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A Multicenter, Open-Label, Randomized, Bupivacaine-Controlled Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Aged 0 to Less Than 6 ...
This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 ...
A Phase 2, Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Rls-0071 in Newborns with Moderate ...
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left ...
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of Xmab541 in Advanced Solid Tumors
The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. ...
A Phase 1B/2A Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of Cnp-103 in Subjects Ages 12-35 with Recent Onset ...
This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. THIS STUDY IS ENROLLING BY INVITATION ...
An Observational, Long-Term Safety Study of Tzield® in Patients with Stage 2 Type 1 Diabetes
The purpose of this research is to collect general information on patients with stage 2 type 1 diabetes (T1D) and further information on the long-term effects of TZIELD® in patients ...
Pregnancy Data Repository to Assess Management of Type 1 Diabetes with Diabetes Technology
The study is being done because we want to learn more about how people with type 1 diabetes in the United States manage their diabetes during pregnancy. We will enroll ...
Rezpegaldesleukin in New Onset Type 1 Diabetes Mellitus
This Phase 2 study is a 2-arm, multi-center, double-masked, placebo-controlled, 2:1 randomized sequential trial design in new onset T1D participants (within 100 days of diagnosis). THIS STUDY IS ENROLLING BY INVITATION ...
Identification of Serum and Urine Biomarkers of Type 1 Diabetes
The purpose of this study is to identify biomarkers (small molecules in the blood) that can predict those people at risk of developing Type 1 diabetes. THIS STUDY IS ENROLLING BY ...
Continuous Glucose Monitor Derived Glucose Dynamic Index as a Diagnostic Marker for Progression to Type 1 Diabetes
This study is being done to develop a way to use information from a continuous glucose monitor (CGM) to predict a person’s progression through the Stages of Type 1 Diabetes ...
Inhale-1St: Technosphere Insulin (Afrezza) in Combination with Basal Insulin for Youth with Newly-Diagnosed Type 1 Diabetes
INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 10 to THIS STUDY IS ...