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 purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices. The study results will be used to support the continuation of the CMDs on the market. In addition, the study will support the manufacturers obligation for post market product surveillance as well as Cook's technology development.
To determine whether the Occuity PM1 device is non-inferior in measuring central corneal thickness when compared to ultrasound pachymetry, the Lenstar and the Pentacam. The Investigation aims to assess long-term safety of the Occuity PM1 device when used under the conditions and for the purposes intended, to ensure it will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons. The central corneal thickness measurements taken by the three devices: Occuity PM1, the ultrasound pachymeter and Lenstar. Demonstrating that the Occuity PM1 Pachymeter is not inferior to the LenStar in terms of equivalency to a 95% confidence level using the Bland Altmen equation/approach based on +/-20micron equivalency. The investigators would like to measure the thickness of the cornea, which is the clear window at the front of the eye. A corneal thickness measurement is important for several reasons. The measurement can tell an eye care professional if the cornea is swollen, which may mean the particiapnt have an increase in fluid within the cornea. Also, assessing corneal thickness can help in the diagnosis of glaucoma and the measurement is important if the participant is going to have eye surgery. The instruments that are currently in use are usually very large and quite expensive and therefore not ideal for use as part of routine eye care. Some instruments require contact with the surface of the eye, which may be uncomfortable. Occuity Ltd. is a medical device company based in Reading, which has been investigating this. They have developed a new instrument (called the 'PM1 Pachymeter') for measuring the thickness of the cornea. The instrument shines a harmless low power beam into the eye and then measures the light reflected back from the eye in order to check the thickness of the cornea. The low power beam is not a visible light and so the participant will not be able to see it. s study will assess how closely the eye measurements taken from the new PM1 Pachymeter matches eye measurements taken from two other devices that are currently on the market. The goal is to provide a non-contact, hand-held meter that is fast and easy to use without the need to contact the eye.
Recently, many families have been formed through gamete donation, a reproductive treatment where the ensuing children do not share a genetic link with either parents. However, despite such an increase, little is known about the parent-child relationship. Indeed, only two longitudinal studies have provided scientific background about family functioning in gamete donation. These studies showed that in egg donation families, the parent-child relationship was normal for parenting, parent psychological health, and child adjustment. A more recent study evaluated mother-infant interaction in egg donation families comparing them with those created through IVF with their own gametes. Data collected showed that in egg donation families the mother-infant relationship quality appeared to be less optimal. Mothers were less interactive and stimulating, and infants showed lower involvement and less responsiveness with respect to their mothers Overall, the evidence suggests that women conceiving through egg donation likely require a variable period of adaptation to parenting. Here, the investigators aim to evaluate this interaction at an earlier stage, that is during the gestation. The specific bond that parents develop towards the fetus during pregnancy is called "parental-fetus attachment". Previous studies showed that the quality of the parental-fetus attachment is predictive of the quality of the postnatal parent-infant relationship and the child development The purpose is to evaluate whether the lack of genetic link with their offspring could undermine the parental attachment to the fetus, comparing couples conceiving through egg donation with those who get pregnant through a standard IVF treatment with their own gametes. No studies have been performed so far on this matter. To assess the mother-father fetus attachment, the investigators will administer standardized and validated questionnaires to couples undergoing IVF with their own gametes, or egg donation cycles. For women, the investigators will use the Maternal Antenatal Attachment Scale . For men, the investigators will use the Paternal Antenatal Attachment Scale (PAAS-IT) . Furthermore, to also assess the emotional status of both partners, the investigators will use the Matthey Generic Mood Questionnaire . Seeing that in the general population the maternal-fetal attachment level increases once women have completed the principal prenatal genetic screenings (like NIPT, CVS or amnio) and once they start perceiving the fetal movements, the investigators will administer the same questionnaire twice: between the 19-23 weeks and between the 28-32 weeks of gestation. This approach will enable monitoring of the evolution of the maternal and paternal fetal attachment at relevant gestational time-points. As a result of the knowledge gathered from this study, the investigators will be able to develop a specific intervention strategy to promote this fundamental process for egg donation families.
"Being able to participate in games and activities with their friends" is one of the things that matters most to boys with haemophilia. At present, there is a lack of robust evidence to determine whether muscle strengthening exercise can improve or negatively affect outcomes for young children with haemophilia. With the help of boys with haemophilia, their parents and physiotherapists the investigators have developed an exercise programme designed to increase muscle strength. Using this intervention the investigators will undertake a single-blinded, two-arm pragmatic randomised controlled trial (RCT) of a 12-week intervention verses usual care of boys with haemophilia aged 6-12 years of age.
The research will be conducted as a quantitative experimental study (as an intervention). For the primary DV, quality of life, there are two effective measures. - Health-related Quality of Life (HRQoL) scales of the SF-36 short form - Euro-QoL instruments (EQ-5D). Additionally, secondary variables assessed will be: - (Physical Activity (the International PA questionnaire, short form - IPAQ) - General Anxiety (the Generalised Anxiety Disorder Assessment - GAD-7 - Symptoms of Depression (the Patient Health Questionnaire - PHQ-9) - Habitual diet will be assessed with the EPIC food frequency questionnaire, - Memory function through the Gorilla online questionnaire (Memory Intrusion - TB1 and TB2). - Health locus of control (Multidimensional Health Locus of Control form C) Participants in the intervention group will be required to complete a 30-minute walk five days a week for 12 weeks. This will be in addition to any regular walking or exercise they are currently doing, which will be assessed via questionnaire at baseline. In the control group, participants will be asked to continue with their daily routines and usual level of physical activity. The baseline measurements will be taken before the intervention at week zero. Subsequently, all the participants will attend a virtual meeting (screening visit) to learn about the key aspects of the research, including the required actions of the control and intervention groups, how to use the act watch and report the required data. All participants in the intervention group and the control group will be required to wear acti-watches, which will be given to them for free. Participants in both groups will be asked to report the number of steps covered each week. Participants will report this information through an online link provided by the researcher. Each participant will access their data through an app that comes with the watch, however, the researchers will not have access to the app
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
Chronic myeloid leukaemia (CML) diagnosis is based on the demonstration of a BCR-ABL fusion transcript expressed by the Philadelphia (Ph) chromosome by RQ-PCR and/or the demonstration of t(9;22)(q34;q11) by conventional karyotyping or interphase FISH. As per standard practice, response to therapy is monitored using either molecular or cytogenetic tests or both; specifically, patients are monitored by quantitative PCR on peripheral blood, supplemented by bone marrow karyotyping if it was clinically indicated. ABL kinase mutational analysis is carried out when the transcript ratio has increased over two sequential samples or on clinical demand. Testing for T315I mutation is also performed for patients who fail to respond to first line TKI and all patients who acquire TKI resistance over the course of their treatment. Data collection is initiated six months after date of diagnosis; research nurses working to agreed operating procedures and data standards visit each of the 14 hospitals in the region and abstract a core clinical dataset from the patients' medical records. The information collected includes demographic details, baseline blood count data and first line treatment. All details are abstracted onto structured forms and entered onto the web-based system, which integrates Haematological Malignancy Research Network (HMRN) and Haematological Malignancy Diagnostic Service (HMDS) data. An important feature of data acquisition is the emphasis on primary source information; data from radiology reports, blood tests, clinical examination, and clinician summaries are recorded, enabling embedded algorithms in the database system to automatically generate stage and prognostic scores. Further data abstraction from the medical records has been undertaken to capture information on subsequent treatment lines. Information on date and cause of death were obtained from the National Health Service (NHS) Central Register.
Understanding more about how diseases that cause dementia develop is critical as the number of people living with, or affected by, dementia in Scotland continues to grow. The IONA Longitudinal Cohort Study (LCS) has been set up to gather information about people's cognitive health (their memory and thinking abilities), their lifestyle and health risk factors for future dementia (such as hearing loss and obesity), genetics and disease biomarkers, over a number of years. The IONA LCS has three main objectives: Firstly to develop this cohort that is well characterised (also known as being "well-phenotyped") that represent the Scottish population (taking into consideration age, sex, ethnicity and education). The second objective is to use this data to build disease models to better understand trajectories of diseases, and identify any sub-populations who have different (i.e. better, worse) disease trajectories. Finally the third objective for IONA LCS is to offer people an optional consent to hear about future studies they may be interested in taking part in.
PoZibio™ capsules contains Lactobacillus paracasei which has been heat-killed (post-biotic). The researchers will recruit a cohort of middle aged and older adults (>50 years) who will be randomised into PoZibio™ (2 x capsules daily) or placebo (2 x capsules daily) supplementation for 6 weeks. Subjects will be asked to take both capsules in the morning with their breakfast. The placebo will be matched to the active product by taste and texture. Electroencephalography (EEG) shall be combined with 3 psychological tasks, to measure a variety of cognitive domains including attention, processing speed, accuracy, and response inhibition. These psychological tasks shall include the Stroop task, the Go/No-go task, and the Flanker task. Before taking part in the psychological tasks, participants shall be required to have their EEG resting state recorded, requiring them to participate in an Eyes Open/Closed Task. The Mini Mental State Exam (MMSE) questionnaire shall be used as a digital screening tool to assess global cognitive function in participants both prior to and following the 6-week PoZibio trial. The geriatric depression scale (GDS) shall also be used as a digital screening tool to assess for depressive symptomatology in older adults. The EQ-5D questionnaire shall be used to obtain an overall profile of the health state and quality of life of participants before and after the trial. The researchers will collect venous blood samples for the investigation into the chemical composition using metabolomics, the quantification of short chain fatty acids as well as clinical biochemistry, before and after the trial. Aim: A randomised, placebo controlled parallel human clinical trial of heat-treated Lactobacillus paracasei (post-biotics) in healthy middle aged and older subjects is proposed, to assess the potential for clinically relevant benefits in terms of cognitive function.
When assessing an injured child, doctors must decide whether or not there is an underlying bony fracture. The current way of doing this is by x-ray. In 2011, 46,000 children attended Sheffield Children's Hospital Emergency Department and 10,400 x-rays were taken - predominately for diagnosis of fractures. For foot and wrist, 2,215 x-rays were 'normal' with no fracture, at a cost of £119,610 (at a tariff of £54 per x-ray). Considering the cost and undesired effect of radiation exposure, a better way to discriminate those patients with fracture is needed. The non-invasive technique of thermal imaging holds promise as a putative technique. The investigators have earlier demonstrated the potential of thermal imaging for vertebral fractures, diagnosing limp and measuring respiration rate. This study investigates thermal imaging to screen for wrist fractures. The objectives are: (i) accurately identify fracture location, (ii) exclude cases that are sprain and thus reduce the need for their x-ray. The confirmation of a fracture would still require a x-ray. As the study is in collaboration with Sheffield Children's Hospital, only children will be included, however the findings will also be applicable to adults. Thermal imaging is a completely safe and harmless operation, as the camera is non-contact and emits no radiation. Any trauma, such as a wrist fracture, results in changes in blood flow that in turn affects the skin surface temperature of the skin overlying the injury. These changes affect the amount of emitted infrared radiation and will be recorded and explored to find a marker to differentiate fractures and sprains.