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NCT ID: NCT01927328 Recruiting - Gastric Cancer Clinical Trials

Iron Replacement in Oesophagogastric Neoplasia

IRON
Start date: August 2013
Phase: Phase 4
Study type: Interventional

40 eligible patients with confirmed esophageal or gastric adenocarcinoma and anemia will be randomized to a control or intervention group for management of this anemia. The control group treatment will consist of standard treatments as governed by the clinical team (eg oral iron, blood transfusions) whilst the intervention group will be treated with intravenous iron III isomaltoside (Monofer ®). It is hypothesized that intravenous iron supplementation is more efficacious than standard therapies.

NCT ID: NCT01924585 Recruiting - Quality of Life Clinical Trials

Surgery in Persons of Older Age

SAGE
Start date: December 2012
Phase: N/A
Study type: Observational

Surgery in persons of older AGE (SAGE) is an observational study of patients aged 60 years and older undergoing major colorectal surgery. That is to say we are looking at how older patients recovery following surgery, and that patients who volunteer to take part will absolutely not have any changes made to patients planned treatment or surgery. Patients (identified by their Consultant) will be asked if they would like to participate in the study, agreeing to undertake an additional questionnaire, blood test, provide a urine specimen and several basic physical tests during the pre-assessment visit taking an additional 30-45 minutes. This will not affect their treatment in any way. Participation is voluntary. At the time of the pre-assessment process the patient will then be approached by a researcher, who will explain the study in more detail and obtain written consent. The questionnaire is a combination of questions, which have been used in other similar studies and may be used to identify people who are fitter than others to undergo surgery. These questions are not too dissimilar to those that may be asked during the pre-assessment process. In fact some hospitals use some of these questions (but not usually all) routinely during a hospital admission process. Several basic physical tests will be performed: hand grip strength test and some basic walking and chair rising tests. These will be supervised by the trained researcher to ensure they are carried out safely. A small blood sample (20ml) will be obtained, ideally at the same time as blood is taken for the standard pre-operative assessment process. We will also take urine specimens. The blood sample and urine specimens will be saved for tests later. There are several potential blood and urine tests that may be related to physical frailty/impairment and the aging process. The patient will undergo surgery as planned and be discharged from hospital. No researcher will interfere with the planned care or conduct any data collection at this point. At approximately 1. 3, 6 and 12 months following surgery the patient will be asked to complete the questionnaire either in person, by phone or mail. If reviewed in a clinic at the time of their postoperative follow-up checks, then we will repeat the basic physical tests again also. The patient's notes will be reviewed by a researcher (who is also a doctor) to see what operation was performed, the length of hospital stay, and if any problems developed. The patients GP may also be contacted if additional information is required. This study, while based on several others, is the first of its kind to see how persons recover after surgery being assessed over one year. We will recruit for 18 months across two hospitals aiming to recruit 200 patients during this time.

NCT ID: NCT01923090 Recruiting - Healthy Volunteers Clinical Trials

Finasteride, Dutasteride and Insulin Action

FIND-IT
Start date: August 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if an enzyme in the body (5-alpha reductase, 5αR) is important in controlling how the body handles sugar and fat. The investigators believe that 5αR is a crucial step in regulating these actions as well as controlling how insulin works in the body but regulating the amount of steroid hormones including cortisol and testosterone in the body. In previous clinical studies, the investigators have shown that the activity of 5αR increases as you gain weight and decreases with weight loss. In addition, work that the investigators have performed in the laboratory has shown that if you increase 5αR levels in liver cell grown in the laboratory, the amount of fat that they contain increases. The investigators would therefore like to demonstrate the effect of inhibition 5αR on the regulation of insulin, glucose and fat in the body.

NCT ID: NCT01922869 Recruiting - Clinical trials for Pharmacokinetics of Flavonoids in Humans

An Acute Human Intervention With Flavonoid to Investigate Absorption, Metabolism and Excretion

COB
Start date: July 2013
Phase: N/A
Study type: Interventional

The era of general dietary recommendations for the whole population may be coming to an end, as it is becoming apparent that we are all unique and do not respond in the same way to the same foods. Within a decade it is believed that doctors will be able to take profiles of their patients, identify specific diseases for which they are at risk and create personalised nutrition plans accordingly. At the University of East Anglia, UK the investigators are interested in particular food compounds known as flavonoids which can be found in foods such as chocolate, orange juice and blackberries (COB). The study will determine if factors such as age, gender, genetics and the bacteria present in our guts contribute to variability between individuals in their absorption, metabolism and excretion of flavonoids.

NCT ID: NCT01920438 Recruiting - Clinical trials for Two Interventions (PEG and RIG) Compared Against Each Other

Outcome Study of Endoscopically Inserted Gastrostomy (PEG)Versus Radiologically-guided Insertion of Gastrostomy (RIG)in Children

PEG Vs RIG
Start date: December 2011
Phase: N/A
Study type: Interventional

A gastrostomy is a feeding tube that communicates from the skin directly into the stomach. It is a device frequently used in children that have feeding difficulties or are unable to maintain normal growth via oral feeds. The same device may be inserted in two ways: the percutaneous endoscopic method (PEG) which is guided by the use of an endoscope (flexible camera), or the radiologically inserted method (RIG) which is guided by the use of X-ray imaging. Both methods of insertion have been used in children for more than 20 years, but it is not clear which is the best method. Both methods are associated with complications, including injury to other abdominal organs and leakage leading to sepsis. There are no randomised controlled trials comparing the two techniques. We aim to compare the outcome of both methods of gastrostomy insertion in children, with emphasis on the complication rates. We have devised a complication score with weightage assigned to each complication according to its severity. A randomised controlled trial will be performed in children requiring a gastrostomy, 100 per group. The primary outcome will be the overall total complication rate.

NCT ID: NCT01907295 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

National Cohort Study of Idiopathic and Heritable Pulmonary Arterial Hypertension

NAIAD
Start date: February 2014
Phase:
Study type: Observational [Patient Registry]

Pulmonary arterial hypertension (PAH), or high blood pressure in the lungs, is a rare condition that can shorten life. Although the cause of this disease is usually unknown, in about 70% of heritable and 15-20% of idiopathic cases there is a change in a gene (a mutation) that controls how blood vessels grow and function. The gene is called bone morphogenetic protein type receptor 2 (BMPR2). Although mutations in BMPR2 are a risk factor for PAH, not everyone with a mutation gets the disease. Additional genetic and environmental factors are likely to contribute. The investigators suspect that mutations in other genes are responsible for some cases of PAH. In this study the investigators aim to recruit all patients with PAH and some of their relatives and follow them up for several years. The investigators hope to discover new mutations for this disease and to determine what factors lead to poor outcome, and to understand what triggers disease in patients with mutations. Who can participate? Adults with PAH, their relatives and controls (one off blood sample)

NCT ID: NCT01893034 Recruiting - Clinical trials for Femoroacetabular Impingement

Trial for Femoroacetabular Impingement Treatment

FAIT
Start date: July 2013
Phase: N/A
Study type: Interventional

Femoroacetabular Impingement (FAI) describes a condition of the hip where additional bone results in the abutment of the femoral neck against the rim of the acetabulum. This gives rise to localised cartilage damage and pain, but also increases the risk of developing osteoarthritis. The purpose of this study is to compare the effectiveness of arthroscopic surgery versus physiotherapy and activity modification for the treatment of this condition.

NCT ID: NCT01892722 Recruiting - Multiple Sclerosis Clinical Trials

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Start date: July 26, 2013
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)

NCT ID: NCT01892163 Recruiting - Clinical trials for Diabetic Macular Edema

Multicentre Randomised Clinical Trial Comparing Fixed vs Pro re Nata (PRN) Dosing of 700 μg Dexamethasone

OZDRY
Start date: March 2013
Phase: Phase 3
Study type: Interventional

Multicentre randomized controlled trial to evaluate whether 5 monthly fixed dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (Ozurdex) is as efficacious as Optical coherence tomography (OCT)-guided PRN dosing in patients with refractory diabetic macular edema.

NCT ID: NCT01891240 Recruiting - Pregnancy Clinical Trials

IMproved PRegnancy Outcome by Early Detection

IMPROvED
Start date: November 2013
Phase: N/A
Study type: Observational

The overall objective of the IMPROvED project is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for preeclampsia. This will involve a multicentre, phase IIa clinical predictive study to assess and refine novel and innovative prototype tests based on emerging metabolomic and proteomic technologies developed by SMEs (small to medium size enterprise) within the consortium. The study will i) recruit 5000 first-time pregnant women; ii) establish a high calibre biobank, augmented by accurate clinical metadata; iii) determine whether prototype predictive assays and algorithms translate to the clinical environment; iv) assess potential synergy of a combined metabolomic and proteomic approach and v) progress regulatory approval and development of the selected test into the clinical arena.