Subscribe to Pediatrics

AALL1621: A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

Cancer Pediatrics Leukemia Lymphoma Pediatric Subjects Adult Subjects

This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.

CF Biobank

Pediatrics Pulmonology Lung Disease Pediatric Subjects Adult Subjects Female Subjects Male Subjects

Diabetes in Turner Syndrome

Pediatrics Endocrinology Diabetes Reproductive Disorders Pediatric Subjects Adult Subjects Female Subjects Male Subjects

201612502

Pediatrics Pediatric Subjects

Primary Objective

The primary objective of the study was to establish the effects of givinostat versus placebo administered chronically over 18 months to slow disease progression in ambulant DMD subjects.

Secondary Objectives

The secondary objectives of this study were:

* To assess the safety and tolerability of givinostat versus placebo administered chronically in DMD subjects
* To evaluate the PK profile of givinostat administered chronically in DMD subjects
* To evaluate the impact on quality of life (QoL) and activities of daily living of givinostat versus placebo administered chronically.

Oxytocin and Maternal Addiction

Pediatrics Healthy Subjects Pediatric Subjects Adult Subjects Female Subjects Male Subjects

A prior study by the principal investigator of this project identified dopamine- and oxytocin-related brain pathways that showed a diminished response when addicted mothers viewed the faces of their own vs. unknown infants, compared with non-addicted mothers. These areas include the hypothalamus, striatum and ventromedial prefrontal cortex. In addition, the investigators plan to examine activation patterns within the salience network, which includes the anterior cingulate cortex and the anterior insula. Oxytocin, a neuropeptide with decreased blood levels seen in addicted mothers, is integrally involved in maternal brain and behavioral responses. When administered intranasally, the pilot data has shown enhanced activation of the striatum, prefrontal cortex (PFC) and amygdala.

The purpose of this study is to continue and expand upon the previous investigation of maternal addiction, by conducting a randomized, double-blinded, placebo controlled, crossover study of intranasal oxytocin on maternal brain responses. 150 mothers from the University of Iowa and the Yale Child Study Center will be enrolled (75 with a history of drug addiction and 75 matched control mothers), along with their 2 to 12-month-old infants, to participate in four study visits over a two-month period.