PubMed Journals Articles About "Ganaxolone Phase Data Supports Progressing Phase Patients With" - Page: 2 RSS

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Showing "Ganaxolone Phase Data Supports Progressing Phase Patients with" PubMed Articles 26–50 of 58,000+

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...

Phase of Illness in palliative care: Cross-sectional analysis of clinical data from community, hospital and hospice patients.

Phase of Illness describes stages of advanced illness according to care needs of the individual, family and suitability of care plan. There is limited evidence on its association with other measures of symptoms, and health-related needs, in palliative care.

Inability of positive phase II clinical trials of investigational treatments to subsequently predict positive phase III clinical trials in glioblastoma.

Glioblastoma is the most common primary malignant brain tumor in adults, but effective therapies are lacking. With the scarcity of positive phase III trials, which are increasing in cost, we examined the ability of positive phase II trials to predict statistically significant improvement in clinical outcomes of phase III trials.

Phase II study of cabozantinib in patients with progressive glioblastoma: subset analysis of patients naive to antiangiogenic therapy.

Cabozantinib is a tyrosine kinase inhibitor with activity against VEGFR2 and MET that has demonstrated clinical activity in advanced solid tumors. This open-label, phase II trial evaluated cabozantinib in patients with recurrent or refractory glioblastoma (GBM; NCT00704288).

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...

In situ Observation of Phase Transformation in MnAl(C) Magnetic Materials.

The phase transformation in two modes, including both displacive and massive growth of τ-phase from ε-MnAl(C), was observed by in situ transmission electron microscopy. The exact temperature range for different phase transformation modes was determined by magnetic measurements. The displacive growth of ε→τ in Mn54Al46 (or Mn54Al46C2.44) occurs at temperatures below 650 K (or 766 K), above which both modes coexist. One-third or less of the ε-phase can be transformed into τ-phase via displacive mode w...

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...

HPLC thermodynamic study of new potential antiepileptic compounds on cholesterol column using isocratic elution with methanol/water and acetonitrile/water eluent systems.

Basic thermodynamic functions responsible for retention of new 1,2,4-triazole derivatives exhibiting varied antiepileptic activity on cholesterol-based stationary phase were determined. Evaluation of the Gibbs energy change, the change in enthalpy and the change in entropy was based on the van 't Hoff relationship representing ln k vs. 1/T. A detailed discussion of the van 't Hoff equation, exploring the influence of the phase ratio on deviations from linearity in a Van 't Hoff plot is presented. We show ch...

Optimized random phase only holograms.

We propose a simple and efficient technique capable of generating Fourier phase only holograms with a reconstruction quality similar to the results obtained with the Gerchberg-Saxton (G-S) algorithm. Our proposal is to use the traditional G-S algorithm to optimize a random phase pattern for the resolution, pixel size, and target size of the general optical system without any specific amplitude data. This produces an optimized random phase (ORAP), which is used for fast generation of phase only holograms of ...

The Preclinical Discovery and Development Of Brivaracetam For The Treatment Of Focal Epilepsy.

Brivaracetam (BRV) is a new AED currently licensed for the adjunctive treatment of adult patients with focal epilepsies. It is a ligand of the ubiquitous synaptic vesicle glycoprotein 2A (SV2A). Areas covered: This paper covers the preclinical and subsequent clinical development of BRV focusing on the discovery of the SV2A protein as the main target for levetiracetam (LEV) and the main similarities and differences between LEV and BRV in terms of pharmacodynamic and pharmacokinetic properties. Phase II and P...

Autofocusing-based phase correction.

Phase artifacts due to B0 inhomogeneity can severely degrade the quality of MR images. The artifacts are particularly prominent in long-TE scans and usually appear as ghosting and blur. We propose a retrospective phase correction method based on autofocusing. The proposed method uses raw data acquired with standard imaging sequences, and does not rely on navigators or external measures of field inhomogeneity.

Bayesian sample size determination for a Phase III clinical trial with diluted treatment effect.

When Phase III treatment effect is diluted from what was observed from Phase II results, we propose to determine the Bayesian sample size for a Phase III clinical trial based on the normal, uniform, and truncated normal prior distributions of the treatment effects on an interval, which starts from an acceptable treatment effect to the observed treatment effect from Phase II. After incorporating the prior information of the treatment effects, the Bayesian sample size is the number of patients of the Phase II...

Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial.

A relationship between reduced brain tissue oxygenation and poor outcome following severe traumatic brain injury has been reported in observational studies. We designed a Phase II trial to assess whether a neurocritical care management protocol could improve brain tissue oxygenation levels in patients with severe traumatic brain injury and the feasibility of a Phase III efficacy study.

Ruxolitinib-associated infections: a systematic review and meta-analysis.

Ruxolitinib exerts immunosuppressive activity that may increase the risk of infectious complications. We performed a systematic review of the literature with the aim of estimating the risk of infections in patients treated with ruxolitinib. Studies were identified by electronic search of MEDLINE and EMBASE database. Differences in the incidence of infectious events between ruxolitinib and comparison groups were expressed as odds ratios (ORs) and 95% confidence intervals (95% CI). Five phase III randomized c...

An acute phase reaction with intravenous bisphosphonate use in a patient with recently diagnosed Graves' disease.

Given the immune background, we hypothesize that active Grave's hyperthyroidism is a risk factor for an acute phase reaction associated with the use of bisphosphonates. We recommend that in patients with Graves' thyrotoxicosis and hypercalcemia, consider the risk of an acute phase reaction if planning to give bisphosphonate therapy.

Phase 1 dose escalation multicenter trial of pracinostat alone and in combination with azacitidine in patients with advanced hematologic malignancies.

Pracinostat is a potent histone deacetylase inhibitor with antitumor activity in both solid tumor and acute myeloid leukemia (AML) cell lines. Pracinostat is reported to have modest clinical activity in patients with advanced solid tumors. Given the higher preclinical sensitivity of hematologic malignancies to pracinostat, the authors conducted a phase 1 study to assess the safety, maximum tolerated dose, recommended phase 2 dose, efficacy, pharmacokinetics, and pharmacodynamics of pracinostat in patients w...

A Phase 2 Randomized Controlled Study of Tralokinumab in Subjects with Idiopathic Pulmonary Fibrosis.

Interleukin (IL)-13 is a potential therapeutic target for idiopathic pulmonary fibrosis (IPF); preclinical data suggest a role in tissue fibrosis, and expression is increased in subjects with rapidly progressing disease.

Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial.

Telotristat ethyl, a tryptophan hydroxylase inhibitor, was efficacious and well tolerated in the Phase 3 TELESTAR study in patients with carcinoid syndrome (CS) experiencing ≥4 bowel movements per day (BMs/day) while on somatostatin analogs (SSAs). TELECAST, a Phase 3 companion study, assessed safety and efficacy of telotristat ethyl in patients with CS (diarrhea, flushing, abdominal pain, nausea, or elevated urinary 5-hydroxyindoleacetic acid [u5-HIAA]) with

Infection-free Clinical Response Among Patients With Hidradenitis Suppurativa Who Were Treated With Adalimumab: Results from Two Phase 3 Studies.

The objective of this study is to assess the rates of infection-free achievement of hidradenitis suppurativa clinical response (HiSCR) using integrated data from 2 phase 3, placebo-controlled trials, PIONEER I and II.

Alirocumab for the treatment of hyperlipidemia in high-risk patients: an updated review.

Alirocumab is a fully human immunoglobulin G1 monoclonal antibody directed against proprotein convertase subtilisin/kexin type 9 (PCSK9) approved for the treatment of hypercholesterolemia in high-risk patients. The objective is to provide an updated review of the recent data published for alirocumab. Areas covered: The efficacy and safety of alirocumab has been initially evaluated in a comprehensive phase 3 program conducted in more than 6 000 patients with primary non-familial and heterozygous familial hyp...

The eigenvalue problem in phase space.

We formulate the standard quantum mechanical eigenvalue problem in quantum phase space. The equation obtained involves the c-function that corresponds to the quantum operator. We use the Wigner distribution for the phase space function. We argue that the phase space eigenvalue equation obtained has, in addition to the proper solutions, improper solutions. That is, solutions for which no wave function exists which could generate the distribution. We discuss the conditions for ascertaining whether a position ...

Phase conjugate digital inline holography (PCDIH).

Digital inline holography (DIH) provides instantaneous three-dimensional (3D) measurements of diffracting objects; however, phase disturbances in the beam path can distort the imaging. In this Letter, a phase conjugate digital inline holography (PCDIH) configuration is proposed for removal of phase disturbances. Brillouin-enhanced four-wave mixing produces a phase conjugate signal that back propagates along the DIH beam path. The results demonstrate the removal of distortions caused by gas-phase shocks to r...

Computer-generated hologram using binary phase with an aperture.

Computer-generated holograms (CGHs) have attracted more and more attention in some application fields, such as 3D displays, optical security, and beam shaping. In this paper, a strategy is presented for optical information verification based on CGH using binary phase (1 bit) with an aperture. The input is encoded into the cascaded phase-only masks based on CGH via iterative phase retrieval, and one extracted phase mask is binarized in which one part is selected according to an aperture and further embedded...

Benefits and Sustainability of a Learning Collaborative for Implementation of Treat to Target in Rheumatoid Arthritis: Results of the TRACTION Trial Phase II.

We conducted a two-phase randomized controlled trial of a Learning Collaborative (LC) to facilitate implementation of treat to target (TTT) to manage rheumatoid arthritis (RA). We found substantial improvement in implementation of TTT in Phase I. Herein, we report on a second 9 months (Phase II) where we examined maintenance of response in Phase I and predictors of greater improvement in TTT adherence.

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