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NCT ID: NCT02158065 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Impact of "Telecoaching Program" on Physical Activity in Patients With COPD

MrPAPP
Start date: May 2014
Phase: N/A
Study type: Interventional

The purpose of this 3 month randomized intervention study is to investigate the additional effect of a physical activity telecoaching program on physical activity in patients with COPD, compared with usual care.

NCT ID: NCT02157922 Completed - Cystic Fibrosis Clinical Trials

A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis

SMR-2984
Start date: October 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder formulation, in adult subjects with cystic fibrosis.

NCT ID: NCT02157883 Completed - Clinical trials for Advanced Non Small Cell Lung Cancer

Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva)

Start date: November 6, 2014
Phase: Phase 1
Study type: Interventional

This is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy. Part A will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic (PK) parameters of AZD9291. On completion of Part A, patients may continue to take AZD9291 tablets (Part B) following the collection of the 216 hour sample on Day 19 if they and the Investigator deem it appropriate, until such time as their disease progresses, the Investigator believes they are no longer deriving clinical benefit, or they stop taking AZD9291 for any other reason

NCT ID: NCT02157792 Completed - Clinical trials for Advanced Solid Tumor

M6620 First in Human Study

Start date: December 10, 2012
Phase: Phase 1
Study type: Interventional

An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics (PK) of M6620 in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors

NCT ID: NCT02157246 Completed - Clinical trials for Hypoxia in Rectal Cancer

RHYTHM-I: Investigating Hypoxia in Rectal Tumours

RHYTHM-I
Start date: October 2013
Phase: N/A
Study type: Interventional

A low level of oxygen in cancer cells makes them less likely to respond to chemotherapy and radiotherapy treatments. There is interest in using new drugs that improve the level of oxygen in tumours. Another approach would be to increase the radiotherapy dose to tumours with low oxygen levels. Before we can do this for patients with rectal cancer, we need to develop a reliable way of identifying areas of low oxygen within the rectal tumour. This will make us able to tell which patients may be suitable for such a change in their treatment. Traditionally, the level of oxygen in tumours is measured by inserting a needle into the tumour and measuring it directly. This is not possible in rectal cancer. This study has been designed to identify the best alternative method. We would like to do a blood test, take samples of cancer tissue and some detailed scans (18F-fluoromisonidazole (F-MISO) positron emission tomography, perfusion computed tomography, functional magnetic resonance imaging). The results of these tests will be compared to decide which gives us the most comprehensive and reliable information. Patients in Group A go straight to surgery. By looking for markers of low oxygen levels on the tumour that has been removed, we will be able to find out which of the study tests performed before the tumour was removed is the best. By repeating the scans we will be able to see how reliable they are and how much they change on a day to day basis. We think that tumours that still have low levels of oxygen after 8 to 10 doses of radiotherapy are the least likely to respond to treatment. Group B will have scans before radiotherapy treatment and after 8 to 10 doses of radiotherapy to see if we can identify the patients that have persistent low levels of oxygen.

NCT ID: NCT02156973 Completed - Anxiety Clinical Trials

Using Media to Reduce Anxiety for Cardiac Computed Tomography

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

Coming for a cardiac test can be a daunting experience. Despite providing written information sheets for patients, experience in the scanner demonstrates that many patients are ill-prepared when they attend for cardiac computed tomography (CT). Heart rate control is essential for high image quality, as this prolongs cardiac diastole (during which imaging occurs) and results in less motion blur, but this may be challenging to achieve in the context of an anxious patient. In such situations, additional radiation exposure is required to optimise the chances of diagnostic images. Thus, poor patient selection and preparation has been shown to increase the radiation burden to the patient, as well as to increase the rate of non-diagnostic scans, leading to patients needing additional, alternative testing. This can be distressing for patients and increases downstream costs for the hospital. Poor patient awareness is also known to increase the anxiety of attending for a test. Improved patient information and understanding has been shown to improve outcomes in a wide variety of hospital settings. Evidence from cardiac catheterisation angiography suggests that the use of alternative information formats can reduce patient anxiety and improve patient satisfaction, as well as improving their understanding of the technical requirements of a test. The latter may contribute to improved preparation - for example, patients who do not understand the requirements for cardiac CT, particularly the need for a slow heart rate, will often consume caffeine, stop their heart-slowing drugs, or even run or cycle to their appointment. We have agreed a collaboration with Plymouth University to create patient information videos for CT. These will utilise the expertise of media students (their department also runs a commercial arm, due to the quality of their output), in conjunction with the clinical requirements and patient participation groups, to create an accessible, engaging and informative film. We wish to evaluate the impact of this method of conveying information to patients on how well they are prepared to undergo testing. If this concept is successful, it may be of use to patients undergoing a huge range of tests or treatments across specialities. We therefore need to demonstrate the efficacy (or otherwise) of such an intervention.

NCT ID: NCT02156804 Completed - Melanoma Clinical Trials

A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)

Start date: October 7, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.

NCT ID: NCT02155582 Completed - Clinical trials for Non Hodgkin Lymphoma

Copanlisib Pharmacodynamic Study

Start date: August 12, 2014
Phase: Phase 1
Study type: Interventional

This study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.

NCT ID: NCT02155504 Completed - Healthy Volunteers Clinical Trials

A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP3700 in Healthy Male Subjects

Start date: May 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP3700 in healthy male subjects. This study will also explore the effect of itraconazole (another drug) on the PK of ASP3700, as well as to evaluate the safety and tolerability of ASP3700 alone and in combination with itraconazole in healthy male subjects.

NCT ID: NCT02155062 Completed - Healthy Volunteers Clinical Trials

Biomarkers of Whole Grain Wheat and Rye Intake

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

Alkylresorcinols (AR) are a group of lipids found in the bran fraction of wheat and rye grains. AR are absorbed into the bloodstream and their metabolites are excreted in urine in measurable amounts following ingestion of wholegrain (WG) wheat or rye cereal. As AR are absent in refined cereals, plasma AR and urinary AR metabolites are proposed as suitable biomarkers of dietary intake of WG wheat and rye cereal, with a number of studies supporting this proposal. Different AR species are present in characteristic quantities in WG wheat in comparison to WG rye cereals, which can allow identification of the main source of WG (wheat or rye) in individuals by analysing the AR concentrations in blood. However the patterns of urinary AR metabolite excretion following wheat or rye intake have not yet been investigated to determine if there are differences according to WG source. The present study aims to: (i) investigate the differences in AR metabolite excretion pattern in spot and 24 hour urine samples after following a predominantly WG rye-based diet in comparison to a predominantly WG wheat-based diet and in comparison to control (refined cereal diet) (ii) compare the validity and reproducibility of AR metabolites in spot urine samples in comparison to 24 hour urine samples.