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Filter by:Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film delivery compared to iv injection for chemotherapy induced nausea or vomiting (CINV). Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.
Influence of inguinal hernia repair on sperm autoimmunity using MAR test
Dysphagia is caused by multiple factors, and respiratory-swallowing discoordination is considered to be one of the factors. The investigators recently developed a visual and auditory breathing-swallowing coordinated training device. In this study, investigators examined the validity of a this device for healthy subjects. The investigators will examine which respiratory phase the swallowing occurs when the swallowing is started in accordance with the signal lighting and voice of this device.
The purpose of the Study is to compare the outcomes of the surgical and the percutaneous approach to the upper extremity access (axillary or brachial artery) during endovascular procedures on the aortic valve, the aorta, and its side branches.
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
Stroke can lead to signficiant neurological deficits, and about one-third of stroke patients will be diagnosed of vascular mild cognitive impairment or post-stroke dementia. Post-stroke dementia includes all types of dementia that happen after stroke, irrespective of their cause, and vascular dementia (VaD), degenerative dementia (especially Alzheimer's disease), or mixed dementia (dementia as a result of the coexistence of vascular lesions of the brain and neurodegenerative lesions) are the most common causes of post-stroke dementia. However, it is difficult to determine to what extent cognitive impairment may be attributable to stroke versus concomitant Alzheimer disease. With the advent of PET imaging technique, we are able to conduct a multi-modal neuroimaging study to explore the composite influence of vascular injury, amyloid plaque and Tau protein the the cognitive performance after stroke.
The purpose of this Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA™ 2000 device in healthy adult volunteers for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection. This study is divided into 2 parts: Part 1- dose finding stage and Part 2- dose expansion stage.
The primary objectives of this study are: - To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory Syndrome in Children (MIS-C), and - To determine immunologic mechanisms and immune signatures associated with disease spectrum and subsequent clinical course during the year of follow-up.
Psoriatic arthritis (PsA) is a type of joint disease that can lead to severe joint damage and disability within the first few years of the disease. This is why early detection and treatment of the disease is essential to prevent serious joint damage and improve long-term outcomes in these patients. However, there is currently no reliable way to tell the difference between PsA and other types of joint disease. This makes it difficult to detect PsA early. Enthesitis is an inflammation of the area where muscle tendons and ligaments attach to bones. Enthesitis is a key feature in PsA and can be easily detected using ultrasonography. The aim of this research study is to develop a system to evaluate enthesitis using ultrasonography, which can be used as an effective tool in the early detection of PsA. This will help in providing patients with early treatment to prevent further joint damage.
The study will include 20 people with hand OA awaiting surgery in the fingers. Participants will undergo dual-energy CT, cone-beam CT, ultrasound, clinical examination, blood sampling and questionnaires. Images will be analysed for the presence of joint-associated crystal including monosodium urate, calcium pyrophosphate and calcium hydroxyapatite. Material obtained during surgery will be used for crystal verification and calculation of diagnostic accuracy of dual-energy CT and cone-beam CT.