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NCT ID: NCT04873258 Recruiting - Healthy Clinical Trials

Development of a Non-invasive Screening Tool to Predict NAFLD

Start date: September 27, 2019
Phase:
Study type: Observational

A generic screening study to establish structural and/or functional baselines of specific organs.

NCT ID: NCT04872309 Recruiting - Asthma Clinical Trials

MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology

MURDOCH
Start date: September 4, 2019
Phase:
Study type: Observational

Lung magnetic resonance imaging (MRI) with proton and inhaled inert gases has demonstrated a clinical ability to provide valuable structural and functional information in lung disease. Advances in lung MRI methods have led to the STH department handling clinical imaging referrals from local and national respiratory units. Hyperpolarised Xenon-129 gas MRI is now the gold-standard MRI modality used in clinical practice for asthma and COPD in Sheffield. In this new study, the investigators will use Xenon gas MR imaging and 19F gas MR imaging to obtain physiological, structural, and functional information about patients with known respiratory disease, namely asthma and COPD. Up to 20 patients with asthma and up to 20 patients with COPD will be recruited. Study visits will involve lung function tests and imaging using proton MRI, hyperpolarised xenon gas MRI, and 19F perfluoropropane MRI. After initial baseline assessments, patients will be followed up after 3 and 6 years to investigate the utility of MRI and lung function measurements in tracking disease progression over time. In addition, during the COVID-19 pandemic will also be studying the long term effects of this novel disease. The investigators will use Xenon gas MR imaging and pulmonary vascular 1H MR imaging to obtain physiological, structural, and functional information about patients with COVID-19, including hospitalised patients and mild, non-hospitalised COVID-19 patients. Participants may be invited for baseline assessments during the symptomatic phase of the disease and/or be followed up after 6, 12, 24 and 52 weeks (in line with clinical follow up for hospitalised patients) to investigate long term effects of this novel disease. This novel approach will provide mechanistic insight in to clinical observations such as : (i) why previously healthy patients can respond so poorly to oxygen/ventilation therapy, (ii) why patients respond to proning, and (iii) whether this is caused by alveolar-capillary interstitial changes and /or microvascular clotting in the pulmonary vasculature (leading to V/Q mismatch), and (iv) whether these acute changes lead to long term interstitial lung disease.

NCT ID: NCT04870450 Recruiting - Coronavirus Clinical Trials

When Distance is an Act of Love: Exploring the Use of Video Diaries for Family Members of Intensive Care Patients

Start date: January 26, 2021
Phase:
Study type: Observational

Due to Covid-19, intensive care (ICU) patients are not allowed visitors or have severely restricted visiting. After being admitted to ICU most patients are unconscious or extremely weak and therefore cannot speak on a phone or video call to a family member. Before these visiting restrictions, family members of patients admitted to ICU as a result of being critically ill were already known to suffer significant psychological distress and may now face increased distress given they are unable to visit a loved one. Previous research demonstrates that keeping a paper diary has been found to be helpful for ICU patients and families. When lockdown measures were announced, NHS Scotland introduced video diaries as an emergency measure to try to support communication with families and reduce distress. vCreate is an NHS Trusted secure video messaging service that helps patients, families and clinical teams stay connected throughout their care journey. The use of video diaries may have a positive impact for family members but there is a risk that they could also have negative effects for some people. There is a need to explore both ICU healthcare professionals and family members' experiences of using video diaries. At the same time it is also important to test the feasibility and acceptability of measures of distress and psychological well-being on family members during and after their experience of video diaries. In doing so, some initial recommendations about video diaries can be made and a larger subsequent study planned to test their effect on family members and healthcare professionals.

NCT ID: NCT04870333 Recruiting - Covid19 Clinical Trials

PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V

PROTECT-V
Start date: February 19, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

COVID-19 (SARS-CoV2 virus) was declared a global pandemic by the WHO on 11th March 2020. Currently there are no drugs proven to prevent COVID-19 or to reduce the severity of illness if given as prophylaxis. Although vaccines are now available, there remains a need for other prophylactic agents until vaccine use becomes widespread globally and effectiveness and durability is established, particularly in immunocompromised individuals, for whom vaccine responses may be suboptimal. Efforts are underway to repurpose established drugs with well understood drug interactions and safety profiles. PROTECT-V is a platform trial to test prophylactic interventions against SARS-CoV2 infection in vulnerable patient populations at particularly high risk of COVID-19 and its complications, seeking to identify treatments that either might prevent the disease from occurring or may reduce the number of cases where the disease becomes serious or life-threatening. In PROTECT-V, multiple agents can be evaluated on the same platform across vulnerable populations, with the option of adding additional treatments at later time points as these become available. The expectation is for as many sites as possible to recruit to all available trial treatments at any time, however, the platform structure and randomisation/data collection systems allow sites to open the trial treatment arms according to their capacity. The trial opened with intranasal niclosamide and matched placebo, aiming to recruit 1500 vulnerable renal patients in February 2021. A parallel study protocol, was conducted in India, sponsored by The George Institute. Recruitment of around 750 Indian patients was completed in with the rest of the study arm recruitment in November 2022. The Niclosamide arm of the study was completed in June 2023. The second agent, intranasal and inhaled ciclesonide and matched placebo, was meant to be added to the platform in mid-2022 in the same renal patient population however it was unable to be included due to other factor. Sotrovimab and matched placebo have been added to the platform in August 2022 which aim to recruit approximately 800-1000 patients from the main study population with additional patient groups with primary immunodeficiency, any Haematology or Oncology patient who is currently receiving or has received chemotherapy or who is immunocompromised as a result of their disease or treatment, those with a diagnosis of an autoimmune or inflammatory disease receiving immunosuppression and also haematopoietic stem cell transplant recipients.

NCT ID: NCT04870047 Recruiting - Clinical trials for Intracranial Aneurysm

Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

COATING
Start date: September 3, 2021
Phase: N/A
Study type: Interventional

To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.

NCT ID: NCT04868851 Recruiting - Diabetes Clinical Trials

mHealth Biometrics for Young People With Diabetes

MOTIVATE-HfH
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The investigators aim to undertake a feasibility randomised controlled trial (RCT) to investigate whether mHealth technology, allowing biometric informed feedback and coaching on exercise and PA, can be effective in children with diabetes. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future RCT.

NCT ID: NCT04868188 Recruiting - Covid19 Clinical Trials

Pharmacokinetics of Voriconazole in Adult ECMO Patients

Start date: August 24, 2021
Phase:
Study type: Observational

Given the high burden of fungal co-infection in patients admitted to ICU and improved outcomes with prompt anti-fungal treatment, it is of vital importance that the doses of anti-fungal are optimum to improve the dismal outcome of influenza/Covid-19 Associated Pulmonary Aspergillosis. Due to the reported difficulties in dosing appropriately in ECMO patients, a prospective observational study is required to accurately evaluate the pharmacokinetics of voriconazole in patients supported on ECMO. This is to ensure that the dose of voriconazole is optimised to improve efficacy and reduce toxicity.

NCT ID: NCT04867837 Recruiting - Clinical trials for Acute Major Bleeding

Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor

Start date: September 1, 2021
Phase: Phase 3
Study type: Interventional

This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor. Patients will be randomised 1:1 to either of two study groups: low-dose vs. high-dose OCTAPLEX.

NCT ID: NCT04867408 Recruiting - Clinical trials for Inflammatory Bowel Disease 1

Endoscopic Severity Image Recognition to Advance Research and Training in Inflammatory Bowel Disease (EVEREST - IBD)

Start date: September 17, 2021
Phase:
Study type: Observational

To develop and train a convolutional neural network to detect and characterize disease severity of inflammatory bowel disease during endoscopy

NCT ID: NCT04866563 Recruiting - Chronic Cough Clinical Trials

A Study of Efficacy and Safety of AX-8 in Chronic Cough

Start date: August 11, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, crossover, multicenter study of AX-8 in participants with unexplained or refractory chronic cough designed to evaluate the effectiveness of AX-8 in reducing cough frequency.