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NCT ID: NCT02394626 Recruiting - Glioblastoma Clinical Trials

Surgery for Recurrent Glioblastoma

RESURGE
Start date: May 1, 2015
Phase: Phase 2
Study type: Interventional

Patients with glioblastoma face a grim prognosis. Despite recent advancement in neurosurgical technology and neuro-oncology glioblastomas almost invariably progress or recur after a median of 4-8 months. The strategy to repeat tumor resection at recurrence in order to minimize tumor load and thus to facilitate subsequent second-line therapy has been shown to be feasible and safe. However, evidence for a survival benefit of surgery for recurrent glioblastoma is scarce and relies entirely on retrospective analyses. While most retrospective analyses report an apparent survival benefit, an EORTC meta-analysis on second-line therapies found no survival difference in patients with or without surgery at recurrence. With regard to the risks and costs inherent to surgery for glioblastoma, a randomized controlled trial is required. The purpose of the study is to compare the effect of craniotomy and tumor resection followed by adjuvant second-line therapy to no surgery followed by second-line therapy on overall survival, neurological status, and quality of life. Analysis of overall survival will be used to improve sample size estimation of a subsequent phase III trial for craniotomy and tumor resection of glioblastoma recurrence in cooperation with the EORTC.

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: NCT02392559 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders

HAUSER-RCT
Start date: March 24, 2016
Phase: Phase 3
Study type: Interventional

A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.

NCT ID: NCT02391558 Completed - Clinical trials for Diabetic Retinopathy

Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography

OCTA
Start date: September 2015
Phase: N/A
Study type: Observational

Clinical evaluation of noninvasive OCT Angiography using a Zeiss OCT Prototype to replace fluorescein angiography.

NCT ID: NCT02386800 Recruiting - Clinical trials for Acute Myeloid Leukemia

CINC424A2X01B Rollover Protocol

Start date: March 5, 2015
Phase: Phase 4
Study type: Interventional

This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.

NCT ID: NCT02385019 Recruiting - Clinical trials for Graft vs Host Disease

A Phase 1/2 Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease

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

Phase 1/2 clinical study for the treatment of steroid-refractory chronic graft versus host disease after an allogeneic transplant of hematopoietic progenitors with donor CliniMACS-selected regulatory T cells

NCT ID: NCT02384330 Completed - Clinical trials for Upper Limb Spasticity Post-Stroke

Botulinum Toxin A Associated Costs in the Treatment of Upper Limb Spasticity Post Stroke

P_Dysport_CS
Start date: November 2014
Phase:
Study type: Observational

This study aims to estimate the costs of botulinum toxin A utilization in standard practice for the treatment of upper limb spasticity post-stroke in Portugal. It will consider the three most used locally available brands of botulinum toxin A which show similar efficacy and safety profiles thus making it relevant to understand if choosing between one or another brand can depend directly on economic factors. The study will estimate direct and indirect drug-associated costs as determinant variables for the price of each drug and the standard drug dose used in clinical practice.

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: NCT02380170 Completed - Urosepsis Clinical Trials

Epidemiology and Outcomes of Gram Negative Urosepsis

SERPENS
Start date: September 2014
Phase:
Study type: Observational

The study aims to get an insight on the causative bacteria of sepsis derived from the urinary tract. Furthermore, it is the intention to understand the outcomes of these patients. For this purpose a non-interventional, observational study will be conducted.

NCT ID: NCT02377037 Completed - Metabolic Cost Clinical Trials

Metabolic Cost of Sitting, Standing, and Transitions

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

There is already a lot of scientific evidence supporting the benefits of public health recommendations regarding physical activity (the accumulation of at least 150 minutes of at least moderate intensity physical activity per week). However, these 30 daily minutes represent only about 3% of the waking period. Recent data suggest that most of the population spends on average 8-9 hours / day of sedentary behavior (SB). SB is characterized by any activity with a metabolic cost (MC) below 1.5 METs, mainly actions in the sitting position. In fact, there is evidence that the more time spent sitting higher the risk of disease and mortality, with sitting directly associated with diseases such as type II diabetes, cardiovascular diseases and even cancer. The average life expectancy may increase by ~ 2 years if the investigators reduce sitting about 3h/ day. Additionally, how people accumulate sitting time seems to be a major factor, with prolonged sitting associated with a higher risk of disease. Short-term experimental studies indicate that sedentary lifestyles affect energy balance enhancing weight gain. While there is some research regarding the MC associated with "sitting" and "standing" behaviors, the results are contradictory. Besides these conflicting results, the impact of transitions between these two types of behavior and how these transitions can contribute to MC increase have never been investigated. Our hypothesis is that, in both men and women, the simple replacement of sitting for "standing" may not substantially increase MC, but instead, the largest contribution may reside on the transitions between these two states of behavior. Therefore, the investigators will perform a study with the following purposes: Examine MC and HR associated with "sitting", "standing", and transitions between these two types of behavior in adults of both gender, apparently healthy with variable body composition profiles.