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NCT ID: NCT05702034 Not yet recruiting - Clinical trials for Ischemic Stroke; Ischemic Attack, Transient

A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

LIBREXIASTROKE
Start date: February 9, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.

NCT ID: NCT05686356 Not yet recruiting - Tuberculosis Clinical Trials

A Pan-TB Regimen Targeting Host and Microbe

panTB-HM
Start date: January 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This project will develop the first regimen meeting WHO criteria for a pan-TB indication, ie, not requiring knowledge of RIF susceptibility. The regimen will test sutezolid at 2 dose levels, with the approved anti-TB drugs bedaquiline and pretomanid, in a phase 2c trial. It will also test whether the addition of N-acetylcysteine (NAC), a re-purposed host-directed WHO essential medicine, can protect the lung and liver against oxidative damage, preserve lung function, and accelerate the eradication of MTB infection by replenishing glutathione (GSH).

NCT ID: NCT05685238 Not yet recruiting - Haemophilia A Clinical Trials

A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4)

FRONTIER4
Start date: February 3, 2023
Phase: Phase 3
Study type: Interventional

This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often the participants will receive Mim8 in this study depends on the treatment participant receives in the current Mim8 study participant is taking part in. The study will last for up to 5.5 years. The duration of the study depends on when the participant enrolled in this study. The study will end if Mim8 is approved and marketed in participant's country during the study, or the study will end in 2028, whichever comes first. Mim8 will be injected under the skin with a thin needle either once a week, once every two weeks or once a month. Participants will get up to 262 injections; the number of injections depends on how often participants will get injections. While taking part in this study, there are some restrictions about what medicine participants can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

NCT ID: NCT05678062 Recruiting - Eclampsia Clinical Trials

Point-of-care Ultrasound Abnormalities in Eclampsia

Start date: November 21, 2022
Phase: N/A
Study type: Interventional

Preeclampsia (PE) and eclampsia remain leading causes of maternal morbidity and mortality, in both high-, low-and-middle-income countries. Preeclampsia is a complex, multisystem disease which, in its severe form, affects the cardiovascular, renal, hepatic, neurological and haematological systems. Given the complexity of the disease, anaesthesia management for caesarean section in these patients remains challenging. Preeclampsia may be complicated by the development of eclampsia, which involves one or more seizures, which complicates anaesthesia and obstetrics management, and requires. urgent admission and delivery. Recent studies have demonstrated novel markers of severity of PE, including point-of-care ultrasound (POCUS), acid-base changes secondary to low serum albumin, and brain natriuretic peptide (BNP). POCUS is playing an increasing role in perioperative diagnosis, and newer, less expensive devices are continuously being developed. These will in all likelihood play an important role in South Africa in the near future. In a recent trial performed at the University of Cape Town, a comprehensive acid-base analysis in women with PE with severe features demonstrated significant abnormalities in independent acid-base determinants. In addition, strong indications were found that changes in acid-base status following a decrease in serum albumin are more pronounced in early onset PE and may be associated with urgent delivery. In other clinical arenas in critically ill patients, low serum albumin is associated with increased lung water, increased intracranial pressure, and outcome. The research team hypothesised that similar associations might be found in women with late onset preeclampsia with severe features. Using POCUS, it was found that there was no association between serum albumin level and PIS or optic nerve sheath diameter (ONSD). PIS was however associated with cardiac dysfunction, as was BNP.

NCT ID: NCT05669755 Not yet recruiting - Obesity Clinical Trials

REDEFINE 3: A Research Study to See the Effects of CagriSema on Heart Disease in People Living With Obesity and Diseases in the Heart and Blood Vessels

REDEFINE 3
Start date: March 1, 2023
Phase: Phase 3
Study type: Interventional

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with obesity and cardiovascular disease. Participants will either get CagriSema or a dummy medicine which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 3 years. Participants will have 22 clinic visits with the study doctor or study staff. Women cannot take part if pregnant, breastfeeding or plan to get pregnant during the study period. Women who are able to become pregnant must use highly effective birth control and will be counselled on the use of birth control.

NCT ID: NCT05664490 Not yet recruiting - Depression Clinical Trials

Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings

Start date: February 2023
Phase: N/A
Study type: Interventional

Adolescent girls and young women (AGYW) at risk of HIV in sub-Saharan Africa, frequently (20-50%) have symptoms of common mental disorders, including depression, anxiety, and stress. These symptoms are associated with suboptimal adherence to HIV pre-exposure prophylaxis (PrEP), a highly effective HIV prevention approach. In this project, the team seeks to address poor mental health and consequent impacts on PrEP adherence and among AGYW at risk of HIV by testing an evidence-based mental health intervention (the Youth Friendship Bench SA) adapted for PrEP delivery programs.

NCT ID: NCT05662995 Recruiting - Preeclampsia Clinical Trials

Point-of-care Ultrasound Abnormalities in Early Onset Preeclampsia

Start date: November 28, 2022
Phase: N/A
Study type: Interventional

The study is planned to describe the prevalence and severity of cardiac, lung and optic-nerve sheath diameter (ONSD) ultrasound abnormalities in women with early onset preeclampsia with severe features. These findings will be compared with point-of-care ultrasound (POCUS) abnormalities demonstrated in our recent study on late onset preeclampsia. The primary aim of the current study will be to examine the association between pulmonary interstitial edema (PIS), as identified by lung ultrasound, and cardiac dysfunction on echocardiography, and brain natriuretic peptide (BNP), in early onset preeclampsia, after comprehensive echocardiographic assessment. The secondary aims are to assess ONSD, and to explore the association between PIS or ONSD and serum albumin. A further secondary aim will be to explore the association between POCUS abnormalities and cardiotocography abnormalities and early delivery.

NCT ID: NCT05660980 Not yet recruiting - HIV-1-infection Clinical Trials

Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age

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

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age

NCT ID: NCT05649137 Recruiting - Obesity Clinical Trials

A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight

Start date: January 4, 2023
Phase: Phase 3
Study type: Interventional

This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years.

NCT ID: NCT05648110 Recruiting - Clinical trials for COVID-19, SARS-CoV-2

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA)

SUPERNOVA
Start date: December 16, 2022
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the safety and neutralizing activity of AZD5156 for prevention of COVID-19 in immunocompromised individuals.