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NCT ID: NCT06206369 Recruiting - Clinical trials for Peripheral Arterial Disease

Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression

VASCULAIDRETRO
Start date: October 31, 2023
Phase:
Study type: Observational

The VASCULAID-RETRO study, within the broader VASCULAID project, aims to create artificial intelligence (AI) algorithms that can predict cardiovascular events and the progression of abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD). The study plans to gather and analyze data from at least 5000 AAA and 6000 PAD patients, combining existing cohorts and retrospectively collected data. During this project, AI tools will be developed to perform automatic anatomical segmentation and analyses on multimodal imaging. AI prediction algorithms will be developed based on multisource data (imaging, medical history, -omics).

NCT ID: NCT06205953 Recruiting - AL Amyloidosis Clinical Trials

A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)

EUREKA
Start date: January 1, 2024
Phase:
Study type: Observational

A prospective patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers from across Europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools.

NCT ID: NCT06204783 Recruiting - Heart Failure Clinical Trials

Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort II: Structural Heart Interventions (PLUTO-II)

PLUTO-II
Start date: November 14, 2022
Phase:
Study type: Observational

The aim of PLUTO-II is to use biventricular pressure-volume (PV) loop measurements to improve the understanding of direct changes in cardiac and hemodynamic physiology induced by transcatheter aortic valve implantation (TAVI) or tricuspid edge-to-edge repair (TEER). These procedures evoke immediate changes in cardiac mechanoenergetics, ventricular-vascular interaction as well as ventricular (in)dependency. Within the context of PLUTO-II, patients will undergo biventricular PV-loop measurements before and after TAVI or TEER. In future, the application of perprocedural PV loop monitoring may tailor the daily individual decision making process during structural interventions in the catheterization laboratory.

NCT ID: NCT06204237 Recruiting - Clinical trials for Critical Limb Ischemia

Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD/CLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)

CHASE
Start date: February 1, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of [89Zr]Zr-DFO-APAC in patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and healthy volunteers. The main questions it aims to answer are: - What is the safety, tolerability and pharmacokinetic profile (PK: both systemic and local vascular injury site-specific PK) of [89Zr]Zr-DFO-APAC? - What is the biodistribution and internal radiation dosimetry of the tracer dose of [89Zr]Zr-DFO-APAC? - What is the binding and retention time of [89Zr]Zr-DFO-APAC to arteries and atherosclerotic or microvascular lesions? Participants will receive a dose of the [89Zr]Zr-DFO-APAC (IMP) and PET/CT imaging is performed on days 1, 3 and 7, and follow-up visit 7-14 days post IMP dosing.

NCT ID: NCT06203899 Recruiting - Depressive Symptoms Clinical Trials

Depression and Suicide Prevention in Adolescents Attending Special Schools

STORM
Start date: December 13, 2023
Phase: N/A
Study type: Interventional

Depression is a major public health concern. In Dutch adolescents, the prevalence of major depressive disorder is estimated at 3.8%, and one in five adolescents report depressive symptoms. Depression is a risk factor in adolescent suicide. School-based prevention programs, for example the STORM approach, are effective in decreasing depressive symptoms among adolescents with elevated depressive symptoms at screening. However, not all adolescents attend general education. In the Netherlands, 7% of all adolescents enters special education (voortgezet speciaal onderwijs and prakijkonderwijs). They form a vulnerable subgroup concerning developing depressive symptoms and suicidality. To adapt and implement programs for these students, is complex yet crucial. This study aims to screen adolescents, offer them a prevention program to prevent the onset or continuation of depression and evaluate the effectiveness of this program. It is a randomised controlled trial with two conditions. The main study parameter is depressive symptomatology. Secondary study parameters are suicidality, anxiety and somatic complaints. Eligible students enter the second or third grade of special education, presenting elevated depressive symptoms. All adolescents will be screened for depressive and suicidal symptoms. Those reporting suicidality will be guided to specialised care, together with their parents. Adolescents with elevated depressive symptoms in the experimental condition will be offered the CBT-based preventive group training Op Volle Kracht in their school setting. The control condition consists of monitoring, and is offered the training if the intervention has shown to be effective. Participants will fill in longitudinal measurements. At all times, adolescents will be guided to mental health care if necessary. Furthermore, teachers in all participating schools will attend a training on how to detect and address depressive and suicidal symptoms among adolescents. The potential value of the study is that we can offer adolescents in the special educational sector a prevention program that is proven to be effective. In order to achieve this goal we need to evaluate the effectiveness of this prevention program in this target group. We are of opinion, however, that the risks associated with participation can be considered negligible. It is specifically aimed at depressive symptoms, within a population which receives care for other problems.

NCT ID: NCT06202703 Recruiting - Clinical trials for Vaccine-Preventable Diseases

Fine Needle aSpiration of Lymph nodEs to Study vAccine-induced Immunity

SEA
Start date: April 15, 2023
Phase: N/A
Study type: Interventional

Rationale Causing a wide range of infectious diseases, including pneumonia, otitis media and meningitis, S. pneumoniae represents an important global health problem. Pneumococcal vaccines are clinically effective in preventing invasive pneumococcal disease, but the underlying immune response is likely to differ due to the inclusion of T cell epitopes in the conjugate, but not purified polysaccharide vaccine. However, these differences remain scantly studied. Lymph node fine needle aspiration (FNA) has been recently described to study vaccine-induced germinal centre responses in depth and represents a promising tool to study the underlying immune mechanisms of pneumococcal vaccines. Insight into the underlying immune mechanisms of vaccines could improve future vaccine design, e.g. by refining dosing intervals. Objective Determine timing of peak germinal centre B cell frequency following pneumococcal vaccination. Main trial endpoints The main trial endpoint is represented by the frequency of germinal centre B cells (BGC) in lymph node aspirates at various time points after vaccination, as measured by spectral flow cytometry. Both total BGC cells and S. pneumoniae polysaccharide-specific BGC frequencies will be determined. Trial design Pilot intervention study without a comparator. Trial population Healthy individuals between the age of 20 - 40 Interventions Subjects will be vaccinated once with Prevenar13. FNA of the draining lymph node will be performed and blood will be drawn at baseline, followed by weekly collection during the first four weeks, every other week between weeks 4 - 8 and a final collection time point after 12 weeks, resulting in a total of 8 sampling time points over the course of three months. Draining lymph node size will be assessed by ultrasound every other day during the first two weeks and then alongside lymph node FNA for the remainder of the study.

NCT ID: NCT06199050 Recruiting - Breast Cancer Clinical Trials

The Effect of 360° Virtual Reality Movies on Fear and Anxiety

ENGAGE
Start date: June 16, 2023
Phase: N/A
Study type: Interventional

To assess the effect of web-based 360° Virtual Reality movies on fear and anxiety, The investigators would like to assess the patient-perceived level of fear and anxiety quantitatively, making use of several questionnaires.

NCT ID: NCT06197321 Recruiting - Clinical trials for Coronary Artery Disease

Non-invasive Prediction of Fluid and Noradrenaline Responsiveness Using the Carotid Wave Intensity.

VACC
Start date: January 15, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to study a new method to compute ventricular-arterial coupling (VAC) in adult intensive care patients after cardiac surgery. VAC is a metric that describes the interaction between the heart and the arterial system. The new method of measuring VAC uses carotid ultrasound measurements. The main questions this study aims to answer are: - Can VAC measured using carotid ultrasound predict the hemodynamic response to drugs? - What is the concordance of VAC measurements obtained via carotid ultrasound with VAC measurements obtained via the standard, single-beat method? Measurements will be performed in the operating room and at the ICU.

NCT ID: NCT06193915 Recruiting - Clinical trials for Distal Radius Fractures

Ultrasound Guided Hematoma Block in Distal Radius Fractures

Start date: January 5, 2024
Phase: N/A
Study type: Interventional

This study will investigate the effectiveness of analgesia of ultrasound hematoma block compared to 'blind' hematoma block in patients with dislocated distal radius fracture.

NCT ID: NCT06193525 Recruiting - Clinical trials for Advanced Breast Cancer

FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test

FUTURE
Start date: September 16, 2019
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to prove that the RECAP test is capable of selecting advanced breast cancer patients sensitive for treatment with the PARP inhibitor talazoparib. Participants will undergo an ultrasound-guided biopsy and a blood withdrawal. Homologous Recombination (HR) deficient patients (approximately 30%) can start talazoparib treatment until progression of the disease or unacceptable side-effects and their response will be evaluated.