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NCT ID: NCT02181894 Completed - Clinical trials for Ventilator Adverse Event

Identifying the Most Accurate Method for Predicting the Safe Depth of Orally Placed Neonatal Endotracheal Tubes (ETT).

Start date: November 2014
Phase:
Study type: Observational

Placing artificial airways in infants is often performed under emergent life-saving conditions, which necessitates a procedure that is both accurate and efficient. Intubations of the newborn are often necessary before an accurate weight can be reported and estimations are often inaccurate. The current national standard uses body weight to predict the appropriate tube depth yet this approach tends to place the tube too deep for the smallest and most vulnerable neonate; and placement accuracy of any size infant is only 50-70%. The consequence of malpositioned ETTs resulting from poor oxygenation, lung hyperinflation, pneumothoraces and death has been suggested to cost $20 to $54 million annually. The morbidity and the financial impact suggest an optimal and accurate approach to place ETT in neonates has not been identified. Other methods to estimate the proper depth of the orotracheal tube have shown promise yet no comparison studies have been performed. Identifying the most accurate method to safely place neonatal orotracheal tubes will improve placement precision and reduce adverse events and their associated costs. Hypothesis Compared to weight, sternal to xyphoid length and shoulder to elbow length, the nasal to tragus length will become the most accurate method for predicting the safe depth of orally placed neonatal endotracheal tubes.

NCT ID: NCT02179879 Completed - Labor Pain Clinical Trials

Development and Validation of Metrics Lumbar Labor Epidural Catheter Placement

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

Procedural skills play an important role in anaesthetic expertise. More focused training and assessment of procedural skills will be needed in the future as training moves from an apprenticeship based training system to competency based assessment. Currently various techniques exists to assess procedural skills of anaesthetist. For epidural catheter placement, task specific check list, global rating scales and cumulative sum techniques have been developed and validated. These techniques aim either for better qualitative outcome sacrificing objectivity or rely on self-reporting. A decrease in objectivity in turn hampers inter-rater reliability which is an essential component of a valid assessment model. Checklists type assessments force the developer to comprehensively characterize the procedure of interest and then validate the completed procedure characterization. This approach has been quantitatively shown to have higher assessment reliability levels compared to Likert-scale assessment. The objective of the project is to develop and validate a comprehensive procedure characterization for labor epidural catheter placement. Another objective is to compare this new assessment tool with existing checklist and global rating scale for labor epidural to establish concurrent validity.5 A well-developed objective, validated procedure characterization serves as a master tool which has multiple applications. It helps to build a training programme for the procedure, allows providing metrics based feedback to trainees using simulator, helps to assess the performance of trainees and in future might be used as benchmark to allow competency based progression in the training.

NCT ID: NCT02177110 Completed - Metastatic Melanoma Clinical Trials

A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma

SYS-ACT
Start date: September 2014
Phase:
Study type: Observational

This is an exploratory prospective translational multicentre study. Melanoma is the 5th most common cancer diagnosed in Ireland and its incidence among women and men is above the European average. Following treatment the elimination of cancer cells ultimately occurs by the activation of apoptotic cell death pathways. The SYS-ACT approach builds on a combination of mathematical systems of modelling, quantitative biochemistry and cell biology, and specifically predicts the drug responsiveness of melanoma cell lines to various apoptosis-inducing treatments. The investigators propose to validate the SYS-ACT approach and application in a translational systems medicine study.

NCT ID: NCT02172950 Completed - Hemophilia A Clinical Trials

An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A

Start date: October 13, 2014
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.

NCT ID: NCT02171975 Completed - Anaesthesia Clinical Trials

Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia

Start date: February 2014
Phase: N/A
Study type: Interventional

Multiple passes and attempts while administering spinal anesthesia are associated with a greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma. The investigators hypothesised that the routine use of pre-procedural ultrasound-guided paramedian spinals reduces the number of passes required to achieve enter the subarachnoid space when compared to the conventional landmark-guided midline approach.

NCT ID: NCT02166606 Completed - Bradycardia Clinical Trials

INGEVITY™ Observational Trial

GENTLE
Start date: April 2014
Phase:
Study type: Observational

The objectives of this registry are to 1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events 2. Gather data on actual number of MRI scans performed in the patient cohort implanted with an ImageReady system including information about scanned body parts. 3. Collect physician feedback on lead handling with the INGEVITY lead in a real-life, market-released standard of care environment using devices on intended purpose and which are authorized to bear the CE (Communauté Européenne) marking / are approved for use in the applicable area of participating centers. No additional invasive or other burdensome examinations are to be carried out other than the ones conducted by the centers per their general standard of care.

NCT ID: NCT02164864 Completed - Atrial Fibrillation Clinical Trials

Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

Start date: July 22, 2014
Phase: Phase 3
Study type: Interventional

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome). The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.

NCT ID: NCT02160353 Completed - Clinical trials for High Risk Localised Prostate Carcinoma

Neo-adjuvant Abiraterone Prostate Study

Start date: July 9, 2015
Phase: Phase 2
Study type: Interventional

The role of this study is to focus on the potential role of abiraterone acetate in treatment-naive patients newly diagnosed with high-risk localised prostate cancer requiring combined hormonal therapy and radiotherapy.

NCT ID: NCT02160171 Completed - Neonatal Seizures Clinical Trials

ANSeR- The Algorithm for Neonatal Seizure Recognition Study

ANSeR
Start date: April 2013
Phase: N/A
Study type: Observational

A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR

NCT ID: NCT02156804 Completed - Melanoma Clinical Trials

A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)

Start date: October 7, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.