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NCT ID: NCT05139563 Active, not recruiting - Acceptability Clinical Trials

South African Male User Research on Acceptability of Implants and Injections

SAMURAI
Start date: July 12, 2022
Phase: N/A
Study type: Interventional

The overall aims of SAMURAI (South African Male User Research on Acceptability of Implants and Injections) are to assess acceptability of, and preferences for, novel long-acting pre-exposure prophylaxis (LA-PrEP) delivery formulation use among key end-users: heterosexual men and men-who-have-sex-with-men (MSM) in South Africa, a country most impacted by human immunodeficiency virus (HIV) incidence and prevalence. Early involvement of men in product development is an important opportunity to measure and address product acceptability and factors that may influence adherence and to foster male ownership of novel HIV prevention delivery modalities.

NCT ID: NCT05127434 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus

A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

Start date: November 17, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.

NCT ID: NCT05104866 Active, not recruiting - Breast Cancer Clinical Trials

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

Start date: October 18, 2021
Phase: Phase 3
Study type: Interventional

The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.

NCT ID: NCT05093933 Active, not recruiting - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)

VICTOR
Start date: November 2, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.

NCT ID: NCT05089656 Active, not recruiting - Clinical trials for Type 2 Spinal Muscular Atrophy

Efficacy and Safety of Intrathecal OAV101 (AVXS-101) in Pediatric Patients With Type 2 Spinal Muscular Atrophy (SMA)

STEER
Start date: February 1, 2022
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy, safety and tolerability of intrathecal (IT) OAV101 in treatment naive patients with Type 2 spinal muscular atrophy (SMA) who are ≥ 2 to < 18 years of age over a 15 month trial duration.

NCT ID: NCT05082285 Active, not recruiting - Clinical trials for Infections, Meningococcal

A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants

Start date: November 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-2Gen) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.

NCT ID: NCT05079919 Active, not recruiting - Clinical trials for Severe Hypertriglyceridemia

A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

Start date: October 25, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

NCT ID: NCT05064059 Active, not recruiting - Colorectal Cancer Clinical Trials

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

Start date: November 10, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

NCT ID: NCT05063240 Active, not recruiting - HIV Infections Clinical Trials

Mobile Phone Text Messaging Plus Motivational Interviewing: Effects on Breastfeeding, Child Health Outcomes

MTM-MI
Start date: July 22, 2022
Phase: N/A
Study type: Interventional

Background Lack of breastfeeding, at a minimum, doubles the risk of infant death in the first six months of life. Many infants in low resourced settings at high risk of infectious disease morbidity and death are deprived of the immunological and nutritional benefits of breast milk, through an attenuated duration of breast milk exposure. South Africa has one of the lowest exclusive breastfeeding rates in Africa, 8% in infants under 6 months of age. Mobile phone text messaging as a simple, low-cost intervention improves medication adherence among patients with HIV, diabetes and tuberculosis. Motivational interviewing has been beneficial across many health problems, including HIV viral load suppression, body weight loss, and alcohol and tobacco use. Combining a number of intervention approaches is more likely to influence behaviour change than an individual approach. Investigators assume that continued breastfeeding is sustained among women living with HIV receiving weekly text messages combined with motivational interviewing and that this contributes to improved infant health outcomes. Objectives: 1. To determine the effects of mobile phone text messaging combined with motivational interviewing versus standard of care on: (a) Continued exclusive breastfeeding to six month of child age, (b) Continued any form of breastfeeding to 6 month of child age. 2. To determine the contribution of the combined intervention on improved infant health outcomes: (a) Infant morbidity (all -cause hospitalization) and death (all -causes, (b) Infant growth. Methods Investigators propose a group sequential clinical trial to determine whether text messaging combined with motivational interviewing will prolong breastfeeding and the contribution of the combined intervention on improved infant health outcomes. The study will recruit 275 women living with HIV and HIV exposed infants at birth and randomly assign study interventions for 6 months.

NCT ID: NCT05047445 Active, not recruiting - COVID-19 Clinical Trials

A First Time in Human Phase 1 Open-Label Study of the COVIDITY Vaccine Administered by Needle-free Injection

Start date: October 1, 2021
Phase: Phase 1
Study type: Interventional

The main objectives of this study are to assess the safety, tolerability and immunogenicity of the candidate SARS-CoV-2 vaccine, COVIDITY, when administered using a needle-free ID or IM injection device.