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NCT ID: NCT02212301 Completed - Eye Dryness Clinical Trials

Comparison of Two Marketed Lenses in a Controlled Environment

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

This study is comparing two silicone hydrogel contact lenses in a controlled environment for identification of characteristics associated to vision.

NCT ID: NCT02212236 Completed - Clinical trials for Psychological Distress

Psychological Intervention for Distress During HSCT

Start date: September 2014
Phase: Phase 2
Study type: Interventional

This Phase II trial aims to evaluate a new psychological intervention to alleviate distress during haematopoietic stem cell transplantation (HSCT) together with examining feasibility. HSCT is a complex procedure aimed at a range of haematological and autoimmune illnesses. Over 3,000 individuals undergo the procedure every year in the UK with substantial benefits. However, it is very costly, intensive, and has a range of debilitating side effects. Consequently, patients often experience considerable distress, which can impede recovery. A 90-minute, group-based intervention has been developed to address this need based on psychological theory of adjustment to illness-related difficulties. It is delivered by the transplant team and involves provision of information to foster more helpful perceptions about HSCT and facilitating more helpful coping with its difficulties. To evaluate the effectiveness of the intervention in alleviating distress, 60 patients about to undergo HSCT at two sites (Sheffield & Nottingham) will be randomly allocated into two groups. Patients in the intervention group will receive the new intervention prior to transplantation together with treatment as usual (TAU) while patients in the control group will receive TAU alone. Participants and the researcher collecting the data will be blind to the allocation. Demographic and relevant clinical information will be recorded at the end of participation to ensure effectiveness of randomisation. For both groups, resilience, distress, coping, and procedure-related perceptions will be measured at four time points: (i) prior to the intervention/transplantation, (ii) day of transplant, (iii) two weeks following the transplant, and (iv) four weeks following the transplant. It is hypothesised that patients in the intervention group will experience higher resilience and lower distress compared to controls and that this difference will be mediated by procedure-related perceptions and coping. A subgroup of participants of those randomised to the group intervention will be invited to participate in a feedback interview at the end.

NCT ID: NCT02212041 Completed - Schizophrenia Clinical Trials

Electronic Cigarettes in Smokers With Mental Illness

APUS e-Cigs
Start date: September 24, 2014
Phase: N/A
Study type: Interventional

People with mental illness are more likely to smoke and are more severely addicted to nicotine than the general population. As a result, the number of deaths related to tobacco is higher. Smoking is highly addictive because it delivers nicotine very quickly. Research studies show that people who use nicotine replacement therapies (such us patches, gums, etc) are more likely to quit smoking than those who try to quit without using these nicotine products. Recently a new electronic nicotine delivery system (ENDS), also known as electronic cigarette (e-cigarette) is rapidly gaining popularity. Electronic cigarettes are devices that mimic traditional cigarettes and deliver nicotine but do not carry the dangerous chemicals contained in tobacco cigarettes. Given the increasing popularity of e-cigs, there is an urgent need to improve our understanding of both the potential benefits and risks of e-cigs use in people with serious mental illness. In this pilot we propose inviting 50 people with schizophrenia (or schizophrenia-related disorder) who are not intending to quit smoking in the near future to take part in a study in which we will provide 6-weeks of free e-cigs, followed by a 4-week period in which they will not receive free e-cigs and we monitor which products participants choose, and a final 24-week follow-up visit. During the 24-week study period we will assess the use of e-cigs and tobacco cigarettes, the exposure to nicotine and tobacco toxicants, nicotine withdrawal symptoms, the changes in respiratory symptoms and psychiatric symptoms as well as the e-cigs perceived benefits and risks.

NCT ID: NCT02211495 Completed - Diabetes Clinical Trials

ULCERS - Electrical Stimulation in Diabetic Foot Ulceration

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

The investigators hypothesise that use of a medical device, that increases blood flow to the foot, will speed up ulcer healing in symptomatic diabetes

NCT ID: NCT02211456 Completed - Heart Failure Clinical Trials

An Assessment of Dual Site Left Ventricular Endocardial Pacing

DOUBLE-CRT
Start date: December 2014
Phase: N/A
Study type: Interventional

We are investigating ways to help patients with heart failure, which is caused by damaged hearts which function less well, and cause symptoms of breathlessness, fatigue, lack of energy and swelling. Cardiac Resynchronisation Therapy (CRT) pacemakers are used to improve the pumping function of the main heart chamber in certain suitable people with heart failure. CRT requires a pacemaker with 2 wires, one placed inside the right heart chamber and one normally placed on the outside of the left heart chamber. These two wires act together to re-time the coordination of the heartbeat, which is known to improve heart function. The investigators are assessing whether they might be able to improve heart function even more by placing two wires on the inside of the left heart chamber, rather than one around the outside. The investigators wish to assess whether: 1. Using two wires within the left side of the heart gives a greater increase in heart function than one. 2. It is possible to choose the best spot inside of the heart by measuring the pattern of the heart beat. 3. Is it possible to use a different type of heart monitor placed outside the body instead of a monitor wire inside the heart to assess improvement in heart function? They are investigating this in people with hearts that beat less effectively than normal.

NCT ID: NCT02211209 Completed - Clinical trials for Familial Chylomicronemia Syndrome

The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome

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

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome

NCT ID: NCT02211014 Completed - Clinical trials for Multiple Myeloma (MM)

An Open-Label, Phase 1b Study of Acalabrutinib With and Without Dexamethasone in Subjects With Multiple Myeloma

Start date: February 2015
Phase: Phase 1
Study type: Interventional

To characterize the safety profile of acalabrutinib with and without dexamethasone in subjects with relapsed or refractory Multiple Myeloma (MM)

NCT ID: NCT02210260 Completed - Colorectal Cancer Clinical Trials

Pain Relief After Colorectal Surgery: Spinal Combined With Painbuster® vs Painbuster® Alone.

PROSP
Start date: September 2013
Phase: N/A
Study type: Interventional

Limiting surgical stress and managing postoperative pain are well understood to influence recovery and outcome from major surgery for colorectal cancer and both are fundamental aspects of enhanced recovery protocols. Traditional approaches for dealing with these problems such as epidural or patient controlled intravenous opioid analgesia are associated with problems that may be detrimental to postoperative recovery and surgical outcome. As a result there is evidence in the literature of increasing interest in alternative techniques such as intrathecal anaesthesia or continuous wound infusion of local anaesthetic, however nobody has examined the effect of combining the techniques or their impact on the surgical stress response. We intend to compare patients undergoing major resections for colorectal cancer receiving intrathecal anaesthesia in combination with a wound infusion of local anaesthetic with those receiving a continuous wound infusion alone. We will examine the surgical stress response and postoperative pain control in addition to objective measures of postoperative recovery. We suggest that our approach will attenuate the surgical stress response and provide optimal pain control that will ultimately translate in improved recovery and outcome following surgery for colorectal cancer.

NCT ID: NCT02210221 Completed - Clinical trials for Traumatic Brain Injury

CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBI

CENTER-TBI
Start date: December 19, 2014
Phase:
Study type: Observational [Patient Registry]

The research aims of the CENTER-TBI study are to: 1. better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a European context, and 2. identify the most effective clinical interventions for managing TBI. Specific aims 1. To collect high quality clinical and epidemiological data with repositories for neuro-imaging, DNA, and serum from patients with TBI. 2. To refine and improve outcome assessment and develop health utility indices for TBI. 3. To develop multidimensional approaches to characterisation and prediction of TBI. 4. To define patient profiles which predict efficacy of specific interventions ("Precision Medicine"). 5. To develop performance indicators for quality assurance and quality improvement in TBI care. 6. To validate the common data elements (CDEs) for broader use in international settings, and to develop a user-friendly web based data entry instrument and case report form builder. 7. To develop an open database compatible with Federal Interagency Traumatic Brain Injury Research (FITBIR). 8. To intensify networking activities and international collaborations in TBI. 9. To disseminate study results and management recommendations for TBI to health care professionals, policy makers and consumers, aiming to improve health care for TBI at individual and population levels. 10. To develop a "knowledge commons" for TBI, integrating CENTER-TBI outputs into systematic reviews.

NCT ID: NCT02210091 Completed - Hemophilia A Clinical Trials

BAX 855 Pediatric Study

Start date: October 31, 2014
Phase: Phase 3
Study type: Interventional

The study purpose is: - To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly prophylactic treatment with BAX 855 or 50 exposure days (EDs), whichever occurs last. - To compare pharmacokinetic (PK) parameters to ADVATE. - To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes. - To evaluate safety and immunogenicity.