PubMed Journals Articles About "Acceleron Provides Updated Results From Phase Studies Luspatercept" RSS

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Showing "Acceleron Provides Updated Results from Phase Studies Luspatercept" PubMed Articles 1–25 of 59,000+

Updated efficacy analysis including secondary population results for OAK: a randomized phase III study of atezolizumab vs docetaxel in patients with previously treated advanced non-small cell lung cancer.

The efficacy and safety of atezolizumab vs docetaxel as second- or third-line treatment in patients with advanced non-small cell lung cancer in the primary (n=850; ITT850) and secondary (n=1225; ITT1225) efficacy populations of the randomized phase III OAK study at an updated data cutoff were assessed.

Quantitative decision-making in randomized Phase II studies with a time-to-event endpoint.

One of the most critical decision points in clinical development is Go/No-Go decision-making after a proof-of-concept study. Traditional decision-making relies on a formal hypothesis testing with control of type I and type II error rates, which is limited by assessing the strength of efficacy evidence in a small isolated trial. In this article, we propose a quantitative Bayesian/frequentist decision framework for Go/No-Go criteria and sample size evaluation in Phase II randomized studies with a time-to-even...

No Clinical Benefit of Intramuscular Delivery of Bone Marrow-derived Mononuclear Cells in Nonreconstructable Peripheral Arterial Disease: Results of a Phase-III Randomized-controlled Trial.

Prospects for no-option, end-stage peripheral artery disease (PAD) patients remain poor. Although results from open and semiblinded studies fuel hope for cell-based strategies in no-option patients, so far conclusions from the available placebo-controlled studies are not supportive. With the intention to end the remaining controversy with regard to cell therapy for PAD we conducted a confirmatory, double-blinded randomized placebo-controlled phase 3 trial.

The pre-stimulus oscillatory alpha phase affects neural correlates of early visual perception.

A growing number of studies suggest the phase of ongoing alpha oscillations in the brain influences visual perception. However, it remained largely unconsidered if this is associated with a phase dependence of neurophysiological processes especially in the visual cortex. Therefore, this study investigated the link between the pre-stimulus oscillatory alpha phase and neural correlates of early visual perception. In 64 subjects a 64-channel EEG system was used to examine the phase dependence of pattern-revers...

Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: Results through 48 Weeks from Two Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Studies (CIMPASI-1 and CIMPASI-2).

Certolizumab pegol, the only Fc-Free, PEGylated anti-tumor necrosis factor biologic, demonstrated clinically meaningful improvements and suggested a positive risk-benefit balance in phase 2 studies in adults with moderate-to-severe chronic plaque psoriasis.

Association between serum leptin levels and breast cancer risk: An updated systematic review and meta-analysis.

Many studies have indicated that leptin is correlated with breast cancer occurrence and tumor behavior. However, this issue remains controversial. Therefore, we conducted an updated meta-analysis to investigate the role of leptin in breast cancer.

« Doctor, I am fasting during chemotherapy » : illusion or new clinical facts ?

Fasting concomitantly with oncology treatments (chemotherapy mainly) induces a growing interest among patients following overmediatisation of recent discoveries. The goal of this article is to provide updated information about this approach. According to preclinical studies, fasting may be a way to increase the therapeutic index of major oncology treatments. However, clinical data is based on small exploratory studies only and the results of larger scale studies are not yet available. The approach of fastin...

Sirolimus in Liver Transplant Recipients with Hepatocellular Carcinoma: An Updated Meta-Analysis.

Previous studies have indicated that sirolimus (SRL) may be effective for HCC patients undergoing liver transplantation (LT). However, the following results are still contradictory and do not have a clear conclusion. Therefore, we conducted an updated meta-analysis by retrieving published data in EMBASE, PubMed, and the Cochrane Library up to October 2017. Both efficiency and safety of SRL were analyzed using pooled odds ratio (ORs) with 95% confidence interval (CIs). A total of 11 studies involving 7,695 H...

Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: Results Through 48 Weeks of a Phase 3, Multicenter, Randomized, Double-Blinded, Etanercept- and Placebo-Controlled Study (CIMPACT).

Phase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity.

Absolute sensitivity of phase measurement in an SU(1,1) type interferometer.

Absolute sensitivity is measured for the phase measurement in an SU(1,1) type interferometer, and the results are compared to that of a Mach-Zehnder interferometer operated under the condition of the same intra-interferometer intensity. The interferometer is phase locked to a point with the largest quantum noise cancellation, and a simulated phase modulation is added in one arm of the SU(1,1) interferometer. Both the signal and noise level are estimated at the same frequency range, and we obtained 3 dB imp...

Occupational extremely low frequency magnetic fields (ELF-MF) exposure and hematolymphopoietic cancers - Swiss National Cohort analysis and updated meta-analysis.

Previous studies have examined risks of leukaemia and selected lymphoid malignancies in workers exposed to extremely low frequency magnetic fields (ELF-MF). Most studies evaluated hematolymphopoietic malignancies as a combined category, but some analyses suggested that effects may be contained to some specific leukaemia or lymphoma subtypes, with inconsistent results.

On the estimation of the incidence and prevalence in two-phase longitudinal sampling design.

Two-phase sampling design is a common practice in many medical studies. Generally, the first-phase classification is fallible but relatively cheap, while the accurate second phase state-of-the-art medical diagnosis is complex and rather expensive to perform. When constructed efficiently it offers great potential for higher true case detection as well as for higher precision at a limited cost. In this article, we consider epidemiological studies with two-phase sampling design. However, instead of a single tw...

Endothelial nitric oxide synthase gene polymorphisms and risk of erectile dysfunction: An updated meta-analysis of genetic association studies.

Endothelial nitric oxide synthase (eNOS) polymorphisms have been implicated as risk factors for erectile dysfunction (ED), but the results of genetic association studies are inconclusive. We performed a meta-analysis of published studies investigating the association between ED and three eNOS polymorphisms, intron 4 VNTR, G894T and T786C in humans.

Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment?

Human protection policies require favorable risk-benefit judgments prior to launch of clinical trials. For phase I and II trials, evidence for such judgment often stems from preclinical efficacy studies (PCESs). We undertook a systematic investigation of application materials (investigator brochures [IBs]) presented for ethics review for phase I and II trials to assess the content and properties of PCESs contained in them. Using a sample of 109 IBs most recently approved at 3 institutional review boards bas...

Apalutamide: The established and emerging roles in the treatment of advanced prostate cancer.

Prostate cancer (PCa) is the most common cancer in elderly males. Androgen deprivation therapy (ADT) is still the cornerstone of initial treatment, however the vast majority of patients develop castration resistant prostate cancer (CRPC). Several studies with numerous androgen receptor (AR)-directed agents have emerged since the approval of abiraterone acetate and enzalutamide. One of these agents is apalutamide, which seems to be a promising AR antagonist for the treatment of CRPC. Areas covered: The autho...

Reversible Phase Transitions in the Phospholipid Monolayer.

The polymorphism of phospholipid monolayers has been extensively studied because of its importance in surface thermodynamics, soft matter physics, and biomembranes. To date, the phase behavior of phospholipid monolayers has been nearly exclusively studied with the classical Langmuir-type film balance. However, due to experimental artifacts caused by film leakage, the Langmuir balance fails to study the reversibility of two-dimensional surface phase transitions. We have developed a novel experimental methodo...

Microfluidic Droplet-Based Tool to Determine Phase Behavior of a Fluid System with High Composition Resolution.

The goal of this work is to develop a simple microfluidic approach to characterizing liquid-liquid phase behavior in complex aqueous mixtures of organics and salts. We take advantage of the permeability of inexpensive microfluidic devices to concentrate aqueous solutions on chip. We demonstrate a technique that allows phase boundaries to be identified with high compositional resolution and small sample volumes. Droplets of single phase samples are produced on-chip and concentrated in the device beyond the p...

An updated assessment of morbidity and mortality following skull base surgical approaches.

Updated multi-institutional database studies assessing perioperative risk factors on 30-day morbidity and mortality after skull base surgeries are limited. We aim to identify perioperative risk factors and report the incidence of 30-day morbidity and mortality in adult patients after skull base surgery.

SCN1A rs3812718 polymorphism is associated with epilepsy: An updated meta-analysis.

To clarify the association between SCN1A rs3812718 polymorphism and epilepsy, we performed an updated meta-analysis. PubMed, Science Direct, Embase, Springer, Google Scholar, and Cochrane databases were searched before January 20, 2018. Odds ratios and 95% confidence intervals were used to assess the strength of associations. Finally, simply eight studies were included in this meta-analysis and all together recruited 7184 individuals, and they consisted of 3595 cases and 3589 controls. Based on the quality ...

Phase 1 pharmacokinetics and phase 3 efficacy of testosterone nasal gel in subjects with seasonal allergies.

NATESTOtestosterone nasal gel (TNG) is a liquid gel that is applied in the nose for the treatment of male hypogonadism. There is a reasonable concern that administration of TNG to patients with active rhinitis could modify absorption. Results from two clinical studies are reported wherein subjects with allergic rhinitis (AR) subjects are treated with TNG.

SN2 Reactions in Hydrocarbon Solvents Using Ammonium Terminated Polyisobutylene Oligomers as Phase Solubilizing Agents and Catalysts.

Although SN2 reactions have been thoroughly studied in polar aprotic and protic solvents, not many studies have been done to study the rate of SN2 reaction in nonpolar solvents like alkanes due to the insolubility of anionic nucleophiles in these solvents. In this study, we investigated the use of N,N-diethyl-N-methylammonium terminated polyisobutylene (PIB) oligomer as a phase solubilizing agent for nucleophilic anions that could react with hydrocarbon-soluble substrates in alkanes. The results of these ki...

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.

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 ...

Occurrence and Gas-particle Partitioning of Polycyclic Aromatic Hydrocarbons in the Air of Liaodong Bay.

The gas-and particle-phase polycyclic aromatic hydrocarbons (PAHs) were collected from the air of Liaodong Bay in May and August to investigate their occurrence and gas/particle distribution. The 24 PAHs were analyzed for gas-and particle-phase samples, and the concentrations of total gas-and particle-phase PAHs were found to be 28.8 ng·m and 24.0 ng·m, respectively. The concentrations of the gas-phase PAHs were higher in August than in May, and the concentrations of the particle-phase PAHs were higher in...

Phase-lags in large scale brain synchronization: Methodological considerations and in-silico analysis.

Architecture of phase relationships among neural oscillations is central for their functional significance but has remained theoretically poorly understood. We use phenomenological model of delay-coupled oscillators with increasing degree of topological complexity to identify underlying principles by which the spatio-temporal structure of the brain governs the phase lags between oscillatory activity at distant regions. Phase relations and their regions of stability are derived and numerically confirmed for ...

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