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 primary objective of the study is to evaluate the safety and tolerability of 2 dosing regimens of pozelimab and cemdisiran combination therapy during the open-label treatment period (OLTP) The secondary objectives of the study are: - To evaluate the effect of the combination treatment on the following parameters of intravascular hemolysis: lactate dehydrogenase (LDH) control, breakthrough hemolysis, and inhibition of total complement hemolysis activity (CH50) - To evaluate the effect of the combination treatment on hemoglobin levels - To evaluate the effect of the combination treatment on red blood cell (RBC) transfusion requirements - To evaluate the effect of the combination treatment on clinical outcome assessments (COAs) measuring fatigue and health related quality of life - To assess the concentrations of total pozelimab in serum and total complement component (C) 5 and cemdisiran in plasma - To assess immunogenicity to pozelimab and cemdisiran - To evaluate the long-term safety and efficacy of pozelimab and cemdisiran in an optional open-label extension period (OLEP) - To assess safety after treatment intensification with pozelimab and cemdisiran
This is a multi-center screening study with the primary objective to determine the prevalence of KIT D816V mutation in peripheral blood in patients with evidence of systemic mast cell activation (MCA).
Pilot trial： The feasibility study of the programme modules has a pre-post design with no control group, with the aims of assessing programme implementation, cultural and contextual relevance, and study feasibility. Although there will be no comparison group and it is not designed to test effects, the study also has a provisional goal of reductions in child physical and emotional abuse at immediate post-intervention. Pre-post design: The ePLH parent support groups will be delivered over a 8 week period (i.e., 7-8 short online interactive group sessions, two per week). The programme will include text/audio messages, illustrated comics, videos, and activity assignments for parents to do with their children. ePLH facilitators will moderate discussions around the parenting theme, support parents on an individual basis, and encourage them to apply the parenting skills at home. Parents will be prompted to give feedback regarding successes and challenges applying these parenting skills via audio or text messages during the week. The facilitators will begin the next group engagement with a brief voice summary of the feedback and address possible solutions to 2-3 key challenges. Facilitators will also be provided with weekly supervision by an ePLH coach or trainer. A designated research assistant will provide parent support groups with needed technical support during the implementation - including IT-related support. Data bundles will be provided for internet access and to incentivise engagement.
There is little information on how Crohn's disease progresses in between a patient's clinic visits and how stress impacts symptom change including flare-ups. The purpose of this research study is to see if digital tools like smartphones, and wearable devices are helpful in finding out new information that may explain fluctuation in symptoms. This study is a feasibility study that will try to identify biomarkers, collected through a smartphone app and wearable devices paired with clinical information collected during clinic visits to track participants' overall health for 6 to 12 months. The data collected will be used to identify and predict symptoms associated with Crohn's disease flare ups. The aim of this work is to inform knowledge of what triggers Crohn's disease worsening that might lead to advances in management.
This is a worldwide, multicenter, non-interventional, retrospective study of patient medical records from metastatic breast cancer (mBC) patients previously identified as human epidermal growth factor receptor 2 negative (HER2-neg), regardless of hormone status.
The purpose of this study was to evaluate the implementation of inclisiran in a regional primary care setting in the UK Inclisiran, also known as KJX839, is a medication made to reduce the level of "bad" cholesterol (LDL-cholesterol) in the blood. Inclisiran works in a way that makes the liver produce less of a substance called 'PCSK9'. PCSK9 reduces the ability of the liver to remove LDL-cholesterol from the blood. By lowering the production of PCSK9, Inclisiran leads to more LDL-cholesterol being removed by the liver from the blood, thereby reducing LDL-cholesterol overall.
The UK Medicine and Healthcare products Regulatory Agency (MHRA) granted temporary authorisation to three Covid-19 vaccines in December 2020 and January 2021. These vaccinations include: - Covid-19 mRNA BNT162b2 vaccine (Pfizer-BioNtech vaccine); - ChAdOx1-S vaccine (Astra Zeneca vaccine); - Covid-19 mRNA vaccine (Moderna vaccine). Any other Covid-19 vaccines approved for use by the MHRA in immunocompromised and immunocompetent patients are to be included in this study. The above vaccines have received temporary authorisation after placebo-controlled phase 3 studies confirmed their safety and efficacy in over 100,000 volunteers. People who were immunocompromised or were receiving chemotherapy, radiotherapy or immunoglobulin treatment were excluded from these studies. Safety, efficacy, and durability of antibody response in these studies has been assessed for up to 14 weeks only. These vaccines are being rolled out in the UK and have been recommended for use for immunosuppressed individuals including patients undergoing chemotherapy, immunotherapy, radiotherapy, and those who have undergone stem cell transplantation. Though the MHRA has approved vaccination for immunocompromised patients there is no published evidence to confirm safety and efficacy in these patients. The durability of antibody response and whether this is affected by concurrent chemotherapy, immunotherapy, radiotherapy treatment is also unknown. This observational study aims to evaluate the immune response to Covid-19 vaccines in haematology patients who have immune suppression either due to disease, treatment, or both. The investigators plan to measure Anti-SARS-COV2 IgG antibody levels at 3-5 time points 30 days apart after patients have received their 2nd dose of Covid-19 vaccine. The investigators will also collect any adverse events reported by patient including Covid-19 infection or disease after vaccination. The study plans to recruit 50 haematology patients who are clinically assessed by a haematologist as immunosuppressed due to their disease, treatment, or both. The study also plans to recruit 30 healthy (immunocompetent) volunteers who would be the control group for comparison of antibody response and durability.
The purpose of this study is to assess the problems and a range of nutritional and clinical outcomes that occur with two feeding tubes used by children having a bone marrow transplant. Children and parents will also be interviewed to ask about their experiences of tube feeding.
Inflammatory arthritis such as rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are characterized by synovial inflammation of joints, potentially leading to joint destruction and functional disability. Inflamed joints have lower oxygen levels. Studying how oxygen level within the joint affect inflammation may lead to new treatments for patients with arthritis. Anti-inflammatory corticosteroid injection into the joint is well tolerated and widely used in clinical practice but its effects on oxygen level within joints is unknown. Therefore, patients who require corticosteroid injection into the joint as routine clinical care will have biological samples collected before and after the injection. This will give new information to put into context the biological effects within the joint, and accelerate development of new treatment approaches in the future.
This is a single-center, open-label, non-randomized, single dose study in healthy male subjects. It was planned to enroll 2 cohorts of 5 subjects (10 subjects in total), with the target of achieving data in 4 evaluable subjects per cohort. Five subjects were to receive a single oral dose of APX001 and not more than (NMT) 3.1 megabecquerel (MBq) (84.0 microcurie [μCi]) 14C in the fed state. Five subjects were to receive a single IV administration containing APX001 and NMT 3.4 MBq (93.0 μCi) 14C in the fed state.