• Title/Summary/Keyword: Clinical observation

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Characteristics and Clinical Course of Fusiform Middle Cerebral Artery Aneurysms According to Location, Size, and Configuration

  • Seo, Dongwook;Lee, Si Un;Oh, Chang Wan;Kwon, O-Ki;Ban, Seung Pil;Kim, Tackeun;Byoun, Hyoung Soo;Kim, Young Deok;Lee, Yongjae;Won, Yu Deok;Bang, Jae Seung
    • Journal of Korean Neurosurgical Society
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    • v.62 no.6
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    • pp.649-660
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    • 2019
  • Objective : To analyze the angiographic features and clinical course, including treatment outcomes and the natural course, of fusiform middle cerebral artery aneurysms (FMCAAs) according to their location, size, and configuration. Methods : We reviewed the literature on adult cases of FMCAAs published from 1980 to 2018; from 25 papers, 112 FMCAA cases, for which the location, size, and configuration could be identified, were included in this study. Additionally, 33 FMCAA cases in our hospital were included, from which 16 were assigned to the observation group. Thus, a total of 145 adult FMCAA cases were included. We classified the FMCAAs according to their location (l-type 1, beginning from prebifurcation; l-type 2, beginning from bifurcation; l-type 3, beginning from postbifurcation), size (small, <10 mm; large, ${\geq}10mm$; giant, ${\geq}25mm$), and configuration (c-type 1, classic dissecting aneurysm; c-type 2, segmental ectasia; c-type 3, dolichoectatic dissecting aneurysm). Results : The c-type 3 was more commonly diagnosed with ischemic symptoms (31.8%) than hemorrhage (13.6%), while 40.9% were found accidentally. In contrast, c-type 2 was more commonly diagnosed with hemorrhagic symptoms (14.9%) than ischemic symptoms (10.6%), and 72.3% were accidentally discovered. According to location, ischemic symptoms and hemorrhage were the most frequent symptoms in l-type 1 (28.6%) and l-type 3 (34.6%), respectively. Most of l-type 2 FMCAAs were found incidentally (68.4%). Based on the size of FMCAAs, only 11.1% of small aneurysms were found to be hemorrhagic, while 18.9% and 26.0% of large and giant aneurysms were hemorrhagic, respectively. Although four aneurysms of the 16 FMCAAs in the observation group increased in size and one aneurysm decreased in size during the observation period, no rupture was seen in any case and there were no significant predictors of aneurysm enlargement. Of 104 FMCAAs treated, 14 cases (13.5%) were aggravated than before surgery and all the aggravated cases were l-type 1. Conclusion : While ischemic symptoms occurred more frequently in l-type 1 and c-type 3, hemorrhagic rather than ischemic symptoms occurred more frequently in l-type 3 and c-type 2. In case of l-type 1 FMCAAs, more caution is required in determining the treatment due to the relatively high complication rate.

A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation

  • Guk Jin Lee;Hyunho Kim;Sung Shim Cho;Hyung Soon Park;Ho Jung An;In Sook Woo;Jae Ho Byun;Ji Hyung Hong;Yoon Ho Ko;Der Sheng Sun;Hye Sung Won;Jong Youl Jin;Ji Chan Park ;In-Ho Kim;Sang Young Roh;Byoung Yong Shim
    • Journal of Gastric Cancer
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    • v.23 no.2
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    • pp.315-327
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    • 2023
  • Purpose: Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy. Materials and Methods: Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level. Results: Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250-0.890; P=0.020). Conclusions: After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.

Clinical Competence and Self-confidence of New Graduate Nurses with an Integrated Nursing Curriculum of Simulation with Problem-Based Learning (문제중심학습 연계 시뮬레이션 기반 통합간호교육과정을 이수한 신졸업간호사의 간호수행능력과 자신감)

  • Roh, Young Sook;Kim, Sunghee;Yang, Sun Hee;Kang, Yoon Sook
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.14 no.7
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    • pp.3349-3357
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    • 2013
  • The purpose of this study was to verify the effectiveness of an integrated nursing curriculum based on simulation with problem-based learning (PBL) by comparing the clinical competence and the self-confidence of newly graduated nurses. A non-equivalent control group post-test design was employed to compare the clinical competence and the self-confidence in the clinical performance examination using standardized patients between 39 newly graduated nurses with the traditional nursing curriculum and 35 with the integrated nursing curriculum. Data analysis involved Fisher's exact test, t-test, Pearson's correlation coefficient, and ANCOVA with the SPSS 19.0 program. The total clinical competence mean score graded by the standardized patients was not different between the two groups. However, the total clinical competence mean score graded by faculty was significantly higher in the integrated curriculum group than the traditional curriculum group. The mean self-confidence score was significantly higher in the integrated curriculum group than the traditional curriculum group. Active teaching-learning strategies including simulation or PBL in the nursing curriculum could benefit for nursing students by inducing favorable clinical competence and self-confidence. Longitudinal follow-up studies based on observation are needed to explore the patient outcomes in addition to the learner outcomes in clinical settings.

A Proposal for Research Process of Botanical Drug based Clinical Traditional Korean Medicine - Historical Evidence-Based Medicine II - (한의학임상에 기초를 둔 천연물신약 연구과정에 대한 소고 - 역사적 근거 발굴부터 천연물신약 임상시험계획승인신청까지 -)

  • Eom, Seok-ki;Kim, Se-hyun;Kim, Kyung-suk;Park, Sang-jae;Eo, Wan-kyu;Choi, Won-cheol
    • Journal of Korean Medical classics
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    • v.23 no.4
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    • pp.63-102
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    • 2010
  • Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group's experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group's experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.

Effects of Risperidone in Acute Manic Patients: An Open Clinical Trial (급성 조증환자에서 Risperidone의 치료효과: 임상 개방 연구)

  • Paik, In Ho;Lee, Chang Uk;Lee, Chul;Lee, Soo Jung;Kim, Jae Hyun
    • Korean Journal of Biological Psychiatry
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    • v.2 no.2
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    • pp.281-286
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    • 1995
  • Objects : Manic phase of bipolar disorder is treated with a combination of mood stabilizer and antipsychotic drug, especially in the acute phase. Such combined treatment is often required for the clinical management of manic symptoms until therapeutic effects of mood stabilizer become evident. The present study was the first open trial to evaluate the efficacy of risperidone, and safety of the combination of mood stabilizer and risperidone in the treatment of acute manic patients. Method : This study was performed as an open clinical study. The subjects of this study were 42 patients who had been admitted with first manifestations or acute exacerbations of illness were selected, using DSM-III-R criteria for bipolar disorder, manic episode. Patients were rated using the the Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI), Extrapyramidal Symptom Rating Scale(ESRS). Other adverse events were assessed by a symptom checklist and by observation by medical personnel. Vital signs were monitored in a standard way and electrocardiography, routine laboratory analysis were performed. Results : Thirty patients(67%) completed the 12-week trial period. The CGI showed a good therapeutic effect with a minimal incidence or severity of side effects. The majority of patients showed a continuos reduction in their BPRS scores. The extrapyramidal symptoms assessed on ESRS generally showed mild to moderate degree. laboratory porameters showed no significant changes during the course of treatment. Conclusion : The results of the study showed a good efficacy of the risperidone in manic patients and further controlled studies are warranted.

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Clinical Observation of Effect on Severity of Symptoms and Safety of Auto-microneedle Therapy in Patients with Peripheral Facial Paralysis (자동 미세침이 말초성 안면마비 환자의 증상 정도 및 안전성에 미치는 영향에 대한 임상 관찰)

  • Lee, Ung-In;Kwon, You-Jung;Kim, Hyun-Ho;Yoo, Je-Hyuk;Kim, Kyung-Wook;Kang, Jung-Won;Lee, Sang-Hoon
    • Journal of Acupuncture Research
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    • v.29 no.4
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    • pp.35-42
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    • 2012
  • Objectives : This study was to observe clinical application of auto-microneedle therapy system (AMTS) in patients with peripheral facial paralysis. Methods : 27 peripheral facial paralysis patients were observed after taking AMTS at Facial Palsy Center, Kyung Hee University Oriental Medicine Hospital from March 1, 2011 to January 9, 2012. We assessed the symptoms of facial paralysis with Yanagihara unweighted grading system, Sunnybrook facial grading system(SBGS) and facial disability index(FDI), and observed adverse events and total safety of the treatment. Results : The scores of facial palsy scales increased after AMTS in Yanagihara grading system and Sunnybrook facial grading system. AMTS-related adverse events were mild pain(5.9%) and fatigue(3.5%), which needed no extra treatment. The total safety evaluation was between 'safe' and 'nearly safe' level. There were no other serious adverse events. In addition, patients were satisfied with subjective improvement including facial tingling and numbness. Conclusions : AMTS can be applied as an adjunctive treatment for patients with peripheral facial paralysis due to its safety and clinical usefulness. It is easier to stimulate wide skin area in a short time. Further clinical research is required to investigate the effectiveness of ATMS in a more rigorous RCTs.

A Study on Safety Assessment and VAS Change Observation Before and After Non-toxic Bee Venom Treatment in Pain Patients Using Questionnaire: Retrospective Chart Review (설문조사를 이용한 통증환자의 무독화 봉독 시술에 따른 안전성 평가 및 시술 전후 VAS변화 관찰 연구: 후향적 차트리뷰)

  • Hwang, Yun-Kyeong;Jung, Taek-Geun;Cho, Sung-Woo;Kim, Won-Ill
    • Journal of Korean Medicine Rehabilitation
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    • v.27 no.1
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    • pp.53-65
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    • 2017
  • Objectives The purpose of this study is to evaluate the safety of Non-toxic bee venom (BV) and observe VAS change before and after Non-toxic BV treatment in pain patients. Methods We surveyed the clinical practitioners who treated with Non-toxic BV in pain patients who visited the Korean medical clinic. The questionnaire survey was conducted for clinical practitioners who agreed to participate after hearing the explanation for the purpose and characteristics of the questionnaire. Patients in the questionnaires were reviewed based on their medical records from July 1, 2016 to October 28, 2016. Results We received 445 cases and selected 403 cases finally. 2 cases, however, were not able to continue treatment for 3 weeks and were eliminated. Depending on when the pain occurred, we divided the 401 cases into three groups (Acute, Subacute, Chronic group). In all groups, VAS scores were significantly decreased after treatment. Adverse reactions following Non-toxic BV treatment had occurred was 16 cases (3.60%). Except for 3 cases with hives, most of adverse reactions were mild or moderate and were not in need of extra treatment. The total safety of treatment for 3 weeks was mostly safe. The number of cases discontinued treatment was 42 cases (9.44%). Most of these cases, treatment was stopped for personal reason unrelated to the Non-toxic BV treatment. Conclusions These results suggest that the Non-toxic BV treatment has no serious adverse reactions and is a relatively safe treatment. Further studies are needed to prove the efficacy and clinical safety of Non-toxic BV treatment.

Changes in Acute Poststreptococcal Glomerulonephritis: An Observation Study at a Single Korean Hospital Over Two Decades

  • Kuem, Sueng-Woo;Hur, Sun-Mi;Youn, You-Sook;Rhim, Jung-Woo;Suh, Jin-Soon;Lee, Kyung-Yil
    • Childhood Kidney Diseases
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    • v.19 no.2
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    • pp.112-117
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    • 2015
  • Purpose: The incidence of acute poststreptococcal glomerulonephritis (APSGN) in Korea has changed. This study aimed to evaluate the epidemiological and clinical changes of APSGN observed in a single Korean institution over two decades. Methods: We retrospectively analyzed the data of 99 children (0-15 years of age) who were admitted to our institution with APSGN between 1987 and 2013. The patients were selected based on the depression of serum complement 3 (C3, <70 mg/dL) and elevated titer of antistreptolysin O (ASO, >250 IU/dL) as evidence of previous streptococcal infection. Results: In the 99 patients, the mean age was $8.3{\pm}2.7$ years, and the male-to-female ratio was 2.2:1 (66:30). The annual number of cases fluctuated markedly, and most cases were observed during the late autumn and winter months. However, there have been few cases reported in the past 5 years. Clinical manifestations at presentation, including hypertension and generalized oedema, and the duration of hospitalization were higher and longer in patients admitted during the first half of the study period than during the most recent half-period, suggesting a more severe clinical course in the former group. Conclusions: APSGN has become a rare disease in Korea with a trend towards a less severe clinical course. This finding suggests that the prevalence of infection-related immune-mediated diseases could change over-time, together with environmental and possibly pathogen-host relationship changes.

Clinical Practice Satisfaction in the Department of Emergency Medical Service Students (응급구조과 학생의 임상실습 만족도)

  • Choi, Sung-Soo
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.14 no.2
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    • pp.759-767
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    • 2013
  • This study analysed Emergency Medical Technology(EMT) students' satisfaction in clinical practice. It was discovered that satisfaction was a means of 3.61(${\pm}0.70$) and the factor which had a significant influence on satisfaction was desired job area (F=3.98, p=0.004). The factors which were significant to satisfaction were practice beginning grade(t=0.43, p=0.038), period of practice(F=2.82, p=0.025), and departments(F=11.81, p=0.000) In respect to significant positive correlations between practice procedures and satisfaction, observation frequency (r=0.221, p=0.000) and practice frequency(r=0.170, p=0.002) had significantly positive correlations with satisfaction. Based on the results above, it is suggested that to enhance EMT students' satisfaction in clinical practice, students should have clear points of view on their job and practice beginning grade and practice period should be properly considered according to characteristics of students. Also, effective practice programs which carefully consider peculiarity of Emergency Medical Technology should be developed further.

Electroencephalography for the diagnosis of brain death

  • Lee, Seo-Young;Kim, Won-Joo;Kim, Jae Moon;Kim, Juhan;Park, Soochul;Korean Society of Clinical Neurophysiology Education Committee
    • Annals of Clinical Neurophysiology
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    • v.19 no.2
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    • pp.118-124
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    • 2017
  • Electroencephalography (EEG) is frequently used to assist the diagnosis of brain death. However, to date there have been no guidelines in terms of EEG criteria for determining brain death in Korea, despite EEG being mandatory. The purpose of this review is to provide an update on the evidence and controversies with regarding to the utilization of EEG for determining brain death and to serve as a cornerstone for the development of future guidelines. To determine brain death, electrocerebral inactivity (ECI) should be demonstrated on EEG at a sensitivity of $2{\mu}V/mm$ using double-distance electrodes spaced 10 centimeters or more apart from each other for at least 30 minutes, with intense somatosensory or audiovisual stimuli. ECI should be also verified by checking the integrity of the system. Additional monitoring is needed if extracerebral potentials cannot be eliminated. Interpreting EEG at high sensitivities, which is required for the diagnosis of brain death, can pose a diagnostic challenge. Furthermore, EEG is affected by physiologic variables and drugs. However, no consensus exists as to the minimal requirements for blood pressure, oxygen saturation, and body temperature during the EEG recording itself, the minimal time for observation after the brain injury or rewarming from hypothermia, and how to determine brain death when the findings of ECI is equivocal. Therefore, there is a strong need to establish detailed guidelines for performing EEG to determine brain death.