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NCT ID: NCT02060721 Completed - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

MERIT-2
Start date: February 3, 2015
Phase: Phase 2
Study type: Interventional

Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

NCT ID: NCT02060526 Completed - Sanfilippo Syndrome Clinical Trials

Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of rhHNS Administration Via an IDDD in Pediatric Patients With Early Stage MPS IIIA Disease

Start date: February 26, 2014
Phase: Phase 2
Study type: Interventional

Sanfilippo syndrome Type A, or Mucopolysaccharidosis (MPS) IIIA, is a rare lysosomal storage disease caused by deficiency of the enzyme heparan N-sulfatase (sulfamidase). In the absence of this enzyme, there is an accumulation of the glycosaminoglycan, heparan sulfate, resulting in progressive neurodegeneration. Symptoms are usually first noted in the 1st or 2nd year of life, although definitive diagnosis is often delayed, with an average age of diagnosis of 4.5 years. The disease is characterized by developmental delays initially, followed by neurological developmental arrest, then regression. These developmental deficits are typically associated with severe behavioral disturbances. Patients have a significantly reduced lifespan, with few surviving beyond the 2nd or 3rd decade. The purpose of this study is to evaluate the safety and efficacy of recombinant human heparan-N-sulfatase (rhHNS) in pediatric patients with Early Stage Mucopolysaccharidosis Type III A Disease.

NCT ID: NCT02060357 Completed - Clinical trials for Coronary Artery Disease

Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes (OCT-DES)

OCT-DES
Start date: November 2011
Phase: N/A
Study type: Interventional

The aim of this study is a comparative evaluation of re-endothelailisation of the Integrity Resolute zotarolimus eluting stent (Medtronic) and of the Promus Element erolimus eluting stent (Boston Scientific), in patients with diabetes. We plan to compare endothelial coverage and neointimal proliferation using OCT and compare this data to published results from conventional stents.

NCT ID: NCT02060292 Completed - COPD Clinical Trials

Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease

NOVASC COPD
Start date: April 2014
Phase:
Study type: Observational

Cognitive impairment is a known consequence of cerebral small-vessel disease. Moderate to severe cognitive impairment has been shown in up to 60% of certain individuals with COPD and is likely to profoundly influence an individual's ability to manage their disease. In addition to cerebral small vessel damage and cognitive dysfunction, other organs such as the heart, kidneys, and retina are likely to be susceptible to small-vessel damage in COPD. Several large population studies have shown that COPD is a significant independent risk factor for myocardial infarction, with the effect most marked in early, mild disease. We propose to compare non-invasive MR brain imaging of white matter microstructure (diffusion tensor), cerebral perfusion (arterial spin labelling) and accumulated cerebral small vessel disease (cerebral microbleeds), in COPD patients to smokers without COPD. In addition we plan to explore mechanisms of cerebral small vessel disease in COPD by looking for associations between arterial stiffness, end organ vascular damage and cognitive function.

NCT ID: NCT02059655 Completed - Clinical trials for Graves' Ophthalmopathy

Prostaglandin F2-alpha Eye Drops in Thyroid Eye Disease (Bima Study)

BIMA
Start date: November 2014
Phase: Phase 4
Study type: Interventional

The purpose of the study is to establish whether Bimatoprost eye drops are effective in reducing proptosis in inactive thyroid eye disease (TED) patients and improving quality of life in patients with TED. Current standard NHS treatment/care for inactive TED is artificial tears (used as the placebo in this study) or surgery if appropriate. The IMP is Bimatoprost eye drops PGF2α (0.03%). This is already licensed eye drops usually used for glaucoma. Therefore the current trial's indication is outside its licenced indication. The Investigational Medicinal Product (IMP) will be used according to its licenced dosage and form. This is the first time that Bimatoprost will be used in the treatment of TED

NCT ID: NCT02059447 Completed - Tinnitus Clinical Trials

A Comparison of the Benefits of Mindfulness Based Cognitive Therapy, Relaxation Therapy and a Waiting List Control in the Management of Distress in Chronic Tinnitus Patients

Start date: December 2013
Phase: N/A
Study type: Interventional

The principal hypotheses to be tested is that Mindfulness Based Cognitive Therapy (MBCT) reduces the distressing impact of tinnitus to a significantly greater extent than a waiting list control or relaxation therapy. This study is a mixed design, with two groups assessed at a number of time points. The primary outcome measure will be that of tinnitus distress, and secondary outcomes will be taken of psychological distress and tinnitus loudness. The outcome measures will be measured first at 8 weeks pre-treatment. All subjects then wait for 8 weeks before being randomly allocated to either an 8 week course of Mindfulness-Based Cognitive Therapy (MBCT) (Group 1) or an 8 week course of Relaxation Therapy (RT) (Group 2). All participants will be assessed at two main time-points (pre and post-treatment). The outcome measures will be repeated at 1 and 6 month follow-up points.

NCT ID: NCT02059434 Completed - Asthma Clinical Trials

Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD

Start date: September 1, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of single doses of LAS190792 administered by inhalation to patients with mild persistent asthma and moderate to severe chronic obstructive pulmonary disease (COPD) and also to assess the ability of LAS190792 to produce bronchodilation (opening of the airways).

NCT ID: NCT02059291 Completed - Clinical trials for Hereditary Periodic Fevers

Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers

Start date: June 27, 2014
Phase: Phase 3
Study type: Interventional

This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.

NCT ID: NCT02058654 Completed - Nutritional Status Clinical Trials

A Clinical Study to Investigate the Effects of Creatine Supplementation on Muscle Energetics and Cognitive Function in Young Healthy Male Athletes and an Ageing Population

Start date: December 1, 2013
Phase: Phase 1
Study type: Interventional

This study will examine the impact of creatine supplementation on muscle function and cognitive performance in young and older subjects.

NCT ID: NCT02058641 Completed - Atherosclerosis Clinical Trials

Effect of Darapladib on Cantharidin-Induced Inflammatory Blisters in Subjects With Type 2 Diabetes Mellitus (T2DM)

Start date: February 26, 2014
Phase: Phase 1
Study type: Interventional

This will be an exploratory, open-label, single sequence, two part study (Part A and an optional Part B). The aim of this study will be to assess whether systemic inhibition of Lipoprotein associated phospholipase A2 (Lp-PLA2) in humans, effected by 11 days of once daily dosing to steady state with 160 milligrams (mg) of enteric coated (EC) darapladib, will specifically reduce the number of macrophages and/or result in a higher proportion of M2 macrophages in skin blisters induced by cantharidin (a chemical agent that causes blisters). In Part A of the study, a cohort of 8 subjects with type 2 diabetes mellitus will be recruited. In Part B of the study, a cohort of 8 additional healthy subjects with matching age (+/- 24 months) and gender to Part A may be recruited.