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NCT ID: NCT02393859 Completed - Clinical trials for Leukemia, Acute Lymphoblastic

Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

Start date: November 10, 2015
Phase: Phase 3
Study type: Interventional

B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse. In general, pediatric treatment regimens are more intense than those employed in adults and include courses of combination chemotherapy. Standard of care chemotherapy is associated with considerable toxicity. There is a lack of novel treatment options for subjects who relapse or are refractory to treatment. Therefore, innovative therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. This study will evaluate the event-free survival (EFS) after treatment with blinatumomab when compared to standard of care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal residual disease compared to SOC chemotherapy will also be investigated.

NCT ID: NCT02392910 Completed - Heart Failure Clinical Trials

Hospitalization & Mortality in Patients With Iron Deficiency CKD and HF Treated With i.v. Iron.

Start date: March 2006
Phase: Phase 4
Study type: Interventional

Iron deficiency, independent of anemia, appears to increase morbidity and mortality as well as impairing health-related quality of life in chronic heart failure (CHF), and these effects are compounded when patients also experience chronic kidney disease (CKD). This study was designed to determine the effects of intravenous iron treatment on morbidity and mortality following an initial 6-month period and a longer period of up to 5 years.

NCT ID: NCT02391766 Enrolling by invitation - Quality of Life Clinical Trials

Group Intervention Empowerment Dementia

Start date: September 2014
Phase: Phase 0
Study type: Interventional

After diagnosis of a dementing illness, patients and their spouses have many concerns related to the disease and their future. This often leads to poor psychological well-being and reduced health-related quality of life (HRQoL) of the family. Support for Empowerment has been proven to be an effective method to improve prognosis of asthma, heart failure, osteoarthritis.and diabetes. However empowering interventions have not been studied in dementia. Therefore, the investigators aim was to examine, in an objective-oriented group intervention, the efficacy of empowerment support program (ESP) on the HRQoL of dementia patients and their spousal caregivers as well as on the sense of competence and psychological well-being of caregivers. Methods: During the years 2014 to 15, 180 dementia patients and their spouses will be recruited from memory clinics or day centers and randomized into two arms: 90 patients for group-based ESP sessions including topics selected by the participants and the use of the by us for us guides, 90 patients will serve as controls in usual community care. Sessions may include topics on dementia, active lifestyle and prevention for cognitive decline, spousal relationship, future planning and emotional well-being. The patients and spouses will have their separate group sessions (ten participants per group) once a week for eight weeks.

NCT ID: NCT02388906 Active, not recruiting - Melanoma Clinical Trials

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

CheckMate 238
Start date: March 19, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

NCT ID: NCT02386553 Active, not recruiting - Clinical trials for Spinal Muscular Atrophy

A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy

NURTURE
Start date: May 18, 2015
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to examine the efficacy of multiple doses of Nusinersen administered intrathecally in preventing or delaying the need for respiratory intervention or death in infants with genetically diagnosed and presymptomatic spinal muscular atrophy (SMA). Secondary objectives of this study are to examine the effects of Nusinersen in infants with genetically diagnosed and presymptomatic SMA.

NCT ID: NCT02386358 Completed - Chagas Disease Clinical Trials

Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial

TRAENA
Start date: March 1999
Phase: Phase 3
Study type: Interventional

The purpose of this study is: 1. -to determine whether benznidazole (BZN) will be able to modify the natural evolution of chronic Chagas disease in adult patients by means of a randomized, double-blind clinical trial (RCT). Also: 2. -to validate therapeutic efficacy with new methods, such as recombinant antigen F29 of Trypanosoma cruzi visualized by conventional ELISA, in the context of the RCT compared with conventional serology (CS) 3. -to develop the real-time polymerase chain-reaction (RT-PCR) to quantify the parasite load as an early therapeutic effect. 4. to determine the potential of such serological and parasitological methods as predictors of therapeutic effect or failure.

NCT ID: NCT02386098 Terminated - HIV Infections Clinical Trials

Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults

Start date: July 8, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether the combination of BMS-955176 with atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious, safe, and well-tolerated in HIV-1 infected treatment experienced adults.

NCT ID: NCT02383589 Completed - Pemphigus Vulgaris Clinical Trials

A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)

Start date: May 26, 2015
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm, multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day) oral prednisone or equivalent. Participants must have a confirmed diagnosis of PV within the previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of active disease at screening. Approximately 135 participants will be enrolled at up to 60 centers worldwide. Participants will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab placebo plus MMF. Randomization will be stratified by duration of illness. The study will consist of three periods: a screening period of up to 28 days, a 52-week double-blind treatment period, and a 48-week safety follow up period that begins at the time of study treatment completion or discontinuation.

NCT ID: NCT02383108 Completed - HIV Infection Clinical Trials

Strategy for Maintenance of HIV Suppression With Once Daily Integrate Inhibitor+Darunavir/Ritonavir in Children

SMILE
Start date: June 2016
Phase: Phase 2/Phase 3
Study type: Interventional

A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to once daily integrase inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants.

NCT ID: NCT02382120 Completed - Clinical trials for Cardiovascular Disease

Accuracy of Non-invasive Effective Pulmonary Perfusion Measurement by CO2

Start date: March 2, 2015
Phase:
Study type: Observational

Cardiac output monitoring is mandatory in most surgical and critical care patients. Many techniques to assess cardiac output are invasive and/or have many limitations, contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal is an interesting option due to the simplicity and non-invasive nature of its calculation. The present study was designed to compare the cardiac output measurement using a capnodynamic formula versus the reference thermodilution method.