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https://www.readbyqxmd.com/read/29454255/effects-of-adjunctive-eslicarbazepine-acetate-on-neurocognitive-functioning-in-children-with-refractory-focal-onset-seizures
#1
Sergiusz Jóźwiak, P Veggiotti, J Moreira, H Gama, F Rocha, P Soares-da-Silva
PURPOSE: This was a phase-II, randomized, double-blind (DB), placebo-controlled study aimed to evaluate neurocognitive effects of eslicarbazepine acetate (ESL) as adjunctive therapy in pediatric patients with refractory focal-onset seizures (FOS). METHODS: Children (6-16years old) with FOS were randomized (2:1) to ESL or placebo. Treatment started at 10mg/kg/day, was up-titrated up to 30mg/kg/day (target dose), and maintained for 8weeks, followed by one-year open-label follow-up...
February 13, 2018: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/29454034/add-on-high-frequency-deep-transcranial-magnetic-stimulation-dtms-to-bilateral-prefrontal-cortex-in-depressive-episodes-of-patients-with-major-depressive-disorder-bipolar-disorder-i-and-major-depressive-with-alcohol-use-disorders
#2
Chiara Rapinesi, Georgios D Kotzalidis, Stefano Ferracuti, Nicoletta Girardi, Abraham Zangen, Gabriele Sani, Ruggero N Raccah, Paolo Girardi, Maurizio Pompili, Antonio Del Casale
BACKGROUND: Dorsolateral prefrontal cortex (DLPFC) is critically involved in mood and alcohol use disorders. OBJECTIVE: We aimed to investigate the safety of intervention with add-on bilateral prefrontal high-frequency deep transcranial magnetic stimulation (dTMS) and between-group differences in treatment response in patients with different types of depressive episodes, including major depressive episodes in the course of major depressive disorder (MDD), bipolar disorder, type I (BD-I), and MDD with alcohol use disorder (MDAUD)...
February 14, 2018: Neuroscience Letters
https://www.readbyqxmd.com/read/29453628/safety-tolerability-and-preliminary-activity-of-imgn529-a-cd37-targeted-antibody-drug-conjugate-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-a-dose-escalation-phase-i-study
#3
Anastasios Stathis, Ian W Flinn, Sumit Madan, Kami Maddocks, Arnold Freedman, Steven Weitman, Emanuele Zucca, Mihaela C Munteanu, M Lia Palomba
Background CD37 is expressed on B-cell lymphoid malignancies, thus making it an attractive candidate for targeted therapy in non-Hodgkin lymphoma (NHL). IMGN529 is an antibody-drug conjugate comprising a CD37-binding antibody linked to the maytansinoid DM1, a potent anti-mitotic agent. Methods This first-in-human, phase 1 trial recruited adult patients with relapsed or refractory B-cell NHL. The primary objective was to determine the maximum tolerated dose (MTD) and recommended phase 2 dose. Secondary objectives were to evaluate safety, pharmacokinetics, and preliminary clinical activity...
February 17, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29453627/a-phase-i-and-pharmacokinetic-study-of-taladegib-a-smoothened-inhibitor-in-japanese-patients-with-advanced-solid-tumors
#4
Hideki Ueno, Shunsuke Kondo, Shusuke Yoshikawa, Koichi Inoue, Valérie Andre, Masaomi Tajimi, Haruyasu Murakami
Background This phase I dose-escalation study investigated the safety of the Smoothened inhibitor taladegib in Japanese patients with advanced solid tumors. Methods Patients received taladegib orally once daily for 28-day cycles, using a 3 + 3 dose-escalation method. The primary objective was the safety and tolerability of taladegib at doses up to the global recommended dose (400 mg). Secondary objectives included pharmacokinetics, changes in skin glioma-associated oncogene homolog 1 (Gli1) transcript levels, and antitumor activity...
February 17, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29453626/drug-approval-based-on-randomized-phase-3-trials-for-relapsed-malignancy-analysis-of-oncologic-drugs-granted-accelerated-approval-publications-and-clinical-trial-databases
#5
Sumimasa Nagai, Keiya Ozawa
Background As relapsed disease is frequently the first target of newly developed therapies, it is vital to address the difficulty in demonstrating the efficacy of new drugs for relapsed malignancy in randomized phase 3 trials. Methods We analyzed the approved indications, target populations, and development status of post-marketing confirmatory trials of all oncology-related drugs that were granted accelerated approval for both hematological and solid malignancies. Furthermore, we searched for randomized phase 3 trials for adult patients with relapsed lymphoid malignancy, other than chronic lymphocytic leukemia (CLL) and multiple myeloma (MM)...
February 17, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29453596/effectiveness-of-the-sesquiterpene-%C3%AE-bisabolol-in-dogs-with-naturally-acquired-canine-leishmaniosis-an-exploratory-clinical-trial
#6
V Corpas-López, G Merino-Espinosa, C Acedo-Sánchez, V Díaz-Sáez, M C Navarro-Moll, F Morillas-Márquez, J Martín-Sánchez
The use of natural products is a promising approach for treating visceral leishmaniosis. (-)-α-Bisabolol is a sesquiterpene that have been proved active in vivo on Leishmania infantum-infected mice without showing toxicity. A single-centre, parallel-group, randomized, exploratory study was designed to assess its efficacy in a canine leishmaniosis model involving naturally infected dogs. In this clinical trial, 12 dogs were allocated into two groups and were treated with either meglumine antimoniate (100 mg/kg) through subcutaneous route or (-)-α-bisabolol (30 mg/kg) through oral route for two treatment series of 30 days, separated by a 30-day interval...
February 16, 2018: Veterinary Research Communications
https://www.readbyqxmd.com/read/29453543/toxic-and-beneficial-potential-of-silver-nanoparticles-the-two-sides-of-the-same-coin
#7
Lilian Rodrigues Rosa Souza, Veronica Santana da Silva, Leonardo Pereira Franchi, Tiago Alves Jorge de Souza
Nanotechnology has allowed great changes in chemical, biological and physical properties of metals when compared to their bulk counterparts. Within this context, silver nanoparticles (AgNPs) play a major role due to their unique properties, being widely used in daily products such as fabrics, washing machines, water filters, food and medicine. However, AgNPs can enter cells inducing a "Trojan-horse" type mechanism which potentially leads to cellular autophagy, apoptosis or necrosis. On the other hand, this cytotoxicity mechanism can be optimized to develop drug nanocarriers and anticancer therapies...
2018: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29453114/levetiracetam-monotherapy-for-the-treatment-of-infants-with-epilepsy
#8
Pinar Arican, Pinar Gencpinar, Dilek Cavusoglu, Nihal Olgac Dundar
PURPOSE: Levetiracetam is a broad-spectrum anti-epileptic drug that is effective against both focal and generalized epilepsies. In this study, we aimed to evaluate the efficacy, tolerability and safety of levetiracetam monotherapy in the management of different seizure types in children with epilepsy under the age of two. METHOD: This retrospective study was conducted on children with a diagnosis of epilepsy from January 2014 to January 2017. To be included in the study, patients were required to be less than two years of age at the time levetiracetam was initiated as initial monotherapy and to be followed clinically for at least 6 months...
February 12, 2018: Seizure: the Journal of the British Epilepsy Association
https://www.readbyqxmd.com/read/29452942/early-safety-and-efficacy-of-the-combination-of-bedaquiline-and-delamanid-for-the-treatment-of-patients-with-drug-resistant-tuberculosis-in-armenia-india-and-south-africa-a-retrospective-cohort-study
#9
Gabriella Ferlazzo, Erika Mohr, Chinmay Laxmeshwar, Catherine Hewison, Jennifer Hughes, Sylvie Jonckheere, Naira Khachatryan, Virginia De Avezedo, Lusine Egazaryan, Amir Shroufi, Stobdan Kalon, Helen Cox, Jennifer Furin, Petros Isaakidis
BACKGROUND: Bedaquiline and delamanid have been approved for treatment of multidrug-resistant (MDR) tuberculosis in the past 5 years. Because of theoretical safety concerns, patients have been unable to access the two drugs in combination. Médecins Sans Frontières has supported the use of combination bedaquiline and delamanid for people with few treatment options since 2016. We describe early safety and efficacy of regimens containing the bedaquiline and delamanid combination in patients with drug-resistant tuberculosis in Yerevan, Armenia; Mumbai, India; and Khayelitsha, South Africa...
February 13, 2018: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29452834/pain-and-analgesic-drugs-in-chronic-venous-ulcers-with-topical-sevoflurane-use
#10
Adrian Imbernon-Moya, Francisco Javier Ortiz-de Frutos, Mónica Sanjuan-Alvarez, Isabel Portero-Sanchez, Raúl Merinero-Palomares, Victoria Alcazar
OBJECTIVE: Pain in chronic venous ulcers (CVUs) notably increases with the usual cleaning of the wound. Chronic pain is usually poorly controlled even with the multiple analgesic treatments available. Analgesics can have different serious adverse effects and medical interactions in old patients with several comorbidities. This study reports the efficacy and safety of topical sevoflurane for treatment of pain in CVUs. METHODS: We report a descriptive and retrospective study of 30 patients older than 65 years with painful CVUs refractory to conventional analgesic treatments...
February 13, 2018: Journal of Vascular Surgery
https://www.readbyqxmd.com/read/29451870/long-term-efficacy-and-safety-of-rilpivirine-plus-abacavir-and-lamivudine-in-hiv-1-infected-patients-with-undetectable-viral-load
#11
Nadia Galizzi, Laura Galli, Andrea Poli, Nicola Gianotti, Elisabetta Carini, Alba Bigoloni, Giuseppe Tambussi, Silvia Nozza, Adriano Lazzarin, Antonella Castagna, Daniela Mancusi, Roberta Termini
INTRODUCTION: A regimen with rilpivirine (RPV), abacavir (ABC) and lamivudine (3TC) is simple and may allow the sparing of tenofovir and protease inhibitors. However, data on use of this combination as a strategy of switch are limited. Aims of the study were to assess the long-term efficacy and safety of this regimen. METHODS: Retrospective study on HIV-1 infected patients followed at the Infectious Disease Department of the San Raffaele Scientific Institute, HBsAg-negative, HLA B5701-negative, with no documented resistance to RPV, ABC and 3TC, with HIV-RNA<50 copies/mL who started RPV plus ABC/3TC from March 2013 to September 2015...
2018: PloS One
https://www.readbyqxmd.com/read/29451603/from-medicinal-chemistry-to-human-health-current-approaches-to-drug-discovery-for-cancer-and-neglected-tropical-diseases
#12
Leonardo G Ferreira, Glaucius Oliva, Adriano D Andricopulo
Scientific and technological breakthroughs have compelled the current players in drug discovery to increasingly incorporate knowledge-based approaches. This evolving paradigm, which has its roots attached to the recent advances in medicinal chemistry, molecular and structural biology, has unprecedentedly demanded the development of up-to-date computational approaches, such as bio- and chemo-informatics. These tools have been pivotal to catalyzing the ever-increasing amount of data generated by the molecular sciences, and to converting the data into insightful guidelines for use in the research pipeline...
February 15, 2018: Anais da Academia Brasileira de Ciências
https://www.readbyqxmd.com/read/29451407/advancements-in-drug-development-for-diarrhea-predominant-irritable-bowel-syndrome
#13
Giovanni Dothel, Maria Raffaell Barbaro, Emanuel Raschi, Giovanni Barbara, Fabrizio De Ponti
Introduction Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common disorder characterized by a complex pathophysiology hampering optimal targeted drug development. Recent advances in our understanding of key underlying mechanisms prompted novel therapeutics including novel pharmacological approaches. Areas covered This review summarizes the latest advancements in the pipeline of IBS-D drugs focusing on new pharmacological targets, efficacy and safety of medicinal products considering the recent harmonization of regulatory requirements by the FDA and the EMA...
February 16, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29451287/computational-identification-of-the-binding-mechanism-of-a-triple-reuptake-inhibitor-amitifadine-for-the-treatment-of-major-depressive-disorder
#14
Weiwei Xue, Panpan Wang, Gao Tu, Fengyuan Yang, Guoxun Zheng, Xiaofeng Li, Xiaoxu Li, Yuzong Chen, Xiaojun Yao, Feng Zhu
Amitifadine, the only drug ever clinically tested in Phase 3 for treating depression, is a triple reuptake inhibitor (TRI) that simultaneously interacts with human monoamine transporters (MATs) including hSERT, hNET and hDAT. This novel multi-target strategy improves drug efficacy and reduces the toxic side effects of drugs. However, the binding modes accounting for amitifadine's polypharmacological mode of action are still elusive, and extensive exploration of the amitifadine-target interactions between amitifadine and MATs is urgently needed...
February 16, 2018: Physical Chemistry Chemical Physics: PCCP
https://www.readbyqxmd.com/read/29451077/intravitreal-aflibercept-versus-ranibizumab-for-wet-age-related-macular-degeneration-a-cost-effectiveness-analysis
#15
Luis Hernandez, Tereza Lanitis, Clifford Cele, Hector Toro-Diaz, Andrea Gibson, Andreas Kuznik
BACKGROUND: Age-related macular degeneration (AMD) is the leading cause of vision loss in the United States. The most severe vision loss occurs in patients with neovascular AMD, known as wet AMD (wAMD). The most commonly used antivascular endothelial growth factor (VEGF) therapies approved by the FDA to treat patients with wAMD are ranibizumab, 0.5 mg administered by intravitreal injection once a month (approximately every 28 days), and intravitreal aflibercept injection (IAI), 2 mg every 4 weeks (monthly) for the first 12 weeks (3 months), followed by IAI 2 mg once every 8 weeks (2 months)...
February 16, 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29450893/dofetilide-for-suppression-of-atrial-fibrillation-in-hypertrophic-cardiomyopathy-a-case-series-and-literature-review
#16
JoEllyn C Moore, Lena Trager, Lucille E Anzia, Walid Saliba, Mohamed Bassiouny, Mandeep Bhargava, Mina Chung, Milind Desai, Ross Garberich, Harry Lever, Bruce D Lindsay, Jay Sengupta, Patrick Tchou, Oussama Wazni, Bruce L Wilkoff
BACKGROUND: Limited medical options are available for rhythm control in patients with atrial fibrillation (AF) and hypertrophic cardiomyopathy (HCM). There are no published reports of dofetilide use in this population. METHODS: A retrospective chart review was conducted on1,404 patients loaded on dofetilide for AF suppression at the Cleveland Clinic from 2008-2012, 25 of whom were found to have HCM. RESULTS: The HCM cohort was 32% female, 76% with persistent AF, mean age of 59 ± 10 years and mean ejection fraction (EF) of 54 ± 9 %...
February 16, 2018: Pacing and Clinical Electrophysiology: PACE
https://www.readbyqxmd.com/read/29450890/efficacy-and-safety-of-eslicarbazepine-acetate-monotherapy-in-patients-converting-from-carbamazepine
#17
Ladislav Pazdera, Michael R Sperling, Jay H Harvey, Maria C Sam, Laura A Strom, David Blum, Todd Grinnell, Hailong Cheng
OBJECTIVE: To evaluate the influence of prior use of carbamazepine (CBZ) and other antiepileptic drugs (AEDs) with a putatively similar mechanism of action (inhibition of voltage-gated sodium channels; VGSCs) on seizure outcomes and tolerability when converting to eslicarbazepine acetate (ESL), using data pooled from 2 controlled conversion-to-ESL monotherapy trials (studies: 093-045, 093-046). METHODS: Adults with treatment-resistant focal (partial-onset) seizures were randomized 2:1 to ESL 1600 or 1200 mg once daily...
February 16, 2018: Epilepsia
https://www.readbyqxmd.com/read/29450805/ph-responsive-cap-co-poly-methacrylic-acid-based-hydrogel-as-an-efficient-platform-for-controlled-gastrointestinal-delivery-fabrication-characterization-in-vitro-and-in-vivo-toxicity-evaluation
#18
Syed Ahmed Shah, Muhammad Sohail, Muhammad Usman Minhas, Nisar-Ur-Rehman, Shahzeb Khan, Zahid Hussain, Mudassir, Arshad Mahmood, Mubeen Kousar, Asif Mahmood
Cellulose acetate phthalate-based pH-responsive hydrogel was synthesized for fabrication of polymeric matrix tablets for gastro-protective delivery of loxoprofen sodium. Cellulose acetate phthalate (CAP) was cross-linked with methacrylic acid (MAA) using free radical polymerization technique. Fourier transform infrared (FTIR) spectra confirmed the formation of cross-linked structure of CAP-co-poly(methacrylic acid). Thermogravimetric analysis (TGA) and differential scanning calorimetry (DSC) confirmed the thermal stability of polymeric networks, and scanning electron microscopy (SEM) and energy-dispersive X-ray spectrum (EDS) images unveiled that the prepared formulations were porous in nature and thus the developed formulations had shown better diffusibility...
February 15, 2018: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/29450684/application-and-impact-of-run-in-studies
#19
Michael Fralick, Jerry Avorn, Jessica M Franklin, Abdurrahman Abdurrob, Aaron S Kesselheim
BACKGROUND: A run-in phase is often employed prior to randomization in a clinical trial to exclude non-adherent patients, placebo responders, active drug non-responders, or patients who do not tolerate the active drug. This may impact the generalizability of trial results. OBJECTIVE: To determine if clinical outcomes differed between randomized controlled trials with run-in phases compared with randomized controlled trials of the same medication without run-in phases...
February 15, 2018: Journal of General Internal Medicine
https://www.readbyqxmd.com/read/29450468/activity-and-safety-of-cetuximab-plus-modified-folfoxiri-followed-by-maintenance-with-cetuximab-or-bevacizumab-for-ras-and-braf-wild-type-metastatic-colorectal-cancer-a-randomized-phase-2-clinical-trial
#20
Chiara Cremolini, Carlotta Antoniotti, Sara Lonardi, Giuseppe Aprile, Francesca Bergamo, Gianluca Masi, Roberta Grande, Giuseppe Tonini, Claudia Mescoli, Giovanni Gerardo Cardellino, Luigi Coltelli, Lisa Salvatore, Domenico Cristiano Corsi, Cristiana Lupi, Donatello Gemma, Monica Ronzoni, Emanuela Dell'Aquila, Federica Marmorino, Francesca Di Fabio, Maria Laura Mancini, Lorenzo Marcucci, Gabriella Fontanini, Vittorina Zagonel, Luca Boni, Alfredo Falcone
Importance: The combination of a triple-drug chemotherapy regimen with an anti-epidermal growth factor receptor (EGFR) agent as a first-line treatment of metastatic colorectal cancer (mCRC) showed promising activity along with safety concerns in single-arm phase 2 trials. The role of maintenance following chemotherapy and anti-EGFR and the optimal regimen to be adopted are not established. Objectives: To evaluate the activity and safety of cetuximab plus modified FOLFOXIRI (mFOLFOXIRI) and explore the role of maintenance with cetuximab or bevacizumab in RAS and BRAF wild-type mCRC...
February 15, 2018: JAMA Oncology
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