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NCT ID: NCT05429775 Completed - Healthy Volunteers Clinical Trials

In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects

Start date: December 26, 2018
Phase: Phase 1
Study type: Interventional

This is a single centre, open-label, sequential, single dose 4-period crossover, scintigraphic imaging study in healthy male and non-pregnant, non-lactating female subjects.

NCT ID: NCT05428696 Not yet recruiting - Healthy Clinical Trials

Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants

Start date: September 5, 2022
Phase: Phase 1
Study type: Interventional

This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.

NCT ID: NCT05428007 Not yet recruiting - Melanoma Clinical Trials

Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma

Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

The study will evaluate how safe the study drug is, how well you tolerate it, and how it works in the body and the disease's response to the drug. The study drug being tested is sarilumab, when given with the combination of ipilimumab, nivolumab, and relatlimab in patients with stage III or stage IV melanoma that cannot be removed by surgery. Previous studies have provided a strong rationale for combining sarilumab, with ipilimumab, nivolumab and relatlimab in metastatic melanoma to reduce side effects and potentially work better for this type of cancer. Sarilumab is an FDA-approved inhibitor of the receptor for the cytokine IL-6, currently approved for the treatment of rheumatoid arthritis, but it is not FDA-approved to treat melanoma. This means that the use of Sarilumab to treat melanoma is considered investigational. The other drugs which will be administered in this study, ipilimumab and nivolumab, are also monoclonal antibodies, but they target different proteins. Ipilimumab and nivolumab are both approved by the FDA to treat advanced stage III and IV melanomas. The nivolumab + relatlimab FDC (fixed dose combination) being used in this study is considered investigational, meaning it is not approved by the FDA.

NCT ID: NCT05427838 Recruiting - Stroke Clinical Trials

Simulation Training in Emergency Department Imaging 2

STEDI2
Start date: April 7, 2022
Phase:
Study type: Observational

Background and study aims: Computerised Tomography (CT) head scans are frequently requested by Emergency Department (ED) clinicians as one of the investigations for their patients. This often causes a delay when waiting for specialist radiologists to report the findings of the scan. The purpose of this study is to see if online training can improve the ability of ED clinicians to interpret the scans themselves, to a level sufficient to make clinical decisions based on their findings and to explore what aspects of this process they find most challenging. Participants: Emergency Department clinicians who are working in the Emergency Departments of participating sites between April to September 2022 (inclusive), who request CT Head scans as part of their routine clinical practice. What does the study involve?: 180 ED clinicians will be recruited across 6 hospital sites in the United Kingdom. All will undertake a baseline online assessment to measure their accuracy in interpreting CT head scans. One group will then undertake an online training module, with a subsequent assessment immediately afterwards, then over the following 3 months will record interpretations for 30 CT head scans. Head images encountered in participants' routine clinical practice, and their findings, will be compared with the radiology reports for each scan. Participants will then undertake further online assessments 3 and 6 months after the start of the study. Their overall results will be compared with a control group, who will undergo the same process, but undertake the online training after they have tried to interpret 30 scans in their clinical practice. Participants will continue to base their clinical decisions on radiologist reports, not their own interpretations, so patient care will not be affected by this study.

NCT ID: NCT05425043 Recruiting - Pediatric Cancer Clinical Trials

Granulocyte Transfusions After Umbilical Cord Blood Transplant

Start date: September 14, 2021
Phase: N/A
Study type: Interventional

Although most children with leukaemia are cured using drugs (chemotherapy) alone, for some children additional treatments are needed. Stem cell transplant can cure children where chemotherapy and other drugs have failed. In this case, the immune cells of the donor attack the leukaemia cells of the patient. Cord blood collected from the placenta of unrelated babies is often used as a donor cell source and appears to work well at controlling leukaemia and less likely to cause complications such as when the immune cells also mistakenly attack healthy tissues (called graft versus host disease, GVHD). The investigators have noticed that during cord blood transplant, the donor immune system appears to recover more quickly and not be associated with GVHD, when a type of blood transfusion containing white cells are also given to the patient. The infused white cells appear to stimulate the donor immune cells to expand much more than usually seen. During this research, the investigators will study this immune cell expansion during cord blood transplant in children with difficult-to-cure leukaemia who also receive a transfusion of white cells, termed granulocytes. The investigators will assess the safety of the effects of the white cell transfusions and the immune cell expansion on the child, and look at the outcomes on the patient's leukaemia, and whether there is GVHD or not.

NCT ID: NCT05423587 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Genicular Artery Embolisation for Knee Osteoarthritis II

GENESISII
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

This clinical study is designed as a double-blind sham controlled randomised trial with the option of sham group crossover to receive the GAE treatment at 6 months after unblinding. This study will determine if embolisation of abnormal neovasculature arising from branches of the genicular arteries reduces pain in patients with knee osteoarthritis. The study patient population will consist of up to 110 subjects with knee pain for at least 3 months that is resistant to conservative treatment measures. Subjects will be treated with knee embolisation or 2 mL of saline in the sham arm. At 6 months, all subjects in the sham arm will be allowed to cross-over and receive the embolisation procedure with a follow-up duration of 18 months. The total planned study duration is 3.5 years.

NCT ID: NCT05422937 Not yet recruiting - COVID-19 Clinical Trials

Symptom Patterns and Life With Longer Term COVID-19 in Children and Young People (SPLaT-19 Cohort & Qualitative Study)

SPLaT-19
Start date: June 20, 2022
Phase:
Study type: Observational

Introduction: While there is a substantial body of knowledge about acute Covid-19 in children and young people (CYP), less is known about long-COVID, where symptoms continue beyond four weeks, particularly since the most recent wave of the Omicron variant and the UK childhood vaccination programme roll out. This study aims to provide a picture of longer-term effects of an acute Covid-19 infection in CYP and identify their needs. Methods and analysis: The study comprises an observational prospective cohort study and a linked qualitative study. The cohort study will identify CYP aged 8-17 years in the West Midlands of England and, irrespective of Covid-19 status, invite them to complete an online questionnaire at point of recruitment, and after 3, 6, 9 and 12 months. CYP who have experienced long-term effects of COVID-19 will be invited to interview and, those who are currently experiencing symptoms, will be invited to record their experiences in a diary. Adults working in professional or third sector/voluntary roles with CYP will be invited to take part in a focus group to explore the perceived impact of Long-COVID on the wider experience of CYP. Approximately 900 participants will be needed for the cohort study to ensure the sample size is suitable, with approximately 20 CYP invited to interview and approximately 8 professionals invited to a focus group. Descriptive statistics will be used to describe incidence rates of symptoms and symptom resolution trajectories, and comparisons made between exposed and non-exposed groups. Logistic regression models will be used to estimate associations between candidate predictors and development of Long-COVID at each follow-up point. Linear regression will be used to estimate associations between candidate predictors and poor outcome in terms of health-related quality of life, as described by the KIDSCREEN10. Qualitative data will be analysed thematically using the constant comparison method. Ethics and dissemination: Research Ethics Committee and Health Research Authority approvals will be sought. Information about where to seek support will be provided to participants to mitigate against risks of harm. Study findings will be presented at conferences and published in open access journals.

NCT ID: NCT05422599 Recruiting - Sleep Disturbance Clinical Trials

Enhancement of Sleep Quality and Mood Following Supplementation With Lemon Balm in an Adult Population (Lemslp)

Start date: May 5, 2022
Phase: N/A
Study type: Interventional

This study aims to investigate the effect of a 4-week dietary intervention of 300mg encapsulated aqueous lemon balm extract on measures of sleep quality, mood and well-being, alongside relevant biomarkers of circadian rhythms in healthy adults aged 18-40 years with mild sleep problems (PSQI entry of 5 and above). Three visits to the university alongside completing some home tests involving self-test stool, saliva and mood tests and wearing an wrist-secured actiwatch over 4-weeks whilst recording a daily sleep diary will be monitored to estimate sleep changes. Mood ratings, stool and saliva biomarkers will serve as a proxy to sleep improvement.

NCT ID: NCT05421975 Recruiting - Sarcoidosis Clinical Trials

Evaluating Airway Sarcoidosis Pathology With MRI

EASY MRI
Start date: June 28, 2021
Phase:
Study type: Observational

Sarcoidosis is a condition where inflamed cells clump together to form granulomas, which can lead to inflammation or scarring. It can affect any organ of the body, but most commonly affects the lungs. Symptoms can be highly variable, and some patients have no symptoms where as others may develop fatigue or breathlessness. The causes of sarcoidosis are poorly understood. It commonly affects adults in their 30's or 40's. Some patients present with symptoms suggestive of involvement in the airways, such as cough. Inhalers containing steroid are commonly used, but there is a poor understanding of which patients may benefit. Part of the problem is the lack of a sensitive way of measuring these effects and knowledge of how sarcoidosis affects the airways physiologically. The investigators would like to know more about the disease process of sarcoidosis, particularly where it involves the airways. This study will use a number of techniques in order to better understand to disease process. In order to assess whether sarcoidosis produces changes in airway ventilation (and whether these changes are stable or change over a short time period). This pilot study aims to recruit 6 patients who will have magnetic resonance imaging (MRI) with inhaled xenon gas. During this technique, xenon and nitrogen mixture is inhaled and during a subsequent breath-hold, images of the lungs are taken. This creates a detailed view of the lung airway tree, to explore how the disease affects the airways and deeper lung tissue. This technique will be used alongside lung function tests, commonly performed in the laboratory setting and cardiopulmonary exercise testing, to see what happens in the lungs of this group of patients when they reach peak exercise capacity.

NCT ID: NCT05421949 Active, not recruiting - Clinical trials for Pulmonary Artery Hypertension

Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH

REPEAT-PAH
Start date: February 19, 2021
Phase:
Study type: Observational

The purpose of this study is to examine N-terminal pro brain natriuretic peptide (NT-proBNP) and brain natriuretic peptide (BNP) biomarkers in a number of different settings including assessing the repeatability of laboratory and point of care testing (POCT), the effect of a time delay and exercise have on laboratory measurements. Also to compare the clinical and analytical performances of NT-proBNP and BNP POCT samples across the spectrum of disease severity and finally assess whether POCT in PAH can detect change in patients commencing or escalating PAH treatment.