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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 ...
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 ...
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 ...
A Global Phase 3 Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Intravenous AOC 1001 for the Treatment of Myotonic Dystrophy ...
To evaluate the long-term safety and tolerability of AOC 1001 in DM1 patients.THIS STUDY IS ENROLLING BY INVITATION ONLY - The study will invite participants with DM1 who completed ...
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. ...
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 ...
A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy with Dbv712 250 Mcg in 1-Through 3-Year-Old Children with Peanut Allergy ...
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.THIS STUDY IS ...
A Phase 1/2 Trial of CBL0137 in Patients with Relapsed or Refractory Solid Tumors Including CNS Tumors and Lymphoma
This phase I/II trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with solid tumors, including central nervous system (CNS) tumors or lymphoma that ...