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NCT ID: NCT02795767 Completed - Hemophilia A Clinical Trials

A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors

HAVEN 2
Start date: July 22, 2016
Phase: Phase 3
Study type: Interventional

This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This study will open two additional non-randomized cohorts to investigate once every 2 weeks (Q2W) and once every 4 weeks (Q4W) regimens in pediatric participants.

NCT ID: NCT02795676 Completed - Fabry Disease Clinical Trials

Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function

BALANCE
Start date: June 2016
Phase: Phase 3
Study type: Interventional

This was a randomized, double-blind, active control study of the enzyme replacement therapy (ERT) drug PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients who had been treated for approximately 1 year with agalsidase beta and who had been on a stable dose of that product for at least 6 months were randomized in a 2:1 ratio to either switch to PRX-102 or to continue treatment with agalsidase beta. Both treatments were delivered by intravenous infusions every two weeks, at a dosage of 1 mg/kg.

NCT ID: NCT02795481 Completed - Stroke Clinical Trials

The SMARTChip Stroke Study

Start date: July 13, 2016
Phase:
Study type: Observational

Stroke is one of the leading causes of death and disability in the UK and currently costs the country £7bn per year. There is an overwhelming need to accurately and rapidly triage patients to allow best use of finite NHS specialist resources for the treatment of stroke. A simple blood test of substances (the purines) that result from cellular metabolism and are produced in excess when brain cells are starved of oxygen and glucose (as occurs during a stroke) is proposed. The sensors designed by the investigators are used to measure blood purines during a procedure in which blood flow to the brain is reduced to allow surgical interventions on the major arteries that supply the brain. Previous studies by the investigators have shown that as soon as blood flow to the brain is reduced, purines are produced within minutes and are detectable in systemic arterial blood. The current project will now compare the levels of purines in the blood of stroke patients and controls. The purines will be measured on admission to hospital and 24 hours later. The occurrence and magnitude of a stroke will be determined by an MRI scan given between 24 and 72hrs after admission. This study will establish whether purines are elevated in the blood of stroke patients on admission to hospital compared to healthy controls, and whether this correlates with the size of the stroke and damage to the brain.

NCT ID: NCT02794389 Completed - Anorexia Nervosa Clinical Trials

Glutathione Levels and Compulsivity

Start date: March 2016
Phase: N/A
Study type: Interventional

The investigators will examine whether compulsivity in those who score above-average (but below clinical cut-off) on an eating disorder questionnaire can be altered by 9 days of N-acetyl cysteine (NAC). N-acetyl cysteine has been shown to be of some benefit in individuals with other compulsive disorders, such as trichotillomania and addiction, so this research investigates whether a short period of time taking N-acetyl cysteine changes compulsivity, measured using cognitive tasks and questionnaires.

NCT ID: NCT02794324 Completed - Breast Cancer Clinical Trials

The HeartSpare Study (Stage I)

Start date: February 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Radiotherapy (RT) has a major curative role in women with early breast cancer, and is recommended routinely after lumpectomy and selectively after mastectomy. It has contributed to a halving of breast cancer mortality in the UK over the last 2 decades despite ever-rising cancer incidence. RT in women with left-sided tumours often exposes the underlying heart to a damaging dose. The heart is very sensitive to RT, and there were 1-2 deaths from heart disease for every 100 breast cancer patients treated during the 1960s-70s. The situation has improved in recent years, but standard RT techniques still deliver significant radiation doses to heart tissue. Two potentially simple techniques reduce heart dose. In one, women are taught to breathe in deeply and to hold their breath for about 20 seconds while RT is given. The downward movement of the diaphragm pulls the heart away from the RT beam. In the other technique, women lie on their fronts, instead of on their backs as they normally do for breast RT. In this position, the breast falls away from the rib cage and reduces exposure of the heart. Neither technique is routinely available to women receiving breast RT in the UK for reasons that this research aims to address. The investigators need to: 1) confirm that patient position can be reproduced with millimetre precision every day using these techniques, 2) minimise costs of equipment, time and personnel required to support such techniques, 3) select the most appropriate technique for different patients and 4) train staff in centres across the UK to deliver techniques safely and effectively. By addressing all of these issues, the study aims ultimately to make heart-sparing RT available to all UK women that might benefit from treatment, thereby significantly reducing the burden of heart disease in breast cancer survivors.

NCT ID: NCT02794285 Completed - Clinical trials for Active Systemic Lupus Erythematosus

Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

TULIP SLE LTE
Start date: June 30, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.

NCT ID: NCT02794168 Completed - Clinical trials for Traumatic Brain Injury

Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury

NOSTRA-III
Start date: June 2016
Phase: Phase 3
Study type: Interventional

This study evaluates the efficacy of an infusion of Ronopterin (VAS203) on clinical outcome in patients with moderate and severe traumatic brain injury. Half of the participants will receive Ronopterin (VAS203), while the other half will receive placebo.

NCT ID: NCT02793570 Completed - Pregnancy Clinical Trials

Non-contrast 3D MR Angiography for Assessment of the Thoracic Aorta in Pregnancy

Start date: January 2015
Phase: N/A
Study type: Observational

Introduction: Native magnetic resonance angiography (MRA) is recommended to assess the thoracic aorta during pregnancy, avoiding the risks of ionising radiation and contrast agent administration. This guidance is however, based only on consensus opinion supported by limited case reports (level of evidence C). Aim: To evaluate the feasibility of performing native 3D steady-state free-precession (SSFP) MRA in pregnant subjects with inherited aortopathy to guide timing and mode of delivery.

NCT ID: NCT02792647 Completed - Healthy Volunteers Clinical Trials

A Study of Multiple Oral Doses of IX-01 in Healthy Male Subjects

Start date: May 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety and tolerability of IX-01 after multiple doses, and to determine the PK of IX-01 and activity of CYP3A4.

NCT ID: NCT02792621 Completed - Clinical trials for Impaired Mitochondrial Function, Muscle Performance

Increasing Mitochondrial Function on Skeletal Muscle Performance in Older Men

Rejuvenate
Start date: November 8, 2016
Phase: N/A
Study type: Interventional

As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced mobility and quality of life. To understand and reverse this negative process investigators need to find new ways of improving the ability of muscle to perform physical activity. There is some evidence that supplements may improve how the mitochondria work, and investigators want to explore this idea in more detail, by measuring how the muscles work and respond to exercise before and after taking the supplement. This will give us the basic information investigators would need to see if this is a useful idea.