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NCT ID: NCT01930786 Completed - Muscle Spasticity Clinical Trials

An Adult Spasticity Registry of OnabotulinumtoxinA Treatment

ASPIRE
Start date: October 16, 2013
Phase:
Study type: Observational

This is a registry study in adults with spasticity to determine onabotulinumtoxinA use in clinical practice. Treatment will be administered in accordance with physician standard practice. All treatment decisions lie with the physician.

NCT ID: NCT01930344 Completed - Clinical trials for Gall Bladder Disease

Investigating Three-Dimensional Versus Two-Dimensional Imaging in Laparoscopic Cholecystectomies

Start date: May 2013
Phase: N/A
Study type: Interventional

During laparoscopic surgery, your surgeon operates through 'keyhole' incisions in your abdomen. These allow long tools and a camera to pass to perform the surgery and allow the surgeon to see inside you. The cameras images are seen on a television screen, and this is viewed, like you watch television at home, in a two-dimensional (2D), form. This can make performing laparoscopic surgery very challenging, as you have to learn to appreciate depth while performing surgical tasks. Recent advances in viewing technology mean we now have the capability for comfortable three-dimensional (3D) viewing of laparoscopic surgery, and many centers have shown its superiority over 2D in lab-based experiments. However, this technology has never been compared against our normal gold standard 2D imaging in laparoscopic operations. This study aims to investigate whether there is a quantifiable benefit in using these new 3D imaging systems over 2D for laparoscopy, as we hypothesise that there is a marked benefit using 3D over 2D. Patients who have been placed on the waiting list for keyhole surgery to remove their gallbladder will be invited to take part in the study. If they agree, they will undergo the standard operation for removing their gallbladder as planned already. At the beginning of the operation they will be randomised (selected by chance) into one of two groups. One group will have their surgery performed to our current 'Gold standard' with the surgeon using a 2D camera and screen. The other group will have the exact same operation but with the surgeon using a 3D camera and screen. The intra-abdominal part of the operation will be recorded and viewed by an independent observer who is a surgeon, to assess for technical performance differences between operations performed in 2D and 3D, as well as time taken for the surgery. There are no extra risks to taking part and being randomised to the 3D group. The laparoscopic camera is the same size as a 2D camera and used in the same way. There are no real disadvantages, as patients will still undergo the operation they were booked for and will experience no change in their treatment. The aim is to compare 2D and 3D Day Case Laparoscopic Cholecystectomies, to see if there is a marked difference with this new technology. Lab based studies imply that 3D imaging systems reduce surgical errors and operating time therefore could improve patient safety. This study may help improve laparoscopic surgery for future patients.

NCT ID: NCT01929746 Completed - Healthy Clinical Trials

Daclizumab Japanese PK Study

Start date: October 2013
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of BIIB019 (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC) dose (75 mg or 150 mg) Japanese and Caucasian adult healthy volunteers. The secondary objective of this study in this study population is to assess the safety and tolerability of BIIB019 administered as a single SC dose (75 mg or 150 mg).

NCT ID: NCT01929694 Completed - Clinical trials for Affect and Exertion During and Post-exercise

The Effect of Consuming a guaraná and Vitamin/Mineral Complex Pre-exercise on Affect, Exertion, Metabolism and Cognition

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

Consuming a guaraná and vitamin and mineral complex can improve mental fatigue and cognitive function at rest; guaraná also contains caffeine, which can reduce perceived exertion and increase fat burning during exercise. The purpose of this study is to test whether consuming a guaraná and vitamin and mineral product before exercise influences affect (mood), physical exertion and fat burning during exercise and mental fatigue, cognitive performance and affect post-exercise.

NCT ID: NCT01929564 Completed - Clinical trials for Cardiovascular Diseases

Broccoli and Vascular Health Study

BASH
Start date: July 2012
Phase: N/A
Study type: Interventional

The participants of this study will be men & women ≥50 years who are deemed to have a 10-30% risk of developing CVD over the next 10 years. Their risk will be calculated using the Joint British Societies 2 (JBS2) guidelines on the prevention of CVD in clinical practise algorithm. This takes into account the participants age, sex, cholesterol values, blood pressure,family history and their ethnicity (SE Asian or not). The participants will be randomly assigned to one of two groups with the aid of a computer program called "minim" which uses their age, sex, BMI and smoking status to determine which broccoli each participant will consume on the intervention. Each participant will consume 4 x 100g of their assigned broccoli, each week for 12 weeks on top of their normal diet. They will be allowed to eat the broccoli whenever they want during the week, but will be asked to note down when they eat it. A steamer will be provided so participants can cook their broccoli for the required 4-5 minutes. Participants will be asked to keep two diet diaries during their time on the intervention, one before they start the intervention and one towards the end. Blood samples and urine will also be collected, pre and post intervention, for the analysis of biomarkers of CVD. This is joint project based at two sites, the Institute of Food (IFR) Research in Norwich and the University of Reading(UoR), in Reading. Samples from the participants at both sites will be analysed at IFR, UoR and companies in the United States.

NCT ID: NCT01929109 Completed - Clinical trials for Kidney Failure, Chronic

A Study of LY2409021 in Participants With Different Levels of Kidney Function

Start date: August 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study was to measure how much of the study drug, LY2409021, gets into the blood stream and how long it takes the body to get rid of it when given to participants with different levels of kidney function. There were five study groups. Each participant only enrolled in one group. Participants in groups 1 through 4 were healthy or have mild, moderate, or severe kidney disease. They completed one study period lasting about 29 days. Study group 5 enrolled participants with kidney disease who were on dialysis. They have completed two study periods which together last about 59 days. Screening was required within 21 days prior to the start of the study for all participants.

NCT ID: NCT01928771 Completed - Asthma Clinical Trials

Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

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

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.

NCT ID: NCT01928602 Completed - Chronic Aphasia Clinical Trials

Computerised Therapy in Chronic Stroke

CATChES
Start date: November 2013
Phase: N/A
Study type: Interventional

The few studies looking systematically into the neurophysiological and neuropsychological components of available therapies for chronic aphasia are highly heterogeneous in nature. Results from these studies have, unsurprisingly, indicated heterogeneous results, such as dissimilar neural outcomes associated with neuropsychological gains. There is, therefore, no consensus of how a successful therapy— that is, one that produces a measurable language gain in either production or comprehension —impacts the functional language networks of the brain in a specific type of aphasia population. A recent study has shown that inner speech (the imagination of speech) involves networks and areas dissociable from those implicated in speech production. Further, behavioural analysis has shown an interesting discrepancy between inner speech and overt speech (also called speech production) in a small chronic aphasia population: some participants elicited poor inner speech coupled with relatively intact overt speech, while others elicited relatively intact inner speech coupled with poor overt speech. This unexplored discrepancy implies that inner speech and speech production are dissociable, though share similar networks. This discrepancy, and the notion that these speech components share a similar network, drives this study's hypothesis that improvement in speech production after rehabilitation might be facilitated by an intact inner speech network. Much as good athletes visualise their performance before the actual event in order to increase their chances of success, so too might intact inner speech facilitate speech production, helping to visualise the word in order to increase the success of produced speech. By studying a specific component of speech—inner speech—in a relatively homogeneous population of chronic expressive aphasics, the present study provides an explicit, critical means of understanding neurophysiological (as assessed by functional magnetic resonance imaging) and neuropsychological (as assessed by language batteries and personal questionnaires/interviews) changes occurring during speech therapy. As a secondary objective, this study will explore the effectiveness, feasibility and adherence to an at-home computerised aphasia software delivered via a portable tablet.

NCT ID: NCT01928147 Completed - Clinical trials for Hepatitis C, Chronic

A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients

Start date: August 2013
Phase: Phase 1
Study type: Interventional

PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the dose-related safety and tolerance of PPI-383 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study will assess how much PPI-383 is absorbed into the bloodstream. In Part II, the dose-related effect of PPI-383 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.

NCT ID: NCT01927926 Completed - Obesity Clinical Trials

The Effects of Consuming Whey Protein Polydextrose Snacks on Appetite and Energy Intake

Start date: May 2008
Phase: N/A
Study type: Interventional

Developing functional foods that enhance satiety may be beneficial to individuals to help manage body weight. We have previously shown that consuming a mid-morning liquid preload with increasing proportion of energy derived from whey protein and addition of polydextrose reduced voluntary energy intake at a lunchtime meal compared to a liquid preload of the same energy content but lower in protein and containing no polydextrose. This study aims to investigate if these results can be replicated when the preload is in the form of a snack bar. We will also investigate whether the daily consumption of the snack bar has an effect on energy intake, subjective appetite and metabolic parameters compared to a control snack of the same energy but with a minimal protein content and without the addition of polydextrose. We hypothesize that the whey protein polydextrose snack will reduce voluntary energy intake at a subsequent test meal, suppress subjective appetite ratings compared with the control snack bar.