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NCT ID: NCT01658436 Completed - Clinical trials for Advanced Pancreatic Neuroendocrine Tumors (pNET)

BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.

Start date: November 2012
Phase: Phase 2
Study type: Interventional

This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy.

NCT ID: NCT01658345 Completed - Aortic Stenosis Clinical Trials

Microvascular Dysfunction in Aortic Stenosis

PRIMID-AS
Start date: April 2012
Phase: N/A
Study type: Observational

Aortic stenosis (AS), or narrowing of the aortic valve, is the commonest condition requiring valve surgery in the developed world. It is currently not known what determines who will go on to develop symptoms. Exercise testing may be able to identify these patients better than the severity of the narrowing itself, but with some limitations. The purpose of this study is to compare whether MRI scanning or exercise testing can better identify patients with AS who are likely to benefit from surgery. Design: The investigators will measure blood flow to the heart muscle with MRI scanning and perform exercise testing in 170 patients with AS and follow them for up to up to 2 years. Expected outcomes: MRI scanning will more accurately identify those patients with AS who will need surgery during this period. Anticipated Health Benefits: improved selection of patients with AS who are likely to benefit from early surgery. This is likely to reduce deaths in such patients.

NCT ID: NCT01658124 Completed - Clinical trials for Gastrointestinal Bleeding

Haemorrhage Alleviation With Tranexamic Acid- Intestinal System

HALT-IT
Start date: July 2013
Phase: Phase 3
Study type: Interventional

Severe bleeding in the digestive system is a common symptom of many diseases. Each year, about 50,000 people end up in British hospitals because of this problem and about 5,000 of them die. The most common cause of this bleeding is stomach ulcers. In sub-Saharan Africa, schistosomiasis (parasitic worms) is responsible for about 130,000 deaths from stomach bleeding each year. From previous research in other bleeding conditions such as surgery and trauma, we know that a drug called tranexamic acid can reduce bleeding and save lives. We now want to do the HALT-IT trial to see if giving tranexamic acid can save lives and if there are any complications in people with severe bleeding from the digestive system.

NCT ID: NCT01657292 Completed - Burns Clinical Trials

Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds

Start date: August 2012
Phase: Phase 3
Study type: Interventional

The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10 in the acceleration of wound healing of grade 2a burn wounds.

NCT ID: NCT01656902 Completed - Clinical trials for Traumatic Articular Cartilage Defects in the Knee Joint

Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture in Knee Cartilage Defects

N3D
Start date: May 2013
Phase: Phase 3
Study type: Interventional

In this phase 3 clinical trial, a second generation ACI (autologous chondrocyte implantation technique) is compared to standard of care therapy (microfracture) to treat traumatic cartilage defects of the knee for efficacy and safety. The investigated study treatment NOVOCART 3D plus is a biphasic biological scaffold which contains cultivated chondrocytes derived from the patient in a previous tissue harvest procedure. Allocation to the study treatment is done by randomization in a ration of 2:1 in favor to ACI (investigational product). Follow-up data for efficacy is collected for 2 years: follow-up visits are performed 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months after treatment; additional data for safety will be collected for up to 5 years: 36, 48, and 60 months after treatment. The study involves knee surgery (by arthroscopy, or mini-arthrotomically for implantation surgery), and blood withdrawal for safety within the first year after treatment. Initial imaging is required at baseline. Optional MRI imaging and biomarker collection is done as substudy at specific sites only.

NCT ID: NCT01656720 Completed - Faecal Incontinence Clinical Trials

A Multi-centre, Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose-ranging Study in Patients With Faecal Incontinence; to Evaluate the Efficacy, Safety and Tolerability of Locally Applied NRL001 Over an 8 Week Treatment Period

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

The purpose of this study is to evaluate the safety, tolerability and efficacy of NRL001 in the treatment of faecal incontinence, compared against placebo

NCT ID: NCT01656668 Completed - Cough Clinical Trials

Study of the Safety and Effectiveness of BC1036 Capsules to Treat Frequent Long-Term Cough

Start date: July 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of BC1036 (theobromine) on cough-related quality of life and cough severity following 2 weeks' treatment.

NCT ID: NCT01656421 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Assessment of Risk in Chronic Airways Disease Evaluation

ARCADE
Start date: May 2011
Phase:
Study type: Observational

Patients with chronic obstructive pulmonary disease (COPD) have an increased risk of cardiovascular disease,osteoporosis, muscle wasting and diabetes mellitus. Cardiovascular disease is a major cause of death in such patients and it may be related to excess stiffening of the walls of major arteries, such as the aorta, and it has been suggested to represent premature aging. However, there is little known of the development of these problems, which were previously considered to be due to smoking and which is now known not to be the only factor. The investigators will study a large group of patients with mild to very severe airflow obstruction based on the NICE 2010 classification of severity and a matched comparator group free of COPD. This study involves three assessments of the development of the complications of COPD over a five year period. The key measure will be the rate of change in the aortic wall stiffness, an accepted indicator of the risk of heart disease. Changes in wall stiffness will be related to the severity of lung disease; other known cardiovascular risk factors, such as high blood pressure, increased blood cholesterol and to cardiovascular events including heart attacks and death; and to the presence of other complications, such as osteoporosis, muscle wasting and diabetes mellitus. These measures will be analysed in the context of changes in bodywide inflammation and metabolic function and the changes in the rate of ageing. This increased knowledge of interacting factors in the complications of COPD is likely to lead to studies of treatments to avoid their development.

NCT ID: NCT01656213 Completed - Stroke Clinical Trials

Randomised Control Trial for Improving Functional Outcome From Stroke in End Stage Renal Disease Patients

Start date: July 2012
Phase: N/A
Study type: Interventional

TITLE Randomised Control Trial (RCT) for improving functional outcome from stroke in renal disease patients DESIGN Eandomised Conrol Study AIMS 1. Undertake detailed characterisation of stroke (including recently developed imaging techniques at Imperial) of stroke in renal disease patients including clinical, imaging and epidemiological data 2. To Investigate if passive intervention using hand grip device during dialysis sessions will improve functional outcome from stroke in end stage renal disease patients. OUTCOME MEASURES 1. Primary outcome:. 3 months change in Upper-Extremity Fugl-Meyer scores. 2. Secondary outcome: 3 months change in NIHS & Bartel scores POPULATION Ischaemic and haemorrhagic stroke patients with renal disease treated at Hammersmith's Hospital's renal Unit. . ELIGIBILITY Data of all patients with renal disease and imaging proven stroke will be retrospectively analysed. RCT will be conducted on End Stage Renal Disease patients with acute (<7 days) stroke affecting arm. DURATION 2 years

NCT ID: NCT01656135 Completed - Clinical trials for End-stage Renal Failure

Reference Group Trial for The ONE Study

Start date: December 2012
Phase: Phase 4
Study type: Interventional

To investigate the progression of the immunological response in living-donor kidney transplant recipients treated with a standard immunosuppressive regimen. Clinical, immunological, and health-economic data collected during this Reference Group Trial will be used to corroborate historical renal transplantation statistics and generate reference ranges for future clinical studies that will test immunoregulatory cell therapy as an adjunct immunosuppressive treatment in renal transplantation.