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NCT ID: NCT06212050 Enrolling by invitation - Aortic Stenosis Clinical Trials

Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis

Neo2BAV
Start date: September 15, 2023
Phase:
Study type: Observational

The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis. The clinical, procedural, and imaging characteristics will be collected from patients with severe BAV stenosis, regardless of the phenotype, and treated with TAVI using the ACURATE neo2 bioprosthesis worldwide.

NCT ID: NCT06097572 Enrolling by invitation - Food Allergy Clinical Trials

Improved Diagnostics in Food Allergy Study

ID-in-FA
Start date: October 18, 2023
Phase: N/A
Study type: Interventional

The investigators will conduct low-dose intranasal allergen challenges on children and young people with an indeterminate diagnosis of food allergy to cow's milk or peanut. Blood samples will also be taken, for conventional blood allergy diagnostics (allergy-specific Immunoglobulin E) and mast cell activation test (MAT). The data will be used to determine the diagnostic accuracy of two complementary, novel approaches to diagnose food allergy, in a representative clinical cohort.

NCT ID: NCT05929807 Enrolling by invitation - Achondroplasia Clinical Trials

A Clinical Trial to Investigate Long-term Safety, Tolerability, and Efficacy of Weekly Subcutaneous Doses With TransCon CNP in Children and Adolescents With Achondroplasia

AttaCH
Start date: June 21, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

TransCon CNP administered once-weekly in children and adolescents with achondroplasia who have completed a prior TransCon CNP clinical trial. Participants who complete a prior TransCon CNP trial and meet all eligibility criteria will be invited to continue into the long-term open label extension trial to receive 100 µg CNP/kg/week of TransCon CNP. Trial treatment will be completed when the participant reaches 16 years of age for females and 18 years of age for males and have femur and tibial epiphyseal closure. TransCon CNP treatment will continue if femur and tibial epiphyseal closure is not confirmed at the age of 16 years for females, and 18 years for males. Treatment with TransCon CNP will be completed once femur and tibial epiphyseal closure is confirmed by radiographic imaging. The trial duration is individual for each trial participant. Visits will occur every 12-14 weeks throughout the trial.

NCT ID: NCT05619783 Enrolling by invitation - Clinical trials for Amyotrophic Lateral Sclerosis

Extension Study Evaluating The Safety And Tolerability of AMX0035

Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the safety and tolerability of AMX0035 over 108 weeks of open label treatment for participants previously enrolled in Study A35-004 (PHOENIX).

NCT ID: NCT04816331 Enrolling by invitation - Clinical trials for Neonatal Encephalopathy

Follow-up of Inflammatory Responses and Multiorgan Outcomes FoLlowing Neonatal Brain injurY

FIREFLY
Start date: August 4, 2020
Phase:
Study type: Observational [Patient Registry]

Babies who have brain injury also frequently have involvement of their kidneys, lung and heart. Although clinical care in the neonatal period is well defined there are few guidelines and evidence for developmental, heart and kidney followup in childhood. The investigators aim to develop and implement guidelines for health care workers and families on Followup after Neonatal Brain Injury. Inflammation is an important factor in brain injury of newborns and also affects their heart lungs and other parts of their body. The investigators will use tests from the newborn period to predict outcome and help parents with planning health needs for their baby rather than waiting until any issues arise later on. By understanding inflammation the investigators can find methods to decrease the negative effects and improve outcomes in the future for babies and families.

NCT ID: NCT04260269 Enrolling by invitation - Solid Tumor Clinical Trials

Feasibility of Switching Fluoropyrimidine Due to Cardiotoxicity Study

CardioSwitch
Start date: June 1, 2018
Phase:
Study type: Observational

The purpose of the present study is to evaluate cardiotoxicity during re-challenge of a different modality of fluoropyrimidine (primary end-point S-1 and secondary any other fluoropyrimidine) after having perceived cardiotoxicity with a fluoropyrimidine based regimen previously. The patient population is being treated for solid tumors.

NCT ID: NCT03859895 Enrolling by invitation - Paget Disease Clinical Trials

Zoledronate In the Prevention of Paget's Disease: Long Term Extension

ZiPP-LTE
Start date: April 5, 2019
Phase:
Study type: Observational

Paget's disease of the bone (PDB) is a metabolic bone disorder which in some individuals can cause pain, bone deformity, arthritis and deafness, although in many patients it does not cause symptoms. Paget's disease has a strong genetic component and SQSTM1 is the most important susceptibility gene. People who inherit mutations in SQSTM1 have a high risk of developing PDB later in life. This study is an extension of the ZiPP (Zoledronate in the Prevention of Paget's) study which was is randomised trial currently in progress to determine if the bisphosphonate zoledronic acid (ZA) can prevent or delay the development of PDB-like bone lesions compared with a dummy treatment (placebo) in people who inherit SQSMT1 gene mutations. Although the ZiPP study will provide information on whether early ZA treatment can favourably influence bone lesion development the significance of this to the patient in terms of symptoms is unclear as yet. The aim of the extension study is to keep these individuals under surveillance for any symptoms or signs of PDB over a further 5 year period and to evaluate if there has been any progression of PDB-like lesions by bone scan at the end of this period.

NCT ID: NCT03847831 Enrolling by invitation - Physical Activity Clinical Trials

Feasibility Study of the Pilot Post-primary Active School Flag (PPASF) Program

PPASF
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The Feasibility of the post-primary Active School Flag (PPASF) programme. The PPASF is an initative from the Department of Education and Skills in a whole-school program to increase physical activity opportunities involving the students in second level education schools in Ireland. Various actors involved in the process include admin, teachers, and students to create more physical activity opportunities for the students in the school. Process evaluation and fidelity of the program are carried out during the year long process for certificate and two years for achieving the flag. Results of this study will inform the design and implementation of the PPASF in a national roll out across Irish second level education schools.

NCT ID: NCT03568318 Enrolling by invitation - Atopic Dermatitis Clinical Trials

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

AD Up
Start date: August 9, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

NCT ID: NCT03282487 Enrolling by invitation - Clinical trials for Adrenal Insufficiency

Optimising Steroid Replacement in Patients With Adrenal Insufficiency

Start date: September 5, 2017
Phase: Phase 4
Study type: Interventional

Adrenal insufficiency is a condition where the adrenal glands do not produce an adequate amount of steroid hormones. The aetiology of adrenal insufficiency can be primary or secondary. Patients will adrenal insufficiency have increased morbidity and mortality. In recent years there has been concern regarding what is the optimal dose and regimen of steroid replacement for patients. Unfortunately there is no accurate way of monitoring if a patient is on too much or too little steroid. We have shown in hypopituitary patients with secondary adrenal insufficiency that higher doses of hydrocortisone may be harmful. This reason for this is not fully understood. In recent years, a modified release hydrocortisone tablet (Plenadren) taken once per day (unlike conventional immediate release hydrocortisone which requires twice or thrice daily regimen) has come on the market. This tablet has shown to a have a steroid profile that more closely resembles normal physiology, avoiding the peak steroid levels that occur during thrice daily regimens, which may be of importance for improving outcome in adrenal insufficiency patients. It also shown improved cardiovascular risk factors, glucose metabolism and quality of life in compared to conventional treatment. The aim of our study is to assess the effect of hydrocortisone therapy on how the body uses and breaks down (metabolises) steroids. This will be done by several different research methods: by measuring markers of steroid action and metabolism in blood, urine and within the fat tissue under the skin in the abdomen. These results will be compared in the same patient while on their usual hydrocortisone and after switching to modified release hydrocortisone for 12 weeks, and to results from a normal healthy control group who are not on steroid replacement. This will be the first study to assess the impact of this new modified release hydrocortisone in relation to tissue steroid metabolism. The results will potentially help us to improve the treatment of patients with steroid deficiency and reduce the side effects seen in these patients.