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NCT ID: NCT02336685 Completed - Pain Clinical Trials

Study of Efficacy, Safety of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3001

Start date: July 7, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as adjunctive therapy compared with placebo in participants with chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis that is not adequately controlled by current pain therapy.

NCT ID: NCT02336451 Completed - Clinical trials for ALK-positive Non-small Cell Lung Cancer

A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges

Ascend-7
Start date: April 1, 2015
Phase: Phase 2
Study type: Interventional

This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was performed by a Novartis designated central laboratory. Patients waited for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.

NCT ID: NCT02336412 Completed - Stroke Clinical Trials

Short Message Service (SMS) Reminders for Stroke Secondary Preventative Medications

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

Secondary preventative medications are prescribed to reduce the risk of recurrent stroke following ischaemic stroke. However, continuation rates can be as low as 50% and are likely to be multifactorial. One factor will be patients forgetting to take the medication or a reduced appreciation of the importance of the medication as the time from the stroke passes. Numerous approaches to improve persistence to secondary preventative medications have been tried. One simple approach is use of mobile phone text messages as a reminder for patients to take their medications. In this study, we will introduce an educational and motivational strategy to inform patients about their medications and explore whether a reminder intervention, using Short Message Service (SMS), improves adherence to antiplatelet drugs, antihypertensive medications and lipid lowering drugs. We will also explore whether this improves blood pressure and cholesterol levels in the first 3 months after stroke.

NCT ID: NCT02336074 Completed - HIV Clinical Trials

Research In Viral Eradication of HIV Reservoirs

RIVER
Start date: November 27, 2015
Phase: Phase 2
Study type: Interventional

This study will be a two-arm prospective 1:1 randomised controlled trial comparing: Arm A: cART preferably including raltegravir (combination ART cART - control) Arm B: cART preferably including raltegravir (cART) plus ChAdV63.HIVconsv (ChAd) prime and MVA.HIVconsv (MVA) boost vaccines; followed by a 28-day course of vorinostat (10 doses in total). We hypothesise that this intervention in primary HIV infection will confer a significant reduction in the latent HIV reservoir when compared with cART alone. .

NCT ID: NCT02335892 Completed - Clinical trials for Relapsing Remitting Multiple Sclerosis

PROFILE - Evaluation of QoL and PRO Outcomes in Patients Taking Fingolimod

PROFILE
Start date: November 11, 2014
Phase:
Study type: Observational

Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients. Patients will complete questionnaires at baseline, 3, 6 and 12 months.

NCT ID: NCT02335086 Completed - Clinical trials for Coronary Atherosclerosis

DNA Damage & Repair Proteins In Patients With Atherosclerotic Coronary Artery Disease

DECODE
Start date: September 2014
Phase: N/A
Study type: Observational

The purpose of this study is: 1. To examine the association between stable and unstable coronary artery disease (CAD) with markers of DNA damage and repair, 2. To examine the association between plaque morphology as assessed by frequency-domain optical coherence tomography (FD-OCT) and markers of DNA damage and repair in order to identify potential markers of plaque instability, 3. To examine the association between markers of DNA damage and repair and major adverse cardiovascular events defined as death, MI and unplanned percutaneous or surgical revascularization,

NCT ID: NCT02334306 Completed - Clinical trials for Primary Sjögren's Syndrome

A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

Start date: June 8, 2015
Phase: Phase 2
Study type: Interventional

A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

NCT ID: NCT02333240 Completed - Pre-Eclampsia Clinical Trials

Self-management of Postnatal Anti-hypertensive Treatment: a Trial Development Pilot Study

SNAP-HT
Start date: April 2015
Phase: N/A
Study type: Interventional

New-onset raised blood pressure (BP) affects about one in ten pregnancies. For some women, raised BP is an indication of pre-eclampsia: newly arising high blood pressure in pregnancy combined with protein leaking into the urine. After birth, women's BP remains elevated for a period of time, but in most cases returns to normal over 2-12 weeks. During this period medication needs to be adjusted to achieve the correct control. Research suggests that better BP control during this period is associated with improved long-term health outcomes. The investigators would like to find out whether home BP monitoring, and self-adjustment of medications according to an individualised protocol, could improve BP control and patient satisfaction. This pilot study has been set up to inform the planning of a large-scale multi-centre randomised controlled trial by testing the feasibility of the protocol. The investigators want to increase our experience of applying this management approach in this subset of patients; to select the most appropriate primary outcome measure and to estimate the effect size of this intervention; to assess recruitment potential; and to evaluate feasibility of coordinating this trial across several centres. The primary objective of the large-scale trial will be to determine whether the self-management approach can improve BP control in women with medicated hypertensive disorders of pregnancy in the postnatal period. Women recruited to the study will be randomly assigned to one of two groups: self-management or usual care. Participants allocated to 'usual care' will have their BP monitored and medication adjusted by their general practitioner (GP) and midwife as normal. Participants allocated to the 'self-management' group will use a home BP monitor daily following discharge from hospital after birth. They will be provided with an individualised schedule for gradually decreasing their medication(s) in line with their BP readings. Women will be followed up for 6 months.

NCT ID: NCT02333175 Completed - Parkinson's Disease Clinical Trials

Care for Late Stage Parkinsonism

CLaSP
Start date: September 2014
Phase: N/A
Study type: Interventional

The aim of this project is to evaluate the needs and provision of care for patients in the late stages of Parkinsonism and their carers in several European countries, to compare the effectiveness of different health and social care systems, and to lay the foundation for improved outcomes in this population. The investigators will undertake an in-depth assessment of patients and their care arrangements in a population recruited through networks in six European countries. The systems and procedures that are used in the provision of care will be reviewed through a systematic literature review, interviews and assessments of patients, carers and health care providers, and through a trial comparing assessment by a specialist with management suggestions, guidance and access to telephone advice to that of usual care. Through interviews, questionnaire assessment and review of current health-care and social care arrangement, the investigators will assess the needs, provision of care and use of health-care resources, and their impact on patient and carer outcomes in different countries. National and regional databases will also be interrogated to identify current practice and use of healthcare resources and drug usage. A systematic literature review of the evidence for effective management strategies, analysis of the study data, and evaluation of change in outcomes following specialist review will provide the basis for recommendations in the management of late stage Parkinsonism. The investigators will also evaluate potentially useful outcome measures for use in this patient group. In addition to charting the needs and current care provision for late stage Parkinsonism in different European countries, its cost and effectiveness, and an analysis of health-care and social care predictors of improved outcome, the project will produce a platform for the assessment of patients with late stage Parkinsonism, their current treatment and care provision, as well as guidelines on the management of this late disease phase.

NCT ID: NCT02333058 Completed - Clinical trials for Myelodysplastic Syndromes (MDS)

Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies

Start date: November 21, 2014
Phase: Phase 2
Study type: Interventional

The primary goal of this study is to evaluate an alternative myeloablative, but reduced toxicity conditioning regimen in children, to describe the safety and efficacy of intravenous (i.v.) Treosulfan administered as part of a standardised Fludarabine-containing conditioning and to contribute to the current pharmacokinetic model to be able to finally give age (or body surface area) dependent dose recommendations. The treatment regimens given in the protocol MC-FludT.17/M are based on sufficient clinical safety and efficacy data. Considering the vital indication for allogeneic haematopoietic stem cell transplantation of the selected patient population, the risk-benefit assessment is therefore reasonably in favour of the study conduct.