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NCT ID: NCT03630250 Completed - Clinical trials for Meningitis, Bacterial

Challenge of the Nasopharynx With Neisseria Lactamica Expressing the Meningococcal Protein Neisseria Adhesin A (NadA)

NadA-Lac4
Start date: October 18, 2018
Phase: Early Phase 1
Study type: Interventional

This study is part of a research programme that aims to improve ways of protecting people from serious illnesses such as meningitis and sepsis caused by a bacterium called Neisseria meningitidis (N. meningitidis), using a closely related but harmless bacterium called Neisseria lactamica (N. lactamica). Investigators have previously given nose drops containing N. lactamica to over 350 volunteers - this is known as inoculation. In these studies the investigators have shown that they can cause colonisation of many inoculated volunteers (35-60%) with N. lactamica. Colonisation is when bacteria survive on or in a person without causing any illness or disease. N. lactamica specifically colonises the nose and throat. Investigators have also shown that colonisation with N. lactamica results in an immune (antibody) response. In this study investigators will be using a genetically modified version of N. lactamica which contains a single gene from N. meningitides. It is anticipated that the presence of this gene will change the number of people who are colonised and how long people remain colonised for, as well as causing them to produce an immune response to N. meningitides. The purpose of this study are to prove that inoculation with this modified N. lactamica does not cause any symptoms or illness, and to analyse the immune response produced in healthy volunteers.

NCT ID: NCT03630042 Completed - Clinical trials for Waldenstrom Macroglobulinemia

Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström's Macroglobulinaemia

PembroWM
Start date: September 6, 2019
Phase: Phase 2
Study type: Interventional

This study is for patients who have previously been treated for Waldenström's macroglobulinaemia (WM) and their disease has either not responded (known as refractory disease) or has returned (known as relapsed disease). Through this study, the researchers would like to find out whether treating these patients with drugs called rituximab and pembrolizumab is a safe and effective combination for this disease. In this study, pembrolizumab and rituximab will be given together. In other studies pembrolizumab has been shown to be effective at treating diseases similar to WM. The researchers want to test whether giving pembrolizumab and rituximab together is safe and effective.

NCT ID: NCT03629795 Completed - Trisomy 21 in Fetus Clinical Trials

Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA Centaur PAPPA and BhCG Assays

Start date: November 17, 2017
Phase:
Study type: Observational

Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.

NCT ID: NCT03629496 Completed - Feasibility Study Clinical Trials

Developing an Arts-based Intervention for Patients With End-stage Kidney Disease Whilst Receiving Haemodialysis

Start date: September 3, 2018
Phase: N/A
Study type: Interventional

This research study aims to develop an arts-based intervention for patients with end-stage kidney disease (ESKD) that can be implemented during haemodialysis sessions, and to assess the feasibility of a randomised controlled trial (RCT). Haemodialysis is the most common treatment for patients with ESKD; it involves attending hospital three times a week for a period of four hours each time, during that time the patient is connected to a dialysing unit that drains and filters their blood, performing the role of the damaged kidneys. Patients with ESKD receiving haemodialysis report low quality of life (QoL) and poor mental health. Arts-based interventions have been used in a variety of different settings to improve both QoL and mental health, but there's a lack of research assessing their effectiveness in patients with ESKD receiving haemodialysis. This study will develop an arts-based intervention by reviewing the existing literature and forming an advisory group consisting of patients, healthcare staff, artists and academics. Once developed a feasibility RCT will be conducted on a haemodialysis unit. The feasibility RCT will involve establishing the recruitment, participation and retention rates of patients who are eligible for inclusion. A process evaluation will be conducted alongside the feasibility trial; this will involve interviews with patients and focus groups with staff to explore experiences of the intervention. Finally a feasibility economic evaluation will be conducted to explore methods for a cost-effectiveness analysis within an RCT. The hope is this study will contribute to a future RCT that will evaluate the impact of arts-based interventions on the QoL and mental health of patients receiving haemodialysis.

NCT ID: NCT03629080 Completed - Clinical trials for Kidney Transplantation

A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients

Start date: December 12, 2018
Phase: Phase 2
Study type: Interventional

HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative patients receiving a kidney transplant from a CMV-Seropositive living donor and CMV-Seropositive patients.Patients enrolled should have a living donor kidney transplantation ideally planned between two to four months after the first injection of study drug (HB-101 or placebo).

NCT ID: NCT03629041 Completed - Topical Anaesthesia Clinical Trials

A Study of the Use of Microneedle Patches to Deliver Topical Lidocaine in the Oral Cavity

Start date: July 31, 2018
Phase: Phase 1
Study type: Interventional

To look at the effect on patient perceived pain resulting from infiltration injection with local anaesthetic in a dental syringe with prior application of topical anaesthetic to the oral mucosa on a microneedle patch compared to a patch with no microneedles. To look at the safety of the patches when applied to the oral mucosa.

NCT ID: NCT03627585 Completed - Clinical trials for Heart Failure, Systolic

Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

PPPR
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity. This will be achieved by showing in a single centre, phase II, double-blind, randomised, placebo-controlled trial that reducing the amount of pacemaker beats to a minimum reverses these changes and extends battery life.

NCT ID: NCT03627130 Completed - Clinical trials for Acute Coronary Syndrome

The Use of Inorganic Nitrate for the Prevention of Contrast-induced Nephropathy

NITRATE-CIN
Start date: November 29, 2018
Phase: Phase 2
Study type: Interventional

Contrast-induced nephropathy (CIN), an acute kidney injury resulting from the administration of intravascular iodinated contrast media, is an important cause of morbidity/mortality following coronary angiographic procedures in high-risk patients. Despite preventative measures intended to mitigate the risk of CIN, there remains a need for an effective intervention. Dietary inorganic nitrate therapy, which through its chemical reduction in the body delivers nitric oxide has shown promise in attenuating CIN, but its effectiveness in preserving long-term renal function is unknown.

NCT ID: NCT03626584 Completed - Cardiac Amyloidosis Clinical Trials

PET/MR Imaging In Patients With Cardiac Amyloidosis

Start date: August 25, 2017
Phase:
Study type: Observational

PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. It has recently been combined with CT (computed tomography) and MRI (magnetic resonance imaging) scanning to more accurately identify abnormalities within the heart. Cardiac amyloidosis, a condition which causes thickening of heart muscle due to abnormal protein deposits, is of particular interest. There are different forms of this condition and at present samples of tissue need to be taken and analysed in order to assess these accurately, which carries risks. The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. The investigators will use a PET tracer which is widely used in cardiac imaging as it is hoped this will enable characterisation of abnormal areas within the heart in this condition in a way which hasn't been done before. All participants will undergo PET scanning, where a radioactive tracer is injected into a vein before the scan. The radioactive substance only lasts for a short time and is safe, passed out of the body in urine. If successful, this imaging method will enable us to detect differences between different forms of cardiac amyloidosis in a non-invasive way, improving the diagnostic capabilities in this condition.

NCT ID: NCT03626012 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 in Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis

Start date: September 10, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of BIIB078 in adults with C9ORF72-Amyotrophic Lateral Sclerosis (ALS). The secondary objectives of this study are to evaluate the pharmacokinetic profile of BIIB078 and to evaluate the effects of BIIB078 on clinical function. As the first-in-human study, the study enrolls a small number of participants in each cohort. Every participant in a cohort is treated with the same dose or placebo. The study is designed to evaluate and confirm the safety of each dose before enrolling and exposing new participants to a higher dose in the next cohort.