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NCT ID: NCT01958749 Not yet recruiting - Clinical trials for Tympanic Membrane Perforation

Fat Graft Myringoplasty With and Without Platelet Rich Plasma (PRP) for Treating Smaller Tympanic Membrane Perforations

Start date: n/a
Phase: N/A
Study type: Interventional

The current standard treatment for chronic tympanic membrane perforations (TMP) involves having fat grafted from the patient and inserted into the ear, through the perforation, to promote healing using the fat graft myringoplasty (FGM) technique. Platelet rich plasma (PRP) has also been used to promote TMP healing and involves having the patient provide a blood sample, which is processed to produce PRP and applied to the perforation. This prospective, multi-centre study will evaluate whether combining both these techniques can improve the rate of closure in patients with chronic TMP involving <50% of the membrane. Patients will be randomized to receive either the standard FGM treatment or FGM treatment with the addition of PRP. At 3 months postintervention a blinded observer will rate the degree of TMP closure. Differences in closure rates between the 2 groups will be compared.

NCT ID: NCT01955525 Not yet recruiting - Clinical trials for Acute Coronary Syndrome

Long-term Follow-up of Health Related Quality of Life in Patients With Acute Coronary Syndrome

EMMACE-3X
Start date: November 2013
Phase: N/A
Study type: Observational [Patient Registry]

This study is aiming to i)measure longterm health related quality of life (HRQL) outcomes of the EMMACE3 patients hospitalised with acute coronary syndromes (ACS) and evaluate possible associations with their cardiovascular profile and to ii) Linkage these data to multiple electronic healthcare records

NCT ID: NCT01949207 Not yet recruiting - Varicose Veins Clinical Trials

RCT - Does Treating Incompetent Perforators Reduce Recurrence?

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

The aim of this randomised case-controlled trial is to investigate whether ablation of incompetent perforating vein in addition to ablation of truncal vein reduces the rate of recurrent varicose veins post-treatment compared with patients who only have ablation of the truncal vein, who are left with untreated incompetent perforating veins.

NCT ID: NCT01948479 Not yet recruiting - Diabetic Clinical Trials

Insole Optimisation for Ulcer Prevention: a Feasibility Trial

Start date: January 2014
Phase: N/A
Study type: Interventional

Insoles are designed to reduce increased loads and re-ulceration risk in patients with diabetes. The investigators previous research findings suggest that an instant insole solution may benefit some, but effectiveness is difficult to predict. The investigators propose a feasibility study using in-shoe pressure analysis to optimise the protective effect of insoles and footwear with the aim of reducing re-ulceration rates. Early indications from exploratory case studies within the real world clinical setting suggest that by implementing the investigators previous published research findings the investigators can optimise effectiveness and reduce outcome variability of protective footwear and insoles provided to patients at risk of re-ulceration. However a further randomised control trial is necessary to evaluate the effectiveness of in-shoe pressure analysis in reducing re-ulceration rates within the NHS setting. The proposed feasibility study will recruit 20 participants from the multidisaplinary diabetic foot clinic Derriford Hospital and allocate them to either 1) Routine insoles and footwear provision or 2) Routine insole and footwear provision, and temporary insole provision with optimisation. The findings from the feasibility study will inform protocol development for a larger clinical trial. The results of the feasibility study will be used to strengthen a protocol for a grant application to conduct the main RCT. A secondary output from the pilot study will be the dissemination of findings in a peer reviewed journal and at conference.

NCT ID: NCT01943656 Not yet recruiting - Spinal Cord Injury Clinical Trials

Eyegaze Systems for Spinal Cord Injury: A Feasibility Study

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

As technologies are advancing quickly in the healthcare setting, new solutions have become available helping disable people to enhance their ability to communicate. One of these advances is the introduction of the 'eye gaze system'. Through processing eye movements, this device allows a person to write, speak, use the Internet and even control systems in the home or office. In the currently proposed study we aim to evaluate the psychological and functional effects of using the Tobii™ Eyegaze System by inpatients with tetraplegia who are unable to use arms and legs and sometimes are not able to talk because of an impaired respiratory function. Volunteering inpatients will be recruited at the National Spinal Injuries Centre. Volunteers will be instructed and trained to use the Tobii™ Eyegaze System. The number of sessions required to successfully master the device depends on the learning curve of the patient. The progress will be documented accordingly. After successful completion of the training and supervised use, the inpatients will be offered the Tobii™ Eyegaze System for unsupervised use, 4 hours a week, for the following 2 months. It is hypothesised that using the Tobii™ Eyegaze System by inpatients with tetraplegia results in improved disability perception and independence scores. For the current feasibility study 12 participants will be recruited and assessed for 'Appraisal of Disability', 'Mood', 'Assistive Technology perception' and 'eyeskills' to instruct the computer system. Positive study outcomes will encourage future studies of the role of the Tobii™ Eyegaze System in both a rehabilitation and home environment.

NCT ID: NCT01940289 Not yet recruiting - Foot Pain Clinical Trials

Validation of Algometry for Use in the Human Foot

Start date: January 2014
Phase: N/A
Study type: Interventional

The primary aim is to examine whether there is a consistent range of pressure threshold values for the asymptomatic foot.Previous studies established the inter/intra-clinician reliability of pressure threshold measuring and have established a normative range of values within the trunk and upper body. Since the establishment of these values, pressure threshold testing has been used extensively in the head, neck, shoulders and spine as a clinical tool and a research aid. There has been little work using it in the lower limb and there are no guideline measurements for the clinician. By establishing a range of values for the foot,this study will enable the clinician to employ pressure threshold measuring as a clinical tool to easily and accurately identify areas of dysfunction and to objectively measure the effectiveness of treatment. It will allow the clinician to establish a degree of improvement or deterioration as it occurs in a patient's condition. Secondary aims are to examine whether there is a correlation between visual analogue pain scale (VAS) scores and algometric pressure threshold scores for subjects with forefoot pain. This will help validate the tool for use in the foot. Since VAS is well documented and validated, this study will examine whether there is a correlation between VAS and algometry and whether there are gender or age differences in the range of measurements obtained. These areas have been addressed in previous studies but results have been contradictory and inconclusive and none of the previous studies focused on the foot. An asymptomatic group of 384 subjects & symptomatic group of 160 subjects shall be selected from those attending a podiatric clinic for routine foot care who meet the inclusion criteria . Outcome me will be algometric pressure threshold testing, visual analogue pain scales and foot function index questionnaires.

NCT ID: NCT01924897 Not yet recruiting - Clinical trials for Colorectal Neoplasms

Preop CPET Testing and Exercise Training in Colorectal Patients

Start date: n/a
Phase: N/A
Study type: Interventional

Colorectal Surgery Preoperative Exercise Training is a study being run by the colorectal surgery team at the Norfolk and Norwich University Hospital and the University of East Anglia to look at the role of exercise before surgery to improve recovery following an operation. Having an operation to remove part of the bowel puts physical stress on the body. We know that training can help the body cope with physical stress in the same way that an athlete trains before a competition. We hypothesise that the body may recover more quickly if it is trained prior to an operation with regular and simple exercises. Cardiopulmonary exercise testing (CPET) is used to evaluate the function of the lungs, heart and muscles at rest and during exercise. CPET testing is often done as part of standard pre-operative assessment in many hospitals for patients before undergoing major surgery. Some studies have demonstrated that CPET can be used to predict outcomes following surgery (such as time taken till discharge, complication rates). The study consists of two parts: Study 1) CPET variables to predict outcomes in surgery - patients will undergo a CPET test to determine baseline fitness. Blood tests will be taken around the time of surgery to examine whether biochemical markers in the bloodstream (when used in combination with results from the CPET test) can predict outcomes and recovery following colorectal surgery. Patients will then be monitored to assess their speed of recovery and rate of complications following surgery. This will enable us to determine which CPET variables or combination of variables are most useful in the prediction of post-operative complications following colorectal surgery. 2) The second study will consist of an exercise intervention involving several sessions of supervised exercise in a laboratory. Before and at the end the exercise training regime, CPET measurements will be taken to see if fitness has improved with exercise. This part of of the study is to determine if it is feasible to implement a structured, supervised exercise programme for patients awaiting elective colorectal cancer surgery. The results of this study will be used to inform a larger randomised controlled trial to examine the influence of exercise on CPET variables and postoperative outcomes.

NCT ID: NCT01918137 Not yet recruiting - Clinical trials for Effect on Cerebrovascular Reactivity

The Effect of a Deep-fried Chocolate Bar or Porridge on Cerebral Blood Flow

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

The deep fried chocolate bar is a snack that the international community strongly associates with Scotland. It has previously been cited as being "a symbol of all that is wrong with the high-fat, high-sugar Scottish diet". Despite the snack's reputation, no medical research has been performed to examine the effects of consuming a deep fried chocolate bar on the human body. In contrast to the deep fried chocolate bar, porridge has been shown to reduce the risk of cardiovascular disease, but its effect on cerebral blood flow has yet to be directly assessed. This study will focus on the potential (patho)physiological cerebrovascular effects of the deep fried chocolate bar and porridge. The research question to be addressed in this study is "Does eating a deep fried chocolate bar or bowl of porridge induce changes in cerebral blood flow and cereborvascular reactivity in healthy adults?" To assess the acute effects on eating either food on blood flow through the largest artery in the brain, the investigators will give healthy volunteers one regular-sized deep-fried chocolate bar or a bowl of porridge. Blood flow through the largest artery in the brain will be assessed using simple ultrasounds tests. The investigators aim to recruit 24 volunterrs who will visit twice, consuming a different food on each visit.

NCT ID: NCT01909024 Not yet recruiting - Varicose Veins Clinical Trials

Pelvic Embolisation to Reduce Recurrent Varicose Veins - Recurrent

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

The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic embolisation) in females with recurrent leg varicose veins, who have a proven contribution to their leg varicose veins from pelvic venous reflux, have a reduction in future recurrence after endovenous laser treatment for recurrent varicose veins in the legs.

NCT ID: NCT01901731 Not yet recruiting - Varicose Veins Clinical Trials

Pelvic Embolisation to Reduce Recurrent Varicose Veins - Primary

Start date: March 2014
Phase: N/A
Study type: Interventional

The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic coil embolisaton) in females with leg varicose veins, who have a proven contribution to their leg varicose veins from pelvic reflux, have a reduction in recurrence after varicose vein surgery.