• Title/Summary/Keyword: Randomized response

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Desflurane Inhalation Provide Cardiovascular Stability During Intubation but Prevention of Rocuronium Injection Pain

  • Ko, Hyun-Min;Hong, Hun-Pyo;Yoon, Ji-Young;Yoon, Ji-Uk;Lee, Do-Won;Kim, Cheul-Hong
    • Journal of The Korean Dental Society of Anesthesiology
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    • v.13 no.3
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    • pp.117-120
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    • 2013
  • Background: Desflurane has very short induction time because its physical characteristics. But its pungent odor and tendency to irritate the upper airway make it unsuitable for induction of anesthesia. This study was performed to determine what time is prefer to start the desflurane inhalation. Methods: Forty adults (17-45 years) were enrolled in a randomized, double-blind study. Twenty start desflurane inhalation just after loss of consciousness, and the others received desflurane after intubation. We monitored vital signs, BIS, desflurane concentration, rocuronium injection pain response, and airway irritation signs. Results: The demographic data were not different two groups. Early inhalation group showed more stable cardiovascular response than that of late inhalation group. But rocuronium injection pain response and airway irritation sings were not different between two groups. Conclusions: Early inhalation of desflurane (6 vol%) just after loss of consciousness attenuates cardiovascular responses during intubation.

Evaluation of efficacy of Valsalva maneuver for attenuating propofol injection pain: a prospective, randomized, single blind, placebo controlled study

  • Kumar, Sanjay;Khuba, Sandeep;Agarwal, Anil;Gautam, Sujeet;Yadav, Madhulika;Dixit, Aanchal
    • Korean Journal of Anesthesiology
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    • v.71 no.6
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    • pp.453-458
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    • 2018
  • Background: Pain on injection is a limitation with propofol use. The effect of the Valsalva maneuver on pain during propofol injection has not been studied. This maneuver reduces pain through the sinoaortic baroreceptor reflex arc and by distraction. We aimed to assess the efficacy of the Valsalva maneuver in reducing pain during propofol injection. Methods: Eighty American Society of Anesthesiologists class I adult patients undergoing general anesthesia were enrolled and divided into two groups of 40 each. Group I (Valsalva) patients blew into a sphygmomanometer tube raising the mercury column up to 30 mmHg for 20 seconds, while Group II (Control) patients did not. Anesthesia was induced with 1% propofol immediately afterwards. Pain was assessed on a 10-point visual analog scale (VAS), where 0 represented no pain, and 10, the worst imaginable pain, and a 4-point withdrawal response score, where 0 represented no pain, and 3, the worst imaginable pain. Scores were presented as median (interquartile range). Results: We analyzed the data of 70 patients. The incidence of pain was significantly lower in the Valsalva than in the control group (53% vs. 78%, P = 0.029). The withdrawal response score was significantly lower in the Valsalva group (1.00 [0.00-1.00] vs. 2.00 [2.00-3.00], P < 0.001). The VAS score was significantly lower in the Valsalva group (1.00 [0.00-4.00] vs. 7.00 [6.25-8.00], P < 0.001). Conclusions: A prior Valsalva maneuver is effective in attenuating injection pain due to propofol; it is advantageous in being a non-pharmacological, safe, easy, and time-effective technique.

The effect of methyltestosterone on in vitro fertilization outcomes: A randomized clinical trial on patients with low ovarian response

  • Venus Haj Aliakbar;Fatemeh Davari Tanha;Firouzeh Akbari Asbagh;Mahbod Ebrahimi;Zahra Shahraki
    • Clinical and Experimental Reproductive Medicine
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    • v.51 no.2
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    • pp.158-162
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    • 2024
  • Objective: The aim of this study was to compare the outcomes of in vitro fertilization (IVF) in patients with a poor ovarian response who used methyltestosterone, versus those using a placebo, in an infertility clinic setting. Methods: This clinical trial included 120 women who had undergone IVF with intracytoplasmic sperm injection due to poor ovarian reserve and infertility. The study took place at the Yas Infertility Center in Tehran, Iran, between January 1, 2018 and January 1, 2019. In the intervention group, 25 mg of methyltestosterone was administered daily for 2 months prior to the initiation of assisted reproductive treatment. The control group was given placebo tablets for the same duration before starting their cycle. Each group was randomly assigned 60 patients. All analyses were performed using SPSS ver. 23 (IBM Corp.). Results: The endometrial thickness in the intervention group was 7.57±1.22 mm, whereas in the control group, it was 7.11±1.02 (p=0.028). The gonadotropin number was significantly higher in the control group (64.7±13.48 vs. 57.9±9.25, p=0.001). However, there was no significant difference between the two groups in the antral follicular count. The chemical and clinical pregnancy rates in the intervention group were 18.33% and 15% respectively, compared to 8.33% and 6.67% in the control group. The rate of definitive pregnancy was marginally higher in the intervention group (13.3% vs. 3.3%, p=0.05). Conclusion: The findings of this study suggest that pretreatment with methyltestosterone significantly increases endometrium thickness and is associated with an increase in the definitive pregnancy rate.

Intrapleural Doxycycline and Bleomycin in the Management of Malignant Pleural Effusions : A Randomized Study (악성 흉막삼출액에서 Doxycycline과 Bleomycin을 이용한 흉막경화요법의 치료효과 비교)

  • Oh, Won Sup;Choi, Jin;Kim, Yong Su;Do, Yong Hee;Jang, Tae Won;Jung, Maan Hong
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.1
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    • pp.85-92
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    • 1997
  • Background : The standard treatment of recurrent, symptomatic malignant pleural effusion is intrapleural instillation of a chemical agent in an attempt to achieve a sterile inflammation and pleurodesis. There are many drugs used as pleural sclerosing agents, but the efficiency and side effects are different. The present study was undertaken to compare the commonly used drugs, doxycycline and bleomycin. Methods : Thirty-four patients with malignant pleural effusion who needed repeated thoracentesis were randomized to receive treatment with intrapleural instillation of doxycycline or bleomycin Fluid volumes before and after pleurodesis, drainge time, and side effects were analyzed, and the response to treatment was evaluated by clinical examination and chest radiography during admission in the hospital. Also median survival rime were evaluated according to the responses. Results : The response rate was higher in the patients receiving doxycycline than in those receiving bleomycin (87.5% vs 50.0%, p=0.02), and fever, nausea and vomiting were more common in the patients receiving bleomycin. The median survival time was significantly longer in the patients who responded to the sclerotherapy regardless of sclerosing agents. Conclusions : Chemical pleurodesis with doxycycline or bleomycin could reduce or stop pleural effusions and prolong the median survival rimes in these patients. Doxycycline appeared to be more efficient as sclerosing agent than bleomycin in the short-term follow-up periods. But a prospective study with a larger number of patients is warranted.

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Comparison of the Efficacy and Safety of EFGR Tyrosine Kinase Inhibitor Monotherapy with Standard Second-line Chemotherapy in Previously Treated Advanced Non-small-cell Lung Cancer: a Systematic Review and Meta-analysis

  • Qi, Wei-Xiang;Shen, Zan;Lin, Feng;Sun, Yuan-Jue;Min, Da-Liu;Tang, Li-Na;He, Ai-Na;Yao, Yang
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.10
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    • pp.5177-5182
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    • 2012
  • Purpose: To compare the efficacy and safety of epidermal growth factor receptor tyrosine kinase inhibitormonotherapy (EFGR-TKIs: gefitinib or erlotinib) with standard second-line chemotherapy (single agent docetaxel or pemetrexed) in previously treated advanced non-small-cell lung cancer (NSCLC). Methods: We systematically searched for randomized clinical trials that compared EGFR-TKI monotherapy with standard second-line chemotherapy in previously treated advanced NSCLC. The end points were overall survival (OS), progression-free survival (PFS), overall response rate (ORR), 1-year survival rate (1-year SR) and grade 3 or 4 toxicities. The pooled hazard ratio (HR) or risk ratio (RR), with their corresponding 95% confidence intervals (CI) were calculated employing fixed- or random-effects models depending on the heterogeneity of the included trials. Results: Eight randomized controlled trials (totally 3218 patients) were eligible. Our meta-analysis results showed that EGFR-TKIs were comparable to standard second-line chemotherapy for advanced NSCLC in terms of overall survival (HR 1.00, 95%CI 0.92-1.10; p=0.943), progression-free survival (HR 0.90, 95%CI 0.75-1.08, P=0.258) and 1-year-survival rate (RR 0.97, 95%CI 0.87-1.08, P=0.619), and the overall response rate was higher in patients who receiving EGFR-TKIs(RR 1.50, 95%CI 1.22-1.83, P=0.000). Sub-group analysis demonstrated that EGFR-TKI monotherapy significantly improved PFS (HR 0.73, 95%CI: 0.55-0.97, p=0.03) and ORR (RR 1.96, 95%CI: 1.46-2.63, p=0.000) in East Asian patients, but it did not translate into increase in OS and 1-year SR. Furthermore, there were fewer incidences of grade 3 or 4 neutropenia, febrile neutropenia and neutrotoxicity in EGFR-TKI monotherapy group, excluding grade 3 or 4 rash. Conclusion: Both interventions had comparable efficacy as second-line treatments for patients with advanced NSCLC, and EGFR-TKI monotherapy was associated with less toxicity and better tolerability. Moreover, our data also demonstrated that EGFR-TKImonotherapy tended to be more effective in East Asian patients in terms of PFS and ORR compared with standard second-line chemotherapy. These results should help inform decisions about patient management and design of future trials.

A Pharmacogenomic-based Antidepressant Treatment for Patients with Major Depressive Disorder: Results from an 8-week, Randomized, Single-blinded Clinical Trial

  • Han, Changsu;Wang, Sheng-Min;Bahk, Won-Myong;Lee, Soo-Jung;Patkar, Ashwin A.;Masand, Prakash S.;Mandelli, Laura;Pae, Chi-Un;Serretti, Alessandro
    • Clinical Psychopharmacology and Neuroscience
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    • v.16 no.4
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    • pp.469-480
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    • 2018
  • Objective: Pharmacogenomic-based antidepressant treatment (PGATx) may result in more precise pharmacotherapy of major depressive disorder (MDD) with better drug therapy guidance. Methods: An 8-week, randomized, single-blind clinical trial was conducted to evaluate the effectiveness and tolerability of PGATx in 100 patients with MDD. All recruited patients were randomly allocated either to PGATx (n=52) or treatment as usual (TAU, n=48) groups. The primary endpoint was a change of total score of the Hamilton Depression Rating Scale-17 (HAMD-17) from baseline to end of treatment. Response rate (at least 50% reduction in HAMD-17 score from baseline), remission rate (HAMD-17 score ${\leq}7$ at the end of treatment) as well as the change of total score of Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) from baseline to end of treatment were also investigated. Results: The mean change of HAMD-17 score was significantly different between two groups favoring PGATx by -4.1 point of difference (p=0.010) at the end of treatment. The mean change in the FIBSER score from baseline was significantly different between two treatment groups favoring PGATx by -2.5 point of difference (p=0.028). The response rate (71.7 % vs. 43.6%, p=0.014) were also significantly higher in PGATx than in TAU at the end of treatment, while the remission rate was numerically higher in PGATx than in TAU groups without statistical difference (45.5% vs. 25.6%, p=0.071). The reason for early drop-out associated with adverse events was also numerically higher in TAU (n=9, 50.0%) than in PGATx (n=4, 30.8%). Conclusion: The present study clearly demonstrate that PGATx may be a better treatment option in the treatment of MDD in terms of effectiveness and tolerability; however, study shortcomings may limit a generalization. Adequately-powered, well-designed, subsequent studies should be mandatory to prove its practicability and clinical utility for routine practice.

Effect of different levels of xylooligosaccharide in sugar on glycemic index and blood glucose response in healthy adults (자일로올리고당 함유비율이 다른 설탕이 건강한 성인의 혈당지수와 혈당반응에 미치는 영향)

  • Nam, Hyekyoung;Kyung, Myungok;Seo, Sheungwoo;Jung, Sangwon;Chang, Moon-Jeong
    • Journal of Nutrition and Health
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    • v.48 no.5
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    • pp.398-406
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    • 2015
  • Purpose: In the present study, we aimed to evaluate the effect of sucrose containing 2 different levels of xylooligosaccharide on the glycemic index (GI) and blood glucose response in healthy adults. Methods: Healthy adults (4 male participants and 6 female participants, n = 10) were randomized to receive glucose, sucrose, sucrose containing 7% xylooligosaccharide active elements (Xylo 7), or sucrose containing 10% xylooligosaccharide active elements (Xylo 10). Each participant was administrated one of these materials once a week for 8 weeks and an oral glucose tolerance test was performed. Results: We found a reduction in the glycemic response to sucrose that included xylooligosaccharide active elements (Xylo 7 and Xylo 10). The glycemic indices of sucrose, Xylo 7 and Xylo 10 were 68.9, 54.7, and 52.5, respectively. The GI values of Xylo 7 and Xylo 10 were similar to that of foods with low GI. The percentage reduction of GI value caused by sucrose containing xylooligosaccharide active elements was significantly different and dose-dependent as compared to that caused by sucrose alone (p < 0.05). The reduction in the glycemic response to Xylo 7 and Xylo 10 was 21% and 24%, respectively, as compared to the glycemic response to sucrose. The attenuation of the glycemic response to Xylo 10 tended to be higher than that for Xylo 7 when the percentage of body fat was increased. Conclusion: These results demonstrated that xylooligosaccharide active elements may be effective in protecting humans against overconsumption of sucrose.

Clomiphene Citrate Challenge Test and Its Clinical Correlation with Prognostic Factors of Ovarian Response (Clomiphene Citrate 부하검사와 난소 반응 예측 인자와의 연관성에 관한 연구)

  • Moon, Shin-Yong;Chae, Hee-Dong;Kim, Kwang-Rye;Suh, Chang-Suk;Kim, Seok-Hyun;Choi, Young-Min;Shin, Chang-Jae;Kim, Jung-Gu;Lee, Jin-Yong
    • Clinical and Experimental Reproductive Medicine
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    • v.23 no.3
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    • pp.283-292
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    • 1996
  • Objective: To determine the cutoff value of clomiphene citrate challenge test(CCCT) that can predict the normal and abnormal(diminished) ovarian response group and to assess the usefulness of CCCT as a predictor of ovarian reserve. Materials and Methods: From March 1994 to Februry 1996, CCCT was performed to 129 infertile patients and among them, 20 patients whose basal FSH on the third day of menstrual cycle was more than 20 mIU/ml were excluded. At the same time, the same CCCT was performed to the fifteen healthy volunteers with proven fertility to determine the cutoff value of CCCT. Results; 1) A FSH value higher than 23.4 mIU/ml, measured on the 10th day of menstrual cycle, was defined as a abnormal ovarian response. The cutoff value of 23.4 mIU/ml is more than 2 standard deviations(SD) above the mean value of 15 healthy women after CCCT. 2) The abnormal CCCT group, the subpopulation with a FSH value of 23.4 mIU/ml or more, was 7.3%(8/109) and their mean age was higher than the normal CCCT group($36.5{\pm}4.5$ vs. $32.9{\pm}4.8$, P = 0.059). And the percentage of the patients older than 35 years of the abnormal CCCT group was significantly higher than that of the normal CCCT group(62.5% vs. 38.6%, p <0.05). 3) There was no correlation between the hormone values of the third day and the 10th day of menstrual cycle before and after CCCT except between FSH of the third day and the 10th day. Conclusion: The CCCT is a good method to predict the individual ovarian response to COH for ART, especially in the patients who has no other abnormal findings that predict poor prognosis. And it is neccessary to determine the cutoff value of CCCT by the large numbers of randomized study, and combining the previously proven prognostic factors, it can be applicated in many individual centers for evaluate the ovarian response before ART program.

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Efficacy and Toxicity of Anti-VEGF Agents in Patients with Castration-Resistant Prostate Cancer: a Meta-analysis of Prospective Clinical Studies

  • Qi, Wei-Xiang;Fu, Shen;Zhang, Qing;Guo, Xiao-Mao
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.19
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    • pp.8177-8182
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    • 2014
  • Background: Blocking angiogenesis by targeting vascular endothelial growth factor (VEGF) signaling pathway to inhibit tumor growth has proven to be successful in treating a variety of different metastatic tumor types, including kidney, colon, ovarian, and lung cancers, but its role in castration-resistant prostate cancer (CRPC) is still unknown. We here aimed to determine the efficacy and toxicities of anti-VEGF agents in patients with CRPC. Materials and Methods: The databases of PubMed, Web of Science and abstracts presented at the American Society of Clinical Oncology up to March 31, 2014 were searched for relevant articles. Pooled estimates of the objective response rate (ORR) and prostate-specific antigen (PSA) response rate (decline ${\geq}50%$) were calculated using the Comprehensive Meta-Analysis (version 2.2.064) software. Median weighted progression-free survival (PFS) and overall survival (OS) time for anti-VEGF monotherapy and anti-VEGF-based doublets were compared by two-sided Student's t test. Results: A total of 3,841 patients from 19 prospective studies (4 randomized controlled trials and 15 prospective nonrandomized cohort studies) were included for analysis. The pooled ORR was 12.4% with a higher response rate of 26.4% (95%CI, 13.6-44.9%) for anti-VEGF-based combinations vs. 6.7% (95%CI, 3.5-12.7%) for anti-VEGF alone (p=0.004). Similarly, the pooled PSA response rate was 32.4% with a higher PSA response rate of 52.8% (95%CI: 40.2-65.1%) for anti-VEGF-based combinations vs. 7.3% (95%CI, 3.6-14.2%) for anti-VEGF alone (p<0.001). Median PFS and OS were 6.9 and 22.1 months with weighted median PFS of 5.6 vs. 6.9 months (p<0.001) and weighted median OS of 13.1 vs. 22.1 months (p<0.001) for anti-VEGF monotherapy vs. anti-VEGF-based doublets. Conclusions: With available evidence, this pooled analysis indicates that anti-VEGF monotherapy has a modest effect in patients with CRPC, and clinical benefits gained from anti-VEGF-based doublets appear greater than anti-VEGF monotherapy.

The effects according to the timing of thoracic radiotherapy in limited stage small cell lung cancer (제한병기 소세포폐암에서 흉부 방사선 치료의 도입 시기에 따른 치료 효과의 비교 분석)

  • Park, Sang Ki;Kim, Geun Hwa;Jeong, Seong Su;Shin, Kyoung Sang;Kim, Ae Kyoung;Cho, Hai Jeong;Suhr, Jee Won;Kim, Jae Sung;Cho, Moon June;Kim, Ju Ock;Kim, Sun Young
    • Tuberculosis and Respiratory Diseases
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    • v.43 no.6
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    • pp.903-915
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    • 1996
  • Background: Combination chemotherapy is now considered to be the cornerstone of small cell lung cancer (SCLC). management but the optimal management of limited SCLC is not well defined. The role of thoracic radiotherapy (TRT) is less well established. Recent meta-analyses reports revealed that TRT combined with chemotherapy produce "good" local control and prolonged survival. But other reports that survival was not changed. The liming, dose, volume and fractionation for TRT with the combined chemotherapy of SCLC remains unsettled. In this study, we analyzed the effects according to the timing of thoracic radiotherapy in limited SCLC. Method: All fifty one patients received cytoxan, adriamycin and vincristine(CAV) alternating with etoposide and cisplatin(VPP) every 3 weeks for 6 cycles were randomized prospectively into two groups: concurrent and sequential. 27 patients received 4500cGy in 30 fractions(twice daily 150cGy fractional dose) over 3 weeks 10 the primary site concurrent with the first cycle of VPP(concurrent gorup). 24 patients received 4000 to 5000cGy over 5 or 6 weeks after completion of sixth cycles of chemotherapy(sequential group). Results: 1. Response rates and response duration : Response rates were not significantly different between two groups(p=0.13). But response duration was superior in the concurrent group(p=0.03). 2. Survival duration was nor different between two groups(p=0.33). 3. Local control rate was superior in the concurrent group(p=0.00). 4. Side effects and toxicities: Hematologic toxicities, especially leukopenia, infection and frequency of radiation esophagitis were higher in the concurrent group (p=0.00, 0.03, 0.03). Conclusion: The concurrent use of TRT with chemotherapy failed to improve the survival of limited stage SCLC patients compared with the sequential use of TRT but response duration and local control rate were superior in the concurrent group. Frequency of radiation esophagitis, life threatening hematologic toxicities and infection were more frequent in the concurrent group than sequential group. So, the selection of an optimal schedule of chemotherapy combined with TRT that would lead to a major increase in survival with minimal toxicity is remained to be validated in large scale study in the future.

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