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NCT ID: NCT02781480 Completed - Clinical trials for Leber Congenital Amaurosis

Clinical Trial of Gene Therapy for the Treatment of Leber Congenital Amaurosis (LCA)

OPTIRPE65
Start date: April 2016
Phase: Phase 1/Phase 2
Study type: Interventional

A clinical trial of AAV2/5 vector for patients with Defects in RPE65

NCT ID: NCT02781428 Completed - Bladder Cancer Clinical Trials

To Detect the Sensitivity of the UroMark Assay

DETECT II
Start date: September 26, 2016
Phase:
Study type: Observational

This is a prospective multicentre observational study to assess the sensitivity of the UroMark assay to detect bladder cancer in participants with new or recurrent disease. The study will recruit patients with newly detected or recurrent bladder cancer. The reference standard will be histopathological confirmation of tumour stage and (Ta, T1, ≥T2) and grade 1, 2 or 3 diseases with or without CIS, or CIS alone. Patients with a visual diagnosis of bladder cancer following cystoscopy will be approached and asked to consent for this study. Consenting participants will be provided with a urine sample collection kit and asked to provide a urine sample. Samples can be provided at home and posted to the receiving lab using the stamped addressed envelope. The urine sample must be obtained before TURBT and following TURBT, patients with NMIBC who require surveillance cystoscopy will be asked to provide a urine sample at 3 monthly intervals for up to 2 years. The study will be conducted in at least 11 NHS trusts. As DETECT II is an observation study requiring provision of a urine sample, it will be possible for patients in DETECT II to be recruited to other trials.

NCT ID: NCT02781064 Completed - Clinical trials for Cardiovascular Disease

STATIN: Web-based Investigation of Side Effects

STATINWISE
Start date: September 1, 2016
Phase: Phase 4
Study type: Interventional

Statins are known to cause rare but serious side effects such as rhabdomyolysis (breakdown of muscle tissue) but many patients stop taking statins due to less severe symptoms, such as muscle pain or fatigue. This study aims to determine whether symptoms occurring during statin use are caused by statins. The trial will compare patient-reported side effects of statins (20mg atorvastatin) vs. placebo. Patients will be randomized to alternating treatment blocks of either statin or placebo split into six two-month treatment periods. At the end of each period, patients will be asked to self-report side effects using a website or mobile app.

NCT ID: NCT02780856 Completed - Dental Caries Clinical Trials

Safety and Performance Evaluation of the Calcivis System

Start date: January 14, 2017
Phase: N/A
Study type: Interventional

This is a prospective, multi-centre clinical study to evaluate the safety and performance of the Calcivis Caries Activity Imaging System. Dentists will identify tooth surfaces as either sound (inactive) or unsound (active caries lesion present) according to ICDAS staging (International Caries Detection and Assessment System). Images of the tooth surface will be taken with the Calcivis System immediately before and after application of a disclosing solution containing a bioluminescent protein. Presence or absence of elevated luminescence on the images will indicate activity / inactivity of the presence or absence of active demineralisation on the tooth surfaces. The study will be deemed a success if there is 70% agreement and above between: 1. elevated luminescence and the presence of active caries as determined by the dentists, and 2. absence of luminescence and the determination of a sound tooth surface by the dentists.

NCT ID: NCT02780661 Completed - Denture Cleansers Clinical Trials

Frequency of Denture Cleanser Use and Denture Cleanliness

Start date: June 20, 2016
Phase: N/A
Study type: Interventional

This method development study will be a two treatment arm, randomized, cross over study in a population with edentulous upper arch restored with a maxillary complete denture. The lower may be a partial or full edentulous mandibular arch that may be restored with a stable complete, partial or implant supported denture.

NCT ID: NCT02780622 Completed - Clinical trials for Participants on Warfarin Therapy

A Pharmacokinetics, Pharmacodynamics and Safety Study of Warfarin in Combination With Tamiflu (Oseltamivir)

Start date: February 2008
Phase: Phase 4
Study type: Interventional

This is an open-label, randomized, 2-period crossover study, to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be randomized to receive either Treatment A followed by Treatment B (AB) or Treatment B followed by Treatment A (BA) in 2 treatment periods. Treatment A includes participant's usual warfarin therapy, and Treatment B includes warfarin therapy along with repeated doses of oseltamivir twice daily for 4 days, and once on Day 5. The treatment periods will be separated by a washout period of at least 4 days.

NCT ID: NCT02780557 Completed - Clinical trials for Language Development

How Parents Can Help Babies Learn to Talk With Picture Books.

Start date: August 24, 2016
Phase: N/A
Study type: Interventional

The aim of this project is to test whether giving parents advice about book reading is effective in promoting language learning for infants from a range of socio-economic backgrounds.

NCT ID: NCT02780492 Completed - Clinical trials for Duchenne Muscular Dystrophy

Outcome Measures in Duchenne Muscular Dystrophy: A Natural History Study

Start date: April 11, 2012
Phase:
Study type: Observational

Novel emerging therapies for Duchenne Muscular Dystrophy (DMD) require a deeper understanding of DMD natural history. This study aim to assess the natural history of DMD through a composite assessment tool capable of capturing disease progression linking ambulant and non-ambulant phases of the disease.

NCT ID: NCT02780375 Completed - Cancer Clinical Trials

Feasibility Study Testing Transcriptional Responses as an Indicator of Individualised Responses to Radiation Effects

RTGene
Start date: September 12, 2016
Phase:
Study type: Observational

Peripheral blood samples will be taken with informed consent from radiotherapy patients undergoing standard radiotherapy at The Royal Marsden before and during treatment for breast, lung, gastrointestinal and genitourinary tumours. Responses from panels of up to 800 coding and non-coding RNAs will be assessed in the samples using the nCounter system. Candidate genes identified by Public Health England, Columbia University and/or in the literature as being specific to radiation responses will be included, together with genes relevant to systemic inflammatory responses, to identify transcriptional responses for a range of doses and exposures on an inter-individual basis. Data will be analysed using existing and new statistical tools focused on count data modelling. The intended outcome is identification of a radiation specific panel of genes to inform individual radiation responses and if the results are favourable, a large scale follow up to this proposed pilot is expected in due course.

NCT ID: NCT02779712 Completed - Stroke Clinical Trials

Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2)

ReCAST-2
Start date: August 1, 2016
Phase: Phase 2
Study type: Interventional

Stroke has an enormous impact on both individual and society. Novel treatments are required to relieve this burden and remote ischaemic conditioning (RIC) is one such approach. RIC refers to applying non-lethal ischaemia to an area distant from an organ you are trying to protect (e.g. the brain). Pre-clinical animal stroke studies have shown RIC to be neuroprotective and help restore functional outcome when compared to control. These outcomes are achieved simply by transiently occluding the blood supply to a limb (e.g. the arm) very soon after the stroke occurs. The mechanisms of protection are unclear but may be due enhancing the body's ability to protect itself from further injury by favorably altering cerebral blood flow or reducing the detrimental effects of oxygen free radicals. Ischaemic conditioning (IC) is an intervention already applied during cardiac surgery to protect the heart from damage and it may be effective after an acute myocardial infarction. The investigators therefore plan to conduct a pilot randomised controlled trial assessing the feasibility of applying RIC (4 cycles of blood pressure cuff inflation for 5 minutes) in patients within 6 hours of ischaemic stroke. The primary outcome is feasibility of RIC. Secondary outcomes include tolerability, safety and clinical efficacy. The results will inform the design of future trials of a potential intervention is that is pragmatic, non-invasive and simple to administer.