• Title/Summary/Keyword: Clinical trial

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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.

A CASE OF TREATMENT-RESISTANT CHILDHOOD-ONSET SCHIZOPHRENIA WITH LONG-TERM TRIAL OF CLOZAPINE (치료저항성 소아기 발병 정신분열증의 Clozapine 장기치험 1례)

  • Jang, Soon-Ah;Kim, Kyung-Hee;Lee, Hong-Shick;Song, Dong-Ho
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.9 no.1
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    • pp.98-104
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    • 1998
  • A 12-year-old girl with a 6 year history of childhood-onset schizophrenia required 2 hospitalizations and long-term clozapine trial due to inadequate responses to combinations of typical neuroleptics and traditional treatments of schizophrenic disorder. On admission, she had continuous auditory and visual hallucinations, persecutory delusion, emotional instability, regression of behaviors including temper tantrums as well as specific developmental delays in learning, language, and motor coordination. The clozapine trial significantly reduced most of the positive symptoms, and facilitated in successful discharge from the hospital. During the 4 year clozapine treatment, no significant adverse reactions were noted, and she returned to a structured school setting with minimal degrees of schizophrenic symptoms. From this clinical experience, we suggest that clozapine might be safe and effective in treating treatment-refractory schizophrenic children.

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The Current Status of Utilization of Palliative Care Units in Korea: 6 Month Results of 2009 Korean Terminal Cancer Patient Information System (말기암환자 정보시스템을 이용한 우리나라 암환자 완화의료기관의 이용현황)

  • Shin, Dong-Wook;Choi, Jin-Young;Nam, Byung-Ho;Seo, Won-Seok;Kim, Hyo-Young;Hwang, Eun-Joo;Kang, Jina;Kim, So-Hee;Kim, Yang-Hyuck;Park, Eun-Cheol
    • Journal of Hospice and Palliative Care
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    • v.13 no.3
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    • pp.181-189
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    • 2010
  • Purpose: Recently, health policy making is increasingly based on evidence. Therefore, Korean Terminal Cancer Patient Information System (KTCPIS) was developed to meet such need. We aimed to report its developmental process and statistics from 6 months data. Methods: Items for KTCPIS were developed through the consultation with practitioners. E-Velos web-based clinical trial management system was used as a technical platform. Data were collected for patients who were registered to 34 inpatient palliative care services, designated by Ministry of Health, Welfare, and Family Affairs, from $1^{st}$ of January to $30^{th}$ of June in 2009. Descriptive statistics were used for the analysis. Results: From the nationally representative set of 2,940 patients, we obtained the following results. Mean age was $64.8{\pm}12.9$ years, and 56.6% were male. Lung cancer (18.0%) was most common diagnosis. Only 50.3% of patients received the confirmation of terminal diagnosis by two or more physicians, and 69.7% had an insight of terminal diagnosis at the time of admission. About half of patients were admitted to the units on their own without any formal referral. Average and worst pain scores were significantly reduced after 1 week when compared to those at the time of admission. 73.4% faced death in the units, and home-discharge comprised only 13.3%. Mean length of stay per admission was $20.2{\pm}21.2$ days, with median value of 13. Conclusion: Nationally representative data on the characteristics of patients and their caregiver, and current practice of service delivery in palliative care units were obtained through the operation of KTCPIS.

The Clinical and Cost Effectiveness of Medical Nutrition Therapy for Patients with Type 2 Diabetes Mellitus (제2형 당뇨병환자에서 임상영앙치료의 임상적 효과와 비용효과 연구)

  • Cho, Youn-Yun;Lee, Moon-Kyu;Jang, Hak-Chul;Rha, Mi-Yong;Kim, Ji-Young;Park, Young-Mi;Sohn, Cheong-Min
    • Journal of Nutrition and Health
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    • v.41 no.2
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    • pp.147-155
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    • 2008
  • Medical nutrition therapy (MNT) is considered a keystone of medical treatment of chronic diseases. However, only few studies have evaluated medical and economical outcome of MNT. The study was performed on the patient with type 2 diabetes mellitus to evaluate the effect of clinical and cost-effective outcomes of MNT. Subjects from two general hospitals were randomly assigned to two different groups; One receiving basic nutritional education (BE) (n = 35), and the other receiving intensive nutritional education (IE) (n = 32) for a 6-month clinical trial. The group which received BE had a single visit with a dietitian, while the other group which received IE had an initial visit with a dietitian addition to two visits during the first 4 weeks of the study periods. Anthropometric parameters, blood components, and dietary intake were measures at the beginning of study period and after 6 month. Cost-effective analysis included direct labor costs, educational materials and medication cost difference during 6 months. After 6 month, subjects from IE group showed significant reduction of body weight (p <0.05) and systolic blood pressure (p <0.05), whereas BE group did not show any significant changes. Result from biochemical indices showed glycated hemoglobin concentration was significantly reduced by 0.7% (p <0.05) only in the IE group. The ratio of energy intake to prescribed energy intake decreased significantly in both groups (p <0.05). Mean time taken for a dietitian to educate the subject was 67.9 ${\pm}$ 9.3 min/person for BE group, while 96.4 ${\pm}$ 12.2 min/person for IE group. Mean number of educational materials was 1.9 ${\pm}$ 0.7/person for BE group and 2.5 ${\pm}$ 0.7/person for IE group. Change in glycated hemoglobin level along the 6 month period of study can be achieved with an investment of \88,510/% by implementing BE and \53,691/% by implementing IE. Considering the net cost-effect of blood glucose control and HbA Ic, IE which provides MNT by dietitian had a cost efficiency advantage than that of BE. According to this study, MNT provided by dietitian had a significant improvements in medical and clinical outcomes compared to that of BE intervention. Therefore, MNT protocol should be performed by systemic intensive nutrition care by dietitian in clinical setting to achieve good therapeutic results of DM with lower cost.

Optimal Scheme of Postoperative Chemoradiotherapy in Rectal Cancer : Phase III Prospective Randomized Trial (직장암의 근치적 수술 후 화학요법과 방사선치료의 순서)

  • Kim Young Seok;Kim Jong Hoon;Choi Eun Kyung;Ahn Seung Do;Lee Sang-Wook;Kim Kyoung-Ju;Lee Je Hwan;Kim Jin Cheon;You Chang Sik;Kim Hee Cheol
    • Radiation Oncology Journal
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    • v.20 no.1
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    • pp.53-61
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    • 2002
  • Purpose : To determine the optimal scheme of postoperative chemoradiotherapy in rectal cancer by comparing survival, Patterns of failure, toxicities in early and late radiotherapy groups using a Phase III randomized prospective clinical trial. Materials and Methods : From January 1996 to March 1999, 307 patients with curatively resected AJCC stage II and III rectal cancer were assigned randomly to an 'early (151 patients, arm 1)' or a 'late (156 patients, arm II)' and were administered combined chemotherapy (5-FU $375\;mg/m^2/day$, leucovorin $20\;mg/m^2$, IV bolus daily, for 3 days with RT, 5 days without RT, 8 cycles with 4 weeks interval) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Patients of arm I received radiation therapy from day 1 of the first cycle of chemotherapy and those of arm II from day 57 with a third cycle of chemotherapy. The median follow-up period of living patients was 40 months. Results : Of the 307 patients enrolled, fifty patients did not receive scheduled radiation therapy or chemotherapy. The overall survival rate and disease free survival rate at 5 years were $78.3\%\;and\;68.7\%$ in arm I, and $78.4\%\;and\;67.5\%$ in arm II. The local recurrence rate was $6.6\%\;and\;6.4\%$ (p=0.46) in arms I and II, respectively, no significant difference was observed between the distant metastasis rates of the two arms ($23.8\%\;and\;29.5\%$, p=0.16). During radiation therapy, grade 3 diarrhea or more, by the NCI common toxicity criteria, was observed in $63.0\%\;and\;58.2\%$ of the respective arms (p=N.S.), but most were controlled with supportive care. Hematologic toxicity (leukopenia) greater than RTOG grade 2 was found in only $1.3\%\;and\;2.6\%$ of patients in each respective arm. Conclusion : There was no significant difference in survival, patterns of failure or toxicities between the early and late radiation therapy arms. Postoperative adjuvant chemoradiation was found to be a relatively safe treatment but higher compliance is needed.

The Ability of Anti-tumor Necrosis Factor Alpha(TNF-${\alpha}$) Antibodies Produced in Sheep Colostrums

  • Yun, Sung-Seob
    • 한국유가공학회:학술대회논문집
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    • 2007.09a
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    • pp.49-58
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    • 2007
  • Inflammatory process leads to the well-known mucosal damage and therefore a further disturbance of the epithelial barrier function, resulting abnormal intestinal wall function, even further accelerating the inflammatory process[1]. Despite of the records, etiology and pathogenesis of IBD remain rather unclear. There are many studies over the past couple of years have led to great advanced in understanding the inflammatory bowel disease(IBD) and their underlying pathophysiologic mechanisms. From the current understanding, it is likely that chronic inflammation in IBD is due to aggressive cellular immune responses including increased serum concentrations of different cytokines. Therefore, targeted molecules can be specifically eliminated in their expression directly on the transcriptional level. Interesting therapeutic trials are expected against adhesion molecules and pro-inflammatory cytokines such as TNF-${\alpha}$. The future development of immune therapies in IBD therefore holds great promises for better treatment modalities of IBD but will also open important new insights into a further understanding of inflammation pathophysiology. Treatment of cytokine inhibitors such as Immunex(Enbrel) and J&J/Centocor(Remicade) which are mouse-derived monoclonal antibodies have been shown in several studies to modulate the symptoms of patients, however, theses TNF inhibitors also have an adverse effect immune-related problems and also are costly and must be administered by injection. Because of the eventual development of unwanted side effects, these two products are used in only a select patient population. The present study was performed to elucidate the ability of TNF-${\alpha}$ antibodies produced in sheep colostrums to neutralize TNF-${\alpha}$ action in a cell-based bioassay and in a small animal model of intestinal inflammation. In vitro study, inhibitory effect of anti-TNF-${\alpha}$ antibody from the sheep was determined by cell bioassay. The antibody from the sheep at 1 in 10,000 dilution was able to completely inhibit TNF-${\alpha}$ activity in the cell bioassay. The antibodies from the same sheep, but different milkings, exhibited some variability in inhibition of TNF-${\alpha}$ activity, but were all greater than the control sample. In vivo study, the degree of inflammation was severe to experiment, despite of the initial pilot trial, main trial 1 was unable to figure out of any effect of antibody to reduce the impact of PAF and LPS. Main rat trial 2 resulted no significant symptoms like characteristic acute diarrhea and weight loss of colitis. This study suggested that colostrums from sheep immunized against TNF-${\alpha}$ significantly inhibited TNF-${\alpha}$ bioactivity in the cell based assay. And the higher than anticipated variability in the two animal models precluded assessment of the ability of antibody to prevent TNF-${\alpha}$ induced intestinal damage in the intact animal. Further study will require to find out an alternative animal model, which is more acceptable to test anti-TNF-${\alpha}$ IgA therapy for reducing the impact of inflammation on gut dysfunction. And subsequent pre-clinical and clinical testing also need generation of more antibody as current supplies are low.

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Effects of adherence to Korean diets on serum GGT and cardiovascular disease risk factors in patients with hypertension and diabetes (고혈압 및 당뇨병 환자에서 한식 섭취가 혈청 GGT와 심혈관질환 위험인자에 미치는 영향)

  • Jung, Su-Jin;Chae, Soo-Wan
    • Journal of Nutrition and Health
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    • v.51 no.5
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    • pp.386-399
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    • 2018
  • Purpose: This study examined whether the supply of healthy Korean diets for 12 weeks is effective in improving the risk factors related to serum GGT and cardiovascular diseases in patients with hypertension and diabetes. Methods: This study selected 41 patients, who were treated with hypertension and diabetes. The Korean diet was composed of cooked-rice, soup, kimchi, and various banchan with one serving called bapsang, which emphasize proportionally high consumption of vegetables and fermented foods, moderate to high consumption of legumes and fish, and low consumption of animal foods. The control group was instead instructed to "eat and exercise as usual" while following the Korean Diabetes Association's dietary guidelines with an intake that can assist in glycemic control, maintain adequate weight, and meet the nutritional requirements. The Korean diet group (21 patients) were served three healthy Korean meals a day for 12 weeks, and the control group (20 patients, who trained in the diet guideline of diabetes) maintained their usual diabetic diet. The serum GGT, blood pressure, heart rate, glycemic control data, cardiovascular risk indicators, and changes in diet measured at the four visits (week 0, 4, 8, and 12) during the course of 12 weeks were compared and evaluated. Results: The serum GGT (p < 0.001), HbA1c (p = 0.004), heart rate (p = 0.007), weight (p = 0.002), Body Mass Index (p = 0.002), body fat mass (p < 0.001), body fat (%) (p < 0.001), and free fatty acid (p = 0.007) in the Korean diet group decreased significantly after the dietary intervention compared to the control group. The amount of intake of rice, whole grains, green vegetables, Kimchi, and soybean fermented food were increased significantly compared to the control group (p < 0.001). The Korean diet group showed significant decreases (p < 0.001) in the intake of animal protein, lipid, and cholesterol derived from animal foods compared to the control group but significant increases (p < 0.001) in the intake of total calories, folic acid, dietary fiber, sodium, potassium, and vitamins A, E, and C. Conclusion: In patients with hypertension and diabetes, it was confirmed that regular eating of a healthy Korean diet helps improve the risk factors for GGT and cardiovascular diseases.

Nicardipine Hydrochloride Injectable Phase IV Clinical Trial-Study on the antihypertensive effect and safely of nicardipine for acute aortic dissection (급성대동맥해리에 대한 혈압강하요법으로서의 Nicardipine.HCI 주사액(Perdipine$^{circledR}$)의 유효성 및 안전성을 검토하기 위한 다기관 공동, 공개 제4상 임상시험)

  • Kim, Kyung-Hwan;Moon, In-Sung;Park, Jang-Sang;Koh, Yong-Bok;Ahn, Hyuk
    • Journal of Chest Surgery
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    • v.35 no.4
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    • pp.267-273
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    • 2002
  • Background: We performed a phase IV clinical trial to examine the usefulness of a continuous infusion of nicardipine hydrochloride to control hypertension in patients with acute aortic dissection. material and Method: Systolic/diastolic blood pressure, and heart rate were monitored before and after the intravenous administration of nicardipine in 31 patients with aortic diseases. The period of nicardipine administration in each patient was from 3 to 14 days. Efficacy was evaluated by determining the average amount of blood pressure reduction on the 3rd day of drug administration. The dosage of another antihypertensive agent was slowly tapered down, and ultimately replaced by the test drug. Result: 28 patients were diagnosed as acute aortic dissection, 2 patients as rupture of the aortic arch aneurysm, and 1 patient as traumatic aortic rupture. Mean age was 53.9 $\pm$ 14.9(29~89) years, and 21 patients(67.7%) were male. 14 patients(32.3%) had complications associated with underlying aortic disease: aortic insufficiency in 7, hemopericardium in 6, acute renal failure in 1, paraplegia in 1, lower extremity ischemia in 1, and hemothorax in 1. The time needed to reach the target blood pressure was within 15 minutes in 16, from 15 to 30 minutes in 10, from 30 to 45 minutes in 3 and from 45 to 60 minutes in 2, and their baseline average systolic, diastolic, and mean arterial blood pressures(mmHg) were 147$\pm$23, 82.3$\pm$ 18.6, and 104 $\pm$ 18, respectively. Average systolic, diastolic, and mean arterial blood pressures(mmHg) on the third day of nicardipine infusion were 119$\pm$ 12, 69$\pm$9, and 86$\pm$8, and they all showed statistically significant decrease(p<0.05). The average systolic, diastolic, and mean arterial blood pressure(mmHg) after the discontinuation of the nicardipine infusion were 119 $\pm$ 15, 71 $\pm$ 14, and 86$\pm$ 13, respectively. No significant difference was observed between the average pressures measured on the third day and those measured after the discontinuation of the nicardipine infusion, and no definite side effects were observed during the study period. Conclusion: Nicardipine hydrochloride was both effective and safe at controlling blood pressure in patients with acute aortic dissection.

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.