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Clinical Therapeutics

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https://www.readbyqxmd.com/read/29336846/sex-differences-in-prevalence-of-emergency-department-patient-substance-use
#1
Robert D Cannon, Gillian A Beauchamp, Paige Roth, Jennifer Stephens, David B Burmeister, David M Richardson, Alanna M Balbi, Tennessee D Park, Stephen W Dusza, Marna Rayl Greenberg
PURPOSE: Substance use and misuse is prevalent in emergency department (ED) populations. While the prevalence of substance use and misuse is reported, sex-specific trends in ED populations have not been documented. We set out to determine the sex-specific prevalence of ED patient substance use during this current epidemic. METHODS: A retrospective electronic data abstraction tool, developed for quality-improvement purposes, was used to assess ED visits in 3 hospitals in northeastern Pennsylvania...
January 11, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29329750/women-and-the-experience-of-pain-and-opioid-use-disorder-a-literature-based-commentary
#2
Andrew L Koons, Marna Rayl Greenberg, Robert D Cannon, Gillian A Beauchamp
It is generally understood that pain experience and opioid abuse have relied on male-dominated models. However, sex and gender play a role in both pain experience and opioid use disorder. Using the previously validated Texas Tech University Health Sciences Center Sex and Gender Specific Health PubMed Advanced Search Tool, the authors used pertinent literature to develop this literature-based commentary on sex and gender differences in pain experience and opioid use disorder. Women report their experience of pain more frequently, have increased rates of diagnoses related to pain, have increased pain sensitivity, and have a variable response to pain and analgesia...
January 9, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29317112/cannabinoid-disposition-after-human-intraperitoneal-use-an-insight-into-intraperitoneal-pharmacokinetic-properties-in-metastatic-cancer
#3
Catherine J Lucas, Peter Galettis, Shuzhen Song, Nadia Solowij, Stephanie E Reuter, Jennifer Schneider, Jennifer H Martin
BACKGROUND: Medicinal cannabis is prescribed under the provision of a controlled drug in the Australian Poisons Standard. However, multiple laws must be navigated in order for patients to obtain access and imported products can be expensive. Dose-response information for both efficacy and toxicity pertaining to medicinal cannabis is lacking. The pharmacokinetic properties of cannabis administered by traditional routes has been described but to date, there is no literature on the pharmacokinetic properties of an intraperitoneal cannabinoid emulsion...
January 6, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29306569/erratum-to-patient-and-physician-reported-satisfaction-with-systemic-lupus-erythematosus-treatment-in-us-clinical-practice-clin-ther-2017-39-1811-1826
#4
Katie Pascoe, Steve Lobosco, David Bell, Ben Hoskin, David J Chang, Bonnie Pobiner, Sulabha Ramachandran
No abstract text is available yet for this article.
January 3, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29305017/potential-usefulness-of-early-potassium-supplementation-for-preventing-severe-hypokalemia-induced-by-liposomal-amphotericin-b-in-hematologic-patients-a-retrospective-study
#5
Naoto Okada, Momoyo Azuma, Masaki Imanishi, Yoshito Zamami, Yasushi Kirino, Toshimi Nakamura, Kazuhiko Teraoka, Masahiro Abe, Keisuke Ishizawa
PURPOSE: Liposomal amphotericin B (L-AMB) is an essential antifungal agent for patients with hematologic diseases; however, the drug causes severe hypokalemia at a high frequency. Meanwhile, there is little evidence regarding the risk factors for L-AMB-induced severe hypokalemia, and the prevention protocol has not been established. The goal of this study was to identify the risk factors related to severe hypokalemia induced by L-AMB in hematologic patients. METHODS: Seventy-eight hematologic patients with a first administration of L-AMB were enrolled in the study...
January 2, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29290374/physical-compatibility-of-meropenem-and-vaborbactam-with-select-intravenous-drugs-during-simulated-y-site-administration
#6
James M Kidd, Lindsay M Avery, Tomefa E Asempa, David P Nicolau, Joseph L Kuti
PURPOSE: Meropenem/vaborbactam is a novel intravenous antibiotic combining the carbapenem, meropenem, with a novel β-lactamase inhibitor, vaborbactam. Meropenem/vaborbactam is administered as a 3-hour infusion given every 8 hours, thereby potentially restricting an intravenous line for 9 h/d. Intravenous medications may be given concurrently via Y-site when compatibility data are available. Herein, physical compatibility was determined for the identification which medications can be coadministered with meropenem/vaborbactam via Y-site...
December 28, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29287750/exercise-as-a-countermeasure-to-declining-central-nervous-system-function-in-multiple-sclerosis
#7
Robert W Motl, Brian M Sandroff
PURPOSE: The decline of central nervous system (CNS) function is a hallmark characteristic of multiple sclerosis (MS) that can manifest as cognitive impairment. We believe that exercise represents a potential behavioral approach for counteracting the declines in CNS structure and associated function among persons with MS (ie, exercise as a countermeasure of CNS decline). This theory is important because disease-modifying drugs represent a first-line approach for modifying the immune system and its effects on the CNS, but these drugs do not generally demonstrate robust improvements in cognitive performance...
December 26, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29287749/phase-1b-study-of-the-safety-pharmacokinetics-and-disease-related-outcomes-of-the-matrix-metalloproteinase-9-inhibitor-andecaliximab-in-patients-with-rheumatoid-arthritis
#8
David L Gossage, Blanka Cieslarová, Sophe Ap, Hao Zheng, Yan Xin, Preeti Lal, Guang Chen, Victoria Smith, John S Sundy
PURPOSE: Andecaliximab (GS-5745) is a highly selective monoclonal antibody against matrix metalloproteinase-9 (MMP9), a proteolytic enzyme implicated in the pathogenesis of rheumatoid arthritis (RA). This study assessed the safety and pharmacokinetic (PK) parameters of andecaliximab in patients with RA and evaluated the effects of andecaliximab treatment on exploratory disease biomarkers. METHODS: In this double-blind, Phase 1b trial, patients with active RA were randomized (4:1) to receive 400-mg andecaliximab or placebo every 2 weeks for a total of 3 intravenous infusions...
December 26, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29277375/adherence-measurements-in-clinical-trials-and-care
#9
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
December 22, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29277374/aerobic-exercise-as-an-adjuvant-to-aphasia-therapy-theory-preliminary-findings-and-future-directions
#10
Stacy M Harnish, Amy D Rodriguez, Deena Schwen Blackett, Christopher Gregory, Lauren Seeds, Jeffrey H Boatright, Bruce Crosson
PURPOSE: This study investigated whether participation in aerobic exercise enhances the effects of aphasia therapy, and the degree to which basal serum brain-derived neurotropic factor (BDNF) concentrations fluctuate after the beginning of aerobic exercise or stretching activities in individuals with poststroke aphasia. METHODS: The study used a single-subject, multiple-baseline design. Seven individuals with chronic poststroke aphasia participated in 2 Blocks of aphasia therapy: aphasia therapy alone (Block 1), followed by aphasia therapy with the addition of aerobic activity via bicycle ergometer (n = 5) or stretching (n = 2) (Block 2)...
December 22, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29276132/getting-the-brain-into-shape-exercise-in-neurological-disorders
#11
EDITORIAL
Jane B Allendorfer, Marcas M Bamman
No abstract text is available yet for this article.
December 21, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29275065/reduced-time-in-therapeutic-range-and-higher-mortality-in-atrial-fibrillation-patients-taking-acenocoumarol
#12
José Miguel Rivera-Caravaca, Vanessa Roldán, María Asunción Esteve-Pastor, Mariano Valdés, Vicente Vicente, Francisco Marín, Gregory Y H Lip
PURPOSE: The efficacy and tolerability of vitamin K antagonists (VKAs) depends on the quality of anticoagulant control, reflected by the mean time in therapeutic range (TTR) of international normalized ratio 2.0 to 3.0. In the present study, we aimed to investigate the association between TTR and change in TTR (ΔTTR) with the risk of mortality and clinically significant events in a consecutive cohort of atrial fibrillation (AF) patients. METHODS: We included 1361 AF patients stable on VKAs (international normalized ratio 2...
December 20, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29275064/role-of-physical-activity-and-exercise-in-alleviating-cognitive-impairment-in-people-with-epilepsy
#13
Jane B Allendorfer, Ricardo M Arida
Many persons with epilepsy (PWE) experience problems with a wide range of cognitive functions, including learning, memory, attention, and executive control. These deficits in cognition result in diminished quality of life for PWE and are related to many factors, including the etiology of their epilepsy, recurrent seizures, side effects of antiseizure medications, or a combination of these factors. Various treatments to ameliorate cognitive deficits experienced by PWE have been implemented, although noninvasive and nonpharmacologic strategies may be more appealing options due to their relatively low cost, reduced risk of side effects, and/or reduced potential interactions with antiseizure medications...
December 20, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29273471/exposure-and-dose-response-analyses-in-dose-selection-and-labeling-of-fda-approved-biologics
#14
Ken Ogasawara, Christopher D Breder, Dora H Lin, G Caleb Alexander
PURPOSE: Biological drug products, or products derived from living cells, represent an increasingly important part of the pharmaceutical market. Despite this, little is known about how sponsors determine the dose to be studied in registrational trials or to be proposed in labeling for biologics. We examined how exposure-response and dose-response analyses were used to determine dosing in pivotal trials or the labeling for all biologics approved by the Center for Drug Evaluation and Research, the US Food and Drug Administration (FDA) between 2003 and 2016...
December 19, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29273470/relative-bioavailability-of-silybin-a-and-silybin-b-from-2-multiconstituent-dietary-supplement-formulations-containing-milk-thistle-extract-a-single-dose-study
#15
Wen-Yi Li, Guo Yu, Renee M Hogan, Rajesh Mohandas, Reginald F Frye, Eric Gumpricht, John S Markowitz
PURPOSE: The purpose of this study was to compare the bioavailability between 2 milk thistle-containing dietary supplements, Product B and IsaGenesis, in healthy volunteers. METHODS: Bioavailability between Product B, originally formulated as a powdered capsule, and IsaGenesis, reformulated as a soft gel, were compared by measuring silybin A and silybin B as surrogate pharmacokinetic markers for differences in absorption and bioavailability. For this randomized, open-label, crossover pharmacokinetic study, 12 healthy volunteers consumed a single-dose serving of each supplement separated by at least a 7-day washout period...
December 19, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29268957/use-of-%C3%AE-2-adrenergic-agonists-to-improve-surgical-field-visibility-in-endoscopy-sinus-surgery-a-systematic-review-of-randomised-controlled-trials
#16
REVIEW
Maria Angeles Quijada-Manuitt, Yolanda Escamilla, Antonio Vallano, Alda Cardesín, Manuel Bernal-Sprekelsen, Caridad Pontes
PURPOSE: We assessed the evidence for the use of α2-adrenergic agonists (A2AAs) in bleeding control and field quality in endoscopic sinus surgery. METHODS: We systematically reviewed randomized clinical trials (RCTs) assessing A2AAs in endoscopic sinus surgery. Abstracts were reviewed by 2 investigators for eligibility, and selected articles were fully reviewed. Data on study design, population, A2AA drug and control groups, bleeding and surgical field quality outcomes, and adverse effects were extracted and synthesized...
December 18, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29248384/efficacy-and-tolerability-of-telmisartan-amlodipine-hydrochlorothiazide-versus-telmisartan-amlodipine-combination-therapy-for-essential-hypertension-uncontrolled-with-telmisartan-amlodipine-the-phase-iii-multicenter-randomized-double-blind-tahyti-study
#17
Ki-Chul Sung, Yong-Seog Oh, Dong-Hun Cha, Soon-Jun Hong, Kyung-Heon Won, Ki-Dong Yoo, Seung-Woon Rha, Young-Keun Ahn, Jeong-Cheon Ahn, Ji-Yong Jang, Tack-Jong Hong, Sang-Kyoon Cho, Sang-Ho Park, Min-Su Hyon, Chang-Wook Nam, In-Ho Chae, Byung-Su Yoo, Jong-Min Song, Jin-Ok Jeong, Young Won Yoon, Byung-Soo Kim, Tae-Hyun Yang, Deok-Kyu Cho, Sang-Hyun Kim, Yu-Jeong Choi, Ji-Hun Ahn, Dong-Woon Jeon, Hyo-Soo Kim
PURPOSE: This 8-week study in Korea aimed to evaluate the efficacy and tolerability of a telmisartan/amlodipine + hydrochlorothiazide (TAH) combination versus telmisartan/amlodipine (TA) combination in patients with essential hypertension that did not respond appropriately to 4-week treatment with TA. METHODS: All patients who met the inclusion criteria received TA (40/5 mg) during a 4-week run-in period (period 1). Patients who met the criteria for essential hypertension (mean sitting systolic blood pressure [MSSBP], ≥140 and <200 mm Hg, or ≥130 and<200 mm Hg in those with diabetes mellitus or chronic kidney disease) after period 1 were randomly assigned to receive TA 40/5 mg + hydrochlorothiazide 12...
December 13, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29246708/prescription-of-dpp-4-inhibitors-to-type-2-diabetes-mellitus-patients-with-renal-impairment-a-uk-primary-care-experience
#18
Dionysis Spanopoulos, Brendan Barrett, Michael Busse, Toni Roman, Chris Poole
Members of the dipeptidyl peptidase-4 inhibitor drug class are indicated for glycemic control in patients with type 2 diabetes mellitus and all, except linagliptin, require dose adjustment in renal impairment. A cross-sectional analysis of a cohort of type 2 diabetes mellitus patients treated with dipeptidyl peptidase-4 inhibitors identified in the Clinical Practice Research Datalink was conducted to explore compliance with the renal adjustment requirements of the Summaries of Product Characteristics. Approximately one third of type 2 diabetes mellitus patients with creatinine clearance <50 mL/min who were at risk of inappropriate prescribing, were initiated on a DPP-4 inhibitor at a higher dose than the specified in their respective Summary of Product Characteristics...
December 12, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29229228/factors-influencing-norvancomycin-concentration-in-plasma-and-cerebrospinal-fluid-in-patients-after-craniotomy-and-dosing-guideline-a-population-approach
#19
Xingang Li, Yuanxing Wu, Shusen Sun, Qiang Wang, Zhigang Zhao
PURPOSE: Antibacterial spectrum and activity of norvancomycin are comparable with vancomycin, and it has been widely used in China. Norvancomycin can penetrate into the cerebrospinal fluid (CSF) through the damaged blood-brain barrier in patients after craniotomy. Because higher inter-individual variability was observed, we aimed to identify factors related to drug concentration to guide clinicians with norvancomycin dosing. METHODS: After craniotomy, patients with an indwelling catheter in the operational area/ventricle were intravenously administered norvancomycin...
December 8, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29223557/efficacy-and-safety-of-adding-omega-3-fatty-acids-in-statin-treated-patients-with-residual-hypertriglyceridemia-romantic-rosuvastatin-omacor-in-residual-hypertriglyceridemia-a-randomized-double-blind-and-placebo-controlled-trial
#20
Chee Hae Kim, Kyung Ah Han, Jaemyung Yu, Sang Hak Lee, Hui Kyung Jeon, Sang Hyun Kim, Seok Yeon Kim, Ki Hoon Han, Kyungheon Won, Dong-Bin Kim, Kwang-Jae Lee, Kyungwan Min, Dong Won Byun, Sang-Wook Lim, Chul Woo Ahn, SeongHwan Kim, Young Joon Hong, Jidong Sung, Seung-Ho Hur, Soon Jun Hong, Hong-Seok Lim, Ie Byung Park, In Joo Kim, Hyoungwoo Lee, Hyo-Soo Kim
PURPOSE: The purpose of this study was to examine the efficacy and safety of adding ω-3 fatty acids to rosuvastatin in patients with residual hypertriglyceridemia despite statin treatment. METHODS: This study was a multicenter, randomized, double-blind, placebo-controlled study. After a 4-week run-in period of rosuvastatin treatment, the patients who had residual hypertriglyceridemia were randomized to receive rosuvastatin 20 mg/d plus ω-3 fatty acids 4 g/d (ROSUMEGA group) or rosuvastatin 20 mg/d (rosuvastatin group) with a 1:1 ratio and were prescribed each medication for 8 weeks...
December 6, 2017: Clinical Therapeutics
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