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NCT ID: NCT01896531 Completed - Gastric Cancer Clinical Trials

A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Start date: August 14, 2013
Phase: Phase 2
Study type: Interventional

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 [mFOLFOX6]) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either ipatasertib or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle.

NCT ID: NCT01896115 Completed - Parkinson's Disease Clinical Trials

CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation

CUSTOM-DBS
Start date: June 2013
Phase: N/A
Study type: Interventional

The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.

NCT ID: NCT01896102 Completed - Clinical trials for Cerebral Adrenoleukodystrophy (CALD)

A Study of the Efficacy and Safety of Hematopoietic Stem Cells Transduced With Lenti-D Lentiviral Vector for the Treatment of Cerebral Adrenoleukodystrophy (CALD)

Start date: August 21, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

This trial assessed the efficacy and safety of autologous cluster of differentiation 34 (CD34+) hematopoietic stem cells, transduced ex-vivo with Lenti-D lentiviral vector (also called elivaldogene autotemcel or eli-cel), for the treatment of cerebral adrenoleukodystrophy (CALD). A participant's blood stem cells were collected and modified (transduced) using the Lenti-D lentiviral vector encoding human adrenoleukodystrophy protein. After modification (transduction) with the Lenti-D lentiviral vector, the cells were transplanted back into the participant following myeloablative conditioning. Participants in this study will be continuously followed in study LTF-304.

NCT ID: NCT01895946 Completed - Clinical trials for Safety and Tolerability,

Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

OAK
Start date: December 2013
Phase: Phase 1
Study type: Interventional

Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

NCT ID: NCT01895751 Completed - Unstable Angina Clinical Trials

Conservative Non-Invasive Versus Routine Invasive Management in Coronary Artery Bypass Surgery Patients With Non ST Elevation Elevation Acute Coronary Syndrome

CABG-ACS
Start date: April 2012
Phase: Phase 4
Study type: Interventional

Background: Most coronary artery bypass grafts (CABG) are diseased or blocked within 10 years of surgery meaning CABG survivors have an ever increasing risk of recurrent angina, heart attack and death. Given the large number of CABG survivors in the United Kingdom (UK), and the complexities of their clinical management, their heart health problems and related treatment are an increasing challenge in the UK National Health Service (NHS) and worldwide. There is considerable controversy in the NHS and internationally about how to best manage patients with prior CABG and unstable angina / non-ST elevation acute coronary syndromes (NSTE-ACS). This is because there is no robust evidence to inform treatment practices or clinical guidelines since, historically, these patients have been excluded from randomised trials. This is the rationale for our study. Aims: Our overall aim is to undertake a clinical trial of conservative non-invasive management with optimal drug therapy versus routine invasive management in NSTE-ACS patients with prior CABG during routine clinical care in NHS hospitals across the UK. Our trial is a proof-of-concept study of feasibility, safety, potential efficacy and health economics. Hypothesis: A routine invasive approach in NSTE-ACS patients with prior CABG will not be superior to a conservative non-invasive approach with optimal medical therapy. Design: The pilot study will involve 60 patients recruited in large urban hospitals (Western Infirmary, Glasgow Royal Infirmary) and district general hospitals (Royal Alexandra Hospital, Royal Blackburn Hospital (RBH)) to reflect usual practice in the UK. One of these hospitals (RBH) has an on-site cardiac catheterization laboratory, whereas the other hospitals refer patients who have been triaged for invasive management to the regional cardiothoracic centre (the Golden Jubilee National Hospital). In this proof of concept study, the investigators aim to gather information about screening, recruitment, randomisation, patient characteristics (including comorbidity and quality of life) and initial clinical outcomes to inform the design of the definitive trial. The follow-up will be in line with standard clinical care i.e. 30-42 days and 1 year. The investigators will hold data in the longer term to enable long-term follow-up analyses. The investigators will record information on NSTE-ACS patients with prior CABG who are ineligible to take part or who do not wish to be randomised as part of all follow-up registry of 'all-comers'.

NCT ID: NCT01895543 Completed - Clinical trials for Chronic Idiopathic Constipation

Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

Echo 3
Start date: September 2013
Phase: Phase 3
Study type: Interventional

Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation

NCT ID: NCT01895335 Completed - Multiple Sclerosis Clinical Trials

Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients

TERI-PRO
Start date: June 2013
Phase: Phase 4
Study type: Interventional

Primary Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Patient Reported Outcomes (PROs). Secondary Objectives: To describe disease progression using Patient Reported Outcomes (PROs). To describe clinical outcomes (ie, treated relapses) in teriflunomide treated patients. To describe the change in cognition in teriflunomide treated patients. To describe safety of teriflunomide in patients treated (based on adverse events reporting). To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment. To compare Patient Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

NCT ID: NCT01895309 Completed - Clinical trials for Rheumatoid Arthritis

A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Start date: June 2013
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy. In some countries, after 52 weeks of treatment with either SB4 or Enbrel, subjects will be enrolled into an open label extension period. Subjects will receive SB4 for an additional 48 weeks.

NCT ID: NCT01894243 Completed - Solid Tumours Clinical Trials

Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment

Start date: March 13, 2014
Phase: Phase 1
Study type: Interventional

This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow patients with mild or moderate hepatic impairment or normal hepatic function continued access to olaparib after the PK phase and will provide additional safety data.

NCT ID: NCT01894048 Completed - Asthma Clinical Trials

Targeted Small Airways Therapy in Persistent Asthma

ANDA3
Start date: October 28, 2013
Phase: Phase 4
Study type: Interventional

The mainstay of asthma treatment is with inhaled steroids (commonly called a 'preventer') to keep the symptoms of asthma under control. Increasing strengths of steroid inhaler may be required in order to gain control of asthma, and this is usually guided both by symptoms and simple measurements of lung function such as peak flow. The airways (breathing tubes) in the lungs get smaller the further into the lungs they go. Most simple measurements of lung function only reflect the larger 'central' airways and don't provide information on the smaller 'peripheral' airways.Newer measurements have been developed that can now give us accurate information on how the smaller airways are working.Indeed the small airways seem to play a significant role in asthma in terms of inflammation and airway narrowing. Recently, new types of steroid inhalers have been developed that have a much smaller particle size than other standard inhaled steroids.These have been shown to go deeper into the lungs, thus getting into the smaller airways. There have been a few studies suggesting that this might improve asthma control. However, we do not know if when small airway function is shown to be abnormal, whether this improves with extra-fine particle inhaled steroids, nor whether by improving small airway function specifically this translates into improved asthma control. In this study we wish to study asthmatic patients who are not completely controlled on standard particle size inhaled steroids, in addition to having evidence of abnormal small airway function. By doing this we want to find out whether changing to the same dose of an extra-fine particle inhaled steroid instead will improve asthma control by getting deeper into the lungs and improving small airway function.