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NCT ID: NCT06392009 Recruiting - Clinical trials for Tuberous Sclerosis Complex

A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II

Start date: May 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Study RAD-GRIN-201 is a phase 1B/2A trial to assess safety, tolerability, pharmacokinetics (PK), and potential efficacy of radiprodil in participants with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) type II. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A and one year in Part B/long-term treatment period. The treatment period in Part B may be extended based on a favorable benefit/risk profile.

NCT ID: NCT06391671 Recruiting - Pediatric Obesity Clinical Trials

The Stress-obesity Axis: a Metabolomics Approach Towards Personalized Nutrition in Adolescents

FAME
Start date: January 11, 2022
Phase:
Study type: Observational [Patient Registry]

The ultimate aim of this project is to establish a validated strategy that allows for personalized intervention in adolescents (11 to 17 years) whom are assigned a state of overweight or obesity. The investigators will assess the following hypotheses: - Weight condition is reflected by the fecal metabolome (WP1) - Emotional stress is implicated in weight condition (WP1) - Functionality of the gut microbiome is related to the diet-stress-obesity axis (WP2) - Dietary pattern impacts the fecal metabolome and gut microbiome (WP2) - Personalized dietary intervention outperforms generalized dietary approaches (WP3) Participants will: - Produce a saliva, stool and hair sample - Fill in questionnaires regarding mental health, medical health and demographic information - Fill in a food frequency questionnaire and a 24-hrecalls - Be measured (height, weight, fat% and waist circumference) The samples will be analyzed using a technique called metabolomics to identify biomarker candidates with diagnostic and/or prognostic potential. Additionally, microbiome analysis will be performed to map the microbiome of all groups.

NCT ID: NCT06390514 Recruiting - Deaf Children Clinical Trials

The Benefits of Vibrating Floors for Deaf Children

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

In view of the difficulties observed in the oral language development of deaf children, it is essential to offer them appropriate and effective care as early as possible. One of the modalities frequently used clinically to stimulate this perception of language in the deaf child is to use the tactile sense via vibrations. One such tactile tool used by speech therapists is the vibrating floor, which enables the child to feel sounds through the vibrations perceived by his or her body. Although used in many institutions, there is very little scientific evidence to date of the effectiveness of using the vibrating floor with deaf children.

NCT ID: NCT06388330 Completed - Clinical trials for Functional Dyspepsia

The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms

FFD
Start date: April 26, 2019
Phase: N/A
Study type: Interventional

In this study, the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD.

NCT ID: NCT06387901 Not yet recruiting - Breast Cancer Clinical Trials

Investigating Paclitaxel Toxicity in Breast Cancer: The Roles of Physical Activity and Body Composition.

PABTOX
Start date: May 6, 2024
Phase:
Study type: Observational

This study looks into how a common breast cancer treatment, paclitaxel, can sometimes cause severe side effects that make it hard for patients to continue treatment. These side effects can significantly affect a patient's quality of life and even impact their recovery and overall health costs. What's interesting about this research is that it considers how a patient's lifestyle, specifically their physical activity levels and body makeup (like how much muscle and fat they have), might influence these side effects. The researchers are doing a detailed study with 40 women receiving paclitaxel treatment, tracking how the drug is processed in their bodies and how their body composition and physical activity might play a role in the side effects they experience. They are using a special method to monitor drug levels in the blood and are also keeping tabs on the patients' health and physical activity through questionnaires and modern tracking devices. The goal here is twofold: first, to better understand why these side effects happen to some people and not others, and second, to develop a model that can predict who might be at higher risk for these side effects based on their body composition, lifestyle, and how their body handles the drug. This could lead to more personalized treatment plans that could help reduce the risk of severe side effects and improve the overall treatment experience for patients with breast cancer. In simpler terms, this research is trying to find a way to make breast cancer treatment with paclitaxel safer and more comfortable by considering how a person's lifestyle and body type might affect their reaction to the drug. This could make a big difference in helping patients complete their treatment successfully and with a better quality of life.

NCT ID: NCT06387862 Not yet recruiting - Clinical trials for Left Ventricular Dysfunction

Pharmacokinetics of Inhaled Levosimendan

Symbiov
Start date: April 20, 2024
Phase: Phase 2
Study type: Interventional

Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan.

NCT ID: NCT06386900 Enrolling by invitation - Overreaching Clinical Trials

The Impact of Grand Tour Cycling on Sleep and the Hematological and Metabolomic Profile in World-class Cyclists

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

This project aims to identify the effect of a 3-week Grand Tour (e.g. Tour de France, Giro d'Italia, and Vuelta a España) on sleep, hematological parameters and the serum metabolome in world-class cyclists.

NCT ID: NCT06385951 Recruiting - Alzheimer Disease Clinical Trials

Spatial Navigation for the Early Detection of Alzheimer's Disease.

ALLO-task
Start date: March 5, 2024
Phase: N/A
Study type: Interventional

Alzheimer's Disease (AD) is the most common form of dementia and may contribute to 60-70 % of all cases. An early, accurate diagnosis of AD will become increasingly important with disease-modifying therapies. Different types of fluid and neuroimaging biomarkers are available for the early detection of AD. However, implementation of routine use of these biomarkers in clinical settings is held back due to the risk of overdiagnosis, increased cost and invasiveness of the assessment method. Therefore, novel biomarkers are needed beyond the amyloid and tau pathologies for the early diagnosis of AD. Neuropsychological paper and pencil tests can detect AD and discriminate between different clinical stages. Since medial temporal lobe structures, including the hippocampus and entorhinal cortex (EC), are involved in spatial navigation and degenerate in the earliest stages of AD, spatial navigation can be considered as an early cognitive biomarker of the disease. Nonetheless, the measurement of spatial navigation needs further improvement since the current paper and pencil tests lack ecological validity. Therefore, the test environment should be set up in immersive Virtual Reality (iVR). Dr. Andrea Castegnaro (Space and Memory Lab of University College of London) developed the Allocentric Spatial Update Task (ALLO task), which is an iVR task measuring egocentric and allocentric spatial abilities. Therefore, the main objective of this study is to evaluate whether allocentric and egocentric spatial navigation, measured by the ALLO iVR task can be considered a cognitive biomarker for the early detection of AD. In addition, the investigators want to report on the neuronal correlates of both spatial navigation strategies. Through the Department of Neurology of the University Hospital of Ghent, which has a large cognitive disorders clinic, patients with mild cognitive impairment and mild Alzheimer's dementia will be recruited. Participants will undergo standard clinical assessment, including a neuropsychological examination, Magnetic Resonance Imaging, a 18F-fluorodeoxyglucose PET and a Lumbar Puncture. In addition, participants will also be asked to undergo Tau PET imaging, Amyloid PET imaging and complete the ALLO iVR task. Healthy controls will also be recruited and have to undergo the same investigations, except for the amyloid PET and lumbar puncture.

NCT ID: NCT06384105 Recruiting - Urolithiasis Clinical Trials

Study of the Patient Radiation Dose During Five Endourological Procedures

PRDE
Start date: December 19, 2023
Phase: N/A
Study type: Interventional

In the medical world more and more procedures are performed with the use of ionizing radiation (x-ray), both diagnostic and therapeutic. The main and most known risk is the development of malignancies as a result of the use of ionizing radiation. Purpose of this study: To examine the patient radiation dose (PRD) if the frames per second (FPS) are set differently during the five most performed endourological procedures where fluoroscopy is used (insertion/replacement of ureteral stent, (mini-)percutaneous nephrolithotomy (PCNL/PNL), ureterorenoscopy (URS) and extracorporeal shock wave lithotripsy (ESWL/SWL)) and to propose an acceptable PRD for these procedures in a multicentric study.

NCT ID: NCT06383975 Not yet recruiting - Clinical trials for Persistent Atrial Fibrillation

VEin of MArshall Ethanolization vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF

VEMAPULSE
Start date: April 29, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare two ablation techniques to treat patients with persistent atrial fibrillation (irregular and often very rapid heart rhythm). An ablation is a procedure during which some scars are made on the inside of the heart to break up the electrical signals that cause the irregular heartbeat. In this trial researchers will compare a new technique, which uses tiny electric shocks to make the scars, to the standard technique, which uses heat. The main question the trial aims to answer is: • Does the new technique work as well as the standard technique to prevent the irregular heartbeat from returning within one year of the procedure? Participants will: - Undergo an ablation with either the new or the standard technique - Visit the hospital 1, 3, 6, 9 and 12 months after the procedure for a check-up - Wear a device to register their heart rhythm for 24 hours before the 3 month visit and for 72 hours before the 6, 9 and 12 month visit - Record their heart rhythm at home every week - Complete a questionnaire 3, 6, 9 and 12 months after the procedure