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NCT ID: NCT02089035 Completed - Clinical trials for Hypercholesterolemia

Replacement of Saturated Fat in Dairy on Total Cholesterol

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

The consumption of milk and dairy products is recognised as an essential part of a healthy diet as it represents an important source of key micro- and macronutrients. Nevertheless, there is still a widespread conviction that the overall high energy density and concentration of long-chain saturated fatty acids (SFA) present in dairy have detrimental health effects, contributing to the progression of cardiovascular disease, obesity and diabetes. Supplementation of the bovine diet with a source of MUFA, such as rapesee oil, has become an achievable strategy in order to reduce the amount of SFA present in dairy products. The aim of this project is to observe the effects of three types of dairy products (UHT milk, cheese and butter) produced from milk derived from cows fed withhigh-oleic sunflower oil, on CVD risk biomarkers and plasma total cholesterol levels in adults with an increased risk of developing CVD. The aim is to determine whether an isoenergetic exchange of dairy products will affect vascular function and CVD biomarkers.

NCT ID: NCT02088892 Completed - Tuberculosis Clinical Trials

A Clinical Challenge Study of BCG in Healthy Volunteers

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

TB031 is a challenge study comparing two different strains of the Bacille Calmette-Guérin (BCG) vaccine at standard and high dose.

NCT ID: NCT02088684 Completed - Breast Cancer Clinical Trials

Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

Start date: May 19, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to explore the clinical utility of the three investigational agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with fulvestrant. This is a multi-center, open-label Phase Ib/II study. The Phase Ib portion of the study is a dose escalation to estimate the MTD and/or RP2D for three regimens: LEE011 with fulvestrant; LEE011 and BKM120 with fulvestrant; LEE011and BYL719 with fulvestrant. The Phase II portion of the study was planned to be a randomized study to assess the anti-tumor activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120 with fulvestrant, and LEE011 and BYL719 with fulvestrant in patients with ER+/HER2- locally advanced or metastatic breast cancer. Approximately 216 adult women with ER+/HER2- locally advanced or metastatic breast cancer were planned to be enrolled.

NCT ID: NCT02088541 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

Selinexor (KPT-330) in Older Patients With Relapsed AML

SOPRA
Start date: March 2014
Phase: Phase 2
Study type: Interventional

This is a randomized, multicenter, open-label, phase 2 study of the SINE compound, selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Participants age ≥ 60 years with relapsed or refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.

NCT ID: NCT02087111 Completed - Hepatitis C Clinical Trials

Telaprevir in Genotype 3 HCV

TIG3
Start date: April 2014
Phase: Phase 4
Study type: Interventional

Patients with genotype 3 hepatitis C who have advanced liver disease (cirrhosis) have a very high chance of developing fatal complications of their disease unless they receive effective treatment. Unfortunately the best drugs that are currently available to treat genotype 3 hepatitis C (pegylated interferon and ribavirin) only work in about 50% of patients with advanced liver disease and therefore a large number of patients who have failed treatment are waiting for new, better drugs. Currently there are no treatments available for these patients. Telaprevir is a new drug that is licensed to treat genotype 1 hepatitis C and which works very well in these patients. In patients with genotype 3 hepatitis C small scale trials and laboratory studies show that some patients do respond quite well and others respond a little bit when given telaprevir. In patients who have exhausted all other treatment options the investigators speculate that telaprevir treatment may help some patients by clearing their infection. The purpose of this study is to see if telaprevir can help these patients and to determine if the investigators can predict in advance which people can be helped.

NCT ID: NCT02086084 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

ECCO2R as an Adjunct to NIV in AECOPD

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

Chronic obstructive pulmonary disease (COPD) is one of the UKs commonest chronic diseases and is responsible for a significant number of acute hospital admissions. COPD is characterised by progressive destruction in the elastic tissue within the lung, causing respiratory failure. The clinical course of COPD is characterised by recurrent acute exacerbations (AECOPD), causing considerable morbidity and mortality. Patients with moderate to severe acute exacerbations present with increased work of breathing and hypercapnia. The standard for respiratory support in this setting is non-invasive ventilation (NIV), a management strategy underpinned by a considerable evidence base. However despite NIV, up to 30% of patients with AECOPD will 'fail' and require intubation and mechanical ventilation. The mortality rate for patients requiring NIV is approximately 4%, if conversion to mechanical ventilation occurs the mortality is 29%. The last decade has seen an increasing interest in the provision of extracorporeal support for respiratory failure. The key element that has underpinned improving survival has been technological advancement. This has resulted in pumps causing less blood trauma and inflammatory response, better percutaneous cannulation techniques and coated circuits with reduced heparin requirements. Overall this has significantly reduced the complications associated with the provision of extracorporeal support. One variation of this technique (extra-corporeal CO2 removal ECCO2R) allows CO2 clearance from the blood. This approach has been the subject of a number of animal experiments and uncontrolled human case series demonstrating improved arterial CO2 and reduced work of breathing. Our own unpublished series demonstrates the same physiological changes. However to date the benefits of this approach have not been tested in a randomised controlled trial. The hypothesis is that the addition of ECCO2R to NIV will shorten the duration of NIV and reduce likelihood of intubation.

NCT ID: NCT02086019 Completed - Clinical trials for Acute Coronary Syndromes

Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes

RINCAL
Start date: May 1, 2014
Phase: N/A
Study type: Interventional

For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an invasive-guided strategy will prove superior to a conservative strategy with respect to a combined endpoint of all cause mortality and non-fatal myocardial infarction.

NCT ID: NCT02085993 Completed - Clinical trials for Immune Thrombocytopenic Purpura

Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training

Start date: July 2014
Phase: N/A
Study type: Observational

Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Data will be collected from the subjects' dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.

NCT ID: NCT02085603 Completed - Cancer Clinical Trials

SarCaBon: A Randomised Phase II Trial of Saracatinib Versus Placebo for Cancer-induced Bone Pain

SarCaBon
Start date: March 2014
Phase: Phase 2
Study type: Interventional

This study is designed to assess whether a drug called Saracatinib is helpful in controlling bone pain from cancer. The investigators do not know if it will be, so half of the patients in the study will receive the drug and half will get placebo. Saracatinib is a drug that has been tried in patients with many different forms of cancer. It seems to have effects in bone and so the investigators hope that it will have an effect in those with cancer that has spread to the bones.

NCT ID: NCT02085226 Completed - Stroke Clinical Trials

Art as Creative Engagement for Stroke

ACES
Start date: July 2013
Phase: N/A
Study type: Interventional

Title: A C E S Study: Can an arts based creative engagement intervention (CEI) following stroke improve psychosocial outcomes? A feasibility trial of a creative engagement intervention for inpatient rehabilitation. This is a feasibility randomised controlled trial of a novel intervention for stroke rehabilitation examining effects of participation in visual arts activities on psychosocial outcomes after stroke. The investigators hypothesise that participation in a visual arts based intervention (CEI) will improve stroke recovery variables, mood and self-esteem in stroke survivors receiving in-patient rehabilitation compared to viewing a portfolio of artwork. The results of the study will inform a sample size calculation for a full trial.