• Title/Summary/Keyword: Clinical investigation

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Clinical and molecular detection of fowl pox in domestic pigeons in Basrah Southern of Iraq

  • Isam Azeez Khaleefah;Hassan M. Al-Tameemi;Qayssar Ali Kraidi;Harith Abdulla Najem;Jihad Abdulameer Ahmed;Haider Rasheed Alrafas
    • Korean Journal of Veterinary Research
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    • v.64 no.1
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    • pp.7.1-7.6
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    • 2024
  • Bird species, particularly poultry and other bird types, including domestic pigeons, are susceptible to fowl pox, a contagious viral disease. The main goal of this study was to validate clinical avipoxvirus diagnoses using molecular analytical methods. The essential components of the investigation were the clinical signs, visible abnormalities, histological changes, and polymerase chain reaction analysis. Twenty out of 120 pigeons had clinical symptoms, which included yellowish crust or nodules near the feet, eyes, and beak. An erosive epidermal lesion and an epidermal acanthotic papular lesion with basal vacuolation were maculopapular evidence associated with significant epidermal hyperkeratosis, as confirmed by histological analysis. In addition, the results showed keratinocyte necrosis beneath the hyperkeratotic epidermal layer, together with superficial and deep dermal perivascular lymphocytic infiltration. In addition, the P4b core protein gene underwent phylogenetic analysis. The sequence analysis results indicated a high degree of similarity across the local strains, with just minor variations observed. Five sample sequences were selected and submitted to the NCBI database. These sequences were identified as OR187728, OR187729, OR187730, OR187731, and OR187732. All the various strains in this research may be classified under clade A of the chicken pox virus phylogenetic classification. This study presents the first description and characterization of pox virus infections in domestic pigeons inside the Basrah governorate.

Epidemiological Characteristics of Nontuberculous Mycobacterial Pulmonary Disease in South Korea: A Meta-analysis of Individual Participant Data

  • Geunin Lee;Sol Kim;Shihwan Chang;Hojoon Sohn;Young Ae Kang;Youngmok Park
    • Tuberculosis and Respiratory Diseases
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    • v.87 no.3
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    • pp.386-397
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    • 2024
  • Background: Despite the global increase in nontuberculous mycobacterial pulmonary disease (NTM-PD), clinical characteristics show geographical variations. We investigated the clinical characteristics of patients with NTM-PD in South Korea. Methods: We systematically reviewed articles concerning patients with NTM-PD in South Korea until February 2022. Individual participant data, regardless of treatment, were collected using a standard case report form. Results: Data of 6,489 patients from 11 hospitals between 2002 and 2019 were analyzed. The mean age was 61.5±11.7 years, of whom 57.7% were women. Mycobacterium avium (41.4%) and Mycobacterium intracellulare (38.4%) comprised most of the causative species, followed by Mycobacterium abscessus subspecies abscessus (8.6%) and M. abscessus subspecies massiliense (7.8%). Bronchiectasis (59.4%) was the most common pulmonary comorbidity. Although reported cases of NTM-PD increased over the years, the proportions of causative species and radiologic forms remained similar. Distinct clinical characteristics were observed according to age and sex. Men were older at the time of diagnosis (median 63.8 years vs. 59.9 years, p<0.001), and had more cavitary lesions than women (38.8% vs. 21.0%, p<0.001). The older group (≥65 years) had higher proportions of patients with body mass index <18.5 kg/m2 (27.4% vs. 18.6%, p<0.001) and cavitary lesions (29.9% vs. 27.6%, p=0.009) than the younger group. Conclusion: We conducted a meta-analysis of the clinical characteristics of patients with NTM-PD in South Korea, and found age- and sex-related differences in disease-specific severity. Further investigation would enhance our comprehension of the nature of the disease, and inherited and acquired host factors.

Investigation for the Induction of Quality Inscription System with Herbal Medicine (한약재 품질 표시 제도의 도입을 위한 조사)

  • Lee, Mi-Young;Kim, Ho-Kyoung;Jeon, Won-Kyung;Jung, Gye-Jin;Ju, Young-Seung;Ju, Young-Seung;Ko, Byoung-Seob
    • Korean Journal of Oriental Medicine
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    • v.6 no.1
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    • pp.59-68
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    • 2000
  • The purpose of this study is to encourage the circulation of good quality of oriental medicine and to improve national welfare. Investigation for the induction of quality inscription system was conducted by mail and interview. The data were analyzed by SAS. The major results were as follows: The portion of subjects agree to necessity of quality inscription was 78.5%. In the question of side effect against quality inscription, the rate of negative was 67.7%. The responses answered that the necessity of quality inscription was not economical profit but authority of knowledge and improvement on health(37.8%), established market for herbal medicine(34.7%) and effect of clinical care(23.9%), respectively These results might be useful information for establishing of quality inscription system for herbal medicine.

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Pharmaceutical Data Exclusivity - Comparative Study and Future Direction in Korea (의약품 자료독점제도의 국가별 현황과 국내 제도의 발전방향)

  • Park, Syl-Vi-A
    • Journal of Pharmaceutical Investigation
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    • v.39 no.4
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    • pp.299-307
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    • 2009
  • Data exclusivity is one of the most important intellectual property rights of pharmaceuticals. During data exclusivity period, third parties are prohibited from relying on the data which the original company has submitted to regulatory authority for drug application. I investigated data exclusivity systems for pharmaceuticals in the US, EU, Canada and Korea. New chemical entities were usually given the longest periods of data exclusivity compared to drugs with new indication or new formulation, although the protection periods varied by country. For new drugs to be entitled to a data exclusivity, strict conditions should be met. Data exclusivity has also been provided as an incentive to promote clinical investigation and drug development for pediatric population or orphan diseases. In Korea, data exclusivity was adopted in 1995 as an additive provision to "drug re-examination" which is to investigate post-marketing safety information of new drugs. It was introduced with few discussion on the purposes or effects of data exclusivity on pharmaceutical industry and pharmaceutical market in this country. I found that Korea's data exclusivity system falls short of considerations on valuing innovation of pharmaceutical research. It is necessary to improve data exclusivity system in order to promote innovative pharmaceutical development and to balance intellectual property rights protection and access to drugs in this country.

Bioequivalence of Boryung Torsemide Tablet to Torem Tablet (Torasemide 10 mg) by High Performance Liquid Chromatography/UV Detector

  • Cho, Hea-Young;Kang, Hyun-Ah;Park, Chan-Ho;Kim, Se-Mi;Kim, Dong-Ho;Park, Sun-Ae;Kim, Kyung-Ran;Hur, Hyeon;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.5
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    • pp.323-328
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    • 2005
  • The purpose of the present study was to evaluate the bioequivalence of two torasemide tablets, Torem tablet (Roche Korea Co., Ltd., Korea, reference drug) and Boryung Torsemide tablet (Boryung Pharmaceutical Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (furosemide) to human serum, serum samples were extracted using 5 mL of ethyl acetate. Compounds were analyzed by reverse-phase HPLC method with UV detection. This method showed linear response over the concentration range of 0.05 ug/mL with correlation coefficient of 0.999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ug/mL which was sensitive enough for pharmacokinetic studies. Twenty-eight healthy male Korean volunteers received each medicine at the torasemide dose of 20 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Serum concentrations of torasemide were monitored by an HPLC-UV for over a period of 12 hr after the administration. $AUC_{t}$(the area under the serum concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum serum drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the serum concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_{t}$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_{t}$ ratio and the $C_{max}$ ratio for Boryung Torsemide/Torem were log 0.97-10g 1.03 and log 0.93log 1.12, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Boryung Torsemide tablet and Torem tablet are bioequivalent.

Clinical Application of M-number for Aortic Cannulas During Cardiopulmonary Bypass (심폐바이패스시 대동맥캐늘라에 대한 M-NUMBER의 임상 적용)

  • 김원곤;박성식
    • Journal of Chest Surgery
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    • v.29 no.5
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    • pp.510-516
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    • 1996
  • Cardiopulmonary bypass cannulas are usually characterized by the French number. However this de- scription provides only the external diameter of the cannula, which gives no information about the press- ure-flow characteristics of the cannula itself. A standardized system to describe the pressure-flow characteristics of a given cannula has recently been proposed and has been termed the M-number It is reported that the pressure-flow characteristics of a particular cannula can be determined from a novo- gram or chart, if the experimentally derived M-number of the cannula is known. In this regard, we conducted an investigation to analyze correlation between experimentally and clinical y derived M-numbers using three different sizes of pediatric aortic cannulas in fifty cardiac patients on cardiopulmonary bypass. The clinical and experimental M-numbers showed a strong correlation. The clinical M-numbers were typically 0.)5 to 0.55 greater than the experimental M-numbers. The clinical M-numbers also showed an inverse relationship to the temperature change of the patient, most probably due to an increase in blood viscosity from hypothermia. This inverse clinical M-numbersltemperature re- lationship was more marked in higher M-number cannulas. The clinical data obtained in this study suggest that the experimentally derived M-numbers correlated strongly with the clinical performance of the cannula with the significant influence of the temperature.

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Development of a Food Retention Questionnaire for Functional Dyspepsia and the Analysis of Its Reliability and Validity (기능성소화불량의 식적설문지 개발과 신뢰도 및 타당도 검정)

  • Hwang, Mi-ni;Ha, Na-yeon;Ko, Seok-jae;Park, Jae-woo;Kim, Jin-sung
    • The Journal of Internal Korean Medicine
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    • v.40 no.3
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    • pp.390-408
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    • 2019
  • Objectives: Several pattern diagnosis questionnaires have been developed to objectify the process of pattern diagnosis in Korean medicine. In this context, this study aimed to develop a food retention questionnaire for functional dyspepsia (FRQ-FD) by modifying the previously developed food retention questionnaire (FRQ) and to verify its reliability and validity. Furthermore, this study aimed to identify the optimal cut-off value of the FRQ-FD for standardization and use in clinical situations. Methods: To develop the FRQ-FD, we extracted the major symptoms of food retention pattern for functional dyspepsia from Chinese/Korean medicine textbooks and requested an importance survey from experts using the Delphi method. The first draft of the FRQ-FD was composed of 25 questions comprising 8 questions from the textbooks and the Delphi method and 17 questions from the FRQ already developed in 2013. To analyze its reliability, validity, and optimal cut-off value, 60 subjects were enrolled in this study from June 25 to August 13, 2018. Thirty patients were diagnosed as both functional dyspepsia and food retention pattern, and 30 healthy participants were not. All participants were requested to fill up the FRQ-FD, Stomach Qi Deficiency Questionnaire (SQDQ), Scale for Stomach Qi Deficiency pattern (SSQD), visual analog scale (VAS) for dyspepsia, Nepean Dyspepsia Index-Korean version (NDI-K), and functional dyspepsia-related quality of life (FD-QoL). Results: No statistically significant differences were found in sex distribution, age, and body mass index between the patient group and the control group. As five questions affected the reliability negatively and three questions affected the clinical validity negatively, we decided to exclude the eight questions upon further investigation. The Cronbach's ${\alpha}$ coefficient of the revised FRQ-FD (17 items) was 0.899, and its clinical validity was verified. Construct validity was analyzed by factor analysis and produced five factors. Statistically significant positive correlations were found between the revised FRQ-FD and the other dyspepsia scales, namely, SQDQ, SSQD, VAS, NDI-K, and FD-QoL. VAS and NDI-K especially had strong positive correlations with FRQ-FD. Conclusions: The FRQ-FD developed in this study can provide fundamental reliability and validity for a pattern diagnosis questionnaire. FRQ-FD can help to diagnose food retention pattern in functional dyspepsia patients. Further studies are required to inspect several statistical factors.

Investigation of the Environment and Working Scope of Optometric Personnel in Ophthalmology (안과검안인력의 근무 환경 및 업무 범위에 관한 조사)

  • Han, Minho;Park, Junbeom;Jeon, Okhwan;Hwang, Eul Sung;Park, Hyun Jin;Lee, Min Woo;Kim, Gibong;Koo, Bon-Kyeong;An, Younghoi
    • Korean Journal of Clinical Laboratory Science
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    • v.54 no.3
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    • pp.224-238
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    • 2022
  • The environment and scope of work of optometric personnel in ophthalmology are unknown. We aimed to investigate these topics using an online survey. Based on the results obtained, we also make policy proposals from the perspective of clinical laboratory technologists to the University-Association-Academy. The age distribution of the study subjects was as follows; 20s (40.7%), 30s (28.4%), 40s (23.5%), and 50s (7.4%). Women constituted 56.0% of the cohort, and careers were evenly distributed from <1 to ≥15 years. We found optometric personnel had high levels of work-related stress, frequent occupational diseases, and that their duties were wide in scope. More manpower is needed to reduce work stress and improve work satisfaction. Clinical laboratory technologists held more senior positions at 48% compared to others and the occupational distribution was closely related to the senior occupation (P<0.001). Clinical laboratory technologists were responsible for about 30 types of eye examinations, and the most frequently performed examination was the refraction test; anomaloscopic examinations took the most time (27 minutes). Taken together, clinical laboratory technologists perform various eye exams. Given the importance of clinical laboratory technologists in optometry, a multifaceted effort is required at the University-Association-Academy.

An Epidemiologic Investigation on an Outbreak of Anthrax Occurred in Kyongju by Eating Dead Cow's Meat (경주시 배반동에서 발생한 탄저병에 관한 역학조사)

  • Lim, Hyun-Sul;Cheong, Hae-Kwan;Kim, Joung-Soon;Ohr, Hee-Choul;Rhie, Dong-Mo;Kim, Ho-Hoon
    • Journal of Preventive Medicine and Public Health
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    • v.27 no.4 s.48
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    • pp.693-709
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    • 1994
  • This epidemiologic study was carried out to investigate cauuse and magnitude of food-poisoning like epidemic occurred among inhabitants of a village who have eaten dead cow's meat near Kyongju in February of 1994, around lunar new year, The investigation consisted of interview survey on all inhabitants of 77 households (111 males and 119 females) and their visitors (40 males and 35 females), skin test with anthraxinum (Russian product), study on clinical characteristics for the patients hospitalized, and microbiologic examination on microbes isolated from cow's meat, patient and soils of dead cow's barn. The results obtained are as followings; 1. The proportion of the inhabitants who ingested the dead cow's meat was 36.4%. The incidence rate of the disease was 65.1% for males, 41.7% for females and the cases were distributed evenly for all age groups. The group ingested raw meat showed higher incidence than the group ingested cooked meat. There was no case among people who did not eat the meat. 2. The most clinical symptoms were significantly more frequent among cases than non-cases : sore throat (57%), nausea (51%), fever (47%), indigestion (43%), cough (41%), anorexia (41%), abdominal distention (41%), and abdominal pain (39%) were the major symptoms among cases. 3. Among 29 cases hospitalized out of total 61 cases, three patients, all old and feeble persons, deceased from the disease resulting in 4.9% fatality rate among total patient and 10.3% among hospitalized. Septicemia and meningitis were the causes of the deaths. 4. Three strains isolated from patients, and three strains from dead cow's meat and soil revealed typical microbiologic characteristics of Bacillus Anthracis, which also proved to be fatal to experimentally infected mice.

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Development and Evaluation of a Patient-Reported Outcome (PRO) Scale for Breast Cancer

  • Zhang, Jun;Yao, Yu-Feng;Zha, Xiao-Ming;Pan, Li-Qun;Bian, Wei-He;Tang, Jin Hai
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.18
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    • pp.8573-8578
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    • 2016
  • Background: This study was guided by principles of the theoretical system of evidence-based medicine. In particular, when searching for evidence of breast cancer, a measuring scale is an instrument for evaluating curative effects in accordance with the laws and characteristics of medicine and exploring the establishment of a system for medically assessing curative effects. At present, there exist few tools for evaluating curative effects. Patient-reported outcomes (PROs) refer to outcomes directly reported by patients (without input or explanations from doctors or other intermediaries) with respect to all aspects of their health. Data obtained from PROs provide evidence of treatment effects. Materials and Methods: In accordance with the tenets of theoretical medicine and ancient medical theory regarding breast cancer, principles for developing a PRO scale were established, and a theoretical model was developed and a literature review was performed, items from this pool were combined and split, and an initial scale was constructed. After a pilot survey and additional modifications, a pre-questionnaire scale was formed and used in a field investigation. After the application of statistical methods, the item pool was used to create a formal scale. The reliability, validity and feasibility of this formal scale were then assessed. Results: In a clinical investigation, 479 responses were recovered, with an acceptance rate of 95%. a combination of various methods was employed, and the items that were selected by all methods or more than half of the methods were employed in the questionnaire. In these cases, the screening methods were combined with certain features of the item, A total of four domains and 38 items were reserved. The reliability analysis indicated that the PRO scale was relatively reliable. Conclusions: Scientific assessment proved that the proposed scale exhibited good reliability and validity. This scale was readily accepted and could be used to assess the curative effects of medical therapy. However, given the limited scope of this investigation, the capacity for adapting this scale to incorporate other theories could not be determined.