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04:29 EST 17th December 2018 | BioPortfolio

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Showing "Ganaxolone Phase Data Supports Progressing Phase Patients With" PubMed Articles 1–25 of 59,000+

Imatinib and Everolimus in Patients With Progressing Advanced Chordoma: A Phase 2 Clinical Study.

We present the results of an academic phase 2 study on imatinib plus everolimus in patients who have progressive advanced chordoma.

The need for information among patients with hematological malignancies: Psychometric analyses of the 62-item Hematology Information Needs Questionnaire (HINQ-62).

The purpose of this study was to investigate the psychometric characteristics (content validity, internal consistency, and subscale structure) of the Hematology Information Needs Questionnaire-62 (HINQ-62), a patient reported outcome measure (PROM) for assessing the need for information among patients with hematological malignancies (HM-patients). Baseline data were used from a prospective study on the need for information which 336 newly diagnosed HM-patients had completed. In phase 1 (design phase), data ...

Formation of lead ferrites for immobilizing hazardous lead into iron-rich ceramic matrix.

A strategy of immobilizing lead in the framework of ferrite-ceramic matrix, to reduce its environmental hazard was explored in this study. The mechanisms of incorporating lead into lead ferrites (δ-phase (2PbO·FeO), γ-phase (PbO·(2-2.5)FeO) and β-phase (PbO·(5-6)FeO)) was revealed by observing the phase transformation in the products. The δ-phase was dominantly formed at low temperature of 700-800 °C at Pb/Fe of 1/1-1/3. The significant growth of γ-phase was observed at 750-850 °C and Pb/Fe of...

A Hybrid Phase I-II/III Clinical Trial Design Allowing Dose Re-Optimization in Phase III.

Conventionally, evaluation of a new drug, A, is done in three phases. Phase I is based on toxicity to determine a \maximum tolerable dose" (MTD) of A, phase II is conducted to decide whether A at the MTD is promising in terms of response probability, and if so a large randomized phase III trial is conducted to compare A to a control treatment, C; usually based on survival time or progression free survival time. It is widely recognized that this paradigm has many flaws. A recent approach combines the first t...

Investigational small molecules in phase II clinical trials for the treatment of epilepsy: cannabidivarin, selurampanel (BGG492) and ganaxolone.

Epilepsy is a neurological disorder that significantly impacts the quality of life of the affected person and affects approximately 70 million people globally. Despite advances in research, nearly a third of patients have refractory or pharmacoresistant epilepsy. Even though numerous antiepileptic drugs (AEDs) have been approved over the past decade, there are no agents that halt the development of epilepsy. Thus, new and improved AEDs to prevent refractory seizures and modify the disease are necessary. Are...

A comparison between phase-III trials and a phase-IV study of nalmefene in alcohol use disorder patients. Is there a difference?

Concerns regarding the external validity of phase-III trials are common to many medical disciplines, with relevant discrepancies found between experimental and clinical samples in some diseases such as hypertension. The aim of this study was to compare the samples included in the pivotal, phase-III clinical trials of nalmefene with that of a recently conducted phase-IV trial. Baseline characteristics of the studies were compared through univariate analysis. Significant differences were found in the percenta...

Survival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1: Expanded analysis of a global phase 3 trial.

In the phase 3 randomised NAPOLI-1 clinical study, a 45% increase in median overall survival (OS) was shown with liposomal irinotecan, 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) versus 5-FU/LV in patients with metastatic pancreatic cancer progressing after gemcitabine-based therapy. Here, we report data from a pre-specified, expanded analysis of outcomes in the per-protocol (PP) population.

Efficacy and Safety of Sunitinib in Patients With Well-Differentiated Pancreatic Neuroendocrine Tumours.

Background: In a phase III study, sunitinib led to a significant increase in progression- free survival (PFS) vs. placebo in patients with pancreatic neuroendocrine tumours (panNETs). This study was a post-marketing commitment to support the phase III data. Methods: In this ongoing, open-label, phase IV trial (NCT01525550), patients with progressive, advanced unresectable/metastatic, well-differentiated panNETs received continuous sunitinib 37.5 mg once daily. Eligibility criteria were similar to the phase ...

MetScore: Site of Metabolism Prediction Beyond CYP P450 Enzymes.

The metabolism of xenobiotics by humans and other organisms is a complex process involving numerous enzymes that catalyze phase I (functionalization) and phase II (conjugation) reactions. We here introduce MetScore, a machine learning model that can predict both phase I and phase II reaction sites of drugs. We developed cheminformatics workflows to filter and process reactions to obtain suitable phase I and phase II data sets for model training. Employing a recently developed molecular representation based ...

Pharmacokinetics and C-Reactive Protein Modelling of Anti-IL-6 Antibody (PF-04236921) in Healthy Volunteers and Patients with Autoimmune Disease.

The purpose of this study was to characterize pharmacokinetics (PK) of PF-04236921, a novel anti-IL-6 monoclonal antibody, and its pharmacokinetics/pharmacodynamics (PK/PD) relationship on serum C-Reactive Protein (CRP) in healthy volunteers and patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Crohn's disease (CD) METHODS: Population modelling analyses were conducted using nonlinear mixed effects modelling. Data from 2 phase 1 healthy volunteer studies, a phase 1 RA study, a ...

Long-Term Survival of Patients With Melanoma With Active Brain Metastases Treated With Pembrolizumab on a Phase II Trial.

Pembrolizumab is active in melanoma, but activity in patients with untreated brain metastasis is less established. We present long-term follow-up of pembrolizumab-treated patients with new or progressing brain metastases treated on a phase II clinical trial ( identifier: NCT02085070).

Noninvasive intracranial pressure assessment using otoacoustic emissions: An application in glaucoma.

The theory that glaucoma patients have a lower intracranial pressure (ICP) than healthy subjects is a controversial one. The aim of this study was to assess ICP noninvasively by determining the relationship between distortion product otoacoustic emission (DPOAE) phase and body position and to compare this relationship between patients with primary open angle glaucoma (POAG), patients with normal tension glaucoma (NTG), and controls. The relationship was also calibrated using published data regarding invasiv...

Transient activation of AMP-activated protein kinase at G1/S phase transition is required for control of S phase in NIH3T3 cells.

AMP-activated protein kinase (AMPK) functions as a cellular energy sensor by monitoring the cellular AMP:ATP ratio and plays a central role in cellular and whole-body energy homeostasis. Recent studies have suggested that AMPK also contribute to cell cycle regulation, but its role in this field remains almost elusive. In the present study, we report that AMPKα1 was transiently activated during G/S transition phase in NIH3T3 cells in the absence of any metabolic stress. Inhibition of AMPK activity at G/S tr...

Fast and accurate wavefront reconstruction in two-frame phase-shifting interferometry with unknown phase step.

A fast and accurate wavefront reconstruction method for two-frame phase-shifting interferometry is proposed. The unknown phase step between the two interferograms is estimated directly by solving a quartic polynomial equation, and then the phase map is readily reconstructed after obtaining the phase step. The whole phase reconstruction process is nearly analytical and thus very fast and easy to realize. Good performance of the proposed method is demonstrated by reconstructing the phase maps from simulated a...

Structure and Metallicity of Phase V of Hydrogen.

A new phase V of hydrogen was recently claimed in experiments above 325 GPa and 300 K. Because of the extremely small sample size at such record pressures the measurements were limited to Raman spectroscopy. The experimental data on increase of pressure show decreasing Raman activity and darkening of the sample, which suggests band gap closure and impending molecular dissociation, but no definite conclusions could be reached. Furthermore, the available data are insufficient to determine the structure of p...

Phase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer.

nab-Paclitaxel has demonstrated efficacy in adults with solid tumours and preclinical activity in paediatric solid tumour models. Results from phase I of a phase I/II study in paediatric patients with recurrent/refractory solid tumours treated with nab-paclitaxel are reported.

Quantitative differential phase contrast imaging at high resolution with radially asymmetric illumination.

Half-circle illumination-based differential phase contrast (DPC) microscopy has been utilized to recover phase images through a pair of images along multiple axes. Recently, the half-circle based DPC using 12-axis measurements significantly provides a circularly symmetric phase transfer function to improve accuracy for more stable phase recovery. Instead of using half-circle-based DPC, we propose a new scheme of DPC under radially asymmetric illumination to achieve circularly symmetric phase transfer functi...

Bose-Einstein Condensation of Magnons and Spin Superfluidity in the Polar Phase of ^{3}He.

The polar phase of ^{3}He, which is topological spin-triplet superfluid with the Dirac nodal line in the spectrum of Bogoliubov quasiparticles, has been recently stabilized in a nanoconfined geometry. We pump magnetic excitations (magnons) into the sample of polar phase and observe how they form a Bose-Einstein condensate, revealed by coherent precession of the magnetization of the sample. Spin superfluidity, which supports this coherence, is associated with the spontaneous breaking of U(1) symmetry by the ...

Simple-structured, subfemtosecond-resolution optical-microwave phase detector.

We demonstrate a simple all-fiber photonic phase detector that can measure the phase (timing) difference between an optical pulse train and a microwave signal with subfemtosecond resolution and -60  dB-level amplitude-to-phase conversion coefficient. It is based on passive phase biasing of a Sagnac loop by the intrinsic phase shift of a symmetric 3×3 fiber coupler. By eliminating the necessity of magneto-optic components or complex radio frequency (RF) electronics for phase biasing of the Sagnac loop, ...

Improved phase-attenuation duality method with space-frequency joint domain iterative regularization.

A common problem of in-line phase contrast imaging systems based on laboratory source and detector is the negative effects of finite source size, limited spatial resolution, and system noise. These negative effects swamp the fine phase contrast fringes and impede the precise retrieval of phase maps. This study aims to develop a novel phase retrieval method to restore phase information that is lost due to an imperfect system.

Endoscopic diffraction phase microscopy.

In this Letter, we present, to our knowledge, the first endoscopic diffraction phase microscopy (eDPM) system. This instrument consists of a gradient-index-lens-based endoscope probe followed by a DPM module, which enables single-shot phase imaging at a single-cell-level resolution. Using the phase information provided by eDPM, we show that the geometric aberrations associated with the endoscope can be reduced by digitally applying a spectral phase filter to the raw data. The filter function is a linear com...

PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma.

Background No systemic therapies have been approved for the treatment of advanced cutaneous squamous-cell carcinoma. This cancer may be responsive to immune therapy, because the mutation burden of the tumor is high and the disease risk is strongly associated with immunosuppression. In the dose-escalation portion of the phase 1 study of cemiplimab, a deep and durable response was observed in a patient with metastatic cutaneous squamous-cell carcinoma. Methods We report the results of the phase 1 study of cem...

Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial.

This phase III, double-blind, randomised, placebo-controlled trial (and extension phase) was designed to assess the efficacy and safety of velmanase alfa (VA) in alpha-mannosidosis (AM) patients.

Changes in metabolic parameters and body weight in brexpiprazole-treated patients with acute schizophrenia: pooled analyses of phase 3 clinical studies.

To analyze the effect of brexpiprazole on metabolic parameters and body weight in adults with schizophrenia, including clinically relevant subgroups of patients, based on data from two pivotal phase 3 studies (NCT01393613; NCT01396421) and a long-term extension study (NCT01397786).

Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study.

Angiogenesis is critical to colorectal cancer (CRC) growth and metastasis. Phase I/II studies have demonstrated the efficacy of nintedanib, a triple angiokinase inhibitor, in patients with metastatic CRC. This global, randomized, phase III study investigated the efficacy and safety of nintedanib in patients with refractory CRC after failure of standard therapies.

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