2,053 research outputs found
The Institution of the Private Attorney General: Perspectives from an Empirical Study of Class Action Litigation
The Institution of the Private Attorney General: Perspectives from an Empirical Study of Class Action Litigation
Safety and efficacy data supporting U.S. FDA approval of intracameral phenylephrine and ketorolac 1.0%/0.3% for pediatric cataract surgery: clinical safety and pupil and pain management
Purpose:
To assess the safety of phenylephrine and ketorolac (PE/K) 1.0%/0.3% compared with phenylephrine (PE) 1.0% in children aged 0 to 3 years undergoing cataract surgery. The effect of PE/K to PE on intraoperative pupil diameter and postoperative pain were also compared.
Setting:
Multicenter study in the United States.
Design:
Randomized double-masked phase 3 clinical trial.
Methods:
This study was powered to assess safety only. Depending on randomization, 4 mL of PE/K 1.0%/0.3% or PE 1.0% was injected into the surgical irrigation solution. Safety endpoints were assessed up to 90 days postoperatively. From surgical videos, a masked central reader measured the change in pupil diameter from immediately prior to incision to wound closure. Postoperative pain was measured using Alder Hey Triage Pain Score at 3 hours, 6 hours, 9 hours, and 24 hours following wound closure and recorded by parent/caregiver.
Results:
Seventy-two patients received masked intervention. There were no notable changes in vital signs or ophthalmological complications in either group. Mean change in pupil diameter was similar between PE/K 1.0%/0.3% and PE 1.0% (mean difference in area under the curve −0.071; P = .599). Postoperative ocular pain scores and overall mean scores were lower in PE/K group at all individual time points, and differences in overall mean scores were statistically significant at 6 and 24 hours (P = .029 and 0.021, respectively).
Conclusions:
PE/K 1.0%/0.3% was safe for use in children and maintained mydriasis during cataract surgery. Postoperative pain levels were lower in the PE/K 1.0%/0.3% group
Study of the q^2-Dependence of B --> pi ell nu and B --> rho(omega)ell nu Decay and Extraction of |V_ub|
We report on determinations of |Vub| resulting from studies of the branching
fraction and q^2 distributions in exclusive semileptonic B decays that proceed
via the b->u transition. Our data set consists of the 9.7x10^6 BBbar meson
pairs collected at the Y(4S) resonance with the CLEO II detector. We measure
B(B0 -> pi- l+ nu) = (1.33 +- 0.18 +- 0.11 +- 0.01 +- 0.07)x10^{-4} and B(B0 ->
rho- l+ nu) = (2.17 +- 0.34 +0.47/-0.54 +- 0.41 +- 0.01)x10^{-4}, where the
errors are statistical, experimental systematic, systematic due to residual
form-factor uncertainties in the signal, and systematic due to residual
form-factor uncertainties in the cross-feed modes, respectively. We also find
B(B+ -> eta l+ nu) = (0.84 +- 0.31 +- 0.16 +- 0.09)x10^{-4}, consistent with
what is expected from the B -> pi l nu mode and quark model symmetries. We
extract |Vub| using Light-Cone Sum Rules (LCSR) for 0<= q^2<16 GeV^2 and
Lattice QCD (LQCD) for 16 GeV^2 <= q^2 < q^2_max. Combining both intervals
yields |Vub| = (3.24 +- 0.22 +- 0.13 +0.55/-0.39 +- 0.09)x10^{-3}$ for pi l nu,
and |Vub| = (3.00 +- 0.21 +0.29/-0.35 +0.49/-0.38 +-0.28)x10^{-3} for rho l nu,
where the errors are statistical, experimental systematic, theoretical, and
signal form-factor shape, respectively. Our combined value from both decay
modes is |Vub| = (3.17 +- 0.17 +0.16/-0.17 +0.53/-0.39 +-0.03)x10^{-3}.Comment: 45 pages postscript, also available through
http://w4.lns.cornell.edu/public/CLNS, submitted to PR
Measurement of the Charge Asymmetry in
We report on a search for a CP-violating asymmetry in the charmless hadronic
decay B -> K*(892)+- pi-+, using 9.12 fb^-1 of integrated luminosity produced
at \sqrt{s}=10.58 GeV and collected with the CLEO detector. We find A_{CP}(B ->
K*(892)+- pi-+) = 0.26+0.33-0.34(stat.)+0.10-0.08(syst.), giving an allowed
interval of [-0.31,0.78] at the 90% confidence level.Comment: 7 pages postscript, also available through
http://w4.lns.cornell.edu/public/CLNS, submitted to PR
Branching Fractions of tau Leptons to Three Charged Hadrons
From electron-positron collision data collected with the CLEO detector
operating at CESR near \sqrt{s}=10.6 GeV, improved measurements of the
branching fractions for tau decays into three explicitly identified hadrons and
a neutrino are presented as {\cal
B}(\tau^-\to\pi^-\pi^+\pi^-\nu_\tau)=(9.13\pm0.05\pm0.46)%, {\cal B}(\tau^-\to
K^-\pi^+\pi^-\nu_\tau)=(3.84\pm0.14\pm0.38)\times10^{-3}, {\cal B}(\tau^-\to
K^-K^+\pi^-\nu_\tau)=(1.55\pm0.06\pm0.09)\times10^{-3}, and {\cal B}(\tau^-\to
K^-K^+K^-\nu_\tau)<3.7\times10^{-5} at 90% C.L., where the uncertainties are
statistical and systematic, respectively.Comment: 10 pages postscript, also available through
http://w4.lns.cornell.edu/public/CLNS, to appear in Phys. Rev. Let
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