Promoter: University of Birmingham (UK)
University of Birmingham (UK) Update l'année dernière

Accuracy of Bladder Ultrasound Study (BUS) Background and study aims Overactive bladder syndrome is often described as urgency that occurs with or without incontinence and usually with an increased frequency of urination and the need to go to toilet in the night. In a UK study, overactive bladder symptoms were found in 12% of the general population. In individuals over 40 years of age, 34% report significant lower urinary tract symptoms. Urinary symptoms alone can be unreliable in diagnosing overactive bladder syndrome, so some doctors recommend a test called urodynamics. With this test, we can diagnose whether the bladder muscle is overactive (detrusor overactivity). Urodynamics involves a catheter inserted in the urethra (the tube from the bladder to outside of the body) which can cause discomfort and carries a small risk of infection. An alternative is to measure the thickness of the bladder wall by ultrasound. This is a simpler, more, comfortable test. We do not know for certain how accurate ultrasound will be at detecting detrusor overactivity that is why we are undertaking this research study. Who can participate? All women who have been referred to this hospital by the GP with symptoms of increasingly frequent toilet visits or feel a sudden urgent need to pass urine are being invited to take part. It is hoped 600 women from several hospitals will take part in the study. What does the study involve? If you agree to take part, we will measure the bladder wall thickness by means of an ultrasound examination, which obtains images of the body without the use of x-rays. In order to perform this scan it is necessary to gently insert the tip of an ultrasound probe into the vagina. This is a simple and usually painless procedure. The probe is a little bigger than the size of a finger or a tampon, and produces pictures on a TV screen. . The test will take no more than five minutes to perform. You will then have the test called urodynamics. This is the test which the doctors may perform regardless of whether you are in the study to confirm the diagnosis. We (the researchers) would also like women to answer some questions of acceptability, quality of life and disease severity. You will be given an anonymous questionnaire to complete before you leave hospital as we want to find out the how you found the tests and the research study. We will also ask you to fill in some of these questionnaires, six months after your tests, to give us an idea of any treatment you may have received. What are the possible benefits and risks of participating? We hope that the test results will help you get the most appropriate treatment for your urinary symptoms without further tests. However, there may be no benefit from taking part. Also, of course, the information we get from this study may in the future help us reduce the need for urodynamics in women with overactive bladder. All women who participate in the study will undergo a urodynamics to confirm the diagnosis. This involves some discomfort and 5% risk of urinary tract infection Where is the study run from? The central study organisers are based at the University of Birmingham. The Clinical Trials Unit at the University of Birmingham will collect and analyse the data. When is the study starting and how long is it expected to run for? The study began recruiting in April 2011 and is due to continue recruiting until April 2013, with follow up and reporting being completed by December 2013. Who is funding the study? The study is funded by a grant from the NIHR Health Technology Assessment programme. Who is the main contact? The BUS study office bus-study@contact.bham.ac.uk

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Closed trial
University of Birmingham (UK) Update l'année dernière

A study to assess the effectiveness and value for money of a programme to prevent primary school age children becoming overweight and obese Background and study aims The number of children in the UK who are overweight is rising. This can lead to several health problems both in childhood and as an adult. So far, ways of preventing children becoming overweight that have been tried have not been successful. The programme that we are testing in this study has been developed in a previous study in Birmingham, and the initial results show that the programme may reduce the likelihood of children becoming overweight. This larger study will enable us to assess more accurately the success of the programme in helping children to keep their weight at a healthy level. Who can participate? Children in year 1 (age 5-6) at 50 primary schools across the West Midlands, and their parents. What does the study involve? Participating schools are randomly allocated into two groups. The programme of activities is run in one group of schools and not run in the other group. We can then compare the schools that have received the programme with those who have not. The programme consists of several elements: activities to increase the amount of physical activity children do in school, healthy cooking sessions for parents and children, a healthy eating and physical activity course run by Aston Villa football club, and information and ideas on local leisure activities for families. Measurements are necessary to properly assess the effects of the programme. We measure your child’s height, weight, waist and blood pressure. We also measure the thickness of the skin (at the waist, on the arm, on the thigh and on the upper back), and proportion of body fat (this involves your child standing on a special type of weighing scales). Children also wear a physical activity monitor for 5 days. Children are asked some simple questions about how they see themselves and their life in general. Parents of children taking part are asked to help fill in a simple 24 hour food questionnaire for their child and a questionnaire asking about the lifestyles of family members and other aspects of family life. We repeat the measurements and questionnaires at further points in the study. Later in the study parents may be contacted to ask if they would be happy to participate in an interview or focus group. What are the possible benefits and risks of participating? While there are no direct benefits to children taking part in this study, the results will help us to assess the success of a programme to prevent children becoming overweight, and therefore prevent them from having health problems that are related to obesity. If this study shows that the programme is successful, it can be introduced in schools across the country. All the measurements are completely safe. There is a very small risk of a mild skin reaction to the sticky pads that are used to attach the physical activity monitor. In the unlikely event that this happens, the monitor and sticky pads can be removed and it will clear up on its own. Where is the study run from? The University of Birmingham (UK) When is the study starting and how long is it expected to run for? September 2010 to August 2015 Who is funding the study? Health Technology Assessment Programme (UK) Who is the main contact? Dr Peymane Adab p.adab@bham.ac.uk

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Closed trial
University of Birmingham (UK) Update l'année dernière

BASIL-2: Bypass v Angioplasty in Severe Ischaemia of the Leg - 2 Background and study aims One in every 1000-2000 people in the UK will be diagnosed with advanced cases of Severe Limb Ischemia (SLI) yearly. As a result of a combination of smoking, diabetes, high blood pressure, high cholesterol levels, kidney failure and the ageing process, some people develop ‘hardening’ of the arteries in their legs. In SLI, even minor injuries to the foot can fail to heal, resulting in the development of ulceration, even gangrene. Unless the blood supply to the leg and foot is improved, many people affected by SLI will lose their limb and/or die within 12 months. As well as causing great suffering, SLI places a large financial burden upon health and social care services. The two treatments currently available for SLI are vein bypass (VB) and best endovascular treatment (BET). In VB a vein is used to bypass the blockage. BET involves opening up the diseased arteries with balloons and sometimes the use of little metal tubes called stents. Both treatments have pros and cons and there is debate and uncertainty as to which is preferable, when, in which arteries, and in which patients. Who can participate? This study aims to recruit 600 adult patients with SLI from the participating hospitals. What does the study involve? Patients will be randomly allocated to receive either vein bypass surgery or the best endovascular treatment. Patients will be followed up clinically for 3 years and asked to complete questionnaires at 10 time points over this time. The 10 time points have been selected to occur at the same time as the patient would normally have a clinical appointment - there are no additional appointments. What are the possible benefits and risks of participating? Not provided at time of registration. Where is the study run from? The study is run from about 40 hospitals within the British Isles. When is the study starting and how long is it expected to run for? The study runs from May 2014 until October 2019. Recruitment starts in May 2014 and continues for 3 years. Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK). Who is the main contact? Clinical Lead: Professor Andrew Bradbury, andrew.bradbury@btinternet.com Administrative contact: Mr Hugh Jarrett, h.jarrett@bham.ac.uk

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Closed trial
University of Birmingham (UK) Update l'année dernière

Which Healthy Heart Diet for people living with HIV? Background and study aims Successful treatment for HIV has lead to an ageing HIV-positive population with heart disease as the most common cause of death. The underlying cause of the increased risk of heart disease observed in HIV is not understood, and cannot be explained by traditional risk factors. Lifestyle intervention is recommended, with a low-fat diet to promote cholesterol reduction. The addition of functional foods (such as plant stanols and nuts) produces more dramatic reductions in cholesterol. This is based on evidence from the general population. This study will find out if the Ultimate Cholesterol Lowering Plan (UCLP) will have a similar effect in people who have raised cholesterol due to their HIV infection and treatment. Who can participate? Adults with HIV infection on stable antiretroviral therapy and raised cholesterol can take part in this study. What does the study involve? Participants will be randomly allocated to receive dietary advice on either reducing saturated fat alone, or together with increasing intake of nuts, plant stanols, soya protein, olive oil, beans and oats (components of the UCLP), delivered for 6 months. Results from blood tests, questionnaires and interviews will assess the impact of the UCLP on the risk of heart disease in adults with HIV infection on antiretroviral therapy. What are the possible benefits and risks of participating? If this diet can significantly reduce blood cholesterol levels, patients may reduce their risk of a heart attack. Risks to participants are not expected in this study. Potential malabsorption of fat soluble vitamins will be monitored. Participants will be directed to their doctor in the case of any health concerns arising during the study. Where is the study run from? The study is run from the Heart of England NHS Foundation Trust (UK), University Hospital Birmingham (UK) and Coventry and Warwickshire Partnership NHS Trust (UK). When is the study starting and how long is it expected to run for? The study starts in September 2013 and is expected to run until September 2016. Who is funding the study? National Institute for Health research (NIHR), UK. Who is the main contact? Mrs Clare Stradling clare.stradling@heartofengland.nhs.uk

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Closed trial
University of Birmingham (UK) Update l'année dernière

Rapid Primary care Initiation of Drug treatment for TIA (RAPID−TIA) Background and study aims People who have a transient ischemic attack (TIA) or minor stroke are at high risk of another stroke, particularly in the first week after the event. A recent study has shown that starting secondary prevention drugs early, in a specialist clinic, significantly lowers the risk of another stroke. RAPIDTIA is a pilot study to determine the feasibility of a larger study to see whether it is better for patients to receive extra medication to prevent further stroke from the primary care doctor or wait until they have been seen by a specialist. Who can participate? Approximately 170 patients with symptoms suggestive of TIA or minor stroke will be recruited from the catchment of three hospital TIA clinics (Birmingham, Cambridge and Oxford) and the emergency departments of these hospitals. What does the study involve? Participants with a probable diagnosis of TIA will be entered into the whole pilot study, those with possible TIA will be entered into the diagnostic study only. Participants with a probable TIA will be randomised to receive usual treatment as recommended by current guidelines (the control group) or usual treatment plus additional medications usually initiated by a specialist. All participants will be seen by a specialist as per current practice who will record final diagnosis and adjust medication accordingly. A further follow up appointment will be scheduled after 90 days. In addition, approximately 10 patients and 10 healthcare professionals will be invited to participate in one in-depth semi-structured interview lasting up to one hour. The interview will help us to identify how trial procedures might be modified for the main trial. What are the possible benefits and risks of participating? Benefits include starting secondary prevention medication on the same day instead of waiting, which may reduce the risk of another stroke. Risks include extension of haemorrhagic stroke from dual anti-platelet treatment, uncertainty about the effect of early statin treatment, and unnecessary treatment due to overdiagnosis. Where is the study run from? University of Birmingham When is the study starting and how long is it expected to run for? The study will run from December 2008 to December 2012. Who is funding the study? National Institute for Health Research (NIHR) Who is the main contact? Dr Kate Fletcher k.fletcher@bham.ac.uk

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Closed trial
University of Birmingham (UK) Update l'année dernière

LiverMultiscan - replacing liver biopsy Background and study aims Chronic liver disease is a major contributor to ill health in western society and is the fifth biggest killer in England and Wales. In the UK it is the only major cause of death that is becoming more common. The health problems associated with chronic liver disease are mainly due to scarring in the liver, which is known as fibrosis. The current best method for assessing fibrosis is a liver biopsy. This is where a needle is used to take a sample of liver tissue to be analysed in the lab. A liver biopsy can be used to tell your doctor about the possible cause for liver damage and how bad that damage is. Having a liver biopsy is uncomfortable and carries a small but significant risk. This risk means that it is not often justified to repeat biopsies to monitor progress in liver damage over time or to monitor a patient’s response to treatment. There are several techniques to assess liver damage without a biopsy but at the moment these are not as reliable as a liver biopsy. The main problem with these ‘non-invasive’ methods of assessing fibrosis are that they have a limited ability to detect the early stages of fibrosis, where patients have the most to gain. This study aims to assess a new magnetic resonance imaging (MRI) technique called LiverMultiscan for the staging and long-term monitoring of chronic liver disease. There are three strands to this study. The first is called Comprehensive Assessment of the Liver with MRI (CALM). This compares LiverMultiscan with liver biopsy. The second and third are called Longitudinal Assessment with MRI in PSC (LAMP) and Longitudinal Assessment with MRI in Autoimmune Liver Disease (LAMALD). These look at the ability of LiverMultiscan to track the progression of autoimmune liver disease. Who can participate? CALM: men or women aged 18 or over having a liver biopsy as part of their routine care to investigate a known or suspected liver condition. LAMP/LAMALD: men or women aged 18 or over with autoimmune liver disease who do not need a biopsy. What does the study involve? CALM: we will offer a LiverMultiscan to patients who are having a liver biopsy as part of their routine care. We will compare the data from the LiverMultiscan with the results from the biopsy. Participants will also have a blood test and a quick, painless ultrasound scan called a Fibroscan. LAMP/LAMALD: we will offer a LiverMultiscan to patients who have autoimmune liver disease. This includes conditions such as primary sclerosing cholangitis (PSC), primary biliary cirrhosis (PBC) and autoimmune hepatitis. People taking part in this part of the study do not need a liver biopsy. We will ask these people to attend for a LiverMultiscan at the start of the study and again 18 months later to see if LiverMultiscan can track any changes in the liver over time. In each part of the study patients will continue with their routine care throughout. No one will miss out on any treatment by taking part. What are the possible benefits and risks of participating? There is no immediate benefit to taking part; however, this study may develop a technique that could benefit you or others in the future by making the assessment and monitoring of liver disease quicker and safer. MRI scans are safe and painless and so there are no risks to taking part in this project. Where is the study run from? CALM is being carried out between the Universities of Birmingham and Edinburgh. The lead centre is Birmingham and the project will be co-ordinated from there. LAMP/LAMALD take place in Birmingham only. When is the study starting and how long is it expected to run for? We started recruiting people to the study in January 2014. The study will continue until September 2018. Who is funding the study? The CALM & LAMP studies are funded by the UK’'s innovation agency, the Technology Strategy Board. LAMALD is funded by the NIHR Rare Diseases Translation Research Collaboration. Who is the main contact? Dr Katherine Arndtz (Clinical Research Fellow) k.arndtz@bham.ac.uk

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Closed trial
University of Birmingham (UK) Update l'année dernière

The ELMS Trial: ELectrical and Magnetic Stimulation to mitigate Intensive Care Unit-acquired weakness after trauma Background and study aims Immobilisation causes the size and strength of the muscles to reduce quickly. Intensive Care Unit-Acquired Weakness is a common problem which is not well understood. A combination of wasting of muscle and inflammation affecting nerves and muscles can cause loss of function and reduced quality of life. This can have long-term consequences, lasting for years. Previous studies suggest that artificially stimulating muscle activity in intensive care patients may reduce these processes. This has never been tested amongst a group of patients who have all had major injuries. Previous research has mainly looked at stimulation of leg muscles with electricity. The use of magnetic stimulation has never been tested. We will find out if stimulation of the arms in patients who have been admitted to the ICU due to major injury will stimulate the arms (due to their importance in activities of daily living) and will find out about the role of magnetic stimulation as an alternative to electrical stimulation. This is an initial (small-scale) study. This means that the main aim of this study is to collect enough information to tell us how many patients would have to be studied to provide a definite answer about the possible benefits of stimulation. Who can participate? Patients who have severe injuries who are admitted to the critical care unit at the Queen Elizabeth Hospital, Birmingham, can participate in this study. What does the study involve? Participants will receive either active electrical, active magnetic or sham stimulation. This will be chosen at random, with an equal chance of receiving any given stimulation. The stimulation will be applied to their arms every day for ten days. Blood samples will be taken when the participant agrees to take part and before and after the stimulation on three occasions. Before the stimulations begin, muscles in the arms will be assessed with ultrasound and a small sample (called a biopsy) will be taken from the biceps muscle. These will be done again at the end of the ten-day stimulation period. At the end, electrodes will be attached to the hands and arms in order to test the function of various nerves. These tests are known as nerve conduction studies. Tests of arm muscle strength will also be performed. When the participant is ready to leave the hospital, their ability to perform activities of daily living (feeding, dressing, walking, etc) will be assessed. Their quality of life will be measured at the time of discharge and six months later. What are the possible benefits and risks of participating? It is possible that participants who receive active stimulation might retain more strength in their muscles and be able to do more than patients who receive sham stimulation. Muscle biopsy carries slight risks (such as bleeding, discomfort or infection) and nerve conduction studies may be uncomfortable. Where is the study run from? The study is run from Queen Elizabeth Hospital, Birmingham, UK. When is study starting and how long is it expected to run for? The study is expected to start in late 2013. It is expected that patients will be recruited over a six-month period with follow-up continuing for a further six months after recruitment is completed. Who is funding the study? The study is funded by the NIHR Surgical Reconstruction & Microbiology Research Centre, UK. Who is the main contact? Mr Iain Smith iain.smith@uhb.nhs.uk

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Closed trial
University of Birmingham (UK) Update l'année dernière

Spironolactone TO Prevent cardiovascular events in early stage Chronic Kidney Disease (CKD) Background and study aims About 1 in 10 people are living with reduced kidney function because mild (early stage) chronic kidney disease (CKD) is common and kidney function reduces with age. Patients with CKD have reduced survival rate due to high rate of heart and blood vessel diseases. Even people with mild CKD have premature stiffening and reduced function of their heart and blood vessels. Our previous research of 112 people with early CKD from a specialist hospital kidney clinic showed that a 'water tablet' called spironolactone improves heart structure and function as well as reduced blood vessel stiffness. This study aims to confirm the findings in people with early CKD managed at general practices. Who can participate? The study will recruit 240 adult patients from 20 general practices in South Birmingham area who have estimated kidney function between 30- 59% on the blood test (mild CKD). What does the study involve? Patients who are willing to participate in the study will be assigned to receive ‘study medication’, which are either spironolactone or placebo (dummy capsules) at random. Both participants and doctors will not know who is taking which capsules. Blood and urine test, blood pressure and blood vessel stiffness will be measured before starting the ‘study medication’. Blood vessel stiffness is measured by how fast the pulse travels from neck to groin using cuffs which detect pulse on both sites. Participants will be taking the ‘study medication’ for 40 weeks, during which time they will be followed-up and monitored regularly at their local general practices with blood tests, blood pressure measurements and side effect questionnaire. After 40 weeks of receiving the ‘study medication’, all participants will have repeat blood and urine tests, blood pressure and blood vessel stiffness measured. All the tests will be repeated 6 weeks after stopping the ‘study medication’. The total duration of the study is 46 weeks. What are the possible benefits and risks of participating? Our previous research study showed that spironolactone improves heart function and reduces hardening of the blood vessels in patients with mild kidney disease in specialist hospital kidney clinic setting. Patients’ participation in this study will contribute to an improved understanding of spironolactone and its effects on blood vessel and kidney disease in the primary care setting. The information gained from this study will also contribute to further studies and may help improve the treatment of people with kidney disease in the future. The most common side effects from spironolactone are diarrhoea, drowsiness, headache, nausea, stomach cramping and vomiting. Such effects are usually mild and temporary and resolve when the drug is stopped. Other less common but serious side effects are severe allergic reactions (rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue), black, tarry, or bloody stools, change in the amount of urine produced, confusion, dark urine, decreased sexual ability, enlarged breasts in men, irregular or missed menstrual periods, severe or persistent stomach pain, symptoms of abnormal fluid or electrolyte levels (i.e.: fast, slow, or irregular heartbeat, increased thirst, muscle weakness, severe or persistent dry mouth, nausea, or vomiting, severe or persistent dizziness or drowsiness, unusual fatigue or sluggishness, tingling sensation), yellowing of the skin or eyes. With the exception of the blood tests, study procedures should not cause any pain or discomfort. There are small risks of increased levels of salts in the blood, reduced kidney function or low blood pressure with the use of spironolactone, requiring the withdrawal of the study medication. However, the dose of the trial medication is relatively low and all participants will be closely monitored by kidney specialists during study to ensure that those risks are minimised. Where is the study run from? The study is run from the local general practices in South Birmingham area When is the study starting and how long is it expected to run for? June 2013 to June 2015 Who is funding the study? National Institute for Health Research - Research for Patient Benefit (UK) Who is the main contact? Dr Odettte Chagoury o.l.chagoury@bham.ac.uk

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Closed trial