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https://www.readbyqxmd.com/read/28107773/safety-and-effectiveness-of-tofogliflozin-in-elderly-japanese-patients-with-type-2-diabetes-mellitus-a-post-marketing-study-j-step-el-study
#1
Kazunori Utsunomiya, Naoki Shimmoto, Masayuki Senda, Yuji Kurihara, Ryoji Gunji, Shoko Fujii, Seigo Kakiuchi, Hisataka Fujiwara, Hiroyuki Kameda, Masahiro Tamura, Kohei Kaku
AIMS/INTRODUCTION: While sodium glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We conducted a 1-year post-marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus. MATERIALS AND METHODS: This was a prospective, observational, and multicenter post-marketing study conducted in the context of routine clinical practice...
January 20, 2017: Journal of Diabetes Investigation
https://www.readbyqxmd.com/read/28107570/efficacy-and-safety-of-interleukin-17-antagonists-in-patients-with-plaque-psoriasis-a-meta-analysis-from-phase-3-randomized-controlled-trails
#2
Dan Wu, Si-Yuan Hou, Shuai Zhao, Lin-Xin Hou, Ting Jiao, Nan-Nan Xu, Ning Zhang
BACKGROUND: The interleukin-17 (IL-17) cytokine pathway plays a key role in the development of psoriasis. Antibodies targeting IL-17 or blocking its receptor may be a new therapeutic approach for psoriasis. To assist treatment selection in daily practice it is essential to understand the benefit and risk profile of IL-17 antagonists. OBJECTIVE: We performed a meta-analysis to evaluate the efficacy and safety of IL-17 antagonists in patients with psoriasis. METHODS: We searched a number of databases for relevant randomized clinical trials (RCTs) published before May 2016...
January 20, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28107559/a-randomized-double-blind-placebo-controlled-dose-escalation-first-in-man-study-phase-0-to-assess-the-safety-and-efficacy-of-topical-cytosolic-phospholipase-a2-inhibitor-avx001-in-patients-with-mild-to-moderate-plaque-psoriasis
#3
S H Omland, A Habicht, P Damsbo, J Wilms, B Johansen, R Gniadecki
BACKGROUND: Cytosolic Phospholipase A2 (cPLA2α) is an enzyme suggested as a therapeutic target in inflammatory skin diseases. AVX001, a cPLA2α-inhibitor was investigated in a randomized, double-blind, placebo-controlled, split-design, first-in-man study in patients with mild to moderate psoriasis. OBJECTIVES: The primary objective was to evaluate cutaneous safety and tolerability of AVX001 in doses from 0.002%-5.0%. Safety was assessed as local skin reaction adverse events (LSRAE) grade 3-4...
January 20, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28107397/efficacy-and-safety-of-everolimus-for-maintenance-immunosuppression-of-kidney-transplantation-a-meta-analysis-of-randomized-controlled-trials
#4
Jinyu Liu, Dong Liu, Juan Li, Lan Zhu, Chengliang Zhang, Kai Lei, Qiling Xu, Ruxu You
BACKGROUND: Conversion to everolimus is often used in kidney transplantation to overcome calcineurin inhibitor (CNI) nephrotoxicity but there is conflicting evidence for this approach. OBJECTIVES: To investigate the benefits and harm from randomized clinical trials (RCTs) involving the conversion from CNI to everolimus after kidney transplantation. METHODS: Databases were searched up to March 2016. Two reviewers independently assessed trials for eligibility and quality, and extracted data...
2017: PloS One
https://www.readbyqxmd.com/read/28107284/postsurgical-perforation-of-the-esophagus-can-be-treated-using-a-fully-covered-stent-in-children
#5
Chantal Chauvet, Arnaud Bonnard, Alexis Mosca, Marc Bellaïche, Pascale Philippe-Chomette, Jérôme Viala
OBJECTIVES: Surgery and conservative treatment of esophageal or gastric perforations are both often associated with poor results and carry a high morbidity and mortality rate. The aim of the present study was to evaluate the effectiveness and safety of using fully covered self-expending metallic stents (SEMS) in children with upper digestive leaks. METHODS: This retrospective study reviewed all children with esophageal or gastric perforation who were treated with placement of an SEMS from January 2011 to January 2015...
February 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28106903/continuous-treatment-with-lenalidomide-and-low-dose-dexamethasone-in-transplant-ineligible-patients-with-newly-diagnosed-multiple-myeloma-in-asia-subanalysis-of-the-first-trial
#6
Jin Lu, Jae H Lee, Shang-Yi Huang, Lugui Qiu, Je-Jung Lee, Ting Liu, Sung-Soo Yoon, Kihyun Kim, Zhi X Shen, Hyeon S Eom, Wen M Chen, Chang K Min, Hyo J Kim, Jeong O Lee, Jae Y Kwak, Wai Yiu, Guang Chen, Annette Ervin-Haynes, Cyrille Hulin, Thierry Facon
The phase 3 FIRST (Frontline Investigation of REVLIMID + Dexamethasone Versus Standard Thalidomide) trial demonstrated that lenalidomide plus low-dose dexamethasone (Rd) until disease progression (Rd continuous) is an effective treatment option for transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Given genetic differences between Asian and Western populations, this subanalysis of the FIRST trial examined the safety and efficacy of Rd (given continuously or for 18 cycles [Rd18]) and MPT (melphalan, prednisone, thalidomide) in 114 Asian patients from Mainland China, South Korea and Taiwan...
January 20, 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28106685/totally-implantable-venous-access-devices-a-review-of-complications-and-management-strategies
#7
Omidreza Tabatabaie, Gyulnara G Kasumova, Mariam F Eskander, Jonathan F Critchlow, Nicholas E Tawa, Jennifer F Tseng
OBJECTIVE: Totally implantable venous access devices (portacaths, or "ports"), are widely used for intermittent central venous access especially for cancer patients. Although ports have a superior safety margin compared with other long-term venous access devices, there are a number of complications associated with their use. METHODS: This is a narrative review. We searched PubMed and Google Scholar for articles about complications related to the use of portacaths...
February 2017: American Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28105994/angiographic-outcomes-of-orsiro-biodegradable-polymer-sirolimus-eluting-stents-and-resolute-integrity-durable-polymer-zotarolimus-eluting-stents-results-of-the-orient-trial
#8
Si-Hyuck Kang, Woo-Young Chung, Joo Myung Lee, Jin-Joo Park, Chang-Hwan Yoon, Jung-Won Suh, Young-Seok Cho, Joon-Hyung Doh, Jin Man Cho, Jang-Whan Bae, Tae-Jin Youn, In-Ho Chae
AIMS: We performed a randomised controlled open-label non-inferiority trial to compare angiographic outcomes between the ultra-thin strut, biodegradable hybrid polymer Orsiro sirolimus-eluting stent (O-SES) and the durable biocompatible polymer Resolute Integrity zotarolimus-eluting stent (R-ZES). METHODS AND RESULTS: A total of 372 patients planned to undergo percutaneous coronary revascularisation were randomly assigned 2:1 to treatment with O-SES or R-ZES (250 and 122 patients, respectively)...
January 20, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28105733/vitamin-d-supplementation-for-sickle-cell-disease
#9
REVIEW
Htoo Htoo Kyaw Soe, Adinegara Bl Abas, Nan Nitra Than, Han Ni, Jaspal Singh, Abdul Razzak Bin Mohd Said, Ifeyinwa Osunkwo
BACKGROUND: Sickle cell disease is a genetic chronic haemolytic and pro-inflammatory disorder. The clinical manifestations of sickle cell disease result from the presence of mutations on the beta globin genes that generate an abnormal haemoglobin product (called haemoglobin S) within the red blood cell. Sickle cell disease can lead to many complications such as acute chest syndrome, stroke, acute and chronic bone complications (including painful vaso-occlusive crisis, osteomyelitis, osteonecrosis and osteoporosis)...
January 20, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28105618/-efficacy-analysis-of-fecal-microbiota-transplantation-in-the-treatment-of-406-cases-with-gastrointestinal-disorders
#10
Ning Li, Hongliang Tian, Chunlian Ma, Chao Ding, Xiaolong Ge, Lili Gu, Xuelei Zhang, Bo Yang, Yue Hua, Yifan Zhu, Yan Zhou
OBJECTIVE: To evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for gastrointestinal disorders. METHODS: Retrospective analysis of the clinical data of 406 patients who underwent FMT from May 2014 to April 2016 in the Intestinal Microenvironment Treatment Centre of Nanjing General Hospital was performed, including patients with constipation(276 cases), recurrent Clostridium Difficile infection (RCDI, 61 cases), ulcerative colitis(44 cases), irritable bowel syndrome (15 cases) and Crohn's disease(10 cases)...
January 25, 2017: Zhonghua Wei Chang Wai Ke za Zhi, Chinese Journal of Gastrointestinal Surgery
https://www.readbyqxmd.com/read/28105158/time-dependent-transition-of-the-immunoglobulin-g-subclass-and-immunoglobulin-e-response-in-cancer-patients-vaccinated-with-cholesteryl-pullulan-melanoma-antigen-gene-a4-nanogel
#11
Noriaki Kyogoku, Hiroaki Ikeda, Takahiro Tsuchikawa, Takehiro Abiko, Aki Fujiwara, Takehiro Maki, Yoshiyuki Yamamura, Masaomi Ichinokawa, Kimitaka Tanaka, Naoko Imai, Yoshihiro Miyahara, Shinichi Kageyama, Hiroshi Shiku, Satoshi Hirano
A phase I+II clinical trial of vaccination with MAGE-A4 protein complexed with cholesteryl pullulan melanoma antigen gene-A4 nanogel (CHP-MAGE-A4) is currently underway in patients with MAGE-A4-expressing cancer. In the present study, the primary phase I endpoint was to test the safety of the administration of 300 µg CHP-MAGE-A4 with and without OK-432. Another aim of the study was to clarify the details of the specific humoral immune response to vaccination. The 9 patients enrolled for phase I were vaccinated 6 times, once every 2 weeks: 3 patients with 100 µg and 3 patients with 300 µg CHP-MAGE-A4, and 3 patients with 300 µg CHP-MAGE-A4 plus 0...
December 2016: Oncology Letters
https://www.readbyqxmd.com/read/28105133/a-prospective-study-to-evaluate-the-efficacy-and-safety-of-oral-acetyl-l-carnitine-for-the-treatment-of-chemotherapy-induced-peripheral-neuropathy
#12
Yuanjue Sun, Yongqian Shu, Baorui Liu, Ping Liu, Changping Wu, Rongsheng Zheng, Xiaohua Zhang, Zhixiang Zhuang, Yongchuan Deng, Leizhen Zheng, Qing Xu, Bin Jiang, Xuenong Ouyang, Jianfei Gao, Nong Xu, Xiaoyi Li, Su Jiang, Chaofan Liang, Yang Yao
The present study aimed to evaluate the efficacy and safety of acetyl-L-carnitine (ALC) for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). The study was carried out as a prospective, randomized, double-blind, placebo-controlled and paralleled clinical study. A total of 239 patients with CIPN were selected as the study subjects. Of the 239 subjects, 118 subjects received 3 g/day ALC orally for 8 weeks and 121 received a placebo. The primary endpoint was improvement of peripheral neuropathy by at least one grade...
December 2016: Experimental and Therapeutic Medicine
https://www.readbyqxmd.com/read/28104716/source-3-registry-design-and-30-day-results-of-the-european-post-approval-registry-of-the-latest-generation-of-the-sapien-3tm-transcatheter-heart-valve
#13
Olaf Wendler, Gerhard Schymik, Hendrik Treede, Helmut Baumgartner, Nicolas Dumonteil, Leo Ihlberg, Franz-Josef Neumann, Giuseppe Tarantini, José L Zamorano, Alec Vahanian
BACKGROUND: -The SOURCE 3 Registry is a European multicentre, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3(TM) (Edwards Lifesciences, Irvine, CA/USA). Its purpose is to document outcomes of clinical safety and performance after European approval was given. METHODS: -In this manuscript we present the 30-day outcome of the SOURCE 3 Registry. All data is self-reported and all participating centres have committed to support their consecutive experience with the SAPIEN 3(TM) transcatheter heart valve, dependent on patients consent, before the start of the study...
January 19, 2017: Circulation
https://www.readbyqxmd.com/read/28104709/utility-of-social-media-and-crowd-sourced-data-for-pharmacovigilance-a-scoping-review-protocol
#14
Andrea C Tricco, Wasifa Zarin, Erin Lillie, Ba Pham, Sharon E Straus
INTRODUCTION: Adverse events associated with medications are under-reported in postmarketing surveillance systems. A systematic review of published data from 37 studies worldwide (including Canada) found the median under-reporting rate of adverse events to be 94% in spontaneous reporting systems. This scoping review aims to assess the utility of social media and crowd-sourced data to detect and monitor adverse events related to health products including pharmaceuticals, medical devices, biologics and natural health products...
January 19, 2017: BMJ Open
https://www.readbyqxmd.com/read/28104490/increasing-trainee-reporting-of-adverse-events-with-monthly-trainee-directed-review-of-adverse-events
#15
Alla Smith, Jonathan Hatoun, James Moses
OBJECTIVE: Underreporting of adverse events by physicians is a barrier to improving patient safety. In an effort to increase resident and medical student (hereafter "trainee") reporting of adverse events, trainees developed and led a monthly conference during which they reviewed adverse-event reports, identified system vulnerabilities and designed solutions to those vulnerabilities. METHODS: Monthly conferences over the 22-month study period were led by pediatric trainees, and attended by fellow trainees, departmental leadership, and members of the hospital's quality improvement team...
January 16, 2017: Academic Pediatrics
https://www.readbyqxmd.com/read/28104306/midterm-and-one-year-outcome-of-amphilimus-polymer-free-drug-eluting-stent-in-patients-needing-short-dual-antiplatelet-therapy-insight-from-the-astute-registry-amphilimus-italian-multicenter-registry
#16
Cosmo Godino, Mauro Chiarito, Michael Donahue, Luca Testa, Riccardo Colantonio, Alberto Cappelletti, Alberto Monello, Valeria Magni, Diego Milazzo, Rosario Parisi, Annamaria Nicolino, Shahram Moshiri, Rossella Fattori, Gianfranco Aprigliano, Altin Palloshi, Giuseppe Caramanno, Matteo Montorfano, Francesco Bedogni, Carlo Briguori, Alberto Margonato, Antonio Colombo
BACKGROUND: To assess clinical outcomes of patients needing short dual antiplatelet therapy (S-DAPT) after PCI with Cre8 polymer-free amphilimus eluting-stent (AES). The Cre8-AES with pure i-Carbofilm coating was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS: We performed a sub-analysis of unrestricted consecutive patients treated with Cre8-AES between August 2011 and January 2015. Two groups were formed: 1) patients discharged with S-DAPT (≤3-month), because of high bleeding risk or attending urgent non-cardiac surgery; and 2) patients discharged with Recommended DAPT duration (R-DAPT; ≥6-month)...
January 5, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28104297/brachytherapy-for-the-palliation-of-dysphagia-owing-to-esophageal-cancer-a-systematic-review-and-meta-analysis-of-prospective-studies
#17
Lorenzo Fuccio, Daniele Mandolesi, Andrea Farioli, Cesare Hassan, Leonardo Frazzoni, Alessandra Guido, Nicola de Bortoli, Savino Cilla, Chiara Pierantoni, Francesco Saverio Violante, Franco Bazzoli, Alessandro Repici, Alessio Giuseppe Morganti
BACKGROUND: The management of dysphagia owing to esophageal cancer is challenging. Brachytherapy has been proposed as an alternative option to stent placement. We performed a systematic review to examine its efficacy and safety in the resolution of dysphagia. METHODS: Prospective studies recruiting at least 20 patients with malignant dysphagia and published up to April 2016 were eligible. The dysphagia-free survival (DFS) and adverse event rates were pooled by means of a random effect model...
January 16, 2017: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
https://www.readbyqxmd.com/read/28104211/balloon-post-dilation-following-implantation-of-a-self-expanding-transcatheter-aortic-valve%C3%A2-bioprosthesis
#18
J Kevin Harrison, G Chad Hughes, Michael J Reardon, Robert Stoler, Paul Grayburn, Robert Hebeler, David Liu, Yanping Chang, Jeffrey J Popma
OBJECTIVES: This study sought to explore the impact of balloon post-dilation (BPD) on outcomes in the CoreValve US Clinical Trials. BACKGROUND: BPD following transcatheter aortic valve replacement (TAVR) has been used in selected cases to optimize hemodynamic results. METHODS: Procedural details of 3,532 patients were examined to determine whether BPD was performed after self-expanding TAVR. "Best practice" guidelines recommended BPD for treatment of suboptimal intraprocedural valve function, primarily manifested by moderate or severe residual aortic regurgitation (AR)...
January 23, 2017: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28104210/9-month-clinical-and-angiographic-outcomes-of-the-cobra-polyzene-f-nanocoated-coronary-stent-system
#19
Donald E Cutlip, Kirk N Garratt, Victor Novack, Mark Barakat, Perwaiz Meraj, Luc Maillard, Andrejs Erglis, Rajiv Jauhar, Jeffrey J Popma, Robert Stoler, Sigmund Silber
OBJECTIVES: The aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions. BACKGROUND: Polyzene-F-coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies. METHODS: Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial...
January 23, 2017: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28104150/comparison-of-mizoribine-and-mycophenolate-mofetil-with-a-tacrolimus-based-immunosuppressive-regimen-in-living-donor-kidney-transplantation-recipients-a-retrospective-study-in-china
#20
Y Shi, H Liu, X-G Chen, Z-Y Shen
BACKGROUND: A retrospective study was conducted to investigate the prevalence of gastrointestinal (GI) symptoms as well as the efficacy and safety of mizoribine (MZR) and mycophenolate mofetil (MMF) in Chinese living-donor kidney transplantation (LDKT). METHODS: Forty-two recipients enrolled between January 2012 and March 2014 were treated with either MZR (n = 22) or MMF (n = 20). All patients were treated in combination with a tacrolimus-based immunosuppressive regimen, besides the study drugs...
January 2017: Transplantation Proceedings
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