• Title/Summary/Keyword: Multicenter study

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Flumazenil administration in suspected patients with acute hypnotics and sedatives poisoning: risk-benefit re-evaluation (급성 진정제 중독 추정 환자에서 플루마제닐의 투여: 위험도/이익 재평가)

  • Huh, Jae Hong;Choi, Sang Chun;Lim, Yong Gyun;Lampotang, Samsun;Park, Eung Jung
    • Journal of The Korean Society of Clinical Toxicology
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    • v.14 no.2
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    • pp.92-99
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    • 2016
  • Purpose: The use of flumazenil administration in the emergency department is still controversial because of concerns about adverse effects. The present study was conducted to re-evaluate the risk-benefit ratio associated with flumazenil administration to patients suspected of having acute hypnotics and sedatives poisoning in the emergency department. Methods: A retrospective chart review study was conducted for patients whose final diagnoses were "poisoning" and "benzodiazepine" or "sedatives-hypnotics" from Mar. 2006 to Feb. 2015. The basal characteristics of the patients, including past medical history, ingredients and dose of ingested drug and co-ingested drugs were investigated. For patients administered flumazenil, responsiveness and time from admission to flumazenil administration were investigated with supplement. All collected data were analyzed in aspect terms of risk/benefit. Results: A total of 678 patients were included in our study. Benzodiazepine was the most common sedative/hypnotic drug prescribed, and the frequency of prescription continuously increased. The proportion of TCA as co-ingestion decreased from 13.1% to 3.9% in patients with acute sedative/hypnotic poisoning. Flumazenil was administered to 55 patients (8.1%), of which 29 patients (52.7%) were applied to contraindications. Fifty-three patients (96.4%) showed positive responsiveness, including partial responsiveness after flumazenil administration. No severe adverse events were identified. Conclusion: Based on the current trends in prescription patterns for sedative/hypnotic drugs, increased use of non-TCA antidepressants, and responsiveness to administration of flumazenil, benefit seemed weighted more in this study, although the observed benefits were based on limited results. Further prospective multicenter studies will be needed to optimize benefit-risk ratio.

Analysis of maxillofacial prosthetics at university dental hospitals in the capital region of Korea

  • Kim, Jee-Hwan;Shin, Soo-Yeon;Paek, Janghyun;Lee, Jong-Ho;Kwon, Ho-Beom
    • The Journal of Advanced Prosthodontics
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    • v.8 no.3
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    • pp.229-234
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    • 2016
  • PURPOSE. The purpose of this study was to investigate the demographic patterns of maxillofacial prosthetic treatment to identify the characteristics and geographic distribution of patients with maxillofacial prosthetics in the capital region of Korea. MATERIALS AND METHODS. This retrospective analytical multicenter study was performed by chart reviews. This study included patients who visited the department of prosthodontics at four university dental hospitals for maxillofacial prosthetic rehabilitation. Patients with facial and congenital defects or with insufficient medical data were excluded. The patients were classified into three categories based on the location of the defect. Patients' sex, age, and residential area were analyzed. Pearson's chi-square test with a significance level of 0.05 was used to analyze the variables. RESULTS. Among 540 patients with maxillofacial prosthetics, there were 284 (52.59%) male patients and 256 (47.41%) female patients. The number of the patients varied greatly by hospital. Most patients were older than 70, and the most common defect was a hard palate defect. Chi-square analysis did not identify any significant differences in sex, age, and distance to hospital for any defect group (P>.05). CONCLUSION. The results of this study indicated that there was imbalance in the distribution of patients with maxillofacial prosthetic among the hospitals in the capital region of Korea. Considerations on specialists and insurance policies for the improvement of maxillofacial prosthetics in Korea are required.

Temozolomide during and after Radiotherapy for Newly Diagnosed Glioblastomas : A Prospective Multicenter Study of Korean Patients

  • Joo, Jin-Deok;Chang, Jong-Hee;Kim, Jeong-Hoon;Hong, Yong-Kil;Kim, Young-Hoon;Kim, Chae-Yong
    • Journal of Korean Neurosurgical Society
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    • v.52 no.2
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    • pp.92-97
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    • 2012
  • Objective : This study was performed to determine the safety and outcome of concurrent chemoradiotherapy (CCRT) and adjuvant chemotherapy with temozolomide for Korean patients with a newly diagnosed glioblastoma. Methods : Patients were recruited from four institutions between 2004 and 2007. The patients received fractionated focal irradiation in daily fractions of 2 Gy given 5 days per week for 6 weeks and daily temozolomide, followed by 6 cycles of adjuvant temozolomide. The primary endpoint was overall survival (OS) and the secondary endpoints were progression-free survival (PFS), response, and safety. Results : A total of 103 patients were enrolled in this study. Ninety-six patients (93%) completed the CCRT and 54 patients (52%) received 6 cycles of adjuvant temozolomide. The response rate was 73% (53/73) and the tumor control rate was 92% (67/73). Of the 96 patients who completed the CCRT, the median OS was 18.0 months and the 1- and 2-year OS rates were 74 and 38%, respectively. The median PFS was 10.0 months and the 1- and 2-year PFS rates were 33 and 16%, respectively. The only significant prognostic factor of survival was the extent of surgical resection (p<0.05). CCRT resulted in grade 3 or 4 hematologic toxic effects in 8% of patients. No opportunistic infections were noted. Conclusion : This study is the first prospective multi-institutional report of CCRT and adjuvant chemotherapy with temozolomide for patients with a newly diagnosed glioblastoma in Korea. The current protocol may prolong the survival of Korean patients with a glioblastoma and may be tolerable in terms of toxicity.

Nutritional education for management of osteodystrophy (NEMO) trial: Design and patient characteristics, Lebanon

  • Karavetian, Mirey;Abboud, Saade;Elzein, Hafez;Haydar, Sarah;de Vries, Nanne
    • Nutrition Research and Practice
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    • v.8 no.1
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    • pp.103-111
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    • 2014
  • This study aims to determine the effect of a trained dedicated dietitian on clinical outcomes among Lebanese hemodialysis (HD) patients: and thus demonstrate a viable developing country model. This paper describes the study protocol and baseline data. The study was a multicenter randomized controlled trial with parallel-group design involving 12 HD units: assigned to cluster A (n = 6) or B (n = 6). A total of 570 patients met the inclusion criteria. Patients in cluster A were randomly assigned as per dialysis shift to the following: Dedicated Dietitian (DD) (n = 133) and Existing Practice (EP) (n = 138) protocols. Cluster B patients (n = 299) received Trained Hospital Dietitian (THD) protocol. Dietitians of the DD and THD groups were trained by the research team on Kidney Disease Outcomes Quality Initiative nutrition guidelines. DD protocol included: individualized nutrition education for 2 hours/month/HD patient for 6 months focusing on renal osteodystrophy and using the Trans-theoretical theory for behavioral change. EP protocol included nutrition education given to patients by hospital dietitians who were blinded to the study. The THD protocol included nutrition education to patients given by hospital dietitian as per the training received but within hospital responsibilities, with no set educational protocol or tools. Baseline data revealed that 40% of patients were hyperphosphatemics (> 5.5 mg/dl) with low dietary adherence and knowledge of dietary P restriction in addition to inadequate daily protein intake ($58.86%{\pm}33.87%$ of needs) yet adequate dietary P intake ($795.52{\pm}366.94$ mg/day). Quality of life (QOL) ranged from 48-75% of full health. Baseline differences between the 3 groups revealed significant differences in serum P, malnutrition status, adherence to diet and P chelators and in 2 factors of the QOL: physical and social functioning. The data show room for improvement in the nutritional status of the patients. The NEMO trial may be able to demonstrate a better nutritional management of HD patients.

Analysis of Korean Medicine Treatment in Children with Cerebral Palsy (뇌성마비 아동의 한의치료 양상 분석)

  • Jeong, Hyunwoo;Hur, Youngjin;Yun, Youngju
    • The Journal of Korean Medicine
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    • v.40 no.1
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    • pp.12-23
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    • 2019
  • Objectives: The purpose of this study was to analyze the aspects of the Korean medicine (KM) treatment among children with cerebral palsy (CP) according to the disease characteristics. Methods: In a prospective observational multicenter study for children with CP, we analyzed 78 baseline questionnaires of children having experience of KM treatments such as acupuncture and Korean herbal medicine and 43 follow-up data of children who have received KM during the one observation year. Results: Of all the 182 participants, 38 children were currently getting KM treatment and 40 children have discontinued KM treatment. Children with non-spastic CP and more health problems tended to use KM. The most frequent reason for quitting acupuncture therapy was 'suffering of children' and the highest reason of stopping herbal medicine was 'rejection of children'. Among the 133 participants finished one year follow-up, 43 children have received at least one KM treatment. The average number of acupuncture therapy was twice a week and the average monthly cost of acupuncture therapy and herbal medicine were 65,922 won and 476,003 won, respectively. Children under 32 month old have received significantly more acupuncture and children with non-spastic CP have taken significantly more herbal medicine. Conclusions: Further study will be required to confirm the effectiveness of KM and increase the utilization of KM among the children with CP. More efforts should be made to increase the convenience of acupuncture therapy and herbal medicine and to expand the insurance coverage of KM for children with CP.

An analysis of patients referred to the advanced general hospital pain clinic center: multicenter study in province of Jeollabuk-do, Korea (3차 병원 통증 클리닉에 의뢰되어 오는 환자들의 특성 분석: 전라북도 지역의 다기관 연구)

  • Kim, Yeon-dong;Lee, Cheolhyeong
    • Journal of the Korea Convergence Society
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    • v.12 no.2
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    • pp.311-316
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    • 2021
  • The number of patients referred to pain clinic is increasing. The purpose of this study was to describe and understand characteristic of patients referred to the tertiary pain clinic. This study was conducted on 587 patients who had been referred to pain clinics at three university hospitals in the Jeollabuk-do region from January 2011 to December 2015. The data was retrospectively collected on a record sheet prepared in the clinic. we analyzed these patients according to their age, sex, chief complaint, pain location, coexisting disease, referring department, referral causes. There were various medical problems addressed by a pain clinic consultation. It is reasonable to develop standardized guidelines for pain management. To do so, it is necessary to identify the characteristics of the patients. A study with more patients in another area will be helpful in characterizing the patients referred to the pain clinic in Korea.

The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP- (소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.1
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

A multicenter clinical study of installed US II Plus/GS II Osstem implants after bone graft (골 이식술 후 Osstem Implant (US II Plus/GS II)의 다기관 임상연구)

  • Chung, Kwang;Oh, Chul-Jung;Ha, Ji-Won;Kook, Min-Suk;Park, Hong-Ju;Oh, Hee-Kyun;Kim, Su-Gwan;Kim, Young-Kyun;Kim, Woo-Cheol
    • The Journal of the Korean dental association
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    • v.50 no.12
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    • pp.743-754
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    • 2012
  • urpose : The purpose of this study was to evaluate the US II plus/GS II Osstem$^{(R)}$ implants through the study for the clinical success rate during the installation of the Osstem¢Á implants after bone graft. Materials and Methods : This study was researched in the 4 medical institutions: Chonnam National University, Chosun University, Bundang Seoul National University Hospital, and FM dental clinic from May, 2002 to September, 2009. Based on the total number of 60 patients whose treatment was the installation of the US II plus/GS II Osstem¢Á implants after bone graft, we evaluated success rate of implants. We analysis the distribution of patient's age and gender, edentulous area, bone type, fixture length and diameter, installation and loading time, donor site, bone graft material and method, antagonistic teeth, and survival and success rate. From these analyses we got the following results. Results : 1. In this study, the total number of patients who have been installed with US II plus implant was 27, and total of 52 implants were installed. The average age was 38.9, with 16 male, and 11 female patients. 2. The total number of patients who have been installed with GS II implant was 33, and total of 54 implants were installed. The average age was 49.7, with 24 male, and 9 female patients. 3. As for bone graft method, either autogenous bone or a mix of autogenous and heterogenous bone was used(88.4%) for US II plus. Chin, iliac, and Maxillary tuberosity were the donor sites for autogenous bone graft, and onlay method of bone graft was performed. 4. Allogenic bone or a mix of autogenous and heterogenous bone was used(77.8%) for GS II. Chin, ramus, and tibia were the donor sites for autogenous bone graft, and GBR method of bone graft was performed. 5. The duration from the installation of implants to setting of final prosthesis was average of 16 months and 10 months for US II plus and GS II respectively. Also, the final follow up period was average of 31 months and 28 months respectively. During this period, one GS II implant was removed from 1 patient due to failure of early osteointegration. 6. The survival rates were 100% and 98.1%, and success rates were 94.2% and 94.4% for US II plus and GS II implant respectively. Conclusion : On the evaluation of our clinical study, both US II plus and GS II Osstem¢Á implants showed the excellent clinical results after bone graft.

Diabetes Mellitus as a Risk Factor for High Grade Renal Cell Carcinoma

  • Otunctemur, Alper;Ozbek, Emin;Sahin, Suleyman;Dursun, Murat;Besiroglu, Huseyin;Koklu, Ismail;Erkoc, Mustafa;Danis, Eyyup;Bozkurt, Muammer;Gurbuz, Ahmet
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.9
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    • pp.3993-3996
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    • 2014
  • Background: Diabetes is a chronic disease characterized by impaired fasting blood glucose that leads to disturbances in various organs. In this study, we evaluated relationships between tumor size and grade in a population of diabetic and non-diabetic patients with renal cell carcinoma. Materials and Methods: Between 2007-2013, in our clinic radical nephrectomy performed to 310 patients for renal tumors and pathology reported renal cell carcinoma cases were enrolled in the study. Patients with and without a history of diabetes regarding fasting glucose and HgA1c levels were evaluated during surgery for tumor size and Fuhrman grade. Results: Diabetes was found in 95 patients. The mean age of the patients with and without diabetes mellitus was 64.3 (40-79) and 58.4 (31-87) years, respectively. In the diabetes group 51% of patients had a tumor size over 7 cm and 54% a tumor grade over Fuhrman 3. The respective figures in the non-diabetes group were 35% and 30% (p<0.05 in both cases). Conclusions: Renal cancer appears more aggressive in patients with diabetes. In this study lifestyle and risk factors with diabetes regulation were observed to be important for renal cancer patients. Multicenter studies are needed in larger series for more accurate results.

Reduction of the cetrorelix dose in a multiple-dose antagonist protocol and its impact on pregnancy rate and affordability: A randomized controlled multicenter study

  • Dawood, Ayman S.;Algergawy, Adel;Elhalwagy, Ahmed
    • Clinical and Experimental Reproductive Medicine
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    • v.44 no.4
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    • pp.232-238
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    • 2017
  • Objective: To determine whether reducing the cetrorelix dose in the antagonist protocol to 0.125 mg had any deleterious effects on follicular development, the number and quality of retrieved oocytes, or the number of embryos, and to characterize its effects on the affordability of assisted reproductive technology. Methods: This randomized controlled study was conducted at the Fertility Unit of Tanta Educational Hospital of Tanta University, the Egyptian Consultants' Fertility Center, and the Qurrat Aien Fertility Center, from January 1 to June 30, 2017. Patients' demographic data, stimulation protocol, costs, pregnancy rate, and complications were recorded. Patients were randomly allocated into two groups: group I (n = 61) received 0.125 mg of cetrorelix (the study group), and group II (n = 62) received 0.25 mg of cetrorelix (the control group). Results: The demographic data were comparable regarding age, parity, duration of infertility, and body mass index. The dose of recombinant follicle-stimulating hormone units required was $2,350.43{\pm}150.76$ IU in group I and $2,366.25{\pm}140.34$ IU in group II, which was not a significant difference (p= 0.548). The duration of stimulation, number of retrieved oocytes, and number of developed embryos were not significantly different between the groups. The clinical and ongoing pregnancy rates likewise did not significantly differ. The cost of intracytoplasmic sperm injection per cycle was significantly lower in group I than in group II (US $ $494.66{\pm}4.079$ vs. US $ $649.677{\pm}43.637$). Conclusion: Reduction of the cetrorelix dose in the antagonist protocol was not associated with any significant difference either in the number of oocytes retrieved or in the pregnancy rate. Moreover, it was more economically feasible for patients in a low-resource country.