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https://www.readbyqxmd.com/read/28926521/blockade-of-hla-antibody-triggered-classical-complement-activation-in-sera-from-subjects-dosed-with-the-anti-c1s-monoclonal-antibody-tnt009-results-from-a-randomized-first-in-human-phase-1-trial
#1
Jakob Mühlbacher, Bernd Jilma, Markus Wahrmann, Johann Bartko, Farsad Eskandary, Christian Schörgenhofer, Michael Schwameis, Graham C Parry, James C Gilbert, Sandip Panicker, Georg A Böhmig
BACKGROUND: Complement may play a key role in antibody-mediated rejection. A promising therapeutic approach may be classical pathway (CP) inhibition at the level of early component C1. METHODS: In this first-in-human, double-blind, randomized placebo-controlled phase 1 trial, we evaluated the safety and complement inhibitory effect of TNT009, a humanized monoclonal anti-C1s antibody. Sixty-four adult healthy volunteers received either single (n = 48; 7 consecutive cohorts, 0...
October 2017: Transplantation
https://www.readbyqxmd.com/read/28926514/a-randomized-multicenter-double-blind-study-to-evaluate-the-safety-and-efficacy-of-estradiol-vaginal-cream-0-003-in-postmenopausal-women-with-dyspareunia-as-the-most-bothersome-symptom
#2
Robin Kroll, David F Archer, Yuhua Lin, Vilma Sniukiene, James H Liu
OBJECTIVE: Vulvovaginal atrophy (VVA) is characterized by vaginal changes, dyspareunia, and itching/irritation. Efficacy and safety of a lower-dose estradiol vaginal cream (0.003%) were evaluated in postmenopausal women with VVA-related dyspareunia. METHODS: This was a phase 3, randomized, double-blind, placebo-controlled study. Sexually active postmenopausal women with moderate-severe dyspareunia as the most bothersome symptom, ≤5% vaginal superficial cells, and vaginal pH >5...
September 18, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28926159/randomized-controlled-feasibility-trial-of-intranasal-ketamine-compared-to-intranasal-fentanyl-for-analgesia-in-children-with-suspected-extremity-fractures
#3
Stacy L Reynolds, Kathleen K Bryant, Jonathan R Studnek, Melanie Hogg, Connell Dunn, Megan A Templin, Charity G Moore, James R Young, Katherine Rivera Walker, Michael S Runyon
OBJECTIVE: We compared the tolerability and efficacy of intranasal sub-dissociative ketamine to intranasal fentanyl for analgesia of children with acute traumatic pain and investigated the feasibility of a larger non-inferiority trial that could investigate the potential opioid sparing effects of intranasal ketamine. METHODS: This randomized controlled trial compared intranasal ketamine 1 mg/kg to intranasal fentanyl 1.5 μg/kg in children 4-17 years old with acute pain from suspected, isolated extremity fractures presenting to an urban level II pediatric trauma center from December 2015 to November 2016...
September 19, 2017: Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine
https://www.readbyqxmd.com/read/28926120/glecaprevir-pibrentasvir-for-hcv-genotype-3-patients-with-cirrhosis-and-or-prior-treatment-experience-a-partially-randomized-phase-iii-clinical-trial
#4
David Wyles, Fred Poordad, Stanley Wang, Laurent Alric, Franco Felizarta, Paul Y Kwo, Benedict Maliakkal, Kosh Agarwal, Tarek Hassanein, Frank Weilert, Samuel S Lee, Jens Kort, Sandra S Lovell, Ran Liu, Chih-Wei Lin, Tami Pilot-Matias, Preethi Krishnan, Federico J Mensa
BACKGROUND: This study assessed the efficacy and safety of ribavirin (RBV)-free coformulated glecaprevir/pibrentasvir (G/P) in patients with hepatitis C virus (HCV) genotype (GT) 3 infection with either prior treatment experience and/or compensated cirrhosis, a patient population with limited treatment options. METHODS: SURVEYOR-II, Part 3 was a partially-randomized, open-label, multicenter, phase 3 study. Treatment-experienced (prior interferon (IFN) or pegIFN ± ribavirin or SOF plus ribavirin ± pegIFN therapy) patients without cirrhosis were randomized 1:1 to receive 12 or 16 weeks of G/P (300 mg/120 mg) once daily...
September 19, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28925801/mf59-adjuvanted-influenza-vaccine-fluad%C3%A2-elicits-higher-immune-responses-than-a-non-adjuvanted-influenza-vaccine-fluzone%C3%A2-a-randomized-multicenter-phase-iii-pediatric-trial-in-mexico
#5
Aurelio Cruz-Valdez, Gabriel Valdez-Zapata, Sanjay S Patel, Flavia V Castelli, Marcia G Garcia, Wim T Jansen, Ashwani Kumar Arora, Esther Heijnen
The poor immune response elicited by trivalent influenza vaccines (TIVs) in children can be enhanced by the addition of adjuvants. This observer-blind, randomized Phase III trial assessed the immunogenicity and safety of the MF59-adjuvanted trivalent influenza vaccine FLUAD® (aTIV) and a non-adjuvanted TIV, in healthy children (aged 6 to <72 months) from 3 centers in Mexico, during the 2014-2015 season. The primary objectives were to assess the non-inferiority of aTIV to TIV, measured by geometric mean titers (GMTs), and the safety of aTIV and TIV...
September 19, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28925169/-systematic-review-on-safety-of-salvianolate-injection
#6
Zhi-Wei Chen, Yan-Ming Xie, Xing Liao, Gui-Qian Wang
To systematically evaluate the safety of salvianolate injection in clinical medication. A systematic literature search was performed in the databases of Cochrane Library, Medline, Embase, the Web of Science, Clinical Trials, CNKI, VIP, WanFang Data and CBM. Literature screening was done according to inclusion and exclusion criteria, and quality was assessed according to internationally recognized quality evaluation criteria. Then the data were reviewed for analysis. 148 papers were included, consisting of 122 randomized controlled trials(RCTs), 10 non-randomized controlled trials(NRCTs), 4 case series studies, and 12 case reports...
October 2016: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/28924018/ibrutinib-for-chronic-graft-versus-host-disease-after-failure-of-prior-therapy
#7
David Miklos, Corey S Cutler, Mukta Arora, Edmund K Waller, Madan Jagasia, Iskra Pusic, Mary E Flowers, Aaron C Logan, Ryotaro Nakamura, Bruce R Blazar, Yunfeng Li, Stephen Chang, Indu Lal, Jason Dubovsky, Danelle F James, Lori Styles, Samantha Jaglowski
Chronic graft-versus-host disease (cGVHD) is a serious complication of allogeneic stem cell transplantation with few effective options available after failure of corticosteroids. B and T cells play a role in the pathophysiology of cGVHD. Ibrutinib inhibits Bruton's tyrosine kinase in B cells and interleukin-2-inducible T-cell kinase in T cells. In preclinical models, ibrutinib reduced severity of cGVHD. This multicenter, open-label study evaluated the safety and efficacy of ibrutinib in patients with active cGVHD with inadequate response to corticosteroid-containing therapies...
September 18, 2017: Blood
https://www.readbyqxmd.com/read/28923793/dose-comparison-study-of-allogeneic-mesenchymal-stem-cells-in-patients-with-ischemic-cardiomyopathy-the-trident-study
#8
Victoria Florea, Angela C Rieger, Darcy L Difede, Jill El-Khorazaty, Makoto Natsumeda, Monisha N Banerjee, Bryon A Tompkins, Aisha Khan, Ivonne H Schulman, Ana M Landin, Muzammil Mushtaq, Maureen H Lowery, John Byrnes, Robert C Hendel, Mauricio G Cohen, Krystalenia Valasaki, Marietsy V Pujol, Eduard Ghersin, Roberto Miki, Cindy Delgado, Fouad A Abuzeid, Mayra Vidro-Casiano, Russell Saltzman, Daniel DaFonseca, Lina V Caceres, Kevin N Ramdas, Adam Mendizabal, Alan W Heldman, Raul D Mitrani, Joshua M Hare
Rationale: Cell dose and concentration play crucial roles in phenotypic responses to cell-based therapy for heart failure. Objective: To compare the safety and efficacy of two doses of allogeneic bone marrow-derived human mesenchymal stem cells (hMSC) identically delivered in patients with ischemic cardiomyopathy (ICM). Methods and Results: Thirty patients with ICM received in a blinded manner either 20 million (20M, n=15) or 100 million (100M, n=15) allogeneic hMSCs via transendocardial injection (10 0.5 cc injections/patient)...
September 18, 2017: Circulation Research
https://www.readbyqxmd.com/read/28923561/update-on-the-safety-of-phosphodiesterase-type-5-inhibitors-for-the-treatment-of-erectile-dysfunction
#9
REVIEW
Faysal A Yafi, Ira D Sharlip, Edgardo F Becher
INTRODUCTION: Phosphodiesterase type 5 inhibitors (PDE5Is) have demonstrated efficacy in the treatment of erectile dysfunction (ED). Although historically found to have limited drug-related adverse events, emerging data have suggested that PDE5Is might be associated with melanoma or recurrence of prostate cancer after radical prostatectomy. AIM: To summarize the literature on the safety of PDE5Is. METHODS: A literature review was performed through PubMed from 1990 through 2016 regarding ED...
September 8, 2017: Sexual Medicine Reviews
https://www.readbyqxmd.com/read/28923239/a-novel-formulation-of-inhaled-sodium-cromoglicate-pa101-in-idiopathic-pulmonary-fibrosis-and-chronic-cough-a-randomised-double-blind-proof-of-concept-phase-2-trial
#10
Surinder S Birring, Marlies S Wijsenbeek, Sanjay Agrawal, Jan W K van den Berg, Helen Stone, Toby M Maher, Ahmet Tutuncu, Alyn H Morice
BACKGROUND: Cough can be a debilitating symptom of idiopathic pulmonary fibrosis (IPF) and is difficult to treat. PA101 is a novel formulation of sodium cromoglicate delivered via a high-efficiency eFlow nebuliser that achieves significantly higher drug deposition in the lung compared with the existing formulations. We aimed to test the efficacy and safety of inhaled PA101 in patients with IPF and chronic cough and, to explore the antitussive mechanism of PA101, patients with chronic idiopathic cough (CIC) were also studied...
September 8, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28922692/phosphodiesterase-4-inhibitors-for-chronic-obstructive-pulmonary-disease
#11
REVIEW
Jimmy Chong, Bonnie Leung, Phillippa Poole
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is associated with cough, sputum production or dyspnoea and a reduction in lung function, quality of life and life expectancy. Apart from smoking cessation, there are no other treatments that slow lung function decline. Roflumilast and cilomilast are oral phosphodiesterase 4 (PDE4) inhibitors proposed to reduce the airway inflammation and bronchoconstriction seen in COPD. This is an update of a Cochrane review first published in 2011 and updated in 2013...
September 19, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28922255/systematic-review-and-meta-analysis-fecal-microbiota-transplantation-for-treatment-of-active-ulcerative-colitis
#12
Neeraj Narula, Zain Kassam, Yuhong Yuan, Jean-Frederic Colombel, Cyriel Ponsioen, Walter Reinisch, Paul Moayyedi
BACKGROUND: Changes in the colonic microbiota may play a role in the pathogenesis of ulcerative colitis (UC) and restoration of healthy gut microbiota may ameliorate disease. A systematic review and meta-analysis was conducted to assess fecal microbiota transplantation (FMT) as a treatment for active UC. METHODS: A literature search was conducted to identify high-quality studies of FMT as a treatment for patients with UC. The primary outcome was combined clinical remission and endoscopic remission or response...
August 23, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28921890/phase-ii-study-of-dabigatran-in-children-with-venous-thrombosis-pharmacokinetics-safety-and-tolerabilty
#13
J M L Halton, M Albisetti, B Biss, L Bomgaars, M Brueckmann, S Gropper, R Harper, F Huang, M Luciani, H Maas, I Tartakovsky, L G Mitchell
BACKGROUND: The current standard-of-care treatments for pediatric venous thromboembolism (VTE) have limitations. Dabigatran etexilate (DE), a direct thrombin inhibitor, may offer an alternative therapeutic option. OBJECTIVES: To assess the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of DE oral liquid formulation (OLF) in pediatric patients with VTE. PATIENTS/METHODS: Patients who had completed planned treatment with low-molecular-weight heparin or oral anticoagulants for VTE were enrolled in two age groups (2-<12 and 1-<2 years) and received DE OLF based on an age- and weight-adjusted nomogram...
September 16, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28921814/nabilone-pharmacotherapy-for-cannabis-dependence-a-randomized-controlled-pilot-study
#14
Kevin P Hill, Matthew D Palastro, Staci A Gruber, Garrett M Fitzmaurice, Shelly F Greenfield, Scott E Lukas, Roger D Weiss
BACKGROUND AND OBJECTIVES: We assessed the safety, tolerability, and preliminary efficacy of nabilone, a cannabinoid agonist, to treat cannabis dependence. METHODS: Eighteen adults with DSM-IV cannabis dependence were randomized to receive either 2 mg/day of nabilone (n = 10) or placebo (n = 8) for 10 weeks in addition to medication management. Twelve participants, six in each group, completed treatment. The safety and tolerability of nabilone was assessed at each visit...
September 18, 2017: American Journal on Addictions
https://www.readbyqxmd.com/read/28919143/long-term-safety-of-glycopyrrolate-eflow-%C3%A2-cs-in-moderate-to-very-severe-copd-results-from-the-glycopyrrolate-for-obstructive-lung-disease-via-electronic-nebulizer-golden-5-randomized-study
#15
Gary T Ferguson, Thomas Goodin, Robert Tosiello, Alistair Wheeler, Edward Kerwin
BACKGROUND: The use of long-acting bronchodilators is an essential component of the management of chronic obstructive pulmonary disease (COPD). The GOLDEN 5 Phase III, randomized, active-controlled, open-label study was conducted to evaluate the long-term safety and tolerability of a nebulized glycopyrrolate formulation (SUN-101) delivered via the investigational eFlow(®) Closed System (eFlow(®) CS) nebulizer in subjects with moderate-to-very-severe COPD. METHODS: Subjects were randomized in a 4:3 ratio to nebulized glycopyrrolate 50 μg twice daily (BID) or tiotropium 18 μg once daily (OD) and treated for 48 weeks...
August 24, 2017: Respiratory Medicine
https://www.readbyqxmd.com/read/28919011/dabrafenib-plus-trametinib-in-patients-with-previously-untreated-braf-v600e-mutant-metastatic-non-small-cell-lung-cancer-an-open-label-phase-2-trial
#16
David Planchard, Egbert F Smit, Harry J M Groen, Julien Mazieres, Benjamin Besse, Åslaug Helland, Vanessa Giannone, Anthony M D'Amelio, Pingkuan Zhang, Bijoyesh Mookerjee, Bruce E Johnson
BACKGROUND: BRAF(V600E) mutation occurs in 1-2% of lung adenocarcinomas and acts as an oncogenic driver. Dabrafenib, alone or combined with trametinib, has shown substantial antitumour activity in patients with previously treated BRAF(V600E)-mutant metastatic non-small-cell lung cancer (NSCLC). We aimed to assess the activity and safety of dabrafenib plus trametinib treatment in previously untreated patients with BRAF(V600E)-mutant metastatic NSCLC. METHODS: In this phase 2, sequentially enrolled, multicohort, multicentre, non-randomised, open-label study, adults (≥18 years of age) with previously untreated metastatic BRAF(V600E)-mutant NSCLC were enrolled into cohort C from 19 centres in eight countries within North America, Europe, and Asia...
September 8, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28918877/raltegravir-1200-mg-once-daily-versus-raltegravir-400-mg-twice-daily-with-tenofovir-disoproxil-fumarate-and-emtricitabine-for-previously-untreated-hiv-1-infection-a-randomised-double-blind-parallel-group-phase-3-non-inferiority-trial
#17
Pedro Cahn, Richard Kaplan, Paul E Sax, Kathleen Squires, Jean-Michel Molina, Anchalee Avihingsanon, Winai Ratanasuwan, Evelyn Rojas, Mohammed Rassool, Mark Bloch, Linos Vandekerckhove, Peter Ruane, Yazdan Yazdanpanah, Christine Katlama, Xia Xu, Anthony Rodgers, Lilly East, Larissa Wenning, Sandy Rawlins, Brenda Homony, Peter Sklar, Bach-Yen Nguyen, Randi Leavitt, Hedy Teppler
BACKGROUND: Once daily regimens are preferred for HIV-1 treatment, to facilitate adherence and improve quality of life. We compared a new once daily formulation of raltegravir to the currently marketed twice daily formulation. METHODS: In this randomised, double-blind, parallel-group, phase 3, non-inferiority study, we enrolled participants aged 18 years or older with HIV-1 RNA of 1000 or more copies per mL and no previous antiretroviral treatment at 139 sites worldwide...
September 11, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28918758/medical-device-recalls-in-canada-from-2005-to-2015
#18
Anna R Gagliardi, Julie Takata, Ariel Ducey, Pascale Lehoux, Sue Ross, Patricia L Trbovich, Anthony Easty, Chaim M Bell, David R Urbach
OBJECTIVES: Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace...
September 18, 2017: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/28917955/lidocaine-gel-for-urethral-catheterization-in-children-a-meta-analysis
#19
Michael E Chua, Paul Nimrod B Firaza, Jessica M Ming, Jan Michael A Silangcruz, Luis H Braga, Armando J Lorenzo
OBJECTIVE: To compare the efficacy and safety of lidocaine gel vs nonanesthetic gel (NAG) in reducing transurethral bladder catheterization (TUBC) procedural pain in children. STUDY DESIGN: A systematic literature search was done using electronic medical databases and trial registries up to September 2016 with no language restrictions. Randomized controlled trials (RCTs) that assessed the efficacy and safety of lidocaine gel vs NAG in reducing TUBC-associated pain in children were screened, identified, and appraised...
September 13, 2017: Journal of Pediatrics
https://www.readbyqxmd.com/read/28917379/effectiveness-and-safety-of-acupuncture-in-the-treatment-of-parkinson-s-disease-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#20
REVIEW
Hyeonseok Noh, Seungwon Kwon, Seung-Yeon Cho, Woo-Sang Jung, Sang-Kwan Moon, Jung-Mi Park, Chang-Nam Ko, Seong-Uk Park
OBJECTIVE: This study aimed to examine the effectiveness and safety of acupuncture in the treatment of Parkinson's disease (PD). METHODS: English, Chinese, and Korean electronic databases were searched up to June 2016. Randomized controlled trials (RCTs) were eligible. The methodological quality was assessed using Cochrane's risk of bias tool. Meta-analysis was performed using RevMan 5.3. RESULTS: In total, 42 studies involving 2625 participants were systematically reviewed...
October 2017: Complementary Therapies in Medicine
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