• 제목/요약/키워드: Clinical trial center

검색결과 696건 처리시간 0.031초

마우스 혈장과 조직에서의 doxorubicin 측정 HPLC-MS/MS 방법 (Validation of a HPLC MS/MS Method for Determination of Doxorubicin in Mouse Serum and its Small Tissues)

  • 박정선;김혜경;이혜원;이미현;김현기;채수완;채한정
    • 한국임상약학회지
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    • 제16권1호
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    • pp.23-27
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    • 2006
  • Doxorubicin (DXR) is a type of anti-cancer drug called an 'anthracycline glycoside', It works by impairing DNA synthesis, a crucial feature of cell division, and thus is able to target rapidly dividing cells. Doxorubicin is a very serious anti-cancer medication with definite potential to do great harm as well as great good. A liquid chromatography-tandem mass spectroscopy (LC-MS/MS) method was developed to identify and quantify DXR in small-volume biological samples. After the addition of internal standard (IS, $5{\mu}L\;of\;1{\mu}M/ml$ daunorubicin methanol solution) into the serum sample, the drug and IS were extracted by methanol. Following vortex for a 1min and centrifugation at 15,000g for 10 min the organic phase was transferred and evaporated under a vacuum. The residue was reconstituted with $350{\mu}L$ of mobile phase and $10{\mu}L$ was injected into C18 column with mobile phase composed of 0.05M ammonium acetate (0.1 M acetic acid adjusted to pH 3.5) and acetonitrile (40:60, v/v). The flow rate was kept constant at $350{\mu}L/min$. The ions were quantified in the multiple reaction mode (MRM), using positive ions, on a triple quadrupole mass spectrometer. The lower limits of quantification for Doxorubicin in plasma and small tissues were approximately 0.5 ng/mL and 0.5 ng/mL respectively. Intra- and inter-assay accuracy (% of nominal concentration) and precision (% CV) for all analytes were within 15%, respectively.

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Clinical Factors Influencing the Trial and Purchase of Bilateral Microphones with Contralateral Routing of Signal in Patients with Asymmetric Sensorineural Hearing Loss

  • Seong, Jeon;Yang, Seung Koo;Jang, Pilkeun;Lee, Sang-Yeon;Carandang, Marge;Choi, Byung-Yoon
    • Journal of Audiology & Otology
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    • 제24권1호
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    • pp.29-34
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    • 2020
  • Background and Objectives: Bilateral microphones with contralateral routing of signal (BiCROS) hearing aid is an option for hearing rehabilitation in individuals with asymmetric sensorineural hearing loss (ASNHL). The clinical factors influencing the trial and purchase of BiCROS were investigated. Subjects and Methods: We reviewed the medical records of 78 patients with ASNHL who were recommended to use BiCROS and analyzed the demographic and audiological factors influencing the trial and purchase of BiCROS. Results: Among the 78 patients, 52 (66.7%) availed of the free BiCROS trial and 21 (26.9%) purchased BiCROS. The mean pure tone audiometry (PTA) air conduction (AC) threshold of the better- and worse-hearing ears were 44.2±12.8 dB and 90.7±22.5 dB HL, respectively. The decision for trial or purchase of BiCROS was not influenced by age, sex, duration of hearing loss of the worse-hearing ear, or PTA AC threshold or speech discrimination score of both ears. The first and third quartiles of the PTA AC thresholds for the better-hearing ear of BiCROS buyers were 38.75 dB and 53.75 dB HL, respectively. The counterpart values for the worse-hearing ear were 72.50 dB and 118.75 dB HL, respectively. Conclusions: The clinical factors analyzed in this study were found to be irrelevant to the trial and purchase of BiCROS in patients with ASNHL. Nevertheless, the distribution range of the auditory thresholds of the subjects using BiCROS can be a useful basis for the counseling of patients with ASNHL and selection of candidates for BiCROS use.

소시호탕연조엑스의 단회 경구투여 후 안전성 평가에 대한 단일기관 연구 (Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study)

  • 안성후;박경태;염승룡;권영달;조혜영
    • 한방재활의학과학회지
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    • 제30권2호
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    • pp.153-164
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    • 2020
  • Objectives This study is designed to evaluate the safety of Soshihotang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times-screening, pre administration, post administration and follow up-during the whole trial. The incidence of all adverse effects are shown in percentage. The mean and standard deviation were used to to describe and summarize continuous data. To evalate the effectiveness of the intervention, data of blood tests was analyzed by Wilcoxon signed rank test or paired T-test (p<0.05). Results In the case of red blood cell, hemoglobin, hematocrit, neutrophils, protein, albumin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Soshihotang soft extract were considered to be safe for healthy male volunteers.

뇌졸중 후 우울증의 진단과 치료 (Diagnosis and Treatment of Poststroke Depression)

  • 김재민;신희영
    • 생물정신의학
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    • 제12권2호
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    • pp.89-97
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    • 2005
  • Depression is a frequently developed psychiatric symptom after stroke. Poststroke depression(PSD) causes not only psychological distress related to depression but also other disturbances in many areas such as cognitive function, activities of daily living and quality of life. Therefore, a comprehensive understanding of accurate detection and appropriate treatment of depression is mandatory in patients with stroke. This review focused on the current knowledge of PSD.

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Pharmacokinetic and Pharmacodynamic Modeling of a Proton Pump Inhibitor

  • Bae, Kyun-Seop;Jang, In-Jin
    • 대한약학회:학술대회논문집
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    • 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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    • pp.223-224
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    • 2002
  • Pharmacokinetic (PK) and pharmacodynamic (PD) study of a new reversible proton pump inhibitor (YH1885, Yuhan Pharmaceutical Co.) was done as a phase 1 clinical trial in Seoul national University Hospital Clinical trialcenter. Single dose of 60, 100, 150, 200, and 300mg were administered to total 20 healthy subjects under fasting state. Six subjects were given 100 mg after food and 12 subjects were given multiple doses of 150 and 300 mg every day for 7 days under fasting state. (omitted)

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메트포르민의 사용과 위암 발생 (The Metformin Use and Gastric Cancer Risk)

  • 김영일
    • Journal of Digestive Cancer Reports
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    • 제8권2호
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    • pp.97-101
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    • 2020
  • Metformin is a widely used first-line anti-diabetic drug worldwide. Epidemiologic studies using the large population-based cohort database have shown the association between metformin uses and reduced risk of various type cancers including gastric cancer. In the gastric cancer prevention, metformin use was associated with the significant reduction of gastric cancer risk, especially for long-term metformin users. However, there is no well-designed randomized controlled clinical trial investigating the effect of metformin as a chemopreventive drug for gastric cancer. Therefore, further well-designed clinical trials will be needed to implement metformin for chemoprevention of gastric cancer.

The Effect of GCSB-5 a New Herbal Medicine on Changes in Pain Behavior and Neuroglial Activation in a Rat Model of Lumbar Disc Herniation

  • Cho, Hee Kyung;Kim, So-Yeon;Choi, Mi Jung;Baek, Seung Ok;Kwak, Sang Gyu;Ahn, Sang Ho
    • Journal of Korean Neurosurgical Society
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    • 제59권2호
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    • pp.98-105
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    • 2016
  • Objective : Lumbar disc herniation can induce sciatica by mechanical compression and/or chemical irritation. The aim of this study was to compare the effects of GCSB-5 (Shinbaro$^{(R)}$) and NSAIDs on pain-related behavior and on the expressions of microglia, astrocytes, CGRP, TRPV1, IL-6, and CX3CL1 in a rat model of lumbar disc herniation. Methods : 112 male Sprague-Dawley rats underwent implantation of nucleus pulposus to a dorsal root ganglion (DRG). Rats were divided into five groups as follows; a saline group (the vehicle control group) (n=27), a 10 mg/kg aceclofenac group (the aceclofenac group) (n=22), and 100, 300 or 600 mg/kg GCSB-5 groups (the GCSB-5 100, 300, or 600 groups) (n=21 for each group). Rats were tested for mechanical allodynia at 3 days after surgery and at 1 day, 3 days, 7 days, 14 days, 21 days, 28 days, 35 days, 42 days, 49 days, and 56 days after treatment commencement. Immunohistochemical staining of microglia (Iba1), astrocytes (GFAP), CGRP, and TRPV1, and PCR for IL-6 and CX3CL1 were performed on spinal dorsal horns and DRGs at 56 days after medication commencement. Results : After 56 days of GCSB-5 300 administration, mechanical withdrawal thresholds were significantly increased (p<0.05), and immunohistochemical expressions of Iba1, GFAP, CGRP, and TRPV1 were reduced than other groups, but this difference was not statistically significant. Conclusion : These results indicate GCSB-5 reduces mechanical allodynia and downregulates neuroglial activity and the expressions of CGRP and TRPV1 in the spinal segments of a rat model of lumbar disc herniation.

Preoperative imaging of the inferior alveolar nerve canal by cone-beam computed tomography and 1-year neurosensory recovery following mandibular setback through bilateral sagittal split ramus osteotomy: a randomized clinical trial

  • Hassani, Ali;Rakhshan, Vahid;Hassani, Mohammad;Aghdam, Hamidreza Mahaseni
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제46권1호
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    • pp.41-48
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    • 2020
  • Objectives: One of the most common complications of bilateral sagittal split ramus osteotomy (BSSRO) is neurosensory impairment of the inferior alveolar nerve (IAN). Accurate preoperative determination of the position of the IAN canal within the mandible using cone-beam computed tomography (CBCT) is recommended to prevent IAN dysfunction during BSSRO and facilitate neurosensory improvement after BSSRO. Materials and Methods: This randomized clinical trial consisted of 86 surgical sites in 43 patients (30 females and 13 males), including 21 cases (42 sides) and 22 controls (44 sides). Panoramic and lateral cephalographs were obtained from all patients. In the experimental group, CBCT was also performed from both sides of the ramus and mandibular body. Neurosensory function of the IAN was subjectively assessed using a 5-point scale preoperatively and 7 days, 1 month, 3 months, 6 months, and 12 months post-surgery. Data were analyzed using Fisher's test, Spearman's test, t-test, linear mixed-model regression, and repeated-measures ANCOVA (α=0.05, 0.01). Results: Mean sensory scores in the control group were 1.57, 2.61, 3.34, 3.73, and 4.20 over one year and were 1.69, 3.00, 3.60, 4.19, and 4.48 in the CBCT group. Significant effects were detected for CBCT intervention (P=0.002) and jaw side (P=0.003) but not for age (P=0.617) or displacement extent (P=0.122). Conclusion: Preoperative use of CBCT may help surgeons to practice more conservative surgery. Neurosensory deficits might heal faster on the right side.