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NCT ID: NCT01175239 Active, not recruiting - Clinical trials for X-linked Severe Combined Immunodeficiency

Gene Therapy for X-linked Severe Combined Immunodeficiency (SCID-X1)

Start date: April 2011
Phase: N/A
Study type: Interventional

X-linked severe combined immunodeficiency (SCID-X1) is an inherited disorder that results in failure of development of the immune system in boys. This trial aims to treat SCID-X1 patients using gene therapy to replace the defective gene.

NCT ID: NCT01174810 Active, not recruiting - Parkinson's Disease Clinical Trials

Exendin-4 as a Treatment for Parkinson's Disease - Pilot Study

Start date: July 2010
Phase: Phase 2
Study type: Interventional

Exenatide is a licensed, safe and effective treatment for patients with Diabetes mellitus. Laboratory work has shown strong, reproducible evidence that this drug has beneficial "disease modifying" effects when given to animals with a range of experimental models of Parkinson's disease (PD). This project aims to make an initial evaluation of possible benefits of Exenatide among patients with moderate symptoms of PD. The drug will be given as a twice daily 10microgram injection under the skin in a similar way to one of the conventional "symptomatic" treatments for PD (Apomorphine). Forty patients with moderate symptoms of PD will be recruited and randomised to receive Exenatide injections twice daily, or to act as controls in this open label trial. Detailed assessments will be made of all patients at baseline and periodically for a total of 14 months. The primary outcome measure will be the change between baseline and follow up, in the severity of a validated PD assessment scale (the UPDRS part 3 motor score) after an overnight period free of conventional PD medication. Secondary measures will include adverse event reports, self completed questionnaires, and blood test results. Aside from these assessments, all patients will continue their regular PD medications throughout the trial with adjustments made only according to clinical need. In a subgroup of patients (n=10), brain scans that assess the severity of PD, will be performed at both baseline and follow up to help understand possible mechanisms of action of Exenatide.

NCT ID: NCT01171573 Active, not recruiting - Myositis Clinical Trials

Investigating Genes in Patients With Polymyositis and Dermatomyositis

UKMYONET
Start date: January 2001
Phase:
Study type: Observational

Polymyositis (PM), dermatomyositis (DM) and inclusion body myositis (IBM)belong to a group of inflammatory muscle disorders, of unknown cause, that are characterised by skeletal muscle inflammation and progressive muscular weakness, which can be debilitating and chronic in nature (occasionally fatal). The current treatment options for these conditions are steroids and various other immunosuppressive drugs. However, these are usually only partially effective at reducing symptoms, and their toxic side effects also limit their usefulness. In order to develop more specific treatments for myositis in the future (and therefore more effective), it is important to understand the exact mechanisms that cause the disease in the first instance. In other similar inflammatory diseases such as rheumatoid arthritis (RA) and systemic lupus (SLE), it is known that changes to the Human Leukocyte Antigen(HLA), as well as certain inflammatory cytokines, are involved in both the development and expression of the disease. As many of the inflammatory mechanisms that cause damage in PM, DM and IBM are similar to those in RA and SLE, it seems likely that similar genetic factors will also be involved in the development and expression of PM, DM and IBM. In order to understand the genetic aspects / causes of myositis, and ultimately develop more effective treatment therapies in the future, patients with PM, DM or IBM, will be asked to give 20 mls of blood. These blood samples, along with the patient's clinical details, will then be sent to the Centre for Integrated Genomic Medical Research (CIGMR), at The University of Manchester, where all of the genetic analyses will take place. By understanding the genetic cause of the disease, it should be possible to design specific drugs for treating the condition in the future.

NCT ID: NCT01165034 Active, not recruiting - Clinical trials for Breathless Patients With Any Established Underlying Medical Diagnosis

Development of King's College Hospital Breathlessness Service

Start date: July 2010
Phase: Phase 3
Study type: Interventional

Breathlessness is a common, distressing symptom in advanced malignant and non malignant disease, and impacts significantly on quality of life. Breathlessness in end stage disease is also responsible for significant healthcare resource usage. Escalante [1] reported hospital admission rates of 60% in patients presenting to a cancer treatment centre with breathlessness. Preliminary trials of breathlessness clinics with selected groups of patients have been promising, but lack data on their cost effectiveness. The principal aim of the research is to develop and evaluate the effectiveness and cost effectiveness of a multidisciplinary outpatient breathlessness support service (BSS) for the palliation of breathlessness, in advanced malignant and non malignant disease. This is a phase II study that aims to test the hypothesis that a BSS will improve patient mastery over breathlessness and reduce the use of healthcare resources (including GP consultations,accident and emergency attendances, and length of hospital stay) compared with usual best medical care alone (UC),at an acceptable level of cost effectiveness.The outcomes of this study will also help to determine sample size,develop and test methods for a phase III trial that will follow on from this project. This study will run over 2 years. Breathless patients with advanced malignant and non malignant disease who have already been optimally medically managed will be eligible. The service will be run in the outpatient department of King's College Hospital, and patients will also be assessed in their own home and by telephone interviews. At baseline we will assess respiratory function and breathlessness mastery and severity using validated scales, and health service usage. Individuals will be randomised to the intervention group [IG] (n=55) or UC (n=55). The IG will attend the new outpatient clinical service with multiprofessional input. Assessments will be repeated at 4, 10 & 24 weeks. 1.Escalante, C.P., Martin, C.G., Elting, L.S. et al., Dyspnea in cancer patients. Etiology, resource utilization, and survival implications in a managed care world. Cancer, 1996. 78(6): p. 13149.

NCT ID: NCT01163513 Active, not recruiting - Clinical trials for Acute Coronary Syndromes

Coronary Mortality in South Asians: Aetiologic and Prognostic Effects

CALIBER
Start date: August 2009
Phase: N/A
Study type: Observational

The purpose of this study is to determine the extent to which South Asian ethnicity is both an etiologic and prognostic factor for coronary disease, and investigate factors influencing outcomes.

NCT ID: NCT01150084 Active, not recruiting - Exercise Clinical Trials

"Step by Step": A Feasibility Study of the Promotion of Lunchtime Walking to Increase Physical Activity and Improve Mental Well-being in Sedentary Employees

Start date: September 2009
Phase: Phase 0
Study type: Interventional

Increasing rates of sedentary living, often complemented by obesity, among large segments of the adult population are associated with costs to individual health and well-being and thereby to society as a whole. Although some workplaces offer physical activity opportunities, those employees who tend to need it the most (i.e., the health needy) are often not attracted. In this project, the investigators propose to develop and evaluate a programme that is targeted to the sedentary health needy employees. The investigators will work with the corporate partner (a large university) to attract such employees through an extensive social marketing driven campaign. A 16-week lunchtime walking programme is proposed in which walking groups are offered followed by support and motivational strategies for longer term independent walking. The investigators will examine the effects of the programme on total amount of walking (including a follow-up assessment 4 months later) and will use innovative technology (Smartphones) to also examine the effect of lunchtime walks on well-being and work performance within and between participants.

NCT ID: NCT01133977 Active, not recruiting - Stage IV Melanoma Clinical Trials

E7080 in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma

Start date: December 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Primary: - Phase Ib: To define the safety, tolerability and maximum tolerated dose (MTD) of E7080 administered in combination with dacarbazine. - Phase II: To evaluate the safety and tolerability of E7080 administered in combination with dacarbazine, compared with dacarbazine alone. Secondary: -Phase II: to make a preliminary assessment of the efficacy of E7080 administered in combination with dacarbazine, compared with dacarbazine alone.

NCT ID: NCT01123447 Active, not recruiting - Surgery Clinical Trials

Surgical Treatment Versus Non-surgical Treatment of Ulnar Fractures

Start date: July 2, 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if surgery using a plate and screws to fix a forearm fracture (ulnar shaft) will improve functional outcome compared to non-operative treatment out to 1 year of follow-up. It is hypothesized that in skeletally mature patients with isolated ulnar shaft fractures, the patients treated with surgery will have improved functional outcomes compared to non-surgical treatment with below-elbow cast at 1-year follow-up. This will be measured by the Disabilities of the Arm, Shoulder and Hand (DASH) scores. Secondary outcomes will include SF-36, range of motion, pain, grip strength, return to work, and time to union.

NCT ID: NCT01115868 Active, not recruiting - Scarring Clinical Trials

Prevascar in African Continental Group Scarring

Start date: April 2010
Phase: Phase 1
Study type: Interventional

There is considerable variation in scarring, within and between people, and between different ethnic groups. Individuals with more pigmented skin are more prone to severe scarring than those traditionally termed white. Prevascar is being developed by Renovo for use as a potential treatment for reducing scarring. Renovo's histological analysis of wounds and scars in human non drug studies demonstrates an increase in wound and scar width in subjects of African Caribbean ancestry over a 12 month period. It is hypothesised that IL-10 may be a potentially beneficial therapy for the reduction of scarring in Non Caucasians of African-Caribbean ancestry. This Renovo clinical trial will be carried out primarily to establish the effects of four doses of Prevascar on 1cm incisional and excisional scars in subjects of African Continental Group ancestry, as compared to placebo, and to further investigate the safety and tolerance of intradermally injected Prevascar in wounds.

NCT ID: NCT01107340 Active, not recruiting - Osteoarthritis Clinical Trials

AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study

Start date: January 2010
Phase: N/A
Study type: Interventional

This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.