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NCT ID: NCT05089630 Active, not recruiting - Clinical trials for Cytomegalovirus Infections

A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults

Start date: October 14, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the candidate CMV recombinant protein subunit (CMVsu) vaccine consisting of a combination of glycoproteins B (gB) and pentamer antigens adjuvanted, regardless of baseline CMV sero-status. This FTiH study will be conducted in healthy adults 18 to 50 years of age, in which the 4 dose levels of the vaccine will be administered in a step-wise dose escalation manner, based upon safety adjudication.

NCT ID: NCT05089084 Active, not recruiting - Clinical trials for Familial Chylomicronemia

Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)

PALISADE
Start date: January 11, 2022
Phase: Phase 3
Study type: Interventional

The purpose of AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 plozasiran) in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of plozasiran or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive plozasiran.

NCT ID: NCT05088759 Active, not recruiting - ASCVD Clinical Trials

Randomized Controlled Trial of Alert-Based Computerized Decision Support for Optimizing Low-Density Lipoprotein Management

LDL-ALERT
Start date: October 8, 2021
Phase: N/A
Study type: Interventional

A 400-patient U.S.-based single-center Quality Improvement Initiative in the form of a randomized controlled trial focused on the feasibility of implementation of this electronic alert-based CDS (EPIC BPA) based on LDL-C values. The 400 patients will be comprised of 200 in the "Hospitalized Patient Cohort" and 200 in the "Outpatient Clinic Cohort." The allocation ratio will be 1:1 for an electronic alert-based CDS (EPIC BPA) notification versus no notification.

NCT ID: NCT05088616 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Native American Diabetes Project

Start date: October 28, 2021
Phase: N/A
Study type: Interventional

Diabetes in the American Indian and Alaska Native (AIAN) population is a public health crisis that is best addressed using a holistic approach. Given the disproportionate rates of diabetes and diabetes-related outcomes among AIANs, this is the perfect opportunity to provide a culturally tailored health promotion intervention among the largest urban AIAN population in the U.S.; approximately 171,163 AIANs reside in Los Angeles County. It is imperative to develop culturally tailored interventions with a community-based participatory research approach. Particularly given a legacy of historical mistrust, development of trusted and mutually beneficial partnerships is imperative. The goal of this pilot study is to reach up to 312 Native Americans with diabetes to participate in an intervention to lower blood sugar and feelings of social isolation. The intervention will include 12 weeks of diabetes-friendly, medically tailored meals, and four weeks of virtual diabetes wellness classes. Participants will also attend an initial meet-and-greet before the classes start, a check-in meeting after the classes end, and up to three additional follow-up meetings. There may also be an in-person meeting near the end of the study. Partners for these activities include Project Angel Food and United American Indian Involvement (UAII). Each of the four virtual classes will be held for 90-minutes through the Zoom platform. Each participant will be part of a 180-day cohort. Participants will complete surveys and attend three clinic visits as part of the study.

NCT ID: NCT05087628 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

PRV-3279-2a Trial in Systemic Lupus

PREVAIL-2
Start date: January 24, 2022
Phase: Phase 2
Study type: Interventional

The PREVAIL-2 study is designed to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) patients with active disease after amelioration induced by corticosteroid treatment.

NCT ID: NCT05087095 Active, not recruiting - Clinical trials for Brain Metastases, Adult

Managing Distress in Malignant Brain Cancer

Start date: March 23, 2022
Phase: N/A
Study type: Interventional

To identify potential adaptations of the managing cancer and living meaningfully (CALM) intervention that will be required for service members, Veterans, their beneficiaries, and civilian cancer metastasis to the brain (bMET) populations.

NCT ID: NCT05087056 Active, not recruiting - Clinical trials for Meningitis, Meningococcal

Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

Start date: December 29, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.

NCT ID: NCT05086731 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer

Start date: October 22, 2021
Phase: N/A
Study type: Interventional

This clinical trial evaluates the feasibility and acceptability of a mobile health device in improving oral chemotherapy adherence in women with triple negative breast cancer that has not spread to other places in the body (non-metastatic). A mobile health device, called SMRxT smart pill bottle may help doctors to remind patients to take medicine on time and monitor their symptoms.

NCT ID: NCT05086705 Active, not recruiting - Breast Carcinoma Clinical Trials

EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer

Start date: October 7, 2020
Phase: N/A
Study type: Interventional

This trial studies how well EMBr Wave technology works in reducing hot flashes in women with a history of breast cancer. Hot flashes are a common symptom experienced by menopausal women. The standard treatment for hot flashes is hormone replacement therapy, however hormone replacement therapy cannot be used in women with a history of, or active, breast cancer. EMBr Wave is a personal heating and cooling device worn on the wrist. EMBr Wave may help reduce hot flash severity in women with a history of breast cancer.

NCT ID: NCT05086302 Active, not recruiting - Obesity Clinical Trials

Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study

Start date: December 3, 2021
Phase:
Study type: Observational [Patient Registry]

A prospective, Multicenter open-label post approval trial for adults with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The study aims to demonstrate that the safety of the device in the post market setting is comparable to what was observed in the US pivotal study.