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NCT ID: NCT03963219 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

Clinical Assessment of a Novel Advanced Bolus Calculator for Type 1 Diabetes 5

ABC4D5
Start date: August 22, 2019
Phase: N/A
Study type: Interventional

The main objective of this study is to assess safety and efficacy of the ABC4D compared to standard therapy (standard bolus calculator) in adults with type 1 diabetes on multiple daily injections (MDI) of insulin in an out-of-clinic setting. Hypothesis: ABC4D is non-inferior to a standard bolus calculator and has an equivalent impact on time in target in adults with type 1 diabetes on MDI

NCT ID: NCT03963128 Recruiting - Injury Clinical Trials

Vitamin D Supplementation in the Armed Forces

D_SAF
Start date: November 6, 2017
Phase: N/A
Study type: Interventional

The study will comprise of an original investigation that will take the form of a prospective intervention (two matched groups) study. Condition-1 will be a vitamin D supplementation group (50.000 IU every two months), and Condition-2 will be a placebo supplementation group. The primary research aim of this project is to evaluate the effectiveness of vitamin D supplementation to reduce stress fracture risk and susceptibility to skin, soft tissue infection (SSTI) and respiratory infection in Royal Marine recruits undertaking arduous physical training in a randomised control trial (RCT). The secondary research aims are: 1. To investigate whether supplementation of vitamin D3 at a dose of 50.000 IU every two months (equivalent to 800 IU per day) is effective in reducing the risk of stress fracture and susceptibility to skin, soft tissue and respiratory infection. 2. To examine changes in vitamin D status (relative to baseline serum 25(OH)D concentration), serum PTH concentration, and markers of bone turnover in response to vitamin D3 supplementation during the winter and summer months. 3. To identify interactions between dietary intakes, physical fitness, physical characteristics (body mass, BMI, thigh girth), smoking habit, alcohol consumption, and stress fracture prevalence with serum 25(OH)D status, serum PTH concentration and markers of bone turnover in the vitamin D3 supplemented group vs. the placebo supplemented group.

NCT ID: NCT03961334 Recruiting - Stroke, Ischemic Clinical Trials

MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention

MOSES
Start date: December 5, 2019
Phase: Phase 3
Study type: Interventional

The present trial is addressing the question if a biologically distinct subgroup of ischemic stroke patients without known atrial fibrillation at admission, selected by a cut-off level of MRproANP concentration, which represents a underlying increased risk of cardiac thrombogenicity, benefits from direct oral anticoagulation (DOAC) within 7 days of symptom onset versus standard of care (antiplatelet) as preventive treatment.

NCT ID: NCT03959904 Recruiting - Clinical trials for Surgery--Complications

The Impact of Abdominal Wall Closure Technique on Incidence of Incisional Hernia in Kidney Transplantation

Start date: March 10, 2020
Phase: N/A
Study type: Interventional

STUDY SUMMARY Incisional hernias, or swellings of the abdominal scar after surgery, remain problematic especially after transplant surgery. This is because they can cause complications, including trapping of bowel or the transplant. This can cause life threatening emergencies but is at the very least unsightly and uncomfortable for the patient. Transplant patients are especially likely to develop hernias because of the diseases causing the renal failure and the drugs that they take to dampen the immune system. There is evidence from other surgery that the stitching methods that are used to close the wounds might decrease the risk of surgical hernias. This is achieved by placing smaller and more numerous sutures (stitches) in the wound to increase the strength of the repair. However, this has never been tested formally in transplant where it may provide significant benefit. We intend to do some initial investigation of whether using the smaller stitches may provide benefit over more traditional methods that are currently being used. We will look at early complications after surgery but also the rate of hernia formation later. We hope to improve outcomes and reduce complications for our transplant patients by doing this. In addition we will collect blood and tissue samples from both live kidney donors and the recipients to microscopically analyse their collagen to identify potential factors which may indicate risk of hernia formation.

NCT ID: NCT03956199 Recruiting - Clinical trials for Pulpitis - Irreversible

Pulpotomy vs.Root Canal Treatment in Managing Irreversible Pulpitis

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The study aims to compare two methods of repairing and saving a badly damaged or infected tooth. One method is called root canal treatment (RoCT) and the other (new method) is called pulpotomy. RoCT involves removing the damaged area of the tooth including the tooth nerve (called the pulp), cleaning, disinfecting and sealing it. Pulpotomy however attempts to preserve as much of the tooth nerve as possible (keeping the tooth alive). RoCT is more expensive and painful. Therefore, some patients delay or avoid getting treated, resulting in later complications treated in an emergency setting. This research will aim to show that pulpotomy is less painful, less involved (i.e. less invasive), less time consuming and consequently more cost effective. Long term costs of dental treatment as well as the improved quality of life will therefore offer benefits for patients, public and the NHS who use dental services. Caries (tooth decay) is the most common diseases in the world. The NHS spends at least £3.4 billion per year on dental visits or at dental hospitals. This does not include private (societal) costs to individuals who do not qualify for NHS dental treatment. Consequently, those who end up avoiding or delaying treatment result in complications often treated through the NHS. We have therefore chosen a randomized controlled trial design, a gold standard method to compare the effectiveness of the two treatment options. The participants will be 168 dental patients (male or female) from different parts (London and Liverpool) of the UK so that results can be generalized. This design was considered in consultation with a member of the public (a co-applicant) who will be involved in the trial from the start to completion. The results will be published and discussed at conferences as well as through our patient and public network.

NCT ID: NCT03955614 Recruiting - Surgery Clinical Trials

Intelligent Operating Room

inOr
Start date: October 4, 2019
Phase: N/A
Study type: Interventional

The widely varied practice of surgery, alongside rapidly expanding specialised knowledge and evolving technology as well as the fast turnover of operating theatre staff means they often face unfamiliar operations, techniques and equipment. To the investigator's knowledge, there is no formal induction for the work undertaken specifically within the operating theatre. Many studies have shown that standardised practices, formal training and mental rehearsal improve surgical performance. In this context, Artificial Intelligence (AI) is expected to have vast applications in surgery, particularly through standardisation, clinical decision and training support as well as patient-centred care optimisation. Digital SurgeryTM developed GoSurgeryTM software to consolidate induction processes, support training and achieve standardised surgical practices, ultimately improving surgical performances and patient outcomes. GoSurgeryTM allows surgeons to prepare step-by-step standardised workflows of procedures, including equipment, tips and warnings. In preparation for surgery, workflows can used by operating team staff as a form of induction and mental rehearsal. During the surgery, using pedal-controlled tablets, relevant information for each step of the procedure is presented. GoSurgeryTM has developed AI computer vision to recognise the steps and automatically present the workflows without user-intervention. After the surgery, the AI will allow surgeons to review their performances uploaded onto a personal virtual Hub and compare timing of steps to their previous repository of cases, as well as giving them the ability to share any interesting or difficult cases, supporting learning opportunities and monitoring of progression. This feasibility study sets the bases to test the ability of GoSurgeryTM to improve induction processes, team performance, surgical training and patient outcomes. The research will compare preparedness and performance of operating staff with/without the use of GoSurgeryTM, through questionnaires, observational team assessments, technical measures and patient outcomes. Data will be collected at Imperial College Trust, Chelsea and Westminster Hospital and University College Hospital on patients undergoing general surgery. Anonymised images of keyhole surgery shall be analysed in collaboration with Digital SurgeryTM to develop the AI computer vision software.

NCT ID: NCT03955445 Recruiting - C3 Glomerulopathy Clinical Trials

Long-term Efficacy, Safety and Tolerability of LNP023 in C3G

Start date: October 3, 2019
Phase: Phase 3
Study type: Interventional

This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of LNP023 in subjects with C3 glomerulopathy

NCT ID: NCT03954574 Recruiting - Clinical trials for Pulmonary Circulation Diseases

Pulmonary Hemodynamics During Exercise - Research Network

PEX-NET
Start date: December 1, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data.

NCT ID: NCT03953300 Recruiting - Asthma Clinical Trials

Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics

CHINOOK
Start date: October 17, 2019
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics. Changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ICS) plus long acting B2-agonist (LABA) with or without additional controller medication. Patients who complete treatment will enter 4 weeks follow-up period.

NCT ID: NCT03950388 Recruiting - Mental Health Clinical Trials

Trial of a Ward-Based Intervention to Improve Access to Psychologically-Informed Care and Psychological Therapy for Mental Health In-Patients

TULIPS
Start date: October 21, 2019
Phase: N/A
Study type: Interventional

The Care Quality Commission (2017) concludes that too often care for people with severe mental health problems on mental health inpatient wards institutionalises people, rather than helping them to have an independent life in the community. There is good evidence that psychological interventions improve patient well-being and independent living, but patients on acute mental health wards often do not have access to evidence-based psychological therapies which are strongly advised by NICE guidance for severe mental health problems (e.g. NICE, 2011). The overall aim of this programme of work is to increase patient access to psychological therapies on acute mental health inpatient wards. Stage one of the programme aimed to identify barriers and facilitators to delivering therapy in these settings through a large qualitative study. The key output of stage one was an intervention protocol that is designed to be delivered on acute wards to increase patient access to psychologically-informed care and therapy. Stage two of the programme aims to test the effects of the intervention on patient wellbeing and serious incidents on the ward which are routinely collated by wards and patient and staff contact is not required (primary outcomes), patient social functioning and symptoms, staff burnout, ward atmosphere from staff and patient perspectives and cost effectiveness of the intervention (secondary outcomes). The study is a single blind, pragmatic, cluster randomised controlled trial and will recruit thirty-four wards across England that will be randomised to receive the new intervention plus treatment as usual, or treatment as usual only. Primary and secondary outcomes will be assessed at baseline and 6-month and 9-month follow-ups, with serious incidents on the ward collected at an additional 3-month follow-up. A process evaluation will be nested within the trial to understand factors that influence the effects of the intervention and implementation in real world settings.