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NCT ID: NCT05915026 Recruiting - Children Clinical Trials

A Study to Learn How Gadoquatrane Moves Into, Through, and Out of the Body and How Safe it is in Children (From Birth to <18 Years), Who Will Undergo a Contrast Enhanced MRI (Quanti Pediatric)

Start date: August 16, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to help children under the age of 18 with any known or suspected problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI). MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve their evaluation. The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd), which is needed for the increase in signal intensity and contrast in MRI. The gadolinium in these contrast agents is caged in a molecule (chelate complex). Researchers are developing new contrast agents with a lower amount of Gd needed per CE-MRI investigation. Gadoquatrane is one of these new contrast agents. It has been tested in several studies previously. The main purpose of this study is to learn how gadoquatrane moves into, through, and out of the body and how safe it is in children. The researchers will measure the amount of gadoquatrane in the blood at different time points after a single injection. The participants will undergo an MRI examination and receive gadoquatrane once at a dose of 0.04 mmol Gd/kg (corresponding to 0.1 mL/kg). It is injected into the participant's vein (also called an intravenous injection) during the MRI examination. Each participant will be in the study for between 8 and 38 days with up to 5 doctor visits, including the screening phase of up to 28 days with no more than 2 visits. Once a participant has received the injection of gadoquatrane, the remaining study duration is 7 (±1) days. At the start or during the study, the doctors and their study team will: - check the weight and height of the participant, - ask for information including age and medical history, - take participants' blood samples, - ask participants and/or their guardians questions about medicines they are taking, - check blood pressure, heart rate and body temperature, - check the area where the participants had the intravenous injection, - do pregnancy tests in girls of childbearing age, - review the MRI scans obtained in the study and decide on the diagnosis - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

NCT ID: NCT05913518 Recruiting - Clinical trials for Alcohol Use Disorder

Neurofeedback Training of Metacognition in Subjects With Alcohol Use Disorder. Disorder Induces Neural Modifications: an Event-related Potentials Study

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

Addressing cognitive deficits in alcohol use disorder (AUD) supports recovery. Impaired metacognitive functioning in AUD causes compromised recognition of the interoceptive state leading to the maintenance of alcohol abuse despite negative consequences. By promoting greater self-awareness and self-regulation, neurofeedback training is of high relevance in metacognition remediation to support abstinence. The main objective of the present study is to validate neurofeedback as a complementary clinical tool to overcome metacognitive deficits that represent a significant factor in the maintenance of harmful consumption behavior and relapse phenomena in AUD.

NCT ID: NCT05912517 Recruiting - Clinical trials for Hemolytic Disease of the Fetus and Newborn

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

AZALEA
Start date: December 20, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.

NCT ID: NCT05911633 Recruiting - Clinical trials for Hepatocellular Carcinoma Non-resectable

BioPearlâ„¢ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)

BIOPEARL-ONE
Start date: February 29, 2024
Phase: N/A
Study type: Interventional

The primary objective of the study is to confirm technical success and safety of BioPearlâ„¢ microspheres loaded with Doxorubicin in the treatment of unresectable hepatocellular carcinoma (HCC). The secondary objective of the study is to investigate the efficacy of BioPearlâ„¢ microspheres loaded with Doxorubicin in the treatment of subjects with unresectable HCC.

NCT ID: NCT05908279 Recruiting - Parkinson Disease Clinical Trials

Gait Control in Parkinson Disease

GAIT-PD
Start date: May 1, 2023
Phase:
Study type: Observational

Previous work has shown that a statistical property of gait characterised by long-range autocorrelation functions is altered in Parkinson disease (PD). On the other hand it has been suggested that the same property is linked to the ability in healthy humans to co-regulate the amplitude and cadence of strides towards maintaining a constant speed. Here the investigators want to better understand why it is altered in PD by measuring the transitions between gait instructed by a metronome, and gait without metronome. The experimental conditions will allow the comparisons between these transitions across PD and healthy groups of volunteers, and assess differences based on statistical and computational modelling. The link with potential freezing episodes will also be studied to assess whether the statistical determinants of gait control in this population can be used as a proxy or predictor of the occurence of freezing episodes.

NCT ID: NCT05908266 Recruiting - Parkinson Disease Clinical Trials

Flexible Reaching Control in Parkinson Disease

REACH-PD
Start date: May 1, 2023
Phase:
Study type: Observational

Current research and theories have highlighted that the parameters linked to movement planning, e.g. the decision to select a movement goal, and adaptation, e.g. the ability to update control dependent on a novel dynamical context, are update quickly and within an ongoing movement in the general population. In parallel, it has been suggested that the evaluation of movement costs is a function of the basal ganglia, and it is impaired in Parkinson disease (PD). Here the investigators want to test whether these mechanisms also alter the ability of patients to update control during an ongoing action. A positive result would confirm that movement-related costs and dynamical representations depend on the integrity of the basal ganglia, in contrast a negative result would indicate that the deficit in PD is more specifically related to movement initiation, which would invite one to reconsider the cause of bradykinesia in this population.

NCT ID: NCT05907590 Recruiting - Fibromyalgia Clinical Trials

Proprioception and Interoception in Patients With Fibromyalgia

Start date: July 25, 2022
Phase:
Study type: Observational

The goal of this observational study is to learn about interoception and proprioception in patients with fibromyalgia. The main questions it aims to answer are: - Is there a significant difference in interoception between patients with fibromyalgia and healthy controls? - Is there a significant difference in proprioception between patients with fibromyalgia and healthy controls? The participants will perform: - The respiratory occlusion discrimination task - A postural control task where the effect of muscle vibration on center of gravity displacement is examined - The head repositioning accuracy task The participants will also fill out different questionnaires. Researchers will compare healthy controls to see if there is a significant difference.

NCT ID: NCT05907538 Recruiting - Fibromyalgia Clinical Trials

Interoception in Patients With Medically Unexplained Symptoms

Start date: July 25, 2022
Phase:
Study type: Observational

The goal of this observational study is to learn about interoception in patients with stress related syndromes (overstrain, burnout; SRS) and functional disorder (fibromyalgia/ chronic fatigue syndrome; FD). The main questions it aims to answer are: - Is there a significant difference in interoception between patients with SRS and healthy controls? - Is there a significant difference in interoception between patients with FD and healthy controls? - Is there a significant difference in interoception between patients with SRS and FD? The participants will perform the respiratory occlusion discrimination task and have to fill out some questionnaires. Researchers will compare healthy controls to see if there is a significant difference.

NCT ID: NCT05907096 Recruiting - Clinical trials for Delayed Graft Function

ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function

VARVARA
Start date: February 17, 2024
Phase: Phase 2
Study type: Interventional

This is a phase 2 study to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function

NCT ID: NCT05904886 Recruiting - Clinical trials for Carcinoma, Hepatocellular

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152)

SKYSCRAPER-14
Start date: September 14, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).