• Title/Summary/Keyword: Non-clinical trial

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Placebo Effects and Clinical Trials of Neuropsychiatric Drugs (위약효과와 신경정신약물의 임상시험)

  • Kim, Sung-Wan;Jang, Ji-Eun;Yoon, Jin-Sang
    • Korean Journal of Biological Psychiatry
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    • v.19 no.4
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    • pp.164-171
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    • 2012
  • The placebo effect, a response observed during the placebo arm of a clinical trial, is produced by the psychobiological action of the placebo as well as by other potential contributors to symptom amelioration such as spontaneous improvement, regression to the mean, biases, concurrent treatments, and study design. From a psychological viewpoint, there are many mechanisms that contribute to placebo effects, including expectations, conditioning, learning, and anxiety reduction. Placebo responses are also mediated by opioid and non-opioid mechanisms including dopamine, serotonin, cholecystokinin, and immune mediators. During recent years, a trend towards increased placebo effects in clinical trials of neuropsychiatric drugs has been noted. Indeed, the placebo effects observed in clinical trials constitute an increasing problem and interfere with signal-detection analyses of potential treatments. Several potential factors including protocol/study design and conduct related factors may account for the placebo effect observed in clinical trials. This paper reviews key issues related to this problem and aims to identify potential solutions.

Effect of Paretic and Non-paretic Side Spine Taping on Balance Ability in Patients with Stroke

  • Cho, Yonghun;Park, Shinjun;Kim, Soonhee
    • Journal of International Academy of Physical Therapy Research
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    • v.10 no.2
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    • pp.1779-1784
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    • 2019
  • Background: A number of researchers have attempted to improve the balance of stroke patients, however there is still a question as to whether taping is effective in increasing balance. Objective: To determine the effect of paretic and non-paretic side taping on the balance ability in patients with stroke. Design: A single-blind randomized controlled trial Methods: This randomized single-blind controlled clinical trial with a repeated measures study included 45 subjects who were randomly assigned to paretic side taping groups (n=15), non-paretic side taping groups (n=15), and trunk exercise groups (n=15). Trunk exercise and paretic side taping groups had taping on the paralyzed erector spinae, while the non-paretic side taping group had taping on the non-paralyzed erector spinae. Trunk exercises were performed for 30 minutes to promote core muscles. The balance ability measured the center of pressure movement (paretic side, non-paretic side,forward, backward, limit of stability) in the sitting position. All measurements were evaluated using BioRescue. Results: All three groups showed significant increase in all variables after 4 weeks. The paretic and non-paretic side taping groups had a significant increase in all variables after 30 min of attachment. However, there was no significant difference among the three groups. Conclusions: Paralysis and non-paralysis taping improved the balance ability of patients with stroke in an immediate effect of 30 min. However, after 4 weeks of intervention, taping with trunk exercise did not differ from single trunk exercise. In future studies, various analyses need to be conducted through more diverse evaluations.

Clinical and microbiological effects of the supplementary use of an erythritol powder air-polishing device in non-surgical periodontal therapy: a randomized clinical trial

  • Park, Eon-Jeong;Kwon, Eun-Young;Kim, Hyun-Joo;Lee, Ju-Youn;Choi, Jeomil;Joo, Ji-Young
    • Journal of Periodontal and Implant Science
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    • v.48 no.5
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    • pp.295-304
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    • 2018
  • Purpose: This study was undertaken to evaluate the clinical and microbiological effects of an erythritol powder air-polishing device (EPAP) as a supplement to scaling and root planing (SRP) therapy in patients with moderate chronic periodontitis. Methods: Clinical and microbiological evaluations were performed at 21 sites treated with SRP (control) and 21 sites treated with SRP+EPAP (test). All examinations were performed before treatment, 1 month after treatment, and 3 months after treatment. Results: There were no significant clinical differences between the test group and the control group. Microbiological analysis revealed that the relative expression level of Porphyromonas gingivalis was significantly lower in the test group than in the control group at 1 month after treatment. Clinical and microbiological results showed improvements at 1 month compared to baseline; in contrast, the results at 3 months after treatment were worse than those at 1 month after treatment. Conclusions: In this study, both SRP and SRP+EPAP were clinically and microbiologically effective as non-surgical periodontal treatments. In particular, the SRP+EPAP group showed an antimicrobial effect on P. gingivalis, a keystone bacterium associated with the onset of chronic periodontitis, in a short-term period. Periodic periodontal therapy, at intervals of at least every 3 months, is important for sustaining the microbiological effects of this treatment.

Review of Clinical Researches about Korean Medicine Treatment on Language Disorder of Cerebral Palsy (뇌성마비 언어장애에 대한 한의 치료 연구 동향)

  • Kim, Lakhyung;Yu, Gyung
    • The Journal of Pediatrics of Korean Medicine
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    • v.26 no.4
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    • pp.32-37
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    • 2012
  • Objectives: The purpose of this study was to obtain some understanding about Korean medicine treatment on language disorder in cerebral palsy for future practice and the research, from the clinical studies. Methods: The literature was searched using the database-China Academic Journals (CAJ). Clinical studies of Korean medicine treatment for language disorder in cerebral palsy, including Randomized controlled trial (RCT), case control study, case series, case report were analyzed. Results: Fifteen Clinical studies met our inclusion criteria; One case study and six case series, one non-randomized controlled trial and seven RCTs. Acupuncture treatment, especially Head acupuncture, was the major treatment for language disorder of cerebral palsy in clinical studies, as it was used in fourteen studies. Acupoint massage, tuina, and acupoint injection were employed as treatment methods in the studies. Acupuncture treatment was used for language disorder of cerebral palsy combined with language therapy and other rehabilitation treatment in many studies. The effectiveness in the treatment groups, regardless of treatment methods, was higher than that of control group in all RCT studies. Conclusions: The results of this study could be used in the practice and the future study about language disorder of cerebral palsy.

A Review on Clinical Studies of the Acupuncture and Moxibustion Therapy for Gastroesophageal Reflux Disease in China by Searching CAJ (CAJ 검색을 통해 살펴 본 중국에서의 역류성 식도질환 침구치료 임상연구 동향에 대한 고찰)

  • Kang, Sei-Young
    • Korean Journal of Acupuncture
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    • v.32 no.1
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    • pp.1-12
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    • 2015
  • Objectives : The purpose of this study was to review the acupuncture and moxibustion therapy for gastroesophageal reflux disease(GERD) in China. Methods : The literatures were searched using the database-China Academic Journals(CAJ)(~2015.1.). Clinical studies of acupuncture and moxibustion therapy for GERD such as randomized controlled trial(RCT), non-randomized controlled trial(NRCT), case series, or case report were included. Results : Thirty studies met our inclusion criteria: 24 RCTs, 4 NRCTs, 1 case series, 1 case report. Various kinds of treatment such as body acupuncture, abdominal acupuncture, acupuncture therapy with finger on back-shu point, electroacupuncture, acupoint injection, auricular acupuncture, and moxibustion were used in the clinical studies. The treatment groups take herbal medicines at the same time in 16 studies, and proton pump inhibitor(PPI) and histamine 2 receptor antagonist were used as a comparative treatment in the most of studies. Acupuncture or moxibustion treatments were done daily or 2~3 times a week for 5 days~18 weeks. All of studies reported higher effective rate in the acupuncture or moxibustion treatment group compared to the western medication control group. Conclusions : The results of this study could be used for the future practice and the clinical research about the acupuncture and moxibustion therapy for GERD.

Acupuncture for Parkinson's Disease in China (중국에서의 파킨슨병 침치료 임상연구 동향)

  • Kim, Lak-Hyung;Jang, In-Soo;Kang, Sei-Young
    • Korean Journal of Acupuncture
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    • v.28 no.4
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    • pp.147-158
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    • 2011
  • Objectives : The purpose of this study was to obtain some knowledge about the acupuncture treatments on Parkinson's disease for the future practice and the research from the clinical studies in China. Methods : The literatures were searched using the data base-China Academic Journals (CAJ) (1994-2011). Clinical studies of acupuncture for Parkinson's disease such as randomized controlled trial (RCT), non-randomized controlled trial (NRCT), case series, case report were included. Results : Of 145 articles, 52 Clinical studies met our inclusion criteria: 20 RCTs, 7 NRCTs, 22 case series and 3 case reports. Various kinds of acupuncture treatments such as scalp acupuncture, body acupuncture, abdominal acupuncture, acupoint injection, eye acupuncture and thick needle acupuncture (粗鍼) were used in the clinical studies. The treatment and control groups take Madopa Tablet (Levodopa + Benserazide HCl) in the same time in many studies, and Madopa treatment was used as a comparative treatment in the most of studies. Acupuncture treatment was done daily or 2~3 times a week for 2~20 weeks. All of studies reported high effective rate in the treatment group compared to control group. Conclusions : The results of this study could be used for the future study about the acupuncture therapy for Parkinson's disease.

Review of Clinical Trials on Infrared Thermography Using Search of Papers in Medline within 5 Years (적외선 체열영상을 이용한 최신 해외 임상연구 동향)

  • Hwang, Deok-Sang;Park, Kyoung-Sun;Kim, Eun-Gyung;Lee, Chang-Hoon;Jang, Jun-Bock;Lee, Kyung-Sub
    • Journal of Oriental Medical Thermology
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    • v.8 no.1
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    • pp.13-17
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    • 2010
  • Purpose : This study is to the recent trends of clinical trial using infrared thermography and to review its application in medicine. Methods : We searched for papers which had used infrared thermography in Medicine within 5 years, using English. Results : A total of 23 papers were but 8 were found, but 8 were not related to non-invasive infrared thermography. The other 15 papers were clinical trials about the effect of acupuncture and therapeutic massage, evaluation of post-hepatic neuralgia, sleep disorder, and regional circulation. Conclusion : These results suggest that infrared thermography can be used as a reliable and helpful method in many clinical trials.

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Applying Clinical Judgment Rubric for Evaluation of Simulation Practice for Nursing Students : A Non-Randomized Controlled Trial

  • Kim, Hyun-Ju
    • International Journal of Contents
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    • v.14 no.2
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    • pp.35-40
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    • 2018
  • The purpose of this study is to investigate the effects of debriefing using Lasater's Clinical Judgment Rubric to study nursing students' academic self-efficacy, clinical performance, and clinical judgment. The experiment group was subjected to debriefing by applying the Clinical Judgment Rubric, while general debriefing was applied to the control group. The results of the study are as follows: Clinical judgment scores were improved after debriefing for both groups, significantly higher for students in the experimental group compared to the control group. However, there was no significant difference between the two groups in academic self-efficacy or clinical performance. In conclusion, the debriefing based on the Clinical Judgment Rubric used in this study proved to be effective in improving the clinical judgment of nursing students.

Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for Lung Cancer] (폐암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰)

  • Han, Gajin;Cho, Minji;Park, Eunjoo;Seong, Sin;Kim, Sungsu;Kim, Kwan-Il;Jung, Hee-Jae;Lee, Beom-Joon;Leem, Jungtae
    • The Journal of Korean Medicine
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    • v.40 no.1
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    • pp.153-173
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    • 2019
  • Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

A Case Report of a Patient with Parkinson's Disease Treated with Acupuncture and Exercise Therapy (침 및 운동 치료로 호전된 파킨슨병 환자 1례에 대한 증례보고)

  • Park, Miso;Park, SangSoo;Lee, Seung Hyun;Hur, WangJung;Yoo, Horyong
    • The Journal of Internal Korean Medicine
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    • v.43 no.5
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    • pp.1018-1028
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    • 2022
  • Objectives: Parkinson's disease is characterized by progressive, irreversible damage to dopamine neurons in the substantia nigra pars compacta, as well as motor and non-motor symptoms. This disease currently has no dependable disease-modifying treatment. In this paper, we describe the treatment of a 67-year-old female with Parkinson's disease using acupuncture and exercise therapy. Case Presentation: Clinical symptoms and the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria were used to diagnose the patient with Parkinson's disease. Over a 12-week period, the patient visited a Korean medicine hospital 18 times and was treated with acupuncture and exercise therapy in addition to anti-Parkinson's drugs. Before and after treatment, clinical examinations were performed using tools such as the Unified Parkinson's Disease Rating Scale, Fall Efficacy Scale, Parkinson's Disease Questionnaire, Berg Balance Scale, and Non-Motor Symptoms Scale. Furthermore, functional near-infrared spectroscopy was used to assess cortical hemodynamics. All clinical examination results improved after 12 weeks of intervention. In particular, improvements on the Total Unified Parkinson's Disease Rating Scale and Part III of this scale demonstrated large, clinically important differences. Conclusion: This case suggests that combining acupuncture and exercise therapy could produce an effective treatment for Parkinson's disease patients.