Studies have shown that children with liver transplants demonstrate deficits on intellectual, academic, and language measures. However, limited information is known about the long-term cognitive development of these children. In this study, 15 children who were at least 2 yr post-liver transplantation (LT) were compared on cognitive measures to an equated group of 15 children with cystic fibrosis (CF). Children with CF were selected as a clinical control given similarities in disease onset and chronicity, as well as physical growth and development. Results indicated that children with LT tended to have lower verbal intelligence quotient scores and performed significantly lower than CF children on language measures, particularly on receptive language tasks. No significant differences were obtained on measures of academic achievement or visual-spatial performance. In the LT group, days in the intensive care unit, total number of days spent in the hospital during the first year following the transplant, and elevated pretransplant bilirubin levels significantly predicted the speech and language delays.
Inhaled glutathione in the dose administered did not demonstrate clinically relevant improvements in lung function, pulmonary exacerbation frequency, or patient-reported outcomes. Glutathione delivery to the airways was not associated with changes in markers of oxidation, proteolysis, or inflammation. Clinical trial registered with www.clinicaltrials.gov (NCT00506688) and https://eudract.ema.europa.eu/index.html (EudraCT 2005-003870-88).
Examined which of several apparent risk variables were predictors of internalizing and externalizing problems in 48 girls who were referred for therapy after disclosing sexual abuse. Specifically, the effects of abuse characteristics, support from nonoffending parents, victims' coping strategies, and victims' cognitive appraisals on symptomatology were assessed. As hypothesized, results indicated that internalizing and externalizing problems were associated with different sets of predictor variables. Victims' self-reports of depression and anxiety were related to lower perceived support from nonoffending parents, more use of cognitive avoidance coping, and more negative appraisals of the abuse. These results were partially replicated when using parent-report measures of depression, but were not replicated for parent reports of victim anxiety. Incest was the only variable that was significantly related to parent-reported anxiety. Parent-reported aggressive behaviors were predicted by level of abuse-related stress; and aggression, social problems, and sexual problems were all related to the tendency to cope by controlling others. Social problems were also related to coping by self-distraction. Regression analyses were done for each dependent variable to examine which predictors accounted for unique variance when controlling for other significant zero-order correlates. Implications of these results for understanding variability in symptom expression among sexual abuse victims are discussed.
Developing effective therapies against chronic wound healing deficiencies is a global priority. Thus we evaluated the safety of two different doses of topically administered autologous APOSEC, the secretome of apoptotic peripheral blood mononuclear cells (PBMCs), in healthy male volunteers with artificial dermal wounds. Ten healthy men were enrolled in a single-center, randomized, double-blinded, placebo-controlled phase 1 trial. Two artificial wounds at the upper arm were generated using a 4-mm punch biopsy. Each participant was treated with both topically applied APOSEC and placebo in NuGel for 7 consecutive days. The volunteers were randomized into two groups: a low-dose group (A) receiving the supernatant of 12.5 × 106 PBMCs and a high-dose group (B) receiving an equivalent of 25 × 106 PBMCs resuspended in NuGel Hydrogel. Irradiated medium served as placebo. The primary outcome was the tolerability of the topical application of APOSEC. All adverse events were recorded until 17 days after the biopsy. Local tolerability assessment was measured on a 4-point scale. Secondary outcomes were wound closure and epithelization at day 7. No therapy-related serious adverse events occurred in any of the participants, and both low- and high-dose treatments were well tolerated. Wound closure was not affected by APOSEC therapy.
Introduction
PRI‐002 is an orally available anti–amyloid beta (Aβ) prionic compound developed for direct disassembly of toxic Aβ oligomers relevant to Alzheimer's disease.
Methods
Two placebo‐controlled clinical phase I trials with oral dosing of PRI‐002 were conducted in healthy young subjects: A single ascending dose trial (4, 12, 36, 108, or 320 mg PRI‐002 or placebo) in 40 participants followed by a multiple ascending dose study with daily 160 mg PRI‐002 for 14 days or 320 mg for 28 days in 24 participants. The main objectives were safety, tolerability, and evaluation of pharmacokinetic (PK) parameters.
Results
PRI‐002 was safe and well tolerated after single and multiple oral administration up to the highest doses. PRI‐002 was absorbed rapidly and drug exposure increased proportional to dose. During repeated daily administration, the drug accumulated by a factor of about three. Steady‐state conditions were reached after 1 to 2 weeks.
Conclusions
The safety and PK results encourage further clinical development of PRI‐002.
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