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Clinical and Translational Science

H-P Feng, P Vaddady, Z Guo, F Liu, D Panebianco, V Levine, L Caro, J R Butterton, M Iwamoto, W W Yeh
Use of agents to suppress gastric acid secretion is common among patients with hepatitis C virus (HCV) infection. The aims of this open-label, three-period, fixed-sequence study were to evaluate the effect of famotidine and pantoprazole on the pharmacokinetics and safety of elbasvir/grazoprevir fixed-dose combination (FDC) in 16 healthy subjects. Elbasvir and grazoprevir each exhibited similar pharmacokinetics following single-dose administration of elbasvir/grazoprevir with or without famotidine or pantoprazole...
June 17, 2017: Clinical and Translational Science
E Dubcenco, P M Beers-Block, L P Kim, P Schotland, J G Levine, C A McCloskey, E D Bashaw
Proton pump inhibitors (PPIs) have become known for both their therapeutic effect and good safety profile. An application was submitted to the US Food and Drug Administration for approval of a reformulated PPI product that failed bioequivalence testing, but was submitted on the basis of the long history of PPI use as a "surrogate" for equivalence. This review evaluates the safety data for PPIs, discuss variability of pharmacokinetic parameters of PPIs in the reformulation setting, and potential implications of those changes for long-term safety...
June 15, 2017: Clinical and Translational Science
I H Bartelink, N Zhang, R J Keizer, N Strydom, P J Converse, K E Dooley, E L Nuermberger, R M Savic
Disappointing results of recent tuberculosis chemotherapy trials suggest that knowledge gained from preclinical investigations was not utilized to maximal effect. A mouse-to-human translational pharmacokinetics (PKs) - pharmacodynamics (PDs) model built on a rich mouse database may improve clinical trial outcome predictions. The model included Mycobacterium tuberculosis growth function in mice, adaptive immune response effect on bacterial growth, relationships among moxifloxacin, rifapentine, and rifampin concentrations accelerating bacterial death, clinical PK data, species-specific protein binding, drug-drug interactions, and patient-specific pathology...
May 31, 2017: Clinical and Translational Science
D J Bowen, T Hyams, M Goodman, K M West, J Harris-Wai, J-H Yu
No abstract text is available yet for this article.
May 29, 2017: Clinical and Translational Science
S-D Li, Y-B Chen, L-G Qiu, M-Q Qin
The objective of this study was to explore the mechanism underlying osteoblast suppression in the process of hematopoietic stem cells mobilization induced by granulocyte colony-stimulating factor (G-CSF). The apoptosis of human and mouse osteoblasts was examined by detecting caspase 3. The levels of serum DKK1 and osteocalcin in the supernatant of co-culture of mouse osteoblasts and mouse bone marrow nucleated cells were measured. The number of mouse osteoblasts co-cultured with mouse bone marrow nucleated cells was measured and the osteocalcin mRNA level was also measured...
May 29, 2017: Clinical and Translational Science
B T Gufford, G R Ainslie, J R White, M E Layton, J M Padowski, G M Pollack, M F Paine
Easy-to-use naloxone formulations are needed to help address the opioid overdose epidemic. The pharmacokinetics of i.v., i.m., and a new i.n. naloxone formulation (2 mg) were compared in six healthy volunteers. Relative to i.m. naloxone, geometric mean (90% confidence interval [CI]) absolute bioavailability of i.n. naloxone was modestly lower (55%; 90% CI, 43-70% vs. 41%; 90% CI, 27-62%), whereas average (±SE) mean absorption time was substantially shorter (74 ± 8.8 vs. 6.7 ± 4.9 min). The opioid-attenuating effects of i...
May 15, 2017: Clinical and Translational Science
S Xinqiang, Z Mu, C Lei, L Y Mun
Epigallocatechin-3-gallate (EGCG) is the most abundant and biologically active catechin in green tea, and it exerts multiple effects in humans through mechanisms that remain to be clarified. The present study used bioinformatics to identify possible mechanisms by which EGCG reduces the risk of ovarian cancer. Possible human protein targets of EGCG were identified in the PubChem database, possible human gene targets were identified in the National Center for Biotechnology Information database, and then both sets of targets were analyzed using Ingenuity Pathway Analysis (IPA)...
May 15, 2017: Clinical and Translational Science
R A Boyd, L DiCarlo, J W Mandema
We carried out a dose-response model-based meta-analysis to assess venous thromboembolism (VTE) and bleeding with factor Xa (FXa) inhibitors (apixaban, edoxaban, rivaroxaban) and a thrombin inhibitor (dabigatran) compared with European (EU) (40 mg q.d.) and North American (NA) (30 mg Q12H) dose regimens of a low molecular weight heparin (enoxaparin) following orthopedic surgery. Statistically significant differences in both VTE and bleeding outcomes were found between the NA and EU doses of enoxaparin, with odds ratios (95% confidence interval) for the NA vs...
May 3, 2017: Clinical and Translational Science
V Slowik, U Apte
No abstract text is available yet for this article.
May 3, 2017: 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
A Roda, R Aldini, C Camborata, S Spinozzi, P Franco, M Cont, A D'Errico, F Vasuri, A Degiovanni, L Maroni, L Adorini
Obeticholic acid (OCA) is a semisynthetic bile acid (BA) analog and potent farnesoid X receptor agonist approved to treat cholestasis. We evaluated the biodistribution and metabolism of OCA administered to carbon tetrachloride-induced cirrhotic rats. This was to ascertain if plasma and hepatic concentrations of OCA are potentially more harmful than those of endogenous BAs. After administration of OCA (30 mg/kg), we used liquid chromatography-mass spectrometry to measure OCA, its metabolites, and BAs at different timepoints in various organs and fluids...
April 14, 2017: Clinical and Translational Science
A M Keeler, M K ElMallah, T 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
J P Kitzmiller, J A Luzum, A Dauki, R M Krauss, M W Medina
Cholesterol-lowering response to 40 mg simvastatin daily for 6 weeks was examined for associations with common genetic polymorphisms in key genes affecting simvastatin metabolism (CYP3A4 and CYP3A5) and transport (SLCO1B1). In white people (n = 608), SLCO1B1 521C was associated with lesser reductions of total and low-density lipoprotein cholesterol. Associations between SLCO1B1 521C and cholesterol response were not detected in African Americans (n = 333). Associations between CYP3A4*22 or CYP3A5*3 and cholesterol response were not detected in either race, and no significant race-gene or gene-gene interactions were detected...
May 2017: Clinical and Translational Science
(no author information available yet)
No abstract text is available yet for this article.
May 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.
May 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.
May 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...
May 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)...
May 2017: Clinical and Translational Science
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