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NCT ID: NCT01713348 Completed - Diabetes Mellitus Clinical Trials

Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes

SIGN
Start date: October 2012
Phase: Phase 4
Study type: Interventional

To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic control by; 1. regularly checking and understanding Continuous Glucose data & trend arrows at times other than the standard pre-meal bolus calculation test times and 2. review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care Professional (HCP) and adjusting behaviours & therapy from interpretation of the Continuous Glucose profiles.

NCT ID: NCT01712789 Completed - Multiple Myeloma Clinical Trials

Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

STRATUS
Start date: November 6, 2012
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years. In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses. The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.

NCT ID: NCT01712594 Completed - Type 1 Diabetes Clinical Trials

Safety and Effectiveness Study of a Closed Loop System Maintaining Patients' Glucose Levels During an Overnight Period

Start date: May 2013
Phase: N/A
Study type: Interventional

Currently, patients diagnosed with type 1 diabetes rely on either finger stick or sensor glucose readings when making their insulin dosage decisions. Designing a computerized system that mimics the way insulin is produced naturally in a person who does not have type 1 diabetes holds many challenges; all of which cannot be addressed in just one study. The purpose of the Medtronic Overnight Closed Loop study is to assess the performance of a system designed to automatically infuse the correct insulin dose during the hours that the patient is sleeping. The system consists of an insulin pump that provides insulin to the patient through an infusion set. A sensor inserted just under the patient's skin measures glucose levels and a transmitter sends this information to the pump. To enable the sensor to register the glucose information correctly, it must be set (calibrated) by a finger stick blood glucose 3-4 times a day. In the commercially released system, the physician would recommend the continuous background (basal) insulin rates and the patient would be required to make decisions regarding extra insulin (bolus) for meals or as a response to high glucose levels. In the Closed Loop System, a mobile control system is added to these devices. This consists of an Android phone, a closed loop algorithm and a translator. This system is designed to translate the sensor information and direct the pump to provide the required dosage of insulin automatically without requiring input from the patient. Reliable calibration has proved challenging, and so it is important that the system function safely, even when calibration is inaccurate. In this study, a calibration error will be introduced under very controlled circumstances. This testing will identify if the system can maintain acceptable overnight glucose levels, regardless of whether or not calibration is ideal.

NCT ID: NCT01712438 Completed - Severe Hemophilia A Clinical Trials

Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients

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

Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.

NCT ID: NCT01712386 Completed - COPD Clinical Trials

Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and Exercise

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

Patients with moderate chronic obstructive pulmonary disease (COPD) typically have reduced exercise capacity. This is because their lungs are damaged and because of increased work of breathing. In some patients, exercise capacity is reduced to such a level that even simple activities of daily living, such as washing and dressing, may impose a challenge. Recent findings in healthy young people suggest that increasing the amount of nitrate in our diet in the form of beetroot juice can improve the ability to exercise. Studies involving cycling have shown that less oxygen is needed to perform the same level of exercise after taking more nitrate in the diet. Nitrate (found in abundance in beetroot) is known to be converted in the body to nitric oxide (NO), a substance which increases blood flow and may affect the energy-producing mechanisms inside muscle cells. A recent exciting finding is that such dietary nitrate supplementation appears to reduce the amount of oxygen needed to complete moderate intensity exercise (walking) in healthy individuals. It is the purpose of this study to see if such effects could be seen in COPD patients. If this is indeed the case, then it may suggest that a period of dietary supplementation of a relatively cheap, widely available, and natural food product may improve the ability of patients to undergo everyday tasks and ultimately improve their quality of life. To help investigators understand the effects of dietary nitrate supplementation on the ability to exercise in COPD patients, the investigators will recruit 15 people with mild to moderate disease. They will complete a series of undemanding exercise tests on three separate occasions. On one occasion they will have had a course of nitrate rich beetroot juice leading up to the tests, and on the other occasion they will have had a course of beetroot juice with the nitrate removed. The investigators will monitor blood pressure, levels of nitrate and nitrite in the blood, oxygen uptake and functional capacity during the tests which will allow us to assess any effects that may have occurred as a result of increased nitrate intake.

NCT ID: NCT01712256 Completed - HIV-1 Infection Clinical Trials

Re-boosting of HIV-1 Infected Subjects With Vacc-4x

Re-boost
Start date: December 2012
Phase: Phase 2
Study type: Interventional

During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced immunological response and eventually immune deficiency. Vacc-4x is a peptide-based HIV immunotherapy vaccine and is anticipated to strengthen the immune system's response to HIV. All patients participating in this trial have previously received the vacc-4x vaccine in order to reduce the amount of HIV-1 virus in the blood and increase the immune response. The primary objective of this study is to evaluate if a re-boost with Vacc-4x could further reduce the amount of HIV-1 virus and increase the immune response.

NCT ID: NCT01711359 Completed - Clinical trials for Rheumatoid Arthritis

A Study in Participants With Moderate to Severe Rheumatoid Arthritis

RA-BEGIN
Start date: November 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether baricitinib therapy alone is noninferior to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs).

NCT ID: NCT01711047 Completed - Clinical trials for Persistent Atrial Fibrillation

Benefit of CFAE Ablation

BOCA
Start date: March 2010
Phase: N/A
Study type: Interventional

The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation in addition to pulmonary vein isolation and linear ablations improves single procedural success rate over a 12 month follow up period.

NCT ID: NCT01711008 Completed - Clinical trials for Alteration of Cognitive Function

The Effect of Breakfast Size Prior to Morning Exercise on Cognition, Mood and Appetite in Habitually Active Women

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

Both regular exercise and breakfast consumption have well known health benefits. Consuming breakfast prior to morning exercise may influence appetite, mood and cognitive function later in the day. The purpose of this study is to test whether the amount of food consumed at breakfast prior to exercise influences these parameters in active women.

NCT ID: NCT01710995 Completed - Acid Reflux Clinical Trials

A Three-Period Study to Investigate the Relative Bioavailability and Pharmacodynamic Profiles of a Zegerid 20mg Capsule, Zegerid 20mg Powder for Oral Suspension and Losec 20mg Capsule in Healthy Adult Volunteers Under Fasting Conditions

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the effectiveness of Zegerid 20mg capsules and powder and Losec 20mg capsules in healthy volunteers under fasting conditions.