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NCT ID: NCT04592536 Completed - Panic Disorder Clinical Trials

A Trial of the Effect of CVL-865 on Panic Symptoms Induced by Carbon Dioxide Inhalation in Healthy Subjects

Start date: October 6, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine anxiolytic effect of multiple doses of CVL-865 using an experimental medicine model of carbon dioxide (CO2) inhalation in healthy volunteers.

NCT ID: NCT04592406 Completed - Clinical trials for Contrast-induced Nephropathy

Data on the Prevention of Complications of Prophylactic Intravenous Hydration in Patients With eGFR < 30

CVP
Start date: December 1, 2018
Phase:
Study type: Observational

At Maastricht University Medical Centre (Maastricht UMC+) a specialised unit was established where a dual screening process including both renal and cardiac parameters is used to minimize the risk of contrast-induced acute kidney injury as well as the risk of prophylactic hydration in eGFR<30mL/min/1.73m2 patients. Very little data exists on patients with eGFR <30mL/min/1.73m2 in this context. The current study aims to describe post-contrast outcomes of patients to whom this screening method has been applied.

NCT ID: NCT04591262 Completed - Healthy Clinical Trials

A Study To Asses Mass Balance And Absolute Bioavailability Of 14C PF-06826647 In Healthy Male Participants

Start date: November 10, 2020
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the metabolism and excretion following a single oral administration of 14C-PF-06826647-LR (14C labelled PF-06826647 with lower radioactivity per mass unit) in fed conditions. This information will enable assessment of clearance mechanisms of PF-06826647 as well as identify metabolites. In addition, this study will determine absolute bioavailability of PF-06826647 and understand intravenous (IV) pharmacokinetic (PK).

NCT ID: NCT04590768 Completed - Clinical trials for Gastrointestinal Complication

Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)

Start date: October 12, 2020
Phase: N/A
Study type: Interventional

This study aims to assess the impact of daily intake of 11 grams of Fermotein™ on gastrointestinal complaints and several other health related biomarkers. Furthermore, consumer acceptance is investigated. The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with fermotein based meals and a 18-day intervention with control meals. At the start and at the end of the intervention, a blood sample will be collected. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.

NCT ID: NCT04590352 Completed - Clinical trials for SARS-CoV-2 Infection

Mucosal Immunity Against SARS-CoV-2 Infection in COVID-19 Patients

MuCo
Start date: March 26, 2020
Phase:
Study type: Observational

In this study nasal fluid (mucosal lining fluid), nose and throat swabs and blood was collected from patients with a confirmed SARS-CoV-2 infection who remained in home isolation, as well as from their household contacts who remained in home quarantine. On the collected nose and throat swabs a coronavirus PCR was performed. Antibodies against SARS-CoV-2 were measured in the mucosal lining fluid and blood samples.

NCT ID: NCT04589910 Completed - Clinical trials for Mechanical Ventilation Complication

Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound.

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

Critically ill children treated with invasive mechanical ventilation (iMV) in a paediatric intensive care unit (PICU) may suffer from complications leading to prolonged duration of ventilation and PICU stay. Prolonged ventilation is associated with haemodynamic dysfunction, neuromuscular insufficiency, malnutrition, metabolic disorders and diaphragmatic muscle weakness. Evidence from adult critical care supports the existence of ventilator induced diaphragmatic dysfunction, defined as a iMV-induced loss of diaphragmatic force - generating capacity - characterised by muscle fibre atrophy, myofibril necrosis and disorganization. Diaphragm function or contractility can be assessed by measuring the diaphragm thickening during inspiration and expiration with ultrasound and is expressed as a thickening fraction (TF). A low diaphragm contractile activity in adults has been associated with rapid decreases in diaphragm thickness, whereas high contractile activity has been associated with increases in diaphragm thickness. Contractile activity decreased with increasing ventilator driving pressure and controlled ventilator mode. Maximal thickening fraction (a measure of diaphragm function) was lower in patients with decreased as well as increased diaphragm thickness than in patients with unchanged thickness (p=0.05). Titrating ventilatory support to maintain normal levels of inspiratory effort may prevent changes in diaphragm configuration associated with iMV, but more research is needed to confirm this supposition. Only one study has shown the presence of diaphragm atrophy in critically ill children on iMV for acute respiratory failure. The diaphragm contractility, measured as thickening fraction, was strongly correlated with a spontaneous breathing fraction. Norm data for diaphragmatic thickness and TF in children are only available for healthy neonates (n=15) and children (n=48) from 8 till 20 years of age. The purpose of this study is to determine values of normal diaphragm thickness and TF in children aged 0-8 years by ultrasound. This age range reflects the largest patient group treated in the PICU. Once these values are known, the clinical relevance of the measuring of the diaphragm thickness of ventilated children by ultrasound can be further studied. Objective of the study: Primary objective: To determine diaphragm thickness and thickening fraction in healthy children below or equal to 8 years of age. Secondary objective: To determine the interrater reliability of operators performing the ultra-sound Study design: prospective, cohort study. Study population: Healthy children in four age groups: 0-6 months; 6 months-1 year; 2-4 years; and 5-8 years. Participants will be recruited in two ways: Group 1. Parents of children scheduled to undergo a daycare procedure will asked permission for their child to join the study. These children undergo a minor procedure and are assumed to have a normal diaphragm; therefore are considered 'healthy''. Group 2. Health professionals working on the PICU or other departments of Erasmus MC-Sophia as well as family, friends and neighbours of members of the research group will be asked to recruit 'healthy' children. The investigators will recruit participants by means of brochures in which children and/or caregivers are invited to contact the researchers when interested to participate in this study. Primary study parameters/outcome of the study: To determine diaphragm thickness and thickening fraction in healthy children below or equal to 8 years of age. Secondary study parameters/outcome of the study (if applicable): To determine the interrater reliability of operators performing the ultra-sound

NCT ID: NCT04587427 Completed - Clinical trials for Bone Metastatic Castration-resistant Prostate Cancer

A Study to Learn More About How Radium-223 is Being Used With Other Treatments in European Patients Who Have Not Received Radium-223 Before

DIRECT
Start date: May 15, 2021
Phase:
Study type: Observational

In this study data from people with metastatic castration-resistant prostate cancer (mCRPC) with bone metastasis are studied. mCRPC is a prostate cancer which has spread to other parts of the body even when the amount of testosterone in the body was reduced. Bone metastasis is when the cancer has spread to the bones. The study drug, radium-223, is currently available as a treatment for mCRPC with bone metastasis. But, its combination with certain other cancer treatments may lead to medical problems. Therefore the instructions about how doctors should use radium-223 with other cancer treatments were changed. In this study, the researchers want to learn more about how doctors are now using radium-223 to treat patients with mCRPC and bone metastasis. The participants in this study will include men in Denmark, Germany, or the Netherlands. They will not have received radium-223 before. They will have at least 6 months of medical records before starting treatment with radium-223. The researchers will collect the participants' medical records up to December 2020. The researchers will review information from the participants' medical records and medical claims from hospitals where the participants received radium-223. They will look at the medical records of participants who first started receiving radium-223 before there were new instructions about using it with other cancer treatments. They will also look at the medical records of participants who first started receiving radium-223 after there were new instructions. They will then count how many participants received other specific cancer treatments with radium-223. They will compare the results of the participants' who received radium-223 before the new instructions and those who received it after the new instructions. There are no required visits or tests in this study.

NCT ID: NCT04584788 Completed - Oxygen Deficiency Clinical Trials

Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Start date: November 30, 2020
Phase: N/A
Study type: Interventional

Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.

NCT ID: NCT04580914 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation

NEwTON AF
Start date: April 12, 2021
Phase: N/A
Study type: Interventional

The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation.

NCT ID: NCT04577066 Completed - Clinical trials for Plasmodium Falciparum Malaria

Safety and Preliminary Protective Efficacy of Genetically Attenuated GA2 Parasites.

Start date: September 27, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will consist of two phases and be aimed at assessing the safety and tolerability of the new genetically attenuated GA2 malaria parasite (Phase 1) and its preliminary protective efficacy against controlled human malaria infection (Phase 2) in healthy Dutch volunteers.