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Showing "Ganaxolone Phase Data Supports Progressing Phase Patients with" PubMed Articles 1–25 of 58,000+

Cyclic Continuous Max-Flow: A Third Paradigm in Generating Local Phase Shift Maps in MRI.

Sensitivity to phase deviations in MRI forms the basis of a variety of techniques, including magnetic susceptibility weighted imaging and chemical shift imaging. Current phase processing techniques fall into two families: those which process the complex image data with magnitude and phase coupled, and phase unwrapping-based techniques that first linearize the phase topology across the image. However, issues, such as low signal and the existence of phase poles, can lead both methods to experience error. Cycl...

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 ...

Isocapnic buffering phase: a useful indicator of exercise endurance and prognosis in patients with coronary artery disease.

The significance of the isocapnic buffering (IB) phase - the period between the first ventilatory threshold (1stVT) and respiratory compensation point (RCP) - has not been adequately established in patients. This study aimed to determine the clinical significance of the IB phase in coronary artery disease (CAD) patients.

CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from two Phase II trials.

Central nervous system (CNS) metastases are common in patients with non-small-cell lung cancer (NSCLC). Osimertinib has shown systemic efficacy in patients with CNS metastases and early clinical evidence shows efficacy in the CNS. To evaluate osimertinib activity further, we present a pre-specified subgroup analysis of CNS response using pooled data from two Phase II studies: AURA extension (NCT01802632) and AURA2 (NCT02094261).

Advanced bladder cancer : From chemo- to immunotherapy.

In November 2016, the results of a phase III clinical trial with the protein cell death (PD)-1 inhibitor pembrolizumab for second-line treatment of metastatic urothelial carcinoma were published and showed an overall survival benefit in comparison with conventional chemotherapy with vinflunine, docetaxel, or paclitaxel. In a similar trial the PD-L1 antibody atezolizumab showed no significant benefit in comparison to chemotherapy in the subgroup of PD-L1-positive patients and, thus, missed its primary end...

Effects of Dietary and Lighting Conditions on Diurnal Locomotor Activity and Body Temperature in Microminipigs.

The effects of dietary and lighting conditions on diurnal rhythm of locomotor activity (LA) and body temperature (BT) using four adult male microminipigs were investigated. Different feeding times, diet and lighting conditions were applied sequentially for 3 weeks in each phase as follows: Phase I: Morning mealtime, normal diet, 12-h lights on; phase II: mealtime changed to afternoon; phase III: diet changed to high-fat diet; phase IV: lighting changed to 20-h on; and phase V: phase I repeated. LA was measu...

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...

Model-Based Meta-Analysis for Multiple Myeloma: A Quantitative Drug-Independent Framework for Efficient Decisions in Oncology Drug Development.

The failure rate for phase III trials in oncology is high; quantitative predictive approaches are needed. We developed a model-based meta-analysis (MBMA) framework to predict progression-free survival (PFS) from overall response rates (ORR) in relapsed/refractory multiple myeloma (RRMM), using data from seven phase III trials. A Bayesian analysis was used to predict the probability of technical success (PTS) for achieving desired phase III PFS targets based on phase II ORR data. The model demonstrated a str...

Development and Implementation of a Standardized Heparin Protocol for Left-Sided Pediatric Electrophysiology Procedures.

Heparin is used to decrease the risk of thromboembolic complications during electrophysiology studies (EPS); however, there is wide practice variation and minimal evidence to guide heparin dosing, particularly in pediatric patients. This study retrospectively analyzed heparin dosing and response, measured via activated clotting time (ACT), in patients undergoing EPS and used these data (pre-protocol cohort, n = 40), as well as guidance from available literature to implement a standardized heparin protoc...

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials.

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...

Disability progression in multiple sclerosis: a Tunisian prospective cohort study.

Data regarding multiple sclerosis (MS) course in North Africans are scarce and mainly retrospective. To prospectively assess disability progression of multiple sclerosis in Tunisia. Analysis was performed in 600 patients from the MS database of the Mongi Ben Hmida National Institute of Neurology (Tunis, Tunisia), prospectively recorded over a 10-year period. Two MS phases were defined: phase 1, from MS clinical onset to Disability Status Scale (DSS) 3; and phase 2, from DSS 3 to DSS 6. Median durations of b...

Quantitative comparison of incisal tooth wear in patients receiving one-phase or two-phase treatment for skeletal Class III malocclusion with anterior crossbite.

The present study aimed to compare the amount of incisal tooth wear in the maxillary central incisors of patients with skeletal Class III malocclusion and anterior crossbite receiving one-phase or two-phase treatment. The hypothesis was that tooth wear would differ according to treatment modalities.

Chloride imbalance between serum and CSF in the acute phase of neuromyelitis optica.

We collected serum-cerebrospinal fluid (CSF)-paired samples during the acute phase of clinical episodes in MS and NMO patients, together with paired samples from non-MS/NMO patients, to compare the quotients of proteins and electrolytes among them. In NMO, the quotient of chloride was significantly higher in the acute phase of optic neuritis and brain lesions, but it was significantly lower in the acute phase of myelitis. Such findings were not observed in MS or in non-MS/NMO cases. With the coexistence of ...

Hypotension Risk Based on Vasoactive Agent Discontinuation Order in Patients in the Recovery Phase of Septic Shock.

Patients with septic shock often require vasoactive agents for hemodynamic support; however, the optimal approach to discontinuing these agents once patients reach the recovery phase is currently unknown. The objective of this evaluation was to compare the incidence of hypotension within 24 hours based on the discontinuation order of norepinephrine (NE) and vasopressin (AVP) in patients in the recovery phase of septic shock.

Coupled Interfacial Tension and Phase Behavior Model Based on Micellar Curvatures.

This paper introduces a consistent and robust model that predicts interfacial tensions for all microemulsion Winsor types and overall compositions. The model incorporates film bending arguments and Huh's equation, and is coupled to phase behavior so that simultaneous tuning of both interfacial tension (IFT) and phase behavior is possible. The oil-water interfacial tension and characteristic length are shown to be related to each other through the hydrophilic-lipophilic deviation (). The phase behavior is ti...

A functional pipeline framework for landmark identification on 3D surface extracted from volumetric data.

Landmarks, also known as feature points, are one of the important geometry primitives that describe the predominant characteristics of a surface. In this study we proposed a self-contained framework to generate landmarks on surfaces extracted from volumetric data. The framework is designed to be a three-fold pipeline structure. The pipeline comprises three phases which are surface construction, crest line extraction and landmark identification. With input as a volumetric data and output as landmarks, the pi...

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...

Tivantinib for second-line treatment of MET-high, advanced hepatocellular carcinoma (METIV-HCC): a final analysis of a phase 3, randomised, placebo-controlled study.

Tivantinib (ARQ 197), a selective, oral MET inhibitor, improved overall survival and progression-free survival compared with placebo in a randomised phase 2 study in patients with high MET expression (MET-high) hepatocellular carcinoma previously treated with sorafenib. The aim of this phase 3 study was to confirm the results of the phase 2 trial.

Efficacy and safety of nilotinib 300 mg twice daily in patients with chronic myeloid leukemia in chronic phase who are intolerant to prior tyrosine kinase inhibitors: Results from the Phase IIIb ENESTswift study.

Some patients receiving a tyrosine kinase inhibitor (TKI) for the first-line treatment of chronic phase chronic myeloid leukemia (CML-CP) experience intolerable adverse events. Management strategies include dose adjustments, interrupting or discontinuing therapy, or switching to an alternative TKI.

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.

Assessing the Correlation of Fecal Calprotectin and the Clinical Disease Activity Index in Patients With Ulcerative Colitis.

It has been shown that fecal calprotectin can be used to evaluate mucosal inflammation better than using clinical indices and serum markers. The aim of this study was to assess the use of fecal calprotectin for evaluating the disease activity in 2 groups of patients with ulcerative colitis and a control group. The study population consisted of 30 patients with active-phase ulcerative colitis, 30 remission-phase patients, and 30 healthy control patients. After obtaining informed consent, we took blood and fe...

Tungsten-Assisted Phase Tuning of Molybdenum Carbide for Efficient Electrocatalytic Hydrogen Evolution.

Phase tuning during crystal phase transformation is an important but challenging step toward the development of effective hydrogen evolution reaction (HER) catalysts. Herein, we report on a feasible approach to achieve effective polycrystalline molybdenum carbides during transformation from α-phase to β-phase through the regulation of additive (tungsten) amount. Benefiting from the optimal Mo-C bond lengths and abundant active sites, molybdenum carbide prepared with a moderate addition of tungsten enhance...

A phase 1/2 dose-finding, safety, and activity study of cabazitaxel in pediatric patients with refractory solid tumors including tumors of the central nervous system.

This phase 1/2 study (NCT01751308) evaluated cabazitaxel in pediatric patients. Phase 1 determined the maximum tolerated dose (MTD) in patients with recurrent/refractory solid tumors, including central nervous system (CNS) tumors. Phase 2 evaluated activity in pediatric recurrent high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).

Collecting standardised oral health data via mobile application: A proof of concept study in the Netherlands.

FDI World Dental Federation, founded as Fédération Dentaire Internationale, has taken the initiative to develop the Oral Health Observatory, a mobile application to conduct oral health surveys worldwide. The aim is to collect reliable standardized international data on oral health and oral health care via a network of dentists. A proof of concept study project was set up in the Netherlands to test the methodology and to validate the approach. Data about caries, gingivitis, oral self-care and oral health r...

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