Clinical Trials Logo

Filter by:
NCT ID: NCT06045806 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

KarMMa-9
Start date: October 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

NCT ID: NCT06044454 Recruiting - Lung Cancer Clinical Trials

Radiograph Accelerated Detection and Identification of Cancer in the Lung

RADICAL
Start date: December 4, 2023
Phase:
Study type: Observational

Lung cancer is the most common cause of cancer death in the UK yet compared to Europe it has low survival rates.The NHS aims to find 75% of cancers at an early stage as this can improve the chances of survival. To support this target, Qure.ai have developed the UK-approved qXR product, which is a software program that automatically analyses chest x-rays using artificial intelligence to identify features associated with lung cancer, indicative of other diagnoses, or that contain no abnormal features ('normal'). qXR is a class IIb medical device that can be used by radiologists to prioritise reporting based upon the presence or absence of these features. This may improve the accuracy and efficiency of reporting these images. The project includes different elements including: i) Clinical effectiveness study across 3 sectors within NHS Greater Glasgow and Clyde (NHSGGC).The primary objective is to assess the clinical effectiveness of qXR to prioritise patients that have suspected lung cancer (identified from AI analysis of a chest x-ray) for follow-on CT. Secondary objectives include: i) To assess the potential utility of qXR within the optimised lung cancer pathway in terms of the impact on both patient treatment and radiological workflow. ii) To assess the safety of qXR at ruling out patients from entry onto the cancer pathway iii) A technical evaluation utilising retrospective and prospective cohorts. The technical retrospective study will determine the performance of qXR using a sample of 1000 CXR images from all chest x-ray referral sources across all sectors (this differs from the prospective study, which only examines outpatient referred chest x-rays). iii) A health economic evaluation. Use of per patient healthcare utilisation costs to model cost benefits of qXR, including implementation of supported reporting of normal CXR. iv) A qualitative evaluation to assess acceptability and barriers to scale-up and implementation

NCT ID: NCT06043986 Recruiting - Nurse's Role Clinical Trials

Would Artificial Intelligence Reduce Delays to Nurse Response Times

WAiRD
Start date: May 23, 2023
Phase:
Study type: Observational

Patients are admitted to wards at all times of day and night and in various states of ill health. As this research is non interventional and does not impact on patient safety, the guidance from the ethics committee was reviewed and agreed that it would be appropriate to enrol every admission into the 2 bed bays and gain consent within 24 hours of admission.All data collected within the trial using the smart tablets will be associated to a study number, no patient details will be stored on the smart tablet and therefore the cloud data store.It has been discussed with the trust information governance and this complies with their regulations. Any patient identifiable data will be kept by the research team. All data will be archived and stored as per the Sponsors policy. The novel nurse call system has been designed to be user friendly to all patients regardless of age, learning ability and first language used. By using colours, images and words in the hope that this will be accessible to all. The nursing staff on the ward advised on the main reasons for the nurse call system activation and therefore the icons used in the novel system were adapted from this. This trial was discussed in the patient and public involvement group. As this is a pilot trial, any adaptions that need to be made will be made before the large scale trial.

NCT ID: NCT06042907 Recruiting - Contracture Clinical Trials

Development, Validation, and Evaluation of a Risk Assessment Tool for Contractures: the ORACLE Study

Start date: September 11, 2023
Phase:
Study type: Observational

The Observational Risk Assessment for Contractures- Longitudinal Evaluation (ORACLE) is a risk assessment tool for contractures. The tool was originally designed and developed by a group of multidisciplinary health professionals within Dorset Healthcare University NHS Foundation Trust (DHUFT). Bournemouth University and DHUFT sponsored a match funded studentship to establish the academic validation of the tool. The results from the previously conducted studies (Phase One) as part of this project: (i) a systematic review of the literature and an (ii) online Delphi survey with field experts provided initial evidence for further development, content validity, and modification of the tool. The current study (Phase Two) aims to establish the psychometric validation, acceptability, and usability of the modified tool through formal testing on adult care home residents in Dorset. It consists of two streams of work: Stream A aims to establish the psychometric validation by completing the ORACLE assessments on adult care home residents. The assessments will be performed by the care home staff. In Stream B, a realist evaluation will be performed to explore the usability and practicality of ORACLE with selected care home managers and staff who were involved in organising and completing the assessments on ORACLE respectively. The results from this two-phase design will then inform further revisions of the tool if required.

NCT ID: NCT06042673 Recruiting - Clinical trials for Postmenopausal Women

Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers

Start date: July 6, 2023
Phase: N/A
Study type: Interventional

Dietary fat plays a crucial role as a modifiable risk factor influencing both non-fasting lipaemia and vascular reactivity. Notably, the intake of dietary saturated fatty acids (SFAs) has been associated with adverse effects on blood lipid profiles, whereas increased consumption of unsaturated fatty acids (UFAs) has shown potential to improve lipid health. Pomegranate seed oil (PSO) stands out due to its high content of conjugated α-linolenic acids (CLnAs). However, research comparing the impact of these fatty acids on postprandial vascular function, particularly in postmenopausal women, remains limited. A cross-over, single-blind, randomised acute postprandial study will be conducted in 15 healthy postmenopausal women. Participants will be assigned to consume the test meals either a placebo (50 g of mixed fat; 4:0.5:0.5 palm oil: rapeseed oil: safflower oil) or PSO (40 g of mixed fat and 10g of PSO) in random order on 2 separate occasions, with 4-6 weeks between each study visit. The anthropometric, blood pressure, and arterial stiffness, will be taken for each study visit. Blood samples will be collected for the measurement of fasting lipids, glucose, insulin, inflammatory markers, and whole blood culture. The findings from this study will contribute to the evidence base on how consuming meals rich in PSO influence the level of blood lipids as well as other biomarkers for cardiovascular disease.

NCT ID: NCT06042231 Recruiting - Atrial Fibrillation Clinical Trials

Impact of Cardiac Prehabilitation, REhabilitation and Patient EDucation on Outcomes in Patients Undergoing First-time AF Ablation

CREED AF
Start date: November 2, 2023
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is a term used to describe an irregular, and often very rapid, heartbeat. AF increases the risk of a number of diseases associated with the heart and cardiovascular system. Ablation is a procedure to treat AF. It uses small burns or freezes to cause some scarring on the inside of the heart to help break up the electrical signals that cause irregular heartbeats. This can help the heart maintain a normal rhythm. Currently patients who are referred for AF ablation do not receive any additional support as part of standard care to improve the outcomes of their ablation procedure. Whereas cardiac rehabilitation is a recognised part of comprehensive care for coronary heart disease patients (patients whose hearts struggle to receive blood), with exercise and education consistently identified as central elements to their rehabilitation. This treatment is not yet recommended for AF ablation patients. Therefore, the CREED AF Study is investigating whether a tailored comprehensive exercise and education intervention can improve outcomes in patients who are undergoing first time AF ablation. Central to the CREED AF study is the 'prehabilitation' intervention, whereby exercise and education training will be conducted before AND after AF ablation. 106 participants is the target recruitment, they will be randomised to either receive the CREED AF intervention (exercise and education intervention before AND after AF ablation) or a standard care (control) group. The standard care group will receive a one off 1-to-1 patient education session with a trained practitioner before their AF ablation procedure. This research study does not affect the AF ablation procedure that patients will have as part of their standard of care.

NCT ID: NCT06042023 Recruiting - Surgery Clinical Trials

Remote Patient Monitoring for Preoperative Risk Assessment

REMOTES
Start date: December 19, 2022
Phase: N/A
Study type: Interventional

Preoperative risk assessment (an evaluation of overall health before surgery) is important to determine the overall risk of mortality and complications for patients undergoing major abdominal surgery to allow the appropriate allocation of sparse hospital resources. The current gold standard for preoperative assessment is cardiopulmonary exercise testing (CPET). CPET is, however, not available in all centres that perform major surgery, it is a costly test, and therefore only high-risk patients are tested. Finding new ways of conducting preoperative assessment could improve overall surgical safety, patient experience and reduce cost. The preoperative use of remote vital signs monitoring can provide important information about the patients' fitness and overall health and may be used for preoperative assessment. This study will use a remote monitoring patch to monitor patients' vital signs before surgery. The aim is to evaluate the utility and patient acceptability of the remote monitoring system and the feasibility of a randomised controlled trial of this type of assessment. Additionally, the study will assess the correlation between the data captured by the remote monitoring system and the CPET results to evaluate the remote monitoring system's ability to predict risk of surgery. The study will take place in Leeds Teaching hospitals. Adult patients undergoing major abdominal surgery that require CPET before surgery are eligible. Participants will be monitored at home with the patch monitor for 3-5 days before surgery, in addition to their planned preoperative assessment. During remote monitoring, patients will be asked to complete questionnaires on their general health and experience using the patch paired with the mobile phone as part of the monitoring system. Clinical data from the electronic hospital records and general practitioner records available on the trust system will then be collected after surgery to assess complications and calculate risk scores.

NCT ID: NCT06040658 Recruiting - Surgery Clinical Trials

Frailty Assessment in Vascular Hot Clinic Setting - Feasibility and Prognostic Value

FAVOUR
Start date: March 15, 2023
Phase:
Study type: Observational

A single-centre prospective study of feasibility assessing the suitability of introducing routine frailty screening in a controlled, and reproducible, outpatient department setting for Vascular Surgery patients. This study will also perform head-to-head comparisons of the prognostic value of five frailty assessment tools, selected based on the previous demonstration of their popularity and familiarity within the speciality, their designs being based on different theories of frailty and that some are endorsed by local healthcare police. Inter-user variability (patient self assessment and clinician assessment will also be compared).

NCT ID: NCT06040528 Recruiting - Clinical trials for Myocardial Infarction

Early Discharge Pathway Registry

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Despite the year-on-year decrease, coronary artery disease (CAD) still remains one of the leading causes of mortality worldwide. With advances in technology and our understanding of cardiac disease, we can now treat CAD using minimally invasive interventional techniques. This has revolutionised treatment for and improved the lives of many patients with CAD. Although trials have assessed various therapeutic strategies in various populations, real-world evidence of intervention and medical treatment among patients with CAD is increasingly recognised as an important part of providing safety and efficacy data and improving the care we provide. Regional heart attack services have improved clinical outcomes following ST-segment elevation myocardial infarction (STEMI) by facilitating early reperfusion by primary percutaneous coronary intervention (PCI). Early discharge after primary PCI is welcomed by patients and increases the efficiency of health care. This data will add to that literature by assessing the characteristics and outcomes of patients with CAD, concentrating on those who are discharged via the early discharge pathway. It will also identify and characterise predictors of outcomes, and improve risk stratification and diagnostic evaluation.

NCT ID: NCT06040086 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

MIRANDA
Start date: September 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.