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https://www.readbyqxmd.com/read/28819776/tongxinluo-capsule-for-cardiac-syndrome-x-a-systematic-review-and-meta-analysis
#1
Hui-Min Mao, Mi Liu, Hua Qu, Li-Qiong Wang, Da-Zhuo Shi
OBJECTIVE: To evaluate the efficacy and safety of Tongxinluo Capsule (, TXL) for patients with cardiac syndrome X (CSX). METHODS: Randomized controlled trials (RCTs) regarding TXL in the treatment of CSX were searched in Chinese Biomedicine Literature Database, China National Knowledge Infrastructure, Chinese Scientific Journal Database, Wanfang Database, PubMed, EMBASE, Cochrane Central Register of Controlled Trial, websites of the Chinese and International Clinical Trial Registry platform up to June 30, 2015...
August 17, 2017: Chinese Journal of Integrative Medicine
https://www.readbyqxmd.com/read/28819380/phase-ii-trial-of-adjuvant-immunotherapy-with-autologous-tumor-derived-gp96-vaccination-in-patients-with-gastric-cancer
#2
Kecheng Zhang, Zheng Peng, Xiaohui Huang, Zhi Qiao, Xinxin Wang, Ning Wang, Hongqing Xi, Jianxin Cui, Yunhe Gao, Xijian Huang, Hua Gao, Bo Wei, Lin Chen
Background/Aims: Autologous, tumor-derived, heat shock protein gp96 peptide complexes have antitumor potential. We conducted the first Phase II trial to evaluate the safety and efficacy of gp96 vaccination in adjuvant settings for patients with gastric cancer. Methods: We enrolled 73 consecutive patients from October 2012 to December 2015. Thirty-eight patients received gp96 vaccination plus chemotherapy and 35 received chemotherapy alone. The primary endpoints were disease-free survival (DFS) and toxicity...
2017: Journal of Cancer
https://www.readbyqxmd.com/read/28818546/glecaprevir-plus-pibrentasvir-for-chronic-hepatitis-c-virus-genotype-1-2-4-5-or-6-infection-in-adults-with-compensated-cirrhosis-expedition-1-a-single-arm-open-label-multicentre-phase-3-trial
#3
Xavier Forns, Samuel S Lee, Joaquin Valdes, Sabela Lens, Reem Ghalib, Humberto Aguilar, Franco Felizarta, Tarek Hassanein, Holger Hinrichsen, Diego Rincon, Rosa Morillas, Stefan Zeuzem, Yves Horsmans, David R Nelson, Yao Yu, Preethi Krishnan, Chih-Wei Lin, Jens J Kort, Federico J Mensa
BACKGROUND: The once-daily, ribavirin-free, pangenotypic, direct-acting antiviral regimen, glecaprevir coformulated with pibrentasvir, has shown high rates of sustained virological response in phase 2 and 3 studies. We aimed to assess the efficacy and safety of 12 weeks of coformulated glecaprevir and pibrentasvir in patients with hepatitis C virus (HCV) infection and compensated cirrhosis. METHODS: We did this single-arm, open-label, multicentre phase 3 study at 40 sites in Belgium, Canada, Germany, South Africa, Spain, and the USA...
August 14, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28818217/thirty-sixth-month-follow-up-of-first-in-human-use-of-cyanoacrylate-adhesive-for-treatment-of-saphenous-vein-incompetence
#4
Jose I Almeida, Julian J Javier, Edward G Mackay, Claudia Bautista, Daniel J Cher, Thomas M Proebstle
OBJECTIVE: The objective of this study was to evaluate the long-term safety and effectiveness of endovenous cyanoacrylate (CA)-based closure of incompetent great saphenous veins. METHODS: This was a prospective, single-arm, single-center feasibility study conducted at the Canela Clinic (La Romana, Dominican Republic) to assess the effectiveness and safety of a CA-based adhesive for great saphenous vein closure at 36 months after treatment. Thirty-eight subjects were treated by injection of small boluses of CA under ultrasound guidance and without the use of perivenous tumescent anesthesia or postprocedure graduated compression stockings...
September 2017: Journal of Vascular Surgery. Venous and Lymphatic Disorders
https://www.readbyqxmd.com/read/28817180/preventable-and-mitigable-adverse-events-in-cancer-care-measuring-risk-and-harm-across-the-continuum
#5
Allison Lipitz-Snyderman, David Pfister, David Classen, Coral L Atoria, Aileen Killen, Andrew S Epstein, Christopher Anderson, Elizabeth Fortier, Saul N Weingart
BACKGROUND: Patient safety is a critical concern in clinical oncology, but the ability to measure adverse events (AEs) across cancer care is limited by a narrow focus on treatment-related toxicities. The objective of this study was to assess the nature and extent of AEs among cancer patients across inpatient and outpatient settings. METHODS: This was a retrospective cohort study of 400 adult patients selected by stratified random sampling who had breast (n = 128), colorectal (n = 136), or lung cancer (n = 136) treated at a comprehensive cancer center in 2012...
August 17, 2017: Cancer
https://www.readbyqxmd.com/read/28816509/shp465-mixed-amphetamine-salts-in-the-treatment-of-attention-deficit-hyperactivity-disorder-in-children-and-adolescents-results-of-a-randomized-double-blind-placebo-controlled-study
#6
Matthew Brams, Ann C Childress, Michael Greenbaum, Ming Yu, Brian Yan, Margo Jaffee, Brigitte Robertson
OBJECTIVE: The aim of this study was to evaluate the efficacy, safety, and tolerability of SHP465 mixed amphetamine salts (MAS) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHODS: This randomized, double-blind dose-optimization study enrolled children and adolescents (6-17 years) meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision ADHD criteria and having baseline ADHD Rating Scale IV (ADHD-RS-IV) total scores ≥28...
August 17, 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28816346/homocysteine-lowering-interventions-for-preventing-cardiovascular-events
#7
REVIEW
Arturo J Martí-Carvajal, Ivan Solà, Dimitrios Lathyris, Mark Dayer
BACKGROUND: Cardiovascular disease, which includes coronary artery disease, stroke and peripheral vascular disease, is a leading cause of death worldwide. Homocysteine is an amino acid with biological functions in methionine metabolism. A postulated risk factor for cardiovascular disease is an elevated circulating total homocysteine level. The impact of homocysteine-lowering interventions, given to patients in the form of vitamins B6, B9 or B12 supplements, on cardiovascular events has been investigated...
August 17, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28816020/real-world-efficacy-and-safety-of-ombitasvir-paritaprevir-r-dasabuvir-ribavirin-in-genotype-1b-patients-with-hcv-liver-cirrhosis
#8
Carmen Monica Preda, Corneliu Petru Popescu, Cristian Baicus, Theodor Voiosu, Mircea Manuc, Corina Silvia Pop, Liana Gheorghe, Ioan Sporea, Anca Trifan, Marcel Tantau, Alina Tantau, Emanoil Ceausu, Doina Proca, Ileana Constantinescu, Simona Maria Ruta, Mircea Diculescu, Alexandru Oproiu
BACKGROUND: Direct antiviral agents (DAA) showed very good results in terms of efficacy and safety in clinical trials, but real life data are still needed in order to confirm this profile. MATERIAL AND METHODS: In Romania, through a nationwide government-funded programme in 2015-2016, approx.5800 patients with virus C liver cirrhosis received fully reimbursed DAA therapy with OBV/PTV/r+DSV+RBV for 12 weeks. We analysed a national prospective cohort enrolling the first 2070 patients, all with genotype 1b...
August 17, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28815660/absorption-and-tolerability-of-taste-masked-hydrocortisone-granules-in-neonates-infants-and-children-under-6-years-of-age-with-adrenal-insufficiency
#9
Uta Neumann, Martin J Whitaker, Susanna Wiegand, Heiko Krude, John Porter, Madhu Davies, Dena Digweed, Bernard Voet, Richard J Ross, Oliver Blankenstein
OBJECTIVES: There is no licensed, dose-appropriate formulation of hydrocortisone for children with adrenal insufficiency (AI) and patients rely on compounded adult medication. The aim of this study was to evaluate the absorption, palatability and safety of Infacort(®) , an immediate-release, granule formulation of hydrocortisone with taste masking. STUDY DESIGN: Single site with satellites attended by a "flying" doctor from investigator site. Open-label, single-dose study in three consecutive child cohorts (n=24) with AI; Cohort 1, children aged 2 to <6 years (n=12); Cohort 2, infants aged 28 days to <2 years (n=6); Cohort 3, neonates aged 1 to <28 days (n=6)...
August 16, 2017: Clinical Endocrinology
https://www.readbyqxmd.com/read/28815602/efficacy-and-safety-of-amphotericin-b-formulations-a-network-meta-analysis-and-a-multicriteria-decision-analysis
#10
Fernanda S Tonin, Laiza M Steimbach, Helena H Borba, Andreia C Sanches, Astrid Wiens, Roberto Pontarolo, Fernando Fernandez-Llimos
OBJECTIVES: Despite its broad spectrum, conventional amphotericin B (AB) is associated with serious adverse events. Lipid-based formulations may offer safer options. We aimed to synthesize the evidence of efficacy and safety of AB formulations. METHODS: We performed a systematic review and network meta-analysis (NMA) to compare all available formulations: conventional AB; lipid complex or ABLC; colloidal dispersion or ABCD; liposomal or LAB; AB in Intralipid. Randomized controlled trials were searched in four databases...
August 17, 2017: Journal of Pharmacy and Pharmacology
https://www.readbyqxmd.com/read/28815562/treadmill-training-and-body-weight-support-for-walking-after-stroke
#11
REVIEW
Jan Mehrholz, Simone Thomas, Bernhard Elsner
BACKGROUND: Treadmill training, with or without body weight support using a harness, is used in rehabilitation and might help to improve walking after stroke. This is an update of the Cochrane review first published in 2003 and updated in 2005 and 2014. OBJECTIVES: To determine if treadmill training and body weight support, individually or in combination, improve walking ability, quality of life, activities of daily living, dependency or death, and institutionalisation or death, compared with other physiotherapy gait-training interventions after stroke...
August 17, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28815476/long-term-safety-and-effectiveness-of-adalimumab-for-moderate-to-severe-psoriasis-results-from-7-year-interim-analysis-of-the-esprit-registry
#12
Alan Menter, Diamant Thaçi, Jashin J Wu, William Abramovits, Francisco Kerdel, Dilek Arikan, Dianlin Guo, Arijit Ganguli, Mareike Bereswill, Anne Camez, Wendell C Valdecantos
INTRODUCTION: ESPRIT (NCT00799877) is an ongoing 10-year international prospective observational registry evaluating the long-term safety and effectiveness of originator adalimumab in routine clinical practice for adult patients with chronic plaque psoriasis. Herein, we report the long-term safety, effectiveness, and patient-reported outcomes (PROs) following adalimumab treatment over the first 7 years of the ESPRIT registry. METHODS: All treatment-emergent (All-TE) adverse events (AE) since the initial (first ever) dose of adalimumab were assessed...
August 16, 2017: Dermatology and Therapy
https://www.readbyqxmd.com/read/28815410/efficacy-and-safety-of-a-4-factor-prothrombin-complex-concentrate-for-rapid-vitamin-k-antagonist-reversal-in-japanese-patients-presenting-with-major-bleeding-or-requiring-urgent-surgical-or-invasive-procedures-a-prospective-open-label-single-arm-phase-3b-study
#13
Shigeki Kushimoto, Toshio Fukuoka, Akio Kimura, Kazunori Toyoda, Andres Brainsky, Amy Harman, Thomas Chung, Masahiro Yasaka
Rapid vitamin K antagonist (VKA) reversal is required in patients experiencing major bleeding or requiring urgent surgery. Four-factor prothrombin complex concentrate (4F-PCC; Beriplex(®)/Kcentra(®)) was shown in two large randomized controlled, international phase 3b trials to be an effective alternative to plasma for urgent VKA reversal. In the present prospective, open-label, single-arm phase 3b trial, we evaluate the efficacy and safety of 4F-PCC in Japanese patients. Eleven patients [international normalized ratio (INR) ≥2] requiring rapid VKA reversal owing to major bleeding (n = 6) or before urgent surgical/invasive procedures (n = 5) were administered 4F-PCC dosed based on INR and weight...
August 16, 2017: International Journal of Hematology
https://www.readbyqxmd.com/read/28814674/rilonacept-maintains-long-term-inflammatory-remission-in-patients-with-deficiency-of-the-il-1-receptor-antagonist
#14
Megha Garg, Adriana A de Jesus, Dawn Chapelle, Paul Dancey, Ronit Herzog, Rafael Rivas-Chacon, Theresa L Wampler Muskardin, Ann Reed, James C Reynolds, Raphaela Goldbach-Mansky, Gina A Montealegre Sanchez
BACKGROUND: Deficiency of IL-1 receptor antagonist (DIRA) is a rare autoinflammatory disease that presents with life-threatening systemic inflammation, aseptic multifocal osteomyelitis, and pustulosis responsive to IL-1-blocking treatment. This study was performed (a) to investigate rilonacept, a long-acting IL-1 inhibitor, in maintaining anakinra-induced inflammatory remission in DIRA patients, (b) to determine doses needed to maintain remission, and (c) to evaluate the safety and pharmacokinetics of rilonacept in young children (<12 years)...
August 17, 2017: JCI Insight
https://www.readbyqxmd.com/read/28814576/children-s-hospitals-solutions-for-patient-safety-collaborative-impact-on-hospital-acquired-harm
#15
Anne Lyren, Richard J Brilli, Karen Zieker, Miguel Marino, Stephen Muething, Paul J Sharek
OBJECTIVES: To determine if an improvement collaborative of 33 children's hospitals focused on reliable best practice implementation and culture of safety improvements can reduce hospital-acquired conditions (HACs) and serious safety events (SSEs). METHODS: A 3-year prospective cohort study design with a 12-month historical control population was completed by the Children's Hospitals' Solutions for Patient Safety collaborative. Identification and dissemination of best practices related to 9 HACs and SSE reduction focused on key process and culture of safety improvements...
August 16, 2017: Pediatrics
https://www.readbyqxmd.com/read/28814461/subcutaneous-immunoglobulin-in-myasthenia-gravis-exacerbation-a-prospective-open-label-trial
#16
Grayson Beecher, Dustin Anderson, Zaeem A Siddiqi
OBJECTIVE: To investigate the efficacy, tolerability, and safety of subcutaneous immunoglobulin (SCIg) in patients with mild to moderate myasthenia gravis (MG) exacerbation. METHODS: We performed a prospective, open-label, phase 3 trial in patients with MG aged 18 years or older and mild to moderate worsening (transition from Myasthenia Gravis Foundation of America class I to II/III or class II to III), treated with SCIg (2 g/kg), self-administered over 4 weeks...
August 16, 2017: Neurology
https://www.readbyqxmd.com/read/28813838/developing-safe-fall-strategies-for-lower-limb-exoskeletons
#17
Mahsa Khalili, Jaimie F Borisoff, H F Machiel Van der Loos
One of the main challenges in the use of a powered lower limb exoskeleton (LLE) is to ensure that balance is maintained throughout the operation of the device. Since no control strategy has yet been implemented that prevents falls in the case of a loss of balance, head or other serious injuries may occur during independent use of LLEs in the event of a fall. These safety concerns limit LLEs in the community to supervised use only. Using the backward fall as a model, we used optimization techniques to develop safe fall control strategies in order to avoid head impact and mitigate the impact velocity of the hips...
July 2017: IEEE ... International Conference on Rehabilitation Robotics: [proceedings]
https://www.readbyqxmd.com/read/28812030/safety-of-human-papillomavirus-9-valent-vaccine-a-meta-analysis-of-randomized-trials
#18
REVIEW
Ana Paula Ferreira Costa, Ricardo Ney Oliveira Cobucci, Janine Medeiros da Silva, Paulo Henrique da Costa Lima, Paulo César Giraldo, Ana Katherine Gonçalves
Vaccination against human papillomavirus (HPV) has been progressively implemented in most developed countries for approximately 10 years. In order to increase the protection of the vaccines, a 9-valent vaccine (HPV9) was developed, which provides protection against nine types of the virus. Studies evaluating its safety are rare. Thus, we performed a meta-analysis of three clinical trials assessing adverse effects on women randomly vaccinated with HPV9 or tetravalent vaccine (HPV4), with the objective of analyzing whether the HPV9 is as safe as HPV4...
2017: Journal of Immunology Research
https://www.readbyqxmd.com/read/28811858/effectiveness-of-ipragliflozin-for-reducing-hemoglobin-a1c-in-patients-with-a-shorter-type-2-diabetes-duration-interim-report-of-the-assign-k-study
#19
Kotaro Iemitsu, Takehiro Kawata, Takashi Iizuka, Masahiro Takihata, Masahiko Takai, Shigeru Nakajima, Nobuaki Minami, Shinichi Umezawa, Akira Kanamori, Hiroshi Takeda, Shogo Ito, Taisuke Kikuchi, Hikaru Amemiya, Mizuki Kaneshiro, Atsuko Mokubo, Tetsuo Takuma, Hideo Machimura, Keiji Tanaka, Taro Asakura, Akira Kubota, Sachio Aoyanagi, Kazuhiko Hoshino, Masashi Ishikawa, Yoko Matsuzawa, Mitsuo Obana, Nobuo Sasai, Hideaki Kaneshige, Fuyuki Minagawa, Tatsuya Saito, Kazuaki Shinoda, Masaaki Miyakawa, Yasushi Tanaka, Yasuo Terauchi, Ikuro Matsuba
BACKGROUND: Ipragliflozin is a selective sodium glucose co-transporter 2 inhibitor. The ASSIGN-K study is investigating the efficacy and safety of ipragliflozin for type 2 diabetes mellitus (T2DM) in the real-world clinical setting. METHODS: Japanese T2DM patients with inadequate glycemic control despite diet and exercise with/without pharmacotherapy were enrolled in an investigator-driven, multicenter, prospective, observational study examining the efficacy and safety of ipragliflozin treatment (50 mg/day for 52 weeks)...
September 2017: Journal of Clinical Medicine Research
https://www.readbyqxmd.com/read/28811354/safety-and-efficacy-of-baricitinib-through-128-weeks-in-an-open-label-longterm-extension-study-in-patients-with-rheumatoid-arthritis
#20
Edward C Keystone, Mark C Genovese, Douglas E Schlichting, Inmaculada de la Torre, Scott D Beattie, Terence P Rooney, Peter C Taylor
OBJECTIVE: To assess the safety and efficacy of baricitinib in patients with rheumatoid arthritis (RA) up to 128 weeks in a phase IIb study (NCT01185353). METHODS: After a 24-week blinded period, eligible patients entered an initial 52-week open-label extension (OLE); patients receiving 8 mg once daily (QD) continued with that dose and all others received 4 mg QD. Doses could be escalated to 8 mg QD at 28 or 32 weeks at investigator discretion when ≥ 6 tender and ≥ 6 swollen joints were present...
August 15, 2017: Journal of Rheumatology
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