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NCT ID: NCT03499015 Recruiting - Clinical trials for Tube Disorders Eustachian

Balloon Dilation of the Eustachian Tube in Children

Start date: December 14, 2018
Phase: N/A
Study type: Interventional

Otitis media with effusion (OME) is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures. Goal of this study will be to evaluate the Balloon Eustachian Tuboplasty (BET) in children as an additional treatment option and to assess long-term effects of BET. Beside the standard procedure, children (4 to 10 years of age), with equal pathology on both ears, will be assigned for BET on side.

NCT ID: NCT03486873 Recruiting - Solid Tumors Clinical Trials

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

Start date: August 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.

NCT ID: NCT03485066 Recruiting - Neuronal Plasticity Clinical Trials

Simultaneous PET/MR Imaging of Human Brain Plasticity

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Background: Neuronal plasticity is the brain's ability to continuously adapt to experiences and learning of new skills. Although this affects multiple characteristics of the brain such as structure, function and metabolism, direct interactions between these aspects are largely missing. Aim: Using recent advancements in neuroimaging we aim to identify novel relationships how neuronal plasticity is related across these characteristics. Design: 40 healthy subjects will undergo two simultaneous PET/MR measurements at baseline and after 4 weeks. During the measurements a cognitively challenging task will be performed and the training group (20 subjects) will practice during the 4-week period. Implications: We combine simultaneous PET/MR and novel task-specific PET imaging to study brain metabolism, structure and function in a single measurement session. This provides optimal sensitivity for assessment of multimodal neuroplasticity associations. Knowledge how cognitive training affects multiple characteristics of the brain will also increase our understanding of disorders like depression, dementia and brain injuries, since these are diagnosed with cognitive evaluations. Considering the vast usage of the applied imaging procedures in diagnosis and therapy monitoring, the thorough investigation of multimodal associations offers benefit for the interpretability of neuroimaging in clinical routine.

NCT ID: NCT03480698 Recruiting - Clinical trials for Acute Ischemic Stroke

Cerebrolysin REGistry Study in Stroke - a High-quality Observational Study of Comparative Effectiveness

C-REGS2
Start date: April 24, 2018
Phase:
Study type: Observational [Patient Registry]

This study investigates the clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with moderate to severe neurological deficits after acute ischemic stroke.

NCT ID: NCT03469609 Recruiting - Enterostomy Clinical Trials

Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)

MUC-FIRE
Start date: June 18, 2018
Phase: N/A
Study type: Interventional

The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care.

NCT ID: NCT03467958 Recruiting - Crohn Disease Clinical Trials

An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

Start date: August 24, 2018
Phase: Phase 3
Study type: Interventional

This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

NCT ID: NCT03464097 Recruiting - Crohn Disease Clinical Trials

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Start date: June 27, 2018
Phase: Phase 3
Study type: Interventional

This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.

NCT ID: NCT03461991 Recruiting - Corneal Dystrophy Clinical Trials

Correlation Between In-vivo Anatomy of Corneal Dystrophies as Assessed by High- Resolution Optical Coherence Tomography (OCT) Measurement and Histological Examination

Start date: August 21, 2018
Phase: N/A
Study type: Interventional

Corneal dystrophies are usually classified histopathologically according to the layer of the cornea that is affected. The International Committee for the Classification of Corneal Dystrophies (IC3D) takes this anatomical classification as referral with summarizing clinical, genetic, and pathological data. Most of this classification relies on slit lamp findings or histologic specimen, since in-vivo imaging of corneal microstructures has only become available in the recent years. With confocal microscopy it is possible to image corneal microstructures at a high resolution, but this technique is limited by its reduced repeatability and the fact that only a small area can be imaged. By the use of optical coherence tomography (OCT) systems it is possible to overcome these limitations. Commercially available systems, however, only have an axial resolution of about 18 µm which is not sufficient for imaging of all corneal layers. Recently, a high-resolution optical coherence tomography (OCT) system was developed at the Center for Medical Physics and Biomedical Engineering that enables a resolution of about 1 µm. With this resolution, all corneal structures and several pathologies can be visualized. In the present study the investigators want to use this OCT system to image corneal dystrophies in patients scheduled for corneal transplantation.

NCT ID: NCT03461393 Recruiting - AMD Clinical Trials

The Effects of Regular Eye-training With a Mobile Device on Adult Patients With AMD

ETAMD
Start date: April 1, 2018
Phase:
Study type: Observational

Data collection and observation of changes within AMD patients performing visual training on mobile devices

NCT ID: NCT03437226 Recruiting - Heart Failure Clinical Trials

Repetitive Levosimendan Infusion for Patients With Advanced Chronic Heart Failure

LeoDOR
Start date: March 8, 2018
Phase: Phase 3
Study type: Interventional

Repetitive levosimendan infusions for patients with advanced chronic heart failure (LeoDOR) A randomised, double-blind, placebo-controlled multicentre study with parallel group design. Mortality and rehospitalisation rates are high in the vulnerable phase following heart failure hospitalisation. Previous studies suggest that these events can be reduced by repeat infusions of levosimendan in patients with advanced heart failure.