• Title/Summary/Keyword: randomized clinical trial

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Accuracy Comparison of Blood Pressure among the Direct Measurement Method and Two Automatic Indirect Measurement Methods in the Patients with Various Blood Pressure (다양한 혈압상태에서 직접혈압을 기준으로 HP 자동혈압기와 국산자동혈압기의 정확도 비교)

  • Song Hyo-Sook;Jun Tae-Gook;Choi Eun-Jung;Kim Mi-Jung
    • Journal of Korean Academy of Fundamentals of Nursing
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    • v.8 no.3
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    • pp.366-378
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    • 2001
  • Objective: The purpose of this study was to identify differences in measurement methods for blood pressure (Direct measurement, HP automatic indirect measurement, and SE 7000 Korean made indirect measurement), and to evaluate the clinical trial of the Korean made automatic indirect blood pressure measurement. Material & Methods: From June, 1999 to February, 2000, fifty five consecutive patients were randomized into hypertension group (n=20), normotension group (n=20), and hypotension group (n= 15). Measuring blood pressure by indirect methods (HP NIBP M 1008B and SE 7000 NIBP Korean made) was done simultaneously in the same arm with arterial line for direct blood pressure measurement (HP M1006A). The procedures were repeated ten times at intervals of 2 minutes. Statistical analysis was Performed using SPSS (version 8.0 for windows) software package. Values were expressed as means and standard deviation and means were compared using t-test. Statistical significance was considered present with a p value less than 0.05. Results: In the hypertension group and noromotension group, the disparity between HP direct measurement and indirect SE 7000 NIBP did not show any differences compared to the disparity between HP direct measurement and indirect HP NIBP. In the hypotension group, the disparity in the diastolic pressure between HP direct measurement and indirect SE 7000 NIBP was significantly different compared to the disparity between HP direct measurement and indirect HP NIBP (p<0.001), however, disparities in systolic pressure did not showed any differences. Conclusion: Direct blood pressure measurement (HP M1006A) can be replaced with indirect blood pressure measurements (HP NIBP M 1008B & SE 7000 NIBP) in normotension and hypertension patients. Korean made indirect measurement was found to be more accurate compared to HP indirect measurement in hypotension Patients, but more study is needed.

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Analysis of Research on Adherence for Secondary Prevention in Patients with Coronary Artery Disease in Korea (국내 관상동맥질환자의 이차예방을 위한 "이행" 관련 논문분석)

  • Son, Youn-Jung;Kim, Sun-Hee;Song, Hyo-Suk
    • Journal of Korean Academy of Fundamentals of Nursing
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    • v.17 no.4
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    • pp.575-587
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    • 2010
  • Purpose: The purpose of this study was to analyze the research on adherence for secondary prevention in patients with coronary artery disease (CAD) in Korea, and to identify the strategies for improvement that should be included in future studies. Methods: Electric literature searches were conducted for Pubmed, CINAHL, RISS4U, KISTI, DBpia, KoreaMed, National Assembly Library, and National Library of Korea. A total of forty two articles published between 1986 and 2009 were selected based on established inclusion criteria. Results: Forty research papers were related to nursing, and there was only one research paper focused 011 elderly people with CAD. There were no papers using concept analysis, qualitative study. or randomized controlled clinical trial. Almost all definitions of adherence were adopted from outdated compliance definitions with the attribute of 'paternalistic obligation', Measurement tools were not based on theoretical framework of adherence but borrowed from tools for measuring self-care, health behavior, or self-efficacy. Overall patient's adherence was analyzed in most studies, except for a few studies which focused on diet and exercise only. Educational strategy was the main strategy used in intervention studies. Conclusions: The concept of adherence and measurement tools need to be clarified, along with development of the specific adherence interventions according to the type of adherence in patients with CAD.

Chuna Manual Therapy for Functional Dyspepsia : A Systematic Review and Meta-analysis (기능성 소화불량증에 대한 추나요법의 효과 : 체계적 문헌고찰과 메타분석)

  • Heo, In;Shin, Byung-Cheul;Hwang, Eui-Hyoung;Hwang, Man-Suk;Kim, Byung-Jun;Kim, So-Yeon;Heo, Kwang-Ho
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.10 no.1
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    • pp.1-14
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    • 2015
  • Objectives : To evaluate the evidence supporting the effectiveness of Chuna manual therapy for functional dyspepsia. Methods : We conducted search across the 3 electronic databases (Pubmed, CAJ and Oasis) to find all of randomized controlled clinical trials(RCTs) that used Chuna manual therapy as a treatment for functional dyspepsia. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool. Results : Thirteen RCTs met our inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy combined with medication treatments in terms of the efficacy rate when compared to medication treatments alone. Positive results were also obtained, in terms of the efficacy rate, when comparing Chuna manual therapy combined with medication plus specific electromagnetic therapy to medication treatments alone. Conclusions : Our systematic review found encouraging but limited evidence of Chuna manual therapy for functional dyspepsia. However, to obtain stronger evidence without the drawbacks of trial design and the quality of studies, we recommend sham-controlled RCTs or comparative effectiveness research to test the effectiveness of Chuna manual therapy.

Applicability of Radioguided Occult Lesion Localization for Non-Palpable Benign Breast Lesions, Comparison with Wire Localization, a Clinical Trial

  • Alikhassi, Afsaneh;Saeed, Farzanefar;Abbasi, Mehrshad;Omranipour, Ramesh;Mahmoodzadeh, Habibollah;Najafi, Massoome;Gity, Masoumeh;Kheradmand, Ali
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.7
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    • pp.3185-3190
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    • 2016
  • Background: This study was designed to compare radioguided versus routine wire localization of nonpalpable non-malignant breast lesions in terms of efficacy for complete excision, ease of use, time saving, and cosmetic outcome. Materials and Methods: Patients with non-palpable breast masses and non-malignant core biopsy results who were candidates for complete surgical lumpectomy were enrolled and randomly assigned to radioguided or wire localization groups. Radiologic, surgical, and pathologic data were collected and analyzed to determine the difficulty and duration of each procedure, ease of use, accuracy, and cosmetic outcomes. Results: This prospective randomized study included 60 patients, randomly divided into wire guided localization (WGL) or radioguided occult lesion localization (ROLL) groups. The mean duration of localization under ultrasound guidance was shorter in the ROLL group (14.4 min) than in the WGL group (16.5 min) (p<0.001). The ROLL method was significantly easier for radiologists (p=0.0001). The mean duration of the surgical procedure was 22.6 min (${\pm}10.3min$) for ROLL and 23.6 min (${\pm}9.6min$) for WGL (p=0.6), a non-significant difference. Radiography of the surgical specimens showed 100% lesion excision with clear margins, as proved by pathologic examination, with both techniques. The surgical specimens were slightly heavier in the ROLL group, but the difference was not significant (p=0.06). Conclusions: The ROLL technique provides effective, fast, and simple localization and excision of non-palpable non-malignant breast lesions.

Effects of α-tocopherol on hemolysis and oxidative stress markers on red blood cells in β-thalassemia major

  • Sovira, Nora;Lubis, Munar;Wahidiyat, Pustika Amalia;Suyatna, Franciscus D.;Gatot, Djajadiman;Bardosono, Saptawati;Sadikin, Mohammad
    • Clinical and Experimental Pediatrics
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    • v.63 no.8
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    • pp.314-320
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    • 2020
  • Background: The accumulation of unpaired α-globin chains in patients with β-thalassemia major may clinically create ineffective erythropoiesis, hemolysis, and chronic anemia. Multiple blood transfusions and iron overload cause cellular oxidative damage. However, α-tocopherol, an antioxidant, is a potent scavenger of lipid radicals in the membranes of red blood cells (RBCs) of patients with β-thalassemia major. Purpose: To evaluate the effects of α-tocopherol on hemolysis and oxidative stress markers on the RBC membranes of patients with β-thalassemia major. Methods: Forty subjects included in this randomized controlled trial were allocated to the placebo and α-tocopherol groups. Doses of α-tocopherol were based on Institute of Medicine recommendations: 4-8 years old, 200 mg/day; 9-13 years old, 400 mg/day; 14-18 years old, 600 mg/day. Hemolysis, oxidative stress, and antioxidant variables were evaluated before and after 4-week α-tocopherol or placebo treatment, performed before blood transfusions. Results: Significant enhancements in plasma haptoglobin were noted in the α-tocopherol group (3.01 mg/dL; range, 0.60-42.42 mg/dL; P=0.021). However, there was no significant intergroup difference in osmotic fragility test results; hemopexin, malondialdehyde, reduced glutathione (GSH), or oxidized glutathione (GSSG) levels; or GSH/GSSG ratio. Conclusion: Use of α-tocopherol could indirectly improve hemolysis and haptoglobin levels. However, it played no significant role in oxidative stress or as an endogen antioxidant marker in β-thalassemia major.

Mandibular changes during initial alignment with SmartClip self-ligating and conventional brackets: A single-center prospective randomized controlled clinical trial

  • Celikoglu, Mevlut;Bayram, Mehmet;Nur, Metin;Kilkis, Dogan
    • The korean journal of orthodontics
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    • v.45 no.2
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    • pp.89-94
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    • 2015
  • Objective: To test the null hypothesis that SmartClip self-ligating brackets are more effective than conventional brackets for initial mandibular alignment and identify influential factors. Methods: Fifty patients were randomly allocated to two equal treatment groups by using an online randomization program: self-ligating group (SmartClip brackets) and conventional group (Gemini brackets). The archwire sequence was standardized. Changes in anterior irregularity index, intercanine width, and intermolar width were assessed on plaster models at 8th and 16th weeks. Changes in incisor position and inclination were assessed on lateral cephalometric radiographs at 16 weeks. Intragroup and intergroup comparisons were performed with paired t-test and Student's t-test, respectively. Multiple linear regression was performed to identify variables affecting improvement in anterior ambiguity. Results: Data of 46 patients were analyzed; those missing an appointment (n = 2) or showing bracket breakage (n = 2) were excluded. Incisor inclination (p < 0.05), intercanine width (p < 0.05), and intermolar width (p > 0.05) increased at 8 and 16 weeks in both the groups; no significant intergroup differences were noted (p > 0.05). Initial anterior irregularity index and intercanine width change were significantly associated with improvement in anterior irregularity (p < 0.001). Conclusions: The null hypothesis was rejected. Bracket type has little effect on improvement in anterior ambiguity during initial mandibular alignment.

Effect of a Physical Activity Promoting Program Based on the IMB Model on Obese-Metabolic Health Outcomes among Obese Older Adults with Knee Osteoarthritis (슬관절염 비만노인을 위한 IMB 모델 기반 신체활동 증진 프로그램의 효과)

  • Kim, Jung-Suk;Kim, Chun-Ja
    • Journal of Korean Academy of Nursing
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    • v.50 no.2
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    • pp.271-285
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    • 2020
  • Purpose: This study examined the effects of a physical activity promoting program based on the Information-Motivation-Behavioral Skills (IMB) model on physical activity and health outcomes among obese older adults with knee osteoarthritis. Methods: This study utilized a randomized controlled trial with a convenience sample of 75 obese older adults with knee osteoarthritis in a university hospital. The older adults in the intervention group participated in a 12-week program involving weekly group sessions and monitoring calls with education booklets and video clips for exercise dances, while those in the control group received an usual care. Outcomes were measured using self-report questionnaires, anthropometrics, and blood analyses. The intervention effects were analyzed using Mann-Whitney U test and ANCOVA. Results: The mean age of participants was 74.9 years with 84.0% women. The intervention group at 12 weeks showed significantly greater improvements in self-efficacy for physical activity (F=81.92, p<.001), physical activity amounts (Z=-2.21, p=.044), knee joint function (F=15.88, p<.001), and health-related quality of life (F=14.89, p<.001) compared to the control group. Among obese-metabolic outcomes, the intervention group at 12 weeks showed a significant decrease in visceral fat mass (F=7.57, p=.008) and improvement in high-density level cholesterol (F=9.51, p=.003) compared to the control group. Conclusion: Study findings support the need for an IMB based physical activity program for promoting physical activity, knee function and health outcomes in obese older adults with knee osteoarthritis. Longitudinal studies are warranted to confirm the persistence of obese-metabolic effects in clinical settings.

The Effects of Gabapentin in Treatment of Burning Mouth Syndrome: Retrospective Pilot Study

  • Heo, Jun-Young;Ok, Soo-Min;Jeong, Sung-Hee;Kim, Kyung-Hee;Ahn, Yong-Woo
    • Journal of Oral Medicine and Pain
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    • v.39 no.3
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    • pp.96-99
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    • 2014
  • Purpose: The objective of this retrospective pilot study was to evaluate the effectiveness of Gabapentin in patients with primary burning mouth syndrome (BMS). Methods: Ten subjects were diagnosed with primary BMS (8 women and 2 men). The mean age was 60.1 years. They had clinical examination to exclude local factors such as the presence of Candida species, xerostomia, lichen planus, etc. They also underwent hematological examination to exclude secondary BMS due to systemic disorders. Pain was assessed by patients on an 11-point numerical rating score system (0 to 10). Gabapentin was administered at a starting dose of 300 mg/day, slowly titrated up to maximum of 1,800 mg/day. All patients were treated for 4 weeks. Results: One half of the patients (n=5) obtained reduction in pain over the treatment period. Four patients reported no reduction in pain symptoms. One patient reported that symptoms were worsening. The average pain score before the treatment was 6.3 and after the treatment was 5.25. No significant relationship was detected between pretreatment and posttreatment pain score. Only one patient noted mild side effect (dizziness). Conclusions: This retrospective pilot study provides no preliminary evidence that Gabapentin has effect in the management of BMS. However, further research (well-designed, randomized, and controlled trial with large sample) would be needed to investigate the efficacy of Gabapentin in treatment of BMS.

The Clinical Effect of Manipulation of Acupuncture to Shen-Men and Nei-Kuan on Autonomic Nervous Function of Healthy Subjects.

  • Jung, Woo-Sang;Choi, Chang-Min;Hong, Jin-Woo;Park, Seong-Uk;Moon, Sang-Kwan;Park, Jung-Mi;Ko, Chang-Nam;Cho, Ki-Ho;Kim, Young-Suk;Bae, Hyung-Sup
    • The Journal of Korean Medicine
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    • v.28 no.4
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    • pp.69-73
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    • 2007
  • Objectives : With an assumption of the traditional oriental medical theory, we were to evaluate the effect of tonification/sedation-manipulated acupuncture on autonomic nervous activity in healthy subjects. Methods : This study is a randomized cross-over trial. We enrolled healthy subjects, and assigned them randomly into group A or group B. Group A received acupuncture therapy on Shen-Men (He-7) and Nei-Kuan (EH-6) with tonification-manipulation, while Group B received it with sedation-manipulation. Their heart rate variability was monitored for 2 hours. After 3 days of washout period, the subjects were crossed over to the other manipulation method, and the same procedures were performed. Results : There was no statistical significance in the change of RR, SDNN, LF, HF, and LF/HF ratio between the tonification-manipulated and the sedation-manipulated groups. However, HF curve in the tonification manipulated group showed increasing tendency for 15 minutes after acupuncture. Conclusions :We suggest that the traditional tonification-manipulated acupuncture on Shen-Men and Nei-Kuan could increase parasympathetic activity shortly after acupuncture, but further evaluation on a larger sample size is needed to confirm this suggestion.

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Effect of probiotics intake on oral environment changes of the elderly in long-term care facilities (프로바이오틱스 섭취가 장기요양시설 노인의 구강환경 변화에 미치는 효과)

  • Jo, Se-Rim;Cho, Ja-Won;Jang, Jong-Hwa
    • Journal of Korean society of Dental Hygiene
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    • v.20 no.5
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    • pp.753-762
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    • 2020
  • Objectives: This study was aimed at evaluating the effects of changes in the oral environment of the elderly in long-term care facilities after the intake of Weissella cibaria. Methods: The test group ingested the W. cibaria strain Chonnam Medical University (CMU), and the control group ingested the control food. Of all randomized trial subjects, 62 were analyzed (32 in the experimental group and 30 in the control group). In this 8-week demographic study, we evaluated self-perceived halitosis, changes in halitosis, sensory test results, tongue plaque index scores, saliva buffering capacity, and the salivary flow rate. Results: The W. cibaria CMU intake in the elderly in long-term care facilities during the experimental period did not demonstrate statistically significant changes in the salivary flow rate. However, self-perceived halitosis, organoleptic test results, tongue plaque index scores, and salivary buffering capacity demonstrated statistically significant differences between the experimental and control groups. These findings partially confirmed the beneficial effects of the W. cibaria CMU on the oral environment in the elderly. Conclusions: Research results on the role of probiotics in the oral cavity should be summarized, and utilization plans should be sought to obtain a clearer understanding of the clinical efficacy and related factors. The value of probiotic use may be high in improving the oral health of people by enabling treatment and prevention.