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

22:35 EST 18th December 2018 | BioPortfolio

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

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 ...


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...

Stability Characterization of PbI-Added CHNHPbICl Photovoltaic Devices.

The stability of TiO/CHNHPbICl -based photovoltaic devices in ambient air was evaluated upon adding PbI and/or PbCl. X-ray diffraction (XRD) peak intensities corresponding to the perovskite phase were increased by adding PbI. After 7 weeks, the XRD peak intensities corresponding to the perovskite phase decreased and those corresponding to PbI increased. The reaction rate constants for the decomposition of perovskite and formation of PbI were estimated from these data. Thermodynamic calculations of the react...


Lurbinectedin Is Active in Patients with Mutant Breast Cancer.

A phase II trial evaluated lurbinectedin in patients with -mutant and wild-type tumors.

Phospholipid Chain Interactions with Cholesterol Drive Domain Formation in Lipid Membranes.

Cholesterol is a key component of eukaryotic membranes, but its role in cellular biology in general and in lipid rafts in particular remains controversial. Model membranes are used extensively to determine the phase behavior of ternary mixtures of cholesterol, a saturated lipid, and an unsaturated lipid with liquid-ordered and liquid-disordered phase coexistence. Despite many different experiments that determine lipid-phase diagrams, we lack an understanding of the molecular-level driving forces for liquid ...

Nature of Hydrogen Adsorption on Platinum in the Aqueous Phase.

The thermodynamic state of H₂ adsorbed on Pt in the aqueous phase was determined by kinetic analysis of H₂ reacting with D₂O to HDO, HD and D₂ and by DFT based ab inito molecular dynamic simulation of H2 adsorption on Pt (111), Pt (110), and Pt nanoparticles. Dissociative adsorption of H₂ on Pt is significantly weakened in the aqueous phase compared to adsorption at gas-solid interface. Water destabilizes adsorbed H, decreasing the heat of adsorption by 19 - 22 kJ/mol(H₂), while inducing an addi...

An adaptive multi-stage phase I dose-finding design incorporating continuous efficacy and toxicity data from multiple treatment cycles.

Phase I designs traditionally use the dose-limiting toxicity (DLT), a binary endpoint from the first treatment cycle, to identify the maximum-tolerated dose (MTD) assuming a monotonically increasing relationship between dose and efficacy. In this article, we establish a general framework for a multi-stage adaptive design where we jointly model a continuous efficacy outcome and continuous/quasi-continuous toxicity endpoints from multiple treatment cycles. The normalized Total Toxicity Profile (nTTP) is used ...

Charge-governed phase manipulation of few-layer tellurium.

Few-layer tellurium is an emerging quasi-one-dimensional layered material. The striking feature of Te is its presence as various few-layer allotropes (α-δ). Although these allotropes offer substantially different physical properties, only the α phase has been synthesized in neutral few-layers as it is so far the most stable few-layer form. Herein, we show that hole or electron doping could maintain a certain Te phase. The β, α, γ and δ phases appear as the most stable forms of Te bilayer, in sequence...

The long periodicity phase (LPP) controversy part I: The influence of a natural-like ratio of the CEREOS analogue EOS-br in a CERNP/AP based stratum corneum modelling system: A neutron diffraction study.

This study used neutron diffraction to investigate a ceramide-[NP] C24/[AP] C24 /[EOS]-br C30/cholesterol/lignoceric acid (0.6: 0.3: 0.1: 0.7: 1) based stratum corneum modelling system. By adding specifically deuterated ceramides-[NP]-D, [AP]-D, and [EOS]-br-D, detailed information on the lamellar and the nanostructure of the system was obtained. For the short periodicity phase a natural-like lamellar repeat distance of 5.47 ± 0.02 nm was observed, similar to the [NP]/[AP] base system without the [EO...

Protonation of polyaniline-coated silica stationary phase affects the retention behavior of neutral hydrophobic solutes in reversed-phase capillary liquid chromatography.

Thanks to its high conductivity when acid doped, polyaniline is known as a synthetic metal and is used in a wide range of applications, such as supercapacitors, biosensors, electrochromic devices or solar and fuel cells. Emeraldine is the partly oxidized, stable form of polyaniline, consisting of alternating diaminobenzenoid and iminoquinoid segments. When acidified, the nitrogen atoms of emeraldine become protonated. Due to electrostatic repulsion between positive charges, the polarity and morphology of em...

Compromising between phase stability and electrical performance: SrVO3-SrTiO3 solid solutions as SOFC anode components.

The applicability of perovskite-type SrVO3-δ in high-temperature electrochemical energy conversion technology is hampered by the limited stability domain of the perovskite phase. The present work aimed at a compromise between the phase stability and electrical performance by designing the solid solutions in the SrVO3-SrTiO3 system. Increasing titanium content in SrV1-yTiyO3-δ (y = 0-0.9) perovskites is demonstrated to result in a gradual shift of the upper-p(O2) phase stability boundary toward oxidizing c...

Role of Liquid-Liquid Phase Separation in Assembly of Elastin and Other Extracellular Matrix Proteins.

Liquid-liquid phase separation resulting in formation of colloidal droplets has recently attracted attention as a mechanism for rapid and transient assembly of intracellular macromolecules into functional units. Phase separation also appears to be a widespread and evolutionarily ancient mechanism for organization of proteins of the extracellular matrix into fibrillar, polymeric assemblies. Elastin, which provides the physical properties of extensibility and elastic recoil to large arteries, lungs and other ...

Population Pharmacokinetic Modeling With Enterohepatic Circulation for AZD3241 in Healthy Subjects and Patients With Multiple System Atrophy.

AZD3241 is a potent and selective myeloperoxidase inhibitor potentially for the treatment of a number of neurodegenerative disorders, including multiple system atrophy (MSA). The objectives of this work were to develop a population pharmacokinetic (PopPK) model for AZD3241 and to investigate the correlation between AZD3241 exposure and myeloperoxidase inhibition. The PopPK model was developed using AZD3241 data from one phase 1 study in healthy subjects and one phase 2 study in patients with MSA. A one-comp...

The neurorestorative effect of human amniotic fluid stem cells on the chronic phase of neonatal hypoxic-ischemic encephalopathy in mice.

Hypoxic-ischemic encephalopathy (HIE) remains a major cause of cerebral palsy. Increasing evidence has suggested that mesenchymal stem cells have a favorable effect on HIE. However, the efficacy of human amniotic fluid stem cells (hAFS) for HIE, especially in the chronic phase, remains unclear. The aim of this study was to determine the neurorestorative effect of hAFS on the chronic phase of HIE.

Safety and Potential Therapeutic Effect of Two Intracavernous Autologous Bone Marrow Derived Mesenchymal Stem Cells injections in Diabetic Patients with Erectile Dysfunction: An Open Label Phase I Clinical Trial.

This open label, phase I clinical trial (NCT02945462) using 2 consecutive intracavernous autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) for the first time in the treatment of diabetic patients with erectile dysfunction (ED). The primary outcome is to assess the safety and tolerability of intracavernous autologous BM-MSCs, the secondary outcome is to assess efficacy of the procedure.

Irradiation by γ-rays reduces the level of H3S10 phosphorylation and weakens the G2 phase-dependent interaction between H3S10 phosphorylation and γH2AX.

Histone posttranslational modifications regulate diverse nuclear functions, including DNA repair. Here, we use mass spectrometry, western blotting, immunohistochemistry and advanced confocal microscopy in order to show radiation-specific changes in the histone signature. We studied wild-type mouse embryonic stem cells (mESCs) and mESCs with a depletion of histone deacetylase 1 (HDAC1), which plays a role in DNA repair. Irradiation by γ-rays increased the S139 phosphorylation of histone H2AX but reduced the...

Stochastic Endogenous Replication Stress Causes ATR-Triggered Fluctuations in CDK2 Activity that Dynamically Adjust Global DNA Synthesis Rates.

Faithful DNA replication is challenged by stalling of replication forks during S phase. Replication stress is further increased in cancer cells or in response to genotoxic insults. Using live single-cell image analysis, we found that CDK2 activity fluctuates throughout an unperturbed S phase. We show that CDK2 fluctuations result from transient ATR signals triggered by stochastic replication stress events. In turn, fluctuating endogenous CDK2 activity causes corresponding decreases and increases in DNA sy...

Influence of Metal Substitution on the Pressure-Induced Phase Change in Flexible Zeolitic Imidazolate Frameworks.

Metal-organic frameworks that display step-shaped adsorption profiles arising from discrete pressure-induced phase changes are promising materials for applications in both high-capacity gas storage and energy-efficient gas separations. The thorough investigation of such materials through chemical diversification, gas adsorption measurements, and in situ structural characterization is therefore crucial for broadening their utility. We examine a series of isoreticular, flexible zeolitic imidazolate frameworks...

Overview of Biochemical Assays in Lipidic Cubic Phase.

The development of novel biochemical methods to efficiently characterize membrane protein (MP) properties in lipidic cubic phase (LCP) is important for studying complicated MPs and their multimeric complexes. Here, we summarize recent LCP-related assays and provide an outlook on their applications in structure and function studies of MPs.

Phase Transition in Monolayer Water Confined in Janus Nanopore.

The ubiquitous nature of water invariably leads to a variety of physical scenarios that can result in many intriguing properties. We investigate the thermodynamics and associated phase transitions for a water monolayer confined within a quasi-two-dimensional nanopore. An asymmetric nanopore constructed by combining a hydrophilic (hexagonal Boron Nitride) sheet and a hydrophobic (Graphene) sheet leads to an ordered water structure at much higher temperatures compared to a symmetric hydrophobic nanopore consi...

A phase II trial of gemcitabine, S-1 and LV combination (GSL) neoadjuvant chemotherapy for patients with borderline resectable and locally advanced pancreatic cancer.

There has been a pressing need to develop optimal regimen for neoadjuvant chemotherapy (NAC) for pancreatic cancer (PC). The safety and efficacy of gemcitabine, S-1, and LV combination (GSL) therapy as NAC for borderline resectable (BR) and locally advanced (LA) PC was evaluated in this phase II study. Patients with pathologically proven BR or LA PC were enrolled and gemcitabine 1000 mg/m by 30-min infusion on day 1, S-1 40 mg/m orally twice daily, and LV 25 mg orally twice daily on days 1-7 every 2 week...

Rhombohedral-Orthorhombic Ferroelectric Morphotropic Phase Boundary Associated with Polar Vortex in BiFeO Films.

Strongly correlated oxides exhibit multi-degrees of freedoms which are potential for mediating exotic phases with exciting physical properties, such as polar vortex recently found in ferroelectric oxides films. Polar vortex is stabilized by competition between charge, lattice and/or orbital degrees of freedom, which displays vortex-ferroelectric phase transitions and emergent chirality, making it a potential candidate for designing information storage and processing devices. Here, by a combination of contro...

A Combination of NMR Methods to Reveal the Interfacial Structure of a Pharmaceutical Nanocrystal and Nanococrystal in the Suspended State.

The detailed structure of a pharmaceutical nanosuspension was investigated using three NMR methods: solid-state, solution-state, and high resolution-magic angle spinning (HR-MAS) NMR. Carbamazepine (CBZ) and CBZ-saccharin (SAC) cocrystal nanosuspensions were prepared by wet-milling with hydroxypropyl methylcellulose (HPMC) and sodium dodecyl sulfate (SDS) as stabilizing agents. Solid-state C NMR indicated the presence of not only the crystalline drug substance but also solid-state HPMC, even though HPMC was...

The required coefficient of friction in Parkinson's disease: people with freezing of gait.

The required coefficient of friction (RCOF) is frequently reported in the literature as an indicator of slip propensity, a consequence of the collisional aspect of legged locomotion. Little is known about the RCOF in pathological gait. Therefore, this study aimed to quantify the RCOF in subjects with Parkinson's disease (PD) and freezing of gait (FOG) during the OFF-pharma phase, and to investigate the interplay between RCOF parameters and ankle kinematic and kinetic gait variables. Fourteen subjects with P...

Relative phase measures of intersegmental coordination describe motor control impairments in children with cerebral palsy who exhibit stiff-knee gait.

The purpose of this retrospective study was to explore lower limb intersegmental coordination as a clinically important indicator of motor control mechanisms in individuals with cerebral palsy exhibiting stiff-knee gait. We used the relative phase of thigh and foot segments around foot-off to describe motor control, given the relevance of the pre-swing phase of gait to the existence of stiff-knee gait.


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