• Title/Summary/Keyword: Clinical Trials

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Toxicity of the Adenoviral Vector Mediated Gene Therapy (아데노바이러스 유전자치료제의 독성)

  • Chung, In-Jae
    • Environmental Analysis Health and Toxicology
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    • v.24 no.1
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    • pp.71-77
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    • 2009
  • Adenoviral vector(AdV) has been the most widely used viral vector for delivering an exogenous therapeutic gene to human. As of this date, more clinical trials utilize recombinant AdV to treat cancer and monogenic inherited disease as well as vaccine applications. However, the number of clinical trials had dropped markedly following the tragic death of a patient ongoing an AdV therapy for the treatment of an ornithine transcarbamylase deficiency(OTCD). This review is an attempt to provide the information on toxicity generated by AdVmediated gene transfer. It would serve as a sobering reality to researchers and clinicians exploring the use of AdV, as to the complications involved in human application.

Cancer immunotherapy with T-cell targeting cytokines: IL-2 and IL-7

  • Kim, Ji-Hae;Lee, Kun-Joo;Lee, Seung-Woo
    • BMB Reports
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    • v.54 no.1
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    • pp.21-30
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    • 2021
  • Clinical trials have demonstrated that an increased number of effector cells, especially tumor-specific T cells, is positively linked with patients' prognosis. Although the discovery of checkpoint inhibitors (CPIs) has led to encouraging progress in cancer immunotherapy, the lack of either T cells or targets for CPIs is a limitation for patients with poor prognosis. Since interleukin (IL)-2 and IL-7 are cytokines that target many aspects of T-cell responses, they have been used to treat cancers. In this review, we focus on the basic biology of how these cytokines regulate T-cell response and on the clinical trials using the cytokines against cancer. Further, we introduce several recent studies that aim to improve cytokines' biological activities and find the strategy for combination with other therapeutics.

A Brief Review of Preclinical Researches and Clinical Trials of Oxytocin on Behavior-Related Phenotypes in Prader-Willi Syndrome

  • Kim, Jiyeon
    • Journal of mucopolysaccharidosis and rare diseases
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    • v.5 no.1
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    • pp.39-41
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    • 2021
  • Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder of hyperphagia leading to severe obesity, intellectual deficits, compulsivity, and other behavioral problems. PWS is caused by the inactivation of contiguous genes on chromosome 15q11-q13, which complicates the development of targeted, effective therapeutics. Various preclinical studies have been conducted by developing mouse models that exhibit phenotypes similar to PWS. Oxytocin deficiency in PWS is associated with hyperphagia with impaired satiety and, food-seeking and behavior disorders. Here, we summarize the oxytocin study of ingestion behavior tested in the PWS mouse model and published data from clinical trials that have evaluated treatment effectiveness on ingestion behavior and social dysfunction in patients with PWS.

Kidney protective potential of lactoferrin: pharmacological insights and therapeutic advances

  • Zahan, Md. Sarwar;Ahmed, Kazi Ahsan;Moni, Akhi;Sinopoli, Alessandra;Ha, Hunjoo;Uddin, Md Jamal
    • The Korean Journal of Physiology and Pharmacology
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    • v.26 no.1
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    • pp.1-13
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    • 2022
  • Kidney disease is becoming a global public health issue. Acute kidney injury (AKI) and chronic kidney disease (CKD) have serious adverse health outcomes. However, there is no effective therapy to treat these diseases. Lactoferrin (LF), a multi-functional glycoprotein, is protective against various pathophysiological conditions in various disease models. LF shows protective effects against AKI and CKD. LF reduces markers related to inflammation, oxidative stress, apoptosis, and kidney fibrosis, and induces autophagy and mitochondrial biogenesis in the kidney. Although there are no clinical trials of LF to treat kidney disease, several clinical trials and studies on LF-based drug development are ongoing. In this review, we discussed the possible kidney protective mechanisms of LF, as well as the pharmacological and therapeutic advances. The evidence suggests that LF may become a potent pharmacological agent to treat kidney diseases.

Current Status of COVID-19 Vaccine Development: Focusing on Antigen Design and Clinical Trials on Later Stages

  • Pureum Lee;Chang-Ung Kim;Sang Hawn Seo ;Doo-Jin Kim
    • IMMUNE NETWORK
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    • v.21 no.1
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    • pp.4.1-4.18
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    • 2021
  • The global outbreak of coronavirus disease 2019 (COVID-19) is still threatening human health, economy, and social life worldwide. As a counteraction for this devastating disease, a number of vaccines are being developed with unprecedented speed combined with new technologies. As COVID-19 vaccines are being developed in the absence of a licensed human coronavirus vaccine, there remain further questions regarding the long-term efficacy and safety of the vaccines, as well as immunological mechanisms in depth. This review article discusses the current status of COVID-19 vaccine development, mainly focusing on antigen design, clinical trials in later stages, and immunological considerations for further study.

Research Trends on the Thread Embedding Therapy of Neck pain in Traditional Chinese Medicine (경항통에 대한 매선 임상연구의 중국 현황 분석)

  • Jun, Purumea;Kim, Su Ran;Liu, Yan;Park, Ji Eun;Jung, So Young;Han, Chang Hyun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.31 no.5
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    • pp.284-293
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    • 2017
  • Thread embedding therapy is used increasingly for various disease including neck pain. However, the evidence of thread embedding therapy on neck pain and the assessment of their methodology are still limited. This study aimed to investigate the clinical research methodology using thread embedding therapy on neck pain. Thread embedding therapy is used increasingly for various disease including neck pain. However, the evidence of thread embedding therapy on neck pain and the assessment of their methodology are still limited. This study aimed to investigate the clinical research methodology using thread embedding therapy on neck pain. Total 31 studies were included in analysis. Thread embedding therapy usually was used once a week(32.3%), once per 10days(29.0%), once per two weeks (25.8%). The most common concurrent treatment used with thread embedding therapy was Chinese medicine. Among acupuncture points, EX-B2 (61.3%) was most commonly used, followed by GV14(45.2%), GB20(29.0%), GB21(22.6%). For control group, acupuncture were most commonly used(58.1%). All studies reported that the effect of thread embedding therapy was more effective compared to control group. and 11 studies reported side effects. Only 13 studies(41.9%) reported the appropriate randomization method, and the mean Jadad score of included studies was 1.52. Previous clinical trials included in this study showed the effect of thread embedding therapy for neck pain. However, the quality of the studies was not high. Further rigorous clinical trials are need to assess the effect of thread embedding therapy.

A Review on Clinical Studies of Herbal Treatment for Infertility Caused by Polycystic Ovary Syndrome -Focusing on Chinese Clinical Trials- (다낭성 난소증후군의 난임치료에 대한 한약임상연구 경향 분석 -중국의 임상연구를 중심으로-)

  • Won, An-Na;Choi, Min-Sun;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.27 no.4
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    • pp.43-56
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    • 2014
  • Objectives: The purpose of this study is to review the trend of chinese clinical studies of herbal treatment for infertility caused by Polycystic Ovary Syndrome (PCOS). Methods: We searched the clinical studies published from 1979 to 2013 through CAJ (Chinese Academic Journal) with keywords of "PCOS and 不孕" or "多囊卵 巢綜合證 and 不孕". We analyzed the intervention type of clinical studies. In addition, We researched randomized controlled trials (RCTs) published from 2009 to 2013, assessed the quality of RCTs using the Jadad Scale and reanalyzed the intervention type of RCTs. Results: One hundred and seventeen clinical studies were finally selected. Clinical studies of herbal treatment for infertility caused by PCOS increased remarkably after the 2000s in China. Combined herbal medicine and western medicine was used the most frequently. RCTs published from 2009 to 2013 were fifty. Average of Jadad score of RCTs was 1.2. Combined herbal medicine and western medicine was also the most frequently used as intervention in RCTs. Conclusions: Clinical studies on effect of combined herbal medicine and western medicine for infertility caused by PCOS were mostly published in China. But Quality of studies was generally low. Further research on effect of herbal treatment for infertility caused by PCOS is needed.

Outcomes of epidural steroids following percutaneous transforaminal endoscopic discectomy: a meta-analysis and systematic review

  • Song, Yinghao;Li, Changxi;Guan, Jingjing;Li, Cheng;Wu, Haisheng;Cheng, Xinzhi;Ling, Bingyu;Zhang, Jinglang
    • The Korean Journal of Pain
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    • v.35 no.1
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    • pp.97-105
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    • 2022
  • Background: Percutaneous transforaminal endoscopic discectomy (PTED) has been widely used in the treatment of lumbar degenerative diseases. Epidural injection of steroids can reduce the incidence and duration of postoperative pain in a short period of time. Although steroids are widely believed to reduce the effect of surgical trauma, the observation indicators are not uniform, especially the long-term effects, so the problem remains controversial. Therefore, the purpose of this paper was to evaluate the efficacy of epidural steroids following PTED. Methods: We searched PubMed, Embase, and the Cochrane Database from 1980 to June 2021 to identify randomized and non-randomized controlled trials comparing epidural steroids and saline alone following PTED. The primary outcomes included postoperative pain at least 6 months as assessed using a visual analogue scale (VAS) and the Oswestry Disability Index (ODI). The secondary outcomes included length of hospital stay and the time of return to work. Results: A total of 451 patients were included in three randomized and two non-randomized controlled trials. The primary outcomes, including VAS and ODI scores, did not differ significantly between epidural steroids following PTED and saline alone. There were no significant intergroup differences in length of hospital stay. Epidural steroids were shown to be superior in terms of the time to return to work (P < 0.001). Conclusions: Intraoperative epidural steroids did not provide significant benefits, leg pain control, improvement in ODI scores, and length of stay in the hospital, but it can enable the patient to return to work faster.

Pragmatic Clinical Studies: An Emerging Clinical Research Discipline for Improving Evidence-Based Practice of Cardiovascular Diseases in Asia

  • Dong Zhao;Chen Yao
    • Korean Circulation Journal
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    • v.52 no.6
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    • pp.401-413
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    • 2022
  • Pragmatic clinical studies, an emerging clinical research discipline, include a wide range of studies that are largely embedded with routine clinical practice and aim to evaluate the comparative effectiveness and safety of different clinical intervention strategies. Increased availability and quality of electronic medical/health records drives the development of pragmatic clinical studies. In this review, we describe evolution of the conceptual framework of pragmatic clinical studies and share perspectives on the importance of pragmatic clinical studies in evidence-based practice for cardiovascular diseases, as a complement to conventional randomized controlled trials. We also highlight specific needs of pragmatic clinical studies in improving evidence-based practice for cardiovascular disease in Asian countries. The main challenges of pragmatic clinical studies are discussed briefly in this review.

Quantity and Quality Assessment of Randomized Controlled Trials in the Atopic Dermatitis (아토피 피부염 무작위배정 임상연구 논문 질 평가)

  • Park, Hye-Joo;Kwon, Ji-Hye;Yoo, Jong-Hyang
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.27 no.4
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    • pp.45-57
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    • 2014
  • Objective : This study aims to provide fundamental data for new directions(the improvement directions) from searching research papers of randomized controlled trials among thesis of Atopic Dermatitis related to oriental medicine in Korea from 2004 to 2014 and identifying the problem and level of a clinical study through an assessment of the quality, CONSORT statement. Methods : Data was collected through the Koreanstudies Information Service System(KISS). Two experts in Oriental Medicine reviewed the title and abstract in thesis, the results of searching the title, "Atopic dermatitis" and topic, "oriental medicine" at KISS, and then they handsearched Randomized Controlled Trials related to oriental medicine in Korea. According to guidelines defined by CONSORT statement, they assessed whether 37 items were followed by guidelines at yes or no answers in order to evaluate the quality as well. They assessed the definition of each item independently. After comparing, they made a decision on the item of different outcomes through an agreement with a third party. Results : Total number of randomized controlled trials in Atopic Dermatitis related to oriental medicine is eleven. A randomized controlled trial was first published in 2007. One or two papers associated it were released every year except 2013. 9 papers of them were approved by Institutional Review Board and were received written consent. The study included between 20 to 40 subjects for 2-arm parallel study design. The effect of treatment was observed for 4 to 8 weeks. On average, the number followed guidelines was 18.64 among those of 37 CONSORT statement and 50.38% of them was followed overall. Conclusion : As an interest about randomized controlled trials was increased, it was needed to care the standard providing information of CONSORT statement on randomized controlled trials related to oriental medicine in Korea. It is suggested to provide more clear information about it, so that it can be a motive for improving quality of the journal in oriental medicine.