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.
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are - to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II) - to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III) - To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.
Over 3 million in the United Kingdom are now diagnosed with type 2 diabetes, with current estimates suggesting this will rise to over 5 million by 2025. Type 2 diabetes increases the risk of developing cardiovascular disease, kidney disease, depression, neuropathy and dementia, along with being a leading cause of amputation and adult blindness. Sedentary behaviour, defined as any waking moment spend sitting or reclining with energy expenditure equal to or less than 1.5 METs, has emerged as a risk factor in the development of type 2 diabetes. Recent evidence has shown that breaking up prolonged sitting with regular short bouts of activity or standing lower postprandial glucose and insulin. However, the effectiveness of breaking prolonged sitting on glucose metabolism over a longer period of time is unknown. Therefore, the aim of this study is to investigate whether the reduction in postprandial plasma glucose in response to breaking prolonged sitting time is maintained following an intervention to reduce and break up prolonged sitting over a four to five week period. The study will be a single group intervention with pre and post randomised measurement conditions (prolonged sitting and light upright breaks) at both time points. A sample of 43 people (34 to complete), aged 50-75, identified as at risk of or with (drug naive) type 2 diabetes will be sought. The intervention will last approximately 5 weeks. Experimental conditions will be conducted before and after the intervention to assess whether reducing and breaking up prolonged sitting in free living effects glucose metabolism.
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
The primary aim of this study is to assess the relationship between obstructive sleep apnoea (OSA) and cardiac autonomic neuropathy (CAN) in patients with T1D. The secondary aims of this study are to assess: (1) the prevalence of OSA in patients with T1D; (2) the relationship between OSA and metabolic parameters (such as glycaemic control, blood pressure, lipids and weight) in patients with T1D; (3) the relationship between OSA and diabetes-related microvascular complications (retinopathy, nephropathy, peripheral neuropathy) in patients with T1D; and (4) the potential mechanisms for the relationship between OSA and diabetic-related complications if such a relationship is found.
The purpose of this study is to evaluate and compare the Pharmacokinetics (PK) of concomitant administration of Padsevonil (PSL) in the presence and absence of erythromycin in healthy study participants.
Phase 1, 3-part study to assess safety, tolerability and PK of single and multiple doses of itraconazole administered as a dry powder for inhalation (PUR1900) in healthy subjects (parts 1 and 2) and a 2-period crossover study of single doses of itraconazole administered as a dry powder for inhalation (PUR1900) and an oral solution (Sporanox) in adults with mild to moderate, stable asthma (part 3)
Double-masked, uncontrolled, multi-center, study in which participants will be randomized to one of 3 doses of topical ocular PAN 90806 administered once daily for 12 weeks.
Greater Trochanteric Pain Syndrome (GTPS), also known as Trochanteric Bursitis, is a painful condition predominantly affecting middle aged women. It is characterised by pain in the lateral hip exacerbated by movement and lying on the affected side. GTPS encompasses different conditions including gluteus medius/minimus tendinopathy and bursal inflammation. The treatment for this condition begins with conservative treatments of analgesia and physiotherapy, which normally results in a resolution of symptoms. If this fails then steroid injections have been shown to be effective. If this is not successful patients are offered surgery. Steroid injections however may only be effective in the short term and sometimes patients require repeat injections. Platelet rich plasma (PRP) is plasma taken from the blood of the patient that has been treated so that it has a higher than usual concentration of platelets in it. It has been postulated to promote healing in damaged or inflamed tissues. Platelets contain a variety of growth factors, which are involved in healing. It has been used in a variety of orthopaedic conditions such as lateral elbow epicondylitis, patellar tendonitis, rotator cuff pathology and planter fasciitis. Studies have shown varying effects of PRP in these conditions with most promise in plantar fasciitis and patellar tendonitis. These conditions are similar to GTPS. A recent review of treatments for GTPS concluded that more research into PRP efficacy in GTPS is required. We hypothesise that PRP is effective in treating GTPS in patients who have not responded to conservative management (analgesia and physiotherapy). This is an area that lacks research and could be valuable to those suffering from GTPS. Further study is required as PRP could be used as instead of steroid injections or if steroid treatments have failed and this could prevent patients from suffering further or needing surgery. The investigators propose a randomised control trial comparing a normal saline injection with a PRP injection in patients with GTPS, diagnosed by MRI scan, who have not responded to conservative treatments. Patients will receive either PRP or normal saline under ultrasound guidance by a consultant rheumatologist. Sample size calculation has shown that the investigators will need to recruit a total of 100 patients who will be randomised into either arm (50 in each arm). The recruitment period will last 2 years with the whole trial aiming to finish in 4 years from the proposed start date. Neither patients or the study team members assessing the outcomes will know which treatment the patient received. Patients will be followed up at 3, 6 and 12 months. The primary outcome measure will be a patient reported outcome measure (PROM) i-HOT12 (international hip outcome tool) which is a valid and reliable scoring system that assesses patient's ability to return to an active lifestyle through obtaining subjective measures of symptoms, as well as determining emotional and social health status. This will be alongside secondary outcome measures Visual Analogue Pain Score, Modified Harris Hip Score and EQ-5D collected. The proposal was discussed with a group of patients who previously had treatment with Platelet Rich Plasma (PRP) injection for hip pain. A discussion was had with regards the setup of a study and they were enthusiastic about this. A patient information sheet was shown to them and modified as per their comments. Their advice was obtained with regards the setup of this study, the randomisation into placebo arm, followup frequency and the outcome measures. In particular, patients suggested that if placebo was not working then a switch over to treatment arm should be discussed sooner than the initially planned one year. This has been taken into account and six month has been agreed. The proposal was also discussed in the NRES committee who are satisfied with the proposal. Ethical approval has been granted and the study is registered with Health Research Authority England.
This interventional device study aims to compare mainly standard Multiple Daily Injection (MDI) therapy vs. Accu-Chek® Solo Micropump System and investigates participant satisfaction. In addition, a third arm is included to compare to only similar product on the market which is OmniPod. The third arm is for data collection purpose.
The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase III studies GA39688 (NCT03280550) or GA39855 (NCT03280537). Participants will be eligible for enrollment in the study at, or within 28 days after, the Week 24 visit of Studies GA39688/GA39855. After enrollment into this open-label extension (OLE) study, participants will receive 28 weeks of dosing of omalizumab before entering a 24-week off-treatment observation phase of the study. Baseline in this OLE study is defined as the last pre-treatment measurement prior to randomization in Studies GA39688/GA39855 (i.e., baseline of Studies GA39688/GA39855). The data that will be reported from baseline to Week 24 inclusive will come from Studies GA39688/GA39855.