• Title/Summary/Keyword: Clinical Trial Design

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Effects of Bojungikgi-tang and its modifications for Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (빈혈에 대한 보중익기탕 및 그 가미방의 효과: 체계적 문헌고찰과 메타분석)

  • Mikyung Kim;Chang-ho Han
    • The Journal of Korean Medicine
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    • v.44 no.2
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    • pp.181-200
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    • 2023
  • Objectives: This study aimed to evaluate the efficacy and safety of Bojungikgi-tang (BJIG) and its modifications for patients with anemia. Methods: The subject of analysis of this study was a parallel design randomized controlled trial in which BJIG or its modifications was administered orally to patients who met the World Health Organization's anemia criteria and the efficacy and safety were prospectively measured. Electronic databases were searched to retrieve eligible literature published from 1 January 2000 to 12 February 2023. A meta-analysis was conducted, and the risk of bias (RoB) and level of evidence of the included studies was assessed using the Cochrane RoB 2 tool and GRADE method, respectively. Results: Five studies were included in the meta-analysis. When BJIG or its modifications was administered to anemia patients receiving conventional treatment, additional benefits compared to the non-administered group were found in terms of an increase in red blood cell count (mean difference (MD) 0.46 × 1012/L, 95% confidence interval (CI) 0.17 to 0.74), hemoglobin concentration (MD 9.28 g/L, 95% CI 6.06 to 12.51), hematocrit (MD 2.57%, 95% CI 1.76 to 3.38), total effective rate (odds ratio 5.29, 95% CI 2.05 to 13.68), and traditional Chinese medicine symptom scores (standardized MD -1.51, 95% CI -2.79 to -0.24). Conclusions: This study demonstrated the clinical potential of BJIG and its modifications to provide additional benefits to patients with anemia receiving conventional treatment.

Effects of Non-Contact Complex Exercise Program on the Older over 65 Years of Age on Muscle Strength, Falling Efficacy and Balance Ability

  • Sam Ho Park;Youn Jung Oh;Myung Mo Lee
    • Physical Therapy Rehabilitation Science
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    • v.12 no.2
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    • pp.167-176
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    • 2023
  • Objective: The purpose of this study was to investigate the effects of anon-contact complex exercise program on muscle strength, fall efficacy, quality of life, and balance ability in older over 65 years of age. Design: A randomized controlled trial Methods: A total of 37 people in older over 65 years of age participated in the study. Random program was conducted and assigned to the experimental group (n=19) and the control group (n=18). Both groups performed the older people welfare center program. In addition, in the experimental group, a non-contact complex exercise program for muscle and balance exercise was performed. All interventions were performed 2 times a week, for a total of 6 weeks. chair stand test (CST), fall efficacy scale (FES), Euro quality of life 5 dimension (EQ-5D), Berg balance scale (BBS), timed up and go test (TUG), Fullerton advanced balance scale (FAB) were measured before and after the intervention to compare their effectiveness. Results: Both groups showed significant differences in CST, FES, EQ-5D, BBS, and TUG before and after intervention (p<0.05). FAB showed significant differences before and after intervention in all items except for FAB 8 and 9 items in the experimental group. In addition, the experimental group showed significant differences in CST, FES, BBS, TUG, FAB (except 1, 7, 8, 9) compared to the control group (p<0.05). Conclusions: The non-contact complex exercise program is an effective intervention method that has clinical significance in improving muscle strength, fall efficacy and static and dynamic balance abilities for the older over 65 years of age.

Music and Art Therapy for Parkinson's Disease Patients: A Demand Survey (파킨슨병 환자 대상 음악 및 미술 치료 수요 설문조사)

  • Shin Young Park;Miso S. Park;Wang Jung Hur;Jaeson Pyeon;Horyong Yoo
    • Journal of TMJ Balancing Medicine
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    • v.13 no.sup
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    • pp.9-14
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    • 2023
  • Objectives: The purpose of this study was to investigate patients' demand for music and art therapy in the treatment of Parkinson's disease and to understand how patients view the use of music and art therapy as a complementary form of treatment that can improve their quality of life and increase their self-efficacy in addition to medication. Methods: To this end, 60 Parkinson's patients visiting Daejeon Korean Medicine Hospital at Daejeon University were surveyed about music and art therapy. Results: The survey demonstrated a highly positive response to the music program, with strong belief in its efficacy for Parkinson's disease and significant interest in participation. Group music therapy was perceived as effective for enhancing mental health, respiratory function, language disorders, and overall quality of life. Although the art program was also deemed effective, patients showed slightly lower interest and willingness to participate compared to music therapy. The patients preferred 60-minute sessions once a week for about 8 weeks. Conclusions: We propose the following directions for a Parkinson's music and art therapy program. First, develop a once-a-week, 8-week music and art program for Parkinson's patients. Second, design the music program to focus on improving respiratory function and quality of life. Third, the art program focuses on creating a sense of security and comfort through emotional exchange among patients and improving self-efficacy.

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Integrated Effect of Non-Invasive Neuromodulation on Bladder Capacity in Traumatic Spinal Cord Injury Patient: Single Case Report

  • Priyanka Dangi;Narkeesh Arumugam;Dinesh Suman
    • Physical Therapy Rehabilitation Science
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    • v.13 no.1
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    • pp.86-94
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    • 2024
  • Objective: To evaluate the changes in bladder capacity and storage through non-invasive neuromodulation by application of repetitive Trans magnetic stimulation (rTMS) and genital nerve stimulation (GNS) in traumatic spinal cord survivors. Design: A Single Case Study. Method: The Patient was registered in trail with the clinical trial registry of India (CTRI/2022/05/042431). The Patient was interposed with rTMS on lumbar area, from T11-L4 vertebrae with 1 Hz and the intensity was 20% below that elicited local paraspinal muscular contraction for 13 minutes. GNS was placed over dorsum of the penis with the cathode at the base and anode 2 cm distally at 20 Hz, 200 microseconds, Continuous and biphasic current was delivered and amplitude of stimulation necessary to elicit the genito-anal reflex. For assessment, Neurological examination was done for peri-anal sensation (PAS), voluntary anal contraction (VAC) and bulbocavernous reflex (BCR), deep anal pressure (DAP), and American Spinal Injury Association Impairment Scale (ASIA scale). Outcome assessment was done using Urodynamics, Spinal Cord Independence Measure Scale Version-III (SCIM-III), American Spinal Injury Association Impairment Score (ASIA Score), Beck's Depression Inventory Scale (BDI). The baseline evaluation was taken on Day 0 and on Day 30. Results: The pre-and post-data were collected through ASIA score, SCIM-III, BDI and Urodynamics test which showed significant improvement in bladder capacity and storage outcomes in the urodynamics study across the span of 4 weeks. Conclusion: rTMS along with GNS showed improvement in bladder capacity & storage, on sensory-motor score, in functional independence of individual after SCI.

Evaluation of marginal and internal gap under model-free monolithic zirconia restoration fabricated by digital intraoral scanner (디지털 구강스캐너로 모형 없이 제작한 전부지르코니아 수복물의 변연 및 내면 적합도 평가)

  • Lee, Jong-Won;Park, Ji-Man
    • The Journal of Korean Academy of Prosthodontics
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    • v.54 no.3
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    • pp.210-217
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    • 2016
  • Purpose: The aim of this study was to evaluate the marginal and internal adaptation of monolithic zirconia restoration made without physical model by digital intraoral scanner. Materials and methods: A prospective clinical trial was performed on 11 restorations as a pilot study. The monolithic zirconia restorations were fabricated after digital intraoral impression taking by intraoral scanner (TRIOS, 3shape, Copenhagen, Denmark), computer-aided designing, and milling manufacturing process. Completed zirconia crowns were tried in the patients' mouth and a replica technique was used to acquire the crown-abutment replica. The absolute marginal discrepancy, marginal gap, and internal gap of axial, line angle, and occlusal part were measured after sectioning the replica in the mesiodistal and buccolingual direction. Statistical analysis was performed using Kruskal-Wallis and Mann-Whitney U test (${\alpha}=.05$). Results: From the adaptation analysis by replica, the statistically significant difference was not found between mesiodistal and buccolingual sections (P>.05), but there was significant difference among the measurement location (P<.01). The amount of absolute marginal discrepancy was larger than those of marginal gap and internal gap (P<.01). Conclusion: Within the limitations of this study, the adaptation accuracy of model-free monolithic zirconia restoration fabricated by intraoral scanner exhibited clinically acceptable result. However, the margin of zirconia crown showed tendency of overcontour and cautious clinical application and follow up is necessary.

Effect of Hanwoo Diets Containing Linseed on Plasma Cholesterol Levels of Humans to Beef Consumption and Change in n-6/n-3 Fatty Acid of Loin Fat (아마씨앗 첨가 한우사료가 등심 지방의 n-6/n-3 변화 및 이를 섭취한 사람의 혈중 콜레스테롤 함량에 미치는 영향)

  • Park, Sang-Oh;Park, Byung-Sung;Yuh, In-Suh;Hwangbo, Jong;Bang, Han-Tae
    • Journal of the Korean Applied Science and Technology
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    • v.31 no.2
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    • pp.265-276
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    • 2014
  • The purpose of this study was to evaluate the effect on lowering blood LDL-C in an adult human, by taking n-6/n-3 balanced Hanwoo beef and reducing n-6/n-3 in loin of Hanwoo beef. The randomized complete block design was used to conduct an experiment with a total of 20 castrated Hanwoo cattles, which were divided into two groups. Each group had 10 cattles, and the control group consisted of absence of linseed, while n-3 treatment group (n-3 group) had linseed. The results showed that n-6/n-3 in loin and blood was decreased to under 4:1 in n-3 group, while oleic acid as an monounsaturated fatty acid was increased by 52.79% compared to the control group. In above 70% of the clinical subjects who ate the balanced Hanwoo beef, the blood triglyceride, total cholesterol, and LDL-C were decreased by 25.35, 5.22, and 17.59%. However, in the subjects who ate the imported beef, and not the common Hanwoo beef, the same parameters were increased by 9.05, 8.21, and 21.70%, respectively. When the balanced Hanwoo beef were eaten, HDL-C were increased by 6.07% but the imported beef and common Hanwoo beef had those values decreased by 14.46 and 11.46%, respectively. The blood glucose was decreased by 6.42 and 11.82% in the subjects who ate balanced Hanwoo beef and common Hanwoo beef, respectively but the subjects who ate the imported beef had an increase by 15.19%.

A Meta-analysis of the effects of Academic-related Satisfaction Intervention Programs for Nursing Students in Korea (메타분석을 이용한 간호 대학생의 학업 관련 만족도 중재프로그램의 효과)

  • Kim, Mina;Kim, Young A
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.20 no.10
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    • pp.218-228
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    • 2019
  • This study was conducted to review and analyze the academic-related satisfaction intervention programs for Korean nursing students and to provide evidence-based data. The data included in the meta-analysis were 25 studies published from 2001 to July 2018, and the design of the study consisted of 1 randomized controlled trial and 24 non-randomized controlled trials. The study subjects were nursing students from 1st to 4th grade, and the intervention program was conducted in theoretical and practical classes. The sample size was 1182 (mean: 47.3) in the experimental group and 1137 in the control group (mean: 45.5). The intervention program consisted of 1~16 weeks/1~16 sessions/7~240 minutes per session. Dependent variables were as follows: major satisfaction, learning satisfaction, satisfaction with the classroom practice, and satisfaction with the clinical practice. Satisfaction with the classroom practice (Hedges' g=0.876[95% CI: 0.405, 1.346]), satisfaction with the clinical practice (Hedges' g=0.515[95% CI: 0.312, 0.718]), and overall academic-related satisfaction (Hedges' g=0.630[95% CI: 0.371, 0.889]) were statistically significant and above intermediate levels in the meta-analysis. The study results are significant in that the objective results were confirmed by integrating the previous studies dealing with the academic-related satisfaction intervention program of nursing students.

Case Series of Patients with Parkinson Syndrome visited in Oriental Medicine Hospital (한방병원에 내원한 파킨슨 증후군 환자 증례군 보고)

  • Lee, Seung-yeop;Kim, Mi-young;Kim, Young-jee;Choi, Won-woo;Min, In-kyu;Sun, Jong-joo;Hong, Jin-woo;Na, Byong-jo;Jung, Woo-sang;Moon, Sang-kwan;Cho, Ki-ho;Kim, Young-suk
    • The Journal of the Society of Stroke on Korean Medicine
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    • v.8 no.1
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    • pp.34-39
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    • 2007
  • Objective : To report cases of patients with Parkinson's syndrome. Design : Case-series Patients and methods : 35 of patients with Parkinson's syndrome who visited Department of Cardiovascular and Neurologic Diseases of Kyunghee Oriental Medical Center were treated by acupuncture and herbal medicine from May until December 2007. 35 patients were participated in this study. 21 patients were dropped out during the trial, and we evaluated symptom progress of 14 patients by using several questionnaires such as Unified Parkinson's Disease Rating Scale(UPDRS), modified Hoehn & Yahr stage (H&Y stage) and Schwab & England ADL scale(S&E ADL scale). Results : The whole group consists of 14 male patients and 21 female patients. Mean±SD age range is 64.5±8.4. There were no significant differences of the demographic and clinical characteristics between the case group and drop-out group. The mean±SD medical treatment period of the Case group were 8.4±6.3weeks, the mean±SD of the total score in first medical treatment UPDRS section 1~3 were 29.6±11.0, the mean±SD of the final score were 27.1±12.6, all of which showed significant improvement(p=0.007). There were no significant changes on the H&Y stage and S&E ADL scale. Conclusion : Patients with Parkinson's syndrome who visited Department of Cardiovascular and Neurologic diseases of Kyunghee Oriental Medical Center had a tendency of showing improvement in clinical symptoms.

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Effects for kangaroo care: systematic review & meta analysis (캥거루 케어가 미숙아와 어머니에게 미치는 효과 : 체계적 문헌고찰 및 메타분석)

  • Lim, Junghee;Kim, Gaeun;Shin, Yeonghee
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.3
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    • pp.599-610
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    • 2016
  • This paper reports the results of a systematic review (SR) and meta-analysis research to compare the effect of Kangaroo care, targeting mothers and premature infants. A randomized clinical trial study was performed until February 2015. The domestic literature contained the non-randomized clinical trial research without restriction according to the level of the study design. A search of the Ovid-Medline, CINAHL, PubMed and KoreaMed, the National Library of KOREA, the National Assembly Library, NDSL, KISS and RISS. Through the KMbase we searched and combined the main term ((kangaroo OR KC OR skin-to-skin) AND (care OR contact)) AND (infant OR preterm OR Low Birth Weight OR LBW), ((kangaroo OR kangaroo OR kangaroo) AND (care OR nursing care OR management OR skin contact)) was made; these were all combined with a keywords search through the selection process. They were excluded in the final 25 studies (n=3051). A methodology checklist for randomized controlled trials (RCTs) designed by SIGN (Scottish Intercollegiate Guidelines Network) was utilized to assess the risk of bias. The overall risk of bias was regarded as low. In 16 studies that were evaluated as a grade of "++", 9 studies were evaluated as a grade of "+". As a result of meta-analysis, kangaroo care regarding the effects of premature mortality, severe infection/sepsis had an insignificant effect. Hyperthermia incidence, growth and development (height and weight), mother-infant attachment, hypothermia incidence, length of hospital days, breast feeding rate, sleeping, anxiety, confidence, and gratification of mothering role were considered significant. In satisfaction of the role performance, depression and stress presented contradictory research results for individual studies showing overall significant difference. This study has some limitations due to the few RCTs comparing kangaroo care in the country. Therefore, further RCTs comparing kangaroo care should be conducted.

Near Infrared Spectroscopy for Diagnosis: Influence of Mammary Gland Inflammation on Cow´s Milk Composition Measurement

  • Roumiana Tsenkova;Stefka Atanassova;Kiyohiko Toyoda
    • Near Infrared Analysis
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    • v.2 no.1
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    • pp.59-66
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    • 2001
  • Nowadays, medical diagnostics is efficiently supported by clinical chemistry and near infrared spectroscopy is becoming a new dimension, which has shown high potential to provide valuable information for diagnosis. The investigation was carried out to study the influence of mammary gland inflammation, called mastitis, on cow´s milk spectra and milk composition measured by near infrared spectroscopy (NIRS). Milk somatic cell counts (SCC) in milk were used as a measure of mammary gland inflammation. Naturally occurred variations with milk composition within lactation and in the process of milking were included in the experimental design of this study. Time series of unhomogenized, raw milk spectral data were collected from 3 cow along morning and evening milking, for 5 consecutive months, within their second lactation. In the time of the trial, the investigated cows had periods with mammary gland inflammation. Transmittance spectra of 258 milk samples were obtained by NIRSystem 6500 spectrophotometer in 1100-2400 nm region. Calibration equations for the examined milk components were developed by PLS regression using 3 different sets of samples: samples with low somatic cell count (SCC), samples with high SCC and combined data set. The NIR calibration and prediction of individual cow´s milk fat, protein, and lactose were highly influenced by the presence of mil samples from animals with mammary gland inflammation in the data set. The best accuracy of prediction (i.e. the lower SEP and the higher correlation coefficient) for fat, protein and lactose was obtained for equations, developed when using only “healthy” samples, with low SCC. The standard error of prediction increased and correlation coefficient decreased significantly when equations for low SCC milk were used to predict examined components in “mastitis” samples with high SCC, and vice versa. Combined data set that included samples from healthy and mastitis animals could be used to build up regression models for screening. Further use of separate model for healthy samples improved milk composition measurement. Regression vectors for NIR mild protein measurement obtained for “healthy” and “mastitic” group were compared and revealed differences in 1390-1450 nm, 1500-1740 nm and 1900-2200 nm regions and thus illustrated post-secretory breakdown of milk proteins by hydrolytic enzymes that occurred with mastitis. For the first time it has been found that monitoring the spectral differences in water bands at 1440 nm and 1912 nm could provide valuable information for inflammation diagnosis.