• Title/Summary/Keyword: observational study

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Effect of Portal Vein Chemotherapy on Liver Metastasis after Surgical Resection of Colorectal Cancer

  • Yu, Dong-Sheng;Li, Ying;Huang, Xin-En;Lu, Yan-Yan;Wu, Xue-Yan;Liu, Jin;Cao, Jie;Xu, Xia;Xiang, Jin;Wang, Guo-Ping
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.9
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    • pp.4699-4701
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    • 2012
  • Objective: To explore the effect of portal vein chemotherapy on liver metastasis after surgical resection of colorectal cancer. Methods: Patients fulfilling the eligibility criteria were assigned to receive either surgery plus 1-week continuous infusion of 5-FU (study group) or surgery alone (observational group). Patients in the study group received portal vein chemotherapy, whereby 5-FU (1000 mg/d) and heparin (5000 IU/d) infusion was initiated from the day of surgery and lasted for 7 consecutive days. Liver metastasis was monitored during five years follow-up postoperatively. Results: Sixty four patients were recruited and assigned to the study group (12 with colon and 20 with rectal cancer) or the control group (10 with colon and 22 with rectal cancer). Liver metastasis rate was 12.5% in study and 25.0% in observational group, the difference being significant (P<0.01). Conclusion: Portal vein chemotherapy could be an effective treatment in preventing liver metastasis after surgical resection of colorectal cancer.

STUDY OF SOLAR ACTIVE REGIONS BASED ON BOAO VECTOR MAGNETOGRAMS

  • MOON YONG-JAE;PARK YOUNG DEUK;YUN HONG SIK;CHO EUN-AH
    • Journal of The Korean Astronomical Society
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    • v.32 no.2
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    • pp.127-136
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    • 1999
  • In this study we present the study of solar active regions based on BOAO vector magnetograms and H$\alpha$ filtergrams. With the new calibration method we analyzed BOAO vector magnetograms taken from the SOFT observational system to compare with those of other observing systems. In this study it has been demonstrated that (1) our longitudinal magnetogram matches very well the corresponding Mitaka's magnetogram to the extent that the maximum correlation yields r=0.962 between our re-scaled longitudinal magnetogram and the Mitaka's magnetogram; (2) according to a comparison of our magnetograms of AR 8422 with those taken at Mitaka solar observatory their longitudinal fields are very similar to each other while transverse fields are a little different possibly due to large noise level; (3) main features seen by our longitudinal magnetograms of AR 8422 and AR 8419 and the corresponding Kitt Peak magnetograms are very similar to each other; (4) time series of our vector magnetograms and H-alpha observations of AR 8419 during its flaring (M3.1/1B) activity show that the filament eruption followed the sheared inversion line of the quadrupolar configuration of sunspots, indicating that the flare should be associated with the quadrupolar field configuration and its interaction with new filament eruption. Finally, it may be concluded that the Solar Flare Telescope at BOAO works normally and it is ready to do numerous observational and theoretical works associated with solar activities such as flares.

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Prospective Observational Study of Acupuncture Adverse Events: 50 Patients Hospitalized for Peripheral Facial Palsy Treatments (침치료 이상반응에 대한 전향적 관찰: 말초성 안면신경마비 입원 환자 50명을 대상으로)

  • Kim, Dong-Hyuk;Kim, Kyung-Wook;Kim, Jong-Han;Kim, Hyun-Ho;Park, Ji-Min;Yoo, Je-Hyuk;Nam, Dong-Woo;Lee, Sang-Hoon;Choi, Do-Young
    • Journal of Acupuncture Research
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    • v.28 no.4
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    • pp.65-76
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    • 2011
  • Objectives : The aim of this study is to survey adverse events of acupuncture in the course of peripheral facial palsy treatments. Methods : The prospective observational study included patients hospitalized to receive acupuncture treatments for peripheral facial palsy. All patients were surveyed daily for adverse events associated with the acupuncture treatments applied the day before. Results : A total of 50 patients received $37.68{\pm}20.37$ acupuncture treatments in average. 36 patients reported experiencing at least one adverse event. Total 163 adverse events were reported. Common adverse events were bleeding(62), bruise(33), pain(30), tiredness(11), hematoma(7). The others were paresthesia(4), erythema(3), delay of removing needles(2), edema(2), aggravation of symptoms(2), declining of appetite(2), pruritus(1), drowsiness(1), anxiety(1), sweating(1), headache(1). Conclusions : Acupuncture has adverse events, like any therapeutic approaches. However, it is a relatively safe treatment. In future study, organized large scale prospective survey should be carried out to fully prove that acupuncture is safe.

Incidence and Management of Toxicity Associated with L-Asparaginase in the Treatment of ALL and NK/T-Cell Lymphoma: an Observational Study

  • Yeang, Shu Hui;Chan, Alexandre;Tan, Chuen Wen;Lim, Soon Thye;Ng, HengJoo
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.7
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    • pp.3155-3160
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    • 2016
  • Background: L-asparaginase (ASNase) is commonly used in the treatment of acute lymphoblastic leukemia (ALL) and natural killer (NK)/T-cell lymphoma. This study was designed to describe the incidence of toxicity associated with ASNase in Asian adults. Secondary objectives were to investigate the management and impact of toxicity on subsequent ASNase use, and to compare the actual management against current recommendations. Materials and Methods: In this retrospective, multi-center, observational study, Asian patients ${\geq}18$ years old who received ${\geq}1$ dose of the native E. coli ASNase from 2008 to 2013 were included. Patients were excluded if they did not receive ASNase. Endpoints of this study were development of specific toxicities, whether ASNase was discontinued or re-challenged, and developmentg of recurrent toxicity. All data analyses were performed using SPSS version 20.0. Results: A total of 56 patients were analyzed. Mean (${\pm}SD$) age was 36.2 (${\pm}15.2$) years old, with 62.5% being males, 55.4% with ALL and 28.6% with NK/T-cell lymphoma. Hypersensitivity (12.5%) was associated with the highest incidence of toxicity (6 out of 7 patients had Grade 3 and 4 toxicity), followed by 10.7% for hepatic transaminitis, 3.6% for non-CNS thrombosis and 1.8% each for hyperbilirubinemia and pancreatitis. Hypersensitivity recurred in the 3 patients who were re-challenged with E. coli ASNase. Conclusions: ASNase is associated with a wide range of toxicities, with hypersensitivity being the most commonly observed among Asian adult patients.

Significance of the tethered maxillary frenulum: a questionnaire-based observational cohort study

  • Naimer, Sody A.;Israel, Ariel;Gabbay, Aviezer
    • Clinical and Experimental Pediatrics
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    • v.64 no.3
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    • pp.130-135
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    • 2021
  • Background: The clinical significance of lip-tie, or a tethered maxillary frenulum, remains under debate. Clinicians and parents are often perplexed when deciding whether procedures available to relieve a seemingly tight or severe maxillary frenulum are needed. Purpose: No previous studies have assessed the consequences of not subjecting a tethered maxillary frenulum in newborns to surgical intervention. This study aimed to contribute the first prospective trial on this topic with a relatively extended follow-up of these newborn infants. Methods: This prospective observational questionnaire-based cohort trial was performed in a community setting and aimed to determine whether lip-tie is associated with an increased likelihood of eventual feeding or oral disorders. Results: The convenience sample comprised of 61 consecutively arriving infants with concomitant tethered frenula who were treated at the clinic for various reasons. This cohort was compared with a random sample of 66 age-matched children for a mean follow-up period of 6.42 years. Infants undergoing oropharyngeal procedures were excluded. Awareness of a deviation in oral structures was reported by 18% of the study group versus 0% of the controls. Mothers participating in the study group (24.6%) less frequently recalled painful nipples or discomfort during breastfeeding than those in the control group (47.0%) (P<0.01). There were no intergroup differences in other types of feeding difficulty, dental hygiene, pronunciation, or speech development. Conclusion: Our findings suggest that a tethered labial frenulum is not associated with an increase in breastfeeding disturbances or oral disorders. These data encourage clinicians to question the need to intervene in cases of tethered maxillary frenula.

Analysis of Korean Medicine Treatment in Children with Cerebral Palsy (뇌성마비 아동의 한의치료 양상 분석)

  • Jeong, Hyunwoo;Hur, Youngjin;Yun, Youngju
    • The Journal of Korean Medicine
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    • v.40 no.1
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    • pp.12-23
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    • 2019
  • Objectives: The purpose of this study was to analyze the aspects of the Korean medicine (KM) treatment among children with cerebral palsy (CP) according to the disease characteristics. Methods: In a prospective observational multicenter study for children with CP, we analyzed 78 baseline questionnaires of children having experience of KM treatments such as acupuncture and Korean herbal medicine and 43 follow-up data of children who have received KM during the one observation year. Results: Of all the 182 participants, 38 children were currently getting KM treatment and 40 children have discontinued KM treatment. Children with non-spastic CP and more health problems tended to use KM. The most frequent reason for quitting acupuncture therapy was 'suffering of children' and the highest reason of stopping herbal medicine was 'rejection of children'. Among the 133 participants finished one year follow-up, 43 children have received at least one KM treatment. The average number of acupuncture therapy was twice a week and the average monthly cost of acupuncture therapy and herbal medicine were 65,922 won and 476,003 won, respectively. Children under 32 month old have received significantly more acupuncture and children with non-spastic CP have taken significantly more herbal medicine. Conclusions: Further study will be required to confirm the effectiveness of KM and increase the utilization of KM among the children with CP. More efforts should be made to increase the convenience of acupuncture therapy and herbal medicine and to expand the insurance coverage of KM for children with CP.

Comparative observational study of aminophylline with prophylactic and therapeutic uses for clinical outcomes in preterm infants

  • Bae, Mi Hye;Lee, Na Rae;Han, Young Mi;Byun, Shin Yun;Park, Kyung Hee
    • Kosin Medical Journal
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    • v.33 no.3
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    • pp.380-385
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    • 2018
  • Objectives: Aminophylline has been used for prevention or treatment of apnea in preterm infants with idiopathic apnea of prematurity. The aim of this study was to assess the clinical usefulness of prophylactic in comparison with therapeutic aminophylline therapy. Methods: This retrospective observational study included infants born with a birth weight of < 2,500 g or at < 36 weeks of gestation. Infants born between August 2013 and July 2014 who received aminophylline therapy within 24 hr after birth were assigned to the prophylactic group, while infants born between August 2014 and July 2015 who received aminophylline therapy after obvious apnea were assigned to the therapeutic group. We compared clinical characteristics, including days of ventilator and oxygen therapy and bronchopulmonary dysplasia (BPD) between both groups. Results: Sixty-four patients and 25 infants were identified in the prophylactic and therapeutic groups, respectively. The mean gestational age and birth weight were $32.57{\pm}1.96weeks$ and $1765{\pm}205g$, respectively, in the prophylactic group and $32.46{\pm}1.82weeks$ and $1770{\pm}250g$, respectively, in the therapeutic group. No significant differences in clinical characteristics were found between the two groups. Similar clinical outcomes, including days of ventilator and oxygen therapy, intraventricular hemorrhage (IVH), periventricular leukomalacia, and BPD, were observed between the two groups. Conclusions: The present study showed that the prophylactic use of aminophylline does not improve the clinical outcomes, including BPD, IVH, and ventilator dependency as compared with therapeutic use. In other words, routine prophylactic use of aminophylline is unnecessary.

Korean Domestic Trends of Clinical Research and Direction of Intervention for Fibromyalgia (섬유근통에 대한 국내 임상 연구 동향 및 중재 방향)

  • Lee, Jung-Han;Geum, Ji-Hye;Woo, Hyeon-Jun;Lee, Chang-Hoon;Chung, Chong-Hyuk;Lee, Myeung-Su
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.15 no.2
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    • pp.43-54
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    • 2020
  • Objectives The purpose of this review was to analyze the trend of clinical research related to fibromyalgia and to suggest the direction of intervention Methods We reviewed the clinical research by searching seven Korean web databases and classified the studies by the year of publication, academic field, and study design. Results A total of 75 clinical studies were selected. Except for 2002, more than one study was annually published; however, the number was below 10. In the academic field, there were 34 in the medical field, 21 in the Korean medicine field, and 15 in the nursing science field. By study design, there were 62 observational studies, mostly case reports and case-control studies. There were 13 experimental studies, including non-random control studies and one group pre and post-test design studies. Conclusions Fibromyalgia-related clinical research requires a greater number of studies, and a study design with a high level of evidence should be conducted along with various observational and intervention studies. Additionally, multidisciplinary and integrated intervention plans and research are needed.

An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients

  • Eun-Yeong Cho;Jung-Eun Cho;Eun-Bin Lee;Seung Soo Yoo;Jung Hyun Chang
    • Tuberculosis and Respiratory Diseases
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    • v.86 no.1
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    • pp.33-46
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    • 2023
  • Background: Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. Methods: This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 ㎍/25 ㎍) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician's evaluation (effective, ineffective/no change, worsening, indeterminable) and lung function improvement. Results: Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. Conclusion: This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment.

An Observational Multi-Center Study Protocol for Distribution of Pattern Identification and Clinical Index in Parkinson's Disease (파킨슨병 변증 유형 및 지표 분포에 대한 전향적 다기관 관찰연구 프로토콜)

  • HuiYan Zhao;Ojin Kwon;Bok-Nam Seo;Seong-Uk Park;Horyong Yoo;Jung-Hee Jang
    • The Journal of Internal Korean Medicine
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    • v.45 no.1
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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)