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NCT ID: NCT02219490 Completed - Clinical trials for Chronic Hepatitis C Virus (HCV) Infection Genotype 1

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

TOPAZ-I
Start date: October 30, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

NCT ID: NCT02219178 Completed - Multiple Myeloma Clinical Trials

Study of the Efficacy and Safety of RsqVD Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

Start date: November 2014
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the overall response rate after 4 cycles and the best response to induction therapy with combination of lenalidomide, subcutaneous bortezomib, and dexamethasone (RsqVD) in patients with newly diagnosed multiple myeloma.

NCT ID: NCT02218632 Completed - Clinical trials for Classical Galactosaemia

Glycosylation in Patients With Galactosaemia

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

Galactosaemia is an inherited condition caused by a lack of an enzyme (catalyst) which normally breaks down galactose (the sugar found in milk products). This affects 1:19,000 births annually in Ireland (the highest incidence worldwide) and is screened for by the National Newborn Screening Programme. When an affected infant is diagnosed, galactose is immediately restricted from the diet. This prevents often fatal liver disease and other immediate complications. However, despite early treatment the majority of affected patients go on to develop long-term complications such as intellectual impairment, neurological complications, speech difficulties and infertility in females. The underlying mechanisms for these complications are unclear. The investigators have shown in detailed biochemical and gene analysis studies that major abnormalities affecting the function of complex molecules in the body, particularly glycoproteins, (consisting of sugar chains attached to proteins) persist in treated individuals which may lead to disturbances of the body's intrinsic cellular machinery and relate to the complications seen. In this research the investigators expand on from their earlier studies to see if they can identify biomarkers and parts of the galactose/glycosylation pathways which could be modified or changed with new treatments to improve outcomes for this condition (i.e., IgG N glycans). In more detail, the investigators test the use of the most abundant glycoprotein in human plasma (IgG) as an improved clinical test for monitoring the galactose control needed in patients and also to see if some patients (including children aged 5-12 yrs) might have a better predicted outcome with moderate increases of galactose in the diet. The investigators believe that these studies greatly improve the understanding of Galactosaemia with a view to improving current treatment options and future outcomes.

NCT ID: NCT02214134 Completed - Clinical trials for Any Stage of Lung Cancer (Any Histotype)

SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access

SPECTAlung
Start date: May 22, 2015
Phase:
Study type: Observational [Patient Registry]

SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the molecular characteristics of their disease. The thoracic tumors include lung cancer, malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular characteristics are identified, there might be the possibility to offer these patients access to targeted clinical trials.

NCT ID: NCT02208050 Completed - Clinical trials for Secondary Progressive Multiple Sclerosis

A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS

Start date: February 21, 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine the effect of treatment with fampridine in patients with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb dysfunction (as defined by a 9-HPT time of between 15-90 seconds) and Kurtzke EDSS scores in the range 4.0-7.0 on upper limb function assessed by the nine-hole peg test (9-HPT) and the Jebson Taylor Hand Function Test (JTT). Fampridine has been shown to be effective in improving motor function, specifically walking ability in prior studies in this patient population and is currently licensed for this use in Europe and the United States. Upper limb dysfunction is common in SPMS and PPMS and often underestimated. Fampridine effects action potential conduction in demyelinated nerve fibres and we would hypothesise that the improvement previously reported in walking ability would be similar to that on upper limb dysfunction. Our study aims to address this question using both independent and patient reported outcomes in the context of a randomised placebo controlled crossover trial.

NCT ID: NCT02203266 Completed - Asthma Clinical Trials

Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting

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

The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to: - Improved compliance with prescribed inhaler use - Improved technique of inhaler use - A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage. - An improvement in patient quality of life scores

NCT ID: NCT02198651 Completed - Clinical trials for Rheumatoid Arthritis

A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects

PREDICTRA
Start date: January 5, 2015
Phase: Phase 4
Study type: Interventional

The primary objective of the study was to investigate the association between residual disease activity at Baseline as detected by Magnetic Resonance Imaging (MRI) and the occurrence of flares in participants with rheumatoid arthritis (RA) randomized to an adalimumab dose tapering regimen controlled by adalimumab withdrawal.

NCT ID: NCT02189681 Completed - Anaesthesia Clinical Trials

Landmark Guided Midline Versus Pre-procedural Ultrasound Guided Paramedian at L5S1 for Spinal Anaesthesia

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

Spinal anesthesia is widely performed using a surface landmark based 'blind' technique. Multiple passes and attempts while administering spinal anesthesia are associated with a greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma. Real time and pre-procedural neuraxial ultrasound techniques have been used to improve the success rate of spinal anesthesia. The use of real time ultrasound-guided spinal anesthesia has to date been limited to case series and case reports.Its use may be limited by the requirement for wide bore needles and the technical difficulties associated with simultaneous ultrasound scanning and needle advancement. The use of pre-procedural ultrasound has been shown to increase the first pass success rate for spinal anesthesia only in patients with difficult surface anatomic landmarks. No technique has been shown to improve the success rate of dural puncture when applied routinely to all patients. Routine use of pre-procedure ultrasound guided paramedian approach results in 50% reduction in number of passes required for spinal anaesthetic, from a study at Cork University Hospital (awaiting publication). L5-S1 is the widest interlaminar space and provides minimal contribution to overall movement of lumbar spine.This interspinous space might still be accessible even if the patient has minimal spine flexion. We also noted that spinal needle insertion via the L5-S1 interspace was associated with the fewest passes in the pre-procedure guided ultrasound group (although non-significant). We hypothesise that the routine use of pre-procedural ultrasound-guided paramedian spinal technique at L5S1 interspinous space will result in fewer needle passes to enter the subarachnoid space when compared to the conventional landmark based midline approach.

NCT ID: NCT02185079 Completed - Labor Pain Clinical Trials

The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia

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

Procedural skills are an important determinant of clinical outcomes for certain patient groups. Training for procedural skills in the medical profession is still largely based on an apprenticeship model. For example, trainees learning to perform epidural anaesthesia do so by "practicing" on patients under direct supervision by seniors (consultants or senior registrars/residents). Learning a complex and high risk procedural skill on patients is not ideal. As medical training moves from apprentice based to competency based training along and as for the number of clinical learning opportunities for trainees is less, it is necessary to develop a comprehensive training programme which enables effective and efficient learning without compromising on patient safety. Metrics-based performance based progression has shown to improve clinical performance not only in novices but also in experts. We envisage a standard methodology which could address the deficiencies in procedural training currently. This would entail development and validation of a set of metrics for a particular procedure, evaluation of a proficiency based progression training programme based on those metrics to and demonstration of improved clinical performance and clinical outcome associated with that programme. Although elements of this "end -end" approach have been demonstrated previously for various procedures, we propose to apply this methodology in its entirety to placement of a lumbar epidural catheter for analgesia for patients in labor. To date we have developed and are validating a set of metrics for this procedure. Proficiency based training leading to better procedural skills leading to better patient outcomes has not been studied so far. Epidural analgesia during labor lends itself as an excellent model for evaluating the whole process. It has a specific procedural skill which is closely linked to patient outcome which is measurable and occurs in finite time interval. The hypothesis of the study is that in novice anaesthetic trainees, training with metrics based performance based progression in addition to improving the clinical performance will also reduce the failure rates of labor epidural analgesia to 5% when compared to 25% achieved by conventional training.

NCT ID: NCT02182440 Completed - Acute Kidney Injury Clinical Trials

A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI

STOP-AKI
Start date: December 18, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.