• Title/Summary/Keyword: e-Clinical Trials

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Bioequivalence of Bambucol Tablet 10 mg to $Bambec^{(R)}$ Tablet 10 mg (Bambuterol Hydrochloride 10 mg) (밤벡$^{(R)}$ 정 10밀리그람(염산밤부테롤 10밀리그람)에 대한 밤부콜 정 10밀리그람의 생물학적동등성)

  • Cho, Hea-Young;Choi, Ji-Hoon;Yoo, Hee-Doo;Lee, Yong-Bok
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.3
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    • pp.235-241
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    • 2010
  • Bambuterol hydrochloride, dimethylcarbamic acid 5-[2-(1,1-dimethylethyl)amino-1-hydroxyethyl]-1,3-phenylene ester hydrochloride, is the prodrug of active ${\beta}_2$-adrenergic metabolite terbutaline. The purpose of the present study was to evaluate the bioequivalence of two bambuterol hydrochloride tablets, $Bambec^{(R)}$ tablet 10 mg (Yuhan Co., Ltd.) and Bambucol tablet 10 mg (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). In vitro release of bambuterol from two bambuterol hydrochloride formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty eight healthy male Korean volunteers, $23.86{\pm}1.65$ years in age and $68.98{\pm}9.58$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 10 mg as bambuterol hydrochloride were orally administered, blood samples were taken at predetermined time intervals, and the concentrations of bambuterol in serum were determined using column switching HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test with K-BE Test 2002 was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Bambec^{(R)}$, were -8.10%, -3.82% and 12.65% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (i.e., log 0.8093~log 1.0302 and log 0.8564~log 1.1280 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Bambucol tablet 10 mg was bioequivalent to $Bambec^{(R)}$ tablet 10 mg.

The effect of preheating resin composites on surface hardness: a systematic review and meta-analysis

  • Elkaffas, Ali A.;Eltoukhy, Radwa I.;Elnegoly, Salwa A.;Mahmoud, Salah H.
    • Restorative Dentistry and Endodontics
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    • v.44 no.4
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    • pp.41.1-41.13
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    • 2019
  • Objectives: This paper presents a systematic review and meta-analysis of the effect of preheating on the hardness of nanofilled, nanoceramic, nanohybrid, and microhybrid resin composites. Materials and Methods: An electronic search of papers on MEDLINE/PubMed, ScienceDirect, and EBSCOhost was performed. Only in vitro studies were included. Non-English studies, case reports, clinical trials, and review articles were excluded. A meta-analysis of the reviewed studies was conducted to quantify differences in the microhardness of the Z250 microhybrid resin composite using the Comprehensive Meta-Analysis software. Results: Only 13 studies met the inclusion criteria for this systematic review. The meta-analysis showed that there were significant differences between the non-preheated and preheated modes for both the top and bottom surfaces of the specimens (p < 0.05). The microhardness of the Z250 resin composite on the top surface in the preheated mode (78.1 ± 2.9) was higher than in the non-preheated mode (67.4 ± 4.0; p < 0.001). Moreover, the microhardness of the Z250 resin composite on the bottom surface in the preheated mode (71.8 ± 3.8) was higher than in the non-preheated mode (57.5 ± 5.7, p < 0.001). Conclusions: Although the results reported in the reviewed studies showed great variability, sufficient scientific evidence was found to support the hypothesis that preheating can improve the hardness of resin composites.

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.

Interventions of Korean Medicine for Hip Pain: A Literature Review of Case Studies (고관절 통증에 대한 한의학적 치료: 증례연구의 문헌적 분석)

  • Park, Sang-Cheol;Sung, Soo-Hyun;An, Tteul-E-Bom;Shin, Byung-Cheul;Choi, Gwang-Ho;Park, Jong-Hyun
    • Journal of Korean Medicine Rehabilitation
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    • v.27 no.1
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    • pp.27-35
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    • 2017
  • Objectives This study aimed to review case studies on interventions of Korean medicine for hip pain. Methods We searched seven electronic databases for relevant studies up to Oct 2016. Case studies of Korean medicine interventions for hip pain were included and analysed. Results 15 case studies were included (Korean databases; n=15) and Total number of patients was 17 cases. A total of 13 types of interventions were reported, of which acupuncture (93.3%), herbal medicine (80.0%) and pharmacopuncture (40.0%) were the most frequently used. GB30 (66.7%), LR3 (41.7%), BL36 (33.3%) and ST31 (33.3%) were used in at least 4 papers. Cheongpa-jeon (25.0%) and symptom change (46.7%) were most frequently used in herbal medicine and outcome measure respectively. Conclusions Clinical studies, especially double-blinded randomized controlled trials, of Korean medicine interventions for hip pain must be conducted to obtain definite conclusions.

Aging and Skin Aging (노화와 피부노화에 대한 고찰)

  • Nam Hae-jeong;Kim Yoon-bum
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.17 no.1
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    • pp.16-33
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    • 2004
  • In Oriental medicine, aging is just a natural process like change of seasons. Ancient Oriental people accepted it as a natural thing to be growing older and to die at last. The science of aging has advanced dramatically. In the last 2 decades, advances in genetics and molecular biology have led to extraordinary new understandings in how cells age, how apoptosis programs cells to die, and how neuroendocrinology plays a role in the lifespan of organisms. Today, the matter of primary concern about aging is a cellular and mitochondrial damage of human body induced by reactive oxygen species(ROS). The skin aging can be divided into two areas, intrinsic(chronologic)-aging and photo-aging. There are lots of photo damage about skin aging. The skin is increasingly exposed to ultraviolet(UV) irradiation in life. Therefore, the risk of photo-oxidative damage of the skin induced by reactive oxygen species(ROS) has increased substantially. Nowadays, many people believe that they can stop or at least delay the process of aging. There are lots of treatments that promise to slow the process of aging and the associated ailments. Many of these treatments, for example, exercise, Vit E, Vit C therapy, hormone therapy, restrict diet, are gradually being subjected to clinical trials. But in spite of all efforts, researches and investigations, there is no single method or treatment which is revealed to be truly effective for delaying progress of aging. Every methods insisted on effect for delaying aging process, has its dark side. All we can do is just keeping ourself healthy until the time of death.

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Development of the anti-cancer food scoring system 2.0: Validation and nutritional analyses of quantitative anti-cancer food scoring model

  • Hong, Yeo-Jin;Kim, Jeongseon;Lee, Hye Yoon;Rim, Chai Hong
    • Nutrition Research and Practice
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    • v.14 no.1
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    • pp.32-44
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    • 2020
  • BACKGROUND/OBJECTIVE: We have previously designed the anti-cancer food scoring model (ACFS) 1.0, an evidence-based quantitative tool analyzing the anti-cancer or carcinogenic potential of diets. Analysis was performed using simple quantitative indexes divided into 6 categories (S, A, B, C, D, and E). In this study, we applied this scoring model to wider recipes and evaluated its nutritional relevance. MATERIALS/METHODS: National or known regional databases were searched for recipes from 6 categories: Korean out-dining, Korean home-dining, Western, Chinese, Mediterranean, and vegetarian. These recipes were scored using the ACFS formula and the nutrition profiles were analyzed. RESULTS: Eighty-eight international recipes were analyzed. All S-graded recipes were from vegetarian or Mediterranean categories. The median code values of each category were B (Korean home-dining), C (Korean out-dining), B (Chinese), A (Mediterranean), S (vegetarian), and D (Western). The following profiles were correlated (P < 0.05) with ACFS grades in the univariate trend analysis: total calories, total fat, animal fat, animal protein, total protein, vitamin D, riboflavin, niacin, vitamin B12, pantothenic acid, sodium, animal iron, zinc, selenium, and cholesterol (negative trends), and carbohydrate rate, fiber, water-soluble fiber, vitamin K, vitamin C, and plant calcium (positive trends). Multivariate analysis revealed that animal fat, animal iron, and niacin (negative trends) and animal protein, fiber, and vitamin C (positive trends) were statistically significant. Pantothenic acid and sodium showed non-significant negative trends (P < 0.1), and vitamin B12 showed a non-significant positive trend. CONCLUSION: This study provided a nutritional basis and extended the utility of ACFS, which is a bridgehead for future cancer-preventive clinical trials using ACFS.

Oral food challenges in children

  • Yum, Hye-Yung;Yang, Hyeon-Jong;Kim, Kyung-Won;Song, Tae-Won;Kim, Woo-Kyung;Kim, Jung-Hee;Ahn, Kang-Mo;Kim, Hyun-Hee;Lee, Soo-Young;Pyun, Bok-Yang
    • Clinical and Experimental Pediatrics
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    • v.54 no.1
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    • pp.6-10
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    • 2011
  • Many patients assume that allergic reactions against foods are responsible for triggering or worsening their allergic symptoms. Therefore, it is important to identify patients who would benefit from an elimination diet, while avoiding unnecessary dietary restrictions. The diagnosis of food allergy depends on the thorough review of the patients's medical history, results of supplemented trials of dietary elimination, and in vivo and in vitro tests for measuring specific IgE levels. However, in some cases the reliability of such procedures is suboptimal. Oral food challenges are procedures employed for making an accurate diagnosis of immediate and occasionally delayed adverse reactions to foods. The timing and type of the challenge, preparation of patients, foods to be tested, and dosing schedule should be determined on the basis of the patient's history, age, and experience. Although double-blind, placebo-controlled food challenges(DBPCFC) are used to establish definitively if a food is the cause of adverse reactions, they are time-consuming, expensive and troublesome for physician and patients. In practice, An open challenge controlled by trained personnel is sufficient especially in infants and young children. The interpretation of the results and follow-up after a challenge are also important. Since theses challenges are relatively safe and informative, controlled oral food challenges could become the measure of choice in children.

Current Pharmacogenetic Approach for Oxaliplatin-induced Peripheral Neuropathy among Patients with Colorectal Cancer: A Systematic Review (대장암 환자의 옥살리플라틴(oxaliplatin) 유도 말초신경병증에 대한 약물유전학적 접근: 체계적 문헌고찰)

  • Ahn, Soojung;Choi, Soyoung;Jung, Hye Jeong;Chu, Sang Hui
    • Journal of Korean Biological Nursing Science
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    • v.20 no.2
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    • pp.55-66
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    • 2018
  • Purpose: Peripheral neuropathy is common among colorectal cancer (CRC) patients who undergo oxaliplatin-based (OXL) chemotherapy. A pharmacogenetic approach can be used to identify patients at high-risk of developing severe neuropathy. This type of approach can also help clinicians determine the best treatment option and prevent severe neurotoxicity. The purpose of this study is to investigate the evidence of pharmacogenetic markers for OXL-induced peripheral neuropathy (OXIPN) in patients with CRC. Methods: A systematic literature search was conducted using the following databases up to December 2017: Pubmed, EMBASE, and CINAHL. We reviewed the genetic risk factors for OXIPN in observational studies and randomized controlled clinical trials (RCTs). All processes were performed independently by two reviewers. Results: Sixteen studies published in English between 2006 and 2017 were included in this review. A genome-wide association approach was used in one study and various candidate genes were tested, based on their functions (e.g., DNA damage or repair, ion channels, anti-oxidants, and nerve growth etc.). The genes associated with incidence or severity of OXIPN were ABCG2, GSTP1, XRCC1, TAC1, and ERCC1. Conclusion: This study highlighted the need and the importance of conducting pharmacogenetic studies to generate evidence of personalized OXIPN symptoms management. Additional studies are warranted to accelerate the tailored interventions used for OXIPN in patients with CRC (NRF-2014R1A1A3054386).

Comparative study on the antimicrobial and antiinflammatory activity of commercially available toothpastes (수종의 상용 세치제들의 향균 및 향염효과 비교연구)

  • Rhyu, In-Chul
    • Journal of Periodontal and Implant Science
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    • v.26 no.2
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    • pp.557-566
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    • 1996
  • It is known that some natural extracts from plants have a various range of antimicrobial and antiinflammatory activity. There are lots of clinical trials to develop toothpastes containing natural extracts for prevention of dental caries and gingival inflammation. The purpose of this study was to evaluate antimicrobial and antiinflammatory activity of magnolol containing toothpastes and other commercial toothpastes. Eleven kinds oftoothpastes were used. They include magnolol, sanguinarine, Myrrha, Mori radicis cortex,Cimicifugae rhizoma, sodium fluoride, aminocaprolactic acid etc. Six strains of bacteria were used for this test, ego Porphylomonas gingivalis, Prevotellain-termedia, Actinobacillus actinomy cetemcomitans, Streptococcus mutans, Stretococcus sanguis, and Actinomyces species. Antimicrobial activity was determined by an agar dillution method and a broth microdillution method. Antiinflammatory activity was assessed by the inhibition of $PGE_2$ production from gingival fibroblast with the addition of rHIL-1 and centrifuged solution of toothpastes. Control group was only rHIL-1 additive sample. $PGE_2$ enzyme immunoassay systemfAmersham, In. Buckinghamshire, U.K). $PGE_2$ level was measured by ELISA reader with 450 nm, The results from the study revealed that toothpastes containing natural extracts generally had high antimicrobial and antiinflammatory activity. Especially magnolol containing toothpaste showed higher antimicrobial activity than other toothpastes, and sanguinarine containing toothpaste showed particularly high antimicrobial activity in A. actinomicetemcomitans and A. viscosus. In some degree all toothpastes inhibited $PGE_2$ production, but magnolol containing toothpaste was potent inhibitor of $PGE_2$. Sodium chloride containing toothpaste had also effective result. The results suggested that toothpastes containing natural extracts were promising in plaque control and prevention of dental caries and gingivitis.

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Effect of smear layer deproteinization on bonding of self-etch adhesives to dentin: a systematic review and meta-analysis

  • Alshaikh, Khaldoan H.;Hamama, Hamdi H.H.;Mahmoud, Salah H.
    • Restorative Dentistry and Endodontics
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    • v.43 no.2
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    • pp.14.1-14.16
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    • 2018
  • Objectives: The aim of this systematic review was to critically analyze previously published studies of the effects of dentin surface pretreatment with deproteinizing agents on the bonding of self-etch (SE) adhesives to dentin. Additionally, a meta-analysis was conducted to quantify the effects of the above-mentioned surface pretreatment methods on the bonding of SE adhesives to dentin. Materials and Methods: An electronic search was performed using the following databases: Scopus, PubMed and ScienceDirect. The online search was performed using the following keywords: 'dentin' or 'hypochlorous acid' or 'sodium hypochlorite' and 'self-etch adhesive.' The following categories were excluded during the assessment process: non-English articles, randomized clinical trials, case reports, animal studies, and review articles. The reviewed studies were subjected to meta-analysis to quantify the effect of the application time and concentration of sodium hypochlorite (NaOCl) and hypochlorous acid (HOCl) deproteinizing agents on bonding to dentin. Results: Only 9 laboratory studies fit the inclusion criteria of this systematic review. The results of the meta-analysis revealed that the pooled average microtensile bond strength values to dentin pre-treated with deproteinizing agents (15.71 MPa) was significantly lower than those of the non-treated control group (20.94 MPa). Conclusions: In light of the currently available scientific evidence, dentin surface pretreatment with deproteinizing agents does not enhance the bonding of SE adhesives to dentin. The HOCl deproteinizing agent exhibited minimal adverse effects on bonding to dentin in comparison with NaOCl solutions.