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NCT ID: NCT05663944 Active, not recruiting - Clinical trials for Advanced Chronic Liver Disease

REpurposing SirolimUS in Compensated Advanced Chronic Liver Disease. The RESUS Proof of Concept Study

RESUS
Start date: July 25, 2022
Phase: Phase 2
Study type: Interventional

Background: Advanced liver scarring leads to liver failure, liver cancer and premature death. It mainly affects people in the working age group (18-65 years) and is the only major cause of death that is still increasing every year in the UK. It costs the NHS £2.1 billion a year. This will continue to rise due to increasing alcohol misuse and the obesity crisis. Advanced liver scarring remains incurable as there is no treatment to slow progression of scarring. Sirolimus is a medication that has been used to prevent rejection after organ transplantation for over 20 years. It reduces liver scarring, improves liver functioning and prolongs life in animals. It has also been shown to reduce liver scarring in patients after liver transplantation. Sirolimus, therefore offers a potential treatment option for liver scarring. Question and Objectives: If used in patients with advanced liver scarring, can sirolimus slow the progression of scarring? The main objective is to undertake a small-scale study (proof of concept) to investigate if sirolimus could slow the progression of scarring in patients with advanced liver scarring using clinically relevant biomarkers, which will see if the liver responds to treatment. How it will be done: The study will be conducted in Nottingham University Hospitals NHS Trust. 45 patients with advanced liver scarring will be randomly given either sirolimus or placebo tablets daily for 6 months. Participants will have a liver biopsy and a MRI scan at the start and end of the study to measure the change in the biomarkers of liver scarring. A reduction in these markers will indicate successful treatment. Participants will be monitored for safety of the drug. Potential Impact: If found efficacious, sirolimus would provide an acceptable treatment for patients with advanced liver scarring and would also save a substantial sum of money for the NHS.

NCT ID: NCT05657691 Active, not recruiting - Clinical trials for Major Depressive Disorder

Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD)

Start date: November 28, 2022
Phase: Phase 2
Study type: Interventional

Xanamem is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD). This XanaCIDD Phase II study in MDD is to investigate the safety and efficacy of Xanamemâ„¢ in treating patients with cognitive and depressive symptoms. Trial participants will be randomized to either receive 10mg of Xanamemâ„¢ once daily or a Placebo at a 1:1 ratio in a double-blinded fashion.

NCT ID: NCT05651711 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

ROCKET-Horizon
Start date: December 14, 2022
Phase: Phase 3
Study type: Interventional

The co-primary objectives of the study are to: - Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). - Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

NCT ID: NCT05650229 Active, not recruiting - Clinical trials for Primary Mitochondrial Disease

Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease

FALCON
Start date: December 13, 2022
Phase: Phase 2
Study type: Interventional

The primary objective of the FALCON study is to evaluate the efficacy of KL1333 on selected disease manifestations of primary mitochondrial disease (PMD) following 48 weeks of treatment. This objective involves evaluating the efficacy of KL1333 versus placebo on fatigue symptoms and impacts on daily living as well as on functional lower extremity strength and endurance. Additionally, the study evaluates the safety and tolerability of KL1333.

NCT ID: NCT05648903 Active, not recruiting - Type2diabetes Clinical Trials

The Transform Type 2 Diabetes Study

Transform
Start date: January 7, 2022
Phase: N/A
Study type: Interventional

The aim of this mixed-methods, 12-month interventional study is to understand the effectiveness and acceptability of dietary interventions in type 2 diabetes mellitus (T2DM) in an ethnically diverse population. Three dietary interventions will be offered (total diet replacement, intermittent fasting and a low-carbohydrate diet) and two modes of remote care delivery will be used (group and one-to-one).

NCT ID: NCT05648227 Active, not recruiting - Respiratory Disease Clinical Trials

Validation of an Artificial Intelligence Enabled Diagnostic Support Software (ArtiQ.Spiro) in Primary Care Spirometry Datasets - a Retrospective Analysis

Start date: July 1, 2022
Phase:
Study type: Observational

A retrospective study to evaluate the diagnostic performance of an Artificial Intelligence enabled software (ArtiQ.Spiro) in UK primary care spirometry datasets.

NCT ID: NCT05648110 Active, not recruiting - Clinical trials for COVID-19, SARS-CoV-2

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study

SUPERNOVA
Start date: December 16, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19. The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061. Sub-study: This Phase II sub-study of SUPERNOVA will assess the safety, PK, and predicted neutralizing activity of AZD3152 compared with EVUSHELD for pre-exposure prophylaxis of COVID-19.

NCT ID: NCT05643794 Active, not recruiting - Fibromyalgia Clinical Trials

A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome

Start date: December 21, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate efficacy and safety of rozanolixizumab to treat adult study participants with severe fibromyalgia syndrome (FMS).

NCT ID: NCT05643495 Active, not recruiting - Clinical trials for Alpha-1 Antitrypsin Deficiency

A Study to Evaluate Efficacy and Safety of VX-864 in Participants With the PiZZ Genotype

Start date: February 23, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of VX-864 in participants with the PiZZ genotype over 48 weeks.

NCT ID: NCT05633355 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

ROCKET-Orbit
Start date: January 30, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.