• 감성과학
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• 제19권1호
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• pp.95-110
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• 2016

언캐니 밸리 현상이란 인간 유사성을 보이는 대상에 대한 부정적 감정의 발생되는 상황을 의미하며, 이는 언캐니 자극에 대한 범주화 과정에서 초래된 인지적 부담이 원인일 가능성이 있다. 본 연구는 인지적 부담 가설에 근거해 비인간, 인간 및 언캐니 얼굴에 대한 oddball 과제를 실시하고 세 얼굴이 촉발시킨 사건관련전위를 관찰했다. 실험 1에서는 도식적 얼굴을 사용해 전체 시행 중 80%의 시행에서 비인간 얼굴을(일반 시행), 10% 시행에서 인간(표적 시행) 그리고 나머지 10%의 나머지 시행에서 언캐니 얼굴(언캐니 시행)을 제시하였다. 그 결과, oddball 시행에 해당하는 표적 및 언캐니 시행의 반응이 상대적으로 부정확했으며 반응시간 또한 지연되었으나 세 시행 유형 간 P3 및 N170 성분의 차이는 분명하지 않았다. 실험 2에서는 3-D 랜더링을 통해 사실감을 증가시켜 범주적 상충의 정도를 증가시킨 얼굴 자극을 사용한 결과 행동적 수준에서 실험 1과 유사한 결과가 관찰되었다. 반면 N170의 경우 일반 시행에 비해 표적과 언캐니 시행의 정점 전위가 분명하게 증가하였으며, P3 성분의 경우 일반 시행에서 진폭이 가장 낮았고 언캐니와 표적 시행 간에는 차이가 없었다. P3 성분의 잠재기 또한 일반, 표적, 언캐니 순으로 지연된 것이 관찰되었다. 실험 1과 2에 걸친 N170와 P3의 발현 패턴의 변화는 언캐니 얼굴이 감각적 수준에서는 인간의 얼굴로 식별되지만 이를 비표적으로 범주화할 것을 oddball 과제에서 강제하기 때문에 초래된 범주화 상충이 원인인 것으로 짐작된다. 또한 사실감이 추가된 언캐니 얼굴 자극이 사용되었을 때 범주화 상충에 의한 인지적 부담이 증가했다는 점은 언캐니 밸리 현상의 배후로 추정되는 인지적 부담이 자극의 복잡성 증가에 따른 상충 정보의 증가에 의해 유발될 가능성을 시사한다.

• 대한두경부종양학회지
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• 제38권2호
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• pp.7-13
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• 2022

Human papillomavirus (HPV) is a causative agent for a subset of oropharyngeal cancer (OPC). The current standard of care (SOC) for locally advanced OPC is 70 Gy definitive radiotherapy (RT) concurrent with cisplatin, which entails significant proportions of acute and late grade 3 or higher toxicities. Accordingly, discovery of favorable prognosis of HPV-related OPC has led to enthusiasm to attenuate subspecialties therapy in multidisciplinary treatment. Diverse deintensification strategies were investigated in multiple phase 2 trials with an assumption that attenuated treatments result in comparable oncologic outcome and less toxicities compared with SOC. Several trials on chemotherapy deintensification revealed that concomitant administration of cisplatin is not to be omitted or substituted for cetuximab without compromising progression-free survival or local control. A transoral robotic surgery (TORS) is investigated as alternative local treatment, but TORS plus SOC or mild deintensified adjuvant RT showed similar toxicities and inferior oncologic outcomes compared with SOC definitive RT or moderately deintensified RT. However, it has been reported that TORS plus deintensified 30-36 Gy adjuvant RT results in excellent outcome and less late toxicity compared with SOC adjuvant RT. Several phase 2 trials reported apparently equivalent progression-free survival and local control and similar adverse effects with moderately deintensified 60 Gy RT compared with SOC 70 Gy RT. Further dose reduction below 60 Gy has been investigated using biology-directed approaches, which use response to induction chemotherapy or metabolic images to triage HPV-positive OPC for deintensified RT. In summary, these trials provide valuable insights for future directions. Available evidence consistently showed that moderately deintensified RT is effective and safe for HPV-positive OPC in both definitive and adjuvant settings. Concurrent cisplatin remains an essential component without which progression-free survival is significantly compromised for advanced HPV-positive OPC. A simple incorporation of TORS to SOC may be detrimental for oncologic outcome without anticipated toxicity reduction. Given the lack of level 1 evidence, it is prudent to curb an unjustified deviation from the current SOC and limit any deintensified strategies to clinical trials and adhere to the current SOC.

• 한국임상약학회지
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• 제5권2호
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• pp.33-49
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• 1995

The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) accounted for 41 or $51.9\%$, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12, and 21 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.

• Journal of Pharmaceutical Investigation
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• 제30권2호
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• pp.139-143
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• 2000

Gene therapy is becoming a very promising and feasible medical intervention as the understanding of human diseases extends to their molecular levels. Since the first US Food and Drug Administration (FDA)-approved human gene therapy protocol was approved in 1990, over 300 human clinical trial protocols had been approved worldwide so far. Even though some of the domestic gene therapy clinical trials also proved promising and more are awaiting, it should be emphasized that many safety aspects as well as effectiveness aspects should be considered during the development process. Moreover, there seems to be less restricted guidelines from the National Control Authority (NCA) in initiating human clinical trials. This article is intended to suggest some basis and points to consider in the development and evaluation of gene therapy products including antisense oligonucleotides pharmaceuticals.

• 생물정신의학
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• 제19권4호
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• pp.153-158
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• 2012

Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

• BMB Reports
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• 제56권9호
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• pp.488-495
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• 2023

Mitochondrial transplantation is a promising therapeutic approach for the treatment of mitochondrial diseases caused by mutations in mitochondrial DNA, as well as several metabolic and neurological disorders. Animal studies have shown that mitochondrial transplantation can improve cellular energy metabolism, restore mitochondrial function, and prevent cell death. However, challenges need to be addressed, such as the delivery of functional mitochondria to the correct cells in the body, and the long-term stability and function of the transplanted mitochondria. Researchers are exploring new methods for mitochondrial transplantation, including the use of nanoparticles or CRISPR gene editing. Mechanisms underlying the integration and function of transplanted mitochondria are complex and not fully understood, but research has revealed some key factors that play a role. While the safety and efficacy of mitochondrial transplantation have been investigated in animal models and human trials, more research is needed to optimize delivery methods and evaluate long-term safety and efficacy. Clinical trials using mitochondrial transplantation have shown mixed results, highlighting the need for further research in this area. In conclusion, although mitochondrial transplantation holds significant potential for the treatment of various diseases, more work is needed to overcome challenges and evaluate its safety and efficacy in human trials.

• 한국한의학연구원논문집
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• 제8권2호통권9호
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• pp.37-46
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• 2002

Clinical trials are experimental studies with human subjects in which various limitations and variables exist by their nature. As a preparatory stage for designing clinical trials in Oriental medicine, this study considers a virtual protocol to show guideline regarding tasks necessary when writing a trials protocol. Clinical trials have many difficulties in planning, procedure, and interpretation of results, and these may be influenced by various biases that are difficult to predict and eliminate. To deal with these issues, clinical trials need a collaboration between medical experts and biostatisticians from the beginning, through the entire trial, until the final analysis. Therefore, the first stage of clinical trials is to write out a trial plan among the experts in each field to derive the best design for the trial.

• 대한기관윤리심의기구협의회지
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• 제5권1호
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• pp.14-20
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• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• 한국의류학회지
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• 제23권8호
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• pp.1098-1109
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• 1999

This study was to examine the effects of textiles materials and wearing types on the thermal regulation responses of human, Cotton polyester wool silk and rayon were chosen as outerwears and acetate was selected as a lining. Blouse-skirt suits blouse-slacks suits and one-piece dress made of selected textiles were examined by human trials, Tests results were as follows ; 1 When subjects wore vlouse-slacks suits Tmsk was showed the highest value. There was a significant difference on Tmsk(p<0.05) when they wore one-piece dress. The temperature of microclimate inside clothing when subjects wore blouse-slacks suits showed the highest value and one-piece dress and then blouse-skirt suits in order. For blouse-skirt suits clothing without lining showed higher temperature of the back of microclimate inside clothing than clothing with lining except cotton(p<0.1) 2. There were no significant consistency of the increasing rates of thermal insulation of garment at fabric test and human trials among polyesterand silk.

• Journal of Hospice and Palliative Care
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• 제13권1호
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• pp.1-6
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• 2010

임상시험은 인간을 대상으로 약물 또는 치료법의 효과를 검증하는 것을 목적으로 하고 있다. 성공적인 임상시험을 위해서는 단순한 자료분석에만 통계의 이용을 제한하지 않고 다양한 영역으로 활용의 폭을 넓히는 것이 필요하다. 연구계획단계에서부터 구체적이고 체계적으로 통계의 활용을 고려하기 위해 효과에 대한 정의, 적정한 표본크기 산정, 통계분석 방법 등 전반적인 통계의 응용을 고찰한다.