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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: NCT02254278 Active, not recruiting - Clinical trials for Stage IVA Oropharyngeal Squamous Cell Carcinoma

Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer

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

This randomized phase II trial studies the side effects and how well modestly reduced-dose intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating patients with oropharyngeal cancer that has spread to other places in the body (advanced). Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether IMRT is more effective with or without cisplatin in treating patients with oropharyngeal cancer.

NCT ID: NCT02252172 Active, not recruiting - Multiple Myeloma Clinical Trials

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

Start date: February 16, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).

NCT ID: NCT02231749 Active, not recruiting - Clinical trials for Metastatic Renal Cell Carcinoma

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

Start date: October 16, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.

NCT ID: NCT02194842 Active, not recruiting - Prostate Cancer Clinical Trials

Phase III Radium 223 mCRPC-PEACE III

PEACE III
Start date: October 2015
Phase: Phase 3
Study type: Interventional

The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) compared to enzalutamide single agent in CRPC patients metastatic to bone

NCT ID: NCT02188355 Active, not recruiting - Clinical trials for Coronary Artery Disease

Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry

e-Ultimaster
Start date: June 2014
Phase:
Study type: Observational [Patient Registry]

The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in unselected patients representing everyday clinical practice. Also the study will assess the impact of non-compliance with dual antiplatelet therapy, one month after stent implementation (frequently observed in every day clinical practice), on stent thrombosis.

NCT ID: NCT02130362 Active, not recruiting - Crohn's Disease Clinical Trials

A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)

CAPE
Start date: August 28, 2014
Phase:
Study type: Observational

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.

NCT ID: NCT02122978 Active, not recruiting - Psoriasis Clinical Trials

Comparing Mindfulness Based Cognitive Therapy and Mindfulness Based Self-compassion Therapy in a Psoriasis Sample

Start date: November 2013
Phase: N/A
Study type: Interventional

Increasing research evidence supports the effectiveness of mindfulness based interventions; however, the exact mechanisms of change are poorly understood. Some evidence proposes that self-compassion is an important mechanism of change in the effectiveness of mindfulness based interventions. The current research will evaluate and compare the effectiveness of two mindfulness meditation approaches; Mindfulness Based Cognitive Therapy (MBCT) and Mindfulness based Self-compassion Therapy (MBSCT), for individuals with psoriasis, a skin condition commonly associated with stress. Blood analyses will be conducted to assess and compare the impact of the interventions on the immune system. Self-report questionnaires will explore participants' psychological functioning (e.g. self-compassion, depression, anxiety, worry). This study will also examine whether a relationship exists between immune functioning and psychological factors. An audio-guided MBSCT programme will be piloted, with a view to trialling as a more cost-effective alternative to traditional mindfulness interventions. Findings will enable us to design more effective interventions in the future, and yield clear results regarding the existence of a definite link between immunological functioning and psychological functioning. The main research hypothesis is that participants who complete a mindfulness based intervention will experience significantly greater psychological well-being, symptom reduction, and greater changes in telomerase and cytokine activity than individuals who only receive treatment as usual for their psoriasis.

NCT ID: NCT02108860 Active, not recruiting - Clinical trials for Wegener's Granulomatosis

Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)

Start date: April 25, 2015
Phase: Phase 3
Study type: Interventional

Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous injection once a week. Participants will continue on study treatment for a minimum of 12 months unless they experience a disease relapse or disease flare. Participants who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would receive open-label abatacept.