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NCT ID: NCT02392234 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation

Start date: March 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.

NCT ID: NCT02392117 Completed - Clinical trials for Diabetes Mellitus, Type 2

Investigating the Safety and Effectiveness of Insulin Degludec in a Real World Population With Type 1 and 2 Diabetes Mellitus

ReFLeCT
Start date: March 16, 2015
Phase:
Study type: Observational

This study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.

NCT ID: NCT02391506 Completed - Osteoarthritis Clinical Trials

Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis

GRIP
Start date: July 29, 2015
Phase: N/A
Study type: Interventional

This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the CMC joint in the hand.

NCT ID: NCT02391337 Completed - Clinical trials for Permanent Atrial Fibrillation

Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF)

RATE-AF
Start date: December 20, 2016
Phase: Phase 4
Study type: Interventional

Atrial fibrillation is a common heart rhythm disturbance, causing important discomfort for patients, a high risk of stroke, frequent hospital admissions and a two-fold increase in death. The number of patients with this condition are expected to double in the next 20 years. Medications to control heart-rate are used in the majority of patients, although the choice of agent is often guided by local preference rather than evidence from controlled trials. Despite the fact that patients with atrial fibrillation have high rates of other cardiac conditions such as heart failure, clinicians have insufficient evidence to personalise the use of different therapies. This feasibility study will allow us to develop a range of methods that can characterise patients according to the pumping and relaxing function of the heart, the burden of symptoms and to identify new blood markers. In this way, the investigators hope to improve clinical practice guidelines, allowing doctors to prescribe appropriate treatments for the right patients. The research will be focused around a randomised trial of two medication strategies, providing much-needed data on the comparison of digoxin and beta-blockers (two commonly-used drugs in patients with atrial fibrillation). It will also allow us to identify the best way to record patient-reported quality of life and develop robust techniques to determine heart function using non-invasive imaging, facilitating the conduct of a large-scale clinical trial. The key objectives of the research programme are to define the optimal medications for patients with atrial fibrillation and identify the most valid, reproducible and cost-effective methods to examine patients. The ultimate aim of the project is to improve clinical outcomes in atrial fibrillation, benefiting patients, the National Health Service and the global community.

NCT ID: NCT02391285 Completed - Clinical trials for Pelvic Floor Dysfunction

Mitigating Chronic Pelvic Floor Dysfunction Following Childbirth by Pelvic Floor Dynamometry

Start date: August 2014
Phase: N/A
Study type: Interventional

To assess the potential clinical utility of measuring pelvic floor muscle tone after childbirth by vaginal dynamometry, the investigators will study 50 consecutive consenting first attendees of the Jessop Wing perineal trauma clinic. In addition to clinical and imaging assessment routinely offered women at this clinic, the investigators will measure their active and passive pelvic floor muscle tone using the Auckland vaginal elastometer. The investigators will also assess structural pelvic floor muscle damage (PFMD) in a subset of 10 women (5 symptomatic and 5 asymptomatic) by Magnetic Resonance Imaging (MR) scan of the pelvic hiatus. The investigators will then determine the predictive capacity of vaginal elastometry for symptoms of pelvic floor damage, findings of endoanal sonography, and MR scans of the pelvic floor hiatus. The investigators will determine if vaginal elastometry can prove an objective and accurate frontline assessment tool for the management of PFMD following childbirth. Our observations will generate vital data for powering and designing a large clinical trial evaluating the potential use of the vaginal elastometer as a first line assessment tool of PFMD in the postnatal period. Data will also inform the design of a personalised model for predicting and managing pelvic floor muscle damage during childbirth.

NCT ID: NCT02391259 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Start date: November 2006
Phase: Phase 1
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts

NCT ID: NCT02391116 Completed - Clinical trials for Diffuse, Large B-Cell, Lymphoma

Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Start date: May 8, 2015
Phase: Phase 2
Study type: Interventional

To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker

NCT ID: NCT02390674 Completed - Clinical trials for Myocardial Reperfusion Injury

Ciclosporin to Reduce Reperfusion Injury in Primary PCI

CAPRI
Start date: March 2015
Phase: Phase 2
Study type: Interventional

Routine primary percutaneous coronary intervention (PPCI) for a heart attack involves opening a blocked artery with a balloon then inserting a metal scaffold (stent) to hold the artery open. During this procedure inflammation can occur causing further damage to the heart. The objective of this trial is to determine whether administration of the drug ciclosporin prior to PPCI reduces the amount of damage to the heart relative to treatment with placebo. The damage to the heart is assessed after 12 weeks by an magnetic resonance imaging (MRI) scan. Patients are followed-up after 12 months participation in the study. This is a single centre study looking to recruit 68 patients.

NCT ID: NCT02390258 Completed - Atrial Fibrillation Clinical Trials

Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103

Start date: July 2011
Phase: Phase 1
Study type: Interventional

This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects. Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be assessed following dosing for 10 days in Part 3.

NCT ID: NCT02390063 Completed - Prostate Cancer Clinical Trials

Vaccination in Prostate Cancer (VANCE)

Start date: June 2015
Phase: Phase 1
Study type: Interventional

This is a clinical trial of a new treatment for prostate cancer that is a type of vaccine that could be a new way to treat cancer. A vaccine that could alert the immune system to the presence of cancer cells in the body may enable the immune system to target and kill those cells effectively. This vaccine is intended to work by making the immune system kill cells that have a special protein (called 5T4) that is present on the surface of cancer cells. The vaccine is made up of two recombinant viruses ("ChAdOx1" and "MVA") that have been designed to produce the 5T4 protein and have been modified so that they are weakened and cannot reproduce themselves within the body like normal viruses. Once injected into the body, these viruses make the 5T4 protein and help the body's immune system to learn to target this protein and destroy cancer cells. This is a first-in-human study to evaluate the safety and immunogenicity of ChAdOx1.5T4-MVA.5T4 vaccination regime. It is evaluated in neo-adjuvant setting in low and intermediate risk localised prostate cancer patients who have either decided to have their prostate removed or are stable on active surveillance.