• 제목/요약/키워드: Randomized response

검색결과 354건 처리시간 0.031초

위암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰 (Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for gastric cancer])

  • 한가진;성신;김성수;김진성;박재우
    • 대한한의학회지
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    • 제38권3호
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    • pp.124-142
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    • 2017
  • Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

Pioglitazone treatment decreases follicular fluid levels of tumor necrosis factor-${\alpha}$ and interleukin-6 in patients with polycystic ovary syndrome

  • Kim, Chung-Hoon;Ahn, Jun-Woo;You, Rae-Mi;Kim, Sung-Hoon;Chae, Hee-Dong;Kang, Byung-Moon
    • Clinical and Experimental Reproductive Medicine
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    • 제38권2호
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    • pp.98-102
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    • 2011
  • Objective: To investigate the effects of pioglitazone on controlled ovarian stimulation (COS), IVF outcomes, and follicular fluid (FF) cytokine concentrations in patients with polycystic ovary syndrome (PCOS). Methods: Eighty-six infertile patients with PCOS resistant to clomiphene citrate were randomized to receive pioglitazone (30 mg/day) or placebo on the starting day of oral contraceptive (OC) pretreatment, followed by an IVF protocol using a GnRH antagonist. Pioglitazone or placebo was administered once daily from the starting day of OC to the day of hCG injection. Results: Total dose and days of recombinant follicle-stimulating hormone administered, and the numbers of retrieved and mature oocytes, were significantly lower in the pioglitazone group than in the control group. FF tumor necrosis factor-${\alpha}$ (TNF-${\alpha}$) and interleukin-6 (IL-6) concentrations at oocyte retrieval were also significantly lower in the pioglitazone group. The clinical pregnancy rate was higher and the incidence of severe ovarian hyperstimulation syndrome was lower in the pioglitazone group, but the differences were not statistically significant. Conclusion: Pioglitazone reduces FF TNF-${\alpha}$ and IL-6 levels, and may improve ovarian response to COS in patients with PCOS.

Apical root canal cleaning after preparation with endodontic instruments: a randomized trial in vivo analysis

  • Fornari, Volmir Joao;Hartmann, Mateus Silveira Martins;Vanni, Jose Roberto;Rodriguez, Rubens;Langaro, Marina Canali;Pelepenko, Lauter Eston;Zaia, Alexandre Augusto
    • Restorative Dentistry and Endodontics
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    • 제45권3호
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    • pp.38.1-38.10
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    • 2020
  • Objectives: This study aimed to evaluate vital pulp tissue removal from different endodontic instrumentation systems from root canal apical third in vivo. Materials and Methods: Thirty mandibular molars were selected and randomly divided into 2 test groups and one control group. Inclusion criteria were a positive response to cold sensibility test, curvature angle between 10 and 20 degrees, and curvature radius lower than 10 mm. Root canals prepared with Hero 642 system (size 45/0.02) (n = 10) and Reciproc R40 (size 40/0.06) (n = 10) and control (n = 10) without instrumentation. Canals were irrigated only with saline solution during root canal preparation. The apical third was evaluated considering the touched/untouched perimeter and area to evaluate the efficacy of root canal wall debridement. Statistical analysis used t-test for comparisons. Results: Untouched root canal at cross-section perimeter, the Hero 642 system showed 41.44% ± 5.62% and Reciproc R40 58.67% ± 12.39% without contact with instruments. Regarding the untouched area, Hero 642 system showed 22.78% ± 6.42% and Reciproc R40 34.35% ± 8.52%. Neither instrument achieved complete cross-sectional root canal debridement. Hero 642 system rotary taper 0.02 instruments achieved significant greater wall contact perimeter and area compared to reciprocate the Reciproc R40 taper 0.06 instrument. Conclusions: Hero 642 achieved higher wall contact perimeter and area but, regardless of instrument size and taper, vital pulp during in vivo instrumentation is not entirely removed.

Proline, Sugars, and Antioxidant Enzymes Respond to Drought Stress in the Leaves of Strawberry Plants

  • Sun, Cunhua;Li, Xuehua;Hu, Yulong;Zhao, Pingyi;Xu, Tian;Sun, Jian;Gao, Xiali
    • 원예과학기술지
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    • 제33권5호
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    • pp.625-632
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    • 2015
  • Drought is a severe abiotic stress that affects global crop production. A drought model was created for 'Toyonoka' Fragaria ${\times}$ ananassa, and the effects of drought stress on contents of proline, sugars, and antioxidant enzyme activities were investigated. Strawberry transplants with identical growth were chosen for the experiments and the randomized design included four replications (10 plants per block). The experimental sets differed in the moisture level of the culture medium relative to the range of moisture content as follows: control, 70-85%; mild drought stress, 50-60%; moderate drought stress, 40-50%; and severe drought stress, 30-40%. Drought stress was imposed by limiting irrigation. Plants were sampled and physiological parameters w ere measured on 0, 2, 4, 6, 8, and 10 days after the commencement of droughts tress. The water potential of strawberry leaves decreased in the plants under mild, moderate, and severe stress during the course of the water stress treatment and exhibited a significant difference from the control. Strawberry leaves subjected to drought stress had higher accumulation of proline, sugars, and malondialdehyde, and higher activities of superoxide dismutase, peroxidase, and catalase than leaves of control plants. Malondialdehyde levels increased in parallel with the severity and duration of drought stress. By contrast, antioxidant enzyme activity displayed dynamic responses to drought stress, first increasing and subsequently decreasing as the severity and duration of drought stress increased. These results suggest that strawberry plants respond to drought stress by altering the activities of antioxidant enzymes and the levels of osmotically active metabolites. These biochemical response changes may confer adaptation to drought stress and improve the capacity of plants to withstand water-deficit conditions.

Calibration of Apis Mellifera Hives for Pollination of Brassica Crop at Rawalpindi

  • ABBASI, Khalida Hamid;RAZZAQ, Asif;JAMAL, Muhammad;KHANUM, Saeeda;JAWAD, Khawer;ULLAH, Muhammad Arshad
    • 식품보건융합연구
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    • 제6권2호
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    • pp.17-21
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    • 2020
  • The response of honeybee (Apis mellifera L.) pollination on canola yield with reference to most suitable number of bee hive need per unit area of crops in order to meet optimum pollination needs and better economic yields by comparing number of hives and yield components an experiment was conducted at Beekeeping and Hill Fruit Pests Research, Station Rawalpindi during 2017-18 in complete randomized block design with two sets of four treatments for comparison: 1 hive acre-1, 2 hives acre-1, 3 hives acre-1 and 0 hive acre-1. The hives were kept inside the experimental area. Parameters were assessed: pollination density, pollinator's diversity, agronomic and economic yield. In case of pollination density, the cumulative mean abundance bee species revealed that at 1200 hours, Apis mellifera was the most abundant and frequent visitor with a mean population of 8.69 bees/plant followed by A. dorsata (0.72), Syrphid fly (0.2) and other pollinators. Minimum bee population was observed during 1400 hours, mainly due to the closure of flowers and partially due to high temperature (>35℃). Pollinator diversity revealed that A. mellifera was the most dominant pollinator of Brassica crop with highest abundance (71%). A. dosata ranked 2nd (16%) followed by A. florea (6%) respectively.

A randomized study to establish the effects of spirulina in type 2 diabetes mellitus patients

  • Lee, Eun-Hee;Park, Ji-Eun;Choi, Young-Ju;Huh, Kap-Bum;Kim, Wha-Young
    • Nutrition Research and Practice
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    • 제2권4호
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    • pp.295-300
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    • 2008
  • Spirulina is a microscopic and filamentous cyanobacterium that contains essential amino acids, essential fatty acids, vitamins, minerals and anti-oxidative components. The purpose of this study was to examine effects of spirulina intervention in Korean patients with type 2 diabetes. The subjects were 37 type 2 diabetic patients who visited a diabetic clinic in Seoul and randomly assigned into spirulina (8 g/day) or control group. During the intervention period of 12 weeks, subjects were asked to keep usual diet and prohibited to take any functional foods or dietary supplements. Spirulina supplementation for 12 weeks did not affect anthropometric parameters, however, lowered plasma triglycerides level significantly (p<0.05). Spirulina supplementation also resulted in a significant reduction in plasma malondialdehyde level (p<0.05) and an increase in plasma adiponectin level (p<0.1). The lipid lowering effect of spirulina supplementation was different according to serum lipid levels of the subjects before entering the intervention. The subjects with higher initial triglyceride level showed higher reduction in plasma triglyceride and blood pressure. The subjects with higher initial total cholesterol and LDL-cholesterol level showed higher reduction in plasma concentrations of total cholesterol, LDL-cholesterol, IL-6, and blood pressure. It seems that spirulina supplementation is more effective in subjects with dyslipidemia. This study provides the evidence for beneficial effects of spirulina supplementation on blood lipid profiles, inflammatory variables, and antioxidant capacity in Korean patients with type 2 diabetes. The results suggest that spirulina is a promising agent as a functional food for diabetes management.

Montelukast Reduces Serum Levels of Eosinophil-Derived Neurotoxin in Preschool Asthma

  • Kim, Chang-Keun;Callaway, Zak;Park, Jin-Sung;Nishimori, Hisashi;Ogino, Tikatoshi;Nagao, Mizuho;Fujisawa, Takao
    • Allergy, Asthma & Immunology Research
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    • 제10권6호
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    • pp.686-697
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    • 2018
  • Purpose: Several markers for eosinophilic inflammation have been proposed to predict response to asthma treatment. However, definitive criteria for treatment decisions have not yet been established. We investigate a potentially useful relatively non-invasive biomarker, eosinophil-derived neurotoxin (EDN), to predict favorable responses to budesonide or montelukast, common treatment for children with asthma. Methods: Young children (1 to 6 years old) were enrolled in this randomized, parallel, 2-group, open-label trial. Criteria for eligibility included: 1) being symptomatic during the run-in period; and 2) having a serum EDN (sEDN) level ${\geq}53ng/mL$, with positive specific immunoglobulin E to house dust mite. Eligible patients were randomly placed into 2 groups: the BIS group received budesonide inhalation suspension (BIS) 0.5 mg once daily; the MONT group received montelukast 4 mg once daily. Ineligible patients were invited to receive montelukast 4 mg once daily (OBS group). Treatment period was 12 weeks. Results: Asthma control days increased significantly in the BIS and MONT groups (P < 0.000) over the 12-week study period. There was no significant change in sEDN in the BIS group but there was a significant decrease in the MONT group (P < 0.000). Patients in the OBS group with high EDN levels (> 53 ng/mL) showed a significant decrease due to MONT treatment (P = 0.023). Rescue medication usage significantly decreased in the BIS and MONT groups (P < 0.000). Conclusions: EDN is a useful relatively non-invasive biomarker for predicting responses to montelukast and budesonide treatment of preschool children with beta2-agonist responsive recurrent wheeze and multiple-trigger wheeze (Trial registry at UMIN Clinical Trials Registry, UMIN000008335).

소화성 궤양에 대한 오패산의 치료효과 : 체계적 문헌고찰과 메타분석 (The Effect of Opae-san for Peptic Ulcer Disease: A Systematic Review and Meta-Analysis)

  • 이유리;조나경;김경순;최홍식;김승모
    • 대한한방내과학회지
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    • 제39권6호
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    • pp.1136-1149
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    • 2018
  • Objectives: The aim of this study was to perform a meta analysis of randomized controlled trials (RCTs) that applied Opae-san to peptic ulcer. Methods: The databases NDSL, RISS, KISS, KISTI, Oasis, DBpia, Cochrane, EMBASE, Pubmed, and CNKI were searched to identify RCTs that evaluated the therapeutic response to Opae-san on peptic ulcer. The selected studies were assessed using Cochrane Group's risk of bias tool. Results: 12 RCTs were selected from a total of 312 identified. Combined therapies of Opae-san plus triple therapy were superior to only triple therapy in achieving the effective rate (risk ratio=1.26, 95% CI: 1.17 to 1.35, p<0.001, I2=0%), the helicobacter pylori eradication rate (risk ratio=1.23, 95% CI: 1.12 to 1.34, p<0.001, I2=7%) and the recurrence rate (risk ratio=0.31, 95% CI: 0.12 to 0.82, p=0.02, I2=0%). But only Opae-san was not superior in achieving the effective rate compared to anti gastric secretion drugs. Conclusions: The current evidence suggests that combined therapies of Opae-san plus triple therapy yield a higher effective rate, and helicobacter pylori eradication rate and a lower recurrence rate. However, in most of these studies, it is difficult to evaluate the bias and therefore better designed studies are needed.

층화 및 층화 이표본 조건부 무관질문모형 (A Stratified and Two Sample Stratified Conditional Unrelated Question Model)

  • 이기성
    • Journal of the Korean Data Analysis Society
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    • 제20권6호
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    • pp.2883-2893
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    • 2018
  • 본 논문에서는 모집단이 층으로 구성되어 있고 얻고자 하는 속성이 민감할 때, 덜 민감한 속성 B와 강요응답으로 구성되어 있는 확률장치를 통해 "예"라고 응답한 사람들에게만 민감한 속성 A 와 무관한 속성 Y를 포함하고 있는 Greenberg et al.(1969)의 무관질문모형을 사용하도록 하여 모집단이 층화된 경우 층화추정을 위한 층화 조건부 무관질문모형을 제안하였다. 그리고 제안한 층화 조건부 무관질문모형에서 각 층에 표본을 배분할 때 비례배분과 최적배분 문제를 다루었다. 또한 층화 조건부 무관질문모형을 무관한 속성이 미지인 경우 두 개의 독립표본을 이용하는 층화 이표본 조건부 무관질문모형으로 확장하였으며, 제안한 층화 이표본 조건부 무관질문모형의 두 번째 단계에서 사용되는 h층의 표본의 크기에 대한 최적값을 도출하여 최소분산을 구하였다. 마지막으로 층화 조건부 무관질문모형이 층화 무관질문모형과 층화 Carr et al.(1982)의 모형보다 효율적이 되는 조건을 제시하여 일정한 조건하에서 제안한 모형이 기존 모형들보다 효율적임을 보였으며, 제안한 층화 조건부 무관질문모형이 ${\pi}_{h2}$ 값이 작고 ${\pi}_{hy}$ 값이 작을수록 층화 Carr et al.(1982)의 모형보다 효율적임을 수치적으로 보였다.

간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰 (Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial on Herbal Medicinal Product for Liver Cancer])

  • 한가진;김동훈;박은주;성신;김성수;임정태
    • 대한한방내과학회지
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    • 제40권1호
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    • pp.89-116
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    • 2019
  • Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."