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NCT ID: NCT02826863 Recruiting - Dravet Syndrome Clinical Trials

A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

Start date: July 15, 2016
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, parallel-group, placebo-controlled, study to assess the efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric and young adult subjects with Dravet syndrome. Subjects who qualify for the study will be randomized (1:1:1) in a double-blind manner to receive 1 of 2 doses of ZX008 or placebo. All subjects will be titrated to their randomized dose over a 14-day Titration Period. Following titration, subjects will continue treatment at their randomly assigned dose over a 12-week Maintenance Period. Total treatment time from the beginning of the Titration Period through the end of the Maintenance Period is 14 weeks.

NCT ID: NCT02823821 Recruiting - Clinical trials for End-Stage Kidney Disease

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

RESOLVE
Start date: June 2016
Phase: Phase 4
Study type: Interventional

This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.

NCT ID: NCT02820389 Recruiting - Colorectal Cancer Clinical Trials

CT Colonography as the Initial Diagnostic Imaging Tool for Patients With Suspected Colorectal Cancer

CTCS
Start date: June 14, 2016
Phase: N/A
Study type: Observational

This study aims to evaluate whether the use of Computed Tomography Colonography (CTC) for patients with low to intermediate risk of suspected colorectal cancer decreases overall NHS costs and waiting times whilst increasing patient satisfaction compared to clinical practice with utilisation of Optical Colonoscopy.

NCT ID: NCT02820103 Recruiting - Clinical trials for Acute Coronary Syndrome

Reducing Acute Coronary Syndrome Patient Delay

RAPiD
Start date: February 20, 2017
Phase: N/A
Study type: Interventional

1. To test the effectiveness of the theory-based interventions (text+visual and text-only BCT-based interventions) against usual care in changing patients' intentions to phone ambulance immediately with symptoms of ACS ≥ 15 minutes duration. 2. To determine the most effective mode of delivery by comparing the text+visual BCT-based intervention with text-only BCT-based intervention. 3. To investigate any unintended consequences of the intervention on intentions to phone an ambulance for non-life-threatening symptoms.

NCT ID: NCT02817360 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients

Start date: February 2016
Phase: Phase 4
Study type: Interventional

Purpose and rationale The purpose of this study is to evaluate the effect of high dose Renin-Angiotensin System (RAS)-antagonists and beta-blocker treatment for the primary prevention of cardiac events in a population of patients with Type 2 diabetes mellitus (T2DM) with no evidence of a preexisting cardiac disease. An additional aim is to demonstrate an interaction between concentrations of amino-terminal pro-B type natriuretic peptide (NT-proBNP as a surrogate of imminent cardiac risk) and treatment effects and the economic impact of the intervention overall and in the biomarker stratified subgroups. Primary objective Superiority of high dose treatment with RAS-antagonists and beta-blockers compared to conventional therapy regarding the reduction of unplanned hospitalization or death due to a cardiac event in T2DM patients with a NT-proBNP > 125pg/ml. There is an additional eye-substudy for Viennese sites only. The purpose of this sub-study is to evaluate the effect of high dose RAS-antagonists and beta blocker treatment on early subclinical signs of diabetic micro-angiopathy and neuropathy. An additional aim will be the evaluation of the possible impact of the cardiovascular risk factor NT-proBNP on the onset and progression of diabetic retinopathy.

NCT ID: NCT02813135 Recruiting - Pediatric Cancer Clinical Trials

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

ESMART
Start date: August 3, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This proof-of-concept platform trial is designed to cover the targeting of several survival pathways in oncogenesis that are currently not adequately employed for pediatric patients in Europe (Geoerger 2017; Geoerger 2019). The aims of the trial are: 1. To determine the recommended phase II dose (RP2D) of a specific anticancer agent and/or a relevant combination in a pediatric population, to document its tolerability and 2. To explore first signals of activity in a molecularly enriched study population.

NCT ID: NCT02807025 Recruiting - Healthy Clinical Trials

Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases

RESPI-SAM
Start date: September 2015
Phase: N/A
Study type: Observational

Nasal, tracheal and bronchial sampling of MLF in patients with idiopathic pulmonary fibrosis(IPF), sarcoidosis, tuberculosis(TB), asthma and COPD. Similar sampling from healthy controls for comparative data. Aim: To characterise the molecular basis of the upper and lower airway mucosa inflammatory response in different respiratory diseases. To assess molecular biomarkers and signatures to see if these can aid diagnosis, stratification of these respiratory diseases. To direct personalised medicine and rationalise therapy. Outcome measures:Measurement of levels of inflammation, coagulation, complement activation and fibrosis in MLF, transcriptomics from nasal curettage and airway brushings and to assess the tolerability of absorption procedures in these patients.

NCT ID: NCT02804815 Recruiting - Breast Cancer Clinical Trials

Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours

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

Add-Aspirin aims to assess whether regular aspirin use after standard curative therapy can prevent recurrence and improve survival in individuals with non-metastatic common tumours. The question will be assessed in four different tumour types (breast, colorectal, gastro-oesophageal and prostate) by means of parallel cohorts within an overarching trial protocol. Eligible participants will be randomly assigned (double-blind) to either aspirin 100mg, aspirin 300mg or a matched placebo, to be taken daily for at least 5 years. Disease recurrence and survival will be assessed, along with adherence, toxicity, and other potential effects of aspirin (eg. cardiovascular). There is a large body of evidence indicating that aspirin has anti-cancer effects. Meta-analyses of cardiovascular trials of aspirin have shown short-term effects on cancer mortality and a decrease in risk of metastases, suggesting a role for aspirin in the treatment as well as prevention of cancer. Additionally, large observational studies of individuals taking aspirin after cancer treatment have shown improved disease-specific and overall mortality for specific tumour types. In the treatment setting, the risks of side effects associated with aspirin are expected to be outweighed by potential benefits. However, this has not yet been assessed in a randomised trial. As a low cost, generic and widely available drug, which is generally safe, if aspirin is shown to be effective, it could have a huge impact on cancer outcomes globally.

NCT ID: NCT02801149 Recruiting - Scaphoid Fracture Clinical Trials

The Use of MRI in the Assessment of Suspected Scaphoid Fracture With Negative Findings on the Initial Plain Radiography

SMRI
Start date: June 6, 2016
Phase: N/A
Study type: Interventional

Given that: 1) various clinical complications may arise from a misdiagnosed scaphoid fracture; and 2) clinical and radiographic diagnosis of scaphoid fracture is often challenging, particularly at the time of presentation, this study aims to evaluate whether the use of Magnetic Resonance Imaging (MRI) in the investigation of patients presenting with a suspected scaphoid fracture, with negative findings from the initial conventional radiography (4-view plain x-ray), leads to improved levels of efficiency, quality of care and patient experience. This study is a single centre randomised, non-blinded, prospective study. Participants will be randomised, following the initial negative conventional radiography, to either: no further imaging at A&E (consistent with current clinical practice); or 2) wrist MRI. The study considers a follow-up period of 6 months.

NCT ID: NCT02800837 Recruiting - Clinical trials for Coronary Artery Disease (Left Main)

Clinical Study to Evaluate the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease

TRUNC
Start date: May 2016
Phase: N/A
Study type: Observational

Prospective, non-randomized, multi-center study assessing the long term safety and efficacy of the self expandable sirolimus eluting Xposition S stent in the treatment of unprotected left main coronary artery disease.