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NCT ID: NCT03150498 Completed - Healthy Clinical Trials

A Food Effects Study and Optional Multi Dose Study to Assess PK of BTD-001

Start date: May 3, 2017
Phase: Phase 1
Study type: Interventional

This is a single-centre, open-label study in healthy male and non-pregnant, non-lactating females. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data. Part 1 is a single dose, two period crossover to assess food affect of oral BTD-001. Optional Part 2 is a non-randomised, single arm study multi dose design to evaluate PK profile of BTD-001

NCT ID: NCT03150459 Completed - Cirrhoses, Liver Clinical Trials

Simvastatin Plus Rifaximin in Decompensated Cirrhosis

LIVERHOPE
Start date: July 26, 2017
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to investigate whether the combination of two different drugs, simvastatin and rifaximin, is safe in the treatment of patients with decompensated cirrhosis. The secondary purpose is to see if this combination results in an improvement in inflammation markers in patients with cirrhosis and in an improvement in analytic parameters of progression of liver disease.

NCT ID: NCT03149848 Completed - HIV Infections Clinical Trials

Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects

Start date: June 6, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase I, single-center, open-label, fixed-sequence, 2-period crossover study in healthy adults to evaluate the effect of oral rifabutin (RBT) 300 milligram (mg) on the pharmacokinetics of oral cabotegravir (CAB) 30 milligram ( mg). This study will evaluate the drug-drug interaction (DDI) potential between CAB and RBT to inform dosing strategies for tuberculosis in subjects receiving CAB for human immunodeficiency virus (HIV) treatment or prevention. In Treatment Period 1 (Treatment A) participants will receive CAB 30 mg once daily for 14 days, followed by Treatment Period 2 (Treatment B) where participants will receive RBT 300 mg once daily with CAB 30 mg once daily for 14 days. The total study duration will be approximately for 10 weeks. Approximately 15 healthy subjects will be enrolled to ensure that 12 subjects complete dosing and critical assessments.

NCT ID: NCT03149744 Completed - Respiratory Rate Clinical Trials

Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor

Start date: February 28, 2017
Phase:
Study type: Observational

This investigation is looking at a currently available technology to see if it could have another use i.e. in helping to diagnose patients with sleep apnoea. With 2-4% of the population suffering from this disease, and the current wait time for a test at approximately 20 weeks, it is hoped that a simple screening method could help speed up the process of finding these patients and getting them on treatment faster. The current standard of care test involves a sleep study in the patients own home with a device with multiple parts and wires. The RespiraSense Sleep Screener is completely cableless and consists of one small, discrete unit attached to the patients side and a mobile device plugged in by the bed. Patients at Queen Alexandra Hospital who are prescribed sleep studies will be invited to participate. The RespiraSense Sleep Screener data is only for comparison purposes and will have no effect on their clinical care. If patients agree to participate they will undergo the sleep study with both devices in the same night and may be followed up with over the phone on their experiences with the test.

NCT ID: NCT03148873 Completed - Respiratory Rate Clinical Trials

RespiraSense Versus Capnography & Manual Counting

Start date: May 8, 2017
Phase:
Study type: Observational

Your respiratory rate is your number of breaths per minute. The standard way for this to be measured is by a nurse looking at you for one minute and manually counting your breaths over this time. They normally do this once every few hours. At times, it can be useful to have your respiratory rate continuously monitored. A device that can do this is a capnograph. For the patient, this involves wearing a tube in their nose and around their ears while trying to minimise their movement and talking so the measurements can be taken. This research study is looking at a new respiratory rate monitor and comparing how well it works against the current accepted methods. Patients who are admitted to the Acute Medical Unit will be invited to participate should they meet all eligibility criteria. Subjects will be monitored for two hours: (i) For the first hour subjects will wear a capnograph, RespiraSense and have their respiratory rate manually counted by a research nurse. During this time the subject will be asked to keep talking and moving to a minimum. (ii) For the second hour subjects will wear RespiraSense and have their respiratory rate manually counted by a research nurse. During this time the subject can talk and move as they wish.

NCT ID: NCT03148795 Completed - Prostate Cancer Clinical Trials

A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer

Start date: July 4, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone).

NCT ID: NCT03148457 Completed - Ischaemic Stroke Clinical Trials

Early Versus Late Initiation of Direct Oral Anticoagulants in Post-ischaemic Stroke Patients With Atrial fibrillatioN (ELAN): an International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial

ELAN
Start date: November 6, 2017
Phase: N/A
Study type: Interventional

When to start anticoagulation in patients with an acute ischaemic stroke and atrial fibrillation (AF) is a relevant unanswered question in clinical practice. Direct oral anticoagulants (DOACs) are highly effective for secondary stroke prevention in these patients, but DOACs were never initiated <7 days after stroke onset in recent trials. The ELAN trial will determine the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF. The main objective is to estimate the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF. The secondary objectives are to assess all vascular events and all-cause mortality after early initiation of DOACs in patients with acute ischaemic stroke related to AF compared to late initiation.

NCT ID: NCT03146988 Completed - Bioequivalence Clinical Trials

Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta

Start date: April 10, 2017
Phase: Phase 1
Study type: Interventional

Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy adult subjects.

NCT ID: NCT03146949 Completed - Clinical trials for Cardiopulmonary Bypass

Blood Isoflurane Concentration and the Oxygenator

Start date: January 5, 2017
Phase: N/A
Study type: Interventional

This study compares two oxygenators commonly in use to establish whether they effect the amount of isoflurane in the patient's blood. Half of the patients will be placed in a group using the Sorin Inspire oxygenator and half into the group using the Medtronic Affinity Fusion oxygenator.

NCT ID: NCT03146858 Completed - Clinical trials for Primary Percutaneous Coronary Intervention

Prolonged Enoxaparin In Primary Percutaneous Coronary Intervention; A Pilot Pharmacodynamic Study

PENNY PCI
Start date: August 25, 2017
Phase: Phase 4
Study type: Interventional

Heart attacks are caused by a clot blocking one or more of the heart arteries (coronary arteries). When complete blockage of one of the arteries occurs, emergency treatment to unblock the affected artery and rescue the heart muscle at risk is essential. This is usually achieved by performing an emergency procedure called primary percutaneous coronary intervention (PPCI). Anticlotting treatment is also necessary to reduce the chances of further heart attacks. As part of standard care, tablets that target small cells called platelets (central to blood clot formation) are given as soon as an acute heart attack is suspected. These tablets include aspirin and ticagrelor/prasufrel. Although both ticgrelor and prasugrel are effective, the onset of action is delayed by up to 8 hours when given in context of an acute heart attack. This delay in onset of action can increase the risk of further heart attacks. Enoxaparin is an anticlotting treatment that targets the other aspect of clot formation known as coagulation cascade. Enoxaparin or an alternative is recommended as a single does to support the PPCI procedure. The effects of a single shot of enoxaparin do not last long enough to bridge the gap in anticlotting treatment caused by the delayed action of ticagrelor/prasugrel. Since the investigators have realised the delayed onset of action of tablet therapy, the investigators have been using another drug called tirofiban as a drip. Tirofiban blocks platelets effectively, but greatly increases the risk of bleeding events. The investigators believe that giving enoxaparin as a drip for 3-6 hours (following the single dose) instead of tirofiban, would be sufficient to bridge the gap in anticlotting effect without greatly increasing the risk of bleeding. This is a pilot study to assess the effects of enoxaparin drip in patients presenting with acute heart attacks and undergoing emergency treatment with PPCI.