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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 ...
Alnylam ALN-APP-001: Phase I, Placebo-Controlled Trial of ALN-APP in Participants with Early-Onset Alzheimer’S Disease
Who is Eligible Ages 18+ Must have had symptoms of Alzheimer’s disease prior to age 65 Diagnosis of Alzheimer’s disease Must be able to complete MRI Must be able to tolerate lumbar puncture No history of ...
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 ...
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
Obesity prevalence in persons with T1D has increased, which further complicates managementd risk for complications. The proposed study is relevant to public health because it helps us understand the role ...
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 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 ...
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease with ...
Why is this study being done?In some people, the liver makes an abnormal version of the alpha-1 antitrypsin (AAT) protein, called Z-AAT. Making an abnormal version of the AAT protein ...
A Phase 1 Trial of Targeted Immunotherapy with Daratumumab Following Myeloablative Total Body Irradiation (TBI)-Based Conditioning and Allogeneic Hematopoietic Cell Transplantation in Children, Adolescents and ...
A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, ...