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NCT ID: NCT03107013 Completed - Clinical trials for Molecular Mechanisms of Pharmacological Action

A Study to Investigate the Mass Balance of BTD-001

HV103
Start date: April 3, 2017
Phase: Phase 1
Study type: Interventional

This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects to assess the mass balance recovery of carbon-14 (14C)-BTD-001.

NCT ID: NCT03106987 Completed - Clinical trials for Epithelial Ovarian Cancer

A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.

OReO
Start date: June 8, 2017
Phase: Phase 3
Study type: Interventional

The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled, multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer)

NCT ID: NCT03106909 Completed - Stroke Clinical Trials

Pulmonary CT in Pneumonia Complicating Stroke

Start date: April 10, 2017
Phase:
Study type: Observational

Pneumonia commonly complicates stroke and has a profound impact on clinical outcomes. Accurate and timely diagnosis of pneumonia complicating stroke remains a major challenge as several issues potentially confound diagnosis. Chest X-ray (CXR), a central component in the diagnostic work-up, may have limited utility in the early stages as they are often of suboptimal quality, and infrequently confirm typical diagnostic infiltrates. Blood biomarkers of the stress-immune response have received considerable attention, but interpretation has been limited by differing methodologies, including definition of pneumonia. Bacterial organisms in the oral cavity may also be of relevance as biomarkers of post-stroke pneumonia. Major challenges facing frontline clinicians are therefore whether to initiate antibiotics; if so, when and for how long. These issues have antibiotic stewardship implications for clinicians in terms of potential for under-treatment or over-treatment with antibiotics based on CXR appearances. Pulmonary Computed Tomography (CT) could be of value as a radiological reference standard when pneumonia is suspected after stroke, and enable more rigorous evaluation of the diagnostic performance of CXR (and other candidate biomarkers) to inform decision-making when pneumonia is suspected. The overall primary aim is therefore to investigate the feasibility and reliability of using pulmonary CT as a radiological reference standard for evaluating suspected pneumonia complicating stroke. The secondary aims are to explore the diagnostic accuracy of CXR and blood biomarkers (index tests) when pneumonia is suspected during hospital admission after stroke using pulmonary CT as a reference standard.

NCT ID: NCT03105947 Completed - Clinical trials for Cardiovascular Risk Factor

Trial of Different Dietary Fats on Blood Lipids and Metabolic Measures in Healthy Participants

COB
Start date: June 22, 2017
Phase: N/A
Study type: Interventional

This is a randomised trial in which healthy volunteers, men and women aged 50-75 years from the general community are randomized into one of three arms: participants will be provided with 50 gm extra virgin coconut oil,or 50 grams butter or 50 extra virgin olive oil to be eaten daily for a month. The key outcome is blood low density lipoprotein cholesterol concentrations and secondary outcomes blood lipid profile (total cholesterol, high density lipoprotein cholesterol, triglycerides) and anthropometric measures: weight and waist circumference. This trial is powered to detect a difference of 0.5 mmol/L LDL-cholesterol difference between the trial arms.

NCT ID: NCT03105128 Completed - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Start date: May 10, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).

NCT ID: NCT03104790 Completed - Influenza Clinical Trials

Assessment of Viral Shedding in Children Previously in Receipt of Multiple Doses of Live Attenuated Influenza Vaccine (LAIV) Compared to Influenza Vaccine-naïve Controls

Flushed
Start date: October 2, 2017
Phase: Phase 4
Study type: Interventional

LAIV shedding studies in children could be an important way to confirm whether impediments to viral replication do indeed explain these observed reductions in vaccine effectiveness(VE), whether prior vaccination has any influence on replication and what future implications (if any) this might have for the UK paediatric LAIV programme. LAIV virus replication in children will be dependent on virological and host factors. The virus factors include replicative fitness of individual strains and the susceptibility to inhibition by other replicating strains (ability to compete). Host factors which may influence this include pre-existing specific immunity as a result of prior infection or previous vaccination (with either LAIV or IIV), and innate immune factors including mucosal immunity. Understanding the relative importance of different factors over two seasons when the strain composition of the A/H1N1pdm09 LAIV virus will change and by comparing previously unvaccinated and highly vaccinated groups (with both LAIV and IIV), can potentially give unique insights into their contribution to the US LAIV observations. With the change of the A/H1N1pdm09 vaccine strain in 2017/18, demonstrating improved performance (in terms of VE, virus shedding and immunogenicity) and what contribution prior vaccination might make will be key evidence for both the UK, but also the US. Information presented at the ACIP in June 2018 from the 2016/17 and 2017/18 seasons will be key to inform US future decisions around use of LAIV. This is a parallel group, non randomised study which will enrol at least 400 children. Both written informed consent from parent/ guardian and written assent from the child will be in place prior to any study procedure. The two groups will be defined by previous influenza vaccination history, with around half the children naïve to any influenza vaccination (LAIV or IIV) and half having had at least three doses of LAIV with or without IIV. All will follow the same schedule of vaccination and oral fluid collection at day 0 (by the nurse in the home or at the GP surgery); nasal swab collection (by the parent at home on days 1,3,6); day 21 oral fluid collection (by nurse or parent at home or at GP surgery).

NCT ID: NCT03104777 Completed - Obesity, Childhood Clinical Trials

A Trial to Improve the Healthiness of Packed Lunches in Primary School Aged Children

Start date: November 9, 2016
Phase: N/A
Study type: Interventional

Public Health England's (PHE) Behavioural Insights Team are leading and fully funding a randomised controlled research trial in collaboration with Derby City Council's Public Health Team and the Health and Social Care Research Centre at Derby University to test an intervention designed to help families provide healthier packed lunches for Primary School aged children.

NCT ID: NCT03104530 Completed - Cadmium Body Burden Clinical Trials

Crabmeat and Health Study

Start date: May 24, 2017
Phase: N/A
Study type: Observational

The brown meat from crab may contain high levels of the heavy metal cadmium. Cadmium is found in the environment and long-term exposure can cause accumulation in the body. High cadmium levels can be toxic to the kidney and have been statistically associated with an increased risk of cancer in the lungs, endometrium, bladder, and breast. This study aims to investigate if regular consumers of brown crabmeat have a higher body burden of cadmium than nonconsumers. This is important as no other studies that have addressed this subject. The results of this research may provide guidance on the consumption of brown meat from crab. The hypothesis of the proposal is that regular habitual consumption of brown crabmeat increases the body burden of cadmium. This study will recruit 25 healthy participants who consume brown crab meat and 25 healthy participants who do not consume brown crab meat. Volunteers will be eligible if they are ages 40 years and older, non-smokers, and have not had significant occupational exposure to cadmium. Eligibility will be determined using a questionnaire that consenting volunteers will be asked to complete. Eligible participants will be asked to attend a study visit at the Rowett Institute or at a GP practice in Stromness (depending on participant location). Participants will be weighed and asked to provide a urine sample as well as a 40 ml (2-3 tbsp.) non-fasted blood sample. The blood and urine samples will be processed at the Rowett Institute or at the Balfour Hospital in Kirkwall (depending on where the study visit took place). Analysis will be completed at the Rowett Institute where whole blood will be analysed for cadmium, selenium, and zinc and the serum for creatinine and ferritin. Urine samples will be measured for cadmium, B2-microglobulin and creatinine. Recruitment is expected to take place over 4 months. Study participants will have the option of receiving feedback on their cadmium, zinc, selenium and ferritin levels.

NCT ID: NCT03104413 Completed - Crohn's Disease Clinical Trials

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Start date: December 18, 2017
Phase: Phase 3
Study type: Interventional

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.

NCT ID: NCT03104127 Completed - Stroke Clinical Trials

Effect of Using a Lower Limb Robotic Device for Patients With Chronic Stroke

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

This study will investigate if a lower limb robotic device can be used in a community setting to increase the amount of physical activity that individuals undertake following stroke and consequently improve biomechanical, physiological and health outcomes, in patients with stroke.