• Title/Summary/Keyword: Complex Trial Protocol

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Revalidation of the Complex Trial Protocol using participant-oriented countermeasures (설문 기반 대응방안을 사용한 복합시행 프로토콜의 재평가)

  • Kim, Hyemin;Song, Inuk;Chang, Eunhee;Kim, Hyun Taek
    • Korean Journal of Forensic Psychology
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    • v.11 no.1
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    • pp.89-115
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    • 2020
  • Traditional deception detection methods had examined the difference of one's autonomic physiological responses through asking crime-related and crime-unrelated questions. There has been a continuing controversy regarding the accuracy and validity of the test, and thus, many researchers were motivated to explore and develop alternative efficient methods of detection in which one of them is known as P300-based Complex Trial Protocol (CTP). The P300-based CTP detects deception through comparing the P300 amplitudes between probe and irrelevant stimuli and is known as a counterstrategy of countermeasures. However, many previous studies have used countermeasures created from Rosenfeld et al.'s work (2008). The present study initially conducted a survey asking open-ended questions about the countermeasure use to acquire participant-oriented countermeasures for the main experiment. Then, the study aimed to evaluate whether the CTP can accurately detect deception even in the use of survey-based countermeasures. We firstly selected a set of participant-oriented countermeasures through survey questions. Then, a total of 50 participants were divided into three groups (innocent, guilty, and countermeasures) and performed the CTP. Those assigned to the countermeasures group covertly performed mental countermeasures during the CTP. The results of P300 amplitude analysis revealed that the guilty group's P300 amplitude of probe stimuli was significantly larger than that of irrelevant stimuli. Countermeasures group also had a significantly larger P300 amplitude for probe stimuli compared to irrelevant stimuli, even in the use of countermeasures. The results of bootstrapped amplitude difference (BAD) showed a detection accuracy rate of 81.25%, 82.35%, 82.35% for the innocent, guilty, and countermeasures groups, respectively. These findings demonstrate that the CTP can obtain a high detection rate in participant-oriented countermeasures and suggest the potential use of the CTP in the field.

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Scoping Review of Prospective Clinical Studies, Projects, and Clinical Study Protocol for Korean Medicine Treatment on Dementia (국내 치매에 대한 한의치료 전향적 임상연구, 과제, 임상시험 프로토콜의 현황조사)

  • Kim, Je-Beom;Lee, Dong-Yoon;Ha, Da-Jung;Kwon, Chan-Young
    • The Journal of Korean Medicine
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    • v.42 no.3
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    • pp.99-118
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    • 2021
  • Objectives: The aim of this study is to review and analyze the trends in prospective clinical research (PCR), project, clinical study protocol of Korean medicine (KM) for dementia. Methods: We searched PCRs of KM on dementia in six electronical databases, up to January 28, 2021. Moreover, the clinical research protocol and projects of KM for dementia were searched. Results: Total eight PCRs, nine projects, and three clinical study protocols were included. In the PCRs, there were one randomized controlled trial, five before and after study, and two comparative group before-after studies. Four of them used herbal medicine, two used acupuncture, one study used both herbal medicine and acupuncture, and the other one used moxibustion. Jowiseungchung-tang was the most frequently used herbal medicine. BL62, KI6 were used in electro-acupuncture, auricular-Shenmen in auricular acupuncture, and GV20 in moxibustion. The most frequent outcome was Korean-Dementia Rating Scale (K-DRS). One reported significant increase in K-DRS score, one reported 60% improvement, and the other studies mostly reported no significant difference. In the projects including 20 clinical studies of dementia, herbal medicine, integrative medicine and acupuncture were mainly used. In the protocols, herbal medicine, complex KM intervention, and integrative medicine were used. Conclusions: Currently, the number of PCRs of KM for dementia is very scarce. Therefore, the researcher's interest in this field and national research support should be made more, and the quality of clinical research in the future can be further improved by supplementing the limitations of previously published clinical research.

Preoperative short course radiotherapy with concurrent and consolidation chemotherapies followed by delayed surgery in locally advanced rectal cancer: preliminary results

  • Aghili, Mahdi;Sotoudeh, Sarvazad;Ghalehtaki, Reza;Babaei, Mohammad;Farazmand, Borna;Fazeli, Mohammad-Sadegh;Keshvari, Amir;Haddad, Peiman;Farhan, Farshid
    • Radiation Oncology Journal
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    • v.36 no.1
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    • pp.17-24
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    • 2018
  • Purpose: This study aimed to assess complications and outcomes of a new approach, that is, combining short course radiotherapy (SRT), concurrent and consolidative chemotherapies, and delayed surgery. Materials and Methods: In this single arm phase II prospective clinical trial, patients with T3-4 or N+ M0 rectal adenocarcinoma were enrolled. Patients who received induction chemotherapy or previous pelvic radiotherapy were excluded. Study protocol consisted of three-dimensional conformal SRT (25 Gy in 5 fractions in 1 week) with concurrent and consolidation chemotherapies including capecitabine and oxaliplatin. Total mesorectal excision was done at least 8 weeks after the last fraction of radiotherapy. Primary outcome was complete pathologic response and secondary outcomes were treatment related complications. Results: Thirty-three patients completed the planned preoperative chemoradiation and 26 of them underwent surgery (24 low anterior resection and 2 abdominoperineal resection). Acute proctitis grades 2 and 3 were seen in 11 (33.3%) and 7 (21.2%) patients, respectively. There were no grades 3 and 4 subacute hematologic and non-hematologic (genitourinary and peripheral neuropathy) toxicities and perioperative morbidities such as anastomose leakage. Grade 2 or higher late toxicities were observed among 29.6% of the patients. Complete pathologic response was achieved in 8 (30.8%) patients who underwent surgery. The 3-year overall survival and local control rates were 65% and 94%, respectively. Conclusion: This study showed that SRT combined with concurrent and consolidation chemotherapies followed by delayed surgery is not only feasible and tolerable without significant toxicity but also, associated with promising complete pathologic response rates.