• Title/Summary/Keyword: preliminary clinical trial

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The Effect of Sa-am Acupuncture Treatment for Major Symptom of Hwa-byung : A Preliminary Study (화병의 핵심증상에 대한 사암침 치료의 효과 : 예비연구)

  • Lee, Sang-Ryong;Park, Yang-Chun;Hong, Kwon-Eui;Koo, Young-Sun;Jo, Jeong-Hyo;An, Joung-Jo;Kang, Wee-Chang;Kim, Jong-Woo;Choi, Sun-Mi;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.18 no.1
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    • pp.79-94
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    • 2007
  • Objective : The Purpose of this research is to examine the effect of Sa-am acupuncture treatment(Sim-seungkyuk) for major symptoms of Hwa-byung. Method : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with sham acupuncture in the treatment for major symptoms of Hwa-byung. likert scale(5 score) for major symptom of Hwa-byung was measured as the 1st evaluative instrument, and STAXI-K, STAI-K, BDI-K and HRV were also measured as the 2nd evaluative instrument at the before treatment and after treatment. Results : 26 volunteers participated in this study by dividing two groups, each 13 persons in trial group and control group at random. In comparison of likert scale for major symptoms, after treatment the total score of likert scale for major symptoms decreased significantly in both group than before treatment. And after treatment, the total score of trial group decreased less than those of control group in comparison between two groups. especially after 2 weeks from all treatment, there was significant difference between two groups. Conclusion : We considered that Shim-seungkyuk of Sa-am acupuncture treatment will be not recommended to treatment of Hwa-byung because this study could not prove effect of Shim-seungkyuk treatment for Hwa-hyung in spite of preliminary study. This study will be used to provide a fundamental data for development of clinical research as preliminary study of Hwa-byung.

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Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: preliminary results of a randomized controlled trial

  • Aghili, Mahdi;Khalili, Nastaran;Khalili, Neda;Babaei, Mohammad;Farhan, Farshid;Haddad, Peiman;Salarvand, Samaneh;Keshvari, Amir;Fazeli, Mohammad Sadegh;Mohammadi, Negin;Ghalehtaki, Reza
    • Radiation Oncology Journal
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    • v.38 no.2
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    • pp.119-128
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    • 2020
  • Purpose: Colorectal cancer is becoming an increasing concern in the middle-aged population of Iran. This study aimed to compare the preliminary results of short-course and long-course neoadjuvant chemoradiotherapy treatment for rectal cancer patients. Materials and Methods: In this clinical trial we recruited patients with rectal adenocarcinoma located from 5 cm to 15 cm above the anal verge. Patients in group I (short-course) received three-dimensional conformational radiotherapy with a dose of 25 Gy/5 fractions in 1 week plus concurrent XELOX regimen (capecitabine 625 mg/㎡ from day 1-5 twice daily and oxaliplatin 50 mg/㎡ on day 1 once daily). Patients in group II (long-course) received a total dose of 50-50.4 Gy/25-28 fractions for 5 to 5.5 weeks plus capecitabine 825 mg/㎡ twice daily. Both groups underwent consolidation chemotherapy followed by delayed surgery at least 8 weeks after radiotherapy completion. The pathological response was assessed with tumor regression grade. Results: In this preliminary report on complications and pathological response, 66 patients were randomized into two study groups. Mean duration of radiotherapy in the group II (long-course) was 5 ± 1 days (range, 5 to 8 days) and 38 ± 6 days (range, 30 to 58 days). The median follow-up was 18 months. Pathological complete response was achieved in 32.3% and 23.1% of patients in the shortcourse and long-course groups, respectively (p = 0.558). Overall, acute grade 3 or higher treatment-related toxicities occurred in 24.2% and 22.2% of patients in group I and II, respectively (p = 0.551). No acute grade 4 or 5 adverse events were observed in either group except one grade 4 hematologic toxicity that was seen in group II. Within one month of surgery, no significant difference was seen regarding grade ≥3 postoperative complications (p = 0.333). Conclusion: For patients with rectal cancer located at least 5 cm above the anal verge, short-course radiotherapy with concurrent and consolidation chemotherapy and delayed surgery is not different in terms of acute toxicity, postoperative morbidity, complete resection, and pathological response compared to long-course chemoradiotherapy.

Radiology Residents' Independent Diagnosis of Appendicitis Using 2-mSv Computed Tomography: A Secondary Analysis of a Large Pragmatic Randomized Trial

  • Jungheum Cho;Hae Young Kim;Seungjae Lee;Ji Hoon Park;Kyoung Ho Lee
    • Korean Journal of Radiology
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    • v.24 no.6
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    • pp.529-540
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    • 2023
  • Objective: To compare the diagnostic performance and clinical outcomes of 2-mSv computed tomography (CT) and conventional-dose CT (CDCT), following radiology residents' interpretation of CT examinations for suspected appendicitis. Materials and Methods: Altogether, 3074 patients with suspected appendicitis aged 15-44 years (28 ± 9 years, 1672 females) from 20 hospitals were randomly assigned to the 2-mSv CT (n = 1535) or CDCT (n = 1539) groups in a pragmatic trial from December 2013 and August 2016. Overall, 107 radiology residents participated in the trial as readers in the form of daily practice after online training for 2-mSv CT. They made preliminary CT reports, which were later finalized by attending radiologists via addendum reports, for 640 and 657 patients in the 2-mSv CT and CDCT groups, respectively. We compared the diagnostic performance of the residents, discrepancies between preliminary and addendum reports, and clinical outcomes between the two groups. Results: Patient characteristics were similar between the 640 and 657 patients. Residents' diagnostic performance was not significantly different between the 2-mSv CT and CDCT groups, with a sensitivity of 96.0% and 97.1%, respectively (difference [95% confidence interval {CI}], -1.1% [-4.9%, 2.6%]; P = 0.69) and specificity of 93.2% and 93.1%, respectively (0.1% [-3.6%, 3.7%]; P > 0.99). The 2-mSv CT and CDCT groups did not significantly differ in discrepancies between the preliminary and addendum reports regarding the presence of appendicitis (3.3% vs. 5.2%; -1.9% [-4.2%, 0.4%]; P = 0.12) and alternative diagnosis (5.5% vs. 6.4%; -0.9% [-3.6%, 1.8%]; P = 0.56). The rates of perforated appendicitis (12.0% vs. 12.6%; -0.6% [-4.3%, 3.1%]; P = 0.81) and negative appendectomies (1.9% vs. 1.1%; 0.8% [-0.7%, 2.3%]; P = 0.33) were not significantly different between the two groups. Conclusion: Diagnostic performance and clinical outcomes were not significantly different between the 2-mSv CT and CDCT groups following radiology residents' CT readings for suspected appendicitis.

Two-year survival analysis of twisted wire fixed retainer versus spiral wire and fiber-reinforced composite retainers: a preliminary explorative single-blind randomized clinical trial

  • Sobouti, Farhad;Rakhshan, Vahid;Saravi, Mahdi Gholamrezaei;Zamanian, Ali;Shariati, Mahsa
    • The korean journal of orthodontics
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    • v.46 no.2
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    • pp.104-110
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    • 2016
  • Objective: Traditional retainers (both metal and fiber-reinforced composite [FRC]) have limitations, and a retainer made from more flexible ligature wires might be advantageous. We aimed to compare an experimental design with two traditional retainers. Methods: In this prospective preliminary clinical trial, 150 post-treatment patients were enrolled and randomly divided into three groups of 50 patients each to receive mandibular canine-to-canine retainers made of FRC, flexible spiral wire (FSW), and twisted wire (TW). The patients were monitored monthly. The time at which the first signs of breakage/debonding were detected was recorded. The success rates of the retainers were compared using chi-squared, Kaplan-Meier, and Cox proportional-hazard regression analyses (${\alpha}=0.05$). Results: In total, 42 patients in the FRC group, 41 in the FSW group, and 45 in the TW group completed the study. The 2-year failure rates were 35.7% in the FRC group, 26.8% in the FSW group, and 17.8% in the TW group. These rates differed insignificantly (chi-squared p = 0.167). According to the Kaplan-Meier analysis, failure occurred at 19.95 months in the FRC group, 21.37 months in the FSW group, and 22.36 months in the TW group. The differences between the survival rates in the three groups were not significant (Cox regression p = 0.146). Conclusions: Although the failure rate of the experimental retainer was two times lower than that of the FRC retainer, the difference was not statistically significant. The experimental TW retainer was successful, and larger studies are warranted to verify these results.

Development of an Eye Cure Protocol for ICU Patients (중환자실 입원 환자의 눈 간호를 위한 근거기반 지침 개발)

  • Yoo, Ji-Soo;Lee, Won-Hee;Kim, So-Sun;Ko, Il-Sun;Oh, Eui-Geum;Chu, Sang-Hui;Lee, Ju-Hee;Kang, Se-Won;Song, Eun-Kyeung;Chang, Soo-Jung;Kim, Bok-Hee;Lee, Jung-Eun
    • Journal of Korean Academy of Fundamentals of Nursing
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    • v.15 no.1
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    • pp.34-44
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    • 2008
  • Purpose: The purpose of this study was to develop an eye care protocol for intensive care unit (ICU) patients. Method: A systematic review was conducted to develop an eye care protocol for ICU patients. Searches were performed using computerized databases (CINAHL, MEDLINE, EBM Review) and citation search from 1996 to January 2007. For the keywords, "eye care", and "randomized controlled trial" were used to identify experimental studies regarding eye care for ICU patients. After reviewing the collected studies, a preliminary eye care protocol algorithm was created. Then, content validity was examined with ophthalmologists and ICU nurses. Results: Six studies were included to serve as a basis for framing of the preliminary algorithm. The final eye care protocol was completed after verifying the preliminary algorithm's content validity. The final eye care protocol was organized in the following manner: 3 items in the assessment stage, 7 items in the no-risk stage, 4 items in the low-risk stage, and 5 items in the high-risk stage. Conclusion: The results indicate that, for ICU patients, nurses can broaden their knowledge regarding ocular diseases, as well as improve their practice-based eye care nursing performance.

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Preliminary Study for Development of Pattern Identification Tool of Chronic Cough (만성기침 변증도구 개발을 위한 기초연구)

  • Kim, Kwan-il;Shin, Seung-won;Lee, Na-la;Lee, Beom-joon;Jung, Hee-jae;Jung, Sung-ki;Lee, Jun-hee
    • The Journal of Internal Korean Medicine
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    • v.36 no.1
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    • pp.22-39
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    • 2015
  • Objectives : The aim of this study was to develop a standard tool of pattern identification for chronic cough, which will be applied to clinical research. Methods : The items and structures of the instrument were based on reviews of textbooks and published literature. The advisor committee on this study consisted of 11 Korean respiratory internal medicine professors, one clinical fellow, and five clinicians with 10 years of experience. The questionnaire, which includes the signs and symptoms of chronic cough, was studied by the delphi method. Delphi examination was carried out via email, through evaluating the importance of symptoms included in each pattern. Results : We divided the pattern identification of chronic cough into five patterns: Wind-Cold, Phlegm-Turbidity, Liver-Fire, Lung Deficiency, and Kidney Yang Deficiency. By the Delphi method and a score evaluation, 38 items were chosen for pattern identification of chronic cough. Conclusions : Through this study, we created a Korean instrument for the pattern identification tool for chronic cough. We expect to apply this tool to subsequent research as its validity and reliability are further confirmed.

Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women with Overactive Bladder; a Pilot Study of Randomized Clinical Controlled Trial (폐경 여성의 과민성 방광에 대한 전침 치료와 침 치료의 유효성과 안전성 평가 ; 무작위 대조군 예비 임상시험)

  • Nam, Eun-Young;Jung, Seung-Hyun;Bae, In-Suk;Choi, Su-Ji;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.31 no.1
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    • pp.84-98
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    • 2018
  • Objectives: The purpose of this pilot study was to examine the feasibility of recruiting women into a clinical trial designed to examine the effects of acupuncture and electroacupuncture in treating overactive bladder (OAB) in menopause women. We tried to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing OAB symptoms and improving disease-specific quality of life. We also tried to determine the appropriate treatment duration of OAB, with safety of performing acupuncture and electroacupuncture treatment. Methods: This study was a randomized clinical trial. 7 menopause women were randomly assigned to a electroacupuncture group (EA group) (n=4) or acupuncture group (AC group) (n=3) and received electroacupuncture or acupuncture treatment twice a week (16 sessions) in 8 weeks, and follow up assessment was performed after the end of treatment. Overactive Bladder Symptom Score (OABSS), 3-day bladder diary, and King's Health Questionnaire (KHQ) were performed 4 times (at baseline (visit 0), the middle of treatment (visit 8), after the end of treatment (visit 16), and at 4 weeks of follow-up (visit 17)) and analyzed. 2 subjects were dropped out, and finally 5 subjects completed the study. Statistical analysis was performed using SPSS 18.0 for window program. Results: There was an significant improvement in night-time frequency after the treatment (visit 17) in PP (Per-protocol) group analysis (p=0.042). In additional ITT (Inter-to-treat) group analysis, the OABSS (p=0.042) and night-time frequency (p=p=0.017) were improved significantly after the treatment (visit 17). But there was no significant difference of KHQ before and after the treatment. Also there was no significant difference between EA and AC group after the treatment (visit 16, 17). Conclusions: The results of this pilot study suggested that it was feasible to recruit subjects and perform the study procedures, after reconstructing several details of study protocol in performing further clinical trial.

Clinical Trial of Herbal Medicine Formula Mahwangjeongcheon-tang on Patients with Asthmatic Symptom: A Preliminary Study (기관지천식 증상에 대한 마황정천탕의 안전성 유효성 예비 임상 연구)

  • Park, Soo-Jung;Choi, Na-Rae;Kim, Koo;Yoo, Jong-Hyang;Lee, Si-Woo;Joo, Jong-Cheon
    • Journal of Sasang Constitutional Medicine
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    • v.25 no.4
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    • pp.373-383
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    • 2013
  • Objectives The purpose of this clinical trial was evaluate the safety and efficacy of Mahwangjeongcheon-tang (MJT). Methods Twenty six volunteers were recruited as subjects. They were divided into two groups, which were MJT test group and placebo group. The investigated items related to the safety were the weight, the results of renal function and liver function. The investigated items related to the efficacy are the results of the spirometer, the clinical asthma measurement scale in oriental medicine-V (CAMSOM-V) and the quality of life questionnaire for adult Korean asthmatics (QLQAKA). Results There are no difference in the weight, the results of the renal functions and the liver functions between MJT test group and placebo group. There are the some differences in the result of the questionnaires related to the efficacy between MJT test group and placebo group. The significant difference were observed in the CAMSOM-V at the 4th visit. Conclusion MJT is the safe and effective herbal prescription that is useful to the asthma patients.

Preliminary Study on Effectiveness of Dexamethasone-Soaked Gelatin Sponges for Reducing Pain after Lumbar Microdiscectomy : A Randomized Controlled Trial

  • Shin, Dong-Ah;Gong, Tae-Sik;Shin, Dong-Gyu;Kwon, Chang-Young;Kim, Hyoung-Ihl
    • Journal of Korean Neurosurgical Society
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    • v.39 no.1
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    • pp.11-15
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    • 2006
  • Objective : A prospective, randomized, controlled clinical study is performed to verify the effectiveness of epidural dexamethasone-soaked gelatin sponges to reduce postoperative pain following lumbar microdiscectomy. Methods : Twenty-three patients (10 men and 13 women) undergoing lumbar microdiscectomy were included. Five pieces of gelatin sponge measuring $1{\times}1cm$ [Gelfoam; Pharmacia & Upjohn. Kalamazoo, MI, USA], soaked with either 5mg dexamethasone or an equal amount [2mL] of saline, were left on the decompressed nerve root after unilateral hemilami-nectomy, flavectomy and discectomy. Results : Subjective visual analog scale[VAS] scores of leg pain in the dexamethasone group on the first, third and first postoperative days [2.5, 2.5, 1.7, respectively] were significantly lower than in the control group [5.0, 4.8, 3.6][P<0.05]. No side effects related to the dexamethasone-soaked gelatin sponges were observed. Conclusion : The intraoperative application of dexamethasone-soaked gelatin sponges during lumber microdiscetomy can provide effective-postoperative analgesia without complications.

Non-randomized, one way cross-over, open label preliminary clinical trial for silk protein based oral gargling

  • Kang, Yei-Jin;Ahn, Se-Hui;Kim, Yong-Wan;Jo, You-Young;Kweon, HaeYong;Kim, Seong-Gon
    • International Journal of Industrial Entomology and Biomaterials
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    • v.38 no.1
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    • pp.14-17
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    • 2019
  • Oral gargling solution has been used for the control of halitosis. The purpose of this study was to compare the level of hydrogen sulphide concentration between silk oral gargling solution and commercially available oral gargling solution. Total 21 volunteers were included in this study. The relative level of hydrogen sulphide concentration was calculated to the baseline level. In terms of the primary endpoint of the trial, relative level of hydrogen sulphide concentration was $50.84{\pm}33.19%$ with silk group, versus $71.07{\pm}21.83%$ with Listerine group ($P_{non-inferiority}=0.003$). In conclusion, the results of oral gargling with a silk protein for healthy individual were non-inferior to oral gargling with Listerine for hydrogen sulphide concentration reduction.