• Title/Summary/Keyword: Randomized response

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Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: preliminary results of a randomized controlled trial

  • Aghili, Mahdi;Khalili, Nastaran;Khalili, Neda;Babaei, Mohammad;Farhan, Farshid;Haddad, Peiman;Salarvand, Samaneh;Keshvari, Amir;Fazeli, Mohammad Sadegh;Mohammadi, Negin;Ghalehtaki, Reza
    • Radiation Oncology Journal
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    • v.38 no.2
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    • pp.119-128
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    • 2020
  • Purpose: Colorectal cancer is becoming an increasing concern in the middle-aged population of Iran. This study aimed to compare the preliminary results of short-course and long-course neoadjuvant chemoradiotherapy treatment for rectal cancer patients. Materials and Methods: In this clinical trial we recruited patients with rectal adenocarcinoma located from 5 cm to 15 cm above the anal verge. Patients in group I (short-course) received three-dimensional conformational radiotherapy with a dose of 25 Gy/5 fractions in 1 week plus concurrent XELOX regimen (capecitabine 625 mg/㎡ from day 1-5 twice daily and oxaliplatin 50 mg/㎡ on day 1 once daily). Patients in group II (long-course) received a total dose of 50-50.4 Gy/25-28 fractions for 5 to 5.5 weeks plus capecitabine 825 mg/㎡ twice daily. Both groups underwent consolidation chemotherapy followed by delayed surgery at least 8 weeks after radiotherapy completion. The pathological response was assessed with tumor regression grade. Results: In this preliminary report on complications and pathological response, 66 patients were randomized into two study groups. Mean duration of radiotherapy in the group II (long-course) was 5 ± 1 days (range, 5 to 8 days) and 38 ± 6 days (range, 30 to 58 days). The median follow-up was 18 months. Pathological complete response was achieved in 32.3% and 23.1% of patients in the shortcourse and long-course groups, respectively (p = 0.558). Overall, acute grade 3 or higher treatment-related toxicities occurred in 24.2% and 22.2% of patients in group I and II, respectively (p = 0.551). No acute grade 4 or 5 adverse events were observed in either group except one grade 4 hematologic toxicity that was seen in group II. Within one month of surgery, no significant difference was seen regarding grade ≥3 postoperative complications (p = 0.333). Conclusion: For patients with rectal cancer located at least 5 cm above the anal verge, short-course radiotherapy with concurrent and consolidation chemotherapy and delayed surgery is not different in terms of acute toxicity, postoperative morbidity, complete resection, and pathological response compared to long-course chemoradiotherapy.

Rapid onset of efficacy predicts response to therapy with certolizumab plus methotrexate in patients with active rheumatoid arthritis

  • Kang, Young Mo;Park, Young-Eun;Park, Won;Choe, Jung-Yoon;Cho, Chul-Soo;Shim, Seung-Cheol;Bae, Sang Cheol;Suh, Chang-Hee;Cha, Hoon-Suk;Koh, Eun Mi;Song, Yeong-Wook;Yoo, Bin;Lee, Shin-Seok;Park, Min-Chan;Lee, Sang-Heon;Arendt, Catherine;Koetse, Willem;Lee, Soo-Kon
    • The Korean journal of internal medicine
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    • v.33 no.6
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    • pp.1224-1233
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    • 2018
  • Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7% vs. 27.5%, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ${\geq}1.2$ (43.8%) at week 4 than in nonresponders. Among 18 (22.2%) and 14 patients (35.0%) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate. Conclusions: CZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.

Rapid Seismic Vulnerability Assessment Method for Generic Structures (일반 구조물에 대한 신속한 지진 취약성 분석 방법)

  • Jeong, Seong-Hoon;Choi, Sung-Mo;Kim, Kang-Su
    • Journal of the Korea Concrete Institute
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    • v.20 no.1
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    • pp.51-58
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    • 2008
  • Analytical probabilistic vulnerability analysis requires extensive computing effort as a result of the randomness in both input motion and response characteristics. In this study, a new methodology whereby a set of vulnerability curves are derived based on the fundamental response quantities of stiffness, strength and ductility is presented. A response database of coefficients describing lognormal vulnerability relationships is constructed by employing aclosed-form solution for a generalized single-degree-of-freedom system. Once the three fundamental quantities of a wide range of structural systems are defined, the vulnerability curves for various limit states can be derived without recourse to further simulation. Examples of application are given and demonstrate the extreme efficiency of the proposed approach in deriving vulnerability relationships.

Haematologic Parameters in Metastatic Colorectal Cancer Patients Treated with Capecitabine Combination Therapy

  • Inanc, Mevlude;Duran, Ayse Ocak;Karaca, Halit;Berk, Veli;Bozkurt, Oktay;Ozaslan, Ersin;Ozkan, Metin
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.1
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    • pp.253-256
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    • 2014
  • Background: The standard treatment in the metastatic colorectal cancer consists of 5-FU based infusional regimens. However, with oral fluoropyrimidines, equal tumor responses may be obtained. Capecitabine causes macrocytosis of the cells by inhibition of DNA synthesis. In this context, a relationship was found between mean corpuscular volume (MCV) and response to therapy in breast cancer patients treated with Capecitabine, but whether this relationship also pertains in colorectal cancer has not been established. Materials and Methods: A total of 102 metastatic colorectal cancer patients treated with a oxaliplatin (XELOX)${\pm}$Bevacizumab combination were retrospectively evaluated. Patients were randomized into three groups. Hematological parameters (MCV, MPV, PCT, PLT, NLR) were recorded retrospectively, before treatment and after 3 cycles of chemotherapy. Results: After three cycles of therapy, 20 (19.6%) patients had progressive disease (PD), 41 (40.1%) had stable disease (SD), and 41 (40.1%) demonstrated a partial response (PR). In 62 (60.7%) treatment was with capesitabin plus XELOX therapy, and in 40 (39.2%) it was XELOX-Bevacizumab combination therapy. There was no difference among three groups before the treatment in terms of MCV, MPV, PCT, PLT, and NLR. MCV showed significant increase in chemotherapy response groups (PR and SD). In addition, a significant decrease was observed for platelet count in chemotherapy response groups. While NLR decrease was seen in only a PR group, PCT decrease was observed in all three groups. PCT and PLT values were higher in patients receiving Bevacizumab. Conclusions: PLT, PCT, MPV, and NLR values were decreased due to Capecitabine-based chemotherapy, however MCV was increased. PCT and PLT values were higher in patients who received Bevacizumab than those who did not. MCV, PLT, and NLR can be considered as important factors in predicting response to colorectal carcinoma treatment.

Acupuncture for Chronic Fatigue Syndrome and Idiopathic Chronic Fatigue: a Pilot Randomized Controlled Trial (만성 피로증후군과 특발성 만성 피로에 대한 침 치료 효과: 무작위 대조 예비 임상연구)

  • Kim, Jung-Eun;Kang, Kyung-Won;Kim, Ae-Ran;Kim, Joo-Hee;Kim, Tae-Hun;Park, Hyo-Ju;Shin, Mi-Suk;Lee, Min-Hee;Lee, Sang-Hun;Lee, Seung-Hoon;Jung, So-Young;Jung, Hee-Jung;Hong, Kwon-Eui;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.29 no.5
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    • pp.109-118
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    • 2012
  • Objectives : The aim of this study was to evaluate the effectiveness and safety of acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue. Methods : A randomized, controlled pilot trial was conducted. Twenty-four participants were randomized into one of the two groups: an acupuncture group(n=12) and wait-list group(n=12). The treatment group received 12 sessions of acupuncture over 4 weeks. Eight points($GV_{20}$; bilateral GB20, $BL_{11}$, $BL_{13}$, $BL_{15}$, $BL_{18}$, $BL_{20}$, and $BL_{23}$) were selected for needling. The control group did not receive acupuncture treatment during study period and follow-up were done in the $5^{th}$ and $9^{th}$ weeks after randomization in both groups. The primary outcome was fatigue severity scale(FSS) and the secondary outcomes included a short form of stress response inventory(SRI-short form), beck depression inventory(BDI), and insomnia severity index(ISI). Safety was assessed at every visit. Results : There were statistically significant differences in the between group values of FSS at $5^{th}$ weeks after randomization(p=0.0002), SRI-short form, BDI, and ISI at $5^{th}$, $9^{th}$ weeks after randomization(p<0.01). There were no adverse events. Conclusions : The results suggest that acupuncture is associated with benefits on the short-term outcomes in chronic fatigue syndrome and idiopathic chronic fatigue.

Clonazepam Treatment of Pathologic Aerophagia in Children with Mental Retardation

  • Lee, Ga-Hyun;Jang, Hyo-Jeong;Hwang, Jin-Bok
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.17 no.4
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    • pp.209-213
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    • 2014
  • Purpose: Pathologic aerophagia (PA) may lead to bowel perforation or volvulus in mentally retarded patients. The authors investigated the effects of clonazepam on the management of PA in children with severe to profound mental retardation (MR). Methods: This study was undertaken as a retrospective case analysis of 21 PA patients with MR who were followed for over 12 months and diagnosed as having PA. Patients were assigned to two management groups, that is, to a clonazepam randomized open-labeled, treatment group or a reassurance group. The following were recorded and analyzed; age, response, remission rate to clonazepam treatment, and the side effect of clonazepam. It was defined positive response (response+) as being symptom-free for a whole week within 1 month of commencing treatment and remission(+) as being symptom-free for a whole month within 6 months of treatment. Results: The average age of the 21 PA children with MR was 10 years and 13 patients were female. Symptom duration before diagnosis of PA was 7 months. Clinical features of the clonazepam-trial group (n=11) and the reassurance group (n=10) were non-significantly different. Response(+) was achieved by 2 patients (18.2%) in the clonazepamtrial group and by no patient in the reassurance group. Remission(+) was achieved by 6 patients (54.5%) in the clonazepam-trial group and by one patient (10%) in the reassurance group (p=0.040). Conclusion: When PA children with MR with severe bowel distention are considered for surgical treatment to prevent acute abdomen, a trial of clonazepam could be recommended.

Chemotherapy for Head and Neck Squamous Cell Carcinoma (두경부 상피세포암의 화학요법)

  • Roh Jae-Kyung
    • Korean Journal of Head & Neck Oncology
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    • v.6 no.1
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    • pp.11-23
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    • 1990
  • Systemic chemotherapy is usually regarded as the standard treatment for palliation in patients with recurrent or metastatic cancer who have failed the definite local treatment with surgery and/or radiotherapy. Recently, with the introduction of more active chemotherapeutic agents and combinations, systemic chemotherapy is being increasingly used before or after local therapy in patients with previously untreated locally advanced head and neck cancer. The most active agents for the head and neck caner are methotrexate, 5-fluorouracil (5-FU), cisplatin and bleomycin. The overall response rates to each of these four drugs are 15-30% expecially when used as first line therapy. But most of these responses are partial with a mean duration of 3-5 months. Various combinations with methotrexate, 5-FU, cisplatin, and bleomycin have been tried with overall response rates of 50-90%, and 10-20% of complete responses. The introduction of chemotherapy prior to local therapy, induction chemotherapy, has been investigated with improved survivals in patients with complete response, especially pathologic, though improvement in overall survival has not been proved yet after the induction chemotherapy. Other therapeutic modalities, such as 'Sandwich' chemotherapy between surgery and radiotherapy, concomittent chemo-radiotherapy and post local treatment adjuvant chemotherapy have been pursued with some hopeful results but these trials should be compared with prospective randomized Phase III trials. To increase the response rates and enhance the survival, important work still remains; 1. Identification of better prognostic factors, 2. Improvement in staging, 3. Development of more active and safter chemotherapeutic agents, 4. Identification of the proper sequence for the addition of chemotherapy to multimodality treatment, and 5. Testing the value of such chemotherapy in locally advanced cancer patients.

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The influence of obesity on the effects of spirulina supplementation in the human metabolic response of Korean elderly

  • Park, Hee-Jung;Lee, Hyun-Sook
    • Nutrition Research and Practice
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    • v.10 no.4
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    • pp.418-423
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    • 2016
  • BACKGROUND/OBJECTIVES: Spirulina, a blue-green alga, is widely produced and commercialized as a dietary supplement with bio- and immune-modulatory functions. We have previously shown that spirulina had favorable effects on lipid profiles, immune functions, and antioxidant capacity in healthy Korean elderly. Despite favorable effect of spirulina supplementation, some sub-populations have shown a poor response to supplementation. Obesity is a factor related to poor-response. Therefore, the purpose of this study was to determine the immuno-modulation, antioxidant capacity, and lipid-lowering effect of spirulina in obese and non-obese Korean elderly. SUBJECTS/METHODS: The subjects were 78 elderly aged 60-87 years. In a randomized double blind, placebo-controlled study, subjects were fed either placebo or spirulina daily, at 8 g for 12 weeks. Subjects were divided into the non-obese group and the obese group based on body mass index (BMI) criteria for Asians suggested by the International Obesity Task Force: $BMI<25kg/m^2$ (non-obese) and $BMI{\geq}25kg/m^2$ (obese). RESULTS: In the non-obese group, spirulina supplementation showed a significant lowering effect on plasma concentration of total cholesterol and LDL-cholesterol, a significant increase in interleukin (IL)-2 concentration (P < 0.01) and a significant increment (P < 0.05) in IL-2/IL-6 ratio, and a significant increase in total antioxidant status level and a significant decrease in thiobarbituric acid reactive substances level. However, these effects were not observed in the obese group. CONCLUSION: These results demonstrated that blood lipid lowering and immune and antioxidant improving response for spirulina supplement was affected by obesity in Korean elderly.

Effects of far infrared radiological materials on immune response and changes of fecal microorganism in pigs (돼지에 있어 원적외선 방사물질의 첨가가 면역반응 및 분중 미생물의 변화에 미치는 영향)

  • Kwon, Ki-bum;Kim, In-ho;Hong, Jong-wook;Moon, Tea-hyun;Choi, Sang-yul;Seok, Ho-bong
    • Korean Journal of Veterinary Research
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    • v.41 no.1
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    • pp.37-42
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    • 2001
  • This research was conducted to investigate the effects of far infrared radiological materials on growth performance, immune response and changes of microbial flora in feces for growing pigs. Twelve growing pigs($Duroc{\times}Yorkshire{\times}Landrace$, average initial body weight of $15.6{\pm}0.5kg$) were used in a 40 day growth assay. Treatments were control(saline injection with diet: S); saline injection with Bio-Plus in diet(SBP); and vaccination with Bio-Plus in diet(VBP) in a randomized complete block design with initial BW as the blocking criterion. Serum concentrations of IgG of SBP and VBP were higher than those of S at day 10(p<0.05), 20(p<0.05), 30(p<0.05) and 40(p<0.05). Pigs fed with treatment diets had increased lymphocyte level compared to S at day 20(p<0.05) and 40(p<0.05). Cortisol was lower in treatments than in S at day 30(p<0.05). At day 20, there was no significant difference in E. coli among the treatments. However, it was observed that E, coli of the treatments was decreased compared to S at day 40(p<0.01). Lactobacillus of SBP was significantly higher(p<0.05) than that of S at day 40. In conclusion, the results of the experiment suggest that far infrared radiological materials could be a very beneficial immune response for growing pigs in health aspects.

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The Effects of Neurofeedback Training on Physical, Psychoemotional Stress Response and Self-Regulation for Late Adolescence: A Non-Randomized Trial (뉴로피드백 훈련이 후기청소년의 신체적, 정서심리적 스트레스 반응과 자기조절에 미치는 효과: 비무작위 연구)

  • Choi, Moon-Ji;Park, Wan-Ju
    • Journal of Korean Academy of Nursing
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    • v.48 no.2
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    • pp.208-220
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    • 2018
  • Purpose: The aim of this study was to analyze the effects of neurofeedback training for reducing stress and enhancing self-regulation in late adolescence to identify the possibility of use for nursing intervention. Methods: A nonequivalent control group pre-post quasi-experimental design was used. Participants were 78 late adolescents assigned to the experimental group (n=39) that received the neurofeedback training and the control group (n=39). Data were collected on heart rate variability (HRV) and skin conductance level (SCL) to assess stress-biomarker response. The questionnaire contained 164 items from: Positive and Negative Affect Schedule (PANAS), Symptom Checklist-90-Revised (SCL-90-R) and Self-regulatory Ability scale. The neurofeedback training was based on the general adaptation syndrome and body-mind medicine. The intervention was conducted in a total of 10 sessions for 30 minutes per session with high-beta, theta and sensory motor rhythm training on scalp at central zero. Results: There were significant difference in standard deviation of normal to normal interval (p=.036) in HRV and SCL (p=.029) of stress-biomarker response between the two groups. Negative affect (p=.036) in PANAS and obsessive compulsive (p=.023) and depression (p<.001) in SCL-90-R were statistically significant. Self-regulation mode (p=.004) in self-regulation ability scale showed a significant difference between the two groups. Conclusion: The results indicated that the neurofeedback training is effective in stress-biomarkers, psychoemotional stress response and self-regulation. Therefore, neurofeedback training using neuroscientific approach based on brain-mind-body model can be used as an effective nursing intervention for late adolescents in clinics and communities for effective stress responses.