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

Gemcitabine plus sirolimus for relapsed and progressing osteosarcoma patients after standard chemotherapy: a multicenter, single-arm phase II trial of Spanish Group for Research on Sarcoma (GEIS).

Patients with relapsed unresectable osteosarcoma represents an unmet need, so active and safe systemic treatments are required. FAS and mTOR pathways are implicated in progressing osteosarcoma, and we had preclinical and clinical experience with a scheme that targets both pathways. Therefore, we designed a phase II trial with gemcitabine plus rapamycin, to determine the efficacy and safety, in this subset of patients.

Functional brain connectivity in resting-state fMRI using phase and magnitude data.

The output of BOLD fMRI consists of a pair of magnitude and phase components. While the magnitude data has been widely accepted for brain function analysis, we can also make use of the phase data (unwrapped) since this is a good representation of the internal magnetic field. In this work, we discuss the use of fMRI phase data for brain function analysis.

Phase-error estimation and image reconstruction from digital-holography data using a Bayesian framework.

The estimation of phase errors from digital-holography data is critical for applications such as imaging or wavefront sensing. Conventional techniques require multiple i.i.d. data and perform poorly in the presence of high noise or large phase errors. In this paper, we propose a method to estimate isoplanatic phase errors from a single data realization. We develop a model-based iterative reconstruction algorithm that computes the maximum a posteriori estimate of the phase and the speckle-free object reflect...

Circadian Phase and Phase Angle Disorders in Primary Insomnia.

We aimed to identify the prevalence of circadian phase and phase angle abnormalities in patients with insomnia.

Reduction of intracerebral hemorrhage in hemodialysis patients after reducing aspirin use: A quality-assurance observational study.

There is so far no international consensus concerning the prescription of antithrombotic agents in hemodialysis patients. It is not clear yet why they cause more bleeding in some patients and are beneficial in others. We therefore tried to find out what triggers bleeding in this population. This is an observational before-and-after study that included all patients undergoing hemodialysis in our center between 2005 and 2015. We divided the study into two phases: phase one (125 patients) where aspirin was use...

A randomized, double blind, placebo controlled phase 2 study of maintenance therapy with tasquinimod in patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy.

This phase II study was conducted to assess clinical efficacy of tasquinimod maintenance therapy in patients with metastatic castrate-resistant prostate cancer not progressing during first-line docetaxel-based therapy.

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...

Efficacy and Safety Outcomes in Patients With Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab Because of Adverse Events: A Pooled Analysis of Randomized Phase II and III Trials.

Purpose Approximately 40% of patients with advanced melanoma who received nivolumab combined with ipilimumab in clinical trials discontinued treatment because of adverse events (AEs). We conducted a retrospective analysis to assess the efficacy and safety of nivolumab plus ipilimumab in patients who discontinued treatment because of AEs. Methods Data were pooled from phase II and III trials of patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for four doses, followed by nivoluma...

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).

Informed Consent and Decision Making Among Participants in Novel-Design Phase I Oncology Trials.

Although phase I clinical trials are the gateway to progress in cancer therapies, this setting poses ethical challenges to ensure that patients provide consent free from misunderstandings of therapeutic intent or unrealistic expectations of benefit. The design of phase I oncology trials has evolved rapidly over time and today includes more targeted agents and combinations of experimental drugs with standard drugs, which may further complicate how patients understand phase I research participation.

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...

First-in-man phase I study assessing the safety and pharmacokinetics of a 1-hour intravenous infusion of the doxorubicin prodrug DTS-201 every 3 weeks in patients with advanced or metastatic solid tumours.

DTS-201 is a doxorubicin (Dox) prodrug that shows encouraging data in experimental models in terms of both efficacy and safety compared with conventional Dox. The purpose of this phase I study was to assess the safety profile, to establish the recommended dose (RD) for clinical phase II studies and to assess potential anticancer activity of the compound.

A Phase 1 study of ARQ 087, an oral pan-FGFR inhibitor in patients with advanced solid tumours.

ARQ 087 is an orally administered pan-FGFR inhibitor with multi-kinase activity. This Phase 1 study evaluated safety, pharmacokinetics, and pharmacodynamics of ARQ 087 and defined the recommended Phase 2 dose (RP2D).

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.

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 ...

Comparison of Renal Outcome among Japanese Patients with or without Microangiopathic Hemolysis in Malignant Phase Hypertension: A Single-Center Retrospective Study.

Although microangiopathic hemolysis (MAH) is a well-known complication of malignant phase hypertension (MPH), only less data on whether MAH in MPH predicts renal outcome exist. Therefore, we evaluated whether MAH was associated with the renal outcome in patients with MPH.

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...

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.

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