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NCT ID: NCT02320084 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care

OPAL
Start date: September 2013
Phase:
Study type: Observational

The purpose of this study is to look at the long term safety profile of Orfadin treatment in patients suffering from hereditary tyrosinemia type 1 (HT-1). Patients included in the study will use Orfadin according to normal clinical practice.

NCT ID: NCT02314325 Recruiting - Clinical trials for Severe Haemophilia A

Subclinical Joint Bleeding in Irish Adults With Severe Haemophilia A on Personalised Prophylaxis Regimens

PERSONAL
Start date: April 2014
Phase: Phase 4
Study type: Interventional

This trial is designed to assess if there is evidence of subclinical joint bleeding on MRI/X-Ray in adults with severe Haemophilia A while on standard and/or pharmacokinetically tailored prophylaxis regimens. Participants with severe Haemophilia A will have longitudinal MRI and XRay imaging of their elbows, ankles and knees at 0, 6 and 18 months while on standard ( 0-6 months) and then pharmacokinetically tailored (7-18 months) recombinant Factor VIII prophylaxis.

NCT ID: NCT02313909 Terminated - Stroke Clinical Trials

Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)

NAVIGATE ESUS
Start date: December 23, 2014
Phase: Phase 3
Study type: Interventional

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

NCT ID: NCT02310945 Recruiting - Knee Osteoarthritis Clinical Trials

Pain Sensitization and Outcome Following Physiotherapy in Patients With Knee Osteoarthritis

Start date: June 2014
Phase: N/A
Study type: Observational

Pain is the dominant symptom of knee osteoarthritis and recent evidence suggests factors outside of local joint pathology, such as pain sensitization, can contribute significantly to the pain experience. It is unknown how pain sensitization influences outcomes from commonly employed interventions such as physiotherapy. The aims of this study are, firstly to identify people with knee OA who display signs and symptoms associated with pain sensitization using clinical tools and quantitative sensory testing. Secondly, we will investigate if indications of pain sensitization at baseline are associated with poor outcome following physiotherapy. Methods and analysis: This is a multi-centre prospective cohort study with 140 participants. Eligible patients with moderate/severe symptomatic knee osteoarthritis will be identified at hospital outpatient clinics. A baseline assessment will provide a comprehensive description of the somatosensory characteristics of each participant by means of clinical examination, quantitative sensory testing and validated questionnaires measuring pain and functional capacity. Participants will then undergo physiotherapy treatment, in line with current clinical guidelines. Follow-up post physiotherapy treatment (estimated to be at 3 months) will assess pain, disability (sub-scales of Western Ontario and McMasters University Score Osteoarthritis Index) and participants' global rating of change. These primary outcome measures will dichotomise participants into treatment 'responders' and 'non-responders' according to the Osteoarthritis Research Society International (OARSI) treatment responder criteria. For data analysis results from pressure pain thresholds, temporal summation and conditioned pain modulation will create a composite score of pain sensitization. Logistic regression will explore the relationship between response to physiotherapy and pain sensitization at baseline while accounting for various cofounders.

NCT ID: NCT02308527 Active, not recruiting - Neuroblastoma Clinical Trials

Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children

BEACON
Start date: July 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate whether Bevacizumab (an anti-VEGF monoclonal antibody) added to a backbone chemotherapy regimen (Temozolomide, Irinotecan-Temozolomide or Topotecan-Temozolomide) demonstrates activity in children with relapsed or refractory neuroblastoma. Also, to investigate whether the addition of Irinotecan or Topotecan to Temozolomide increases the activity of chemotherapy.The primary objective of the study is the best response (Complete Response or Partial Response) while trial treatment, within 18 or 24 weeks depending on the arm of the trial the participant is randomised to. Secondary endpoints are assessing the side effects, the length of time before progression (Progression Free Survival) and overall survival (OS). This trial will address two important questions: - does targeting blood vessel development using bevacizumab, (a monoclonal antibody against the Vascular Endothelial Growth Factor (VEGF)), add to the effect on a tumour when used with existing chemotherapy, compared to the effect of the existing chemotherapy alone (temozolomide)? NOTE- This question has been completed. - does the addition of a second chemotherapy drug (irinotecan or topotecan) increase the effect on a tumour compared to the effect of one alone (temozolomide) NOTE - This question has been completed. - does the addition of dinutuximab beta added to a backbone chemotherapy (temozolomide or temozolomide + topotecan) increase the effect of backbone alone. Patients aged 1-21 years of age with relapsed or refractory high-risk neuroblastoma are randomised to one of two treatment arms: temozolomide-topotecan (TTo) or dinutuximab beta-temozolomide-topotecan (dBTTo). Temozolomide (T), irinotecan-temozolomide (IT), bevacizumab-T (BT), BIT (bevacizumab-IT), bevacizumab-temozolomide-topotecan (BTTo) and dinutuximab beta-temozolomide (dBT) are now closed to recruitment.

NCT ID: NCT02308085 Active, not recruiting - Early Breast Cancer Clinical Trials

Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

POSITIVE
Start date: December 4, 2014
Phase: N/A
Study type: Interventional

The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.

NCT ID: NCT02307669 Recruiting - Asthma Clinical Trials

Inhaler Adherence in Severe Unstable Asthma

INCA-SUN
Start date: December 2015
Phase: N/A
Study type: Interventional

The investigators hypothesize that aligning digital data on PEF and adherence with the patient's own clinical course achieves better asthma control and identifies risks for future loss of control, compared to current best practice. The study has an adherence optimisation phase, week 1-12 followed by a medication management phase, week 12 to week 32. The investigators will compare two asthma education interventions, standard Guideline recommended practice and feedback from the individual's own INCA device, which assesses inhaler adherence and relates adherence with changes in PEF and symptom scores over time. The study has two co-primary endpoints, one will be a comparison of the adherence to therapy and the other will be a comparison of the appropriateness of medication prescriptions between the two study groups.

NCT ID: NCT02306291 Completed - Clinical trials for Leukemia, Myeloid, Acute

Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML

Start date: March 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease.

NCT ID: NCT02304484 Completed - Clinical trials for Hypercholesterolemia

Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

Start date: November 24, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

NCT ID: NCT02301442 Completed - Multiple Sclerosis Clinical Trials

Step it Up: An Exercise and Behaviour Change Programme for People With Multiple Sclerosis

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

Exercise has consistently yielded short-term, positive effects on health outcomes in people with multiple sclerosis (MS). However, these effects have not been maintained in the long-term. Behaviour change interventions aim to promote long-term positive lifestyle change. This study, namely, "Step it Up" will compare the effectiveness of an exercise plus Social Cognitive Theory (SCT)-based behaviour change intervention with an exercise plus control education intervention on walking mobility among people with MS.