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NCT ID: NCT05356923 Completed - Clinical trials for Myocardial Infarction

PROFILE-MI - The FAPI Fibrosis Study

Start date: April 21, 2021
Phase:
Study type: Observational

The investigators here propose to investigate the timing and pattern of myocardial fibrosis activity following acute myocardial infarction using hybrid 68Ga-FAPI positron emission tomography and cardiovascular magnetic resonance. The investigators hypothesise that peak fibrosis activity will occur within 2-4 weeks of acute myocardial infarction and will predict subsequent scar formation and cardiac remodelling. Simultaneously, matrix remodelling and fibrosis activity in aortic and coronary atheroma will be assessed enabling the exploration of the presence of unstable atheroma.

NCT ID: NCT05356546 Completed - Cardiac Disease Clinical Trials

TYRX™ Pocket Health Study

Start date: May 31, 2022
Phase:
Study type: Observational

Medtronic, Inc. is sponsoring the TYRX™ Pocket Health Study to evaluate the histological and morphometric parameters of the device capsule in participants who underwent a cardiovascular implantable electronic device (CIED) procedure with a TYRX™ Absorbable Antibacterial Envelope and are returning for a CIED replacement procedure.

NCT ID: NCT05355116 Completed - Clinical trials for Temperature Change, Body

Different Cryocompression Devices and Skin Temperature of the Knee

Start date: April 20, 2022
Phase: N/A
Study type: Interventional

Cryotherapy after surgery is widely utilised and has numerous practical applications for post-operative rehabilitation. Previous research has suggested that during cold therapy, the skin temperature of the knee should be reduced to 10-15°C to maximise the therapeutic benefits of cooling while avoiding the risk of cold injuries such as nerve damage and frostbite (Wilke and Weiner, 2003; Bleakley, McDonough and MacAuley, 2004). However, a recent study noted that where cryocompression devices have previously been used to reduce the skin temperature <10°C, no complications relating to the device have been reported, suggesting that the risk to the user at these lower temperatures is minimal (Bellon et al., 2019). The temperature range at which a cryocompression device should be set in order to achieve a skin temperature within the therapeutic range of 10-15°C is unknown. Furthermore, there is evidence to suggest that the temperature setting of the device does not equal that to which the skin is reduced (Selfe et al., 2009). Therefore, it is not sufficient to assume that the temperature setting of a cryocompression device accurately reflects skin temperature. Modern cryotherapy devices often consist of some sort of cuff that can be wrapped around the knee, with a connecting tube to a central unit that supplies and circulates ice-water to and from the cuff in order to cool the intended body part. Such devices offer differing levels of control over the temperature of the ice-water as it leaves the central unit, but nothing is known about how this correlates to the skin temperatures that are achieved during a cryotherapy treatment. The aim of this study is to determine the ability of five different cryocompression.devices to effectively lower the skin temperature of the treatment area to within the therapeutic range.

NCT ID: NCT05352789 Completed - Clinical trials for Stem Cell Transplant Complications

Nutrition and Metabolic Prehabilitation in HSCT Patients UK and ROI. BSBMT Multi-centre Survey.

Start date: August 1, 2020
Phase:
Study type: Observational

To explore current practices of nutrition and metabolic screening, assessment and management prior to Haematopoietic Stem Cell Transplant (HSCT) in UK and ROI transplant centres. Nutrition and metabolic parameters assessed in the survey include glycaemic control, lipid function, liver function, nutritional screening, nutritional assessment, nutrition intervention (tube feeding, diet, micronutrient) and exercise. This work will be used to inform the design of a UK dual centre feasibility study of personalised nutrition and metabolic care for HSCT patients prior to transplantation.

NCT ID: NCT05350982 Completed - Clinical trials for Adrenal Insufficiency

Neonatal, Infant and Toddler Salivary Study (NITS Study)

NITS
Start date: June 7, 2021
Phase:
Study type: Observational

Currently, the only way to analyse glucocorticoids for the screening or diagnosis of AI in young children is via plasma obtained by invasive capillary or venous blood sampling. Thus, there is an unmet need for a safe and simple salivary collection technique for use in children under the age of six years. The development of the SalivaBio offers potential for salivary collection, which is safe, easy and less-invasive than current practice. The SaliPac has been developed to offer a more tolerable and pleasant way of sampling saliva using a SalivaBio in very young children which the investigators envisage being used by parents/carers at home to sample and then post to the hospital for GC analysis.

NCT ID: NCT05349838 Completed - HIV-1-infection Clinical Trials

An Open-Label, Multi-Centre, Randomised, Switch Study to Evaluate the Virological Efficacy Over 96 Weeks Of 2-Drug Therapy With DTG/RPV FDC in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With NNRTIs Resistance Mutation K103N

WISARD
Start date: November 5, 2018
Phase: Phase 3
Study type: Interventional

HIV-1 infected subjects that experience virological failure while on non nucleoside reverse-transcriptase inhibitors (NNRTIs), including those with the K103N mutation, are usually switched to a boosted PI-based regimen or other antiretroviral (ARV) combinations. The same is true for subjects who need to start antiretroviral therapy and have acquired virus that is already resistant to antiretrovirals. These "second line" combinations are often associated with numerous issues that can have a potential impact on the quality of life (QoL) of these patients. Therefore a simpler and better tolerated alternative second line treatment option would be a useful tool for the clinical management of these patients. The aim of this study is to assess the efficacy and tolerability of a dual combined therapy of Dolutegravir (DTG) 50 mg OD + Rilpivirine (RPV) 25 mg OD in virologically suppressed participants with previous virological failure with NNRTIs and having the clinically significant mutation K103N. The secondary objective of the study is to assess whether a simplification of the treatment in terms of pill burden, long term metabolic toxicity and potential for drug interactions improves the QOL of the participants. The study will also evaluate DTG & RPV concentrations in the blood plus changes in cell associated virus. In order to compare the first line treatment (boosted PI and/or other antiretroviral combinations) and the DTG+RPV combination, two thirds of study participants will be switched to DTG+RPV immediately and receive DTG+RPV for 96 weeks. The other third will be switched after 48 weeks of continuing on their first line treatment and receive DTG+RPV for 48 weeks. All participants will then be followed up for a further 30 days. Participants will be recruited from sites across Europe, and randomised onto either arm of the study. After randomisation, participants will attend approximately 10 visits over the course of two years.

NCT ID: NCT05348226 Completed - Clinical trials for Heart Failure With Reduced Ejection Fraction

The ENVI Study: Effect of Entresto on Left Ventricular Remodelling on Cardiac MRI

ENVI
Start date: June 9, 2021
Phase:
Study type: Observational

A prospective, single centre, observational cohort study at University Hospital Southampton NHS Foundation Trust of 50 consecutive patients with Heart Failure with reduced Ejection Fraction and Ejection Fraction ≤35% who are eligible for sacubitril/valsartan (Entresto) initiation as per European Society of Cardiology guidelines. Participants will have baseline and repeat cardiac magnetic resonance imaging (CMR) scans after 4-6 months of Entresto therapy. The CMR scans will be compared. Clinical outcomes at 6 months including combined outcome of death and/or heart failure hospitalisation, KCCQ-12 questionnaire, 6-minute walk test, routine blood tests and NTproBNP will also be described. This study will be the first to examine the effects of sacubitril/valsartan (Entresto) therapy on left ventricular reverse remodelling in patients with symptomatic HFrEF as demonstrated by Cardiac Magnetic Resonance Imaging.

NCT ID: NCT05347849 Completed - Clinical trials for Pharmacokinetics in Healthy Adults

Single Ascending Dose Study With BPL-003 in Healthy Subjects

Start date: February 14, 2022
Phase: Phase 1
Study type: Interventional

The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects

NCT ID: NCT05347394 Completed - Acute Pain Clinical Trials

A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy Participants

Start date: April 8, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of VX-708 in healthy participants.

NCT ID: NCT05346458 Completed - Clinical trials for Coronary Artery Disease

Measuring Blood Flow in Heart Vessels With a New Fibre Optic Sensor

Start date: December 14, 2022
Phase: N/A
Study type: Interventional

The purpose of this investigation is to see if the newly developed "iKOs™ microcatheter" can safely and accurately measure flow and pressure within the heart arteries of 10 patients undergoing angiogram and pressure wire tests.