Pruritus Severity and Serum Phosphate in CKD: A Post Hoc Analysis of Difelikefalin Studies.

Key Points: No correlation was observed between pruritus severity and serum phosphate or response to placebo or difelikefalin in patients with CKD-associated pruritus undergoing hemodialysis. Difelikefalin improved itch versus placebo irrespective of baseline serum phosphate.

Background: CKD-associated pruritus (CKD-aP) has historically been associated with elevated serum phosphate (sP).

Extended-Release Calcifediol: A Data Journey from Phase 3 Studies to Real-World Evidence Highlights the Importance of Early Treatment of Secondary Hyperparathyroidism.

Background: Early secondary hyperparathyroidism (SHPT) diagnosis and treatment are crucial to delay the progression of SHPT and related complications, in particular, cardiovascular events and bone fractures. Extended-release calcifediol (ERC) has been developed for the treatment of SHPT in patients with stage 3/4 chronic kidney disease (CKD) and vitamin D insufficiency (VDI).

Summary: This review compares baseline characteristics and treatment responses of SHPT patients receiving ERC in phase 3 studies with those treated with ERC in a real-world study.

Difelikefalin in Black/African American Hemodialysis Patients with Moderate-to-Severe Pruritus: Post hoc Analysis of KALM-1 and KALM-2.

Introduction: Black and African American (AA) people are over-represented in the kidney failure population; therefore, the safety and efficacy of difelikefalin in Black/AA patients was evaluated.

Methods: This was a post hoc, pooled exploratory subgroup analysis of the Phase 3 KALM-1 and -2 studies. Patients undergoing hemodialysis (HD) who had moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) at enrollment were stratified into self-reported Black/AA or White subgroups.

Impact of Difelikefalin on the Health-Related Quality of Life of Haemodialysis Patients with Moderate-To-Severe Chronic Kidney Disease-Associated Pruritus: A Single-Arm Intervention Trial.

Objective: Chronic kidney disease-associated pruritus (CKD-aP) can have a substantial negative impact on health-related quality of life (HRQoL), including an increased risk of depression, anxiety and sleep disturbance. This trial aimed to assess the impact of intravenous difelikefalin on HRQoL in haemodialysis patients with moderate-to-severe CKD-aP.

Methods: Post hoc analysis of an open-label, multicentre, single-arm intervention trial assessed pruritus severity and HRQoL at baseline and at 12 weeks of difelikefalin treatment using Worst Itching Intensity Numerical Rating Scale (WI-NRS), Sleep Quality Numeric Rating Scale (SQ-NRS), 5-D itch scale, Skindex-10 scale, EQ-5D-5L with Pruritus Bolt-On (EQ-PSO).

An Approach to Assessing the Influence of Environmental and Occupational Cancer Hazard Identification on Policy Decision-Making.

Background: Cancer hazard identification is critical to informing decisions on preventive actions. However, the influence of cancer hazard assessments on the creation of health-protective regulations is poorly understood. Although prior studies have measured the health and economic benefits of regulatory actions in general, we are not aware of efforts to explicitly study the influence of cancer hazard identification on policy decisions in the United States.

Difelikefalin improves itch-related sleep disruption in patients undergoing haemodialysis.

Background: Poor sleep quality is associated with higher mortality and lower quality of life in patients with chronic kidney disease-associated pruritus (CKD-aP). Difelikefalin reduces itch in patients with CKD-aP undergoing haemodialysis (HD). This post hoc analysis of the Phase 3 difelikefalin studies (Study 3105 and the pooled dataset from KALM-1 and KALM-2) evaluated whether itch reduction in individuals with CKD-aP improved sleep quality.

Protocol for the Open Sky School: a two-arm clustered randomized controlled trial to test the effectiveness of a nature-based intervention on mental health of elementary school children.

Background: This article outlines the protocol for a trial to test the effectiveness of a nature-based intervention called Open Sky School to reduce mental health problems among elementary school children. Experimental studies show that contact with nature (e.g.

Estimation of the accuracy of an ELISA test applied to bulk tank milk for predicting herd-level status for Salmonella Dublin in dairy herds using Bayesian Latent Class Models.

Enzyme-Linked Immunosorbent Assay (ELISA) test is commonly used for detection of antibodies to Salmonella Dublin in individual bovine milk samples. However, little is known about its accuracy when used on bulk tank milk for determining herd-level S. Dublin status and when evaluated without assuming a perfect reference test.

Patient Perspectives of IBD Care and Services: An Integral Part of a Pan-Canadian Quality Improvement Initiative.

Background: As beneficiaries of health service improvement initiatives, patients should have their perspectives of and gaps in care elicited to inform and guide the development of quality indicators to assess health care services. The purpose of this study was to identify patient perspectives amenable for conversion into measurable inflammatory bowel disease (IBD) care quality indicators.

Methods: Crohn's and Colitis Canada's Promoting Access and Care through Centres of Excellence (PACE) program organized four patient focus groups in three Canadian provinces in 2016 to capture the perspective of patients on IBD care services.

Healthcare practitioner experiences and willingness to prescribe pre-exposure prophylaxis in the US.

Background And Objectives: Less than 10 percent of the more than one million people vulnerable to HIV are using pre-exposure prophylaxis (PrEP). Practitioners are critical to ensuring the delivery of PrEP across care settings. In this study, we target a group of prescribers focused on providing HIV care and seeking up-to-date information about HIV.

Repeatability of a Commercially Available ELISA Test for Determining the Herd-Level subsp. Serovar Dublin Status in Dairy Herds Using Bulk Milk.

An Enzyme-Linked Immunosorbent Assay (ELISA) is currently available for detection of antibodies against Dublin in bovine milk. However, when used in a surveillance program, samples may undergo various storage conditions. The objective of this study was to estimate the repeatability of an ELISA test when used on fresh and frozen samples.

Benefits of implementing a rapid access clinic in a high-volume inflammatory bowel disease center: Access, resource utilization and outcomes.

Background: Emergency situations in inflammatory bowel diseases (IBD) put significant burden on both the patient and the healthcare system.

Aim: To prospectively measure Quality-of-Care indicators and resource utilization after the implementation of the new rapid access clinic service (RAC) at a tertiary IBD center.

Methods: Patient access, resource utilization and outcome parameters were collected from consecutive patients contacting the RAC between July 2017 and March 2019 in this observational study.

Molecular Characterization of a Familial 13.6-Mb 20p11.1p12.1 Duplication without Clinical Consequence.

Chromosomal microarray (CMA) is currently considered as a first-tier test in the genetic assessment of patients presenting with intellectual disability and/or multiple congenital abnormalities. The distinction between pathogenic CNVs, polymorphisms, and variants of unknown significance can be a diagnostic dilemma for cytogeneticists. The size of the CNV has been proposed as a useful criterion.

Perceived Quality of Care is Associated with Disease Activity, Quality of Life, Work Productivity, and Gender, but not Disease Phenotype: A Prospective Study in a High-volume IBD Centre.

Background And Aims: Measuring quality of care [QoC] in inflammatory bowel diseases [IBD] has become increasingly important, yet complex assessment of QoC from the patients' perspective is rare. We evaluated perceived QoC using the Quality of Care Through the Patient's Eyes-IBD [QUOTE-IBD] questionnaire, and investigated associations between QoC, disease phenotype, work productivity, and health-related quality of life [HRQoL] in a high-volume IBD centre.

Methods: Consecutive patients attending McGill University Health Centre [MUHC]-IBD Centre completed the QUOTE-IBD, Short Inflammatory Bowel Disease Questionnaire [SIBDQ], IBD-Control, and Work Productivity and Activity Impairment [WPAI] questionnaires.

Impact of Experimentally Induced Cognitive Dietary Restraint on Eating Behavior Traits, Appetite Sensations, and Markers of Stress during Energy Restriction in Overweight/Obese Women.

Weight loss has been associated with changes in eating behaviors and appetite sensations that favor a regain in body weight. Since traditional weight loss approaches emphasize the importance of increasing cognitive dietary restraint (CDR) to achieve negative energy imbalance, it is difficult to untangle the respective contributions of energy restriction and increases in CDR on factors that can eventually lead to body weight regain. The present study aimed at comparing the effects of energy restriction alone or in combination with experimentally induced CDR on eating behavior traits, appetite sensations, and markers of stress in overweight and obese women.

Development of a mnemonic screening tool for identifying subjects with Hunter syndrome.

Unlabelled: The Hunter Outcome Survey (HOS), an international, long-term observational registry of patients with Hunter syndrome, was used to develop a simple mnemonic screening tool (HUNTER) to aid in the diagnosis of Hunter syndrome. Data regarding the prediagnosis prevalence of ten specific signs and symptoms present in individual patients enrolled in the HOS were used to develop the HUNTER mnemonic screening tool. A total score of 6 or greater using a weighting scheme in which certain manifestations were assigned a weight of 2 (facial dysmorphism, nasal obstruction or rhinorrhea, enlarged tongue, enlarged liver, enlarged spleen, joint stiffness) and others assigned a weight of 1 (hernia, hearing impairment, enlarged tonsils, airway obstruction or sleep apnea) correctly identified 95 % of patients who had no family history of Hunter syndrome or who were not diagnosed prenatally.

IgG-detection devices for the Tus-Ter-lock immuno-PCR diagnostic platform.

The number of new Immuno-PCR technologies and applications is steadily growing as a result of a general need for more sensitive immunoassays for early detection of diseases. Although Immuno-PCR has been demonstrated to be superior to its immunoassay counterpart, it is still regarded as a challenging technology due to various problems arising from its increased detection power, such as high background noise as well as substantial batch-to-batch reproducibility issues. Current efforts have intensified to produce homogeneous universal protein-DNA conjugates to simplify this technology and render it more robust.

Combining RNA-DNA swapping and quantitative polymerase chain reaction for the detection of influenza A nucleoprotein.

The detection of proteinaceous antigens generally relies on traditional immunoassays and, more recently, on immuno-PCR (polymerase chain reaction) assays and their derivatives, which do not take advantage of the intrinsic function or binding property of a protein. The RNA-binding nucleoprotein has been shown to be an excellent target for the development of various influenza A diagnostics due to its high antigenicity and the presence of large numbers in the virus. It binds nonspecifically to the sugar-phosphate backbone of RNA as well as to single-stranded DNA (ssDNA) in vitro.

Development of a protease activity assay using heat-sensitive Tus-GFP fusion protein substrates.

Proteases are implicated in various diseases and several have been identified as potential drug targets or biomarkers. As a result, protease activity assays that can be performed in high throughput are essential for the screening of inhibitors in drug discovery programs. Here we describe the development of a simple, general method for the characterization of protease activity and its use for inhibitor screening.

Prevalence and characterization of cardiac involvement in Hunter syndrome.

Objectives: To assess the prevalence of cardiovascular signs and symptoms in a large group of patients with Hunter syndrome, an X-linked metabolic disorder caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase.

Study Design: The Hunter Outcome Survey was established to characterize the natural history of Hunter syndrome and to assess the response to enzyme replacement therapy. Echocardiographic and electrocardiographic examination results were available for 102 patients who were enzyme replacement therapy-naïve in the Hunter Outcome Survey (median age at examination, approximately 8 years) as of Jan 23, 2009.

Pharmacokinetic studies in women of 2 novel oral formulations of tranexamic acid therapy for heavy menstrual bleeding.

Two randomized, open-label clinical studies involving healthy female volunteers aged 18-45 years (study 1, N = 32; study 2, N = 40) are described, which characterize the pharmacokinetics and steady-state dosage regimen performance of 2 novel, modified-release tranexamic acid tablet formulations. The objective of these studies was to identify the optimum product formulation to advance into late-phase clinical trials for heavy menstrual bleeding. For study 1, participants received single 1.

Thorough cardiac QTc interval conductance assessment of a novel oral tranexamic acid treatment for heavy menstrual bleeding.

Objective: To assess the effect of a novel oral tranexamic acid treatment on cardiac repolarization in a randomized, double-blind, positive- and placebo-controlled, four-treatment single-dose cross-over inpatient study.

Methods: QTc interval and drug exposure relationship analyses were performed using triplicate digital electrocardiographs (ECGs) collected from 12-lead Holter monitors from healthy females (n = 48) with plasma drug concentrations and pharmacokinetics simultaneously evaluated over 24 h post-dose. Therapeutic (1.

Ultrasensitive detection of antibodies using a new Tus-Ter-lock immunoPCR system.

A system consisting of a protein LG coated surface for the capture of mammalian antibodies (target), and an antigen fused to Tus and stoichiometrically linked to a DNA template via the Tus-Ter-lock sequence allowed the ultrasensitive detection of 5.5 attomol of target by real-time immunoPCR in complex media.