13 research outputs found

    A Designer\u27s guide to the evaluation of digital proofs

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    Digital color proofs and pre-proofs are used by graphic artists and commercial printers throughout the prepress process. However the prepress process has undergone radical changes over the past decade due to the introduction of desk top publishing and desktop prepress. Alongside of the desktop publishing revo lution has come a multitude of new digital proofing technologies for use in this ever changing environment. Technologies including, but not limited to, liquid inkjet, dye sublimation, continuous inkjet, color laser, and thermal wax transfer printers have provided an entire range of color accuracy and price suitability to many of their users. However one needs to be able to understand the practical applications and limitations of these technologies to make a suitable choice for a specific prepress operation or design process. Therefore a handbook for the users of digital proofs has been created for their benefit. The underlying structure of this handbook is based on the following six chap ters. The first chapter, entitled Communicating with Prepress and the Attributes of Digital Proofing, contains multiple parts. Firstly, it contains information for the designer in regards to the advantages and disadvantages of all types of digital output devices. It discusses the advantages which digital output devices may or may not have over conventional proofing systems. Additionally, ideas such as the vantages and drawbacks of preproofers and proofers is elaborated upon. Information for this part of the chapter was obtained through questionnaires completed by, and interviews with print buyers, art directors, and production managers from advertising agencies and prepress providers in the Rochester area. More information for this section of the first chapter was obtained through various manufacturer\u27s literature, printing industry reports and various periodi cals. Chapter One also discusses ideas behind the application of color printers (preproofers) and digital proofers. These ideas address issues which pertain to the application of specific printing and proofing processes to specific phases of the creative and production processes. Additionally, discussions regarding proof ing costs, qualities, and production turnaround time may be found in this part of the first chapter. Information for this section of Chapter One was obtained through information found in printing and publishing related periodicals, as well as in manufacturers\u27 literature. Finally, the first chapter develops a system for the correction of digital preproofs and proofs. Multiple groups of ideas pertaining to the correction of digital output are discussed. Some of these include sections entitled Digital File Tracking and Identification, Evaluation of Design Elements, Evaluating Colors, Element Positioning, and Element Dimension Adjustments. Information for this part of the chapter was obtained through the evaluation of previously corrected digital con tract proofs and preproofs, as well as the interviews and questionnaires men tioned above. The second chapter, entitled Proofing Typography, displays the many different ways that printing and proofing technologies affect text type and display typog raphy. Using the CD-Rom included in the back of the book, one may view on screen how the following technologies affect type ranging from 3 points to 72 points in size: liquid inkjet, large format liquid inkjet, phase-change inkjet, ther mal wax transfer, dye sublimation, continuous inkjet, and dye ablation. Information and samples for this chapter were obtained through printing and proofing system manufacturers and advertising agencies in the Rochester area. The Color Primer and Chapter Three: Proofing for Imagery and Color, contain information for the designer which may be applied to proper evaluation of color on color prints and digital proofs. The Color Primer discusses subjects such as color space, the additive and subtractive color theories, and common color mea surement tools. Chapter Three then applies some of this knowledge in its discus sions of proper lighting conditions for viewing prints and proofs, and different human factors which influence the highly subjective evaluation of all digital color output. Information for this chapter was gathered using graphic arts and printing industry related periodicals and industry-wide books related to color and its reproduction. The fourth chapter, entitled Substrates and Digital Output, educates the design er about the effects on text, imagery, and graphics which occur when creating digital prints and proofs on a variety of papers. Various paper surfaces such as gloss, semi-gloss and matte surfaces are addressed. The affects of colored paper on imagery and graphics are also elaborated upon. Additionally, printing and proofing processes are discussed in regards to the substrates that they accept for output. Information for this chapter was gathered through manufacturers\u27 litera ture and various industry related books and periodical articles. The Proofing Process Supplement was created to familiarize the designer with all currently popular forms of digital output technology. The process supplement discusses the imaging processes used by the following digital output technolo gies: liquid inkjet, phase-change inkjet, thermal wax transfer, dye sublimation, continuous inkjet, and dye ablation. Additionally, the supplement contains brief explanations regarding screening technologies. Information for the process sup plement was gathered through manufacturers\u27 literature, interviews with pre press providers in the Rochester area, and interviews with technical representa tives from the manufacturers of devices which use the above digital, color out put technologies. Chapter Five, entitled Image Fidelity, simply illustrates how all of the current ly popular printing and proofing technologies affect graphics and imagery. Using the CD-Rom included with the guidebook, the reader may view magni fied and normal views of printing and proof sample imagery. Information noted by the reader in the proofing process supplement may then be actively applied when viewing these samples. Information and sample prints for the fifth chapter were gathered from several manufacturers and advertising agencies in the Rochester area. The sixth chapter, entitled The Acceptance of Digital Contract Proofing, discusses a new definition of the contract proof in regards to the evolution of digital proof ing. This chapter provides ideas for the designer, art director, and print buyer to realize when considering the use of digital contract proofing. Several questions are raised concerning what requirements a digital contract proof must fulfill depending upon the areas of its application and any agreements between the designer and prepress provider regarding their specific definition of a digital contract proof. Additionally, specific advantages of digital contract proofs, such as their ability to fingerprint a press and/or press run, are discussed. Finally, a discussion pertaining to the education of all users of digital proofing technolo gies is presented to aid the overall acceptance of digital contract proofing. Information for this chapter was obtained through the extensive interviews of leading technical and product oriented representatives from the manufacturers of currently used digital contract proofing systems. Many conclusions have been reached with the completion of this guidebook. In brief, the first and most prominent conclusion which may be reached states that the acceptance of digital contract proofing lies within the education of all designers, art directors and print buyers about digital printing and proofing technologies. As the use of digital contract proofing grows, education and inter est by all creative professionals will orient them towards their use of digital proofing systems. The next conclusion which has been reached is that the proper application of color printers and digital proofers is of major importance for the designer due to the added flexibility and rewards which result from the use of digital color out put devices throughout the creative and production processes. Another conclu sion which may be reached is that the display of proofing and printing process effects on text, graphics, and imagery serves to directly inform the creative pro fessional how these elements may be distorted by the utilized output device. Knowledge gained by the creative professional in regards to these effects helps to answer many questions regarding print or proof quality and proper output device application. Finally, additional knowledge gained by designers which pertains to proper viewing of all color output, color theories, color measurement, and proofing sub strates helps them to better communicate with those prepress and print professionals involved in the production process

    The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test into Clinical Practice

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    To examine the extent of the evaluation required to achieve diagnostic resolution and the test performance characteristics of a targeted methylation cell-free DNA (cfDNA)-based multi-cancer early detection (MCED) test, ~6200 participants ≥50 years with (cohort A) or without (cohort B) ≥1 of 3 additional specific cancer risk factors will be enrolled in PATHFINDER (NCT04241796), a prospective, longitudinal, interventional, multi-center study. Plasma cfDNA from blood samples will be analyzed to detect abnormally methylated DNA associated with cancer (i.e., cancer “signal”) and a cancer signal origin (i.e., tissue of origin). Participants with a “signal detected” will undergo further diagnostic evaluation per guiding physician discretion; those with a “signal not detected” will be advised to continue guideline-recommended screening. The primary objective will be to assess the number and types of subsequent diagnostic tests needed for diagnostic resolution. Based on microsimulations (using estimates of cancer incidence and dwell times) of the typical risk profiles of anticipated participants, the median (95% CI) number of participants with a “signal detected” result is expected to be 106 (87–128). Subsequent diagnostic evaluation is expected to detect 52 (39–67) cancers. The positive predictive value of the MCED test is expected to be 49% (39–58%). PATHFINDER will evaluate the integration of a cfDNA-based MCED test into existing clinical cancer diagnostic pathways. The study design of PATHFINDER is described here

    Safety, tolerability, and efficacy of PBT2 in Huntington's disease: A phase 2, randomised, double-blind, placebo-controlled trial

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    Background: PBT2 is a metal protein-attenuating compound that might reduce metal-induced aggregation of mutant huntingtin and has prolonged survival in a mouse model of Huntington's disease. We aimed to assess the safety, tolerability, and efficacy of PBT2 in patients with Huntington's disease. Methods: In this 26-week, randomised, double-blind, placebo-controlled trial, adults ( ≥ 25 years old ) with early-stage to mid-stage Huntington's disease were randomly assigned ( 1:1:1 ) by a centralised interactive response system to once daily PBT2 250 mg, PBT2 100 mg, or placebo. Randomisation was stratified by site with a block size of three. Participants, carers, the steering committee, site investigators, study staff, and the study sponsor were masked to treatment assignment. Primary endpoints were safety and tolerability. The safety population consisted of all participants who were randomly assigned and had at least one dose of study drug. The principal secondary endpoint was cognition, measured by the change from baseline to week 26 in the main composite Z score of five cognitive tests ( Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test, and Stroop Word Reading Test ) and scores on eight individual cognitive tests ( the five aforementioned plus the Trail Making Test Part A, Montreal Cognitive Assessment, and the Speeded Tapping Test ). The intention-to-treat population comprised participants who were randomly assigned and had at least one efficacy assessment after administration of study drug. This trial is registered with [http://clinicaltrials.gov/] ClinicalTrials.gov, [http://clinicaltrials.gov/show/NCT01590888] NCT01590888. Findings: Between April 18, 2012, and Dec 14, 2012, 109 participants were randomly assigned to PBT2 250 mg ( n=36 ), PBT2 100 mg ( n=38 ), or placebo ( n=35 ) at 19 research centres in Australia and the USA. 32 ( 89% ) individuals on PBT2 250 mg, 38 ( 100% ) on PBT2 100 mg, and 34 ( 97% ) on placebo completed the study. Six serious adverse events ( acute coronary syndrome, major depression, pneumonia, suicide attempt, viral infection, and worsening of Huntington's disease ) occurred in five participants in the PBT2 250 mg group, three ( fall with subdural haematoma, suicide attempt, and hospital admission for stabilisation of Huntington's disease ) occurred in two participants in the PBT2 100 mg group, and one ( increasing aggression ) occurred in a participant in the placebo group. The site investigators deemed all, except the worsening of Huntington's disease, as unrelated to study drug. 32 ( 89% ) participants on PBT2 250 mg, 30 ( 79% ) on PBT2 100 mg, and 28 ( 80% ) on placebo had at least one adverse event. Compared with placebo, neither PBT2 100 mg ( least-squares mean 0·02, 95% CI −0·10 to 0·14; p=0·772 ) nor PBT2 250 mg ( 0·07, −0·05 to 0·20; p=0·240 ) significantly improved the main composite cognition Zscore between baseline and 26 weeks. Compared with placebo, the Trail Making Test Part B score was improved between baseline and 26 weeks in the PBT2 250 mg group ( 17·65 s, 0·65–34·65; p=0·042 ) but not in the 100 mg group ( 0·79 s improvement, −15·75 to 17·32; p=0·925 ); neither dose significantly improved cognition on the other tests. Interpretation: PBT2 was generally safe and well tolerated in patients with Huntington's disease. The potential benefit on executive function will need to be confirmed in a larger study. Funding: Prana Biotechnology Limited
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