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NCT ID: NCT04957589 Completed - Clinical trials for Diabetes Mellitus Type 2 in Obese

VLCD & Adjuvant Exercise Effect in Overweight Diabetic Men

VLCDeXDM
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Sarcopenia is defined as the incremental age-related loss of skeletal muscle in humans which generally begins from forty years old. It is associated with an overall reduction in quality of life and increased morbidity and mortality. Patients with type two diabetes mellitus (T2DM) are particularly at risk of developing sarcopenia, partly due to the condition and also due to the common incidence after or during middle age. A promising recently-investigated and effective conservative approach to T2DM is through very low calorie diets (VLCD). Some studies have shown that the diabetic status of some patients can be reversed through VLCD. However, VLCD will theoretically result in an acceleration of sarcopenia. This presents as a limiting factor for the implementation of VLCD in this at-risk patient group. Skeletal muscle tissue is encouraged to grow in size or be maintained through two means - an increase in circulating protein breakdown products, or through resistance exercise (RE). Additionally, RE has been shown to increase the body's sensitivity to insulin, the main hormone which controls circulating glucose levels and is frequently impaired in T2DM, as well as temporarily decreasing glucose levels. The precise mechanism by which these happen is not fully understood yet. In this study, the effect of a VLCD is used, alongside one form of exercise (high intensity interval training, HIT), in overweight, middle-aged male patients with T2DM. 10 patients are to be recruited into each group (control/VLCD-only and VLCD with HIT) at our centre. Patient weight, markers of muscle protein synthesis, glucose levels and changes to blood vessels will be investigated before, during and after across a six week timeframe. Investigations will include muscle and fat biopsies, blood samples, ultrasound scans, strength testing and deuterium oxide (D2O) isotope ingestion for later non-invasive body fluid sample mass spectrometric analysis.

NCT ID: NCT04957160 Completed - Clinical trials for Advanced Renal Cell Carcinoma (aRCC)

Cabozantinib Post First-line Immuno-oncology Checkpoint Inhibitor Containing Combination

CARINA
Start date: September 9, 2021
Phase:
Study type: Observational

This study will collect real-world data for the new treatment pathways for all patients with Advanced Renal Cell Carcinoma (ARCC) who were treated with a 1L IO (first-line, Immuno-Oncology checkpoint inhibitor) combination therapy and progressed to a 2L treatment with particular focus to understanding where cabozantinib is prescribed after 1L IO containing combination therapy.

NCT ID: NCT04957147 Completed - Clinical trials for Dilated Cardiomyopathy

Reverse Remodelling and Remission Markers in the Serial Evaluation of Recent-onset Dilated Cardiomyopathy

REMIT-DCM
Start date: August 1, 2019
Phase:
Study type: Observational

Approximately 30-40% of patients with non-ischaemic dilated cardiomyopathy (DCM) undergo significant left ventricular reverse remodelling in response to guideline-directed therapies. This is characterised by improvement in systolic dysfunction and regression of left ventricular dilatation. In some patients, extensive left ventricular reverse remodelling is accompanied by resolution of symptoms and normalisation of cardiac biomarkers, resulting in a state of clinical remission. The mechanistic drivers behind left ventricular reverse remodelling and clinical remission are poorly understood. Current techniques to predict ventricular remodelling trajectory and clinical remission in patients with recent-onset DCM are limited. The purpose of this study is to characterise predictors and markers of left ventricular reverse remodelling and clinical remission in patients with recent-onset DCM using molecular markers, genetics and advanced CMR imaging.

NCT ID: NCT04956900 Completed - Venous Leg Ulcer Clinical Trials

Clinical Trial Enzyme Application Targeting Venous Leg Ulcers

CLEANVLU
Start date: August 9, 2021
Phase: Phase 2
Study type: Interventional

This is an adaptive open-label, first-in-human (Phase IIa) study designed to assess the safety (and efficacy) of Aurase Wound Gel, an enzymatic debridement product, intended for topical application to sloughy venous leg ulcers (VLU)

NCT ID: NCT04955340 Completed - Mycosis Fungoides Clinical Trials

A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat

Start date: October 12, 2021
Phase: Phase 1
Study type: Interventional

Resminostat is a potent, orally available inhibitor of Class I, IIb and IV histone deacetylases (HDACs), including a pronounced activity against HDAC6. Resminostat targets epigenetic changes observed in tumour cells and has the potential to provide significant benefit to patients with advanced malignancies by inhibiting tumour progression and metastasis or even inducing tumour regression. This will be a Phase 1, open-label, non-randomized, single dose study of the absorption, metabolism, excretion of [14C] resminostat following a single oral dose in healthy male participants. The purpose of this study is to determine the absorption, metabolism, and excretion (AME) of [14C] resminostat and to characterize and determine the metabolites present in plasma, urine, and, where possible, faeces in healthy male participants following a single oral administration. Knowledge of the metabolism and excretion of parent drug and its metabolites is useful for evaluating the Metabolites in Safety Testing requirements elucidated in the International Conference on Harmonisation (ICH) M3, and the likelihood of effects of renal or hepatic impairment on the disposition of resminostat, and the likelihood for drug-drug interactions with resminostat. The results from this study may guide future study designs using special populations or evaluating the potential for drug-drug interactions.

NCT ID: NCT04955093 Completed - Clinical trials for Autistic Disorders Spectrum

Heart Rate Variability Biofeedback in Young People With Autism

Start date: May 30, 2016
Phase: N/A
Study type: Interventional

Biofeedback is a process that allows people to obtain information about their internal physiological reactions and thereby learn to control them. Researchers studying the brain and nervous system have found that regulating heart rate can help us to relax. Controlling heart rate using biofeedback has been shown in some studies to help people manage symptoms of stress such as anxiety and depression. This research will explore whether biofeedback can help people with autism or Asperger syndrome reduce reported symptoms of stress. Participants with a diagnosis of high functioning autism will be invited to use a biofeedback device that helps them to regulate their heart rate. People who enrol for the study will be randomly assigned different biofeedback devices. Training and support in the use of the device will be provided to participants. Assessment will involve obtaining questionnaire reports from participants and their carers about participant levels of anxiety, depression and sensory symptoms, demographics and lifestyle. These assessments will be carried out at the beginning, in the middle and at the end of the study to see if there are any differences in how each participant's heart rate changes, whether there are any changes in participant's reported symptoms. Participants will be asked to give daily reports on their progress to monitor stress levels, usability of device and dropout rates. The overall aim is to determine whether biofeedback is a way of helping people with autism to reduce symptoms of stress.

NCT ID: NCT04955002 Completed - Psychological Clinical Trials

Food Choice, Psychological Bias, and Genetic Predisposition

Start date: June 9, 2021
Phase:
Study type: Observational

This project aims to assess if food choice is impacted by loss aversion (LA), and if this differs based on genetic predisposition to LA, in a UK healthy cohort.

NCT ID: NCT04953338 Completed - Anxiety Disorders Clinical Trials

Mental Health Associations With Vitiligo

Start date: June 18, 2021
Phase:
Study type: Observational

This cohort study is a large population-based study in the UK to determine the risks of comorbid mental health conditions (including depression, anxiety and other potential psychological complications of vitiligo) in adults with vitiligo compared to controls and to evaluate whether the relative risks may vary by different ethnicity.

NCT ID: NCT04952961 Completed - Vulvar Cancer Clinical Trials

Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study

Start date: November 4, 2021
Phase: N/A
Study type: Interventional

Vulval cancer, while rare, has increased in incidence by 17% since the 1990s. It is strongly associated with age, thus this increasing trend is likely to continue with extended life expectancy. Vulval cancer is highly treatable when detected early. Women with chronic vulval conditions including lichen sclerosus, lichen planus and vulval intraepithelial neoplasia are at increased risk of developing vulval cancer. Most patients are in hospital follow-up, however regular vulval self-examination can pick up lesions earlier. There are no formalised methods of teaching self-examination and no evidence that it is acceptable to women. The main objective of this study is to pilot an intervention to promote and support vulval self-examination for women at increased risk of vulval cancer including those with lichen sclerosus, lichen planus and vulval intraepithelial neoplasia. Findings from this feasibility study will inform the design of a randomised trial comparing the interventions versus control with an embedded cost-effectiveness analysis.

NCT ID: NCT04952909 Completed - Clinical trials for Risk of Coronary Obstruction Following TAVR Procedure

The ShortCutâ„¢ Study Protocol

Start date: January 21, 2022
Phase: N/A
Study type: Interventional

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCutâ„¢ device for splitting bioprosthetic aortic valve leaflets in patients who are presented for a valve-in-valve transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.