A multicenter clinical trial of gadolite oral suspension as a contrast agent for MRI

The purpose of this study was to assess the effectiveness and safety of Gadolite Oral Suspension as a gastrointestinal (GI) contrast agent for MRI in a phase II and two phase III multicenter clinical trials. Gadolite was administered to 306 patients with known or suspected abdominal and/or pelvic disease. MRI with T1- and T2-weighted sequences was performed before and after ingestion. Efficacy was evaluated by having two masked readers rate the certainty of their MR diagnosis (0 = uncertain, 1 = probable, 2 = definite) on randomly presented pre- and post-Gadolite Oral Suspension enhanced images. Principal investigators also evaluated the images and established the final diagnosis. Vital signs, clinical chemistries, and adverse events were documented. Blood and urine samples were analyzed for gadolinium content to determine whether Gadolite Oral Suspension was absorbed systemically. Certainty in MR diagnosis increased significantly (P < .001) for both blinded readers between pre- and post-Gadolite images (.49–1.18 for reader 1; .46–1.53 for reader 2). Sensitivity, specificity, and accuracy also increased for both masked readers. No gadolinium was detected in blood or urine samples. There were no serious adverse events and no apparent drug-related trends in mean vital signs or laboratory values. Gadolite is a highly effective, safe, and well tolerated contrast agent for clinical use with MRI.     

Self-Concept and Satisfaction With Physical Appearance in Youth With and Without Oral Clefts

This study investigated relationships between child/parent dissatisfaction with child facial appearance and the self-concept/social competence of 8- to 15-year-old children with (N = 34) and without (N = 34) oral clefts. Children in both groups had normative psychosocial adjustment, but also reported moderate dissatisfaction with facial appearance. Cleft group parents were more likely to agree with their child's dissatisfaction. When cleft group parents were more dissatisfied with child facial appearance, their children reported better quality of life. Results suggest that parents of children with clefts reporting greater dissatisfaction may respond in positive ways that enhance quality of life.     

Balance and recovery from a perturbation are impaired in people with functional ankle instability.

OBJECTIVE: To determine if differences in balance and recovery would be found between controls and participants with unilateral or bilateral functional ankle instability (FAI). DESIGN: Cross-Sectional Study. SETTING: University laboratory and Community premises. PARTICIPANTS: Twenty healthy participants(C), 19 participants with unilateral FAI [both the uninjured (UC) and unstable ankle (UI) were included] and 22 participants with bilateral FAI (BI). MAIN OUTCOME MEASURES: Balance was measured in single leg stance as: number of part foot lifts in 30 s; magnitude of medio-lateral ankle movement in two foot positions; and ability to balance on the ball of the foot. Recovery was determined by time to return to baseline medio-lateral ankle movement after a 15 degree inversion perturbation. RESULTS: The controls lifted the foot fewer times than the other three groups [C = 12.7 +/- 1.8 (mean +/- SE) foot lifts, UC = 22.9 +/- 2.5, UI = 25.1 +/- 2.3, and BI = 21.1 +/- 2.2, t-test, P = 0.006] and recovered significantly faster than the unstable ankles [C = 1.53 +/- 0.42 sec (median +/- SE), UI = 2.34 +/- 0.30 sec, BI = 2.15 +/- 0.70 sec, P < 0.02]. With FAI measured by the Cumberland Ankle Instability Tool, the external control group balanced on demi-pointe better than both instability groups (P < 0.05), and recovered quicker than all groups. CONCLUSION: There are differences in balance and recovery between external controls and participants with both unilateral and bilateral FAI but not between the legs of participants with unilateral FAI.     

Allodynia in rats infected with varicella zoster virus—a small animal model for post-herpetic neuralgia

The most common complication of herpes zoster is post-herpetic neuralgia (PHN), which has been defined as severe pain occurring 1 month after rash onset or persisting for greater than 3 months. PHN is classed as a neuropathic pain that is associated with mechanical allodynia where normally innocuous tactile stimuli are perceived as painful. The development of therapies to treat PHN has been hampered by the lack of animal models, which mimic the clinical situation. We have previously reported that varicella zoster virus (VZV) infection in the rat results in mechanical allodynia and thermal hyperalgesia. Here, we report that following VZV infection of the left footpad rats develop a chronic mechanical allodynia, which is present for longer than 60 days post-infection and which resolves by 100 days PI. The model is robust and reproducible with animals consistently developing allodynia by 3 days PI and continuing to present with symptoms for at least 30 days. The reproducible nature of the induction and course of the allodynia allows the use of this model to determine the effect of various compounds on, and to investigate the pathogenic mechanisms underlying the development of VZV-induced allodynia. Comparative studies using HSV-1 show that the induction of the chronic allodynia is VZV-specific and is not a result is of virus replication-induced tissue damage or accompanying inflammation.Therefore, we propose that the rat VZV infection model could prove useful in studying the mechanisms underlying post-herpetic neuralgia.