• 제목/요약/키워드: Clinical form

검색결과 1,586건 처리시간 0.031초

Prediction of the human in vivo antiplatelet effect of S- and R-indobufen using population pharmacodynamic modeling and simulation based on in vitro platelet aggregation test

  • Noh, Yook-Hwan;Han, Sungpil;Choe, Sangmin;Jung, Jin-Ah;Jung, Jin-Ah;Hwang, Ae-Kyung;Lim, Hyeong-Seok
    • Translational and Clinical Pharmacology
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    • 제26권4호
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    • pp.160-165
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    • 2018
  • Indobufen ($Ibustrin^{(R)}$), a reversible inhibitor of platelet aggregation, exists in two enantiomeric forms in 1:1 ratio. Here, we characterized the anti-platelet effect of S- and R-indobufen using response surface modeling using $NONMEM^{(R)}$ and predicted the therapeutic doses exerting the maximal efficacy of each enantioselective S- and R-indobufen formulation. S- and R-indobufen were added individually or together to 24 plasma samples from drug-naïve healthy subjects, generating 892 samples containing randomly selected concentrations of the drugs of 0-128 mg/L. Collagen-induced platelet aggregation in platelet-rich plasma was determined using a Chrono-log Lumi-Aggregometer. Inhibitory sigmoid $I_{max}$ model adequately described the anti-platelet effect. The S-form was more potent, whereas the R-form showed less inter-individual variation. No significant interaction was observed between the two enantiomers. The anti-platelet effect of multiple treatments with 200 mg indobufen twice daily doses was predicted in the simulation study, and the effect of S- or R-indobufen alone at various doses was predicted to define optimal dosing regimen for each enantiomer. Simulation study predicted that 200 mg twice daily administration of S-indobufen alone will produce more treatment effect than S-and R-mixture formulation. S-indobufen produced treatment effect at lower concentration than R-indobufen. However, inter-individual variation of the pharmacodynamic response was smaller in R-indobufen. The present study suggests the optimal doses of R-and S-enantioselective indobufen formulations in terms of treatment efficacy for patients with thromboembolic problems. The proposed methodology in this study can be applied to the develop novel enantio-selective drugs more efficiently.

팔강변증의 진단율 향상을 위한 형색맥증진단(形色脈證診斷)시스템 설계 - 한열변증을 중심으로 - (Proposal of Form-Color-Pulse-Symptom Diagnostic System for Enhancement of Diagnostic Rate of 8 Principle Pattern Identification - Focusing on Cold Heat Pattern Identification -)

  • 지규용;이인선;전수형;김종원
    • 동의생리병리학회지
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    • 제33권3호
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    • pp.163-168
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    • 2019
  • In order to enhance the 8 principle pattern diagnosis rate comparing with diagnostic method by self-report questionnaire on cold/heat pattern in the clinical practice, a new diagnostic method using form-color-pulse-symptom (FCPS) system is proposed. FCPS system is composed of outputs of cold/heat pattern through the calculation process of contribution degree to the cold, heat pattern and qi, blood, yin, yang deficiency patterns, based on analysis of 16 mechanisms of disease calculated by diagnostic system of oriental medicine (DSOM) first. And second component is an output of differentiated 8 principle patterns in detail through binding and calculating process with digital informations of pulse, color, form, constitution obtained by computerized measurement system. Putting together above two processes consecutively, cold-heat complex or true/false cold/heat patterns and personalized characters of cold/heat patterns of each patient can be subdivided through a computation method of determining each pattern. In conclusion, 8 principle pattern identification can be performed more accurately using FCPS system than existent self report questionnaire method. These hypothetic proposal is needed to be proven by clinical trial for the future and then the accurate numbers used in each calculational function should be revised properly.

동종골수이식 공여자 간호를 위한 표준임상지침서 개발 (Development of the Clinical Pathway for the Allogeneic Bone Marrow Transplantation Donor Nursing)

  • 설미이
    • 종양간호연구
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    • 제4권2호
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    • pp.110-123
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    • 2004
  • The purpose of this study was to develop a clinical pathway for the allogeneic bone marrow transplantation donor. For this study, a conceptual framework was developed through a review of the literature including six steps which are using in Jones Hopkins Hospital. USA. The researcher reviewed 129 medical re-cords of donor who had bone marrow donation between January 2002 to January 2004, to identify the overall service contents required by these patients and to make a preliminary clinical pathway. A content validity test was done for the preliminary clinical pathway, a professional group screened 51 medical re-cords and adopted with 3 hospitalization days as the clinical pathway framework. In the fifth step, clinical pathway test was also done to 7 donors from April 28th to July, 2004. After these processes the final clinical pathway was developed. The results of this study are as follows: 1. The vertical axis of the clinical pathway Includes the following 9 items: vital signs, nursing assessment, activity, diet, intervention, medication, test, consultation and patient teaching. The duration of the horizontal axis was 3days from admission to discharge 2. Analysis of the 129 medical records indicated that the average length of stay was 3 4 days. The medical performance according to the vertical axis in the preliminary clinical pathway consisted of 51 items After clinical validity test, it steel consisted of 51 items in the final form. 3. Clinical Validity test was done to 7 bone marrow donors. During these process, The first patient was deleted because he was out of the criteria the investigate set and 6 patients were used, finally The result of this study indicated all of 7 donors were discharged on expected day. 4. Clinical pathway enables to improve the quality of care, multidisciplinary team work It also helps nursing bone marrow donor, effective education to donor or medical member. The results of this study suggest that clinical pathway may be able to improve the quality of nursing care for bone marrow transplantation donors.

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Microhybrid versus nanofill composite in combination with a three step etch and rinse adhesive in occlusal cavities: five year results

  • Tuncer, Safa;Demirci, Mustafa;Oztas, Evren;Tekce, Neslihan;Uysal, Omer
    • Restorative Dentistry and Endodontics
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    • 제42권4호
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    • pp.253-263
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    • 2017
  • Objectives: The aim of the study was to evaluate the 5-year clinical performance of occlusal carious restorations using nanofill and microhybrid composites, in combination with 3-step etch-and-rinse adhesives, in patients who were going to commence orthodontic treatment. Materials and Methods: A total of 118 restorations for occlusal caries were conducted prior to orthodontic treatment. Occlusal restorations were performed both with Filtek Supreme XT (3M ESPE) and Filtek Z250 (3M ESPE) before beginning orthodontic treatment with fixed orthodontic bands. Restorations were clinically evaluated at baseline and at 1, 2, 3, 4, and 5-year recalls. Results: None of the microhybrid (Filtek Z250) and nanofill (Filtek Supreme XT) composite restorations was clinically unacceptable with respect to color match, marginal discoloration, wear or loss of anatomical form, recurrent caries, marginal adaptation, or surface texture. A 100% success rate was recorded for both composite materials. There were no statistically significant differences in any of the clinical evaluation criteria between Filtek Z250 and Filtek Supreme XT restorations for each evaluation period. Conclusions: The composite restorations showed promising clinical results relating to color matching, marginal discoloration, wear or loss of anatomical form, recurrent caries, marginal adaptation, and surface texture at the end of the 5-year evaluation period.

국내 의약품 정보 데이터베이스의 비교 평가 (A Comparative Evaluation of Drug Information Databases in Korea)

  • 김수정;오정미;신현택
    • 한국임상약학회지
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    • 제11권1호
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    • pp.30-41
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    • 2001
  • Recently, the use of electronic drug information databases has been increased alternative to printed references. However, databases vary widely in quality and quantity of drug information provided and many questions have arisen about their accuracy, completeness, and reliability. This study was designed to compare and evaluate the drug information contained in four Korean drug information databases which are available on CD-ROM and internet. Four Korean drug information databases selected to be evaluated were eKIMS, Datapower, KPA Standard Drug Information and Korean Drug Formulary. Databases were searched and evaluated from August 10 to September 30, 2000 by the same trained searcher to minimize the bias. The database evaluation form was developed for objective evaluation of each databases in terms of credibility of database, convenience of use and other characteristics. The second form was developed for quantitative and qualitative assessment of the drug information provided by the databases. The results of the study showed that there were no significant differences in 4 databases in terms of convenience of use and other characteristics. However, for credibility of databases, Korean Drug Formulary was significantly superior to all other databases (P<0.05). It showed that information provided by Korean Drug Formulary was the best in terms of pharmacokinetics, chemistry, comparisons and eKIMS was the best in terms of drug identification (P<0.05). For accuracy and completeness of information provided, the study could not find a significant difference between 4 databases (P>0.05).

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Clinical results of conservative management in patients with full-thickness rotator cuff tear: a meta-analysis

  • Karasuyama, Masaki;Gotoh, Masafumi;Tahara, Keiji;Kawakami, Junichi;Madokoro, Kazuya;Nagamatsu, Takashi;Imai, Takaki;Harada, Nobuya;Kudo, Yu;Shiba, Naoto
    • Clinics in Shoulder and Elbow
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    • 제23권2호
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    • pp.86-93
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    • 2020
  • Background: Several systematic reviews have reported on the conservative treatment of full-thickness rotator cuff tears; however, clinical results of this treatment still remain determined. Methods: PubMed, Cochrane Library, PEDro, and CINAHL databases were systematically searched for randomized clinical trials and observational studies. Two independent researchers reviewed a total of 2,981 articles, 28 of which met the criteria for inclusion in the study. Clinical outcome measures included Constant score, visual analog scale score for pain, range of motion, and short-form 36 questionnaires. The meta-analysis used a linear mixed model weighted with the variance of the estimate. Results: The meta-analysis showed a significant improvement after surgery. Pain score is 26.2 mm (1 month) to 26.4 mm (3 months), and 24.8 mm (12 months) (P<0.05); active abduction: 153.2° (2 months), 159.0° (6 months), 168.1° (12 months) (P<0.05); Constant score: 67.8 points (2 months) to 77.2 points (12 months) (P<0.05); short-form 36 questionnaires "vitality" section: 57.0 points (6 months) to 70.0 points (12 months) (P<0.05). Conclusions: Our data confirmed the effectiveness of conservative treatment in patients with full-thickness rotator cuff tears 12 months post-intervention. The results suggest that conservative treatment for patients with full-thickness rotator cuff tears should be the first line of treatment before considering surgery.

Clinical Utility of the Minnesota Multiphasic Personality Inventory-Adolescent Restructured Form in the Assessment of Internalizing and Externalizing Disorders in Adolescents: A Preliminary Approach

  • Hye Ji Yun;Eun Hee Park;Hyun Ju Hong
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • 제34권4호
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    • pp.268-274
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    • 2023
  • Objectives: This study investigated whether the Minnesota Multiphasic Personality Inventory-Adolescent Restructured Form (MMPI-ARF) can differentiate between two groups of adolescents, one diagnosed with internalizing disorders and another with externalizing disorders, and examined the clinical utility of the MMPI-A-RF by examining which subscales can significantly discriminate between these two groups. Methods: A total of 105 adolescents aged 13-18 years completed the MMPI-A-RF (53 internalizing disorder and 52 externalizing disorder groups). Independent t-test, chi-square test (χ2), and discriminant analysis were used to examine whether MMPI-A-RF can distinguish between the two groups. Results: Sixteen MMPI-A-RF scales best predicted differences between the groups with internalizing and externalizing disorders. Fourteen scales (Higher-Order Scale [Emotional/Internalizing Dysfunction], Restructured Clinical [RC] Scale [RC demoralization, Somatic Complaints (RC1), and Low Positive Emotions (RC2)], Personality Psychopathology Five Scale [Introversion/Low Positive Emotionality-Revised, Negative Emotionality/Neuroticism-Revised], Somatic/Cognitive Scale [Malaise, Head Pain Complaints, and Gastrointestinal Complaints], Internalizing Scale [Stress/Worry, Self-Doubt], Externalizing Scale [Negative School Attitudes], Interpersonal Scale [Social Avoidance, Shyness]) were associated with the internalizing disorder group, whereas two scales (Externalizing Scale [Conduct Problems, Negative Peer Influence]) were associated with the externalizing disorder group. Conclusion: The MMPI-A-RF can be an efficient assessment tool for a quick diagnosis as it can classify individuals with internalizing and externalizing disorders in clinical settings that lack a variety of assessment tools for children and adolescents.

어혈 진단 설문지 개정 연구 (Revision of the modified Blood Stasis Questionnaire II)

  • 장수빈;강병갑;고미미;김평화;정지연
    • 대한예방한의학회지
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    • 제24권2호
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    • pp.95-102
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    • 2020
  • Objectives : The objective of this study was to revise the modified Blood Stasis Questionnaire II. Methods : This revision focused on refining the Korean literature expression of Blood Stasis Questionnaire II consisting of 30-question questionnaire. Seven external experts and five researchers of Korean Institute of Oriental Medicine reviewed the questionnaire and its protocol, while the addition or deletion of questions and changes in scoring method were not dealt with in this revision. Results : Among thirty questions, four questions were corrected to appropriate expressions. In case of eight questions, explanations in Korean or Chinese were added. Thirteen questions in the phrase were changed in sentence form to unify the whole questionnaire. Conclusions : This study introduces the revised version of the modified Blood Stasis Questionnaire II. It is expected that clinical demand of this questionnaire will increase and it will be used vigorously in blood stasis research.

한의약 임상시험 전문인력양성 교육프로그램 개발의 필요성에 대한 설문조사 (Survey on the Need to Develop Training Educational Program for Oriental Medical Clinical Trial)

  • 신선화;오달석;김보영;최선미
    • 한국한의학연구원논문집
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    • 제13권2호통권20호
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    • pp.127-133
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    • 2007
  • Objectives : This study were aimed to estimate the needs for clinical research educational program development focused on oriental medicine. Methods : Department Medical Research of Korea Institute of Oriental Medicine surveyed 204 certified subjects in total by using web-based questionnaires through e-mail from Jan. 17th to Jan. 31th, 2007. Reply from 62 on-line correspondents were collected and statistically analyzed. Results : The number of clinical trial involving oriental medicine continues to increase. According to the survey, many Issues were raised as problems such as difficulty of recruitment, lack of fund and lack of stepped program. Emphasized issues were clinical research methodologies, development of protocols and case report form (CRF), and Regulations including Institutional Review Boards (IRBs) in these three consecutive education training program. Conclusion : The results of this study may contribute to the development of an educational program for oriental medicine, a program that should be taken into consideration for developing practical items, such as, problem-based learnings which reflects participants' actual needs in their works. Also this report be used for future strategy plans and execution of training program for oriental medical clinical trial.

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전국 한의과대학(원)의 진료수행평가(CPX) 현황과 향후 과제 (The current status and future operations of Clinical Performance Evaluation (CPX) in the nationwide colleges (graduate schools) of Traditional Korean Medicine)

  • 조학준;민성호
    • 한국의사학회지
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    • 제33권2호
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    • pp.9-21
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    • 2020
  • To analyze current status of CPX in colleges of Traditional Korean Medicine nationwide and investigate the operations required for its development and distribution, we investigate current status of CPX in the nationwide colleges of Traditional Korean Medicine and suggest an improvement plan. A total of 7 colleges (graduate schools) performed CPX using the standardized patients as of July 2020 out of 13 colleges (graduate schools). Because there are a significant number of CPX modules developed by the colleges of Traditional Korean Medicine, a wide array of characteristics of Traditional Korean Medicine are covered, based on the literatures of Traditional Korean medicine. The scope of Clinical Presentation should established and a CPX module should be standardized to expand and distribute CPX in the education of Traditional Korean Medicine. If multiple colleges collect, train and manage the standardized patients in cooperation, CPX could be performed more effectively. Furthermore, medical clinical performance guide for Traditional Korean Medicine should be developed in cooperation. Greater support in the form of manpower, finance, and administration are required to distribute CPX to all colleges and develop various CPX modules.