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https://www.readbyqxmd.com/read/29346837/a-phase-1-randomized-placebo-and-active-controlled-crossover-study-to-determine-the-effect-of-single-dose-ertugliflozin-on-qtc-interval-in-healthy-volunteers
#1
Vaishali Sahasrabudhe, Didier Saur, Kyle Matschke, Steven G Terra, Anne Hickman, Isabelle Huyghe, Haihong Shi, David L Cutler
Ertugliflozin, a selective sodium-glucose cotransporter-2 inhibitor, is being developed for the treatment of type 2 diabetes mellitus. This randomized, 6-sequence, 3-period crossover study assessed the effect of ertugliflozin (100 mg; supratherapeutic dose) vs placebo and moxifloxacin (400 mg; positive control) on the QT interval corrected for heart rate (QTc) in 42 male or female healthy subjects. Triplicate electrocardiograms were performed predose and serially over 48 hours postdose in each treatment period...
January 18, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29346833/phase-1b-trial-of-ficlatuzumab-a-humanized-hepatocyte-growth-factor-inhibitory-monoclonal-antibody-in-combination-with-gefitinib-in-asian-patients-with-nsclc
#2
Eng-Huat Tan, Wan-Teck Lim, Myung-Ju Ahn, Quan-Sing Ng, Jin Seok Ahn, Daniel Shao-Weng Tan, Jong-Mu Sun, May Han, Francis C Payumo, Krista McKee, Wei Yin, Marc Credi, Shefali Agarwal, Jaroslaw Jac, Keunchil Park
Hepatocyte growth factor (HGF)/c-Met pathway dysregulation is a mechanism for epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). Ficlatuzumab (AV-299; SCH 900105), a humanized IgG1 κ HGF inhibitory monoclonal antibody, prevents HGF/c-Met pathway ligand-mediated activation. This phase 1b study assessed the safety/tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of ficlatuzumab plus gefitinib in Asian patients with previously treated advanced non-small cell lung cancer (NSCLC)...
January 18, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29346639/comparison-of-dopamine-d3-and-d2-receptor-occupancies-by-a-single-dose-of-blonanserin-in-healthy-subjects-a-positron-emission-tomography-study-with-11c-phno
#3
Amane Tateno, Takeshi Sakayori, Woo-Chan Kim, Kazuyoshi Honjo, Haruo Nakayama, Ryosuke Arakawa, Yoshiro Okubo
Background: Blockade of D3 receptor, a member of the dopamine D2-like receptor family, has been suggested as a possible medication for schizophrenia. Blonanserin has high affinity in vitro for D3 as well as D2 receptors. We investigated whether a single dose of 12 mg blonanserin, which was within the daily clinical dose range (i.e., 8-24 mg) for the treatment of schizophrenia, occupies D3 as well as D2 receptors in healthy subjects. Methods: Six healthy males (mean 35...
January 13, 2018: International Journal of Neuropsychopharmacology
https://www.readbyqxmd.com/read/29346131/toxicological-profile-and-safety-pharmacology-of-a-single-dose-of-fibroblast-activation-protein-%C3%AE-based-doxorubicin-prodrug-in-vitro-and-in-vivo-evaluation
#4
Sichao Huang, Yuchen Zhang, Jinsong Zhong, Ying Pan, Shaohui Cai, Jun Xu
Fibroblast activation protein-α (FAPα) is a promising tumor-associated target expressed by reactive stromal fibroblasts in tumor tissue. FAPα has a postprolyl peptidase activity and can specifically cleave N-terminal benzyloxycarbonyl (Z)-blocked peptides, such as the substrate Z-Gly-Pro-AMC. Doxorubicin (DOX) is an effective antitumor drug, but its application is greatly limited by toxic adverse effects owing to poor tumor selectivity. Based on these facts, we previously designed a FAPα-targeting prodrug of doxorubicin (FTPD) which can be selectively hydrolyzed by FAPα...
January 17, 2018: Anti-cancer Drugs
https://www.readbyqxmd.com/read/29346028/biophysics-model-of-heavy-ion-degradation-of-neuron-morphology-in-mouse-hippocampal-granular-cell-layer-neurons
#5
Murat Alp, Francis A Cucinotta
Exposure to heavy-ion radiation during cancer treatment or space travel may cause cognitive detriments that have been associated with changes in neuron morphology and plasticity. Observations in mice of reduced neuronal dendritic complexity have revealed a dependence on radiation quality and absorbed dose, suggesting that microscopic energy deposition plays an important role. In this work we used morphological data for mouse dentate granular cell layer (GCL) neurons and a stochastic model of particle track structure and microscopic energy deposition (ED) to develop a predictive model of high-charge and energy (HZE) particle-induced morphological changes to the complex structures of dendritic arbors...
January 18, 2018: Radiation Research
https://www.readbyqxmd.com/read/29345736/palbociclib-in-combination-with-letrozole-as-first-line-treatment-for-advanced-breast-cancer-a-japanese-phase-ii-study
#6
Norikazu Masuda, Reiki Nishimura, Masato Takahashi, Kenichi Inoue, Shinji Ohno, Hiroji Iwata, Yuko Mori, Satoshi Hashigaki, Yasuaki Muramatsu, Takashi Nagasawa, Yoshiko Umeyama, Masakazu Toi
This single-arm, open-label, phase II study in 42 Japanese postmenopausal patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer evaluated the efficacy, safety, and pharmacokinetics of first-line palbociclib (125 mg once daily, 3 weeks on/1 week off) coadministered with letrozole (2.5 mg once daily). The primary endpoint of investigator-assessed 1-year progression-free survival probability was 75.0% (90% CI, 61.3%-84.4%), far surpassing the 40% lower limit of the 90% CI supporting efficacy...
January 18, 2018: Cancer Science
https://www.readbyqxmd.com/read/29345426/single-dose-intravenous-iron-in-southeast-asian-heart-failure-patients-a-pilot-randomized-placebo-controlled-study-practice-asia-hf
#7
Tee Joo Yeo, Poh Shuan Daniel Yeo, Farid Abdul Hadi, Timothy Cushway, Kim Yee Lee, Fang Fang Yin, Anne Ching, Ruili Li, Seet Yoong Loh, Shir Lynn Lim, Raymond Ching-Chiew Wong, Bee Choo Tai, Arthur Mark Richards, Carolyn S P Lam
AIMS: Iron deficiency is highly prevalent in Southeast Asians with heart failure (HF) and associated with worse outcomes. This trial aimed to assess the effect of intravenous iron in Southeast Asians hospitalized with decompensated HF. METHODS AND RESULTS: Fifty patients hospitalized for acute decompensated HF, regardless of ejection fraction, with iron deficiency (defined as serum ferritin <300 ng/mL if transferrin saturation is <20%) were randomized to receive either one dose of intravenous ferric carboxymaltose (FCM) 1000 mg or placebo (0...
January 18, 2018: ESC Heart Failure
https://www.readbyqxmd.com/read/29344912/capillary-leak-syndrome-as-a-complication-of-antibody-mediated-rejection-treatment-a-case-report
#8
Juan C Ramirez-Sandoval, Ricardo Varela-Jimenez, Luis E Morales-Buenrostro
We report a case of capillary leak that developed during treatment of antibody-mediated rejection in a kidney transplant recipient. A 53-year-old female transplant recipient experienced an increase in serum creatinine from 1.1 to 1.8 mg/dL. Antibody-mediated rejection was diagnosed by graft biopsy. She was treated with five plasmapheresis sessions (on alternate days with albumin replacement), five doses of immunoglobulin (5 g/dose at 100 mg/kg), a single dose of rituximab (500 mg), and four doses of bortezomib on days 1, 4, 7, and 10 (1...
January 17, 2018: CEN Case Reports
https://www.readbyqxmd.com/read/29344794/ticagrelor-for-secondary-prevention-of-atherothrombotic-events-after-myocardial-infarction-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#9
REVIEW
Xavier G L V Pouwels, Robert Wolff, Bram L T Ramaekers, Anoukh Van Giessen, Shona Lang, Steve Ryder, Gill Worthy, Steven Duffy, Nigel Armstrong, Jos Kleijnen, Manuela A Joore
The National Institute for Health and Care Excellence (NICE) invited AstraZeneca, the manufacturer of ticagrelor (Brilique®), to submit evidence on the clinical and cost effectiveness of ticagrelor 60 mg twice daily (BID) in combination with low-dose aspirin [acetylsalicylic acid (ASA)] compared with ASA only for secondary prevention of atherothrombotic events in patients with a history of myocardial infarction (MI) and who are at increased risk of atherothrombotic events. Kleijnen Systematic Reviews Ltd (KSR), in collaboration with Maastricht University Medical Centre+, was commissioned as the evidence review group (ERG)...
January 18, 2018: PharmacoEconomics
https://www.readbyqxmd.com/read/29344779/trigeminal-neuropathy-in-vestibular-schwannoma-a-treatment-algorithm-to-avoid-long-term-morbidity
#10
Luke Galloway, Nachi Palaniappan, Geoffrey Shone, Caroline Hayhurst
BACKGROUND: Trigeminal neuropathy (TGN) can occur as a presenting feature of vestibular schwannoma (VS) or as an adverse effect of radiosurgery. This study was designed to evaluate a treatment algorithm for presenting symptoms of TGN in patients with VS, and a new radiosurgery dosimetric tolerance to avoid TGN after treatment. Outcome was measured after microsurgery (MS), stereotactic radiosurgery (SRS), hypofractionated stereotactic radiotherapy (HSRT), and fractionated radiotherapy (FRT)...
January 17, 2018: Acta Neurochirurgica
https://www.readbyqxmd.com/read/29344306/131i-labeled-copper-sulfide-loaded-microspheres-to-treat-hepatic-tumors-via-hepatic-artery-embolization
#11
Qiufang Liu, Yuyi Qian, Panli Li, Sihang Zhang, Jianjun Liu, Xiaoguang Sun, Michael Fulham, Dagan Feng, Gang Huang, Wei Lu, Shaoli Song
Purpose: Transcatheter hepatic artery embolization therapy is a minimally invasive alternative for treating inoperable liver cancer but recurrence is frequent. Multifunctional agents, however, offer an opportunity for tumor eradication. In this study, we were aim to synthesized poly (lactic-co-glycolic acid) (PLGA) microspheres encapsulating hollow CuS nanoparticles (HCuSNPs) and paclitaxel (PTX) that were then labeled with radioiodine-131 (131I) to produce 131I-HCuSNPs-MS-PTX. This compound combines the multi-theranostic properties of chemotherapy, radiotherapy and photothermal therapy...
2018: Theranostics
https://www.readbyqxmd.com/read/29344198/combination-of-cecropinxj-and-ly294002-induces-synergistic-cytotoxicity-and-apoptosis-in-human-gastric-cancer-cells-via-inhibition-of-the-pi3k-akt-signaling-pathway
#12
Li-Jie Xia, Yan-Ling Wu, Fu-Chun Zhang
The aim of the present study was to investigate the cytotoxic and apoptotic effects of cecropinXJ against human gastric cancer BGC823 cells, either alone, or in combination with a specific phosphatidylinositol 3-kinase (PI3K) inhibitor, LY294002. Cell viability and the apoptosis rate were measured using flow cytometry with Annexin-V staining. Additionally, the expression levels of several RAC-α serine/threonine kinase (Akt) phosphorylation-associated proteins and apoptosis-regulating proteins were evaluated by western blot analysis...
December 2017: Oncology Letters
https://www.readbyqxmd.com/read/29344184/therapeutic-effects-of-adenovirus-mediated-cd-and-nis-expression-combined-with-na131i-5-fc-on-human-thyroid-cancer
#13
Meng-Hui Yuan, Long-Xiao Wei, Run-Suo Zhou, Hai-Feng Xu, Jun-Yan Wang, Qian-Rong Bai
Thyroid cancer is the most common type of malignant endocrine tumor diagnosed. Previous studies have indicated that gene therapy is the most promising and effective therapeutic method for thyroid cancer. Therefore, in the present study, Na131I/5-fluorocytosine (5-FC) treatment was combined with cytosine deaminase (CD, encoded by the CDA gene) and sodium iodide symporter (NIS, encoded by the SLC5A5 gene) to act together as a therapeutic tool for thyroid cancer. The present study explored the combined cytotoxic effects of adenovirus-mediated CD and NIS under the control of the progression elevated gene-3 (PEG-3) promoter (Ad-PEG-3-CD-NIS) with Na131I/5-FC against the human thyroid cancer TT cell line in vitro...
December 2017: Oncology Letters
https://www.readbyqxmd.com/read/29343971/assessment-of-the-cardiac-safety-between-cetuximab-and-panitumumab-as-single-therapy-in-chinese-chemotherapy-refractory-mcrc
#14
Xue-Miao Tang, Hao Chen, Qing Li, Yiling Song, Shuping Zhang, Xiao-Shuan Xu, Yiwei Xu, Shulin Chen
Objective: The cardiac safety of cetuximab and panitumumab, particularly as single agents, has not been investigated extensively. This trial was designed to specifically evaluate the cardiac safety of cetuximab and panitumumab as single therapy in Chinese chemotherapy-refractory metastatic colorectal cancer (mCRC) patients. Patients and methods: Sixty-one patients received cetuximab at an initial dose of 400 mg/m2 intravenously over 120 minutes on day 1 (week 1), followed by a maintenance dose of 250 mg/m2 intravenously over 60 minutes on day 1 of each 7-day cycle...
2018: OncoTargets and Therapy
https://www.readbyqxmd.com/read/29343790/interference-experiment-with-asymmetric-double-slit-by-using-1-2-mv-field-emission-transmission-electron-microscope
#15
Ken Harada, Tetsuya Akashi, Kodai Niitsu, Keiko Shimada, Yoshimasa A Ono, Daisuke Shindo, Hiroyuki Shinada, Shigeo Mori
Advanced electron microscopy technologies have made it possible to perform precise double-slit interference experiments. We used a 1.2-MV field emission electron microscope providing coherent electron waves and a direct detection camera system enabling single-electron detections at a sub-second exposure time. We developed a method to perform the interference experiment by using an asymmetric double-slit fabricated by a focused ion beam instrument and by operating the microscope under a "pre-Fraunhofer" condition, different from the Fraunhofer condition of conventional double-slit experiments...
January 17, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29343731/impact-of-tissue-kinetic-heterogeneity-on-pet-quantification-case-study-with-the-l-1-11c-leucine-pet-method-for-cerebral-protein-synthesis-rates
#16
Mattia Veronese, Alessandra Bertoldo, Giampaolo Tomasi, Carolyn Beebe Smith, Kathleen C Schmidt
Functional quantification with PET is generally based on modeling that assumes tissue regions are kinetically homogeneous. Even in regions sufficiently small to approach homogeneity, spillover due to resolution limitations of PET scanners may introduce heterogeneous kinetics into measured data. Herein we consider effects of kinetic heterogeneity at the smallest volume accessible, the single image voxel. We used L-[1-11C]leucine PET and compared rates of cerebral protein synthesis (rCPS) estimated voxelwise with methods that do (Spectral Analysis Iterative Filter, SAIF) and do not (Basis Function Method, BFM) allow for kinetic heterogeneity...
January 17, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29343658/differences-in-signal-intensity-and-enhancement-on-mr-images-of-the-perivascular-spaces-in-the-basal-ganglia-versus-those-in-white-matter
#17
Shinji Naganawa, Toshiki Nakane, Hisashi Kawai, Toshiaki Taoka
PURPOSE: To elucidate differences between the perivascular space (PVS) in the basal ganglia (BG) versus that found in white matter (WM) using heavily T2-weighted FLAIR (hT2-FL) in terms of 1) signal intensity on non-contrast enhanced images, and 2) the degree of contrast enhancement by intravenous single dose administration of gadolinium based contrast agent (IV-SD-GBCA). MATERIALS AND METHODS: Eight healthy men and 13 patients with suspected endolymphatic hydrops were included...
January 18, 2018: Magnetic Resonance in Medical Sciences: MRMS
https://www.readbyqxmd.com/read/29343454/rational-design-and-evaluation-of-hbsag-polymeric-nanoparticles-as-antigen-delivery-carriers
#18
Hitesh Kumar Dewangan, Tarun Pandey, Lakshmi Maurya, Sanjay Singh
The present work is focused on the development and evaluation of single dose sustained-release Hepatitis B surface antigen (HBsAg) loaded nanovaccine for Hepatitis B. The conventional treatment suffers from repeated administration and hence requires a booster dose. Therefore, polymeric nanovaccine of HBsAg was developed by double emulsion solvent evaporation technique, utilizing central composite design for formulation optimization. The effects of independent variables (like polymer amount, stabilizer concentration, aqueous/organic phase ratio and homogenizer speed) were also studied on critical quality attributes like particle size and entrapment efficiency...
January 14, 2018: International Journal of Biological Macromolecules
https://www.readbyqxmd.com/read/29343448/optimizing-the-dose-of-local-infiltration-analgesia-and-gabapentin-for-total-knee-arthroplasty-a-randomized-single-blind-trial-in-128-patients
#19
Maurik H M van Haagen, Hennie Verburg, Brechtje Hesseling, Lauri Coors, Nick T van Dasselaar, Pim N J Langendijk, Nina M C Mathijssen
BACKGROUND AND PURPOSE: Effective analgesia is essential for postoperative recovery and rehabilitation in TKA. The challenge of analgesic regimes is to obtain adequate pain relief and maximum muscle control to mobilize and rehabilitate patients early. However, the optimal dose and best composition are not known. We hypothesized that there would be no differences in reported postoperative pain on the day of the TKA surgery as well as the first day after surgery when different combinations of ropivacain for LIA and gabapentin are given...
January 14, 2018: Knee
https://www.readbyqxmd.com/read/29343085/a-lack-of-systemic-absorption-following-the-repeated-application-of-topical-quetiapine-in-healthy-adults
#20
Bryce Kayhart, Maria I Lapid, Sarah Nelson, Julie L Cunningham, Virginia H Thompson, Jonathan G Leung
In the absence of suitable oral or intravenous access for medication administration and when the intramuscular medications are undesirable, alternative routes for drug delivery may be considered. Antipsychotics administered via an inhaled, intranasal, rectal, or topical route have been described in the literature. Topically administered antipsychotics have been previously reported to produce negligible systemic absorption despite being used in clinical practice for nausea and behavioral symptoms associated with dementia...
January 1, 2018: American Journal of Hospice & Palliative Care
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