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NCT ID: NCT05687279 Recruiting - Clinical trials for Respiratory Syncytial Virus Infection

Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)

Start date: January 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to < 24 months of age.

NCT ID: NCT05662332 Not yet recruiting - Type 2 Diabetes Clinical Trials

A Study of LY3209590 Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)

QWINT-1
Start date: January 20, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to determine the efficacy and safety of LY3209590 administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.

NCT ID: NCT05654623 Not yet recruiting - Clinical trials for Advanced Breast Cancer

A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.

VERITAC-2
Start date: December 30, 2022
Phase: Phase 3
Study type: Interventional

A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.

NCT ID: NCT05639894 Recruiting - Clinical trials for Respiratory Syncytial Virus Infection

Study of a Respiratory Syncytial Virus mRNA Candidate With 2 Different Lipid Nanoparticle-based Formulations in Adults Aged 18 to 50 Years and 60 Years and Older

Start date: November 17, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of a respiratory syncytial virus (RSV) messenger ribonucleic acid (mRNA) vaccine candidate formulated with 2 different lipid nanoparticles (LNPs) (ie, LNP containing CL-0059 or CL-0137) in healthy adult participants aged between 18 and 50 years, and 60 years and older. The primary objectives of this study are to assess the safety and immunogenicity profiles across the dose-level groups (low, medium, and high doses) with 2 LNPs (CL-0059 and CL-0137). In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population. The duration of each participant's participation is 12 months for the Sentinel and Main Cohorts and 24 months overall for the subset of participants enrolled in the Booster Cohort.

NCT ID: NCT05630196 Recruiting - Clinical trials for Chronic Low-back Pain

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain

Start date: December 8, 2022
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to assess whether LY3857210 is safe and efficacious in relieving chronic low back pain (CLBP). This trial is part of the chronic pain master protocol (H0P-MC-CPMP) which is a protocol to accelerate the development of new treatments for chronic pain.

NCT ID: NCT05627128 Recruiting - Crohn Disease Clinical Trials

A Culturally Tailored Dietary Intervention to Treat Crohn's Disease

DAIN
Start date: September 6, 2022
Phase: N/A
Study type: Interventional

The goal of the study is to test the efficacy of a dietary intervention in inducing clinical response and remission for patients with Crohn's disease in a randomized controlled trial. The intervention diet: DAIN has been adapted from the Inflammatory Bowel Disease Anti-Inflammatory Diet or IBD-AID™ taking into account the food availability and preferences of Puerto Ricans. DAIN also includes traditional foods commonly consumed in the typical Puerto Rican diet while maintaining the fundamental components of the IBD-AID™.

NCT ID: NCT05626322 Not yet recruiting - Clinical trials for Diffuse Large B-Cell Lymphoma

Effects of PF-07901801,Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Start date: January 18, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn about the effects of three study medicines (PF-07901801, tafasitamab, and lenalidomide) when given together for the treatment of diffuse large B-cell lymphoma (DLBCL) that: - is relapsed (has returned after last treatment) or - is refractory (has not responded to last treatment) DLBCL is a type of non-Hodgkin lymphoma (NHL). NHL is a cancer of the lymphatic system. It develops when the body makes abnormal B lymphocytes. These lymphocytes are a type of white blood cell that normally help to fight infections. This study is seeking participants who are unable or unwilling to undergo a stem cell transplant. Stem cell transplant is when doctors put healthy blood cells back into your body. Everyone in this study will receive all three medicines. Participants will receive PF-07901801 and tafasitamab at the study clinic by intravenous (IV) infusion (given directly into a vein). Study interventions will be administered in 28-day cycles. PF-0791801 will be given weekly for the first three cycles and then every two weeks. Tafasitamab will administered on Days 1, 4, 8, 15 and 22 in cycle 1, weekly in cycles 2 and 3 and then every 2 weeks in cycle 4 and beyond. Lenalidomide will be taken by mouth at home every day for Days 1 to 21 of each 28-day cycle for the first 12 cycles. Participants can continue to take PF-07901801 and tafasitamab until their lymphoma is no longer responding. Lenalidomide is discontinued after 12 cycles. PF-07901801 will be given at different doses to different participants. Everyone taking part will receive approved doses of tafasitamab and lenalidomide. We will compare the experiences of people receiving different doses of PF-07901801. This will help us to determine what dose is safe and effective dose when combined with the other 2 study medicines.

NCT ID: NCT05624606 Recruiting - Clinical trials for Influenza Immunization

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older

Start date: November 28, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 3 dose levels of Quadrivalent Influenza mRNA Vaccine MRT5410 compared to an active control (QIV SD, QIV HD [adults ≥ 65 years of age only], or RIV4) in adults 18 years of age and older.

NCT ID: NCT05620576 Recruiting - Chronic Pain Clinical Trials

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05)

Start date: November 14, 2022
Phase: Phase 2
Study type: Interventional

This study is being done to test the safety and efficacy of the study drug LY3852710 for the treatment of diabetic peripheral neuropathic pain.

NCT ID: NCT05620563 Recruiting - Clinical trials for Osteoarthritis, Knee

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain

OA05
Start date: November 22, 2022
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of LY3857210 in participants with Osteoarthritic Pain