• Title/Summary/Keyword: human clinical trial

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The Effects of the Epithelial Cells of Genital Tract on the Development of Mouse Early Embryos and Human Fertilized Oocytes (생쥐 초기배아와 사람의 수정란의 발생에 미치는 생식수관 상피세포의 영향에 관한 연구)

  • Lee, H.J.;Byun, H.K.;Kim, J.W.;Hwang, J.H.;Jun, J.Y.;Kim, M.K.
    • Clinical and Experimental Reproductive Medicine
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    • v.21 no.3
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    • pp.315-323
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    • 1994
  • Mammalian oviductal epithelial cells have been known to improve in vitro fertilization and embryonic development. Recently, co-cultured human embryos with the epithelial cells in human genital tract has been reported to improve the pregnancy rate. The purpose of the study was to investigate the effects of the epithelial cells of human genital tract on the development of mouse early embryos and human fertilized oocytes. The epithelial cells of human genital tract were collected from the fallopian tubes which were obtained during hysterectomy in fertile women and from the endometrium during endometrium biopsy. Collected human ampullary cells(HACs) and endometrial cells(HECs) were cultured for 10 days to establish primary monolayer. Second passaged HACs and HECs were obtained by trypsinization were cryopreserved in PBS with 1.5 M DMSO for later use. To investigate the effect when co-cultured with HACs and HECs, we tried to apply strict quality control on mouse embryo, from two cell to blastocyst prior to human trial. The results of quality control were as follows; In Group I (Ham's F10 with 10% FCS), Group IT (co-cultured with HACs) and Group ill (co-cultured with HECs), developmental rates to blastocyst were 63.3%(253/400), 76.0%(304/ 400),74.0%(296/400), respectively. Hatching rates were 36.8%(147/400), 41.80/0(167/400), 38.0%(152/400), respectively(p<0.05). To perform the human IVF, cryopreserved HACs were thawed at 37$^{\circ}C$ waterbath, seeded on the well dish and cultured for 48 hI'S. The pronuclear stage embryos were transferred to the seeded well dish. After 24 hRS, co-cultured embryos were examined and transferred to patient's uterus. The results of human IVF when co-cultured with HACs were that fertilization and developmental rates were 61.8% (256/414), 95.3% (244/256) as compared with 57.2% (279/488) and 94.6%(264/279) in Ham's F10 supplemented with 10% FCS(control). However, 62.9% (161/256) of co-cultured human embryos showed good embryos(no or slight fragmentation) as compared with 53.8 % (150/279) in control(p < 0.05). Pregnancy rate was 40.0% (12/30) when co-cultured with HACs whereas 30.6%(11/36) in control. In conclusions, co-culture system using HACs and HECs improved the developmental and hatching rates of mouse embryo. Also, in human IVF system when co-cultured with HACs, it improved both the quality of human embryos and the pregnancy rate.

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Effects of Whey Protein-rich Meal Substitute in 4-Week Diet Trial on Body Weight, Body Fat, and Body Composition of Overweight or Obese Females (유청단백 함유 체중조절용 식사대체제를 이용한 4주 다이어트 프로그램이 과체중 및 비만 여성의 체중, 체지방 및 체성분에 미치는 영향)

  • Xi, Mei-Zhu;Zhang, Yi-Lin;Choi, Young-Bin;Jeong, Gi-Hee;Kim, Gun-Woo;Park, Yong-Woo;Lee, Bog-Hieu
    • Journal of the East Asian Society of Dietary Life
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    • v.26 no.1
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    • pp.25-33
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    • 2016
  • The study was performed to investigate the effects of whey protein-rich meal substitute added with vitamins, minerals, and lactobacillus powder probiotics on weight loss, body fat, and body composition in 24 female volunteers for 4 weeks. Whey protein-rich meal substitute was consumed with low-fat, high calcium milk (1% fat, 260 mg/200 mL) twice a day. Subjects submitted 3-day diet records and a life-style questionnaire before the study. During the study, subjects were required to turn in a diet record every day and consume the meal substitute formula in the metabolic ward at C university for 4 weeks. Anthropometric measurements were carried out weekly by Inbody 7.0. The dietary intake and anthropometric data were analyzed to compare changes before and after the study by paired t-test with SPSS version 23.0. The subjects were mostly early 20's and either overweight or obese and highly motivated to lose weight. Most of the subjects consumed three meals per day regularly and spent mostly 10~15 minutes for a meal. Their caloric intake was relatively low and decreased from 1,360 kcal at week 0 to 1,100 kcal after 4 weeks. However, total protein intake increased while carbohydrate and fat intakes decreased (p<0.05) after the trial. Nine vitamin intakes after the study improved compared to those before the study (p<0.05). After the study, subjects showed lower body weight (-1.8 kg), body fat (-0.94 kg), percent body fat (-0.86%), as well as waist circumference (-4.52 cm), hip circumference (-0.44 cm), waist hip ratio (-0.05), and triceps skinfold thickness (-2.39 mm) compared to those at week 0 (p<0.05). Muscle mass tended to be less compared to week 0, although there was no significant differences between weeks 0 and 4. In conclusion, diet trial with whey protein-rich meal substitute induced weight loss and positively changed body fat parameters and body composition.

Development of a Korean Diet Score (KDS) and its application assessing adherence to Korean healthy diet based on the Korean Food Guide Wheels

  • Lee, Myoungsook;Chae, Soo Wan;Cha, Youn-Soo;Cho, Mi Sook;Oh, Hea Young;Kim, Mi Kyung
    • Nutrition Research and Practice
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    • v.7 no.1
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    • pp.49-58
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    • 2013
  • The most critical point in the assessment of adherence to dietary guidelines is the development of a practical definition for adherence, such as a dietary pattern score. The purpose of this study was to develop the Korean Diet Score (KDS) based on the Korean Food Balance Wheel and to examine the association of KDS with various lifestyle characteristics and biochemical factors. The dietary data of 5,320 subjects from the 4th Korean National Health and Nutritional Examination Survey were used for the final analysis. The food guide was composed of six food group categories; 'grain dishes', 'fish and meat dishes', 'vegetable dishes', 'fruits', 'milk' and 'oils and sugars'. Based on the recommended serving numbers for each group, the scores measuring adherence to this food guide were calculated from the dietary information from the 24-hour dietary recall questionnaire, and then its correlation with various characteristics was assessed. KDS was significantly associated with several clinical, lifestyle and socioeconomic factors as well as diagnosed disease history. The higher quintile group of KDS showed a significantly lower level in fasting blood glucose, systolic blood pressure, triglycerides, current smoking and drinking as well as higher leisure time activity, house income and education. Furthermore, the KDS quintile group of women was inversely associated with hypertension, osteoporosis and diabetes. A higher KDS quintile was characterized with a higher intake of several critical nutrients, such as Ca, Fe and vitamins as well as a desirable nutrition balance such as the ratio of macronutrients. Our results demonstrate that KDS is a beneficial tool in assessing the adherence to a healthy diet based on the Korean dietary guidelines. We suggest that KDS could be a useful indicator for evaluating the dietary balance of the Korean population.

Survey of Conflict of Interest in the Clinical Research for IRB Members and Researchers (임상시험심사위원회 위원과 연구자를 대상으로 임상연구에서 이해상충에 대한 설문조사연구)

  • Maeng, Chi Hoon;Kang, Su Jin;Lee, Sun Ju;Yim, Hyeon Woo;Choe, Byung-in;Shin, Im Hee;Huh, Jung-Sik;Kwon, Ivo;Yoo, Soyoung;Lee, Mi-Kyung;Shin, Hee-Young;Kim, Duck-An
    • The Journal of KAIRB
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    • v.2 no.1
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    • pp.23-31
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    • 2020
  • Purpose: To obtain opinions from Korean Institutional Review Board (IRB) members' self-evaluation on ability to conduct fairness review of clinical trial protocol with presence of conflict of interest and from investigators and IRB members on financial conflict of interest through surveying. Methods: IRB members and researchers in 9 different hospitals were asked to answer survey questions via email. Results: Responders were 115 personnel (IRB Chair/vice 18, medical member 30, non-medical member 28, and researcher 39) from 9 centers. Compared to IRB medical members, IRB chair/vice respondents scored higher with statistically significance on 10 point scale (8.44±1.381 vs. 7.30±1.685, p=0.005) when asked to self-evaluate fairness reviewing a protocol proposed by an investigator from the same department and a protocol from the company that supports the scientific committee of responders. When reviewing a protocol proposed by a hospital director, non-medical members scored statistically significantly higher than medical-members (7.47±1.76 vs. 8.07±2.70, p=0.034). When asked about the limitation of labor fee for principal investigator on phase 3 Human clinical trials of the Investigational new drug, while the responses range was wide, 60% answered that labor cost of principal investigator should be less than 30% of total budget for clinical trials with a budget of 100 million won. 51.3% answered that there is no need to disclose the labor cost of the principal investigator in the consent form. Since every investigator can be influenced unconsciously by conflict of interest, the answer that 'responder agrees that there is need for management' was the most chosen answer (IRB member 61.8%, investigator 64.1%, multiple answers allowed). Conclusion: Considering scores on questions of fairness by IRB members were between 7.23-8.56 on scale of 0 to 10 point when IRB members were asked about reviewing a clinical trial protocol, it cannot be said with absolute certainty that there is no issue regarding fairness in the review process. Therefore, there should be more ways to safeguard fairness for these issues. There is a need that the disclosure amount of honorarium from sponsor should be lower than 100 million Korean won. Considering the results of the survey in which respondents expressed their thoughts, it is likely that more education on the concept of conflict of interest is needed.

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Analysis of Plasma Proteome before and after Oral Administration of Acidic Polysacharide from Panax Ginseng, Double-blind, Placebo-controlled, Randomised Trial (인삼 다당체 경구 투여 전 ${\cdot}$ 후 혈장의 proteome 분석;무작위배정, 이중 맹검, 위약비교시험)

  • Lee, Seon-Goo;Cho, Young-Ho;Kang, Tae-Gyu;Yang, Ha-Young;Yoo, Byong-Chul;Cho, Chong-Kwan;Yoo, Hwa-Seung
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.21 no.5
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    • pp.1185-1193
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    • 2007
  • Ginsing polysaccharide, known to have an immune regulating effect, was administered to 23 randomly selected healthy male subjects with a mean age of 23 years in accordance with an IRB approval. Then, these subjects underwent physico-chemical tests and serum proteome was analyzed from the blood sample taken from these subjects. Analyses of proteome involved image analysis, protein sections and protein identification in sequence after two-dimensional electrophoresis was carried out. During the physico-chemical test, 4 subjects were excluded from the study. In the proteome analysis, identified were 5 spots such as SP40, 40, Cytokeratin 9, hypothetical protein LOC544932, Apolipoprotein E ,similar to Human albumin, which showed differences in the amount of protein expression. In conclusion, changes of 5 proteins were remarkable before and after administration of ginsing polysaccharides. In certain cases, hepatic and renal slight injury occurred. Thus, further clinical study on dosage regimen would be necessary for securing the basis for concentration-dependent effectiveness and safety.

Effect of pectoralis major myofascial release massage for breastfeeding mothers on breast pain, engorgement, and newborns' breast milk intake and sleeping patterns in Korea: a randomized controlled trial

  • Won-Ryung Choi;Yeon-Suk Kim;Ju-Ri Kim;Myung-Haeng Hur
    • Women's Health Nursing
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    • v.29 no.1
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    • pp.66-75
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    • 2023
  • Purpose: Supportive interventions to improve breastfeeding practice are needed in nursing. This study investigated the effects of pectoralis major myofascial release massage (MRM) on breast pain and engorgement among breastfeeding mothers and on breast milk intake and sleep patterns among newborns. Methods: Breastfeeding mothers who had delivered between 37 and 43 weeks and had 7-to 14-day-old newborns were recruited from a postpartum care center in Gunpo, Korea. Participants were randomized to the MRM or control group. The outcome variables were breast pain and breast engorgement among breastfeeding mothers and breast milk intake and sleep time among newborns. The experimental treatment involved applying MRM to separate the pectoralis major muscle and the underlying breast tissue in the chest. After delivery, the first MRM session (MRM I) was provided by a breast specialist nurse, and the second (MRM II) was administered 48 hours after MRM I. Results: Following MRM, breast pain (MRM I: t=-5.38, p<.001; MRM II: t=-10.05, p<.001), breast engorgement (MRM I: right, t=-1.68, p =.100; left, t=-2.13, p=.037 and MRM II: right, t=-4.50, p<.001; left, t=-3.74, p<.001), and newborn breast milk intake (MRM I: t=3.10, p=.003; MRM II: t=3.09, p=.003) differed significantly between the groups. Conclusion: MRM effectively reduced breast engorgement and breast pain in breastfeeding mothers, reducing the need for formula supplementation, and increasing newborns' breast milk intake. Therefore, MRM can be utilized as an effective nursing intervention to alleviate discomfort during breastfeeding and to improve the rate of breastfeeding practice (clinical trial number: KCT0002436).

Randomized, Double-blind, and Placebo-controlled a Human Study for Growing of Stature via the Analysis of Effect of Ferment Oyster Extract: Study Protocol (발효굴추출물의 경구 섭취가 소아 신장 성장에 미치는 효과 및 안전성 평가를 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜)

  • Kim, Hee-Yeon;Park, Beom-Chan;Cheon, Jin-Hong;Choi, Jun-Yong;An, Byeong-Min;Park, Joung-Hyun;Lee, Bae-Jin;Kim, Kibong
    • The Journal of Pediatrics of Korean Medicine
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    • v.33 no.4
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    • pp.37-46
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    • 2019
  • Objectives The purpose of this study is to confirm the efficacy and safety of the treatment of with fermented oyster extract on height growth in children with short stature. Methods A total of 100 people, between 6 and 11 years old, will be participated in a randomized, double-blind, and placebo-controlled human study. The fermented oyster group will take 500 mg of fermented oyster extract once a day for 24 weeks. The placebo group will take 3400 mg of fructooligosaccharide as placebo once a day for 24 weeks. The outcomes of the intervention will be measured at the baseline, 6 week, 12 week, 18 week, and 24 week. The primary outcome is the changes in height from the baseline. The secondary outcomes are growth rate, height SDS, bone age, GH, IGF-1, IGFBP-3, osteocalcin, BALP, DPD, and LH. Results This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB-2019002). Recruitment of the research participants will be opened from May 2019 till December 2019. Conclusions This study will provide clinical information to determine the efficacy and safety of the treatment with fermented oyster extract on height growth in children with short stature.

Assessment of the Therapeutic Potential of Persimmon Leaf Extract on Prediabetic Subjects

  • Khan, Mohd M.;Tran, Bao Quoc;Jang, Yoon-Jin;Park, Soo-Hyun;Fondrie, William E.;Chowdhury, Khadiza;Yoon, Sung Hwan;Goodlett, David R.;Chae, Soo-Wan;Chae, Han-Jung;Seo, Seung-Young;Goo, Young Ah
    • Molecules and Cells
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    • v.40 no.7
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    • pp.466-475
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    • 2017
  • Dietary supplements have exhibited myriads of positive health effects on human health conditions and with the advent of new technological advances, including in the fields of proteomics, genomics, and metabolomics, biological and pharmacological activities of dietary supplements are being evaluated for their ameliorative effects in human ailments. Recent interests in understanding and discovering the molecular targets of phytochemical-gene-protein-metabolite dynamics resulted in discovery of a few protein signature candidates that could potentially be used to assess the effects of dietary supplements on human health. Persimmon (Diospyros kaki) is a folk medicine, commonly used as dietary supplement in China, Japan, and South Korea, owing to its different beneficial health effects including anti-diabetic implications. However, neither mechanism of action nor molecular biomarkers have been discovered that could either validate or be used to evaluate effects of persimmon on human health. In present study, Mass Spectrometry (MS)-based proteomic studies were accomplished to discover proteomic molecular signatures that could be used to understand therapeutic potentials of persimmon leaf extract (PLE) in diabetes amelioration. Saliva, serum, and urine samples were analyzed and we propose that salivary proteins can be used for evaluating treatment effectiveness and in improving patient compliance. The present discovery proteomics study demonstrates that salivary proteomic profile changes were found as a result of PLE treatment in prediabetic subjects that could specifically be used as potential protein signature candidates.

Study on the Repeatability and Reproductivity of a Moire Body Shape Analyser (모아레를 이용한 체형분석의 반복성 재현성에 관한 연구)

  • Lee, Dong-Yup;Park, Young-Bae;Oh, Hwan-Sub
    • The Journal of the Society of Korean Medicine Diagnostics
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    • v.10 no.2
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    • pp.121-131
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    • 2006
  • Background : As each human has a look in the face of oneself, he or she has a look of him or herself in the shape of the body also. And for the shape of the body which gives a big clue in diagnosis in musculoskeletal disorders. Therefor many means are used and developed for diagnosis through body shape or posture analysis for musculoskeletal disorders. X-ray, CT, MRI has been used for diagnosis through image in this way to tell about the inside of the human body. On the other side, moire topography was used for information about the exterior of the human body, but yet only minimal information such as the number of contour lines in each side was available. Therefor there were a few studies to use moire topography or other methods to get information about the surface of the human body in numeric values. The instrument used in this study which is a laser projection moire, is another trial to get numeric data about the surface of the human body. The instrument is composed of laser projector and a computer software to recompose and analyse the image data into depth, height, angle and length. Objectives : The study was focused on whether the instrument is reliable for clinic use, and to seek the proper environment and posture for the examination, and among the data the software provides, which items are more reliable and useful. Methods : For reproductivity and repeatability, 4 testers tested 2 persons. And to how if the body shape changes according to the posture and which posture gives the most reliable data, the test was performed in 6 different positions. Results : Result, the instrument showed sufficient repeatability and reproductivity for clinical use. And among the items the software provides, the length of the back, the angle of the back in the sagittal and coronal plane showed reliable results. And there was difference in the results according to the posture, and Therefor, in following studies using this instrument or similar type of posture analysing instruments, the length of the back, the angle of the back in the sagittal and coronal plane could be reliable item to use.

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Multifaceted Usage of HPV Related Tests and Products in the Management of Cervical Cancer - a Review

  • Nalliah, Sivalingam;Karikalan, Barani;Kademane, Kumaraswamy
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.6
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    • pp.2145-2150
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    • 2015
  • HPV viruses are integral to the development of cervical cancer. The pathogenesis has been extensively studied. To date, numerous HPV tests and products have been developed and successfully utilized in diagnosis, treatment and prevention of cervical cancer. The HPV DNA test, when combined with other routine cervical cancer screening and diagnostic tests namely exfoliative cytology, visual inspection with acetic acid (VIA) and colposcopy has increased the detection rate of cervical cancer. HPV DNA products could also be measured in other body fluids like urine, lymph node tissue, and serum. HPV association could also be quantified by measuring other parameters like HPV mRNA, viral load, viral integration and methylation status. Vaccination against HPV has been found to decrease the incidence of cervical cancer. Further, therapeutic vaccines for cervical cancer against HPV continue to evolve. All these findings pertaining to HPV could possibly decrease the incidence of cervical cancer in the near future. This review aims to give an overview of the HPV tests and products in use and those under trial currently.