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https://www.readbyqxmd.com/read/28525561/decade-long-profile-of-imaging-biomarker-use-in-ophthalmic-clinical-trials
#1
Edoardo Villani, Domenico Massaro, Matteo Scaramuzzi, Pedram Hamrah, Felipe A Medeiros, Paolo Nucci
Purpose: The purpose of this study was to investigate the use of imaging biomarkers in published clinical trials (CTs) in ophthalmology and its eventual changes during the past 10 years. Methods: We sampled from published CTs in the fields of cornea, retina, and glaucoma between 2005-2006 and 2015-2016. Data collected included year of publication, phase, subspecialty, location, compliance with Consolidated Standards for Reporting Trials, impact factor, presence and use of imaging biomarkers (diagnostic, prognostic and predictive; primary and secondary surrogate endpoints), and use of centralized reading centers...
May 1, 2017: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/28525388/association-between-body-mass-index-and-presence-of-carotid-plaque-among-low-income-adults-aged-45-years-and-older-a-population-based-cross-sectional-study-in-rural-china
#2
Yongzhong Lou, Bin Li, Lan Su, Zhenhong Mu, Minghao Sun, Hongfei Gu, Jingxian Ni, Yanan Wu, Jun Tu, Jinghua Wang, Xianjia Ning
Carotid plaque is a good surrogate endpoint for assessing arterial atherosclerosis, and atherosclerosis is a reliable predictor of cardiovascular diseases. However, the effect of body mass index on carotid plaque is unknown. Therefore, we aimed to explore the association between body mass index and carotid plaque in a low-income Chinese population. Residents aged ≥45 years and free of stroke and cardiovascular diseases were enrolled and divided into four groups based on body mass index. B-mode ultrasonography was performed to measure carotid plaque...
May 4, 2017: Oncotarget
https://www.readbyqxmd.com/read/28524743/nanoparticle-exposures-from-nano-enabled-toner-based-printing-equipment-and-human-health-state-of-science-and-future-research-needs
#3
Sandra Vanessa Pirela, John Martin, Dhimiter Bello, Philip Demokritou
Toner formulations used by laser printers (LP) and photocopiers (PC), collectively called "toner-based printing equipment" (TPE), are nano-enabled products (NEP) because they contain several engineered nanomaterials (ENM) that improve toner performance. It has been shown that during consumer use (printing), these ENM are released in the air, together with other semi-volatile organic nanoparticles, and newly formed gaseous co-pollutants such as volatile organic compounds (VOC). The aim of this review is to detail and analyze physico-chemical and morphological (PCM), as well as the toxicological properties of particulate matter (PM) emissions from TPE...
May 19, 2017: Critical Reviews in Toxicology
https://www.readbyqxmd.com/read/28515862/guidelines-for-collection-and-processing-of-lungs-from-aged-mice-for-histological-studies
#4
John Morton, Timothy A Snider
Pulmonary inflammation and the development of spontaneous lung tumors are important age-related lesions in mice. Therefore, gross and histological examination of the respiratory system is a critical component of geropathology research studies for translating surrogate endpoints to clinical aging studies. Collection, trimming, and processing of lung tissue from aged mice require a high-quality sequential process since aged mice are irreplaceable resource-intensive animal models. This protocol provides a basic technique that provides excellent sections for histological evaluation of the respiratory system of old mice suitable for most research applications...
2017: Pathobiology of Aging & Age related Diseases
https://www.readbyqxmd.com/read/28509580/use-of-minimal-residual-disease-assessment-in-the-treatment-of-chronic-lymphocytic-leukemia
#5
Carolyn Owen, Anna Christofides, Nathalie Johnson, Tatiana Lawrence, David MacDonald, Carol Ward
Progress in chronic lymphocytic leukemia (CLL) therapies has extended greatly the length and depth of remission, with the goal of treatment advancing towards a cure for some patients. Accordingly, clinical endpoints must evolve to capture these outcomes, and to provide faster access to novel therapies. Minimal residual disease (MRD) is an important endpoint representing more accurately the depth of remission than complete response (CR), and is highly prognostic of progression-free survival (PFS) and overall survival (OS)...
May 16, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28502810/outcome-selection-and-measurement-in-pragmatic-trials
#6
Paco Welsing, Katrien Oude Rengerink, Sue Collier, Laurent Eckert, Maarten van Smeden, Antonio Ciaglia, Gaelle Nachbaur, Sven Trelle, Aliki Taylor, Matthias Egger, Iris Goetz
Results from pragmatic trials should reflect the comparative treatment effects encountered in patients in real-life clinical practice to guide treatment decisions. Therefore pragmatic trials should focus on outcomes that are relevant to patients, clinical practice, and treatment choices. This 6(th) paper in the series (see box) discusses different types of outcomes and their suitability for pragmatic trials, design choices for measuring these outcomes and their implications and challenges. Measuring outcomes in pragmatic trials should not interfere with real-world clinical practice to ensure generalizability of trial results and routinely collected outcomes should be prioritized...
May 11, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28501991/innovations-in-clinical-trial-design-in-the-era-of-molecular-profiling
#7
Julia D Wulfkuhle, Alexander Spira, Kirsten H Edmiston, Emanuel F Petricoin
Historically, cancer has been studied, and therapeutic agents have been evaluated based on organ site, clinical staging, and histology. The science of molecular profiling has expanded our knowledge of cancer at the cellular and molecular level such that numerous subtypes are being described based on biomarker expression and genetic mutations rather than traditional classifications of the disease. Drug development has experienced a concomitant revolution in response to this knowledge with many new targeted therapeutic agents becoming available, and this has necessitated an evolution in clinical trial design...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28500351/non-targeted-effects-models-predict-significantly-higher-mars-mission-cancer-risk-than-targeted-effects-models
#8
Francis A Cucinotta, Eliedonna Cacao
Cancer risk is an important concern for galactic cosmic ray (GCR) exposures, which consist of a wide-energy range of protons, heavy ions and secondary radiation produced in shielding and tissues. Relative biological effectiveness (RBE) factors for surrogate cancer endpoints in cell culture models and tumor induction in mice vary considerable, including significant variations for different tissues and mouse strains. Many studies suggest non-targeted effects (NTE) occur for low doses of high linear energy transfer (LET) radiation, leading to deviation from the linear dose response model used in radiation protection...
May 12, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28490514/vitamin-d-supplementation-has-no-effect-on-insulin-sensitivity-or-secretion-in-vitamin-d-deficient-overweight-or-obese-adults-a-randomized-placebo-controlled-trial
#9
Aya Mousa, Negar Naderpoor, Maximilian Pj de Courten, Helena Teede, Nicole Kellow, Karen Walker, Robert Scragg, Barbora de Courten
Background: Vitamin D supplementation has been proposed as a potential strategy to prevent type 2 diabetes. Existing clinical trials have been limited by short duration, low doses of vitamin D, variability in participants' vitamin D-deficiency status, and the use of surrogate measures of body composition, insulin sensitivity, and insulin secretion.Objective: To address existing knowledge gaps, we conducted a double-blind, randomized, placebo-controlled trial to investigate whether vitamin D supplementation that is provided in a sufficient dose and duration to vitamin D-deficient individuals would improve insulin sensitivity or secretion as measured with the use of gold-standard methods...
May 10, 2017: American Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28488380/addition-of-oxaliplatin-to-neoadjuvant-radiochemotherapy-in-mri-defined-t3-t4-or-n-rectal-cancer-a-randomized-clinical-trial
#10
Peiman Haddad, Monir Miraie, Farshid Farhan, Mohammad-Sadegh Fazeli, Afsaneh Alikhassi, Afsaneh Maddah-Safaei, Mahdi Aghili, Bita Kalaghchi, Mohammad Babaei
BACKGROUND: Clinical trials investigating the effects of addition of oxaliplatin to neoadjuvant radiochemotherapy in locally advanced rectal cancers (LARCs) have brought controversial results for pathologic complete response as an endpoint. This randomized clinical trial investigated downstaging as a short-term surrogate for progression-free survival (PFS). METHODS: Patients with magnetic resonance imaging (MRI) defined T3, T4 or N+ histologically proven adenocarcinoma of rectum within 15 cm from anal verge were randomly assigned to receive 50-50...
May 10, 2017: Asia-Pacific Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28486773/nonpublication-of-trial-results-for-new-neurological-drugs-a-systematic-review
#11
REVIEW
Amanda K Hakala, Dean Fergusson, Jonathan Kimmelman
OBJECTIVE: To evaluate nonpublication rates among trials of new successful and unsuccessful neurological drugs. METHODS: 'Licensed' drugs consisted of all novel agents receiving FDA licensure 2005 to 2012 inclusive in seven neurological disorders. 'Stalled' drugs included all experimental agents tested in the same domains that had at least one completed phase III trial in the same timeframe but failed to receive FDA approval. Trials of these drugs were included in our sample if their primary outcome collection occurred before October 1, 2010...
May 9, 2017: Annals of Neurology
https://www.readbyqxmd.com/read/28485043/validation-of-surrogate-endpoints-in-cancer-clinical-trials-via-principal-stratification-with-an-application-to-a-prostate-cancer-trial
#12
Shiro Tanaka, Yutaka Matsuyama, Yasuo Ohashi
Increasing attention has been focused on the use and validation of surrogate endpoints in cancer clinical trials. Previous literature on validation of surrogate endpoints are classified into four approaches: the proportion explained approach; the indirect effects approach; the meta-analytic approach; and the principal stratification approach. The mainstream in cancer research has seen the application of a meta-analytic approach. However, VanderWeele (2013) showed that all four of these approaches potentially suffer from the surrogate paradox...
May 8, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28484124/propensity-score-matched-comparison-of-midterm-angiographic-outcomes-of-sirolimus-versus-everolimus-and-biolimus-eluting-stents-for-de-novo-coronary-stenosis
#13
Kenichiro Suzuki, Tetsuya Ishikawa, Makoto Mutoh, Hiroshi Sakamoto, Chikara Mori, Takayuki Ogawa, Koichi Hashimoto, Takeyuki Kubota, Kimiaki Komukai, Michihiro Yoshimura
We conducted propensity-score matched comparisons of midterm angiographic outcomes of sirolimus (SES) versus either everolimus- (EES) or biolimus- (BES) eluting stents after placements for coronary stenosis in a daily practice environment since previous randomized trials did not demonstrate the superiority of EES and BES over SES in terms of midterm angiographic outcomes.The present study was a non-randomized, retrospective, and lesion-based study, recruiting angiographically followed-up lesions within 550 days after successful and elective SES (n = 1793), EES (n = 1303), or BES (n = 324) placement for de novo native coronary stenosis during the period from August 2004 to January 2014 at 6 institutes...
May 8, 2017: International Heart Journal
https://www.readbyqxmd.com/read/28480775/drug-development-challenges-and-strategies-to-address-emerging-and-resistant-fungal-pathogens
#14
Matthew W McCarthy, Thomas J Walsh
Invasive fungal infections represent an expanding threat to public health. The recent emergence of Candida auris, which is often resistant to existing antifungal agents and is associated with a high mortality rate, underscores the urgent need for novel drug development strategies. Areas covered: In this paper, we examine both challenges and opportunities associated with antifungal drug development and explore potential avenues to accelerate the development pipeline, including data sharing, surrogate endpoints, and the role of historical controls in clinical trials...
May 15, 2017: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/28480313/an-immune-competent-murine-model-to-study-elimination-of-aav-transduced-hepatocytes-by-capsid-specific-cd8-t-cells
#15
Brett Palaschak, Damien Marsic, Roland W Herzog, Sergei Zolotukhin, David M Markusic
Multiple independent adeno-associated virus (AAV) gene therapy clinical trials for hemophilia B, utilizing different AAV serotypes, have reported a vector dose-dependent loss of circulating factor IX (FIX) protein associated with capsid-specific CD8(+) T cell (Cap-CD8) elimination of transduced hepatocytes. Hemophilia B patients who develop transient transaminitis and loss of FIX protein may be stabilized with the immune-suppressive (IS) drug prednisolone, but do not all recover lost FIX expression, whereas some patients fail to respond to IS...
June 16, 2017: Molecular Therapy. Methods & Clinical Development
https://www.readbyqxmd.com/read/28475703/cibinetide-improves-corneal-nerve-fiber-abundance-in-patients-with-sarcoidosis-associated-small-nerve-fiber-loss-and-neuropathic-pain
#16
Daniel A Culver, Albert Dahan, Daiva Bajorunas, Maria Jeziorska, Monique van Velzen, Leon P H J Aarts, Jinny Tavee, Martijn R Tannemaat, Ann N Dunne, Rita I Kirk, Ioannis N Petropoulos, Anthony Cerami, Rayaz A Malik, Michael Brines
Purpose: Sarcoidosis frequently is complicated by small nerve fiber loss (SNFL), which can be quantified using corneal confocal microscopy (CCM). Prior studies suggest that the innate repair receptor agonist cibinetide reverses corneal nerve loss. This phase 2b, 28-day, randomized trial of 64 subjects with sarcoid-associated SNFL and neuropathic pain assessed the effect of cibinetide on corneal nerve fiber area (CNFA) and regenerating intraepidermal fibers (GAP-43+) as surrogate endpoints for disease modification, pain severity, and functional capacity (6-minute walk test [6MWT])...
May 1, 2017: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/28475700/biomarkers-and-surrogate-endpoints-in-drug-development-a-european-regulatory-view
#17
Kerstin Wickström, Jane Moseley
Purpose: To give a European regulatory overview of the requirements on and the use of biomarkers or surrogate endpoints in the development of drugs for ocular disease. Methods: Definitions, methods to validate new markers, and circumstances where surrogate endpoints can be appropriate are summarized. Results: The key endpoints that have been used in registration studies so far are based on visual acuity, signs, and symptoms, or on surrogate endpoints...
May 1, 2017: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/28475699/biomarkers-and-surrogate-endpoints-lessons-learned-from-glaucoma
#18
Felipe A Medeiros
With the recent progress in imaging technologies for assessment of structural damage in glaucoma, a debate has emerged on whether these measurements can be used as valid surrogate endpoints in clinical trials evaluating new therapies for the disease. A discussion of surrogates should be grounded on knowledge acquired from their use in other areas of medicine as well as regulatory requirements. This article reviews the conditions for valid surrogacy in the context of glaucoma clinical trials and critically evaluates the role of biomarkers such as IOP and imaging measurements as potential surrogates for clinically relevant outcomes...
May 1, 2017: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/28472339/foreword-biomarkers-and-surrogate-endpoints-in-ophthalmic-clinical-research
#19
Edoardo Villani, Stela Vujosevic
No abstract text is available yet for this article.
May 1, 2017: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/28469085/gdf15-is-elevated-in-mice-following-retinal-ganglion-cell-death-and-in-glaucoma-patients
#20
Norimitsu Ban, Carla J Siegfried, Jonathan B Lin, Ying-Bo Shui, Julia Sein, Wolfgang Pita-Thomas, Abdoulaye Sene, Andrea Santeford, Mae Gordon, Rachel Lamb, Zhenyu Dong, Shannon C Kelly, Valeria Cavalli, Jun Yoshino, Rajendra S Apte
Glaucoma is the second leading cause of blindness worldwide. Physicians often use surrogate endpoints to monitor the progression of glaucomatous neurodegeneration. These approaches are limited in their ability to quantify disease severity and progression due to inherent subjectivity, unreliability, and limitations of normative databases. Therefore, there is a critical need to identify specific molecular markers that predict or measure glaucomatous neurodegeneration. Here, we demonstrate that growth differentiation factor 15 (GDF15) is associated with retinal ganglion cell death...
May 4, 2017: JCI Insight
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