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NCT ID: NCT05646394 Recruiting - Clinical trials for Antiphospholipid Syndrome

Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS

Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this registry is to gather more information on the efficacy and safety of various antithrombotic regimens. The registry collects data on patients with antiphospholipid syndrome and an arterial event within the past 12 months, on treatment with either A) a VKA with therapeutic range, INR 2.0-3.0 plus low-dose aspirin (75-100 mg daily), B) a VKA alone with therapeutic range, INR 2.0-3.0, C) a VKA with therapeutic range, INR 3.0-4.0, or D) with a dual antiplatelet regimen. The follow-up is 2 years.

NCT ID: NCT05644145 Enrolling by invitation - Yellow Fever Clinical Trials

Immunogenicity of Yellow Fever Vaccine in a Pediatric Population Vaccinated at 12-23 Months of Age in Argentina

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

Northern Argentina is a risk area for yellow fever (YF). Recent studies have suggested that immunity wanes in children vaccinated between 9 and 23 months of age. In 2015, a collaborative study conducted by the Ministry of Health (MoH) of Argentina, the Pan American Health Organization (PAHO), and the US Centers for Disease Control and Prevention (CDC) assessed the immunogenicity and safety of co-administration of YF and MMR vaccines in a pediatric population at 12-13 months of age. A total of 741 children presenting for routine immunization at 12-13 months of age enrolled and completed the study. It is now four to seven years since this pediatric group received their YF vaccinations. This cohort is unique because their initial YF vaccination and immune response to the vaccine dose are well characterized. Contact information collected during the earlier study will be used to locate the children. If consent is obtained, a 5ml specimen of blood will be collected and shipped to the CDC's Arboviral Diseases Reference Laboratory (ADRL) in Fort Collins, CO for plaque reduction neutralization testing using a 50% cut-off (PRNT50) to detect YF virus-specific neutralizing antibodies. Children with neutralizing antibody titers that are higher than their baseline titer collected approximately 28 days following YF vaccination will have PRNTs done for cross-reacting flaviviruses.

NCT ID: NCT05643573 Terminated - Atrial Fibrillation Clinical Trials

A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke

OCEANIC-AF
Start date: December 5, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people with atrial fibrillation and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel). Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them. Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding. The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke. To see how well the study treatment asundexian works researchers compare: - how long asundexian works well and - how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening: - stroke and/or - systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study. To see how safe asundexian is, the researchers will compare how often major bleedings occur after taking the study treatments asundexian and apixaban, respectively. Major bleedings are bleedings that have a serious or even life-threatening impact on a person's health. The study participants will be randomly (by chance) assigned to 1 of 2 treatment groups, A and B. Dependent on the treatment group, the participants will either take the study treatment asundexian by mouth once a day or apixaban by mouth twice a day for approximately 9 - 33 months. Each participant will be in the study for approximately 9 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. Those participants who do not want or are unable to have visits to the study site may join the study remotely in selected locations. The location name contains the abbreviation - DCT in such cases. During the study, the study team will: - take blood samples - do physical examinations - examine heart health using an electrocardiogram (ECG) - check vital signs such as blood pressure and heart rate - do pregnancy tests - ask the participants questions about their quality of life - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05642325 Recruiting - Clinical trials for Uveitic Macular Edema

Vamikibart in Participants With Uveitic Macular Edema

Sandcat
Start date: March 23, 2023
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.

NCT ID: NCT05641272 Not yet recruiting - Allergic Rhinitis Clinical Trials

Clinical Trial to Evaluate the Efficacy and Safety of Polymerized, Mannan-Conjugated Dermatophagoides Allergen Extract

MM09-SLIM
Start date: November 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Prospective, randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of polymerized and mannan conjugated allergen extract of Dermatophagoides for the treatment of allergic rhinitis/rhinoconjunctivitis with or without asthma. The main objective of the clinical trial is to evaluate the clinical efficacy of the investigational medicinal product, administered sublingually, compared to placebo for the treatment of moderate-severe rhinitis/rhinoconjunctivitis with or without mild to moderate asthma and controlled using the Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (R-CSMS).

NCT ID: NCT05641025 Active, not recruiting - Liver Cirrhosis Clinical Trials

Prediction of Multidrug-resistant Bacterial Infection in Patients With Cirrhosis

Start date: November 16, 2022
Phase:
Study type: Observational

The aim of this study is to identify predictive factors of infections caused by multidrug-resistant organisms in patients with cirrhosis and to develop and validate (internally and externally) a predictive model that might be useful to use in clinical settings to stratify the risk and lead clinical decision-making strategies.

NCT ID: NCT05638737 Completed - Clinical trials for Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

A Study in Participants With Non-cirrhotic NASH With Fibrosis

COSMOS
Start date: October 26, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Participants will be in the trial for up to 24 weeks, including a screening period lasting up to 8 weeks, a 12-week treatment period, and a 4-week safety follow-up period Participants are not expected to directly benefit from treatment during this trial. Participants will help researchers learn more about and how to develop AZD4831 to treat NASH.

NCT ID: NCT05638009 Recruiting - Hypertension Clinical Trials

The ECLA/PHRI Intervention in the Community Trial

EPIC
Start date: November 14, 2022
Phase: N/A
Study type: Interventional

EPIC is a cluster-randomized, double-blind trial to evaluate the effect of two potassium-enriched salt substitute preparations (one available in the Argentine market and one derived from it), compared to regular salt on systolic blood pressure in subjects ≥ 18 and ≤ 90 years old from Rosario department households in Santa Fe Province, Argentina.

NCT ID: NCT05636176 Recruiting - Heart Failure Clinical Trials

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

HERMES
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

NCT ID: NCT05633355 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

ROCKET-Orbit
Start date: January 30, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.