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NCT ID: NCT02525523 Completed - Pouchitis Clinical Trials

Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics

Start date: December 3, 2015
Phase: Phase 3
Study type: Interventional

A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic antibiotic refractory pouchitis. Subjects will undertake a <2 week screening period to provide baseline data and be assessed for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1 basis to either a) 240 mg alicaforsen enema or b) matching placebo. Study drug will be administered once nightly (on going to bed) up to and including week 6. Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy assessments at Week 3, 6, 10, 18 and 26. Subjects may receive certain permitted medications as per Entry Criteria, which must remain at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a dose change to an existing concomitant medication for pouchitis, other than those detailed in the protocol, will not be permitted. Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary card. Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks 6 and 10). Where technically feasible, each endoscopy will provide at least one biopsy sample for histopathology. In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will be assessed. Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods and stool samples will be collected to evaluate relevant biomarkers.

NCT ID: NCT02525198 Completed - Clinical trials for Mild Cognitive Impairment

The Cognitive Ageing Nutrition and Neurogenesis (CANN) Trial

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

There is a dearth of research which takes a multi-compound approach to dietary interventions, in humans, aimed at improving outcome measures of cognition. Animal research in particular points towards fatty acids and flavonoids having a potentiating effect on each other, and possibly even being synergistic. Thus, study products will be administered in the present trial comprising both of these compounds, with a view to investigating their potential effects on cognition in older adults with mild cognitive impairment (MCI) or subjective memory impairment (SMI).

NCT ID: NCT02524730 Completed - Clinical trials for Arthroplasty, Replacement, Knee

Scorpio NRG (eNeRGize) Cruciate Retaining (CR) Post-market International Outcome Study

Scorpio NRG
Start date: May 18, 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.

NCT ID: NCT02524093 Completed - Multiple Sclerosis Clinical Trials

The Impact of Positive Mental Training in Multiple Sclerosis

PosMTMS
Start date: January 2016
Phase: N/A
Study type: Interventional

Depression and anxiety are common in MS and often go untreated. Even symptoms which do not meet the threshold for a psychiatric diagnosis can have a significant impact on quality of life. Positive Mental Training (PosMT) is a 12 week programme which aims to help people overcome the negative thinking and feelings that come with worry and low mood and become more positive, confident and resilient. To find out if Positive Mental Training is helpful in MS the investigators are running a randomised controlled trial. The initial study is a pilot tiral, the primary function being examination of the feasibility and acceptability of this treatment in MS. Though sample size is small and consequently it may not be powered to detect a significant change in symptoms in association with the treatment, this will also be examined.

NCT ID: NCT02523391 Completed - Dyslipidaemia Clinical Trials

Bioequivalence Study of Capsule and Tablet Formulations of TA-8995

Start date: July 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the pharmacokinetics of capsule and tablet formulations of TA-8995 in healthy male subjects aged 18 to 55 years.

NCT ID: NCT02523339 Completed - Clinical trials for Retinal Vein Occlusion

Study of Retinal Oxygenation in Central Retinal Vein Occlusion

Start date: October 2014
Phase:
Study type: Observational

The purpose of the study is to test if oxygen saturation in retinal vessels is correlated with clinical parameters, such as visual acuity, central retinal thickness and presence of neovascularization. Retinal oximetry is performed with fundus camera based oximeters. The study will not entail change in treatment of the disease.

NCT ID: NCT02523170 Completed - Pancreatic Cyst Clinical Trials

A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas

CONCYST
Start date: July 2014
Phase: N/A
Study type: Interventional

A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by standard surveillance. This part of the study will recruit 60 patients.

NCT ID: NCT02523157 Completed - Mental Health Clinical Trials

Wellbeing in Pregnancy: Evaluating an Intervention to Improve Women's Emotional Wellbeing in Pregnancy

WiP
Start date: August 2015
Phase: N/A
Study type: Interventional

The Wellbeing in Pregnancy (WiP) project is an online pilot randomized controlled trial which aims to evaluate an intervention to improve women's emotional wellbeing in pregnancy.

NCT ID: NCT02523131 Completed - Diabetes Mellitus Clinical Trials

Home Testing of Day and Night Closed Loop With Pump Suspend Feature

APCam11
Start date: May 2016
Phase: N/A
Study type: Interventional

The main study objective is to determine whether day and night automated closed loop glucose control combined with pump suspend feature will improve glucose control and reduce the burden of hypoglycaemia compared to sensor augmented insulin pump therapy alone. This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a three-month period of home study during which day and night glucose levels will be controlled either by a closed loop system combined with pump suspend feature (intervention group) or by sensor augmented insulin pump therapy (control group). It is expected that up to 100 subjects, aiming for 84 randomised subjects [42 youth (6 to 21 years), and 42 adults (22 years and older)], with type 1 diabetes will be recruited through paediatric and adult outpatient diabetes clinics in each of the investigation centres. Subjects who drop out within the first four weeks of the intervention may be replaced. Participants will all be on subcutaneous insulin pump therapy and will have proven competencies both in the use of the study insulin pump and the study CGM device. Subjects in the intervention group will receive appropriate training in the safe use of closed loop insulin delivery system and pump suspend feature. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is between group differences in the time spent in the target glucose range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on CGM glucose levels during the 12 week free living phase. Secondary outcomes are HbA1 at the end of treatment period, the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes.

NCT ID: NCT02522845 Completed - Varicose Veins Clinical Trials

Compression Therapy Following Endothermal Ablation

COMETA
Start date: May 2015
Phase: N/A
Study type: Interventional

This study will be looking at the effect of compression therapy in patients having endovenous treatment for truncal incompetence of their varicose veins using either radiofrequency ablation (RFA) or endovenous laser therapy (EVLT). Patients will be randomised to either the compression group (group A) or the no compression group (group B). The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.