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Clinical Trial Search Results
 

Official Title

INDIGO Community: Investigating DIGital Outcomes in a community setting for patients living with and beyond a diagnosis of cancer. To understand more about the long-term outcomes and service use of patients living with and beyond a diagnosis of cancer Phase II randomised feasibility research administering questionnaires in a mixed methods study.

Brief Title

INDIGO Community

Trust Start Date

May 22, 2023

Summary

We can use questionnaires to help us understand how a patient feels about their quality of life (QOL) and experiences of care. These surveys are called Patient-Reported Outcome Measures (PROMS).

PROMS have been used in research to understand patients quality of life. However, more needs to be done to understand the quality of life for patients in the long term following a diagnosis of cancer. To do this, we need to understand how to engage participants in this type of research so that we can deliver high volumes of PROMS responses. We will then be in a position to develop a greater understanding of quality of life in those living with and beyond cancer in the long term.

We also do not know what services patients use in the community to help them manage the long-term effects of their cancer or its treatment with the aim of improving their quality of life.

Using a digital survey tool, we hope we can run a project that will help us understand more about the lives of patients after treatment for cancer. We plan to see which PROM allow participants to express their quality of life as rated by the participants. We also want to study how we can keep the amount of time and effort needed to complete the questionnaires as low as possible.

All patients over the age of 16 who have had any type of cancer in the past can take part. Patients will access the survey at a time that suits them using a digital link. They can complete the survey once or if they chose, a second time 12 months later.

Category

Oncology

Official Title

A Phase III, Randomised, Double-Blind, Placebo-controlled, Event driven Study to Evaluate the Effect of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death in Participants with Increased Risk of Developing Heart Failure.

Brief Title

BaxDuo Prevent-HF

Trust Start Date

May 20, 2025

Summary

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.

Category

Cardiology

Official Title

A Phase 2a Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AZD4604 Twice Daily for Twelve Weeks in Adult Patients with Moderate-to-Severe AsthmaUncontrolled on Medium-High Dose ICS-LABA.

Brief Title

AJAX

Trust Start Date

Aug 5, 2025

Summary

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.

Category

Respiratory

Official Title

A Phase III Open-Label Extension Study to evaluate the long-term safety of Astegolimab in patients with chronic obstructive pulmonary disease.

Brief Title

GB43374 Ph 3 follow up study of Astegolimab in Patients with Chronic Obstructive Pulmonary Disease

Trust Start Date

Dec 13, 2024

Summary

Chronic obstructive pulmonary disease (COPD) is a group of conditions that affect the lungs. COPD causes symptoms such as breathlessness and cough. Some people experience episodes when their symptoms flare up (known as ‘COPD exacerbations’). Having COPD exacerbations can affect how the lungs work and is linked to a worsening quality of life. Standard of care treatments for COPD include inhalers of corticosteroids (to reduce inflammation) and bronchodilators (to relax lung muscles and widen airways). Better treatments are needed to prevent COPD from getting worse, reduce exacerbations and improve overall health-related quality of life. Astegolimab is a type of drug called a monoclonal antibody that may effectively reduce COPD exacerbations. Astegolimab is an experimental drug, which means health authorities have not approved it for treating COPD. In two previous clinical trials (called ‘parent’ trials or studies), people with COPD were given astegolimab or placebo (a substance with no active ingredients which looked like astegolimab) as a subcutaneous injection.
This clinical trial is called an ‘extension’ trial or study - people who completed one of the parent trials and agree to join the extension trial will be given astegolimab on a long-term basis. About 2000 people will take part in this extension study and it aims to test the long-term safety of astegolimab in combination with standard of care COPD treatment. Participants will be seen by the trial staff every 2 weeks to be given astegolimab treatment (two injections under the skin). Participants will be seen in the clinic about 2 weeks after the final treatment dose and 3 months later for a follow-up visit. The total time of participation in the clinical trial will be up to 4 years, depending on if astegolimab is approved by health authorities for treating COPD in the participants’ country or if the sponsor decides to stop the trial. Participants can stop treatment and leave the clinical trial at any time.

Category

Respiratory

Official Title

ColoCap: determining the diagnostic accuracy of colon capsule endoscopy compared to standard colonoscopy in patients at risk of colorectal disease.

Brief Title

ColoCap

Trust Start Date

Sep 9, 2025

Summary

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.

Category

Gastroenterology

Official Title

Snapshot Obstetric National Anaesthetic Research Project 1 (SONAR-1)

Brief Title

SONAR 1

Trust Start Date

Apr 1, 2025

Summary

Approximately 25% of UK pregnancies are delivered by lower segment Caesarean section (LSCS). Most women undergoing LSCS do so under epidural or spinal anaesthetic, collectively known as neuraxial anaesthesia (NA). These are injections in the back which are intended to numb the abdomen and pelvis, while the patient remains awake. This study aims to understand the experiences of women undergoing LSCS, and specifically to understand the how often patients may feel intraoperative pain, dissatisfaction and distress.

The initial pilot study will take place at University College London Hospitals for a 4 week enrolment period to ensure any problems or issues with a multicentre study are minimised. All patients undergoing caesarean section which start with neuraxial anaesthesia (awake) during that 4 week period will be provided with a participant information leaflet about the study. These patients will have routine data recorded on a proforma by the anaesthetist responsible for their care. This data will include some information about the patient, the surgery, the anaesthetic and the maternal and fetal outcome.

After surgery and initial recovery is completed, these patients will then be approached to consent for participation in the study. Consenting patients will then be approached to complete two questionnaires - one within 24 hours (+/- 6 hours) of surgery (in person or by phone if discharged from hospital), and one 6 weeks later (+/- 3 days) (by phone). The first questionnaire will ask about women’s experiences of the procedure and their short-term recovery. For women who felt pain or discomfort during their procedure, we will ask about how effective additional pain relief was, and explore how communication was with the anaesthetist and broader obstetric team. The 6 week (+/- 3 days) questionnaire will ask about symptoms of postnatal depression and post-traumatic stress.

The study findings will be used to guide future research looking at interventions to reduce the number of women affected by intra-operative pain and inadequate anesthesia during caesarean section.

Category

Anaestheology

Official Title

UK Heart Failure with Preserved Ejection Fraction Registry

Brief Title

UK HFpEF

Trust Start Date

Apr 25, 2025

Summary

Heart failure occurs when the heart is no longer able to pump blood around the body properly. It can cause breathlessness, swollen feet and ankles, and tiredness. In about half of patients with heart failure, one measure of the heart’s pumping function, called the ‘ejection fraction’, is normal. This type of heart failure is called heart failure with preserved ejection fraction, or HFpEF.

HFpEF remains poorly understood. It is not clear why some people develop HFpEF, or what determines the severity of the condition. Treatment options may be limited.

Patients with HFpEF have traditionally been treated as if they all have the same condition. However, it is becoming clear that the diagnosis of HFpEF includes patients with a range of different underlying heart and blood vessel abnormalities, as well as different underlying conditions which may contribute to their heart failure.

This study is called the UK Heart Failure with Preserved Ejection Fraction Registry, or UK HFpEF. It aims to gain a better understanding of why people develop HFpEF, develop better tests to diagnosis it, identify and test new treatments, and follow the health of the people taking part over many years. We hope that many thousands of patients with HFpEF will take part.

Category

Cardiology

Official Title

Understanding escalation area and corridor care in UK emergency departments: An observational cohort and Delphi study.

Brief Title

UNCORKED

Trust Start Date

Mar 3, 2025

Summary

Crowding in emergency departments is a recognised public health challenge. Crowding leads to patient care being delivered in areas not originally designed for this use known as ‘escalation areas’. Although a formal definition of an escalation area does not exist, examples include ambulance waiting areas, repurposed clinical areas outside the usual emergency department footprint and non-clinical areas such as hospital corridors. There is a lack of data about how many patients are receiving care in such environments, and what impact this has on their care and outcomes. In this study, we will begin to address these questions by:

1. Estimating the number of patients cared for in escalation areas.
2. Describing which patients experience escalation area care.
3. Reporting 28 day mortality and hospital length of stay for those who experience corridor care
3. Defining emergency department escalation areas.

The results will provide much-needed data on escalation area use, which will inform discussions on how best to address this problem and future research related to escalation area care and its impact on patient outcomes.

Category

Emergency Medicine

Official Title

Investigating the benefits and harms of reduced daily dose oral isotretinoin in the treatment of acne: A parallel group, assessor blind, non-inferiority, multicentre randomised controlled trial, with an internal pilot.

Brief Title

ACNE-ID

Trust Start Date

Mar 3, 2025

Summary

Although many teenagers experience acne, around 1 in 10 of people get severe acne that can scars their skin. Having acne on your face and body as a young person can affect your confidence, sometimes leading to low mood and anxiety. However, there is a very effective treatment for severe acne called isotretinoin.  Although isotretinoin works well at clearing acne at this dose, nearly everyone (8 in 10) experience side effects such severe drying of the lips, skin and lining of the nose. Other side effects can occur including aching muscles and tiredness (2 in 10) and acne flares when starting treatment (2 in 10). Isotretinoin can also harm an unborn child which is why strict contraception (e.g. combined oral contraceptive pill and condoms) is needed during treatment.
One way to reduce these side effects is to give a lower dose of isotretinoin possibly over a longer period of time. But we want to be sure a lower dose clears acne as well as the standard dose, and if people are happy to take the tablets for a longer time. It is also possible that if the acne is not fully treated at a lower dose, it will come back soon after stopping treatment.
The current standard dose of isotretinoin is ≥0.5mg per kg daily, the low dose for the trial is around half the dose 0.25mg per kg daily. Participants in standard dose group will have the dose increased throughout the treatment course. It is expected that participants on the lower dose will likely take the tablets for longer than participants on the standard dose.

Category

Dermatology

Official Title

A phase III, multi-centre, randomised placebo-controlled trial of oral iron supplementation for the prevention of maternal anaemia

Brief Title

PANDA - Prevention of Anaemia

Trust Start Date

Mar 26, 2025

Summary

Iron tablets is the main form of treatment of anaemia, but it is not known whether routine taking of iron, started early in pregnancy, to prevent anaemia, has clinical benefits for the mother and baby. Currently, there is no recommendation for taking of iron tablets and given the high burden of anaemia during later pregnancy, it is likely that many women develop low iron levels during pregnancy.

The trial research question is whether iron tablet taking using a low-dose given from early pregnancy (first booking clinic) will improve mother and baby outcomes, compared to a placebo (dummy table).

Category

Reproductive Health

Official Title

Confederation of Respiratory Critical Care Trials

Brief Title

CoReCCT

Trust Start Date

Feb 7, 2025

Summary

CoReCCT (the Confederation of Respiratory Critical Care Trials) has been established as a novel concept to group a range of respiratory critical care trials, with an overarching aim to streamline trial delivery across areas such as governance, contracting, and data collection. The overriding objective is to improve deliverability by minimising burden on participating sites and participants.

The primary aim of the clinical trials (domains) within CoReCCT is to test the clinical and cost effectiveness of four interventional strategies on the patient outcomes in hospitalised adults with moderate to severe acute respiratory failure that may require tracheal intubation and mechanical ventilation support.

The interventional strategies are presented as a series of clinical trials (domains), which occur both sequentially and concurrently along the clinical care pathway of a patient with moderate to severe acute respiratory failure. These domains include the Awake Prone Study (pre-intubation), PROTECT Airways trial (intubation), RELEASE trial and NAVA trial (both post-intubation).

Category

Critical Care

Official Title

Optimised pre-clinical Assessment of Suitable Investigational agents for preciSion medicine in myeloma - OASIS

Brief Title

Pre-clinical assessments for precision medicine in myeloma - OASIS

Trust Start Date

Apr 2, 2025

Summary

OASIS is a multi-centre tissue and data collection study for patients with symptomatic multiple myeloma that ultimately aims at identifying novel future therapies for patients with an unmet clinical need. The patient blood and bone marrow material collected in the study is used for laboratory cell culture drug testing to pre-clinically identify the most promising drug candidates for future clinical development. Patient material will also be tested to identify molecular features, e.g. gene mutations, of the tumour that could predict response to a specific therapy. This could speed up a future clinical development plan in the sense of tailored, stratified therapy. Outcome data of participants will be collected and also correlated with molecular features of the tumour to identify groups of patients that have an unmet clinical need when treated with standard therapies on the NHS. These groups will be prioritised for the future molecularly stratified clinical drug development programs. Patients may be informed about results of the molecular tumour testing if it may open therapeutic options for them, e.g. a molecularly targeted clinical trial for tumours with a specific mutation.

Category

Oncology

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