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NCT ID: NCT02973607 Completed - Hypertension Clinical Trials

Effects of a Reduction in Renal Function on Cardiovascular Structure and Function

CRIB-DONOR II
Start date: May 23, 2017
Phase:
Study type: Observational

Chronic kidney disease (CKD) is present in 1 in 7 of the population and confers a high risk of cardiovascular disease. The pathophysiology of cardiovascular disease in CKD is poorly understood because CKD is always accompanied by confounding factors including the underlying disease process (e.g. diabetes mellitus, systemic vasculitis) and the consequences of CKD including hypertension, anaemia and inflammation. Nephrectomy in kidney donors causes a 30% reduction in renal function providing an ideal study population to measure prospectively the effects of reduced kidney function on the cardiovascular system. The CRIB-Donor study (ClinicalTrials.gov Identifier:NCT01028703) demonstrated adverse effects on cardiovascular structure and function at 12 months compared to controls including an increase in left ventricular mass. This proposal will measure the changes in cardiovascular structure and function, cardiovascular age and biochemical changes at 5 years providing information on the long term effects of reduced renal function.

NCT ID: NCT02973308 Completed - Clinical trials for Abdominal Aortic Aneurysm

The Inter and Intra Reliability of Cardiopulmonary Exercise Testing in Abdominal Aortic Aneurysm Patients

CPEX
Start date: July 3, 2016
Phase: N/A
Study type: Interventional

Exercise testing is commonly being used in patients before surgery to test their overall fitness. One group it is being used in is patients who have an enlarged blood vessel in their stomach. This is known as an abdominal aortic aneurysm. The exercise test used is known as a cardiopulmonary exercise test as it looks at both heart and lung function at the same time. Whilst this test is commonly used there have been no studies (to date) which have looked at how reliable this test is; this means how well the investigators can obtain the same (or very similar) results after multiple tests. The investigators would like to test this reliability both between patients and the clinicians performing the testing.

NCT ID: NCT02973243 Completed - Clinical trials for Myocardial Infarction

The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III

Start date: October 5, 2016
Phase: N/A
Study type: Observational

To evaluate the effect of automated recording on frequency of recorded scores, number of automated notifications and serious events.

NCT ID: NCT02973152 Completed - Clinical trials for Vocal Cord Paralysis Unilateral

Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness.

VOCALIST
Start date: May 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to help determine the most effective treatment for participants with Unilateral Vocal Fold Paralysis. There are currently two types of operations used to treat this condition. One operation is called thyroplasty. Doctors place a small piece of safe plastic into the side of the participant's voice box to push the weak vocal cord into a position to enable better speech and swallowing. In the other operation called laryngeal reinnervation, doctors repair the neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better speech and swallowing. The investigators do not know which of these methods is better and are conducting this study to start comparing the two operations so that a larger clinical trial can be conducted in the future to tell us which operation is best.

NCT ID: NCT02972723 Completed - Clinical trials for Chronic Hepatitis C Infection

Metformin Therapy in HCV Infection

Start date: March 2011
Phase: Phase 4
Study type: Interventional

Hepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease worldwide. Current therapy for HCV with interferon based therapies results in cure rates of around 5055% which leaves a significant number of patients without effective therapy. HCV induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce the response to antiHCV therapy. This finding stimulated initial studies looking at agents that may reduce insulin resistance as additional therapy in HCV infection. A study using metformin in addition to interferon and ribavirin showed a nonsignificant increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection AND demonstrable insulin resistance. The assumption was made that the potential effect of metformin was likely to be on insulin resistance and thus by modulating this enhances response. The investigators (Prof M Harris, University of Leeds) have data (currently unpublished)suggesting that metformin may have an antiviral effect independent of its effect on insulin resistance, thus raising the possibility that metformin may have a direct antiviral effect in vivo. Given that the development of specific antiHCV agents which target viral proteins such as its polymerase and protease are in trial development but have so far proved either highly toxic or are likely to have a huge cost there is considerable rationale for looking at alternative potential antiHCV agents and in this context metformin is cheap, readily available and has an excellent safety profile. This pilot study therefore addresses the question "Does metformin therapy result in a significant drop in HCV viral load in chronically infected patients?"

NCT ID: NCT02972645 Completed - Healthy Clinical Trials

A Study of LY3305677 in Healthy Participants

Start date: December 5, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it. This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it. This study involves a single dose of LY3305677 administered by subcutaneous injection (SC). Participation in this study is expected to last up to 16 weeks.

NCT ID: NCT02972606 Completed - HIV Clinical Trials

OPEN Study: Pain Management Treatment Needs Interviews

Start date: November 2016
Phase:
Study type: Observational

Presently, there are few options for medically managing HIV-related painful peripheral sensory neuropathy (HIV-SN). Psychological treatments, including Cognitive Behavioural Therapy (CBT), represent a potentially viable addition to the treatment of painful HIV-SN. However, there is a scarcity of research on psychological treatment approaches for pain management in people with HIV. This study will use in-depth semi-structured interviews to examine the needs of people with painful HIV-SN for a psychologically-based pain management treatment that may be delivered over the Internet. Interview questions will examine participants' needs in terms of treatment content and delivery format. Men and women, ethnic minorities, and people who use recreational drugs will be sampled to ensure that interview responses reflect the views of people most commonly suffering from this condition. Approximately 30 people will be recruited for the study. The interviews will be audio recorded, transcribed verbatim, and coded to identify themes. The interview responses will be used to develop and tailor a version of CBT for people with painful HIV-SN. It is hoped that tailoring the treatment based on the qualitative interview responses will increase the acceptability of the treatment and will improve treatment adherence rates for a future study.

NCT ID: NCT02972476 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Microbiome Use to Stratify Use of Inhaled Corticosteroids: MUSIC Trial

MUSIC
Start date: December 2016
Phase: Phase 4
Study type: Interventional

A randomised controlled trial to test the hypothesis that inhaled therapies for chronic obstructive pulmonary disease (COPD) have differential effects on the upper airway microbiome. COPD is the third leading cause of death worldwide. Exacerbations drive disease progression and worsening quality of life and therefore prevention of exacerbations has been a major goal of treatment. Patients with COPD are frequently prescribed inhaled corticosteroids (ICS) which have been shown to reduce exacerbations in combination with long acting beta2-adrenoceptor agonists (LABA). In recent years, all ICS preparations have been associated with a significant increased risk of pneumonia in either randomised trials or observational studies leading to warnings from national regulatory authorities and leading experts. This has led to a re-evaluation of the role of ICS in COPD treatments. It is likely that the risk of pneumonia is not equal across all ICS doses and molecules. There is a compelling rationale for ICS having a strong effect on the upper airway microbiome, and that this may be one mechanism of increased pneumonia risk with these drugs. The existing literature regarding ICS and pneumonia risk are lacking; 1) there are no head to head trials comparing different ICS preparations and 2) the comparator in these studies to date have been long acting beta2-adrenoceptor agonists alone, whereas the most appropriate comparator in current management would be combined LABA and long-acting muscarinic antagonist (LAMA). The MUSIC TRIAL is a multi-centre randomised open label controlled parallel group study with four treatment arms and a total of 120 participants. Severe COPD patients currently treated with inhaled corticosteroid therapy will be randomised to treatment with one of three preparations of ICS in combination with LABA or the control arm of dual bronchodilator therapy following a four week washout period. Participants will return monthly to determine if there are changes in the microbiome in their upper airway. This study will establish one potential mechanism for the increased susceptibility to pneumonia in ICS users and assess intraclass differences in ICS molecules and the effect of ICS dose on the microbiome. Demonstrating that different COPD treatments can have different effects on the lung microbiome is an important step in understanding clinical differences in the safety and effectiveness of different treatments for severe COPD.

NCT ID: NCT02972125 Completed - Healthy Volunteers Clinical Trials

A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects

Start date: November 2016
Phase: Phase 1
Study type: Interventional

This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet and Dry Syrup in Healthy Male Japanese Subjects

NCT ID: NCT02971969 Completed - Hemophilia B Clinical Trials

Long-Term Safety, Tolerability, and Efficacy of DTX101 (AAVrh10FIX) in Adults With Moderate/Severe to Severe Hemophilia B

Start date: January 2017
Phase:
Study type: Observational

A long-term follow-up study to evaluate the safety, tolerability, and efficacy of DTX101 in adult males with moderate/severe to severe hemophilia B.