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NCT ID: NCT04690270 Not yet recruiting - Overweight Clinical Trials

Sumatriptan and Glucose

Start date: January 4, 2021
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to establish the proof of concept for a brain serotonin pathway controlling blood glucose control in humans. We will examine whether activation of serotonin receptors by a single dose of sumatriptan (a drug used for the treatment of migraine) can lead to short term changes in blood glucose homeostasis. Thus far, this has been shown only in animal models but no study in humans has directly investigated this research question. Briefly, in this study we will give a single dose of sumatriptan (100 mg) to each participant in a small sample (10 to 12) of overweight or obese, otherwise healthy humans. It will take place in the Translational Research Facility which is embedded in the Cambridge University Hospitals NHS Foundation Trust. The research staff have extensive experience and expertise in the procedures which will be used. The study will involve a screening visit and 2 subsequent visits at which sumatriptan/placebo will be taken and the glucose metabolism will be assessed using a Botnia clamp (3h procedure involving insulin and glucose infusions given intravenously with frequent blood sampling to assess insulin secretion and sensitivity). There will be about 60 days between screening visit and the last visit. The entire study (including the recruitment and data analysis) is expected to complete in about 12 months. If sumatriptan alters glucose control, this might support future testing in disease models i.e. people with type 1 diabetes (T1D) and/or type 2 diabetes (T2D). Ultimately, if successful, either sumatriptan could be repurposed and/or other drugs from this group (triptans) could be developed for diabetes.

NCT ID: NCT04665492 Not yet recruiting - Clinical trials for Spinal Cord Injuries

EEG Predictors of Neuropathic Pain in SCI

Start date: January 15, 2021
Phase:
Study type: Observational

Spinal cord injury (SCI), induced by damage to the spinal cord, can cause life-altering levels of disability including the development of chronic pain. Central Neuropathic Pain (CNP) typically develops within months after injury in 40-50% of SCI patients, affecting everyday activity, sleep and mood. There is no cure for CNP, it can be very difficult to treat and is often refractory to any pharmacological treatments. In a previous study (study no. 14/WS/1029) the principle investigators showed that the likelihood of CNP developing can be predicted by defining characteristics of brain waves that are related to pain. We will use electroencephalograph (EEG) to measure brain activity in people early after SCI, before they develop pain, knowing that about half will develop pain within a year. We aim to recruit 80 participants, aged 18-80; 40 with subacute spinal injury (level C3-T12) and no symptoms of CNP; 20 with symptoms of CNP and 20 able-bodied participants. Completeness of injury is irrelevant. Patients will be recruited by clinical consultants within national spinal units in Glasgow and Stoke Mandeville. Patients will undergo two EEG recording sessions in which they will imagine movements while we record EEG. Sessions will also involve basic sensory testing and completion of questionnaires. Able-bodied participants will be recruited by the Philosophy Doctor (PhD) candidate at the University of Glasgow and undergo only one EEG session (identical to SCI patients). The primary aim of this study is to use early EEG markers of CNP to optimise and validate an existing computer program based on machine learning to enable more accurate prediction of pain in newly injured patients with the hope of aiding future treatments. Secondary aims include characterising EEG features which might describe different phases in patients' development of CNP and exploring possible differences between pain at/below the level of SCI based on EEG markers.

NCT ID: NCT04658056 Not yet recruiting - Clinical trials for Benign Prostatic Hyperplasia

UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

Start date: January 2021
Phase:
Study type: Observational

A post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the WATER Study (NCT02505919) - which was a prospective multi-centre randomized blinded study comparing Aquablation of the prostate with the AQUABEAM Robotic System with standard transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS).

NCT ID: NCT04649268 Not yet recruiting - Clinical trials for Peripheral Vestibular Disorder

Comparison of Optokinetic Stimulation Treatments

Start date: December 28, 2021
Phase: N/A
Study type: Interventional

Persons with a vestibular (e.g. inner ear) disorder often report visual induced dizziness (ViD) symptom (i.e. postural and/or gait instability, dizziness, disorientation) provocation or exacerbation in environments with busy or conflicting visual motion including crowds and supermarkets. ViD is frequently associated with high disability levels, prolonged illness and poorer clinical outcome. Thus, effective treatment is a priority. Vestibular rehabilitation incorporating structured exposure to Optokinetic Stimulation (OKS) (e.g. a form of computer based intervention that involves the observation of moving visual targets to encourage visual scanning) significantly improves ViD symptoms with similar improvement noted for both 'low-tech' OKS provided via a DVD or a 'high-tech', expensive, full-field stimulus. No studies have investigated if 'lower-tech', cheaper Virtual Reality (VR) systems may be beneficial in treating ViD symptoms and whether these VR systems are more effective than an OKS DVD. The first aim of this work is to compare the effect of an OKS DVD vs "lower-tech" VR system on ViD symptoms in persons with a chronic peripheral vestibular disorder aged 18-50 years old. This study may help to identify more optimal treatment strategies in persons with a vestibular disorder.

NCT ID: NCT04646798 Not yet recruiting - Clinical trials for Distal Humerus Fracture

Hemiarthroplasty Or Total Elbow Arthroplasty in the Elderly.

HOT
Start date: November 30, 2020
Phase: N/A
Study type: Interventional

A feasibility study to assess the practicality, and obtain preliminary data to inform, a definitive Randomise Control Trial (RCT) in patients over the age of 65 diagnosed with un-reconstructible distal humeral fractures, to determine if there are differences in functional outcomes between those undergoing a hemiarthroplasty and a total elbow arthroplasty? Over an 18 month recruitment period the investigators will assess recruitment rates and participants willingness to be randomised to one of two routine clinical treatments. During a 1 year routine clinical follow up period (at 3 time points), routinely collected orthopaedic outcome data will be recorded and differences between groups explored.

NCT ID: NCT04630977 Not yet recruiting - Obesity Clinical Trials

Long-term Intervention Effects of a Personalized, Home-based Exercise Program and Nutritional Advice, Along With the Inclusion of a Pre-workout Multi-ingredient Supplement on the Body Composition, Functional Capacity and Quality of Life of Middle-aged and Older Adults (40-70 Years)

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

The purpose of this study is to analyse the potential benefits of ingesting a commercially available pre-workout multi-ingredient supplement providing ~90 Kcal. for 25g of powder: carbohydrates -isomaltulose, fructose, maltodextrin- 15 g, essential amino-acids -Beta-alanine -L-arginine AKG, L-Leucine, Taurine, L-citrulline- 6.8 g, Creatine monohydrate: 2g, Guarana Extract: 800mg, total caffeine: 160mg, and Magnesium: 112.5mg) vs Placebo CHO intake on body composition, physical performance, Happiness Score (specially designed by our sponsor company, including different self-reported and validated tests on their short form) and every workout: Self-perceived energy feeling and adherence to the intervention.

NCT ID: NCT04594447 Not yet recruiting - Clinical trials for Total Knee Replacement

Physica System KR vs Physica System CR (K-20)

Start date: September 30, 2021
Phase: N/A
Study type: Interventional

Post-market, monocentric, randomised, open-label, parallel group, prospective study conducted in patients who have to perform a total knee replacement (TKR) with Physica KR or Physica CR system.

NCT ID: NCT04577339 Not yet recruiting - Peritonitis Clinical Trials

The Best Care for Abdominal Emergencies Study

BCAE
Start date: December 1, 2020
Phase:
Study type: Observational

This is a single-centre retrospective cohort study utilising electronic hospital records. The aim of this study is to improve care for all patients with an intestinal emergency, irrespective of whether they have surgery or not. Data will be derived from electronic patient records collected as part of routine clinical patient care on all general adult wards (excluding maternity) between 2013 and 2020. We will then identify patients who had an emergency laparotomy, and those who had a laparoscopic procedure. We aim to identify 2 further groups where treatment is non-surgical (but could be medical or interventional radiology) or where treatment is considered futile, suggesting that an early focus on end of life care might be appropriate. The primary objective is to provide mortality rates for different treatment options, and analysis of short- and long-term outcomes. The secondary endpoints are to define patient sub-groups with similar health characteristics based on clinical data and an established risk index and to use statistical analysis to predict the risk of death for each patient group and treatment option, which will allow us to identify the best care pathways for each cluster.

NCT ID: NCT04493775 Not yet recruiting - Chronic Pain Clinical Trials

Smartphone-based Brainwave Entrainment (BWE) Technology in Chronic Pain

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Is brainwave entrainment a feasible tool for managing long-term pain in a patient population in the home-setting? Long-term pain affects 4 in 10 people in the UK and can impact on all aspects of life. Many people find that their pain is not well controlled on the treatments that are currently available, or they experience unpleasant side-effects from painkillers. There is therefore an urgent need for new safe and effective treatments for long-term pain. One new approach to treatment is to target alpha brainwaves - rhythmic brain activity that is known to be associated with reduced pain. Alpha brainwaves can be increased by looking at flashing lights or listening to rhythmic sounds at the same rhythm as the brainwaves. This is known as "brainwave entrainment" (BWE) and can be delivered through a smartphone application. The aim of this study is to test the suitability, acceptability and benefits of the brainwave entrainment smartphone application for people with long-term pain, and to inform the design of a future larger study. The investigators aim to recruit 40 participants. Individuals may be eligible if they are over 18 years old and have suffered persistent pain for longer than 3 months. Participants will attend a 3-hour session in the laboratory in either Manchester or Leeds. They will undergo brainwave entrainment for different lengths of time whilst their brain activity and pain levels are recorded to determine the most effective "dose" of entrainment for that individual. They will then use the smartphone application at home 3 times a day for 4 weeks, and will complete pain, sleep, fatigue and quality of life questionnaires. At the end of the study, the investigators will conduct interviews to gain in-depth feedback. The total duration for each participant is around 7 weeks. This study is funded by a Leeds Cares Clinical Research Fellowship.

NCT ID: NCT04478929 Not yet recruiting - Barrett Esophagus Clinical Trials

Early Detection of Barrett's Esophagus Through Deep Image Retrieval

Start date: August 2020
Phase:
Study type: Observational

Barrett's oesophagus is a condition in which the area between the oesophagus and stomach no longer closes, allowing acidic contents of the stomach to enter the oesophagus and damage the lining. The project aims to assist clinicians by offering informed biopsy process, in which the system presents the operator with clinical outcomes of patients with visually similar GI tracts. The project goal is to assess the use of artificial intelligence-based similarity detection systems to better inform biopsy placement, increasing the reliability of bi-yearly inspections.