• Title/Summary/Keyword: Non-clinical trial

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Early gonadotropin-releasing hormone antagonist protocol in women with polycystic ovary syndrome: A preliminary randomized trial

  • Shin, Jae Jun;Park, Kyung Eui;Choi, Young Min;Kim, Hye-Ok;Choi, Dong-Hee;Lee, Woo Sik;Cho, Jung-Hyun
    • Clinical and Experimental Reproductive Medicine
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    • v.45 no.3
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    • pp.135-142
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    • 2018
  • Objective: To prospectively evaluate the efficacy and safety of a fixed early gonadotropin-releasing hormone (GnRH) antagonist protocol compared to a conventional midfollicular GnRH antagonist protocol and a long GnRH agonist protocol for in vitro fertilization (IVF) in patients with polycystic ovary syndrome (PCOS). Methods: Randomized patients in all three groups (early antagonist, n = 14; conventional antagonist, n = 11; long agonist, n = 11) received 21 days of oral contraceptive pill treatment prior to stimulation. The GnRH antagonist was initiated on the 1st day of stimulation in the early antagonist group and on the 6th day in the conventional antagonist group. The GnRH agonist was initiated on the 18th day of the preceding cycle. The primary endpoint was the number of oocytes retrieved, and the secondary endpoints included the rate of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) and the clinical pregnancy rate. Results: The median total number of oocytes was similar among the three groups (early, 16; conventional, 12; agonist, 19; p= 0.111). The early GnRH antagonist protocol showed statistically non-significant associations with a higher clinical pregnancy rate (early, 50.0%; conventional, 11.1%; agonist, 22.2%; p= 0.180) and lower incidence of moderate-to-severe OHSS (early, 7.7%; conventional, 18.2%; agonist, 27.3%; p= 0.463), especially among subjects at high risk for OHSS (early, 12.5%; conventional, 40.0%; agonist, 50.0%; p= 0.324). Conclusion: In PCOS patients undergoing IVF, early administration of a GnRH antagonist may possibly lead to benefits due to a reduced incidence of moderate-to-severe OHSS in high-risk subjects with a better clinical pregnancy rate per embryo transfer. Further studies with more subjects are required.

A Review of Clinical Studies for Chinese Medicine Treatment of Idiopathic Thrombocytopenic Purpura Using the CNKI Database (특발성 혈소판 감소성 자반증의 중의치료에 대한 임상연구 동향 - CNKI검색을 중심으로)

  • Ji-eun Bae;Jae-won Park;Jun-kyu Lim;Mi-so Park;Jeong-su Hong;Dong-jin Kim
    • The Journal of Internal Korean Medicine
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    • v.43 no.6
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    • pp.1045-1062
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    • 2022
  • Objectives: The aim of this study was to analyze the latest clinical studies on Korean medicine treatment of idiopathic thrombocytopenic purpura (ITP) in the Chinese National Knowledge Infrastructure (CNKI) database. Methods: We searched the last 6 years of clinical studies discussing Oriental medicine-based treatments for ITP in the CNKI database. A meta-analysis of 13 RCTs was performed by synthesizing the outcomes, including the measured platelet count and total effective rate. The quality of the studies was assessed using Cochrane's risk of bias (RoB) tool. RevMan 5.4.1 software was used for data analysis. Results: Of the 15 selected studies, 1 was a non-randomized controlled trial (nRCT), 2 were case series, and 12 were randomized controlled trials (RCTs). Treatments in all studies included oral herbal medicine. The most frequently used herbal decoction was the Liangxue Jiedu prescription (凉血解毒方), and the most commonly used herb was Agrimonia pilosa (仙鶴草), Astragali Radix (黃芪), Fossilia Glycyrrhizae Radix et Rhizoma (甘草), and Rehmannia glutinosa Liboschitz ex Steudel (地黃). The meta-analysis showed significantly better improvement in platelet counts and total effective rate for ITP in the treatment group than in the control group. Conclusion: Treatment with herbal medicine was effective in treating ITP. However, the significance of this conclusion is somewhat limited due to the low quality of the available studies. Multifaceted and scientifically designed clinical studies are required to develop treatments for ITP based on Korean medicine. The results of this study could be used as basic data for further ITP studies.

The consideration for methods of statistical analysis about the thesis published in the journal of korean oriental medical Ophthalmology & Otolaryngology & Dermatology from 2003 to 2005 (2003년부터 2005년까지 안이비인후피부과 학회지에 게재된 논문들의 통계적 분석 방법에 대한 고찰)

  • Kim, Keoo-Seok;Nam, Hae-Jung;Park, Owe-Suk;Kim, Hee-Jeong;Cha, Jae-Hoon;Kim, Yoon-Bum
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.19 no.3 s.31
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    • pp.134-145
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    • 2006
  • Objective : This study was carried out to investigate what type of assumption and conditions are needed for the application of various statistical techniques such as descriptive statistics, t-test, analysis of variance, correlation analysis, regression analysis and chi-square test and to evaluate that they are used correctly in the research process. Methods : One more methods of statistical analysis were used in 91 papers among 162 papers selected from the journal of Korean oriental medical Ophthalmology & Otolaryngology & Dermatology from April 2003 to December 2005. So we analysed the type of statistical analysis method in 91 papers(clinical and experimental study) and assessed the their validity of statistical techniques by the check list consisting of 34 items(3 items for validity assessment of descriptive statistics, 6 items for t-test, 7 items for analysis of variance, correlation analysis and regression analysis, respectively, 4 items for chi-square test) Results : 1. The type of 65(40%) cases is experimental trial, the type of 55(34%) cases is case report, the type of 26(16%) cases is clinical trial and the type of 16(10%) cases is review, in 91 papers using statistical techniques among 162 papers selected from the journal of Korean oriental medical Ophthalmology & Otolaryngology & Dermatol-ogy from April 2003 to December 2005. 2. One more methods of statistical analysis were used in the experimental and clinical study. When we classified 125 units using statistical analysis methods in 91 papers according to statistical techniques such as descriptive statistics, t-test, analysis of variance, correlation analysis, regression analysis and chi-square test, the number of independent sample t-test is 33(26%), the number of only descriptive statistics is 28(22%), the number of independent sample t-test is 33(26%), the number of only descriptive statistics is 28(22%), the number of one way ANOVA is 15(12%), the number of non-parametric test 10(8%). 3. After carrying out one way ANOVA, the number of using multiple comparison methods is 15(Scheffe:6(26%), Duncan:4(17%), Dunnett:3(13%), Tukey:2(9%)) out of 23 (total case carrying out one way ANOVA). 8(35%) out of 23 did not enforce multiple comparison methods after carrying out one way ANOVA. 4. From the assessment of validity about 63 cases using statistical techniques(except descriptive statistics), 5(8%) cases are proper, the other 58(92%) are improper, so we recognized a serious misuse of statistical application in our journal. 5. The number of case below 10 sample size in experimental and clinical study(except descriptive statistics) is 31(34%) and frequent. Also the number of case containing no mention of sample size is 41(45%, including culture study). 6. For example of statistical error, there are wrong choice of statistical technique, lack of check on standard assumption(such as standard distribution, equivariance, independence), and so on. Conclusions : We investigated the validity of statistical analysis methods in our journal by check list consisting of 34 items and suggested correct statistical analysis methods. We should practice the spread of education about statistical analysis methods and precis application, enhance objectivity and reliability of our thesis and further correspond with purpose of scientific study.

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The Clinical Effects of an Herbal Antimicrobial Feed Additive in Growing Chickens (천연물 유래 항생제 대체 사료첨가제의 육계 임상 효능에 대한 연구)

  • Oh, Hong-Geun;Park, Hyun;Kim, Youn-Chul;Lee, Hyun-A;Kim, Ok-Jin
    • Journal of Veterinary Clinics
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    • v.27 no.1
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    • pp.17-22
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    • 2010
  • The natural herbal antimicrobial additive, Flavo-$SK^{TM}$, was developed by Zoonosis Research Center of Wonkwang University. The purpose of this study was to evaluate the effects of Flavo-$SK^{TM}$ on the health status and performance of growing chickens. This study was conducted on the growing chickens (n=20,000) for 31 days in a growing chickens husbandry. The animals were divided with two groups; Flavo-$SK^{TM}$ treated group (n=10,000) and commercial diet feeding group (n=10,000). The Flavo-$SK^{TM}$ treated animals had provided with commercial diet adding the Flavo-$SK^{TM}$ as 0.29%. During the study period, we compared clinical signs, weight increase rate, diet consumption amount, gross finding, necropsy findings and histopathological findings between the treated group and non treated group. As the results of this clinical trial, the natural herbal antimicrobial additive, Flavo-$SK^{TM}$, showed the effects on disease reduction. It is suggested that Flavo-$SK^{TM}$ has the antimicrobial effects.

Effects of Transcranial Direct-Current Stimulation Therapy on Primary Chronic Insomnia: A Proof-of Concept Clinical Trial (일차성 만성불면증 환자에서 경두개 직류전기자극법 치료 효과: 개념 증명 연구)

  • Jun, Jin-Sun;Kim, Tae-Joon;Koo, Sun A;Park, Ji-Sook;Kim, Keun Tae;Yang, Tae-Won;Lim, Jung-Ah;Byun, Jung-Ick;Sunwoo, Jun-Sang;Jung, Ki-Young
    • Journal of Sleep Medicine
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    • v.15 no.2
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    • pp.37-42
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    • 2018
  • Objectives: To assess the effect and safety of transcranial direct-current stimulation (tDCS) in primary chronic insomnia. Methods: A one-month, double-blind, randomized, sham-controlled trial was performed. A total of 7 patients with primary chronic insomnia received tDCS using anodal (n=3), cathodal (n=2), or sham stimulation (n=2). They were followed up at 1 week and 1 month after treatment. The primary outcome measures included improvement in total sleep time (TST), sleep latency (SL), and sleep efficiency (SE) at 1 month follow-up. Results: TST and SE were improved with tDCS at 1 month follow-up in all patients (100%) of the anodal group, one (50%) of the cathodal group, and one (50%) of the sham group. tDCS improved SL at 1 month follow-up in two patients (67%) of the anodal group, one (50%) of the cathodal group, and none (0%) of the sham group. With respect to adverse events, transient itching sensation occurred in one patient of the anodal group. None of the other groups reported adverse events. Conclusions: Our results suggest that tDCS may be effective and safe for treatment of primary chronic insomnia. A larger controlled study needs to be further investigated.

Review of the Radiation Risk and Clinical Efficacy Associated with Computed Tomography Cancer Screening (암의 조기발견을 위한 CT촬영에서의 임상적 효능과 방사선위해에 대한 고찰)

  • Kim, Hyun Ja
    • Journal of Radiation Protection and Research
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    • v.38 no.4
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    • pp.214-227
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    • 2013
  • Computed tomographic scan as a screening procedures in asymptomatic individuals has seen a steady increase with the introduction of multiple-raw detector CT scanners. This report provides a brief review of the current controversy surrounding CT cancer screening, with a focus on the radiation induced cancer risks and clinical efficacy. 1. A large study of patients at high risk of lung cancer(the National Lung Screening Trial[NLST]) showed that CT screening reduced cancer deaths by 20%(1.33% in those screened compared with 1.67% in those not screened). The rate of positive screening tests was 24.2% and 96.4% of the positive screening results in the low-dose CT group were false-positive. Radiation induced lung cancer risk was estimated the most important in screening population because ERR of radiation induced lung cancer does not show the decrease with increasing age and synergistic connection between smoking and radiation risk. Therefore, the radiation risk may be on the same order of magnitude as the benefit observed in the NLST. Optimal screening strategy remain uncertain, CT lung cancer screening is not yet ready for implementation. 2. Computed tomographic colonography is as good as colonoscopy for detecting colon cancer and is almost as good as colonoscopy for detecting advanced adenomas, but significantly less sensitive and specific for smaller lesions and disadvantageous for subsequent therapeutic optical colonoscopy if polyps are detected. The average effective dose from CT colonography was estimated 8-10 $mS{\nu}$, which could be a significant dose if administered routinely within the population over many years. CT colonography should a) achieve at least 90% sensitivity and specificity in the size category from 6 and 10 mm, b) offer non-cathartic bowl preparation and c) be optimized and standardized CT parameters if it is to be used for mass screening. 3. There is little evidence that demonstrates, for whole-body scanning, the benefit outweighs the detriment. This test found large portion of patient(86~90.8%) had at least one abnormal finding, whereas only 2% were estimated to have clinically significant disease. Annual scans from ages 45 to 75 years would accrue an estimated lifetime cancer mortality risk of 1.9%. There is no group within the medical community that recommends whole-body CT. No good studies indicate the accuracy of screening CT, at this time. The benefit/risk balance for any of the commonly suggested CT screening techniques has yet to be established. These areas need further research. Therefore wild screening should be avoided.

A Clinical Study of Acupuncture with Aromatherapy on Poststroke Depression Patients (중풍후우울증 환자에 대한 향기침요법의 임상적 연구)

  • Chung, Sae-Yun;Hwang, Jae-Woong;Kim, Seok-Min;Jung, Jae-Han;Choi, Chang-Min;Jung, Woo-Sang;Moon, Sang-Kwan;Cho, Ki-Ho;Kim, Young-Suk;Sun, Jong-Joo
    • The Journal of Internal Korean Medicine
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    • v.27 no.2
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    • pp.480-487
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    • 2006
  • Objectives : In this study we investigated BDI(Beck Depression Inventory) improvement of poststroke depression Patients who took the acupuncture with aromatherapy, in order to examine its capacity as a new treatment and to establish a primary data for further studies of developments of diverse Practical acupunctures. Methods : Physicians applied the acupuncture with aromatherapy every day for two weeks. We had evaluated baseline characteristics and BDI of all Patients, and revaluated BDI and examined the side effects two weeks later. The qualified Patients were classified into two groups, depression group (more than 10 points and 10 in BDI) and non-depression group (less than 10 points in BDI) according to the baseline BDI. Results : The study was completed with 27stroke patients. The acupuncture with aroma therapy was applied in 18 post-stroke depression patients and 9 non-depression patients for 2 weeks. And the result showed that the BDI scores in the depression group decreased to $16.5{\pm}11.1$ after the treatment (compared to $24.4{\pm}11.5$ before the treatment). so proved the significant effect on post-stroke depression of the acupuncture. On the other hand. the scores in the non-depression group increased to $9.2{\pm}9.5$ (compared to $3.3{\pm}3.0$). Conclusions : The acupuncture with aromatherapy applied on post-stroke depression patients showed the effect of BDI improvement. Further researches are needed to evaluate the distinct functional mechanism of acupuncture with aromatherapy, and to estimate its effectiveness by well-designed randomized controlled trial.

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Efficacy and Safety of Miniscalpel Acupuncture, Non-Steroidal Anti-Inflammatory Drugs or Combined Treatment for Chronic Neck Pain: An Assessor-Blinded Randomized Controlled Pilot Study (만성 경항통(목부위 통증)의 도침요법, 진통제, 복합치료의 효능 및 안전성 연구)

  • Gong, Han Mi;Jun, Seungah;Chung, Yeon-Joong;Kim, Ju-Ran;Lee, Jung Hee;Lee, Hyun-Jong;Park, Chung A;Kim, Jae Soo
    • Korean Journal of Acupuncture
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    • v.37 no.1
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    • pp.14-23
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    • 2020
  • Objectives : We investigated the efficacy and safety of miniscalpel acupuncture (MA) treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) for chronic neck pain (CNP) in an assessor-blinded randomized controlled pilot trial to establish a basis for larger-scale randomized controlled studies on this subject. Methods : Participants (n=36) were recruited and randomly allocated to the MA group, NSAIDs and combined treatment group. The MA group received MA three times over three weeks. The NSAIDs group was administered orally with zaltoprofen 80mg t.i.d. over three weeks. The combined treatment group received MA and zaltoprofen in the same manner as MA and NSAIDs groups. The primary outcome was pain as assessed by a visual analogue scale (VAS) and the secondary outcomes were assessed using the Neck Disability index (NDI), EuroQol 5-dimension questionnaire (EQ-5D), and Patients' Global Impression of Change scale (PGIC). Assessments were made at week 0 (baseline), 1, 2, 3 (primary end point) during treatment and at week 7 (4 weeks after the end of treatment). Results : 35 participants completed the study. No serious adverse event occurred and blood test results were within normal limits. The improvement of VAS and NDI was significantly greater in combined and MA group than that in NSAIDs group (p<0.017). The combined group showed better outcomes in EQ-5D at visit 2 and 5, in PGIC at visit 4 than the NSAIDs group (p<0.017). No significant differences were found between combined and MA group. Conclusions : Our results suggest that both combined and MA group can be more effective in improving pain control than NSAIDs group. A large-scale clinical study is warranted to further clarify these findings.

Efficacy and safety of equine cartilage for rhinoplasty: a multicenter double-blind non-inferiority randomized confirmatory clinical trial

  • Chang, Yongjoon;Yun, Hyunjong;Choi, Jong Woo;Suh, Joong Min;Jeong, Woo Shik;Park, Hojin;Kang, Min Kyu;Shin, Yongho;Kim, Kuylhee;Chung, Chul Hoon
    • Archives of Craniofacial Surgery
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    • v.23 no.4
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    • pp.152-162
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    • 2022
  • Background: The efficacy and safety of equine cartilage as a competent xenograft material for rhinoplasty were evaluated and compared to the outcomes of rhinoplasty using silicone implants. Methods: We performed a multicenter, double-blind, non-inferiority, and randomized confirmatory study. Fifty-six patients were randomized 1:1 to the study group (using MegaCartilage-E) and control group (using silicone implants). The Rhinoplasty Outcome Evaluation (ROE) score, photo documentation, Global Aesthetic Improvement Scale (GAIS), and adverse event data were obtained until 12 months after surgery. The primary efficacy, which is the change in ROE score 6 months after surgery, was assessed in the modified intention-to-treat set. The secondary efficacy was evaluated in the per-protocol set by assessing the change in ROE score 6 and 12 months after surgery and nasofrontal angle, the height of the nasion, and GAIS 1, 6, and 12 months after surgery. Results: The change in ROE score of the study group was non-inferior to that of the control group; it increased by 24.26±17.24 in the study group and 18.27±17.60 in the control group (p= 0.213). In both groups, all secondary outcome measures increased, but there was no statistical difference. In the safety set, treatment-emergent adverse events occurred in 10 patients (35.71%) in the study group and six patients (21.43%) in the control group (p= 0.237). There were 13 adverse device events in the study group and six adverse device events in the control group (p= 0.515). Conclusion: Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.

Current situation of Translational research on Acupuncture, Moxibustion and Pharmacopuncture (침구와 약침에 대한 중개연구 현황)

  • Sin, Dae Chul;Song, Ho Sueb
    • Journal of Acupuncture Research
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    • v.33 no.2
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    • pp.109-116
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    • 2016
  • Objectives : Our primary objective lies in understanding the current landscape of translational research on acupuncture, moxibustion and pharmacopuncture. Methods : We searched our own selection of keywords of acupuncture, moxibustion and pharmacopuncture and translational research from three overseas databases (Pubmed, Scopus, Medicine) and four domestic databases (DBpia, KISS, Riss4u, Korea Med). Results : We have chosen 41 articles in total-40 articles on acupunture, 6 article on moxibustion(5 articles were duplicated in use in each category). Origin-wise, 48.8 %/24.8 %/17.0 % of our articles pool came from USA/China/Korea, respectively. UK, Austria, Thailand and Italy contributed the rest of our article pool. For those articles written in USA and China, review articles were the most common type. For the US articles, all 10 review articles were non-systematic reviews, while, for China's contribution, one out of 4 review articles were systematic review. Type-wise, our research pool's breakdown is as follows ; 17 review articles, 11 experimental research, 2 randomized controlled trials(RCT), 1 clinical trial, 4 conference reports, 1 letter, 1 study protocol and 4 uncategorized. Topic-wise, brain-neurology was most frequently referred with 8 articles, followed by parkinson's disease (3 articles) and epilepsy (2 articles). Conclusion : 1. In terms of research submission articles, Korea appears to be lacking translational research on acupuncture, moxibustion and pharmacopuncture, compared to USA and China, in our view. 2. Unlike the cases of USA and China, most of Korean translational research is limited to doing a T1 level of translational research. In order to bring bench-to-bedside to light. we believe, there should be more studies, and thereby a certain level of activation, to the T2 level of translational research in Korea. 3. Further, in our view there should be more efforts to improve article quality at the T1 level of translational research, which eventually becomes the fundamentals of the next level of research (i.e. T2 research), as well as to increase the number of research submissions, going forward.