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NCT ID: NCT02476942 Completed - Hemophilia A Clinical Trials

A Prospective Study to Collect High-Quality Documentation of Bleeds, Health-Related Quality of Life (HRQoL), and Safety Outcomes in Patients With Hemophilia A Treated With Standard-of-Care Treatment

Start date: May 26, 2015
Phase: N/A
Study type: Observational

This non-interventional study will prospectively collect detailed, high-quality documentation of bleeds, HRQoL, and safety in patients with hemophilia A with or without FVIII inhibitors treated according to local routine clinical practice (receiving FVIII replacement or bypassing agents as either episodic or prophylactic treatment). Actual patients will be enrolled from routine clinical practice in this observational study.

NCT ID: NCT02476682 Completed - Adenomatous Polyps Clinical Trials

Non-invasive Risk Stratification of CR AMN/SSP

FIT
Start date: January 11, 2016
Phase:
Study type: Observational

The purpose of this study is to determine the clinical utility of stool and blood methylation tests for detection of advanced mucosal neoplasia (AMN) and sessile serrated polyps (SSP).

NCT ID: NCT02474524 Completed - Schizophrenia Clinical Trials

Self-Management and Recovery Technology Psychosocial Intervention Trial

SMARTTherapy
Start date: January 1, 2015
Phase: N/A
Study type: Interventional

This project is a component of a broader research program referred to as "Self-Management and Recovery Technology (SMART): Use of online technology to promote self-management and recovery in people with psychosis", which has been funded by the Victorian Department of Health Mental Illness Research Fund (MIRF33). The overall research program is examining the therapeutic potential of using online (Internet-based) educational and multimedia resources in mental health services. It involves the development of a website which can be accessed via an internet browser on a desktop computer, tablet computer, or smartphone. It consists of a series of educational modules containing textual information, exercises, audio, and video clips designed to promote self-management and recovery in people with a history of persisting mental illness. This particular project (SMART-Therapy) involves a randomised controlled trial examining the use of a discrete 8-session psychosocial intervention delivered in addition to routine care which utilises these online materials. The intervention will involve a mental health worker meeting with the participant with a tablet computer (e.g. iPad) on which online materials can be viewed, and used to guide an interaction with the participant. The randomised controlled trial will include 148 participants, who will be randomised to receive one of two interventions: (a) meeting with a support worker using the SMART website to guide interaction (health intervention), or (b) meeting with a support worker delivering a social interaction-based control condition (social intervention). In each condition, there will be 8 x 50min face-to-face sessions over 3 months. Assessments will be completed pre-randomisation, and at 3, 6 and 9 months. The primary hypothesis is that participants randomised to the health intervention will show greater improvement in personal recovery than participants randomised to the social intervention, and that these improvements will be maintained at follow-up (6 and 9 months following intake).

NCT ID: NCT02474355 Completed - Lung Cancer Clinical Trials

Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC

ASTRIS
Start date: September 18, 2015
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the efficacy and safety of single agent AZD9291 in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy.

NCT ID: NCT02474134 Completed - Multiple Sclerosis Clinical Trials

Comparison Study of PF530 and Betaferon in Healthy Subjects

Start date: March 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the safety, tolerability, and blood levels of two interferon beta-1b products, Betaferon and PF530, in healthy volunteers.

NCT ID: NCT02472145 Completed - Clinical trials for Leukemia, Myeloid, Acute

An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy

Start date: August 4, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.

NCT ID: NCT02470884 Completed - Clinical trials for Coronary Artery Disease

FAST Feasibility Study

Start date: June 15, 2015
Phase: N/A
Study type: Interventional

A prospective multi-center, single arm feasibility study to assess the safety and performance of the Boston Scientific Fully Absorbable Scaffold.

NCT ID: NCT02470481 Completed - Psoriatic Arthritis Clinical Trials

A Study in Participants With Psoriatic Arthritis Attending Dermatology Clinics

PARIS
Start date: March 2015
Phase: Phase 4
Study type: Observational

The purpose of this study is to conduct full psychometric testing of the Early Arthritis for Psoriatic Patients (EARP) questionnaire in Australian, Korean and Chinese populations

NCT ID: NCT02470416 Completed - Polyps Clinical Trials

Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

SPIDA
Start date: October 2015
Phase: N/A
Study type: Interventional

Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps. The investigators aim to investigate the prevalence of small bowel polyps in patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas by performing small bowel capsule endoscopy and comparing the results to those acquired from a control cohort undergoing VCE for accepted indication at our centre.

NCT ID: NCT02469298 Completed - Virus Diseases Clinical Trials

Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza

Start date: June 1, 2015
Phase: Phase 2
Study type: Interventional

Study 201682 is a Phase IIa, randomized, double blind, placebo-controlled four arm outpatient study evaluating the safety, tolerability and clinical effect of danirixin or danirixin + oseltamivir combination in comparison to placebo or oseltamivir twice daily for 5 days in otherwise healthy adults with laboratory confirmed influenza infection. Danirixin is a selective and reversible C-X-C Chemokine Receptor 2 (CXCR2) antagonist that inhibits neutrophil transmigration and activation to areas of inflammation. The study endpoints are intended to test the hypothesis that inhibition of neutrophil activation by approximately 50-60% (as previously measured by cluster of differentiation [CD11b] expression in response to chemokine [C-X-C motif] ligand 1 [CXCL1] stimulation ex vivo in human studies) will not impact safety parameters or worsen clinical manifestations of disease, disease-related events of interest, or viral load, and may possibly improve these parameters when administered within 48 hours of symptom onset. The aim of this exploratory study is to obtain data on the safety, tolerability and clinical effect of GSK1325756 (danirixin [DNX]) alone or in combination with oseltamivir (OSV) in otherwise healthy adults with acute, uncomplicated influenza prior to future evaluation in hospitalized patients with complicated influenza. The primary objective is to assess safety and tolerability of DNX with and without a neuraminidase inhibitor through the evaluation of AEs, SAEs, clinical laboratory tests, vital signs, and electrocardiogram (ECG) parameters. Safety assessments will also include an assessment of disease related events (DREs) of interest and associated antibiotic use. The Influenza Intensity and Impact Questionnaire (FluiiQâ„¢) will be used in the study to document patient reported outcomes (PROs). The screening visit in Australia will be composed of a pre-screen for influenza infection with an influenza rapid antigen test followed by a screen for the remaining eligibility criteria for those subjects with a positive result on the influenza rapid antigen test. FluiiQ is trademark owned by Measured Solutions for Health Private Limited.