• Title/Summary/Keyword: crossover rate

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The Effect of Operative Treatment for Lessor Toes Deformity Concomitant with Hallux Valgus on Clinical Outcomes (무지 외반증과 동반된 소족지 기형에 대한 수술적 교정치료가 임상 결과에 미치는 영향)

  • Park, Ji-Kang;Kim, Yong-Min;Kim, Dong-Soo;Park, Kyoung-Jin;Cho, Byung-Ki;Jeong, Ho-Seung
    • Journal of Korean Foot and Ankle Society
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    • v.17 no.3
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    • pp.225-233
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    • 2013
  • Purpose: This study was performed to evaluate the impact of the lesser toe operation on the overall clinical outcomes, and to analyze the clinical results of concomitant surgery for hallux valgus and lesser toe deformities. Materials and Methods: Forty-six cases underwent surgery for hallux valgus with concomitant lesser toe deformities were followed up for at least 1 year. Lesser toe deformities consisted of 9 crossover toes, 10 claw toes, 12 hammer toes and 15 bunionettes. Clinical evaluation was performed according to AOFAS (American Orthopaedic Foot and Ankle Society) score, patient's satisfaction score, and pain VAS (visual analogue scale) score. Hallux valgus angle (HVA), intermetatarsal angle (IMA), and period to union were measured. Preoperative expectation about lesser toe deformities, postoperative satisfaction, complication rate, hospitalization period, medical expenses, and frequency of outpatient follow-up were analyzed. Results: AOFAS score, VAS score, HAV and IMA had improved significantly. On preoperative expectation of patients, correction of lesser toe deformities was ranked third, following the improvement of big toe(bunion) pain and the correction of hallux valgus. Patient's satisfaction score was average 92.8 points, and the importance of lesser toe operation was 30.2%. When compared to hallux valgus operation only, there were average 2.5 days of additional hospitalization, 2.4 times of additional outpatient follow-up, 386000 won of additional medical expenses. Conclusion: Combined operation for hallux valgus and concomitant lesser toe deformities showed good clinical results. When compared to hallux valgus operation only, there were longer hospitalization, more frequent follow-up, more medical expenses, more complications. However, lesser toe deformity correction in patients underwent hallux valgus operation is considerable, because of high preoperative expectation and postoperative satisfaction.

Music for Pediatric Patients in Medical Settings: A Systematic Review of Randomized Controlled Trials (소아환자를 위한 음악: 무작위 임상연구의 체계적인 문헌고찰)

  • Lee, Jin Hyung
    • Journal of Music and Human Behavior
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    • v.10 no.2
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    • pp.1-33
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    • 2013
  • The aim of this study was to systematically review the latest clinical trials in music medicine and medical music therapy for pediatric patients. Thirteen databases were searched to obtain randomized controlled/crossover design studies published between the year 2000 and 2012 in English language. Out of 1012 articles retrieved in the initial search, fifteen studies were identified based on an exclusion criteria. Overall, selected articles involved children 1 month to 18 years, sample size of 11 to 150, and total participants of 987. Studies were classified and compared as music medicine or music therapy studies through a systematic synthesis assessing general characteristics, methodological quality, measured outcomes, types of interventions and the study results. Seven music medicine and eight music therapy studies measured seven dependent variables using thirty-six different measurement tools with a large heterogeneity in the selection, type, and method of music interventions. Evaluation of the methodological quality revealed that many studies did not provide a full report of the research method, and did not meet some or most methodological standards, such as randomization, allocation concealment, double or partial blinding, and intention to treat analysis. Although overall research results were positive if not significant, poor methodological quality and heterogeneity in design and intervention strategies raise the question of research bias and trustworthiness issues. The systematic review concluded that music may have a valuable clinical effect in addressing the physical and psychosocial needs of hospitalized children, although more rigorous, homogeneous and replicable studies are greatly needed.

Bioequivalence of MelaxTM Capsule to MobicTM Capsule (Meloxicam 7.5 mg) (모빅 캡슐(멜록시캄 7.5 mg)에 대한 멜락스 캡슐의 생물학적동등성)

  • Lee, Ye-Rie;Yeom, Seung-Bock;Ko, Youn-Jung;Ko, Jung-Kil;Kim, Ho-Hyun;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.5
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    • pp.413-418
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    • 2004
  • A bioequivalence of $Melax^{TM}$ capsules (Chong Kun Dang Pharm., Korea) and $Mobic^{TM}$ capsules (Boehringer Ingelheim Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 15 mg dose of meloxicam of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2\;{\times}\;2$ crossover design. Concentrations of meloxicam in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 72 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Melax^{TM}/Mobic^{TM}$ were 0.95 - 1.04 and 0.98 - 1.14, respectively. This study demonstrated a bioequivalence of $Melax^{TM}$ and $Mobic^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of PirosTM Tablets to ActosTM Tablets (Pioglitazone HCl 15 mg) (액토스TM정(염산 피오글리타존 15 mg)에 대한 피로스TM정의 생물학적 동등성)

  • Kang, Jong-Min;Lee, Myung-Jae;Seo, Ji-Hyung;Choi, Sang-Jun;Lee, Jin-Sung;Ryu, Ju-Hee;Tak, Sung-Kwon;Yim, Sung-Vin;Hong, Seung-Jae;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.39 no.2
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    • pp.133-139
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    • 2009
  • The purpose of the present study was to evaluate the bioequivalence of two pioglitazone HCl tablets, $Actos^{TM}$, tablets (Lilly Korea. Ltd., Korea) as a reference drug and $Piros^{TM}$, tablets (Reyon Pharm. Co., Ltd., Korea) as test drug, according to the guideline of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received one tablet containing pioglitazone HCl 15 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of pioglitazone were monitored for over a period of 36 hr after administration by using a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The area under the plasma concentration-time curve from time zero to 36 hr ($AUC_{0-36hr}$), maximum plasma drug concentration ($C_{max}$) and time to reach $C_{max}$ ($T_{max}$) were complied from the plasma concentration-time data. Analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_{0-36hr}$ and $C_{max}$. The 90% confidence intervals of the $AUC_{0-36hr}$ ratio and the $C_{max}$ ratio for $Piros^{TM}$/$Actos^{TM}$. were log 0.8753-log 1.1286 and log 0.8669-log 1.1734, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25, recommended by KFDA. In all of these results, we concluded that the $Piros^{TM}$. tablet was bioequivalent to the $Actos^{TM}$. tablet, based on the rate and extent of absorption.

Bioequivalence of MeloxifenTM Capsule to MobicTM Capsule(Meloxicam 7.5 mg) (모빅캡슐(멜록시캄 7.5mg)에 대한 멜록시펜캡슐의 생물학적 동등성)

  • Lee, Jin-Sung;Tak, Sung-Kwon;Seo, Ji-Hyung;Kang, Jong-Min;Ryu, Ju-Hee;Yim, Sung-Vin;Hong, Seung-Jae;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.39 no.6
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    • pp.457-463
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    • 2009
  • The purpose of the present study was to evaluate the bioequivalence of meloxicam capsule, $Mobic^{TM}$ capsule( Boehringer Ingelheim Ltd., Korea) as a reference drug and $Meloxifen^{TM}$ capsule (Kukje Pharma Ind. Co., Ltd., Korea) as a test drug, according to the guidelines of Korea Food and Drug Administration(KFDA). Thirty two healthy male Korean volunteers received capsule containing meloxicam 7.5 mg in a $2{\times}2$ crossover study. There was a one-week above washout period between the doses. Plasma concentrations of meloxicam were monitored for over a period of 72 hr after administration by using a high performance liquid chromatography-tandem mass spectrometer(LC-MS/MS). $AUC_t$(the area under the plasma concentration-time curve from time zero to 72 hr), $C_{max}$(maximum plasma drug concentration) and $T_{max}$(time to reach $C_{max}$) were complied from the plasma concentration-time data. Analysis of variance(ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Meloxifen^{TM}/Mobic^{TM}$ were log 0.8605-log 0.9847 and log 0.9765-log 1.1503, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25, recommended by KFDA. In all of these results, we concluded that $Meloxifen^{TM}$ capsule was bioequivalent to $Mobic^{TM}$ capsule, based on the rate and extent of absorption.

Bioequivalence of RoxithrinTM Tablet to RulidTM Tablet (Roxithromycin 150 mg) (루리드 정(록시스로마이신 150 mg)에 대한 록시스린 정의 생물학적동등성)

  • Joung, Sun-Koung;Lee, Yun-Young;Cho, Tae-Seob;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.34 no.3
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    • pp.209-214
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    • 2004
  • A bioequivalence study of $Roxithrin^{TM}$ tablet (Kukje Pharma. Ind. Co., Ltd.) to $Rulid^{TM}$ tablet (Han Dok Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the roxithromycin dose of 300 mg in a $2{\times}2$ crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography for over a period of 36 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 36 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Roxithrin^{TM}/Rulid^{TM}$ were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of $Roxithrin^{TM}$ and $Rulid^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of Etodin Capsule to Kuhnillodin Capsule (Etodolac 200 mg) (건일로딘 캡슐(에토돌락 200mg)에 대한 에토딘 캡슐의 생물학적동등성)

  • Lee, Myung-Jae;Kang, Jong-Min;Choi, Sang-Jun;Lee, Jin-Sung;Tak, Sung-Kwon;Seo, Ji-Hyung;Rew, Jae-Hwan;Yim, Sung-Vin;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.38 no.6
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    • pp.421-427
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    • 2008
  • The purpose of the present study was to evaluate the bioequivalence of two etodolac capsules, Kuhnillodin capsule (Kuhnil. Co., Ltd., Seoul, Korea) as reference drug and Etodin capsule (Myungmun Pharm. Co., Ltd., Seoul, Korea) as test drug, according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-three healthy male Korean volunteers received one capsule at the dose of 200 mg etodolac in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of etodolac were monitored by a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) for over a period of 24 hr after the administration. $AUC_{0-24\;hr}$ was calculated by the linear trapezoidal rule method. $C_{max}$ and $T_{max}$ were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) was carried out using logarithmically transformed $AUC_{0-24\;hr}$ and $C_{max}$. The 90% confidence intervals of the $AUC_{0-24\;hr}$ ratio and the $C_{max}$ ratio for Etodin/Kuhnillodin were $\log\;0.97{\sim}\log\;1.08$ and $\log\;0.89{\sim}\log\;1.19$, respectively. These values were within the acceptable bioequivalence intervals of $\log\;0.80{\sim}\log\;1.25$. Thus, our study demonstrated that Etodin was bioeqiovalent to Kuhnillodin preparation when the rate and extent of absorption between two preparations were compared.

Extraction of Oil from Canola Seeds with Supercritical Carbon Dioxide (초임계 이산화탄소를 이용한 캐놀라 오일 추출)

  • Hwang, Ah-Reum;Jung, In-Il;Lim, Gio-Bin;Ryu, Jong-Hoon
    • KSBB Journal
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    • v.24 no.4
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    • pp.367-376
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    • 2009
  • In this study, two supercritical extraction systems of different scale, analytical-scale and lab-scale, were employed to investigate the extraction efficiency of canola oil from canola seeds using supercritical carbon dioxide ($SCCO_2$) as an extraction solvent. The effects of various parameters such as extraction temperature ($40{\sim}80^{\circ}C$), pressure (200~500 bar), particle size, and $SCCO_2$ flow direction on the extraction rate and yield were examined in detail. Triglycerides and fatty acids in the extracted canola oil were analyzed quantitatively by high-performance liquid chromatography and gas chromatography. The solubility values of canola oil in $SCCO_2$ could be calculated from the experimental results. Similar extraction yields were obtained from both analytical-scale and lab-scale extraction systems. The extraction rates obtained under solvent ($SCCO_2$ ) upflow conditions were found to be higher than those of solvent downflow extraction. However, the effect of $SCCO_2$ flow direction on the extraction yield was observed to be relatively insignificant.

Bioequivalence of EtodolTM Tablet to KuhnillodineTM Tablet (Micronized Etodolac 200 mg) (건일로딘 정(미결정에토돌락 200 mg)에 대한 에토돌 정의 생물학적동등성)

  • Lee, Jung-Ae;Lee, Yun-Young;Cho, Tae-Seob;Park, Young-Joon;Moon, Byoung-Seok;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.4
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    • pp.319-325
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    • 2004
  • A bioequivalence of $Etodol^{TM}$ tablets (Yuhan corporation) and $Kuhnillodine^{TM}$ tablets (Kuhnil Pharm. Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 mg dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2{\times}2$ crossover design. Concentrations of etodolac in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Etodol^{TM}/Kuhnillodine^{TM}$ were 1.01-1.10 and 0.87-1.06, respectively. This study demonstrated a bioequivalence of $Etodol^{TM}$ and $Kuhnillodine^{TM}$ with respect to the rate and extent of absorption.

The Effects of Active Movement Myofascial Decompression Therapy and Static Myofascial Decompression Therapy on Range of Motion, Muscle Strength, Functional Movement in Young Adults. (젊은 성인에서 능동 움직임을 결합한 근막감압치료 적용과 정적 적용이 관절가동범위, 근력, 기능적 움직임에 미치는 영향)

  • Lee, Jee-Hyun;Kim, Tae-Hyeon;Kang, Si-Yun;Kum, Do-Gun;Lee, Sung-Yeon;Do, Kwang-Sun;Kim, Chang-Sook;Bae, Ju-Han;Park, Jun-Hyuck;Kim, Jae-Eun
    • Journal of The Korean Society of Integrative Medicine
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    • v.9 no.3
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    • pp.165-173
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    • 2021
  • Purpose : Myofascial decompression is frequently mentioned as a method applied to cupping. The purpose of this study is to evaluate and compare active range of motion (AROM), muscle strength, and functional movement by applying myofascial decompression to the hamstrings. Methods : This study evaluated AROM, muscle strength, and functional movement by applying active movement myofascial decompression and static myofascial decompression to the dominant leg, respectively, in a crossover design conducted with normal adults (n=21) in their average 20s enrolled at G University in G city, Gyeongsangbuk-do. Active movement myofascial decompression was implemented for five minutes at a rate of 100 bpm to make the beats in flexion and extension respectively. Static myofascial decompression was only performed for five minutes while at rest. All of these interventions were performed at a cupping depth of two mm. After a one-week washout period, static was applied again to compare the same dependent variables. Results : Regarding AROM and muscle strength, both groups showed significant differences in the before and after results (p<.05). However, in the Functional Reach Aspect and Single Leg Hop test, the active movement myofascial decompression group showed better results. There was no statistical difference between the Active movement myofascial decompression group and Static myofascial decompression group in any dependent variable (p<.05). Conclusion : As a result of this experiment, both active movement myofascial decompression and static myofascial decompression had a positive effect on dependent variable. Therefore this study is meaningful in that it is easier and simpler to see the effect on flexibility, muscle strength, and functional movement just by implementing movement myofascial decompression.