College Readiness through an Innovative Concurrent Enrollment Program for Underrepresented College Bound Students

This paper explores several key findings of the first three cohorts of the South Los Angeles Mathematics (SLAM) Project. The SLAM Project is a longitudinal study designed to learn the best practices to employ in order to increase college access and success for underrepresented students. In particular, this project tackles the mathematics remediation crisis directly in order to ensure that the students in the program begin their postsecondary careers in credit bearing courses and shorten their time to degree. The program is unique in its student selection and instructional model. Quantitative and qualitative results indicate significant effects of college level coursework on student perceptions, attitudes, and persistence rates

An Evaluation of the Anchor-Site Phase of Family to Family

Examines updated outcomes of Casey's initiative to help states improve the quality of foster care while reducing its prevalence through community partnerships; team decision making; foster family recruitment, development, and support; and self-evaluation

Analysis of Nausea in Clinical Studies of Lubiprostone for the Treatment of Constipation Disorders

BACKGROUND: Lubiprostone is a ClC-2 chloride channel activator approved for the treatment of chronic idiopathic constipation (CIC) and opioid-induced constipation (OIC) in adults and irritable bowel syndrome with constipation (IBS-C) in women. Lubiprostone is generally well tolerated, with nausea being the most common adverse event. AIMS: To characterize nausea with lubiprostone using pooled results from clinical studies in patients with CIC, OIC, or IBS-C. METHODS: Data from three 3- and 4-week placebo-controlled studies and three long-term open-label studies were pooled for the CIC analysis. The OIC and IBS-C analyses each used pooled data from three 12-week placebo-controlled studies and one 36-week open-label extension study. RESULTS: The populations included the following numbers of patients: CIC, 316 (placebo) and 1113 (lubiprostone 24 mcg twice daily [BID]); OIC, 652 (placebo) and 889 (lubiprostone 24 mcg BID); and IBS-C, 435 (placebo) and 1011 (lubiprostone 8 mcg BID). The incidence of nausea in lubiprostone-treated patients ranged from 11.4 to 31.1%, with the highest incidence in patients with CIC. Among patients with any nausea, most reported only mild or moderate severity (96.5-99.1% across indications) and only one event (83.6-88.7%); most events occurred within the first 5 days of treatment. CONCLUSIONS: Nausea was the most common adverse event following the treatment with lubiprostone. Event rates varied by indication and dose, and the majority of nausea adverse events were mild to moderate in severity. Nausea events predominantly occurred early in the treatment period in all of the pooled study populations

Tolerability of NGX-4010, a capsaicin 8% patch, in conjunction with three topical anesthetic formulations for the treatment of neuropathic pain

Lynn R Webster1, John F Peppin2, Frederick T Murphy3,4, Jeffrey K Tobias5, Geertrui F Vanhove51Lifetree Clinical Research and Pain Clinic, Lifetree Medical Inc, Salt Lake City, UT, USA; 2Clinical Research Division, The Pain Treatment Center of the Bluegrass, Lexington, KY, USA; 3Altoona Center for Clinical Research, Duncansville, PA, USA; 4University of Pennsylvania, School of Medicine, Philadelphia, PA, USA; 5NeurogesX Inc, San Mateo, CA, USABackground: The objective of this study was to assess the safety, tolerability, and preliminary efficacy of NGX-4010, a capsaicin 8% patch, following pretreatment with three different topical anesthetics in patients with peripheral neuropathic pain.Methods: This open-label, multicenter study enrolled 117 patients with post-herpetic neuralgia, HIV-associated distal sensory polyneuropathy, or painful diabetic neuropathy. Patients received pretreatment with one of three lidocaine 4%-based topical anesthetics (L.M.X.4® [Ferndale Laboratories Inc, Ferndale, MI], Topicaine® Gel [Estela Basso, Jupiter, FL], or Betacaine Enhanced Gel 4 [Tiberius Inc, Tampa, FL]) for 60 minutes followed by a single 60- or 90-minute NGX-4010 application, and were followed for 12 weeks. Tolerability and safety measures included “pain now” Numeric Pain Rating Scale (NPRS) scores, dermal assessments, medication use for treatment-related pain, adverse events (AEs), clinical laboratory parameters, physical examinations, and vital signs. The primary efficacy variable was the percentage change in mean NPRS scores for “average pain for the past 24 hours” from baseline to weeks 2 through 12.Results: Treatment with NGX-4010 following pretreatment with any of the three topical anesthetics was generally safe and well tolerated. Nearly all patients completed ≥90% of the planned NGX-4010 application duration. The most common treatment-related AEs, application-site burning and application-site pain, were transient, mostly mild or moderate, and could be adequately managed by local cooling or short-acting oral opioid analgesics. Although slightly more patients used medication for treatment-related discomfort following pretreatment with Topicaine compared with L.M.X.4 or Betacaine, there were no statistical differences between the topical anesthetics. Neuropathic pain reduction from baseline to weeks 2 through 12 was approximately 30% and was similar among the topical anesthetics; the proportion of responders ranged from 45% to 50%.Conclusion: Treatment with NGX-4010 following pretreatment with any of the three topical anesthetics was generally safe and well tolerated; no significant differences in the parameters measured were noted between the pretreatment groups.Keywords: neuropathic pain, capsaicin patch, tolerability, topical anesthetic

Peripherally acting mu-opioid antagonist for the treatment of opioid-induced constipation: Systematic review and meta-analysis

Background and Aim Opioid-induced constipation (OIC) is a frequent adverse event (AE) that impairs patients' quality of life (QOL). Peripherally acting mu-opioid receptor antagonists (PAMORAs) have been recognized as a treatment option for OIC, but the effect consistent across the studies has not been evaluated. Methods We conducted a quantitative meta-analysis to explore the efficacy of PAMORA for OIC (registered with PROSPERO: CRD42018085298). We systematically searched randomized controlled trials (RCTs) in Medline, Embase, and Central databases. Change from baseline in spontaneous bowel movements, pooled proportion of responders, QOL, and AEs were calculated and compared with results in placebo cases. Results We included 31 RCTs with 7849 patients. A meta-analysis revealed that patients under PAMORA therapy had considerably improved spontaneous bowel movement from baseline compared with those given placebo (20 RCTs; mean difference, 1.43; 95% confidence interval [CI], 1.18-1.68; n = 5622) and more responded (21 RCTs; risk ratio [RR], 1.81; 95% CI, 1.55-2.12; n = 4821). Moreover, QOL of patients receiving PAMORA was significantly better (8 RCTs; mean difference, -0.22; 95% CI, -0.28 to -0.17; n = 2884). AEs were increased significantly in the PAMORA group (26 RCTs; RR, 1.10; 95% CI, 1.06-1.15; n = 7715), especially in gastrointestinal disorders, whereas serious AEs were not significant (17 RCTs; RR, 1.04; 95% CI, 0.85-1.28; n = 5890). Conclusion Peripherally acting mu-opioid receptor antagonist has been shown to be effective and durable for patients with OIC and is the only drug with confirmed evidence in meta-analysis. The possibility of publication bias was the limitation of this study.ArticleJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY.34(5):818-829(2019)journal articl

Effects of concurrent intravenous morphine sulfate and naltrexone hydrochloride on end-tidal carbon dioxide

<p>Abstract</p> <p>Background</p> <p>Respiratory depression, a potentially fatal side-effect of opioid-overdose, may be reversed by timely administration of an opioid antagonist, such as naloxone or naltrexone. Tampering with a formulation of morphine sulfate and sequestered naltrexone hydrochloride extended release capsules (MS-sNT) releases both the opioid morphine and the antagonist naltrexone. A study in recreational opioid-users indicated that morphine and naltrexone injected in the 25:1 ratio (duplicating the ratio of the formulation) found MS-sNT reduced morphine-induced euphoric effects vs intravenous (IV) morphine alone. In the same study, the effects of morphine + naltrexone on end-tidal carbon dioxide (EtCO₂), a measure of respiratory-depression, were evaluated and these data are reported here.</p> <p>Methods</p> <p>Single-center, placebo-controlled, double-blind crossover study. Non-dependent male opioid users were randomized to receive single IV doses of placebo, 30 mg morphine alone, and 30 mg morphine + 1.2 mg naltrexone. EtCO₂was measured by noninvasive capnography.</p> <p>Results</p> <p>Significant differences in EtCO₂least-squares means across all treatments for maximal effect (E_max) and area under the effect curve (AUE_0-2, AUE_0-8, AUE_0-24) were detected (all p ≤ 0.0011). EtCO₂E_maxvalues for morphine + naltrexone were significantly reduced vs morphine alone (42.9 mm Hg vs 47.1 mm Hg, p < 0.0001) and were not significantly different vs placebo (41.9 mm Hg). Median time to reach maximal effect (TE_max) was delayed for morphine + naltrexone vs morphine alone (5.0 h vs 1.0 h).</p> <p>Conclusions</p> <p>Results provide preliminary evidence that the naltrexone:morphine ratio within MS-sNT is sufficient to significantly reduce EtCO₂when administered intravenously to non-dependent male recreational opioid-users. Further studies with multiple measures of respiratory-function are warranted to determine if risk of respiratory depression is also reduced by naltrexone in the tampered formulation.</p

Community volunteer support for families with young children: Protocol for the volunteer family connect randomized controlled trial

Background: Use of community volunteers to support vulnerable families is a widely employed strategy with a long history. However, there has been minimal formal scientific investigation into the effectiveness of volunteer home visiting programs for families. There is also a need for research examining whether volunteer home visiting leads to improved outcomes for volunteers. Objective: The objective of this paper is to describe the research protocol for a pragmatic randomized controlled trial (RCT) of the Volunteer Family Connect intervention, a volunteer home visiting program designed to support families of young children who experience social isolation or a lack of parenting confidence and skills. The project is being conducted in partnership with 3 leading not-for-profit organizations, designed to contribute to the body of evidence that informs decisions about appropriate family support services according to the level of need. It is the first study to examine outcomes for both the families and the volunteers who deliver the service. Methods: The RCT is being conducted in 7 sites across Australia. We aim to recruit 300 families to the study: 150 control (services as usual) and 150 intervention (services as usual + volunteer home visiting) families. Intervention families will receive the service for 3-12 months according to their needs, and all participants will complete 6 data collection points over 15 months. A minimum of 80 volunteers will also be recruited, along with a matched community comparison group. The volunteers will complete 3 data collection points over 12 months. Primary outcomes include community connectedness and parenting competence. Secondary outcomes include parent physical and mental health; general parent well-being; parent empowerment; the child-parent relationship; sustainability of family routines; child immunization; child nutrition or breastfeeding; number of accidental injury reports; and volunteer health, well-being, and community connectedness. Results: This effectiveness trial was funded in 2016, and we aim to complete data collection by the end of 2018. The first results are expected to be submitted early in 2019. Conclusions: There is a need to rigorously assess volunteer home visiting and whether it has a unique and important role on the service landscape, complementary to professional services. This research is the first trial of a volunteer home visiting program to be conducted in Australia and one of the largest of its kind worldwide