• Title/Summary/Keyword: Human trials

검색결과 386건 처리시간 0.026초

치유문화에서 나타나는 자아 제한성의 문제: 고통수기들을 중심으로 (The Problem of Self-Limitation in Therapeutic Culture: Focusing on Misery Memoirs)

  • 서길완
    • 영미문화
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    • 제14권1호
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    • pp.73-94
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    • 2014
  • Accounts from therapeutic culture seem often to associate the selfish, or at least self-centered quest for self-fulfillment with individual choice or satisfaction, self-expression, expressive individualism, and emotionalism. These associations point to the downside of therapy as they present it as constituting a culture of narcissism, selfishness, or irresponsibility. While some of these characterizations contain useful insights, they overlook what are maybe some of the most important features of a therapeutic outlook. This paper aims to reveal that the therapeutic imperative is not so much geared towards the realization of self-fulfillment, as it is the promotion of self-limitation. Therapeutic culture tends to posit the self in a fragile and feeble form and insist that the management of life requires the continuous intervention of therapeutic expertise. Because of this, the elevated concern with the self is underpinned by anxiety, pain, suffering, and survival, rather than seen as a positive vision of realizing the human potential. Therapeutic culture has in this way helped to construct a diminished sense of self by which one is seen as suffering from an emotional deficit and vulnerability. This paper demonstrates this downside of therapeutic culture concerning self-limitation and the sense of a diminished self by examining popular "misery memoirs." Misery memoirs are widely consumed by the general public, therefore tend to be treated by contemporary therapeutic culture as a gospel on the therapeutic ideal for self-fulfillment and self-discovery. This is, despite the existence of hidden evidence to the contrary, because of their redemptive, happy endings that show individuals overcoming difficult trials such as child abuse, incestuous rape, and domestic violence. Individual self-fulfillment and self-discovery in such stories are not achieved through the active agency of the subject but through the passive endurance of pathological symptoms and with the aid of expertise and outside support. Therefore, such stories put victims in the limited position.

Albendazole and Mebendazole as Anti-Parasitic and Anti-Cancer Agents: an Update

  • Chai, Jong-Yil;Jung, Bong-Kwang;Hong, Sung-Jong
    • Parasites, Hosts and Diseases
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    • 제59권3호
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    • pp.189-225
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    • 2021
  • The use of albendazole and mebendazole, i.e., benzimidazole broad-spectrum anthelmintics, in treatment of parasitic infections, as well as cancers, is briefly reviewed. These drugs are known to block the microtubule systems of parasites and mammalian cells leading to inhibition of glucose uptake and transport and finally cell death. Eventually they exhibit ovicidal, larvicidal, and vermicidal effects on parasites, and tumoricidal effects on hosts. Albendazole and mebendazole are most frequently prescribed for treatment of intestinal nematode infections (ascariasis, hookworm infections, trichuriasis, strongyloidiasis, and enterobiasis) and can also be used for intestinal tapeworm infections (taeniases and hymenolepiasis). However, these drugs also exhibit considerable therapeutic effects against tissue nematode/cestode infections (visceral, ocular, neural, and cutaneous larva migrans, anisakiasis, trichinosis, hepatic and intestinal capillariasis, angiostrongyliasis, gnathostomiasis, gongylonemiasis, thelaziasis, dracunculiasis, cerebral and subcutaneous cysticercosis, and echinococcosis). Albendazole is also used for treatment of filarial infections (lymphatic filariasis, onchocerciasis, loiasis, mansonellosis, and dirofilariasis) alone or in combination with other drugs, such as ivermectin or diethylcarbamazine. Albendazole was tried even for treatment of trematode (fascioliasis, clonorchiasis, opisthorchiasis, and intestinal fluke infections) and protozoan infections (giardiasis, vaginal trichomoniasis, cryptosporidiosis, and microsporidiosis). These drugs are generally safe with few side effects; however, when they are used for prolonged time (>14-28 days) or even only 1 time, liver toxicity and other side reactions may occur. In hookworms, Trichuris trichiura, possibly Ascaris lumbricoides, Wuchereria bancrofti, and Giardia sp., there are emerging issues of drug resistance. It is of particular note that albendazole and mebendazole have been repositioned as promising anti-cancer drugs. These drugs have been shown to be active in vitro and in vivo (animals) against liver, lung, ovary, prostate, colorectal, breast, head and neck cancers, and melanoma. Two clinical reports for albendazole and 2 case reports for mebendazole have revealed promising effects of these drugs in human patients having variable types of cancers. However, because of the toxicity of albendazole, for example, neutropenia due to myelosuppression, if high doses are used for a prolonged time, mebendazole is currently more popularly used than albendazole in anti-cancer clinical trials.

임상시험용 의약품의 안전성 정보보고를 위한 평가 등 관리방안 설문조사 연구 (A survey for Management of Drug Safety Evaluation System for Investigational Product)

  • 이보미;박상준;심다영;이하은;이정은;김상희;조혜경;신주영
    • 한국임상약학회지
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    • 제31권1호
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    • pp.53-60
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    • 2021
  • Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

Effect on the Center of Pressure of Vision, Floor Condition, and the Height of Center of Mass During Quiet Standing

  • Kim, Seung-su;Lim, Kitaek;Choi, Woochol Joseph
    • 한국전문물리치료학회지
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    • 제28권2호
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    • pp.154-160
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    • 2021
  • Background: Theoretically, balance is affected by the height of center of mass (COM) during quiet standing. However, no one examined this in humans with variables derived from the center of pressure (COP). Objects: We have conducted balance experiment to measure COP data during quiet standing, in order to examine how the COP measures were affected by the height of COM, vision, floor conditions, and gender. Methods: Twenty individuals stood still with feet together and arms at sides for 30 seconds on a force plate. Trials were acquired with three COM heights: 1% increased or decreased, and not changed, with two vision conditions: eyes closed (EC) and eyes open (EO), and with two floor conditions: unstable (foam pad) and stable (force plate) floor. Outcome variables included the mean distance, root mean square distance, total excursion, mean velocity, and 95% confidence circle area. Results: All outcome variables were associated with the COM height (p < 0.0005), vision (p < 0.0005), and floor condition (p < 0.003). The mean velocity and 95% confidence circle area were 5.7% and 21.8% greater, respectively, in raised COM than in lowered COM (24.6 versus 23.2 mm/s; 1,013.4 versus 832.3 mm2). However, there were no interactions between the COM height and vision condition (p > 0.096), and between the COM height and floor condition (p > 0.183) for all outcome variables. Furthermore, there was no gender difference in all outcome variables (p > 0.186). Conclusion: Balance was affected by the change of COM height induced by a weight belt in human. However, the effect was not affected by vision or floor condition. Our results should inform the design of balance exercise program to improve the outcome of the balance training.

Intraovarian platelet-rich plasma administration could improve blastocyst euploidy rates in women undergoing in vitro fertilization

  • Merhi, Zaher;Seckin, Serin;Mouanness, Marco
    • Clinical and Experimental Reproductive Medicine
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    • 제49권3호
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    • pp.210-214
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    • 2022
  • Objective: Platelet-rich plasma (PRP) therapy has received a considerable attention as an adjunct to fertility treatments, especially in women with very low ovarian reserve and premature ovarian insufficiency. Although recent studies have demonstrated that PRP led to improvements in folliculogenesis and biomarkers of ovarian reserve, the effect of intraovarian PRP administration on embryo genetics has not been studied. Methods: We report a pilot study of patients who had preimplantation genetic testing for aneuploidy (PGT-A) before and then within 3 months following PRP administration. Twelve infertile women with at least one prior failed in vitro fertilization (IVF) cycle underwent ovarian stimulation (cycle 1) with a gentle stimulation protocol and PGT-A performed at the blastocyst stage. Following cycle 1, autologous intraovarian PRP administration was performed. Within 3 months following PRP administration, the patients underwent cycle 2 and produced blastocysts for PGT-A. The percentage of euploid embryos between both cycles was compared. Results: The mean age of all participants was 40.08±1.46 years, and their mean body mass index was 26.18±1.18 kg/m2. The number of good-quality embryos formed at the blastocyst stage was similar between cycle 1 and cycle 2 (3.08±0.88 vs. 2.17±0.49, respectively; p=0.11). Among all patients in cycle 1, 3 of 37 embryos were euploid (8.11%) while in cycle 2, 11 out of 28 embryos were euploid (39.28%, p=0.002). Three clinical pregnancies were noted among this patient group. Conclusion: This novel study is the first to present an improvement in the embryo euploidy rate following intraovarian PRP application in infertile women with prior failed IVF cycles. The growth factors present in PRP may exhibit a local paracrine effect that could improve meiotic aberrations in human oocytes and thus improve euploidy rates. Whether PRP improves live birth rates and lowers miscarriage rates remains to be determined in large trials.

Recent Progress in Immunotherapy for Gastric Cancer

  • Jeesun Yoon;Tae-Yong Kim;Do-Youn Oh
    • Journal of Gastric Cancer
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    • 제23권1호
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    • pp.207-223
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    • 2023
  • Gastric cancer (GC) is the fourth leading cause of cancer-related deaths worldwide. Under the standard of care, patients with advanced GC (AGC) have a median survival time of approximately 12-15 months. With the emergence of immunotherapy as a key therapeutic strategy in medical oncology, relevant changes are expected in the systemic treatment of GC. In the phase III ATTRACTION-2 trial, nivolumab, a monoclonal anti-programmed cell death 1 (PD-1) antibody, as a third- or later-line treatment improved overall survival (OS) compared with placebo in patients with AGC. Furthermore, nivolumab in combination with 5-fluorouracil and platinum as a first-line treatment improved OS in patients with human epidermal growth factor receptor-2 (HER2)-negative AGC in the global phase III CheckMate-649 study. Another anti-PD-1 antibody, pembrolizumab, in combination with trastuzumab and cytotoxic chemotherapy as a first-line treatment, significantly improved the overall response rate in patients with HER2-positive AGC. Therefore, immune checkpoint inhibitors (ICIs) are essential components of the current treatment of GC. Subsequent treatments after ICI combination therapy, such as ICI rechallenge or combination therapy with agents having other modes of action, are being actively investigated to date. On the basis of the success of immunotherapy in the treatment of AGC, various clinical trials are underway to apply this therapeutic strategy in the perioperative and postoperative settings for patients with early GC. This review describes recent progress in immunotherapy and potential immunotherapy biomarkers for GC.

Therapeutic Potential of Active Components from Acorus gramineus and Acorus tatarinowii in Neurological Disorders and Their Application in Korean Medicine

  • Cheol Ju Kim;Tae Young Kwak;Min Hyeok Bae;Hwa Kyoung Shin;Byung Tae Choi
    • 대한약침학회지
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    • 제25권4호
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    • pp.326-343
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    • 2022
  • Neurological disorders represent a substantial healthcare burden worldwide due to population aging. Acorus gramineus Solander (AG) and Acorus tatarinowii Schott (AT), whose major component is asarone, have been shown to be effective in neurological disorders. This review summarized current information from preclinical and clinical studies regarding the effects of extracts and active components of AG and AT (e.g., α-asarone and β-asarone) on neurological disorders and biomedical targets, as well as the mechanisms involved. Databases, including PubMed, Embase, and RISS, were searched using the following keywords: asarone, AG, AT, and neurological disorders, including Alzheimer's disease, Parkinson's disease, depression and anxiety, epilepsy, and stroke. Meta-analyses and reviews were excluded. A total of 873 studies were collected. A total of 89 studies were selected after eliminating studies that did not meet the inclusion criteria. Research on neurological disorders widely reported that extracts or active components of AG and AT showed therapeutic efficacy in treating neurological disorders. These components also possessed a wide array of neuroprotective effects, including reduction of pathogenic protein aggregates, antiapoptotic activity, modulation of autophagy, anti-inflammatory and antioxidant activities, regulation of neurotransmitters, activation of neurogenesis, and stimulation of neurotrophic factors. Most of the included studies were preclinical studies that used in vitro and in vivo models, and only a few clinical studies have been performed. Therefore, this review summarizes the current knowledge on AG and AT therapeutic effects as a basis for further clinical studies, and clinical trials are required before these findings can be applied to human neurological disorders.

Antiviral Potential of the Genus Panax: An updated review on their effects and underlying mechanism of action

  • Yibo Zhang;Xuanlei Zhong;Zhichao Xi;Yang Li;Hongxi Xu
    • Journal of Ginseng Research
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    • 제47권2호
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    • pp.183-192
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    • 2023
  • Viral infections are known as one of the major factors causing death. Ginseng is a medicinal plant that demonstrated a wide range of antiviral potential, and saponins are the major bioactive ingredients in the genus Panax with vast therapeutic potential. Studies focusing on the antiviral activity of the genus Panax plant-derived agents (extracts and saponins) and their mechanisms were identified and summarized, including contributions mainly from January 2016 until January 2022. P. ginseng, P. notoginseng, and P. quinquefolius were included in the review as valuable medicinal herbs against infections with 14 types of viruses. Reports from 9 extracts and 12 bioactive saponins were included, with 6 types of protopanaxadiol (PPD) ginsenosides and 6 types of protopanaxatriol (PPT) ginsenosides. The mechanisms mainly involved the inhibition of viral attachment and replication, the modulation of immune response by regulating signaling pathways, including the Janus kinase (JAK)/signal transducer and activator of transcription (STAT) pathway, cystathionine γ-lyase (CSE)/hydrogen sulfide (H2S) pathway, phosphoinositide-dependent kinase-1 (PDK1)/ protein kinase B (Akt) signaling pathway, c-Jun N-terminal kinase (JNK)/activator protein-1 (AP-1) pathway, and nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) pathway. This review includes detailed information about the mentioned antiviral effects of the genus Panax extracts and saponins in vitro and in vivo, and in human clinical trials, which provides a scientific basis for ginseng as an adjunctive therapeutic drug or nutraceutical.

프로바이오틱스의 호흡기감염에 대한 항바이러스 효과: 총설 (Antiviral Effect of Probiotics against Respiratory Tract Infections: A Review)

  • 천정환;서건호;김영선;윤혜영;김현진;오형석;황원욱;강석형;정하정;김현주;정동관;송광영
    • Journal of Dairy Science and Biotechnology
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    • 제41권2호
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    • pp.57-66
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    • 2023
  • Majority of the respiratory infectious diseases that are generally prevalent in Korea from autumn to winter are caused by viruses such as respiratory syncytial virus and influenza A virus. Therefore, there is rapidly rising interest in determining the antiviral effects of probiotics against respiratory viruses and elucidating the probable mechanism behind it. Various human clinical trials as well as animal experiments have shown that some probiotics potentially have antiviral activity based on their immunomodulatory effect. Hence, this review describes in detail the various possibilities of using probiotics as antiviral agents against respiratory viruses and their potential effects. Also, it provides basic data regarding the availability of different probiotics relevant for their production by dairy and food industries.

염증성 장 질환에서 전침을 중심으로 한 미주신경자극에 대한 고찰 (Vagus Nerve Stimulation Through Electro-acupuncture for Inflammatory Bowel Disease)

  • 김민정;김동원;박채현;박재우;고석재
    • 대한한방내과학회지
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    • 제44권3호
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    • pp.455-465
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    • 2023
  • Inflammatory bowel disease (IBD) is defined as a chronic inflammatory-mediated disease that causes ulceration and inflammation in the gastrointestinal tract. Among most patients, the course of chronic inflammation repeatedly shows intermittent exacerbations and alternating remissions. However, despite the various therapeutic options to relieve symptoms, such as corticosteroids, TNF-α inhibitors, and antibiotic drugs, there is no known cure for IBD. Nonetheless, previous research has revealed that the autonomic nervous system is involved in the pathophysiology of IBD. In this study, we reviewed clinical trials confirming the therapeutic effect of vagus nerve stimulation (VNS) on IBD in vivo. We searched in vivo and human studies on Pubmed using keywords combined with "vagus nerve stimulation", "VNS", and "inflammatory bowel disease". All studies included in this review reported that direct VNS is effective in relieving symptoms of IBD and has no severe adverse effects. The most frequently stimulated site was the unilateral cervical vagus nerve area, and parameters for stimulation were set as 5-20 Hz. Based on the results, we aim to summarize the evidence for the efficacy of VNS on IBD and suggest the possibility of auricular electroacupuncture treatment as a therapeutic option for IBD.