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NCT ID: NCT05955365 Recruiting - Clinical trials for Atrial Fibrillation (AF)

Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation

MATRIX-2
Start date: December 18, 2023
Phase: Phase 4
Study type: Interventional

Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined. The currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant. In the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events. In this study the investigators would like to investigate whether treatment with a single antithrombotic drug ("monotherapy strategy") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications ("standard-of-care strategy").

NCT ID: NCT05953467 Recruiting - Emergency Care Clinical Trials

Healthcare Seeking Behavior of Frequent Emergency Care Visitors

FEC
Start date: July 11, 2023
Phase:
Study type: Observational

This retrospective study is part of a research line from Zuyderland Medical Centre focusing on the acute care chain. The aim of the study is to focus on the frequent visitors of the Emergency Department (ED) and bridge the gap to out-of-hours primary care. Although the Dutch healthcare system is unique with their 24/7 accessibility to primary care, crowding within the acute care chain is a growing problem, even in the Netherlands. Patients visiting an ED multiple times a year, the so called frequent visitors are one of the contributing factors of ED crowding. This relatively small group of patients accounts for a disproportionate number of many ED visits. In the United States, it is estimated that between 4.5 and 8% of patients are responsible for almost one third of the total annual number of ED visits, by visiting the ED four or more times per year. Dutch research by vd Linden found that 0.5% of total ED patients visited their ED frequently, however, they defined frequent visitors using a threshold of 7 visits per year. In our study, the cutoff of more than four visits per year to define a frequent visitor is used. This study aims to gain insight in who Dutch frequent visitors are, or - in other words - what their baseline characteristics are, which complaints are responsible for their healthcare seeking behavior, and do these patients also seek medical help at other places during out-of-hours like a General Practitioner Cooperative (GPC)? Existing ED and GCP data will be used to identify patients who either visited the ED or one of the adjacent GPCs 4 times or more in one year. Using these data, this study aims to answer the following questions: Primary objective: - How many patients present to the ED of the Zuyderland hospital in Heerlen and Sittard 4 times or more a year and what are the characteristics of these frequent visitors of the ED? Secondary objective: - How many patients present to the GPC of South East Limburg 4 or more times a year and what are their characteristics of frequent visitor? - Is there an association between the characteristics of frequent visitors of the ED of the Zuyderland hospital and subsequent (frequent) presentation at the GPC?

NCT ID: NCT05952583 Recruiting - Clinical trials for Fetal Growth Retardation

Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

CONTRAST
Start date: February 17, 2023
Phase:
Study type: Observational [Patient Registry]

Optimal diagnostic management and underlying pathophysiological mechanisms of selective fetal growth restriction (sFGR) in monochorionic diamniotic (MCDA) twin pregnancies have not been fully clarified. The current diagnostic classification system based on three different umbilical artery flow patterns has no increasing scale of severity and the predictive value is limited. Since there is no treatment available for sFGR, predicting fetal deterioration is key in preventing single or double fetal demise. Outcome prediction is furthermore important in the selection of cases that will be offered selective reduction (to provide the larger twin with better prospects), as well as determining monitor frequency and possible hospital admission. As outcome prediction is clinically challenging, patient counselling is too, and parents often encounter a great deal of uncertainty during the pregnancy. Furthermore, little is known about the brain development of sFGR children (both during pregnancy and after birth). Moreover, the psychological impact of an sFGR pregnancy of the future parent)s) has not been studied before. The impact of these factors should be taken into account during patient counseling, which is currently not the case. By our knowledge, this is the first international, multicenter, prospective cohort study on that will address the abovementioned questions and knowledge gaps in MCDA pregnancies complicated by selective fetal growth restriction.

NCT ID: NCT05950854 Recruiting - Clinical trials for Osteoarthritis, Knee

3D Joint Space Evaluation in Knee Osteoarthritis: The Importance of Weight-bearing and Flexion

3DJSW-MRI
Start date: November 1, 2023
Phase:
Study type: Observational

Rationale: Osteoarthritis (OA) is mainly characterized by cartilage degeneration. In knee OA, measuring the distance between the tibia and femur, known as the joint space width (JSW), is an often-used method to quantify the progression of the disease or the effectiveness of treatments, because it is an indirect measure of cartilage degeneration. However, JSW is often measured while the patient is standing (weight-bearing) with slightly flexed knees, with a flexion angle of around 7-10 degrees, while direct cartilage thickness measurements are usually performed while the patient is lying down (non-weight-bearing) with an extended leg [1]. Because of this difference in positioning, it is difficult to compare different JSW and cartilage thickness measures, as it is not clear what happens with the JSW distribution in the joint when a patient changes position between weight-bearing/non-weight-bearing and flexion/extension. In this study, we aim to identify the changes that occur in the knee of OA patients under the influence of weight-bearing and/or flexion, to enable comparing joint space measures from different positions. In this research we want to use MRI as a three-dimensional imaging technique because there is no radiation involved.. Objective: To evaluate how the 3D knee joint space distribution in knee OA patients changes under the influence of weight-bearing (upright) and flexion MRI scanning. Study design: Explorative cross-sectional study. Study population: 21 patients with symptomatic knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) are included from the orthopaedics department of Medisch Spectrum Twente in Enschede. Main study parameters/endpoints: The primary study parameter is the change in medial joint space width between the different positions (weight-bearing/non-weight-bearing and flexion/extension).

NCT ID: NCT05949645 Recruiting - Emphysema or COPD Clinical Trials

Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema

BREATHE-2
Start date: August 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants at up to 5 study centers located in Europe and the United Kingdom. The main questions this clinical trial aim to answer are: Is it safe? Does it work? Participants who meet eligibility criteria will have up to two procedures 30 days apart, in which up to 3 implants will be placed in each lung during the procedure(s). Participants will be asked to return for follow-up visits at 30 days, and 3, 6, and 12 months after the procedure(s).

NCT ID: NCT05949125 Recruiting - Clinical trials for Acute Myeloid Leukemia, in Relapse

Dose-escalating Trial With Allo-RevCAR01-T Cells in Combination With CD123 Target Module (R-TM123) for Participants With Selected Hematologic Malignancies Positive for CD123

Start date: January 3, 2024
Phase: Phase 1
Study type: Interventional

The Allo-RevCAR01-T-CD123 drug is a combination of a cellular component (Allo-RevCAR01-T) with a recombinant antibody derivative (R-TM123), which together form the active drug. The cellular component Allo-RevCAR01-T consists of an allogeneic human T-cell genetically multi-edited and expressing a reversed, universal chimeric antigen receptor (RevCAR) presenting an extracellular peptide epitope (RevCAR epitope). R TM123 functions as a bridging module between Allo RevCAR01-T and a CD123-expressing target cancer cell by selectively binding the RevCAR epitope and CD123.

NCT ID: NCT05948761 Recruiting - Parkinson Disease Clinical Trials

Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease

TALISMAN-2
Start date: July 4, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

To explore the safety, feasibility and net symptomatic effects of multiple (3x/week, for 4 weeks) intermittent hypoxia treatment sessions in individuals with PD. Secondary outcomes include exploring induction of relevant neuroprotective pathways as measured in serum.

NCT ID: NCT05948475 Recruiting - Cholangiocarcinoma Clinical Trials

Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

FIRST-308
Start date: December 20, 2023
Phase: Phase 3
Study type: Interventional

This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma

NCT ID: NCT05946941 Recruiting - Sjögren's Syndrome Clinical Trials

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

POETYK SjS-1
Start date: September 11, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.

NCT ID: NCT05944614 Recruiting - Marfan Syndrome Clinical Trials

Towards Optimal Treatment of Marfan Syndrome

TOWER
Start date: February 23, 2023
Phase:
Study type: Observational

The purpose of this study is to determine whether new magnetic resonance imaging techniques can be used as a biomarker of aortic disease severity in patients with Marfan syndrome.