DBS Under FCC and International Regulation

This Article examines the legal and technological development of DBS in both the domestic and international fora. Part II examines the development of DBS and information policy concerning DBS in the United States. The Article then in part III discusses the international positions of the developed nations, the developing countries, and the Soviet bloc on the DBS issues and reveals the results thus far in the policy debate among these nations and the United States. Part IV concludes the Article with a brief outline of the possibilities for international cooperation to solve the DBS controversy

Broadband UBVRI Photometry of Horizontal-Branch and Metal-Poor Candidates from the HK and Hamburg/ESO Surveys. I

We report broadband UBV and/or BVRI CCD photometry for a total of 1857 stars in the thick-disk and halo populations of the Galaxy. The majority of our targets were selected as candidate field horizontal-branch or other A-type stars (FHB/A, N = 576), or candidate low-metallicity stars (N = 1221), from the HK and Hamburg/ESO objective-prism surveys. Similar data for a small number of additional stars from other samples are also reported. These data are being used for several purposes. In the case of the FHB/A candidates they are used to accurately separate the lower-gravity FHB stars from various higher-gravity A-type stars, a subsample that includes the so-called Blue Metal Poor stars, halo and thick-disk blue stragglers, main-sequence A-type dwarfs, and Am and Ap stars. These data are also being used to derive photometric distance estimates to high-velocity hydrogen clouds in the Galaxy and for improved measurements of the mass of the Galaxy. Photometric data for the metal-poor candidates are being used to refine estimates of stellar metallicity for objects with available medium-resolution spectroscopy, to obtain distance estimates for kinematic analyses, and to establish initial estimates of effective temperature for analysis of high-resolution spectroscopy of the stars for which this information now exists.Comment: 22 pages, including 3 figures, 5 tables, and two ascii files of full data, accepted for publication in the Astrophysical Journal (Supplements

Broadband UBVR_CI_C Photometry of Horizontal-Branch and Metal-poor Candidates from the HK and Hamburg/ESO Surveys. I.

We report broadband UBV and/or BVR_CI_C CCD photometry for a total of 1857 stars in the thick-disk and halo populations of the Galaxy. The majority of our targets were selected as candidate field horizontal-branch or other A-type stars (FHB/A, N = 576), or candidate low-metallicity stars (N = 1221), from the HK and Hamburg/ESO objective-prism surveys. Similar data for a small number of additional stars from other samples are also reported. These data are being used for several purposes. In the case of the FHB/A candidates they are used to accurately separate the lower gravity FHB stars from various higher gravity A-type stars, a subsample that includes the so-called blue metal poor stars, halo and thick-disk blue stragglers, main-sequence A-type dwarfs, and Am and Ap stars. These data are also being used to derive photometric distance estimates to high-velocity hydrogen clouds in the Galaxy and for improved measurements of the mass of the Galaxy. Photometric data for the metal-poor candidates are being used to refine estimates of stellar metallicity for objects with available medium-resolution spectroscopy, to obtain distance estimates for kinematic analyses, and to establish initial estimates of effective temperature for analysis of high-resolution spectroscopy of the stars for which this information now exists

Preoperative pelvic MRI and 2-[18F]FDG PET/CT for lymph node staging and prognostication in endometrial cancer—time to revisit current imaging guidelines?

Objective This study presents the diagnostic performance of four different preoperative imaging workups (IWs) for prediction of lymph node metastases (LNMs) in endometrial cancer (EC): pelvic MRI alone (IW1), MRI and [18F]FDG-PET/CT in all patients (IW2), MRI with selective [18F]FDG-PET/CT if high-risk preoperative histology (IW3), and MRI with selective [18F]FDG-PET/CT if MRI indicates FIGO stage ≥ 1B (IW4). Methods In 361 EC patients, preoperative staging parameters from both pelvic MRI and [18F]FDG-PET/CT were recorded. Area under receiver operating characteristic curves (ROC AUC) compared the diagnostic performance for the different imaging parameters and workups for predicting surgicopathological FIGO stage. Survival data were assessed using Kaplan-Meier estimator with log-rank test. Results MRI and [18F]FDG-PET/CT staging parameters yielded similar AUCs for predicting corresponding FIGO staging parameters in low-risk versus high-risk histology groups (p ≥ 0.16). The sensitivities, specificities, and AUCs for LNM prediction were as follows: IW1—33% [9/27], 95% [185/193], and 0.64; IW2—56% [15/27], 90% [174/193], and 0.73 (p = 0.04 vs. IW1); IW3—44% [12/27], 94% [181/193], and 0.69 (p = 0.13 vs. IW1); and IW4—52% [14/27], 91% [176/193], and 0.72 (p = 0.06 vs. IW1). IW3 and IW4 selected 34% [121/361] and 54% [194/361] to [18F]FDG-PET/CT, respectively. Employing IW4 identified three distinct patient risk groups that exhibited increasing FIGO stage (p < 0.001) and stepwise reductions in survival (p ≤ 0.002). Conclusion Selective [18F]FDG-PET/CT in patients with high-risk MRI findings yields better detection of LNM than MRI alone, and similar diagnostic performance to that of MRI and [18F]FDG-PET/CT in all.publishedVersio

Exploration of two methods for quantitative Mitomycin C measurement in tumor tissue in vitro and in vivo

Two methods of quantifying Mitomycin C in tumor tissue are explored. A method of ultraviolet-visible absorption microscopy is developed and applied to measure the concentration of Mitomycin C in preserved mouse tumor tissue, as well as in gelatin samples. Concentrations as low as 60 μM can be resolved using this technique in samples that do not strongly scatter light. A novel method for monitoring the Mitomycin C concentrations inside a tumor is developed, based on microdialysis and ultraviolet-visible spectroscopy. A pump is used to perfuse a microdialysis probe with Ringer’s solution, which is fed to a flow cell to determine intratumor concentrations in real time to within a few μM. The success and limitations of these techniques are identified, and suggestions are made as to further development. To the authors’ knowledge these are the first attempts made to quantify Mitomycin C concentrations in tumor tissue

Diffusion-Weighted MRI for Verification of Electroporation-Based Treatments

Clinical electroporation (EP) is a rapidly advancing treatment modality that uses electric pulses to introduce drugs or genes into, e.g., cancer cells. The indication of successful EP is an instant plasma membrane permeabilization in the treated tissue. A noninvasive means of monitoring such a tissue reaction represents a great clinical benefit since, in case of target miss, retreatment can be performed immediately. We propose diffusion-weighted magnetic resonance imaging (DW-MRI) as a method to monitor EP tissue, using the concept of the apparent diffusion coefficient (ADC). We hypothesize that the plasma membrane permeabilization induced by EP changes the ADC, suggesting that DW-MRI constitutes a noninvasive and quick means of EP verification. In this study we performed in vivo EP in rat brains, followed by DW-MRI using a clinical MRI scanner. We found a pulse amplitude–dependent increase in the ADC following EP, indicating that (1) DW-MRI is sensitive to the EP-induced changes and (2) the observed changes in ADC are indeed due to the applied electric field

Safety and efficacy of midline catheters versus peripheral intravenous catheters: A pilot randomized controlled trial

Background: Despite pervasive need for peripheral intravenous catheters, insertion is often difficult, and approximately two thirds fail prematurely. Midline catheters are an alternative long peripheral catheter, inserted in the upper arm, ideal for patients with difficult access. Aim: The aim of this study is to test feasibility of the protocol and compare the efficacy and safety of midline catheters to peripheral intravenous catheters. Design: A parallel-group, pilot randomized controlled trial of adult medical/surgical hospitalized patients, from a single Australian referral hospital. Methods: Participants with difficult vascular access (≤2 palpable veins) and/or anticipated ≥5 days of peripherally compatible intravenous therapy were recruited between May 2019 and March 2020. Participants were randomized to (1) peripheral intravenous catheter or (2) midline catheter. Primary feasibility outcome measured eligibility, recruitment, protocol adherence, retention and attrition. Primary clinical outcomes measured device insertion failure and post-insertion failure. Results: In total, n = 143 participants (71 peripheral intravenous catheters and 72 midline catheters) were recruited; n = 139 were analysed. Most feasibility criteria were met. Peripheral intravenous catheters had shorter functional dwell time, with higher incidence of post-insertion failure compared to midline catheters. Conclusion: Midline catheters appear to be superior for patients with difficult vascular access or receiving prolonged intravenous therapy; a large, multi-centre trial to confirm findings is feasible

Long-Term Safety of PEGylated Coagulation Factor VIII in the Immune-Deficient Rowett Nude Rat

Turoctocog alfa pegol (N8-GP) is a glycoPEGylated human recombinant factor VIII for the treatment of hemophilia A. The safety profile of rFVIII, and polyethylene glycols (PEG) technology, is well-established. Conducting long-term toxicity studies in animals using human proteins can be complicated by anti-drug antibody (ADA) development. To evaluate long-term safety of N8-GP, 26- and 52-week toxicity studies were conducted in immune-deficient rats dosed intravenously every fourth day with 0, 50, 150, 500, or 1200 IU/kg N8-GP. Observations included clinical observations, body weight, ophthalmoscopy, hematology, chemistry, coagulation, urinalysis, toxicokinetics, antibody analysis, and macroscopic/microscopic organ examination. Immunohistochemical staining examined the distribution of PEG in the brain. No adverse test item-related findings were seen and PEG was not detected in the brain. Exposure was confirmed for ~75% of the animals dosed with 500 and 1200 IU/kg N8-GP; the high lower limit of quantification of the bioanalysis assay prevented confirmation of exposure in the lower doses. A small number of animals developed ADAs, and the proportion of animals surviving until scheduled termination was >80%. N8-GP was well tolerated, and the immune-deficient rat proved suitable for testing long-term toxicity of human proteins that are immunogenic in animals