• Title/Summary/Keyword: Ongoing Clinical trials

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Ongoing Clinical Trials of Vaccines to Fight against COVID-19 Pandemic

  • Chiranjib Chakraborty;Ashish Ranjan Sharma;Manojit Bhattacharya;Garima Sharma;Rudra P. Saha;Sang-Soo Lee
    • IMMUNE NETWORK
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    • v.21 no.1
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    • pp.5.1-5.22
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    • 2021
  • Coronavirus disease 2019 (COVID-19) has developed as a pandemic, and it created an outrageous effect on the current healthcare and economic system throughout the globe. To date, there is no appropriate therapeutics or vaccines against the disease. The entire human race is eagerly waiting for the development of new therapeutics or vaccines against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Efforts are being taken to develop vaccines at a rapid rate for fighting against the ongoing pandemic situation. Amongst the various vaccines under consideration, some are either in the preclinical stage or in the clinical stages of development (phase-I, -II, and -III). Even, phase-III trials are being conducted for some repurposed vaccines like Bacillus Calmette-Guérin, polio vaccine, and measles-mumps-rubella. We have highlighted the ongoing clinical trial landscape of the COVID-19 as well as repurposed vaccines. An insight into the current status of the available antigenic epitopes for SARS-CoV-2 and different types of vaccine platforms of COVID-19 vaccines has been discussed. These vaccines are highlighted throughout the world by different news agencies. Moreover, ongoing clinical trials for repurposed vaccines for COVID-19 and critical factors associated with the development of COVID-19 vaccines have also been described.

Statistical Consideration of Vaccine Clinical Trials (백신임상시험에 대한 통계적 고찰)

  • Nam, Ju-Sun;Kang, Seung-Ho
    • The Korean Journal of Applied Statistics
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    • v.24 no.4
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    • pp.633-646
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    • 2011
  • Clinical vaccines studies (that include cancer prevention vaccines and therapeutic vaccines) are ongoing to improve the quality of life and lengthen the human lifespan. Recently clinical trials and research on vaccines have become more active due to the prevalence of new viruses such as the A(H1N1) virus that freighted the whole word in 2009. In this paper we will describe the statistical aspects of clinical vaccine trials and outline the current situation of domestic and international vaccine development.

Novel Systemic Therapies for Advanced Gastric Cancer

  • Kim, Hong Jun;Oh, Sang Cheul
    • Journal of Gastric Cancer
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    • v.18 no.1
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    • pp.1-19
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    • 2018
  • Gastric cancer (GC) is the second leading cause of cancer mortality and the fourth most commonly diagnosed malignant diseases. While continued efforts have been focused on GC treatment, the introduction of trastuzumab marked the beginning of a new era of target-specific treatments. Considering the diversity of mutations in GC, satisfactory results obtained from various target-specific therapies were expected, yet most of them were unsuccessful in controlled clinical trials. There are several possible reasons underlying the failures, including the absence of patient selection depending on validated predictive biomarkers, the inappropriate combination of drugs, and tumor heterogeneity. In contrast to targeted agents, immuno-oncologic agents are designed to regulate and boost immunity, are not target-specific, and may overcome tumor heterogeneity. With the successful establishment of predictive biomarkers, including Epstein-Barr virus pattern, microsatellite instability status, and programmed death-ligand 1 (PD-L1) expression, as well as ideal combination regimens, a new frontier in the immuno-oncology of GC treatment is on the horizon. Since the field of immuno-oncology has witnessed innovative, practice-changing successes in other cancer types, several trials on GC are ongoing. Among immuno-oncologic therapies, immune checkpoint inhibitors are the mainstay of clinical trials performed on GC. In this article, we review target-specific agents currently used in clinics or are undergoing clinical trials, and highlight the future clinical application of immuno-oncologic agents in inoperable GC.

Evaluation of the Clinical Effectiveness of Laser Acupuncture for Disease Specific : Systematic Reviews and Meta-analyses (질환별 레이저 침의 임상적 효과 평가 : 체계적 문헌고찰 및 메타분석)

  • DaeJin Kim;Byunghee Choi;Taeyeung Kim;Sukang Park;Jinyoug Kwak
    • Journal of Biomedical Engineering Research
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    • v.45 no.2
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    • pp.81-89
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    • 2024
  • Purpose : This study conducted a systematic review and meta-analysis to evaluate the clinical effectiveness of laser acupuncture for each condition using information from laser acupuncture trials registered on clinicaltrials.gov from January 2013 to June 2023. Methods : We quantitatively and qualitatively analysed the results of 16 clinical trials of laser acupuncture whose research results were confirmed. A risk of bias assessment was also carried out to assess the quality of each clinical trial. Results : A meta-analysis including three clinical trials was conducted to evaluate the comparative effectiveness of laser acupuncture and sham laser acupuncture in reducing pain and found that the laser acupuncture group had a statistically significant reduction in pain compared with the sham laser acupuncture group. In addition, 11 of the 13 trials not included in the meta-analysis showed a positive effect of laser acupuncture. Conclusion : Although laser acupuncture has a long history of clinical use and a lot of research, there is still some scepticism due to the lack of a clear mechanism of action and inconsistent reports of clinical effectiveness. In addition, there is a significant lack of systematic reviews of clinical evidence for major disease specific, and ongoing research is needed to establish an objective evidence base for the clinical effectiveness of laser acupuncture.

Current Development Status of Cytokines for Cancer Immunotherapy

  • Kyoung Song
    • Biomolecules & Therapeutics
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    • v.32 no.1
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    • pp.13-24
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    • 2024
  • Cytokines influence the overall cancer immune cycle by triggering tumor antigen expression, antigen presenting, immune cell priming and activation, effector immune cell recruitment and infiltration to cancer, and cancer killing in the tumor microenvironment (TME). Therefore, cytokines have been considered potential anti-cancer immunotherapy, and cytokine-based anti-cancer therapies continue to be an active area of research and development in the field of cancer immunotherapy, with ongoing clinical trials exploring new strategies to improve efficacy and safety. In this review, we examine past and present clinical developments for major anticancer cytokines, including interleukins (IL-2, IL-15, IL-12, IL-21), interferons, TGF-beta, and GM-CSF. We identify the current status and changes in the technology platform being applied to cytokine-based immune anti-cancer therapeutics. Through this, we discuss the opportunities and challenges of cytokine-based immune anti-cancer treatments in the current immunotherapy market and suggest development directions to enhance the clinical use of cytokines as immuno-anticancer drugs in the future.

Differentiation of Human Mesenchymal Stem Cells towards Neuronal Lineage: Clinical Trials in Nervous System Disorders

  • Hernandez, Rosa;Jimenez-Luna, Cristina;Perales-Adan, Jesus;Perazzoli, Gloria;Melguizo, Consolacion;Prados, Jose
    • Biomolecules & Therapeutics
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    • v.28 no.1
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    • pp.34-44
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    • 2020
  • Mesenchymal stem cells (MSCs) have been proposed as an alternative therapy to be applied into several pathologies of the nervous system. These cells can be obtained from adipose tissue, umbilical cord blood and bone marrow, among other tissues, and have remarkable therapeutic properties. MSCs can be isolated with high yield, which adds to their ability to differentiate into non-mesodermal cell types including neuronal lineage both in vivo and in vitro. They are able to restore damaged neural tissue, thus being suitable for the treatment of neural injuries, and possess immunosuppressive activity, which may be useful for the treatment of neurological disorders of inflammatory etiology. Although the long-term safety of MSC-based therapies remains unclear, a large amount of both pre-clinical and clinical trials have shown functional improvements in animal models of nervous system diseases following transplantation of MSCs. In fact, there are several ongoing clinical trials evaluating the possible benefits this cell-based therapy could provide to patients with neurological damage, as well as their clinical limitations. In this review we focus on the potential of MSCs as a therapeutic tool to treat neurological disorders, summarizing the state of the art of this topic and the most recent clinical studies.

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.

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.

Radiomics and Deep Learning from Research to Clinical Workflow: Neuro-Oncologic Imaging

  • Ji Eun Park;Philipp Kickingereder;Ho Sung Kim
    • Korean Journal of Radiology
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    • v.21 no.10
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    • pp.1126-1137
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    • 2020
  • Imaging plays a key role in the management of brain tumors, including the diagnosis, prognosis, and treatment response assessment. Radiomics and deep learning approaches, along with various advanced physiologic imaging parameters, hold great potential for aiding radiological assessments in neuro-oncology. The ongoing development of new technology needs to be validated in clinical trials and incorporated into the clinical workflow. However, none of the potential neuro-oncological applications for radiomics and deep learning has yet been realized in clinical practice. In this review, we summarize the current applications of radiomics and deep learning in neuro-oncology and discuss challenges in relation to evidence-based medicine and reporting guidelines, as well as potential applications in clinical workflows and routine clinical practice.

Multimodal Treatment Strategies in Esophagogastric Junction Cancer: a Western Perspective

  • Goetze, Thorsten Oliver;Al-Batran, Salah-Eddin;Berlth, Felix;Hoelscher, Arnulf Heinrich
    • Journal of Gastric Cancer
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    • v.19 no.2
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    • pp.148-156
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    • 2019
  • Esophagogastric junction (EGJ) cancer is a solid tumor entity with rapidly increasing incidence in the Western countries. Given the high proportion of advanced cancers in the West, treatment strategies routinely employed include surgery and chemotherapy perioperatively, and chemoradiation in neoadjuvant settings. Neoadjuvant chemoradiation and perioperative chemotherapy are mostly performed in esophageal cancer that extends to the EGJ and gastric as well as EGJ cancers, respectively. Recent trials have tried to combine both strategies in a perioperative context, which might have beneficial outcomes, especially in patients with EGJ cancer. However, it is difficult to recruit patients for trials, exclusively for EGJ cancers; therefore, the results have to be carefully reviewed before establishing a standard protocol. Trastuzumab was the first drug for targeted therapy that was positively evaluated for this tumor entity, and there are several ongoing trials investigating more targeted drugs in order to customize effective therapies based on tissue characteristics. The current study reviews the multimodal treatment concept for EGJ cancers in the West and summarizes the latest reports.