• Title/Summary/Keyword: Clinical Trials

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The influence of magnet on tissue healing after immediate implantation in fresh extraction sites in dogs (성견에서 발치 후 즉시 식립 임플란트에 설치한 자석이 주위 조직에 미치는 영향)

  • Yu, Seok-Min;Cho, In-Ho;Shin, Soo-Yeon
    • The Journal of Korean Academy of Prosthodontics
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    • v.47 no.4
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    • pp.435-444
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    • 2009
  • Statement of problem: The clinical use of electric and electomagnetic fields for fracture healing applications began in the early 1970s. Since then, several technologies have been developed and shown to promote healing of fractures. Developments of these devices have been aided in recent years by basic research and several well controlled clinical trials not only in the medical field but in dentistry. Purpose: The purpose of this study was to compare alveolar bone reduction following immediate implantation using implants onto which magnets were attached in fresh extracted sockets. Material and methods: Four mongrel dogs were involved. Full buccal and lingual mucoperiosteal flaps were elevated and third and fourth premolars of the mandible were removed. Implants with magnets and implants without magnets were installed in the fresh extracted sockets and after 3 months of healing the animals were sacrificed. The mandibles were dissected and each implant sites were sampled and processed for histological examination. Results: The marginal gaps that were present between the implant and walls of the sockets at the implantation stage disappeared in both groups as a result of bone fill and resorption of the bone crest. The buccal bone crests were located apical of its lingual counterparts. At the 12 week interval the mean of marginal bone resorption in the control group was significantly higher than that of the magnet group. The majority of specimens in magnet group presented early bone formation and less resorption of the buccal marginal bone compared to the control group. Conclusion: Within the limitations of this study, it could be concluded that implants with magnets attached in the early stages of implantation may provide more favorable conditions for early bone formation and reduce resorption and remodeling of marginal bone.

Study for the Synthesis of $[^{123}I]$Idoxifene and Its Uptake in the Breast Cancer Cell ($[^{123}I]$Idoxifene 합성과 유방암의 세포섭취에 관한 연구)

  • Cho, Young-Sub;Yang, Seung-Dae;Suh, Yong-Sup;Chun, Kwon-Soo;Ahn, Soon-Hyuk;Lim, Soo-Jung;Lim, Sang-Moo;Yu, Kook-Hyun
    • The Korean Journal of Nuclear Medicine
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    • v.34 no.5
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    • pp.410-417
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    • 2000
  • Purpose: Idoxifene is currently entering phase II clinical trials for the treatment of advanced breast cancer. The radiolabeled idoxifene using $[^{123}I]$ provides an opportunity for clinical pharmacology with single photon emission computed tomography (SPECT). The purpose of this study was to prepare radiolabeled idoxifene using $[^{123}I]$ and to determine its cell uptake of breast cancer cell line. Materials and Methods: With a view to evaluating new anticancer drugs, we are investigating the novel antiestrogen pyrrolidino-4-iodotamoxifen (idoxifene). $[^{123}I]$Idoxifene has been prepared in no-carrier-added form using a tributyl stannylated precursor which has been synthesized by means of (2-chloroethoxy)benzene with (${\pm}$)-2-phenylbutanoic acid on the basis of previously reported standard methods. The biodistribution and dynamic behavior of the compound were investigated using the comparative breast cancer cell line, MCF-7 (estrogen receptor-positive) and MDA-MB-468 (non-estrogen receptor). Results and Conclusion: Acylation of (2-chloroethoxy)benzene with (${\pm}$)-2-phenylbutanoic acid gave the versatile ketone (81%) which reacted with 1,4-diiodobenzene to give triphenylethylene as a mixture of E and Z geometric isomers, which were separated by the recrystallization in ethanol. The E-isomer was treated with pyrrolidine to give idoxifene (67%). In order to incorporate radioactive iodine into the 4-position, the 4-stannylated precursor was prepared (30%). The yield of radioiodination was 90-92% with a high radiochemical purity greater than 98%. The ratio of tumor uptake of the breast cancer cell line between MCF-7 and MDA-MB-468 was about 1.7.

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Radiotherapy Results of Uterine Cervix Cancer Stape IIB : Overall Survival, Prognostic factors, Patterns of Failure and Late Complications (자궁경부암 병기 IIB에서의 방사선 치료 성적: 생존율 및 예후인자, 치료 후 실패양상, 만성 합병증)

  • Kim Eun-Seog;Choi Doo-Ho;Huh Seung-Jae
    • Radiation Oncology Journal
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    • v.16 no.1
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    • pp.51-61
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    • 1998
  • Purpose : Treatment of choice for uterine cervix cancer stage IIB is radiotherapy. We analyzed survivals, Prognostic factors, patterns of failure and complications. Materials and Methods : This is a retrospective analysis of 167 patients with stage IIB carcinoma of uterine cervix treated with curative external pelvic and high dose rate intracavitary radiotherapy at the Department of Therapeutic Radiology, Soonchunhyang University Hospital from August 1985 to August 1994. All the patients followed up from 3 to 141 months(mean 60 months) and age of patients ranged from 31 to 78 years at presentation(mean : 55 years). Results : Overall complete response rate was $84\%$. The response rate for squamous cell carcimoma and adenocarcinoma were $86\%$ and $60\%$, respectively. Overall 5-years survival rate and disease free survival rate was 62 and $59\%$, respectively Mass size and treatment response were significant Prognostic factors for survival Pathologic type and parametrial involvement were marginally significants Prognostic factors. Local failure was 43 cases, distant metastasis was 14 cases and local failure plus distant metastasis was 3 cases, and most of local failures occurred within 24 months, distant metastasis within 12 months after treatment Twenty eight($16.8\%$) patients developed late rectal and urinary complications There were tendency to increasing severity and frequency according to increased fractional dose and total(rectal and bladder) dose. Conclusions : Survival rate was significantly related to tumor size and radiotherapy response. Tumor size should be considered in the clinical s1aging. To increased survival and local control, clinical trials such as decreasing duration of radiotherapy or addition of chemotherapy is needed. To detect early recurrence, regular follow up after RT is important. Because total rectal and bladder dose affected late complications. meticulous vaginal packing is needed to optimize dose of normal tissues and to decrease late complications.

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A Study on the Quality Control of Transvaginal Ultrasound Transducer using ATS-539 Ultrasound Phantom (ATS-539 초음파 팬텀을 이용한 경질 초음파 검사용 탐촉자의 정도관리에 대한 연구)

  • Park, Ji Hye;Heo, Yeong Cheol;Kim, Yon min;Han, Dong Kyoon
    • Journal of the Korean Society of Radiology
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    • v.15 no.4
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    • pp.463-472
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    • 2021
  • Demand for examinations using transvaginal transducer with high frequencies is increasing to observe pelvic organs in gynecological ultrasound tests. However, the quality control of the replacement probe in clinical trials is not properly implemented and the evaluation criteria have not been established. Therefore, 58 transvaginal transducers and 20 convex transducers were applied to the ATS-539 ultrasound phantom for 20 ultrasound devices currently in clinical use to obtain their respective images and measure them quantitatively and qualitatively. For quantitative measurements, vertical measurement, horizontal measurement, and focal zone and qualitative measurements, dead zone, axial·lateral resolution, sensitivity, functional resolution, gray scale·dynamic range were performed. Quantitative statistical analysis showed significant differences between the two transducers in the lateral measurement and local area (p<0.05). qualitative comparative analysis showed differences in sensitivity and functional resolution. This occurs due to the difference in frequency between transducers and the transducer's injection geometry. Based on the above experiments, the tolerance for horizontal measurement is raised to 10% (±8 mm), the tolerance for sensitivity is observed up to 6 cm deep, which is 12 cm deep,which is the level of the third quartile (75%). The permissible range of functional resolution is up to 6 (12 cm), 6 (12 cm), 11 (11 cm), 9 (9 cm), 6 (6 cm) target, which is the level of the third quartile (75%). It is considered reasonable to adjust the depth of targets in gray scale·dynamic range to measure at a depth of 2 cm, which is 50% of the depth of 4 cm. As above, the criteria for evaluating the quality of transvaginal transducer for use in the past have been proposed and it is expected that this study will be used as a basic data for the production of phantom exclusively for transvaginal transducer in the future.

Neurotechnologies and civil law issues (뇌신경과학 연구 및 기술에 대한 민사법적 대응)

  • SooJeong Kim
    • The Korean Society of Law and Medicine
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    • v.24 no.2
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    • pp.147-196
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    • 2023
  • Advances in brain science have made it possible to stimulate the brain to treat brain disorder or to connect directly between the neuron activity and an external devices. Non-invasive neurotechnologies already exist, but invasive neurotechnologies can provide more precise stimulation or measure brainwaves more precisely. Nowadays deep brain stimulation (DBS) is recognized as an accepted treatment for Parkinson's disease and essential tremor. In addition DBS has shown a certain positive effect in patients with Alzheimer's disease and depression. Brain-computer interfaces (BCI) are in the clinical stage but help patients in vegetative state can communicate or support rehabilitation for nerve-damaged people. The issue is that the people who need these invasive neurotechnologies are those whose capacity to consent is impaired or who are unable to communicate due to disease or nerve damage, while DBS and BCI operations are highly invasive and require informed consent of patients. Especially in areas where neurotechnology is still in clinical trials, the risks are greater and the benefits are uncertain, so more explanation should be provided to let patients make an informed decision. If the patient is under guardianship, the guardian is able to substitute for the patient's consent, if necessary with the authorization of court. If the patient is not under guardianship and the patient's capacity to consent is impaired or he is unable to express the consent, korean healthcare institution tend to rely on the patient's near relative guardian(de facto guardian) to give consent. But the concept of a de facto guardian is not provided by our civil law system. In the long run, it would be more appropriate to provide that a patient's spouse or next of kin may be authorized to give consent for the patient, if he or she is neither under guardianship nor appointed enduring power of attorney. If the patient was not properly informed of the risks involved in the neurosurgery, he or she may be entitled to compensation of intangible damages. If there is a causal relation between the malpractice and the side effects, the patient may also be able to recover damages for those side effects. In addition, both BCI and DBS involve the implantation of electrodes or microchips in the brain, which are controlled by an external devices. Since implantable medical devices are subject to product liability laws, the patient may be able to sue the manufacturer for damages if the defect caused the adverse effects. Recently, Korea's medical device regulation mandated liability insurance system for implantable medical devices to strengthen consumer protection.

Low Dose Cisplatin as a Radiation Sensitizer in Management of Locally Advanced Scluamous Cell Carcinoma of the Uterine Cervix : Evaluation of Acute Toxicity and Early Response (국소 진행된 자궁경부암의 방사선치료와 저용량 cisplatin 항암요법 동시치료시 급성독성 밀 초기반응 평가)

  • Kim Hunjung;Cho Young Kap;Kim Chulsu;Kim Woo Chul;Lee Sukho;Loh J K
    • Radiation Oncology Journal
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    • v.17 no.2
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    • pp.113-119
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    • 1999
  • Purpose : To evaluate possible acute toxicity and early response of concurrent radiation therapy and low dose daily cisplatin as a radiosensitizer in patients with locally advanced uterine cervical carcinomas. Materials and Method : From December 1996 to January 1999, 38 previously untreated Patients with locally advanced squamous cell carcinoma of the uterine cervix (from stage IIB to stage IIIB) were treated at Inha University Hospital. All patients underwent standard pretreatment staging Procedures after the initial evaluation by gynecologists and radiation oncologists. Sixteen Patients with huge cervical mass (>4 cm) were submitted to the group treated with concurrent radiation therapy and low dose daily cisplatin while the remainder was treated with radiation therapy alone. Radiation therapy consisted of 4500 cGy external beam irradiation to whole pelvis (midline block after 3000 cGy), 900$\~$1000 cGy boost to involved parametrium, and high dose-rate intracavitary brachytherapy (a total dose of 3000$\~$3500 cGy/500 cGy per fraction to point A, twice per week). In the group treated with low dose cisplatin concurrently, 10 mg of daily intravenous cisplatin was given from the 1st day of radiation therapy to the 20th day of radiation therapy. Acute toxicity was measured according to expanded common toxicity criteria of the NCI (C) Clinical Trials. Early response data were analyzed at minimum 4 weeks' follow-up after completion of the treatment protocol. Results: Hematolgic toxici쇼 was more prominent in patients treated with radiation therapy and cisplatin. Six of 16 patients (37.5$\~$) treated with radiation therapy and cisplatin and one of 22 patients (4.5$\~$) treated with radiation therapy alone experienced grade 3 leukopenia. In Fisher's exact test, there was statistically significant difference between two groups regarding leukopenia (P=0.030). There was no apparent difference in the frequency of gastrointestinal and genitourinary toxicity between two groups (P=0.066). Three of 16 patients (18.7$\~$) treated with radiation therapy and cisplatin and two of 22 patients (9.1$\~$) treated with radiation therapy alone experienced more than 5 kg weight loss during the treatment. There was no statistically significant difference on weight loss between two groups (P=0.63). Two patients on each group were not evaluable for the early response because of incomplete treatment. The complete response rate at four weeks' follow-up was 80$\~$(16/20) for the radiation therapy alone group and 78$\~$ (11/14) for the radiation therapy and cisplatin group. There was no statistically significant difference in early response between two treatment groups (P=0.126). Conclusion : This study led to the conclusion that the hematologic toxicity from the treatment with concurrent radiation therapy and low dose daily cisplatin seems to be more prominent than that from the treatment of radiation therapy alone. There was no grade 4 hematologic toxicity or mortality in both groups. The hematologic toxicity in both treatment groups seems to be well managable modically. Since the risk factors were not balanced between two treatment groups, the direct comparison of early response of both groups was not possible. However, preliminary results regarding early response for patients with bulky cervical tumor mass treated with radiation therapy and low dose daily cisplatin was encouraging. Longer follow-up is necessary to evaluate the survival data. A phase III study is needed to evaluate the efficacy of concurrent daily low dose cisplatin with radiation therapy in bulky cervical cancer.

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The Ability of Anti-tumor Necrosis Factor Alpha(TNF-${\alpha}$) Antibodies Produced in Sheep Colostrums

  • Yun, Sung-Seob
    • 한국유가공학회:학술대회논문집
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    • 2007.09a
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    • pp.49-58
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    • 2007
  • Inflammatory process leads to the well-known mucosal damage and therefore a further disturbance of the epithelial barrier function, resulting abnormal intestinal wall function, even further accelerating the inflammatory process[1]. Despite of the records, etiology and pathogenesis of IBD remain rather unclear. There are many studies over the past couple of years have led to great advanced in understanding the inflammatory bowel disease(IBD) and their underlying pathophysiologic mechanisms. From the current understanding, it is likely that chronic inflammation in IBD is due to aggressive cellular immune responses including increased serum concentrations of different cytokines. Therefore, targeted molecules can be specifically eliminated in their expression directly on the transcriptional level. Interesting therapeutic trials are expected against adhesion molecules and pro-inflammatory cytokines such as TNF-${\alpha}$. The future development of immune therapies in IBD therefore holds great promises for better treatment modalities of IBD but will also open important new insights into a further understanding of inflammation pathophysiology. Treatment of cytokine inhibitors such as Immunex(Enbrel) and J&J/Centocor(Remicade) which are mouse-derived monoclonal antibodies have been shown in several studies to modulate the symptoms of patients, however, theses TNF inhibitors also have an adverse effect immune-related problems and also are costly and must be administered by injection. Because of the eventual development of unwanted side effects, these two products are used in only a select patient population. The present study was performed to elucidate the ability of TNF-${\alpha}$ antibodies produced in sheep colostrums to neutralize TNF-${\alpha}$ action in a cell-based bioassay and in a small animal model of intestinal inflammation. In vitro study, inhibitory effect of anti-TNF-${\alpha}$ antibody from the sheep was determined by cell bioassay. The antibody from the sheep at 1 in 10,000 dilution was able to completely inhibit TNF-${\alpha}$ activity in the cell bioassay. The antibodies from the same sheep, but different milkings, exhibited some variability in inhibition of TNF-${\alpha}$ activity, but were all greater than the control sample. In vivo study, the degree of inflammation was severe to experiment, despite of the initial pilot trial, main trial 1 was unable to figure out of any effect of antibody to reduce the impact of PAF and LPS. Main rat trial 2 resulted no significant symptoms like characteristic acute diarrhea and weight loss of colitis. This study suggested that colostrums from sheep immunized against TNF-${\alpha}$ significantly inhibited TNF-${\alpha}$ bioactivity in the cell based assay. And the higher than anticipated variability in the two animal models precluded assessment of the ability of antibody to prevent TNF-${\alpha}$ induced intestinal damage in the intact animal. Further study will require to find out an alternative animal model, which is more acceptable to test anti-TNF-${\alpha}$ IgA therapy for reducing the impact of inflammation on gut dysfunction. And subsequent pre-clinical and clinical testing also need generation of more antibody as current supplies are low.

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Effect of Ratio of Demineralized Bone Powder with Alginate Microcapsules on Articular Cartilage Regeneration (탈미네랄 골분이 비율별로 포접된 알지네이트 미세캡슐을 이용한 조직공학적 연골재생)

  • Kim, A Ram;Kim, Hye Min;Lee, Jung Keun;Lee, Ji Hye;Song, Jeong Eun;Yoon, Kun Ho;Lee, Dongwon;Khang, Gilson
    • Polymer(Korea)
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    • v.36 no.6
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    • pp.768-775
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    • 2012
  • Alginate, obtained from the seaweeds, is a widely used biomaterial for cell transplantation, since its positive effect on viability of capsulized cells and its easier encapsulation capability of living cells. Demineralized bone powder (DBP), derived from the natural bone tissue, is widely applied for clinical trials for its low rate of reaction and antigenicity. A chondrocyte was seeded into an alginate with DBP of different contents, and a microcapsule was produced. The adhesion and proliferation of cells was observed through the MTT analysis, and the PCR was applied to estimate the content of the glycosaminoglycan (sGAG) and collagen, and confirm the specific genetic pattern of the chondrocytes. Also, the alginate microcapsule where the chondrocyte is seeded was extracted after transplantation under the skin of a nude mouse, and was immunochemically stained. The experimental result confirmed that the alginate microcapsule containing 1% of DBP not only showed the highest proliferation of cell but had a positive effect of chondrocytes by the interaction between the alginates and the growth factor in DBP. It can be expected that the microcapsule with application of the alginates and DBP might be an appropriate scaffold for tissue engineering.

Research on prescription candidates for Parkinson's disease in 『Dongeuibogam』 (『동의보감(東醫寶鑑)』에 수록된 파킨슨병 치료 처방(處方) 후보군 선별 연구)

  • Hwang, Min-Seob;Park, Hye-Jin;Kim, Si-Won;Baek, Jin-Ung
    • Herbal Formula Science
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    • v.26 no.1
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    • pp.65-80
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    • 2018
  • Objectives : This study aims to sort out prescription candidates for four major symptoms of Parkinson's disease from Korean traditional medical publication, "Dongeuibogam". Methods : Medical terms related to four major symptoms of Parkinson's disease were primarily selected from "Dongeuibogam". Prescriptions that include at least one or more medical terms which are selected above were classified by the four major symptoms of Parkinson's disease, and finally analyzed to sort the most effective candidates. Results & Conclusions : 1. There are 18 medical terms in efficacy ($ch{\grave{i}}$ $z{\grave{o}}ng$, $j{\bar{u}}$ $lu{\acute{a}}n$, $j{\bar{i}}ng$${\check{u}}$ $ju{\check{a}}n$($ju{\check{a}}n$, $qu{\acute{a}}n$) $lu{\acute{a}}n$, $j{\bar{i}}ng$${\check{u}}$ $lu{\acute{a}}n$($lu{\acute{a}}n$) $t{\grave{o}}ng$, $j{\bar{i}}n$ $lu{\acute{a}}n$, $j{\bar{i}}n$ $t{\grave{i}}$, $sh{\check{o}}u$ $zh{\grave{e}}n$, $y{\acute{a}}ng$ $sh{\check{o}}u$, $lu{\acute{a}}n$ $j{\acute{i}}$, $lu{\acute{a}}n$ $b{\grave{i}}$, $r{\grave{o}}u$ $r{\acute{u}}n$, $zh{\grave{a}}n$ $di{\grave{a}}o$, $zh{\grave{a}}n$ $y{\acute{a}}o$, $zh{\grave{i}}$ $z{\acute{u}}$, $ch{\grave{e}}$ $t{\grave{o}}ng$, $ch{\bar{o}u}$ $ch{\grave{e}}$, $f{\bar{e}}ng$ $ch{\grave{u}}$, $ch{\grave{u}}$ $nu{\grave{o}}$) related to tremor, one of four major symptoms of Parkinson's disease. 2. There are 9 medical terms in efficacy ($qi{\acute{a}}ng$ $j{\acute{i}}$, $qi{\acute{a}}ng$ $zh{\acute{i}}$, $qi{\acute{a}}ng$ $t{\grave{o}}ng$, $j{\bar{u}}$ $j{\acute{i}}$, $j{\bar{i}}n$ $j{\acute{i}}$, $sh{\bar{e}}n$ $qi{\acute{a}}ng$, $lu{\acute{a}}n$ $j{\acute{i}}$, $y{\bar{a}}o$ $j{\acute{i}}$ $qi{\acute{a}}ng$, $xi{\grave{a}}ng$ $qi{\acute{a}}ng$) related to rigidity, one of four major symptoms of Parkinson's disease. 3. 38 prescription candidates (jiaweishouxingyuan, jiaweilonghusan, gehuajiexingtang, qiangfutang, qianghuoxuduantang, dawugongsan, duhuojishengtang, mahuangzuojingtang, fangfengbaizhumulitang, fangfengtongshengsan, baizhutang, buxinwan, fulingtang, binsusan, xieqingwan, sanbitang, shengdiqinliantang, shujinbaoansan, xingxiangsan, xiaotanfulingwan, shengjunwan, shenmizuojingtang, wuyaoshunqisan, yuzhenwan, wenjingyiyuantang, yiziqingjinsan, ziyinningshentang, shaoyaogancaotang, dingtongsan, zhushazhijiasan, cangzusan, chuanxiongfulingtang, tiedanyuan, choubaowan, duomingsan, xuanhusuosan, xuefengtang, huoluodan) were selected for tremor, one of the four major symptoms of Parkinson's disease. 4. 21 prescription candidates (qianghuoshengshitang, guizhiqianghuotang, guizhifuzitang, jiuweiqianghuotang(qianghuochonghetang), xiongzhixiangsusan, daqianghuotang, mahuangguizhitang, muguajian, fuzilizhongtang, shenzhusan, lianqiaobaidusan, yuzhensan, niuhuangjinhudan, renshenbaidusan, shaoyaogancaotang, jiuzhumuguazhou, cangzusan, shenxiangtianmatang, xiangjiaosan, xuefengtang, huishousan) were selected for rigidity, one of the four major symptoms of Parkinson's disease. 5. The results in this study ought to be verified by subsequent studies and clinical trials.

Anti-cancer Effects of Cultivated Orostachys japonicus on Human Colon Cancer Cell Line SW480 (인체대장암세포주 SW480에 대한 재배 와송의 항암효과 연구)

  • Park, Sookyoung;Won, Jinyoung;Park, Kanghui;Hong, Yonggeun
    • Journal of Life Science
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    • v.28 no.7
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    • pp.819-826
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    • 2018
  • Orostachys japonicus (OJ) is a medicinal herb with immunoregulatory, anti-aging, anti-oxidative, and many other therapeutic properties. The purpose of this study was to elucidate the anti-cancer property of cultivated OJ. SW480 cell viability was significantly reduced by cumulative exposure to OJ extract. We also observed inhibitory effects of OJ after 72 hr through the growth and migration of SW480 cells using scratch assay. SW480 cells in OJ-free medium began to move into the scratch site at 24 hr; however, cells in medium containing OJ did not migrate into the scratch site until 48 hr. Male C57BL/6 mice (4 weeks old) were orally administered OJ extract for 31 days before injection of SW480 cells. At 7, 14, and 28 days after subcutaneous injection of SW480 cells, tumor weight and volume were analyzed. The body weight of the OJ-treated group was continuously increased during administration of the OJ extract relative to the control group. Injection of SW480 cells caused a reduction in body weight in all groups; however, the OJ-treated group exhibited a significant increase in body weight after 14 days. Tumor weight and volume were lower in the OJ-treated group than in the control group after 28 days. Although these results suggest that OJ suppresses the proliferation and migration of human colon cancer cells, additional studies are required to provide preclinical evidence before launching clinical trials evaluating OJ as an anti-cancer biohealth product.