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NCT ID: NCT04238676 Active, not recruiting - Clinical trials for Chronic Low-back Pain

Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain

Start date: January 20, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1b study to investigate the efficacy of PP353 compared to placebo in the treatment of chronic low back pain associated with bone oedema.

NCT ID: NCT04236609 Active, not recruiting - Clinical trials for Coronary Artery Disease

Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global

ABILITY
Start date: June 15, 2020
Phase: N/A
Study type: Interventional

To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome

NCT ID: NCT04232969 Active, not recruiting - Parkinson's Disease Clinical Trials

Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease

Exenatide-PD3
Start date: January 20, 2020
Phase: Phase 3
Study type: Interventional

This study is a clinical trial in patients with Parkinson's disease (PD), of a drug called exenatide, which is already licensed for the treatment of patients with type 2 diabetes. There have been several groups that have confirmed that exenatide has beneficial effects of nerve cells when tested in the laboratory, which raises the possibility that exenatide may slow down or stop the degeneration of PD. In an open label trial in patients with PD who self administered the drug for a period of 48 weeks, the investigators have previously shown that the drug is well tolerated and shows encouraging effects on the movement and non-movement aspects of the disease. A double blind placebo controlled trial involving 60 participants was then conducted which indicated that exenatide may be a "neuroprotective" drug, i.e. one that stops the nerve cells dying in PD. The next step is therefore to confirm this "neuroprotective" effect and to see whether this effect can be reproduced in a multi-centre setting including a larger number of participants. An important objective is to explore whether any positive effects remain static or increase when the treatment is continued over a 96 week period. In order to explore this, a randomised, double blind, parallel group, placebo controlled, Phase 3 trial of Exenatide is being undertaken (Exenatide-PD3).

NCT ID: NCT04227782 Active, not recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

MRI and Stable Isotope Tracer Studies for Detecting the Progression of Non-Alcoholic Steatohepatitis (NASH)

MRI-Detect
Start date: March 1, 2020
Phase:
Study type: Observational

One-third of the world's population suffers from Non-Alcoholic Fatty Liver Disease (NAFLD), that is a disease with an accumulation of fat in the liver. Some patients with NAFLD will progress in their disease to develop inflammation, scarring of the liver tissue, and cirrhosis that can lead to liver failure. The mechanisms of the disease and its progression are still not fully understood. It is therefore critical to find early markers that can identify the patients that will progress so that they can be treated early. A compound called L-carnitine, synthesised in the body from two amino acids; lysine and methionine, is critical for fat metabolism. Some studies have shown that it is decreased in liver disease patients and that L-carnitine supplementation can protect the liver function. This study aims to increase the understanding of the mechanisms behind NAFLD disease progression through its different stages. This may help diagnostic methods to be developed to predict the patients at risk for developing severe liver disease. Furthermore, fat metabolism and L-carnitine levels will be established in the different disease stages to evaluate whether fat metabolism could be compromised. Magnetic Resonance Imaging (MRI) will be used for imaging of the whole liver and the heart to investigate metabolism and function non-invasively. Whole-body metabolism and how carbohydrates are taken up from diets are converted to fats in the body will be explored using stable isotope labelling. This study will recruit 30 participants with NAFLD; 10 each for low-risk NALFD, biopsy-proven NASH and compensated NASH cirrhosis. Participants will undergo MRI, followed by a stable isotope labelled study, where through blood- and breathe samples, metabolism will be investigated. An additional 10 healthy participants will be assessed using MR techniques to assess whether an injection of L-carnitine can lead to increase of L-carnitine in the liver such that it can be detected by MR. This is to validate a methodology prior to using it in NAFLD participants.

NCT ID: NCT04226248 Active, not recruiting - Parkinson Disease Clinical Trials

CHIEF PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease)

CHIEF PD
Start date: January 2, 2020
Phase: Phase 3
Study type: Interventional

Parkinson's disease is a common condition particularly affecting older people. Falls are a very frequent complication of the disease affecting 60% of people with Parkinson's every year. As the population ages, the number of people living with Parkinson's disease and the occurrence of complications will increase. The loss of the chemical dopamine in the brain causes walking in Parkinson's to become slower, unsteady and irregular. People with the condition are therefore at a very high risk of falling. To some extent, people can compensate for these changes by paying more attention to their walking. However, Parkinson's also diminishes memory and thinking ability. This decreases people's ability to pay attention to their walking, especially when doing something at the same time. Cholinesterase inhibitor (ChEis) are drugs that are currently used to treat people with memory problems in Parkinson's. The effect of these drugs on falls in Parkinson's has been tested to show that treatment has the potential to almost halve the number of falls. This trial aims to definitively determine whether cholinesterase inhibitors (ChEi), can prevent falls in Parkinson's and whether this treatment is cost effective. 600 participants with Parkinson's disease will be enrolled from hospitals throughout the UK. Participants will be randomly assigned to either receive the drug (ChEi) via a patch or receive a placebo (dummy) treatment via a patch. Neither the researchers nor the participants will know which group they are in. Participants will take the medication for 12 months and record any falls that they experience in diaries. If successful, this treatment in Parkinson's disease, would tackle one of the most disabling complications of the disease and positive findings will provide robust evidence to change clinical practice.

NCT ID: NCT04225871 Active, not recruiting - Clinical trials for Generalized Myasthenia Gravis

Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis

RAISE-XT
Start date: December 23, 2019
Phase: Phase 3
Study type: Interventional

The RAISE-XT study is an open-label extension study to evaluate the long-term efficacy, safety, and tolerability of zilucoplan in subjects with gMG who have previously participated in a qualifying Ra Pharmaceuticals sponsored zilucoplan study.

NCT ID: NCT04225715 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B

Piranga
Start date: July 5, 2020
Phase: Phase 2
Study type: Interventional

This is a study designed to evaluate the safety, tolerability and efficacy of New Molecular Entity (NME) combination therapies in Chronic Hepatitis B (CHB) participants with preserved liver function and without significant fibrosis/cirrhosis. The platform design allows comparison of multiple NME combination therapies against a common control, and introduction of additional treatment arms at later study time points. Each arm will consist of a screening phase (up to 8 weeks), treatment phase (up to 48 weeks) and post-treatment follow-up phase (48 weeks). The safety and efficacy will be monitored throughout the study.

NCT ID: NCT04225156 Active, not recruiting - Clinical trials for Primary Immune Thrombocytopenia

A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).

ADVANCE+
Start date: June 2, 2020
Phase: Phase 3
Study type: Interventional

This is an open-label long-term multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in adult patients with primary ITP.

NCT ID: NCT04223778 Active, not recruiting - HIV Infection Clinical Trials

Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

Start date: February 18, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified background antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.

NCT ID: NCT04222972 Active, not recruiting - Neoplasms Clinical Trials

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

AcceleRET-Lung
Start date: July 24, 2020
Phase: Phase 3
Study type: Interventional

This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease.