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NCT ID: NCT03027024 Completed - Cataract Clinical Trials

Clinical Study to Investigate Visual Performance of IOL: FineVision HP

Start date: February 27, 2017
Phase: N/A
Study type: Interventional

This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.

NCT ID: NCT03026985 Completed - Critical Illness Clinical Trials

Acute Skeletal Muscle Wasting and Relation to Physical Function in Patients Requiring ECMO

Start date: January 25, 2017
Phase: N/A
Study type: Observational

The purpose of this study is to describe the changes in quadriceps muscle size and quality over the first 10 days on extracorporeal membrane oxygenation (ECMO) using ultrasound imaging. This study will also examine the relationship between those changes and muscle strength and level of physical function at day 10 and day 20 after ECMO commencement.

NCT ID: NCT03026348 Completed - Clinical trials for Respiratory Syncytial Viruses

Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults

Start date: January 2017
Phase: Phase 2
Study type: Interventional

This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300 eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions of subjects in various strata will not be pre-specified and the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the treatment groups. Serology measures consistent with the study outcomes will be reported.

NCT ID: NCT03025542 Completed - Clinical trials for Chronic Plaque Psoriasis

A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis

Start date: December 27, 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

NCT ID: NCT03023020 Completed - Clinical trials for Coronary Artery Disease

Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen

MASTER DAPT
Start date: April 4, 2017
Phase: N/A
Study type: Interventional

The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube). This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.

NCT ID: NCT03022461 Completed - Clinical trials for Advanced Refractory Left Ventricular Heart Failure

HeartMate 3 CE Mark Study Long Term Follow-up

HM3 CE LTFU
Start date: June 23, 2014
Phase:
Study type: Observational

The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up. The study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that completed the 2-year follow-up in the HeartMate 3 CE Mark study.

NCT ID: NCT03022175 Completed - Healthy Volunteers Clinical Trials

A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR741 in Healthy Volunteers

Start date: December 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of single and multiple intravenous doses of SPR741 when administered to healthy adult volunteers.

NCT ID: NCT03020160 Completed - Hemophilia A Clinical Trials

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks in Participants With Hemophilia A

HAVEN 4
Start date: January 30, 2017
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, non-randomized study will assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at a dose of 6 milligrams per kilogram (mg/kg) every 4 weeks in participants with hemophilia A with or without inhibitors against factor VIII (FVIII). The study consists of 2 parts: a pharmacokinetic (PK) run-in part followed by an expansion part.

NCT ID: NCT03019913 Completed - Critical Illness Clinical Trials

Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients

Start date: January 2017
Phase:
Study type: Observational

Muscle wasting is a significant problem in critically ill patients, with reported losses of a half to three percent per day over the first ten days (for an average 70kg person this equates to 3 to 20kg of muscle loss). Low skeletal muscle mass at admission to the intensive care unit (ICU) and the loss of lean tissue have been associated with negative clinical outcomes, including increased incidence of infections, length of stay, mortality and muscle weakness. It is therefore crucial that technology is utilised to: 1) identify ICU patients with low muscularity on admission, 2) to help understand the factors impacting muscle loss and to 3) assess the effectiveness of interventions aimed at maintaining skeletal muscle mass in this population. The measurement of lean body mass in patients admitted to the ICU is challenging however, due to the large fluid shifts that occur in this population and logistical issues in moving patients to specialised machinery for body composition analysis. Currently, there is no validated method for accurately assessing a patient's muscle mass at the bedside in the intensive care setting. It is therefore important to investigate the accuracy, feasibility and reliability of bedside methods such as subjective physical assessment of muscle mass, mid arm muscle circumference, ultrasound and bioimpedance analysis to assess muscularity in this population who are primarily bedbound. In order to do this, a critical comparison is required between these methods and muscularity assessed by a "reference" body composition method, such computed tomography (CT) image analysis. Briefly, quantification of skeletal muscle at the abdomen area utilising abdominal CT images has been shown to be highly representative of whole body skeletal muscle volume. We wish to conduct a pilot, feasibility study (n= 50), which will recruit patients who have a CT scan (containing abdomen area), performed for clinical purposes. Our primary aim will be to investigate whether muscularity assessed with non-invasive bedside methods (ultrasound, bioimpedance analysis, SGA physical assessment, mid arm muscle circumference) are correlated with skeletal muscle mass quantified by a "reference method" (CT image analysis).

NCT ID: NCT03019185 Completed - Alport Syndrome Clinical Trials

A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL

CARDINAL
Start date: March 2, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.