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NCT ID: NCT03153137 Completed - Clinical trials for Congenital Heart Disease

Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects

RUBATO
Start date: August 14, 2017
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.

NCT ID: NCT03153111 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

SERENADE
Start date: July 11, 2017
Phase: Phase 2
Study type: Interventional

This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease. The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.

NCT ID: NCT03153046 Completed - Schizophrenia Clinical Trials

The Effects of Prebiotics on Cognitive Functioning and Weight Gain in Psychosis

Prepsy
Start date: May 8, 2017
Phase: N/A
Study type: Interventional

The investigators propose a maltodextrin-controlled cross over experimental medicine study that aims to examine the role of the immune system in cognitive processes and weight gain in 40 adult patients with psychosis, stable on antipsychotic medication for over 1 month. There is evidence suggesting the immune system is linked to brain function and weight gain, both parameters that has been implicated in psychosis and antipsychotic use, and may underlie some schizophrenic features. The fermentation of galacto-oligosaccharides (GOS), which are short chain carbohydrates composed mostly of galactose sugar molecules, by the intestinal microbiota has been shown to modulate the immune system and reduce the inflammatory response in both animals and humans. Since the intestinal ecosystem is highly sensitive to dietary changes, the growth of beneficial gut bacteria can be enhanced using a natural food supplement similar to GOS known as prebiotics. The study will be controlled by taking maltodextrin as a control supplement. Both prebiotics and maltodextrin are short chain sugar compounds. The study will involve asking patients to take dietary supplement for a total of 24 weeks; GOS for 12 weeks and maltodextrin for 12 weeks as a control. Participants will be randomised into groups, with half receiving maltodextrin followed by GOS, and half receiving GOS followed by maltodextrin. Participants will be assessed on cognitive function and weight gain at 3 specified time points.

NCT ID: NCT03152370 Completed - Clinical trials for Neoadjuvant Therapy in Rectal Cancer

Preoperative Radiotherapy and E7046 in Rectum Cancer

PRAER 1
Start date: May 17, 2017
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, Phase 1b study in participants with locally advanced rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by magnetic resonance imaging (MRI). It is conducted to assess the safety, to assess the tolerability, and to determine the recommended Phase 2 dose (RP2D) of E7046 in combination with pre-operative chemoradiotherapy. The study will also assess the efficacy of the combination in the expansion part at RP2D.

NCT ID: NCT03152149 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

INvestigating COPD Outcomes, Genomics and Neutrophilic Inflammation With Tiotropium and Olodaterol

INCOGNITO
Start date: June 1, 2017
Phase: Phase 4
Study type: Interventional

This protocol describes a randomised controlled trial to test the hypothesis that 6 months of treatment with tiotropium and olodaterol will result in a reduction in bacterial load, an improvement in neutrophilic inflammation and clinical benefits compared with treatment with inhaled fluticasone furoate and vilanterol in patients with neutrophilic Chronic obstructive pulmonary disease (COPD). COPD is the third leading cause of death worldwide and a major cause of morbidity in the UK. Exacerbations drive disease progression and worsening quality of life and therefore prevention of exacerbations has been a major goal of treatment. In recent years, attempts have been made to phenotype COPD patients in order to target therapies to the correct groups of patients that will benefit. Inhaled corticosteroids (ICS) are primarily effective for patients with eosinophilic inflammation, while there are few established therapies for patients with neutrophilic disease. In recent years, all ICS preparations have been associated with a significant increased risk of pneumonia and this risk appears to be greatest in patients with non-eosinophilic inflammation. Combined treatment with long acting beta-agonists (LABA) and long acting muscarinic antagonists (LAMA) combinations appears to be a safer and more effective alternative for patients with non-eosinophilic disease. The combination of tiotropium and olodaterol in particular, has strong preclinical data supporting beneficial effects on neutrophilic inflammation. The trial is a multi-centre randomised open label controlled parallel group study with two treatment arms in 80 participants. Moderate to very severe COPD patients and currently treated with inhaled corticosteroid therapy will be randomised to treatment with either the combination of tiotropium and olodaterol (LABA/LAMA) or fluticasone furoate and vilanterol (ICS/LABA). Participants will return at 1 month, 2 months, 3 months and 6 months for sampling of the lower airway by sputum samples and the upper airway using oropharyngeal and nasopharyngeal swabs. Sputum will be used to test for airway neutrophilic inflammation. This study will make an important contribution to understanding "phenotyping" in COPD by identifying whether the combination of tiotropium and olodaterol improves airway bacterial load and restores neutrophil function in patients with neutrophilic COPD.

NCT ID: NCT03151941 Completed - Multiple Sclerosis Clinical Trials

Respiratory Monitoring of Intrathecal Baclofen- a Feasibility Study

Start date: March 6, 2017
Phase: N/A
Study type: Observational

The methodology is a feasibility study to determine the feasibility of assessing people in the community with a neurological condition before proceeding towards a full powered community trial evaluating the influence of intrathecal baclofen.

NCT ID: NCT03151551 Completed - Psoriatic Arthritis Clinical Trials

A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

SPIRIT-H2H
Start date: August 24, 2017
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.

NCT ID: NCT03151512 Completed - Prostate Cancer Clinical Trials

UNDISTORT Correction of Distortions in Diffusion MRI V1.0

UNDISTORT
Start date: March 29, 2017
Phase:
Study type: Observational

This is a three-year project funded by a Cancer Research UK Multidisciplinary Award and brings together a team from UCL Division of Medicine, Computer Science and University College London Hospital. The aim is to develop Magnetic Resonance (MR) sequences and mathematical algorithms to reduce the distortions in MR images, especially of the prostate.

NCT ID: NCT03150810 Completed - Clinical trials for Locally Advanced or Metastatic Solid Tumors

Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors

Start date: June 28, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study is to determine the safety and tolerability of pamiparib, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined with TMZ, to select the recommended Phase 2 dose (RP2D) and schedule of pamiparib in combination with TMZ, and to determine the antitumor activity of pamiparib in combination with TMZ.

NCT ID: NCT03150589 Completed - Clinical trials for Age-Related Macular Degeneration

A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Start date: March 14, 2018
Phase: Phase 3
Study type: Interventional

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.