Ahmadbundgaard0835

BMD at total hip (TH; coefficient -0.077, 95% CI -0.113--0.040, p ≤ 0.001; n = 7715) and femoral neck (FN; coefficient -0.044, 95% CI -0.065--0.023, p ≤ 0.001; n = 7662) were significantly associated with risk of falls in patients with osteoporosis.

This analysis identified the risk of falls in patients with low BMD and osteoporosis and an association of falls with age and BMD. Therefore, patients with osteoporosis need to receive mandatory fall risk mitigation measures, and the BMD at total hip or femoral neck could function as an indicator for the risk of falling.

This analysis identified the risk of falls in patients with low BMD and osteoporosis and an association of falls with age and BMD. Therefore, patients with osteoporosis need to receive mandatory fall risk mitigation measures, and the BMD at total hip or femoral neck could function as an indicator for the risk of falling.

To report population pharmacokinetic (PK) analysis of the phase 1 study (FPA144-001, NCT02318329) and to select a clinical dose and schedule that will achieve an empirical target trough concentration (C

) for an anti-fibroblast growth factor receptor 2b antibody, bemarituzumab.

Nonlinear mixed-effect modeling was used to analyse PK data. In vitro binding affinity and receptor occupancy of bemarituzumab were determined. Simulation was conducted to estimate dose and schedule to achieve an empirical target C

in a phase 2 trial (FIGHT, NCT03694522) for patients receiving first-line treatment combined with modified 5-fluourouracil, oxaliplatin and leucovorin (mFOLFOX6) forgastric and gastroesophageal junctionadenocarcinoma.

Bemarituzumab PK is best described by a two-compartment model with parallel linear and nonlinear (Michaelis-Menten) elimination from the central compartment. Albumin, gender, and body weight were identified as the covariates on the linear clearance and/or volume of distribution in the central compartment, and no dose adjustment was warranted. An empirical target of bemarituzumab C

of ≥ 60µg/mL was projected to achieve > 95% receptor occupancy based on in vitro data. Fifteen mg/kg every 2weeks, with a single dose of 7.5mg/kg on Cycle 1 Day 8, was projected to achieve the target C

on Day15 in 98% of patients with 96% maintaining the target at steady state, which was confirmed in the FIGHT trial.

A projected dose and schedule to achieve the target C

was validated in phase 1 of the FIGHT trial which supported selection of the phase 2 dose and schedule for bemarituzumab.

A projected dose and schedule to achieve the target Ctrough was validated in phase 1 of the FIGHT trial which supported selection of the phase 2 dose and schedule for bemarituzumab.

The purpose of this clinical study was to be the first to explore whether ART-123, a recombinant human soluble thrombomodulin, prevents oxaliplatin-induced peripheral neuropathy (OIPN).

This randomized, phase IIa trial enrolled stage II/III colon cancer patients who received adjuvant mFOLFOX6 chemotherapy. Participants were randomly allocated to 3 arms in a double-blind manner placebo (placebo days 1-3); 1-day ART (ART-123 day 1, placebo days 2-3); and 3-day ART (ART-123 days 1-3). ART-123 (380U/kg/day) or placebo was infused intravenously before each 2-week cycle of mFOLFOX6. OIPN was assessed with the Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) score by participants and the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) by investigators.

Seventy-nine participants (placebo n = 28, 1-day ART n = 27, 3-day ART n = 24) received study drugs. The least-squares mean FACT/GOG-Ntx-12 scores at cycle 12 from the mixed effect model for repeated measures were 28.9 with placebo, 36.3 with 1-day ART (vs. placebo 7.3 [95% CI 1.9to12.8, p = 0.009]), and 32.3 with 3-day ART (vs. placebo 3.4 [95% CI -.1 to 9.0, p = 0.222]). selleck chemicals llc The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo -23.5 [95% CI -48.4 to 4.0], p = 0.108), and 45.8% with 3-day ART (vs. placebo -18.5 [95% CI -44.2 to 9.4], p = 0.264). Common adverse events were consistent with those reported with mFOLFOX6; no severe bleeding adverse events occurred.

ART-123 showed a potential preventive effect against OIPN with good tolerability. A larger study with 1-day ART is warranted. NCT02792842, registration date June 8, 2016.

ART-123 showed a potential preventive effect against OIPN with good tolerability. A larger study with 1-day ART is warranted. NCT02792842, registration date June 8, 2016.

Analysis of head magnetic resonance images (MRI) of patients with active bone conduction implants (BCIs) is challenging. Currently, there are two generations of the transcutaneous Bonebridge system (BCI601 and BCI602), the main difference between them being the transducer design and thickness. The aim was to compare the effect of transducer placement and artifact reduction sequences on legibility of MRI scans.

Four Thiel-fixed human head specimens were used BCI601 was implanted in sinodural and middle fossa placement, and BCI602 in middle fossa and retrosigmoid approach. Images were obtained with a Signa

1.5T MR. A metal artifact reduction sequence known as MAVRIC (multiacquisition variable-resonance image combination) was used. Each specimen was scanned using standard axial T2 SE and compared with axial MAVRIC artifact reduction sequences.

Qualitatively, limits of the artifact produced by the implant were better defined with MAVRIC than with standard T2 sequences. Assessment of contralateral internal auditory canal (IAC) was possible in all cases. Placement of the BCI602 in the middle fossa allowed the view of the ipsilateral IAC using MAVRIC sequence. Quantitatively, the artifact was reduced with MAVRIC sequence from 6.3 to 59.7%, depending on the position of implant and model; the middle fossa placement and the BCI602 being those generating shorter artifact radio.

Artifact optimized sequences as MAVRIC reduce the artifact caused by the Bonebridge system. The middle fossa approach allows a better visualization of IAC canal in the ipsilateral ear with both implant versions, but the effect is more prominent with the BCI602.

Artifact optimized sequences as MAVRIC reduce the artifact caused by the Bonebridge system. The middle fossa approach allows a better visualization of IAC canal in the ipsilateral ear with both implant versions, but the effect is more prominent with the BCI602.