• Title/Summary/Keyword: Trial drug

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Randomized Clinical Controlled Trials of a Herb Remedies in Korea - Systematic Review (한약을 이용한 한국에서의 무작위 임상시험 개괄적 검토)

  • Oh, Rai-Young;Seol, In-Chan;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.31 no.4
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    • pp.1-8
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    • 2010
  • Objective: The study aimed to review all randomized controlled clinical trials (RCTs) performed in Korea with herbal medicine, to produce further useful information for herbal-drug development. Methods: All papers reporting RCT with herbal drugs were collected via public database of Korea Science and Technology Integration Services, and various Oriental medicine journals. Then, the clinical question, herbal medicine, result, RCT design, and its conductor were analyzed. Results: A total of 20 RCTs were finally selected, and most of them were performed after 2003. The main subjects of RCT were related to heart and blood circulation, dermatitis, respiration disorder, Sasang constitution, or psychiatric disorders. Eight RCTs were done with a single herb while 12 RCTs were with multiple herbal formulae. In particular, three RCTs for atopic dermatitis with three formulae showed positive results. The quality of RCT was considered as better than average. Conclusions: This study revealed the current status of RCT using herbal drugs. This result would provide helpful information for research and drug development using traditional herbal medicine.

Data Mining for High Dimensional Data in Drug Discovery and Development

  • Lee, Kwan R.;Park, Daniel C.;Lin, Xiwu;Eslava, Sergio
    • Genomics & Informatics
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    • v.1 no.2
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    • pp.65-74
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    • 2003
  • Data mining differs primarily from traditional data analysis on an important dimension, namely the scale of the data. That is the reason why not only statistical but also computer science principles are needed to extract information from large data sets. In this paper we briefly review data mining, its characteristics, typical data mining algorithms, and potential and ongoing applications of data mining at biopharmaceutical industries. The distinguishing characteristics of data mining lie in its understandability, scalability, its problem driven nature, and its analysis of retrospective or observational data in contrast to experimentally designed data. At a high level one can identify three types of problems for which data mining is useful: description, prediction and search. Brief review of data mining algorithms include decision trees and rules, nonlinear classification methods, memory-based methods, model-based clustering, and graphical dependency models. Application areas covered are discovery compound libraries, clinical trial and disease management data, genomics and proteomics, structural databases for candidate drug compounds, and other applications of pharmaceutical relevance.

Efficacy of Geru (red ochre) in controlling the bleeding in patients of Adolescent menorrhagia

  • Kotagasti, Tabassum
    • CELLMED
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    • v.5 no.2
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    • pp.12.1-12.3
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    • 2015
  • Adolescent menorrhagia is defined as excessive menstrual bleeding from menarche to adolescents. It is a distressing condition both for the patient as well as for her parents. If it is not managed in time itmay pose significant health problems that may leads to blood transfusion. We determined the efficacy of Geru (Red ochre) in controlling the amount and duration of blood flow in patients of Adolescent menorrhagia. This study included 40 teenage girls, who presented with heavy bleeding during menstruation to Outpatient Department, Sameena Maternity Nursing Home, Hyderabad during the year of 2013. Assessment of each case was done by history and Pictorial Blood loss Assessment Chart (PBAC) score. Geru powder was given for 2 cycles and results were assessed. The data was analyzed statistically. The mean PBAC score before treatment was $497.04{\pm}389.92$ and after trial in $1^{st}$ and $2^{nd}$ it was found to be $471.13{\pm}162.18$ and $310.13{\pm}142.15$ respectively. On basis of results it was concluded that single unani drug Geru is enough in controlling bleeding and was found effective by its astringent and styptic properties.

Differences in Diet-Related Attitudes and Demographics by Type of Food-Lifestyle: Focused on Adults in Their 20s and 30s (식생활 라이프스타일 유형에 따른 다이어트 관련 태도와 인구 통계학적 특성의 차이분석: 20, 30대 성인을 중심으로)

  • Park, Kwang Hee
    • Human Ecology Research
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    • v.53 no.6
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    • pp.655-665
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    • 2015
  • This study classified respondents by food-lifestyle and investigated differences in diet-related attitudes and demographic variables among food-lifestyle groups. Diet-related attitudes consisted of variables such as interest in diet, trial number of diet, diet period, weight loss, diet motivation, verification of products approved by the Ministry of Food and Drug Safety, verification of manufacturer's reliability, examination of damage cases and side effects, and awareness of consumer protection law. This study administered a questionnaire survey to adults between the ages of 20 and 39 who lived in Daegu and Uijeongbu from November 17th to December 14th 2014. Data collected from 293 respondents were analyzed using descriptive statistics, factor analyses, cluster analysis, analysis of variance (ANOVA) and chi-square tests. Four clusters (passive eating habit group, active eating habit group, convenience oriented group, and taste and health oriented group) were developed according to four factors of food-lifestyle (health-conscious, popularity-seeking, taste-seeking, convenience-seeking). The results of the ANOVA and chi-square tests indicated significant differences in interest in diet, awareness of consumer protection law, verification of products approved by the Ministry of Food and Drug Safety, verification of manufacturer's reliability, examination of damage cases and side effects, gender, education levels and household monthly income levels among food-lifestyle groups.

The Effects of Nafamostat Mesilate on a Bleeding Risk as an Anticoagulant During Use as a Continuous Renal Replacement Therapy: Systematic Review

  • Kang, YoungJu;Moon, Su Jee;Kang, Hye-Young
    • The Journal of Health Technology Assessment
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    • v.6 no.2
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    • pp.133-141
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    • 2018
  • Objectives: In the past, the pharmaceutical drug heparin was mostly used as the anticoagulant for continuous renal replacement therapy (CRRT), but the duration time is long to have the risk of a bleeding adverse effect, and in that case the drug therapy Nafamostat mesilate was utilized instead, as it is more safe in this case, with a short half-life and is increasing in use to permit lower concerns for bleeding incidents. However, there are insufficient number of large-scale studies on the comparison of Nafamostat mesilate and heparin. Methods: In this study, a systematic review are used to compare the bleeding risk of Nafamostat mesilate and Heparin, as subjected to patients and procedures for measuring risks performed with a CRRT, and the filter life span is to be evaluated as well in this patients. Results: As a result of literature review search, a total of 6 studies were included in systematic review. The reducing risk of bleeding and filter life span was analyzed. The retrospective cohort studies confirm that Nafamostat mesilate is less at risk of bleeding than heparin. And a cohort study confirms that Nafamostat mesilate is longer filter lifespan than heparin and randomized controlled trial studies show that Nafamostat mesilate is longer filter lifespan than not using the anticoagulants. Conclusion: Nafamostat mesilate is considered to be a good therapeutic option because it has a longer filter life span as well as the advantage of reducing bleeding.

Comparison of Methods for Detection of Escherichia coli O157:H7 in Ground Beef and Radish Sprouts

  • Lee, Jae-Hoon;Hyeon, Ji-Yeon;Heo, Seok;Hwang, In-Gyun;Kwak, Hyo-Sun;Choi, In-Soo;Park, Chan-Kyu;Seo, Kun-Ho
    • Food Science of Animal Resources
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    • v.30 no.2
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    • pp.179-184
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    • 2010
  • Escherichia coli O157:H7 is a food-borne pathogen that causes bloody diarrhea, hemorrhagic colitis, and hemolytic uremic syndrome (HUS). We compared three selective media and evaluated the performance of immunomagnetic separation (IMS) for the detection of low levels of E. coli O157:H7 in ground beef and radish sprouts with different levels of background flora. Bulk food samples (500 g for each trial) were artificially inoculated with nalidixic acid-resistant E. coli O157:H7 at the lowest dose that would generate 20 partial-positive samples of 25 g each. All samples were homogenized in mTSB (225 mL) and incubated overnight at $37^{\circ}C$. IMS was performed using the enriched mTSB samples (1 mL) along with conventional spreads plated onto three different selective media: Sorbitol MacConkey agar (SMAC), Sorbitol MacConkey agar with cefixime and tellulite (CT-SMAC), and Sorbitol MacConkey agar with nalidixic acid (NAL-SMAC) as the gold standard. Two suspicious colonies from each medium were selected and confirmed usinga serological test after transfer to tryptic soy broth with yeast extract (TSAYE). CT-SMAC was better than SMAC for detecting E. coli O157:H7 in all food types. Although there was no statistical difference in the number of positive samples when using IMS vs. non-IMS techniques, more positive samples were detected when IMS was used in both ground beef and radish sprouts. It appears that the improvement was more significant in radish sprouts, which had a higher level of background flora than ground beef. The results also suggest that the combination of CT-SMAC and IMS is sufficient to recover low levels of E. coli O157:H7 in high background flora food samples.

Combinatorial Antitumor Activity of Oxaliplatin with Epigenetic Modifying Agents, 5-Aza-CdR and FK228, in Human Gastric Cancer Cells

  • Park, Jong Kook;Seo, Jung Seon;Lee, Suk Kyeong;Chan, Kenneth K;Kuh, Hyo-Jeong
    • Biomolecules & Therapeutics
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    • v.26 no.6
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    • pp.591-598
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    • 2018
  • Epigenetic silencing is considered to be a major mechanism for loss of activity in tumor suppressors. Reversal of epigenetic silencing by using inhibitors of DNA methyltransferase (DNMT) or histone deacetylases (HDACs) such as 5-Aza-CdR and FK228 has shown to enhance cytotoxic activities of several anticancer agents. This study aims to assess the combinatorial effects of genesilencing reversal agents (5-Aza-CdR and FK228) and oxaliplatin in gastric cancer cells, i.e., Epstein-Barr virus (EBV)-negative SNU-638 and EBV-positive SNU-719 cells. The doublet combinatorial treatment of 5-Aza-CdR and FK228 exhibited synergistic effects in both cell lines, and this was further corroborated by Zta expression induction in SNU-719 cells. Three drug combinations as 5-Aza-CdR/FK228 followed by oxaliplatin, however, resulted in antagonistic effects in both cell lines. Simultaneous treatment with FK228 and oxaliplatin induced synergistic and additive effects in SNU-638 and SNU-719 cells, respectively. Three drug combinations as 5-Aza-CdR prior to FK228/oxaliplatin, however, again resulted in antagonistic effects in both cell lines. This work demonstrated that efficacy of doublet synergistic combination using DNMT or HDACs inhibitors can be compromised by adding the third drug in pre- or post-treatment approach in gastric cancer cells. This implies that the development of clinical trial protocols for triplet combinations using gene-silencing reversal agents should be carefully evaluated in light of their potential antagonistic effects.

Effect of Cimetidine and Phenobarbital on Metabolite Kinetics of Omeprazole in Rats

  • Park Eun-Ja;Cho Hea-Young;Lee Yong-Bok
    • Archives of Pharmacal Research
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    • v.28 no.10
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    • pp.1196-1202
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    • 2005
  • Omeprazole (OMP) is a proton pump inhibitor used as an oral treatment for acid-related gastrointestinal disorders. In the liver, it is primarily metabolized by cytochrome P-450 (CYP450) isoenzymes such as CYP2C19 and CYP3A4. 5-Hyroxyomeprazole (5-OHOMP) and omeprazole sulfone (OMP-SFN) are the two major metabolites of OMP in human. Cimetidine (CMT) inhibits the breakdown of drugs metabolized by CYP450 and reduces, the clearance of coad-ministered drug resulted from both the CMT binding to CYP450 and the decreased hepatic blood flow due to CMT. Phenobarbital (PB) induces drug metabolism in laboratory animals and human. PB induction mainly involves mammalian CYP forms in gene families 2B and 3A. PB has been widely used as a prototype inducer for biochemical investigations of drug metabolism and the enzymes catalyzing this metabolism, as well as for genetic, pharmacological, and toxicological investigations. In order to investigate the influence of CMT and PB on the metabolite kinetics of OMP, we intravenously administered OMP (30 mg/kg) to rats intraperitoneally pretreated with normal saline (5 mL/kg), CMT (100 mg/kg) or PB (75 mg/kg) once a day for four days, and compared the pharmacokinetic parameters of OMP. The systemic clearance ($CL_{t}$) of OMP was significantly (p<0.05) decreased in CMT-pretreated rats and significantly (p<0.05) increased in PB-pretreated rats. These results indicate that CMT inhibits the OMP metabolism due to both decreased hepatic blood flow and inhibited enzyme activity of CYP2C19 and 3A4 and that PB increases the OMP metabolism due to stimulation of the liver blood flow and/or bile flow, due not to induction of the enzyme activity of CYP3A4.

Ginseng consumption and risk of cancer: A meta-analysis

  • Jin, Xin;Che, Dao-biao;Zhang, Zhen-hai;Yan, Hong-mei;Jia, Zeng-yong;Jia, Xiao-bin
    • Journal of Ginseng Research
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    • v.40 no.3
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    • pp.269-277
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    • 2016
  • Background: The findings of currently available studies are not consistent with regard to the association between the risk of cancer and ginseng consumption. Therefore, we aimed to evaluate this association by conducting a meta-analysis of different studies. Methods: To systematically evaluate the effect of ginseng consumption on cancer incidence, six databases were searched, including PubMed, Ovid Technologies, Embase, The Cochrane Library, China National Knowledge Infrastructure, and Chinese VIP Information, from 1990 to 2014. Statistical analyses based on the protocol employed for a systematic review were conducted to calculate the summary relative risks (RRs) and 95% confidence intervals (CIs). Results: We identified nine studies, including five cohort studies, three case-control studies, and one randomized controlled trial, evaluating the association between ginseng consumption and cancer risk; these studies involved 7,436 cases and 334,544 participants. The data from the meta-analysis indicated a significant 16% lower risk of developing cancer in patients who consumed ginseng (RR = 0.84, 95% CI = 0.76-0.92), with evidence of heterogeneity (p = 0.0007, $I^2$ = 70%). Stratified analyses suggested that the significant heterogeneity may result from the incidence data for gastric cancer that were included in this study. Publication bias also showed the same result as the stratified analyses. In addition, subgroup analyses for four specific types of cancer (colorectal cancer, lung cancer, gastric cancer, and liver cancer) were also performed. The summary RRs for ginseng intake versus no ginseng consumption were 0.77 for lung cancer, 0.83 for gastric cancer, 0.81 for liver cancer, and 0.77 for colorectal cancer. Conclusion: The findings of this meta-analysis indicated that ginseng consumption is associated with a significantly decreased risk of cancer and that the effect is not organ specific.

Role Performance and Related Factors of Clinical Research Nurses in New Drug Development (신약개발을 위한 임상연구간호사의 역할수행과 관련 요인)

  • Park, Jeaeun;Kim, Shinmi
    • Journal of Korean Biological Nursing Science
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    • v.22 no.3
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    • pp.213-221
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    • 2020
  • Purpose: The purpose of this study was to explore the role performance and related factors of clinical research nurses (CRN) in the process of clinical trials of new drug development. Methods: Study participants were CRN whose affiliation was in non-capital areas and who had been working longer than three months at the time of the data collection. The data collection was conducted with a semi-structured questionnaire development by Hwang & Go, 2011 comprising 16 items of participants' characteristics and 60 items of role performance via in-person and online. Additionally, opinions which would be necessary to establish the CRN role were questioned for the future. A total of 141 questionnaires of 151 questionnaires responses were analyzed using descriptive statistics, t-test, and ANOVA for data analysis as appropriate. Results: The level of overall role performance was above average (5.61±0.90) with the highest in subject care (6.04 ± 0.96) and management and the lowest in self-development (4.39 ± 1.52). The only factor affecting overall role performance was employment status and the only sub-category affected by factors of employment status, and some general characteristics was self-development. Conclusion: From study results, it can be concluded that the CRN seem to perform their proper role. Nonetheless, self-development should be considered as critical aspect for better CRN competency, which is an important aspect toward improving the CRN role performance. Additionally, efforts to improve the level of role performance must be established through stable employment and concrete departmental placement as suggested in this study.