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Clinical Trial Search Results
Official Title
Swallow Strength and Skill Training With Biofeedback in Acute Post Stroke Dysphagia
Brief Title
Swallow Training With Biofeedback in Acute Post Stroke Dysphagia (ssSIP)
Trust Start Date
May 15, 2023
Summary
About 50% of people who have a stroke experience difficulty swallowing. There is a growing evidence base showing that swallowing therapy can help to improve swallowing, but we don't know which type or how much therapy is most beneficial. The investigators are further developing one particular intervention - swallow strength and skill training with biofeedback. This involves practicing strong or effortful swallows and practicing controlling the timing of swallowing using visual feedback on a screen showing the activity of the muscles involved in swallowing. The investigators want to know whether trained clinicians are able to deliver this therapy in acute hospital settings early after stroke. The investigators also want to explore whether there is an effect of dose in improving swallowing and other health factors. To do this the investigators will conduct a trial across several stroke units in the east midlands. The study aims to recruit 120 participants who have had a stroke and have dysphagia and who will randomly be placed in one of three groups. One group will get a standard dose therapy (10 x 35 minute sessions over 2 weeks), another group with receive a high dose therapy (20 x 35 minute sessions over 2 weeks) and the third will receive 'usual care' which is what they would usually get from their current service. The investigators will look at what therapy participants actually get, what factors might influence this and the training, support and conditions that enable clinicians to deliver the therapy. The investigators will also assess the participants swallowing and collect information on their health, face to face at the beginning and after the therapy and over the phone at three months
Category
Stroke
Official Title
Statins in organ donor management: an evaluation of the benefits of a single dose of simvastatin given to potential organ donors declared dead by neurological criteria on outcomes in organ recipients
Brief Title
Statins for Improving Organ Outcome in Transplantation
Trust Start Date
Jun 12, 2023
Summary
All organs removed from donors have already suffered a degree of damage. As the brain dies (and all of these donors are brain-stem dead) chemicals are released which cause an “inflammation” of the whole body. Measurements of this “inflammation” link to how well the organs function in the recipient after transplant.
Statins are cholesterol-lowering drugs that have benefits across a range of health problems. In particular, statins damp down inflammation in the body and in individual organs. Statins protect the lungs and kidneys in a range of illnesses.
Recently, transplant doctors in Finland linked all this information in an innovative clinical study. Organ donors who were about to donate their heart were randomly allocated to receive a dose of a statin. After the transplant, the recipients who received a heart from a donor who had statins had less heart damage. The numbers were modest, and no survival advantage could be demonstrated. There was a small benefit for lung and liver recipients, but importantly there was no disadvantage in receiving any organ from a donor who had received the drug.
A significant number of hearts and other organs offered for transplant by the donor family are not used; for the heart, this figure is about 75%. The reason for being so selective is that poor function of the donor heart in the recipient is by far the most common cause of death after a transplant. Any step in the donor which might improve the transplanted heart could have a major benefit to the recipient. The same principle applies to all the other organs transplanted.
The aim of this study is to investigate whether giving deceased organ donors a single dose of the drug simvastatin, a very commonly used and safe drug, is beneficial for transplant recipients.
Category
Surgery
Official Title
The clinical and cost-effectiveness of testing for Group B Streptococcus: a cluster randomised trial with economic and acceptability evaluations (GBS3)
Brief Title
Routine testing for Group B Streptococcus in pregnancy (GBS3 trial)
Trust Start Date
May 4, 2023
Summary
Group B Streptococcus (GBS) is a bacterium present in the vagina of approximately 1 in 4 pregnant women. Giving women antibiotics in labour reduces the risk of their babies developing GBS infection. Current UK practice is to offer antibiotics when the baby is at higher risk of developing the infection based on maternal risk factors. This “risk factor” screening is imperfect: some babies born to mothers without risk factors still develop an infection and many women with risk factors do not carry GBS but receive antibiotics unnecessarily. A better solution is “routine testing” of every pregnant woman, and offering antibiotics in labour to those who are carrying GBS.
Category
Maternity
Official Title
A Multicenter, International, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel-group, 2-arm, Phase 3 Study to Compare the Efficacy and Safety of the Oral FXIa Inhibitor Asundexian (BAY 2433334) With Apixaban for the Prevention of Stroke or Systemic Embolism in Male and Female Participants Aged 18 Years and Older With Atrial Fibrillation at Risk for Stroke
Brief Title
A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke (OCEANIC-AF)
Trust Start Date
Jun 19, 2023
Summary
Researchers are looking for a better way to treat people with atrial fibrillation and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel).
Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them.
Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding.
The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. The way it works, it aims to further improve the standard of care with regard to the risk of bleeding.
The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke
Category
Cardiovascular
Official Title
The EXTEND Trial: Fixed-extended-duration Antibiotics (28 Days) Compared to Standard Care Antibiotic Durations in Adult Patients With Complicated Intra-abdominal Infection and Their Impact on Treatment Failure
Brief Title
EXTENDed Antibiotic Durations Compared to Standard Durations for Patients With Complicated Intra-abdominal Infection. (EXTEND)
Trust Start Date
Mar 10, 2023
Summary
A multicentre, open label, two-arm, parallel group, pragmatic, randomised controlled trial with internal pilot. A total of 1166 consenting adult patients with cIAI will be recruited and randomised on a 1:1 basis between 28-days antibiotics and standard care antibiotics. Patients will be followed up for 180 days to determine cost effectiveness and the rate of treatment failure in each group.
Category
Surgery
Official Title
A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention with Multiple Dosing Regimens
Brief Title
Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
Trust Start Date
Mar 27, 2023
Summary
Mean change from the Observation Phase in the number of migraine days per month over the entire Double-blind Treatment Phase (Weeks 1-12) [ Time Frame: 3 months (12 weeks) ]
Change from baseline in mean number of migraine days per month
Category
Neurological
Official Title
Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis, Differences between Interventions (RAPSODI-UK)
Brief Title
Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis
Trust Start Date
Mar 6, 2023
Summary
The aim of this study is to find the best type of joint replacement for the treatment of painful osteoarthritis of the shoulder.
With increasing age, shoulder osteoarthritis is common and causes severe pain and stiffness making everyday activities difficult. A shoulder replacement is an effective solution, reducing pain and allowing the shoulder to move better. The operation replaces damaged bone with new metal and plastic parts. There are two types of shoulder replacement:
1. Anatomic Total Shoulder Replacement which relies on the tendons (Rotator Cuff) around the shoulder to be intact and healthy
2. Reverse Total Shoulder Replacement, which is usually used when the rotator cuff becomes weaker or torn
The rotator cuff can weaken with age which may cause an anatomic replacement to stop working. This could mean a further operation to change the shoulder to a reverse total shoulder replacement. For this reason, an increasing number of patients are offered reverse shoulder replacements even when their rotator cuff is intact. Currently, there is no scientific evidence to support this change and no guidance to recommend which is the best type of shoulder joint replacement. We will investigate which type of surgery gives value for money and the best outcome.
The local PPI Group played a central role in designing this study. They felt that this is an important question to answer and that with surgery it is vital to get ‘it’ right the first time both for the patient and for economic reasons. We, therefore, asked 34 surgeons in a survey about their practice and found 87% already perform or would consider a reverse shoulder in patients with an intact rotator cuff and 74% would be willing to change practice based on the results of the study evidence. Fourteen people who are volunteers for the hospital completed a survey containing a study information sheet. Thirteen said that they would consider being randomised to a study of this type. The PPI group influenced the choice of outcome measure and suggested the addition of a linked qualitative study. A member of the group has agreed to be a co-applicant for the study. All participant documentation will be written with input from the PPI group, strengthened with support from diversity and inclusion experts
Category
Musculoskeletal
Official Title
Multi-centre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: The ASPIRED study.
Brief Title
ASPIRED
Trust Start Date
Jan 25, 2023
Summary
Syncope (sudden loss of consciousness also known as blackout or fainting) causes over 600,000 people to visit emergency departments every year in the UK. Often, by the time the patient is seen by the medical team they have fully recovered making it hard to diagnose the underlying problem. A mobile heart ECG monitoring device has recently been developed (BodyGuardian Mini; Preventice Solutions). This device can record the patient’s heartbeat and heart electrical rhythm tracing for up to 14 days. By wearing the mobile heart monitor after attendance at the Emergency Department there may be a better chance of finding an underlying problem that caused the blackout. This study aims to recruit people who, after investigation at the Emergency Department a cause hasn’t been found for their episode of blackout. The goal is to discover if by providing patients with a 14-day mobile heart ECG monitor, doctors can better diagnose and treat the cause of a sudden loss of consciousness and reduce the number of further episodes and their potential serious consequences (i.e. injury, anxiety, poor quality of life and on rare occasions, death), reduce hospital admissions, reduce overall health costs and increase quality of life. At the moment it is not known how long patients who have this type of monitor should be monitored for, so this study will also answer this question.
Category
Injuries & Emergencies
Official Title
PRE-DX – the impact of earlier genomic testing in the treatment of breast cancer
Brief Title
PRE-DX Study
Trust Start Date
Jan 20, 2023
Summary
Currently, the treatment of breast cancer patients follows a standard clinical care pathway where a biopsy (a small sample of tissue taken from the body, in this case of the cancer cells) is collected during surgery. The biopsy sample is tested using the Oncotype DX test which gives a Recurrence Score (RS) that clinicians can use to determine the need for adjuvant treatments (radiotherapy and/or chemotherapy) in addition to surgery.
This study aims to assess the impact on patient management if the Oncotype DX test is requested on a biopsy sample taken at the time of diagnosis as opposed to a sample obtained during surgery. The availability of the Oncotype DX RS score earlier in the clinical care pathway may streamline the pathway, reducing the time to start adjuvant cancer therapy, reducing the demand on health care services, and improving patient experience.
Category
Cancer
Official Title
A study to define the platelet count below which critically ill patients should receive a platelet transfusion before an invasive procedure
Brief Title
Threshold for Platelets Study (T4P)
Trust Start Date
Nov 17, 2022
Summary
Platelets are cells in the blood that help form clots and stop bleeding. People treated in a critical care unit often have a low number of platelets (platelet count) in their blood because they are very unwell. Platelet transfusions are made up of platelets collected from screened, healthy donors. Platelet transfusions are sometimes given before these procedures if the patient’s platelet count is low. This is thought to reduce the possible risk of bleeding from the procedure.
However, platelet transfusions also carry risks such as inflammation, infection, and allergic reactions, and may not work as effectively in unwell patients.
Currently, we do not know the platelet count below which giving a platelet transfusion might be beneficial. Surveys of doctors working in UK critical care units have shown uncertainty over the platelet count below which doctors should give a platelet transfusion. As a result, platelet transfusions are currently given to patients with a wide range of different platelet counts and there is no set threshold.
This study will test five different thresholds to find out the safest count below which platelet transfusions should be given before invasive procedures are carried out in intensive care.
Category
Critical care
Official Title
A Randomised Placebo-Controlled Trial of Antenatal Corticosteroids for Planned Birth in Twins: STOPPIT-3
Brief Title
STOPPIT-3
Trust Start Date
Sep 6, 2022
Summary
This study aims to find out if the drug antenatal corticosteroids (ACS) given to women with a twin pregnancy prior to a planned birth of twins after 35 weeks of pregnancy reduces breathing difficulties in the twin babies.
Antenatal corticosteroids (ACS) help to mature babies’ lungs and may reduce breathing difficulties and the need for high levels of respiratory (breathing) support. They are routinely used in single pregnancies that deliver early, but the use of ACS in twin births has not been studied in detail and so it is not clear if they will work in twin pregnancies. Because of the lack of evidence, there is currently no guidance on giving ACS in twin pregnancies, so whether or not women pregnant with twins receive steroids as part of routine care varies depending on their hospital. ACS may also have some unwanted side effects such as lowering babies’ blood sugar and affecting their growth. We need to be certain about the benefits and risks of giving ACS before all women with twin pregnancy in the UK are offered a course of ACS prior to a planned birth.
Twin pregnancies are monitored more closely as they have a higher risk of complications than a single pregnancy, and there is a greater chance of the babies being born before 37 weeks of pregnancy. Twin births account for about 3% of live births but around 15-20% of admissions to the neonatal unit.
Current guidance recommends that twins who share a placenta (monochorionic twins) should be born from 36 weeks of pregnancy if there are no medical problems requiring earlier birth, whilst twins with a placenta each (dichorionic twins) should be born from 37 weeks of pregnancy, as evidence shows this is safer than delivering later on in the pregnancy. Being born slightly early means that twins are at higher risk of admission to neonatal units for support with their breathing, which separates mothers and babies at a crucial time.
Category
Maternity
Official Title
The Giant PANDA study: which blood pressure medication is best for pregnant women with high blood pressure?
Brief Title
Giant PANDA
Trust Start Date
Aug 31, 2022
Summary
Around 10% of women in the UK have high blood pressure in pregnancy, which without treatment can cause serious complications for the woman and baby. We want to find out which of the two most commonly used medicines to treat high blood pressure in pregnancy (labetalol and nifedipine) in the NHS is best at treating high blood pressure without having troublesome side-effects for the woman or baby. Both medications have been widely used in the UK for many years and are considered safe in pregnancy.
The study aims to find out which blood pressure medication is best at treating high blood pressure in pregnancy.
Study results will help to understand which medication best treats high blood pressure in pregnancy and is safe for the baby, helping doctors and women with high blood pressure decide which medication is best for each woman and their baby.
Category
Maternity
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