• Title/Summary/Keyword: trial test

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Pharmacokinetic Properties and Bioequivalence of Cefcapene Pivoxil Hydrochloride 75 mg in Korean Healthy Volunteers (건강한 한국인 피험자에서 Cefcapene Pivoxil Hydrochloride 75 mg 제제의 생물학적동등성시험)

  • Jeon, Ji-Young;Im, Yong-Jin;Hwang, Min-Ho;Kim, Yun-Jeong;Han, Su-Mi;Jo, Myeong-Jin;Kim, Hee-Sun;Kim, Sun-Young;Chae, Soo-Wan;Kim, Kang-Seog;Kim, Min-Gul
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.1
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    • pp.9-12
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    • 2012
  • Background: Cefcapene pivoxil hydrochloride, is an ester-type oral cephem antibiotic. This study was performed to compare the pharmacokinetics and evaluate the bioequivalence of two cefcapene pivoxil hydrochloride 75 mg formulations. Method: In a randomized $2{\times}2$ crossover study, sixty healthy male volunteers were randomly assigned into two groups. After a single dose of 75 mg cefcapene pivoxil hydrochloride oral administration, blood samples were collected at specific time intervals from 0-12 hours. The plasma concentrations of cefcapene pivoxil hydrochloride were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The pharmacokinetic parameters such as $AUC_{last}$, $AUC_{inf}$ and $C_{max}$, were calculated and the 90% confidence intervals for test/reference ratio for pharmacokinetic parameters were obtained by analysis of variance on logarithmically transformed data. Results: The mean value for $AUC_{last}$ in test and reference drug was $4053.1{\pm}876.5\;ng{\cdot}hr/mL$ and $3595.7{\pm}1029.1\;ng{\cdot}h/mL$, respectively. The mean value for $C_{max}$ in test and reference drug was $1324.9{\pm}321.4$ ng/mL and $1159.1{\pm}335.9$ ng/mL, respectively. The 90% confidence intervals of the $AUC_{last}$ and $C_{max}$ ratio for test drug and reference drug were log 1.09-log1.22 and log 1.09-log1.24, respectively. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. Conclusion: This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in these health volunteers. Both formulations were safe and well tolerated in 75 mg of cefcapene pivoxil hydrochloride.

A STUDY ON DEVELOPMENT OF VLBI CORRELATION SUBSYSTEM TRIAL PRODUCT (VLBI상관서브시스템 시작품의 개발에 관한 연구)

  • Oh, Se-Jin;Roh, Duk-Gyoo;Yeom, Jae-Hwan;Chung, Hyun-Soo;Lee, Chang-Hoon;Kobayashi, Hideyuki;Kawaguchi, Noriyuki;Kawakami, Kazuyuki
    • Publications of The Korean Astronomical Society
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    • v.24 no.1
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    • pp.65-81
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    • 2009
  • We present the performance test results of VLBI Correlation Subsystem (VCS) trial product which was being developed for 1 year from August 2007. It is a core component of Korea-Japan Joint VLBI Correlator (KJJVC). The aim for developing VCS trial product is to improve the performance of VCS main product to reduce the efforts and cost, and to solve the design problems by performing the preliminary test of the manufactured trial product. The function of VCS trial product is that it is able to process the 2 stations-1 baseline, 8 Gbps/station speed, 1.2 Gbps output speed with FX-type. VCS trial product consists of Read Data Control Board (RDC), Fourier Transform Board (FTB), and Correlation and Accumulation Board (CAB). Almost main functions are integrated in the FTB and CAB board. In order to confirm the performance of VCS trial product functions, the spectral analysis, delay compensation and correlation processing experiments were carried out by using simulation and real observation data. We found that the overflow problem of re-quantization after FFT processing was occurred in the delay compensation experiment. We confirmed that this problem was caused by valid bit-expression of the re-quantized data. To solve this problem, the novel method will be applied to VCS main product. The effectiveness of VCS trial product has been verified through the preliminary experimental results, but the overflow problem was occurred.

1Gbps x 16 channel Wavelength Division Multiplexing-Passive Optical Network Field Trial Test (1Gbps x 16채널 WDM-PON 필드 테스트)

  • Kim, Geun-Young;Park, Hyung-Jin;Kim, Jin-Hee;Jeong, Ki-Tae
    • The Journal of Korean Institute of Communications and Information Sciences
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    • v.34 no.9A
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    • pp.704-711
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    • 2009
  • In this paper, we report the results of the field trial test of 1GbpsX16channels Injection locking FP-LD based WDM-PON system which could guarantee 40Mbps minimum bandwidth per subscriber, We have confirmed the system reliability, also verified that the system could reliably deliver the service such as internet, VoD through the systems during the field trial test.

Safety and Effectiveness of Fluoroscopy-Guided Acupotomy for Carpal Tunnel Syndrome: Protocol for a Pilot Randomized, Patient-Assessor Blind, Parallel Clinical Trial

  • Yang, Muhack;Kim, Jae Kyoun;Park, Gun Woo;Cha, Eunhye;Jang, Jongwon;Seo, Jihye;Lee, Sangkwan;Kim, Sungchul
    • Journal of Acupuncture Research
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    • v.36 no.2
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    • pp.100-106
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    • 2019
  • Background: In Korean medicine, carpal tunnel syndrome is treated by stimulating the acupoints around the wrist. Although a deep understanding of anatomy and guidance is needed to stimulate these acupoints to avoid undesirable side-effects, currently there are no published guidelines for acupotomy treatment. The aim of this study is to evaluate the effectiveness and safety of fluoroscopy-guided acupotomy compared with conventional acupotomy treatment. Methods: This is a randomized, patient-assessor, patient blind, parallel clinical trial. A total of 30 patients will be enrolled at Wonkwang University Gwangju Hospital, and will be allocated to either an experimental group or a control group. The experimental group will be treated using fluoroscopy-guided acupotomy and the control group will be treated using the conventional acupotomy method. Results: The primary outcome measure will be identification of a cross-section area of the median nerve measured by ultrasonography, and the secondary outcome measure will be the alleviation of pain measured by the Visual Analogue Scale, improvement in the Nerve Conduction Study, Tinel test, Phalen's test, EuroQol 5-dimension scale, and Boston Carpal Tunnel Questionnaire score. Safety components will be measured by monitoring vital signs, electrocardiographs, blood tests, general chemical tests, urine tests and pregnancy tests. In addition, observations for adverse effects will be performed during the trial. Conclusion: This study will provide a more effective, and less harmful way of treating carpal tunnel syndrome compared with conventional acupotomy. Fluoroscopy-guided acupotomy will help practitioners to be accurate in direction and depth of the needle for treating carpal tunnel syndrome.

Pregabalin versus Gabapentin Efficacy in the Management of Neuropathic Pain Associated with Failed Back Surgery Syndrome

  • Laith Thamer Al-Ameri;Mohammed Emad Shukri;Ekhlas Khalid Hameed;Ahmed Abed Marzook
    • Journal of Korean Neurosurgical Society
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    • v.67 no.2
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    • pp.202-208
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    • 2024
  • Objective : Failed back surgery syndrome (FBSS) is a common long-term complication following spine surgeries characterized by chronic persistent pain; different strategies of management were employed to deal with it. This clinical trial aims to compare the efficacy of Pregabalin and Gabapentin in the management of this condition. Methods : A double-blind, randomized, comparative study (clinical trial registry NCT05324761 on 11th April 2022) with two parallel arms with Pregabalin and Gabapentin were used in arms one and two, respectively. Visual analog scale was used for basal and endpoint assessment of pain. T-test and analysis of covariance were used to deal with different variables. A pairwise test was used to compare pairs of means. Results : Of 66 patients referred to the trial, 64 were eligible, with 60 patients completing the 30 days trial. Both pregabalin and gabapentin effectively reduce pain, with significant p-values of 0.001 for each group. However, the pregabalin group was superior to gabapentin in pain reduction (p=0.001). Gender was an insignificant factor (p=0.574 and p=0.445 for the pregabalin and gabapentin groups, respectively, with a non-significant reduction (p=0.393) for both groups in total. Location of stenosis before surgery and type of surgery performed show non-significant effect on pain reduction for both groups. Conclusion : Both pregabalin and gabapentin effectively and safely relieve neuropathic pain associated with FBSS; pregabalin was significantly more effective irrespective of the patients' gender.

The Study on the Effect of Loading Condition on Ship Manoeuvrability (흘수변화가 선박 조종 성능에 미치는 영향에 관한 연구)

  • Im, Nam-Kyun;Kweon, Suk-Am;Kim, Se-Eun
    • Journal of the Society of Naval Architects of Korea
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    • v.42 no.2 s.140
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    • pp.105-112
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    • 2005
  • IMO standards for ship manoeuvrability were applied from January 1, 2004. Though model test or sea trial in full load condition is needed, it is not always possible to get such data for every ships. Therefore it is required to study the effect of loading conditions on ship manoeuvrability. Approximate formulae to estimate the hydrodynamic forces acting on a ship and the 2nd overshoot angle of $10^{\circ}$/$10^{\circ}$ zig-zag test in certain loading condition are proposed in this study These were derived from the results of model test and sea trial data. Captive model tests for 7 ships with 15 different loading conditions and sea trial data including free running test of 6 cases were used. Compared with experiment data and prediction formulae already proposed by others, the approximate formulae in this study show good agreement with model test results.

A Randomized single blind controlled clinical trial on safety and efficacy of a Unani formulation (Itrifal-e-Sagheer) in dyslipidemia

  • Alam, Sazid;Alam, MD Anzar;Quamri, MA;Sofi, Ghulamuddin;Khan, Mohd. Qudratullah;Ansari, Shabnam
    • CELLMED
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    • v.10 no.1
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    • pp.8.1-8.7
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    • 2020
  • Aim:'Itrifal-e-Sagheer', a compound Unani formulation has been indicated in disease conditions simulating dyslipidemia. The present study was done to substantiate the efficacy of 'Itrifal-e-Sagheer' in dyslipidemia on scientific parameters. Materials and methods: A randomized, single blind, controlled, clinical trial was carried out on 30 patients of dyslipidemia who were randomly allocated into test (n = 15) or control (n = 15) groups. The test drug, Itrifal-e-Sagheer and control drug, Abana® were given to respective group for 45 days along with lifestyle modification. Results: The test drug significantly alleviated the symptoms of subjective parameters (palpitation, breathlessness and weight gain) (p<0.05). There was statistically significant reduction in lipid profile of the patients in test group (p<0.05) than control drug treatment. Conclusion: The study evidenced that Itrifal-e-Sagheer is potentially effective and safe in the treatment of dyslipidemia. However, a multicentric study with robust study design is required to generalize the results.

The perception in regard to the clinical trial of dental hygienists (치과위생사의 임상시험에 대한 인식도)

  • Chang, Na-Hee;Jung, Ui-Jung;Jang, Gye-Won
    • Journal of Korean society of Dental Hygiene
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    • v.14 no.6
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    • pp.839-847
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    • 2014
  • Objectives: The purpose of the study was to investigate the perception of clinical trials of dental hygienist. Methods: A self-reported questionnaire was filled out by 126 dental hygienists in Seoul, Kyonggi and other area from October 1 to November 15, 2012. The instrument of the study was adapted from Jung and reconstructed. The questionnaire consisted of general characteristics of the subjects(9 questions) and recognition for clinical trials(10 questions). Recognition for clinical trials instrument included recognition for clinical trial conception(2 questions), objective recognition(5 questions), and subjective recognition for clinical trial(3 questions). The instrument was score by Likert 5 scale and Cronbach alpha was 0.936 in the study. Data were analyzed by SPSS 20.0 program and set at p<0.05. Independent t-test, chi-square test, one way ANOVA, and post-hoc Duncan test were done. Results: Those who had higher ages and higher education tended to have longer clinical careers(p<0.05). There was a significant difference in clinical trials between the level of education, clinical dental hygienists and professors. The differences in problem perception for activation of clinical trial according to workplace appeared to lack of publicity and inadequacy of facilities(p<0.05). Conclusions: To improve the perception of the clinical trials in dental hygienists, it is necessary to prepare the human resources programs, the additional curricula, continuing education courses and active publicity.

Clinical Trial to Evaluate the Hot Flush Relief Efficacy and Safety of Yiseontang-gami in Climacteric Women with Hot Flushes (갱년기 여성의 안면홍조에 대한 이선탕가미방(二仙湯加味方)의 증상 완화 효과 및 안전성 평가를 위한 임상연구)

  • Jung, Su-Kyoung;Kim, Dong-Il
    • Journal of Oriental Medical Thermology
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    • v.7 no.1
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    • pp.1-13
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    • 2009
  • Purpose: To evaluate the hot flush relief efficacy of Yiseontang-gami in climacteric women with hot flushes, a vasomotor symptom. Methods: The 20 subjects who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine(Yiseontang-gami)during thirty-day. The evaluating indexes of this trial are hot flush VAS, hot flush frequency, hot flush consistence time, sweating VAS, palpitation VAS, sleep disturbance VAS, MRS, MENQOL, PGA. Results: The results were as follows 1. 4 subjects dropped out of the clinical trial and 16 subjects completed it. 2. After Yiseontang-gami treatment, hot flush VAS, hot flush frequent, sweating VAS, Palpitation VAS, sleep disturbance VAS improved significantly. 3. After Yiseontang-gami treatment, hot flush consistence time was not improved significantly. 4. After Yiseontang-gami treatment, blood test value were not different significantly. Conclusion: In this clinical trial we consider that Yiseontang-gami is suitable treatment for the hot flushes and related symptoms.

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Clinical Trial to Evaluate the Hot Flush Relief Efficacy and Safety of Yiseontang-gami in Climacteric Women with Hot Flushes (갱년기 여성의 안면홍조에 대한 이선탕가미방(二仙湯加味方)의 증상완화 효과 및 안전성 평가를 위한 임상연구)

  • Jung, Su-Kyoung;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.21 no.3
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    • pp.75-89
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    • 2008
  • Purpose: To evaluate the hot flush relief efficacy of Yiseontang-gami in climacteric women with hot flushes, a vasomotor symptom. Methods: The 20 subjects who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine(Yiseontang-gami)during thirty-day. The evaluating indexes of this trial are hot flush VAS, hot flush frequency, hot flush consistence time, sweating VAS, palpitation VAS, sleep disturbance VAS, MRS, MENQOL, PGA. Results: The results were as follows 1. 4 subjects dropped out of the clinical trial and 16 subjects completed it. 2. After Yiseontang-gami treatment, hot flush VAS, hot flush frequent, sweating VAS. Palpitation VAS, sleep disturbance VAS improved significantly. 3. After Yiseontang-gami treatment, hot flush consistence time was not improved significantly. 4. After Yiseontang-gami treatment, blood test value were not different significantly. Conclusion: In this clinical trial we consider that Yiseontang-gami is suitable treatment for the hot flushes and related symptoms.

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