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NCT ID: NCT02026531 Completed - Clinical trials for Pulmonary Hypertension

Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease

Start date: November 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The diagnosis of a patient with pulmonary hypertension (PH) requires many investigations. At present cardiac catheterisation is the cornerstone investigation in these patients where it is used to establish disease severity and estimate prognosis. It is an invasive procedure which is expensive and not without risk to the patient. Despite the multitude of tests performed, identifying those patients with PH who have a poor diagnosis can be difficult. The aim of this study is to improve the assessment of patients with PH using novel magnetic resonance techniques.

NCT ID: NCT02026245 Completed - Clinical trials for Rheumatoid Arthritis

A Comparison of Two Electronic Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis

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

In this study we will compare two electronic goniometric gloves to see if they can be used in research on joint movement in arthritis. One of the gloves we will use is the commercially available '5DT Ultra 14 glove', the other is a glove that we have specially designed and developed for use in people with arthritis. Both gloves are 'high-end' gloves with sensors for all of the finger and thumb joints. We aim to find out if the gloves are accurate and if they can be worn and used without too much discomfort by people with arthritis.

NCT ID: NCT02026063 Completed - Carcinoid Syndrome Clinical Trials

Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

TELEPATH
Start date: January 14, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.

NCT ID: NCT02025530 Completed - Stillbirth Clinical Trials

The Midlands and North of England Stillbirth Study

MiNESS
Start date: April 1, 2014
Phase:
Study type: Observational

The United Kingdom has one of the highest rates of stillbirth in Europe, with more than 4,000 stillbirths every year; which equates to more than 11 deaths every day. Furthermore, this rate has changed very little over the last 20 years. This loss of life and the adverse psychological consequences urgently needs addressing. A recent New Zealand study investigating modifiable factors associated with stillbirth (the Auckland Stillbirth Study) found that mothers who did not go to sleep on their left side had a twofold risk of late stillbirth (≥28 weeks gestation) compared to mothers who did go to sleep on their left side. These novel findings need urgent confirmation. This proposed study aims to confirm or refute these findings and to ascertain whether a preventative programme should be introduced. This proposed study aims to confirm or refute the findings of the Auckland Stillbirth Study. Participants will be recruited from maternity units in the Midlands and North of England (led by centres in Liverpool, Manchester, West Yorkshire and Birmingham). 291 women with a singleton late stillbirth without congenital abnormality will be interviewed by research midwives shortly after the birth. A control group of 580 women with ongoing pregnancies will be interviewed at a gestation group matched to that at which stillbirths occurred. These data will determine whether an intervention study should be considered. If there is a causal relationship between maternal sleep position and late stillbirth we estimate that upto 37% of late stillbirths might be prevented.

NCT ID: NCT02025348 Completed - Clinical trials for Plasma Concentration

Explore the Performance of IntelliCap.

Start date: January 2014
Phase: Phase 0
Study type: Interventional

This is an open-label, randomised, 4-way crossover study in twelve healthy male volunteers. The study will characterise the performance of IntelliCap® by evaluating the plasma concentration and pharmacokinetic profile of a probe drug (IMP; metoprolol) released from IntelliCap® with three different release profiles and the plasma concentration and pharmacokinetic profile of the same probe drug after a single dose of an oral solution.

NCT ID: NCT02024789 Completed - Down Syndrome Clinical Trials

A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS)

Start date: May 5, 2014
Phase: Phase 2
Study type: Interventional

This multi-center, randomized, double-blind, 3-arm, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RG1662 in adults and adolescents with Down syndrome. Subjects will be randomized to receive RG1662 either at low or high dose or placebo orally twice daily for 26 weeks.

NCT ID: NCT02024737 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

SILO2 (Signal Intensity Lung washOut)

SILO2
Start date: February 2014
Phase:
Study type: Observational

Chronic Obstructive Pulmonary Disease (COPD) is a leading and still increasing cause of disease and death worldwide, affecting those in both developed and developing countries. This imparts a massive burden of ill health, in turn imposing huge healthcare costs to society. For effective treatment of COPD (as opposed to providing short term relief) early disease must be targeted. The small airways of the lung (those less than 2mm) are the first affected in COPD, but current methods to assess their function are relatively insensitive. There is therefore a need for new, accurate methods for detection of small airway dysfunction with sensitivity to shortterm change and regional discrimination. In previous studies with hyperpolarised (HP) 3He MRI in smokers with normal pirometry and patients with early stage COPD, we showed sensitivity to early changes in lung ventilation and structure. The hyperpolarised gas MRI technique is safe. In particular, the lack of ionizing radiation permits patients to be imaged on multiple occasions. This and its inherent sensitivity to regional lung ventilation and function make it an ideal imaging tool for the assessment of novel lung therapies for diseases of the small airways. The purpose of this pilot study is to determine short and long term reproducibility of a comprehensive set of functional imaging data; using hyperpolarised gas MRI, conventional MRI and lung physiology measurements in patients with moderate to severe COPD. In addition,how sensitive the imaging techniques are to changes in lung function after treatment with a standard (bronchodilator) inhaler will also be assessed. This pilot study will serve as a platform for future larger scale studies, aimed at better understanding of and intervention in early COPD.

NCT ID: NCT02023697 Completed - Prostatic Neoplasms Clinical Trials

Standard Dose Versus High Dose and Versus Extended Standard Dose Radium-223 Dichloride in Castration-resistant Prostate Cancer Metastatic to the Bone

Start date: March 10, 2014
Phase: Phase 2
Study type: Interventional

This study will assess different doses and regimens of radium-223 dichloride on the incidence of symptomatic skeletal events. Eligible subjects must have castration resistant prostate cancer with 2 or more skeletal metastases documented within 8 weeks of randomization. Subjects will be randomized to one of 3 treatment arms in a 1:1:1 fashion: a standard regimen of radium-223 dichloride of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 6 months, a high dose regimen of 80 kBq/kg (88 kBq/kg after implementation of NIST update)injections every month for 6 months or an extended duration regimen of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 12 months. Following the treatment phase, subjects will be followed up every 12 weeks for a minimum of 2 years, at which point they will enter a long term follow-up period during which they are seen every 6 months for up to 7 years after the last dose of radium dichloride. Symptomatic skeletal event and safety endpoints will be assessed at each clinic visit. Pain and analgesic use data will be collected every 4 weeks through Week 48. Additionally, radiological assessments including MRI/CT of the abdomen and pelvis and chest CT, as well as technetium-99 bone scans will be performed at Weeks 8, 16, and 24 and continue every 12 weeks thereafter until disease progression is documented in either the bone or in soft tissue. Radiological imaging will be evaluated by blinded central review.

NCT ID: NCT02023606 Completed - Clinical trials for Impulsive Aggression Comorbid With ADHD

Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M

Start date: November 2013
Phase: Phase 1
Study type: Interventional

An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion of Radio Labeled SPN-810M in Healthy Adult Male Volunteers

NCT ID: NCT02022761 Completed - Asthma Clinical Trials

Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate TwinCaps® DPI in Adults With Chronic Asthma

Start date: October 2013
Phase: Phase 1
Study type: Interventional

This is a single centre, randomized, double-blind, placebo-controlled, single ascending dose study, in which the safety and pharmacokinetics of laninamivir octanoate administered by inhalation via the TwinCaps® DPI will be assessed in adults with mild or moderate chronic asthma.