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NCT ID: NCT02680756 Completed - Crohn's Disease Clinical Trials

Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD

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

The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).

NCT ID: NCT02680574 Completed - Anemia Clinical Trials

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

Start date: February 2016
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

NCT ID: NCT02680340 Completed - Osteoarthritis Clinical Trials

POLARSTEM Retrospective Multicenter Study

PR
Start date: January 2016
Phase: N/A
Study type: Observational

The primary purpose of this study is to demonstrate the POLARSTEMâ„¢ Ti/HA cumulative femoral stem revision rate at 10 years. The secondary purpose of this study is to provide 10 years of safety and effectiveness data of POLARSTEMâ„¢ Ti/HA in terms of radiographic and clinical performance

NCT ID: NCT02680210 Completed - Cognition Disorders Clinical Trials

Self-defining Memories in Patients With a TBI

IDENTITY
Start date: February 4, 2016
Phase: N/A
Study type: Interventional

The study will be conducted over 18 months. The main objective of this study is to explore the relationships between autobiographical memory and specific cognitive measures, as well as emotional and behavioural measures in patients who have suffered a moderate to severe TBI. Secondary objectives are to assess the psychometric properties of a self-defining memories questionnaire and to characterize autobiographical memory in the TBI population.

NCT ID: NCT02679846 Completed - Epilepsy Clinical Trials

Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring

SAVE
Start date: February 19, 2016
Phase: N/A
Study type: Interventional

SAVE is a stratified cluster-randomised controlled, parallel group, open-label trial, with Epileptic Monitoring Unit (EMU) as the units of randomisation and patients as the unit of analysis. The focus of research is the management of AntiEpileptic Drugs (AEDs) withdrawal during long term Video EEG (VEEG) monitoring in patients with drug resistant seizures. This non-standardised medical practice, which aims at promoting the occurrence of seizures during the time limit of the monitoring period, exposes patients to significant risks which should be minimised by harmonisation of practice and a standardised protocol of AEDs withdrawal. SAVE will assess the impact of a standardised protocol of AEDs withdrawal during long-term VEEG monitoring on the frequency of seizure-related serious adverse events occurring during these monitorings and on the ability to obtain VEEG recording of seizures within appropriate time limits. 10 of the 22 EMUs will be randomised to the group where the standardised protocol of AEDs withdrawal will be used systematically, while the other ten EMUs will continue their current non-standardised practice of AEDs withdrawal, and will serve as a control group. The setting of the study will include a 6 months evaluation phase, prior to randomisation, during which the organisational characteristics, baseline EMUs' activity, current management of AEDs withdrawal, and rate of Serious Adverse Events (SAEs) of each participating center will be evaluated. The standardised study protocol of AEDs withdrawal has been defined on the basis of a systematic review of all relevant publications in the field.

NCT ID: NCT02678819 Completed - Cognitive Aids Clinical Trials

Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises.

SIMMAX
Start date: July 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a wearable digital cognitive aid has an effect in the management of simulated crises in anesthesia or intensive care.

NCT ID: NCT02678572 Completed - Melanoma, Ocular Clinical Trials

Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma

FOCUS
Start date: February 1, 2016
Phase: Phase 3
Study type: Interventional

This study will evaluate patients who have melanoma that has spread from the eye to the liver: Patients in the study will be treated with Melphalan/HDS up to 6 total treatment, and will be followed until death. This study will evaluate the safety and effects of the treatment on how long patients live and how long it takes for the cancer to advance or respond to the treatment.

NCT ID: NCT02678559 Completed - Clinical trials for Coronary Artery Disease

Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres

PreDeARM
Start date: February 2016
Phase: N/A
Study type: Interventional

The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations will be measured on preload dependency or preload independency status. The principal purpose is to determine if variations of stroke volume during standardized ARM can predict the preload dependency status.

NCT ID: NCT02678533 Completed - Fanconi Anemia Clinical Trials

Mobilization and Collection of Peripheral Blood Stem Cells in Patients With Fanconi Anemia Using G-CSF and Plerixafor

FancoMob
Start date: February 10, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the feasibility of Plerixafor used in combination with G-CSF (Granulocyte Colony Stimulating Factor) in 5 Fanconi anemia patients to mobilize and collect a sufficient number of peripheral blood CD34+ cells for peripheral blood apheresis, for further gene therapy study.

NCT ID: NCT02678312 Completed - Clinical trials for Pediatric Heart Failure

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure

Start date: November 3, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.