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NCT ID: NCT01313689 Completed - Leukaemia Clinical Trials

Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia

Start date: April 14, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.

NCT ID: NCT01311648 Completed - Haemophilia A Clinical Trials

BAY81-8973 Pediatric Safety and Efficacy Trial

Start date: June 9, 2011
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the safety and efficacy of the treatment with BAY81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe hemophilia A. The secondary objectives were - To assess the safety and efficacy of BAY81-8973 during surgeries. - To assess incremental recovery of BAY81-8973. - To assess pharmacokinetic (PK) parameters in a subset of children (Previously treated patients [PTPs] and previously untreated patients [PUPs] / minimally treated patients [MTPs] - participation in PK sampling was voluntary and required consent).

NCT ID: NCT01309087 Completed - Lung Cancer Clinical Trials

Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA

AEGIS
Start date: January 2009
Phase: N/A
Study type: Observational

The primary objective of this study is to substantiate prediction accuracy(with a tighter 95% confidence interval compared to current diagnostic modalities), of a lung cancer biomarker for risk stratification of patients into high and low risk categories to aid in clinical evaluation of the patient.

NCT ID: NCT01307397 Completed - Malignant Melanoma Clinical Trials

A Study of Vemurafenib in Participants With Metastatic Melanoma

Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.

NCT ID: NCT01303172 Completed - Clinical trials for Advanced Pancreatic Cancer

A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer

Start date: June 2011
Phase: Phase 2
Study type: Interventional

To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in combination with gemcitabine to gemcitabine alone on safety and tolerability (including QoL), clinical signs and symptoms of disease, selected markers of tumour burden and immunological status, and disease outcome.

NCT ID: NCT01302431 Completed - Multiple Sclerosis Clinical Trials

Nurse-Led Manualized Telephone Support Intervention

Start date: April 2011
Phase: N/A
Study type: Interventional

The primary aim of this study is to determine if a manual based telephone intervention support service for people who support people with Multiple Sclerosis (PwMS), initiated by nurse specialists who provide care to PwMS, has a positive impact on the lives of PwMS and their support persons. For support persons this impact is determined by measurable support person/carer self-efficacy and preparedness to care, burden, quality of life, service utilization and satisfaction with the support service. For PwMS this is determined by their qualitative experience of the type of care they receive from their carer. A secondary aim is to determine the possible economic benefits of the introduction of such an intervention nationally. A support person is the person nominated by the PwMS as the person who provides the most support or physical assistance to a person with MS who is not a paid service provider.

NCT ID: NCT01298570 Completed - Clinical trials for Colorectal Cancer Metastatic

Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer

Start date: April 7, 2011
Phase: Phase 2
Study type: Interventional

This randomized (2:1), multi-center, placebo-controlled, phase II efficacy study is designed to compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients with mCRC previously treated with a FOLFOX regimen.

NCT ID: NCT01295294 Completed - Uterine Hemorrhage Clinical Trials

Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)

Start date: March 2011
Phase: Phase 4
Study type: Interventional

The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic acid) can control irregular bleeding during the first 3 months of using Mirena. The study drugs tested are tested against placebo ("dummy medication not containing any active drug"). Treatment period is followed by a one-month period when study drugs are not taken but Mirena use is continued.

NCT ID: NCT01291836 Completed - Acute Kidney Injury Clinical Trials

Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin Evaluation of Symptomatic Heart Failure Study

AKINESIS
Start date: December 2010
Phase:
Study type: Observational

AKINESIS is a clinical study to assess the utility of blood and urine NGAL tests in predicting worsening kidney function in patients who present with acute heart failure (AHF) and who are treated with diuretics. It is believed that rising NGAL levels in the blood and/or urine can predict acute kidney injury. It is also believed that patients who are admitted to the hospital with high NGAL levels in the blood/urine will have poorer outcomes.

NCT ID: NCT01289990 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

Start date: February 2011
Phase: Phase 3
Study type: Interventional

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.