Comparison of false positive and false negative rates of two indices of individual reliable change: Jacobson-Truax and Hageman-Arrindell methods.

Background: Quantification of change is crucial for correctly estimating the effect of a treatment and for distinguishing random or non-systematic changes from substantive changes. The objective of the present study was to learn about the performance of two distribution-based methods [the Jacobson-Truax Reliable Change Index (RCI) and the Hageman-Arrindell (HA) approach] that were designed for evaluating individual reliable change.

Methods: A pre-post design was simulated with the purpose to evaluate the false positive and false negative rates of RCI and HA methods.

Efficacy of Amphetamine Extended-Release Oral Suspension in Children with Attention-Deficit/Hyperactivity Disorder: Effect Size Across the Day.

To evaluate the treatment effect size throughout the day of amphetamine extended-release oral suspension (AMPH EROS; Tris Pharma, Inc., Monmouth Junction, NJ, USA) in a laboratory classroom study conducted in children aged 6-12 years with attention-deficit/hyperactivity disorder (ADHD). A analysis was performed to assess the overall effect size as well as the effect size at each time point from early morning through evening (1, 2, 4, 6, 8, 10, 12, and 13 hours postdose) for each efficacy measure evaluated in a 5-week, randomized, dose-optimized, double-blind, placebo-controlled, laboratory classroom assessment, efficacy, and safety study of AMPH EROS ( = 99).

[The ethics of biomedical research in Gonzalo Herranz].

This paper explains basic ideas of Gonzalo Herranz on research ethics, in general and on human beings, obtained from the study of the fragmentary material that has been preserved (drafts and class outlines). Among other ideas, I present his thoughts on the ethical foundations of the researcher's actions: the target of the researcher, the active and passive duty to investigate, the freedom of research and the peculiarities of the relationship between the researcher and the subject of research/patient.

Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of Amphetamine Extended-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder.

To evaluate the efficacy and safety of amphetamine extended-release tablets (AMPH ER TAB) in adults with attention-deficit/hyperactivity disorder (ADHD). In a 5-week forced-dose titration phase, subjects were randomized to either oral double-blind AMPH ER TAB 5-mg starting dose or matching placebo, once daily in the morning. Safety and efficacy assessments were completed weekly.

Quantitative GC-TCD Measurements of Major Flatus Components: A Preliminary Analysis of the Diet Effect.

The impact of diet and digestive disorders in flatus composition remains largely unexplored. This is partially due to the lack of standardized sampling collection methods, and the easy atmospheric contamination. This paper describes a method to quantitatively determine the major gases in flatus and their application in a nutritional intervention.

Breath analysis using electronic nose and gas chromatography-mass spectrometry: A pilot study on bronchial infections in bronchiectasis.

Background And Aims: In this work, breath samples from clinically stable bronchiectasis patients with and without bronchial infections by Pseudomonas Aeruginosa- PA) were collected and chemically analysed to determine if they have clinical value in the monitoring of these patients.

Materials And Methods: A cohort was recruited inviting bronchiectasis patients (25) and controls (9). Among the former group, 12 members were suffering PA infection.

Full Workflows for the Analysis of Gas Chromatography-Ion Mobility Spectrometry in Foodomics: Application to the Analysis of Iberian Ham Aroma.

Gas chromatography-ion mobility spectrometry (GC-IMS) allows the fast, reliable, and inexpensive chemical composition analysis of volatile mixtures. This sensing technology has been successfully employed in food science to determine food origin, freshness and preventing alimentary fraud. However, GC-IMS data is highly dimensional, complex, and suffers from strong non-linearities, baseline problems, misalignments, peak overlaps, long peak tails, etc.

Assessing Palatability of a New Amphetamine Extended-Release Tablet Formulation for the Treatment of ADHD.

Introduction/objective: ADHD is, for many people, a lifelong disease that requires chronic medication use. Stimulant therapy is often recommended as first-line treatment for ADHD. Adherence to stimulant treatment among patients diagnosed with ADHD is poor.

Comprehensive Volatilome and Metabolome Signatures of Colorectal Cancer in Urine: A Systematic Review and Meta-Analysis.

To increase compliance with colorectal cancer screening programs and to reduce the recommended screening age, cheaper and easy non-invasiveness alternatives to the fecal immunochemical test should be provided. Following the PRISMA procedure of studies that evaluated the metabolome and volatilome signatures of colorectal cancer in human urine samples, an exhaustive search in PubMed, Web of Science, and Scopus found 28 studies that met the required criteria. There were no restrictions on the query for the type of study, leading to not only colorectal cancer samples versus control comparison but also polyps versus control and prospective studies of surgical effects, CRC staging and comparisons of CRC with other cancers.

A single-dose, comparative bioavailability study comparing amphetamine extended-release oral suspension with extended-release mixed amphetamine salts capsules.

Background: To evaluate the relative bioavailability of a single dose of amphetamine extended-release oral suspension (AMPH EROS) compared with a single dose of extended-release mixed amphetamine salts (ER MAS) in healthy, fasted adult subjects.

Methods: The study population consisted of healthy adult volunteers. The study drug used in this study was 7.

Change in the center of the distribution and in the individual scores: Relation with heteroskedastic pre- and post-test distributions.

Background: Although average-based effect size (ES) and percentage of individual changes (PIC) are quite different, they are not independent: larger ESs lead to higher PICs. However, this association has not been sufficiently explored.

Method: We analyzed this association based on data simulated in the context of a pre-post design, with and without control groups.

Single-dose pharmacokinetics of amphetamine extended-release tablets compared with amphetamine extended-release oral suspension.

Objective: Evaluate the relative bioavailability of single-dose amphetamine extended-release tablet (AMPH ER TAB) 20 mg, swallowed whole or chewed, and amphetamine extended-release oral suspension (AMPH EROS) 2.5 mg/mL; evaluate food effect on AMPH ER TAB.

Methods: Healthy volunteers (18-55 years) were randomized to 1 dose of AMPH ER TAB 20 mg swallowed (fasted), chewed (fed/fasted), or 20 mg AMPH EROS (fasted).

Single-Dose Pharmacokinetics of Amphetamine Extended-Release Oral Suspension in Healthy Adults.

This single-dose pivotal study evaluated the pharmacokinetics of amphetamine extended-release oral suspension (AMPH EROS) under fasted and fed conditions and the relative bioavailability of AMPH EROS and immediate-release mixed amphetamine salts (IR MAS) in adults. This open-label, randomized, three-period, three-treatment, six-sequence crossover study enrolled 30 healthy adult participants who were randomly assigned to receive either 1 dose of AMPH EROS 18.8 mg under fed or fasted conditions or 30 mg of IR MAS under fasted conditions.

Application of an Array of Metal-Oxide Semiconductor Gas Sensors in an Assistant Personal Robot for Early Gas Leak Detection.

This paper proposes the application of a low-cost gas sensor array in an assistant personal robot (APR) in order to extend the capabilities of the mobile robot as an early gas leak detector for safety purposes. The gas sensor array is composed of 16 low-cost metal-oxide (MOX) gas sensors, which are continuously in operation. The mobile robot was modified to keep the gas sensor array always switched on, even in the case of battery recharge.

Statistics for Evaluating Pre-post Change: Relation Between Change in the Distribution Center and Change in the Individual Scores.

In a number of scientific fields, researchers need to assess whether a variable has changed between two time points. Average-based change statistics () such as Cohen's or Hays' ω evaluate the change in the distributions' center, whereas Individual-based change statistics () such as the Standardized Individual Difference or the Reliable Change Index evaluate whether each case in the sample experienced a reliable change. Through an extensive simulation study we show that, contrary to what previous studies have speculated, and statistics are closely related.

Early-Onset Efficacy and Safety Pilot Study of Amphetamine Extended-Release Oral Suspension in the Treatment of Children with Attention-Deficit/Hyperactivity Disorder.

Objective: To determine whether amphetamine extended-release oral suspension (AMPH EROS) has an onset of effect at 30 minutes postdose in children with attention-deficit/hyperactivity disorder (ADHD).

Methods: This randomized, double-blind, two-treatment, two-sequence, placebo-controlled crossover pilot study enrolled subjects aged 6-12 years with ADHD and ADHD-Rating Scale-5 scores of ≥90th percentile for sex and age. An optimized dose of 5-20 mg/day of AMPH EROS was determined during a 1-week open-label dose optimization phase based on medication history, symptom control, and tolerability.

Site-Specific Growth and in Situ Integration of Different Nanowire Material Networks on a Single Chip: Toward a Nanowire-Based Electronic Nose for Gas Detection.

A new method for the site-selective synthesis of nanowires has been developed to enable material growth with defined morphology and, at the same time, different composition on the same chip surface. The chemical vapor deposition approach for the growth of these nanowire-based resistive devices using micromembranes can be easily modified and represents a simple, adjustable fabrication process for the direct integration of nanowire meshes in multifunctional devices. This proof-of-concept study includes the deposition of SnO, WO, and Ge nanowires on the same chip.

Instrumental drift removal in GC-MS data for breath analysis: the short-term and long-term temporal validation of putative biomarkers for COPD.

Breath analysis holds the promise of a non-invasive technique for the diagnosis of diverse respiratory conditions including chronic obstructive pulmonary disease (COPD) and lung cancer. Breath contains small metabolites that may be putative biomarkers of these conditions. However, the discovery of reliable biomarkers is a considerable challenge in the presence of both clinical and instrumental confounding factors.