Data-driven strategies for increasing patient diversity in Bristol Myers Squibb-sponsored US oncology clinical trials.

Background/aims: Determining whether clinical trial findings are applicable to diverse, real-world patient populations can be challenging when the full demographic characteristics of enrolled patients are not consistently reported. Here, we present the results of a descriptive analysis of racial and ethnic demographic information for patients in Bristol Myers Squibb (BMS)-sponsored oncology trials in the United States (US) and describe factors associated with increased patient diversity.

Methods: BMS-sponsored oncology trials conducted at US sites with study enrollment dates between 1 January 2013 and 31 May 2021 were analyzed.

Neonatal pain assessment scales: review of the literature.

Introduction: The measurement of pain is the fundamental prerequisite for its proper management. Since newborns are unable to communicate verbally, neonatal algometric scales have been developed. However, no gold standard has been identified yet.

Evaluation of an electronic health record structured discharge summary to provide real time adverse event reporting in thoracic surgery.

Background: The reporting of adverse events (AE) remains an important part of quality improvement in thoracic surgery. The best methodology for AE reporting in surgery is unclear. An AE reporting system using an electronic discharge summary with embedded data collection fields, specifying surgical procedure and complications, was developed.

HDR syndrome: a novel "de novo" mutation in GATA3 gene.

Human GATA3 haploinsufficiency leads to HDR (hypoparathyroidism, deafness, and renal dysplasia) syndrome. The development of a specific subset of organs in which this transcription factor is expressed appears exquisitely sensitive to gene dosage. We report on a 14-year-old patient with symptomatic hypoparathyroidism, sensorineural bilateral deafness, unilateral renal dysplasia, bilateral palpebral ptosis, and horizontal nystagmus.

Role of health care providers in educational training of patients with diabetes.

Diabetes mellitus is a high prevalence chronic disease, in which several health care providers are involved in the treatment of patients. Multifaceted professional and organizational interventions that facilitate structured and regular review of patients are effective in improving the process of care. Moreover, patient education and enhancement of role of nurses improve clinical outcomes and process of care.

Assessment of cardiac autonomic modulation during adolescent obesity.

Objective: To investigate the cardiovascular autonomic function in pediatric obesity of different duration by using standard time domain, spectral heart rate variability (HRV), and nonlinear methods.

Research Methods And Procedures: Fifty obese children (13.9 +/- 1.

Assessing resting heart rate in adolescents: determinants and correlates.

The aim of this study was to evaluate the distribution of resting heart rate and its biological and environmental determinants in adolescents. The study was cross- sectional and the population consisted of 2230 children and adolescents, age range 12-18 years, enrolled randomly from state schools in Turin, Italy. In all participants the following parameters were evaluated: heart rate, blood pressure (BP), weight, height, degree of sexual development, physical activity, parental socio-cultural level.

Assessment of N-methylformamide (NMF) administered orally on a three times weekly schedule: a phase I study.

This phase I study was conducted to reevaluate the dose-limiting toxicities, maximum tolerated (MTD) and recommended phase II doses of oral NMF administered on a three times weekly schedule for 4 out of every 6 weeks. This schedule was based on the observation that prolonged administration of NMF was associated with the most efficacious antitumor activity in preclinical studies. Phase II trials that employed a starting dose of 800 mg/m2, determined in a previous phase I trial, were suspended because of frequent and severe toxicities.

Clinical and pharmacologic reappraisal of dichloromethotrexate.

Dichloromethotrexate (DCMTX) has been the subject of sporadic clinical development for the last 30 years. Although DCMTX was developed in hopes of discovering a more potent antifolate, the potential pharmacologic and toxicologic advantages of the analog have become of greater interest. This phase I and pharmacokinetic trial of DCMTX given on days 1, 8, and 15 every 28 days was undertaken to test these potential advantages.