• Title/Summary/Keyword: Clinical Trials

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Retrospective Study on 469 Halitosis Patients (구취환자 469례에 대한 후향적 연구)

  • Kim, Dae Bok;Kim, Jae Ik;Nam, Seung Kyu;Jeong, Gi Hoon;Kim, Chul Jung;Cho, Chung Sik
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.29 no.5
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    • pp.370-377
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    • 2015
  • There is a growing interest in halitosis and diverse Korean medical studies are being conducted about it. But there are few study about teatment effect of halitosis after Korean medical care, treatment duration, and factor affecting recovery rate. Thus, the purpose of this study is to research clinical characteristic of halitosis patients, factor affecting halitosis, recovery rate of halitosis, treatment duration, factor affecting recovery rate by analyzing halitosis patients retrospectively. People who were over 19 and visited Korean medical clinic in Seoul to want to be treated halitosis in 2014 were analyzed retrospectively. We analyzed general and living characteristics of halitosis patients, halitosis-related symptoms and diseases, level of halitosis and halitosis-related symptoms both before and after treatment, treatment duration of halitosis patients, prescription of halitosis patients, recovery rate of level of halitosis and halitosis-related symptoms by general characteristic and duration of symptoms. Female, thirties, and Nonsmoker had the highest proportion in general characteristic. The average duration of halitosis is 41.6months and treatment duration is 2.55months. The average of sensory evaluation score is 3.40±2.53, subjective evaluation score is 5.02±1.53, lump sensation on throat is 3.52±2.50, postnasal drip is 1.11±1.88, dry mouth is 4.13±2.17, quality of life is 6.07±1.13. Gamichiuitang is used the most among prescriptions. Sensory evaluation, subjective evaluation, lump sensation on throat, postnasal drip, dry mouth, and quality of life had better score compared with pre-treatment. Duration of symptoms is in weak inverse proportion to sensory evaluation, subjective evaluation, dry mouth, quality of life. This study is meaningful in the way to find recovery rate of halitosis after korean medical care, treatment duration, and factor affecting recovery rate not progressed until now. But this study also has limits such as not analyzing objective data using halitosis measuring instrument and lack of methodical scale about quality of life. Therefore, succeeding study such as clinical trials is needed to verify reliability of Korean medical treatment.

Neural Growth Factor Stimulates Proliferation of Spinal Cord Derived-Neural Precursor/Stem Cells

  • Han, Youngmin;Kim, Kyoung-Tae
    • Journal of Korean Neurosurgical Society
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    • v.59 no.5
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    • pp.437-441
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    • 2016
  • Objective : Recently, regenerative therapies have been used in clinical trials (heart, cartilage, skeletal). We don't make use of these treatments to spinal cord injury (SCI) patients yet, but regenerative therapies are rising interest in recent study about SCI. Neural precursor/stem cell (NPSC) proliferation is a significant event in functional recovery of the central nervous system (CNS). However, brain NPSCs and spinal cord NPSCs (SC-NPSCs) have many differences including gene expression and proliferation. The purpose of this study was to investigate the influence of neural growth factor (NGF) on the proliferation of SC-NPSCs. Methods : NPSCs ($2{\times}10^4$) were suspended in $100{\mu}L$ of neurobasal medium containing NGF-7S (Sigma-Aldrich) and cultured in a 96-well plate for 12 days. NPSC proliferation was analyzed five times for either concentration of NGF (0.02 and 2 ng/mL). Sixteen rats after SCI were randomly allocated into two groups. In group 1 (SCI-vehicle group, n=8), animals received 1.0 mL of the saline vehicle solution. In group 2 (SCI-NGF group, n=8), the animals received single doses of NGF (Sigma-Aldrich). A dose of 0.02 ng/mL of NGF or normal saline as a vehicle control was intra-thecally injected daily at 24 hour intervals for 7 days. For Immunohistochemistry analysis, rats were sacrificed after one week and the spinal cords were obtained. Results : The elevation of cell proliferation with 0.02 ng/mL NGF was significant (p<0.05) but was not significant for 2 ng/mL NGF. The optical density was increased in the NGF 0.02 ng/mL group compared to the control group and NGF 2 ng/mL groups. The density of nestin in the SCI-NGF group was significantly increased over the SCI-vehicle group (p<0.05). High power microscopy revealed that the density of nestin in the SCI-NGF group was significantly increased over the SCI-vehicle group. Conclusion : SC-NPSC proliferation is an important pathway in the functional recovery of SCI. NGF enhances SC-NPSC proliferation in vitro and in vivo. NGF may be a useful option for treatment of SCI patients pending further studies to verify the clinical applicability.

Platelet Rich Plasma Injection: Evidence Based Analysis (혈소판 풍부 혈장 주사 요법: 근거 중심의 분석)

  • Oh, Joo Han;Chung, Seok Won
    • The Journal of Korean Orthopaedic Ultrasound Society
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    • v.4 no.2
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    • pp.111-122
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    • 2011
  • Platelet rich plasma (PRP) has been widely used nowadays for several common orthopaedic-related sports medicine conditions with the theoretical basis that PRP supplies numerous autologous growth factors from concentrated platelets needed to promote the healing process of injured tissue. Even though there are many basic sciences, animal studies and some clinical studies regarding PRP injections for musculoskeletal injuries which suggested good results, it is difficult to compare these various studies due to marked methodological differences such as PRP preparation method, the timing, volume and number of injection, and the outcome measurement tool. In addition, many studies have no control groups or a limited sample size, and there are few prospective randomized controlled trials assessing the efficacy of PRP injections. Therefore, well designed high-quality randomized studies are required to confirm the preliminary results until now and provide scientific evidence to support its use, and the paucity of scientific clinical evidence suggest that the administration of PRP on humans for musculoskeletal injuries should be performed with caution.

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Study on the Relationship between Korean Standard of Pattern Identification (II) and Pattern Identification of Cold-Heat and Deficiency-Excess (한국형 중풍 변증 표준안 - II와 한열허실 변증지표의 연관성 연구)

  • Kim, So-Yeon;Lee, Jung-Sup;Oh, Dal-Seok;Kang, Byoung-Kab;Ko, Mi-Mi;Kim, Jeong-Cheol;Kwon, Se-Hyug;Bang, Ok-Sun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.24 no.1
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    • pp.15-21
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    • 2010
  • Previously standardization study for identifying 5 types of pattern identification of stroke patients has been performed and the Korean standard of pattern identification (II) was developed. In the present study we investigated the interactions between total indices designated by the Korean standard of pattern identification(KSPI II) and indices for PI of Cold-Heat and Deficiency-Excess. Indicators for Cold-Heat and Deficiency-Excess are isolated from 58 indices through the survey of oriental medicine doctors and their relationship with KSPI-II indices was analyzed by corresponding analysis method using data of 1581 stroke patients. Means and standard deviations indicated that 2 Cold indices, 14 Heat indices, 12 Deficiency indices, and 5 Excess indices were included for Cold-Heat and Deficiency-Excess pattern identification. The results of corresponding analysis shows the relationship of 57 indices and 4 types of pattern identification (excluding 1 index and 1 pattern among 58 indices and 5 patterns) using the cross-tabulation which was obtained from the clinical data. Most of Cold and Heat index were divided to dimension 1(inertia 51.9%) obtained from the result of corresponding analysis. Deficiency and Excess index were partially associated with dimension 2(inertia 31.7%). These data suggest that pattern identification of Cold-Heat plays an role in the standardization of pattern identification in stroke, although further studies are required by various trials such as analysis of surveys and clinical data.

Role of Reactive Oxygen Species in the Adipogenesis of Adipose-derived Stem Cells (지방유래줄기세포의 지방분화과정에서 활성산소가 미치는 영향)

  • Chang, Hak;Min, Kyung-Hee;Park, Young-In;Kim, Yo-Han;Minn, Kyung-Won
    • Archives of Plastic Surgery
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    • v.38 no.2
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    • pp.131-134
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    • 2011
  • Purpose: Stem cells continue to receive research attention in the clinical fields, and adipose-derived stem cells (ADSCs) have been shown to be a good source raw material. Many plastic surgeons are researching the ADSC adipogenesis with a view of conducting clinical trials, and many attempts have been made to identify the factors that promote the adipogenesis of ADSCs, but comparatively few correlation studies have been undertaken to explore the relation between reactive oxygen species (ROS) and the ADSC adipogenesis. We undertook this study is to investigate the effects of ROS on ADSC adipogenesis. Methods: ADSCs were isolated and cultured from abdominal adipose tissue, and cultured in different media; 1) DMEM(control), 2) adipogenesis induction culture medium, 3) adipogenesis induction culture medium with ROS ($20{\mu}M/50{\mu}M\;H_2O_2$), 4) adipogenesis induction culture medium containing ROS ($20{\mu}M/50{\mu}M\;H_2O_2$) and antioxidant ($10{\mu}M/20{\mu}M$ Deferoxamine). We compared adipogenesis in these different media by taking absorbance measurements after Oil-Red O staining every 5 days. Results: After culturing for 20 days, significant differences were observed between these various culture groups. Absorbance results showed significantly more adipogenesis had occurred in media containing adipogenesis induction culture medium and $H_2O_2$ (in a $H_2O_2$ dose-dependently manner) than in media containing adipogenesis induction culture medium and no $H_2O_2$ (p<0.001). Furthermore, in media containing adipogenesis induction culture medium, $H_2O_2$, and antioxidant, absorbance results were significantly lower than in adipogenesis induction culture medium and $H_2O_2$ (p<0.001). Conclusion: These findings suggest that ROS promote the adipogenesis of ADSCs. We suggests that ROS could be used in the adipose tissue engineering to improve fat cell differentiation and implantable fat tissue organization.

The Study of Dosimetry according to the Thickness of Beam Spoiler on Total Body Irradiation (전신방사선치료시 산란체의 두께에 따른 선량측정)

  • Kim, Youngjae;Jeon, Byeongkyou;Lee, Jaesik;Jung, Jaeeun
    • Journal of the Korean Society of Radiology
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    • v.8 no.5
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    • pp.265-269
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    • 2014
  • The therapy of total body irradiation on leukemia carries out to kill harmful bacteria or suppression of immune system by external beam therapy, which is a preparatory stage to reconstitute bone marrow before a pre-treatment of bone marrow transplantation to patients with health bone marrow cells. In case of this kind of radiation therapy, the spoiler use to increase surface dose of patient which varies depending on distance and thickness between patient and spoiler. In this study, the change was investigated the surface dose according to thickness of spoiler. The 0.5% increase of surface dose was observed with each 2.0 cm when the spioler in acrylic was prepared from 0.5 cm to 3.0 cm at intervals of 0.5 cm was evaluated. Based on this result, it suggests that this kind of application will be somewhat limited on clinical trials directly but proper surface dose can be useful method when is applied on patients of treatment prognosis who are required each different surface dose.

NEW DRUG THERAPY IN CHILD AND ADOLESCENT PSYCHIATRY-NEW LONG-ACTING PSYCHOSTIMULANTS (소아청소년 정신과 영역에서의 새로운 약물치료:새로운 장기작용형 중추신경자극제)

  • Choi, Sung-Ku
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.14 no.1
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    • pp.3-11
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    • 2003
  • Attention-deficit/Hyperactivity disorder(ADHD) is the most common psychiatric disorder of childhood and among the most prevalent chronic health conditions affecting school-aged children. Children with ADHD experience significant functional problems, such as school difficulties, academic underachievement, troublesome interpersonal relationships with family members and peers, and low self-esteem. The most widely used pharmacological treatments for ADHD are psychostimulants, such as methylphenidate and amphetamine salts. These medications provide clinical efficacy by increasing the availability of catecholamines, primarily dopamine, in the frontal lobe of the brain. immediate-release(IR) formulations of sychostimulants were among the most effective psychotrophic medications in the psychopharmacological treatment. However, there are some limitations of IR formulations:the short half-life and duration of efficacy, which result in the need for multiple daily dosing and the poor compliance. These limitations have led to the development of once-daily, extended-release(ER) formulations of methylphenidate and amphetamine salts. However, these ER formulations may not be as immediately helpful to ADHD children due to delayed onset of action and the acute tolerance which is the failure to sustain the efficacy with the same concentration of drug as the initial stage of medication. OROS-methylphenidate(Concerta$^{\circledR}$) given once a day produces an ascending-pattern plasma drug level generated by the osmotically released, timed drug-delivery system. These new formulations of the psychostimulants have been shown to be a useful alternative to old stimulant medications through the evidence by the clinical trials.

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The Effects of Progesterone on Cell Mediated Immunity to Trophoblast in Woman with Recurrent Pregnancy Loss (반복 유산환자의 말초혈액 단핵구와 태반항원을 체외 공동 배양시 세포 매개 면역반응에 프로게스테론이 미치는 영향)

  • Choi, Bum-Chae;Hill, Joseph A.
    • Clinical and Experimental Reproductive Medicine
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    • v.24 no.3
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    • pp.399-405
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    • 1997
  • Progesterone is necessary for successful pregnancy and had immunosuppressive properties. Peripheral blood mononuclear cells (PBMC) from many women with unexplained recurrent spontaneous abortion responded to trophoblast extract in vitro by prolifertion and releasing soluble, heat-labile factors that are toxic to mouse embryos (embryotoxic factors). Accumulating evidence suggests that T Helper (Th)-1 type immunity to trophoblast is correlated with embryotoxic factor production and is associated with pregnancy loss, while Th2-type immunity is associated with successful gestation. The objective of this study was to determine whether progesterone can inhibit Th1-type cytokine secretion (IFN-${\gamma}$, TNF-${\alpha}$) by trophoblast-activated peripheral blood mononuclear cells from 23 nonpregnant women (age 25-35) with unexplained recurrent abortion (median 5, range 3 to 15)who otherwise produce embryotoxic factors in response to trophoblast. We also determined whether progesterone affected Th2-type cytokines (IL-4, IL-10) in this system in vitro and if IL-10 (1,500 pg/mL) could inhibit Th1-type immunity to trophoblast. IFN-${\gamma}$ was detected in 17 of 23 (74%) trophoblast stimulated PBMC culture supernatants ($77.94{\pm}23.79$ pg/mL) containing embryotoxic activity. TNF-${\alpha}$ was detected in 19 (83%) of these same supernatants ($703.15{\pm}131.36$ pg/mL). In contrast, none of the supernatants contained detectable levels of IL-4 or IL-10. Progesterone ($10^{-5}$, $10^{-7}$, $10^{-9}$M) inhibited Th1-type immunity in a dose dependent manner, but had no effect on Th2-type cytokine secretion. The inhibitory effects of progesterone were abrogated with RU486, but did not affect Th2-type cytokine secretion in trophoblast-activated cell cultures. IL-10, like progesterone also inhibited Th1-type cytokine secretion but had no effect on Th2-type cytokines. These data suggest that therapies designed to suppress Th1-type cytokine secretion in women with recurrent abortion who have evidence of Th1-type immunity to trophoblast may be efficacious in preventing pregnancy loss and should be tested in appropriately designed clinical trials.

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Effect of luteal phase support with vaginal progesterone on pregnancy outcomes in natural frozen embryo transfer cycles: A meta-analysis

  • Seol, Aeran;Shim, Yoo Jin;Kim, Sung Woo;Kim, Seul Ki;Lee, Jung Ryeol;Jee, Byung Chul;Suh, Chang Suk;Kim, Seok Hyun
    • Clinical and Experimental Reproductive Medicine
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    • v.47 no.2
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    • pp.147-152
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    • 2020
  • Objective: The purpose of this study was to determine the effect of vaginal progesterone for luteal phase support (LPS) on the clinical pregnancy rate (CPR) in natural frozen embryo transfer (FET) cycles via a meta-analysis. Methods: We performed a meta-analysis of randomized controlled trials (RCTs) and retrospective studies that met our selection criteria. Four online databases (PubMed, Embase, Medline, and the Cochrane Library) were searched between January 2017 and May 2017. Studies were selected according to predefined inclusion criteria and meta-analyzed using R software version 2.14.2. The main outcome measure was CPR. Results: A total of 18 studies were reviewed and assessed for eligibility. One RCT (n = 435) and three retrospective studies (n = 3,033) met the selection criteria. In a meta-analysis of the selected studies, we found no significant difference in the CPR (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.60-1.55) between the vaginal progesterone and control groups. An analysis of the two retrospective cohort studies that reported the live birth rate (LBR) following FET showed a significantly higher LBR in the vaginal progesterone group (OR, 1.72; 95% CI, 1.21-2.46). A subgroup meta-analysis of FET conducted 5 days after injection of human chorionic gonadotropin showed no significant differences between the two groups with regard to the CPR (OR, 1.18; 95% CI, 0.90-1.55) or miscarriage rate (OR, 0.73; 95% CI, 0.36-1.47). Conclusion: The results of this meta-analysis of the currently available literature suggest that LPS with vaginal progesterone in natural FET cycles does not improve the CPR.

Development of an EEG Software for Two-Channel Cerebral Function Monitoring System (2채널 뇌기능 감시 시스템을 위한 뇌파 소프트웨어의 개발)

  • Kim, Dong-Jun;Yu, Seon-Guk;Kim, Seon-Ho
    • Journal of Biomedical Engineering Research
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    • v.20 no.1
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    • pp.81-90
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    • 1999
  • This paper describes an EEG(electroencephalogram) software for two-channel cerebral function monitoring system to detect the cerebral ischemia. In the software, two-channel bipolar analog EEG signals are digitized and from the signals various EEG parameters are extracted and displayed on a monitor in real-time. Digitized EEG signal is transformed by FFT(Fast Fourier transform) and represented as CSA(compressed spectral array) and DSA(density spectral array). Additional 5 parameters, such as alpha ratio, percent delta, spectral edge frequency, total power, and difference in total power, are estimated using the FFT spectra. All of these are effectively merged in a monitor and displayed in real-time. Through animal experiments and clinical trials on men, the software is modified and enhanced. Since the software provides raw EEG, CSA, DSA, simultaneously with additional 5 parameters in a monitor, it is possible to observe patients multilaterally. For easy comparison of patient's status, reference patterns of CSA, DSA can be captured and displayed on top of the monitor. And user can mark events of surgical operation and patient's conditions on the software, this allow him jump to the points of events directly, when reviewing the recorded EEG file afterwards. Other functions, such as forward/backward jump, gain control, file management are equipped and these are operated by simple mouse click. Clinical tests in a university hospital show that the software responds accurately according to the conditions of patients and medical doctors can use the software easily.

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