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NCT ID: NCT03316885 Completed - Cataract Clinical Trials

Post-Market Clinical Investigation of the Clareon® IOL

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

The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.

NCT ID: NCT03315403 Completed - Clinical trials for Community-acquired Pneumonia

Quantitative Polymerase Chain Reaction for Improved Detection of Pneumococci in CAP "CAPTAIN"

CAPTAIN
Start date: April 5, 2018
Phase:
Study type: Observational

The purpose of this study is to evaluate the added diagnostic value of a quantitative polymerase chain reaction targeting the lytA gene in detecting pneumococci in patients with community-acquired pneumonia.

NCT ID: NCT03315221 Active, not recruiting - Safety Clinical Trials

Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.

Renoir
Start date: March 8, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment. Preterm infants have much higher nutrient requirements than term infants. The preferred nutrition for all infants including preterm infants is human milk from the infant's own mother, or alternatively donor human milk, provided it is fortified with several nutrients as human milk alone does not sufficiently meet the nutritional needs of preterm infants. Human milk fortifiers (HMFs) are multicomponent enrichments that can be added to human milk (own mother´s milk or donor milk) to meet the increased nutritional needs of preterm infants. The current Nutricia HMF (control product) has been available in its current composition since 2010. It is a multicomponent HMF providing protein, energy, minerals, and vitamins in accordance with the ESPGHAN recommendations. Recent investigation suggests positive effects on growth and development of preterm infants when lipids are added to their nutrition. Therefore, Nutricia has added lipids to their HMF (test product) for a nutritionally more complete fortification of human milk aiming for optimal growth and optimal cognitive and brain development. The Renoir study will investigate the difference between both HMFs with regards to the growth velocity as well as the safety and tolerance of the new HMF.

NCT ID: NCT03315143 Terminated - Heart Failure Clinical Trials

Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

SCORED
Start date: December 19, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.

NCT ID: NCT03315091 Completed - Solid Tumours Clinical Trials

Phase I Study to Assess the Effect of Food on AZD1775 Pharmacokinetics in Patients With Advanced Solid Tumours

Start date: September 29, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the effect of food on the pharmacokinetics (PK) of a single dose of AZD1775 (printed capsules) in patients with advanced solid tumours.

NCT ID: NCT03314753 Completed - Atrial Fibrillation Clinical Trials

FIRE AND ICE Re-Ablations (Retrospective Data Collection)

Re-Do
Start date: January 18, 2018
Phase:
Study type: Observational

Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.

NCT ID: NCT03314714 Completed - Clinical trials for Lipid Metabolism Disorders

Duality of Lipids: the Athlete's Paradox

LIDDIA
Start date: April 3, 2017
Phase: N/A
Study type: Interventional

Accumulation of intramyocellular lipids (IMCLs) due to increased supply of fatty acids can induce defects in the insulin signaling cascade, causing skeletal muscle insulin resistance. However, the causes for muscle insulin resistance are not well understood. The association of elevated IMCLs and insulin resistance has been shown in obese humans and individuals with type 2 diabetes as well as several animal models of insulin resistance. Despite the strong relationship between IMCLs and insulin resistance, this suggested relationship disappears when well-trained endurance athletes are included into this consideration as this group is highly insulin sensitive. This metabolic enigma has been termed the 'athlete's paradox'. The aim of this project is to resolve the mechanisms contributing to the athlete's paradox.

NCT ID: NCT03314675 Terminated - Heart Failure Clinical Trials

Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients

BIO|PULSE
Start date: February 26, 2018
Phase: N/A
Study type: Interventional

The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and compare measurements to 12-lead ECG data

NCT ID: NCT03314480 Completed - Clinical trials for Craniocerebral Trauma

REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury

REDUCTION
Start date: May 1, 2018
Phase:
Study type: Observational

The aim is to prospectively assess the association between clinical parameters and the presence of maxillofacial fractures in trauma patients admitted to the emergency department. Our hypothesis is that a clinical decision aid of critical parameters reduces unnecessary produced CT scans in maxillofacial trauma patients.

NCT ID: NCT03313921 Active, not recruiting - Myopia Clinical Trials

The MORE Study: Manifest vs. Online Refraction Evaluation

MORE
Start date: January 4, 2018
Phase: N/A
Study type: Interventional

The assessment of the refractive state of the eye is a fundamental and important part of ophthalmic and optometric clinical practice. The development of an unsupervised online subjective refraction method makes a refraction more accessible and can be quite cost-saving. In this study, the investigators want to validate an online refraction method which was recently created in the Netherlands. The study comprises two different set of participants: Part one contains fifty healthy volunteers, 18-40 years of age, with a refractive error and no other ophthalmic pathology. Part two contains fifty patients with an ophthalmic pathology. The online refraction outcomes will be compared to a manifest refraction and automated refraction in a cross-sectional study design.