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NCT ID: NCT02139319 Completed - Knee Osteoarthritis Clinical Trials

Dose-Escalation of Botulinum Toxin in Subjects With Osteoarthritis of the Knee

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

The purpose of the study is to evaluate the safety and tolerability of the drug product at each dose level.

NCT ID: NCT02139306 Completed - Cystic Fibrosis Clinical Trials

Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)

Start date: August 2014
Phase: Phase 3
Study type: Interventional

This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.

NCT ID: NCT02138916 Completed - Clinical trials for Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History

GALATHEA
Start date: June 13, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies

NCT ID: NCT02138318 Completed - Ulcerative Colitis Clinical Trials

High Definition Versus Chromoendoscopy for Dysplasia Detection in Ulcerative Colitis (UC)

Start date: May 1, 2012
Phase: N/A
Study type: Interventional

Patients with ulcerative colitis (UC) have an increased risk for colorectal cancer (CRC) compared to the general population. Regular screening by colonoscopy is an internationally recommended cancer prevention strategy. Random sampling of the mucosa throughout the colon has been the mainstay of conventional surveillance practice to detect abnormalities, known as dysplasia which can progress to CRC. This requires multiple biopsies, to be taken and processed, a practice which is is tedious, expensive, time consuming and has a low pickup rate. Dysplasia in UC is typically flat and patchy and can be easily overlooked with standard conventional white light colonoscopy (WLC). Detection can be improved by the application of dyes which highlight more subtle abnormalities. This practice, known as chromoendoscopy (CE) is better than WLC at dysplasia detection but more time consuming for the patient and cannot guarantee that the whole colon is covered. CE has only been compared in clinical trials with standard definition endoscopy rather than the recently available high definition endoscopes with better resolution and picture. High definition (HD) endoscopy uses a high definition onitor and a high resolution CCD (charge coupled device) providing much better images than standard video endoscopy. HD colonoscopy promises therefore to provide an alternative to CE in UC surveillance without the need for the extra time and experience required for dye spraying for both endoscopists and nursing staff. The investigators plan to do a randomized trial to assess HD colonoscopy alone compared to chromoendoscopy (with HD colonoscopies) for dysplasia detection during surveillance for ulcerative colitis. There have been no trials comparing these two modalities and the investigators hope to provide evidence that the additional benefit of CE over HD colonoscopy would be marginal and therefore CE would be reserved for procedures using standard definition scopes.

NCT ID: NCT02138136 Completed - Clinical trials for Constipation - Functional

Lubiprostone for Children With Constipation

Start date: February 26, 2014
Phase: Phase 3
Study type: Interventional

This study is for children with constipation. Children who completed 3 months of treatment in the earlier study (NCT02042183): - were invited to participate - will receive lubiprostone for 9 more months - will see if lubiprostone safely relieves their constipation if taken for a whole year

NCT ID: NCT02137499 Completed - Clinical trials for Venous Insufficiency

Venous Insufficiency and Neuromuscular Stimulation

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

The investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease.

NCT ID: NCT02136862 Completed - Clinical trials for Alport Syndrome Patients With eGFR Between 45-90 ml/Min/1.73 m2

ATHENA: Natural History of Disease Study in Alport Syndrome Patients

RG012-01
Start date: September 4, 2014
Phase:
Study type: Observational

There is limited published clinical data about the natural history of renal disease in Alport syndrome. The RG012-01 study will collect data to characterize the progression of renal dysfunction in Alport syndrome patients. Patients with a confirmed diagnosis of Alport syndrome who have qualifying GFR will be considered for enrollment. The sequential sampling of subjects' urine and/or blood will allow an assessment of the rate of change of established clinical endpoints, such as GFR and/or the rate of change of other renal biomarkers (proteinuria and β-2 microglobulin) in subjects whose renal function is steadily declining. The identification of surrogate markers that track the decline of renal function and could correlate with time to end-stage renal disease (ESRD) is a key goal of the natural history study.

NCT ID: NCT02136485 Completed - Multiple Sclerosis Clinical Trials

Mindfulness-based Stress Reduction in Multiple Sclerosis

Start date: June 2, 2014
Phase: N/A
Study type: Interventional

This application concerns a proposed randomised controlled trial evaluating the use of Mindfulness-based stress reduction (MBSR) in people with Multiple Sclerosis (MS) in secondary care. MS is an inherently stressful condition, and stress is thought to exacerbate MS. Mental health problems are common in MS, can impair quality of life, and lead to higher rates of suicide. Prior research has shown that cognitive behavioural therapy (CBT) can help mitigate stress and diminish disease activity in MS, but effects are short-lived and there is thus a need to explore whether other psychological approaches might be more beneficial in this regard. MBSR is another psychological stress reduction technique that is thought to operate differently to CBT, via cultivating a state of "meta-cognitive awareness" and has shown to be helpful when used in other long term conditions, such as chronic pain and anxiety, whilst Mindfulness-based cognitive therapy (MBCT - a derivative of MBSR) is effective in treating recurrent depression. All of these conditions are common in MS. However, mindfulness based interventions have not been well studied in MS. The investigators propose to carry out a feasibility study to assess how acceptable and accessible MBSR is as a stress reduction technique in people with MS. The investigators would seek up to 50 participants who would then be randomly assigned to receive MBSR or their usual care. The investigators would seek measurements of health and wellbeing before, immediately following, and 3 months following the MBSR intervention. This would include basic demographic information (age, gender, ethnicity), measures of mental health, and physical health, as well as qualitative semi-structured interviews with selected participants. After this we would offer MBSR to the control group.

NCT ID: NCT02136329 Completed - Acute Kidney Injury Clinical Trials

A Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of Sildenafil (REVATIO®) in Cardiac Surgery

Revaki-001
Start date: June 2013
Phase: Phase 1
Study type: Interventional

The objectives of the study are the following: - To evaluate the pharmacokinetic profile of Sildenafil in cardiac surgery patients at risk of acute kidney injury - To determine the safety and tolerability of Sildenafil in cardiac surgery patients at risk of acute kidney injury

NCT ID: NCT02136316 Completed - Healthy Volunteers Clinical Trials

A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Multiple Ascending Doses of ASP7962 in Healthy Subjects

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

The purpose of this study is to evaluate the safety and tolerability as well as the pharmacokinetics of increasing oral multiple doses of ASP7962 in healthy young male and female subjects.