• Title/Summary/Keyword: e-Clinical Trials

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Analysis of Recent Clinical Studies to Establish Korean Herbal Medicine Clinical Trial Guidelines for the Common Cold (감기 임상시험 가이드라인 제정을 위한 최신 임상시험 연구 분석)

  • Kim, Kwan-il;Lee, Ho-jung;Lee, Beom-joon;Jung, Hee-jae;Jung, Sung-ki;Lee, Jun-hee
    • The Journal of Internal Korean Medicine
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    • v.37 no.1
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    • pp.109-134
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    • 2016
  • Objectives: The aim of this study was to help develop a guideline for the common cold. We searched recent clinical studies of the common cold in Western medicine and reviewed their objectives, inclusion and exclusion criteria, primary outcome, secondary outcome, and assessment tools to establish evidenced-based guideline.Methods: We searched electronic databases (Cochrane Library, MEDLINE, EMBASE) to identify eligible randomized controlled trials (RCTs) about the common cold for the last 10 years. We included 29 RCTs and showed their research summary via their objectives, participants, interventions, control, treatment duration, and results. We also analyzed the definition of the common cold presented in the article, inclusion and exclusion criteria, primary and secondary outcomes, and assessment tools.Results: We reported the aforementioned areas in detail. At first, the definition of the common cold was confused across the articles. Second, herbal medication clinical trials for the common cold have been extensively studied recently. Third, the eligibility criteria frequently included the Jackson Symptom score. Fourth, validated assessment tools (i.e., the Wisconsin Upper Respiratory Symptom Survey-21) have only been used in a few recent studies.Conclusions: Our research will be helpful to establish Korean herbal medicine clinical trial guidelines for the common cold.

Comparison of Korean Medicine Psychotherapy and Traditional Chinese Medicine Psychotherapy for Anxiety: Focusing on Clinical Studies (불안에 대한 한의정신요법과 중의정신요법의 비교고찰: 임상연구를 중심으로)

  • Lee, Ji-Won;Hwang, In-Jun;Park, Min-Ryeong;Kwon, Chan-Young
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.3
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    • pp.301-316
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    • 2022
  • Objectives: To compare Korean medicine (KM) and traditional Chinese medicine (TCM) psychotherapy for anxiety. Methods: Databases including MEDLINE (via PubMed), EMBASE (via Elsevier), Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, and Oriental Medicine Advanced Searching Integrated System were comprehensively searched. Prospective clinical studies on KM or TCM psychotherapy for patients with anxiety disorder or individuals with elevated anxiety levels published up to August 3, 2022 were reviewed. Psychotherapy was divided into counselling, art therapy, and meditation according to its characteristics. Results: A total of 12 clinical studies were reviewed, including nine randomized controlled trials. The most common disorder investigated was post-traumatic stress disorder. Ten studies used TCM psychotherapy and two used KM psychotherapy. As for differences between TCM psychotherapy and KM psychotherapy, TCM psychotherapy utilized pattern identification in the procedure more actively than KM psychotherapy. In addition, some TCM studies have attempted to directly converge Western psychotherapy (i.e., hypnosis) and Eastern psychotherapy (i.e., Taoin qigong therapy). In the case of KM psychotherapy, there was an attempt to incorporate psychotherapy with Sasang constitutional medicine. Reported effects of TCM psychotherapy and KM psychotherapy on anxiety were positive. Conclusions: Research status of KM psychotherapy and TCM psychotherapy for anxiety was investigated, revealing some of their characteristics, commonalities, and differences. Findings of this review have the potential to provide a clue to the development of conventional KM psychotherapy and new medical technology for KM psychotherapy.

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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    • v.24 no.1
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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.

Effect of calcium hydroxide on inflammatory root resorption and ankylosis in replanted teeth compared with other intracanal materials: a review

  • Jahromi, Maryam Zare;Kalantar Motamedi, Mahmood Reza
    • Restorative Dentistry and Endodontics
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    • v.44 no.3
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    • pp.32.1-32.13
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    • 2019
  • Calcium hydroxide (CH) is the gold-standard intracanal dressing for teeth subjected to traumatic avulsion. A common complication after the replantation of avulsed teeth is root resorption (RR). The current review was conducted to compare the effect of CH with that of other intracanal medications and filling materials on inflammatory RR and replacement RR (ankylosis) in replanted teeth. The PubMed and Scopus databases were searched through June 2018 using specific keywords related to the title of the present article. The materials that were compared to CH were in 2 categories: 1) mineral trioxide aggregate (MTA) and endodontic sealers as permanent filling materials for single-visit treatment, and 2) Ledermix, bisphosphonates, acetazolamide, indomethacin, gallium nitrate, and enamel matrix-derived protein (Emdogain) as intracanal medicaments for multiple-visit management of avulsed teeth prior to the final obturation. MTA can be used as a single-visit root filling material; however, there are limited data on its efficacy due to a lack of clinical trials. Ledermix and acetazolamide were comparable to CH in reducing RR. Emdogain seems to be an interesting material, but the data supporting its use as an intracanal medication remain very limited. The conclusions drawn in this study were limited by the insufficiency of clinical trials.

Can carbamide peroxide be as effective as hydrogen peroxide for in-office tooth bleaching and cause less sensitivity? A systematic review

  • Patrick Wesley Marques de Boa;Kaiza de Sousa Santos;Francisca Jennifer Duarte de Oliveira;Boniek Castillo Dutra Borges
    • Restorative Dentistry and Endodontics
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    • v.49 no.2
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    • pp.14.1-14.13
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    • 2024
  • This study aimed to answer the question through a systematic review: Can carbamide peroxide be as effective as hydrogen peroxide and cause less in-office bleaching sensitivity? A literature survey was performed in PubMed/MEDLINE, Embase, Scopus, ISI Web of Science, and gray literature. Primary clinical trials that compared the efficacy or the in-office bleaching sensitivity between carbamide and hydrogen peroxides were included. The risk of bias was evaluated using the RoB2. The certainty of the evidence was assessed using the GRADE approach. DPI training significantly improved the mean scores of the dental undergraduates from 7.53 in the pre-DPI-training test to 9.01 in the post-DPI-training test (p < 0.001). After 6 weeks, the mean scores decreased marginally to 8.87 in the retention test (p = 0.563). DPI training increased their confidence level from 5.68 pre-DPI training to 7.09 post-DPI training. The limited evidence suggests that the 37% carbamide peroxide may be similarly effective to the 35% hydrogen peroxide for bleaching teeth in-office and causes less bleaching sensitivity. However, more well-designed split-mouth clinical trials are necessary to strengthen the evidence.

Marbling and Its Nutritional Impact on Risk Factors for Cardiovascular Disease

  • Smith, Stephen B.
    • Food Science of Animal Resources
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    • v.36 no.4
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    • pp.435-444
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    • 2016
  • This review addresses the role of fat in beef palatability and healthfulness. Particular emphasis is placed on the content of oleic acid in beef, and how this increases with time when cattle are fed a grain-based diet. Oleic acid decreases the melting point of lipids from beef, increasing the perception of juiciness and improving beef flavor. Clinical trials have demonstrated that ground beef containing elevated oleic acid increases, or at the least has no negative effects on the concentration of HDL cholesterol. The amount of fat in published ground beef intervention trials greatly exceeds the amount of fat in equivalent portions of beef from U.S. domestic or Korean Hanwoo cattle. Thus, we conclude 1) Beef cattle should be raised under production conditions that increase the concentration of oleic acid in their edible tissues (i.e., by grain feeding over extended periods of time); and 2) The amount of fat consumed in a typical portion of beef will not increase risk factors for cardiovascular disease.

The Role of Some Vitamins in Respiratory-related Viral Infections: A Narrative Review

  • Jae-Hee Park;Yunjung Lee;Mijoo Choi;Eunju Park
    • Clinical Nutrition Research
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    • v.12 no.1
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    • pp.77-89
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    • 2023
  • This study aimed to find out the effect of vitamins on respiratory-related viral infections, including coronavirus disease 2019 (COVID-19), through the literature reviews. From January 2000 to June 2021, the studies (cohort studies, cross-sectional studies, case-control studies, randomized control trials) related to vitamins (vitamin A, D, E, C, B6, folate, and B12) and COVID-19/severe acute respiratory syndrome/Middle East respiratory syndrome/cold/influenza were selected from the PubMed, Embase, and Cochrane libraries and analyzed. The relationship between vitamins and virus-related respiratory diseases was identified. Through the review, 39 studies were selected on vitamin D, one study on vitamin E, 11 studies on vitamin C, and 3 studies on folate. Regarding COVID-19, 18 studies on vitamin D, 4 studies on vitamin C, and 2 studies on folate showed significant effects of the intake of these nutrients in preventing COVID-19. Regarding colds and influenza, 3 studies on vitamin D, 1 study on vitamin E, 3 studies on vitamin C, and 1 study on folate demonstrated that the intake of these nutrients significantly prevents these diseases. Therefore, this review suggested the intake of vitamins D, E, C, and folate is important for preventing respiratory diseases related to viruses, such as COVID-19, colds, and influenza. The relationship between these nutrients and virus-related respiratory diseases should be continuously monitored in the future.

COVID-19 Antiviral and Treatment Candidates: Current Status

  • Erica Espano;Dajung Kim;Jiyeon Kim;Song-Kyu Park;Jeong-Ki Kim
    • IMMUNE NETWORK
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    • v.21 no.1
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    • pp.7.1-7.24
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    • 2021
  • The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 has severely impacted global health and economy. There is currently no effective approved treatment for COVID-19; although vaccines have been granted emergency use authorization in several countries, they are currently only administered to high-risk individuals, thereby leaving a gap in virus control measures. The scientific and clinical communities and drug manufacturers have collaborated to speed up the discovery of potential therapies for COVID-19 by taking advantage of currently approved drugs as well as investigatory agents in clinical trials. In this review, we stratified some of these candidates based on their potential targets in the progression of COVID-19 and discuss some of the results of ongoing clinical evaluations.

Review of Randomized Controlled Trials on the Therapeutic Effects of Herb Medicine for Premenstrual Syndrome (월경전증후군의 한약 치료 효과에 관한 무작위대조비교임상시험연구에 대한 고찰)

  • Kim, Su-Gyeong;Yoon, Young-Jin
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.4
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    • pp.36-55
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    • 2020
  • Objectives: The present study is carried out to review the efficacy of Korean, Oriental medicine on premenstrual syndrome. Methods: We searched for 7 internet worldwide databases in order to find the studies with the keywords of 'premenstrual syndrome', 'premenstrual syndrome & Oriental medicine', 'premenstrual syndrome & traditional Chinese medicine' and 'premenstrual syndrome & herbal medicine' from 2009 to 2019. after selecting studies based on own criteria, total 8 studies are finally included. the studies were assessed with the Cochrane risk of bias criteria and reviewed systematically. Results: After intervention, cured patient rate in test groups in all of studies were significantly higher than rate in control group. there were significant decrease in headache, anorexia, dry mouth, breast mass, mastodynia, agitation, irascibility, edema, dizziness, fever, anhedonia, depression, inability to sleep, profuse dreaming with herbal medicinal intervention. 3 of those studies checked hormonal level. Estradiol (E2) and Progesteron (P) changed significantly in 2 of studies. Prolactin (PRL) in 1 study decreased significantly. FSH (Follicle stimulating hormone) and LH (Luteinizing hormone) had no significant decrease in 1 study. Conclusions: This review suggests that herbal medicine on premenstrual syndrome is effective without serious adverse effects. however, since unclear risk of bias, the result of this study should be considered carefully. further clinical trials should be carried out in order to academical clinical progress regarding treatment of premenstrual syndrome.

Immunotherapy for Non-small Cell Lung Cancer: Current Landscape and Future Perspectives

  • Sun Min Lim;Min Hee Hong;Hye Ryun Kim
    • IMMUNE NETWORK
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    • v.20 no.1
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    • pp.10.1-10.14
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    • 2020
  • Immune checkpoint inhibitors (ICIs) have shown remarkable benefit in the treatment of patients with non-small-cell lung cancer (NSCLC) and have emerged as an effective treatment option even in the first-line setting. ICIs can block inhibitory pathways that restrain the immune response against cancer, restoring and sustaining antitumor immunity. Currently, there are 4 PD-1/PD-L1 blocking agents available in clinics, and immunotherapy-based regimen alone or in combination with chemotherapy is now preferred option. Combination trials assessing combination of ICIs with chemotherapy, targeted therapy and other immunotherapy are ongoing. Controversies remain regarding the use of ICIs in targetable oncogene-addicted subpopulations, but their initial treatment recommendations remained unchanged, with specific tyrosine kinase inhibitors as the choice. For the majority of patients without targetable driver oncogenes, deciding between therapeutic options can be difficult due to lack of direct cross-comparison studies. There are continuous efforts to find predictive biomarkers to find those who respond better to ICIs. PD-L1 protein expressions by immunohistochemistry and tumor mutational burden have emerged as most well-validated biomarkers in multiple clinical trials. However, there still is a need to improve patient selection, and to establish the most effective concurrent or sequential combination therapies in different NSCLC clinical settings. In this review, we will introduce currently used ICIs in NSCLC and analyze most recent trials, and finally discuss how, when and for whom ICIs can be used to provide promising avenues for lung cancer treatment.