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NCT ID: NCT02218047 Completed - Polycythemia Vera Clinical Trials

AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.

CONTI-PV
Start date: November 2014
Phase: Phase 3
Study type: Interventional

Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic increase of red blood cells and frequently also of white blood cells. The "thickening" of the blood in relation with a modified function of the cells has several consequences like increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the brain as well as fingers and toes and an increased risk of arterial and venous thrombosis (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction, deep vein thrombosis in the legs. In case of a strong increase of platelets there is an additional risk of bleedings. As the disease progresses the size of spleen and liver increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a progression at a later time point to a leukemia (increased formation of white blood cells) can occur. The aim of this study is to show that the study drug AOP2014 (pegylated proline interferon alpha-2b) has the long term efficacy and safety in controlling the disease. A comparison arm is receiving best available therapy as selected by the investigator. Response to the treatment is measured by several blood parameters as well as size of the spleen. Interferon-alpha has been shown to be effective in controlling the blood parameters by immunologically influencing the blood building cells. This can lead to a suppression of the disease-causing stem cells and help healthy stem cells to proliferate. Through this mechanism it is possible that Interferon-alpha can avoid long-term damaging effects of the disease.

NCT ID: NCT02216578 Completed - Clinical trials for Metastatic Gastrointestinal Stromal Tumor

Ph II CABOGIST in GIST

Start date: February 2, 2017
Phase: Phase 2
Study type: Interventional

The study is a multi-center, multi-national, open label, single arm Phase II study of single-agent cabozantinib. The objective of the study is to assess the safety and activity of cabozantinib in patients with metastatic GIST who have previously progressed on imatinib and sunitinib and have not been exposed yet to other KIT- or PDGFR-directed tyrosine kinase inhibitors. Patient will receive cabozantinib until they experience no further benefit from the treatment, becoming intolerant to the drug or wishing to discontinue the treatment. Treatment beyond RECIST 1.1 progression is allowed in patients deriving clinical benefit upon investigator's discretion, provided no other criteria for treatment withdrawal are met.

NCT ID: NCT02212197 Completed - Prostate Cancer Clinical Trials

Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer

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

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 q1m versus Eligard, in patients with prostate cancer. All patients will receive leuprolide acetate administered subcutaneously once monthly during 3 months.

NCT ID: NCT02211209 Completed - Clinical trials for Familial Chylomicronemia Syndrome

The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome

Start date: December 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome

NCT ID: NCT02210221 Completed - Clinical trials for Traumatic Brain Injury

CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBI

CENTER-TBI
Start date: December 19, 2014
Phase:
Study type: Observational [Patient Registry]

The research aims of the CENTER-TBI study are to: 1. better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a European context, and 2. identify the most effective clinical interventions for managing TBI. Specific aims 1. To collect high quality clinical and epidemiological data with repositories for neuro-imaging, DNA, and serum from patients with TBI. 2. To refine and improve outcome assessment and develop health utility indices for TBI. 3. To develop multidimensional approaches to characterisation and prediction of TBI. 4. To define patient profiles which predict efficacy of specific interventions ("Precision Medicine"). 5. To develop performance indicators for quality assurance and quality improvement in TBI care. 6. To validate the common data elements (CDEs) for broader use in international settings, and to develop a user-friendly web based data entry instrument and case report form builder. 7. To develop an open database compatible with Federal Interagency Traumatic Brain Injury Research (FITBIR). 8. To intensify networking activities and international collaborations in TBI. 9. To disseminate study results and management recommendations for TBI to health care professionals, policy makers and consumers, aiming to improve health care for TBI at individual and population levels. 10. To develop a "knowledge commons" for TBI, integrating CENTER-TBI outputs into systematic reviews.

NCT ID: NCT02209337 Completed - Clinical trials for Anterior Vaginal Wall Prolapse

Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse

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

A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients

NCT ID: NCT02207634 Completed - Dyslipidemia Clinical Trials

Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects

EBBINGHAUS
Start date: September 10, 2014
Phase: Phase 3
Study type: Interventional

This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.

NCT ID: NCT02207530 Completed - Clinical trials for Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck

Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Start date: October 23, 2014
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR

NCT ID: NCT02207231 Completed - Psoriasis Clinical Trials

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

VOYAGE 1
Start date: November 26, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.

NCT ID: NCT02205359 Completed - Clinical trials for Heart Failure With Left Bundle Branch Block

AdaptResponse Clinical Trial

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

The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).