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NCT ID: NCT05572463 Withdrawn - Clinical trials for Metastatic Cutaneous Melanoma

A Platform Study of Novel Immunotherapy Products in Participants With Previously Treated Unresectable or Metastatic Cutaneous Melanoma

Start date: November 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a platform study evaluating the safety and efficacy of multiple novel investigational products (IPs) that target unresectable or metastatic cutaneous melanoma in participants who have failed standard treatment.

NCT ID: NCT05507385 Withdrawn - Depression Clinical Trials

Imagine a Brighter Future: An Intervention to Improve Positive Emotions in Young People

IMAGINE-P
Start date: September 2022
Phase: N/A
Study type: Interventional

Depression is a common mental health problem that often begins during adolescence. Onset during adolescence can be disruptive to schoolwork and social relationships and if left untreated can lead to recurrence during adulthood, as well as the development of other mental health problems. Current treatments for depression (for both adults and young people) largely focus on reducing low mood and do not effectively tackle the other hallmark symptom of depression, anhedonia, which is characterised as a loss of enjoyment/ pleasure for previously enjoyed activities. Anhedonia is associated with increased risk of suicidality, so should be an important treatment target. Whilst some adult treatments are beginning to address anhedonia, little research has focussed on young people. It cannot be assumed that adult treatments will work identically in young people, particularly s their brains are still maturing compared to adults. The aim of this study is to complete a randomised feasibility trial, to see if it is possible to run a brief talking therapy for anhedonia in adolescent depression, by targeting one promising cognitive factor known to contribute to low positive affect: positive future mental imagery

NCT ID: NCT05415592 Withdrawn - Clinical trials for Radial Head Fractures

A Study of Participants Undergoing Radial Head Replacement Using the DePuy Synthes Radial Head Replacement System for Partial Replacement of the Elbow Joint

Start date: March 31, 2023
Phase:
Study type: Observational

The purpose of this study is to establish survivorship defined by the cumulative incidence of revision over the first 6 months post-implantation.

NCT ID: NCT05393999 Withdrawn - Lymphoma Clinical Trials

SABRE: A Single-arm Prospective Study Measuring Safety and Tolerability of SARS-CoV-2 Neutralising Antibodies in High-risk Populations

SABRE
Start date: November 29, 2021
Phase: Phase 2
Study type: Interventional

The SABRE study is a single-arm prospective study measuring safety, tolerability and pharmacokinetics of two SARS-CoV-2 neutralising antibodies (BMS-986414 and BMS-986413) amongst high-risk special populations of vaccine non-responders. The aim is to test the hypothesis that for individuals who fail to mount a measurable immune response to a routinely offered SARS-CoV-2 prophylactic vaccine or for those who are not able to receive such a vaccine (for example those receiving a bone marrow transplant or starting chemotherapy treatment), the receipt of subcutaneous injection of two long-acting neutralising antibodies BMS-986414 and BMS-986413 will confer durable high titres and subsequent immunological protection against SARS-CoV-2 infection.120 eligible participants will be enrolled and followed up for 48 weeks after the one-time dosing visit. Primary inclusion criteria are patients age 18 years and older and either 1) have received two doses of a routine NHS standard of care SARS-Cov-2 vaccine and do not have detectable serum SARS-CoV-2 anti-spike antibodies in routine NHS assays more than two weeks post-vaccination, or do not have protective levels of antibody or 2) be ineligible to receive a SARS-CoV-2 prophylactic vaccine. This could be because they need to commence immediate systemic chemotherapy or receive bone marrow and therefore the requirement to initiate profound immune suppression. Primary objectives are to determine the safety, tolerability and detectable SARS-CoV-2 antibody by specific PPD assay in serum at 12 weeks after enrolment.

NCT ID: NCT05374265 Withdrawn - STEMI Clinical Trials

Cardiovascular Magnetic Resonance Guided Open Artery Trial for Revascularization of Late Presenting ST Elevation Myocardial Infarction

CRM-OAT
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Patients with STEMI are usually treated with primary PCI in contemporary practice. However, primary PCI is currently deemed unbeneficial or potentially harmful in patients presenting late after a STEMI. There is limited data to suggest that patients who may have viable myocardium despite presenting late with a STEMI may derive benefit from PCI, which may be denied in current practice. CMR imaging is the reference modality for assessment of left ventricular function and myocardial viability. This feasibility study will randomise late presenting STEMI patients with CMR documented viability to PCI plus optimal medical therapy (OMT) versus OMT alone. The investigator hypothesises that PCI in this cohort will improve left ventricular remodelling and function. Favourable results will lead to an adequately powered multi-centre trial with the potential to improve the management of late resenting STEMI patients and impact on clinical practice guidelines.

NCT ID: NCT05364775 Withdrawn - Nurse's Role Clinical Trials

The Experiences of International Nurses

Start date: August 2023
Phase:
Study type: Observational

The international mobility of the nursing workforce is increasing. One nurse out of every eight now works in a country where they were not born or trained. International nurses play a vital role in the NHS. This study focuses on the workplace experiences of international nurses who have trained outside of the EU. In recent years there have been increasing numbers of nurses from outside of the European Union (EU) registering to work in the UK, notwithstanding the number of nurses from European countries continues to decline as the UK prepares to leave the EU. There is currently a global shortage of nurses. Drivers for UK recruitment of international nurses are founded in shortages of nurses related to increased health care demand, emphasis on safe staffing levels, expenditure on agency nurses and too few commissions for nurse training places, meaning that not enough nurses are entering the NHS. These factors are further exacerbated by staff retention levels and high staff turnover. Nurses' motives to leave their home countries are complex, and gaps in our understandings remain. Possible drivers for migrating to the UK or "pull factors" may include career progression, postgraduate training opportunities, work environment, sensitive employment policies, and economic benefits which enable nurses to send money back to their home countries, while "push" factors have been identified as limited education, lack of health care resources, dangerous working conditions and political instability.

NCT ID: NCT05337930 Withdrawn - Clinical trials for Primary Headache Disorder

Feasibility of a Developmentally-tailored Mobile App for Tracking Mood and Pain in Children With Migraine

Start date: August 4, 2022
Phase: N/A
Study type: Interventional

This study aims to inform the continued development of a mobile app intended to support the treatment of CYP with migraine. After extensive public and patient involvement, Happyr Health has developed a mobile app that allows children and young people to track headache attacks and emotional wellbeing and to access coping techniques. With the use of gamification and storytelling elements, the app aims to engage children to be an active part in tracking and coping with their headaches. The outcomes of this study will inform future adaptations and development cycles of the Happyr Health app. 15 participants aged 10-16 will access the Happyr app for 8 weeks (= intervention). Primary outcomes of acceptability and implementation will be measured via surveys following the 8-week intervention in the app.

NCT ID: NCT05288413 Withdrawn - Clinical trials for Deep Vein Thrombosis

Benefit of Machine Learning to Diagnose Deep Vein Thrombosis Compared to Gold Standard Ultrasound

Start date: March 1, 2022
Phase:
Study type: Observational

The study coordinator aims to compare gold standard deep vein thrombosis (DVT) diagnostic performed by a specialist sonographer to a scan by a non-specialist with a newly developed an automated DVT (AutoDVT) detection software device. The title of the project is: Benefit of Machine learning to diagnose Deep Vein thrombosis compared to gold standard Ultrasound. Currently the process from the DVT symptom begin, to diagnosis and then treatment is all but not straightforward. It implements a laborious journey for the patient from their general practitioner (GP) to accident and emergency (A&E), then to a specialist sonographer. However, handheld Ultrasound devices have recently become available and they have been implemented with a machine learning software. The startup company ThinkSono developed a software which is hoped to divide between thrombosis and no thrombosis. In this single-blinded pilot study, patients which present at St Mary's DVT Clinic will be scanned by the specialist and then by a non-specialist with the machine learning supported device. The accuracy and sensitivity of this device will be compared to the gold standard. This would mean that DVT could be diagnosed at point of care by a non-specialist such as a community nurse or nursing home nurse, for example beneficial for multimorbid confused nursing home patients. This technology could reduce A&E crowding and free up specialist sonographer to focus on other clinical tasks. These improvements could significantly reduce the financial burden for the National Health System (NHS). The AutoDVT has a CE (as the logo CЄ, which means that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards) Certificate under the directive 93/42/ European Economic Community (EEC) for medical devices. It is classified in Class 1 - Active Medical Device - Ultrasound Imaging System Application Software (40873). Furthermore, following standards and technical specifications have been applied: British Standard (BS) European Norm (EN) International Organisation for Standardisation (ISO) 13485:2016, BS EN ISO 14971:2012, Data Coordination Board (DCB)0129:2018, ISO 15233-1:2016.

NCT ID: NCT05230888 Withdrawn - Lung Cancer Clinical Trials

Comprehensive Geriatric Assessment in Elderly Non-Small Cell Lung Cancer Patients

Start date: February 9, 2022
Phase:
Study type: Observational

Lung cancer is responsible for one of the highest incidences of cancer-related mortality globally, and non-small cell lung cancer (NSCLC) accounts for the biggest subtype of lung cancer. In recent years, the use of immunotherapy has revolutionised the management of NSCLC, with better response rates and survival outcomes reported in the literature, compared to traditional cytotoxic chemotherapy. Despite this, doubts remain regarding the true efficacy of immunotherapy in patients > 75 years old, given that this age subgroup is mis-represented in prospective phase III trials, in terms of numbers and baseline functional status, compared to real-world experience. Furthermore, the use of immune checkpoint inhibitors (ICIs) is associated with a spectrum of immune-related adverse events (irAEs), affecting a range of organ systems. Once again, there are doubts about the safety of the use of these agents in patients > 75 years old, and whether baseline performance status and comorbidities are good predictors of efficacy and safety outcomes in this elderly patient subgroup. Comprehensive Geriatric Assessment (CGA) and the vulnerable elders survey (VES-13) are assessment tools that provide a good indication of functional status in elderly patients, in a similar capacity to performance status and comorbidities. This study therefore aims to prospectively examine patients > 70 years old with a diagnosis of NSCLC, commencing immunotherapy. It will assess CGA and VES-13 scores at baseline, and correlate this with certain outcomes such as the incidence of severe adverse effects from immunotherapy at 3 and 6 months, any admissions to hospital arising from immunotherapy toxicities (and the subsequent length of inpatient stay), and mortality within 30 days. In doing so, it will help to determine if CGA and VES-13 scores can be used as a reliable indication of possible future efficacy and toxicity outcomes in this elderly patient subgroup.

NCT ID: NCT05212116 Withdrawn - Clinical trials for Depression in Remission

A Study of SDI-118 in Participants in Remission From Depression

Start date: September 16, 2021
Phase: Phase 1
Study type: Interventional

This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on male and female study participants reporting with cogntive decline and who in remission from depression.