Patients due to attend for a colonoscopy because of suspected serious bowel disease (colitis or colorectal cancer) or for routine surveillance after polyp removal will be invited to join the study. The study is designed to be as similar to a standard colonoscopy as possible. After a day of bowel preparation, the participant will swallow the capsule under supervision, first thing in the morning and then, later that afternoon, a colonoscopy will be performed. This will allow up to 8 hours for the capsule to pass. The participant will not be able to eat during this time and so it will be a long day for participants to cope with, but it will avoid the need for two lots of bowel preparation and investigations on two separate days. This study will allow us to directly compare the capsule findings with those of the colonoscopy and so find out how accurate the capsule is at detecting bowel disease. We will also ask participants and the clinical team what their experience of the capsule has been. Finally, we shall compare the costs of the capsule over those of colonoscopy.

Asthma is a long-term lung condition where inflammation causes the airways to narrow, swell, and create extra mucus.
The trial drug, AZD4604, is taken through an inhaler. There are other asthma treatments taken through inhalers that are currently available, but these may not work well enough for everyone or may cause too many medical problems. AZD4604 is designed to work differently than currently available inhaled asthma treatments. AZD4604 is designed to work by blocking a type of protein that increases inflammation called Janus kinase (JAK) 1.
The possible benefits of taking AZD4604 are reduced asthma attacks, reduced hospitalizations from asthma attacks, and improved asthma symptoms, lung function, and quality of life. These benefits are not guaranteed.
There are oral tablet or capsule treatments that also block JAKs. They are used to treat inflammatory conditions other than asthma. These treatments may not work well enough for people with asthma or be as safe as inhaled treatments because oral medications can affect the whole body. Because AZD4604 is inhaled, it specifically targets the airways.
So, researchers think AZD4604 could help people with asthma that is not controlled well enough by currently available inhaled treatments.
This is a Phase 2, randomized, double-blind, placebo-controlled trial. Randomized means that the treatment each participant takes will be randomly assigned by a computer program. Double-blind means none of the participants, researchers, trial doctors, or other trial staff will know what treatment each participant takes. Placebo-controlled means that some participants will take a placebo. The placebo in this trial looks like AZD4604 but does not have any AZD4604 in it. Participants will be in this trial for up to about 5 months. This trial will include about 320 participants.

Researchers are looking for a better way to reduce development of heart failure and reduce the risk of death from cardiovascular causes in patients with history of cardiovascular disease, high blood pressure and type 2 diabetes (T2D). Heart failure is a condition where heart is unable to pump enough blood to meet the body's needs. This can lead to symptoms such as tiredness, shortness of breath, swelling of the legs and ankles, chest pain and a cough. In this trial researchers are looking into how well a drug called baxdrostat works and how safe it is when combined with drug called dapagliflozin in patients at an increased risk of developing heart failure.
Dapagliflozin is an approved medication to help people with kidney disease with or without T2D. It changes how the kidneys handle sugar, salt, and water, which helps heart and kidneys health. In the present study, all participants will be provided dapagliflozin. Baxdrostat blocks production of hormone aldosterone in the body, helps reduce extra salt and fluid retention in the body and lowers blood pressure and may also reduce the risk of developing heart failure. Researchers want to learn if taking baxdrostat with dapagliflozin could help reduce risk of heart failure and cardiovascular deaths than taking dapagliflozin with a placebo. The placebo will look like baxdrostat but will not have any medicine in it. This trial will include up to about 11,300 participants globally. To join people must be 40 years of age or older and have prior history of cardiovascular disease (prior heart attack or stroke) and T2D with high blood pressure. Participants already taking dapagliflozin or a similar drug (called SGLT2i) will be randomly put in either treatment (Baxdrostat) or placebo arm while also receiving dapagliflozin. Participants who are not already taking dapagliflozin will begin the trial by taking dapagliflozin for 4 weeks before being randomised in the study. The average study duration is approximately 38 months.

Compare the disease-free survival (DFS) of patients with completely resected early stage breast cancer receiving 1 of 2 different schedules of adjuvant chemotherapy comprising epirubicin, cyclophosphamide, methotrexate, and fluorouracil versus 1 of 2 different schedules of adjuvant chemotherapy comprising epirubicin and capecitabine

The objective of this trial is to confirm (or refute) that immediate release melatonin is beneficial when compared to placebo in improving total duration of night-time sleep and in reducing sleep latency (the time taken to fall asleep) in children with neuro-developmental problems. At randomisation, each patient will be allocated their own 'individual patient package' containing either melatonin or placebo. Each child will be given the first dose and kept on that dose for a minimum of seven days. For the next three weeks and at each one-week interval during this time, the child's sleep disorder will be reviewed (using subjective and objective) and the medication either left unchanged or increased to the next dose increment. There are a maximum of 3 dose increments after the starting dose of 0.5 mg, through 2, 6 and up to a maximum of 12 mg. Each child will remain on whichever dose is felt to have been the most effective.

​

The main endpoints for each comparison will be: 1. Complete remission (CR) achievement and reasons for failure (for induction questions), 2. Duration of remission, relapse rates and deaths in first CR, 3. Overall survival, 4. Toxicity, both haematological and non-haematological, and quality of life, 5. Supportive care requirements (and other aspects of health economics)

The primary objectives of this study are to test if aliskiren monotherapy is superior or at least non-inferior to enalapril monotherapy (in the entire study population) and to test if aliskiren/enalapril combination is superior to enalapril monotherapy (in the entire study population and/or in the non-diabetic population) in delaying time to first occurrence of either cardiovascular death or heart failure hospitalization in patients with chronic heart failure (NYHA Class II - IV)

The PICCOLO Trial has two separate objectives. Firstly, to establish whether the toxicity of irinotecan (Ir) therapy is reduced, without loss of efficacy, by modulation with ciclosporin (Cs). Secondly, to establish whether, in patients with K-RAS wild-type tumours not previously treated with anti-EGFR therapy, the efficacy of Ir therapy is improved by the addition of panitumumab (Pan).

To assess the effect of adding 24 weeks of daily dalteparin (Fragmin) to standard treatment for patients with lung cancer in terms of overall survival. Assessed using an open randomised trial.

To find out the pathological complete regression (CR) rate when topically treating lentigo maligna lesions with imiquimod. Pathological Complete Regression means that the lesion has completely been removed when the skin is looked at under a microscope (histopathology).

To determine whether zoledronic acid with chemotherapy and/or endocrine therapy is superior to chemotherapy and/or endocrine therapy alone in improving disease-free survival

Some patients with rectal cancer benefit from receiving chemotherapy and radiotherapy before they have an operation to remove their tumour. This trial will determine whether the addition of a second drug (irinotecan) to the standard treatment of oral chemotherapy using capecitabine and radiotherapy will result in fewer cancer recurrences (regrowth) after the operation and if patients live longer.

To compare 5-year Event Free Survival (EFS) between the two treatment arms. The study is powered to demonstrate superiority of the dasatinib arm over the imatinib arm.

To demonstrate the efficacy of oral ST10-021 in the treatment of iron deficiency anaemia (IDA), as measured by change in haemoglobin (Hb) concentration from baseline to Week 12, in subjects with quiescent Crohn's Disease (CD) where oral ferrous preparations (OFP) have failed or cannot be used.

Questions for patients considered fit for intensive treatment; compare induction schedules (DA and DClo), assess the value of Mylotarg in induction in combination with DA or DClo in course 1, To compare two versus three courses of induction/consolidation treatment, To compare the use of Demethylation maintenance treatment with Azacitidine with no maintenance, Assess the value of Reduced Intensity Allogeneic Stem Cell Transplantation Questions for patients not considered fit for intensive treatment. To compare Low Dose Ara-C versus available novel approaches; Low Dose Ara-C with Mylotarg, Low Dose Ara-C with Zarnestra, Low Dose Clofarabine. During the course of the Programme other novel therapies are expected to become available, and will be considered for inclusion in this comparison.

The primary objective of the study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of CV death, MI, or stroke in subjects with a recent ACS compared with placebo in addition to standard care.

Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients. [?Time?Frame:?Patients will be followed up to 10 years. DFS will be calculated from date of randomization until the date of first documented DFS event, this will be assessed at 2 and 5 years?]

To determine the effect on freedom-from disease progression of a second autologous stem cell transplant (ASCT) compared with low-dose consolidation, following re-induction chemotherapy, in patients with relapsed myeloma previously treated with high-dose chemotherapy and ASCT

To determine whether perioperative endocrine therapy with an aromatase inhibitor (AI) for two weeks before and after surgery (perioperative therapy) followed by standard adjuvant therapy improves outcome compared with standard therapy alone in postmenopausal women with hormone receptor positive breast cancer. To determine whether the proliferation marker Ki67 as measured by immunohistochemistry (IHC) in the excised cancer around 2 weeks after starting AI therapy will predict for relapse free survival (RFS) more effectively than the pre-treatment Ki67 value in the individual patient as suggested in a clinical pilot study. To determine whether molecular profiling 2 weeks after starting endocrine therapy predicts for long-term outcome in postmenopausal women with hormone receptor positive breast cancer better than in untreated patients.

​

1) In low risk patients (aged > or = 18 years and < 40 years, no high risk factors): What is the incidence of thrombosis and major haemorrhage while receiving aspirin only? 2) In intermediate risk patients (aged > or = 40 years and < 60 years, no high risk factors): Does hydroxyurea reduce thrombosis and major haemorrhage when added to aspirin? 3) In high risk patients (aged > or = 60, or other risk factors as defined below in this document): does anagrelide reduce vascular occlusive events as effectively as hydroxyurea? 4) In high risk patients (aged >or = 60, or other risk factors as defined below in this document): is anagrelide as effective as hydroxyurea in reducing elevated platelet counts? 5) What is the effect of the treatment modalities on quality of life?

To determine overall survival at 5 years

​

To demonstrate the efficacy of oral ST10-021 in the treatment of iron deficiency anaemia (IDA), as measured by change in haemoglobin (Hb) concentration from baseline to Week 12, in subjects with quiescent ulcerative colitis (UC) where oral ferrous preparations (OFP) have failed or cannot be used.

To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ?6 months to <18 years.

The principal objective of this research is to determine whether intermittent parent-initiated treatment with oral montelukast in preschool children with a history of wheeze, reduces the need for unscheduled medical attention for wheeze. To assess this treatment will be started by parents or guardians i) at the onset of every cold and continued for a minimum of 7 days or until wheeze has resolved for 48 hours, and ii) for every episode of wheeze not associated with a viral cold, and stopped when symptoms have resolved for 48 hours. For each child, the trial will last 12 months.

Efficacy of nitric oxide, with or without continuing antihypertensive treatment, for management of high blood pressure in acute stroke

The DREAMS trial is a 2 stage study: i) a feasibility study and ii) a phase IV randomsied controlled trial. The objective of the feasibility study is to assess the feasibility of running the phase IV study. This pilot trial will develope effective strategies for patient identification, recruitment and follow-up in the main part of the trial. The objective of the full trial is to determine whether dexamethasone reduces postoperative nausea and vomiting in patients undergoing planned major bowel surgery and to determine it's role in future use in this category of patients.

To determine whether prednisolone or pentoxifylline improve the 28 day mortality (death rate) from severe alcoholic hepatitis

To compare the clinical and cost effectiveness of infliximab and ciclosporin for patients with acute severe steroid resistant ulcerative colitis

To evaluate the efficacy and safety of the two most commonly used systemic treatments for PG. The study aims to test the hypothesis that systemic ciclosporin (4 mg/kg/day) is more effective than systemic prednisolone (0.75 mg/kg/day) for oral therapy of PG. Primary objective: To assess the speed of response to treatment - assessed by digital images at 6 weeks

The aim of this study is to determine if metformin, administered to obese women during pregnancy, reduces the future life risk of obesity and metabolic syndrome in their babies.

To determine if pioglitazone (a drug to treat insulin resistance), compared to placebo (a dummy medication), will reduce the overall risk for fatal or non-fatal stroke or fatal or non-fatal myocardial infarction (MI, commonly known as 'heart attack') among non-diabetic men and women aged 40 years or older with insulin resistance, who have experienced a recent stroke or transient ischaemic attack (a TIA, sometimes termed a 'mini-stroke). We hypothesize that, among non-diabetics with insulin resistance, pioglitazone will reduce the rate of occurrence of any main outcome (fatal or non-fatal stroke or MI) within four years from 27% to 22%.

The aim of this study is to examine if combining hormonal treatment and vigabatrin is better at controlling infantile spasms and at helping development at 18 months of age than taking a hormonal treatment alone.

To determine whether an extended course of prednisolone reduces the time to first relapse in children presenting with steroid sensitive nephrotic syndrome

1) For patients with the same tumour type (characterised by the results of the molecular tests), do the proposed new agents significantly increase the length of time for a patient to die, or for their tumour to increase in size by at least 20% when compared to patients having a treatment break after their first-line chemotherapy, in the time period after standard first-line? 2) Do the patients who have a particular genetic mutation identified by the molecular tests respond better to a proposed new agent than the patients who do not have that particular mutation?

To compare the effect of alirocumab with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia

The primary objective of this trial is to demonstrate the efectiveness of bortezomib in combination with rituximab and CHOP chemotherapy (RB-CHOP) in comparison R-CHOP alone for the treatment of previously untreated patients with diffuse large B cell lymphoma. Efficacy will be determined by the number of patients who are alive and there condition has not progressed (Progression Free Survival). The study also will assess if the molecular profile (phenotype) (either ABC or GCB) determines the benefit from the addition of bortezomib.

Primary objective: A phase III, randomised trial comparing 6 months trastuzumab treatment with 12 months, in patients with Her 2 positive early breast cancer, in terms of disease-free and overall survival.

In women at high risk of preterm labour, does prophylactic vaginal natural progesterone, 200mg daily from 22- 34 weeks gestation, compared to placebo: i Improve obstetric outcome by lengthening pregnancy and thus reducing the incidence of preterm delivery (before 34 weeks gestation)? ii. Improve neonatal outcome by reducing a composite of death and major morbidity? iii. Lead to improved childhood cognitive and neurosensory outcomes at two years? iv. Represent cost effective management for women at high risk of preterm delivery?

To compare a thalidomide-containing regimen with two lenalidomide-containing regimens as induction treatment and to assess the value of lenalidomide maintenance for patients with newly diagnosed myeloma with respect to overall and progression free survival.

To assess the safety of short-term administration (1 month) of intensive antiplatelet therapy (aspirin, dipyridamole and clopidogrel) versus current guideline therapy (dual aspirin and dipyridamole, or clopidogrel monotherapy) in patients with very recent ischaemic stroke or TIA

This trial is intended to assess the efficacy of two doses of Ofatumumab (standard dose or high dose) in combination with chemotherapy (Fludarabine and Cyclophosphamide or Bendamustine) in relapsed B-CLL patients. The efficacy will be assessed by the complete response rates (CR or CR(i) by IWCLL criteria) in each treatment group.

To look at whether a course of Rifaximin after a patient has been successfully treated for C.difficile diarrhoeal infection with a standard course of antibiotics can reduce the rate of the infection returning (recurrence)

To assess the risks, benefits and cost effectiveness of levofloxacin in newly diagnosed symptomatic myeloma by a prospective, multi-centre, randomised, double-blind, placebo-controlled trial.

The objectives of this study are to determine: 1.Is there a role for CEP17 and TOP2A testing in selecting anthracycline or taxane chemotherapy as neo-adjuvant chemotherapy for early breast cancer? 2.Is SLNB post neo-adjuvant chemotherapy in patients with biopsy proven ipsilateral axillary lymph node metastasis at diagnosis sufficiently sensitive to replace routine axillary node clearance?

To determine whether the naturally-occurring omega (?)-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) prevents colorectal adenomas, either alone or in combination with aspirin.

The objective of this study is to determine whether treating patients who have heart failure with clopidogrel 75mg/day is superior to treating them with aspirin 75mg/day. The main focus is on all-cause mortality (death rate) but data on morbidity (illnesses), symptoms, quality of life and on cardiovascular and renal function and anaemia will also be collected. A health economic analysis (to determine the relative cost benifits of the study to the healthcare of the patients within the trial) will be conducted if appropriate. Clearly, if no difference in outcomes is observed there is no value in a detailed health economic assessment.

This trial will assess whether fourteen days intravenous ceftazidime with tobramycin is superior to three months (12 weeks) oral ciprofloxacin. Both treatment regimes will be in conjunction with three months (12 weeks) nebulised colistin.

The primary aim of this study is to assess whether regular aspirin use after completion of primary treatment (given with curative intent) for common non-metastatic solid tumours prevents tumour recurrence and prolongs survival. The question will be addressed in four common cancers (breast, colorectal, gastro-oesophageal and prostate).

To see if taking methotrexate (MTX) in combination with gefitinib is better at reducing the need for surgery against methotrexate alone in the treatment of ectopic pregnancy.

1. To test whether adjuvant treatment with radiotherapy following radical postatectomy leads to better outcomes than regular observation with early salvage treatment given at the tune of a rising PSA - Radiotherapy Timing Randomisation. 2. To test whether, in men receiving post-operative radiotherapy to the prostate bed, the addition of hormone therapy leads to better outcomes; and if so, whether two years of hormone therapy is better than six months - Hormone Therapy Duration Randomisation

A high-quality, multi-centre randomised controlled trial to determine if giving the first 6 weeks of an optimum combination chemotherapy regimen prior to surgery, as opposed to 24 weeks post-surgery, can reduce the risk of recurrence in patients with high-risk operable colon cancer. The effect of the addition of the monoclonal antibody, EGFR, with demonstated results in later stage disease, will also be evaluated.

To assess whether progression free survival (PFS) time (i.e. the length of time during and after medication or treatment during which the disease being treated does not get worse) using ofatumumab plus bendamustine is longer than that using ofatumumab plus chlorambucil.

Is morphine medication, used over one month better than placebo for the relief of chronic refractory breathlessness in people with stable chronic heart failure?

To assess whether tranexamic acid is safe and reduces death or dependency after primary intracerebral haemorrhage (PICH).

This trial aims to determine and compare: 1. The depth of response between standard melphalan conditioning and augmented (adding ixazomib) melphalan conditioning at second ASCT. 2. The impact of adding consolidation and maintenance treatment versus no further treatment, on progression free survival.

To compare the clinical and cost-effectiveness of initiating monotherapy with lamotrigine, levetiracetam or zonisamide in patients with untreated focal onset seizures. To compare the clinical and cost-effectiveness of initiating monotherapy with levetiracetam or valproate in patients with untreated generalised onset seizures or untreated seizures that are difficult to classify.

To compare the clinical and cost-effectiveness of initiating monotherapy with lamotrigine, levetiracetam or zonisamide in patients with untreated focal onset seizures. To compare the clinical and cost-effectiveness of initiating monotherapy with levetiracetam or valproate in patients with untreated generalised onset seizures or untreated seizures that are difficult to classify.

The primary research objectives of the internal pilot RCT are:1) To demonstrate trial processes for approaching women, gaining consent, randomising, treating and assessing outcomes are optimal, and to implement improvements as required; 2) To determine achievable recruitment rates; 3) To determine the likely effect size, to inform a calculation on whether the planned sample size can be reduced whilst maintaining study power; 4) To pilot and modify if required the post-partum questionnaires (assessment of patient satisfaction and collection of health service use outcomes). The primary research objectives of the substantive GOT-IT RCT are: 1) To determine the clinical effectiveness of sublingual GTN in treating RP and avoiding MROP in women with vaginal delivery following failure of current management (defined as a third stage of labour lasting more than 30 mins after active management or 60 mins after physiological followed by active management respectively) (clinical domain).

The primary objective is to demonstrate that rivaroxaban is superior to placebo in subjects with HF and significant CAD, who are receiving standard care, in reducing the risk of the composite of ACM, MI, or stroke following an index event.

The HALT-IT trial will find out whether early administration of tranexamic acid improves outcomes for people who suffered of significant gastrointestinal bleeding. The main outcome is death from haemorrhage within 5 days of randomisation. We will also assess the cause of death.

To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice) compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, and vascular death after ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other defined causes unrelated to atherosclerosis.

To determine whether early treatment with co-amoxiclav reduces the likelihood of re-consultation due to clinical deterioration in at risk children with influenza/influenza-like illness (ILI) within 28 days of study entry.

This study aims to find out whether giving patients who are suspected of having a stroke, a 5mg transdermal glyceryl trinitrate (GTN) patch (a commonly used drug in patients with heart disease) as soon as possible after stroke, and then daily for the next three days, improves outcome

For adults surviving spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, does a policy of starting antiplatelet therapy result in a beneficial net reduction of all serious vascular events over two years compared with a policy of avoiding antiplatelet therapy? The primary objective of the pilot phase is to estimate, when all participants have completed at least two years of follow-up, the relative and absolute effects of antiplatelet drugs on the risk of brain haemorrhage happening again associated with a policy of starting antiplatelet drugs after the acute phase of brain haemorrhage. Ultimately, we want to determine whether antiplatelet drugs are beneficial for patients after brain haemorrhage because the gains from prevention of clotting problems outweigh the risks of bleeding at any site.

The principal objective of this research is to demonstrate, that treatment with the new oral anticoagulant (medication that prevents blood clots from forming) edoxaban reduces the risk of stroke in patients with atrial high rate episodes (episodes of an increased frequency and changed rhythm of beating in the hearts atrium) and additionally an increased risk of stroke (assessed by the ChadVasc scoring system) when compared to the current standard therapy. Current standard therapy is either no treatment at all or treatment with Aspirin, depending on the health condition of the patient

To evaluate the efficacy of the oral soluble guanylate cyclase (sGC) stimulator MK-1242 (vericiguat) in comparison to placebo on a background of standard of care in increasing the time to first occurrence of the composite of CV death or HF hospitalization in subjects with HFrEF.

What is the clinical effectiveness of methylphenidate versus placebo for cancer-related fatigue in patients receiving palliative care?

To determine whether a six day course of oral prednisolone given at the time of URTI reduces the incidence of first URTI-related relapse in children with relapsing steroid sensitive nephrotic syndrome.

Main study principal objective To compare, in women undergoing conservative surgery for pain due to endometriosis, the effectiveness of some or all of the following four post-surgical treatment options in controlling the recurrence of symptoms and improving quality of life: 1) no treatment 2) levonorgestrel-releasing intra-uterine System (LNG IUS) 3) three monthly depot medroxyprogesterone acetate injections (DMPA) 4) the combined oral contraceptive pill (COC), dependent on the groups carried forward from the pilot.

To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NTproBNP from baseline after 12 weeks of treatment in patients with HFpEF. To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in improving exercise capacity as assessed by the six-minute walk test (6MWT) at Week 24 in a subset of patients

To evaluate the efficacy of low molecular weight heparin (LMWH) in women with inherited thrombophilia who have experienced 2 or more recurrent miscarriages and/or intra-uterine foetal death

The primary objective of ORION-4 is to determine the effect of inclisiran sodium, given 3 times in the first year and then 6 monthly for a total of around 5 years, on 'major adverse cardiovascular events' (defined as any occurrence of non-fatal myocardial infarction [heart attack], death from coronary disease, ischaemic stroke [stroke due to insufficient blood supply rather than bleeding] or urgent coronary revascularization procedure [angioplasty or bypass surgery]) during the scheduled treatment period.

This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.

To compare a total of three versus four courses of treatment in total, comparing one versus two courses of HD Ara-C in consolidation. In highrisk patients, to evaluate the value of allogeniec stem cell transplantation (SCT), whether standard allogeneic (allo-SCT) or non-myeloblative "mini" allogeneic (mini-SCT). To assess the clinical value of minimal residual disease monitoring (MRD) for patient overall survival

The purpose of this study is to see if the study drug (Bempedoic acid) reduces the risk of major cardiovascular (heart and blood vessel-related) events in patients with, or at high risk for, heart disease who have had complications related to taking statins. The study will compare the study drug to a placebo in reducing cardiovascular events such as heart attacks, strokes, heart-related surgeries, hospitalisations, and also death occurring for patients in the study. The study will also look at how the study drug may affect the level of cholesterol and certain proteins in the body and how safe the study drug is (for example, what side effects it might cause).

The study is planned to last for 3 years, with a recruitment period of 2 years and will include 200 participants with asthma. Potential participants must have had an asthma attack in the previous 12 months."

The previous aim of this study was to learn more about the effects of a future worldwide influenza (flu) epidemic and its treatment on pregnant women and their babies using the UK Obstetric Surveillance System (UKOSS). The study has now been extended to include information on all pregnant women hospitalised with COVID-19. It will use UKOSS to identify approximately 500 women hospitalised with an influenza pandemic (when the disease has spread across many countries) or COVID-19 in pregnancy over a 6 month period. Information will be collected through doctors and midwives in hospitals throughout the UK. By studying all the pregnant women admitted to hospital, the study hopes to identify whether certain groups of pregnant women are more at risk of the more severe problems caused by an epidemic of flu or COVID-19, and whether any particular additional treatment in pregnancy helps lessen these risks. Pregnancy and delivery information will be compared with that from previous UKOSS studies of approximately 700 women giving birth in the UK identified from the same hospitals who did not have flu or COVID-19. The information collected will be anonymous which means an individual patient cannot be identified. The research will be conducted at the University of Oxford and is funded by the NIHR Health Technology Assessment programme. [COVID-19 amendment 09/03/2020]

Our genes determine how susceptible (likely to get) we are to life-threatening infection, and when a patient is already sick, different genetic factors determine how likely they are to survive. The GenOMICC (Genetics of Susceptibility and Mortality in Critical Care) study will identify the specific genes that cause some people to be more likely to get particular infections and more likely to end up being severely ill. Identifying these genes may help us to use existing treatments better, and to design new treatments to help people survive serious illness. To do this, we will compare cells and DNA (the genetic code that determines all of a person�s characteristics found in the cell nucleus) from carefully selected patients with those from healthy people. The study, which started in 2016, will include COVID-19 patients. [COVID-19 amendment - 23/03/2020]

This study will collect information about newborn babies admitted to hospital who have Coronavirus (COVID-19) or who are born to mothers who have COVID-19 and require hospital care. The information we collect will help us to understand: how babies get COVID-19; what happens to babies when their mother has COVID-19; what treatments are effective in helping babies with COVID-19 to get better; and what happens to babies when they have been treated. We are carrying out the study through a system called the British Paediatric Surveillance Unit (BPSU) www.rcpch.ac.uk/work-we-do/bpsu. Each week every doctor across the UK looking after newborn babies in hospital will be asked by the BPSU if they have looked after a newborn baby with COVID-19 or whose mother has COVID-19. If they have, they will be sent a questionnaire to collect information about the baby and their mother. This identifiable information will be shared with us under special temporary provisions introduced in England & Wales by the Secretary of State for Health and Social Care to allow the processing of confidential patient information without consent for COVID-19 public health, surveillance and research purposes during the current pandemic. [Study relying on COPI notice].

COVID-19 disproportionately affects people over 50 years old with comorbidities and those over 65 years old. The infection causes considerable morbidity and mortality in this population group in particular, and is having a devastating effect on people's health and society internationally. So far, there are no treatments for COVID-19 that have been proven in rigorous clinical trials to be effective. It is essential to identify interventions that may favourably modify progression of the infection. An ideal intervention would one that is safe, with few side-effects, helps prevent disease progression, and can be administered in the community using existing NHS processes and capability.

We propose establishing a platform randomised controlled trial in primary care that can be rapidly deployed to evaluate low risk interventions for high risk people. In the first instance this platform will evaluate a drug called hydroxychloroquine. This is a drug that is already available within the NHS but that has not been subject to randomised controlled trials for this indication in Europe or in community healthcare settings with the aim of reducing the need for hospital assessment. Using a simple, streamlined open trial design, with procedures embedded in existing health service structures and capabilities, our trial aims to give a rapid answer about the effectiveness of trial treatments in modifying the disease course. The goal is to prevent disease progression such that affected individuals will recover sooner, but critically, avoid the need for hospital assessment and admission. The platform trial will be flexible in that it will operate under a master protocol that will allow the addition of further interventions into the trial while it is in progress, should such suitable interventions become available.

The trial will be implemented in the first instance by the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) general practices.

The current coronavirus outbreak (COVID-19) is likely to affect hundreds of pregnant women globally. Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratoy Syndrome (SARS), also coronaviruses, caused more severe illness - particularly lung infections- in pregnant vs. non-pregnant women. There has been a report of nine women affected by COVID-19 in the latter third of their pregnancy, many more are likely to be affected. There is a data-gap on the effect of SARs-CoV-2 infection and COVID-19 at other stages of pregnancy e.g. early pregnancy and its effect on the unborn and newborn baby. Maternity services and individual maternity centres are currently developing their responses using national and WHO guidance for non-pregnant women. PAN-COVID will develop a global database detailing a number of outcomes (death of the baby or mother, stillbirth, miscarriage, pregnancy complications, gestational age at delivery, delivery method and testing the baby for SARS-CoV-2). The aim of this database is to understand the natural history of SARS-CoV-2 and COVID-19 and the impact on mothers and their babies to guide both treatment and prevention.

There are no currently licensed vaccines or specific treatments for COVID-19. This study will enable us to assess how well people of all ages can be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19. It will also give us valuable information on safety aspects of the vaccine and its ability to generate good immune responses against COVID-19. We will enrol small numbers of older adults (56-70 years, then 70+ years) before expanding to large numbers of adults across all ages (18+ years). After this we will also assess the vaccine in a small group of children (5-12 years). In total we will enrol up to 5260 volunteers. There will be between 9 and 14 visits over 12 months with a blood test at each visit. Participants will receive one or two doses of the new COVID-19 vaccine or a licensed vaccine which has been given routinely to teenagers in the UK since 2015 to protect against meningitis and sepsis. Some participants may be asked to complete an electronic diary for 7 days after each vaccine and update the diary if they have any illness for a month after vaccination.

The aim of this trial is to determine the best range of treatments for patients who become severely ill due to COVID-19. Patients admitted to the Intensive Care Unit (ICU) with severe illnesses normally receive a combination of many different treatments to help them recover. For example, there are a number of different possible drugs to fight the coronavirus but patients also require treatment to help their breathing, circulation and kidneys. REMAP-CAP has many recruiting sites around the world and aims to enrol thousands of patients in more than 100 ICUs in the UK. The trial is designed to flexible and adaptive. Each hospital will choose which treatments to make available to patients from those available within the trial. Currently the trial is evaluating different anti-viral drugs (Lopinavir-Ritonavir and hydroxychloroquine), steroids to reduce inflammation and treatments which act on the immune system, often used to treat other conditions such as rheumatoid arthritis, (interferon-�1a, anakinra, tocilizumab and sarilumab). The trial will look at how these drugs work in combination. Additional treatments will be added over time. Information will be reviewed regularly and, dependent upon the results, the trial will allocate more patients to the treatments that seem to be the most effective. Information is available at https://www.remapcap.org/. [COVID-19 amendment - 03/04/2020]

Nursing is hugely important to people in hospital. Nursing care makes a significant difference to the way people experience being in hospital and to their recovery. For people with COVID-19, their symptoms and the infectiousness of the virus pose unique challenges for nurses in delivering this care. This study will inform the development of nursing care protocol specifically addressing the fundamental care requirements of hospitalised patients wit the SARS-CoV-2 virus not invasively ventilated.

We will simultaneously conduct a 12-month prospective study of an additional 6970 patients treated with infliximab (anti-TNF) versus vedolizumab (anti-integrin) using our established clinical network of UK IBD centres. Data from both cohorts will be used to define the impact of immunosuppressive drug therapy and physical distancing strategies on SARS-CoV-2 seroprevalence. Serial testing in the prospective cohort will define the durability and magnitude of protective immune responses.\n\nThis study will provide an evidence base for safer prescribing of immunomodulator and biologic drugs in the COVID-19 era and inform public health policy regarding physical distancing measures, and future vaccination strategies. Although this study will define risk in IBD patients, there are potentially important lessons to be learned for millions of patients across the UK with other immune mediated diseases treated with similar therapies.

Premature births account for a tenth of all world-wide births. Babies who survive are at risk of developing Chronic Lung Disease of Prematurity (CLD) as they have underdeveloped lungs, and also because the necessary treatment (breathing machines and oxygen therapy) in itself causes harm. CLD is defined as needing oxygen at 36 weeks �corrected� gestation. Most babies will come off their oxygen therapy by the end of their hospital stay, however, some babies go home on oxygen placing enormous burden on families. CLD babies also have a higher risk of childhood breathing problems. Inflammation (like redness or soreness) of the lungs is often seen in CLD babies, and a germ called Ureaplasma is often present. Some doctors� think that Ureaplasma is a simple 'bystander', but others believe that it is actively causing harm- we have shown that babies who have Ureaplasma have much greater chances of developing CLD than those who do not. Researchers have previously used antibiotics, such as azithromycin, to treat the Ureaplasma. Azithromycin decreases lung inflammation and is an effective antibiotic against Ureaplasma. A recent report combining 3 studies noted that rates of CLD may improve with azithromycin therapy but the total number of babies included were small. A large study is needed to see if azithromycin therapy can indeed improve CLD rate. We, therefore, will investigate if ten days of intravenous azithromycin improves survival without CLD in premature babies. We shall collect lung fluid samples via their breathing tube or from their nose/back of the mouth, and nappy stool samples. These will be used to see if lung Ureaplasma is successfully treated by azithromycin, and if common germs found in the gut and lungs develop antibiotic resistance. Studying resistance is important as azithromycin will be widely used if we show that the therapy improves rates of CLD.

This study seeks to explore the views and understandings of specific healthcare professionals towards partial ectogenesis (the gestation of a foetus outside of the human body). The targeted healthcare professionals are those working in the fields of midwifery, obstetrics, gynaecology and reproductive and foetal medicine. The study will be conducted with the use of an online survey and semi-structured face to face or telephone interviews.

This is a qualitative research project which aims to explore the experiences of returning to work, and remaining in work, after Head and Neck Cancer (HNC). Up to 8 patients who have completed treatment for HNC will take part in a one-off interview.

The interview will explore patient perspectives about the process of returning to work, and their ongoing continued experience of the workplace. The following will be explored:-
- factors that influenced their return to work journey
- what helps them remain in work
- what influences their work satisfaction
- any problems or concerns they have and how these could have been made easier

Similarities and differences will be examined from a range of different people's perspectives and to establish their concerns. This study forms the ground work for a large study as part of a future PhD.

Globally many people, including healthcare workers (HCWs), are becoming ill and dying from COVID-19. We have evidence that people from ethnic minorities have a higher chance of going to intensive care and dying from COVID-19. This may also be the case for ethnic minorities working in the health system. We want to investigate this using existing data held by national healthcare organisations to understand what the risk of having, and dying from, COVID-19 is for ethnic minority HCWs. We will also follow a group of ethnic minority HCWs over 12 months to see what changes occur in their physical/mental health. In addition we will interview a smaller group of ethnic minority HCWs to understand how risky their jobs are, and how they have changed their professional/social behaviours in response to COVID-19. Using staff data and linking it to healthcare data may be sensitive and so we will explore how to do this in a way that is acceptable. Finally, we want the findings of this research to be useful for HCWs and so we have a stakeholder group of major national organisations to help us do the research, publicise the findings and make recommendations.

This study will be the first-step providing high-quality evidence to support the use of OPBCS as an alternative to mastectomy. It will promote choice, improving outcomes for patients, many of whom will be long-term breast cancer survivors.

The aim of this study is to determine prospectively the negative and positive predictive power of faecal calprotectin for organic disease in new patients referred from primary care with fast track lower gastrointestinal symptoms. The predictive power of faecal calprotectin for patients with colorectal cancer will additionally be assessed. Should this prove to be a safe and effective test then this study would inform an NIHR application to re-model the current fast track and non fast track colorectal guidelines currently used in primary care. Currently the cancer detection rate in high risk patients is thought to be &lt;10%. The diagnosis of organic disease amongst this cohort is likely to be considerably higher. The management of fast track referrals is nonetheless demanding on secondary care resource. If a safe effective mechanism of improving the risk stratification of symptomatic patients could be identified and actioned from the primary care level then considerable savings would accrue.

Patients can develop conditions that require treatment by an emergency operation called a laparotomy. The National Emergency Laparotomy Audit (NELA) was set up and this has improved the outcomes from surgical units performing emergency laparotomies. NELA has improved the care of patients before and after their laparotomy, and thus improved UK wide outcomes. When patients become older and have more medical conditions, they can become frail. Frailty is not just a measure of age, but of a person�s general health and independence and is a range. Being frail makes it more difficult to recover from an illness and operations. A previous research study (ELF), undertaken by researchers involved in this study, found that those patients with a higher frailty score had more problems recovering from an emergency laparotomy, stayed in hospital longer and had decreased rate of going home after the operation. However, there is a group of patients that very little is known about, the older patient that requires a laparotomy as treatment for their emergency condition but do not have the emergency laparotomy (NOLAP). There is little information and research into the total number who not undergo laparotomy, and reasons for not having a laparotomy, frailty and outcomes for these patients. A smaller study has suggested that a third of patients that do not have a laparotomy are alive and well at one month. This multi centre UK study aims to compare the data from those that do not undergo laparotomy with those that do in the older patients. The findings of this study will be used to improve the shared decision making process in this group of patients by providing relatable information to patients but to also improve the patient care and resources available to the patients.

This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.

Our study will take place in six specialist neonatal surgical units across the UK. We are asking parents and health professionals for their views and whether they would take part in a future trial. We will also collect information about babies who have recently had a stoma to find out which factors influence the timing of closure. We will also analyse 6 years of data from an existing database, the National Neonatal Research Database to estimate the numbers of babies affected, understand current practice and outcomes for these babies.

The aim of this study is to assess the short- and long-term psychological impact on patients who have survived an admission to intensive care due to COVID-19, and identify possible predictors of anxiety, depression and trauma symptoms in this patient group.

We aim to identify the proportion of patients surviving an admission to intensive care due to COVID-19 who experience anxiety, depression and/or trauma symptoms in the 6 months post-discharge, assessed using the Hospital Anxiety and Depression Scale (HADS) and the Impact of Event Scale-6 (IES-6). We will attempt to identify demographic, clinical and/or psychosocial predictors of depression, anxiety and/or trauma symptoms at 3-, 6- and 12-months post discharge from ICU.

Patients with narrowed heart arteries experience chest pain, breathlessness and heart attacks. The best way to assess the seriousness of a patient�s condition is to pass a wire down the arteries to measure blood pressure changes. This accurately determines whether a patient will benefit from a procedure to open the blood vessels up. However, only a small minority have this test because the wire is expensive and takes time to use. We have developed a computer model which calculates the pressure measurements from pictures of the blood vessel without needing the wire. This provides the benefits of pressure measurements to thousands more patients, at minimal risk, with cost savings. In this study, we will test our system in real hospital settings, to see how it would influence the care of patients, and how much money it might save. We will not actually alter patient care, because our system has not yet been approved for clinical use, but we can test it out and see what difference it might make. We will do this by asking the specialists to say what their treatment plan is, then reveal our computed measurement of blood flow, and then ask how their plan would differ now they know this information.

This research focuses on young people, aged 13-17 years, who require admission to hospital for psychiatric care. Many types of serious mental ill-health start during the teenage years. In the long term, young people with severe mental health problems are at risk of having poor mental and physical health as well as difficulties with holding down a job, social involvement and activities, and making and maintaining friendships and relationships. These poor outcomes may be more likely if their early experience of support from services is poor and disjointed. This research aims to understand and improve the experience of care for young people with such severe mental health problems that they need to be admitted to inpatient mental health services.

This study will aim to find out how many young people in the UK are admitted far away from home (that is to an adolescent unit further than 50 miles from their home or to a different NHS region) or to adult wards. Over a 12 month period, we will ask doctors (psychiatrists working with young people aged under 18) to complete questionnaires about how many young people are admitted to different types of inpatient care, how long they spent there, and how they got on.