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NCT ID: NCT03709862 Completed - Syphilis Clinical Trials

Global Syphilis Sequencing

Start date: October 8, 2018
Phase:
Study type: Observational

Syphilis is an important sexually transmitted infection. There has been an epidemic of syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a generalised illness often accompanied by rash. Studies on syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches allow the whole genetic sequence of Treponema pallidum to be obtained from a swab. In this study residual DNA collected as part of routine patient care of patients seen at sexual health clinics in the UK will be used for sequencing. No patient contact is involved in the study which is limited to whole genome sequencing using residual material from samples. By better understanding the genome of the T.pallidum insights will be gained in to the pathogenesis of this important sexually transmitted disease.

NCT ID: NCT03709420 Completed - Endometriosis Clinical Trials

A Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics and Pharmacodynamics of FOR-6219

Start date: August 13, 2018
Phase: Phase 1
Study type: Interventional

This is a randomised, double-blind, placebo-controlled, Phase I/Ib study which will assess the safety, tolerability, food effect, pharmacokinetics and pharmacodynamics of FOR-6219, a hydroxysteroid (17B) dehydrogenase (HSD17B1) inhibitor. The study will be performed in three parts: (I) Single ascending doses (SAD) in healthy post-menopausal women; (II) multiple ascending doses (MAD) in post-menopausal women; (III) multiple ascending doses in healthy pre-menopausal women.

NCT ID: NCT03709212 Completed - Physical Activity Clinical Trials

Cultural Influences on Physical Activity and Exercise Beliefs in Patients With Chronic Kidney Disease

CULTURE-CKD
Start date: May 31, 2018
Phase:
Study type: Observational

Cardiovascular disease (CVD) remains the leading cause of death in patients with Chronic Kidney Disease (CKD). Patients who spend a lot of time being inactive have an increased chance of developing CVD. Thus, interventions that can help to increase the levels of physical activity in patients with CKD are needed. A recent study the investigators completed with kidney transplant participants showed a benefit from the investigators supervised exercise programme. However, the investigators results showed that 11 of the 18 patients who dropped out from the 12-month study were from black and minority ethnic groups. Some patient feedback from these participants suggested that cultural beliefs; including women not being comfortable to exercise in front of men in an exercise class environment, and difficulties around appropriate dress for exercise classes, contributed to some of these participants' decisions to withdraw from the study. This has prompted the investigators to investigate, the cultural influences that may contribute to patient decisions about partaking in physical activity and exercise training. The aim of this study is therefore to invite patients with CKD from the three most widely represented ethnic groups found in our South-East London Hospital Trust (Black African and African-Caribbean; South Asian, and White Caucasian patients) to discuss their beliefs and the cultural influences that may affect their decision on whether to engage with exercise and physical activity. Participants will complete a questionnaire on physical activity levels, and a questionnaire that looks at a patient's readiness to be involved in physical activity, prior to attending interviews or group discussions. The questionnaires will be translated for use with non-English speaking participants and will be used to ensure we get views on physical activity from those participants who are active and not, and ready to be involved in physical activity, and not. A combination of individual interviews and group discussions will then be used to explore the understanding of the terms 'physical activity' and 'exercise', and cultural barriers to participation. The investigators will have interpreters present for all discussions, undertaken in the community. The work from this pilot study will be used to inform and design a larger multi-centre study with an aim to design physical interventions that are culturally sensitive, and appropriate for all patients with CKD in the United Kingdom.

NCT ID: NCT03709030 Completed - Clinical trials for Cholecystitis; Acute, Choledocholithiasis

Early MRI in Acute GallstonE Disease

E-MAGED
Start date: July 17, 2019
Phase: N/A
Study type: Interventional

This pilot study aims to determine the utility of direct Magnetic Resonance Cholangiopancreatography (MRCP) in the assessment of suspected acute gallstone disease presentations. This will take the form of a randomized controlled trial, the design of which is based on recent internal audit data which indicated that a high proportion of patients ultimately require MRCP prior to diagnosis, treatment and discharge, and suggested that early scan may improve overall costs and outcomes. Patients with symptoms and signs suggestive of suspected gallstone disease and deranged liver function tests/amylase (i.e. suggestive of a potentially obstructive gallstone disease), will be enrolled across the full range of 'front-door' locations for surgical presentations within the hospital (Emergency Department, Surgical Emergency Unit, Ambulatory Assessment Unit), and randomized to one of two diagnostic pathways which are both existing variations in current clinical care: 1. MRCP is used as the first mode of imaging; 2. following a standard care model (ultrasound then MRCP if deemed appropriate). An assessment will then be undertaken of the cost-effectiveness of early MRCP versus standard care, using the primary outcome measure of cost to diagnostic scan report calculated using hospital episode statistics (HES), with secondary outcome measures to assess the overall utility which include length of stay, time to diagnosis, overall cost of admission using HES, in-hospital complications, Patient Reported Outcome Measures (PROMs), readmission and re-attendance rates (ED/GP), and service/radiology costs.

NCT ID: NCT03708718 Completed - Systemic Sclerosis Clinical Trials

Prednisolone in Early Diffuse Systemic Sclerosis

PRedSS
Start date: December 21, 2017
Phase: Phase 2
Study type: Interventional

This is a randomised placebo-controlled study of moderate dose prednisolone for 6 months in patients with early diffuse cutaneous systemic sclerosis (dcSSc). Seventy-two patients within 3 years of the onset of skin thickening will be recruited from 14 UK centres over 3 years. Co-primary end-points will be the Health Assessment Questionnaire Disability Index (HAQ-DI) and the modified Rodnan skin score (mRSS). Patients will be assessed 5 times: screening, baseline, 6 weeks, 3 and 6 months, with a code-break on exit from the study at 6 months. Please note: From August 2020, the trial was re-started following halt due to Covid-19 as open-label. The placebo arm is the 'no treatment' arm and there is no longer a code-break at study exit.

NCT ID: NCT03708185 Completed - Healthy Clinical Trials

Beta-alanine Supplementation and High-intensity Interval Training

BEAST
Start date: June 4, 2018
Phase: N/A
Study type: Interventional

The present study will seek to quantify whether a period of HIIT alongside β-alanine supplementation will improve the adaptation to training, and therefore performance, more than a period of HIIT alone.

NCT ID: NCT03708146 Completed - Clinical trials for Pulmonary Arterial Hypertension

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 5-1058

Start date: May 28, 2018
Phase: Phase 1
Study type: Interventional

This is a single centre, double-blind, randomised, placebo-controlled, parallel staggered group study of BIA 5-1058 in 11 different cohorts of 15 healthy subjects. Subjects will be randomly assigned to receive once-daily oral doses of BIA 5-1058 or matching placebo for 10 days. The primary objectives of the study are to assess the safety and tolerability of BIA 5-1058 after repeated ascending doses under fed and fasted conditions and to assess the pharmacokinetics (PK) of BIA 5-1058 after repeated ascending doses under fed conditions having matching fasting cohorts for comparison of bioavailability. It is planned that comparison cohorts will be dosed in parallel, i.e. Cohorts 1 and 2, 3 and 4, 5 and 6, 7 and 8 and 9 and 10. Cohorts may be split or dosed sequentially for logistical purposes; however, data from both comparison cohorts (e.g. Cohorts 1 and 2) must be available before dose escalation to the next dose levels.

NCT ID: NCT03708120 Completed - Tick Bites Clinical Trials

Determining the Complete Protection Time of an Insect Repellent With 30% Citriodiol® Against Three Species of Ticks.

Start date: November 15, 2018
Phase: N/A
Study type: Interventional

This study evaluates the length of time an insect repellent product can protect against three species of ticks. Participants will have one arm treated with the repellent, and throughout the next 10 hours, ticks will be given the opportunity to crawl up the treated arm. The test will stop after 10 hours or when the repellent stops working whichever occurs sooner.

NCT ID: NCT03707470 Completed - Muscle Damage Clinical Trials

Made to Measure Compression Garments for Recovery in Rugby Players

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

Aims - To compare the compression pressures exerted by made-to-measure compression garments (CG) with those from standard sized garments - To assess the efficacy of custom fitted, high pressure CG for facilitating the recovery of strength, muscular power and sprint performance, and to compare the effects with those of garments exerting lower pressures and a sham treatment Rationale for study design The results of a recent meta-analysis (unpublished data) have informed the design of this study. The conclusions of the meta-analysis were that CG are most effective for the recovery of: - Force and power performance following eccentric/plyometric exercise - Maximal force production, at least 24 hours post-exercise (for example in strength and power athletes undertaking resistance training programmes) - Additionally, the recovery of high-intensity cardiovascular performance may also be enhanced by the used of CG, when tested 24 hours following exercise which incurs metabolic stress Accordingly, the current study was designed to investigate the effects of CG on the recovery of force, muscular power and sprint performance in rugby players over a 48 hour period following damaging exercise. The exercise protocol chosen (detailed below) provided both mechanical and metabolic recovery demands.

NCT ID: NCT03707353 Completed - Malaria Clinical Trials

An Efficacy Study of IV Boosting With ChAd63/MVA ME-TRAP

Start date: October 30, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Plasmodium falciparum Malaria remains a major global health problem with approximately 200 million cases and 500,000 deaths worldwide annually, mostly in African infants. Current malarial control strategies are threatened by emergence of parasite resistance to drug treatment and resistance of the mosquito vector to certain insecticides. A deployable malaria vaccine is therefore a key strategy for reducing malaria mortality and progressing towards global eradication, but those in clinical trials are currently someway short of WHO targets. ChAd63 ME-TRAP and MVA ME-TRAP are leading candidate vaccines being developed by Adrian Hill's group at the University of Oxford, and collaborators. Since 2007, testing of these vaccines intramuscularly in over 900 volunteers has shown them to be safe, well tolerated and capable of delivering partial efficacy against malaria infection. This study will be the first time studying the efficacy of giving a boosting dose of the vaccines intravenously in what the investigators call a "prime-target" strategy. It follows very encouraging pre-clinical work showing this route can target desirable immune responses to the liver to fight a crucial stage of malaria infection. An ongoing recent phase I study is dose escalating both these vaccines intravenously as a single dose prior to commencing this trial where intramuscular and intravenous doses will be combined for the first time. The investigators will initially recruit 46 healthy UK adult volunteers who will be enrolled into 4 vaccination arms (10 volunteers each) and an unvaccinated control group (6 volunteers) who will undergo a controlled human malaria infection (CHMI). These are standardised, carefully supervised infection experiments used internationally to assess vaccine efficacy. As this is the first time giving intramuscular and intravenous doses of these vaccines in a combined schedule, the investigators will closely profile the safety and immune response during the vaccination follow-up. All trial activity will take place in Oxford.