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NCT ID: NCT05437237 Recruiting - Ischemic Stroke Clinical Trials

Algorithm Development Through AI for the Triage of Stroke Patients in the Ambulance With EEG

AI-STROKE
Start date: June 19, 2022
Phase: N/A
Study type: Interventional

Endovascular thrombectomy (EVT) enormously improves the prognosis of patients with large vessel occlusion (LVO) stroke, but its effect is highly time-dependent. Direct presentation of patients with an LVO stroke to an EVT-capable hospital reduces onset-to-treatment time by 40-115 minutes and thereby improves clinical outcome. Electroencephalography (EEG) may be a suitable prehospital stroke triage instrument for identifying LVO stroke, as differences have been found between EEG recordings of patients with an LVO stroke and those of suspected acute ischemic stroke patients with a smaller or no vessel occlusion. The investigators expect EEG can be performed in less than five minutes in the prehospital setting using a dry electrode EEG cap. An automatic LVO-detection algorithm will be the key to reliable, simple and fast interpretation of EEG recordings by ambulance paramedics. The primary objective of this study is to develop one or more novel AI-based algorithms (the AI-STROKE algorithms) with optimal diagnostic accuracy for identification of LVO stroke in patients with a suspected acute ischemic stroke in the prehospital setting, based on ambulant EEG data.

NCT ID: NCT05432024 Recruiting - Atrial Fibrillation Clinical Trials

Evaluation of Ablation Lesions Using Cardiovascular Magnetic Resonance Imaging

ENABLE-CMR
Start date: March 8, 2023
Phase:
Study type: Observational

Ineffective ablation lesions can cause arrhythmia recurrence after catheter ablation for cardiac arrhythmia. Ablation lesions can be created with various ablation energy modalities. This study uses cardiovascular magnetic resonance imaging to evaluate the ablation lesion characteristics of radiofrequency ablation, ultra-low temperature cryo ablation, and pulsed field ablation. The ablation lesion characteristics of different energy characteristics will be compared. Additionally, arrhythmia recurrence and quality of life will be evaluated for the different energy modalities.

NCT ID: NCT05431348 Recruiting - Glioblastoma (GBM) Clinical Trials

Effect of stRess and exeRcize on the Outcome After Chemo-Radiation

ERROR
Start date: June 1, 2022
Phase:
Study type: Observational

Glioblastoma (GBM) is a highly malignant, incurable primary brain tumor. Due to the nature of this disease and the extent of the treatment (surgery followed by chemoradiation according to the Stupp trial) patients undergo considerable psychological distress. It is known that stress hormones are involved in a wide range of processes involved in cell survival, cell cycle and immune function, and can cause therapy resistance. In this study the effect of stress on outcome after chemoradiation in patients with GBM will be investigated.

NCT ID: NCT05431140 Recruiting - Type 1 Diabetes Clinical Trials

Evaluation of CloudCare in the Treatment of Type 1 Diabetes

Start date: June 20, 2022
Phase:
Study type: Observational

CloudCare is an eHealth application to help health care professionals (HCP) in the management/treatment of type 1 diabetes. The application will automatically check all uploaded glucose parameters from patients glucose monitoring devices and present all these data in a categorized way (using a so called dashboard) to the HCP. In this way the HCP has a direct overview of the condition of her/his patients, and can determine which data request direct action towards the patient and which data do not. It is expected that this system improves outcome and patient experience. In this study this expectation will be studied by measuring the effect of CloudCare on patients' treatment satisfaction, glucose control, HCP satisfaction and the impact on costs.

NCT ID: NCT05431101 Recruiting - Clinical trials for Carpal Tunnel Syndrome

abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release

SENSE
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Carpal Tunnel Syndrome is a prevalent condition, up to 9% in women and 0.6% in men. Surgical decompression in the most effective treatment. After surgery, approximately 1,8% of the patients develop a wound infection. Possibly, the type of sutures used can influence the prevalence of wound infection. In this RCT the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release.

NCT ID: NCT05428735 Recruiting - Clinical trials for Small Future Liver Remnant (FLR)

The DRAGON 2 Trial

DRAGON 2
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).

NCT ID: NCT05425459 Recruiting - Heart Failure Clinical Trials

RESPONDER-HF Trial

Start date: November 17, 2022
Phase: N/A
Study type: Interventional

Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization

NCT ID: NCT05424484 Recruiting - Incisional Hernia Clinical Trials

Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence

MARS
Start date: November 10, 2022
Phase: N/A
Study type: Interventional

The purpose of this prospective, pivotal, multi-center, single-arm, pre-market, investigational clinical study is to assess the safety and performance of Deterniaâ„¢ Self-Gripping Resorbable Mesh when used for suture line reinforcement after midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II). Data from this study will be used to support market applications. The indication under investigation is reinforcement of midline laparotomy to limit the rate of incisional hernia (IH) in clean and clean-contaminated surgeries (CDC Classification I and II).

NCT ID: NCT05423665 Recruiting - Clinical trials for Fetal Growth Restriction

Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies

HEART
Start date: June 22, 2023
Phase:
Study type: Observational

In this project there are 2 time points during the pregnancy included, namely at 21 weeks and 30 weeks of gestation, to measure the predictive values of FGR, strain and strain rate. The fetal growth parameters will be collected at the same time points, to define the growth (differences) throughout gestation of both fetuses. A maternal blood sample will be taken at 21 weeks of gestation to identify the level of exposure to air pollution (black carbon) and the level of biochemical markers of placental dysfunction. Doppler ultrasounds will be used for antenatal identification of placenta insufficiency. At birth, umbilical cord blood and the placenta will be collected. The placenta will be examined, to identify morphological findings which are associated with FGR. The umbilical cord blood and placental biopsy will be used for the level of exposure to air pollution and the level of oxidative stress. One to three days after birth, neonatal strain and strain rate will be measured to define postnatal cardiac remodeling as well as the neonatal blood pressure as cardiovascular risk factor.

NCT ID: NCT05421273 Recruiting - Clinical trials for Failed Back Surgery Syndrome

Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: A Multicenter Randomized Trial (BURST-RAP Study)

BURST-RAP
Start date: February 16, 2022
Phase: N/A
Study type: Interventional

Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome Type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It is still unknown if there are clinical differences between active recharge and passive recharge burst SCS. To date, no clinical studies have been performed that directly compared these two burst stimulation waveforms. The objective of this Randomized Clinical Trial (RCT) is to assess and compare effect of passive recharge burst SCS with active recharge burst SCS on pain relief and motivational-emotional facets of pain