Read by QxMD icon Read

Serious safety event

David Glineur, Marc Hendrikx, Dainis Krievins, Peteris Stradins, Bernhard Voss, Thomas Waldow, Luc Haenen, Martin Oberhoffer, Caroline M Ritchie
Background: Obtaining hemostasis during cardiovascular procedures can be a challenge, particularly around areas with a complex geometry or that are difficult to access. While several topical hemostats are currently on the market, most have caveats that limit their use in certain clinical scenarios such as pulsatile arterial bleeding. The aim of this study was to assess the effectiveness and safety of Veriset™ hemostatic patch in treating cardiovascular bleeding. Methods: Patients (N=90) scheduled for cardiac or vascular surgery at 12 European institutions were randomized 1:1 to treatment with either Veriset™ hemostatic patch (investigational device) or TachoSil® (control)...
2018: Medical Devices: Evidence and Research
Ching-Yen Chen, Tze-Chun Tang, Tzu-Ting Chen, Ya Mei Bai, Huei-Huang Tsai, Hou-Liang Chen, Chun-Jen Huang, Chih-Ken Chen, Chun-Chih Chen, Mei-Chun Hsiao, Chia-Yih Liu, Hong-Shiow Yeh, Nan-Ying Chiu, Cheng-Chen Hsiao, Cheng-Sheng Chen, Tung-Ping Su
Purpose: Paliperidone extended release (ER) is an oral psychotropic treatment formulated to release paliperidone at a controlled, gradually ascending rate. We evaluated the efficacy and safety of switching to paliperidone ER in Taiwanese patients with schizophrenia who were unresponsive or intolerant to previous antipsychotic therapy. Patients and methods: This was a 24-week, open-label, single-arm, multicenter, Phase IV trial. Based on consulting psychiatrists' judgment, patients were deemed eligible for the switch to paliperidone ER; the switch was achieved by cross-tapering, using a recommended starting dose of 6 mg...
2018: Neuropsychiatric Disease and Treatment
Jerold Jeyaratnam, Nienke M Ter Haar, Helen J Lachmann, Ozgur Kasapcopur, Amanda K Ombrello, Donato Rigante, Fatma Dedeoglu, Ezgi H Baris, Sebastiaan J Vastert, Nico M Wulffraat, Joost Frenkel
BACKGROUND: Withholding live-attenuated vaccines in patients using interleukin (IL)-1 or IL-6 blocking agents is recommended by guidelines for both pediatric and adult rheumatic diseases, since there is a risk of infection in an immune suppressed host. However, this has never been studied. This retrospective, multicenter survey aimed to evaluate the safety of live-attenuated vaccines in patients using IL-1 or IL-6 blockade. METHODS: We contacted physicians involved in the treatment of autoinflammatory diseases to investigate potential cases...
March 21, 2018: Pediatric Rheumatology Online Journal
John C Byrd, Stephen Smith, Nina Wagner-Johnston, Jeff Sharman, Andy I Chen, Ranjana Advani, Bradley Augustson, Paula Marlton, S Renee Commerford, Kwame Okrah, Lichuan Liu, Elaine Murray, Elicia Penuel, Ashley F Ward, Ian W Flinn
GDC-0853 is a selective, reversible, and non-covalent inhibitor of Bruton's tyrosine kinase (BTK) that does not require interaction with the Cys481 residue for activity. In this first-in-human phase 1 study we evaluated safety, tolerability, pharmacokinetics, and activity of GDC-0853 in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL). Twenty-four patients, enrolled into 3 cohorts, including 6 patients who were positive for the C481S mutation, received GDC-0853 at 100, 200, or 400 mg once daily, orally...
February 27, 2018: Oncotarget
(no author information available yet)
BACKGROUND: Bilastine is an H1-antihistamine approved for symptomatic treatment of patients with allergic rhinoconjunctivitis or urticaria. The safety profile of bilastine in clinical trials of allergic rhinoconjunctivitis or urticaria, assessed by type and frequency of adverse events (AE), was similar to that of placebo. OBJECTIVE: As part of the risk management plan for bilastine, the safety profile of bilastine in the elderly was assessed. METHODS: A prospective, multicenter, observational, open-label, 3-month follow-up study was performed to assess the safetyprofile of bilastine 20 mg in patients aged greater than or equal to 65 years with allergic rhinoconjunctivitis and/or urticaria...
March 20, 2018: Allergy and Asthma Proceedings:
Rui-Hua Xu, Kei Muro, Satoshi Morita, Satoru Iwasa, Sae Won Han, Wei Wang, Masahito Kotaka, Masato Nakamura, Joong Bae Ahn, Yan-Hong Deng, Takeshi Kato, Sang-Hee Cho, Yi Ba, Hiroshi Matsuoka, Keun-Wook Lee, Tao Zhang, Yasuhide Yamada, Junichi Sakamoto, Young Suk Park, Tae Won Kim
BACKGROUND: Studies of a modified XELIRI (mXELIRI; capecitabine plus irinotecan) regimen suggest promising efficacy and tolerability profiles in the first-line and second-line settings. Therefore, we aimed to compare the efficacy and safety of the mXELIRI regimen with that of standard FOLFIRI (leucovorin, fluorouracil, and irinotecan), with or without bevacizumab in both regimens, as a second-line therapy for metastatic colorectal cancer. METHODS: We did a multicentre, open-label, randomised, non-inferiority, phase 3 trial...
March 16, 2018: Lancet Oncology
Margriet den Boer, Asish Kumar Das, Fatima Akhter, Sakib Burza, V Ramesh, Be-Nazir Ahmed, Eduard E Zijlstra, Koert Ritmeijer
Background: A safe and effective short-course treatment regimen for Post Kala Azar Dermal Leishmaniasis (PKDL) is considered essential for achieving and sustaining elimination of visceral leishmaniasis (VL) in the Indian subcontinent.(1, 2) Here, single dose liposomal amphotericin B (AmBisome) has been adopted as a first line regimen for VL; however the effectiveness and safety of AmBisome for PKDL has not been formally evaluated. Methods: The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3mg/kg on an outpatient basis, was evaluated between April and November 2014 in clinically diagnosed PKDL patients of 12 years and older residing in a highly VL endemic area in Bangladesh...
March 15, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Richard A Pollak, Ira J Gottlieb, Fardin Hakakian, John C Zimmerman, Stewart W McCallum, Randall J Mack, Rosemary Keller, Alex Freyer, Wei Du
OBJECTIVE: To evaluate the analgesic efficacy and safety of a novel intravenous (IV) formulation of meloxicam (30▒mg) in subjects with moderate-to-severe pain following a standardized, unilateral bunionectomy with first metatarsal osteotomy and internal fixation. METHODS: Subjects who met the criteria for moderate-to-severe postoperative pain were randomized to receive bolus injections of meloxicam IV 30▒mg (n=100) or placebo (n=101) administered once daily...
March 16, 2018: Clinical Journal of Pain
Hiroyuki Kishino, Kenichi Takahashi, Miyuki Sawata, Yoshiyuki Tanaka
Hepatitis B vaccines are highly effective in preventing hepatitis B virus infection and have been included in the national immunization program of Japan since 2016. Heptavax®-II is one of two hepatitis B vaccine products licensed in Japan, and its manufacturing process is being modified to reduce variability of manufacturing and optimize immunogenicity. In this study (NCT01463683), the immunogenicity and safety of a modified-process hepatitis B vaccine (mpHBV) were compared to those of the licensed Heptavax®-II...
March 19, 2018: Human Vaccines & Immunotherapeutics
Hanlin Gong, Feng Qin, Hongbo He
Background: Herbal formula Modified Buzhong-Yiqi-Tang (MBYT) has been widely used for the treatment of functional constipation in East Asia, but its efficacy and safety are unclear. Methods: The study was to evaluate the efficacy and safety of MBYT for adult patients with functional constipation. Randomized clinical trials were selected according to predefined inclusion and exclusion criteria. Results: In total, twenty-five randomized controlled clinical trials were included with 2089 patients...
2018: Evidence-based Complementary and Alternative Medicine: ECAM
Massimo Puoti, Graham R Foster, Stanley Wang, David Mutimer, Edward Gane, Christophe Moreno, Ting Tsung Chang, Samuel S Lee, Rui Marinho, Jean-Francois DuFour, Stanislas Pol, Christophe Hezode, Stuart C Gordon, Simone I Strasser, Paul J Thuluvath, Zhenzhen Zhang, Sandra Lovell, Tami Pilot-Matias, Federico J Mensa
BACKGROUND AND AIMS: Glecaprevir plus pibrentasvir (G/P) is a pangenotypic, once-daily, ribavirin-free direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) infection. In nine phase 2 or 3 clinical trials, G/P achieved sustained virologic response 12 weeks post-treatment (SVR12) rates of 93-100% across all six major HCV genotypes (GTs). An integrated efficacy analysis of 8- and 12-week G/P in non-cirrhotic patients with HCV GT1-6 infection was performed. METHODS: Data were pooled from nine phase 2 and 3 trials and included patients with chronic HCV GT 1, 2, 3, 4, 5 or 6 infection without cirrhosis who received G/P (300mg/120mg) for either 8 or 12 weeks...
March 15, 2018: Journal of Hepatology
Soedjatmiko Soedjatmiko, Bernie Endyarni Medise, Hartono Gunardi, Rini Sekartini, Hindra Irawan Satari, Sri Rezeki Hadinegoro, Novilia Sjafri Bachtiar, Rini Mulia Sari
INTRODUCTION: High rate of influenza infection in children made influenza vaccination strongly recommended for all person aged >6 months in Indonesia. Bio Farma Trivalent Influenza HA (Flubio®) vaccine has been used in adolescents and adults, resulted in increased seroconversion, seroprotection rates and geometric mean titer (GMT). However, no data is available regarding its efficacy and safety in children. This study aimed to assess the immunogenicity and safety of Flubio® vaccine in infants and children...
March 15, 2018: Vaccine
Jennifer R Brown, Mehdi Hamadani, John Hayslip, Ann Janssens, Nina Wagner-Johnston, Oliver Ottmann, Jon Arnason, Hervé Tilly, Michael Millenson, Fritz Offner, Nashat Y Gabrail, Siddhartha Ganguly, Sikander Ailawadh, Siddha Kasar, Arnon P Kater, Jeanette K Doorduijn, Lei Gao, Joanne J Lager, Bin Wu, Coumaran Egile, Marie José Kersten
BACKGROUND: Patients with relapsed or refractory lymphoma or chronic lymphocytic leukaemia have a poor prognosis. Therapies targeting more than one isoform of PI3K, as well as mTOR, might increase antitumour activity. We aimed to investigate the efficacy and safety of voxtalisib (also known as XL765 or SAR245409), a pan-PI3K/mTOR inhibitor, in patients with relapsed or refractory lymphoma, or chronic lymphocytic leukaemia/small lymphocytic lymphoma. METHODS: We did a non-randomised, open-label, phase 2 trial at 30 oncology clinics in the USA, Belgium, Germany, France, the Netherlands, and Australia...
March 14, 2018: Lancet Haematology
Tobias Boch, Thomas Luft, Georgia Metzgeroth, Maximilian Mossner, Johann-Christoph Jann, Daniel Nowak, Franziska La Meir, Christiane Schumann, Jennifer Klemmer, Susanne Brendel, Harald Fricke, Claudia Kunz, Christel Weiß, Wolf-Karsten Hofmann, Florian Nolte
In low risk MDS, increased apoptosis of erythroid progenitors mediated via CD95 (Fas) activation has been described to result in peripheral cytopenia. Blockade of the CD95 system can improve erythropoiesis in MDS. Asunercept (APG101) is a fusion protein consisting of the extracellular domain of human CD95 and the Fc domain of human IgG1 blocking the interaction between CD95 and its ligand. Here we report on results from a phase I study in 20 transfusion-dependent low and intermediate risk MDS patients treated with intravenous asunercept (EudraCT 2012-003027-37)...
March 10, 2018: Leukemia Research
Naosuke Kamei, Mitsuo Ochi, Nobuo Adachi, Masakazu Ishikawa, Shinobu Yanada, L Scott Levin, Goki Kamei, Takaaki Kobayashi
PURPOSE: A new cell delivery system using magnetic force, termed magnetic targeting, was developed for the accumulation of locally injected cells in a lesion. The aim of this study was to assess the safety and efficacy of mesenchymal stem cell (MSC) magnetic targeting in patients with a focal articular cartilage defect in the knee. METHODS: MSC magnetic targeting for five patients was approved by the Ministry of Health Labour and Welfare of Japan. Autologous bone marrow MSCs were cultured and subsequently magnetized with ferucarbotran...
March 16, 2018: Knee Surgery, Sports Traumatology, Arthroscopy: Official Journal of the ESSKA
Yunona Khomitskaya, Nadezhda Tikhonova, Konstantin Gudkov, Svetlana Erofeeva, Victoria Holmes, Brian Dayton, Nigel Davies, David W Boulton, Weifeng Tang
PURPOSE: Fixed-combination drug products (FCDPs) combining dapagliflozin and metformin extended release (XR) may provide patients with type 2 diabetes mellitus with an alternative antihyperglycemic treatment, which could improve adherence by reducing tablet burden. This study evaluated the bioequivalence of dapagliflozin/metformin XR FCDP versus the co-administration of the individual monotherapy tablets currently available for use in the Russian Federation. METHODS: Healthy subjects aged 18 to 45 years were enrolled in this randomized, open-label, 2-period crossover study, conducted in a single Russian center...
March 13, 2018: Clinical Therapeutics
Melissa Palmer, Lee Jennings, Debra G Silberg, Caleb Bliss, Patrick Martin
BACKGROUND: Accumulation of toxic free cholesterol in hepatocytes may cause hepatic inflammation and fibrosis. Volixibat inhibits bile acid reuptake via the apical sodium bile acid transporter located on the luminal surface of the ileum. The resulting increase in bile acid synthesis from cholesterol could be beneficial in patients with non-alcoholic steatohepatitis. This adaptive dose-finding study investigated the safety, tolerability, pharmacodynamics, and pharmacokinetics of volixibat...
March 16, 2018: BMC Pharmacology & Toxicology
Ana M Molina, Thomas E Hutson, Dmitry Nosov, Piotr Tomczak, Oleg Lipatov, Cora N Sternberg, Robert Motzer, Tim Eisen
BACKGROUND: Tivozanib is a selective inhibitor of vascular endothelial growth factor receptors 1, 2 and 3 tyrosine kinases. This open-label, crossover clinical study (AV-951-09-902) provided access to tivozanib for patients who progressed on sorafenib in TIVO-1, comparing tivozanib with sorafenib in patients with advanced renal cell carcinoma (RCC). METHODS: Patients enrolled in this single-arm, phase 2 crossover study were previously randomised to sorafenib on TIVO-1, progressed and then crossed over to tivozanib...
March 13, 2018: European Journal of Cancer
Charalampos S Siristatidis, Eleni Sertedaki, Dennis Vaidakis, Christos Varounis, Marialena Trivella
BACKGROUND: In order to overcome the low effectiveness of assisted reproductive technologies (ART) and the high incidence of multiple births, metabolomics is proposed as a non-invasive method to assess oocyte quality, embryo viability, and endometrial receptivity, and facilitate a targeted subfertility treatment. OBJECTIVES: To evaluate the effectiveness and safety of metabolomic assessment of oocyte quality, embryo viability, and endometrial receptivity for improving live birth or ongoing pregnancy rates in women undergoing ART, compared to conventional methods of assessment...
March 16, 2018: Cochrane Database of Systematic Reviews
Marina Chiara Garassino, Byoung-Chul Cho, Joo-Hang Kim, Julien Mazières, Johan Vansteenkiste, Hervé Lena, Jesus Corral Jaime, Jhanelle E Gray, John Powderly, Christos Chouaid, Paolo Bidoli, Paul Wheatley-Price, Keunchil Park, Ross A Soo, Yifan Huang, Catherine Wadsworth, Phillip A Dennis, Naiyer A Rizvi
BACKGROUND: Immune checkpoint inhibitors are a new standard of care for patients with advanced non-small-cell lung cancer (NSCLC) without EGFR tyrosine kinase or anaplastic lymphoma kinase (ALK) genetic aberrations (EGFR-/ALK-), but clinical benefit in patients with EGFR mutations or ALK rearrangements (EGFR+/ALK+) has not been shown. We assessed the effect of durvalumab (anti-PD-L1) treatment in three cohorts of patients with NSCLC defined by EGFR/ALK status and tumour expression of PD-L1...
March 12, 2018: Lancet Oncology
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"