keyword
MENU ▼
Read by QxMD icon Read
search

Serious safety event

keyword
https://www.readbyqxmd.com/read/29148408/effects-and-safety-of-99tc-mdp-in-patients-with-refractory-ankylosing-spondylitis-a-2-stage-30-week-follow-up-clinical-trial
#1
Yunyun Xu, Yi Zhong, Minjing Zhao, Liudan Tu, Meida Fan, Pingping Zhang, Qiujing Wei, Shuangyan Cao, Qiuxia Li, Zetao Liao, Zhiming Lin, Yunfeng Pan, Ou Jin, Jieruo Gu
OBJECTIVES: To evaluate the clinical efficacy and safety in patients with refractory ankylosing spondylitis (AS) initiating 99Tc-MDP therapy and explore the mechanisms. METHODS: Refractory AS patients were enrolled in the clinical trial and received 99Tc-MDP treatments for 3 or 5 courses according to ASAS improvement. Efficacy and safety evaluations were conducted during the follow-up. 37 cytokines were quantified by Luminex at baseline and week 30. p-values<0...
November 14, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/29148154/incident-reporting-behaviours-following-the-francis-report-a-cross-sectional-survey
#2
Gareth Archer, Alison Colhoun
RATIONALE, AIMS, AND OBJECTIVES: Previous studies have shown a lack of engagement in the reporting process. There is limited evidence about whether attitudes and behaviours of doctors in the UK towards incident reporting have changed following the events at Mid Staffordshire National Health Service Foundation Trust and the recommendations that followed. We conducted a relatively large survey of doctors, aiming to assess whether doctors recognised incidents and reported them accordingly, along with their behaviours towards reporting and their suggestions of how incident reporting may be improved...
November 17, 2017: Journal of Evaluation in Clinical Practice
https://www.readbyqxmd.com/read/29148124/the-safety-of-live-attenuated-influenza-vaccine-in-children-and-adolescents-2-through-17%C3%A2-years-of-age-a-vaccine-safety-datalink-study
#3
Matthew F Daley, Christina L Clarke, Jason M Glanz, Stanley Xu, Simon J Hambidge, James G Donahue, James D Nordin, Nicola P Klein, Steven J Jacobsen, Allison L Naleway, Michael L Jackson, Grace Lee, Jonathan Duffy, Eric Weintraub
PURPOSE: To evaluate the safety of live attenuated influenza vaccine (LAIV) in children 2 through 17 years of age. METHODS: The study was conducted in 6 large integrated health care organizations participating in the Vaccine Safety Datalink (VSD). Trivalent LAIV safety was assessed in children who received LAIV between September 1, 2003 and March 31, 2013. Eighteen pre-specified adverse event groups were studied, including allergic, autoimmune, neurologic, respiratory, and infectious conditions...
November 17, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29146169/arthroscopy-after-traumatic-hip-dislocation-a%C3%A2-systematic-review-of-intra-articular-findings-correlation-with-magnetic-resonance-imaging-and-computed-tomography-treatments-and-outcomes
#4
REVIEW
Jacob C Mandell, Richard A Marshall, Michael B Banffy, Bharti Khurana, Michael J Weaver
PURPOSE: To describe the literature concerning patient demographic characteristics and intra-articular injury seen at arthroscopy after traumatic hip dislocation, describe the reported computed tomography (CT) and magnetic resonance findings with arthroscopic correlation, and describe the reported arthroscopic treatments performed with complications and outcomes. METHODS: A systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines for assessment of arthroscopy after hip dislocation...
November 13, 2017: Arthroscopy: the Journal of Arthroscopic & related Surgery
https://www.readbyqxmd.com/read/29146042/outcomes-of-an-online-computerized-cognitive-behavioral-treatment-program-for-treating-chinese-patients-with-depression-a-pilot-study
#5
Albert Yeung, Fang Wang, Fan Feng, Jinhua Zhang, Abigail Cooper, Lan Hong, Weidong Wang, Kathleen Griffiths, Kylie Bennett, Anthony Bennett, Jonathan Alpert, Maurizio Fava
OBJECTIVE: This pilot study examined the feasibility, safety, and effectiveness of using an online computerized cognitive behavioral therapy (CBT) for treating Chinese patients with depression. METHODS: Seventy-five Chinese patients with depression in outpatient clinics were randomized into a 5-week intervention. The intervention group received the Chinese translated version of MoodGYM in addition to usual treatment, and the control group continued with usual treatment...
November 11, 2017: Asian Journal of Psychiatry
https://www.readbyqxmd.com/read/29144028/efficacy-and-safety-of-different-regimens-for-primary-open-angle-glaucoma-or-ocular-hypertension-a-systematic-review-and-network-meta-analysis
#6
Fei Li, Wenbin Huang, Xiulan Zhang
PURPOSE: To assess the efficacy and safety of different regimens, including monotherapy and double therapy, for primary open-angle glaucoma (POAG) or ocular hypertension. METHODS: We searched PubMed, EMBASE and clinicaltrials.gov for studies that fit our inclusion criteria in this network meta-analysis. Randomized controlled trials that report data on efficacy and safety of medications for POAG or ocular hypertension are included. Data on intra-ocular pressure (IOP) lowering effect and incidence of adverse events including hyperaemia and ocular discomfort were extracted and used in mixed-comparison analysis...
November 16, 2017: Acta Ophthalmologica
https://www.readbyqxmd.com/read/29143550/safety-and-tolerability-of-inebilizumab-medi-551-an-anti-cd19-monoclonal-antibody-in-patients-with-relapsing-forms-of-multiple-sclerosis-results-from-a-phase-1-randomised-placebo-controlled-escalating-intravenous-and-subcutaneous-dose-study
#7
Mark A Agius, Gabriela Klodowska-Duda, Maciej Maciejowski, Andrzej Potemkowski, Jing Li, Kaushik Patra, Jacob Wesley, Soraya Madani, Gerard Barron, Eliezer Katz, Armando Flor
BACKGROUND: B cells may be involved in the pathophysiology of multiple sclerosis (MS). Inebilizumab (formerly MEDI-551) binds to and depletes CD19(+) B cells. OBJECTIVES: To assess safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of inebilizumab in adults with relapsing MS. METHODS: This phase 1 trial randomised 28 patients 3:1 (21, inebilizumab; 7, placebo) to inebilizumab (2 intravenous (IV) doses, days 1 and 15: 30, 100 or 600 mg; or single subcutaneous (SC) dose on day 1: 60 or 300 mg) or matching placebo, with follow-up until at least week 24 or return of CD19(+) B-cell count to ⩾80 cells/µL...
November 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/29143230/the-efficacy-of-biologic-therapy-for-the-management-of-palmoplantar-psoriasis-and-palmoplantar-pustulosis-a-systematic-review
#8
REVIEW
Isabelle M Sanchez, Eric Sorenson, Ethan Levin, Wilson Liao
INTRODUCTION: Palmoplantar psoriasis (PP) and palmoplantar pustulosis (PPP) are diseases affecting the hands and/or feet that can cause marked physical discomfort and functional disability. The tumor necrosis factor-alpha antagonists adalimumab, etanercept, and infliximab, the interleukin (IL)-17A inhibitors ixekizumab and secukinumab, and the IL-23 or IL-12/IL-23 inhibitors guselkumab and ustekinumab have been well studied for the treatment of moderate to severe plaque psoriasis. Less is known about the efficacy and safety of these agents for the treatment of PP (hyperkeratotic and pustular forms) and PPP...
November 15, 2017: Dermatology and Therapy
https://www.readbyqxmd.com/read/29142966/oral-magnesium-supplementation-in-chronic-kidney-disease-stages-3-and-4-efficacy-safety-and-effect-on-serum-calcification-propensity-a%C3%A2-prospective-randomized-double-blinded-placebo-controlled-clinical-trial
#9
Iain Bressendorff, Ditte Hansen, Morten Schou, Burton Silver, Andreas Pasch, Pierre Bouchelouche, Lise Pedersen, Lars Melholt Rasmussen, Lisbet Brandi
Introduction: Chronic kidney disease (CKD) is associated with high cardiovascular morbidity and mortality. Recent evidence suggests that increases in both serum and intracellular magnesium (Mg) can slow or even prevent the development of vascular calcification seen in CKD. Serum calcification propensity (T50) is a novel functional test, which is associated with all-cause mortality in CKD and measures the ability of serum to delay the formation of crystalline nanoparticles. Theoretically, increasing serum Mg should improve T50 and thereby reduce the propensity towards ectopic calcification...
May 2017: KI Reports
https://www.readbyqxmd.com/read/29141662/safety-and-tolerability-of-intradiscal-implantation-of-combined-autologous-adipose-derived-mesenchymal-stem-cells-and-hyaluronic-acid-in-patients-with-chronic-discogenic-low-back-pain-1-year-follow-up-of-a-phase-i-study
#10
Hemant Kumar, Doo-Hoe Ha, Eun-Jong Lee, Jun Hee Park, Jeong Hyun Shim, Tae-Keun Ahn, Kyoung-Tae Kim, Alexander E Ropper, Seil Sohn, Chung-Hun Kim, Devang Kashyap Thakor, Soo-Hong Lee, In-Bo Han
BACKGROUND: Adipose tissue-derived mesenchymal stem cells (AT-MSCs) offer potential as a therapeutic option for chronic discogenic low back pain (LBP) because of their immunomodulatory functions and capacity for cartilage differentiation. The goal of this study was to assess the safety and tolerability of a single intradiscal implantation of combined AT-MSCs and hyaluronic acid (HA) derivative in patients with chronic discogenic LBP. METHODS: We performed a single-arm phase I clinical trial with a 12-month follow-up and enrolled 10 eligible chronic LBP patients...
November 15, 2017: Stem Cell Research & Therapy
https://www.readbyqxmd.com/read/29141124/the-effects-of-valbenazine-in-participants-with-tardive-dyskinesia-results-of-the-1-year-kinect-3-extension-study
#11
Stewart A Factor, Gary Remington, Cynthia L Comella, Christoph U Correll, Joshua Burke, Roland Jimenez, Grace S Liang, Christopher F O'Brien
BACKGROUND: Valbenazine, a highly selective vesicular monoamine transporter 2 inhibitor, is approved for the treatment of tardive dyskinesia. This is the first report of long-term effects in adults with tardive dyskinesia. METHODS: Participants with a DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or a mood disorder who completed the 6-week, double-blind, placebo-controlled period of KINECT 3 were eligible to enter the 42-week valbenazine extension (VE) period and subsequent 4-week washout period...
November 14, 2017: Journal of Clinical Psychiatry
https://www.readbyqxmd.com/read/29140444/safety-and-immunogenicity-of-different-formulations-of-norovirus-vaccine-candidate-in-healthy-adults-a-randomized-controlled-double-blind-clinical-trial
#12
G Leroux-Roels, J P Cramer, P M Mendelman, J Sherwood, R Clemens, A Aerssens, I De Coster, A Borkowski, F Baehner, P Van Damme
Background: We investigated safety and immunogenicity of 1-2 doses of different bivalent virus-like particle (VLP) norovirus vaccine candidate (NoV) formulations in healthy 18-64-year-olds. Methods: On Days 1 and 28 participants (n=420) randomized to 14 equal groups received intramuscular control vaccine (hepatitis A) or one of 11 NoV formulations contained varying dosages of GI.1 and GII.4c genotype VLP antigens with Al(OH)3, and 0μg, 15μg or 50μg MPL. Immunogenicity was assessed on Days 1, 28, 56, 208 and 393...
November 13, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/29137346/safety-of-the-neprilysin-renin-angiotensin-system-inhibitor-lcz696
#13
REVIEW
Bo Li, Yunhe Zhao, Bo Yin, Mengfei Helian, Xinmei Wang, Feng Chen, Hongxia Zhang, Hui Sun, Bin Meng, Fengshuang An
Objectives: The combined neprilysin/rennin-angiotensin system inhibitor sacubitril/valsartan (LCZ696) has shown its superiority over ACEI/ARB therapy. In view of the existing concern of its adverse effects, we aimed to provide evidence of the safety of the new drug. Results: A total of 6 randomized trials with 11,821 subjects were included in this analysis. No significant differences were found in any adverse effects between LCZ696 and ACEI/ARB or placebo groups...
October 10, 2017: Oncotarget
https://www.readbyqxmd.com/read/29137237/cryoablation-combined-with-allogenic-natural-killer-cell-immunotherapy-improves-the-curative-effect-in-patients-with-advanced-hepatocellular-cancer
#14
Mao Lin, Shuzhen Liang, Xiaohua Wang, Yinqing Liang, Mingjie Zhang, Jibing Chen, Lizhi Niu, Kecheng Xu
In this study, the clinical efficacy of cryosurgery combined with allogenic natural killer cell immunotherapy for advanced hepatocellular cancer was evaluated. From October 2015 to March 2017, we enrolled 61 patients who met the enrollment criteria and divided them into two groups: 1) the simple cryoablation group (Cryo group, n = 26); and 2) the cryoablation combined with allogenic natural killer cells group (Cryo-NK group, n = 35), the safety and short-term effects were evaluated firstly, then the median progression-free survival, response rate and disease control rate were assessed...
October 10, 2017: Oncotarget
https://www.readbyqxmd.com/read/29136154/the-number-of-oocytes-retrieved-during-ivf-a-balance-between-efficacy-and-safety
#15
Åsa Magnusson, Karin Källen, Ann Thurin-Kjellberg, Christina Bergh
STUDY QUESTION: What is the relationship between the number of oocytes collected in fresh IVF treatments and the likelihood of cumulative delivery rate (fresh and frozen) per oocyte aspiration, severe ovarian hyperstimulation syndrome (OHSS) and thromboembolic events? SUMMARY ANSWER: Cumulative delivery rate per aspiration increases up to 20 oocytes retrieved and then evens out while the incidence of severe OHSS increases more rapidly from around 18 oocytes and thromboembolic events, although rare, occurs in particular if 15 or more oocytes are retrieved...
November 10, 2017: Human Reproduction
https://www.readbyqxmd.com/read/29136037/safety-pharmacokinetics-and-immunological-activities-of-multiple-intravenous-or-subcutaneous-doses-of-an-anti-hiv-monoclonal-antibody-vrc01-administered-to-hiv-uninfected-adults-results-of-a-phase-1-randomized-trial
#16
Kenneth H Mayer, Kelly E Seaton, Yunda Huang, Nicole Grunenberg, Abby Isaacs, Mary Allen, Julie E Ledgerwood, Ian Frank, Magdalena E Sobieszczyk, Lindsey R Baden, Benigno Rodriguez, Hong Van Tieu, Georgia D Tomaras, Aaron Deal, Derrick Goodman, Robert T Bailer, Guido Ferrari, Ryan Jensen, John Hural, Barney S Graham, John R Mascola, Lawrence Corey, David C Montefiori
BACKGROUND: VRC01 is an HIV-1 CD4 binding site broadly neutralizing antibody (bnAb) that is active against a broad range of HIV-1 primary isolates in vitro and protects against simian-human immunodeficiency virus (SHIV) when delivered parenterally to nonhuman primates. It has been shown to be safe and well tolerated after short-term administration in humans; however, its clinical and functional activity after longer-term administration has not been previously assessed. METHODS AND FINDINGS: HIV Vaccine Trials Network (HVTN) 104 was designed to evaluate the safety and tolerability of multiple doses of VRC01 administered either subcutaneously or by intravenous (IV) infusion and to assess the pharmacokinetics and in vitro immunologic activity of the different dosing regimens...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29134822/treating-moderate-to-severe-plaque-psoriasis-with-guselkumab-a-review-of-phase-ii-and-phase-iii-trials
#17
Seth T Howell, Leah A Cardwell, Steven R Feldman
OBJECTIVE: Guselkumab, an anti-interleukin-23 monoclonal antibody was recently approved for the treatment of patients with moderate-to-severe plaque psoriasis. This article will review the available phase II and phase III guselkumab clinical trial data. DATA SOURCES: A PubMed search was conducted using the terms guselkumab, interleukin-23, psoriasis, adalimumab, and ustekinumab (January 2014 to August 2017). STUDY SELECTION AND DATA EXTRACTION: Articles detailing the results of phase II and phase III clinical trials were selected for review...
November 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29134432/phase-iii-study-of-dulanermin-recombinant-human-tumor-necrosis-factor-related-apoptosis-inducing-ligand-apo2-ligand-combined-with-vinorelbine-and-cisplatin-in-patients-with-advanced-non-small-cell-lung-cancer
#18
Xuenong Ouyang, Meiqi Shi, Fangwei Jie, Yuxian Bai, Peng Shen, Zhuang Yu, Xiuwen Wang, Cheng Huang, Min Tao, Zhehai Wang, Conghua Xie, Qi Wu, Yongqian Shu, Baohui Han, Fengchun Zhang, Yiping Zhang, Chunhong Hu, Xitao Ma, Yongjie Liang, Anlan Wang, Bing Lu, Yi Shi, Jinfei Chen, Zhixiang Zhuang, Jiejun Wang, Jianjin Huang, Changhui Wang, Chunxue Bai, Xin Zhou, Qiang Li, Feng Chen, Hao Yu, Jifeng Feng
Background Dulanermin is a recombinant soluble human Apo2 ligand/tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) that activates apoptotic pathways by binding to proapoptotic death receptor (DR) 4 and DR5. The purpose of this study was to evaluate the efficacy and safety of dulanermin combined with vinorelbine and cisplatin (NP) as the first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC). Experimental design Patients were randomly assigned to receive NP chemotherapy (vinorelbine 25 mg/m(2) on days 1 and 8 and cisplatin 30 mg/m(2) on days 2 to 4) for up to six cycles plus dulanermin (75 μg/kg on days 1 to 14) or placebo every three weeks until disease progression, intolerable toxicity, or withdrawal of consent...
November 14, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/29134426/pharmacokinetics-and-safety-of-amenamevir-in-healthy-subjects-analysis-of-four-randomized-phase-1-studies
#19
Tomohiro Kusawake, James J Keirns, Donna Kowalski, Martin den Adel, Dorien Groenendaal-van de Meent, Akitsugu Takada, Yoshiaki Ohtsu, Masataka Katashima
INTRODUCTION: Amenamevir (ASP2151) is a nonnucleoside antiherpesvirus compound available for the treatment of varicella-zoster virus infections. In this article we summarize the findings of four phase 1 studies in healthy participants. METHODS: Four randomized phase 1 studies investigated the safety and pharmacokinetics of single and multiple doses of amenamevir, including the assessment of age group effect (nonelderly vs elderly), food effect, and the relative bioavailability of two formulations...
November 13, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/29133291/watcher-initiative-associated-with-decrease-in-failure-to-rescue-events-in-pediatric-population
#20
Melanie McClain Smith, Maryanne Chumpia, Lindsey Wargo, Julie Nicol, Mark Bugnitz
BACKGROUND AND OBJECTIVES: Improved situation awareness may prevent unplanned ICU transfers. Transfers with serious safety issues may be classified as unrecognized situation awareness failure events (UNSAFE) and are associated with intubation, vasopressors, or >3 fluid boluses within 1 hour before or after ICU arrival. Our aim was to decrease the proportion of unplanned ICU transfers that met UNSAFE criteria by 50% in 1 year. METHODS: We adapted a previously described huddle-based intervention...
November 13, 2017: Hospital Pediatrics
keyword
keyword
63001
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"