A Scale-Out Study of an Evidence-Based Family Meals Program Delivered in the Head Start Setting: Results, Challenges, and Opportunities.

There is need to identify evidence-based early childhood obesity prevention programs that are feasible and demonstrate cost-effectiveness for a broader health impact. This scale-out study leveraged community-engaged principles to compare the feasibility and cost-effectiveness of three delivery modes of a childhood obesity prevention family meals program (Simple Suppers) that demonstrated positive impacts on child and caregiver diet/nutritional health-related outcomes in a previous experimental trial tested among elementary-aged children. This three-arm (in-person, online, hybrid) pre-(T0) and post-(T1)-test study included families recruited from Head Start.

Patterns of participation in summer programming among United States' elementary children from low-income urban households: Results from the project SWEAT study.

Food insecurity increases among marginalized children during the summer when school is out of session. Summer programming that offers access to healthy meals and snacks may reduce the risk. There is a national call in the US for more research to assure equitable access to summer programming.

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education.

Background: Food provision interventions (eg, produce/food prescriptions, food pharmacies, food voucher programs) that bridge clinic and community settings for improved nutritional health outcomes of at-risk patients have gained momentum. Little is known about the role of nutrition education and potential augmented impact on patient outcomes.

Objective: To describe intervention designs and outcomes of direct food provision clinic-community programs aimed at improving diabetes-related outcomes (glycated hemoglobin [HbA1c] levels) among patients with type 2 diabetes (T2DM) or prediabetes and food insecurity, and to compare nutrition education components across interventions.

Online Grocery Shopping and the Supplemental Nutrition Assistance Program (SNAP) Electronic Benefit Transfer Card (EBT): Perceptions of Head Start Caregivers.

The objective of this study was to explore perceptions of online grocery shopping and the online United States Department of Agriculture's (USDA) Supplemental Nutrition Assistance Program (SNAP) Electronic Benefit Transfer card (EBT) program among Head Start caregivers. Three focus groups were conducted between December 2019 and January 2020. Most participants hadn't tried online grocery shopping.

The Diet Quality of a Sample of Predominantly Racial Minority Children From Low-Income Households Is Lower During the Summer vs School Year: Results From the Project Summer Weight and Environmental Assessment Trial Substudy.

Background: Little is known about the diet quality of racial minority children during the summertime when school is out of session and there is risk of accelerated weight gain. Project Summer Weight and Environmental Assessment Trial was an observational, prospective study exploring child weight status and health trends during the summer.

Objective: The objective of this substudy of Project Summer Weight and Environmental Assessment Trial was to examine the diet quality of elementary-aged racial minority children during the summertime vs school year.

Properties of neurons in the superficial laminae of trigeminal nucleus caudalis.

The trigeminal nucleus caudalis (TNc) receives extensive afferent innervation from peripheral sensory neurons of the trigeminal ganglion (TG), and is the first central relay in the circuitry underpinning orofacial pain. Despite the initial characterization of the neurons in the superficial laminae, many questions remain. Here we report on electrophysiological properties of 535 superficial lamina I/II TNc neurons.

Ovarian hormones modulate multidrug resistance transporters in the ovary.

Background: Multidrug resistance transporters (MDRs) are transmembrane proteins that efflux metabolites and xenobiotics. They are highly conserved in sequence and function in bacteria and eukaryotes and play important roles in cellular homeostasis, as well as in avoidance of antibiotics and cancer therapies. Recent evidence also documents a critical role in reproductive health and in protecting the ovary from environmental toxicant effects.

Structured Risk Assessment for First-in-Human Studies.

We describe a structured risk assessment and risk mitigation process that is currently used to evaluate proposed first-in human (FiH) studies. This process balances the inherent risks of an FiH study with maximal protection of subjects. Risk assessment should consider all available data, carefully identifying aspects that may lead to risk for healthy subjects.

Safety in FIH Trials: A Summary of the Symposium "Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost".

A cross-section of clinical research professionals convened at the June 2016 Drug Information Association annual meeting in Philadelphia to discuss and critically analyze the first-in-human (FIH) clinical trial conducted by a French CRO with BIA 10-2474 (BIA) under development for pain relief by Bial-Portela & Ca., S.A.

Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies: A Moderated Forum Session.

This paper summarizes a discussion that took place at the 52nd Annual DIA Meeting in Philadelphia, PA, on June 30, 2016, titled "Hot-Button Protocol and Operational Issues between Sponsors and Sites in Clinical Pharmacology Studies." The symposium was a moderated panel of phase 1 clinical research experts representing the sponsor, and investigational sites. Conference attendees of similar experience joined in the discussion after commentary by each panelist.

Colorado pediatricians' involvement in community activities.

To determine Colorado American Academy of Pediatrics (AAP) pediatricians' involvement in community-based activities and awareness of and interest in the AAP Community Access to Child Health (CATCH) program, a 22-item survey was mailed to all general pediatrician AAP fellows and candidate fellows practicing in Colorado (n = 434). The return rate was 65%. Of the respondents, 73% provide direct patient care as their primary professional activity, 58% reported either current or past involvement in community-based programs outside of their practices, 91% of this community-based work was voluntary, and 80% of the respondents described this work as moderate to very rewarding.

Phase II study of mitoxantrone, leucovorin, and infusional fluorouracil for treatment of metastatic breast cancer.

A new combination of mitoxantrone, folinic acid (leucovorin), and infusional fluorouracil (5-FU) was administered to 57 previously treated patients with metastatic breast cancer to evaluate the response rate, response duration, and toxicity of this regimen. Fifty-three patients who received 313 courses of therapy were assessable for response and toxicity. Median age was 48 years (range, 33 to 80 years), and the patients had received an average of 1.

Radioreceptor assay of dopamine binding activity in human serum after tiospirone administration.

Tiospirone has demonstrated preclinical activities that predict utility as an antipsychotic drug which lacks the potential to produce extrapyramidal side effects. Indeed, human safety trials after single and multiple dose administration did not reveal the presence of any neurological effects. Serum samples from these studies were obtained for radioreceptor assay to determine the level of dopamine binding activity present.

Pharmacokinetics of buspirone in elderly subjects.

Twenty-four men and 24 women ages 20-77 years received a single 15 mg oral dose of buspirone followed by 4 days of 15 mg tid administration. Plasma concentrations of buspirone and 1-pyrimidinylpiperazine following both single and multiple dosing were determined by RIA and GCMS, respectively. There were no significant differences between the young and elderly of either gender with regard to buspirone AUC, Cmax, Tmax and half-life values.

Phase I trial of adjuvant chemotherapy with cyclophosphamide, epirubicin and 5-fluorouracil (CEF) for stage II breast cancer.

Epirubicin is a new anthracycline with a potentially more favorable toxicity profile than the parent compound, doxorubicin. Accordingly, the feasibility and toxicity of 6 courses of adjuvant chemotherapy with cyclophosphamide (C), epirubicin (E), and 5-fluorouracil (F) were assessed in 10 patients with Stage 2 (node positive) breast cancer. Doses of C and F were 600 mg/m2 and E was 75 mg/m2.

Lack of interaction between cimetidine and buspirone.

Simultaneous administration of cimetidine and many benzodiazepine anxiolytics has resulted in decreased body clearance and marked prolongation of the half-life of these agents. The pharmacokinetic interaction of buspirone, a new nonbenzodiazepine anxiolytic, and cimetidine was studied in 10 healthy male volunteers. Each received, in order, buspirone 45 mg/day (days 1-7), no drug (days 8-14), cimetidine 1 g/day (days 15-21), buspirone 45 mg/day plus cimetidine 1 g/day (days 22-28), and cimetidine 1 g/day (days 29-31).

Multiple myeloma with polyneuropathy and coagulopathy. A case report of the polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin change (POEMS) syndrome.

A patient with the syndrome of polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) had multiple myeloma and IgA-kappa monoclonal gammopathy. To our knowledge, of over 50 cases in the literature, this is the only instance of kappa light chains noted in a patient with the complete syndrome. Sural nerve biopsy revealed increased immunofluorescence for IgA and kappa chains.

Inhibition of mitogen- and antigen-induced lymphocyte activation by human leukemia cell gangliosides.

Human leukemia cell gangliosides were found to inhibit in vitro activation of human lymphocytes by lectins and the soluble antigen Candida albicans at concentrations as low as 2 micrograms/2 X 10(5) lymphocytes/0.2-ml cultures. The inhibition was not due to a reduction in the number of viable cells, but to an inhibition of blast formation.

Isolation and characterization of gangliosides from chronic myelogenous leukemia cells.

Gangliosides isolated from the cells of three patients with chronic myelogenous leukemia (CML) were purified by Folch partitioning, diethylaminoethyl Sephadex, Florisil (acetylated gangliosides), and silicic acid chromatography and were structurally analyzed using thin-layer and gas-liquid chromatography, methylation analysis, enzyme degradation, and high-performance liquid chromatography. With these methods, the major gangliosides isolated were II3-alpha-N-acetylneuraminosyl-lactosylceramide, IV3-alpha-N-acetylneuraminosyl-neolactotetraosylceramide (sialosylparagloboside), and a ganglioside with the following structure: NeuAc alpha 2 leads to 3(Gal beta 1 leads to 4 GlcNac beta 1 leads to 3)2Gal beta 1 leads to 4Glc beta 1 leads to 1Cer. This ganglioside has previously been characterized as an "i" active compound.

Gangliosides of human chronic lymphocytic leukemia and hairy cells.

Gangliosides were purified from the cells of two patients with hairy cell leukemia and one patient with chronic lymphocytic leukemia. Quantification of these compounds showed that these cells contain only 5-15% of the amount of lipid-bound sialic acid (gangliosides) per cell as normal lymphocytes. Structural characterization by gas-liquid chromatography, glycosidase treatment and high-performance liquid chromatography demonstrated that the major gangliosides of these leukemia cells were of the lactosyl type.

Gangliosides of human acute leukemia cells.

We characterized the gangliosides from cells of eight patients with different forms of acute leukemia (four lymphoblastic, four nonlymphoblastic) by thin-layer chromatography and high-performance liquid chromatography combined with glycosidase treatment. Our analysis indicated both quantitative and qualitative differences between the gangliosides of acute leukemia and those of normal leukocytes: 1, the absolute amount of ganglioside was decreased in the acute leukemia cells; 2, in general, acute leukemias had a more simplified ganglioside pattern in that they contained a greater proportion of the short-chain ganglioside, II3NeuAc-LacCer (GM#); 3, all of the acute leukemia cells contained reduced quantities of the ganglioside N-acetylneuraminosyl-lactotriaosylceramide, a compound previously found only in normal leukocytes; and 4, a disialylated ganglioside, II3(NeuAc)2-LacCer (GD3), which is not found in normal leukocytes, was isolated from the cells of one patient with acute nonlymphoblastic leukemia. These findings demonstrate important differences between the gangliosides of acute leukemia cells and normal leukocytes.

Vincristine, doxorubicin and mitomycin (VAM) in patients with advanced breast cancer previously treated with cyclophosphamide, methotrexate and fluorouracil (CMF). A clinical trial of the Piedmont Oncology Association (POA).

Thirty-six evaluable patients with advanced breast cancer who had failed prior CMF therapy [15 (42%) as adjuvant treatment and 21 (58%) for advanced disease] were treated with a combination of vincristine, doxorubicin, and mitomycin (VAM). There was one CR and 10 PR, giving a response rate of 31% (P, 95% confidence interval, 15%-47%). Response was not significantly related to age, performance status, disease-free interval, dominant site of disease, number of sites of disease, or estrogen receptor status.

High-performance liquid chromatography of long-chain neutral glycosphingolipids and gangliosides.

We describe a method for analyzing the perbenzoyl derivatives of both neutral glycosphingolipids and gangliosides with a single high-performance liquid chromatography system. Use of this system, combined with endo- and/or exoglycosidase treatment of glycosphingolipids, provides a sensitive method for obtaining structural information on these compounds. This system has two advantages over previously published chromatography procedures: (i) it uses a commercially available column, and (ii) this single column can be used to analyze gangliosides and their neutral glycosphingolipid products generated by neuraminidase treatment.

Neutral glycosphingolipids of human acute leukemias.

Neutral glycosphingolipids were isolated from the malignant cells of several patients with different types of acute leukemia. Analyses were performed by high performance liquid chromatography combined with enzymatic hydrolysis of glycosphingolipids using glycosidases (Escherichia freundii endo-beta-galactosidase, jack bean beta-galactosidase, and beef kidney beta-hexosaminidase). We found that acute leukemia cells contain very little or none of the more complex neutral glycosphingolipids that are found in normal leukocytes or chronic leukemia cells.