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NCT ID: NCT02090881 Completed - Sickle Cell Disease Clinical Trials

Measurement of Cerebral Blood Flow Using Transcranial Doppler Ultrasound in Children With Sickle Cell Disease

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

Sickle cell disease (SCD) affects haemoglobin - the molecule in blood cells which carries oxygen. It causes red blood cells to become abnormal crescent (or sickle)- shaped. Sickled red blood cells cannot travel through small blood vessels as easily as normal red blood cells which can lead to blockages. This means that oxygen may be prevented from getting to where it is needed. Individuals with sickle cell disease also suffer form abnormality in the lining of their blood vessels, which contributes to the damage. Damage and blockage can occur in the blood vessels in the brain and means that children with sickle cell disease have a significant risk of suffering from strokes. Research has shown that transcranial Doppler ultrasonography can be used in this setting to identify children at most risk of getting strokes. Ultrasound is therefore used in children with sickle cell disease to measure the blood flow in the vessels in the brain. This research has formed the basis of the National Health Service (NHS) Standard of Care for Sickle Cell Disease in the United Kingdom (UK) which uses transcranial Doppler ultrasonography at once a year to screen children with sickle cell disease aged 2 to 16. Ultrasound is used because it is portable, does not uses ionising radiation such as x-rays, is non-invasive and gives good results. However, the results are dependent on the operator. This means that the screening service is provided by centres of excellence with experienced scanning staff visiting clinics in smaller hospitals with portable machines. There is a lack of research comparing the use of portable machines to laboratory-based machines. This is important because screening can identify children at high risk of stroke and may be used by clinical staff to make a decision about the care of the child.

NCT ID: NCT02090842 Completed - Hypertension Clinical Trials

Milk Proteins, Ambulatory Blood Pressure and Vascular Function

Start date: February 2014
Phase: N/A
Study type: Interventional

Epidemiological studies demonstrated an inverse associations between cardiovascular events and milk and dairy product consumption. Evidence from human intervention studies suggests that both whey and casein may be effective in blood pressure-lowering, however there is limited data on the impact of milk proteins on vascular function. This research aims to compare the potential acute and chronic impacts of the two main milk proteins (whey and casein) with maltodextrin on blood pressure and vascular function. Furthermore, the effects of these proteins on the markers of insulin resistance, lipid metabolism and inflammatory status will also be investigated in 'at-risk' individuals. This research includes both an acute and chronic intervention study which have been independently powered on the appropriate outcome measures. This has generated different sample size requirements for the two studies (Actual participants on the acute study: n=27, and on the chronic study: n=38).

NCT ID: NCT02090751 Completed - Clinical trials for Age-Related Macular Degeneration

Development of a Device to Measure Dark Adaptation

Start date: July 2014
Phase: N/A
Study type: Observational

Age Related Macular Disease (AMD) is easily the leading cause of blindness in older people in developed countries. It affects between 30 and 50 million individuals worldwide, with around 30% of the over 65's showing early signs of the disease. Severe AMD has a devastating impact on the quality of life; it causes extensive visual impairment, making reading difficult and driving impossible. Patients lose their independence and become a major burden on public health systems. Present treatment options are limited. Many new therapies are under development and all will need evaluation using a test with high specificity and sensitivity for early AMD. The present application will develop such an instrument. The prototype was funded by a previous i4i FS (feasibility study ll-FS-0110-14036). The new device measures sensitivity to a dim flickering light using the same principle as an established european conformity marked (CE marked) instrument. The original method involved lights of different wavelengths and higher intensities. The instrument in this study assesses night vision, which is selectively damaged in early stage AMD. In low lighting, the investigators vision depends on specialized rod photoreceptors. Cone photoreceptors, which provide daytime vision, remain normal in the early stages of the disease. By the time patients complain of reduced (cone-based) visual acuity, they will have had the disease for many years and lost many thousands of photoreceptors.

NCT ID: NCT02090556 Completed - Clinical trials for Rheumatoid Arthritis

Long-term Experience With Abatacept SC in Routine Clinical Practice

ASCORE
Start date: March 26, 2013
Phase:
Study type: Observational

The purpose of this study is to estimate the retention rate of Abatacept SC over 24 months in routine clinical practice, in rheumatoid arthritis patients, in each country involved in the study. The purpose of the UK substudy is to explore whether integrating self-assessment into routine care could maintain tight control (of inflammation/disease activity) and at potentially lower cost resulting in improved health outcomes and cost-effectiveness.

NCT ID: NCT02090413 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis

ASSURE
Start date: May 2014
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin (acetyl salicylic acid [ASA]) taken twice a day (BID) with DMF (dimethyl fumarate) administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with DMF administration reduces the incidence and/or severity of flushing events in subjects with relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with DMF in the clinical practice setting. Secondary objectives of this study are: To evaluate the safety and tolerability of DMF administered with and without enteric-coated ASA in the clinical practice setting; To evaluate the impact of DMF administration on quality of life as measured by the Short Form 36 (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaires.

NCT ID: NCT02090374 Completed - Asthma Clinical Trials

Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen

Start date: March 2014
Phase: N/A
Study type: Interventional

The investigators propose the development of a range of nasal spray challenge models to study the way the nose can respond to different types of nasal challenge that elicit different forms of inflammation. The investigators will carry out nasal challenge with bacterial and viral components and allergens. In this way the nasal upper respiratory tract mucosa is challenged with stimuli of the immune system, causing various types of inflammation. Samples will be taken by blotting the nostril surface and by scraping off tiny surface samples. The nose will be sprayed with a substance that is a single part of a bacteria or virus, or with an allergen. The material delivered by nasal spray is of high purity and is sterile, containing no live bacteria or viruses. The nasal spray substance contains molecular patterns that are recognised as foreign by the immune system, and at the right dose should stimulate the immune system, causing mild nasal inflammation. The study employs noninvasive methods of sampling using absorptive strips. These strips look and feel like tissue paper, and are applied to each nostril for a period of 1 min. A few pinhead-sized tissue samples are taken from inside the nose, using a small disposable sterile plastic probe that has a tiny scoop on its end. In the nasal lining fluid and tissue samples, measurement will taken of a range of molecules and cells that protect against infections and help the immune response. By spraying the nose with a challenge agent in this manner, the nasal immune response can be assessed, which can help us better understand how the human immune system cells and molecules respond to bacteria and viruses. In the future, this may allow the testing of new drugs and vaccines, by seeing if they decrease or stop the inflammation after the nasal challenge.

NCT ID: NCT02090179 Completed - Clinical trials for MPS IIIB (Sanfilippo B Syndrome)

Evaluation of Blood Brain Barrier Integrity and Structural Abnormalities in MPS IIIB Patients Using Multimodal Magnetic Resonance Imaging

Start date: December 2013
Phase: N/A
Study type: Observational

The purpose of the study is to characterize structural abnormalities in the brain and the integrity of the blood brain barrier in patients with mucopolysaccharidosis type IIIB (MPS IIIB).

NCT ID: NCT02089581 Completed - Pain Clinical Trials

A Study of Whether 2 New Oral Formulations of a Strong Pain Killer Release the Same Amount of Drug Into the Body as the Marketed Medication

Start date: April 2014
Phase: Phase 1
Study type: Interventional

To determine whether two new oral formulations of a strong pain killer release the drug into the body in a similar pattern as the already marketed reference capsule formulation with or without food.

NCT ID: NCT02089568 Completed - Infection Clinical Trials

Prophylaxis Of Wound Infections- Antibiotics in Renal Donation

POWAR
Start date: July 2012
Phase: Phase 4
Study type: Interventional

The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney donation surgery prevent infection.

NCT ID: NCT02089542 Completed - Total Thyroidectomy Clinical Trials

Intra-operative Infra-red Fluorescent Imaging in Thyroid and Parathyroid Surgery

Start date: October 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Reliable identification of parathyroid glands is critical to the success of thyroid and parathyroid surgery. In thyroid surgery, inadvertent injury to parathyroid glands may cause temporary or permanent hypoparathyroidism (low calcium levels needing long term treatment). In parathyroid surgery, early identification of normal and/or enlarged parathyroid glands helps in deciding on the extent of surgery and increases the chances of postoperative normal calcium levels. Methylene Blue (Methylthioninium chloride, MB) is a dye that when given intravenously in high doses, is taken up differently by thyroid and parathyroid tissue. It is currently used during parathyroid surgery by some surgeons to help identify enlarged parathyroid glands by visual examination alone. Such visual examination is unhelpful in the identification of 'normal' parathyroid tissue. MB exhibits fluorescent properties in the near-infrared range (light just beyond the visible spectrum). This can be picked up by an appropriate imaging system. This has potential to identify and differentiate between 'normal' parathyroid, 'abnormal' parathyroid and thyroid tissue during surgery. The investigators have established the feasibility of the intra-operative use of a near infra-red fluorescent imaging device called Fluobeam® and demonstrated the ability of this device to pick up near infra-red fluorescence from human tissue after administration of intravenous MB. Animal experiments have shown that doses as low as 0.1mg/kg of MB given intravenously enable fluorescent visualisation of thyroid and parathyroid glands. This study will aim to optimise the dose and timing of administration of MB in human thyroid and parathyroid surgery and to develop a protocol which would then subsequently be assessed for effectiveness in a multi-centred randomized controlled setting.