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University of Manchester (UK) Update l'année dernière

Intervention within the British Autism Study of Infant Siblings (iBASIS) Background and study aims Recent research has opened up the possibility of very early intervention for infants at high risk of developing autism (i.e., who are siblings of children already diagnosed). Theory suggests that some aspects of brain and genetic functioning may be responsive to environment effects, especially during the estimated 1000 hours of one-to-one social interaction in the first year with parents/caregivers. Treatment could therefore be targeted to modify this aspect of the infant’s environment. We have new methods to identify behavioural and biological markers in infancy that may be associated with later emergence of autistic spectrum disorder (ASD). Furthermore, there is indirect evidence that treatment at this age may be appropriate and effective: there are established treatments for diagnosed autism later in the pre-school years which do show effectiveness, and evidence that similar treatment approaches can show positive effects on parent-infant interaction and functioning in non-autistic infants. The aim of this study is to test a targeted treatment at the end of the 1st year in high-risk infant siblings. We aim to work with parents to help them understand their infant’s particular communication style and adapt to it in order to promote their infant’s social and communicative development. Who can participate? 8-10 -month-old infants at high genetic risk of autism (i.e., with an older sibling diagnosed with an autism spectrum disorder). What does the study involve? Participants are randomly allocated to one of two groups. One group receives no treatment and the other group participates in the iBASIS programme. The iBASIS programme takes place in families' homes and involves 10 1-hour visits from a trained therapist over 5 months. Each session involves the therapist making a video recording of the parent and infant interacting and playing at home for about 6 minutes. The therapist and parent will watch the video recordings together and parents will receive detailed feedback from the therapist about their interaction. We look at how opportunities for communication could be enhanced. During each session the therapist will explain clearly what the parent will be doing and parents will be able to ask questions at any time. What are the possible benefits and risks of participating? The study will give information on the feasibility, acceptability and impact of this treatment. Numerous previous studies indicate that there is no evidence of any harmful effect, although we will be evaluating this carefully as part of our work. Where is the study run from? The University of Manchester (UK). When is the study starting and how long is it expected to run for? May 2011 to April 2013. Who is funding the study? Autistica and the Waterloo Foundation (UK). Who is the main contact? Clare Holt clare.holt@manchester.ac.uk

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Closed trial

Exercise training in Diastolic Heart Failure Background and study aims Heart failure with preserved ejection fraction (HFpEF) is one of the three main types of heart failure. It is a common disease, especially in the elderly. Typical risk factors are high blood pressure (hypertension), diabetes, and an inappropriate lifestyle. The consequences are substantial functional limitations and poor quality of life. Patients are also less able to exercise and this has a negative effect on the disease. Currently there is currently no effective treatment but exercise training may be of potential benefit. In this study we want to find out whether regular supervised exercise training can improve patients’ symptoms, their quality of life and the course of the disease. Who can participate? To take part you need to be aged 18 years old or above and have been diagnosed with HFpEF. What does the study involve? You will receive either individually prescribed supervised exercise training on top of usual care or usual care alone. Usual care involves normal and established control of risk factors such as hypertension or high blood cholesterol levels (hyperlipidemia) for 12 months. The allocation to training or usual care will be by chance. Only one half of the patients will receive exercise training. During the 1-year follow-up period, there will be 5 visits (including blood samples, exercise testing and echocardiography). What are the possible benefits and risks of participating? Supervised individually tailored exercise training in stable heart failure patients appears to be a safe treatment , even in elderly patients. In an initial study patients with the same disease were included and there were no adverse events. Exercise may trigger myocardial ischemia (decreased blood flow to the heart) or arrhythmias (irregular heart beat), exercise-related cardiac decompensation (failure of the heart to maintain adequate blood circulation) and inappropriate blood pressure increases. We will minimise these risks by implementation of strict inclusion/exclusion criteria for participants (e.g., blood pressure control, no symptomatic coronary artery disease, inclusion of compensated patients only) and careful evaluation before participation in the study. In addition, you will undergo an exercise stress test (spiroergometry) and echocardiography before inclusion, and if we expect any exercise-related unfavourable side effects, you will not be included in the study. Your training intensity will be individually adjusted on the basis of pre-specified criteria (e.g., heart rate). This will be re-evaluated every 3 months, and individual adaptations of training intensity will be performed, if needed. This procedure ensures that training intensity is always under medical control. Exercise training will be supervised by trained supervisors (e.g., physiotherapists). With the use of safety measures such as permanent supervision and very regular visits, we expect few adverse events.. On the other hand, we do expect significant beneficial effects. The clinical benefit is expected to largely outweigh potential reversible and non-life-threatening side effects. Where is the study run from? The study will be performed in Germany and Austria (20 trial sites). When is study starting and how long is it expected to run for? Patients will be enrolled in the study between September 2011 and September 2013. Follow-up examinations will continue until October 2014. Who is funding the study? The study is funded by the German Research Foundation (Germany). Who is the main contact? Dr F Edelmann fedelmann@med.uni-goettingen.de

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Closed trial
Simon J Davies, MBChB Update l'année dernière

Predictors of Post Operative Outcome in Peripheral Vascular Surgical Patients Over 3000 people each year undergo bypass operations to their lower limbs, and these operations carry significant risks with approximately 1 in 20 of these people dying in hospital, and another 1 in 20 having a heart attack. Assessment of these patients in order to stratify their risk of both dying and having significant complications aid in improving their care, enable better utilisation of scarce critical care resources, and allow us to give patients better information on which to base consent. Aims The aims of the project are to assess the feasibility of exercise testing this group of patients both with cycle and arm exercise, and to identify markers of outcome in this group. Methodology This is a prospective observational study designed to test the hypothesis that a combination of cardiopulmonary exercise testing and blood tests provides prognostic value on outcome measures after surgery for lower limb revascularisation Subjects will have 2 exercise tests, one arm and one cycle, prior to surgery at their preoperative assessment appointment. From these tests we will measure how much work patients can do, how much oxygen they are able to use, and when the heart is unable to deliver enough oxygen to the cells. In addition they will have blood samples taken prior to the operation (brain natriuretic peptide), and on days 1 and 3 (troponin I) after the operation to look at cardiac markers of damage. This data will be used to see if we can predict those patients that have both short and long term complications, and also to see whether the different forms of exercise testing are comparable, or if one type is superior. Expected outcomes We expect that through a combination of exercise testing and blood test we will be able to identify patients at increased risk of complications after surgery. We also expect to find that arm exercise will be a more feasible and informative test that cycle exercise.

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Closed trial
Vincenzo Malafarina, MD Msc Update l'année dernière

Hyperprotein Nutritional Intervention in Elderly Patients With Hip Fracture and Sarcopenia 1. RATIONALE The unique characteristic of our study lies in the attempt to reverse the functional impairment experienced by sarcopenic patients with hip fracture using nutritional intervention. What makes this study different from prior studies is that it will be conducted in a hospital setting, unlike most prior studies, which were conducted in a community setting. The association between muscle mass and strength, inflammatory indices, and functional impairment versus dependence and fragility will also be measured. 2. HYPOTHESIS The hypothesis of our study is that nutritional intervention enriched in metabolites of essential amino acids (beta-hydroxy-beta-methylbutyrate) is effective for treating sarcopenia in elderly patients with hip fracture and improves functional level. 3. OBJECTIVES Primary objective is to assess functional improvement after nutritional intervention in sarcopenic patients with hip fracture, as measured using Barthel index. Secondary objectives will include: 1) to show the relationship between metabolic and inflammatory indices and sarcopenia; 2) to show how sarcopenia and its treatment influence the risk of fall; 3) to show muscle mass improvement; 4) to show increased strength; 5) to assess mortality and morbidity. 4. EXPECTED RESULTS The investigators expect to find that the supplemented group experiences throughout the study period a significant improvement in functional status (Barthel index), an increase in muscle mass, and a reduction in fat mass. An increased strength and a reduction in associated complications (falls) are also expected. The investigators hope to be able to show reductions in inflammatory indices and insulin resistance. To conclude, by improving muscle strength and mass the investigators expect to find a reduction in the disability and dependence of this population group.

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Closed trial
Yangfeng Wu, PhD Update l'année dernière

Clinical Pathways for the Management of Acute Coronary Syndromes - Phase 3,CPACS-3 The burden of chronic, non-communicable disease, of which cardiovascular disease comprises a significant component, has increased rapidly and substantially in China over recent years. Over the coming decades China is predicted to experience a 69% increase in acute coronary disease(ACS), amounting to nearly 8 million additional events. A recent randomized trial of more than 15,000 patients with acute coronary syndromes, the second phase of Clinical Pathway for acute coronary syndromes in China (CPACS-2) study, showed that a quality improvement initiative could improve aspects of hospital care, including the proportion of patients discharged on appropriate medication. The study also identified a number of barriers to improved care including out of pocket costs and administration systems. However, the study was not able to determine the impact on clinical outcomes or the cost-effectiveness of the intervention. The aim of the third phase of the Clinical Pathway for acute coronary syndromes in China (CPACS-3) study is to determine whether a complex intervention comprising a clinical pathway for ACS management in combination with a number of physician and patient-oriented education tools can improve the quality of care and health outcomes among ACS patient admitted to resource-limited (provincial) hospitals. The effectiveness of the intervention will be evaluated using a cluster randomized trial (stepped wedge design) of ACS patients admitted to 104 hospitals in China. The study will incorporate two additional components (1) a qualitative substudy to identify the barriers and enablers to improved care and (2) a study comparing the cost-effectiveness of the intervention compared to usual care, from the perspective of the health care provider. The study will be conducted in conjunction with the Chinese Ministry of Health and the Chinese Society of Cardiology. The findings from CPACS3 will be able to inform health policy-makers about the extent to which quality improvement initiatives can reduce the risk of death and disability among the millions of ACS patients admitted to hospitals in China each year.

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Closed trial
Vijay A Ramchandani, Ph.D Update l'année dernière

Genetics of the Acute Response to Alcohol in Social Drinkers Background: - Previous research has shown that a person s genes can influence how they respond to alcohol. But researchers do not yet know all the genes that might be involved. Objectives: - To identify genes that are related to how non-alcoholic individuals respond to alcohol. Eligibility: - Healthy people between 21 and 30 years of age who have no history of alcohol or drug dependence. Design: - The study requires one or two 9-hour visits to the National Institutes of Health Clinical Center. - Participants must not take any medicines (except birth-control pills for women) for at least 3 days before the visit. They must not drink alcohol for at least 2 days before the visit. - Screening includes a medical history, physical exam, and a urine test for drugs of abuse. - Participants will be given alcohol over about 2.5 hours. This will have about the same effect as having three to four drinks. Frequent breathalyzer tests will check breath alcohol level during the infusion. - Before and during the infusion, participants will complete questionnaires about mood and feelings. Other tests will study thinking, balance, judgment, and risk-taking. Blood samples will be collected four times during the infusion. - Participants will have breakfast at the start of the visit (around 8:00 AM). They will have a snack before the start of the alcohol infusion (around 10:45 AM). Lunch will be served after the alcohol infusion is complete (around 2:20 PM). After the tests, those in the study will have to stay in the Clinical Center until their breath alcohol level falls below 0.02%. This can take up to 2.5 hours. A final blood sample will be drawn at that time. Participants will not be able to drive themselves home after the study visits. Also, they should not take any medicines or operate any machinery for at least 2 hours after leaving NIH.

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Closed trial
Sheffield Teaching Hospitals NHS Trust Update l'année dernière

Support, Positioning and Organ Registration during breast cancer Radiation Therapy: SuPPORT 4 All Background and study aims: Women diagnosed with breast cancer undergo surgical removal of the tumour (lump) as first line treatment. When only the tumour is removed and the patient still has the rest of the breast, radiotherapy is given to reduce the chance of the cancer returning. Previously, radiotherapy to the whole breast was used for this, however, to minimize unwanted side effects, radiotherapy treatments have become more complex, to target only the area affected. It has become important to ensure accurate targeting of the breast within the radiotherapy beam. Currently there are no devices in use that will allow radiation therapists to position a patient’s breast accurately to target treatment. Poor targeting can lead to unwanted side effects. Furthermore, in most radiotherapy departments women undergoing breast radiotherapy lie on the treatment bed naked from the waist upwards while up to 4 staff (including men) adjust their position in preparation for treatment, which can cause stress in the patient. This study aims to develop a support bra that will allow accurate positioning of the breast on a day to day basis, which is acceptable to patients and helps to maintain modesty during treatment. The aim of this first phase is to identify the requirements of patients and staff for a support bra as well as testing a range of materials that could be used for this. The work undertaken in this phase will be followed by the development of a prototype (test product) that will then undergo testing before patients are able to test it. Who can participate? Members of staff who have experience of treating or planning radiotherapy for breast cancer and patients who have had a breast lump surgically removed (but still have the rest of the breast) and underwent radiotherapy for breast cancer. Patients were female and over the age of 18 years. What does the study involve? Patients will be asked to participate in a focus group with other patients to discuss their experience of radiotherapy and to give their views on what a support bra for radiotherapy should look like and how it could be designed. As part of the study patients will be asked to keep a personal journal about their experience during their radiotherapy treatment. Staff participants will be asked to participate in one to one interviews to discuss their view of how a support bra should be designed. The radiotherapy treatment of participants will not be altered in any way. What are the possible benefits and risks of participating? This study is an opportunity to contribute to the development of a support bra that could improve the modesty of patients undergoing radiotherapy for breast cancer. There are no known risks associated with this study. Where is the study run from? The study was run from two radiotherapy centres in Sheffield and Leeds; Sheffield was the lead centre. When is study starting and how long is it expected to run for? This phase of the study started in August 2011 and ran until November 2011. Participants for this phase were recruited for 3 months from August 2011. Who is funding the study? Engineering and Physical Sciences Research Council Who is the main contact? Dr Heidi Probst h.probst@shu.ac.uk

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Closed trial