• 제목/요약/키워드: Multicenter clinical study

검색결과 154건 처리시간 0.029초

Protocol of a Nationwide Observational Study among Patients with Nontuberculous Mycobacterium Pulmonary Disease in South Korea (NTM-KOREA)

  • Kwak, Nakwon;Choi, Hongjo;Jeon, Doosoo;Jhun, Byung Woo;Jo, Kyung-Wook;Kang, Young Ae;Kwon, Yong-Soo;Lee, Myungsun;Mok, Jeongha;Shim, Tae-Sun;Shin, Hong-Joon;Whang, Jake;Yim, Jae-Joon
    • Tuberculosis and Respiratory Diseases
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    • 제83권2호
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    • pp.141-146
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    • 2020
  • Background: The burden of nontuberculous mycobacterial (NTM) pulmonary disease (PD) is increasing globally. To understand the treatment outcomes and prognosis of NTM-PD, a unified registry is needed. In this project, we aim to construct a multicenter prospective observational cohort with NTM-PD in South Korea (NTM-KOREA). Methods: The primary objective of this study is to analyze treatment outcomes according to the species. In addition, recurrence rate, adverse events, the impact of each drug on treatment outcomes as well as the impact of characteristics of mycobacteriology will be analyzed. The inclusion criteria for the study are as follows: fulfilling the criteria for NTM-PD having one of the following etiologic organisms: Mycobacterium avium complex, M. abscessus subspecies abscessus, M. abscessus subspecies massiliense, or M. kansasii; receiving the first treatment for NTM-PD after enrollment; age >20 years; and consenting to participate in the study. Seven institutions will participate in patient enrollment and about 500 patients are expected to be enrolled. Participants will be recruited from 1 March 2020 until 19 March 2024 and will be observed through 19 March 2029. During the follow-up period, participants' clinical course will be tracked and their clinical data as well as NTM isolates will be collected. Conclusion: NTM-KOREA will be the first nationwide observational cohort for NTM-PD in South Korea. It will provide the information to optimize treatment modalities and will contribute to deeper understanding of the treatment outcomes and long-term prognosis of patients with NTM-PD in South Korea.

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

  • 허재홍;최상천;임용균;샘슨램포탕;박은정
    • 대한임상독성학회지
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    • 제14권2호
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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.

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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    • 제8권1호
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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.

Calcific tendinitis of the shoulder in the Korean population: demographics and its relation with coexisting rotator cuff tear

  • Yoo, Yon-Sik;Park, Jin-Young;Kim, Myung-sun;Cho, Nam-Su;Lee, Yong-Beom;Cho, Seung-Hyun;Park, Kyoung Jin;Cho, Chul-Hyun;Lee, Bong Gun;Shin, Dong Joo;Kim, Han-Hoon;Lim, Tae Kang
    • Clinics in Shoulder and Elbow
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    • 제24권1호
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    • pp.21-26
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    • 2021
  • Background: To evaluate the demographics, clinical and radiographic features of calcific tendinitis of the shoulder in the Korean population, specifically focusing on the incidence of coexisting rotator cuff tear. Methods: Between October 2014 and January 2015, we performed a prospective multicenter study with 506 patients from 11 training hospitals in Korea. We collected data of demographics and radiographic analysis based on simple radiographs, clinical assessments based on visual analog scale (VAS) and the American Shoulder Elbow Surgeons (ASES) score, and treatment modalities that are used currently. We also evaluated coexisting rotator cuff tear by ultrasonography (US) or magnetic resonance imaging (MRI) images. Results: There were 402 female patients (79%) with mean age of 55 years (range, 31-87 years). Mean duration of symptoms was 16 months. Mean size of calcific materials was 11.4 mm (range, 0-35 mm). Mean value of VAS and ASES scores were 6.5 (range, 1-10) and 47 (range, 8-95), respectively. Of 383 patients (76%), 59 (15%) had rotator cuff tear including 15 full-thickness tears on US or MRI. Patients with rotator cuff tears were significantly associated with older age, recurrent symptoms, menstrual disorders in females, and having undergone calcification removal surgery and rotator cuff repair (all p<0.05). Conclusions: This study reported demographic, radiographic, and clinical features of calcific tendinitis of the shoulder in Korean population, which were not different from those of Western population. Coexisting rotator cuff tear was found with 15% incidence in this large series, suggesting that further radiographic study to evaluate rotator cuff tear might be needed in some calcific tendinitis patients of older age and presenting with recurrent symptoms.

일반건강특성에 영향을 미치는 사상체질의 심리적, 신체적 요인에 대한 연구 (Study on the Effects of Sasang Psychobiological Factors on General Health Status)

  • 채한;김윤희;박수현;황의형;권영규;이수진
    • 동의생리병리학회지
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    • 제28권4호
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    • pp.452-459
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    • 2014
  • The purpose of this study was to examine the correlation between general health condition and biopsychological traits of Sasang typology which determines the disease susceptibility and treatment responses. We had Korean Constitutional Multicenter Bank (KCMB) listed 1156 participants for measuring Sasang Personality Questionnaire (SPQ) and Body Mass Index (BMI) for biopsychological traits of each Sasang types as well as Short Form 12 (SF12) for general health status. All the analysis was performed with consideration of gender and age. We analyzed the differences in general health status between Sasang types and the correlation between general health status and biopsychological traits of Sasang typology. We also analyzed how much the selected SF12 subscales can be explained with biopsychosocial characteristics. There were no generaliszable differences among Sasang type groups in SF12, no significant correlation between biopsychological traits and SF12 Physical and Mental Component Summary. We found that there were significant correlations between SPQ-Behavior subscale and SF12 Vitality, and the regression model with SPQ-Behavior, SPQ-Emotionality, age and sex can predict 15.4% of the total variances in SF12 Vitality. We discussed the possibility that the Sasang typology is not a determinant of general health status but a moderator for the susceptibility and response. This study would contribute to the development of Sasang type-specific life nurturing program focusing on the psychological perspectives.

A Novel Implantable Cerebrospinal Fluid Reservoir : A Pilot Study

  • Byun, Yoon Hwan;Gwak, Ho Shin;Kwon, Ji-Woong;Kim, Kwang Gi;Shin, Sang Hoon;Lee, Seung Hoon;Yoo, Heon
    • Journal of Korean Neurosurgical Society
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    • 제61권5호
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    • pp.640-644
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    • 2018
  • Objective : The purpose of this pilot study was to examine the safety and function of the newly developed cerebrospinal fluid (CSF) reservoir called the V-Port. Methods : The newly developed V-Port consists of a non-collapsible reservoir outlined with a titanium cage and a connector for the ventricular catheter to be assembled. It is designed to be better palpated and more durable to multiple punctures than the Ommaya reservoir. A total of nine patients diagnosed with leptomeningeal carcinomatosis were selected for V-Port insertion. Each patient was followed up for evaluation for a month after the operation. Results : The average operation time for V-Port insertion was 42 minutes and the average incision size was 6.6 cm. The surgical technique of V-Port insertion was found to be intuitive by all neurosurgeons who participated in the pilot study. There was no obstruction or leakage of the V-Port during intrathecal chemotherapy or CSF drainage. Also, there were no complications including post-operative intracerebral hemorrhage, infection and skin problems related to the V-Port. Conclusion : V-Port is a safe and an easy to use implantable CSF reservoir that addresses problems of other implantable CSF reservoirs. Further multicenter clinical trial is needed to prove the safety and the function of the V-Port.

Multicenter Evaluation of Patients with Cutaneous Malignant Melanoma in Turkey: MELAS Study

  • Uysal-Sonmez, Ozlem;Tanriverdi, Ozgur;Esbah, Onur;Uyeturk, Ummugul;Helvaci, Kaan;Bal, Oznur;Yalcintas-Arslan, Ulku;Budakoglu, Burcin;Oksuzoglu, Berna
    • Asian Pacific Journal of Cancer Prevention
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    • 제14권1호
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    • pp.533-537
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    • 2013
  • Background: Malignant melanoma is a cancer that demonstrates rapid progression and atypical clinically features with a poor prognosis. Aim: This study was performed to determine the clinical characteristics and treatment outcomes of patients with malignant melanoma in Turkey. Methods: The medical records of 98 patients between 2007-2012 at our centers were retrieved from the patient registry. Overall survival (OS) was calculated using the Kaplan-Meier method. Results: In our study, with the median follow-up of all patients with cutaneous MM of 46.3 months, the median OS rate of all cases was 43.6 months and 5-year OS was 48.6%. However, five-year OS rates of patients with localized disease (stage I-II) and node involvement (stage III) were 60.3% and 39.6%, respectively. The median OS of stage IV patients was 8.7 months and 1-year OS rate was 26.2%. We showed that advanced stage, male gender, and advanced age in all patients with MM were significant prognostic factors of OS. Conclusions: Compared with the results of current studies from Western countries, we found similar findings concerning demographical features, histological variables and survival analyses for our patients with cutaneous MM in Turkey.

Outcome of complete acellular dermal matrix wrap with polyurethane implant in immediate prepectoral breast reconstruction

  • Naemonitou, Foteini;Mylvaganam, Senthurun;Salem, Fathi;Vidya, Raghavan
    • Archives of Plastic Surgery
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    • 제47권6호
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    • pp.567-573
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    • 2020
  • Background Polyurethane implants have been used on and off in breast reconstruction since 1991 while prepectoral breast reconstruction has gained popularity in recent times. In this study, we present our outcomes from the use of acellular dermal matrix (ADM) complete wrap with polyurethane implants in prepectoral breast reconstruction. Methods This is a retrospective review of prospectively maintained database from 41 patients receiving complete ADM wrap with prepectoral polyurethane implants over a 3-year period. Selection criteria were adapted from a previous study (4135 Trust Clinical Audit Database) evaluating prepectoral reconstruction with Braxon matrices. Patient demographics, operative data, surgical complications, and outcomes were collected and analyzed. Results A total of 52 implant reconstructions were performed in 41 patients with a mean follow-up of 14.3 months (range, 6-36 months). The overall reported complication rates including early (less than 6 weeks) and late complications. Early complications included two patients (4.9%) with wound dehiscence. One of which had an implant loss that was salvageable. Another patient (2%) developed red-breast syndrome and two women (4.9%) developed with seroma treated conservatively. Late complications included one patient (2%) with grade II capsular contraction, 12 patients with grade I-II rippling and two patients (4.9%) with grade III rippling. Conclusions We present our experience of prepectoral polyurethane implant using complete ADM wrap. This is one of the few papers to report on the outcome of the prepectoral use of polyurethane in immediate implant-based breast reconstruction. Our early observational series show satisfactory outcome and long-term results are warranted by a large multicenter study.

Effect of loading time on the survival rate of anodic oxidized implants: prospective multicenter study

  • Kim, Seok-Gyu;Yun, Pil-Young;Park, Hyun-Sik;Shim, June-Sung;Hwang, Jung-Won;Kim, Young-Kyun
    • The Journal of Advanced Prosthodontics
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    • 제4권1호
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    • pp.18-23
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    • 2012
  • PURPOSE. The purpose of this prospective study was to evaluate the effect of early loading on survival rate or clinical parameter of anodic oxidized implants during the 12- month postloading period. MATERIALS AND METHODS. Total 69 implants were placed in 42 patients. Anodic oxidized implants (GS II, Osstem Cor., Busan, Korea) placed on the posterior mandibles were divided into two groups, according to their prosthetic loading times: test group (2 to 6 weeks), and control group (3 to 4 months). The implant survival rates were determined during oneyear postloading period and analyzed by Kaplan-Meier method. The radiographic peri-implant bone loss and periodontal parameters were also evaluated and statistically analyzed by unpaired t-test. RESULTS. Total 69 implants were placed in 42 patients. The cumulative postloading implant survival rates were 88.89% in test group, compared to 100% in control group (P<.05). Periimplant marginal bone loss (T: $0.27{\pm}0.54$ mm, C: $0.40{\pm}0.55$ mm) and periodontal parameters showed no significant difference between the groups (P>.05). CONCLUSION. Within the limitation of the present study, implant survival was affected by early loading on the anodic oxidized implants placed on posterior mandibles during one-year follow-up. Early implant loading did not influence peri-implant marginal bone loss, and periodontal parameters.

상급종합병원 입원환자의 욕창발생 위험예측을 위한 Braden Scale의 타당도 검증 (Determining Optimal Cut-off Score for the Braden Scale on Assessment of Pressure Injury for Tertiary Hospital Inpatients)

  • 박숙현;최혜연;손연정
    • 중환자간호학회지
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    • 제16권3호
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    • pp.24-33
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    • 2023
  • Purpose : This study aims to establish an optimal cut-off score on the Braden scale for the assessment of pressure injury to detect pressure injury risks among inpatients in a South Korean tertiary hospital. Methods : This retrospective study used electronic medical records, from January to December 2022. A total of 654 patients were included in the study. Of these, 218 inpatients with pressure injuries and 436 without pressure injuries were classified and analyzed using 1:2 Propensity Score Matching (PSM), and the generalized estimating equation was performed using SPSS Version 26 and the R Machlt package program. Results : The cut-off value on the Braden scale for distinguishing pressure injury was 17 points, and the AUC (area under the ROC curve) was 0.531 (0.484-0.579). The sensitivity was 56.6% (45.5-67.7%) and the specificity was 69.7% (66.0-73.4%). With 17 points, the Braden scale cut-off distinguished those who had pressure injuries from those who did not at the time of admission (p < .03). In the pressure injury group, the Braden score on the day of the pressure injury was 14, with significant results in all subcategories except the moisture category. Conclusion : Our findings revealed that a cut-off value of 17 was optimal for predicting the risk of pressure injuries among tertiary hospital inpatients. Future studies should evaluate the optimal cut-off values in different clinical environments. Additionally, it is necessary to conduct multicenter large sample studies to verify the effectiveness of a 17 value in PI risk assessments.