There are about 25435 clinical studies being (or have been) conducted in United Kingdom. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The main objective of the current trial is to investigate safety, tolerability, pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for 4 weeks in patients with COPD.
This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.
Primary Objective: To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy. Secondary Objectives: - To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp[a]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein [VLDL], HDL, and intermediate-density lipoprotein [IDL] particle number). - To assess changes in glycemic parameters with alirocumab vs. usual care treatment. - To demonstrate the safety and tolerability of alirocumab. - To evaluate treatment acceptance of alirocumab. - To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development. - To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).
Background: Peripheral arterial disease is a result of atherosclerotic occlusion in the major arteries supplying the lower limbs and is associated with an increased risk of mortality and morbidity. It results in restricted blood flow to the skeletal muscles causing intermittent claudication (IC). IC presents as cramp like pain affecting 5% of the population >50 years and is associated with a substantial reduction in walking capacity, quality of life and diminished physical function. Supervised exercise programmes have been demonstrated to improve maximum walking distances and NICE recommends group-based supervised exercise for treating patients with IC. However, there is significant variability in the impact of treatment across studies and little agreement on the underlying mechanism whereby exercise increases functional outcomes. Potential mechanisms include skeletal muscle metabolism, VO2 max, anaerobic threshold and endothelial function. Studies are needed to better understand how exercise improves outcome and in whom, so as to better refine and target the treatment. The participation of patients with IC in exercise programmes is low. The investigators need to understand factors influencing participation so that we can improve the number of patients with IC benefiting from the programme The research consists of two workstreams: Workstream one Objective: Assess the extent to which patient baseline characteristics and candidate physiological mechanisms are associated with clinical improvement in IC patients participating in an exercise programme Patients: Patients with documented IC referred from a Vascular Consultant. Eligible patients will be invited to participate in a 12 week supervised exercise programme. Testing Schedule: Measurements will be recorded at baseline (prior to exercise), immediately after the completion of the exercise programme and then three months after. Measurements include: Baseline characteristics that might predict outcome: - Quality of life using the VascuQol questionnaire - Clinical indicators of lower limb function: Ankle brachial pressure index (ABPI), intermittent claudication distance (ICD), Maximum walking distance (MWD). Candidate physiological mechanisms - Aerobic capacity (VO2 max & AT) - Muscular strength and endurance - Muscle morphology (including muscle thickness, pennation angle, fascicle length and elastography) - Endothelial function (sheer stress response as measured by flow mediated dilation) Analysis: Regression analysis will be used to explain variation in patient maximum walking distance at 3 months. The regression will use 9 candidate measures of physiological response and 3 baseline measures to explore what mechanism and patient factors may be associated with clinical improvements. 100 patients recruited over 2 years will give a 90% power to detect an additional increase in variability in MWD explained by each candidate measure of around 5% at the a 0.05 significance level. This research will be used to identify which types of exercise may be most influential in improving outcome and in which patients. Workstream two Objective: Explore the reasons behind patients' participation, non-participation in, experience of and adherence to the exercise programme. Study Design: An interview study of patients with IC routinely referred for supervised exercise. Three groups of patients will be invited to participate. Those who: - Choose not to participate in the exercise programme (Group A) - Agree to participate in the exercise programme (Group B). - Agree to participate but discontinue after at least one session (Group C). Semi-structured face-to-face interviews with 20 patients per group, interviews will be conducted using a topic guide to ensure consistency. The format will be flexible to allow participants to generate naturalistic data on what they consider as important and / or successful in terms of outcome. Data will be analysed thematically and managed using Nvivo software - the approach will be inductive and iterative. This research will be used to redesign the current exercise programme to improve participation and so the impact of exercise in patients with IC.
The primary objective of this study is to assess the safety and tolerability of a single dose and multiple doses of BIIB033 administered to healthy adult Japanese participants. The secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of BIIB033 administered as single and multiple doses in healthy adult Japanese participants and to assess the single-dose and multiple-dose immunogenicity of BIIB033.
This Phase 1, open label, single centre, non-randomised study in patients with advanced solid malignancies consists of two parts: 1. Single Dose Period - will characterise the absorption, metabolism, excretion and pharmacokinetics of a single oral dose of [14C]AZD2014 from the body 2. Multiple Dose Period - will further assess the safety and tolerability and anti-tumour activity of multiple doses of AZD2014 when given as a monotherapy or given in combination with paclitaxel or fulvestrant.
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)
This is a two-cohort, multicenter, open-label study of tafasitamab (MOR208) combined with idelalisib or venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy. Patients completing the study treatment are invited to participate in an optional biomarker sub-study.
This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.