Investigator and independent review committee exploratory assessment and verification of tumor response in a non-Hodgkin lymphoma study

Interpretation of endpoints (e.g. overall response rate) in clinical trials depends on the accurate and reliable measurement and identification of tumors. Regulatory agencies recommend blinded reviews of imaging data by independent review committees (IRCs). Differences in response outcomes that arise between IRCs and site investigators raise regulatory/sponsor concerns. Here, we evaluate discrepant tumor response assessments by the IRC and unblinded investigators (complete versus partial response, respectively) occurring in 52 (13% of 393 IRC-assessed responders) of 447 enrolled patients with treatment-naïve non-Hodgkin lymphoma from a randomized study. The IRC and investigators were \u27likely correct\u27 in 73% and 25% of cases, respectively (p \u3c .001). Investigators were more likely to make errors by misinterpreting lymph node data and not utilizing PET results. This post hoc finding suggests a possible role for post-training site evaluation/audit, with retraining as needed, and a specialized consensus committee for concurrent blinded review of site/central data

Conversion of an intensified fed-batch to an integrated continuous bioprocess

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Composite Fermion Theory, Edge Currents and the Fractional Quantum Hall Effect

We present a mean field theory of composite fermion edge channel transport in the fractional and integer quantum Hall regimes. An expression relating the electro-chemical potentials of composite fermions at the edges of a sample to those of the corresponding electrons is obtained and a plausible form is assumed for the composite fermion Landau level energies near the edges. The theory yields the observed fractionally quantized Hall conductances and also explains other experimental results. We also discuss some experiments that are relevant to the question whether fractional edge states in real devices should be described as Fermi or Luttinger liquids.Comment: 4 pages + 1 figure. Talk presented at EP2DSXI in Nottingham in August, 1995. Self-unpacking uuencoded postscript. Unpacking instructions at beginning of fil

A Database of Cepheid Distance Moduli and TRGB, GCLF, PNLF and SBF Data Useful for Distance Determinations

We present a compilation of Cepheid distance moduli and data for four secondary distance indicators that employ stars in the old stellar populations: the planetary nebula luminosity function (PNLF), the globular cluster luminosity function (GCLF), the tip of the red giant branch (TRGB), and the surface brightness fluctuation (SBF) method. The database includes all data published as of July 15, 1999. The main strength of this compilation resides in all data being on a consistent and homogeneous system: all Cepheid distances are derived using the same calibration of the period-luminosity relation, the treatment of errors is consistent for all indicators, measurements which are not considered reliable are excluded. As such, the database is ideal for inter-comparing any of the distance indicators considered, or for deriving a Cepheid calibration to any secondary distance indicator. Specifically, the database includes: 1) Cepheid distances, extinctions and metallicities; 2) apparent magnitudes of the PNLF cutoff; 3) apparent magnitudes and colors of the turnover of the GCLF (both in the V- and B-bands); 4) apparent magnitudes of the TRGB (in the I-band) and V-I colors at and 0.5 magnitudes fainter than the TRGB; 5) apparent surface brightness fluctuation magnitudes I, K', K_short, and using the F814W filter with the HST/WFPC2. In addition, for every galaxy in the database we give reddening estimates from DIRBE/IRAS as well as HI maps, J2000 coordinates, Hubble and T-type morphological classification, apparent total magnitude in B, and systemic velocity. (Abridged)Comment: Accepted for publication in the Astrophysical Journal Supplement Series. Because of space limitations, the figures included are low resolution bitmap images. Original figures can be found at http://www.astro.ucla.edu/~laura/pub.ht

Metabolic Syndrome and Incident Coronary Heart Disease in Australian Indigenous Populations

This report aims to compare the prediction of the metabolic syndrome (MetS) and its components for morbidity and mortality of coronary heart disease (CHD) in a cohort of Australian Aboriginal and Torres Strait Islander adults (TSIs). A total of 2,100 adults (1,283 Aborigines and 817 TSIs) was followed up for 6 years from 2000. Outcome measures were all CHD events (deaths and hospitalizations). Baseline anthropometric measurements, blood pressure (BP), fasting blood lipids and glucose were collected. Smoking and alcohol intake was self-reported. We found MetS was more prevalent in TSI (50.3%) compared to Aborigines (33.0%). Baseline MetS doubled the risk of a CHD event in Aborigines. Increased fasting triglycerides was stronger in predicting CHD (hazard ratio (HR): 2.8) compared with MetS after adjusted for age, sex, tobacco and alcohol consumption, and baseline diabetes and albuminuria for Aborigines but not among TSIs. MetS was not more powerful than its components in predicting CHD event. In Australian Aborigines, the “triglyceridemic waist” phenotype strongly predicts CHD event, whereas among TSI, baseline diabetes mediated the prediction of increased fasting glucose for CHD event

The HST Key Project on the Extragalactic Distance Scale. XXVIII. Combining the Constraints on the Hubble Constant

Since the launch of the Hubble Space Telescope nine years ago, Cepheid distances to 25 galaxies have been determined for the purpose of calibrating secondary distance indicators. A variety of these can now be calibrated, and the accompanying papers by Sakai, Kelson, Ferrarese, and Gibson employ the full set of 25 galaxies to consider the Tully-Fisher relation, the fundamental plane of elliptical galaxies, Type Ia supernovae, and surface brightness fluctuations. When calibrated with Cepheid distances, each of these methods yields a measurement of the Hubble constant and a corresponding measurement uncertainty. We combine these measurements in this paper, together with a model of the velocity field, to yield the best available estimate of the value of H_0 within the range of these secondary distance indicators and its uncertainty. The result is H_0 = 71 +/- 6 km/sec/Mpc. The largest contributor to the uncertainty of this 67% confidence level result is the distance of the Large Magellanic Cloud, which has been assumed to be 50 +/- 3 kpc

A New 24 micron Phase Curve for upsilon Andromedae b

We report the detection of 24 micron variations from the planet-hosting upsilon Andromedae system consistent with the orbital periodicity of the system's innermost planet, upsilon And b. We find a peak-to-valley phase curve amplitude of 0.00130 times the mean system flux. Using a simple model with two hemispheres of constant surface brightness and assuming a planetary radius of 1.3 Jupiter radii gives a planetary temperature contrast of >900 K and an orbital inclination of >28 degrees. We further report the largest phase offset yet observed for an extrasolar planet: the flux maximum occurs ~80 degrees before phase 0.5. Such a large phase offset is difficult to reconcile with most current atmospheric circulation models. We improve on earlier observations of this system in several important ways: (1) observations of a flux calibrator star demonstrate the MIPS detector is stable to 10^-4 on long timescales, (2) we note that the background light varies systematically due to spacecraft operations, precluding use of this background as a flux calibrator (stellar flux measured above the background is not similarly affected), and (3) we calibrate for flux variability correlated with motion of the star on the MIPS detector. A reanalysis of our earlier observations of this system is consistent with our new result.Comment: Submitted to ApJ. 15 pages, 6 figures, 4 table