• 제목/요약/키워드: Non-clinical trial

검색결과 253건 처리시간 0.029초

A Systematic Review on Prevention and Treatment of Nipple Pain and Fissure: Are They Curable?

  • Niazi, Azin;Rahimi, Vafa Baradaran;Soheili-Far, Sina;Askari, Nafiseh;Rahmanian-Devin, Pouria;Sanei-Far, Zahra;Sahebkar, Amirhossein;Rakhshandeh, Hassan;Askari, Vahid Reza
    • 대한약침학회지
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    • 제21권3호
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    • pp.139-150
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    • 2018
  • Averagely 80% to 90% of breastfeeding women experience the nipple pain and fissures. The important factor for successful breastfeeding is to treat this problem. This study has done as a review with the aim of analysis of the clinical trials in the field of the prevention and treatment of the nipple fissures and pain due to the importance of breastfeeding. For this purpose, the key words of sore, nipples, fissure, trauma, wound, prevention, treatment, therapeutics, therapy, clinical trial, breastfeeding and their Persian synonyms and all of their possible combinations were searched in the national databases: SID and Iran Medex and Magiran, and in the international databases: PubMed, Scopus, Medline, Science direct by May 2017. The Jadad criterion was used to assess the quality of the articles and the articles with a score of 3 or more were included in this study. Finally, 48 clinical trials were reviewed that 17 of them (sample size 1801) scored 3 or more based on the Jadad criterion. Seven articles were also in the non- drug treatment group (sample size 491) and 2 articles in the drug treatment group (sample size 337) and 8 articles in the herbal treatment group (sample size 973).The results show that menthol and warm water compress as well as teaching the correct breastfeeding methods are effective treatments to prevent and treat the nipple pain and fissures. Moreover, applying the herbal medicine for prevention and treatment of the issues raised from breastfeeding may have beneficial such as Aloe vera, Portulaca olearacea. However, more studies with a great methodology are necessary to obtain more accurate evidence.

Ob/ob Mouse에서 비탐-에스의 비 알코올성 지방간 개선 활성 (Bitam-S Improves the Non-alcoholic Fatty Liver Disease in C57BL/6J ob/ob Mice)

  • 한은정;김애경;정성현
    • 약학회지
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    • 제49권4호
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    • pp.306-311
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    • 2005
  • Semisulospira libertine (SL) has been used as a folk medicine for quenching a thirst, hepatic fever and inflammation in oriental countries. Although SL has been anecdotally ascertained to ameliorate the hepatic diseases, there are no sufficient experimental evidences. The purpose of this study was to examine the effect of Bitam-S, in which SL is a main component, on non-alcoholic fatty liver disease manifested in C57BL/6J ob/ob mice. At 6 week old, the ob/ob mice were randomly divided into four groups; control and three treatment groups. The control mice was to receive a regular diet, and the treatment groups were fed a regular diet with either 250mg/kg, 500mg/kg of Bitam-S (BS250 and BS500) or 300mg/kg of metformin (MT300) for a 8-week period. Bitam-S exerted beneficial effects on lipid homeostasis in ob/ob mice that are not necessarily due to its ability to decrease food intake but its specific effects on hepatic lipogenesis related genes (SREBP1a, FAS and SCD-1). The combined effects of Bitam-S to reduce body weight and lipogenic gene expressions, and reduce the deposition of triglyceride in the liver are indicative of a marked improvement in obesity-related non-alcoholic fatty liver disease. Taken together, Bitam-S has potential as a treatment agent for non-alcoholic fatty liver disease and deserves clinical trial in the near future.

비열등성 시험에서 위치 방법에 기초한 표본 수 결정 (Sample size determination based on placements for non-inferiority trials)

  • 김지연;김동재
    • Journal of the Korean Data and Information Science Society
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    • 제24권6호
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    • pp.1349-1357
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    • 2013
  • 임상시험에서 적당한 크기의 표본 수 결정은 통계적으로 유의한 연구결과의 도출과 연구수행의 효율적인 비용을 산출하기 위해서 중요한 사항 중의 하나이다. 기존의 비열등성 시험에서 표본 수 계산방법에는 t 검정법을 이용한 모수적 방법이 있고, Wilcoxon 순위합 검정을 이용하여 Wang 등 (2003)이 제안한 표본 수 계산방법을 Kim과 Kim (2007)이 비열등성 시험에 확장시켜 적용하여 제시한 비모수적 방법이 있다. 본 논문에서는 Orban과 Wolfe (1982)가 제안한 선형위치통계량의 검정법에 Kim (1994)이 계산한 검정력의 결과를 이용한 표본 수 계산 방법을 제안하고, 그에 따른 표본 수 계산결과를 기존에 제시된 표본 수 계산 결과와 비교하였다. 그 결과 기존의 방법들보다 본 논문에서 제안하는 방법으로 계산한 경우의 표본 수가 가장 작게 나왔다. 따라서 모집단에 대해서 구체적인 분포함수를 가정하기 힘든 경우 모수적 방법을 이용하게 되면 검정력이 떨어지거나 유의수준을 제어하지 못하는 문제점을 보완하고, 모수적 방법에 비해 표본 수가 크게 나와 시간이나 비용 면에서 효율적이지 않았던 Wilcoxon 순위합 검정을 이용한 방법의 단점을 보완할 수 있는 방법으로 본 논문에서 제시한 위치 (placement)를 이용한 표본 수 계산이 이용될 수 있다.

화병의 한의학적 치료에 대한 연구동향 (Current Trends in Intervention Studies of Hwabyung in Korean Medicine)

  • 서효원;최은지;김상호;김동희;김락형;김종우;이재혁;임재환;최우진;정선용
    • 동의신경정신과학회지
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    • 제27권4호
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    • pp.261-274
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    • 2016
  • Objectives: To determine the general characteristics of clinical studies about Hwabyung and assess their limitations and alternatives. Methods: Clinical studies that examined the effects of traditional Korean medicine intervention on Hwabyung were included in this study. A systematic search of English, Chinese, Japanese, and Korean databases was performed. The characteristics of included articles were described and those articles were assessed by Risk of Bias (RoB) tool or Risk of Bias for Nonrandomized Studies (RoBANS) tool. Results: Sixteen articles were selected from 1,826 articles. Most clinical studies about Hwabyung were published in Korea. The number of conducted trials was insufficient. The prevailing study design was randomized controlled trial. Traditional Korean medicine intervention used in the trials were acupuncture, herbal medicine, counselling, meditation, emotional freedom technique (EFT), music therapy, art therapy, and multi intervention program. Herbal medicine study used placebo as control while non-pharmacological intervention study mostly used no treatment as control. Most of the trials were supported by the government. Therefore, financial conflict of interest might not exist for results. We judged that some studies had a high risk of bias. In general, most of the studies with a high risk of bias were non-pharmacological intervention studies, and the risk of bias was mainly due to lack of blinding. Conclusions: More clinical studies of Hwabyung are needed. There are some issues about a suitable comparison and effective blinding strategy for non-pharmacological study. Improving methodological quality is required.

Effects of Monensin on Metabolism and Production in Dairy Saanen Goats in Periparturient Period

  • Sadjadian, Rasool;Seifi, Hesam A.;Mohri, Mehrdad;Naserian, Abbas Ali;Farzaneh, Nima
    • Asian-Australasian Journal of Animal Sciences
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    • 제26권1호
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    • pp.82-89
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    • 2013
  • This trial evaluated the effects of dietary supplementation with monensin sodium on dry matter intake, metabolic parameters and milk yield and milk composition of dairy Saanen goats in the periparturient period. Twelve Saanen pregnant dairy goats were assigned to a treatment and a control group. Saanen goats were fed monensin as its 10% sodium salt in the amount of 33 mg/kg of total dry matter intake during 30 d before parturition till d 42 in milk. Blood samples were collected from each goat at d 30, 15 and 7 before expected kidding time and also in d 1, 7, 13, 19, 21, 28, 35 and 42 postpartum. The serum concentrations of ${\beta}$-Hydroxybutyrate (BHBA), non-esterifed fatty acid (NEFA), calcium, magnesium, inorganic phosphorus, cholesterol, triglyceride, urea, total protein, albumin and glucose and aspartate aminotransferase (AST) activity were determined. The BHBA concentration significantly decreased in goats, which received monensin in comparison to controls in the postpartum period (p = 0.049). The concentration of sodium (Na) was significantly influenced by monensin treatment in the postpartum period (p = 0.048). In addition, the difference in dry matter intake was highly significant between the two groups during the pre-partum period. Controls had more dry matter intake (DMI) than treatment goats (p = 0.0001). Mean 3.5% fat corrected milk production was not influenced by monensin treatment. However, milk fat percentage was significantly decreased in monensin treated goats (p = 0.0017).

다계통 위축증의 치료에 대한 임상연구 동향 - CNKI검색을 중심으로 (A Review of Clinical Studies for Treatment of Multiple System Atrophy Using the CNKI Database)

  • 김민지;원서영;김해융;유주영;정은선;유호룡;설인찬;김윤식
    • 대한한방내과학회지
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    • 제41권4호
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    • pp.612-623
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    • 2020
  • Objectives: The aim of this research was to investigate and review the trends in recent clinical studies of multiple system atrophy (MSA) in China. Methods: We searched for clinical studies discussing Oriental medicine-based treatments for MSA in the China National Knowledge Infrastructure (CNKI) database. The search focused on the authors; publication year; type of study; method and duration of treatment; evaluation criteria; and results of the selected articles. Results: Among the articles retrieved from the database, eight case series, two randomized controlled trials (RCTs), and one non-randomized controlled trial (nRCT) were analyzed. Eight articles used acupuncture; ten used herbal medicine. The most frequently used acupoints were GV20, GV24, GB20, PC6, Hyeopcheok Acupoint, CV4, EX-HN3, and GV17. Jihwangeumja was the most commonly used herbal prescription. All 13 studies confirmed the efficacy of Oriental medicine treatments. Conclusions: More varied and scientifically designed clinical studies are required to develop treatments for MSA. The results of this study may provide guidance for further studies of MSA.

Stem Cells in Plastic Surgery: A Review of Current Clinical and Translational Applications

  • Salibian, Ara A.;Widgerow, Alan D.;Abrouk, Michael;Evans, Gregory R.D.
    • Archives of Plastic Surgery
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    • 제40권6호
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    • pp.666-675
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    • 2013
  • Background Stem cells are a unique cell population characterized by self-renewal and cellular differentiation capabilities. These characteristics, among other traits, make them an attractive option for regenerative treatments of tissues defects and for aesthetic procedures in plastic surgery. As research regarding the isolation, culture and behavior of stem cells has progressed, stem cells, particularly adult stem cells, have shown promising results in both translational and clinical applications. Methods The purpose of this review is to evaluate the applications of stem cells in the plastic surgery literature, with particular focus on the advances and limitations of current stem cell therapies. Different key areas amenable to stem cell therapy are addressed in the literature review; these include regeneration of soft tissue, bone, cartilage, and peripheral nerves, as well as wound healing and skin aging. Results The reviewed studies demonstrate promising results, with favorable outcomes and minimal complications in the cited cases. In particular, adipose tissue derived stem cell (ADSC) transplants appear to provide effective treatment options for bony and soft tissue defects, and non-healing wounds. ADSCs have also been shown to be useful in aesthetic surgery. Conclusions Further studies involving both the basic and clinical science aspects of stem cell therapies are warranted. In particular, the mechanism of action of stem cells, their interactions with the surrounding microenvironment and their long-term fate require further elucidation. Larger randomized trials are also necessary to demonstrate the continued safety of transplanted stem cells as well as the efficacy of cellular therapies in comparison to the current standards of care.

신약개발을 위한 임상연구간호사의 역할수행과 관련 요인 (Role Performance and Related Factors of Clinical Research Nurses in New Drug Development)

  • 박재은;김신미
    • Journal of Korean Biological Nursing Science
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    • 제22권3호
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    • pp.213-221
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    • 2020
  • Purpose: The purpose of this study was to explore the role performance and related factors of clinical research nurses (CRN) in the process of clinical trials of new drug development. Methods: Study participants were CRN whose affiliation was in non-capital areas and who had been working longer than three months at the time of the data collection. The data collection was conducted with a semi-structured questionnaire development by Hwang & Go, 2011 comprising 16 items of participants' characteristics and 60 items of role performance via in-person and online. Additionally, opinions which would be necessary to establish the CRN role were questioned for the future. A total of 141 questionnaires of 151 questionnaires responses were analyzed using descriptive statistics, t-test, and ANOVA for data analysis as appropriate. Results: The level of overall role performance was above average (5.61±0.90) with the highest in subject care (6.04 ± 0.96) and management and the lowest in self-development (4.39 ± 1.52). The only factor affecting overall role performance was employment status and the only sub-category affected by factors of employment status, and some general characteristics was self-development. Conclusion: From study results, it can be concluded that the CRN seem to perform their proper role. Nonetheless, self-development should be considered as critical aspect for better CRN competency, which is an important aspect toward improving the CRN role performance. Additionally, efforts to improve the level of role performance must be established through stable employment and concrete departmental placement as suggested in this study.

경추증성 척수증의 한의학적 치료에 대한 국내외 연구 동향 (A Review of the Korean Traditional Medicine for Cervical Spondylotic Myelopathy)

  • 변다영;이기언;노지애;김효준;허석원;한시훈
    • 한방재활의학과학회지
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    • 제29권2호
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    • pp.149-158
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    • 2019
  • Objectives This study was performed to research the trends of Korean traditional medicine treatment for cervical spondylotic myelopathy (CSM). Methods Clinical studies about Korean traditional medicine of CSM were searched in 7 online databases. We extracted the characteristics of selected studies according to author, publication year, country, research design, treatment methods, evaluation tools, and adverse events. Results Nineteen studies were selected in online databases. The included studies consist of 8 uncontrolled trial, 7 case reports, 3 randomized controlled trials and 1 non-randomized controlled trials. In these studies, various Korean traditional medicine treatments were performed, and herbal medicine was the most common. The most commonly used outcomes was effective rate. Conclusions This study showed that Korean traditional medicine could be an effective treatment for CSM. It was suggested that various studies should be conducted to provide objective evidence of the therapeutic effects of Korean traditional medicine treatment for CSM.

한방여성의학에서 추나요법을 활용한 국내 연구 동향 분석 (A Review of the Domestic Study Trends on Obstetrics & Gynecological Diseases with Chuna Manual Therapy)

  • 이진욱;황영식;김규태;박승혁;이진무;이창훈;장준복;황덕상
    • 대한한방부인과학회지
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    • 제32권2호
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    • pp.87-99
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    • 2019
  • Objectives: The aim of this study was to analyse the domestic trends of Chuna manual therapy on Obstetrics and Gynecological Diseases in Korean literature. Methods: We searched for papers which had Chuna manual therapy through 2 related journals and 5 Korean web databases. All relevant papers were selected and extracted to be analyzed according to their study designs, academic journals, and target disease. Results: Nine papers belonged to four types of study designs, systematic review, randomized or non-randomized controlled trial and case report. And they were published in four kinds of academic journals. There were four papers about postpartum pain, two low back pain during pregnancy, and a stress urinary incontinence. The exact Chuna techniques were explained in only seven papers. All of papers have been shown that Chuna manual therapy is useful for obstetrics and gynecological diseases. Conclusions: It has been identified that Chuna manual therapy could be a good treatment for obstetrics and gynecological diseases. However, more clinical and well-designed studies with Chuna manual therapy will be needed.