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NCT ID: NCT05813353 Completed - Clinical trials for Cognitive Impairment

Pre- and Post TAVI Cognitive Functioning and Intraoperative Carotid Flow Measurements

Start date: July 14, 2021
Phase:
Study type: Observational

Purpose: 1. Measuring and optimize the usability of the BAMCOG (games to measure cognitive functioning) 2. Concurrent validation of BAMCOG with MoCA to see if BAMCOG can serve as a monitoring instrument/screener 3. Determination of carotid flow/cerebral blood flow pre- and post implant of prosthesis of aortic valve by ultrasound doppler measurements

NCT ID: NCT05812261 Completed - Atrial Fibrillation Clinical Trials

Lesion Characteristics After Pulsed-Field Ablation in Patients With Atrial Fibrillation and a Left Common Ostium

PFALCO Remap
Start date: July 19, 2023
Phase:
Study type: Observational

This study aims to investigate the lesion characteristics after pulmonary vein isolation using pulsed-field ablation in patients with atrial fibrillation and a common of the left pulmonary veins. The main question it aims to answer is: In which percentage of the patients will pulsed field ablation result in successful isolation of the left common ostium? Nineteen patients will be prospectively included in OLVG. All patients will be treated with pulsed-field ablation (routine care). After the ablation procedure, an electro-anatomical map will be created using the ablation catheter and a mapping system. This map will display the left atrium and the lesion in detail. After the procedure, three experienced operators are asked to draw a line around the LCO in the anatomical map where they would have ablated if conventional radiofrequency ablation was used. The distance between the drawn line and the ablation lesion will be measured at three predefined points. The lesion is considered successful if the mean distance is within ±10mm at all measurement points.

NCT ID: NCT05798273 Completed - Clinical trials for Malignant Brain Tumors

(68^Ga)-GaPSMA-11 PET/MR-imaging of Malignant Intra-axial Brain Tumors

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

PSMA is a transmembrane protein specifically expressed in the vascular endothelium of malignant brain tumors, most notably glioblastoma and not in healthy brain parenchyma. It has been shown to be involved in (neo)angiogenesis and endothelial cell invasion. By means of 68Ga-labeled PSMA ligands, investigators are able to non-invasively visualize/quantify PSMA expression in glioblastoma (neo)vasculature in vivo by means of PET. The primary aim of this study is to confirm PSMA as suitable diagnostic and potential theranostic target in patients with intra-axial brain tumors by means of [68Ga]Ga-PSMA-HBEC-CC ([68Ga]Ga-PSMA-11) PET. The secondary aim is to assess whether uptake is increased with intra-arterial injection in those tumors that show uptake after intravenous injection of [68Ga]Ga-PSMA-11.

NCT ID: NCT05797116 Completed - Preoperative Care Clinical Trials

Practice Variation in Preoperative MDT Meetings

Start date: January 31, 2023
Phase:
Study type: Observational

The goal of this observational survey study is to evaluate the current practice variations of preoperative multidisciplinary team meetings (MDT meetings) for high risk noncardiac surgical patients. The main questions it aims to answer are: - What is the current variation in Dutch hospitals in the practice of preoperative MDT meetings for high risk noncardiac surgical patients? - Which facilitators and barriers influence the implementation process of preoperative MDT meetings? Participants are anesthesiologists in Dutch hospitals who will be asked to fill in a one-time survey. One anesthesiologist per anesthesiology department will be asked to fill in the survey. The survey will take approximately 5 to 10 minutes to complete.

NCT ID: NCT05791565 Completed - Asthma Clinical Trials

Green (Sustainable) VENTOLIN - Pharmacokinetics (PK) Study in Healthy Participants

Start date: April 3, 2023
Phase: Phase 1
Study type: Interventional

This study will be conducted to compare the PK of salbutamol administered via metered dose inhalers (MDI) containing propellants 1,1-difluroethane (HFA-152a) and 1,1,1,2-tetrafluoroethane (HFA-134a) in healthy participants.

NCT ID: NCT05785507 Completed - Clinical trials for Polycystic Ovary Syndrome

PriskA Pilot Study

Start date: March 1, 2023
Phase:
Study type: Observational

Background of the study: With a prevalence up to 15%, polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. Women with PCOS present with diverse features, including reproductive features such as irregular menstrual cycles, subfertility, hirsutism and pregnancy complications, metabolic features such as obesity, insulin resistance, metabolic syndrome, pre-diabetes, type 2 diabetes and cardiovascular factors, and psychological features such as anxiety and depression. Because of the reproductive, metabolic and cardiovascular risk factors it is important to screen and inform these women. However, up to 70% of the affected women remain undiagnosed. In academic hospitals (tertiary care) the diagnosis PCOS will rarely be missed by gynecologists. However, in peripheral hospitals or for internal medicine physicians, PCOS and its criteria are less well known. Therefore, the PCOS risk algorithm (PriskA), a digital tool to use in the assessment of PCOS in patients with signs and symptoms of PCOS, is developed. To exclude patients with a WHO I status, the tool exclude women with low Luteinizing Hormone (LH) and low Follicle-Stimulating Hormone (FSH) in advance. Women with LH and FSH within the normal range will be used in the algorithm for further assessment. The algorithm uses clinical data including age, BMI and information about irregular menstrual cycle in combination with anti-Mullerian hormone (AMH), testosterone and Sex Hormone Binding Globulin (SHBG) to generate a risk score ranging from 0-1. Women having a risk score below 0.2 are considered having a low risk of having PCOS, women with a risk score 0.2-0.8 are considered having a moderate risk of having PCOS and women with a risk score above 0.8 have a high risk of having PCOS. Objective of the study: In this study we aim to assess the validity of the PriskA algorithm to diagnose PCOS in a pilot study with patients presenting with signs and symptoms of PCOS. The study also aims to collect information on the user experience from the clinicians and to provide useful information to support the design of a validation study. Study design: This study will be a prospective, mono-center observational pilot study and it will be conducted at the Department of Reproductive Endocrinology at the Erasmus University Medical Center Rotterdam, the Netherlands. We estimate that the study will be completed within one year. Study population: Women with symptoms of PCOS who are referred to the Department of Reproductive Endocrinology at the Erasmus University Medical Center Rotterdam, and are undergoing a standardized screening (COLA screening, which stands for: (menstrual) Cycle problems, Oligomenorrhea and Amenorrhea). The COLA screening is part of standard clinical care. Women with one or more symptoms of PCOS will be included in the study. Women who eventually getting the diagnosis PCOS by standard screening will be labelled as cases and women who have one PCOS symptom and did not get the diagnosis PCOS will be labelled as controls. Primary study parameters/outcome of the study: The validity of the PriskA tool to diagnose PCOS, by assessing the sensitivity and specificity of the risk probabilities of 0.2 and 0.8.Parameters that will be used: - Testosterone level in serum (using Elecsys using Cobas 6000) - SHBG level in serum (using Elecsys using Cobas 6000). - AMH level in serum (using Elecsys using Cobas 6000). - LH level in serum (using Elecsys using Cobas 6000) - FSH level in serum (using Elecsys using Cobas 6000) - Cycle information - Age - BMI Secondary study parameters/outcome of the study: A secondary study parameter is to assess the number (percentage) and characteristics of patients with a PriskA score between 0.2-0.8. Characteristics will include: menstrual cycle information, age, BMI, serum LH, serum FSH, serum AMH, serum testosterone, serum SHBG, serum progesterone, serum estradiol, total follicle count, PCOS phenotype (if applicable), WHO diagnosis or other endocrinological diagnosis. Another secondary parameter is the user experience of the PriskA tool. This will be collected from every user by a questionnaire. Questionnaires will be collected from every used when he/she completed 20 patients during the study.

NCT ID: NCT05784207 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

An In Silico Trial to Evaluate Prospectively the Performance of a Radiomics Algorithm for UIP Compared to Medical Doctors

Start date: June 1, 2017
Phase:
Study type: Observational

The purpose of this study is to compare AI performance to doctor's performance in the evaluation of IPF/UIP and ILDs without UIP(proven by biopsy).

NCT ID: NCT05779358 Completed - Clinical trials for Non-celiac Gluten Sensitivity

Gluten and (Extra-)Intestinal Symptoms in NCGS

WoW
Start date: October 19, 2018
Phase: N/A
Study type: Interventional

The goal of this randomized, double-blind, placebo-controlled study is to investigate the effect of expectancy related to gluten consumption versus actual gluten intake on overall GI symptoms in individuals with non-coeliac gluten sensitivity (NCGS) The main questions it aims to answer are: - what is the effect of consumer expectancy, related to either gluten-containing or gluten-free oat bread, on short-term (within 8 hours) overall GI symptoms in individuals with NCGS? - what is the effect of actual gluten intake on short-term (within 8 hours) overall GI symptoms in individuals with NCGS Participants will be randomised into four groups: 1. Participants with the expectation of receiving gluten-containing bread and actually receiving gluten-containing oat bread during the test day. (E+ G+) 2. Participants with the expectation of receiving gluten-containing bread, but actually receiving gluten-free oat bread during the test day. (E+ G-) 3. Participants with the expectation of receiving gluten-free bread but actually receiving gluten-containing oat bread during the test day. (E- G+) 4. Participants with the expectation of receiving gluten-free bread and actually receiving gluten-free oat bread during the test day. (E- G-)

NCT ID: NCT05777863 Completed - Aging Clinical Trials

The Effects of a Multidomain Lifestyle Intervention on Brain Functioning and Its Relation With Immunometabolic Markers in Ageing

HELI
Start date: May 10, 2022
Phase: N/A
Study type: Interventional

HELI is a multicenter, randomised controlled trial in two Dutch research centres (Donders Centre for Cognitive Neuroimaging, Nijmegen, and the department of Human Nutrition & Health at Wageningen University) among 104 older adults aged 60-75 years who are at risk for cognitive decline with an intervention duration of 26 weeks (roughly 6 months). Participants are randomized in a 1:1 ratio to a multidomain lifestyle intervention characterized by group-sessions and guidance (high-intensity intervention group) versus online access to general lifestyle-related health information in the form of biweekly leaflets (low-intensity intervention group).

NCT ID: NCT05773625 Completed - Chronic Disease Clinical Trials

JITAIs: Optimization of Effectiveness

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The goal of this feasibility study is to get insight into the receptivity of a JITAI aimed at healthy dietary intake in inhabitants of a small city in the Netherlands. The main question it aims to answer is: • what is the right time and the right location to send notifications to people and for what type of interventions are people most receptive? Furthermore, the aim is to get insight into the relevance and usability of the app, the privacy concerns that people have and the perceived effectiveness of the app on dietary intake. Participants will test our app for 2 weeks, of which they will receive prompts during one week.