• Title/Summary/Keyword: e-Clinical Trials

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A Novel Roux-en-Y Reconstruction Involving the Use of Two Circular Staplers after Distal Subtotal Gastrectomy for Gastric Cancer

  • Hur, Hoon;Ahn, Chang Wook;Byun, Cheul Su;Shin, Ho Jung;Kim, Young Bae;Son, Sang-Yong;Han, Sang-Uk
    • Journal of Gastric Cancer
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    • v.17 no.3
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    • pp.255-266
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    • 2017
  • Purpose: Although Roux-en-Y (R-Y) reconstruction after distal gastrectomy has several advantages, such as prevention of bile reflux into the remnant stomach, it is rarely used because of the technical difficulty. This prospective randomized clinical trial aimed to show the efficacy of a novel method of R-Y reconstruction involving the use of 2 circular staplers by comparing this novel method to Billroth-I (B-I) reconstruction. Materials and Methods: A total of 118 patients were randomly allocated into the R-Y (59 patients) and B-I reconstruction (59 patients) groups. R-Y anastomosis was performed using two circular staplers and no hand sewing. The primary end-point of this clinical trial was the reflux of bile into the remnant stomach evaluated using endoscopic and histological findings at 6 months after surgery. Results: No significant differences in clinicopathological findings were observed between the 2 groups. Although anastomosis time was significantly longer for the patients of the R-Y group (P<0.001), no difference was detected between the 2 groups in terms of the total surgery duration (P=0.112). Endoscopic findings showed a significant reduction of bile reflux in the remnant stomach in the R-Y group (P<0.001), and the histological findings showed that reflux gastritis was more significant in the B-I group than in the R-Y group (P=0.026). Conclusions: The results of this randomized controlled clinical trial showed that compared with B-I reconstruction, R-Y reconstruction using circular staplers is a safe and feasible procedure. This clinical trial study was registered at www.ClinicalTrials.gov (registration No. NCT01142271).

Complementary and Alternative Medicine Among Older Adults in the United States: Current Evidence and Future Directions

  • Yoon, Saun-Joo L.
    • Perspectives in Nursing Science
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    • v.3 no.1
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    • pp.73-89
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    • 2006
  • Complementary and alternative medicine has gained popularity and respectability in recent years in the United States. Since aging is often associated with chronic health conditions that commonly lead to physical and psychosocial disabilities (e.g., depression, functional and/or cognitive disabilities, and decreased quality of life), older adults often seek options to maintain health and treat chronic conditions as an adjunct to conventional medical care. Herbal products, the most commonly used among various complementary and alternative medicines (CAM), should be used with caution due to potential herbal-drug interactions (related to polypharmacy) and herbal-disease interactions (related to comorbidities). Five of the most common chronic conditions in older adults are chronic pain, cardiovascular problems, hypertension, diabetes, and chronic lung problems. A high rate of falls or risk of falling is also a problem unique to this older population. For these conditions, only a few types of CAM (e.g., acupuncture, qi gong, tai chi) were tested, with promising results. However, in spite of evidence supporting the use of certain types of CAM to alleviate some common chronic conditions, findings are limited in terms of other types of CAM tested and both short and long-term effects. More rigorous clinical trials of various CAM types are thus warranted to advance scientific knowledge and establish evidence-based practices to care for the growing number of older adults who deserve to have a better quality of life.

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Acute Organophosphorus Pesticide Poisoning (급성 유기인계 농약 중독)

  • Lee, Mi-Jin;Park, Joon-Seok;Hong, Tai-Yong;Park, Sung-Soo;You, Yeon-Ho
    • Journal of The Korean Society of Clinical Toxicology
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    • v.6 no.2
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    • pp.83-90
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    • 2008
  • Organophosphate (OP) pesticides are the most common source of human toxicity globally, causing high mortality and morbidity despite the availability of atropine as a specific antidote and oximes to reactivate acetylcholinesterase. The primary toxicity mechanism is inhibition of acetylcholinesterase (AchE), resulting in accumulation of the neurotransmitter, acetylcholine, and abnormal stimulation of acetylcholine receptors. Thus, the symptoms (muscarinic, nicotinic, and central nervous system) result from cholinergic overactivity because of AchE inhibition. OP can also cause rhabdomyolysis, pancreatitis, parotitis, and hepatitis. OP therapy includes decontamination, supportive therapy, and the use of specific antidotes such as atropine and oximes. However, there has been a paucity of controlled trials in humans. Here we evaluated the literature for advances in therapeutic strategies for acute OP poisoning over the last 10 years.

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The Antitumor Potentials of Benzimidazole Anthelmintics as Repurposing Drugs

  • Deok-Soo Son;Eun-Sook Lee;Samuel E. Adunyah
    • IMMUNE NETWORK
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    • v.20 no.4
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    • pp.29.1-29.20
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    • 2020
  • The development of refractory tumor cells limits therapeutic efficacy in cancer by activating mechanisms that promote cellular proliferation, migration, invasion, metastasis, and survival. Benzimidazole anthelmintics have broad-spectrum action to remove parasites both in human and veterinary medicine. In addition to being antiparasitic agents, benzimidazole anthelmintics are known to exert anticancer activities, such as the disruption of microtubule polymerization, the induction of apoptosis, cell cycle (G2/M) arrest, anti-angiogenesis, and blockage of glucose transport. These antitumorigenic effects even extend to cancer cells resistant to approved therapies and when in combination with conventional therapeutics, enhance anticancer efficacy and hold promise as adjuvants. Above all, these anthelmintics may offer a broad, safe spectrum to treat cancer, as demonstrated by their long history of use as antiparasitic agents. The present review summarizes central literature regarding the anticancer effects of benzimidazole anthelmintics, including albendazole, parbendazole, fenbendazole, mebendazole, oxibendazole, oxfendazole, ricobendazole, and flubendazole in cancer cell lines, animal tumor models, and clinical trials. This review provides valuable information on how to improve the quality of life in patients with cancers by increasing the treatment options and decreasing side effects from conventional therapy.

Efficacy of oxytocin antagonist infusion in improving in vitro fertilization outcomes on the day of embryo transfer: A meta-analysis

  • Kim, Seul Ki;Han, E-Jung;Kim, Sun Mie;Lee, Jung Ryeol;Jee, Byung Chul;Suh, Chang Suk;Kim, Seok Hyun
    • Clinical and Experimental Reproductive Medicine
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    • v.43 no.4
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    • pp.233-239
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    • 2016
  • Objective: Uterine contraction induced by the embryo transfer (ET) process has an adverse effect on embryo implantation. The aim of this study was to determine the effect of oxytocin antagonist supplementation on the day of ET on in vitro fertilization outcomes via a meta-analysis. Methods: We performed a meta-analysis of randomized controlled trials (RCTs). Four online databases (Embase, Medline, PubMed, and Cochrane Library) were searched through May 2015 for RCTs that investigated oxytocin antagonist supplementation on the day of ET. Studies were selected according to predefined inclusion criteria and meta-analyzed using RevMan 5.3. Only RCTs were included in this study. The main outcome measures were the clinical pregnancy rate, the implantation rate, and the miscarriage rate. Results: A total of 123 studies were reviewed and assessed for eligibility. Three RCTs, which included 1,020 patients, met the selection criteria. The implantation rate was significantly better in patients who underwent oxytocin antagonist infusion (19.8%) than in the control group (11.3%) (n = 681; odds ratio [OR], 1.92; 95% confidence interval [CI], 1.25-2.96). No significant difference was found between the two groups in the clinical pregnancy rate (n = 1,020; OR, 1.57; 95% CI, 0.92-2.67) or the miscarriage rate (n = 456; OR, 0.76; 95% CI, 0.44-1.33). Conclusion: The results of this meta-analysis of the currently available literature suggest that the administration of an oxytocin antagonist on the day of ET improves the implantation rate but not the clinical pregnancy rate or miscarriage rate. Additional, large-scale, prospective, randomized studies are necessary to confirm these findings.

Novel Biomarkers for Prediction of Response to Preoperative Systemic Therapies in Gastric Cancer

  • Cavaliere, Alessandro;Merz, Valeria;Casalino, Simona;Zecchetto, Camilla;Simionato, Francesca;Salt, Hayley Louise;Contarelli, Serena;Santoro, Raffaela;Melisi, Davide
    • Journal of Gastric Cancer
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    • v.19 no.4
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    • pp.375-392
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    • 2019
  • Preoperative chemo- and radiotherapeutic strategies followed by surgery are currently a standard approach for treating locally advanced gastric and esophagogastric junction cancer in Western countries. However, in a large number of cases, the tumor is extremely resistant to these treatments and the patients are exposed to unnecessary toxicity and delayed surgical therapy. The current clinical trials evaluating the combination of preoperative systemic therapies with modern targeted and immunotherapeutic agents represent a unique opportunity for identifying predictive biomarkers of response to select patients that would benefit the most from these treatments. However, it is of utmost importance that these potential biomarkers are corroborated by extensive preclinical and translational research. The aim of this review article is to present the most promising biomarkers of response to classic chemotherapeutic, anti-HER2, antiangiogenic, and immunotherapeutic agents that can be potentially useful for personalized preoperative systemic therapies in gastric cancer patients.

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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    • v.10 no.6
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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).

A survey for Management of Drug Safety Evaluation System for Investigational Product (임상시험용 의약품의 안전성 정보보고를 위한 평가 등 관리방안 설문조사 연구)

  • Lee, Bo Mi;Park, Sang-Jun;Shim, Da-Young;Rhee, Ha Eun;Lee, Jeong-Eun;Kim, Sang Hee;Cho, Hea Kyoung;Shin, Ju-Young
    • Korean Journal of Clinical Pharmacy
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    • v.31 no.1
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    • pp.53-60
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    • 2021
  • Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

Comparison of the Clinical Outcomes of Reconstruction Methods After Distal Gastrectomy: A Systematic Review and Meta-Analysis Based on Randomized Controlled Trials

  • Min, Jae-Seok;Kim, Rock Bum;Seo, Kyung Won;Jeong, Sang-Ho
    • Journal of Gastric Cancer
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    • v.22 no.2
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    • pp.83-93
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    • 2022
  • Background: To analyze the short- and long-term clinical outcomes of 2 reconstruction methods after distal gastrectomy for gastric cancer. Methods: Three keywords, "gastric neoplasm," "distal gastrectomy," and "reconstruction," were used to search PubMed. We selected only randomized controlled trial that compared the anastomosis methods. A total of 11 papers and 8 studies were included in this meta-analysis. All statistical analyses were performed using the R software. Results: Among short-term clinical outcomes, a shorter operation time, reduced morbidity, and shorter hospital stay were found for Billroth type I (B-I) than for Roux-en-Y (RNY) reconstruction in the meta-analysis (P<0.001, P=0.048, P<0.001, respectively). When comparing Billroth type II (B-II) to RNY, the operation time was shorter for B-II than for RNY (P<0.019), but there were no differences in morbidity or length of hospital stay (P=0.500, P=0.259, respectively).Regarding long-term clinical outcomes related to reflux, there were significantly fewer incidents of reflux esophagitis, reflux gastritis, and bile reflux (P=0.035, P<0.001, P=0.019, respectively) for RNY than for B-I in the meta-analysis, but there was no difference between the 2 methods in residual food (P=0.545). When comparing B-II to RNY, there were significantly fewer incidents of reflux gastritis (P<0.001) for RNY than for B-II, but the amount of residual food and patient weight gain showed no difference. Conclusion: B-I had the most favorable short-term outcomes, but RNY was more advantageous for long-term outcomes than for other methods. Surgeons should be aware of the advantages and disadvantages of each type of anastomosis and select the appropriate method.

Therapeutic Potential of Active Components from Acorus gramineus and Acorus tatarinowii in Neurological Disorders and Their Application in Korean Medicine

  • Cheol Ju Kim;Tae Young Kwak;Min Hyeok Bae;Hwa Kyoung Shin;Byung Tae Choi
    • Journal of Pharmacopuncture
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    • v.25 no.4
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    • pp.326-343
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    • 2022
  • Neurological disorders represent a substantial healthcare burden worldwide due to population aging. Acorus gramineus Solander (AG) and Acorus tatarinowii Schott (AT), whose major component is asarone, have been shown to be effective in neurological disorders. This review summarized current information from preclinical and clinical studies regarding the effects of extracts and active components of AG and AT (e.g., α-asarone and β-asarone) on neurological disorders and biomedical targets, as well as the mechanisms involved. Databases, including PubMed, Embase, and RISS, were searched using the following keywords: asarone, AG, AT, and neurological disorders, including Alzheimer's disease, Parkinson's disease, depression and anxiety, epilepsy, and stroke. Meta-analyses and reviews were excluded. A total of 873 studies were collected. A total of 89 studies were selected after eliminating studies that did not meet the inclusion criteria. Research on neurological disorders widely reported that extracts or active components of AG and AT showed therapeutic efficacy in treating neurological disorders. These components also possessed a wide array of neuroprotective effects, including reduction of pathogenic protein aggregates, antiapoptotic activity, modulation of autophagy, anti-inflammatory and antioxidant activities, regulation of neurotransmitters, activation of neurogenesis, and stimulation of neurotrophic factors. Most of the included studies were preclinical studies that used in vitro and in vivo models, and only a few clinical studies have been performed. Therefore, this review summarizes the current knowledge on AG and AT therapeutic effects as a basis for further clinical studies, and clinical trials are required before these findings can be applied to human neurological disorders.