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NCT ID: NCT04674761 Completed - Alagille Syndrome Clinical Trials

Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

ASSERT
Start date: March 19, 2021
Phase: Phase 3
Study type: Interventional

Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.

NCT ID: NCT04674397 Completed - Renal Failure Clinical Trials

BOne Dysfunction in Donor NEphrectomieS

BONES
Start date: July 29, 2015
Phase:
Study type: Observational

Most dialysis patients die from vascular disease, which is statistically associated with changes related to chronic kidney disease associated mineral bone disorder (CKD-MBD)3-9. Understanding the mechanisms behind this high death rate is crucial to improving the length and quality of life for patients with all grades of kidney disease, including those on dialysis. This is a priority for patients and clinicians alike. Most humans with early CKD are asymptomatic and unaware that they have a problem with their kidneys. Therefore they are unlikely to consult a doctor and early CKD is often unrecognised. Patients who are aware of early CKD often have other co-morbidities including diabetes, hypertension and vascular disease which, in the setting of a clinical study, complicate the identification of changes solely resulting from CKD. However over the past decade living kidney donation has become increasingly common and is now the source of organs for more than 120 patients annually at Manchester's renal transplant centre. Prospective donors are carefully examined and known to have normal kidney function without other co-morbidities. They then undergo a planned unilateral nephrectomy and lose approximately 50% of their kidney mass, creating an immediate state of moderate CKD. Over subsequent months the remaining kidney will hypertrophy and partially correct this, although the mechanisms are unknown. In the immediate post-operative period donors are inpatients on the kidney transplant ward and have regular blood and urine tests meaning that careful study of metabolic processes during their recovery is relatively easy by analysis of serial plasma and urine samples. Sequential changes in the plasma and urine levels of different bone turnover markers and metabolites can be analysed and will provide valuable new information to increase our understanding of the initial stage of CKD-MBD development.

NCT ID: NCT04674124 Completed - Mindfulness Clinical Trials

Evaluation of an Online Mindfulness-based Course for New Mothers

Start date: December 13, 2020
Phase: N/A
Study type: Interventional

This research study is aiming to explore whether an online mindfulness programme is accessible and supportive for first time mothers who has a child who is less than 12 months old.

NCT ID: NCT04673630 Completed - Asthma Clinical Trials

Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma

TRAILHEAD
Start date: February 23, 2021
Phase: Phase 1
Study type: Interventional

This study will evaluate the pharmacokinetic (PK) profile of a single subcutaneous (SC) dose of tezepelumab in children aged ≥ 5 to 11 years with asthma.

NCT ID: NCT04673383 Completed - Clinical trials for Major Depressive Disorder

SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients

Start date: February 4, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

SPL026 (N,N-dimethyltryptamine [DMT] fumarate) is a psychedelic tryptamine being developed as a therapy for patients with major depressive disorder (MDD).

NCT ID: NCT04672512 Completed - Healthy Clinical Trials

Single and Multiple Ascending Dose Study of CORT125329 in Healthy Participants

Start date: October 23, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the dose-related safety, tolerability, pharmacokinetics (PK) and pharmacological effects (PD) of CORT125329 after single and multiple ascending oral doses of CORT125329 lipid capsule formulations in healthy participants.

NCT ID: NCT04672499 Completed - Healthy Clinical Trials

Single and Multiple Dose Study of Miricorilant (CORT118335) Tablet Formulations in Healthy Participants

Start date: April 27, 2020
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability, and pharmacokinetics (PK) of miricorilant (CORT118335) tablet formulations following single and multiple oral administration in healthy participants.

NCT ID: NCT04672226 Completed - Clinical trials for Pyridoxine Dependant Epilepsy

Evaluation of PDE MAX

PDE MAX
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

PDE MAX is a single arm prospective, feasibility study in up to 15 participants aged one (1) year and over of PDE MAX for the dietary management of Pyridoxine Dependent Epilepsy.

NCT ID: NCT04671095 Completed - Infection Clinical Trials

Single Use ERCP Performance -SURE Study

SURE
Start date: March 9, 2021
Phase:
Study type: Observational

We do ERCP procedure (Endoscopic procedure with the help of x-rays) for a variety of reasons such as bile duct stones, bile duct obstruction secondary to bile duct narrowing (Strictures) and for bile leak. The incidence of infection post ERCP is around one in 200. There are some group of patients where this risk is significantly increased. In this high risk group, the risk increases from 1 in 75 to in some diseases 1 in 15 (Described in PIS). There are some reports that some of the infection may be contributed by contamination of bacteria in the scope. This happens even after diligently sterilizing the scope. A multi-centre study reported that the risk of contamination is as high as 39% but what we do not know is how many resulted in bacterial infection. We do not know what percentage of infection is secondary to the above. The new single use duodenoscope has been introduced in to the market to minimise the risk of post ERCP infection. It is CE marked and a single centre study reported that the above performance of the above scope was comparable to the standard reusable scope. We want to assess the scope simultaneously in multiple different hospitals. In addition, we also want to assess the cost consequence to the NHS for using the above scope. Hence we want to assess the performance of the scope in the high risk groups for infection.

NCT ID: NCT04671017 Completed - Clinical trials for SARS-CoV-2 Virus Infection

Dose Finding Study to Evaluate The Safety, Tolerability and Immunogenicity of an Inactiviated, Adjuvanted SARS-CoV-2 Virus Vaccine Candidate Against Covid-19 in Healthy Subjects

Start date: December 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A multicenter, 3-arm randomized dose finding study in the UK to evaluate safety, tolerability and immunogenicity of a vaccine candidate against Covid-19. 150 healthy volunteers will be enrolled and receive two shots of the vaccine candidate. All participants who receive two doses of the vaccine candidate will be invited to participate in the Booster phase.