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Human Factors in Patient Safety

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https://www.readbyqxmd.com/read/28531278/cardiovascular-toxic-effects-of-targeted-cancer-therapy
#1
Kazuko Tajiri, Kazutaka Aonuma, Ikuo Sekine
Over the past decade, there has been a major shift in chemotherapy from non-specific cytotoxic drugs to molecular targeted drug therapies. As more molecular targeted therapies are developed, new types of cardiovascular toxicities induced by targeted therapies are a growing problem. Cardiotoxicity induced by the human epidermal growth factor receptor-2 inhibitor trastuzumab manifests as decreased left ventricular ejection fraction. In contrast to anthracycline treatment, most cardiac events occur during trastuzumab treatment, but are reversed quickly when treatment is interrupted and cardiac intervention is established...
May 20, 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28530020/golimumab-a-review-in-inflammatory-arthritis
#2
James E Frampton
Golimumab (Simponi(®)), a fully human monoclonal antibody against tumour necrosis factor-alpha (TNFα), is given once monthly by subcutaneous injection. In the EU, golimumab is approved as monotherapy and/or in combination with methotrexate for the treatment of inflammatory arthritis, including rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis [comprising ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)] in adults, and polyarticular juvenile idiopathic arthritis (pJIA) in children...
May 22, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28529840/adoptive-cell-therapy-with-tregs-to-improve-transplant-outcomes-the-promise-and-the-stumbling-blocks
#3
Mohamed B Ezzelarab, Angus W Thomson
The contribution of regulatory T cells (Treg) to the induction and maintenance of tolerance is well-recognized in rodents and may contribute to long-term human organ allograft survival. The therapeutic efficacy of adoptively-transferred Treg in promoting tolerance to organ allografts is well-recognized in mouse models. Early phase 1/2 clinical studies of Treg therapy have been conducted in patients with type-1 (autoimmune) diabetes and refractory Crohn's disease, and for inhibition of graft-versus-host disease following bone marrow transplantation with proven safety...
December 2016: Current Transplantation Reports
https://www.readbyqxmd.com/read/28529585/efficacy-of-recombinant-human-adenovirus-p53-combined-with-chemotherapy-for-locally-advanced-cervical-cancer-a-clinical-trial
#4
Jie Xiao, Jian Zhou, Min Fu, Li Liang, Qiaoling Deng, Xiaoyun Liu, Fumin Liu
The aim of this study was to evaluate the efficacy and safety of recombinant human adenovirus-p53 (rhAd-p53) combined with neoadjuvant chemotherapy in treatment of locally advanced cervical cancer (LACC). A total of 40 patients with LACC (stage IB2 to IIIA) were randomized into 2 groups (n=20 each): PVB group (cisplatin + vincristine + bleomycin, intravenously) and combined group (rhAd-p53 gene therapy + neoadjuvant chemotherapy). Both groups underwent a course of chemotherapy; the only exception was the injection of the rhAd-p53 solution 1×10(12) VP intratumorally at an interval of three days thrice in the combined group thereafter...
May 2017: Oncology Letters
https://www.readbyqxmd.com/read/28514897/biomaterials-and-bioactive-agents-in-spinal-fusion
#5
Rui M Duarte, Pedro Varanda, Rui L Reis, Ana Rita C Duarte, Jorge Correia-Pinto
Management of degenerative spine pathologies frequently leads to the need for spinal fusion, where bone growth is induced towards stabilization of the interventioned spine. Autologous bone graft (ABG) remains the gold standard inducer, while new bone graft substitutes attempt to achieve effective de novo bone formation and solid fusion. Limited fusion outcomes have driven motivation for more sophisticated and multidisciplinary solutions, involving new biomaterials and/or biologics, through innovative delivery platforms...
May 17, 2017: Tissue Engineering. Part B, Reviews
https://www.readbyqxmd.com/read/28514302/safety-and-efficacy-evaluation-of-pertuzumab-in-patients-with-solid-tumors
#6
Chenjing Zhu, Wenwu Ling, Jing Zhang, Hui Gao, Kai Shen, Xuelei Ma
BACKGROUND: The development of targeted therapies benefits patients with certain markers in the treatment of breast cancer. Pertuzumab is a novel humanized monoclonal antibody that blocks human epidermal growth factor receptor 2 (HER2) dimerization. The Food and Drug Administration has approved pertuzumab in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer. METHODS: To assess the safety and efficacy profile of pertuzumab, we searched PubMed and Embase (articles from January 1966 to January 2015) using the keyword "pertuzumab"...
May 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28511723/feasibility-and-diagnostic-performance-of-dual-tracer-guided-sentinel-lymph-node-biopsy-in-ct1-2n0m0-gastric-cancer-a-systematic-review-and-meta-analysis-of-diagnostic-studies
#7
REVIEW
Ling Huang, Tao Wei, Junjun Chen, Donghui Zhou
BACKGROUND: Dual-tracer-guided sentinel lymph node (SLN) biopsy may provide a promising diagnostic tool to assess accurately the status of lymph node metastasis in the surgical operation and assure the oncologic safety of the function or stomach preserving surgery. The diagnostic performance of this technology in recent studies varied. Thus, we conducted this meta-analysis. METHODS: This systematic review and meta-analysis was registered at the PROSPERO. Eligible studies were searched in the PubMed, EMBASE, Web of Knowledge, and Cochrane Library databases...
May 16, 2017: World Journal of Surgical Oncology
https://www.readbyqxmd.com/read/28498781/phase-i-study-and-biomarker-analysis-of-pyrotinib-a-novel-irreversible-pan-erbb-receptor-tyrosine-kinase-inhibitor-in-patients-with-human-epidermal-growth-factor-receptor-2-positive-metastatic-breast-cancer
#8
Fei Ma, Qiao Li, Shanshan Chen, Wenjie Zhu, Ying Fan, Jiayu Wang, Yang Luo, Puyuan Xing, Bo Lan, Meiying Li, Zongbi Yi, Ruigang Cai, Peng Yuan, Pin Zhang, Qing Li, Binghe Xu
Purpose This phase I study assessed the safety, tolerability, pharmacokinetics, antitumor activity, and predictive biomarkers of pyrotinib, an irreversible pan-ErbB inhibitor, in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Patients and Methods Pyrotinib was administered continuously, orally, once per day to patients who did not have prior exposure to tyrosine kinase inhibitors of HER2. Planned dose escalation was 80, 160, 240, 320, 400, and 480 mg. For pharmacokinetic analysis, timed blood samples were collected on day 1 and day 28...
May 12, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28497176/five-weekly-s-1-plus-cisplatin-therapy-combined-with-trastuzumab-therapy-in-her2-positive-gastric-cancer-a-phase-ii-trial-and-biomarker-study-wjog7212g
#9
Yuji Miura, Yasutaka Sukawa, Shuichi Hironaka, Misuzu Mori, Kazuhiro Nishikawa, Shinya Tokunaga, Hiroyuki Okuda, Takeshi Sakamoto, Keisei Taku, Kazuo Nishikawa, Toshikazu Moriwaki, Yuji Negoro, Yutaka Kimura, Keita Uchino, Katsunori Shinozaki, Hiroharu Shinozaki, Nobuyuki Musha, Hirotsugu Yoshiyama, Takashi Tsuda, Yoshinori Miyata, Naotoshi Sugimoto, Tsuyoshi Shirakawa, Miki Ito, Kimio Yonesaka, Kenichi Yoshimura, Narikazu Boku, Katsuhiko Nosho, Toshimi Takano, Ichinosuke Hyodo
BACKGROUND: Five-weekly S-1 plus cisplatin (SP) therapy is the standard care for advanced gastric or esophagogastric junction cancer (GC/EGJC) in East Asia. However, its efficacy and safety when combined with trastuzumab therapy for human epidermal growth factor receptor 2 (HER2)-positive advanced GC/EGJC remains unclear. METHODS: Patients received 5-weekly SP therapy (S-1 at 40-60 mg twice daily for 21 days plus cisplatin at 60 mg/m(2) on day 8, every 5 weeks) plus trastuzumab therapy (first dose of 8 mg/kg, then 6 mg/kg every 3 weeks)...
May 11, 2017: Gastric Cancer
https://www.readbyqxmd.com/read/28481116/overcoming-the-road-blocks-advancement-of-block-copolymer-micelles-for-cancer-therapy-in-the-clinic
#10
Loujin Houdaihed, James C Evans, Christine Allen
With countless preclinical studies on block copolymer micelles (BCMs) successfully demonstrating the superiority of these advanced drug delivery formulations over conventional formulations, it remains somehow discouraging that only a few have reached clinical evaluation and practice. With a critical eye, this review aims to compare and summarize the preclinical and clinical data available on several BCM formulations and to identify their primary role in drug delivery as "carrier" or "solubilizer". This review focuses on polymeric micelles that have reached clinical evaluation and/or are being pursued commercially...
May 18, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28480041/risk-of-qt-prolongation-and-torsade-de-pointes-associated-with-exposure-to-hydroxyzine-re-evaluation-of-an-established-drug
#11
Anne-Françoise Schlit, Annie Delaunois, Aurore Colomar, Branderley Claudio, Luca Cariolato, Rossen Boev, Jean-Pierre Valentin, Christopher Peters, Victor S Sloan, Jürgen W G Bentz
Several noncardiac drugs have been linked to cardiac safety concerns, highlighting the importance of post-marketing surveillance and continued evaluation of the benefit-risk of long-established drugs. Here, we examine the risk of QT prolongation and/or torsade de pointes (TdP) associated with the use of hydroxyzine, a first generation sedating antihistamine. We have used a combined methodological approach to re-evaluate the cardiac safety profile of hydroxyzine, including: (1) a full review of the sponsor pharmacovigilance safety database to examine real-world data on the risk of QT prolongation and/or TdP associated with hydroxyzine use and (2) nonclinical electrophysiological studies to examine concentration-dependent effects of hydroxyzine on a range of human cardiac ion channels...
June 2017: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28477027/efficacy-and-safety-of-different-molecular-targeted-agents-based-on-chemotherapy-for-gastric-cancer-patients-treatment-a-network-meta-analysis
#12
Zheng Ren, Jinping Sun, Xinfang Sun, Hongtao Hou, Ke Li, Quanxing Ge
Increasing numbers of reports have been published to demonstrate that molecular targeted agents are able to improve the efficacy of chemotherapy in gastric cancer. This network meta-analysis aimed to evaluate the efficacy and safety of different molecular targeted agents, which were divided into six groups based on the targets including hepatocyte growth factor receptor (c-MET), vascular endothelial factor and its receptor (VEGF/VEGFR), human epidermal growth factor receptor 2 (HER2), epidermal growth factor receptor (EGFR), mammalian target of rapamycin (mTOR) and tyrosine kinase inhibitor (TKI)...
April 18, 2017: Oncotarget
https://www.readbyqxmd.com/read/28471371/the-reversal-of-direct-oral-anticoagulants-in-animal-models
#13
Markus Honickel, Necib Akman, Oliver Grottke
Several direct oral anticoagulants (DOACs), including direct thrombin and factor Xa inhibitors, have been approved as alternatives to vitamin K antagonist (VKA) anticoagulants. As with any anticoagulant, DOAC use carries a risk of bleeding. In patients with major bleeding or needing urgent surgery, reversal of DOAC anticoagulation may be required, presenting a clinical challenge. The optimal strategy for DOAC reversal is being refined, and may include use of hemostatic agents such as prothrombin complex concentrates (PCCs; a source of concentrated clotting factors), or DOAC-specific antidotes (which bind their target DOAC to abrogate its activity)...
April 4, 2017: Shock
https://www.readbyqxmd.com/read/28470132/value-based-hr-practices-i-deals-and-clinical-error-control-with-csr-as-a-moderator
#14
Tuan Luu, Chris Rowley, Sununta Siengthai, Vo Thanh Thao
Purpose Notwithstanding the rising magnitude of system factors in patient safety improvement, "human factors" such as idiosyncratic deals (i-deals) which also contribute to the adjustment of system deficiencies should not be neglected. The purpose of this paper is to investigate the role of value-based HR practices in catalyzing i-deals, which then influence clinical error control. The research further examines the moderating role of corporate social responsibility (CSR) on the effect of value-based HR practices on i-deals...
May 8, 2017: International Journal of Health Care Quality Assurance
https://www.readbyqxmd.com/read/28469643/impacts-of-the-retinal-environment-and-photoreceptor-type-on-functional-regeneration
#15
REVIEW
Michèle G DuVal, W Ted Allison
Retinal regeneration is a promising central nervous system (CNS) target amongst the various stem cell therapy pursuits, due to its accessibility for manipulation and its disposition towards longitudinal monitoring of treatment safety and efficacy. We offer our perspective on current hurdles towards functional regeneration of cone photoreceptors. Cones are key: For patients suffering vision loss, cone photoreceptors are a required cellular component to restoring daytime vision, colour vision, and high acuity vision...
March 2017: Neural Regeneration Research
https://www.readbyqxmd.com/read/28467880/teprotumumab-for-thyroid-associated-ophthalmopathy
#16
RANDOMIZED CONTROLLED TRIAL
Terry J Smith, George J Kahaly, Daniel G Ezra, James C Fleming, Roger A Dailey, Rosa A Tang, Gerald J Harris, Alessandro Antonelli, Mario Salvi, Robert A Goldberg, James W Gigantelli, Steven M Couch, Erin M Shriver, Brent R Hayek, Eric M Hink, Richard M Woodward, Kathleen Gabriel, Guido Magni, Raymond S Douglas
BACKGROUND: Thyroid-associated ophthalmopathy, a condition commonly associated with Graves' disease, remains inadequately treated. Current medical therapies, which primarily consist of glucocorticoids, have limited efficacy and present safety concerns. Inhibition of the insulin-like growth factor I receptor (IGF-IR) is a new therapeutic strategy to attenuate the underlying autoimmune pathogenesis of ophthalmopathy. METHODS: We conducted a multicenter, double-masked, randomized, placebo-controlled trial to determine the efficacy and safety of teprotumumab, a human monoclonal antibody inhibitor of IGF-IR, in patients with active, moderate-to-severe ophthalmopathy...
May 4, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28464769/adult-stem-cell-therapy-for-cardiac-repair-in-patients-after-acute-myocardial-infarction-leading-to-ischemic-heart-failure-an-overview-of-evidence-from-the-recent-clinical-trials
#17
Rygiel Katarzyna
Cardiovascular diseases (CVD) still represent the leading cause of mortality worldwide, despite the remarkable advances in interventional cardiology, cardiac surgery, and modern pharmacotherapy, particularly in the setting of acute myocardial infarction (AMI), chronic ischemic heart failure (HF), cardiomyopathy (CM), and the associated left ventricular (LV) dysfunction. A significant loss of cardiomyocytes that underlies all of these conditions was previously considered irreversible. However, current evidence indicates that the human heart has some potential for repair, and over the past decade, many research studies have been exploring the use of stem cells (SCs) to facilitate restoration of myocardium...
May 1, 2017: Current Cardiology Reviews
https://www.readbyqxmd.com/read/28462894/a-survey-of-residents-experience-with-patient-safety-and-quality-improvement-concepts-in-radiation-oncology
#18
Matthew B Spraker, Matthew Nyflot, Kristi Hendrickson, Eric Ford, Gabrielle Kane, Jing Zeng
PURPOSE: The safety and quality of radiation therapy have recently garnered increased attention in radiation oncology (RO). Although patient safety guidelines expect physicians and physicists to lead clinical safety and quality improvement (QI) programs, trainees' level of exposure to patient safety concepts during training is unknown. METHODS AND MATERIALS: We surveyed active medical and physics RO residents in North America in February 2016. Survey questions involved demographics and program characteristics, exposure to patient safety topics, and residents' attitude regarding their safety education...
December 1, 2016: Practical Radiation Oncology
https://www.readbyqxmd.com/read/28460655/the-impact-of-environmental-design-on-doffing-personal-protective-equipment-in-a-healthcare-environment-a-formative-human-factors-trial
#19
Tracey A Herlihey, Stefano Gelmi, Joseph A Cafazzo, Trevor N T Hall
OBJECTIVE To explore the impact of environmental design on doffing personal protective equipment in a simulated healthcare environment. METHODS A mixed-methods approach was used that included human-factors usability testing and qualitative questionnaire responses. A patient room and connecting anteroom were constructed for testing purposes. This experimental doffing area was designed to overcome the environmental failures identified in a previous study and was not constructed based on any generalizable hospital standard...
May 2, 2017: Infection Control and Hospital Epidemiology
https://www.readbyqxmd.com/read/28453759/randomised-double-blind-placebo-controlled-trial-of-ccr9-targeted-leukapheresis-treatment-of-ulcerative-colitis-patients
#20
Michael Eberhardson, Per Karlén, Ludvig Linton, Petra Jones, Annelie Lindberg, Martina Jones Kostalla, Emma Lindh, Anders Odén, Hans Glise, Ola Winqvist
Background and Aims: Ulcerative colitis patients display increased numbers of circulating pro-inflammatory monocyte human leukocyte antigen-DR [HLA-DRhi] monocytes expressing high levels of the gut-homing C-C chemokine receptor 9 [CCR9] and tumour necrosis factor [TNF]-α. The aim of this first-in-human, double-blind, randomised, placebo-controlled trial was to evaluate selective removal of circulating CCR9-expressing monocytes by leukapheresis in patients with moderate to severe ulcerative colitis, with regards to safety, tolerability, and immunological response...
May 1, 2017: Journal of Crohn's & Colitis
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