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NCT ID: NCT03275454 Completed - Clinical trials for Purpura, Thrombocytopenic, Idiopathic

A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP)

Start date: August 14, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to explore the safety, preliminary clinical benefit, and activity of BIVV009 in patients with chronic immune thrombocytopenia.

NCT ID: NCT03274947 Completed - Stroke Clinical Trials

The Utility of Cerebellar Transcranial Magnetic Stimulation in the Neurorehabilitation of Dysphagia After Stroke

Start date: January 14, 2019
Phase: N/A
Study type: Interventional

The study is designed to explore the effectiveness of non-invasive cerebellar stimulation to enhance motor plasticity in the cortex after stroke. The investigators have shown that the human cerebellum is strongly activated during the act of swallowing and when stimulated with single TMS pulses can strongly facilitate the corticobulbar projection to the pharynx in humans. More recently the investigators have identified the most relevant frequency of stimulation of the cerebellum that can produce longer term excitation in the human swallowing motor system. The investigators therefore believe that the potential for cerebellar stimulation in improving swallowing is much greater than other methods for two reasons. Firstly, previous work has shown that unlike successful recovery of hand/arm function which relies on restoring activity in the stroke hemisphere, recovery of swallowing function relies on increased excitability in intact projections from the non-stroke hemisphere. The investigators believe that methods that can enhance these undamaged pathways have a greater chance of inducing recovery in the human swallowing system in unilateral stroke. Additionally cerebellar stimulation produces very high levels of corticobulbar excitation it may also have the advantage of improving dysphagia in posterior fossa strokes. Second, the human cerebellum is relatively easy to target and stimulate and has reduced risk of inducing unwanted effects (such as seizures) which as a consequence makes cerebellar stimulation a more pragmatic method for delivering therapeutic neurorehabilitation to dysphagic stroke patients compared to other more complex/riskier methods. A final factor is that the investigators have developed a "virtual lesion" model of swallowing dysfunction in healthy volunteers which can be reversed quite successfully with other neuro-stimulation protocols. The investigators can therefore use this model to test the effectiveness of cerebellar stimulation protocols (ipsilateral and contralateral cerebellar sites) before choosing the most effective side to apply stimulation in a proof of principle trial/study in a small group of sub-acute dysphagic patients. The hypotheses are that cerebellar TMS will: i. Reverse the brain inhibition and behavioural dysfunction following a virtual lesion model of disrupted swallowing in healthy brain (phase 1); ii. Reduce the degree of aspiration in acute dysphagia after a stroke (phase 2).

NCT ID: NCT03274895 Completed - Clinical trials for Acanthamoeba Keratitis

Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis

Start date: August 13, 2017
Phase: Phase 3
Study type: Interventional

Prospective randomized study to evaluate the efficacy, safety and tolerability of 0.08% polihexanide (PHMB) eye drops in patients affected by acanthamoeba keratitis. 130 subjects were assigned to one of the following 2 treatment groups: Group 1: 0.08% polihexanide (PHMB) + placebo Group 2: 0.02% polihexanide (PHMB) + 0.1% propamidine

NCT ID: NCT03274063 Completed - Gout Clinical Trials

Gout Self-Monitoring Aiming to Reach Target

Gout-SMART
Start date: April 5, 2019
Phase: N/A
Study type: Interventional

This study evaluates whether a supported self-management approach to gout is able to achieve target levels of serum urate, and better control of gout flares.

NCT ID: NCT03273972 Completed - Clinical trials for Cardiovascular Diseases

INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers

Start date: September 7, 2017
Phase: N/A
Study type: Interventional

The INTENSITY-LOW study aims to answer if there are any limits to LDL reduction in relation to benefitting vascular health from a mechanistic viewpoint, and therefore potentially limitations to primary prevention in healthy volunteers by lowering LDL cholesterol using PCSK9 therapies. This research is being carried out because it is unclear what the lowest threshold of LDL cholesterol should be to attain significant reductions in CV risk in healthy individuals. It is also unknown whether there is a true limit of LDL cholesterol below which there is no further improvement in endothelial function in healthy people, and, whether this is associated with a reduction in markers of both systemic and vascular inflammation. This study will hope to provide evidence that the so-called pleiotropic effects of statins are actually mediated by a mechanism of LDL-cholesterol lowering per se and not necessarily a special therapeutic effect of statins. Defining this may help identify individuals from the general population who may benefit from more aggressive lipid-lowering treatment than standard statin treatment in terms of CV morbidity and mortality. This study will be conducted in healthy volunteers only, where participants will be randomized to either the Alirocumab arm (which is a therapy designed to lower cholesterol) or comparator arm. Both Alirocumab and comparator arms will be combined with Atorvastatin (another therapy designed to lower cholesterol) at the second dosing visit. In total, thirty healthy individuals will be recruited to this single centre, randomized, single blind, parallel group, mechanistic physiological study which will be conducted at Cambridge University Hospitals NHS Foundation Trust/University of Cambridge. This study will be open to recruitment for one year and the total study duration for each participant will be approximately 10 weeks. There will be 4 study visits in total with a telephone follow up at the end of the study. Of these visits, two will be dosing visits and the total duration of treatment is approx. 4 weeks. A series of non-invasive haemodynamic assessments and minimally invasive procedures including blood tests and forearm blood flow measurements will be conducted prior, during and post dosing to determine if there is an improvement of endothelia vascular function (as measured by nitric oxide bioavailability) and reduced systemic inflammation. This study is funded by JP Moulton Charitable Foundation.

NCT ID: NCT03273400 Completed - Hamstring Injury Clinical Trials

Effect of Mobilisations on Lumbar and Hamstring

Start date: September 22, 2017
Phase: N/A
Study type: Interventional

To compare the immediate and short-term effects of L4 and L5 Unilateral Posterior Anterior (UPA) Mobilisations on the lumbar and hamstring range of motion and EMG activity of the Erector Spinae and Hamstring muscles. Using a pre-test post-test crossover design subjects lumbar flexion and active knee extension with be recorded prior to and following unilateral zygapophyseal joint mobilisations. Measures will be taken immediately after and then 5, 10, 15, 20, 30 and 60 minutes intervals post intervention. Mobilisation force will be measured via force plates to ensure consistent mobilisation pressure. Following data collection statistical analysis will be undertaken to analyse any potential benefit of lumbar mobilisations to influence the EMG activity of the Erector Spinae and Hamstrings. Functional assessment of lumbar range of motion and hamstring range of motion to be conducted and analyse any effect on movement

NCT ID: NCT03272347 Completed - HIV-1 Infection Clinical Trials

Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)

Start date: November 27, 2017
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.

NCT ID: NCT03272295 Completed - Healthy Volunteers Clinical Trials

A Nicotine Pharmacokinetics and Smoking Behaviour Study Examining Cigarette Ingredients

Start date: September 12, 2017
Phase: N/A
Study type: Interventional

This study will compare nicotine delivery and smoking behaviour in healthy subjects using several combustible cigarette prototypes containing different ingredients which are commonly used in the European Union.

NCT ID: NCT03272269 Completed - Clinical trials for Type 1 Diabetes Mellitus

Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes

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

This clinical study will evaluate the safety of an innovative approach expected to be disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the pancreas. Three doses of the investigational product will be tested in successive cohorts. Although safety is the first objective of this study, we will gather efficacy data and perform a set of immunological tests to further understand the mechanism of action of this new approach in young adults with recent onset type 1 diabetes.

NCT ID: NCT03272113 Completed - Smoking Cessation Clinical Trials

SKIP-IT Smoking Cessation in Pregnancy

SKIP-IT
Start date: December 5, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the feasibility and likelihood of success of a narrative and image-based intervention, administered via text messages, for smoking cessation in pregnant women, prior to undertaking a large scale trial of its effectiveness. A feasibility and pilot trial will be undertaking involving 70 pregnant women who smoke in two NHS Boards.