• 제목/요약/키워드: Human trials

검색결과 386건 처리시간 0.024초

Interleukin-18 Binding Protein (IL-18BP): A Long Journey From Discovery to Clinical Application

  • Soohyun Kim;Hyeon Yu;Tania Azam;Charles A. Dinarello
    • IMMUNE NETWORK
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    • 제24권1호
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    • pp.1.1-1.6
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    • 2024
  • IL-18 binding protein (IL-18BP) was originally discovered in 1999 while attempting to identify an IL-18 receptor ligand binding chain (also known as IL-18Rα) by subjecting concentrated human urine to an IL-18 ligand affinity column. The IL-18 ligand chromatography purified molecule was analyzed by protein microsequencing. The result revealed a novel 40 amino acid polypeptide. To isolate the complete open reading frame (ORF), various human and mouse cDNA libraries were screened using cDNA probe derived from the novel IL-18 affinity column bound molecule. The identified entire ORF gene was thought to be an IL-18Rα gene. However, IL-18BP has been proven to be a unique soluble antagonist that shares homology with a variety of viral proteins that are distinct from the IL-18Rα and IL-18Rβ chains. The IL-18BP cDNA was used to generate recombinant IL-18BP (rIL-18BP), which was indispensable for characterizing the role of IL-18BP in vitro and in vivo. Mammalian cell lines were used to produce rIL-18BP due to its glycosylation-dependent activity of IL-18BP (approximately 20 kDa). Various forms of rIL-18BP, intact, C-terminal his-tag, and Fc fusion proteins were produced for in vitro and in vivo experiments. Data showed potent neutralization of IL-18 activity, which seems promising for clinical application in immune diseases involving IL-18. However, it was a long journey from discovery to clinical use although there have been various clinical trials since IL-18BP was discovered in 1999. This review primarily covers the discovery of IL-18BP along with how basic research influences the clinical development of IL-18BP.

침 관련 근거중심의학의 연구 동향 - Randomized Controlled Trial을 중심으로 - (Research Trends in Evidence Based Medicine on Acupuncture -Randomized Controlled Trial-)

  • 이로민;남상수;이상훈;김용석
    • Journal of Acupuncture Research
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    • 제26권2호
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    • pp.147-158
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    • 2009
  • Objectives : The purpose of this study is to review the recent research trends of evidence based medicine, especially human randomized controlled trials on acupuncture. Methods : The articles were collected by retrieving the database of Pubmed and Journal of Korean Acupuncture & Moxibustion Society. The retrieving period was from October 2003 to September 2008, and the search term was 'acupuncture'. The articles were classified according to their publication journals, countries, publication years, targeted diseases, types of acupuncture and types of control. Results : In total, 558 articles in Pubmed and 35 articles in Journal of Korean Acupuncture & Moxibustion Society were searched. The number of articles on acupuncture research has increased with higher rate since 2000, but the Qualitative development has not achieved the same amplitude. Studies in Korea were insufficient both in Qualitative and Quantitative aspects. In countries, China had the most papers, and in targeted diseases, pain diseases were most dominant. In the types of acupuncture, classical acupuncture, and in the types of control, conventional western treatment showed the highest frequency. Conclusions: We need to do many-sided and more high Quality researches on acupuncture. For that, well-designed randornized trials are absolutely necessary.

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어패럴업계 전문직 종사자의 직무스트레스와 이직에 관한 연구 (Job Stress and Turnover of Fashion Designers and Fashion Merchandisers)

  • 하유선;정성지
    • 한국의류학회지
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    • 제24권8호
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    • pp.1103-1114
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    • 2000
  • The purpose of the study was to investigate the level and the major causes of job stress, and the causes of the high level of job turnover rate of fashion merchandisers and fashion designers. The study also examined the correlations among the major causes of job stress, job results and job turnover rate. A part of the questionnaire consisted of questions on major causes of job stress, job result, and intention and trial to leave a job. The subjects were to rate on 5 point Likert-type scales. The other part included the questions on demographic and individual characteristics of the subjects and their company characteristics. For the survey, the subjects were 99 fashion merchandisers and 128 fashion designers who are employed by mens or womens wear manufacturers. The SAS PC+ package was used to calculate frequency, Cronbach $\alpha$, multiple regressions. The results of the study were as follows: 1. The high degree of the job results were resulted from the high degree of specialties in their job characteristics, high contentment in human relations, career development and income, and low role conflict. 2. Stronger intentions and more trials to leave their job were correlated to better task performance in the workplace, lower commitment to their job, and lower job satisfaction. 3. Higher level of job stress caused by interpersonal relationship in the organization and contentment in career development and income affected stronger intentions and more trials to leave their job.

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Applications of Genetically Modified Tools to Safety Assessment in Drug Development

  • Kay, Hee-Yeon;Wu, Hong-Min;Lee, Seo-In;Kim, Sang-Geon
    • Toxicological Research
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    • 제26권1호
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    • pp.1-8
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    • 2010
  • The process of new drug development consists of several stages; after identifying potential candidate compounds, preclinical studies using animal models link the laboratory and human clinical trials. Among many steps in preclinical studies, toxicology and safety assessments contribute to identify potential adverse events and provide rationale for setting the initial doses in clinical trials. Gene modulation is one of the important tools of modern biology, and is commonly employed to examine the function of genes of interest. Advances in new drug development have been achieved by exploding information on target selection and validation using genetically modified animal models as well as those of cells. In this review, a recent trend of genetically modified methods is discussed with reference to safety assessments, and the exemplary applications of gene-modulating tools to the tests in new drug development were summarized.

경피적 관동맥혈관성형술 후 Re-188을 이용한 혈관 내 방사선조사요법 (Intracoronary Radiation Therapy Using Re-188 after percutaneous Coronary Angioplasty)

  • 채인호;이명묵;이동수
    • 대한핵의학회:학술대회논문집
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    • 대한핵의학회 1999년도 제38차 춘계학술대회
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    • pp.228-241
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    • 1999
  • Percutaneous coronary angioplasty is well established therapeutic modality in the management of coronary artery disease. However, the high restenosis rate of 30 to 50% limits its usefulness. The principal mechanism of restenosis, intimal hyperplasia, is the proliferative response of vessel wall to injury, which consists largely of smooth muscle cells. A large body of animal investigations and a limited number of clinical studies have established the ability of ionizing radiation to reduce neointimal proliferation and restenosis rate significantly. Human studies have been reported that intravascular radiation after first restenosis inhibits a second restenosis. Encouraged by these reports, we are also conducting a double blind, placebo-controlled, randomized trial to evaluate this new therapeutic modality in patients with coronary artery stenosis. The objective of our trial is to determine the safety and efficacy of catheter-based solutional beta emitting radioisotope system in preventing restenosis after angioplasty. This review describes the vascular brachytherapy systems and isotopes that have been utilized in the initial clinical trials performed in this area of post PTCA coronary restenosis. The results of many worldwide ongoing clinical trials will determine whether this new technology will change the future practice of vascular intervention.

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한약물을 이용한 암 치료 관련 무작위 배정 임상시험에 대한 고찰 (Review of Randomized Controlled Trials using Herbal Remedies on Cancer Patients)

  • 박봉기;왕경화;조정효;손창규
    • 대한한의학회지
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    • 제31권5호
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    • pp.12-32
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    • 2010
  • Objective: This study aimed to review herbal remedy-based RCTs on cancer patients in order to produce helpful information for clinical study of herbal medicine in the future. Methods: We collected all RCTs using herbal remedies on cancer patients from Pubmed and Cochrane databases until November 1st, 2009. Elementary information such as nation where performed, clinical question, design, randomization, double-blinding and allocation concealment were analyzed. Results: 153 RCTs were finally selected. 119 RCTs were conduced in China while only 2 were done in Korea. The most frequent targeted cancer was lung cancer as 29 RCTs. The main clinical questions included improvement of quality of life, elongation of survival rate and regression of tumor being 83, 62 and 55 respectively. 112 RCTs used herbal remedies with western therapy. Adequate methods for randomization and allocation concealment were found in 37% and 10% of trials respectively. Conclusions: We found that herbal remedies are used on cancer patients in aspects of both caring for the human body and tumor treatment itself. The study might provide us useful data for cancer-related clinical study using herbal remedies in the future.

미숙아의 장관영양 (Enteral Feeding for Preterm Infants-Benefits and Risks)

  • 신종범
    • Neonatal Medicine
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    • 제16권2호
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    • pp.121-130
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    • 2009
  • Over the past 20 years, neonatal mortality rates for preterm infants, particularly those born extremely preterm and with a very low birth weight, have decreased steadily. As more very immature preterm infants survive, provision of enteral feeding has become a major focus of concern. According to many experts on neonatal nutrition, the goal for the nutrition of preterm infants should be to achieve a postnatal growth rate approximating that of a normal fetus of the same gestational age. Total parenteral nutrition for maintaining nutritional integrity is mandatory before successful transition to enteral feeding. Early initiation of trophic enteral feeding is vital for postnatal adaptation. Recently published randomized controlled trials provide no evidence to support the practice of postponing enteral feeding to reduce the incidence of necrotizing enterocolitis. Early trophic feeding yields demonstrable benefits and there is currently no evidence of any adverse effects following early feeding. Preterm milk from the infant's own mother is the milk of choice, which can always be supplemented with a human milk fortifier. Here we review over 50 randomized controlled trials and over seven systematic reviews published on neonatal parenteral and enteral feeding of preterm infants. Neonatologists must make use of the evidence from these studies as a reference for feeding protocols for preterm infants in their NICUs are to be based.

항문생식기 헤르페스에 대한 한의학적 치료의 국내외 연구동향 분석 (A Review of the Effect of Korean Medicine on Genital Herpes)

  • 박연경;박치영
    • 대한한방부인과학회지
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    • 제31권1호
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    • pp.99-121
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    • 2018
  • Objectives: Genital herpes is common disease in gynecological field. Although various treatment options such as herbal medicine, acupuncture, moxibustion are used in genital herpes, there is not enough evidence about the treatment options. This study is to prove the efficacy of oriental medicine on genital herpes by investigating papers and suggest direction of future research. Method: We searched for papers which had both genital herpes and oriental medicine from Cochrane, Pubmed, Scopus, CNKI, Oasis, Korean traditional knowledge portal, Journal of Korean Obstetrics & Gynecology up to November 2017. After searching papers, we classified according to the study design and analyzed selected studies. Results: Sixteen papers were finally selected. Four papers are laboratory studies with Hartley guinea pig with recurrent genital herpes. Twelve papers are clinical trials which includes one single group trial, one controlled trial, ten randomized controlled trials. All of the studies have shown that herbal medicine is effective in improving the symptom of genital herpes and decreasing the recurrent rate of genital herpes and also has immunoregulatory effect. Conclusions: This study shows that herbal medicine could be a good treatment option for genital herpes. However, more well-designed clinical studies and laboratory studies will be needed.

위축성 질염의 한약 치료 임상 연구에 관한 체계적 문헌 고찰 (Review on Clinical Studies of Traditional Korean Medicine Treatment for Atrophic Vaginitis)

  • 남은영
    • 대한한방부인과학회지
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    • 제32권3호
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    • pp.245-262
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    • 2019
  • Objectives: The purpose of this study is to review clinical studies of traditional Korean medicine treatment (herb medicine) on vaginal atrophy. Methods: Key words "Vaginal atrophy", "Vulvovaginal atrophy", "Vaginal dryness", "Atrophic vaginitis", "Herb medicine", "Acupuncture", "Moxibustion", "Catgut embedding" were searched on 11 database systems (PMC, CENTRAL, EMBASE, CNKI, KTKP, KISS, NDSL, OASIS, DBpia, KMBASE, RISS) on May 31th 2019. In all searches, limits were set for MeSH (human) and language (English, Chinese or Korean). Results: 18 controlled clinical trials were collected in accordance with the selection and exclusion criteria. The types of intervention were herbal medicine, and types of herbal medicine were decoction, cream, suppository, oil, ect. The study results and methods of intervention were analyzed. Conclusions: Among the 18 trials, 5 studies showed that herbal medicine with hormone or antiprotozoal therapy was more effective than hormone or antiprotozoal therapy alone. And 2 studies showed that herbal medicine treatment was more effective than oil treatment of topical use. There was no abnormal vaginal bleeding, breast swelling and pain in TCM group.

Effect of intracanal cryotherapy on postendodontic pain: a systematic review and meta-analysis of randomized controlled trials

  • Gupta, Alpa;Aggarwal, Vivek;Gurawa, Alka;Mehta, Namrata;Abraham, Dax;Singh, Arundeep;Jala, Sucheta;Chauhan, Nishant
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제21권1호
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    • pp.15-27
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    • 2021
  • This systematic review aimed to qualitatively and quantitatively evaluate the effectiveness of cryotherapy in the reduction of postendodontic pain. The review question was, "What will be the success rate of cryotherapy technique among human patients with postendodontic pain?". The review protocol was framed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. Six studies were included in the review, and quantification of five studies was performed through a meta-analysis. In the forest plot representation of the studies comparing the control and cryotherapy groups in terms of the success rate in the management of postendodontic pain, the combined risk ratio (RR) was 0.80 (95% CI: 0.56 to 1.13) with a P value of 0.20. Based on the quantitative analysis, it can be suggested that intracanal cryotherapy does not play a significant role in reducing postendodontic pain.