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NCT ID: NCT06409585 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition

CHIEFTain
Start date: May 1, 2023
Phase:
Study type: Observational

Heart scarring, also known as fibrosis, plays a major role in a lot of heart muscle abnormalities. These abnormalities of the heart muscle can lead to major issues such as symptoms of heart failure, dangerous heart rhythm disturbances and even death. However, a lot of these conditions are still not fully understood and treatment options are limited. We here aim to use a new radioactive dye called 68Ga-FAPI to identify patterns and the activity of heart muscle scarring. This radioactive dye is being used in humans particularly in identifying and monitoring cancers and has shown promise in identifying scarring in the heart as well. This will help us not only understand the underlying disease process and risk stratify these patients but also potentially help us develop new targeted therapies that can affect heart muscle scarring. Participants will undergo a baseline MRI scan using this new dye and a plain MRI scan will repeated 12-18 months after to see if there are any changes in the process.

NCT ID: NCT06409221 Enrolling by invitation - Clinical trials for Triple Negative Breast Cancer

VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study

Start date: May 1, 2024
Phase:
Study type: Observational

Background: Despite improvements in the treatment of Triple Negative Breast Cancer (TNBC), the cancer returns in half of the women and shockingly 40% are dead within 5 years of their initial cancer diagnosis. There is an urgent need to identify reliable biomarkers of response for chemotherapy and immunotherapy. Study Aims: To update Concr's existing predictive algorithms specifically for use in women newly diagnosed with TNBC. The plan is develop technology which will predict which drug the cancer will respond best to, treatment A vs. treatment B AND how the individual's prognosis could change if treatment A is chosen overtreatment B. Study Design: The VISION study is a clinical study looking back in time (retrospective study), specifically focusing on women who were previously diagnosed with early Triple Negative breast cancer and received chemotherapy followed by curative breast surgery. The plan is to collect historical clinical data and previously collected cancer biopsy samples from up to 200 women in order to update Concr's existing treatment prediction algorithms. Hence there are no extra research biopsies needed in order to participate in the Study. Study Sites: UK and Australia Study Funding: This study is funded by the a Techbio company called Concr with support from Innovate UK (UK Government funding).

NCT ID: NCT06408558 Recruiting - Type1 Diabetes Clinical Trials

Safe Use of New Technologies in Diabetes in Flight

SUNDIF
Start date: January 28, 2023
Phase: N/A
Study type: Interventional

Atmospheric pressure can influence how the body handles blood glucose. At high elevations, atmospheric pressure decreases. Research shows that both the elevation and the length of stay at that elevation can influence the body's glucose response. The investigators would like to find out if the change in pressure in the cabin environment during a flight affects the body's handling of glucose. Commercial planes usually fly at 40000 feet (12192 m) but the cabin pressure is re-pressurized to 8000 feet (2438 m) with cabin pressure fixed at 560 mmHg. The normal atmospheric pressure at sea level is 760 mmHg. Since the investigators cannot perform the studies in an aeroplane, a hypobaric chamber will be used to set to this low pressure which will reproduce the cabin environment during a commercial flight. The chamber is located at the research and development company, QinetiQ, MOD Boscombe. The objective of this study is to compare the effect of atmospheric pressure on glucose metabolism during simulated flight conditions during fasting and in response to a mixed liquid meal. This will involve attending three visits; visit 1 (screening), visit 2 and visit 4 and two phone visits. The duration of the study is 15 days or 1 month depending on the participant's availability. Visit 1, informed consent and screening, will take place at CEDAR, Royal Surrey County Hospital, Guildford, followed by two visits of the meal test in random order at CEDAR or QintetiQ, Visit 2, will be a meal test performed at 760 mmHg OR at 560mmHg. Visit 4, will be a further meal test at 560 mmHg OR 760 mmHg. The order of the meal test visits at different ambient pressures will be randomised. The two phone visits will take place the day after the meal test days to enquire about the patient's health after the test.

NCT ID: NCT06408441 Recruiting - Sarcoma,Soft Tissue Clinical Trials

The Epithelioid Hemangioendothelioma Registry of the European Reference Network on Rare Adult Solid Cancers (EURACAN)

EHE
Start date: December 1, 2023
Phase:
Study type: Observational [Patient Registry]

Epithelioid hemangioendothelioma (EHE) is an ultra-rare sarcoma, marked by distinctive molecular and pathological features and with a variable clinical behavior. Its natural history is still partially understood, reliable prognostic and predictive factors are lacking and many questions are still open on the optimal management. In the context of EURACAN, a prospective registry specifically dedicated to EHE was developed and launched with the aim of providing, through high-quality prospective data collection, a better understanding of this disease. The study design is a registry-based cohort study including only new cases of patients with a pathological and molecularly confirmed diagnosis of EHE. The objectives are to improve the understanding of EHE natural history, validate and identify new prognostic and predictive factors, clarify the activity and efficacy of currently available treatment options, describe treatment pattern. It is an hospital-based registry established in centres with expertise in EHE including adult patients with a new pathological and molecularly confirmed diagnosis of EHE starting from the 1st December 2023. The characteristics of each patient in the facility who meets the above-mentioned inclusion criteria will be collected prospectively and longitudinally with follow-up at cancer progression and / or cancer relapse or patient death. The data analyses will include descriptive statistics and analytical analyses. Multivariable Cox's proportional hazards model and Hazard ratios (HR) for all-cause or cause-specific mortality will be used to determine independent predictors of overall survival, recurrence and progression. The registry has been joined by 21 sarcoma reference centers across EU and UK, covering 10 countries. Patients' recruitment started in December 2023. The estimated completion date is December 2033 upon agreement on the achievement of all the registry objectives. The already established collaboration and participation of EHE patient's associations involved in the project will help in promoting the registry and fostering accrual. This registry has been developed with the support of EHE Rare Cancer Charity UK, STATER (Grant Agreement number: 947604, HP-PJ-2019) and EURACAN 2022 (Grant Agreement number: 101085486, EU4H-2022-ERN-IBA) European Health and Digital Executive Agency (HaDEA)

NCT ID: NCT06408324 Completed - Clinical trials for Primary Immune Thrombocytopenia (ITP)

Evaluation of the Use of Thrombopoietin Receptor Agonists in Adults With Primary ITP in Europe

Start date: November 24, 2022
Phase:
Study type: Observational

The goal of this multicenter, observational, retrospective is to evaluate the standards of use of thrombopoietin receptor agonists (TPO-RA) in adult patients with primary immune thrombocytopenia (ITP), with a particular interest on phase of ITP (defined according to time when diagnosis of ITP is established in the medical records: newly diagnosed, 0-3 months; persistent, 3-12 months, and chronic, > 12 months), tolerability, safety, posology and remissions, outside controlled clinical trials. Secondary Objectives: To analyze the patient characteristics that could affect the choice of thrombopoietin receptor agonist for the treatment of ITP, considering specific clinical aspects (such as previous thromboembolic disease, bleeding, platelet count, surgical procedures, etc.). To evaluate the degree of adherence to international guidelines related to the use of thrombopoietin receptor agonists in regular clinical practice. Data will be collected through a retrospective chart review of patients with ITP who started TPO-RA treatment between January 2014 and December 2018.

NCT ID: NCT06407557 Completed - Activity Clinical Trials

Optimizing Older Adults' Home Space for Physical Activity

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

There will be a multi-channel approach to recruitment. Currently, ongoing projects within diverse communities lead in Swansea, Bridgend, and Neath Port Talbot will be approached, and this research will recruit alongside these projects. Regional coordinators and sub-coordinators will be contacted for recruitment, to best ensure participating older adults reflect the typical socio-demographics of Wales. This network will help the researchers to reach older adults who previously took part in different projects. Recruitment letter posters/leaflets will be used as an enrolment technique. Furthermore, the researchers will place advertisements across the University using the intranet and work alongside the City and County of Swansea, Neath Port Talbot, and Bridgend Borough Council to recruit using their sport, play, and community networks. The first stage of recruitment involves approaching diverse community organizations to formally request approval to recruit via their contacts. In-stage gatekeepers will be approached by the researcher to seek permission to contact potential participants via their organization. All interested participants will be asked to contact the researcher directly to further discuss the study and indicate their interest. All participants will provide written informed consent to participate in the study before the baseline assessment is conducted. Moreover, each older adult will receive a sleeping log (to record not wearing time), an accelerometer device, and instructions on how to attach and wear the device for 7 consecutive days. The primary researcher will be contacted if older adults have any queries or issues with the device. The participants will be subsequently randomized to an intervention group or comparison group on the basis of 1:1 allocation. All assessments including questionnaires and a 7-day accelerometer assessment will be repeated post-intervention. An Independent t-test will be run to assess the pre-post difference in the effectiveness of the trial in the intervention and comparison groups. The regression model will be applied to assess the impact of covariates with the dependent variables (MVPA, daily step count, self-efficacy, well-being, and sedentary behaviour). Qualitative data analysis of interview data will use reflexive thematic analysis to illustrate common themes regarding the acceptability of the feasibility trial.

NCT ID: NCT06406946 Recruiting - Anxiety Clinical Trials

Mushrooms, Mood and Mental Wellbeing in Gen Z Women

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The aim of the study is to investigate the effects of 28 days supplementation of Lions mane mushroom and mushroom blend of Lions mane and reishi mushroom, on wellbeing in stressed or anxious women. The study will follow a randomized, double-blind, placebo-controlled, parallel group design. Participants will receive either lion's mane mushroom mane (1.8 gram per day, consisting of 3 x 600mgcapsules), a blend of lion's mane mushroom and reishi mushroom 1.8 gram per day, consisting of 3x600mg capsules) or placebo (1.8-gram microcrystalline cellulose placebo powder, 3x600mg capsules). The trial will utilise Generalised Anxiety Disorder Assessment (GAD-7); the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS); Chalder Fatigue Scale; Rosenberg's Self-Esteem Scale; Perceived Stress Scale (PSS) and Stress Visual Analogue Scales (S-VAS) at baseline and after 28 days supplementation. Participants will complete the HADS and S-VAS at home on days 7, 14 and 21. On day 42 (14 days after treatment ending) participants will complete the GAD-7, HADS and S-VAS. 135 healthy women (who self-report being stressed and/or anxious) aged 18-26 (and born between 1997 and 2013) will be recruited using opportunity sampling. Participants will be supplied with either one of the active treatments or the placebo (allocated by a randomised schedule) whilst visiting the research centre for the testing appointments and will take treatment home to consume daily for the duration of the study. Participants will record time of taking treatment each day in a treatment diary which will be returned to the research centre, along with any unused treatment, upon completion of the study.

NCT ID: NCT06405230 Not yet recruiting - Clinical trials for Lung Cancer, Non-Small Cell

Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Patient-derived Organoids and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)

Start date: August 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to investigate the utility of two biomarker tools: Patient-derived organoid (PDOs) and PDL1 PET imaging for predicting how participants with recurrent NSCLC respond to standard of care treatment in the advanced/metastatic stages.

NCT ID: NCT06404229 Not yet recruiting - Clinical trials for Surgery-Complications

Use of CPETarm for Risk Stratification of Patients With CLTI

Start date: May 28, 2024
Phase: N/A
Study type: Interventional

This is a prospective cohort study of patients undergoing surgery for chronic limb threatening ischaemia. Prior to surgery, patients will undergo CardioPulmonary Exercise testing (CPET) using an arm ergometer. Feasibility outcome measures will be recorded at testing and participants will be followed up for a period of up to 5 years to obtain clinical outcome measures.

NCT ID: NCT06403475 Not yet recruiting - Aphasia Clinical Trials

Transcutaneous Vagus Nerve Stimulation for Language Recovery After Stroke

TRANSLATES
Start date: April 29, 2024
Phase: N/A
Study type: Interventional

Aphasia is an acquired language disorder. Stroke is the most common cause of aphasia, which affects 30% of stroke survivors. Speech and Language Therapy (SLT) can help people with aphasia but it may not be provided at the required intensity. Access to therapy is often limited after the first few months following stroke. People with aphasia can improve with therapy many years after stroke but these benefits have not been found to translate to day to day conversation. Transcutaneous Vagus Nerve Stimulation (tVNS) is a non-invasive technique which involves stimulating a branch of the vagus nerve through the skin of the ear, using a small earpiece. This technique is safe and has been approved for use in headache. There is promising evidence that tVNS can improve motor rehabilitation in chronic stroke. This technique may be helpful in aiding language recovery in individuals with chronic aphasia. The current pilot study will primarily assess the feasibility, safety and tolerability of self-directed tVNS paired with computer-based SLT, in individuals with chronic stroke-related aphasia. Secondly, the study aims to explore the effect of the intervention on word-finding ability and to explore potential mechanisms of action. Participants will be randomly allocated to an active or sham tVNS group. Participants will be asked to use the stimulation device at home for 6 weeks, whilst completing computer-based SLT. To date, there are no published studies exploring the use of tVNS in aphasia. An indication of study feasibility may support the development of a larger RCT to explore treatment efficacy.