Clinical Trials Logo

Filter by:
NCT ID: NCT01867710 Completed - Prostate Cancer Clinical Trials

Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy

Start date: July 16, 2013
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine the safety and clinical benefit of the combinations of abiraterone acetate and prednisone or abiraterone and dexamethasone in prostate cancer patients. Prednisone will be given at one of three different dose schedules. Dexamethasone will be given at one dose schedule. This will include looking at what side effects occur and how often they occur. In addition the impact of the study drug on quality of life and pain will be evaluated. The study will also collect data on subsequent treatment of patients after they come off the study drug (approximately 4.5 years after the start of study treatment of the first subject participating in the study). By analyzing blood samples, the study aims to identify if some markers could help to understand if the treatment with abiraterone is effective and also help to understand if patients can become resistant.

NCT ID: NCT01867684 Completed - Clinical trials for Acquired Brain Injury

Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation

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

Stroke, head injury and other forms of brain injury are a major cause of physical, psychological and social disability in the adult population. Psychological distress is common following brain injury, but the evidence base for specific psychotherapeutic methods in this population is limited, and standard treatment approaches may not be suitable. Recently there has been a growing interest in positive psychology - the study of wellbeing, positive emotions and characteristics, and personal growth. The investigators believe that positive psychotherapy interventions may be beneficial after acquired brain injury, to reduce psychological morbidity. Because such interventions have not previously been applied in this population, the investigators propose to conduct a pilot randomised controlled trial to examine the feasibility of a brief positive psychotherapy intervention in an out-patient setting. This project will produce essential information to allow us to plan future full-scale clinical trials in this area.

NCT ID: NCT01867125 Completed - Asthma Clinical Trials

A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Start date: July 31, 2013
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

NCT ID: NCT01867060 Completed - Stroke Clinical Trials

Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community

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

This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3 months, will detect significantly more cases of PAF than the ACER, used continuously for one week. A case-control sub-study will identify individuals with confirmed PAF, and matched individuals with no evidence of PAF, to identify potential serum biomarkers for PAF. A further case-control study will assess markers of left atrial function in patients with PAF and their matched controls. Another case-control sub-study will determine the significance of frequent Atrial Premature Beats (APBs) in the development of AF over a one year period.

NCT ID: NCT01866436 Completed - Clinical trials for Focus of Study: Cognitive Surgical Skill Acquisition

Educational Study of Multimedia in Surgical Skills Training in Colorectal Surgery

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

To practice independently surgeons require competency in surgical skills, encompassing a combination of technical and non-technical skills. Cognitive skills, aspects of non-technical skills, represent an integral component of surgical competency. Cognitive skills comprise factual knowledge and decision-making. Changing work patterns in the United Kingdom, as specified by the European Working Time Directive (EWTD), have had a profound impact on the delivery of surgical skills training. Surgical trainees are now increasingly removed from normal working hours in which the majority of traditional operative training and experience is gained, leading to a net reduction in trainees' operative exposure. This reduction in operative experience means that surgical competence can no longer be assured on the basis of experience alone. Although there is no educational technology that can replace the craft apprenticeship required to train a competent surgeon, reduction in training hours has led to rapid development of educational tools to augment surgical skills training outside the operating room environment. These tools tend to concentrate on technical skills performance without emphasis on cognitive skills. Trainees in today's era have grown up in a multimedia environment; multimedia is media that uses a combination of text, voiceover, animation and video. Multimedia is an underdeveloped educational resource that can supplement cognitive skills training in operative surgery. The purpose of this study was to design and develop an online multimedia educational tool in a common colorectal surgery procedure ("Anterior Resection") and determine the effectiveness of this tool in teaching and assessment of cognitive skills. Study hypothesis: Multimedia learning is equivalent to conventional teaching "Study Day" in improving scores in cognitive surgical skills.

NCT ID: NCT01866150 Completed - Clinical trials for Rheumatoid Arthritis

A Retrospective, Observational Chart Review of Biologics in Monotherapy Versus the Combination Biologic Plus Methotrexate in Patients With Rheumatoid Arthritis

Start date: April 2013
Phase: N/A
Study type: Observational

This cross-sectional, non-interventional, retrospective chart review will compare the efficacy and safety of biologic monotherapy and biologic and methotrexate combination therapy in patients with rheumatoid arthritis who have had an inadequate response to prior treatment with disease-modifying anti-rheumatic drugs including methotrexate. Data will be collected from patients who have been on first-line biologic treatment for at least 6 months.

NCT ID: NCT01865981 Completed - Clinical trials for Eletrophysiology of iPS-derived Cardiomyocytes

Investigating Hereditary Cardiac Disease by Reprogramming Skin Cells to Heart Muscle

CLUE
Start date: June 2013
Phase:
Study type: Observational

Hereditary cardiac arrhythmias (genetically caused disturbances of heart rhythm) are life threatening conditions affecting otherwise healthy young individuals. Due to the inaccessibility of heart tissue, the abnormal electrical current(s) in the heart cells causing the rhythm disturbance can be difficult to study in detail and therefore in many cases remain untreatable. The investigators propose to study heart cell electrical function from such patients by reprogramming skin cells to become stem cells and then differentiating them to heart muscle cells. The hypothesis of the study is that the differentiated cardiac cells will display electrical abnormalities dependent on the mutation causing the disease. These abnormalities can therefore provide a clue as to the nature of the mutation causing the disease or information about its effective management

NCT ID: NCT01865747 Completed - Clinical trials for Renal Cell Carcinoma

A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma

METEOR
Start date: June 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.

NCT ID: NCT01865721 Completed - Analgesia Clinical Trials

Optimizing the Use of Entonox® During Screening Colonoscopy

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

This study will randomise patients undergoing screening colonoscopy to receive Entonox either continuously or as required. Both these methods are used in the published studies of Entonox and in clinical practice. Null hypothesis There will be no difference in pain levels between these two methods of Entonox administration

NCT ID: NCT01864746 Completed - Breast Cancer Clinical Trials

A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

PENELOPE-B
Start date: October 30, 2013
Phase: Phase 3
Study type: Interventional

The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.