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NCT ID: NCT02485899 Completed - Batten Disease Clinical Trials

An Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 190 in Patients With CLN2 Disease

Start date: February 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The Phase 1/2 study (190-201) evaluated the efficacy and safety of a 300 mg dose of BMN 190 administered every other week (qow) to patients with CLN2. The dose and regimen for this study (190-202) are based on the results of the 190-201 study. The rationale for this phase 2 extension study is to provide patients who complete the 190-201 study with the option to continue BMN 190 treatment. The 190-202 study is an open label extension protocol to assess long-term safety and efficacy.

NCT ID: NCT02485743 Completed - Appetite Clinical Trials

A Trial Comparing a Diet Including Products Aimed at Targeting Satiety

SATIN
Start date: January 2016
Phase: N/A
Study type: Interventional

This multi-centre, randomised controlled trial will be conducted over 12-weeks to evaluate whether lower appetite is associated with weight loss maintenance success. The effect of a healthy diet supplemented with products that could enhance feelings of satiety and reduce food intake after an initial weight loss period to assess weight maintenance. Participants will either receive the active SATIN product or a matched control product. The products contain ingredients which have been shown to positively affect satiety, satiation and/or body weight and are all accepted food ingredients approved for human consumption in Europe. They will be incorporated into different food matrices, e.g. drinks, shakes and cheeses. Corresponding control products without the active ingredients will be provided to participants allocated to the control group. The participants will be instructed in detail on how and when to consume the test products. Participants will be 300 adults (BMI >27kg/m2; Age>18years) who will be tested at three research sites (University of Liverpool, United Kingdom; University of Copenhagen, Denmark and University Rovira I Virgili, Spain). Recruitment will be divided between sites. Participants will attend assessments at one of the three research sites continually throughout the study period. The primary outcome is to assess potential associations between changes in appetite (ad libitum energy intake, acute as well as sustained) and change in body weight during the 12-week follow-up period. Secondary outcomes include assessing waist circumference, body composition (DXA), subjective appetite, biomarkers of health outcomes (blood and urine indices), changes in physical activity as well as consumer benefits of the trial (assessed in a range of questionnaires) to determine diet efficacy.

NCT ID: NCT02485691 Completed - Clinical trials for Prostate Cancer Metastatic

Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent

CARD
Start date: November 9, 2015
Phase: Phase 4
Study type: Interventional

Primary Objective: To compare the radiographic progression-free survival (rPFS) (using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 for tumor lesions and Prostate Cancer Working Group 2 (PCWG2) criteria for bone scan lesions or death due to any cause) with chemotherapy (cabazitaxel plus prednisone, Arm A) versus Androgen Receptor (AR)-targeted therapy (enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC participants who have been treated with docetaxel and who had disease progression while receiving AR-targeted therapy within 12 months of AR treatment initiation (less than or equal to [<=]12 months, either before or after docetaxel). Secondary Objective: - To compare efficacy for: - Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP). - Progression-free survival (PFS). - Overall survival (OS). - Tumor response rate and duration of tumor response. - Pain response and time to pain progression. - Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE. - Health status and Health-related Quality of Life (HRQOL). - To evaluate the correlation of a signature of resistance to AR-targeted agents with clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as expression and localization of proteins including AR isoforms in CTCs. - To evaluate safety in the 2 treatment arms.

NCT ID: NCT02484989 Completed - Clinical trials for Retinopathy of Prematurity

UK Surveillance of Treated Retinopathy of Prematurity

Start date: May 2013
Phase: N/A
Study type: Observational [Patient Registry]

Currently, there is little recent data on regional variations in treatment methods, neonatal units that provide retinopathy (ROP) treatment, facilities for treatment available at each unit including anaesthetic support for such preterm babies, facilities to transfer babies to units that offer treatment etc. While some parts of the UK have established neonatal networks and agreements among units for ROP treatment, in other parts, such arrangements are illdefined. The number of babies needing ROP treatment may be higher since the introduction of revised guidelines in 2008 as earlier treatment has been shown to be beneficial. Collecting epidemiological data through the British Ophthalmic Surveillance Unit (BOSU) on the incidence of treatable ROP, the treatment methods used and facilities for treatment will provide the foundation for effective planning of resources and manpower to deal with the additional demand.

NCT ID: NCT02484924 Completed - Clinical trials for Acute Coronary Syndrome

The Risk of Major Bleeding With Novel Anti-platelets: A Comparison of Ticagrelor With Clopidogrel in a Real World Population of 5000 Patients Treated for Acute Coronary Syndrome

ROBOT-ACS
Start date: June 2010
Phase:
Study type: Observational

A retrospective real world analysis of bleeding events with ticagrelor compared to clopidogrel in ACS patients.

NCT ID: NCT02484729 Completed - Healthy Subjects Clinical Trials

A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 After Single Ascending Doses to Healthy Males

Start date: July 2015
Phase: Phase 1
Study type: Interventional

This study will be a randomized, single-blind, placebo-controlled first-in-human study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along the gastro-intestinal tract will be investigated using the IntelliCap® system in a non-randomized, open-label, fixed-sequence design. The study will be performed at a single study centre.

NCT ID: NCT02483637 Completed - Cryotherapy Effect Clinical Trials

Safety and Feasibility Study of Rejuvenairâ„¢ for Treating Chronic Bronchitis Patients

Feasibility
Start date: February 2016
Phase: N/A
Study type: Interventional

This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic bronchitis patients with airflow restrictions.

NCT ID: NCT02483130 Completed - Psychosis Clinical Trials

Effect of N-acetylcysteine on Brain Glutamate

NAC
Start date: June 2015
Phase: N/A
Study type: Observational

A double-blind, placebo controlled, crossover study to determine whether a single dose of N-acetylcysteine (a nutritional supplement) can reduce brain glutamate levels in patients with a psychotic disorder. Secondary outcomes are to determine the pattern of alteration in brain perfusion and activity following a single dose of N-acetylcysteine.

NCT ID: NCT02482701 Completed - Barrett's Esophagus Clinical Trials

The Captivator EMR Registry

Start date: August 2015
Phase: N/A
Study type: Observational [Patient Registry]

To confirm performance of the Captivatorâ„¢ EMR device for resection of early neoplasia in Barrett's Esophagus.

NCT ID: NCT02482688 Completed - Stroke Clinical Trials

A New Rehabilitation Treatment Following Stroke

Start date: June 4, 2015
Phase: N/A
Study type: Interventional

Stroke is the number one cause of disability in the United Nations with about 1 million new cases each year. Following stroke, patients with perceptual and cognitive impairments have the worst prognostic outcomes. There is evidence to suggest that perceptual and cognitive symptoms can be alleviated by multisensory integration, which has the effect of enhancing motor, perceptual and cognitive processes. This research project will investigate for the first time the functional benefits that stem from multisensory stimulation of attention in stroke patients with perceptual and cognitive impairments. The research project will involve multisensory learning paradigms with stimulus and environmental parameters that optimally enhance perceptual learning and cognitive function. Multisensory learning paradigms will be tailored for patients with stroke to determine the perceptual and cognitive symptoms that can be alleviated, and fMRI will be used to evaluate the underlying neural substrates of the effects. The project will show whether multisensory stimulation provides an effective means of attentional rehabilitation after stroke and whether the effects generalize to everyday life, with long-term outcomes that improve functional independence in patients with stroke.