire were assessed. Results: The clinical index obtained in this study analyzed the frequency statistics and hierarchical clustering analysis to classify new subtypes based on PI. Moreover, the biomarkers and current status of herbal medicine treatment were analyzed using the new subtypes. The results provide comprehensive data to investigate new subtypes and subtype-based biomarkers for the personalized diagnosis and treatment of PD patients. Ethical approval was obtained from the medical ethics committees of the two Korean medicine hospitals. All amendments to the research protocol were submitted and approved. Conclusions: An objective and standardized diagnostic tool is needed for the personalized treatment of PD by traditional Korean medicine. Therefore, we developed a clinical index as the basis for the PI clinical evaluation of PD. Trial Registration: This trial is registered with the Clinical Research Information Service (CRIS) (KCT0008677)

• 동의신경정신과학회지
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• 제35권1호
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• pp.15-26
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• 2024

Objectives: The objective of this study is to develop a specialized clinical research protocol for acupuncture treatment specifically designed for disaster survivors based on insights from an expert survey. Methods: An expert panel comprising specialists in neuropsychiatry, acupuncture, and clinical research methodology was assembled. Initial data to inform the clinical research protocol design was collected utilizing open-ended responses, multiple-choice questions, and a 5-point Likert scale to gauge agreement levels. Next, this data was disseminated to a panel of experts. A cohesive clinical research protocol was then formulated during a core panel meeting by integrating insights from a panel of 10 experts. Results: The protocol developed herein entails a non-randomized controlled study involving participants aged 19~64 years old who have been identified as high-risk or cautious according to the National Trauma Center screening test. The study design includes the establishment of an active control group, which allows for the assessment of an additional effect through comparison with conventional therapy. The selected acupuncture approach involves a combination of manual acupuncture and ear acupuncture. For clinical outcome assessment, the Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5 was proposed to gauge trauma symptoms. Representative scales for various domains such as depression, anxiety, anger, insomnia, pain, and quality of life were also provided for reference. Conclusions: The developed protocol is anticipated to streamline the swift design and initiation of clinical trials during disaster scenarios. It is also designed to be scalable, thereby enabling its application in both non-randomized control group studies and single-group before-and-after comparisons.

• 대한임상약리학회:학술대회논문집
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• 대한임상약리학회 1992년도 정기총회 및 추계학술대회
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• pp.25-25
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• 1992

• Korean Journal of Radiology
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• 제21권11호
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• pp.1239-1247
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• 2020

Objective: To report the mid-term results of a single-center randomized controlled trial comparing drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA) for the treatment of dysfunctional radiocephalic arteriovenous fistulas (RCAVFs). Materials and Methods: In this prospective study, 39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis were randomly assigned to undergo either both DBA and PBA (n = 20, DBA group) or PBA alone (n = 19, PBA group) between June 2016 and June 2018. Primary endpoints were technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates. Statistical analysis was performed using the Kaplan-Meier product limit estimator. Results: Demographic data and baseline clinical characteristics were comparable between the groups. Technical and clinical success rates were 100% in both groups. There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months; p = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months; p = 0.585). No procedural or post-procedural complications were identified. Conclusion: Paclitaxel-coated balloon use did not significantly improve TLPP or TLSP in the treatment of juxta-anastomotic stenosis of dysfunctional RCAVFs.

• 동의생리병리학회지
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• 제20권6호
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• pp.1678-1727
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• 2006

This study was perfromed to develop the assessment guideline and endpoints for clinical trial with anticancer herbal medicine. The botanical products used to humans for long time may be applied to phase 3 clinical trial after submitting the evidences for safety and efficacy of them or completion of basic requirement of phase 1 and phase 2 for safety confirmation and dose determination. Syndrome improvement was chiefly evaluated by Zubrod and karnofsky(%) methods. We suggest the general clinical trial assessment with botanical products, by following assessment points, that is, tumor size for 50 points, survival fate for 10 points, major syndromes for 40 points. It is recommendable that the each symptom of Qi deficiency syndrome, blood deficiency syndrome and Qi stagnation syndrome was allocated by assessment points, Similarly, the each symptom was given the assessment points according to the severity of symptom, for example, slight for 3 points, moderate for 2 points and severe for 1 point in hepatocelluar carcinoma and lung cancer. Then, the efficacy of botanical products was evaluated by the difference between pre-treatment and post-treatment. Asking the neoplastic patients of questionnaire on physical, emotional, cognitive, social and role subjects availability, three more syndromes (Fatigue, Pain and Nausea/Vomit), quality of life(QOL) will be evaluated by GLM statistics. In addition, in case of lung cancer, 13 questions will be asked by the EORTC QLQ-C13 forms. As the assessment of endpoints for efficacy to reduce side effects induced by chemotherapy and radiotherapy, the data of image scanning and hemato-urinalysis can be usefully applied on immune response, weight loss, indigestion, hemopoietic damage and injury of liver and kidney, while the changes of syndromes of side effect can be evaluated by differentiation methods of Qi and blood and five viscera. However, it is still necessary to determine the ratio between scientific analytical method and Oriental differentiation method as well as confirm the Oriental assessment endpoints by clinical trial. In addition, we suggest the continuous development of assessment endpoints on other carcinomas except of hepatocelluar carcinoma and lung cancer in future.

• 대한기관윤리심의기구협의회지
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• 제3권1호
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• pp.11-18
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• 2021

Purpose: The purpose of this study is to investigate a satisfaction survey of untact education and platforms that can be used for untact education to provide recommendations on future development of Education of Persons Conducting Clinical Trials. Methods: Online survey was distributed among students who have taken Untact Education of Persons Conducting Clinical Trials. The result was separated according to topic and descriptive statistics was used for analysis. The satisfaction survey used 10-point scale. Results: Of the 1,720 students who received the survey, 1,347 (78.3%) responded to the lecture satisfaction survey. The satisfaction level for broadcasting program (Kakao TV), an untact educational platform for the education of clinical trial workers at Kyung Hee University Medical Center, was relatively high with 8.09±1.99 points. Average score respondents recommending Kyung Hee University Untact Education of Persons Conducting Clinical Trials was 8.03±1.83 and customer recommendation score (Net Promotor Score) was 27.1%. Satisfaction level of the preferred training time was divided into weekday-morning (8-11 AM) (8.16±1.75), weekday-afternoon (12-4 PM) (7.73±2.07), weekday-evening (5-9 PM) (7.78±2.22), and weekend-morning (9-11 AM) real-time untact education (8.48±1.76) and analyzed. There was a noticeable difference between weekend-morning and weekday-afternoon (p<0.0001) and weekend-morning and weekday-evening (p=0.0001) real-time untact education. When asked about conducting education after COVID-19 pandemic ends, 79.2% (1,012 of 1,279) of the respondents answered that they prefer real-time untact education while 20.8 % (266 of 1,279) preferred face-to-face education. Conclusion: Online education, without time and space constraint, is expected to be the mainstream market in Korea for Education of Persons Conducting Clinical. Kyung Hee University Untact Education of Persons Conducting Clinical has achieved above average satisfaction using Kakao TV. Kyung Hee University Real-time Untact Education of Persons Conducting Clinical Net Promotor Score is 27.1%, which is above industry average, communication with trainees should be considered to improve Net Promotor Score.

• Bulletin of the Korean Chemical Society
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• 제34권11호
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• pp.3284-3288
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• 2013

This paper describes first development and validation of pentafluorophenylprophyl ligand-based liquid chromatography coupled to tandem mass spectrometry (PFPLC-MS/MS) method to determine metformin, a highly polar compound, in human plasma. Metformin and Phenformin (internal standard) were extracted from human plasma 50 ${\mu}L$ with a single-step protein precipitation. The chromatographic separation was performed using a linear gradient elution of mobile phase involving 5.0 mM ammonium formate solution with 0.1% formic acid (A) and acetonitrile (B) over 3.0 min of run time on a Phenomenex Luna PFP column. The detection was performed using a triple-quadrupole tandem mass spectrometer (Waters Quattro micro) with electrospray ionization in the mode of positive ionization and multiple-reaction monitoring (MRM). The developed method was validated with 5.0 ng/mL of lower limit of quantification (LLOQ). The calibration curve was linear over 5-3000 ng/mL of the concentration range ($R^2$ > 0.99). The specificity, selectivity, carry-over effect, precision, accuracy and stability of the method met the acceptance criteria. The method developed in this study had had rapidness, simplicity and ruggedness. The reliable method was successfully applied to high throughput analysis of real samples for a practical purpose of a pharmacokinetic study.