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NCT ID: NCT03096574 Recruiting - Clinical trials for Respiratory Syncytial Virus (RSV)

Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy

Start date: June 1, 2017
Phase:
Study type: Observational

Respiratory Syncytial Virus (RSV) is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide. One possible way to protect the mother and young infant from RSV infection is a vaccine given to women during pregnancy (maternal vaccination), which would pass protection to their unborn child. This may help to prevent RSV in the child's first few months of life when they are most vulnerable to infection. There are two main aims to this study: 1. To pre-emptively gauge the knowledge of RSV and potential acceptability of such vaccines amongst pregnant women and healthcare staff working in midwifery and obstetrics, as well as their attitudes (facilitators and barriers) to being involved in hypothetical future research trials. 2. We also wish to gauge the attitudes to routinely recommended vaccines in pregnancy (pertussis and influenza) The investigators propose to undertake a questionnaire-based study of randomly selected pregnant women and healthcare staff (over 16 years of age) at English teaching hospitals and GP practices. Pregnant women attending for ward reviews or antenatal clinics will approached and asked to complete an anonymous paper questionnaire lasting around 10 minutes. Healthcare staff will be approached in person, or via email, and asked to complete a slightly different questionnaire lasting around 5-10 minutes. No follow up will take place. Using statistical software, the investigators hope to identify factors that might affect patients' understanding of RSV and attitudes to being involved in hypothetical future trials and receiving routine vaccination

NCT ID: NCT03093116 Recruiting - Clinical trials for Metastatic Solid Tumors

A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

TRIDENT-1
Start date: March 7, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

NCT ID: NCT03092661 Recruiting - Clinical trials for Normative Oxygen Saturation Levels in Infants

Baby Oxygen Saturation Study

BOSS
Start date: March 27, 2017
Phase: N/A
Study type: Observational

To define preliminary reference (normative) limits for healthy, newborn baby oxygen saturation parameters using the Masimo Radical 7® monitor. To assess protocol feasibility in terms of acceptability to parents and infants. To inform the design of a future larger study where reference limits will be fully defined across a wider gestational age group.

NCT ID: NCT03090347 Recruiting - NAFLD Clinical Trials

Effects of Dietary Nutrients on Liver and Adipose Tissue Metabolism

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

In health,adipose tissue stores fat from the diet. If the fat tissue stops storing dietary fat then this increases the chance of it being stored in the liver, which is related to increased risk of heart disease and type 2 diabetes. It has been suggested that having a diet high in sugars or certain fats, may cause the fat tissue and liver to change how they function; we would like to investigate this in detail.

NCT ID: NCT03086746 Recruiting - Clinical trials for Myocardial Infarction

VItamin D as a Novel Determinant of Injurious Cardiac Remodelling After acuTE Myocardial Infarction

VINDICATE-MI
Start date: April 1, 2018
Phase:
Study type: Observational [Patient Registry]

To provide insight into why vitamin D levels at baseline predict an adverse outcome including hospitalisation, we will establish whether baseline vitamin D levels are an independent marker of LV remodelling in patients experiencing an ST segment elevation myocardial infarction.

NCT ID: NCT03084419 Recruiting - Clinical trials for Rheumatoid Arthritis

APRIL (AbatacePt in Rheumatoid Arthritis-ILD)

APRIL
Start date: June 26, 2018
Phase: Phase 2
Study type: Interventional

Early initiation of treatment for Rheumatoid arthritis (RA) can prevent several of the long term problems associated with the condition. However, many RA patients develop lung inflammation and scarring, called 'interstitial lung disease' (RA-ILD), contributing to early death in 1 in 5 people. There is no proven treatment for these patients and some medications for RA can in fact worsen their lung disease. There is a need therefore to find safe medications that can not only control RA joint disease, but also prevent progression of RA-ILD. Abatacept is an approved drug for treating RA and is used widely. It is a newer RA medication, with a unique mechanism of action, and it has been shown to prevent progression of joint damage and improve physical function. The investigators aim to assess the safety of this medication in patients with RA-ILD and improve our understanding of the mechanism of lung damage in rheumatoid disease. The investigators will perform a small clinical trial to assess the feasibility of performing a larger randomized controlled trial. A total of 30 patients with RA-ILD will be treated with abatacept infusions fortnightly for the first month, then every 4 weeks for a total of 20 weeks. In order to be eligible for the study, a patient must be able to provide written informed consent, be aged ≥18 years, and have interstitial lung disease that has not responded to or progressed over 6 months despite conventional immunosuppression. Change in lung function (forced vital capacity) at 24 weeks will be evaluated. To assess the mechanisms that may be involved with the development of ILD, the investigators will assess the effects of abatacept on biomarkers obtained from the blood and the lung (bronchoalveolar lavage), including markers of infection (the lung microbiome).

NCT ID: NCT03082859 Recruiting - Type 2 Diabetes Clinical Trials

Acute Exercise and Free-living Glycaemic Control in Type 2 Diabetes

Start date: July 2016
Phase: N/A
Study type: Interventional

Exercise is considered one of the three cornerstones of type 2 diabetes (T2D) care programmes (together with diet and medication), yet the majority of individuals with T2D do not achieve the minimum recommended levels of physical activity. Two of the key barriers to exercise appear to be a 'lack of time' and the high levels of perceived exertion and fatigue. At Ulster University, it has recently been demonstrated that a modified high-intensity interval training (HIT) intervention, consisting of 10-min of low-intensity cycling interspersed with two 20-s 'all-out' sprints (reduced-exertion HIT; REHIT), was effective at improving insulin sensitivity in sedentary men over six weeks. Importantly, these benefits were observed despite the very low time commitment (just 10-min per session) and relatively low ratings of perceived exertion ('somewhat hard'). As REHIT is associated with substantial muscle glycogen breakdown, we hypothesise that this exercise mode may also acutely improve glycaemic control in patients with T2D. This study will: 1. Examine the acute impact of REHIT, compared with a no-exercise control, on 24-hour glycaemic control under dietary-controlled but otherwise 'free-living' conditions using continuous glucose monitoring. 2. Compare the effects of REHIT with currently recommended levels of aerobic exercise and a previously recommended HIT model, both of which have been shown to improve 24-hour glycaemic control in T2D. 3. Collect information on individual's perceptions of each exercise mode through measures of affect, motivation, perceived exertion, fatigue, enjoyment and attentional focus.

NCT ID: NCT03077763 Recruiting - Healthy Volunteers Clinical Trials

The Haem and Nitrite Study - The Effects of Haemoglobin NO-blockade on Nitrite-induced Forearm Vessel Dilatation

Start date: December 2016
Phase: Phase 1
Study type: Interventional

The study is a pharmacodynamic random order cross-over trial investigating the physiological effects of intra-arterial infusion of nitrite following a haemolysed autologous blood transfusion.

NCT ID: NCT03077009 Recruiting - Clinical trials for Non-Insertional Achilles Tendinopathy

Functional Improvement and UTC of the Achilles Tendon After Sodium Hyaluronate Injection for Plantaris Syndrome

Start date: March 20, 2017
Phase: Phase 4
Study type: Interventional

This is a study to assess the benefit of sodium hyaluronate (Ostenil) injection for plantaris friction syndrome (PFS) associated with midportion Achilles tendinopathy. Functional outcome scores will be recorded prior to treatment and at regular intervals up to 2 years. Changes in tendon structure will be assessed using ultrasonographic tissue characterisation (UTC). UTC will be performed prior to treatment and also at regular intervals up to 6 months following injection.

NCT ID: NCT03073967 Recruiting - HSV Infection Clinical Trials

Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects

PRIOH-1
Start date: May 8, 2017
Phase: Phase 3
Study type: Interventional

Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved).