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Clinical Therapeutics

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https://www.readbyqxmd.com/read/27919521/unsolved-forgotten-and-ignored-features-of-the-placebo-response-in-medicine
#1
REVIEW
Paul Enck, Sibylle Klosterhalfen, Katja Weimer
PURPOSE: We aimed to identify topics of research that have been neglected, undervalued, or overseen in the past 2 decades of placebo/nocebo research. METHODS: A highly specialized literature database containing >3200 articles on the placebo or nocebo effects or response was screened for articles covering placebo effects in nutrition, sports medicine, physical therapy, and psychotherapy; for article covering gender, age, and culture as influencing factors; for articles dealing with long-term outcome, multimodality; and for articles related to technical (eHealth, mHealth) aspects of placebo effects...
December 2, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27919520/the-nanjing-glycated-hemoglobin-standardization-program-2012-to-2015
#2
Kui Zhang, Yan Wang, Hongxia Wei, Zhiye Xu
PURPOSE: This study aims to investigate glycosylated hemoglobin (HbA1c), between-laboratory imprecision (%CV), and pass rates from 2012 to 2015 in Nanjing to provide evidence for improving the HbA1c measurement. METHODS: This was a retrospective, descriptive analysis of HbA1c levels obtained from participating hospitals in Nanjing from 2012 to 2015. The HbA1c levels of fresh whole blood samples taken from healthy and diabetic adults were determined within 24 hours...
December 2, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27914633/what-can-big-data-offer-the-pharmacovigilance-of-orphan-drugs
#3
John Price
The pharmacovigilance of drugs for orphan diseases presents problems related to the small patient population. Obtaining high-quality information on individual reports of suspected adverse reactions is of particular importance for the pharmacovigilance of orphan drugs. The possibility of mining "big data" to detect suspected adverse reactions is being explored in pharmacovigilance generally but may have limited application to orphan drugs. Sources of big data such as social media may be infrequently used as communication channels by patients with rare disease or their caregivers or by health care providers; any adverse reactions identified are likely to reflect what is already known about the safety of the drug from the network of support that grows up around these patients...
November 30, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27914632/the-us-food-and-drug-administration-s-risk-evaluation-and-mitigation-strategy-rems-program-current-status-and-future-direction
#4
Jasmanda Wu, Juhaeri Juhaeri
The US Food and Drug Administration (FDA) Amendments Act of 2007 granted the FDA new authorities to enhance drug safety by requiring application holders to submit a proposed Risk Evaluation and Mitigation Strategy (REMS). A REMS is a required risk management plan that uses tools beyond the package insert. REMS elements may include a medication guide and patient package insert for patients and a communication plan focused on health care professionals. Elements to assure safe use (ETASUs) are put in place to mitigate a specific known serious risk when other less restrictive elements of a REMS are not sufficient to mitigate such risk...
November 30, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27914631/some-thoughts-on-pharmacovigilance-and-postmarketing-surveillance
#5
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
November 30, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27913032/intervention-studies-of-inhaled-corticosteroids-combined-with-long-acting-theophylline-or-long-acting-%C3%AE-2-agonists-in-patients-with-moderate-to-severe-asthma-a-randomized-controlled-study
#6
Yan Wang, Ping Chen, Anna Dai, Shengyun Shang, Lingfei Kong
PURPOSE: To evaluate and contrast the therapeutic effect and safety of fluticasone aerosol combined with theophylline tablets in patients with moderate to severe asthma, compared with salmeterol/fluticasone propionate aerosol. METHODS: After a screening period, patients meeting the inclusion criteria were randomly assigned to the experiment group (fluticasone aerosol combined with theophylline tablets) or the control group (salmeterol/fluticasone aerosol combined with placebo tablets) for 12 weeks of treatment...
November 29, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27913031/pharmacovigilance-in-the-new-millennium
#7
EDITORIAL
Paul Beninger
No abstract text is available yet for this article.
November 29, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27913030/confounding-variables-and-the-performance-of-triggers-in-detecting-unreported-adverse-drug-reactions
#8
Fabiana Rossi Varallo, Carolina Dagli-Hernandez, Caroline Pagotto, Tales Rubens de Nadai, Maria Teresa Herdeiro, Patricia de Carvalho Mastroianni
PURPOSE: This study explored the performance of trigger in detecting adverse drug reactions (ADRs), the confounding variables impairing the causal association of the ADRs, and the underreporting rate by hospital health professionals. METHODS: A 6-month cross-sectional study was conducted in a public general hospital. Data collection was conducted in 2 stages: (1) screening of patient hospitalizations to identify suspected ADRs with 9 triggers developed by the Institute of Healthcare Improvement; and (2) chart review to perform the causality assessment of the suspected ADRs identified, to describe the confounding variables associated with detection of suspected ADRs that were not drug induced, and to analyze the positive predictive value of triggers in recognizing ADRs...
November 29, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27913029/pharmacovigilance-and-biomedical-informatics-a-model-for-future-development
#9
Paul Beninger, Michael A Ibara
PURPOSE: The discipline of pharmacovigilance is rooted in the aftermath of the thalidomide tragedy of 1961. It has evolved as a result of collaborative efforts by many individuals and organizations, including physicians, patients, Health Authorities, universities, industry, the World Health Organization, the Council for International Organizations of Medical Sciences, and the International Conference on Harmonisation. Biomedical informatics is rooted in technologically based methodologies and has evolved at the speed of computer technology...
November 29, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27889301/glycemic-control-and-weight-outcomes-for-exenatide-once-weekly-versus-liraglutide-in-patients-with-type-2-diabetes-a-1-year-retrospective-cohort-analysis
#10
Carrie McAdam-Marx, Hiep Nguyen, Marisa B Schauerhamer, Mukul Singhal, Sudhir Unni, Xiangyang Ye, David Cobden
PURPOSE: Data comparing real-world effectiveness of the glucagon-like peptide-1 receptor agonists (GLP-1RAs) exenatide once weekly (QW) and liraglutide in the treatment of type 2 diabetes (T2D) are limited. Furthermore, there is limited information on exenatide QW or liraglutide response by glycemic control and insulin use status. This study identifies 1-year glycosylated hemoglobin (HbA1c) and weight outcomes with exenatide QW and liraglutide in the real-world setting overall and in insulin-naive patients with uncontrolled T2D...
November 23, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27889300/tofacitinib-versus-biologic-treatments-in-patients-with-active-rheumatoid-arthritis-who-have-had-an-inadequate-response-to-tumor-necrosis-factor-inhibitors-results-from-a-network-meta-analysis
#11
Maria-Cecilia Vieira, Samuel H Zwillich, Jeroen P Jansen, Brielan Smiechowski, Dean Spurden, Gene V Wallenstein
PURPOSE: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This analysis compared the efficacy and safety of tofacitinib with biologic disease-modifying antirheumatic drugs in patients with RA and a prior inadequate response (IR) to tumor necrosis factor inhibitors (TNFi). METHODS: A systematic literature review identified 5 randomized placebo-controlled trials that evaluated tofacitinib or biologic disease-modifying antirheumatic drugs (bDMARDs) against placebo in patient populations with RA with a prior IR to TNFi...
November 23, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27887741/evaluation-of-16-genotype-guided-warfarin-dosing-algorithms-in-310-korean-patients-receiving-warfarin-treatment-poor-prediction-performance-in-vkorc1-1173c-carriers
#12
Mina Yang, Rihwa Choi, June Soo Kim, Young Keun On, Oh Young Bang, Hyun-Jung Cho, Soo-Youn Lee
PURPOSE: The purpose of this study was to evaluate the performance of 16 previously published warfarin dosing algorithms in Korean patients. METHODS: The 16 algorithms were selected through a literature search and evaluated using a cohort of 310 Korean patients with atrial fibrillation or cerebral infarction who were receiving warfarin therapy. FINDINGS: A large interindividual variation (up to 11-fold) in warfarin dose was observed (median, 25 mg/wk; range, 7-77 mg/wk)...
November 22, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27871780/type-2-diabetes-hypoglycemia-and-basal-insulins-ongoing-challenges
#13
REVIEW
Ian Blumer, Maureen Clement
Hypoglycemia in people with insulin-treated type 2 diabetes can be a limiting factor for management and a barrier to optimizing glycemic control. Even mild episodes of hypoglycemia can affect an individual's quality of life, and fear of hypoglycemia can lead to underinsulinization. This article explores the prevalence and consequences of hypoglycemia in people with type 2 diabetes with a focus on those who use basal insulins, offering strategies for prevention and management. It also discusses the benefits and challenges associated with new basal insulins, and their potential role in reducing hypoglycemia risk...
November 18, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27866659/value-of-propensity-score-matching-for-equalizing-comparator-groups-in-observational-database-studies-a-case-study-in-anti-infectives
#14
C Daniel Mullins, Frank R Ernst, Michelle R Krukas, Joseph Solomkin, Christian Eckmann, Ahmed Shelbaya, Alvaro Quintana, Arlene Reisman
PURPOSE: Propensity score methodologies can reduce bias and confounding in nonrandomized studies, including pharmaceutical comparative effectiveness studies. An observational case study was developed to demonstrate the impact of propensity score adjustments on outcomes (ie, discharge status) of patients hospitalized for complicated intra-abdominal infections. METHODS: Two cohorts were examined: intensive care unit (ICU) (vs non-ICU) patients and tigecycline-treated patients (vs patients receiving other antibiotics)...
November 17, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27866658/effect-of-modulated-electrohyperthermia-on-the-pharmacokinetics-of-oral-transmucosal-fentanyl-citrate-in-healthy-volunteers
#15
Sun Young Lee, Min-Gul Kim
PURPOSE: This study aimed to determine whether changes occur in fentanyl absorption and disposition when administered in conjunction with modulated electrohyperthermia (mEHT) treatment. METHODS: A randomized, single-dose, crossover, open-label study was used to investigate the effect of mEHT on the pharmacokinetic properties of fentanyl in 12 healthy volunteers. The 12 healthy volunteers were each administered a single dose of oral transmucosal fentanyl citrate (OTFC) or a single dose of OTFC with mEHT...
November 17, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27863704/cardiovascular-effects-of-glucose-lowering-therapies-for-type-2-diabetes-new-drugs-in-perspective
#16
REVIEW
Peter L Thompson, Timothy M E Davis
PURPOSE: The purpose of this study was to review the results of clinical trials assessing the cardiovascular effects of drugs for type 2 diabetes and the cardiovascular effects of newer available drugs. METHODS: We performed a detailed search of PubMed-listed publications, reports from international meetings, and ongoing studies from clinical trials.gov. FINDINGS: Currently available drugs have neutral or, in some cases, negative effects on cardiovascular outcomes...
November 15, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27842713/patterns-and-trends-in-scientific-research-on-generic-drugs
#17
Rut Lucas-Dominguez, Antonio Vidal-Infer, Adolfo Alonso-Arroyo, Carolina Navarro, Juan Carlos Valderrama-Zurián, Rafael Aleixandre-Benavent
PURPOSE: The purpose of this study to investigate the evolution and current status of peer-reviewed publications concerning generic drugs during the past few decades. METHODS: Scientific articles about generic drugs published until 2012 were retrieved through the PubMed/MEDLINE database, and a content analysis was performed. FINDINGS: Our study revealed an increasing number of publications on generics since 1984. Statins, antiretroviral therapies, and antiepileptics, followed by immunosuppressants and antithrombotic agents, were the most common therapeutic drug categories...
November 11, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27837934/evaluation-of-the-effect-of-selumetinib-on-cardiac-repolarization-a-randomized-placebo-and-positive-controlled-crossover-qt-qtc-study-in-healthy-subjects
#18
Diansong Zhou, Karen So, Angela W Dymond, Torbjorn Vik, Nidal Al-Huniti, Gabriella Mariani, Gyorgy Zorenyi, Yifan Huang, Victoria Holmes, Paul Severin, Scott Rasmussen, Paul Martin
PURPOSE: Selumetinib (AZD6244, ARRY-142886) is an oral, potent, and selective allosteric mitogen-activated protein kinase 1/2 inhibitor with a short t1/2. The purpose of this study was to characterize the effect of selumetinib on cardiac repolarization and a potential exposure-QT effect relationship. METHODS: A double-blind (selumetinib), randomized, 3-period crossover study was conducted to assess the effects of a single oral dose of selumetinib (75 mg) on the QTc interval compared with placebo, using moxifloxacin as an open-label positive control, in healthy male subjects aged 18 to 45 years...
November 9, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27836495/duration-of-systemic-inflammatory-response-syndrome-influences-serum-vancomycin-concentration-in-patients-with-sepsis
#19
Masayuki Chuma, Makoto Makishima, Toru Imai, Naohiro Tochikura, Takako Sakaue, Norikazu Kikuchi, Kosaku Kinoshita, Morio Kaburaki, Yoshikazu Yoshida
PURPOSE: Vancomycin (VCM) is used in the treatment of methicillin-resistant Staphylococcus aureus infection. The dosage of VCM must be adjusted by using therapeutic drug monitoring because of the drug's narrow therapeutic concentration window. Although optimal administration based on population pharmacokinetic (PPK) analysis and/or a Bayesian method has improved prediction accuracy, serum concentrations of VCM in patients with sepsis often deviate significantly from predicted values. We investigated factors influencing prediction errors with PPK analysis in VCM dosing...
November 8, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27836494/associations-between-vaginal-infections-and-potential-high-risk-and-high-risk-human-papillomavirus-genotypes-in-female-sex-workers-in-western-kenya
#20
Sonia Menon, Davy Vanden Broeck, Rodolfo Rossi, Emiliono Ogbe, Stacy Harmon, Hillary Mabeya
PURPOSE: Infection with and persistence of high-risk human papillomavirus (HR HPV) are the strongest risk factors for cervical cancer. Little is known about the prevalence and role of concurrent sexually transmitted infections (STIs) found in HPV-infected female sex workers (FSW) in Africa. This study purports to test our a priori hypotheses that STIs are associated with genotypes pertaining to the α-group species 9. The objectives were to determine the prevalence of bacterial vaginosis (BV), Trichomonas vaginalis, and Candida spp in FSW, the association between these STIs and the prevalence of any potential HR and HR HPV genotypes in FSWs...
November 8, 2016: Clinical Therapeutics
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