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NIH RECOVER: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults (Pregnancy Arm)
This study is looking at the long-term implications of COVID-19 infection in pregnant patients. Study participants may be asked to answer sets of questions about ongoing symptoms, give samples such as blood and urine and possibly have some other imaging tests. ... Protocol #: 22-2323 Location: Outpatient CTRC, University of Colorado Hospital |
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Implementing a pharmacist-led protocol to survey and follow-up people living with HIV taking Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) single tablet regimen after being switched from two tablet regimen of Dolutegravir plus Emtricitabine/Tenofovir Alafenamide (DTG + FTC/TAF): patients' satisfaction and adherence
Protocol #: 18-0715 Location: University of Colorado Hospital |
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In-Utero Vascular Accidents in Neonates from COVID-19 Infected Mothers
This study plans to learn more about how COVID-19 infection during pregnancy may have direct effects on the developing baby 30 days after birth. ... Protocol #: 20-1399 Location: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital |
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Influenza-Specific Immunity and Responses to Inactivated Influenza Vaccine in Infants: Effect of Maternal Vaccination During Pregnancy
This study aims to learn more about how babies' immune systems react to the influenza vaccine and if there is any difference between babies whose mothers receive the influenza vaccine, or not, before the baby is born. Study visits will take place during prenatal care and delivery as well a... Protocol #: 20-1074 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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Effect Of Neonatal BCG Administration On Innate And Adaptive Immune Responses To Infection With Rotavirus Live Attenuated Vaccine Strain In HIV-Exposed And Unexposed Infants
Women in this study will consent in the third trimester and have cord blood collected at the time of delivery. The infant will have four visits at Children's Hospital Colorado.... Protocol #: 20-0593 Location: Childrens Hospital Colorado, Highlands Ranch Hospital, University of Colorado Hospital |
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A5418 A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease
Study of Tecovirimat for Human Monkeypox Virus (STOMP)
Phase 3, randomized, placebo-controlled, double-blind trial of tecovirimat for the treatment of human monkeypox virus (HMPXV) disease. The study will also include a cohort of people who will receive open-label tecovirimat including people with protocol-defined severe HMPXV, pregnant and br... Protocol #: 22-1761 Location: Childrens Hospital Colorado |
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A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and
Gender Non-binary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection (GS-US-528-9023)
Protocol #: 21-3252 Location: Outpatient CTRC, Outpatient CTRC |
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A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
The ASSERVO study is testing a potential medicine for infants to see if it may help prevent lower respiratory infections caused by RSV. Study participation includes 1 dose of the medicine or placebo, approximately 3 blood draws, e-diary entries, and nasal swabs collected during any respir... Protocol #: 21-3387 Location: Childrens Hospital Colorado |
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Randomized, Controlled Trial to Evaluate the Anti-inflammatory Efficacy of Letermovir (Prevymis) in Adults with Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes (ELICIT)
Protocol #: 21-4059 Location: Outpatient CTRC, Outpatient CTRC |
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A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in
Infants and Children at Increased Risk for Severe RSV Disease
This trial is testing a study medicine to learn if it can help prevent RSV infection in babies who are more likely to get severe RSV illness. Infants will be randomized to receive either Synagis or the study drug. There are approximately 3 blood draws per season, and participants will be ... Protocol #: 21-4176 Location: Childrens Hospital Colorado |
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Respiratory Virus Transmission Network (RVTN)
The study will collect information from you and other household members on symptoms and patterns of contacts to learn how the virus is transmitted. Your household will be compensated for participating in this study.... Protocol #: 21-4270 Location: Childrens Hospital Colorado |
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Phase II, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-based anti-Cytomegalovirus (CMV) Vaccine (Triplex?), in Adults with Both Human Immunodeficiency Virus (HIV)-1 and CMV Who Are on Potent Combination ART with Conserved Immune Function
Protocol #: 21-4360 Location: Outpatient CTRC, Outpatient CTRC |
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PHACS Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE)
The study is designed to evaluate the health outcomes of women living with HIV over time. Women who elect to participate in this study complete a combination of online surveys, clinical assessments, and interviews, with a blood draw and other samples collected at the time a person enrolls ... Protocol #: 21-3844 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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A Multi-site Observational Study: NIH RECOVER Study of Long COVID in Adults
This is a longitudinal study enrolling individuals with and without SARS-CoV-2 infection at varying stages before and after infection and with or without post-acute sequelae of SARS-CoV-2 (PASC). The aim is to better understand risk factors and occurrence of PASC. Study data including ... Protocol #: 21-4528 Location: Cherry Creek Medical Center, Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital |
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A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease
Eligible and consented participants for the randomized arms (N=530) will be randomized 2:1 to receive either tecovirimat or placebo; participants with severe disease, significant skin conditions, participants with severe immune suppression will receive open-label tecovirimat. Participants ... Protocol #: 22-0797 Location: Adult Infectious Disease Clinical Trials Center, Outpatient CTRC, University of Colorado Hospital |