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NCT ID: NCT04137315 Completed - Clinical trials for Chronic Kidney Diseases

Project Aura: Home Trial of a Home-based Monitoring Service

Start date: February 14, 2020
Phase:
Study type: Observational

This is a data collection study to compare diagnostic methods of a prototype of a home monitoring device against laboratory testing in the hospital.

NCT ID: NCT04137224 Completed - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)

Start date: September 19, 2019
Phase: Phase 2
Study type: Interventional

This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc). The pharmacokinetic study aims to evaluate the relative bioavailability of IgPro20, and characterize pharmacokinetics of IgPro20 and IgPro10, respectively, in participants with dcSSc. Safety, tolerability, and pharmacokinetics of IgPro10 will also be evaluated.

NCT ID: NCT04136379 Completed - Clinical trials for Congenital Heart Disease

Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD

Start date: September 30, 2019
Phase:
Study type: Observational

Summary: Congenital heart disease (CHD) is the most prevalent form of birth defect with a global rate of 1.35 million newborns born with CHD annually. Patients with CHD have an increased risk of cerebrovascular accident (CVA) compared to age-matched control populations. Anticoagulation with warfarin is the mainstay of antithrombotic treatment in these patients and requires frequent monitoring of the International Normalized Ratio (INR). The CoaguChek monitor is a point of care device that enables patients to self-monitor and manage their INR without the need to attend a warfarin clinic. The aim of this study is to compare the efficacy and outcomes of standard clinic management and home management of INR in patients with CHD. Analysis of time in therapeutic range (TTR), INR variability, major and minor bleeding events, incidence of CVA and other thrombotic events will be undertaken. Original Hypothesis: There will be a difference in the proportion of time that patients spend in their therapeutic range and the amount of adverse events that occur between those who use a CoaguChek monitor and those who use standard clinic monitoring of their INR. The primary outcome will be time in therapeutic range (TTR). Secondary outcomes will be INR variability, minor / major bleeding complications and thromboembolic events.

NCT ID: NCT04136327 Completed - Healthy Clinical Trials

A Study in Healthy Male Volunteers to Test How the Test Medicine GLPG1972 is Taken up by the Body When Given by Mouth and Into the Vein as an Injection

Start date: September 13, 2019
Phase: Phase 1
Study type: Interventional

The sponsor wants to investigate in this study how well the test medicine is taken up by the body when given orally (by mouth) as a tablet and solution, and as a solution for infusion (into a vein). The oral solution and solution for infusion will be radiolabelled. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body, what it is broken down into, and how it leaves the body. The sponsor will also look at the safety and tolerability of the test medicine.

NCT ID: NCT04136119 Completed - Critical Illness Clinical Trials

Micronutrients in Critically Ill Patients

MiNuCrit
Start date: November 18, 2019
Phase:
Study type: Observational

Nutritional support is an important component of modern critical care. The practice of vitamin and micronutrient supplementation is variable and official guidelines are not consistent. The primary objective of this observational study is to investigate the clinical practice of micronutrient supplementation during critical illness and to explore the factors underpinning clinical decisions.

NCT ID: NCT04134871 Completed - Schizophrenia Clinical Trials

Walking for Health: an Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With SMI

WORtH
Start date: August 22, 2019
Phase: N/A
Study type: Interventional

People who have a severe mental illness can have poorer physical health and higher mortality rates than the general population. Their medications combined with low levels of physical activity and increased sedentary behaviour can general population and may help people with severe mental illness to be more active. A previous feasibility study has been conducted in the UK in a large city with positive findings. The current study will be conducted in rural settings in Northern Ireland and Republic of Ireland. The intervention will last 13 weeks. People with Severe Mental Illness will be randomly assigned into one of two groups. Both groups will get information on the benefits of physical activity. In addition, one group will be shown how to use a step counter to measure their steps, be invited to a weekly group walk, and meet their coach every 2 weeks contribute to this. Walking is a good way to increase physical activity in the to see how they are getting on and to support them. The research team are interested in finding out how willing clinicians are to recruit people into the study, how willing people are to take part, do people then stick with the programme, and if not the reasons for people dropping out. Qualitative findings will explore whether participants feel they benefited from and enjoyed the programme. Findings will be used to investigate the feasibility to conduct a larger trial like this in the future.

NCT ID: NCT04134728 Completed - Clinical trials for Arthritis, Rheumatoid

Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors

contRAst 3
Start date: October 31, 2019
Phase: Phase 3
Study type: Interventional

This study (contRAst 3 [202018: NCT04134728]) is a Phase 3, randomized, multicenter, double-blind study to assess the safety and efficacy of GSK3196165 in combination with conventional (cs) DMARD[s]) or the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to biologic (b) DMARD[s]) and/or JAK inhibitors. The study will consist of a screening phase of up to 6 weeks followed by 24 week treatment phase in which participants will be randomized in ratio of 6:6:6:1:1:1 to GSK3196165 150 milligrams (mg) subcutaneously (SC) weekly,GSK3196165 90 mg SC weekly, sarilumab 200 mg SC every other week or placebo (three arms) respectively, all in combination with background csDMARD(s). At Week 12, participants in the three placebo arms will switch from placebo to active intervention (either GSK3196165 150 mg SC weekly, GSK3196165 90 mg SC weekly, or sarilumab 200 mg SC every other week). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165, may be included in the long-term extension study (contRAst X [209564: NCT04333147]). Any participant who does not transition into study 209564 will undergo a safety follow-up visit at Week 34 (corresponding to 12 weeks after the last potential dose of sarilumab, at Week 22).

NCT ID: NCT04132973 Completed - Depression Clinical Trials

Investigating Compassion-Based Guided Self-Help for Depression in People With Skin Conditions

Start date: November 12, 2019
Phase: N/A
Study type: Interventional

The study aims to explore whether an online compassion-based guided self-help intervention is perceived as acceptable to people with heterogeneous skin conditions, in terms of retention rates and explicit feedback. The study also aims to investigate the feasibility of providing online compassion-based self-help and email guidance. Changes in depression, self-compassion and skin-related distress will be assessed to give an estimate of likely effect sizes for future research

NCT ID: NCT04132596 Completed - Clinical trials for Spinal Cord Injuries

Spinal Stimulation in Chronic Spinal Cord Injury

Start date: November 11, 2019
Phase: N/A
Study type: Interventional

Electrical spinal stimulation combined with activity-based rehabilitation (ABR) can improve motor and autonomic function in individuals suffering from varying degrees of paralysis. Spinal stimulation studies have included invasive implanted devices and non-invasive transcutaneous systems using different combinations of stimulation current, waveform, amplitude, duration and spinal levels targeted. Invasive and non-invasive systems have been demonstrated to permit individuals with chronic spinal cord injury (SCI), previously considered to have complete injuries on the International Standards for the Neurological Classification of Spinal Cord Injuries (ISNCSCI) scale (Classification A), to regain some degree of voluntary and autonomic function during periods of stimulation. The aim of this study is to evaluate the effects of a novel non-invasive transcutaneous electrical spinal cord stimulation system (tSCS) combined with activity-based rehabilitation in patients who have paralysis of their legs and/or arms. We will examine participants for any changes in sensory, motor or autonomic function. We will use a transcutaneous spinal cord stimulator that has been designed to deliver safe and tolerable bursts of high frequency pulsed current that minimise the capacitance efforts of the skin surface and maximise conductance of a second waveform using low frequency current to target neural structures. We aim to investigate this form of neuromodulation with a small group of individuals with chronic spinal cord injury. Our goal is to observe and describe any short term or lasting changes in function that can safely and comfortably be derived from this combination of spinal stimulation and activity-based rehabilitation. If this therapy can cause lasting improvements in sensory, motor, respiratory or autonomic function, then this may lead to a greater degree of functional independence for these individuals.

NCT ID: NCT04130581 Completed - Muscle Loss Clinical Trials

Brain Stimulation During Arm Immobilisation

ImmobiStim
Start date: May 14, 2018
Phase: N/A
Study type: Interventional

The research project explores how non-invasive brain stimulation can be used to detect and ameliorate loss of muscle strength after inactivity. At present, there is a limited understanding of how to maintain muscle strength during inactivity. Increasing evidence indicates that reduction in muscle strength following immobilisation is associated with reduced cortical motor output. Therefore, the aim of the study is to test if brain stimulation, can maintain cortical motor output and ameliorate the loss of muscle strength following immobilisation.