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NCT ID: NCT02222207 Completed - Clinical trials for Macular Degeneration

Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration

DREAM
Start date: October 2014
Phase: Phase 2
Study type: Interventional

Part A (Phase IIa): Primary objectives: The study part A is designed to investigate whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate the safety and tolerability of the regorafenib eye drops. Part B (Phase IIb): Primary objectives: The study part B is designed to investigate: - how often the regorafenib eye drops need to be given per day - whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate how the different dosings of regorafenib eye drops affect patients vision, the safety and the tolerability.

NCT ID: NCT02219932 Completed - Multiple Sclerosis Clinical Trials

Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis

ENHANCE
Start date: September 2014
Phase: Phase 3
Study type: Interventional

The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on patient-reported walking ability over a 24-week study period. The secondary objectives are: To determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of Multiple Sclerosis (MS), and upper extremity function over a 24-week study period; To evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; To assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.

NCT ID: NCT02217358 Completed - Clinical trials for Recurrent Respiratory Papillomatosis

Value of Narrow Band Imaging (NBI) Endoscopy in the Early Diagnosis of Laryngeal Cancer and Precancerous Lesions

Start date: February 2012
Phase: N/A
Study type: Interventional

The aim of the project is to compare NBI endoscopy and standard endoscopic method using white light and evaluate accuracy both methods in early detection and diagnosis hypopharyngeal and laryngeal precancerous and cancerous lesions. A higher contrast between the mucosal epithelium and blood vessels is achieved in NBI endoscopy using filtered light comparing to white light observations. This allows detection of small mucosal changes, few millimetres in diameter, which are not observable using white light. The second aim in patients with squamous cell carcinoma of the upper aerodigestive tract is to compare extension of mucosal lesions by evaluation of NBI endoscopy and white light endoscopy, which is crucial for perform targeted biopsy and for determination of resection margins in cancer surgery. The investigators expect that dysplastic changes of mucosa or early laryngeal cancerous lesions are detected in white light endoscopy rarely. In case our hypothesis is confirmed, frequency of precancerous and early cancerous lesions of hypopharynx and larynx is more common in patients with non-specific symptoms of laryngeal and pharyngeal diseases.

NCT ID: NCT02213744 Terminated - Breast Cancer Clinical Trials

MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients

HERMIONE
Start date: July 2014
Phase: Phase 2/Phase 3
Study type: Interventional

This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.

NCT ID: NCT02209064 Completed - Clinical trials for Arrhythmias, Cardiac

"EASE" Epicardial Access With the EpiAccess System

EASE2
Start date: December 2013
Phase: N/A
Study type: Interventional

Prospective non-randomized, single arm trial to further evaluate the safety and performance of EpiAccess, the study device, for gaining access to the normal, non-distended pericardial space during epicardial diagnostic or therapeutic (ablation) procedures.

NCT ID: NCT02205814 Completed - Knee Osteoarthritis Clinical Trials

Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee

ALBATROSS-3
Start date: April 2014
Phase: Phase 2
Study type: Interventional

This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm, dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of fasitibant in patients with symptomatic osteoarthritis (OA) of the knee. Approximately 400 male and female patients 40-80 years old, with BMI < 30 kg/m² and with a clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a total of 4 treatment arms. Each arm includes a single intra-articular injection of one of three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation ratio will be 1:1:1:1. The primary efficacy variable will be the change of the Western Ontario and McMaster Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from baseline up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse events and clinical laboratory tests; local tolerability at the injection site will also be assessed. In addition, the population pharmacokinetics and the exposure-response relationship will be evaluated. The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7 planned visits at site, including screening, randomisation, 4 follow-up visits and the End of study visit.

NCT ID: NCT02187432 Recruiting - Clinical trials for Autosomal Dominant Polycystic Kidney Disease

The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe

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

EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational cohort study has the potential to identify progression factors and biomarkers, and to assess disease stage specific mortality, morbidity and health care costs.

NCT ID: NCT02185911 Completed - Anaemia Clinical Trials

Observational Study of Correction of Anaemia With Darbepoetin Alfa at QM Dosing Interval in Patients With CKD Not on Dialysis

ADAPTATION
Start date: June 2014
Phase: N/A
Study type: Observational

To describe anaemia correction via haemoglobin measurements taken throughout observation period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM

NCT ID: NCT02183974 Completed - Clinical trials for Otitis Media With Effusion

Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion

Start date: June 2012
Phase: N/A
Study type: Interventional

The aim of the study was detection of pepsin in effusion in children with OME using Peptest as new quick and cheap method of detection and comparison results with results of other studies in which pepsin was detected by more demanding methods. Such a type of study hasn't been done so far.

NCT ID: NCT02183961 Completed - Clinical trials for Otitis Media With Effusion

Three Methods Used in the Diagnosis of EER in Children With OME

Start date: June 2012
Phase: N/A
Study type: Interventional

Detection of extraesophageal reflux (EER) in children with chronic otitis media with effusion (OME) using three different diagnostic methods and selection of the group of patients with severe EER who could potentially benefit from antireflux therapy.