• Title/Summary/Keyword: Clinical trial center

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A Case of Idiopathic Basal Ganglia Calcification with Dementia (치매가 동반된 특발성 기저핵 석회화 1례)

  • Shin, Hee-Young;Shin, Il-Seon
    • Korean Journal of Biological Psychiatry
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    • v.13 no.1
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    • pp.38-42
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    • 2006
  • The case of a 66- year-old woman with coexisting idiopathic basal ganglia calcification(IBGC) and dementia was presented. The calcification was detected in bilateral basal ganglia, dentate nucleus, and thalamus by brain imaging. Serum calcium and phosphorus levels were normal. The underlying diseases of calcification of basal ganglia such as parathyroid dysfunction and other infectious, toxic, or metabolic illness were excluded. The patient had memory impairment and frontal executive dysfunction without aphasia, agnosia, apraxia, and visuospatial impairment in neuropsychological test. It suggested that the cognitive impairment might be due to the dysfunction of frontal-subcortical circuit.

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Long-term cosmesis following a novel schedule of accelerated partial breast radiation in selected early stage breast cancer: result of a prospective clinical trial

  • Sayan, Mutlay;Hard, Daphne;Wilson, Karen;Nelson, Carl;Gagne, Havaleh;Rubin, Deborah;Heimann, Ruth
    • Radiation Oncology Journal
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    • v.35 no.4
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    • pp.325-331
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    • 2017
  • Purpose: There is controversy regarding the cosmetic outcome after accelerated partial breast radiation (APBR). We report the cosmetic outcome from a single-arm prospective clinical trial of APBR delivered using intensity-modulated radiation therapy (IMRT) in elderly patients with stage I breast cancer (BC), using a novel fractionation schedule. Materials and Methods: Forty-two patients aged ${\geq}65$, with Stage I BC who underwent breast-conserving surgery were enrolled in a phase I/II study evaluating a 2-week course of APBR. Thirty eligible patients received 40 Gy in 4 Gy daily fractions. Cosmetic outcome was assessed subjectively by physician/patient and objectively by using a computer program (BCCT.core) before APBR, during, and after completion of the treatment. Results: The median age was 72 years, the median tumor size was 0.8 cm, and the median follow-up was 50.5 months. The 5-year locoregional control in this cohort was 97% and overall survival 87%. At the last follow-up, patients and physicians rated cosmesis as 'excellent' or 'good' in 100% and 91 %, respectively. The BCCT.core program scored the cosmesis as 'excellent' or 'good' in 87% of the patients at baseline and 81% at the last follow-up. The median $V_{50}$ (20 Gy) of the whole breast volume (WBV) was 37.2%, with the median WBV $V_{100}$ (40 Gy) of 10.9%. Conclusion: An excellent rate of tumor control was observed in this prospective trial. By using multiple assessment techniques, we are showing acceptable cosmesis, supporting the use of IMRT planned APBR with daily schedule in elderly patients with early stage BC.

Carboxypeptidase E Is a Novel Modulator of RANKL-Induced Osteoclast Differentiation

  • Kim, Hyun-Ju;Hong, JungMin;Yoon, Hye-Jin;Yoon, Young-Ran;Kim, Shin-Yoon
    • Molecules and Cells
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    • v.37 no.9
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    • pp.685-690
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    • 2014
  • Osteoclasts are large polykaryons that have the unique capacity to degrade bone and are generated by the differentiation of myeloid lineage progenitors. To identify the genes involved in osteoclast development, we performed microarray analysis, and we found that carboxypeptidase E (CPE), a prohormone processing enzyme, was highly upregulated in osteoclasts compared with their precursors, bone marrow-derived macrophages (BMMs). Here, we demonstrate a novel role for CPE in receptor activator of NF-${\kappa}B$ ligand (RANKL)-induced osteoclast differentiation. The overexpression of CPE in BMMs increases the formation of tartrate-resistant acid phosphatase (TRAP)-positive multinuclear osteoclasts and the expression of c-Fos and nuclear factor of activated T cells c1 (NFATc1), which are key regulators in osteoclastogenesis. Furthermore, employing CPE knockout mice, we show that CPE deficiency attenuates osteoclast formation. Together, our data suggest that CPE might be an important modulator of RANKL-induced osteoclast differentiation.

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

  • Park, Jung-Sun;Kim, Hye-Kyung;Lee, Hye-Won;Lee, Mi-Hyun;Kim, Hyun-Gi;Chae, Soo-Wan;Chae, Han-Jung
    • Korean Journal of Clinical Pharmacy
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    • v.16 no.1
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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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    • v.24 no.1
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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.

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

  • An, Sung-Hu;Park, Kyungtae;Yeom, Seung-Ryong;Kwon, Young-Dal;Cho, Hea-Young
    • Journal of Korean Medicine Rehabilitation
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    • v.30 no.2
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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.

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

  • Kim, Jae-Min;Shin, Hee-Yung
    • Korean Journal of Biological Psychiatry
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    • v.12 no.2
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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
    • Proceedings of the PSK Conference
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    • 2002.10a
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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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The Metformin Use and Gastric Cancer Risk (메트포르민의 사용과 위암 발생)

  • Kim, Young-Il
    • Journal of Digestive Cancer Research
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    • v.8 no.2
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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.