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NCT ID: NCT02313077 Completed - Healthy Clinical Trials

A Safety and Immunogenicity Study of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants

Start date: December 17, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous prime-boost vaccine regimens in healthy adult participants.

NCT ID: NCT02312960 Completed - Clinical trials for Neoplasm Metastasis / Bone and Bones

Radium-223 Dichloride Long-term Follow-up Program

Start date: December 18, 2014
Phase: Phase 4
Study type: Interventional

Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .

NCT ID: NCT02312336 Completed - Clinical trials for Acute Myocardial Infarction

A Pilot Study of Transcoronary Myocardial Cooling

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

Patients with heart attacks caused by blocked coronary arteries are usually treated with a technique called primary angioplasty. Although this treatment is very successful it can result in damage to the heart muscle when the artery is opened due to reperfusion injury. Cooling the entire body has been shown to reduce heart muscle damage during heart attacks in some patients but not in others, however it is uncomfortable due to the shivering, expensive and can result in delays in opening the blocked artery. We are investigating a simpler way to cool the heart muscle directly using cooled fluid passed through the catheter without the shortcomings of entire body cooling. This pilot will address safety and feasibility considerations.

NCT ID: NCT02312258 Completed - Multiple Myeloma Clinical Trials

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)

Start date: April 9, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.

NCT ID: NCT02310984 Completed - Clinical trials for Early-Stage Breast Carcinoma

PICTURE Breast XS: Patient Information Combined for Local Therapy oUtcome Assessment in bREast Cancer - Cross-sectional

PICTURE XS
Start date: March 2014
Phase: N/A
Study type: Observational

This project which is fully funded by the European Union FP7 Program is designed to pull together all the information we obtain from scans and x-rays to design a personalised 3-D digital model of each patient, their anatomy and disease. We can then use this as follows: as (i) an aid to surgical planning to enable objective clinical decision making (ii) a decision support tool to communicate the available treatment options to the patient and facilitate shared decision making and provision of personalised care and (iii) to enable standardised objective evaluation of the aesthetic outcome of the treatment procedures. This study aims to demonstrate the ability of the Virtual Physiological Human concept to empower breast cancer patients and assess the impact on their care and quality of life.

NCT ID: NCT02310906 Completed - Clinical trials for Duchenne Muscular Dystrophy

Phase I/II Study of SRP-4053 in DMD Patients

Start date: January 13, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability, efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 53 skipping.

NCT ID: NCT02310802 Completed - Infertility Clinical Trials

OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI

IMPLANT
Start date: November 2014
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the increase in clinical pregnancy rate after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist, compared to placebo.

NCT ID: NCT02310672 Completed - Clinical trials for Pulmonary Arterial Hypertension

REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension

REPAIR
Start date: June 1, 2015
Phase: Phase 4
Study type: Interventional

The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.

NCT ID: NCT02310438 Completed - Hemiparesis Clinical Trials

Music Therapy for The Rehabilitation of Upper Limb With Stroke Patients

TIMPStro
Start date: January 2014
Phase: Phase 2
Study type: Interventional

Impairment of arm function is more common than lower limb impairment in stroke patients and is also more resistant to treatment. Several clinical trials with stroke patients have produced statistically significant gains in upper limb function when using instrumental playing and treatments where rhythm supports the priming and timing of movements. Based on the positive results from controlled and non-controlled trials, the Cochrane review of music therapy for acquired brain injury (Bradt, et al., 2010) recommends further investigation into rhythm based techniques to treat hemiparesis in stroke patients, and that future studies need to examine the relationship between the frequency and duration of interventions and treatment effects. The aim of this study is to examine whether or not a thirty minute, twice weekly, six week, home music therapy treatment, playing set musical patterns on instruments to music is feasible to deliver, and will lead to improved coordination, dexterity and activities of daily living in hemiparetic stroke patients. Twelve patients will be recruited from Cambridgeshire Community Services NHS trust (CCS) who are between one month and two years post stroke with hemiparesis. Participants will have completed and been discharged from community rehabilitation for their upper limb and not be receiving any other treatment for arm function. They will be randomised into two groups: treatment (for immediate treatment following discharge from community rehab) and waiting list (beginning 9 weeks after baseline measure). Participants will be assessed at the beginning and end of treatment (just before starting and just after completing 6 weeks of treatment) by one of two experienced community occupational therapists under contract with CCS, who are also experienced in working with stroke patients and who will be blind to the experiment. The other three measures will be conducted by the chief investigator. The assessment tools will be the Action Research Arm Test (ARAT) and nine hole peg test (9HPT). There will also be a pre and post treatment semi-structured interview for each participant, which will be conducted by the chief investigator. ARAT and 9HPT assessments will be administered to all participants at the same time points: baseline and then at week 6, 9, 15 and 18. Data will be analysed to determine if the treatment is effective compared to no treatment (wait list) following community discharge, and whether earlier intervention (treatment group) yields better results for participants, all of whom will eventually receive treatment.

NCT ID: NCT02310269 Completed - Cushings Disease Clinical Trials

Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease

Start date: March 28, 2013
Phase:
Study type: Observational

This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.