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Clinical and Translational Science

T Burt, R J Noveck, D B MacLeod, A T Layton, M Rowland, G Lappin
No abstract text is available yet for this article.
April 18, 2017: Clinical and Translational Science
Aldo Roda, Rita Aldini, Cecilia Camborata, Silvia Spinozzi, Placido Franco, Massimiliano Cont, Antonia D'Errico, Francesco Vasuri, Alessio Degiovanni, Lorenzo Maroni, Luciano Adorini
Obeticholic acid (OCA) is a semisynthetic bile acid (BA) analogue and potent farnesoid X receptor agonist approved to treat cholestasis. We evaluated the biodistribution and metabolism of OCA administered to CCl4 -induced cirrhotic rats. This was to ascertain if plasma and hepatic concentrations of OCA are potentially more harmful than those of endogenous BA. After administration of OCA (30 mg/kg), we used liquid chromatography-mass spectrometry to measure OCA, its metabolites, and BA at different time-points in various organs and fluids...
April 14, 2017: Clinical and Translational Science
Allison M Keeler, Mai K ElMallah, Terence R Flotte
No abstract text is available yet for this article.
April 6, 2017: Clinical and Translational Science
S Bins, L van Doorn, M A Phelps, A A Gibson, S Hu, L Li, A Vasilyeva, G Du, P Hamberg, Falm Eskens, P de Bruijn, A Sparreboom, Rhj Mathijssen, S D Baker
The oral multikinase inhibitor sorafenib undergoes extensive UGT1A9-mediated formation of sorafenib-β-D-glucuronide (SG). Using transporter-deficient mouse models, it was previously established that SG can be extruded into bile by ABCC2 or follow a liver-to-blood shuttling loop via ABCC3-mediated efflux into the systemic circulation, and subsequent uptake in neighboring hepatocytes by OATP1B-type transporters. Here we evaluated the possibility that this unusual process, called hepatocyte hopping, is also operational in humans and can be modulated through pharmacological inhibition...
March 31, 2017: Clinical and Translational Science
T K Okubo, S Ono
While efficient and less onerous for the industry, the globalization of clinical drug development may lead to limited efforts to optimize drugs for regional conditions. We examined the association between clinical development pathways, approved doses, and postmarketing safety risks in Japan for 135 new molecular entities approved between 2004 and 2011. The risk of drug-related deaths seemed higher when pharmaceutical companies chose exactly the same dose as in the United States, even after conducting Japanese dose-ranging studies...
March 31, 2017: Clinical and Translational Science
A Trivedi, S Stienen, M Zhu, H Li, T Yuraszeck, J Gibbs, T Heath, R Loberg, S Kasichayanula
No abstract text is available yet for this article.
March 15, 2017: Clinical and Translational Science
L H Cavallari, A L Beitelshees, K V Blake, L G Dressler, J D Duarte, A Elsey, J N Eichmeyer, P E Empey, J P Franciosi, J K Hicks, A M Holmes, Ljb Jeng, C R Lee, J J Lima, N A Limdi, J Modlin, A O Obeng, N Petry, V M Pratt, T C Skaar, S Tuteja, D Voora, M Wagner, K W Weitzel, R A Wilke, J F Peterson, J A Johnson
No abstract text is available yet for this article.
March 14, 2017: Clinical and Translational Science
Monica R Shah, Michelle A Culp, Kenneth R Gersing, Patricia L Jones, Mary E Purucker, Tiina Urv, Todd M Wilson, Petra Kaufmann
The Trial Innovation Network, an initiative of the Clinical and Translational Science Award (CTSA) Program, is a national, multi-disciplinary platform that will enable multi-center clinical trials and studies. A key goal of the Trial Innovation Network is to increase the efficiency and effectiveness of clinical trials and studies by focusing on innovation, excellence, and collaboration, leveraging the strength and expertise of the CTSA Program, and fostering partnerships among NIH, researchers, participants, providers, industry, and other stakeholders...
March 8, 2017: Clinical and Translational Science
D S Reddy, E Colman
Here we utilized social media to compare the toxidrome of three lethal chemical exposures worldwide. YouTube videos were the main source from which the data were collected, but published reports and news were also utilized to fill in some gaps. All videos were organized in a database detailing symptoms and severity of each victim, along with demographics such as approximate age and gender. Each symptom was rated as mild, moderate, or severe and corresponding pie graphs for each incident were compared. The videos displayed symptoms ranging from mild to severe cholinergic toxicity and life-threatening convulsions...
February 26, 2017: Clinical and Translational Science
P T Pollak, R J Herman, R D Feldman
Comparing modified-release formulations can be difficult using current bioequivalence criteria. Two 60-mg-once-daily nifedipine formulations are deemed bioequivalent in Canada. This study examined the validity of the assumption that these interchangeable, but different, delivery technologies are therapeutically equivalent in maintaining systolic blood pressure (SBP) control throughout the entire dosing interval. We used 24-h Ambulatory Blood Pressure Monitoring to objectively examine whether formulation switches changed population SBP >2 mmHg (reflecting 6% increased stroke mortality) and in what proportion of patients SBP changed ≥6 mmHg (risking unnecessary therapeutic alterations)...
February 24, 2017: Clinical and Translational Science
B Astruc, H Jenkins, R Jenkins
This phase I, randomized, 4-period, 4-sequence, double-blind, active- and placebo-controlled, crossover study assessed the effects of vonoprazan on the QT/QTc interval in healthy subjects. Subjects received single oral doses of vonoprazan 40 mg, vonoprazan 120 mg, moxifloxacin 400 mg (positive control/open label), and placebo. The primary end point was time-matched, placebo-corrected, baseline-adjusted mean Fridericia-corrected QT interval (ddQTcF). Of 64 subjects (mean age, 37.8 years; 50% male), 63 received all four regimens...
February 15, 2017: Clinical and Translational Science
S Movafagh, D Raj, M Sanaei-Ardekani, D Bhatia, K Vo, M Mahmoudieh, R Rahman, E H Kim, A F Harralson
Identifying noninvasive biomarkers of kidney disease is valuable for diagnostic and therapeutic purposes. Hypoxia inducible factor 1 (HIF-1) expression is known to be elevated in the kidneys in several renal disease pathologies. We hypothesized that the urinary HIF-1a mRNA level may be a suitable biomarker for expression of this protein in chronic kidney disease (CKD). We compared HIF-1a mRNA levels from urine pellets of CKD and healthy subjects. To ensure that urinary HIF-1a mRNA is of kidney origin, we examined colocalization of HIF-1a mRNA with two kidney specific markers in urine cells...
February 9, 2017: Clinical and Translational Science
R N Schuck, R Charlab, G M Blumenthal
No abstract text is available yet for this article.
February 3, 2017: Clinical and Translational Science
M L Rizk, L Zou, R M Savic, K E Dooley
No abstract text is available yet for this article.
February 3, 2017: Clinical and Translational Science
A B Pai, D E Meyer, B C Bales, V E Cotero, M P Pai, N Zheng, W Jiang
Emerging data from global markets outside the United States, where many generic iron sucrose formulations are available, have revealed that non-US generic intravenous (i.v.) iron formulations may have iron release profiles that differ from the reference listed drug (RLD). The first generic i.v. iron approved in the United States was sodium ferric gluconate complex in 2011. We evaluated chelatable and redox labile iron assay methods to measure the amount of labile iron released from i.v. iron formulations in biorelevant matrices in vitro...
February 3, 2017: Clinical and Translational Science
Jeremy L Warner
The vision of matching the right patient to the right treatment at the right time has always been the holy grail of oncology. Until recently, very few cancer patients enjoyed the benefits of truly "personalized" a.k.a. precision therapy. With the exploding knowledge of tumor genotype, as well as increasingly available targeted treatment options, it seems that the era of precision cancer medicine is nigh. However, as with many new paradigms, there has been substantial pushback. This article is protected by copyright...
February 1, 2017: Clinical and Translational Science
(no author information available yet)
No abstract text is available yet for this article.
March 2017: Clinical and Translational Science
S Ryu, S Park, J H Lee, Y R Kim, H S Na, H S Lim, H Y Choi, I Y Hwang, J G Lee, Z W Park, W Y Oh, J M Kim, S E Choi
We performed a double-blinded, genotype-based stratification study to explore the pharmacokinetics and pharmacodynamics of amitriptyline according to CYP2C19 and CYP2D6 genotype in Korean subjects. Twenty-four healthy adults were grouped by genotype of CYP2C19 and CYP2D6. After a single dose of 25 mg of amitriptyline, blood samples were collected and anticholinergic effects were measured. The extent of N-demethylation of amitriptyline significantly decreased in subjects carrying two nonfunctional alleles of CYP2C19...
March 2017: Clinical and Translational Science
J Ipe, M Swart, K S Burgess, T C Skaar
No abstract text is available yet for this article.
March 2017: Clinical and Translational Science
R A Farris, E T Price
Clinical trials suggest that fenofibrate reduces the progression of retinopathies in patients with type 2 diabetes. Furthermore, patients with retinopathies have elevated levels of inflammatory chemokines and dysfunctional retinal angiogenesis. Therefore, we investigated the effects of fenofibrate on the production of inflammatory chemokines and genes associated with angiogenesis. Retinal pigment epithelial cells (RPECs) were cultured with IL-1β and fenofibrate ranging from 1-50 μM. ENA-78, IL-8, and RANTES were measured in cell culture by ELISA...
March 2017: Clinical and Translational Science
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