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NCT ID: NCT03110471 Completed - Dementia Clinical Trials

Nurse-led Medicines' Monitoring in Care Homes: a Process Evaluation

Start date: March 1, 2017
Phase:
Study type: Observational

Lay Summary: The investigators have shown in randomised controlled trials and observation studies that structured nurse-led medicines' monitoring using the WWADR Profile benefits patients, for example, by reducing pain and sedation and identifying high risk cardiovascular conditions. The investigators now aim to understand what is needed to sustain implementation of the WWADR Profile in routine practice and explore future directions. The participants of the investigators previous research, 5 newly recruited care homes, and stakeholders - care home managers, carers, healthcare professionals, and service users - will be asked to contribute interviews, observations and reflective diaries/ accounts. The investigators are interested in their experiences of medication use, medication management, adverse effects and barriers and facilitators of medicine monitoring, and how electronic devices can enhance nurse-led monitoring.

NCT ID: NCT03109730 Completed - Chronic Hepatitis B Clinical Trials

Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

Start date: June 15, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.

NCT ID: NCT03109665 Completed - Glaucoma Clinical Trials

Glaucoma Within Northern Ireland Cohort for the Longitudinal Study of Ageing

GwNICOLA
Start date: March 2, 2017
Phase:
Study type: Observational

Glaucoma is the leading cause of irreversible blindness worldwide. It is caused by damage to the optic nerve between the back of the eye and the brain leading to progressive blindness. The cause is poorly understood but ageing, increased intraocular pressure (IOP) and genetics are all likely to play a role. There is no cure for glaucoma but treatments are available which slow progression. Because vision cannot be restored once lost, early detection, monitoring and early treatment are all essential to preserve visual function. The condition is diagnosed using a combination of the appearance of the optic nerve on clinical examination or photograph and visual field testing (perimetry). Measurement of IOP and measurement of the thickness of the retinal layers at the back of the eye complement diagnostic decisions. The Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) study does not include perimetry in the series of tests carried out on all participants but does include photography of the optic nerve, measurement of IOP and measurement of retinal thickness. Therefore we propose to invite back participants of the NICOLA study who have abnormal optic discs and high eye pressure to return for perimetry to confirm a diagnosis of glaucoma. Calling back participants for perimetry is essential to make the diagnosis not only for estimating prevalence but also for identifying participant's ill-health. The primary aim of this study is to quantify the number of participants in the NICOLA study who have glaucoma and report its risk factors. This will allow an estimate of the number of people in the whole of NI with glaucoma. We will also perform a series of novel tests using state-of-the-art technologies to assess if they are better than current tests at diagnosing glaucoma. This may enable better informed decisions about policy decisions in eyecare.

NCT ID: NCT03109327 Completed - Melanoma Clinical Trials

Investigating the Clinical Utility of the MDS

OMS002_UK
Start date: April 1, 2018
Phase:
Study type: Observational

The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).

NCT ID: NCT03108755 Completed - Healthy Volunteers Clinical Trials

A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP7713 in Healthy Non-Japanese Adult and Elderly Subjects and Healthy Japanese Adult Subjects

Start date: May 23, 2017
Phase: Phase 1
Study type: Interventional

This is a combined Single and Multiple Ascending Oral Dose Study. Part 1 is a Single Ascending Dose (SAD) and Part 2 is Multiple Ascending Dose (MAD). The purpose of the study is to evaluate the safety and tolerability of single and multiple ascending oral doses of ASP7713 in healthy non-Japanese (Part 1) and Japanese (Part 2) adult participants and non-Japanese elderly participants (Part 2). This study will also evaluate the pharmacokinetics of single and multiple ascending oral doses of ASP7713 in non-Japanese (Part1) and Japanese (Part 2) adult participants and non-Japanese elderly participants (Part 2) as well as the effect of a single and multiple oral dose of ASP7713 on the QT interval using Fridericia's Correction (QTcF). In addition, this study will evaluate a potential racial difference in safety, tolerability and pharmacokinetics of multiple oral doses of ASP7713 in healthy non-Japanese and Japanese adult participants (Part 2).

NCT ID: NCT03108625 Completed - Clinical trials for Depressive Disorder, Major

Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

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

Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD

NCT ID: NCT03108534 Completed - Asthma Clinical Trials

A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.

Start date: February 28, 2017
Phase: Phase 2
Study type: Interventional

The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.

NCT ID: NCT03108027 Completed - Asthma Clinical Trials

Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma

QVM149
Start date: June 26, 2017
Phase: Phase 2
Study type: Interventional

This was a randomized, placebo-controlled, double-blind, six-sequence, three-period cross-over study in asthma patients. The study consisted of a 14-day screening period, followed by a 14-day run-in period, and a treatment epoch which consists of three treatment periods, with a minimum duration of 14 days each followed (for the 2 first treatment periods) by a wash-out period. The duration of each treatment period may be extended up to a duration of 18 days if needed for operational reasons. The third treatment period was followed by a Study Completion evaluation at 1-7 days following the last dose. The treatment periods were separated by wash-out periods of 14 to 21 days duration.

NCT ID: NCT03107793 Completed - Crohn Disease Clinical Trials

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab

STARDUST
Start date: April 19, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled with early endoscopic assessment versus a clinically driven (routine care) approach in achieving endoscopic response.

NCT ID: NCT03107221 Completed - Anorexia Nervosa Clinical Trials

Eating Disorders: Online Self-help & Usual Treatment (TAU) vs TAU Only

Start date: August 2016
Phase: N/A
Study type: Interventional

A pilot study exploring whether individuals receiving usual treatment (CBT) from the specialist NHS Tayside Eating Disorders Service and accessing the online self-help "Smart Eating" programme have improved treatment outcomes compared to those receiving usual treatment only. The study will also explore acceptability of the "Smart Eating" self-help programme via a feedback questionnaire.