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https://www.readbyqxmd.com/read/29029278/efficacy-and-safety-of-delafloxacin-compared-with-vancomycin-plus-aztreonam-for-acute-bacterial-skin-and-skin-structure-infections-a-phase-3-double-blind-randomized-study
#1
J Pullman, J Gardovskis, B Farley, E Sun, M Quintas, L Lawrence, R Ling, S Cammarata
Background: Delafloxacin is an investigational anionic fluoroquinolone in development for oral or intravenous administration for the treatment of infections caused by Gram-positive (including MRSA), Gram-negative, atypical and anaerobic organisms. Objectives: To establish the non-inferiority of delafloxacin compared with vancomycin plus aztreonam for the treatment of acute bacterial skin and skin structure infections and to compare the safety of the two antimicrobials...
October 5, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29029236/first-in-human-experience-with-complete-integration-of-neuromodulation-device-within-a-customized-cranial-implant
#2
Chad R Gordon, Gabriel F Santiago, Judy Huang, Gregory K Bergey, Shuya Liu, Mehran Armand, Henry Brem, William S Anderson
BACKGROUND: Neuromodulation devices have the potential to transform modern day treatments for patients with medicine-resistant neurological disease. For instance, the NeuroPace System (NeuroPace Inc, Mountain View, California) is a Food and Drug Administration (FDA)-approved device developed for closed-loop direct brain neurostimulation in the setting of drug-resistant focal epilepsy. However, current methods require placement either above or below the skull in nonanatomic locations. This type of positioning has several drawbacks including visible deformities and scalp pressure from underneath leading to eventual wound healing difficulties, micromotion of hardware with infection, and extrusion leading to premature explantation...
October 6, 2017: Operative Neurosurgery (Hagerstown, Md.)
https://www.readbyqxmd.com/read/29028788/efficacy-and-safety-of-pembrolizumab-in-patients-enrolled-in-keynote-030-in-the-united-states-an-expanded-access-program
#3
Tara C Gangadhar, Wen-Jen Hwu, Michael A Postow, Omid Hamid, Adil Daud, Roxana Dronca, Richard Joseph, Steven J O'Day, F S Hodi, Anna C Pavlick, Harriet Kluger, Romina P Oxborough, Aiming Yang, Mihaela Gazdoiu, Debra A Kush, Scot Ebbinghaus, April K S Salama
KEYNOTE-030 (ClinicalTrials.gov ID, NCT02083484) was a global expanded access program that allowed access to pembrolizumab, an antiprogrammed death 1 antibody, for patients with advanced melanoma before its regulatory approval. Patients with unresectable stage III/IV melanoma that progressed after standard-of-care therapy, including ipilimumab and, if BRAF mutant, a BRAF inhibitor, were eligible to receive pembrolizumab 2 mg/kg every 3 weeks. Response was assessed by immune-related response criteria by investigator review...
November 2017: Journal of Immunotherapy
https://www.readbyqxmd.com/read/29028517/effect-of-carbamazepine-and-oxcarbazepine-on-serum-neuron-specific-enolase-in-focal-seizures-a-randomized-controlled-trial
#4
Rituparna Maiti, Biswa Ranjan Mishra, Soham Sanyal, Debadatta Mohapatra, Sansita Parida, Archana Mishra
Neuron-specific enolase (NSE) is the most investigated biomarker in the context of epilepsy and brain damage. The present study was conducted to investigate the change in serum NSE in patients with focal seizure and the effect of carbamazepine and oxcarbazepine on serum NSE. The present study is a randomized, open-label, parallel design clinical trial (ClinicalTrials.gov Identifier: NCT02705768) conducted on 60 patients of focal seizure. After recruitment, detailed history, clinical evaluations including Chalfont-National Hospital seizure severity scale (NHS3), Quality of Life in Epilepsy Inventory (QOLIE-31) and serum NSE estimation were done at baseline...
October 6, 2017: Epilepsy Research
https://www.readbyqxmd.com/read/29027620/evaluation-of-the-tolerability-and-efficacy-of-sodium-polystyrene-sulfonate-for-long-term-management-of-hyperkalemia-in-patients-with-chronic-kidney-disease
#5
Panagiotis I Georgianos, Ioannis Liampas, Andreas Kyriakou, Vasilios Vaios, Vasilios Raptis, Nikolaos Savvidis, Athanasios Sioulis, Vassilios Liakopoulos, Elias V Balaskas, Pantelis E Zebekakis
PURPOSE: Sodium polystyrene sulfonate (SPS) is a cation-exchanging resin that has been widely used for several decades as first-line therapy of mild chronic hyperkalemia in patients with chronic kidney disease (CKD). However, evidence to prove the long-term tolerability and efficacy of SPS for the treatment of this condition is still missing. METHODS: In this retrospective, observational study, we enrolled 26 outpatients with stages 3-4 CKD who received oral therapy with low-dose SPS for mild chronic hyperkalemia in the Outpatient Nephrology clinic of our Department during 2010-2016...
October 11, 2017: International Urology and Nephrology
https://www.readbyqxmd.com/read/29027615/assessment-of-the-role-of-everolimus-therapy-in-patients-with-renal-cell-carcinoma-based-on-daily-routine-and-recent-research-results
#6
Anikó Maráz, András Csejtei, Judit Kocsis, Miklós Szűcs, Zsuzsanna Kahán, György Bodoky, Magdolna Dank, László Mangel, János Révész, Zoltán Varga, Lajos Géczi
Everolimus is indicated for adults with metastatic renal cell carcinoma (mRCC) after failure of vascular endothelial growth factor receptor-tyrosine kinase inhibitors (TKI). Currently, the therapeutic applicability of EVE has been changing. Multicenter evaluation of efficacy and safety of everolimus in daily routine and definition of patient characteristics with favorable outcome. Data of 165 patients from 9 oncology institutes in Hungary were analyzed retrospectively. Everolimus therapy was used after one TKI in 10 mg starting dose...
October 13, 2017: Pathology Oncology Research: POR
https://www.readbyqxmd.com/read/29027387/safety-and-efficacy-of-ziagen-abacavir-sulfate-in-hiv-infected-korean-patients
#7
Heawon Ann, Ki Hyon Kim, Hyun Young Choi, Hyun Ha Chang, Sang Hoon Han, Kye Hyung Kim, Jin Soo Lee, Yeon Sook Kim, Kyung Hwa Park, Young Keun Kim, Jang Wook Sohn, Na Ra Yun, Chang Seop Lee, Young Wha Choi, Yil Seob Lee, Shin Woo Kim
BACKGROUND: Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen® (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). MATERIALS AND METHODS: An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea...
September 2017: Infection & Chemotherapy
https://www.readbyqxmd.com/read/29026754/medication-discrepancies-and-potentially-inadequate-prescriptions-in-elderly-adults-with-polypharmacy-in-ambulatory-care
#8
Juan Víctor Ariel Franco, Sergio Adrián Terrasa, Karin Silvana Kopitowski
OBJECTIVES: The objective of this study is to describe the frequency and type of medication discrepancies (MD) through medication reconciliation and to describe the frequency of potentially inadequate prescription (PIP) medications using screening tool of older persons' prescriptions criteria. DESIGN: Cross-sectional comparison of electronic medical record (EMR) medication lists and patient's self-report of their comprehensive medication histories obtained through telephone interviews...
January 2017: Journal of Family Medicine and Primary Care
https://www.readbyqxmd.com/read/29026627/marked-peripheral-eosinophilia-due-to-prolonged-administration-of-posaconazole
#9
Maher Alharbi, Rae-Kiran Jhinger, Terence Wuerz, Andrew Walkty
Introduction. Posaconazole is a triazole antifungal that is used in the treatment of a variety of fungal infections, as well as in the management of mucormycosis (on an off-label basis). Eosinophilia associated with exposure to azole antifungals has been described rarely in the literature. Case presentation. A 31-year-old male on peritoneal dialysis (PD) for end-stage renal disease, secondary to diabetic nephropathy, presented to hospital with abdominal pain after a trip to St Lucia. He was taken to the operating room, where the PD catheter was removed and an abdominal-wall abscess was debrided...
June 2017: JMM Case Reports
https://www.readbyqxmd.com/read/29026287/ocular-pharmacokinetics-and-tolerability-of-bimatoprost-ophthalmic-solutions-administered-once-or-twice-daily-in-rabbits-and-clinical-dosing-implications
#10
Jie Shen, Margot L Goodkin, Warren Tong, Mayssa Attar
PURPOSE: Fixed-combination medications can benefit patients requiring multiple agents to lower their intraocular pressure (IOP), but combining agents with complementary mechanisms of action is challenging if their dosing frequency differs. This study compares in vivo pharmacokinetic and ocular tolerability of bimatoprost 0.01% ophthalmic solutions dosed once or twice daily. Reports of twice-daily dosing in glaucoma patients are also reviewed. METHODS: New Zealand White rabbits were administered bimatoprost 0...
2017: Clinical Ophthalmology
https://www.readbyqxmd.com/read/29026276/five-cases-of-childhood-onset-graves-disease-treated-with-either-surgery-or-radio-iodine-therapy
#11
Kouki Tomari, Masahiro Goto, Aya Shimada, Hiroko Yagi, Yuka Nagashima, Yukihiro Hasegawa
There are three major therapeutic options for the treatment of Graves' disease (GD): antithyroid drugs (ATDs), thyroidectomy, and radio-iodine (RAI) therapy. ATDs are the initial treatment option for children. However, some pediatric GD patients who are initially treated with ATDs require other type of treatments later on. We reviewed the medical records of childhood-onset GD cases retrospectively to report the clinical course of patients who received either surgery or RAI therapy subsequent to treatment with ATDs...
2017: Clinical Pediatric Endocrinology: Case Reports and Clinical Investigations: Official Journal of the Japanese Society for Pediatric Endocrinology
https://www.readbyqxmd.com/read/29025888/effect-of-erdosteine-on-the-rate-and-duration-of-copd-exacerbations-the-restore-study
#12
Roberto W Dal Negro, Jadwiga A Wedzicha, Martin Iversen, Giovanni Fontana, Clive Page, Arrigo F Cicero, Edoardo Pozzi, Peter M A Calverley
Oxidative stress contributes to chronic obstructive pulmonary disease (COPD) exacerbations and antioxidants can decrease exacerbation rates, although we lack data about the effect of such drugs on exacerbation duration.The RESTORE (Reducing Exacerbations and Symptoms by Treatment with ORal Erdosteine in COPD) study was a prospective randomised, double-blind, placebo-controlled study, enrolling patients aged 40-80 years with Global Initiative for Chronic Obstructive Lung Disease stage II/III. Patients received erdosteine 300 mg twice daily or placebo added to usual COPD therapy for 12 months...
October 2017: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/29025857/endocrine-side-effects-of-cancer-immunotherapy
#13
Priscilla Cukier, Fernando C Santini, Mariana Scaranti, Ana O Hoff
Immune checkpoint inhibitors have recently become a cornerstone for the treatment of different advanced cancers. These drugs, represented mainly by monoclonal antibodies anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4), anti-programmed cell death protein-1 (PD-1) and anti-PD-1 ligand molecules (PD-L1 and L2), have the ability to reactivate the immune system against tumor cells, but can also trigger a myriad of autoimmune side effects, termed immune-related adverse events (irAEs). In particular, there are a number of endocrine related irAEs...
October 12, 2017: Endocrine-related Cancer
https://www.readbyqxmd.com/read/29025834/study-protocol-for-a-randomised-controlled-trial-harmonising-optimal-strategy-for-treatment-of-coronary-artery-stenosis-coronary-intervention-with-next-generation-drug-eluting-stent-platforms-and-abbreviated-dual-antiplatelet-therapy-host-idea-trial
#14
Chi-Hoon Kim, Jung-Kyu Han, Han-Mo Yang, Kyung Woo Park, Hae-Young Lee, Hyun-Jae Kang, Bon-Kwon Koo, Namho Lee, Tae-Joon Cha, Tae-Hyun Yang, Myung-Ho Jeong, Myeong-Ho Yoon, Seung Uk Lee, Seung Jin Lee, Jin Won Kim, Jin-Man Cho, Kyu-Rock Han, Wook Bum Pyun, Hyo-Soo Kim
INTRODUCTION: We have recently seen the introduction of newer generation drug-eluting stents with ultrathin struts that use advanced polymer technologies. However, the efficacy and safety of these newest stents have not yet been fully explored. In addition, there are still controversies over the optimal duration of dual antiplatelet therapy (DAPT) after stent implantation, particularly for ultrathin stents with the newest polymer technologies. METHODS AND ANALYSIS: The HOST-IDEA trial is a randomised, open-label, multicentre, non-inferiority trial and the first study to directly compare two of these ultrathin sirolimus-eluting stents: Orsiro stent with biodegradable polymer, and polymer-free Coroflex ISAR (CX-ISAR) stent...
October 11, 2017: BMJ Open
https://www.readbyqxmd.com/read/29025285/safety-and-efficacy-of-canagliflozin-in-elderly-patients-with-type-2-diabetes-mellitus-a-1-year-post-marketing-surveillance-in-japan
#15
Maki Goda, Tomoko Yamakura, Kazuyo Sasaki, Takumi Tajima, Makoto Ueno
Objective To evaluate the safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus (T2DM) in clinical settings. Methods We conducted a 1-year post-marketing surveillance (PMS) of canagliflozin in almost all the elderly patients (≥65 years old) with T2DM who began taking canagliflozin during the first 3 months after its launch in Japan. The main outcomes included the incidences of adverse drug reactions (ADRs), serious ADRs and the changes of laboratory tests as well as efficacy variables...
October 13, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29025098/corrigendum-to-meaningful-use-of-health-information-technology-and-declines-in-in-hospital-adverse-drug-events
#16
(no author information available yet)
No abstract text is available yet for this article.
September 6, 2017: Journal of the American Medical Informatics Association: JAMIA
https://www.readbyqxmd.com/read/29025089/oral-ketamine-for-acute-pain-management-after-amputation-surgery
#17
Asokumar Buvanendran, Jeffrey S Kroin, Arvind Rajagopal, Sherry J Robison, Mario Moric, Kenneth J Tuman
Objective: Intravenous ketamine has been shown to provide postoperative analgesia in many clinical trials, in particular to reduce opioid consumption. The primary objective of this pilot study is to determine if multiple dosing over a three-day perioperative period with oral ketamine is a safe treatment method for acute pain after amputation surgery. Methods: Three consented subjects (age 57-60 years) undergoing elective amputation of the lower extremity were included in the study (Institutional Review Board and Food and Drug Administration Investigational New Drug approved)...
September 14, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/29024572/radiological-manifestations-of-immune-related-adverse-effects-observed-in-patients-with-melanoma-undergoing-immunotherapy
#18
Parveen Sidhu, Alexander M Menzies, Georgina Long, Matteo Carlino, Shirleen Lorens, Rony Kapoor
Immunotherapy drugs work by stimulating the patient's own immune system to recognize and destroy cancer cells. This subclass of drugs is increasingly administered to patients with advanced melanoma. They are also commonly incorporated into other cancer therapies such as non-small cell lung cancer, renal cancer, head and neck cancers and Hodgkin lymphoma. The most commonly administered immunotherapeutic agents in the treatment of melanoma include programmed cell death protein 1 (PD-1) inhibitors, cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitors and a subclass of cytokines...
October 11, 2017: Journal of Medical Imaging and Radiation Oncology
https://www.readbyqxmd.com/read/29024490/categorization-of-abuse-potential-related-adverse-events
#19
Edward M Sellers, Myroslava K Romach
All drugs with central nervous system activity must undergo an assessment of their abuse potential, and these data must be included in a New Drug Application. Part of this assessment is an analysis of treatment-emergent adverse events that occur during clinical development. Using an iterative consensus strategy, we evaluated and grouped an available list of 213 flag terms for abuse potential from the Food and Drug Administration, into categories and assessed the relevance of the terms to primary abuse behavior...
October 11, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29024286/modelling-cumulative-exposure-for-inference-about-drug-effects-in-observational-studies
#20
Bassam Farran, Stuart McGurnaghan, Helen C Looker, Shona Livingstone, Eva Lahnsteiner, Helen M Colhoun, Paul M McKeigue
PURPOSE: To demonstrate a modelling approach that controls for time-invariant allocation bias in estimation of associations of outcome with drug exposure. METHODS: We show that in a model that includes terms for both ever-exposure versus never-exposure and cumulative exposure, the parameter for ever-exposure represents the effect of time-invariant allocation bias, and the parameter for cumulative exposure represents the effect of the drug after adjustment for this unmeasured confounding...
October 12, 2017: Pharmacoepidemiology and Drug Safety
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