Reproducibility of in-home CFRD screening using continuous glucose monitoring and mixed meal tolerance test.

Background: Cystic fibrosis related diabetes (CFRD) is associated with insulin-remediable pulmonary decline, so early detection is critical. Continuous glucose monitors (CGM) have shown promise in screening but are not recommended by clinical practice guidelines. Little is known about the reproducibility of CGM results for a given patient.

Protein intake and postprandial hyperglycemia in children and adolescents with type 1 diabetes mellitus, a pilot study.

Background And Aims: To describe the change in glucose and the resulting postprandial hyperglycemia (PPH) that occurs after dietary protein intake (PI) in children with type 1 diabetes (T1D).

Methods: We conducted a self-controlled, non-randomized, prospective pilot study in children with T1D who were given whey protein isolate drinks (carbohydrate-free, fat-free) of increasing protein amounts (0, 12.5, 25, 37.

Dosing Colistimethate Every 8 h Results in Higher Plasma Concentrations of Active Colistin Than Every 12-Hourly Dosing without Increase in Nephrotoxicity: A Phase 1 Pharmacokinetics Trial in Healthy Adult Volunteers.

Despite its use for decades, pharmacokinetic (PK) and safety studies on colistin are limited. We conducted a phase l, open-label trial to evaluate the safety and PK of multiple doses of intravenous (IV) and aerosolized colistimethate sodium (CMS) administered separately and in combination. In total, 31 healthy adults were enrolled into three cohorts of 9, 10, and 12 participants, respectively.

Psychological Characteristics and Goals of Caregivers Choosing Continuous Glucose Monitoring for Children With Type 1 Diabetes.

Background: Continuous glucose monitoring (CGM) can improve glycemic outcomes in pediatric type 1 diabetes management. However, its impact on the psychosocial functioning of caregivers is less well described. The objectives of this pilot study were to explore caregiver reasons for adding CGM to their child's type 1 diabetes management, parental psychosocial function before initiating CGM, and the relationship between the two.

Increased Toxicity Among Adolescents and Young Adults Compared with Children Hospitalized with Acute Lymphoblastic Leukemia at Children's Hospitals in the United States.

Adolescent and young adult (AYA) patients (15-39 years old) with acute lymphoblastic leukemia (ALL) have less favorable outcomes and higher treatment-related mortality as compared with older children with ALL. Minimal data exist regarding how well AYA patients tolerate the intensity of chemotherapy at doses and regimens designed for children, and the toxicities suffered by this population at children's hospitals have not been thoroughly characterized. Pediatric Health Information Systems database was queried to analyze health care outcomes in pediatric (ages 10-14) and AYA patients (ages 15-39) with ALL hospitalized between January 1999 and December 2014.

Barriers to post-placental intrauterine device receipt among expectant minority women.

Purpose: We aimed to identify barriers to breastfeeding-compatible post-placental intrauterine devices (IUDs) for expectant predominantly non-Hispanic African-American women.

Materials And Methods: This cross-sectional survey study, conducted at 3 Cleveland community partner locations, enrolled 119 expectant predominantly unmarried but partnered non-Hispanic African-American women. The survey assessed contraceptive, IUD-specific and breastfeeding attitudes and intentions.

Fecal Calprotectin Is Elevated in HIV and Related to Systemic Inflammation.

Background: Fecal calprotectin (FC), a biomarker of gastrointestinal (GI) inflammation, is used in the diagnosis and management of inflammatory bowel disease. HIV infection severely damages gut-associated lymphoid and epithelial tissues leading to GI inflammation that drives systemic inflammation and increases subsequent risk of comorbidities. For the first time, we compared FC concentrations by HIV and antiretroviral therapy (ART) status and determined the relationship to systemic inflammation.

Lumacaftor/ivacaftor therapy is associated with reduced hepatic steatosis in cystic fibrosis patients.

Background: Hepatic steatosis is a common form of cystic fibrosis associated liver disease (CFLD) seen in an estimated 15%-60% of patients with cystic fibrosis (CF). The pathophysiology and health implications of hepatic steatosis in cystic fibrosis remain largely unknown. In the general population, hepatic steatosis is strongly associated with insulin resistance and type 2 diabetes.

Assessing the Feasibility and Effectiveness of Two Prenatal Breastfeeding Intervention Apps in Promoting Postpartum In-Hospital Exclusive Breastfeeding.

To test the feasibility and possible effects of two iPad-based breastfeeding interventions for expectant minority women and evaluate (1) the intervention effect on exclusive breastfeeding (EBF) intention, (2) intervention acceptability and satisfaction, and (3) follow-up rates of in-hospital EBF. This was a longitudinal survey study with follow-up chart review. Expectant women who completed clinically required breastfeeding education were eligible and were assigned to one of the following interventions by nonrandomized block design: the champion intervention utilized a free commercially available app to identify a supportive breastfeeding champion and the positive messaging intervention offered breastfeeding information in a question-answer format.

A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation.

Objectives: Successful decolonisation of nasal Staphylococcus aureus (SA) carriage by mupirocin is limited by increasing drug resistance. This randomised, open-label, phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial with rapid intrinsic activity against SA.

Methods: The study was performed in 60 healthy adults.

Weight-Related Teasing of Adolescents Who Are Primarily Obese: Roles of Sociocultural Attitudes Towards Appearance and Physical Activity Self-Efficacy.

Adolescents who are obese are at risk for being teased about their appearance with the concomitant negative psychological sequelae. Identifying modifiable variables associated with teasing could inform pediatric weight-management interventions. Characterizing society's role in the victimization of these at-risk individuals could guide anti-bullying programs for schools and broader public health efforts.

Antibiotic Prescription in Young Children With Respiratory Syncytial Virus-Associated Respiratory Failure and Associated Outcomes.

Objectives: To describe antibiotic prescribing practices during the first 2 days of mechanical ventilation among previously healthy young children with respiratory syncytial virus-associated lower respiratory tract infection and evaluate associations between the prescription of antibiotics at onset of mechanical ventilation with clinical outcomes.

Design: Retrospective cohort study.

Setting: Forty-six children's hospitals in the United States.

Effects of Rifamycin Coadministration on Bedaquiline Desmethylation in Healthy Adult Volunteers.

There is an urgent need to identify safe and effective combination treatments for multidrug-resistant (MDR) Mycobacterium tuberculosis infection (TB). Bedaquiline, a new diarylquinoline, is approved for the treatment of MDR pulmonary TB in combination with other drugs, which could include rifabutin, which is also used to treat drug-resistant TB. Both rifabutin and bedaquiline are metabolized via cytochrome P450 3A4, and rifabutin is an inducer of this enzyme.

A Phase 1 Pharmacokinetic and Safety Study of Extended-Duration, High-dose Cefixime for Cephalosporin-resistant Neisseria gonorrhoeae in the Pharynx.

Background: There are no fully oral recommended treatment regimens for gonorrhea. Inadequately treated pharyngeal gonococcal infections are a likely reservoir for transmission and development of antimicrobial resistance. We sought to determine an oral cefixime dosing regimen that would theoretically treat pharyngeal infections by gonococci with minimum inhibitory concentrations 0.

Short-Term Propofol Infusion and Associated Effects on Serum Lactate in Pediatric Patients.

Objectives: This study aimed to determine if short-duration procedural sedation in children with propofol is related to an adverse metabolic stress response measured by serum lactate. Propofol infusion syndrome is associated with high-dose and long-duration infusion. It has not been studied with short-duration, outpatient propofol administration.

Impact of Rifabutin or Rifampin on Bedaquiline Safety, Tolerability, and Pharmacokinetics Assessed in a Randomized Clinical Trial with Healthy Adult Volunteers.

Bedaquiline is a diarylquinoline that specifically inhibits mycobacterial ATP synthase. Bedaquiline has been used to effectively treat tuberculosis (TB) caused by drug-susceptible and drug-resistant Rifamycins are a cornerstone of combination drug regimens for the treatment of TB. This phase 1, open-label, randomized, controlled trial evaluated the effect of steady-state dosing of rifabutin or rifampin on the safety, tolerability, and pharmacokinetics of bedaquiline given as a single dose.

Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth.

Background: Heightened immune activation and exhaustion drive HIV disease progression and comorbidities. Vitamin D has pleiotropic immunomodulatory effects, but little is known about the effects of supplementation in HIV. Our study investigates changes in immune activation and exhaustion markers after 12 months of supplementation in virologically suppressed HIV-infected youth with vitamin D insufficiency.

Effects of Vitamin D Supplementation on Bone Mineral Density and Bone Markers in HIV-Infected Youth.

Background: Low bone mineral density (BMD) is a significant comorbidity in HIV. However, studies evaluating vitamin D supplementation on bone health in this population are limited. This study investigates changes in bone health parameters after 12 months of supplementation in HIV-infected youth with vitamin D insufficiency.

Safety, Tolerability, Systemic Exposure, and Metabolism of CRS3123, a Methionyl-tRNA Synthetase Inhibitor Developed for Treatment of Clostridium difficile, in a Phase 1 Study.

causes antibiotic-associated diarrhea and is a major public health concern. Current therapies disrupt the protective intestinal flora, do not reliably prevent recurrent infections, and will be decreasingly effective should less susceptible strains emerge. CRS3123 is an oral agent that inhibits bacterial methionyl-tRNA synthetase and has potent activity against and aerobic Gram-positive bacteria but little activity against Gram-negative bacteria, including anaerobes.

Neurocognitive dysfunction in HIV-infected youth: investigating the relationship with immune activation.

Background: HIV-infected individuals are at increased risk of neurocognitive impairment compared to the general population. Studies suggest that, despite combination antiretroviral therapy (cART), HIV infection causes immune activation which results in neural damage; however, few data exist in HIV-infected youth.

Methods: HIV-infected youth 8-26-years-old on cART with virological suppression were prospectively enrolled along with healthy controls.

Arterial stiffness in HIV-infected youth and associations with HIV-related variables.

Children and young adults infected with HIV are at elevated risk for cardiovascular disease (CVD). However, scarce data exist on the utility of non-invasive methods to diagnose subclinical CVD, such as pulse wave velocity (PWV), a non-invasive measure of arterial stiffness. The objectives of this study were to assess the relationship of carotid-femoral PWV with subclinical atherosclerosis measured by carotid intima-media thickness (IMT), compare measurements to healthy controls, and evaluate variables associated with PWV in HIV-infected youth.