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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
CSP #2037S - Veterans Affairs Learning Health System Initiative to Assess Novel Screening vs. Usual Care and Treatment With Apixaban vs. Rivaroxaban in Veterans With Atrial Fibrillation (VALIANT-AF-S) Trial
* The goal of the screening trial is to determine whether early screening for atrial fibrillation improves outcomes, including lowering the chance of death, ho…
State-Dependent Interoception, Value-Based Decision Making, and Introspection
Background: Negative emotional states can affect a person s behavior as they make decisions. For example, hunger may make people more impatient; they may then…
A Randomized, Phase III Trial of Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions in Older Women With Early-Stage Breast Cancer (POWER II)
This is a Phase III, multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals…
Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers: A Randomized Controlled Multicenter Crossover Trial
This is a randomized controlled trial evaluating the efficacy of HYALOMATRIX in conjunction with standard of care vs. standard of care alone in treating venous…
Artisse™ Intrasaccular Device IDE
The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck …
A Phase 1 Study of the Polymerase Theta (POLθ) Inhibitor Novobiocin in BRCA- Mutant and Other DNA Damage Repair-Deficient Solid Tumors
This phase I trial tests the safety, side effects, and best dose of novobiocin in treating cancer patients with alterations in deoxyribonucleic acid (DNA) repa…
Phase 1 Study of Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays
Background: Malaria is a disease caused by parasites transmitted to people by mosquitoes. Around the world, there were 241 million cases and 627,000 deaths fr…
A Phase II Randomized Study Comparing BTK Inhibitors (Ibrutinib Plus Rituximab or Zanubrutinib Alone) vs. BCL-2 Inhibitor (Venetoclax) and Rituximab in Previously Untreated Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)
This phase II trial studies the effects of venetoclax and rituximab in comparison to ibrutinib and rituximab or zanubrutinib in treating patients with previous…
A Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Safety and Tolerability of KT-621 in Participants With Asthma Previously Enrolled in a KT-621 Asthma Study
This Phase 2b open-label, long-term extension study is designed to evaluate the long-term safety and efficacy of KT-621 in participants with asthma who were pr…
Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21), in Combination With Oral β-glucan and Randomization of GM-CSF, for High-risk Neuroblastoma
The purpose of the study is to explore the combination of a bivalent vaccine, a sugar called beta-glucan (β-glucan), and a protein called granulocyte-macrophag…
Use of Granulocyte Colony Stimulating Factor (G-CSF) Mobilized Leukapheresis Collections From Healthy Volunteers to Develop Improved Methods of Stem Cell and Lymphocyte Selection for Allogeneic Transplantation
Bone marrow transplants (BMT) are one form of treatment for disorders of the blood, including leukemia. However, because the procedure is often associated with…