scholarly journals Review of the Registration in the Clinical Research Information Service

2016 ◽  
Vol 31 (1) ◽  
pp. 1 ◽  
Author(s):  
Eun-Kyoung Choi ◽  
Mi-Jung Kim ◽  
Nam-Kyoo Lim ◽  
Hyun-Young Park
Keyword(s):  
Clinical Research ◽  
Information Service ◽  
Research Information

scholarly journals Clinical Trial to Analyze the Effect of Oral Intake of Phellinus Linteus(Sanghuang) Extract on Immune Function: A Study Protocol for a Randomized, Double-blind Controlled Trial

2021 ◽  
Author(s):  
Yong Ho Ku ◽  
Hyun Lee ◽  
Hwa Yeon Ryu ◽  
Jae Hui Kang
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Immune Function ◽  
Controlled Trial ◽  
Information Service ◽  
Laboratory Evaluation ◽  
Control Group ◽  
Phellinus Linteus ◽  
Research Information ◽  
Main Trial

Abstract Background: As Korea becomes an aging society, interest in health care has increased. In particular, there is an increasing demand for immune function improvement to prevent infectious diseases. Phellinus linteus (PL) has previously been shown to have immune-enhancing and anticancer effects. We aim to evaluate whether PL mycelium extract, cultured using the PL KCTC0399BP strain, has an increase in immune function using blood test indicators. This clinical trial is designed based on the results of a pilot study as the main trial.Methods: This clinical trial will be a randomized, double-blinded, placebo-controlled trial. Ninety-eight participants will be enrolled and randomly divided into two groups: experimental group (PL 1000 mg) and control group (placebo). Participants will be administered experimental food or placebo for 8 weeks. Blood tests will be performed before food intake and at 8 weeks after the start of the experiment. Laboratory evaluation items are as follows: natural killer cell activity, tumor necrosis factor-α, interferon-γ, interleukin (IL)-1β, IL-2, IL-6, IL-12, immunoglobulin (Ig)G1, IgG2, and IgM. We will mainly use the full analysis set to statistically analyze the effectiveness of treatment.Discussion: This study includes inclusion and exclusion criteria and a well-controlled intervention. This study evaluates the effect of PL extract on immune function and will contribute to knowledge on the value of PL as an immune function health functional food.Clinical research registration: This study has been registered at the Clinical Research Information Service (CRIS) of Korea: CRIS-KCT0005460. Registered , 12 October 2020, https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=17761&ltype=&rtype=Trial status: This clinical trial is in the recruitment stage. Recruitment began in October 21, 2020 and will be completed in March 2021. This trial was registered at the Clinical Research Information Service of South Korea on October 12, 2020. (CRIS-KCT0005460)

scholarly journals The Efficacy of Shinbaro for the Preventive Treatment of Migraine: A Pilot Study

2019 ◽  
Vol 2019 ◽  
pp. 1-7
Author(s):  
Yesol Jung ◽  
Bohee Won ◽  
Mijung Lee ◽  
Jinyoung Chung ◽  
Sung Ju Han ◽  
...  
Keyword(s):  
Clinical Research ◽  
Therapeutic Potential ◽  
Inflammatory Diseases ◽  
Information Service ◽  
Preventive Treatment ◽  
University Hospital ◽  
Research Information ◽  
Serum Calcitonin ◽  
Migraine Frequency ◽  
Headache Diary

Objective. To investigate the therapeutic potential and efficacy of Shinbaro, an herbal medication for inflammatory diseases and bone disorders, as a preventive treatment of migraine. Methods. In this prospective, interventional, single-arm, pre-post study, 37 migraine patients took 600mg bid of Shinbaro for 12 weeks. At 4-week intervals, the migraine frequency and the rescue medications frequency were measured from each patient’s headache diary. The modified Migraine Disability Assessment (MIDAS) questionnaires to assess migraine associated disabilities were also completed at each visit. The serum calcitonin gene-related peptide (CGRP) concentrations before and after 12 weeks of Shinbaro administration were compared. Results. The monthly migraine frequency was significantly reduced from 20.5 days at baseline to 16.4 days at week 12 (P =0.003), and 22% of the participants showed ≥ 50% reduction. The frequency reduction was observed by week 4 (P =0.035) and continuously occurred through week 8 (P =0.001) and week 12 (P =0.003). The rescue medications frequency also decreased significantly from 17.4 days at baseline to 13.2 days at week 12 (P =0.035). Lastly, the serum CGRP concentration dropped from 434.6 pg/mL at baseline to 371.4 pg/mL at week 12, which was statistically significant (P <0.001). Conclusions. Shinbaro demonstrated prophylactic effects in migraine patients, significantly reducing their mean migraine frequency, rescue medications frequency, and the serum CGRP concentration after 12 weeks of treatment. This study is registered in Clinical Research Information Service, Seoul National University Hospital Clinical Research Institute (IRB No. 1604-138-758).

scholarly journals Trends in Clinical Trial Registration in Dentistry: An Analysis of Registered Clinical Trials in the Clinical Research Information Service from 2013 to 2021 in South Korea

2021 ◽  
Vol 10 (3) ◽  
Author(s):  
Hye In Lee ◽  
Young-Ran Yoon
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
South Korea ◽  
Clinical Research ◽  
Information Service ◽  
Allocation Concealment ◽  
Research Information ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Quality Reporting

The Clinical Research Information Service (CRIS) in South Korea provides a clinical trial registry platform in which all clinical trials should be mandatorily and prospectively registered. However, to date, the registration status of clinical trials in the field of dentistry has not been investigated. Therefore, this study aimed to provide an overview of the methodological design and trends of the registered clinical trials over a period of nine years. Information about registered clinical trials in the field of dentistry from the CRIS was comprehensively collected from 2013 to 2021. The details assessed from the collected trials include: type of sponsors, recruitment status, study design, randomization, allocation concealment, single or multi-centric, retrospective or prospective registration, and publication status. A total of 65 registered clinical trials were identified. The number of clinical trials in dentistry in South Korea was found to be less; however, an increasing trend was observed in the recent three years. A majority of the trials were interventional (81.5%), single-centered (86.2%), and conducted on patients (81.5%) and in private hospitals (55.4%). A considerable number of trials had an unclear phase, were retrospectively registered, and rarely published. Regarding the quality, most trials have inadequately reported the method of randomization and allocation concealment. The number of clinical trials in dentistry is still low in South Korea, and most of them were registered retrospectively. A poor-quality reporting of methods at several specific areas was observed. It is necessary for dental investigators to raise awareness of the need to register clinical trials.

scholarly journals Guideline for Selecting Types of Reliability and Suitable Intra-class Correlation Coefficients in Clinical Research

2021 ◽  
Author(s):  
Khalil Taherzadeh Chenani ◽  
Farzan Madadizadeh
Keyword(s):  
Clinical Research ◽  
Correlation Coefficients ◽  
Reliability Test ◽  
Research Information ◽  
Rater Reliability ◽  
Intra Class Correlation ◽  
Medical Researchers ◽  
Different Types ◽  
Test Retest Reliability ◽  
Cluster Correlation

Introduction: Reliability is an integral part of measuring the reproducibility of research information. Intra-cluster correlation coefficient (ICC) is one of the necessary indicators for reliability reporting, which can be misleading in terms of its diversity. The main purpose of this study was to introduce the types of reliability and appropriate ICC indices.  Methods: In this tutorial article, useful information about the types of reliability and indicators needed to report the results, as well as the types of ICC and its applications were explained for dummies. Results: Three general types of reliability include inter-rater reliability, test-retest reliability, and intra-rater reliability was presented. 10 different types of ICC were also introduced and explained. Conclusion: The research results may be misleading if any of the reliability types and calculation criteria types are chosen incorrectly. Therefore, to make the results of the study more accurate and valuable. Medical researchers must seek help from relevant guidelines such as this study before conducting reliability analysis.  

scholarly journals How can we improve knowledge and perceptions of menstruation? A mixed-methods research study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Gayoung Moon ◽  
Inkyung Kim ◽  
Habhin Kim ◽  
Suwan Choe ◽  
Soyeon Jeon ◽  
...  
Keyword(s):  
Young Adults ◽  
Mixed Methods Research ◽  
Online Survey ◽  
Information Service ◽  
World Health ◽  
Future Research ◽  
Research Information ◽  
Clinical Trial Registry ◽  
Knowledge Based ◽  
Menstrual Products

Abstract Background Traditionally, menstrual education has consisted of lectures directed toward women. The objective of this study was to design an innovative menstrual education (ME) program that reflects the needs of both young women and men, and verify its effectiveness. Methods A mixed-method design was used to determine the program needs and assess young adults’ knowledge and perceptions of menstruation and menstrual products. Focus group interviews were conducted with 14 young adults, and 150 young adults participated in an online survey. After developing the ME program, 10 young adults participated in a study to verify its effectiveness. Results Interview results showed young adults wanted more information about menstrual products. The online survey revealed significant differences in knowledge based on participants’ general characteristics and experience; exposure to menstruation and menstrual products positively impacted knowledge and perception. In addition, the results indicated young adults wanted ME content access via mobile and in-person modalities, designed for both genders, drawing on menstrual experts’ knowledge. Based on these results, a multi-experimental menstrual education (MEME) program was designed and included: hands-on exposure to 60 menstrual products, product demonstrations with a female perineal model, a YouTube video created by the researchers, a true-or-false quiz, and question-and-answer sessions with menstrual experts. Conclusions This study clarified the requirements of an innovative menstrual education program. It led to high satisfaction among participants, and improved knowledge and perceptions of menstruation and menstrual products. The online survey showed a correlation between the extent of received ME, and respondents’ perception of menstrual products. This implied that a MEME program could change perceptions when conducted systematically; by extension it could ameliorate menstruation challenges attributed to poverty. Future research could further verify the effectiveness of the MEME program, using a larger sample, and examine its suitability for incorporation into official ME curricula at universities and companies. Trial registration This trial was registered in a Clinical Research Information Service in Korea linked with the World Health Organization’s International Clinical Trial Registry Platform (WHO’s ICTRP) (no. KCT0004715), Registered 07 Feb 2020.

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