• Title/Summary/Keyword: Multicenter clinical study

Search Result 182, Processing Time 0.046 seconds

Multicenter clinical study of childhood periodic syndromes that are common precursors to migraine using new criteria of the International Classification of Headache Disorders (ICHD-II) (편두통의 전 단계인 소아기주기성증후군의 다기관 임상 연구: 국제두통질환분류 제2판 제1차 수정판 적용)

  • Park, Jae Yong;Nam, Sang-Ook;Eun, So-Hee;You, Su Jeong;Kang, Hoon-Chul;Eun, Baik-Lin;Chung, Hee Jung
    • Clinical and Experimental Pediatrics
    • /
    • v.52 no.5
    • /
    • pp.557-566
    • /
    • 2009
  • Purpose : To evaluate the clinical features and characteristics of childhood periodic syndromes (CPS) in Korea using the new criteria of the International Classification of Headache Disorders (ICHD)-II. Methods : The study was conducted at pediatric neurology clinics of five urban tertiary-care medical centers in Korea from January 2006 to December 2007. Patients (44 consecutive children and adolescents) were divided into three groups (cyclic vomiting syndrome [CVS], abdominal migraine [AM], and benign paroxysmal vertigo of childhood [BPVC]) by recurrent paroxysmal episodes of vomiting, abdominal pain, dizziness, and/or vertigo using the ICHD-II criteria and their characteristics were compared. Results : Totally, 16 boys (36.4%) and 28 girls (63.6%) were examined (aged 4-18 yr), with 20 CVS (45.5%), 8 AM (18.2%), and 16 BPVC (36.4%) patients. The mean age at symptom onset was $6.3{\pm}3.6$ yr, $8.5{\pm}2.7$ yr, and $8.5{\pm}2.9$ yr in the CVS, AM, and BPVC groups, respectively, showing that symptoms appeared earliest in the CVS group. The mean age at diagnosis was $8.0{\pm}3.4$ yr, $10.5{\pm}2.6$ yr, and $10.1{\pm}3.2$ yr the CVS, AM, and BPVC groups, respectively. Of the 44 patients, 17 (38.6%) had a history of recurrent headaches and 11 (25.0%) showed typical symptoms of migraine headache, with 5 CVS (25.0%), 2 AM (25.0%), and 4 BPVC (25.0%) patients. Family history of migraine was found in 9 patients (20.4%): 4 in the CVS group (20.0%), 2 in the AM group (25.0%), and 3 in the BPVC group (18.8%). Conclusion : The significant time lag between the age at symptom onset and final diagnosis possibly indicates poor knowledge of CPS among pediatric practitioners, especially in Korea. A high index of suspicion may be the first step toward caring for these patients. Furthermore, a population-based longitudinal study is necessary to determine the incidence and natural course of these syndromes.

Effect of surfactant lavage in severe meconium aspiration syndrome (중증 태변 흡인 증후군에서 인공 폐표면활성제 세정요법의 효과에 관한 비교 연구)

  • Lee, Soon Min;Kim, He Min;Jeon, Ji Hyun;Park, Min Soo;Park, Kook In;Namgung, Ran;Lee, Chul
    • Clinical and Experimental Pediatrics
    • /
    • v.51 no.4
    • /
    • pp.367-371
    • /
    • 2008
  • Purpose : The surfactant dysfunction may play an important role in meconium aspiration syndrome (MAS). We aim to evaluate the effect of surfactant lavage in the treatment of term infants with MAS. Methods : The medical records of 15 neonates with severe MAS admitted at Yongdong Severance Hospital from 2005 to 2007 were reviewed and analyzed. Seven infants with severe MAS necessitating mechanical ventilation underwent tracheobronchial lavage with 20 mL/kg of diluted (5.3 mg phospholipid/mL) surfactant saline suspension ($Newfactan^{(R)}$). Data regarding clinical outcomes was assessed by comparison with 8 control infants with equally severe MAS retrospectively. Results : In the lavage group, radiological improvement was evident after 6 hours of treatment. The duration of artificial ventilation and duration of hospital day were also significantly shorten in the lavage group compared with the control group. The mean oxygen index, mean ventilation index improved significantly within the first 6 hours after treatment. No differences were found in the incidence of major complications and mortality between the two groups. Conclusion : The surfactant lavage seems to be an effective and safe method for treatment of severe MAS. A multicenter, large scaled randomized controlled trial is needed for further study.

A Randomized, Double-Blind Study to Assess the Efficacy and Safety of Oral LB20304 (Gemifloxacin) at Doses of 160mg or 320mg (Equivalent to 200mg or 400mg of the Mesylate Salt) Once Daily for 7 Days for the Treatment of Acute Exacerbations of Chronic Bronchitis (AECB) in Korean Adult Population (한국인에서 만성기관지염의 급성악화를 치료하기 위한 LB20304(Gemifloxacin) 160mg 또는 320mg 1일 1회 7일간 투여의 유효성과 안전성에 대한 연구)

  • Kim, Young Whan;Shim, Young-Soo;Kim, Won Dong;Shim, Tae Sun;Kang, Hong Mo;Choi, ByoungWhui;Kim, Jae-Yeol;Kwon, O Jung;Kim, Hojoong;Kim, Ju Ock;Jung, Ki-Suck;Hyeon, In Gyou;Mo, Eun Kyung;Lee, Seung-Joon;Nam, Gui Hyun;Lee, Kye Young;Park, Jae Seuk
    • Tuberculosis and Respiratory Diseases
    • /
    • v.55 no.1
    • /
    • pp.69-87
    • /
    • 2003
  • Background : LB20304(gemifloxacin) is a new fluoroquinolone antibacterial agent with excellent activity against both Gram-negative and Gram-positive organisms. In vitro studies using clinical isolates have shown gemifloxacin to be highly active against penicillin-resistant strains of S. pneumoniae and in contrast to other reference quinolones, gemifloxacin retained good activity against clinical isolates of S. pneumoniae that were resistant to other members of the quinolone class. Therefore, gemifloxacin is thought to be effective in treating acute bacterial exacerbation of chronic bronchitis(AECB). The objective of this study was to evaluate the efficacy and safety of oral gemifloxacin at doses of 160mg or 320mg once daily for 7 days for the treatment of AECB in Korean adult population. Methods : This was a randomized, multicenter, double-blind, parallel group Phase II study to assess the clinical and antibacterial efficacy and safety of oral gemifloxacin for the treatment of AECB. Treatment Group A (67 patients) took oral gemifloxacin 160mg once daily for seven days and treatment Group B (70 patients) took oral gemifloxacin 320mg once daily for seven days. Results : The demographic profiles of the two treatment groups were similar. The clinical response at follow-up was 84.2% in the gemifloxacin 160-mg group, and 88.7% in the gemifloxacin-320 mg group, showing no statistically significant difference between two treatment groups(p=0.49). The clinical response at the end of therapy was 96.5% in the 160-mg group, and 96.4% in the 320-mg group. The bacteriological response at the end of therapy and follow-up were 81.8% and 78.9%, respectively, in the 160-mg group, and 86.4% and 84.2%, respectively, in the 320-mg group, showing no statistically significant difference between two treatment groups(p=0.68 and 0.68, respectively). S. pneumoniae(12 isolates) and H. influenzae(10 isolates) were the most prevalent pathogens. The MICs were lower for gemifloxacin than other quinolones against these key pathogens, and for S. pneumoniae, the MICs for gemifloxacin were considerably lower(${\leq}0.03$ ug/mL) than those for other quinolones, beta-lactams and macrolides. In the period on-therapy plus 30 days post-therapy, a total of 18 patients(26.9%) in the gemifloxacin 160mg group and 22 patients(31.4%) in the 320mg group reported at least one adverse event(AE). The most frequently reported AE was abdominal pain(3/67 patients, 4.5%) in the gemifloxacin 160mg group and increased level of hepatic enzyme(5/70 patients, 7.1%) in the 320mg group. The overall AE profiles for the two treatment groups were similar. Two out of 67 patients(3.0%) in the gemifloxacin 160mg group and 1/70 patients(1.4%) in the 320mg group reported at least one serious AE, however, none of which was considered by the investigator to be of suspected or probable relationship to study medication. Conclusion : The results of this study showed that gemifloxacin at doses of 160mg or 320mg once daily for 7 days in the treatment of acute exacerbations of chronic bronchitis(AECB) in adult Koreans was a very effective and safe treatment both clinically and bacteriologically.

Validation of Electronic Foot Function Index in Patients with Foot and Ankle Disease: A Randomized, Prospective Multicenter Study (족부 족관절 질환 환자에서 전자식 족부 기능 지수의 인증: 임의 배정, 전향적, 다기관 연구)

  • Lee, Dong Yeon;Kim, Yu Mi;Lee, Jun Hyung;Kim, Jin;Kim, Ji-Beom;Kim, Bom Soo;Choi, Gi Won;Seo, Sang Gyo;Kim, Jun Beom;Park, Se-Jin;Kim, Yoon-Chung;Choi, Young Rak;Lee, Dong-Oh;Cho, Jae-Ho;Chun, Dong-Il;Kim, Hyong Nyun;Park, Jae-Yong
    • Journal of Korean Foot and Ankle Society
    • /
    • v.23 no.1
    • /
    • pp.24-30
    • /
    • 2019
  • Purpose: To evaluate the efficiency of the electronic foot function index (eFFI) through a prospective, random based, multi-institutional study. Materials and Methods: The study included 227 patients ranging in age from 20 to 79 years, visited for surgery in different 15 institutes, and agreed to volunteer. The patients were assigned randomly into a paper-based evaluated group (n=113) and tablet-based evaluated group (n=114). The evaluation was done on the day of hospital admission and the method was changed on the second day of surgery and re-evaluated. PADAS 2.0 (https://www.proscore.kr) was used as an electronic evaluation program. Results: There were no differences in age and sex in both groups. The intraclass correlation coefficient (ICC) evaluation revealed an eFFI ICC of 0.924, showing that both results were similar. The evaluation time was shorter in the tablet-based group than the paper-based group (paper vs tablet, $3.7{\pm}3.8$ vs $2.3{\pm}1.3minutes$). Thirty-nine patients (17.2%) preferred to use paper and 131 patients (57.7%) preferred the tablet. Fifty-seven patients (25.1%) found both ways to be acceptable. Conclusion: eFFI through tablet devices appears to be more constant than the paper-based program. In addition, it required a shorter amount of time and the patients tended to prefer the tablet-based program. Overall, tablet and cloud system can be beneficial to a clinical study.

Incidence and outcome of congenital anomalies of the kidney and urinary tract detected by prenatal ultrasonography: a single center study (산전 초음파로 발견된 선천성 신 요로 기형의 발생률과 임상 결과: 단일 기관 연구)

  • Lim, Gina;Lee, Joo Hoon;Park, Young Seo;Kim, Kun Seok;Won, Hye-Sung
    • Clinical and Experimental Pediatrics
    • /
    • v.52 no.4
    • /
    • pp.464-470
    • /
    • 2009
  • Purpose : This study assessed the incidence and outcome of congenital anomalies of the kidney and urinary tract (CAKUT) detected by prenatal ultrasonography Methods : There were 906 cases of CAKUT detected by prenatal ultrasonography and postnatally confirmed at the Asan Medical Center from October 1989 to October 2007. We investigated the incidence and outcome of these cases by reviewing medical records retrospectively. Results : The order of incidence was hydronephrosis, multicystic dysplastic kidney (MCDK), duplex kidney, vesico-ureteral reflux (VUR), single kidney, hydroureteronephrosis, ectopic kidney, polycystic kidney, ureterocele, and posterior urethral valve (PUV). There were 520 cases (57.4%) of hydronephrosis, and 20% of these needed an operation due to significant obstruction. MCDK was associated with other CAKUT in 25.4% of all cases. Approximately 57.9% of duplex kidney cases needed surgical treatment due to ureterocele and VUR. VUR had a male: female ratio of 10:1. Two out of seven cases of autosomal recessive polycystic kidney had progressed to chronic renal failure. Patients with PUV were relatively uncommon, and one out of nine cases progressed to end-stage renal disease. Conclusion : CAKUTs detected by prenatal ultrasonography were composed of various anomalies, and almost all of them had a good outcome without any intervention. However, in some cases, recurrent urinary tract infection or renal failure occurred, especially in bilateral cases. For further management, a long-term multicenter study is needed to investigate the precise incidence and outcome of each anomaly in the general population.

Safety and Reactogenicity of the Inactivated Poliomyelitis Vaccine (PoliorixTM) in Korea (2006-2012) (우리나라 영아에서 주사용 소아마비 백신(PoliorixTM)의 안전성 및 이상반응에 대한 연구)

  • Sin, Jong Beom;Park, Moon Sung;Ma, Sang Hyuk;Choi, Young Youn;Shin, Son Moon;Kim, Won Duck;Kuriyakose, Sherine;Ulianov, Liliana;Hardt, Karin
    • Pediatric Infection and Vaccine
    • /
    • v.20 no.3
    • /
    • pp.139-146
    • /
    • 2013
  • Objective: As per the requirement of Korean Food and Drug Administration, this post-marketing surveillance was conducted in Korea to evaluate the safety and reactogenicity of Poliorix$^{TM}$ following its introduction in 2006. Methods: In this open, multicenter study, the vaccine was administered as per the current practice of Korean doctors and in reference to the guidebook by the Korean Pediatric Society and as indicated in the Korean label which was as follows - for primary vaccination three doses were given to infants at ages 2, 4 and 6 months whereas, for the booster dose a single dose was given to children aged 4-6 years. Safety data during this six year surveillance was collected using diary cards which were distributed to the parents to record adverse events. Results: A total of 639 subjects were enrolled into the study. Of these, 617 subjects and 22 subjects received the vaccine as a primary and booster dose, respectively. At least one unsolicited symptom was reported in 11.4% (73/639) of the subjects during the 7-day follow-up period; upper respiratory tract infection (2.5%;16/639) was the most frequently reported unsolicited symptom. One subject reported at least one unsolicited symptom (gastroenteritis) of grade 3 intensity within the 31-day post-vaccination period. Approximately 1.7% (11/639) of subjects reported 13 serious adverse events (SAEs). All SAEs were resolved by the end of the study. Conclusion: In Korea, primary and booster vaccination with Poliorix$^{TM}$ was well-tolerated in healthy subjects when administered according to the prescribing information as part of routine clinical practice.

  • PDF

Long-term Results of Taking Anti-oxidant Nutritional Supplement in Intermediate Age-related Macular Degeneration (중기 나이관련황반변성 환자에서 항산화영양제 복용 후 장기 관찰 결과)

  • Bang, Seul Ki;Kim, Eung Suk;Kim, Jong Woo;Shin, Jae Pil;Lee, Ji Eun;Yu, Hyeong Gon;Huh, Kuhl;Yu, Seung-Young
    • Journal of The Korean Ophthalmological Society
    • /
    • v.59 no.12
    • /
    • pp.1152-1159
    • /
    • 2018
  • Purpose: We prospectively investigated clinical changes and long-term outcomes after administration of the drugs recommended by the Age-Related Eye Disease Study-2 to patients with intermediate age-related macular degeneration (AMD). Methods: This prospective multicenter study enrolled 79 eyes of 55 patients taking lutein and zeaxanthin. The primary endpoint was contrast sensitivity; this was checked every 12 months for a total of 36 months after treatment commenced. The secondary endpoints were visual acuity, central macular thickness, and drusen volume; the latter two parameters were assessed using spectral domain optical coherence tomography. Results: The mean patient age was $72.46{\pm}7.16years$. Contrast sensitivity gradually improved at both three and six cycles per degree. The corrected visual acuity was $0.13{\pm}0.14logMAR$ and did not change significantly over the 36 months. Neither the central macular thickness nor drusen volume changed significantly. Conclusions: Contrast sensitivity markedly improved after treatment, improving vision and patient satisfaction. Visual acuity, central retinal thickness, and drusen volume did not deteriorate. Therefore, progression of AMD and visual function deterioration were halted.

Tertiary Cytoreduction for Recurrent Epithelial Ovarian Cancer: a Multicenter Study in Turkey

  • Arvas, Macit;Salihoglu, Yavuz;Sal, Veysel;Gungor, Tayfun;Sozen, Hamdullah;Kahramanoglu, Ilker;Topuz, Samet;Demirkiran, Fuat;Iyibozkurt, Cem;Bese, Tugan;Ozgu, Burcin Salman;Vatansever, Dogan;Tokgozoglu, Nedim;Berkman, Sinan;Turan, Hasan;Bengisu, Ergin;Sofiyeva, Nigar;Demiral, Irem;Meydanli, Mutlu
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.17 no.4
    • /
    • pp.1909-1915
    • /
    • 2016
  • Background: The purpose of this study was to determine the benefit of tertiary cytoreductive surgery (TC) for secondary recurrent epithelial ovarian cancer (EOC), focusing on whether optimal cytoreduction has an impact on disease-free survival, and whether certain patient characteristics could identify ideal candidates for TC. Materials and Methods: Retrospective analysis of secondary recurrent EOC patients undergoing TC at three Turkish tertiary institutions from May 1997 to July 2014 was performed. All patients had previously received primary cytoreduction followed by intravenous platinum-based chemotherapy and secondary cytoreduction for first recurrence. Clinical and pathological data were obtained from the patients' medical records. Survival analysis was caried out using the Kaplan Meier method. Actuarial curves were compared by the two tailed Logrank test with a statistical significance level of 0.05. Results: Median age of the patients was 49.6 years (range, 30-67) and thirty-eight (72%) had stage III-IV disease at initial diagnosis. Twenty six (49%) had optimal and 27 (51%) suboptimal cytoreduction during tertiary debulking surgery. Optimal initial cytoreduction, time to first recurrence, optimal secondary cytoreduction, time interval between secondary cytoreduction and secondary recurrence, size of recurrence, disease status at last follow-up were found to be significant risk factors to predict optimal TC. Optimal cytoreduction in initial and tertiary surgery and serum CA-125 level prior to TC were independent prognostic factors on univariate analysis. Conclusions: Our results and a literature review clearly showed that maximal surgical effort should be made in TC, since patients undergoing optimal TC have a better survival. Thus, patients with secondary recurrent EOC in whom optimal cytoreduction can be achieved should be actively selected.

Characteristics and outcomes of patients with septic shock who transferred to the emergency department in tertiary referral center: multicenter, retrospective, observational study (상급종합병원 및 종합병원 응급실로 전원된 패혈성 쇼크 환자의 특성과 예후: 다기관 후향적 관찰연구)

  • Kim, Min Gyun;Shin, Tae Gun;Jo, Ik Joon;Kim, Won Young;Ryoo, Seung Mok;Chung, Sung Phil;Beom, Jin Ho;Choi, Sung-Hyuk;Kim, Kyuseok;Jo, You Hwan;Kang, Gu Hyun;Suh, Gil Joon;Shin, Jonghwan;Lim, Tae Ho;Han, Kap Su;Hwang, Sung Yeon;Korean Shock Society (KoSS)
    • Journal of The Korean Society of Emergency Medicine
    • /
    • v.29 no.5
    • /
    • pp.465-473
    • /
    • 2018
  • Objective: We evaluated the clinical characteristics and prognoses of patients with septic shock who transferred to the emergency department (ED) in a tertiary referral center. Methods: This study was performed using a prospective, multi-center registry of septic shock, with the participation of 11 tertiary referral centers in the Korean Shock Society between October 2015 and February 2017. We classified the patients as a transferred group who transferred from other hospitals after meeting the inclusion criteria upon ED arrival and a non-transferred group who presented directly to the ED. Primary outcome was hospital mortality. We conducted multiple logistic regression analysis to assess variables related to in-hospital mortality. Results: A total of 2,098 patients were included, and we assigned 717 patients to the transferred group and 1,381 patients to the non-transferred group. The initial Sequential Organ Failure Assessment score was higher in the transferred group than the non-transferred group (6; interquartile range [IQR], 4-9 vs. 6; IQR, 4-8; P<0.001). Mechanical ventilator (29% vs. 21%, P<0.001) and renal replacement therapy (12% vs. 9%, P=0.034) within 24 hours after ED arrival were more frequently applied in the transferred group than the non-transferred group. Overall hospital mortality was 22% and there was no significant difference between transferred and non-transferred groups (23% vs. 22%, P=0.820). Multivariable analysis showed an odds ratio for in-hospital mortality of 1.00 (95% confidence interval, 0.78-1.28; P=0.999) for the transferred group compared with the non-transferred group. Conclusion: The transferred group showed higher severity and needed more organ support procedures than the non-transferred group. However, inter-hospital transfer did not affect in-hospital mortality.

Hemodynamic Instability after Patent Ductus Arteriosus Ligation in Very Low Birth Weight Infants (극소저체중출생아에서 동맥관 개존증 결찰술 후 발생한 혈역동학적 불안정성에 대한 고찰)

  • La, Kyong-Suk;Lee, Jang-Hoon;Choi, Byung-Min;Han, Heon-Seok;Hong, Young-Sook;Lee, Joo-Won
    • Neonatal Medicine
    • /
    • v.17 no.2
    • /
    • pp.201-206
    • /
    • 2010
  • Purpose: Recently, after patent ductus arteriosus (PDA) ligation in preterm infants, unexplained hemodynamic instabilities are reported. To determine the incidence, risk factors and clinical manifestations of hemodynamic instability after PDA ligation in very low birth weight (VLBW) infants. Methods: This retrospective multicenter study enrolled 18 VLBW infants who underwent PDA ligation from January 2002 to February 2008. Hemodynamic instability defined as unexplained cardiopulmonary dysfunction with increased dependency on mechanical ventilation and decreased blood pressure. Results: The mean gestational age and birth weight (BW) of all infants were $27^{+6}{\pm}1^{+6}$ weeks and 951${\pm}$245 g. Hemodynamic instability group (HI) included seven infants (39%) and hemodynamic stability group (HS) included 11 infants (61%). Compared to HS, HI had lower BW (1,033${\pm}$285 g vs. 821${\pm}$126 g, P=0.048) and weight on operation day (1,195${\pm}$404 g vs. 893${\pm}$151 g, P=0.042), longer hospital days (105${\pm}$29 vs. 141${\pm}$39, P=0.038), more severe bronchopulmonary dysplasia (BPD), (no/mild/moderate/severe, 2/5/2/2 vs. 0/1/2/4, P=0.038) and higher preoperative $FiO_2$ (0.29${\pm}$0.06 vs. 0.38${\pm}$0.09, P=0.02). One case of mortality due to sepsis, which was not associated with ligation, was observed among HS. Conclusion: The incidence of hemodynamic instability after PDA ligation in VLBW infants was 39%. Low BW, low weight on operation day and preoperative high $FiO_2$ might be risk factors of hemodynamic instability after PDA ligation in VLBW infants. The hemodynamic instability could increase the severity of BPD and hospital days.