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NCT ID: NCT02132026 Completed - Clinical trials for Calcific Aortic Stenosis

Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis.

SALTIRE II
Start date: November 12, 2014
Phase: Phase 2
Study type: Interventional

Aortic stenosis is a condition whereby one of the heart valves (aortic valve) becomes narrowed, due to calcium deposition, over time. This can lead to chest pain, heart failure and sudden death. It is the commonest valve disease requiring surgery in the developed world and as the population becomes increasingly older, it is predicted that the prevalence of aortic stenosis will double in the next 20 years. Currently the only treatment is replacement of the aortic valve. Whilst this is excellent treatment, not everyone is suitable for it. The primary objective of our study is to determine whether 2 drugs used in the treatment of osteoporosis (a condition of bone thinning) can halt/retard the progression of aortic stenosis. This is on the basis that studies have suggested that altered regulation of calcium metabolism may be an important mechanism perpetuating the disease. Both drugs work by reducing calcium release into the bloodstream from bones and therefore calcification of the aortic valve. 150 patients will therefore be randomly allocated to either of the trial drugs which are denosumab,the bisphosphonate (alendronic acid), or a placebo. Positron Emission Tomography (PET) scanning is a technique where biochemically active molecules are injected and are taken up at sites of ongoing calcification activity where they emit radiation and can be detected by the PET scanner. We have previously shown that this technique can demonstrate areas of newly developing calcification on an aortic valve. We therefore propose that patients receiving bisphosphonates or denosumab will have reduced evidence of active calcification and slower progression of their disease at two years as assessed by Echocardiography (ultrasound) and a change in their calcium score (quantity of calcium on the aortic valve measured using Computed Tomography [CT] ). The data from this study will then be used to design a larger trial.

NCT ID: NCT02131740 Completed - Ectasia Clinical Trials

Eye Rubbing and Transient Change in Corneal Parameters

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

This study addresses the research question: How does eye rubbing affect corneal (clear part of eye) parameters in healthy volunteers The study objectives are: 1. To determine the corneal changes following eye rubbing 2. To assess tear film changes following eye rubbing 3. To investigate if there is an association between eye rubbing and axial length of the eye.

NCT ID: NCT02131649 Completed - Prostate Cancer Clinical Trials

PET/MRI for Men Being Considered for Radiotherapy for Suspected Prostate Cancer Recurrence Post-Prostatectomy

PROPS
Start date: February 2015
Phase: N/A
Study type: Interventional

The PROPS trial is for men being considered for radiotherapy due to the suspicion that their prostate cancer has recurred following the surgical removal of their prostate (prostatectomy). This suspicion is based on rises seen on Prostate Specific Antigen (PSA) blood tests. Only men who demonstrate the absence of disease on standard imaging scans (Computed Tomography (CT) and bone scans) will be invited to participate. This study will be assessing if the imaging probe 18-F Fluorocholine (18F-FCH) used during Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) scans, can better predict who will benefit from radiotherapy by identifying the source of cancer recurrence. This will be determined by measuring the number of men who have disease identified outside of the prostate bed (the small pocket or depression where the prostate used to be) on their 18F-FCH PET scan. Since F-18-FCH has been shown to be more sensitive in detecting prostate cancer that may have spread into lymph nodes or bone, it may potentially identify areas of prostate cancer spread not seen with standard imaging.

NCT ID: NCT02131532 Completed - Stroke Clinical Trials

A Rehabilitation Therapy for Post-stroke Fatigue

Start date: July 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Stroke is a leading cause of adult disability in the community. Fatigue affects about a third of stroke survivors. It results in difficulty taking part in everyday activities, and increases risk of hospitalization and death after stroke. Despite of its high prevalence and distressing consequences, there is no effective treatment. Psychological interventions have improved fatigue in patients with other conditions such as multiple sclerosis. These interventions primarily target patients' beliefs about overcoming fatigue and their physical activities in daily life. Also studies indicated that post-stroke fatigue is associated with mood. Based on this knowledge, the investigator has designed a brief psychological intervention for post-stroke fatigue. The current study is a feasibility study to test the adequacy of intervention manuals and the feasibility of trial processes. This study will need 12 stroke survivors who have post-stroke fatigue and are over three months but within two years after their stroke. Stroke survivors with severe depression or having insufficient capability in cognition or communication will not be included. The investigator will check their eligibility by questionnaires and interviews and then invite eligible people to take part in the study. This intervention will be delivered by a therapist (a clinical psychologist) to each participant through six face-to-face therapy sessions. Each session will be about one hour and be two weeks' apart. During the sessions, participants will discuss with the therapist their fatigue problems, and, with the support from the therapist, work out ways to solve their problems. One month after the last face-to-face session, each participant will receive a feedback session by telephone from the therapist. Each participant will be followed up to three months after the last face-to-face session. After all participants complete their feedback sessions, the investigator will invite them to a group meeting to share their experiences of taking part in this trial and makes suggestions as how their experiences of this intervention, and also of this trial, could be improved.

NCT ID: NCT02131363 Completed - Clinical trials for Onychomycosis of Toenails

A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail

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

This purpose of this study is to evaluate the safety and performance of a treatment kit for ingrowing toenail, primarily by determining the number of subjects who show a reduction in the severity of their ingrowing toenail.

NCT ID: NCT02131090 Completed - Childbirth Clinical Trials

A Comparison of Intrapartum Epidural Fixation Devices: A Randomised Controlled Trial

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

A number of methods are currently used to prevent movement of epidural catheters in women during labour. These usually consist of sticky dressings applied to the patient's back. The purpose of this study is to compare how much epidural catheters move when secured with three commonly used different fixation dressings with the aim of identifying the best method of securing epidural catheters. Movement of epidural catheters has several clinical implications. Usually only a short length of epidural catheter is left in the epidural space, and therefore any significant movement could result in the catheter moving out of the epidural space leading to a loss of the pain relieving effects of the epidural. Once epidural failure has occurred due to catheter migration, a second catheter must be inserted in order to re-establish pain relief and thus the patient is exposed to the risks of epidural insertion for a second time. If the researchers in this study can identify a method of fixing epidural catheters which results in the least amount of catheter movement, then patients could benefit from more reliable epidural pain relief, fewer repeated procedures and the risks associated with repeated procedures. The principle objective of the study is to determine which epidural fixation dressing results in the least amount of epidural catheter movement from the time of epidural insertion (during labour) to the time of epidural removal (after labour).

NCT ID: NCT02130726 Completed - Gastric Cancer Clinical Trials

Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy

STOMACH
Start date: December 2014
Phase: N/A
Study type: Interventional

Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. All while maintaining similar results with regard to tumour resection margin and oncological survival. In gastric cancer the role of laparoscopic surgery remains unclear. Current recommended treatment for gastric cancer consists of radical resection of the stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, It is imperative that a new surgical technique should be non-inferior with regard to radicality and lymph node yield. Preliminary studies show promising results for laparoscopic gastrectomy, but the number of studies is small and due to lower incidence of gastric cancer in the West they are often underpowered. A prospective randomised clinical trial is indicated in order to establish the optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy. Results of the STOMACH trial will further aid in determining the optimal surgical technique in patients with gastric cancer.

NCT ID: NCT02130557 Completed - Clinical trials for Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Start date: July 15, 2014
Phase: Phase 3
Study type: Interventional

Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

NCT ID: NCT02129881 Completed - Clinical trials for End-stage Renal Failure

The ONE Study UK Treg Trial

ONETreg1
Start date: April 2014
Phase: Phase 1/Phase 2
Study type: Interventional

A study to assess cell therapy as a treatment to prevent kidney transplant rejection. The trial will involve purification of naturally occurring regulatory T cells (nTregs) from living-donor renal transplant recipients. The cells will then be grown in the laboratory and re‐infused into the patient five days after the kidney transplant. This trial is part of an international European Union funded consortium aimed at evaluating cellular immunotherapy in solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced by nTreg therapy can eventually be used to recude the need for conventional immunosuppression in transplant recipients.

NCT ID: NCT02129868 Completed - Diabetes Mellitus Clinical Trials

Automated Closed-loop in Children and Adolescents With Type 1 Diabetes

APCam09
Start date: April 2014
Phase: N/A
Study type: Interventional

People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using a pump. Keeping blood sugars in the normal range is known to reduce long term complications. However, achieving treatment goals can be very difficult due to the risk of low glucose levels (hypoglycaemia). One solution is to use a system where the amount of insulin injected closely matches the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives a subcutaneous insulin pump. Previous studies conducted under carefully controlled clinical research facility environment, in Cambridge, United Kingdom, as well as several other centres have shown that closed-loop glucose control is superior to usual insulin pump therapy. The next logical step in the development pathway is to test closed loop systems in the home environment. An essential requirement for conducting closed-loop studies outside clinical research facility is an automated system where wireless data transmission takes place between the glucose sensor and insulin pump. The purpose of the present study is to evaluate the efficacy and safety of automated overnight closed-loop, in children and adolescents with type 1 diabetes, using a novel system which has greatest potential for use in the home setting. The study will take place at a clinical research facility on two occasions, using a standardised protocol. The performance of the closed-loop system will be evaluated on day 1 of continuous glucose monitoring (CGM) sensor life as compared to on days 3 to 4 of sensor life. Data and experience gained from this study will be used for further refinements and development of the system for future home use.