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NCT ID: NCT01927666 Completed - Healthy Clinical Trials

The Conversion of ENcapsulated GlucorAphanin, Gut Microbiota Phylogeny and gEnotype Study (ENGAGE)

ENGAGE
Start date: December 2012
Phase: N/A
Study type: Interventional

The variation in extent of isothiocyanate (ITC) excretion in urine from a capsule delivered dose of glucoraphanin will correlate with differences in (a) the gut microbiota, and (b) the genotype of key polymorphic genes (GSTM1, GSTT1, and other as yet undetermined candidate genes). Our study is a human dietary intervention in which participants will consume one capsule containing 100mg purified glucoraphanin from broccoli. The levels of glucoraphanin delivered by the capsule are similar to one to two portions of broccoli. As this is purified glucoraphanin there is no myrosinase enzyme present. All conversion of the glucoraphanin, contained within the capsule, to ITC will therefore occur by enzymes found in the gut microbiota. The ability of the glucoraphanin in the capsule to be metabolised to ITCs by the gut microflora is unknown and will be assessed by measuring ITCs excreted in the urine. The ITCs will be quantified in urine using validated analytical methods. It has been shown in human dietary intervention studies that the extent of conversion of glucosinolates varies greatly. In order to assess possible causative factors for variation in rate of glucoraphanin metabolism each participant will provide a faecal sample from which their faecal gut microbiota phylogeny will be analysed. For a small number of participants a second faecal sample will be requested (a maximum of 3 participants). It is our aim to select one low, one medium and one high ITC excreter. Ideally the low and high excreters would be within the lowest and highest 5% excretion of ITC and the third participant would be as close to the mean ITC excretion as possible. The aim would be to culture the faecal microbiota over time with repeat dosing of glucoraphanin in order to select for microbiota that are able to metabolise glucoraphanin. It is known that the main hydrolysis product of glucoraphanin, sulforaphane, has a variety of benefits to human health, however there is no known clinical relevance to being a high, medium or low excreter of ITC. For each participant a blood sample will also be requested in order that we can assess whether genotype affects the rate of ITC excretion in urine. The GSTM1 genotype and other, as yet, unidentified candidate genes of each participant will be determined. Whether the genotype affects the rate of ITC excretion either alone or in combination with the phylogenetic profile will be assessed.

NCT ID: NCT01927068 Completed - Clinical trials for Peripheral Arterial Disease

STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)

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

Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries. Cohort 2: To evaluate this patient population for treatment of in-stent restenotic lesions.

NCT ID: NCT01926782 Completed - Clinical trials for Hypercholesterolemia

Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)

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

The purpose of the study is to determine if the study drug (alirocumab)administered every 4 weeks, given by injection under the skin is effective and safe compared with placebo in lowering cholesterol, if used alone or added to the participants' current cholesterol-lowering medication.

NCT ID: NCT01926496 Completed - Clinical trials for Actinic Keratosis (AK)

Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%

Start date: September 11, 2013
Phase: Phase 4
Study type: Interventional

The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream. Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive a second treatment cycle with the same treatment if the first treatment does not clear all AKs. Subjects will be followed over a period of three year (36 months) after first treatment

NCT ID: NCT01926431 Completed - Neural Responses Clinical Trials

Effects of Intense Exercise on Neural Responses to Food.

Start date: September 2009
Phase: N/A
Study type: Interventional

The primary aim of this study was to determine the effects of an acute bout of high intensity exercise on the brains response to viewing pictures of food using functional magnetic resonance imaging (fMRI).

NCT ID: NCT01926236 Completed - Cholangiocarcinoma Clinical Trials

Active Symptom Control Alone or With mFOLFOX Chemotherapy for Locally Advanced/ Metastatic Biliary Tract Cancers

ABC06
Start date: February 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether fit patients (with ECOG performance score of 0-1) with advanced biliary tract cancer (ABC) benefit from chemotherapy in the second-line setting (after prior therapy with cisplatin and gemcitabine) in terms of overall survival.

NCT ID: NCT01925924 Completed - Malocclusion Clinical Trials

RMGI v Composite for Orthodontic Bonding

Start date: February 2009
Phase: N/A
Study type: Interventional

Demineralization during orthodontic (brace) treatment is a common clinical problem leading to unsightly white or brown marks on the teeth. A recent systematic review has shown little evidence that current methods of delivering fluoride are effective at reducing this problem. Design: A multi-centre randomised single blinded controlled clinical trial will be conducted with two parallel groups. Setting: The trial patients will be treated by eight named operators on the Specialist List for Orthodontics held by the General Dental Council and who work either within the hospital service or specialist orthodontic practice. The sample size calculation suggests that each operator will need to treat 40 patients in the trial (approx 1 session per week) plus up to 10 familiarisation patients before. Planned trial interventions: Brackets will be bonded to all teeth in front of the first permanent molars with either a resin-modified glass ionomer cement (Fuji Ortho LC) or a light cured composite control (Transbond). The material to be bonded will be allocated randomly. Outcome measures: The two main outcome measures will be the difference in demineralization of the anterior teeth before and after treatment assessed from photographs and the number of debonded brackets during treatment.

NCT ID: NCT01925625 Completed - Lung Cancer Clinical Trials

Early Cancer Detection Test - Lung Cancer Scotland

ECLS
Start date: August 2013
Phase: N/A
Study type: Interventional

HYPOTHESIS In a high risk population the EarlyCDT-Lung test reduces the incidence of late stage tumours;3 / 4 / Unclassified (U) at diagnosis compared to normal clinical practice.

NCT ID: NCT01925365 Completed - Clinical trials for Cardiovascular Disease

Health Benefits of Whole Grain Oats in Population at Risk of Cardio-metabolic Disease

Start date: May 2009
Phase: N/A
Study type: Interventional

Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia and heart disease, however the mechanisms by which oats or oat fractions exert this effect is not totally clear. Furthermore, several large epidemiological studies and a number of recent meta-analyses of nutritional interventions have reported a positive association between increased whole grain intake and reduced risk of developing a range of chronic diseases. Recognising the important role of the gut microbiota in metabolism and metabolic disease risk, we examined the impact of whole grain oats on the human gut microbiota and cardio-metabolic risk factors. The main aims of this human study is to determine the effectiveness of a low GI whole grain oats breakfast cereal compared to a high GI, refined breakfast cereal to beneficially modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and inflammation markers in an at risk of cardio-metabolic disease population

NCT ID: NCT01925209 Completed - Clinical trials for Sporadic Inclusion Body Myositis

Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients

RESILIENT
Start date: September 26, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).