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NCT ID: NCT03610620 Completed - Clinical trials for Basal Cell Carcinoma

Confocal Microscopy Evaluation of Margin Clearance in Basal Cell Carcinomas in Mohs Surgery

FCM-P
Start date: June 12, 2017
Phase: N/A
Study type: Interventional

This study is comparing the accuracy and speed of the Vivascope 2500 ex-vivo fluorescent confocal microscope with frozen section Mohs histology in evaluating clear margins in basal cell carcinoma in Mohs surgery.

NCT ID: NCT03610360 Completed - Mesothelioma Clinical Trials

DENdritic Cell Immunotherapy for Mesothelioma

DENIM
Start date: June 21, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study is to evaluate the overall survival (OS) rate (determined from the time of randomization in the study) of subjects who receive dendritic cell immunotherapy with MesoPher plus best supportive care (BSC) compared to BSC alone.

NCT ID: NCT03609528 Completed - Prostate Cancer Clinical Trials

CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies

CamPROBE
Start date: February 15, 2019
Phase: N/A
Study type: Interventional

The CamPROBE study investigates the rate of infective complications using the Cambridge Prostate Biopsy Device method of local anaesthetic transperineal prostate biopsies.

NCT ID: NCT03609086 Completed - Pregnancy Clinical Trials

Melatonin in Pregnancy

MEL-P2
Start date: June 6, 2018
Phase:
Study type: Observational

Melatonin is well known for its role in the sleep-wake cycle and is synthesised in response to low light levels from the pineal gland. In our previous study it was found that serum melatonin levels increased dramatically during pregnancy, such that levels were up to 100 fold higher in the third trimester compared to healthy non-pregnant women. The placenta contains the enzymes which are involved in synthesising melatonin but it is unclear if this is the source of the high levels in pregnancy. Severe pre-eclampsia has been reported to be associated with low levels of melatonin. In this study its is proposed to measure serum melatonin immediately before and after delivery and in cord blood and relate the levels to those in the placenta itself. This will contribute to the potential role for melatonin as a biomarker for obstetric disease and potentially as a therapeutic agent in future. This observational pilot study aims to measure serum and placental melatonin levels (as the major metabolite 6-hydroxymelatonin sulphate) in pregnant women undergoing elective Caesarean section.

NCT ID: NCT03608397 Completed - Cervical Dystonia Clinical Trials

Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)

ASPEN-1
Start date: June 20, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of two doses of daxibotulinumtoxinA (DAXI) for injection (high-dose; low-dose in adult subjects with isolated (primary) cervical dystonia (CD).

NCT ID: NCT03607734 Completed - Allergy Clinical Trials

Penicillin Allergy De-Labelling in Elective Surgical Patients (PADLES)

PADLES
Start date: April 24, 2017
Phase: N/A
Study type: Interventional

Penicillin antibiotics are safe and inexpensive, and target selected bacteria rather than killing a broad range. Unfortunately, around 10% of the population are labelled as 'penicillin allergic'. This is often based on side effects such as rash and diarrhoea, and 90-95% of people with the label are not actually allergic to the drug. The label leads to the use of alternative antibiotics, which tend to more toxic, and less specific about which bacteria they kill; this increases the risk of infections with so-called 'super-bugs', compared to patients without the label. People with the label also have an increased length of hospital stay and rates of readmission. These are significant problems for individuals, as well as wider society. Where the diagnosis is in doubt, the gold standard test for allergy is an oral challenge. Patients undergo skin +/- blood tests prior to a challenge, as these can help make the diagnosis. This combined pathway is expensive and time consuming, so testing cannot be offered routinely to all patients. However in patients with 'historic' reactions (many years previously), skin and blood tests become much less useful; in one study, 100% of patients who skin tested positive for amoxycillin allergy, tested negative 5 years later. Patients with historic reactions can therefore proceed directly to an oral challenge without prior skin or blood testing, since these offer little help in making the diagnosis. This streamlines the pathway, making it quick, non-invasive and cheap. Already established practice in several centres in Europe and beyond, this abbreviated pathway is offered on an ad-hoc basis in some centres in the UK. The aim is to demonstrate that this pathway offers a safe and effective way to perform large-scale delabelling of elective surgical patients, who might not otherwise meet NICE criteria for testing.

NCT ID: NCT03607669 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium

Start date: June 1, 2018
Phase:
Study type: Observational

Scanning the heart using magnetic resonance imaging (MRI) enables detailed assessment of its structure and function. MRI can give more detailed information about the heart by using a contrast 'dye' that is injected into a vein during the scan. This can highlight abnormal areas within the heart. Current contrast dyes help identify scarring within the heart, which is useful in people who have had heart attacks. The investigators plan to test new contrast dye containing manganese, which works differently to current agents. They believe it will provide unique insight into how the heart works. There are many different causes of heart problems and the investigators plan to use this new contrast agent to scan three patient groups; (i) heart disease caused by heart attacks, (ii) heart disease with abnormal thickening of the heart muscle, and (iii) heart disease where the heart becomes stretched and enlarged. Healthy volunteers will be scanned for comparison. The study will be carried out at the Royal Infirmary of Edinburgh. Adults between 18 and 65 with stable heart failure can be considered. Women who may be pregnant are unable to participate, as is anyone who has some types of metal in their body, as these people can't have an MRI scan safely. All participants will have 2 MRI scans lasting about an hour each, at least 2 days apart. Some participants will be have 4 MRI scans, over a longer time period. The investigators will also take some blood samples and record a tracing of the heart rhythm and will ensure there are no abnormal side-effects by telephone follow up. The investigators believe this new agent has potential to better measure disease in the heart, improve the ability to establish the cause of heart disease and help monitor the disease over time as well as guide future treatment for individual patients.

NCT ID: NCT03606512 Completed - Clinical trials for Respiratory Syncytial Virus

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age

Start date: January 21, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5*10^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months.

NCT ID: NCT03606447 Completed - Healthy Subjects Clinical Trials

A Study in Healthy Volunteers to Investigate How Much Test Medicine [14C]-Uproleselan is Taken up by the Body When Administered Directly Into the Vein (IV)

Start date: August 14, 2018
Phase: Phase 1
Study type: Interventional

The purpose of the study is to measure how the radiolabelled test medicine [14C]-Uproleselan (GMI-1271) is taken up, broken down and removed from the body when given intravenously (into a vein) in a group of 6 males. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the drug is in the body. Blood urine and fecal samples will be collected at specific times throughout the study to measure amounts of the test medicine in the body.

NCT ID: NCT03606044 Completed - Kidney Neoplasms Clinical Trials

3D Virtual Models as an Adjunct to Preoperative Surgical Planning

Start date: May 1, 2019
Phase:
Study type: Observational

This study aims to determine the feasibility of undertaking a future definitive RCT to evaluate the clinical effectiveness of complementing existing medical scans with a patient-specific interactive 3D virtual model of the patient's body to assist the surgeon with planning for the operation in the best way possible. Renal cancer patients receive a tri-phasic CT scan as routine practice, thus if the standard imaging protocols are followed, there should be ample imaging data available for 3D model creation. This study is a single-site, single-arm, unblinded, prospective, feasibility study aiming to recruit 24 participants from the Royal Free Hospital that are scheduled for robotic-assisted partial nephrectomy. Consenting participants will be recruited over a 6-month period, and interactive 3D virtual models of their anatomy will be generated. These models will be used to aid surgeon-patient communications and to plan for the operation. This study will determine whether a definitive RCT of virtual 3D models as an adjunct to surgery planning is feasible with respect to: recruitment of local authorities and patients; ensuring staff can be adequately trained to deliver programmes within specified timeframes; and assessment of the measurability of key surgical outcomes.