- An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh
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Sandberg J, Gray I, Pearlman A, Terlecki R
- KMID: 2404982
- Investig Clin Urol.
- 2018 Mar;59(2):126-132.
- doi: 10.4111/icu.2018.59.2.126
PURPOSE: To assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States. MATERIALS AND METHODS: We... -
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- Establishing new principles for nutrient reference values (NRVs) for food labeling purposes
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Yates AA
- KMID: 2313299
- Nutr Res Pract.
- 2007 Jun;1(2):89-93.
Many countries such as The Republic of Korea have established their own nutritional standards, collectively termed Nutrient Reference Values(NRVs), and they vary due to the science which was reviewed, the... -
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- A Case of Primaquine-Induced Acute Liver Failure
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Jun MJ, Lee D, Choi YS, Kim EJ, Gong EJ, Chung YH
- KMID: 1867317
- Korean J Med.
- 2014 Jan;86(1):54-58.
- doi: 10.3904/kjm.2014.86.1.54
Primaquine was approved for treatment of malaria in 1952 by the United States Food and Drug Administration (FDA). It has remained the only FDA-licensed drug capable of clearing the intra-hepatic... -
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- Morcellation of apparent benign uterine myoma: assessing risk to benefit ratio
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Bogani G, Chiappa V, Ditto A, Martinelli F, Signorelli M, Lorusso D, Raspagliesi F
- KMID: 2374239
- J Gynecol Oncol.
- 2016 Jul;27(4):e37.
- doi: 10.3802/jgo.2016.27.e37
No abstract available. -
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- Genetically Engineered Mouse Models for Drug Development and Preclinical Trials
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Lee H
- KMID: 2170618
- Biomol Ther.
- 2014 Jul;22(4):267-274.
Drug development and preclinical trials are challenging processes and more than 80% to 90% of drug candidates fail to gain approval from the United States Food and Drug Administration. Predictive... -
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- Current status of pharmaceutical safety management in Korea
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Choi D, Choi M, Ko A
- KMID: 1787245
- J Korean Med Assoc.
- 2012 Sep;55(9):827-834.
- doi: 10.5124/jkma.2012.55.9.827
The reinforcement of regulation on of post-market safety management including adverse drug reactions (ADRs) has received significant emphasiszed significantly over the last several years in Korea. Not only has there... -
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- Clinical trials for vaccine development in registry of Korea Food and Drug Administration
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Kang SY
- KMID: 2391979
- Clin Exp Vaccine Res.
- 2013 Jan;2(1):69-70.
Based on the action plan "Ensuring a stable supply of National Immunization Program vaccines and sovereignty of biopharmaceutical products," Korea Food and Drug Administration (KFDA) has made efforts to develop... -
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- Current status of automated breast ultrasonography
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Shin HJ, Kim HH, Cha JH
- KMID: 2382128
- Ultrasonography.
- 2015 Jul;34(3):165-172.
- doi: 10.14366/usg.15002
Breast ultrasonography (US) is currently considered the first-line examination in the detection Epub ahead of print and characterization of breast lesions. However, conventional handheld US (HHUS) has several limitations such... -
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- Drug Therapy for Obesity
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Kim KS, Park SW
- KMID: 2270999
- Korean J Obes.
- 2012 Dec;21(4):197-202.
Obesity is associated with a substantial increase in metabolic disorders and various cancers. As weight loss achieved with lifestyle intervention is modest, there is a need for drug treatment. Orlistat, phentermine,... -
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- HDAC and HDAC Inhibitor: From Cancer to Cardiovascular Diseases
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Yoon S, Eom GH
- KMID: 2152651
- Chonnam Med J.
- 2016 Jan;52(1):1-11.
- doi: 10.4068/cmj.2016.52.1.1
Histone deacetylases (HDACs) are epigenetic regulators that regulate the histone tail, chromatin conformation, protein-DNA interaction, and even transcription. HDACs are also post-transcriptional modifiers that regulate the protein acetylation implicated in... -
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- Legislative Issues in Disclosing Financial Conflicts of Interest to Participants in Biomedical Research: Effectiveness and Methodology
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Kim JS
- KMID: 2396365
- J Korean Med Sci.
- 2017 Dec;32(12):1910-1916.
- doi: 10.3346/jkms.2017.32.12.1910
This research focuses on the analysis regarding disclosure of financial conflicts of interest (FCOI) after Gelsinger v. University of Pennsylvania (Penn). The main legal issue was that the participants did... -
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- Cefepime Induced Encephalopathy Mimicking Acute Stroke
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Kim YI, Hwang S, Choi B, Hwang J, Lee SH
- KMID: 2464141
- J Korean Neurol Assoc.
- 2019 Nov;37(4):372-375.
- doi: 10.17340/jkna.2019.4.6
Cefepime is a fourth-generation cephalosporin, developed in 1994, and is well known for its adverse effects. In 2002, the Food and Drug Administration adjusted the labeling to account for increased... -
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- Clinical Application of Inhaled Nitric Oxide Therapy in Persistent Pulmonary Hypertension of the Newborn
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Lee EH, Choi BM
- KMID: 2052163
- Neonatal Med.
- 2015 May;22(2):61-70.
- doi: 10.5385/nm.2015.22.2.61
Inhaled nitric oxide (iNO) is recognized as a potent and selective pulmonary vasodilator that does not decrease systemic vascular tone. The therapeutic application of iNO in human was first described... -
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- Current Treatment Strategies for Castration-Resistant Prostate Cancer
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Kim SJ, Kim SI
- KMID: 2315616
- Korean J Urol.
- 2011 Mar;52(3):157-165.
Prostate cancer is the most common cancer in men in United States and the fifth most common cancer in men in Korea. Although the majority of patients with metastatic prostate... -
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- Clinical applications and contemporary trends of hyperbaric oxygen therapy in Korea
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You YH, Kim H, Kim H, Choi S, Kim G
- KMID: 2194896
- J Korean Med Assoc.
- 2014 Jul;57(7):601-606.
- doi: 10.5124/jkma.2014.57.7.601
Hyperbaric oxygen therapy (HBOT) is approved in the United States for 14 accepted indications, which are approved by the HBOT committee of the Undersea and Hyperbaric Medical Society and by... -
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- Effects of Thiazolidinedione and New Antidiabetic Agents on Stroke
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Ahn CH, Lim S
- KMID: 2449891
- J Stroke.
- 2019 May;21(2):139-150.
- doi: 10.5853/jos.2019.00038
Patients with hyperglycemia are at a high risk of cardio- and cerebrovascular diseases. Diabetes patients also have poor outcomes after cerebrovascular disease development. Several classes of drugs are used for... -
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- Clinical Indications for Inhaled Nitric Oxide Therapy in Neonates
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Sung TJ
- KMID: 2052162
- Neonatal Med.
- 2015 May;22(2):55-60.
- doi: 10.5385/nm.2015.22.2.55
Nitric oxide (NO) is a colorless, odorless gas that acts as a potent pulmonary vasodilator. When administered via inhalation, NO rapidly diffuses across the alveolarcapillary membrane and binds to hemoglobin,... -
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- Three Cases of Reversible Agranulocytosis after Treatment with Lamotrigine
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Ahn YM, Kim K, Kim YS
- KMID: 1706126
- Psychiatry Investig.
- 2008 Jun;5(2):121-123.
- doi: 10.4306/pi.2008.5.2.121
Several psychotropic drugs, including clozapine, are known to cause agranulocytosis and this may lead to a fatal condition. Lamotrigine is an anticonvulsant that the Food and Drug Administration (FDA) has... -
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- Patient Blood Management: An Internist's Perspective
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Uhm J
- KMID: 2407800
- Hanyang Med Rev.
- 2018 Mar;38(1):38-48.
- doi: 10.7599/hmr.2018.38.1.38
Patient blood management (PBM) is an evidence-based, patient-focused approach to optimize the management of patient and blood transfusion. While PBM is relatively well established in perioperative care, it is not... -
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- Cardiovascular Outcome Trials of Incretin Therapy (Dipeptidyl Peptidase-4 Inhibitors/Glucagon-Like Peptide-1 Receptor Agonist)
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Jeong IK
- KMID: 2416256
- J Lipid Atheroscler.
- 2018 Jun;7(1):32-41.
- doi: 10.12997/jla.2018.7.1.32
In 2008, the United States Food and Drug Administration issued guidance which mandated long-term cardiovascular outcome trials (CVOTs) to assess the safety of new antidiabetic drugs for type 2 diabetes.... -
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