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Clinical Trial Search Results
Official Title
Randomised trial of Suction for Primary Pneumothorax Early Resolution.
Brief Title
RASPER
Trust Start Date
Jan 9, 2025
Summary
A pneumothorax occurs when air gets into the space between the lung and the chest wall, usually through a small hole in the lung. This causes the lung to collapse, and can occur “spontaneously”, meaning without an injury to the chest. Primary spontaneous pneumothorax (PSP) occurs in young patients without known lung disease. 50% of patients with PSP need to have a tube (or drain) inserted into the chest to remove the air between the lung and chest wall, and admission to hospital. They stay in hospital waiting for the lung to re-inflate for 4 to 8 days.
Category
Respiratory
Official Title
Randomised Controlled Trial of Self-management of Postnatal Antihypertensive Treatment.
Brief Title
SNAP2
Trust Start Date
Nov 5, 2024
Summary
Raised blood pressure (BP) during and following pregnancy affects around 80,000 women each year in the UK, and can lead to very serious problems such as pre-eclampsia or stroke. After birth, a women’s BP can remain elevated, but in most cases returns to normal over 2–12 weeks. During this period, medication needs to be adjusted to achieve the correct control. Research suggests that better BP control during this period is associated with improved long-term health outcomes. This trial aims to test whether a self-management approach can improve BP control in women with medicated hypertensive disorders in the postnatal period. The self-management approach will include self-monitoring and using a Smartphone app. Blood pressure readings will be looked at by their own health care professionals who will oversee any medication changes.
Category
Reproductive Health
Official Title
A randomised controlled trial to investigate clinical and cost effectiveness of Amiodarone vs Beta Blockade for new onset atrial fibrillation in ICU - a pragmatic study.
Brief Title
ABBRUPT
Trust Start Date
Nov 4, 2024
Summary
Patients admitted to Intensive Care Units with a serious illness can go on to develop new onset atrial fibrillation which is a medical emergency. Atrial fibrillation makes the heart less efficient at pumping blood around the body and can result in a very fast heart rate. This can increase the risk of complications such as heart attack and stroke. It is not currently known which is the best treatment for new onset atrial fibrillation in adult patients in the intensive care unit. The ABBRUPT trial is a randomised controlled trial that will compare amiodarone and beta blockade which are both routine treatments used for treating atrial fibrillation. The trial is funded by the National Institute for Health and Care Research and is being run in NHS hospitals throughout the UK. Patients remain in the trial for 90 days. The majority of the data required will be collected from the patient's medical notes. If the patient is discharged from hospital prior to 90 days, a researcher from the hospital will contact the patient by telephone at day 60 and day 90 to complete a brief health questionnaire.
Category
Critical Care
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Adult Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications.
Brief Title
Zilebesiran as Add-on in Patients With High CV Risk and HTN Not Adequately Controlled (KARDIA-3)
Trust Start Date
Jun 3, 2024
Summary
The main aim of this phase II study is to evaluate efficacy and safety of zilebesiran when given subcutaneously (injected under the skin) as an add-on therapy in patients with high blood pressure. It will be evaluated in adult Patients with High Cardiovascular Risk and Hypertension not Adequately Controlled by Standard of Care Antihypertensive Medications.
Category
Cardiovascular
Official Title
A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS).
Brief Title
THARROS
Trust Start Date
May 7, 2024
Summary
The purpose of this study is to learn how well an inhaler called BGF works and how safe it is compared to an inhaler called GFF in adults with COPD who are at risk of COPD flare ups and serious heart events.
This study will include up to about 5,000 participants. All participants will be 40 to 80 years of age, have COPD, and be a current or former smoker. Participants must be at risk of developing COPD flare ups and serious heart events. Participants must not be taking any medication that has inhaled steroids in the previous 12 months.
Treatments and Procedures: All participants will take GFF twice a day for 2 weeks before being randomly assigned to one of the treatment groups Participants will take treatment for at least 3 months and up to 3 years.
Category
Respiratory
Official Title
Randomized, Double-Blind, Placebo-Controlled, Multiple-Attack Study with an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE).
Brief Title
M24-305 Atogepant for the Acute Treatment of Migraine
Trust Start Date
Mar 18, 2024
Summary
This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world.
All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24).
Category
Neurology
Official Title
A Randomised Controlled Trial of Early Valve Replacement in severe Asymptomatic Aortic Stenosis.
Brief Title
EASY-AS
Trust Start Date
Feb 5, 2024
Summary
This is a major pragmatic multi-centre prospective parallel group open randomised controlled trial. The over-arching aim of the study is to determine whether early aortic valve replacement (AVR) results in better clinical outcomes and cost-effectiveness than a strategy of expectant management in asymptomatic patients with severe aortic stenosis (AS).
Category
Cardiovascular
Official Title
The neoGASTRIC trial: Avoiding routine gastric residual volume measurement in neonatal critical care, a multi-centre randomised controlled trial.
Brief Title
The neoGASTRIC trial
Trust Start Date
Feb 1, 2024
Summary
The trial will involve babies born more than 6 weeks early and will recruit about 7000 babies across the UK and Australia. Premature babies will either have no routine gastric residual volumes measured, or have gastric residual volumes measured regularly. This will be decided by chance: babies will have an equal chance of being in either group. The two approaches being compared are already used across the UK and Australia, so there is nothing new about either type of care. NeoGASTRIC will use an opt-out consent, designed to be as simple as possible for families.
Category
Paediatrics
Official Title
Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK) Stepped Wedge Cluster Randomised Trial.
Brief Title
Obstetric Bleeding Study UK (OBS UK)
Trust Start Date
Jan 11, 2024
Summary
Excess bleeding is the most common complication of childbirth. Every year about 50,000 women in the UK lose 1L (2 pints) of blood or more. Many women develop post-traumatic stress disorder, need blood transfusion or admission to intensive care.
There is a lack of knowledge about how best to treat the excess bleeding.
A care bundle for managing bleeding after birth was developed in Wales and rolled out as a quality improvement programme called the ‘Obstetric Bleeding Strategy’ (OBS). The care bundle has four parts: 1) assessment of each woman’s bleeding risk, 2) accurate measurement of blood loss at all births, 3) a consistent approach to escalation of care to more senior clinicians and 4) bedside tests to identify and treat abnormal blood clotting.
The OBS was associated a reduction in major bleeding and blood transfusion but we do not know whether the improved outcomes were due to the OBS programme.
We will recruit about 189,000 women from 36 NHS maternity units over 30-months. All women giving birth in these units will be included, whether they have excess bleeding or not. Maternity units will have a period during which standard care will continue and data collected. Units will then adopt the care bundle over 9-months followed by at least 3-months of data collection. We will compare the rate of blood transfusion after childbirth before and after the OBS was introduced. The effect of the OBS on the psychological well-being of women and birthing partners and its financial cost will also be studied. To better understand how the OBS programme works we will conduct a detailed study of how units adopt it. This includes interviewing staff and women with excess bleeding before and after adoption to understand what they think of the care bundle and whether it changes how teams deliver care.
Category
Reproductive Health
Official Title
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants with Uncontrolled Hypertension on Two or More Medications including Participants with Resistant Hypertension.
Brief Title
BaxHTN - Baxdrostat in Participants with uHTN and rHTN
Trust Start Date
Jan 11, 2024
Summary
This is a randomized trial where some parts are double-blind and some parts are open-label. Randomized means that the treatment each participant receives will be randomly assigned by a computer program. In the double-blind parts, none of the participants, researchers, trial doctors, or other trial staff will know what treatment each participant receives. In the open-label parts, the participants, researchers, trial doctors, and other trial staff will know what each participant is receiving.
Category
Cardiovascular
Official Title
Patient reported outcomes, postoperative pain and pain relief after day case surgery.
Brief Title
The POPPY Study
Trust Start Date
Jan 8, 2024
Summary
The POPPY study aims to find out what recovery from day-case operations is like from the patient’s point of view. We will look at the first week after patients’ operations and then at day 97 to see if they are in pain, and if so what pain relief they are taking.
Category
Perioperative Care
Official Title
A randomized, double-blind, placebo-controlled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients (VICTORION-1 PREVENT).
Brief Title
CKJX839D12302: (VICTORION-1-PREVENT) Preventing Major Adverse Cardiovascular Events
Trust Start Date
Oct 18, 2023
Summary
Study CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram can help prevent cardiovascular events (such as heart attacks, strokes, procedures to improve blood flow, and death) in adults who are at high cardiovascular risk but have not had a major cardiovascular event, and who also have high cholesterol. Having a lot of LDL-cholesterol (also known as “bad” cholesterol) in your blood can lead to build up on your artery walls, creating a thick and fatty deposit (or plaque) that can block blood flow. Blocked arteries can lead to important cardiovascular events, such as heart attack, stroke, or cardiovascular-related death. Inclisiran has been shown to be safe and effective at lowering LDL-cholesterol. This study will help understand if a reduction in LDL-cholesterol with inclisiran will also prevent these important cardiovascular events from occurring. Approximately 14,000 participants in approximately 45 countries will participate in this study.
The study duration is expected to last for 6 years during which each participant will receive a dose of inclisiran or placebo at Day 1, Month 3 and then every six months until the end of the study. At each visit fasting blood samples will be collected and heart rate ad blood pressure will be measured. Participants will be followed to monitor their safety for an additional 4 weeks after the end of the study.
Category
Cardiovascular
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