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NCT ID: NCT06347952 Completed - Breast Cancer Clinical Trials

Mapping Arterial Perforators Within the Breast During Mammoplasty

Map-total
Start date: April 27, 2022
Phase:
Study type: Observational

Breast cancer surgery can often be carried out as part of a breast reduction procedure known as 'therapeutic mammoplasty'. Where a woman has a breast with adequate volume, even larger cancers can be removed in an aesthetically acceptable way with re-shaping of the breast (often reduction and lift) incorporated into the cancer removal. An expectation and desire for most women is that the nipple and areola (known as the 'nipple-areolar complex' or NAC) is not only preserved, but re-positioned (usually lifted) to re-balance the overall aesthetic result. In moving the NAC, the surgeon must ensure an adequate blood supply is maintained to preserve nourishment of the NAC tissue otherwise it can die (necrose) resulting in its removal. The tissue carrying the blood supply is known as a 'pedicle' and is fashioned by the surgeon for each patient during surgery. We know as surgeons, that in most areas of anatomy of the human body there are variations in the pattern of blood vessels. The NAC blood supply is no exception. Yet for each individual patient, the only way to safely know these anatomical patterns is to map them before or during surgery. A surgical tool utilising an aspect of ultrasound (known as doppler) is often used to locate visually (or by hearing) blood flow from blood vessels in operations where such knowledge is critical to the success of the procedure (for example DIEP-based breast reconstruction or chest wall perforator flaps). We would like to evaluate the effectiveness of the routine use of doppler for NAC preservation during mammoplasty procedures to see if it gives the consultant surgeon and/or trainee a greater degree of confidence when shaping the NAC pedicle to preserve its blood supply. In addition, we evaluate the training potential of patients undergoing symmetrising breast reduction, whereby the tissue removed is first mapped using acoustic doppler as for the NAC above.

NCT ID: NCT06335446 Completed - Atrial Tachycardia Clinical Trials

Identification, Electro-mechanical Characterisation and Ablation of Driver Regions in Persistent Atrial Fibrillation

Start date: October 2016
Phase:
Study type: Observational

Atrial fibrillation (AF) is the most common sustained heart rhythm abnormality. Its incidence is increasing partly due to the aging population and it has been referred to as a growing epidemic. AF results in irregular contractions of the heart causing unpleasant symptoms of palpitations and increasing the risk of stroke, heart failure and death. Percutaneous catheter ablation is a safe treatment option in symptomatic patients with AF. The success rate of these procedures have improved with time due to our better understanding of AF, development of new techniques and technology, and greater physician experience. However, the success rate of these procedures still only remains around 70%. This is secondary to our limited ability to find the areas that drive AF. STAR mapping is a novel mapping system that has been developed with a view of better identifying the sites that drive AF through taking into account the mechanisms of AF we have so far demonstrated. To validate this mapping system we aim to use it in patients with atrial tachycardia (AT), which is a heart rhythm abnormality of which the mechanism can be readily identified with the existing mapping systems used in clinical practice. We will demonstrate that the STAR mapping algorithm can effectively map AT.

NCT ID: NCT06332222 Completed - Exercise Recovery Clinical Trials

Recovery With Tart Cherry Supplementation Following a Marathon.

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

The goal of this clinical trial is to compare recovery in healthy, active runners. The main questions it aimed to answer were whether 7 day supplementation with Vistula TC attenuated: - muscle function - inflammation - soreness following a marathon run. Participants will either consume a spray-dried tart cherry supplement or a calorie-matched placebo-control for 7 days, and complete a marathon. Participants will perform functional tests, be assessed for their perceptual recovery and markers of inflammation and muscle damage via: - maximal voluntary contractions - counter movement jumps - visual analog scales to assess soreness - blood samples

NCT ID: NCT06325579 Completed - Dysphagia Clinical Trials

Immersive Virtual Reality for Dysphagia

IVRys
Start date: May 24, 2021
Phase: N/A
Study type: Interventional

People who have suffered a stroke are at high risk of suffering from oropharyngeal dysphagia with long and intensive exercise programmes. Early access to treatment and engaging therapies is very important for recovery. Immersive virtual reality technology presents an innovative treatment that could help patients improve swallowing. The aim of this study is to improve swallowing in stroke patients using two bespoke immersive virtual reality treatment with real-time feedback. The study consisted in a small feasibility study with stroke patients suffering dysphagia (n = 6, aged of 39 to 80 (M=71.17, SD=15.94). Results obtained through interviews with the patients indicated no discomfort reported during the game. All patients reported enjoying the game and feeling engaged and immersive and four out of six patients reported that they would like to use it every day as part of their Speech and Language therapy. The SALT assistant involved in the study stated that the system had the potential to encourage patients to swallow, being more functional than conventional speech therapy. She identified improvements needed for a better functioning of the VR rehabilitation system for Dysphagia. In a future study, wireless headsets will be used, without a laptop, and it will be important to improve the reliability and design of the strain gauge or innovate in the use of a different technology.

NCT ID: NCT06324526 Completed - Quality of Life Clinical Trials

Obesity and Health-related Quality of Life in Patients Receiving Bariatric Surgery in the UK

Start date: June 1, 2017
Phase:
Study type: Observational

United Kingdom National Bariatric Surgery Registry (NBSR) records between 1st June 2017 and 23rd November 2022 were used to identify people undergoing primary bariatric (weight-loss) surgery. People undergoing primary bariatric (weight-loss) surgery with one baseline and at least one follow-up visit within one year from surgery were included. Statistical models were used to estimate the relationship between quality of life as assessed by a questionnaire and body mass index at baseline and over time.

NCT ID: NCT06312163 Completed - Keratoconus Clinical Trials

Validation of Innovative Scheimpflug Topography Derived RGP Contact Lens Designs In Optometry Network

VISION
Start date: June 6, 2022
Phase:
Study type: Observational

The goal of this Prospective, single-site, cohort study is to validate rigid gas permeable corneal contact lens (RGP) designs for keratoconus derived from combining the data from corneal topography scans and contact lenses ordered in patients with keratoconus (KC) attending a UK tertiary NHS Hospital contact lens clinic. The main questions it aims to answer are: - Does a Scheimpflug topography derived RGP contact lens design for keratoconus have the equivalent overall contact lens fit as the patients' own lens? - Is the number of trial lenses required to fit a patient is reduced compared to standard practice? - Is the time taken to fit a contact lens is reduced compared to standard practice? - Is there user acceptance of the new lens? - Are the Axial ege lift (AEL) changes clinically significant? There will be 3 work packages WP1: For each participant data collection will take place over two visits. • Visit 1: Pentacam topography scans and optimal 'virtual' lens selection will take place. • • Visit 2: Participants are fitted with 4 contact lenses (i) the optimal lens design as specified by the virtual fitting module, (ii) a contact lens with a clinically significant step flatter AEL (iii) a contact lens steeper in axial edge lift (AEL) (iv) the participant's own contact lens. Each CL fit will be assessed with slit lamp photography according to the standardised method proposed by Wolffsohn et al. (2013), Anterior segment OCT MS39) (CSO Hansom Instruments, UK) and best-corrected visual acuity with each lens design using high-contrast logMAR . WP2. Participants will attend one appointment where a traditional lens fit, and a lens fitted using the topography guided 'virtual' module will be undertaken (with the fitting method selected for each eye randomised). For each fitting method the total fitting time will be measured and the total number of trial contact lenses used. Patients will be invited to complete a questionnaire that probes their satisfaction of this process. WP3. Clinicians not involved in the study will be invited to examine a demo version of the virtual fitting module and complete the validated system usability scale tool.

NCT ID: NCT06311552 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

Optimising CMR Scan Acquisitions for Novel Equipment/Sequences in Clinical Cardiovascular Populations.

OPTMISE-HFpEF
Start date: January 31, 2022
Phase:
Study type: Observational

The purpose of this study is to develop robust protocols for the optimisation of novel hardware, software and exercise equipment in the magnetic resonance imaging (MRI) environment in various cohorts with cardiovascular disease (CVD) with the first study focusing on those with established heart failure with preserved ejection fraction (HFpEF) or those at risk of or with pre-HFpEF.

NCT ID: NCT06311084 Completed - Clinical trials for Mental Health Disorder

IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People

IMAG2
Start date: November 25, 2022
Phase: N/A
Study type: Interventional

This study aims to investigate acceptability and feasibility of a new version of the Imaginator intervention, Imaginator 2.0, targeting self-harm behaviour in young people aged 12-25 under mental health services in the UK. Following an initial proof-of-concept study of Imaginator (Di Simplicio et al., 2020), we co-designed a new version of the app that supports consolidation and practice of the techniques learnt in therapy, and adapted the protocol to be extended to younger adolescents. Imaginator 2.0 uses 'functional imagery training', training in individuals to develop and use functional (that is, helpful) mental images to support an alternative behaviour instead of self-harm. Mental imagery is the process of picturing something in the mind, and mental images have strong emotional and motivational characteristics. Functional Imagery Training (FIT) within Imaginator helps young people imagine adaptive behaviours as an alternative to self-harm when dealing with distressing emotions.

NCT ID: NCT06309732 Completed - Clinical trials for Testicular Neoplasms

GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT)

GAMEC-II
Start date: July 2006
Phase: Phase 2
Study type: Interventional

St Bartholomew's hospital completed a study using the regimen GAMEC (PEG-filgrastim, actinomycin-D, methotrexate, etoposide, cisplatin). The results of this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. These results are very encouraging and compare very favourably to other treatment protocols. In reviewing this study, it became clear that of the 5 cycles of treatment which were proposed, the first 3 seemed to matter and the last 2 did not appear important. In addition there was a group of patients who appeared to do particularly well namely patients under the age of 35 and those who had a normal LDH (lactate dehydrogenase). LDH is a blood test which monitors cancer activity. Selecting patients which fill both these criteria, this trial aims to see whether the investigators can maintain the good results the investigators have seen but using only 3 cycles of treatment. This will therefore shorten the treatment from 10 weeks to 6 weeks, thus reducing the side effects.

NCT ID: NCT06308744 Completed - Control Condition Clinical Trials

A Large Multi-site Study on Self-administered Mindfulness

Start date: March 23, 2022
Phase: N/A
Study type: Interventional

The use of self-administered mindfulness interventions has increased in recent years. The effectiveness of these interventions on regulating stress/emotions, however, is debated. In the present multi-site study (Nsites = x, Nparticipants = x), the investigators aimed to investigate the effectiveness of four single, brief stand-alone mindfulness exercises in a population unfamiliar with mindfulness meditation. The investigators tested these four interventions in comparison to non-mindful active control conditions using an adaptive Bayesian design. The investigators found [evidence for the efficacy of x exercises/no evidence for the efficacy of x exercises] with an estimated mean effect size of [xx/xx]. This means that… or The investigators recommend that… [recommendation will be provided].