Clinical Trials Logo

Filter by:
NCT ID: NCT05774951 Recruiting - Clinical trials for Breast Cancer, Early Breast Cancer

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

CAMBRIA-1
Start date: March 31, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

NCT ID: NCT05774691 Recruiting - Clinical trials for Aortic Valve Stenosis

Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)

Start date: November 1, 2023
Phase: Phase 4
Study type: Interventional

Heparin reversal by protamine administration after transcatheter aortic valve implantation (TAVI) may reduce bleeding events. However, protamine can also cause life-threatening allergic reactions. High-quality evidence regarding the clinical safety and efficacy of routine protamine administration after TAVI is lacking. The aim of this clinical trial is to determine if routine protamine administration, compared with selective protamine administration, reduces the risk of cardiovascular mortality or bleeding within 30 days after transcatheter aortic valve implantation.

NCT ID: NCT05773989 Recruiting - Clinical trials for Coronary Artery Disease

Pharmacodynamic Outcomes in CCS Patients Treated With an Individualized Treatment Strategy

Start date: January 23, 2024
Phase: Phase 4
Study type: Interventional

Patients with Chronic Coronary Syndrome (CCS) undergoing with elective percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), consisting of aspirin combined with clopidogrel for 6 months. The aim of DAPT is to prevent recurrent thrombotic events, i.e. death, stent thrombosis and/ or myocardial infarction (MI). However, the trade-off of thrombotic prevention by DAPT is an increased risk of bleeding. Multiple strategies to reduce bleeding risk and optimize outcomes have been proposed. On one hand the bleeding risk can be reduced by shortening the duration of DAPT and omitting aspirin. This has been proven effective in patients with acute coronary syndromes (ACS) compared to standard DAPT, without a significant difference in thrombotic events. On the other hand, personalized medicine by means of genotyping to ensure that a patient is treated with an, for them, effective drug, can be a strategy to optimize patients outcomes. In CCS patients the preferred P2Y12-inhibitor is clopidogrel. However, clopidogrel must first be activated by the CYP2C19 enzyme in the liver. Only then can clopidogrel inhibit the P2Y12-receptor and prevent platelet activation. Almost thirty percent of patients has a genetic variation of the gene encoding this CYP2C19 enzyme. In these patients, clopidogrel is not or hardly activated, putting them at a higher risk of thrombotic events than patients who do not have this gene variation. By determining the CYP2C19 genotype, it is possible to estimate whether clopidogrel will be effective or not. In this trial the investigators evaluate the pharmacodynamic effects of genotype guided P2Y12-inhibitor monotherapy in patients with CCS undergoing PCI. In the intervention arm the CYP2C19 genotype will be assessed using a point-of-care test device on the cardiology ward, which can be performed by (research) nurses. Patients with a CYP2C19 loss-of-function (LOF) allel will be treated with monotherapy ticagrelor or prasugrel. Patients who are non-carrier of a LOF allel will receive clopidogrel. The control arm will be treated with the current standard-of-care, which is DAPT, consisting of aspirin combined with clopidogrel for 6 months. The main goals is to assess the antithrombotic effects of individualized P2Y12 monotherapy strategy versus clopidogrel plus aspirin in elective PCI patients.

NCT ID: NCT05773859 Recruiting - Clinical trials for Epithelial Ovarian Cancer

NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer

NEODOC
Start date: March 17, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This goal of this single arm, single center, exploratory phase I/II clinical trial is to learn more about the immunological efficacy, safety and feasibility of an autologous tumor lysate-loaded autologous XP-DC (cDC1)-based vaccine in patients with ovarian cancer.

NCT ID: NCT05773768 Recruiting - Atrial Fibrillation Clinical Trials

EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways

EHRA-PATHS
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

In elderly atrial fibrillation (AF) patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present. The presence of comorbidities also affects outcomes in AF patients. Current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. Healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid AF patients and to reduce costs. The EHRA-PATHS consortium set out to address this need for change in management for multimorbid, elderly AF patients in Europe through the development of new care pathways. The aim of this study is to evaluate the current management of risk factors and comorbidities, and subsequently implement the newly developed care pathways and evaluate if these pathways lead to better management of risk factors and comorbidities in multimorbid, elderly AF patients, compared to current standard care.

NCT ID: NCT05772923 Recruiting - Quality of Life Clinical Trials

Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision

OPAXX
Start date: April 16, 2021
Phase: N/A
Study type: Interventional

The goal of this prospective phase II feasibility study is to evaluate two additional local treatment options in rectal cancer patients with a good clinical response after neoadjuvant (chemo)radiation: contact x-ray brachytherapy versus extension of the waiting interval with or without local excision, and to investigate which rate of organ preservation can be achieved.

NCT ID: NCT05769777 Recruiting - Dermatitis Atopic Clinical Trials

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

ATLANTIS
Start date: April 3, 2023
Phase: Phase 2
Study type: Interventional

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 180 weeks, including: - A screening period of up to 2 to 4 weeks - An open label treatment period of up to 160 weeks (approximately 3 years) - A post-treatment safety follow-up period of at least 20 weeks after the last dose administration The planned number of visits will be 26 visits.

NCT ID: NCT05769621 Recruiting - Propionic Acidemia Clinical Trials

A Retrospective Study to Characterize Participants With Propionic Acidemia

Start date: June 16, 2023
Phase:
Study type: Observational

This is a non-interventional, global, multicenter, retrospective cohort study describing participant characteristics, clinical outcomes, and event rates in participants with propionic acidemia (PA).

NCT ID: NCT05768126 Recruiting - Depressive Disorder Clinical Trials

Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine

PRECISER
Start date: September 29, 2021
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to test the beneficial effects of rivastigmine administration, and predict the treatment outcome with electroencephalography (EEG), in patients with severe depression treated with electroconvulsive therapy (ECT). The study has two main objectives: - to study whether rivastigmine would ameliorate the side-effect profile of ECT - to develop an outcome prediction model based on resting state EEG for both the response to treatment as well as its side effect Participants will be assessed by: - Cognitive tests - Questionnaires of clinical symptoms - Questionnaires of depressive symptoms - Bloodsample - Resting state and task-based EEG Researchers will compare patients with a depressive disorder treated with ECT receiving rivastigmine to placebo patches to see if rivastigmine reduces cognitive side effects.

NCT ID: NCT05767879 Recruiting - Melanoma Stage III Clinical Trials

(Neo)Adjuvant BRAF/MEK Inhibition in pN1c Melanoma

Start date: January 1, 2022
Phase: Phase 2
Study type: Interventional

Phase 2 open-label single arm intervention study administering encorafenib/binimetinib in neo-adjuvant setting followed by surgery and subsequent adjuvant encorafenib/binimetinib in in-transit melanoma patients without lymph node and distant metastases.