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NCT ID: NCT01994226 Completed - Gout Clinical Trials

Colchicine Or Naproxen Treatment for ACute gouT

CONTACT
Start date: January 2014
Phase: Phase 4
Study type: Interventional

Gout is the most common cause of inflamed joints affecting 1.4% of adults in the UK. Most patients are treated entirely in general practice yet primary care management is frequently suboptimal. Acute attacks of gout are excruciatingly painful and require urgent drug treatment to reduce inflammation, most commonly with antiinflammatory drugs(NSAIDs) or colchicine. In primary care, NSAIDs are most commonly used but can cause serious side effects such as stomach ulcers and heart disease, particularly in the elderly. Patients frequently require repeat prescriptions for recurrent attacks of acute gout increasing the risk of drug-related side-effects. Low-dose colchicine is popular amongst rheumatologists as it is effective and well tolerated. However, general practitioners (GPs) prescribe colchicine infrequently, probably because in the past the recommendation was for high doses to be prescribed which commonly caused severe diarrhoea. Recently, prescribing recommendations for colchicine have changed, advocating a lower dose regime. Currently there is no evidence regarding whether NSAIDs or low-dose colchicine is the best treatment for acute gout. This trial will be the first direct comparison of the effectiveness and side effects of a NSAID (naproxen) and low-dose colchicine to treat acute gout in primary care. Naproxen will be used in this trial because it has been shown to be as effective as oral prednisolone for the treatment of acute gout, is safer than other commonly used NSAIDs such as diclofenac and indomethacin, and is inexpensive. Patients consulting their GP with an acute attack of gout in up to 100 general practices will be invited to participate. Treatment success will be assessed by comparing pain reduction between the two drugs. The trial will also monitor side effects, quality of life, and cost effectiveness.

NCT ID: NCT01994135 Completed - Hyperglycaemia Clinical Trials

Effects of Carbohydrase-inhibiting Polyphenols on Glycaemic Response in Vivo

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

Consumption of carbohydrate containing foods or sugary drinks brings about changes to the blood glucose levels. After a meal or drink, blood glucose levels rise until it reaches a peak concentration usually after 30 minutes. When the body senses the increase in blood glucose, a hormonal process involving insulin takes place to ensure that the glucose is taken up from the blood for storage and where it is needed for energy in the body. This process then brings about a decrease in the concentration of glucose until it reaches approximately the starting concentration. The original concentration of glucose is attained approximately 2 hours after eating or drinking a carbohydrate food or sugary drink respectively. Different carbohydrates and sugary drinks have different effects on blood glucose response depending on the amount as well as the type of carbohydrate. Those that give rise to a high glucose response compared to a reference carbohydrate (usually glucose) are said to be high glycaemic index (GI) foods and those with a lower glucose response compared to a reference carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.(1) Research has shown that diets that give rise to a high glucose response are associated with a number of abnormalities like increased metabolic syndrome (2). Metabolic syndrome mostly comprises of insulin resistance and glucose intolerance which gives an increased risk of type 2 diabetes. (3) It also gives rise to other conditions like high blood pressure (arterial hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises. (4) Research has also shown that foods/drinks which raise blood glucose levels gradually (low GI) rather than rapidly (high GI) have health benefits which include reducing the risk of metabolic syndrome (5). In vitro studies have shown that polyphenols found in fruits, vegetables and plant based foods have a positive effect on carbohydrate metabolism and can lower the blood glucose levels. (6) This research will determine whether the presence of polyphenols in the diet has any lowering effect on the blood glucose levels and hence the glycaemic index of foods. This will be determined by asking volunteers to consume polyphenol rich drink/food together with white bread and determine the glycaemic response. The GI of bread will be determined initially as a reference. Analysis will be done by measuring blood glucose response to white bread alone as reference and then to white bread with test sample containing polyphenols and then determine GI and see how the GI of bread will be affected. Other analyses to be done are plasma insulin, glucagon, gastric inhibitory polypeptide (GIP) and glucagon like peptides-1 (GLP-1) as they all relate to glycaemic response. Study hypothesis is that glucose metabolism will be affected. NOTE: 1. Only healthy participants undertook the study (Hence metabolic syndrome participants not part of the study) 2. Only glucose and insulin were analysed in the plasma (hence GIP, GLP-1 and glucagon not part of end points)

NCT ID: NCT01994083 Completed - Clinical trials for Healthy Participants

A Study of Multiple Oral Doses of IX-01 in Healthy Men

Start date: November 2013
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 how the body handles IX-01.

NCT ID: NCT01993888 Completed - Hemorrhage Clinical Trials

The EVARRESTâ„¢ Fibrin Sealant Patch Liver Study

Start date: October 2013
Phase: Phase 3
Study type: Interventional

To evaluate the safety and hemostatic effectiveness of EVARRESTâ„¢ Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

NCT ID: NCT01993186 Completed - Clinical trials for Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS)

Phase 2 Study of Triheptanoin (UX007) for the Treatment of Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS)

Start date: February 28, 2014
Phase: Phase 2
Study type: Interventional

The primary objectives of the study are to evaluate the efficacy of UX007 compared to placebo as measured by the reduction from randomization to Week 8 in frequency of seizures and to evaluate the safety of UX007 via adverse event (AE) rates, laboratory values, and electrocardiogram (ECG).

NCT ID: NCT01992848 Completed - Clinical trials for Coronary Artery Disease

MAP-Calcification: MicroRNAs as Potential Biomarkers for Coronary Artery Calcification

Start date: November 2013
Phase: N/A
Study type: Interventional

Coronary artery disease (CAD) remains the leading cause of mortality in the UK with an estimated 80,000 fatalities in 2010. Coronary artery calcification (CAC) is associated with atherosclerotic plaque burden and cardiovascular mortality. Mechanisms underlying isolated CAC have not been as yet been fully explained. MicroRNAs (miRNAs), known to act as regulators of gene expression, have also emerged as powerful biomarkers in the diagnosis and prognosis of cardiovascular disorders and may be used in the detection of CAC. We aim to investigate the potential for a "microRNA-signature" in patients with CAC by performing a prospective, case-controlled study to identify pathways associated with CAC in humans. Previous research has demonstrated an inverse relationship between CAC and bone mineral density (BMD), suggesting that these processes may be linked. In a further substudy we plan to define the relationship between CAC and BMD as well as a number of markers of bone metabolism.

NCT ID: NCT01992549 Completed - Severe Hemophilia A Clinical Trials

Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII

Start date: April 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.

NCT ID: NCT01991990 Completed - Healthy Volunteer Clinical Trials

A Pharmacodynamic Study to Evaluate Neutrophil Distribution Kinetics and Function Following Single-Dose RoActemra/Actemra (Tocilizumab) in Healthy Volunteers

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

This Phase IV, single-blind , randomized, two-arm study will explore the pharmacodynamics effects of RoActemra/Actemra (tocilizumab) on neutrophil redistribution, function and survival in healthy subjects. Subjects will receive either a single dose of intravenous (IV) RoActemra/Actemra at a dose of 8 mg/kg over one hour on study Day 0 or placebo. Neutrophil kinetics data will be collected for all subjects up to Day 10 of the study. Following the last study visit on Day 10, all subjects will attend two further safety follow-up visits on Day 28 and Day 56.

NCT ID: NCT01991886 Completed - Premature Birth Clinical Trials

Using Nasal High Flow From Birth in Premature Infants - a Pilot Study

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

Recent large studies have shown that not all premature babies need to be intubated (have a breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant routinely. Those studies showed that even very small babies can be safely supported using nasal Continuous Positive Airway Pressure (nCPAP) which is applied tightly to the nose using nasal prongs. This is a type of noninvasive ventilation (NIV) so that the babies continue to breath, albeit with additional support to reduce their work of breathing. However nCPAP has some drawbacks, including that it can cause skin damage to the nose, and that the heating and humidification of the gas is not always sufficient. We have been using, for over 5 years, a different system to support babies after routine intubation. This is another type of noninvasive ventilation called nasal High Flow (nHF) for which we use a Vapotherm Precision Flow device. Published trials show that it is at least as effective as nCPAP to provide NIV and to prevent the subsequent need for intubation and/or surfactant. However nHF is superior to nCPAP in respect it does not cause nose damage and its heating and humidification is excellent. This pilot study aims to describe and evaluate the use of nHF, using a standard commercially available system (Precision Flow, Vapotherm Inc.), from birth, in babies born less than 30 completed weeks gestation, with a view to avoiding intubation and ventilation. This study is important to establish the feasibility of using nHF immediately after birth.

NCT ID: NCT01991795 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus

THEMIS
Start date: February 10, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.