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NCT ID: NCT05706740 Recruiting - Terminal Cancer Clinical Trials

Towards Cancer Patient Empowerment for Optimal Use of Antithrombotic Therapy at the End of Life

SERENITY
Start date: February 28, 2023
Phase:
Study type: Observational

Despite the fact that antithrombotic therapy (ATT) has little or even negative effects on the well-being of cancer patients during their last year of life, stopping ATT is rare in clinical practice. In contrast, antithrombotic therapy is often continued until death, resulting in excess bleeding, higher healthcare costs, and increased disease burden. SERENITY aims to develop an information-driven, palliative care shared decision-making process enabled by a user-friendly, easily accessible, web-based shared-decision support tool (SDST) that will facilitate treatment decisions regarding appropriate use of antithrombotic therapy in cancer patients at the end of life. SERENITY will use a comprehensive approach consisting of a combination of realist review, flash mob research, qualitative interviews, epidemiologic studies, and a randomized controlled trial. The sub-project described here uses the flashmob research approach to address healthcare professionals from various institutions, who deal with end-of-life care in cancer patients, or prescribe antithrombotic medication to cancer patients.The survey will be conducted with approx. 800 physicians from eight European countries, all represented in the SERENITY consortium.

NCT ID: NCT05706298 Recruiting - Type 1 Diabetes Clinical Trials

Active Breaks in People With Type 1 Diabetes

EXTOD-Active
Start date: December 7, 2022
Phase: N/A
Study type: Interventional

the investigators aim to determine the effect of 4 weeks of frequent active breaks from prolonged sitting on time in target glycaemic range in people with type 1 diabetes with high habitual sedentary behaviour.

NCT ID: NCT05705973 Recruiting - Clinical trials for Cardiovascular Disease

Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients

NAGOMI COMPLEX
Start date: April 25, 2023
Phase:
Study type: Observational [Patient Registry]

The NAGOMI COMPLEX PMCF (Post-Market Clinical Follow-up) study has been designed to expand the knowledge about outcomes with the Ultimaster Nagomi™ sirolimus eluting coronary stent system (Ultimaster Nagomi™) in complex PCI subjects. The features for a complex PCI are based upon subgroup analysis of earlier published studies.

NCT ID: NCT05705869 Recruiting - Heart Failure Clinical Trials

Targeted Assessment in High-Risk paTients With dIAbetes to ideNtify Undiagnosed Heart Failure

TARTAN-HF
Start date: December 22, 2022
Phase: N/A
Study type: Interventional

This is a prospective, multicentre, unblinded, randomised, controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients with diabetes.

NCT ID: NCT05705349 Recruiting - HIV-1 Infection Clinical Trials

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

Start date: March 8, 2023
Phase: Phase 3
Study type: Interventional

This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

NCT ID: NCT05705310 Recruiting - Coronary Disease Clinical Trials

Self-management and Theory-based Rehabilitation Encouraging New Gateways to Healthy-Hearts

STRENGTH
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The goal of this intervention is translate current behaviour change in to community cardiac rehabilitation programmes for people living beyond a heart attack. The main question it aims to answer is whether adding a lifestyle change programme promoted maintenance of physical activity changes will be maintained following a cardiac rehabilitation programme. The problem Guidelines recommend that coronary heart disease patients should be offered cardiac rehabilitation which includes exercise programmes, education, and ongoing support within both clinical and community settings. Cardiac rehabilitation programmes reduce the risk of death and illness, but it is likely that patients will stop exercising without enough support. New was to encourage coronary heart disease patients to stay active both during and after taking part in cardiac rehabilitation programmes are needed. The project Behaviour change techniques can encourage patients to stay active for longer. The aim of this project is to see whether behaviour change can encourage coronary heart disease patients taking part in community-based cardiac rehabilitation programmes to stay active for longer compared with patients receiving the standard cardiac rehabilitation programme. The benefits It is hoped that these methods will encourage more cardiac rehabilitation patients to stay physically active for longer and improve health. The results will provide more evidence on using behavioural change techniques in cardiac rehabilitation programmes and have the potential to benefit many patients with coronary heart disease throughout Northern Ireland and the rest of the United Kingdom.

NCT ID: NCT05705284 Recruiting - Aging Clinical Trials

MODIFY or Medication Review in Primary Care Study

MODIFY
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

A third of older people take five or more regular medications (polypharmacy) potentially increasing the risk of side-effects, hospital admission and death, with higher risk among people living with frailty. National recommendations suggest that medications taken by frail older people should be reviewed annually by GPs to identify and reduce/ stop inappropriate medications (deprescribing). Yet this does not happen routinely due to GPs' lack of time, increased workloads and worries about stopping medicines. Recent recommendations suggest involving other non-medical prescribers such as practice-pharmacists and advanced nurse practitioners (ANPs) in reviewing medications. However, it is unknown how staff could work together most effectively and whether they have any training needs. This research will investigate how practice-pharmacists, ANPs and GPs could best work together with patients living with frailty to perform regular medication reviews. There are four work packages (WPs). 1. Review literature to identify what makes a successful medication review and how to safely deprescribe. 2. Interviews with GPs, practice-pharmacists, ANPs, frail older patients and carers will investigate where medication review should take place, the role of involved parties, type of medications that could be deprescribed, staff training needs, barriers and facilitators for implementation, and strategies to address them. 3. Information from WP1&2 will be used to develop the intervention: a structured medication review process using pharmacists, ANPs and GPs and involving frail patients and their families in decisions about medications. This will be refined through workshops with service users, clinicians and commissioners. A training programme to implement the intervention and increase staff confidence in deprescribing will be developed alongside the intervention. 4. Feasibility study for staff in four GP practices to be trained and to implement the intervention.(this will be subject to further amendment).

NCT ID: NCT05705167 Terminated - COVID-19 Clinical Trials

Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care

NEREIDA
Start date: April 19, 2023
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate efficacy of plitidepsin in pre-specified groups of immunocompromised patients with symptomatic COVID-19 requiring hospital care versus control in terms of mortality.

NCT ID: NCT05705154 Recruiting - Anxiety Clinical Trials

Connecting Breath and Mind for CYP With Long COVID

Start date: April 30, 2023
Phase: N/A
Study type: Interventional

Recruitment target: Phase I: Co-design of intervention: 5 to 15 CYP aged between 12-18 years of age referred to the pan-London long COVID MDT. Phase II: Randomised pilot: 40 patients (12-18 years) will be recruited from a potential pool of 214 patients referred to the pan-London long COVID MDT. Methods: Phase I: Co-design Design and setting The intervention will be co-designed with CYP following a process informed by practice-base evidence, which centres the voices and wisdom of CYP, focuses on creativity and playfulness, and systemic and narrative approaches. The process will involve: 1) Refining the intentions of key stakeholders (including ways of bringing psychological and physiological principles into the intervention); 2) Participation of CYP; 3) Creativity and playfulness and 4) Responding to feedback (see Salvo et al., 2022). Phase II. Pilot Population: 40 patients (12-18 years) will be recruited from a potential pool of 214 patients referred to the pan-London long COVID MDT. CYP will be randomised to receive either standard treatment or standard treatment plus intervention. Study Treatment Standard treatment consists of virtual MDT discussion with referrer and advice signposting into local services for specific issues. They are sent leaflets and information. If a patient is severely affected enough to be seen face to face, they are offered an interdisciplinary consultation, and tailored input from therapies and psychological services. Access to bite size videos and leaflets covering the following topics: sleep, pacing, activity management, school reintegration, managing friendships, eating well and emotional wellbeing. Young people are invited to a single virtual group Q&A session to bring any queries after watching the videos. The leaflets and online sessions have been developed by professionals from the Evelina, Great Ormond Street Hospital, Imperial, University College London Hospital, and the Whittington. The bite size videos and live sessions are delivered by a clinical psychologist, a dietitian, specialist nurse, occupational therapist, and physiotherapist. More complex or severely affected patients will receive one to one treatment with members of the MDT as required. Intervention Based on clinical expertise and theory, it is anticipated the following elements may be included in the intervention.: - Progressive breathing pattern retraining, including education, self-observation, relaxation, body scanning, postural re-alignment - Identifying the connections between body and mind to address anxiety and breathlessness - Coping skills for managing anxiety using principles from narrative therapy and mindfulness - Online materials to improve self-efficacy with home practice - Social connection with other CYP for peer support, and resource sharing - Activities to help CYP reconnect with their usual activities, skills, abilities, interests, support systems

NCT ID: NCT05704868 Recruiting - Social Anxiety Clinical Trials

UniVRse: VR-CBT for Students With Social Anxiety

UniVRse
Start date: December 8, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot randomised controlled trial is to evaluate the effectiveness of the UniVRse VR-CBT programme in students with social anxiety. The aims of this trial are: 1. To determine whether a full trial is justified; 2. To establish the effect size on the co-primary outcomes for a sample size calculation for a definitive trial; 3. To address questions concerning study recruitment, retention, and acceptability. Participants will complete a baseline assessment (T0) and then be randomly allocated to receive either UniVRse VR-CBT or join the wait-list control group. UniVRse VR-CBT uses graded exposure techniques delivered using VR to help students feel more confident in university-based situations. Data will be collected post-intervention (T1) along with exit interviews to assess participant experience.