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02:15 EST 25th November 2017 | BioPortfolio

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

Development toward high-resolution X-ray phase imaging.

Since the 1990s, the use of X-ray phase contrast has been extensively studied for imaging weakly absorbing objects consisting of low-Z elements such as biological soft tissues and polymers. The development of X-ray microscopy was also progressing during this time, although absorption contrast was only available. It was straightforward and important to develop phase-contrast X-ray microscopy. One characteristic in the development is that quantitative phase measurement is possible through the acquisition of p...

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.

Using the dual-criteria methods to supplement visual inspection: An analysis of nonsimulated data.

The purpose of our study was to examine the probability of observing false positives in nonsimulated data using the dual-criteria methods. We extracted data from published studies to produce a series of 16,927 datasets and then assessed the proportion of false positives for various phase lengths. Our results indicate that collecting at least three data points in the first phase (Phase A) and at least five data points in the second phase (Phase B) is generally sufficient to produce acceptable levels of false...

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...

Treatment sequence with either irinotecan/cetuximab followed by FOLFOX-4 or the reverse strategy in metastatic colorectal cancer patients progressing after first-line FOLFIRI/bevacizumab: An Italian Group for the Study of Gastrointestinal Cancer phase III, randomised trial comparing two sequences of therapy in colorectal metastatic patients.

The optimal treatment strategy for RAS wild type (WT) mCRC is controversial. Our phase III study investigated the effect of introducing earlier (second-line) or later (third-line) cetuximab in patients progressed after FOLFIRI/bevacizumab first-line.

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.

A phase II trial of arsenic trioxide and temozolomide in combination with radiation therapy for patients with malignant gliomas.

Standard treatment for GBM is radiation (RT) and temozolomide (TMZ). Arsenic trioxide (ATO) is synergistic with RT based on several mechanisms of action previously identified, however not tested herein. The MTD of ATO, RT and TMZ was determined in a Phase I trial. We now present the combined Phase I/II data. Patients with newly diagnosed malignant gliomas were eligible for treatment. Patients were treated with RT (60 GY), TMZ (75 mg/m(2) daily × 42 days) and ATO 0.20 mg/kg daily in week 1 then twice ...

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...

Z-score of Mitral Annular Plane Systolic Excursion is a Useful Indicator of Evaluation of Left Ventricular Function in Patients with Acute-Phase Kawasaki Disease.

We previously reported the clinical usefulness of the mitral annular plane systolic excursion (MAPSE) to evaluate the left ventricular (LV) function in patients with Kawasaki disease (KD) in the acute-phase. However, the feasibility of the MAPSE z-score has not been evaluated in patients with acute KD. We prospectively studied 60 KD patients without coronary aneurysms. The MAPSE z-scores were calculated using our standard MAPSE data. Brain natriuretic peptide (BNP) was measured as a parameter of LV function...

Using Delayed Toxicities to Re-evaluate Tolerability in Phase 2 Trials: A Case Example using Bortezomib.

In advanced stage patients enrolled in dose-finding trials, it is difficult to assess delayed toxicities because frequently patients discontinue after one or two cycles of treatment. Patients enrolled in phase 2 trials are typically followed longer to assess efficacy. Thus, their data may be useful for evaluating long-term tolerability. We illustrate this using as example two phase 2 bortezomib trials (total N = 172) conducted by SWOG. While treatment-related severe toxicity rates based on cycle 1 were acce...

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.

The coefficient of friction in Parkinson's disease gait.

This study aimed to characterize the coefficient of friction (COF) curves of patients with Parkinson's disease (PD) during barefoot gait and to evaluate the relationships between this variable and functional scales. Twenty-two subjects with PD (ON phase of levodopa) and 22 healthy subjects participated in this study. The participants walked barefoot along a pathway that went over two force plates embedded in the floor of the data collection room. The instantaneous COF was calculated as the ratio between the...

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...

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.

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...

Review of phase I and II trials for Wilms' tumour - Can we optimise the search for novel agents?

Survival rates for patients with Wilms' tumour (WT) approximate 90% with refined use of currently available interventions. However, a subgroup of patients, with initial high-risk histopathology or relapsing disease, have a poor prognosis, and it is a challenge to identify and prioritise the development of new innovative approaches for these subgroups. We conducted a systematic literature search for published phase I and II clinical trials that registered patients with WTs and characterised the early phase ...

A comparison of steroid profiles in the testis and seminal vesicle of the catfish (Heteropneustes fossilis).

In the present study, distribution of steroid hormones (estradiol-17β (E2), testosterone (T), corticosteroids and progestins) in the testis and seminal vesicles (SV) of the catfish Heteropneustes fossilis were investigated in two seasons (pre-spawning and spawning phases) of the reproductive cycle. The data showed that the levels of the steroid hormones varied significantly in both reproductive phases and exhibited organ-related differences. Sex steroid levels were highest in the pre-spawning phase and low...

Prospective validation of a prognostic score for patients in immunotherapy phase I trials: The Gustave Roussy Immune Score (GRIm-Score).

Life expectancy evaluation is crucial when selecting patients who may benefit from phase I studies. The Royal Marsden Hospital (RMH) prognostic score, based on three objective variables (number of metastatic sites, lactate dehydrogenase (LDH) and serum albumin) was validated in patients treated with cytotoxics and targeted therapies. We aimed to determine if those factors were applicable to immune-checkpoint therapies (ICTs) in phase I trials and to evaluate new variables that may preclude a better prognosi...

Characteristics of Participants Enrolled onto a Randomized Controlled Trial of Palliative Care for Patients on Phase I Studies.

Advanced cancer patients participating in phase 1 clinical trials experience considerable symptom burden. Palliative care (PC) may benefit these individuals by providing supportive care during clinical research participation. This study investigates integration of a PC intervention among phase 1 trial participants with advanced cancer.

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