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PubMed Journals Articles About "Ganaxolone Phase Data Supports Progressing Phase Patients With" - Page: 20 RSS

21:30 EDT 21st September 2018 | BioPortfolio

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Showing "Ganaxolone Phase Data Supports Progressing Phase Patients with" PubMed Articles 476–500 of 59,000+

Extrapolation of praziquantel pharmacokinetics to a pediatric population: a cautionary tale.

L-praziquantel (PZQ) pharmacokinetic data were analyzed from two relative bioavailability Phase 1 studies in adult, healthy subjects with two new oral dispersion tablet (ODT) formulations of L-PZQ administered under various combinations of co-administration with food, water, and/or crushing. Linear mixed effects models adequately characterized the noncompartmental estimates of the pharmacokinetic profiles in both studies. Dose, food, and formulation were found to significantly affect L-PZQ exposure in both ...


Opioid Use Disorders: Perioperative Management of a Special Population.

Opioid-related overdose deaths have reached epidemic levels within the last decade. The efforts to prevent, identify, and treat opioid use disorders (OUDs) mostly focus on the outpatient setting. Despite their frequent overrepresentation, less is known about the inpatient management of patients with OUDs. Specifically, the perioperative phase is a very vulnerable time for patients with OUDs, and little has been studied on the optimal management of acute pain in these patients. The preoperative evaluation sh...

Development and optimization of a novel automated loop method for production of Cnicotine.

A novel, rapid, and automated loop method for the synthesis of [C]nicotine was developed and optimized. The method involves, a reaction of the precursor, (+) nornicotine or (-) nornicotine, with a gas-phase produced [C]CHI in an 800 µL loop at 75 °C for 5 min followed by a semi-preparatory Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) purification. The optimized synthesis and purification process was complete in  99.9% Radiochemical Purity (RCP), no [C]CHI, no (+) nornicotine, 10...


A phase 3b, multicenter, open-label extension study of the long-term safety of anagrelide in Japanese adults with essential thrombocythemia.

Cytoreductive therapy is used in high-risk essential thrombocythemia (ET) to reduce risk of thrombohemorrhagic complications. Anagrelide is an orally active, quinazolone-derived platelet-lowering agent approved for first-line treatment of high-risk ET in Japan. Long-term safety and efficacy data were collected from 53 Japanese high-risk ET patients (Study 308); 41 patients who completed Study 308 entered this phase 3b, open-label extension (Study 309; NCT01467661). Reductions in mean platelet counts occurre...

Gaming behaviour with Pokémon GO and physical activity: A preliminary study with medical students in Thailand.

Pokémon GO becomes the most rapidly downloaded mobile application in history. This study aimed to determine the physical activity of medical students, who played Pokémon GO, and the change in their use of Pokémon GO and physical activity over time. An observational study was conducted. Physical activity was measured by using self-administered questionnaires at baseline (phase 0), 1 month (phase 1) and 3 months (phase 2) post-Pokémon GO download. The changes in physical activity (phase 0 to 1 and phase 1...

Direct Visualisation of the Structural Transformation between the Lyotropic Liquid Crystalline Lamellar and Bicontinuous Cubic Mesophase.

The transition between the lyotropic liquid crystalline lamellar and the bicontinuous cubic mesophase drives multiple fundamental cellular processes involving changes in cell membrane topology including endocytosis and membrane budding. While several theoretical models have been proposed to explain this dynamic transformation, experimental validation of these models has been challenging due to the short lived nature of the intermediates present during the phase transition. Herein, we report the direct obser...

"Crypto-Display" in Dual-Mode Metasurfaces by Simultaneous Control of Phase and Spectral Responses.

Although conventional metasurfaces have demonstrated many promising functionalities in light control by tailoring either phase or spectral responses of subwavelength structures, simultaneous control of both responses has not been explored yet. Here, we propose a concept of dual-mode metasurface that enables simultaneous control of phase and spectral responses for two kinds of operation modes of transmission and reflection, respectively. In the transmission mode, the dual-mode metasurface acts as conventiona...

Limiting feeding to the active phase reduces blood pressure without the necessity of caloric reduction or fat mass loss.

Reducing body weight has been shown to lower blood pressure in obesity-related hypertension. However, success of those lifestyle interventions is limited due to poor long-term compliance. Emerging evidence indicate that feeding schedule plays a role on the regulation of blood pressure. With two studies, we examined the role of feeding schedule on energy homeostasis and blood pressure. In Study 1, rats were fed a high fat diet (HFD) ad libitum for 24 hours (Control) or for 12 hours during the dark phase (tim...

The Presence and Role of Midplane Cholesterol in Lipid Bilayers Containing Registered or Antiregistered Phase Domains.

Three-component lipid mixtures can produce coexisting liquid ordered (Lo) and liquid disordered (Ld) phases, a model for eukaryotic plasma membrane rafts. In compositionally symmetric bilayers with two phase-separated leaflets, phase domains of the two leaflets may align through registration, where domains are found across from domains of the same phase, or else antiregistration, where domains are found across from domains of the opposite phase. This alignment could serve as a method of information communic...

Phase I Trial: Cirmtuzumab Inhibits ROR1 Signaling and Stemness Signatures in Patients with Chronic Lymphocytic Leukemia.

Cirmtuzumab is a humanized monoclonal antibody (mAb) that targets ROR1, an oncoembryonic orphan receptor for Wnt5a found on cancer stem cells (CSCs). Aberrant expression of ROR1 is seen in many malignancies and has been linked to Rho-GTPase activation and cancer stem cell self-renewal. For patients with chronic lymphocytic leukemia (CLL), self-renewing, neoplastic B cells express ROR1 in 95% of cases. High-level leukemia cell expression of ROR1 is associated with an unfavorable prognosis. We conducted a pha...

Phase Diagrams of TIP4P/2005, SPC/E, and TIP5P Water at High Pressure.

We investigate high pressure ice phases using molecular dynamics simulations. Spontaneous nucleation of a new crystalline solid, named ice T2, is observed in a simulation of TIP4P/2005 water at 260 K and 3.3 GPa. The phase diagram of ices VI, VII, T2 and recently reported two other hypothetical ices, ice R and ice T, is determined using the direct coexistence method and the Clausius-Clapeyron equation for TIP4P/2005, SPC/E and TIP5P water. It is found that there exists at least one pressure region in which ...

Dual-wavelength digital holographic phase and fluorescence microscopy for an optical thickness encoded suspension array.

A dual-wavelength digital holographic phase and fluorescence microscopy system is demonstrated as the decoding and detection platform of an optical thickness encoded suspension array. The phase imaging path is designed to decode optical thickness encoded microcarriers, and the fluorescence imaging path is used to detect the quantitative information of the bound target analytes. The encoding capacity could be more than 100. The decoding reliability of the phase imaging path is verified by a multiplexed immun...

Removal effect of the low-low temperature electrostatic precipitator on polycyclic aromatic hydrocarbons.

The low-low temperature electrostatic precipitator (LLT-ESP) is one of the most used devices for pollutant control in ultra-low emission coal-fired power plants. This study investigated the influence of the LLT-ESP on polycyclic aromatic hydrocarbons (PAHs) distributions in flue gas from an ultra-low emission coal-fired power plant. The total gas-phase PAH concentration was reduced from 27.52 μg/m to 3.38 μg/m. The total particulate-phase PAH concentration decreased from 14.36 μg/m to 0.34 μg/m....

Respiratory modulation of cognitive performance during the retrieval process.

Recent research suggests that cognitive performance might be altered by the respiratory-synchronized activity generated in the brain. Previous human studies, however, have yielded inconsistent results when assessing task performance during distinct respiratory phases (inspiratory phase vs. expiratory phase). We therefore tested whether cognitive performance was regulated based on the timing of breathing components (e.g., expiratory-to-inspiratory (EI) phase transition) during the retrieval process. To deter...

Cisplatin Encapsulation Generates Morphologically Different Multi-Compartments in the Internal Nanostructures of Non-Lamellar Liquid Crystalline Self-Assemblies.

Cisplatin (cis-diamminedichloroplatinum (II)) is among the most potent cytotoxic agents used in cancer chemotherapy. The encapsulation of cisplatin in lipid-based drug carriers has been challenging owing to its low solubility in both aqueous and lipid phases. Here, we investigated cisplatin encapsulation in non-lamellar liquid crystalline (LC) nanodispersions formed from a ternary mixture of phytantriol (PHYT), vitamin E (Vit E) and an anionic phospholipid [either phosphatidylglycerol (DSPG) or phosphatidyl...

Advances in Understanding Stimulus Responsive Phase Behavior of Intrinsically Disordered Protein Polymers.

Proteins and synthetic polymers can undergo phase transitions in response to changes to intensive solution parameters such as temperature, proton chemical potentials (pH), and hydrostatic pressure. For proteins and protein-based polymers, the information required for stimulus responsive phase transitions is encoded in their amino acid sequence. Here, we review some of the key physical principles that govern the phase transitions of archetypal intrinsically disordered protein polymers (IDPPs). These are diso...

Measuring Gait Quality in Parkinson's Disease through Real-Time Gait Phase Recognition.

Monitoring gait quality in daily activities through wearable sensors has the potential to improve medical assessment in Parkinson's Disease (PD). In this study, four gait partitioning methods, two based on thresholds and two based on a machine learning approach, considering the four-phase model, were compared. The methods were tested on 26 PD patients, both in OFF and ON levodopa conditions, and 11 healthy subjects, during walking tasks. All subjects were equipped with inertial sensors placed on feet. Force...

Transmission electron microscopy investigations of the microstructures in rapidly solidified Mg-Sn ribbons.

Ribbons of an Mg-9.76 wt.%Sn alloy have been fabricated using rapid solidification technology. X-ray diffraction and transmission electron microscopy confirm that the rapidly solidified ribbons consist of α-Mg, β-MgSn and β-MgSn phases. The α-Mg grains are refined in the ribbons. The predominant fraction of the β-MgSn phase distributes at the grain boundaries of the α-Mg grains. The minor fraction of the β-MgSn phase reveals a spherical morphology with a typical grain size of 170 nm. The orientat...

Pharmacokinetic Characteristics of Tofacitinib in Adult Patients With Moderate to Severe Chronic Plaque Psoriasis.

Tofacitinib is an oral Janus kinase (JAK) inhibitor. This study characterized the pharmacokinetics of tofacitinib in patients with psoriasis and evaluated the impact of patient factors on disposition. Pooled phase 2/3 data (2981 patients: 9735 concentrations, dose range: 2-15 mg twice daily) up to 56 weeks were used for modeling. A one-compartment model parameterized in terms of apparent oral clearance (CL/F), apparent volume of distribution, zero-order absorption (duration, D), with interindividual variab...

An Unusual Salt Effect in an Interfacial Nucleophilic Substitution Reaction.

This paper reports a kinetic characterization of the interfacial reaction of N-methylpyrrolidine with a self-assembled monolayer presenting an iodoalkyl group. SAMDI mass spectrometry was used to determine the extent of reaction for monolayers that were treated with a range of concentrations of the nucleophile for a range of times. These data revealed a second-order rate constant for the reaction that was approximately 100-fold greater than that for the analogous solution-phase reaction. However, addition o...

Molecular Engineering Toward Coexistence of Dielectric and Optical Switch Behavior in Hybrid Perovskite Phase Transition Material.

Organic-inorganic hybrid perovskites with considerable dielectric differences near the phase transition are potential candidates as phase transition materials (PTMs). However, compared with traditional PTMs, which require multiple switchable channels, the hybrid perovskites so far show only switching behavior in dielectric constants. We herein report a new crystal design strategy and successful synthesis of 2D perovskite (C6H5C2H4NH3)2MnCl4. In this hybrid perovskite, the manganese chloride octahedron is a ...

Generalized ROC methods for immunogenicity data analysis of vaccine phase I studies in a seropositive population.

Immunogenicity data from phase 1 vaccine studies can be difficult to interpret, especially in seropositive populations and when multiple assays are used. We developed 3 statistical methods (Youden index [YI] threshold, receiver-operating characteristic relative to baseline [ROC-B], and ROC of postdose levels [ROC-P]) to characterize complex immunogenicity data by assessing the proportion of a study population that achieved values above thresholds. The YI method calculates a single threshold per assay. Both ...

A randomized phase II trial of trastuzumab plus capecitabine versus lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and taxanes: WJOG6110B/ELTOP.

For human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) with progression on trastuzumab-based therapy, continuing trastuzumab beyond progression and switching to lapatinib combined with chemotherapy are both valid options. We conducted an open-label, randomized phase II trial to compare the efficacy of these strategies.

Ab Initio Calculation of the Miscibility Diagram for Hydrogen-Helium Mixtures.

We use finite-temperature density functional theory coupled to classical molecular dynamics simulation to calculate the miscibility gap of hydrogen-helium mixtures. The van der Waals density functional (vdW-DF) theory is used, which leads to lower demixing temperatures compared to computations using the Perdew-Burke-Ernzerhof functional. Our calculations suggest that current Jupiter models are most likely too hot to allow demixing in the interior. A Jupiter isentrope based on our vdW-DF data is presented. O...

Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: Results Through 48 Weeks of a Phase 3, Multicenter, Randomized, Double-Blinded, Etanercept- and Placebo-Controlled Study (CIMPACT).

Phase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity.


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