Participate in a research study at PRC: Newcastle

The purpose of this study is to understand how people with heart failure are treated, especially with regards to a class of medications for heart failure called “renin-angiotensin-aldosterone system inhibitors (RAASi)”. The study compares the given therapy to the treatment recommendations in guidelines from major cardiovascular diseases associations.

RAASi medications are known to have many benefits for heart failure patients. However, RAASi can also cause high blood potassium in some patients (hyperkalaemia), which can be a dangerous condition. The most common treatment for a high blood potassium is to decrease the dose of, or stop RAASi treatment, despite the overall benefits.

This study will investigate the changes to the RAASi medications overall, and after an episode of high blood potassium in patients who have or who are at a high risk of developing hyperkalaemia. The study will also investigate whether patients treated with RAASi according to the treatment guideline recommendations can potentially benefit by living longer, improving the heart failure symptoms, avoiding hospitalisations and avoiding cardiovascular events. Another aim of this study is to evaluate RAASi treatment patterns and effectiveness of patiromer (a drug which reduces potassium levels in patients with hyperkalaemia) in a subgroup of patients who are already being treated with patiromer as part of their regular medical care.

This study is non-interventional, which means you will not receive any medications or treatments as part of the study. You will continue to receive your regular medical care from your doctor. Taking part in the study involves completing an electronic questionnaire about your symptoms and your quality of life upon enrolment and every 6 months until the end of your time on the study. The questionnaire takes about 5 minutes to complete.

The purpose of this study is to find out whether the daily intake of a dietary supplement with specific galacto-oligosaccharides (GOS) can reduce the symptom severity of patients with irritable bowel syndrome (IBS). Galacto-oligosaccharides are made up of sugars that are found naturally in dairy products, beans and certain root vegetables.

GOS are used as prebiotics. Prebiotics act as food for "good" bacteria in the intestine. The study is testing the assumption that the study product improves your immune function and can result in a favourable change in the gut microbiome (the healthy bacteria that reside in your intestines) composition by increasing the ''good'' gut bacteria. The study compares the effects of the study product (a specific GOS) with the effects of a placebo. A placebo is a substance that looks like the study product but has no active ingredient.

If you take part in the study, you will randomly receive either the study product or the placebo to be taken once a day. You will be asked to visit the study site 3 times in 10 weeks, have 3 telephone calls with a member of the team, and complete questionnaires and diaries from home throughout the course of the study. A visit at the study site will take approximately 1 hour. You will receive compensation for travel and parking expenses incurred to attend the study visits.

This is a clinical trial for patients diagnosed with non-obstructive coronary artery disease. The purpose of this research study is to determine if the study treatment, called inclisiran, taken in addition to statin medication can safely and effectively reduce the total amount of plaque formed in the heart’s vessels. The study will also focus on understanding how your body reacts to the study treatment as well as identifying the patients who would most likely benefit from this treatment using biomarker analysis.

If you take part in the study, you will either receive the study treatment or a placebo, both of which will be given as an injection. You will be in the study for about 24 months and, during that time, will need to have between 8-12 study visits (either in person at the study site, by telephone, and/or at home). During the first 9 months of the trial, you will need to have between 5-8 study visits (either at the study site, by telephone, and/or at your home), depending on the type of statin medication you are currently taking.

This trial is open at PRC: Newcastle and upcoming at PRC: Exeter and PRC: Bradford.

CLOUDS Study - Cross-sectional investigation of burden of disease in newly operated stoma patients

The purpose of this study is to better understand the impact of living with a stoma on people who have had an ileostomy, or a colostomy.

• If you decide to take part, we will arrange a phone call to help you understand more about the study. We will explain in detail about what your participation involves, and you will be able to ask any questions you may have. You are welcome to bring a family member or a friend to this meeting. If you choose to participate in the investigation, we will then ask you to sign a consent form, in which you agree to participate in the study as described in this information sheet.

• During the study you will be invited for a virtual meeting with a member of the research team who will ask you a series of questions about your experience of living with a stoma and some personal information.

• Virtual calls: All meetings will be planned to be virtual using Microsoft Teams, Skype or Face Time, if technically possible. If a virtual visit is not possible, a face-to-face meeting will be scheduled, either at your home or at the hospital site.

• You will also be asked to fill in two (2) surveys. The surveys will be sent to you via a link in an email or SMS (text). The first survey will ask you questions on your personal experience of living with a stoma. The second survey is sent out at the end of the study so that you can feed back your experience of taking part in research. This is a way of demonstrating that your contribution is valued, and to help improve the way research studies are designed and delivered, now and in the future.

• We will ask you to keep information about the study confidential, meaning that you are welcome to discuss the trial with your loved ones and of course also your GP/stoma nurse if there should be a need for this, but we must ask you not to share information about the study in a larger forum, such as on social media.

This study is currently closed to recruitment and in follow-up.

Fremanezumab is a humanized monoclonal antibody that selectively targets calcitonin gene-related peptide and is approved in Europe for migraine prevention in adults with ≥4 migraine days/month. The Pan-European Real Life (PEARL) study is a 24-month, prospective, observational study of fremanezumab in chronic or episodic migraine. End points include proportion of patients with ≥50% reduction in monthly migraine days during 6 months of treatment (primary); changes in monthly migraine days, disability scores and acute headache medication use; adherence and persistence; and effectiveness in patients switching from another calcitonin gene-related peptide pathway-targeting monoclonal antibody. PEARL is being conducted in approximately 100 centers in 11 European countries (estimated n = 1100). PEARL will generate important real-world data on effectiveness of fremanezumab and treatment patterns in patients with chronic migraine or episodic migraine. 

A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinphilic phentoype treated with GSK3511294 compared with mepolizumab or benralizumab

Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)

The purpose of the study is to investigate the effect, safety, and tolerability of the study drug for the treatment of patients with COPD, who continue to have symptoms on current treatment, and who are in need of an additional treatment to their current COPD management (standard of care SoC ). Simply put, we want to see if adding the drug on top of your current treatments improves COPD outcomes/exacerbations, therefore this study treatment will be given in addition to your current controller therapy.

The study is a multicentre study conducted worldwide. It will last approximately 72 weeks and will include 1170 participants, some ex-smokers, some ongoing smokers. Of those, about 740 participants will receive study drug itepekimab and about 430 participants will receive placebo (substance looks exactly like itepekimab but is not medically active). If you provide consent to participate, you will undergo study activities described in the following sections. During the study, the term “study treatment” will refer to either itepekimab or placebo.

This study is randomised, meaning study treatment will be assigned to you on a random basis (like flipping a coin). Your chance of receiving active treatment (itepekimab) if you are a former smoker at study start is 2 out of 3. Your chance of receiving active treatment (itepekimab) if you are a current smoker at study start is 1 out of 2. The study is also “blinded”, which means that both you and the study doctor will not know in which treatment group you are included and which study treatment you are receiving (itepekimab or placebo). However, in an emergency the exact treatment can be identified.

Interventional, randomised, double-blind, parallel-group, placebo-controlled delayed-start study to evaluate the efficacy and safety of eptinezumab in patients with episodic Cluster Headache (eCXH)

This study is currently closed to recruitment and in follow-up.

20170703 is a study in adult participants with Chronic Migraine (CM) and Medication Overuse Headache (MOH). The purpose of conducting the study is to better understand the effectiveness and safety of erenumab compared to placebo when given to a targeted population diagnosed with CM and MOH that have at least one preventative treatment failure, to see if it makes any changes in the number of days participants suffer from monthly headache days (MHD) and are able to revert the medication overuse status.

This study is looking at a combination of two medicines that have been shown in previous clinical trials to help people lose weight. REDEFINE3 is needed to help us understand how effective the combined medication is for also reducing cardiovascular events, such as heart attacks and stroke, for people with heart disease and excess body weight.