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Primary biliary cholangitis (PBC) is typically associated with elevated serum bile acid levels and pruritus, but pruritus is often refractory to treatment with existing therapies. This phase 2 study assessed the efficacy and safety of maralixibat, a selective, ileal, apical, sodium-dependent, bile acid transporter inhibitor, in adults with PBC and pruritus. Adults with PBC and pruritus who had received ursodeoxycholic acid (UDCA) for ≥6months or were intolerant to UDCA were randomized 2:1 to maralixibat (10 or 20mg/day) or placebo for 13 weeks in combination with UDCA (when tolerated). The primary outcome was change in Adult Itch Reported Outcome (ItchRO™) average weekly sum score (0, no itching; 70, maximum itching) from baseline to week 13/early termination (ET). The study enrolled 66 patients (maralixibat [both doses combined], n = 42; placebo, n=24). Mean ItchRO™ weekly sum scores decreased from baseline to week 13/ET with maralixibat (-26.5; 95% confidence interval [CI], -31.8, -21.2) and placebo (-23.4; 95% CI, -30.3, -16.4). The difference between groups was not significant (P=0.48). In the maralixibat and placebo groups, adverse events (AEs) were reported in 97.6% and 70.8% of patients, respectively. Gastrointestinal disorders were the most frequently reported AEs (maralixibat, 78.6%; placebo, 50.0%). Conclusion: Reductions in pruritus did not differ significantly between maralixibat and placebo. However, a large placebo effect may have confounded assessment of pruritus. Lessons learned from this rigorously designed and executed trial are indispensable for understanding how to approach trials assessing pruritus as the primary endpoint and the therapeutic window of bile acid uptake inhibition as a therapeutic strategy in PBC.

The social–emotional interactions between parent and child are critical to an adaptive eating pattern. A complete assessment of feeding and nutrition requires inquiry into the caregiver/parent–child relationship during eating. This article details the 6 areas of social functioning derived from the six functional emotional milestones of the DIR/Floortime (DIR = Developmental, Individual Difference, Relationship) approach. When inquiry into these six areas is included in a comprehensive feeding assessment, there are direct implications for treatment planning and ultimately treatment effectiveness. These six areas are (1) the mood or emotional tone in the mealtime interaction; (2) pleasure in the introduction and exploration of new foods together with parents; (3) the parent’s ability to attune to child’s communicative attempts; (4) the parent’s ability to support the child’s drive to independence; (5) the parent’s ability to engage in play and conversation about feelings, imagination, and creative ideas; and (6) the parents’ ability to provide logical and accurate meanings to the child’s behavior and questions. By gaining a thorough assessment of the child’s interactions with their caregiver/parent, a clinician will be able to formulate intervention strategies that take advantage of the strengths in the relationship, and identify areas where they can support further developmental growth.

The benefits of breastfeeding for the first 6 months are well established for both the typically and atypically developing infant. As the infant develops, complementary foods are introduced to provide nutrients that breast milk can no longer provide in quantities sufficient to meet nutrient needs. Breastfeeding beyond a year continues to confer significant health, emotional, and cognitive benefits, yet for the vulnerable child, the nursing process may interfere with establishing appropriate solid food intake and weight gain. Vulnerable toddlers include those more likely to have early feeding problems: children with reflux, constipation, allergies, or sensory processing issues. Social-emotional concerns presenting in parent or child may influence the toddler’s frequency of nursing and the mother’s milk supply. The clinician should be aware of the potential risk for breastfeeding to interfere with solid food intake when medical or developmental concerns reduce interest in complementary foods. Social supports for parent and child as well as more intensive management of nursing allow for both breastfeeding to continue and appropriate complementary food intake.

To prepare specimens of Hydra viridis that either contain the normal number of nerve cells and no interstitial cells, or lack nerve cells as well as i cells and their derivative cells.

Fenfluramine was administered to 14 outpatient children with the syndrome of autism to determine whether previously produced decreases in blood serotonin concentrations and clinical improvements could be reinstituted. A double-blind medication-placebo crossover design was used. Each patient received fenfluramine 1.5 mg/kg daily (0.75 mg/kg twice daily) for 8 months, followed by placebo for 2 months. Blood serotonin levels promptly fell approximately 49% regardless of baseline levels. Clinical improvement returned, and on some scales gains after 8 months exceeded those noted after only 4 months of treatment. Significant correlations emerged among the amount of clinical response, initially high verbal IQs, and low blood serotonin concentrations. Compliance was excellent, and no clinically relevant side effects or weight changes occurred. It appears that fenfluramine is effective in ameliorating specific symptoms in certain autistic patients. The extent and mechanism of its action remain to be discovered.

Two unobtrusive studies were made of male urinal behavior in a public lavatory. It was found that the presence of another male influenced the subject’s selection of a urinal. Subjects in all but two cases maintained a distance of at least one urinal between themselves and other individuals present at the urinals. The results are discussed in light of the recent work in the areas of privacy and personal space.