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NCT ID: NCT06032221 Recruiting - Clinical trials for Foot Ulcer, Diabetic

Study to Determine the Feasibility of Using an At-home Foot Temperature Monitoring Device (Thermidas)

Start date: July 14, 2023
Phase: N/A
Study type: Interventional

This is a feasibility study, designed to assess the acceptability of At Home Temperature Monitoring (AITM) by patients at high risk of diabetes foot ulceration. The investigation hopes to identify any problems with the study design before progressing to a full-scale evaluation, and will assess the ease of use of the technology and if there are any barriers to using this. Participants will be provided with an infrared camera and SMART phone and trained in how to use them. The participants will then be expected to capture images of both the plantar and dorsal aspects of their feet that will be sent to the research team for review. The two images will be captured once per day. The Intervention period will be 12 weeks. If a raised temperature is identified, the participant will be offered a face to face review appointment where they will receive podiatry treatment (if required), ulcer prevention advice and more detailed thermal imaging. Patient and health care professional (HCP) questionnaires will be used at the start and end of the study period to assess quality of life impact and device ease of use.

NCT ID: NCT06031415 Recruiting - Clinical trials for Rheumatoid Arthritis

Study of GS-0272 in Participants With Rheumatoid Arthritis

MARASLE
Start date: September 28, 2023
Phase: Phase 1
Study type: Interventional

The goals of this clinical study are to learn more about the study drug, GS-0272, and its safety and tolerability following multiple doses in participants with rheumatoid arthritis (RA). The primary objectives of this study are to assess the safety and tolerability of multiple ascending doses of GS-0272 and to characterize the pharmacokinetics of GS-0272 following multiple doses of GS-0272, in participants with RA.

NCT ID: NCT06030518 Recruiting - Abdominal Pain Clinical Trials

Robot-controlled Magnet-Assisted Capsule Endoscopy

MACE
Start date: March 9, 2022
Phase: N/A
Study type: Interventional

Examination of the upper gastrointestinal tract (oesophagus, stomach and duodenum) involves passing a flexible tubular endoscope through the mouth into the stomach. It is commonly performed to identify the cause of abdominal pain, indigestion, diarrhoea and anaemia. As it is an invasive and uncomfortable test, it is usually performed under general anaesthetic in children. However, children and their parents worry about the nature of the procedure which does incur a small risk of both the anaesthetic and the endoscopy. A capsule endoscope is a large pill-sized device containing a battery powered camera which can be swallowed. It was first devised to examine the small bowel (which begins with the duodenum and ends in the colon or large bowel) which is difficult to reach with conventional endoscopes and has been used in children aged over eight years since at least 2005. It is extremely well tolerated. However, it does not provide a comprehensive view of the whole surface area of the stomach which has a convoluted shape, large volume and is collapsed in the fasted state. Recent research in adults shows that a capsule can be steered around a water-filled stomach using two joysticks to control the polarity and distance of an external robot magnet from the patient. This is much better tolerated and appears to be almost as good a diagnostic tool as conventional endoscopy. It has yet to be studied in children. We intend to compare patient acceptability of capsule endoscopy and gastroscopy and see if it is cost effective.

NCT ID: NCT06030349 Recruiting - Quality of Life Clinical Trials

Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome

REFRESHED
Start date: November 28, 2022
Phase:
Study type: Observational

The goal of this observational study is to learn about the use of non-invasive ventilation for treatment of obstructive sleep apnoea syndrome in children with Down Syndrome. The main questions it aims to answer are: - What is the impact of non-invasive ventilation on sleep behaviours and quality of life? - What barriers are faced by children and their families in establishing tolerance to non-invasive ventilation? Participants will be asked to complete questionnaires before and after starting treatment. Researchers will compare this data with the results of sleep studies and non-invasive ventilator downloads recorded as part of standard medical care. A sub-group of up to 20 participants will be invited to take part in 45-60 minute interviews exploring expectations, experiences and barriers encountered during non-invasive ventilation therapy.

NCT ID: NCT06030323 Recruiting - Stroke Clinical Trials

Validation of AI Models to Measure Physical Activity After a Stroke

CaRRAT
Start date: June 24, 2023
Phase:
Study type: Observational

The research team are developing algorithms using artificial intelligence that use information collected by accelerometers to detect a person's position, such as whether an individual is lying, sitting, or standing, and the individual's movements, such as whether they are taking steps or standing up. Sensor location will affect the accuracy of the model and acceptability of the method. The research team are therefore developing algorithms for four different locations. The purpose of the research is for the development of the algorithms and check whether they accurately recognise different positions and movements in people whose movement is affected by a stroke, and by being in a hospital environment (e.g. using a profiling bed). The research team plan to recruit between 34 and 50 participants who are admitted hospital due to having a stroke. After providing informed consent, participants will be asked to complete a one-off assessment with a member of the research team and a ward physiotherapist. Participants will be asked to wear the four sensors, and move through a series of postures, walk for up to six minutes, and stand as many times as they feel able in one minute.

NCT ID: NCT06029972 Recruiting - Ulcerative Colitis Clinical Trials

Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

PALEKONA
Start date: December 5, 2023
Phase: Phase 2
Study type: Interventional

The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo. The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.

NCT ID: NCT06028919 Recruiting - Clinical trials for Ventricular Tachycardia

Power Versus Temperature Controlled Ablation for Treatment of VT

DTinVT
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Ventricular Tachycardia (VT) is a life threatening heart rhythm that comes from the bottom chambers of the heart (the ventricles) and is a leading cause of sudden cardiac death. The majority of patients that are at risk of VT or suffer a cardiac arrest will have an Internal Cardiac Defibrillator (ICD) in situ to treat the abnormal heart rhythm. The ICD can deliver a painful shock to restore normal heart rhythm but importantly does not treat the underlying cause. Current treatment for the prevention of recurrent VT include catheter ablation (CA) or medication. Long-term results with global 12 month VT-free survival rates with CA are around 50%. The trial is to compare 2 different types of ablation catheter that are used to cauterise small areas of unhealthy tissue within the heart that are responsible for VT: Diamond Temp (DT) and Tacticath/Tactiflex (TF). Our hypothesis is that the DT ablation catheter will provide comparable efficacy and safety for the treatment of VT as the current industry gold standard (TF).

NCT ID: NCT06028802 Recruiting - Clinical trials for Ischemic Stroke, Acute

CT Clock Tool Feasibility Study

Start date: October 26, 2023
Phase:
Study type: Observational

Interruption of blood supply to the brain from a blocked blood vessel causes ischaemic stroke. This leads to symptoms relating to the areas of brain affected. For example, people with stroke may suddenly have trouble moving their arms, legs or face, and may find it hard to speak or lose consciousness. There are treatments available to open up the blocked blood vessel: - Thrombolysis involves injecting a medicine to break down the blood clot causing the blockage. - Thrombectomy means pulling the blood clot out through a tiny tube placed within the blood vessel. Both treatments can help restore blood supply to the brain and reverse the symptoms caused by stroke. These treatments are usually only offered when there is a clear onset time for stroke symptoms. However, for around 20% of strokes, the time of onset is unknown. Patients may wake up with symptoms, be confused or be found collapsed. So that treatment can be available to more people, the investigators have developed a method to estimate when an ischaemic stroke began, the CT Clock Tool. This method involves taking measurements from the brain imaging that most patients with stroke routinely get on arrival at hospital (CT or CAT scanning). In other words, no extra tests are needed to use the method; the investigators seek to make better use of existing tests. In this study, the aim is to understand whether it is feasible to use the CT Clock Tool method in the real world. For example, can doctors correctly use the tool during their normal work to produce accurate estimates for the onset time of stroke? The results of this study will be used to plan a future clinical trial for testing the safety of the CT Clock Tool when it is used to treat patients.

NCT ID: NCT06027866 Recruiting - Communication Clinical Trials

A Speech Recognition Application as a Communication Aid for Acute and Critical Care Patients With Tracheostomies

SRAVI
Start date: January 26, 2023
Phase:
Study type: Observational

Patients in acute and critical care often undergo a tracheostomy. A tracheostomy is an incision at the front of the neck to insert a breathing tube directly into the airway. The tube sits in place in the airway using an inflated air-filled cuff. This means that no airflow is directed up and out past the vocal cords through the voice box, and speech is not possible. Being unable to speak can cause distress to patients and may place them at an increased risk of harm if they are unable to express their wishes or needs. It can also increase stress for relatives and healthcare staff as they try to understand what patients are trying to say. Usually when patients cannot talk, staff use different items to help, like a pen and paper. A new communication device that runs on a smartphone or tablet has recently been developed. It is for patients with tracheostomies and works by reading lip movements and translating them into words on the device screen. The aim of this study is to find out if providing adult acute and critical care patients who have a tracheostomy with the use of this lip-reading device could improve how they communicate. This study will include: 1. Using the lip-reading device in acute and critical care to test if it helps patients with tracheostomies to communicate better. 2. Interviews with patients, relatives and focus groups/interviews with staff to find out their views on communication including the use of the new lipreading device. 3. Follow-up with patients approximately 3-months after acute/critical care discharge to complete some further questions about their physical and mental health. The study will take place in three critical care units and one acute care unit in Northern Ireland and is expected to last 18 months. The study has been funded by the Public Health Agency Research and Development Division.

NCT ID: NCT06027684 Recruiting - Critical Illness Clinical Trials

Intensive Care Decision-making, Survival and Dying Well

Start date: October 2, 2023
Phase:
Study type: Observational

The goal of this study is to investigate how the experiences of intensive care patients and their end-of-life wishes affect their willingness to accept intensive care treatment at different chances of survival. The main questions it aims to answer are: - What can ICU survivors' experiences of ICU treatment tell us about what it would be like to die whilst receiving ICU treatment? - How do ICU survivors' reflections about what it might be like to die on ICU relate to their own preferences for their end-of-life care? - What chance of survival would make ICU survivors willing to go through ICU treatment again, in light of the fact that the alternative chance is dying whilst experiencing ICU treatment? - How does the possibility of reduction in health-related quality of life and functional decline as a result of critical illness impact ICU survivors' willingness to accept ICU treatment again? Participating in this study will involve filling out a questionnaire and then taking part in an interview. Participants will be recruited through ICU review clinics and ICU steps groups. The study will last for two years and will be conducted at locations convenient to the participants or via zoom.