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NCT ID: NCT01689207 Completed - Clinical trials for Bacterial Infections

To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)

Start date: September 2012
Phase: Phase 1
Study type: Interventional

This is a randomised, double-blind, 3-part study designed to investigate the safety and tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI, when both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following single administration, and following multiple administrations of ATM-AVI in healthy male and female (females of nonchildbearing potential) volunteers both young and elderly.

NCT ID: NCT01688843 Completed - Bradycardia Clinical Trials

Safety and Performance Study of the INGEVITY Lead

Start date: October 2012
Phase: N/A
Study type: Interventional

The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.

NCT ID: NCT01688141 Completed - Clinical trials for Chronic Kidney Disease

A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease

Start date: January 2010
Phase: N/A
Study type: Interventional

Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%. The study hypothesis is to ascertain if intensive primary care led disease management programmes for CKD, supported by input from secondary care specialists will slow progression of CKD, improve blood pressure control and reduce cardiovascular events in patients on CKD registers. The investigators have partnered with Nene commissioning, a practice based commissioning group representing approximately 80 GP practices in Northamptonshire, to run this study. This will be a cluster randomised trial of an intensive, secondary care supported, CKD management programme in primary care vs normal CKD care. Randomisation will be at the level of the individual general practice. All general practices associated with Nene commissioning will be invited to participate. Randomisation of practices will be performed by the University of Leicester Clinical Trials Unit and the study will adhere to guidelines for undertaking randomised cluster trials. The aims of the study are: 1. To determine whether reinforcement of best practice in the management of key aspects of CKD care by clinical nurse specialists based in primary care, but with close links to colleagues from secondary care, improves clinical outcomes. 2. To foster excellence in CKD care 3. To improve coding of CKD and prevalence on chronic disease registers. 4. To increase interest in, and capacity for primary care research in Northamptonshire. 5. To implement and evaluate a new model of partnership working between primary and secondary care. The primary outcome measures will be changes in estimated glomerular filtration rate (eGFR). Secondary outcome measures will be blood pressure control, proteinuria, incidence of cardiovascular events,other biochemical parameters, referrals to secondary care and hospitalisations and mortality.

NCT ID: NCT01687569 Completed - Clinical trials for Glycaemic Response Measurements

Glycaemic Responses to Cracker Snacks

Start date: September 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether added ingredient affects glycaemic responses to a cracker snack.

NCT ID: NCT01687166 Completed - Clinical trials for Paroxysmal Atrial Fibrillation (PAF)

Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

ZERO-AF
Start date: October 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

NCT ID: NCT01686646 Completed - Common Cold Clinical Trials

Effects of Two Doses of a Common Cold Treatment on Alertness

Start date: November 2011
Phase: Phase 3
Study type: Interventional

This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.

NCT ID: NCT01686581 Completed - Migraine Disorders Clinical Trials

An Observational Study of BOTOX® as Headache Prophylaxis for Chronic Migraine

Start date: July 23, 2012
Phase:
Study type: Observational

This is an observational study to describe the long term use of Onabotulinumtoxin A (BOTOX®) as prescribed by the physician for headache prophylaxis in adults with chronic migraine. All treatment decisions lie with the physician.

NCT ID: NCT01686477 Completed - Insulin Resistance Clinical Trials

PREterM FOrmula Or Donor Breast Milk for Premature Babies

PREMFOOD
Start date: April 2, 2013
Phase: N/A
Study type: Interventional

In order to address this crucial question, central to preterm newborn care, a multicentre United Kingdom (UK) -wide study randomising 4000 preterm babies would be necessary to achieve sufficient power to evaluate the impact on the short-term outcomes necrotising enterocolitis and bloodstream infection, and establish cohorts large enough to address long-term metabolic (such as obesity, type 2 diabetes), cardiovascular (such as blood pressure) and developmental outcomes. This pilot trial will evaluate the practicability and feasibility of such a large multicentre UK randomised controlled trial. In addition to evaluating feasibility and to ensure maximal use of resources allocated, this study will also assess outcomes that are indicative of long term metabolic health.

NCT ID: NCT01685892 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia

Start date: November 29, 2012
Phase: Phase 1
Study type: Interventional

This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199) administered in combination with obinutuzumab to participants with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL). The study is comprised of two stages for each participant population: a dose-finding stage and a safety-expansion stage. The dose-finding stage will explore multiple doses of venetoclax to be used in combination with a fixed dose of obinutuzumab. The dose-finding stage will also explore two schedules for drug administration, Schedule A (venetoclax introduced before obinutuzumab) and Schedule B (venetoclax introduced after obinutuzumab).

NCT ID: NCT01685710 Completed - Renal Failure Clinical Trials

The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

Start date: April 2013
Phase: Phase 4
Study type: Interventional

The aim of the study is to determine whether the application of a glyceryl trinitrate patch (GTN patch) helps arteriovenous fistulas, created for renal dialysis access, mature so that they can be used.