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NCT ID: NCT04049773 Completed - Fatigue Clinical Trials

Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

FatHoM
Start date: July 15, 2019
Phase:
Study type: Observational

To investigate the course and diurnal change of fatigue symptoms and haemodialysis related symptoms in chronic haemodialysis patients, its relation to haemodialysis treatment and the association with other factors by implementing an ecological momentary assessment procedure incorporated in a webapplication.

NCT ID: NCT04042090 Completed - Quality of Life Clinical Trials

The Efficacy, Acceptability, Tolerability and Feasibility of a Therapeutic Virtual Reality Application

PijnVRij
Start date: December 10, 2019
Phase: N/A
Study type: Interventional

This study evaluates the effect of therapeutic Virtual Reality (VR) on quality of life of 60 patients with non-specific chronic low-back pain. 30 patients will be included in the intervention group. These patients will use Reducept, a therapeutic virtual reality application based on diverse cognitive therapies (ACT, mindfulness, EMDR, hypnotherapy), at home over a period of 28 days, for at least 10 minutes each day. This will be an add-on intervention next to standard care, while the patient is waiting to receive actual treatment for chronic pain. 30 patients in the control group will only receive standard care, whilst waiting to receive actual treatment for their chronic pain. Intervention and control group will be compared on a number of outcome measures related to quality of life before using VR, during VR use, just after use and 4 months after final use. This explorative study is necessary to get first insights as a basis for a confirmative study.

NCT ID: NCT04039880 Completed - Clinical trials for Invasive Fungal Infections

Absorption, Metabolism and Excretion of 14C-olorofim in Man

hAME
Start date: July 30, 2019
Phase: Phase 1
Study type: Interventional

Single-centre, open-label, non-randomised, single dose study in 2 cohorts of healthy subjects. It is planned to enrol 6 healthy male subjects in Cohort A (standard mass balance and metabolite profiling cohort) and up to 6 subjects in Cohort B (biliary evaluation cohort); each subject will receive a single oral administration of 120 mg [14C]-olorofim oral solution containing approximately 3.7 MBq (100 µCi).

NCT ID: NCT04039113 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Tezepelumab COPD Exacerbation Study

COURSE
Start date: July 30, 2019
Phase: Phase 2
Study type: Interventional

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT04037618 Completed - Healthy Clinical Trials

Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-EYP001a After a Single Oral Dose

Start date: July 24, 2019
Phase: Phase 1
Study type: Interventional

The study is designed to investigate the absorption, metabolism, and excretion of EYP001a as well as the safety/tolerability of EYP001a following the administration of a single oral dose to healthy male volunteers. The EYP001a dose is administered in a [14C]-labeled form to enable detection and quantitation of dose-related material independent of possible biotransformation.

NCT ID: NCT04035733 Completed - Clinical trials for Bullous Pemphigoid (BP)

rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects

Start date: September 25, 2018
Phase: Phase 2
Study type: Interventional

Bullous pemphigoid (BP) is the most common of the autoimmune blistering skin diseases in Western Europe. [Joly 2012]The study will recruit the new onset or relapsing mild to moderate BP patients. The study population will consist of patients above the age of 18 years with an active episode of BP, confirmed by inclusion and exclusion criteria and who, in the opinion of the Investigator, would benefit from treatment with rVA576. Recombinant rVA576 is a small protein complement C5 and LTB4 inhibitor, which prevents the cleavage of C5 by C5 convertase and thereby inhibits generation of C5b-9 the membrane attack complex (MAC), as well as preventing the release of the anaphylatoxin C5a. rVA576 is effective in inhibiting terminal complement activity irrespective of the activating pathway (classical, lectin or alternative). This Phase IIa open-label single-arm study will evaluate the safety and efficacy of rVA576 in adult mild to moderate Bullous Pemphigoid patients

NCT ID: NCT04035252 Completed - Clinical trials for Abdominal Aortic Aneurysm

Relation betwEen Abdominal Aorta and Carotid Artery Responses to SymPathetic stimulatiON uSing duplEx Ultrasound

RESPONSE
Start date: October 1, 2019
Phase:
Study type: Observational

Abdominal aortic aneurysm (AAA) is a common vascular disease and associated with risk of rupture, but also with a high cardiovascular (CV) event rate. A key difficulty in AAA is predicting these life-threatening complications. Recent studies suggest that the endothelial function of the abdominal aorta might have a correlation with the disease development. A novel, easy to perform, non-invasive test can assess central artery endothelial function (i.e. the carotid artery reactivity (CAR)). The CAR test is based on the cold pressure test (CPT), which induces sympathetic stimulation by placing one hand in cold water. Using duplex ultrasound, central artery blood flow and diameter responses can be examined. Previous work has demonstrated that the CPT is associated with an increase in abdominal aortic diameter, whilst others found that the carotid and coronary artery diameter also shows dilation. Interestingly, a previous study found a strong correlation between carotid and coronary artery diameter responses to the CPT, whilst these artery responses show independent prognostic value for future cardiovascular events in patients with peripheral arterial disease. Possibly, similarity may be present in central artery reactivity to the CPT. To date, no study examined whether carotid and aorta responses are in agreement during the CPT. Given the potential importance of central artery vasoreactivity for AAA, the CAR-test may have potential in this group, especially given the relative simplicity of measuring the carotid artery. The aim of this explorative study is to investigate the correlation between the magnitude of the abdominal aorta and the carotid artery diameter and blood flow responses during the sympathetic stimulation (using the cold pressor test) between healthy young, healthy older and individuals with AAA.

NCT ID: NCT04035226 Completed - Multiple Myeloma Clinical Trials

A Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody Treatment

LocoMMotion
Start date: August 2, 2019
Phase:
Study type: Observational

The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM).

NCT ID: NCT04031001 Completed - Vascular Infections Clinical Trials

Vascular No-React Graft Against Infection

VASC-REGAIN
Start date: December 22, 2017
Phase:
Study type: Observational

This study seeks to demonstrate the effectiveness and safety of the Non-valved Conduit for CE marking on the basis of infection. The rationale for infection resistance with the conduit is that BioIntegral Surgical No-React® treated products have a well-documented history of infection resistance in hybrid vascular settings.

NCT ID: NCT04030598 Completed - Clinical trials for Hereditary Angioedema

A Study to Assess the Clinical Efficacy of Donidalorsen (Also Known as IONIS-PKK-LRx and ISIS 721744) in Participants With Hereditary Angioedema

Start date: January 7, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the clinical efficacy, safety, and tolerability of donidalorsen in participants with hereditary angioedema (HAE) type 1 (HAE-1), HAE type 2 (HAE-2), or HAE with normal C1-inhibitor (C1-INH) and to evaluate the effect of donidalorsen on plasma prekallikrein (PKK) and other relevant biomarkers.