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.
INTRODUCTION Vascular complications in kidney transplantation constitute one-third of the early graft loss (EGL) that can be prevented by timely diagnosed cases. A vascular monitoring device may have a possible role in the early identification of graft hypoperfusion critical to reducing graft loss. AIM To evaluate the feasibility of an Implantable Doppler probe as a vascular monitoring device in kidney transplant patients and by obtaining the vital information, inform the protocol development of a definitive RCT. METHODS AND ANALYSIS A mixed-method research design is selected. The quantitative study will comprise a feasibility RCT (fRCT) that will compare demographical characteristics and surgical outcomes of patients that will undergo kidney transplant surgery with vascular monitoring device (intervention group, n=25) against those with standard care clinical observation (control group, n=25). Descriptive statistics will be used to summarise the results that will assess the vascular monitoring capability of implantable Doppler probe in the early postoperative period of kidney transplant patients. The results will provide estimates for surgical outcomes essential to inform the sample size calculation for the definitive study. Information related to the fluency of research methods, availability of research resources, management support, potential challenges faced during the fRCT will be compiled to generate realistic estimates of important parameters for the definitive study. The results will be following the CONSORT updated guidelines for reporting feasibility studies. Qualitative semi-structured interviews of stakeholders (n=12) recruited by purposive sampling will be conducted to explore their experiences of participating in the study, acquire suggestions regarding application of implantable Doppler probe monitoring, and the post implantation patient care. All interviews will be audio-recorded with verbatim transcription. Data will be analysed following the six-phase guide to doing thematic analysis in the NVivo software. The results will be reported in accordance with the consolidated criteria for reporting qualitative research (COREQ) checklist. IMPACT It is anticipated that this study will also elaborate on a possible role of implantable Doppler probe monitoring to improve kidney transplant patient safety, graft survival, service quality improvement, and financial savings in the NHS.
The primary purpose of the study is to compare therapy with antipsychotic medication (antipsychotic monotherapy or antipsychotic combination) versus no antipsychotic medication, and antipsychotic monotherapy versus antipsychotic combination, regarding time to psychiatric rehospitalization, in participants with a psychotic disorder (that is, schizophrenia, schizotypal disorders, schizoaffective disorders, persistent or acute or induced or non-organic delusional disorders, recurrent depressive disorder with psychotic symptoms).
The study objective was to gather short-term clinical performance data for two soft toric contact lenses.
Researchers have developed a probe that contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe. Photodetectors in the probe detect the backscattered light, which is modulated by pulsation of the cerebral arteries. Changes in the extramural arterial pressure affect the morphology of the recorded optical pulse, so analysis of the acquired signal using an appropriate algorithm could enable the calculation of the intracranial pressure noninvasively (nICP), which would be displayed to clinicians continuously. This pilot study is the first evaluation of the device in patients in who the gold standard comparator of invasive ICP was available. The acquisition of pulsatile optical signals was performed for up to 48 hours in each of the 40 patients who were undergoing invasive ICP monitoring as part of their normal medical treatment. Features of the optical signals would be analysed offline. A machine vector support algorithm would be implemented, with the aim of estimating ICP noninvasively and compared to the gold standard of synchronously acquired invasive ICP data.
Rationale: Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT05 and the reference products EU approved Simponi and US-licensed Simponi, in addition to evaluating the safety and tolerability of AVT05, when administered as a single 50 mg/0.5 mL SC dose.
The goal of this clinical trial is to test a group for pregnant women with depression that aims to help them build a stronger relationship with their unborn baby. The main questions it aims to answer are: - Is the group acceptable to pregnant women with depression? - Is it possible to run this group with pregnant women with depression? Participants will be asked to: - attend the group (which lasts 90mins) - complete questionnaires before and after the group, and 1 month later
A body of evidence from both animal and human research suggests that antidepressant drugs may induce early changes in emotional processing that interact with environmental factors to produce a later change in mood. This experimental medicine study will examine the effect of citalopram on emotional cognition under different environmental conditions (as manipulated by the presence or absence of behavioural activation training). Participants will be administered either citalopram or placebo over the course of two weeks. Citalopram will be taken either alone or in combination with behavioural activation training.
To test whether slowing the rate of delivery of inulin with either psyllium or divided dosing of inulin, will reduce colonic gas production as compared to inulin combined with placebo. To obtain pilot data on link between habitual diet and fermentation of inulin.
Background: Exercise performance is a key predictor for healthy ageing. Laboratory and clinical data have shown strength of a nerve called the vagus nerve, which is lost during age-related disease processes, determines exercise performance. The investigators describe a study protocol designed to test the hypothesis that stimulation of the ear (where the vagus nerve can be safely stimulated) may improve exercise performance alongside beneficial changes in vagus nerve activity in human volunteers. Methods. 28 healthy participants aged 18-75y will be randomly allocated to electrical ear stimulation or placebo treatment for 30 minutes at the same time of day, for 7 consecutive days. Heart monitoring, exercise bike testing, a simple sit-to-stand test and blood sampling will be performed immediately before the first day's intervention and after the last day's intervention. Participants and investigators will be masked to the treatment allocations and analyses. After a 14-day break, participants will perform the same protocol for the opposite intervention to their first treatment allocation. The primary outcome will be the change in VO2Peak (the best measure of exercise performance) following stimulation or placebo protocol. Secondary outcomes include reduction in heart rate after ending the exercise bike test, reduction from peak heart rate after standing from sitting, beat-to-beat heart rate measures and blood inflammatory marker levels. These outcomes will measure exercise performance and vagus nerve function. Safety and complications of the intervention will also be recorded. The study was approved by the NHS Research Ethics Committee (21/LO/0856). Discussion. This 'first-in-man' study will explore whether non-invasive vagus nerve stimulation safely boosts exercise performance and/or vagus nerve activity using electrical ear stimulation, providing data for a device-based approach that may be broadly generalisable to improving health outcomes.
Obstructive lung disease is defined by limitations in expiratory airflow, caused by excess mucus, loss of muscle tone, and structural changes. Over time airflow reduction can lead to gas trapping in the lungs (hyperinflation). Hyperinflation is linked to diminished exercise tolerance, shortness of breath, and a poor quality of life. Early treatment options include inhalers and pulmonary rehabilitation; however, surgical intervention and oxygen therapy may be required in the later stages. More prompt, accurate diagnosis will help to improve patient outcomes and optimise their treatment pathways. Two methodologies used to determine lung volumes and hyperinflation, are nitrogen washout and body plethysmography. The accuracy of each in defining lung volumes in patients with obstructive lung disease is debated in literature. Plethysmography requires the patient to sit in an enclosed box and perform a panting manoeuvre and uses measured changes in volume and pressure to derive lung volumes. Plethysmography has been suggested to overestimate lung volumes in patients with obstructive lung disease. On the other hand, nitrogen washout relies on 'washing out' all the nitrogen from the lungs to calculate lung volumes. Gas trapping and poor airflow circulation that occurs in patients with airflow obstruction may lead to underestimated lung volumes. This study will aim to investigate if there is a significant difference between lung volumes obtained by both nitrogen washout and body plethysmography in patients with obstructive lung disease. Subjects with mild, moderate, severe, and very severe obstruction, including those with no obstruction for comparison will be included, with approximately 10 from each group. They will be asked if they consent to undergo an extra test during their routine hospital appointment, which will add ~15 minutes to their visit.