The 2009 FDA PRO guidance, Potential Type I error, Descriptive Statistics and Pragmatic estimation of the number of interviews for item elicitation.

A statistical methodology named "capture recapture", a Kaplan-Meier Summary Statistic, and an urn model framework are presented to describe the elicitation, then estimate both the number of interviews and the total number of items ("codes") that will be elicited during patient interviews, and present a summary graphical statistic that "saturation" has occurred. This methodology is developed to address a gap in the FDA 2009 PRO and 2012 PFDD guidance for determining the number of interviews (sample size). This estimate of the number of interviews (sample size) uses a two-step procedure.

Type 2-like polarization and elevated CXCL4 secretion of monocyte derived macrophages upon internalization of plasma-derived exosomes from head and neck cancer patients.

Background: Exosomes are closely associated with different aspects of tumor-progression in patients with head and neck squamous cell carcinoma (HNSCC), such as angiogenesis or immune regulation. As extracellular vesicles they are involved in the intercellular communication by transferring their cargo such as proteins and nucleic acids from one cell to another. However, the influence of tumor related plasma-derived exosomes on the polarization and characteristics of monocyte derived macrophages is not fully understood.

Partial recovery of peripheral blood monocyte subsets in head and neck squamous cell carcinoma patients upon radio(chemo)therapy is associated with decreased plasma CXCL11.

Background: Head and neck squamous cell carcinoma (HNSCC) represents a common and heterogeneous malignancy of the oral cavity, pharynx and larynx. Surgery and radio(chemo)therapy are the standard treatment options and also have great influence on the composition of the tumor microenvironment and immune cell functions. However, the impact of radio(chemo)therapy on the distribution and characteristics of circulating monocyte subsets in HNSCC are not fully understood.

Different Influence Pattern of Conventional and Alternative Sources of Smoking on Adhesion Molecules and Cytokine Secretion in THP-1 Monocytes.

Background/aim: Tobacco is a carcinogen that is closely associated with the occurrence of lung cancer and head and neck squamous cell carcinoma (HNSCC). The consumption of tobacco is also leading to alterations in different immune cell subtypes. However, the impact of different conventional and alternative smoking sources on human monocytes remains elusive.

Immunomodulatory Response of the Middle Ear Epithelial Cells in Otitis Media.

Hypothesis: The middle ear (ME) epithelium transforms because of changed immunomodulation during infection.

Introduction: The epithelial cells of the tympanic cavity represent the first line of defense in the context of otitis media. They can convert from a typical mucosal site into a respiratory epithelium and vice versa.

Correlation of Intra-tumoral and Peripheral PD-1/PD-L1 Immunity in Head and Neck Cancer.

Background/aim: Head and neck squamous cell carcinoma (HNSCC) represents a heterogeneous malignant disease of the oral cavity, pharynx, and larynx. HNSCC cells evade the host immune system through alterations in their immunogenicity, production of immunosuppressive mediators, and induction of immunomodulatory cell types. The immune status of solid HNSCC can be considered as hot, cold, or excluded for each patient individually, based on the distribution of tumor infiltrating immune cells.

Systematic Review on Barriers to Access Opioid Analgesics for Cancer Pain Management from the Health Worker Perspective.

The increasing incidence of oncological diseases creates a corresponding need for effective cancer pain management (CPM). The lack of access to and availability of opioid analgesics in most countries leads to avoidable suffering. This systematic review aims to identify barriers to accessing opioids, as described in literature that reflects the perspective of health-care workers.

Differential Effects of Anti-PD-1/PD-L1 Checkpoint Inhibitors on Adhesion Molecules and Cytokine Secretion by THP-1 Monocytes.

Background/aim: Immune checkpoint inhibitors have improved the treatment regimen for human cancers in recent years. Particularly, inhibitors of the checkpoint molecules PD-1/PD-L1 have emerged as promising therapeutic treatments by preventing T-cell anergy and exhaustion. However, the impact of different anti-PD-1/PD-L1 checkpoint inhibitors on human monocytes remains elusive.

Access to cancer pain management in Ecuador from health workers' perspective: a qualitative study.

Ecuador is facing increasing health-related suffering due to cancer; however, the distributed opioid analgesic in the country is below the global average. This study explores the access to cancer pain management (CPM) from the healthcare professionals' perspective in a middle-income country. Thirty problem-centered interviews with healthcare providers were conducted in six cancer facilities and were analyzed thematically.

Hepatocyte mARC1 promotes fatty liver disease.

Background & Aims: Non-alcoholic fatty liver disease (NAFLD) has a prevalence of ∼25% worldwide, with significant public health consequences yet few effective treatments. Human genetics can help elucidate novel biology and identify targets for new therapeutics. Genetic variants in mitochondrial amidoxime-reducing component 1 () have been associated with NAFLD and liver-related mortality; however, its pathophysiological role and the cell type(s) mediating these effects remain unclear.

Plasma‑derived CD16 exosomes and peripheral blood monocytes as correlating biomarkers in head and neck cancer.

Exosomes play an important role in the individual immune regulation in patients with head and neck squamous cell carcinoma (HNSCC) as part of the tumor microenvironment. Patients with HNSCC with advanced tumor stages reveal significantly increased levels of plasma derived CD16 (FcRIIIA) total exosomes as demonstrated in our previous study. Furthermore, increased individual abundances of peripheral blood CD16 non-classical monocytes have been shown to correlate with increased monocytic programmed death ligand 1 (PD-L1) and CD4 T cell disturbances in oropharyngeal cancer.

Exome-Based Rare-Variant Analyses in CKD.

Background: Studies have identified many common genetic associations that influence renal function and all-cause CKD, but these explain only a small fraction of variance in these traits. The contribution of rare variants has not been systematically examined.

Methods: We performed exome sequencing of 3150 individuals, who collectively encompassed diverse CKD subtypes, and 9563 controls.

Diagnostic Utility of Exome Sequencing for Kidney Disease.

Background: Exome sequencing is emerging as a first-line diagnostic method in some clinical disciplines, but its usefulness has yet to be examined for most constitutional disorders in adults, including chronic kidney disease, which affects more than 1 in 10 persons globally.

Methods: We conducted exome sequencing and diagnostic analysis in two cohorts totaling 3315 patients with chronic kidney disease. We assessed the diagnostic yield and, among the patients for whom detailed clinical data were available, the clinical implications of diagnostic and other medically relevant findings.

GLP-1 Induces Barrier Protective Expression in Brunner's Glands and Regulates Colonic Inflammation.

Background: Beneficial roles for glucagon-like peptide 1 (GLP-1)/GLP-1R signaling have recently been described in diseases, where low-grade inflammation is a common phenomenon. We investigated the effects of GLP-1 in Brunner's glands and duodenum with abundant expression of GLP-1 receptors, as well as GLP-1 effect on colonic inflammation.

Methods: RNA from Brunner's glands of GLP-1R knockout and wild-type mice were subjected to full transcriptome profiling.

Applying genetics in inflammatory disease drug discovery.

Recent groundbreaking work in genetics has identified thousands of small-effect genetic variants throughout the genome that are associated with almost all major diseases. These genome-wide association studies (GWAS) are often proposed as a source of future medical breakthroughs. However, with several notable exceptions, the journey from a small-effect genetic variant to a functional drug has proven arduous, and few examples of actual contributions to drug discovery exist.

Distinct developmental profile of lower-body adipose tissue defines resistance against obesity-associated metabolic complications.

Upper- and lower-body fat depots exhibit opposing associations with obesity-related metabolic disease. We defined the relationship between DEXA-quantified fat depots and diabetes/cardiovascular risk factors in a healthy population-based cohort (n = 3,399). Gynoid fat mass correlated negatively with insulin resistance after total fat mass adjustment, whereas the opposite was seen for abdominal fat.

The differential production cross section of the [Formula: see text](1020) meson in [Formula: see text] = 7 TeV [Formula: see text] collisions measured with the ATLAS detector.

A measurement is presented of the [Formula: see text] production cross section at [Formula: see text] = 7 TeV using [Formula: see text] collision data corresponding to an integrated luminosity of 383 [Formula: see text], collected with the ATLAS experiment at the LHC. Selection of [Formula: see text](1020) mesons is based on the identification of charged kaons by their energy loss in the pixel detector. The differential cross section is measured as a function of the transverse momentum, [Formula: see text], and rapidity, [Formula: see text], of the [Formula: see text](1020) meson in the fiducial region 500 [Formula: see text] 1200 MeV, [Formula: see text] 0.

Measurement of Z boson production in Pb-Pb collisions at sqrt[s(NN)]=2.76 TeV with the ATLAS detector.

The ATLAS experiment has observed 1995 Z boson candidates in data corresponding to 0.15  nb(-1) of integrated luminosity obtained in the 2011 LHC Pb+Pb run at sqrt[s(NN)]=2.76  TeV.

Search for dark matter candidates and large extra dimensions in events with a photon and missing transverse momentum in pp collision data at sqrt[s]=7 TeV with the ATLAS detector.

Results of a search for new phenomena in events with an energetic photon and large missing transverse momentum in proton-proton collisions at sqrt[s] = 7 TeV are reported. Data collected by the ATLAS experiment at the LHC corresponding to an integrated luminosity of 4.6 fb(-1) are used.

Search for magnetic monopoles in sqrt[s]=7 TeV pp collisions with the ATLAS detector.

This Letter presents a search for magnetic monopoles with the ATLAS detector at the CERN Large Hadron Collider using an integrated luminosity of 2.0  fb(-1) of pp collisions recorded at a center-of-mass energy of sqrt[s]=7  TeV. No event is found in the signal region, leading to an upper limit on the production cross section at 95% confidence level of 1.

Improved luminosity determination in collisions at [Formula: see text] using the ATLAS detector at the LHC.

The luminosity calibration for the ATLAS detector at the LHC during collisions at [Formula: see text] in 2010 and 2011 is presented. Evaluation of the luminosity scale is performed using several luminosity-sensitive detectors, and comparisons are made of the long-term stability and accuracy of this calibration applied to the collisions at [Formula: see text]. A luminosity uncertainty of [Formula: see text] is obtained for the 47 pb of data delivered to ATLAS in 2010, and an uncertainty of [Formula: see text] is obtained for the 5.

Search for a light charged Higgs boson in the decay channel [Formula: see text] in [Formula: see text] events using collisions at [Formula: see text] with the ATLAS detector.

A search for a charged Higgs boson () in [Formula: see text] decays is presented, where one of the top quarks decays via →, followed by → two jets ([Formula: see text]). The other top quark decays to , where the  boson then decays into a lepton (/) and a neutrino. The data were recorded in collisions at [Formula: see text] by the ATLAS detector at the LHC in 2011, and correspond to an integrated luminosity of 4.

Multi-channel search for squarks and gluinos in [Formula: see text] collisions with the ATLAS detector at the LHC.

A search for supersymmetric particles in final states with zero, one, and two leptons, with and without jets identified as originating from -quarks, in 4.7 fb of [Formula: see text] collisions produced by the Large Hadron Collider and recorded by the ATLAS detector is presented. The search uses a set of variables carrying information on the event kinematics transverse and parallel to the beam line that are sensitive to several topologies expected in supersymmetry.