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NCT ID: NCT02611830 Completed - Colitis, Ulcerative Clinical Trials

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

Start date: December 18, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

NCT ID: NCT02611817 Completed - Crohn's Disease Clinical Trials

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

Start date: January 4, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

NCT ID: NCT02611778 Completed - Clinical trials for Age-related Macular Degeneration (AMD)

Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration

COLUMBUS-AMD
Start date: December 19, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration.

NCT ID: NCT02611713 Completed - Clinical trials for Advanced Parkinson's Disease

Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease

DUOGLOBE
Start date: January 4, 2016
Phase:
Study type: Observational

This study is a non-interventional post-marketing observational study (PMOS) of participants with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical setting. Effectiveness of treatment will be collected with physician and participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6 months thereafter up to 36 months. An additional cohort of participants will be enrolled who in addition will be evaluated with a wearable device.

NCT ID: NCT02611674 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Methodology Study of Novel Outcome Measures to Assess Progression of ALS

Start date: January 6, 2016
Phase:
Study type: Observational

The primary objectives of the study are to estimate and rank-order the longitudinal standardized mean changes over 6 months and over 12 months, for a set of outcome measures administered to participants with amyotrophic lateral sclerosis (ALS), in order to identify measures that are more sensitive to disease progression than Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R). The secondary objectives of this study are: To evaluate the test-retest reproducibility of each outcome measure; To determine correlations between 6 and 12-month changes in all exploratory measures with 18 and 24-month changes in ALSFRS-R and survival; To assess correlations between/among the various measures; To obtain biological samples in order to identify molecular correlates to the clinical measures and to further characterize previously identified and novel molecular biomarkers of disease progression for incorporation into future clinical studies.

NCT ID: NCT02611609 Completed - Clinical trials for Acute Respiratory Distress Syndrome

A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome

MUST-ARDS
Start date: January 2016
Phase: Phase 1/Phase 2
Study type: Interventional

A study to examine the safety (and potential efficacy) of the adult stem cell investigational product, MultiStem, in adults who have Acute Respiratory Distress Syndrome (ARDS). The primary hypothesis is that MultiStem will be safe in ARDS patients.

NCT ID: NCT02611466 Completed - Clinical trials for Osteoarthritis of the Knee

A Study to Assess the Analgesic Efficacy of ASP7962 in Patients With Pain Due to Osteoarthritis of the Knee

OAK
Start date: February 16, 2016
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the analgesic efficacy of ASP7962 relative to placebo. This study will also evaluate the efficacy of ASP7962 relative to placebo on pain on walking, function and stiffness; the time course of efficacy of ASP7962 relative to placebo; the improvement in overall patient status of ASP7962 relative to placebo as well as the safety and tolerability of ASP7962 relative to placebo.

NCT ID: NCT02610738 Completed - Type 1 Diabetes Clinical Trials

Junior KICkOFF: Diabetes Education for Children Under 11 Years

Start date: January 2015
Phase: N/A
Study type: Interventional

The aim of this study is to develop educational packages for children of primary school age with type 1 diabetes and their parents, and to undertake a small scale feasibility study to allow evaluation of the curriculum. Paediatric diabetes teams in the United Kingdom currently deliver education using largely unevaluated teaching materials. By working with the education profession the investigators aim to develop packages which are based on recognised educational theory and practice. The investigators hope that use of these will result in better blood glucose control, reducing the risk of longterm diabetes complications such as eye and kidney disease.

NCT ID: NCT02610634 Completed - Parkinson's Disease Clinical Trials

Visual Function During Gait in Parkinson's Disease: Impact of Cognition and Response to Visual Cues

Start date: July 2013
Phase: N/A
Study type: Observational

Parkinson's disease (PD) is associated with problems of gait such as veering, difficulty turning, an inability to perceive doorways or obstacles, and negotiate uneven terrain. Gait problems, especially veering, may be exacerbated by visuospatial dysfunction which predispose to falls, freezing and festination of gait. Visuospatial dysfunction is common in PD and likely involves peripheral features (e.g. contrast sensitivity) as well as central cognitive mechanisms (e.g. attention). Central neuro-degeneration in PD, PD dementia, and dementia with Lewy Bodies may influence visual function, as impaired visual sampling has been reported in these conditions. Visual sampling is measured via saccadic (fast eye movement) activity, as saccades are the mechanisms through which people orientate and explore the environment. The use of objective devices to reliably measure saccades is important to detect disease related eye movement changes. Emerging visuomotor research has measured visual sampling in PD using devices such as electrooculography and infra-red eye tracking, revealing reduced amplitude, speed and frequency of saccades during various tasks. Despite recent increases in visuomotor research it remains unclear how PD influences visual sampling of the environment during gait and the influence of attentional and cognitive deficits. Recent work demonstrated that people with PD sample their environment less frequently than controls, despite a slower gait. Saccadic timing was unchanged in response to environmental cues. Despite this, environmental visual cues (transverse lines on the floor) have been shown to increase the number of fixations made during gait. However the mechanisms of this response remain unclear. Cognition is likely of importance, with response potentially influenced by attentional control. This observational study aims to examine the influence of cognition on visuomotor control during gait in PD. This aim will be achieved by observation of visual sampling under several environmental challenges (straight walk, doorways, turns, visual cue) and a dual task.

NCT ID: NCT02610140 Completed - Mesothelioma Clinical Trials

Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)

Start date: December 3, 2015
Phase: Phase 2
Study type: Interventional

The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM). 210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine. Treatment will continue until centrally confirmed disease progression or until another criterion is met for withdrawal from the study. Patients will enter follow up phase to capture safety and endpoint data as required. Efficacy will be measured by evaluating progression free survival from randomization. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.