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NCT ID: NCT04362436 Recruiting - Clinical trials for Neuroendocrine Tumors

TheraSphere Selective Internal Radiation Therapy (SIRT) as Treatment for Neuroendocrine Tumours With Liver Mets

ArTisaN
Start date: January 24, 2019
Phase: Phase 2
Study type: Interventional

This is an open label study for patients with inoperable metastatic neuroendocrine liver deposits to see whether treatment with Selective Internal Radiation Therapy (TheraSpheres) could lead to improved treatment response rates with acceptable toxicity (minimal serious adverse events reported). This research will also look at the progression free survival and quality of life of the patients who decide to join the study.

NCT ID: NCT04361734 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

The Role of Lipids in Immune Cell Function in SLE Patients

Start date: February 15, 2016
Phase:
Study type: Observational

The overall aim of this project is to investigate the different types of immune cells found in the blood of patients with Systemic Lupus Erythematosus (SLE) and healthy donors. We know that the amount of fat on the surface of immune cells is an important factor controlling their behaviour. Immune cells from SLE patients are defective and this is associated with changes in the levels of fat on these cells. This project will investigate the level of fat in the blood and on immune cells from patients with SLE and age matched healthy controls, and measure how changes in the amount of fat can affect the way immune cells behave.

NCT ID: NCT04360941 Recruiting - Clinical trials for Metastatic Breast Cancer

PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer

PAveMenT
Start date: August 11, 2020
Phase: Phase 1
Study type: Interventional

This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab. The study will also be investigating how effective the combination is for a subgroup of breast cancer patients whose cancer expresses the androgen receptor (AR) but not the oestrogen (hormone) or HER2 receptors. Palbociclib is a drug used in routine care for hormone-receptor (HR) positive and HER2 negative advanced breast cancer, the most common subtype of breast cancer. It is possible that the combination of palbociclib and avelumab will be a more effective cancer treatment than each drug separately, but this is unknown and this study is needed to establish the best dosage and schedule of each drug as well as how effective the combination is.

NCT ID: NCT04359940 Recruiting - Tetralogy of Fallot Clinical Trials

Effect of Contouring Techniques on CMR Assessment of the Right Ventricle in Repaired Tetraology of Fallot

Start date: January 1, 2013
Phase:
Study type: Observational

Patients with repaired tetralogy of Fallot (RTOF) develop chronic pulmonary regurgitation and require monitoring for right ventricular dilatation. Pulmonary valve replacement can prevent irreversible right ventricular (RV) dilatation and dysfunction and cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. The investigators sought to determine whether the choice of myocardial contouring technique affects preoperative RV volumetric thresholds for intervention.

NCT ID: NCT04359745 Recruiting - Glioblastoma Clinical Trials

Improving Treatment of Glioblastoma: Distinguishing Progression From Pseudoprogression

Start date: March 21, 2019
Phase:
Study type: Observational

Glioblastoma is the most aggressive kind of brain cancer and leads on average to 20 years of life lost, more than any other cancer. MRI images of the brain are taken before the operation, and every few months after treatment, to see if the cancer regrows. It can be hard for doctors to tell if what they see in these images represent growing cancer or a sideeffect of treatment. The similarity of the appearance of the treatment side-effects to cancer is confusing and is known as "pseudoprogression" (as opposed to true cancer progression). If doctors mistake the appearance of treatment side-effects for growing cancer, they may think that the treatment is failing and change the patient's treatment too early or put them into a clinical trial. This means that patients may not be given the full treatment and the results from some clinical trials cannot be trusted. The aim of this study is to provide doctors with a computer program that will use MRI images of the brain that are routinely obtained throughout treatment, in order to help them more accurately identify when the cancer regrows.

NCT ID: NCT04356833 Recruiting - COVID Clinical Trials

Nebulised Rt-PA for ARDS Due to COVID-19

PACA
Start date: April 22, 2020
Phase: Phase 2
Study type: Interventional

Some patients infected with COVID-19 require hospitalisation and develop patients a severe form of a lung disease called respiratory distress syndrome (ARDS). In these patients, the lungs become severely inflamed because of the virus. The inflammation causes fluid from nearby blood vessels to leak into the tiny air sacs in the lungs, making breathing increasingly difficult. This fluid forms small clots in the air sacs, creating a barrier until the cells regenerate. In some patients, this clot does not disappear in a timely fashion or interferes with the development of the new cells. Furthermore, the small clots in the air sacs obstruct the air and oxygen getting deep into the lungs, interfering with proper ventilation. The trial will recruit patients with COVID-19 induced ARDS. Eligible patients (or if patients lack capacity, their legal representative) will be provided with an information sheet and informed consent will be sought. Eligibility will be mainly assessed via routine clinical assessments. Patients will receive a nebulised version of a type of drug called tissue plasminogen activator (rt-PA) that is inhaled using a nebuliser. This is normally a drug used to break down blood clots. In this situation though, it might be useful for stopping clots forming in the lungs, because these might lead to even more difficulties with breathing. The study will run two cohorts sequentially. In cohort 1, 9 consented patients received nebulised rtPA in addition to SOC. 6 patients were receiving IMV and 3 were receiving non invasive support with NIV or CPAP or high flow oxygen or standard oxygen therapy. As an observational arm, matched historical controls who received standard of care were also recruited at a ratio of 2 controls to every 1 treatment arm patient, resulting in 18 historical controls. Originally, the study aimed to recruit 12 patients with 6 on each ventilation type (IMV and non-invasive oxygen support). This would have resulted in 24 historical controls. After the first wave of COVID-19 cases decreased in August 2020 in the UK it became difficult to continue recruitment, so recruitment closed for cohort 1. With a second surge underway in early 2021, cohort 2 will aim to recruit more patients during this period to provide more data on the safety of rtPA. Fewer timepoints will be collected, which will allow for more rapid recruitment while at the same time not compromising safety monitoring. A more flexible dosing regimen for rtPA will be utilised. 30 patients will be recruited in total, with an aim to recruit a minimum of 10 IMV patients and 10 patients on non-invasive oxygen support. To evaluate efficacy, the improvement of oxygen levels over time and safety will be be monitored throughout. Blood samples will be taken to measure markers of clotting and inflammation in both groups. From the end of the treatment phase both groups will be followed up in accordance with SOC for 28 days from the day of first dose of rtPA.

NCT ID: NCT04356781 Recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Do IgG Level Variations in CIDP and MMN Patients Following Initial Intravenous IVIg Treatment Correlate With Ultimate Dosing

digG
Start date: September 28, 2020
Phase:
Study type: Observational

CIDP and MMN are part of a group of chronic inflammatory conditions that affect the peripheral nervous system. In CIDP, there is chronic inflammation of the peripheral nerves and nerve roots leading to demyelination. The myelin sheath is vital in the rapid propagation of nerve impulses between the central nervous system and the peripheral sensory receptors and muscles. By definition CIDP must progress over 8 or more weeks and can either have a slowly progressive disease course or a relapsing course with periods of improvement. Patients typically present with a non-length dependent neuropathy that affects motor (i.e. weakness of proximal or distal muscles, fatigue, swallowing difficulty, double vision, breathing difficulties etc) and sensory function. MMN is a similar condition to CIDP. It is an autoimmune demyelinating neuropathy that leads to slowly progressive asymmetrical weakness that worsens over years without treatment. IVIg is a recognised treatment for CIDP and MMN. A standard starting dose of 2 g/kg/course, spread over 2-5 days, has been widely used in both research and clinical practice. Due to the chronic nature of CIDP and MMN, most patients with these conditions require repeated doses to avoid relapse, but the frequency of courses and the total dose of IVIg per course required to achieve a steady state varies between patients. Given the modest risks involved with IVIg and its cost, the lowest possible dose and frequency of administration are preferred. Current strategies to reduce dose and frequency involve assessing clinical response to lower doses, but this is both time consuming and imprecise.

NCT ID: NCT04354519 Recruiting - COVID-19 Clinical Trials

The United Kingdom Multiple Sclerosis Register Covid-19 Substudy

UKMSRCV19
Start date: March 14, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of the study is to understand the impact of COVID-19 on People with Multiple Sclerosis in the United Kingdom.

NCT ID: NCT04353141 Recruiting - Pneumonia Clinical Trials

International Lung UltraSound Analysis (ILUSA) Study

ILUSA
Start date: April 28, 2020
Phase:
Study type: Observational

Currently there is a great need for an accurately and rapid assessment of patients suspected for Covid-19. Like CT, Lung Ultrasound (LUS) examination can potentially help with the initial triage of patients but also help track the evolution of the disease. LUS can be used in every setting, including settings with limited infrastructure, allowing the reduction of disparities in trials participation. LUS is also a practical approach that can be used by obstetricians/gynecologists, who are the primary care givers in the labour and delivery room. The International Lung UltraSound Analysis (ILUSA) Study is an international multicenter prospective explorative observational study to assess the predictive value of LUS in Covid-19 suspected and diagnosed pregnant patients.

NCT ID: NCT04352933 Recruiting - COVID-19 Clinical Trials

PROLIFIC ChemoprophylaxisTrial (COVID-19)

Start date: May 11, 2020
Phase: Phase 3
Study type: Interventional

The number of confirmed cases of COVID-19 infectious disease arising from the SARS-CoV-2 coronavirus is rising substantially and rapidly, with the potential to overwhelm the ability of the entire National Health Service (NHS) to cope with the increased demand. The availability of personal protective equipment is limited and reports of high risk procedures such as aerosol generating procedures (e.g. intubation for the sickest patients) is a source of great concern for infection transmission. Frontline NHS staff with direct patient contact have the highest likelihood of exposure to SARS-CoV-2 and development of COVID-19 disease. Efforts to protect these workers from development of COVID-19, using drugs to prevent the disease, require urgent evaluation.