David A Carlin

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OBJECTIVES To evaluate the safety, tolerance, and efficacy of palivizumab in children with hemodynamically significant congenital heart disease (CHD). STUDY DESIGN A randomized, double-blind, placebo-controlled trial included 1287 children with CHD randomly assigned 1:1 to receive 5 monthly intramuscular injections of 15 mg/kg palivizumab or placebo.(More)
BACKGROUND Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection in infants. MEDI-493 (palivizumab) is a humanized monoclonal antibody to the fusion protein of RSV and is active in animal models for prevention of pulmonary RSV replication. OBJECTIVE To describe the safety, tolerance, immunogenicity and(More)
Disagreement still exists in the literature as to the significance of the high-intensity zone (HIZ) demonstrated on magnetic resonance imaging (MRI) as a potential pain ¶indicator in patients with low back pain. A prospective blind study was therefore conducted to evaluate the lumbar disc high-intensity zone with the pain provocation response of lumbar(More)
BACKGROUND Findings of small studies have suggested that short treatments with anti-CD3 monoclonal antibodies that are mutated to reduce Fc receptor binding preserve β-cell function and decrease insulin needs in patients with recent-onset type 1 diabetes. In this phase 3 trial, we assessed the safety and efficacy of one such antibody, teplizumab. METHODS(More)
Thirty-five children <2 years of age mechanically ventilated for respiratory syncytial virus (RSV) infection were randomized to receive an intravenous infusion of 15 mg/kg MEDI-493 or placebo. RSV concentration was measured in tracheal secretions by plaque assay before and at 24-h intervals after treatment. The reduction in tracheal RSV concentration from(More)
To evaluate the safety and immunogenicity of palivizumab, 55 children who received palivizumab in the IMpact-RSV trial received 5 monthly doses of 15 mg/kg palivizumab (Synagis) during the subsequent year. The single child with an antipalivizumab titer of >1/40 had no associated serious adverse events and had expected serum palivizumab trough(More)
Sixty-three previously untreated patients with metastatic non-small cell lung cancer (40 patients with adenocarcinoma and 23 with large cell undifferentiated carcinoma) were treated with combination chemotherapy consisting of 5-FU (300 mg/m2) given as an iv bolus on Days 1-4 and vindesine (3 mg/m2) and mitomycin (10 mg/m2), both given as an iv bolus on Day(More)
Protégé was a phase 3, randomized, double-blind, parallel, placebo-controlled 2-year study of three intravenous teplizumab dosing regimens, administered daily for 14 days at baseline and again after 26 weeks, in new-onset type 1 diabetes. We sought to determine efficacy and safety of teplizumab immunotherapy at 2 years and to identify characteristics(More)
Serum levels of the breast cancer-associated tumor marker CA15-3 were evaluated in three patient groups: breast, colorectal and ovarian cancer and in healthy subjects. Of 51 blood samples obtained from 31 patients with metastatic breast cancer (Stage IV disease), 98% had marker levels greater than 30 u/ml and 86% had levels greater than 50 u/ml. In(More)
Protégé was a phase 3, randomized, double-blind, parallel, placebo-controlled 2-year study of three intravenous teplizumab dosing regimens, administered daily for 14 days at baseline and again after 26 weeks, in new-onset type 1 diabetes. We sought to determine efficacy and safety of teplizumab immunotherapy at 2 years and to identify characteristics(More)