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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.

NCT ID: NCT05702684 Recruiting - Colorectal Cancer Clinical Trials

Personalised Cancer Care and Support: Identifying What Good Looks Like

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

The overarching aim is to study the coproduction of personalised care in a digital age by seeking to improve the experience of care and personalised care and support planning for people who live with and beyond colorectal cancer. This study will assess digital health contributions to personalised care and explore how to improve the quality of collaborative digital care planning in cancer services. The electronic holistic needs assessment (eHNA) developed by Macmillan Cancer Support (macmillan.org.uk/healthcare-professionals/innovation-in-cancer-care/holistic-needs-assessmen t/sign-up-to-ehna) will be used as a case study to help advance this aspect of healthcare improvement studies. The primary objective is to gain a better understanding of how personalised care and support planning in the form of the eHNA and consultation works (or not) from the perspectives of people who are living with and beyond colorectal cancer, and clinicians. The secondary objectives are to: i. identify what good practice looks like for digital personalised care and support planning in a specific tumour group (colorectal) and at a point in the cancer pathway (within 31 days of diagnosis) ii. explore if the ARC framework can be used to inform personalised cancer care and support planning The research will review current practice and focus on identifying what good looks like for digital cancer care planning. It will go on to explore how what we know about LWBC can be used to inform the co-design of digital care planning that better supports personalised long-term cancer care. From the outset, this early work will help to inform future issues around generalisability and scaling-up.

NCT ID: NCT05702619 Recruiting - Prostate Cancer Clinical Trials

Hypoxia-driven Prostate Cancer Genomics (HYPROGEN)

HYPROGEN
Start date: October 3, 2021
Phase:
Study type: Observational

Due to the rapid growth, tumour demand for oxygen is often higher than what can be delivered by the newly forming blood vessels. Tumour adaption to this imbalanced oxygen supply and demand (hypoxia) is associated with poor prognosis and genetic changes (genomic instability) that allow it to become more resistant to chemo- and radiotherapy. Patients with hypoxic tumours therefore die earlier. Limited information is available on hypoxia in newly diagnosed prostate cancer, especially to what degree hypoxia in the prostate tumour is associated with the presence of metastases to bones. The Hyprogen trial is a prospective, non-randomised, exploratory biopsy and imaging biomarker study recruiting 60 patients with prostate cancer to better establish the role of hypoxia in prostate cancer cells evolution and early metastatic spread.

NCT ID: NCT05702294 Recruiting - Healthy Clinical Trials

Electronic Urinary Flowmeter to Improve Accuracy of Bladder Diaries .

e-BLaDR
Start date: September 14, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to give an answer to the question of whether an automated calculation of voided volumes would produce a more accurate set of bladder diary data when compared to the traditional ''eye-balling'' method of estimated voided volumes of paper bladder diaries, in female adult patients with lower urinary tract symptoms (LUTS). The main question[s] it aims to answer are: - Does an automated measurement of voided volumes improve the accuracy of bladder diary data? - Does an automated measurement of voided volumes improve the utility of bladder diaries? Participants will be asked to: - void in the disposable measuring jug and record their estimated voided volume for a total of three consecutive days in a paper diary (as per usual care). - transfer their voided volume from the disposable jug to the automated vessel (diary pod) after each void for the same three consecutive days. The reports generated from the paper diaries (estimated volumes) will be compared to the reports generated from the electronic automated measurement of voided volumes to understand whether there is a clinically significant difference between the two. The investigators aim to recruit healthy female adult volunteers with no lower urinary tract symptoms to understand the normal voiding patterns and volumes of adult females using the diary pod. The investigators will also recruit adult females with lower urinary tract symptoms and compare the two methods of capturing the voided volume

NCT ID: NCT05702229 Recruiting - Gastric Cancer Clinical Trials

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Start date: January 16, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase II, open-label, multi-drug, multi-centre study designed to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

NCT ID: NCT05702034 Recruiting - Clinical trials for Ischemic Stroke; Ischemic Attack, Transient

A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE

LIBREXIA-STROK
Start date: February 15, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.

NCT ID: NCT05701917 Recruiting - Clinical trials for Venous Thromboembolism

DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis

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

This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit.

NCT ID: NCT05701358 Recruiting - Clinical trials for Coronary Artery Disease

Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

COMPLETE-2
Start date: June 22, 2023
Phase: N/A
Study type: Interventional

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

NCT ID: NCT05701033 Recruiting - Clinical trials for Mental Health Wellness 1

Does Engagement With Heritage Sites Have the Potential to Improve Sub-clinical Levels of Low Wellbeing in NHS Staff: A Feasibility Study. The HerWellNHS Study

HerWellNHS
Start date: March 6, 2023
Phase:
Study type: Observational

This feasibility study will focus on assessing and identifying the wellbeing effects of self-directed (unmediated) visits to heritage sites for a high-risk population, specifically NHS staff at PHU self-reporting sub-clinical levels of low wellbeing. In particular, it seeks to understand whether wellbeing effects can be derived from unmediated visits to heritage sites, how much exposure to heritage is necessary to experience wellbeing effects, whether and how benefits may be accumulated, how long wellbeing effects may last following visits, and the nature of these wellbeing effects. In addition, it will establish appropriate psychological measures (qualitative and quantitative), test a web-based data collection interface, examine participant choices and their characteristics, and assess participant adherence and response rates prior to developing a clinical trial.