• Title/Summary/Keyword: clinical trial center

Search Result 723, Processing Time 0.029 seconds

The Evolution of Flow-Diverting Stents for Cerebral Aneurysms; Historical Review, Modern Application, Complications, and Future Direction

  • Shin, Dong-Seong;Carroll, Christopher P.;Elghareeb, Mohammed;Hoh, Brian L.;Kim, Bum-Tae
    • Journal of Korean Neurosurgical Society
    • /
    • v.63 no.2
    • /
    • pp.137-152
    • /
    • 2020
  • In spite of the developing endovascular era, large (15-25 mm) and giant (>25 mm) wide-neck cerebral aneurysms remained technically challenging. Intracranial flow-diverting stents (FDS) were developed to address these challenges by targeting aneurysm hemodynamics to promote aneurysm occlusion. In 2011, the first FDS approved for use in the United States market. Shortly thereafter, the Pipeline of Uncoilable or Failed Aneurysms (PUFS) study was published demonstrating high efficacy and a similar complication profile to other intracranial stents. The initial FDA instructions for use (IFU) limited its use to patients 22 years old or older with wide-necked large or giant aneurysms of the internal carotid artery (ICA) from the petrous segment to superior hypophyseal artery/ophthalmic segment. Expanded IFU was tested in the Prospective Study on Embolization of Intracranial Aneurysms with PipelineTM Embolization Device (PREMIER) trial. With further post-approval clinical data, the United States FDA expanded the IFU to include patients with small or medium, wide-necked saccular or fusiform aneurysms from the petrous ICA to the ICA terminus. However, IFU is more restrictive in South Korea than in United States. Several systematic reviews and meta-analyses have sought to evaluate the overall efficacy of FDS for the treatment of cerebral aneurysms and consistently identify FDS as an effective technique for the treatment of aneurysms broadly with complication rates similar to other traditional techniques. A growing body of literature has demonstrated high efficacy of FDS for small aneurysms; distal artery aneurysms; non-saccular aneurysms posterior circulation aneurysms and complication rates similar to traditional techniques. In the short interval since the Pipeline Embolization Device was first introduced, FDS has been firmly entrenched as a powerful tool in the endovascular armamentarium. As new FDS are developed, established FDS are refined, and delivery systems are improved the uses for FDS will only expand further. Researchers continue to work to optimize the mechanical characteristics of the FDS themselves, aiming to optimize deploy ability and efficacy. With expanded use for small to medium aneurysms and posterior circulation aneurysms, FDS technology is firmly entrenched as a powerful tool to treat challenging aneurysms, both primarily and as an adjunct to coil embolization. With the aforementioned advances, the ease of FDS deployment will improve and complication rates will be further minimized. This will only further establish FDS deployment as a key strategy in the treatment of cerebral aneurysms.

Combined effects of dietary zinc at 3 years of age and obesity at 7 years of age on the serum uric acid levels of Korean children

  • Lee, Sung Hee;Lee, Hye Ah;Park, Eun Ae;Cho, Su Jin;Oh, Se Young;Park, Bohyun;Park, Hyesook
    • Nutrition Research and Practice
    • /
    • v.14 no.4
    • /
    • pp.365-373
    • /
    • 2020
  • BACKGROUND/OBJECTIVES: To assess the longitudinal associations of the antioxidant capacity of zinc and body mass index (BMI) with serum uric acid (SUA) in South Korean children. SUBJECTS/METHODS: Using follow-up data from the Ewha Birth and Growth Cohort, we included subjects who were seen at 3 and 7 years of age (n = 183; 90 boys, 93 girls). Daily zinc intake and BMI were assessed at 3 and 7 years of age. SUA measured at 7 years was used as the outcome variable. Using a general linear model, the effects of dietary zinc intake and BMI on SUA were assessed. We also assessed the combined effect of early dietary zinc intake and BMI on SUA in children. RESULTS: The dietary zinc intake at 3 years of age was negatively correlated (ρ = -0.18, P = 0.04), whereas the BMI at 7 years of age was positively correlated (r = 0.18, P = 0.01), with the SUA level at 7 years of age. The dietary zinc intake level at 3 years of age and the BMI level at 7 years of age were, together, significantly related to SUA in children at 7 years of age. SUA was lower in group 1 (normal-weight, high-zinc group) than in the other two groups (group 2: normal-weight, low-zinc and overweight, high-zinc group; and group 3: overweight, low-zinc group). Our results demonstrate the combined effect of zinc intake and BMI on SUA. The combined association remained significant in both the crude and adjusted models (P < 0.01). CONCLUSIONS: SUA was related to combined BMI and dietary zinc intake, and increased zinc intake and normal body weight had a beneficial effect on reducing SUA in children.

The Change of Blood Pressure according to the Number of Measurements and the Number of Visits (측정 횟수 및 방문 횟수에 따른 혈압 변화)

  • Park, Ji-Eun;Lee, Min-Hee;Ryu, Yeon-Hee;Liu, Yan;Jung, Hee-Jung;Hong, Sang-Hoon;Lee, Seung-Deok;Kim, Nam-Kwen;Choi, Sun-Mi
    • Korean Journal of Oriental Medicine
    • /
    • v.18 no.3
    • /
    • pp.111-118
    • /
    • 2012
  • Objective : The aim of this study was to investigate the number of measurements and visits for blood pressure measurement. We also analyzed the change of blood pressure based on the measurement method and measurement interval. Methods : Data of three clinical trials evaluating the effect of acupuncture, moxibustion, and qigong for pre and mild essential hypertension were used. Blood pressure was measured 3 times each visit with 1 or 5 minutes interval, and it was checked until $3^{rd}$ visit. Two trials used sphygmomanometer and another one trial used automatic device for blood pressure measurement. Results : The mean difference between $1^{st}$ and $2^{nd}$, and $2^{nd}$ and $3^{rd}$ measurement were significant in systolic (p<0.001) and diastolic blood pressure (p<0.001). However, in automated measurement or measuring with 1 minute interval, the difference between $2^{nd}$ and $3^{rd}$ was not significant. The mean of $1^{st}$ and $2^{nd}$ measurements was also significantly different from the mean of all three measurements in both systolic (p<0.001) and diastolic blood pressure (p<0.001). While the difference between each visit was not significant in diastolic blood pressure, the systolic blood pressure difference was significant between $1^{st}$ and $2^{nd}$ visit in automated and manual measurement. Conclusion : The mean of two measurements and three measurements were significantly different. The change of blood pressure was different according to the method and interval of blood pressure measurement.

Effect of Pretreatment with Lactobacillus delbrueckii and Streptococcus thermophillus on Tailored Triple Therapy for Helicobacter pylori Eradication: A Prospective Randomized Controlled Clinical Trial

  • Tongtawee, Taweesak;Dechsukhum, Chavaboon;Leeanansaksiri, Wilairat;Kaewpitoon, Soraya;Kaewpitoon, Natthawut;Loyd, Ryan A;Matrakool, Likit;Panpimanmas, Sukij
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.16 no.12
    • /
    • pp.4885-4890
    • /
    • 2015
  • Background: Helicobacter pylori plays an important role in gastric cancer and typical eradication regimens are no longer effective in many countries, including Thailand. The aim of our study was to compare the effect of Lactobacillus delbrueckii and Streptococcus thermophillus on tailored triple therapy for Helicobacter pylori eradication. Materials and Methods: This prospective single-center study was conducted in Thailand. Helicobacter pylori associated gastritis patients were randomized to 2 groups: group 1 (n=100) was tailored triple therapy with placebo (esomeprazole 20 mg bid, clarithromycin 500 mg bid or metronidazole 400 mg tid if clarithromycin resistance and amoxicillin 1000 mg bid), and group 2 was tailored triple therapy plus pretreatment with probiotic containing yogurt. Successful eradication was defined as both negative histology and negative rapid urease test at four weeks after treatment. Results: A total of 200 infected patients were enrolled. PP analysis involved 194 patients: 96 in the tailored triple therapy with placebo group (group 1) and 98 the in tailored triple therapy plus pretreatment with probiotic containing yogurt group (group 2). Successful eradication was observed in 170 (87.6%) patients; by PP analysis, the eradication rate was significantly higher in group 2 (P = 0.04, 95%CI; 0.02-0.13) than in group 1. ITT analysis also showed that the value was significantly higher in the tailored triple threapy plus pretreatment with probiotic containing yogurt group (group 2) (89/100; 89%) than in the tailored triple therapy with placebo group (group 1) (P= 0.01, 95%CI; 0.04-0.15). In terms of adverse events, there was no significant difference between the two groups. Conclusions: Pretreatment with probiotic containing yogurt can improve Helicobacter pylori eradication rates with tailored triple therapy. Adding probiotics does not reduce adverse effects of the medication.

Relationship between Physical Function Factors and Discrimination Experiences of the Elderly in Korea: The 2014 and 2017 National Survey on Living Conditions and Welfare Needs of Korean Older Persons (우리나라 노인의 신체기능 요인과 차별경험의 관련성 연구: 노인실태조사(2014, 2017) 자료 분석)

  • Lee, Kyuhee;Yong, Wangshik;You, Changhoon;Lee, Yongjae;Chung, Woojin
    • Health Policy and Management
    • /
    • v.29 no.4
    • /
    • pp.454-468
    • /
    • 2019
  • Background: Supporting the elderly population is presented as a social issue, and it affects age discrimination, which forms a negative perception and avoids the elderly. Since age discrimination lowers the quality of life of the elderly and hinders social unity, it may be important to research related factors. This study examined the physical function as a factor that influences discrimination experiences and aimed to identify the relationship between physical function factors and discrimination experiences. Methods: In this study, we analyzed 20,225 elderly from the 2014 and 2017 survey of living conditions and welfare needs of Korean older persons, conducted nationwide among older than 65 years. Physical function factors are activities of daily living, instrumental activities of daily living, sight discomfort, hearing discomfort, chewing discomfort, and leg strength as factors of interest. We performed multivariable logistic regression that reflected survey characteristics, adjusting for socio-demographic factors, health related factors, and social-support factors. Results: The number of elderly who faced discrimination experiences was 1,175 (5.8%). The results showed that the odds ratio of facing a discrimination experience in the dependent group was significantly higher compared to the independent group when being transferring out of the room (4.05; 95% confidence interval [CI], 1.50-10.88) and difficulty in hearing (1.25; 95% CI, 1.05-1.49). Even with respect to chewing ability, which was significant in models 1 and 2, they face more discrimination experiences (1.30; 95% CI, 1.11-1.53). Conclusion: These research results indicate that an important strategy for preventing age discrimination is to understand the physical function conditions of the elderly and promote the physical functions of the elderly related to transferring, hearing, and chewing; it is necessary to develop a practical intervention plan that considers these aspects.

Association between Arthritis and Socio-Demographic Factors in Korean Elderlies: The National Survey of Korean Elderly (2014, 2017) Dataset Analysis (우리나라 노인의 관절염 유병과 인구사회적 요인의 관련성: 노인실태조사(2014, 2017) 자료 분석)

  • Ha, Woonkyung;Park, Kwankyu;Kim, Taehyun;Lee, Kyuhee;Lee, Yongjae;Chung, Woojin
    • Health Policy and Management
    • /
    • v.29 no.4
    • /
    • pp.469-481
    • /
    • 2019
  • Background: As South Korea is becoming an aged society very rapidly, the increase in osteoarthritis prevalence raises various public health issues in this country. This study aimed to explore the socio-demographic factors associated with osteoarthritis in the current Korean elderlies. Methods: Using the National Survey of Korean Elderly data (2014, 2017), we analyzed 20,326 elderlies (males, 8,248; females, 12,078) and conducted multivariate logistic regression analyses by sex. The dependent variable is whether a participant was diagnosed with osteoarthritis or not. Independent variables of interest is socio-demographic factors such as age, marital status, household type, residential area, household income, religion, the longest job, the number of close relatives, the number of close friends, and survey year. Control variables are various health behavioral factors and disease-related factors. Results: Prevalence of osteoarthritis was 19.2% in male elderlies and 47.0% in female elderlies. According to the results of the multivariate logistic regression adjusted for all studied control variables, the odds ratio (OR) for having osteoarthritis of under-elementary school graduates (their counterpart was college graduate group) was 1.81 (95% confidence interval [CI], 1.29-2.52) in males and 1.67 (95% CI, 1.12-2.47) in females. The OR of those having a job in agriculture & forestry fishery as their longest job (their counterpart was those who had never participated in labor force during their lifetime) was 5.07 (95% CI, 1.46-17.58) in males and 1.49 (95% CI, 1.27-1.74) in females. In males, the second-low quartile group in household yearly income (their counterpart was the highest quartile group) had the OR of 1.22 (95% CI, 0.98-1.53). In females, the OR of those having a religion of Buddhism (their counterpart was those having no religion) was 1.20 (95% CI, 1.07-1.35) and the OR of those who had no relatives (their counterpart was those having more than 3 close relatives) was 1.31 (95% CI, 1.10-1.56). Conclusion: This study found that in Korean elderlies, education, the longest job, household income, religion, and the number of close relatives are associated with their suffering from osteoarthritis. Further study and designing appropriate interventions are needed to alleviate current and future individual and socioeconomic burdens of osteoarthritis in an aged society like South Korea.

Development of a standardized mucositis and osteoradionecrosis animal model using external radiation

  • Seo, Mi Hyun;Lee, Min Young;Eo, Mi Young;Lee, Suk Keun;Woo, Kyung Mi;Kim, Soung Min
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
    • /
    • v.46 no.4
    • /
    • pp.240-249
    • /
    • 2020
  • Objectives: Although the side effects of radiation therapy vary from mucositis to osteomyelitis depending on the dose of radiation therapy, to date, an experimental animal model has not yet been proposed. The aim of this study was to develop an animal model for assessing complications of irradiated bone, especially to quantify the dose of radiation needed to develop a rat model. Materials and Methods: Sixteen Sprague-Dawley rats aged seven weeks with a mean weight of 267.59 g were used. Atraumatic extraction of a right mandibular first molar was performed. At one week after the extraction, the rats were randomized into four groups and received a single dose of external radiation administered to the right lower jaw at a level of 14, 16, 18, or 20 Gy, respectively. Clinical alopecia with body weight changes were compared and bony volumetric analysis with micro-computed tomography (CT), histologic analysis with H&E were performed. Results: The progression of the skin alopecia was different depending on the irradiation dose. Micro-CT parameters including bone volume, bone volume/tissue volume, bone mineral density, and trabecular spaces, showed no significant differences. The progression of osteoradionecrosis (ORN) along with that of inflammation, fibrosis, and bone resorption, was found with increased osteoclast or fibrosis in the radiated group. As the radiation dose increases, osteoclast numbers begin to decrease and osteoclast tends to increase. Osteoclasts respond more sensitively to the radiation dose, and osteoblasts are degraded at doses above 18 Gy. Conclusion: A standardized animal model clinically comparable to ORN of the jaw is a valuable tool that can be used to examine the pathophysiology of the disease and trial any potential treatment modalities. We present a methodology for the use of an experimental rat model that incorporates a guideline regarding radiation dose.

Sanguinarine Increases Sensitivity of Human Gastric Adenocarcinoma Cells to TRAIL-mediated Apoptosis by Inducing DR5 Expression and ROS Generation (AGS 인체 위암세포에서 DR5의 발현 및 ROS 생성의 증가를 통한 sanguinarine과 TRAIL 혼합처리의 apoptosis 유도 활성 촉진)

  • Lee, Taek Ju;Im, Yong Gyun;Choi, Woo Young;Choi, Sung Hyun;Hwang, Won Deok;Choi, Yung Hyun
    • Journal of Life Science
    • /
    • v.24 no.9
    • /
    • pp.927-934
    • /
    • 2014
  • Sanguinarine, a benzophenanthridine alkaloid originally derived from the root of Sanguinaria canadensis, has been shown to possess antimicrobial, antioxidant, and anti-cancer properties. Although tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) is known to induce apoptosis in cancer cells, but not most normal cells and has shown efficacy in a phase 2 clinical trial, development of resistance to TRAIL by tumor cells is a major roadblock. Our previous study indicated that treatment with TRAIL in combination with subtoxic concentrations of sanguinarine sensitized TRAIL-mediated apoptosis in TRAIL-resistant human gastric carcinoma AGS cells; however, the detailed mechanisms are not fully understood. In this study, we show that sanguinarine sensitizes AGS cells to TRAIL-mediated apoptosis as detected by MTT assay, agarose gel electrophoresis, chromatin condensation and flow cytometry analysis. Combined treatment with sanguinarine and TRAIL effectively induced expression of death receptor (DR) 5 but did not affect expression of DR4 and mitogen activated protein kinases signaling molecules. Moreover, the combined treatment with sanguinarine and TRAIL increased the generation of reactive oxygen species (ROS); however, N-acetylcysteine, ROS scavenger, significantly recovered growth inhibition induced by the combined treatment. Taken together, our results indicate that sanguinarine can potentiate TRAIL-mediated apoptosis through upregulation of DR5 expression and ROS generation.

Comparison of the Change in the Prevalence and Intensity of Schistosoma haematobium Infection Between High and Low Prevalence Areas of White Nile State, Sudan

  • Cha, Seungman;Hong, Sung-Tae;Lee, Jin-Su;Jeong, Hoo Gn;Kwon, In-Sun;Saed, Abd Al Wahab;Elhag, Mousab Siddig;Ismail, Hassan Ahmed Hassan Ahmed;Amin, Mutamad;Lee, Young-Ha
    • Parasites, Hosts and Diseases
    • /
    • v.58 no.4
    • /
    • pp.421-430
    • /
    • 2020
  • This study aimed to investigate whether mass drug administration (MDA) intervention has an equivalent effect on reducing the prevalence and intensity of Schistosoma haematobium infection regardless of the baseline values. A repeated cross-sectional survey was performed targeting students of 12 primary schools in Al Jabalain and El Salam districts of White Nile State, Sudan, at both 1 week before and 8 months after the MDA. Prior to the baseline survey, schoolaged children in Al Jabalain had received MDA interventions twice in 4 years, while those in El Salam had not. The baseline prevalence was 9.1% in Al Jabalain and 35.2% in El Salam, which were reduced to 1.8% and 5.5% at 8 months after the MDA, respectively. The corresponding reduction rates were 80.3% and 84.4%, not significant difference between both districts. However, changes in the geometric mean intensity (GMI) of egg counts were significantly different between both districts. The baseline GMIs were 14.5 eggs per 10 ml of urine (EP10) in Al Jabalain and 18.5 EP10 in El Salam, which were reduced to 7.1 and 11.2 EP10 after treatment, respectively. The corresponding reduction rates were 51.0% and 39.5%. In conclusion, MDA interventions were found to bring about similar relative reduction in prevalence regardless of the baseline value; however, the relative reduction in infection intensity was more salient in the district with a low baseline value for both prevalence and intensity. This clearly points to the importance of repeated MDA interventions in endemic areas, which will eventually contribute to schistosomiasis elimination.

Study on Application of Skin Care Cosmetic and Stabilization of Idebenone by Forming Niosome Vesicle Technology

  • Kim, In-Young
    • Journal of the Korean Applied Science and Technology
    • /
    • v.36 no.2
    • /
    • pp.592-599
    • /
    • 2019
  • This study is to stabilize insoluble and unstable active ingredient which is Idebenone (INCI name: hydroxydecyl ubiquinone) in a multi-lamellar vesicle (MLV) and to stabilize it in the skin care cosmetics. Idebenone is good effective raw material in the treatment of Alzheimer's disease in the medical field and a powerful antioxidant in dermatology. It is well known as a substance that inhibits the formation of melanin and cleans the skin pigment. However, it did not dissolve in any solvent and it was difficult to apply in cosmetic applications. Niosome vesicle was able to develop a nano-particle by making a multi-layer of idebenone encapsulated with a nonionic surfactant, hydrogenated lecithin and glycine soja (soybean) sterols and passing it through a high pressure microfluidizer. Idebenone niosome vesicle (INV) has been developed to have the ability to dissolve transparently in water and to promote transdermal penetration. The appearance of the INV was a yellowish liquid having specific odor, and the particle size distribution of INV was about 10~80 nm. The pH was 5~8 (mean=6.8). This capsulation with idebenone was stored in a $45^{\circ}C$ incubator for 3 months and its stability was observed and quantitatively measured by HPLC. As a result, the stability of the sample encapsulated in the niosome vesicle (97.5%) was about 66.3% higher than that of the non-capsule sample of 32.5%. Idebenone 1% INV was used for the efficacy test and clinical trial evaluation as follows. The anti-oxidative activity of INV was 38.2%, which was superior to that of 12.8% tocopherol (control). The melanin-reducing effect of B16 melanoma cells was better than INV (17.4%) and Albutin (control) (9.6%). Pro-collagen synthesis rate was 128.2% for INV and 89.3% for tocopherol (control). The skin moisturizing effect was 15.5% better than the placebo sample. The elasticity effect was 9.7% better than the placebo sample. As an application field, INV containing 1% of idebenone is expected to be able to develop various functional cosmetic formulations such as skin toner, ampoule essence, cream, eye cream and sunblock cream. In addition, it is expected that this encapsulated material will be widely applicable to emulsifying agents for skin use in the pharmaceutical industry as well as the cosmetics industry.