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NCT ID: NCT02046096 Completed - Pulmonary Embolism Clinical Trials

Cook IVC Filter Study

CIVC
Start date: January 2014
Phase: N/A
Study type: Interventional

This prospective, multicenter, double-arm clinical study further evaluated the safety and effectiveness of Cook's commercially available inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in patients in need of temporary or permanent IVC filter placement for the prevention of pulmonary embolism (PE).

NCT ID: NCT02045953 Completed - Asthma Clinical Trials

A Study to Assess the Systemic Exposure of FLIXOTIDE™ (Fluticasone Propionate) and SERETIDE™ (Fluticasone Propionate and Salmeterol) Given With VENTOLIN™ Mini-Spacer Compared to the Aerochamber Plus Spacer

Start date: January 29, 2014
Phase: Phase 1
Study type: Interventional

The VENTOLIN Mini-Spacer is being developed in order to support patients in the Emerging Markets and Asia Pacific regions who do not have access to affordable spacers. The aim of this exploratory study is to investigate whether the systemic exposure for fluticasone propionate (FP) and salmeterol observed with the VENTOLIN Mini-Spacer is comparable to the systemic exposure for FP and salmeterol observed with the Trudell Aerochamber Plus spacer for both FLIXOTIDE and SERETIDE Metered Dose Inhaler (MDI) products. There will be four study periods in the study and all participants will receive four study treatments during the study. The total duration of study including screening, treatment period, washout period, and follow-up period will be 58 days. Study is planned to enroll 20 healthy subjects. VENTOLIN is a registered trademark of GlaxoSmithKline. FLIXOTIDE is a registered trademark of GlaxoSmithKline. SERETIDE is a registered trademark of GlaxoSmithKline.

NCT ID: NCT02045862 Completed - Overactive Bladder Clinical Trials

A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

SYNERGY II
Start date: March 17, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

NCT ID: NCT02045017 Completed - Multiple Myeloma Clinical Trials

Efficacy and Safety of Pomalidomide and Dexamethasone in RRMM Patients With Renal Insufficiency

Start date: February 28, 2014
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to determine the safety and efficacy and to generate PK and biomarker data for the combination of Pomalidomide and low-dose Dexamethasone in patients with relapsed or refractory multiple myeloma, with moderate or severe renal impairment.

NCT ID: NCT02044809 Completed - Clinical trials for Cannabis Use Disorder

Cannabidiol: a Novel Intervention for Cannabis Use Problems?

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

The purpose of this trial is to investigate a novel treatment for cannabis dependence: cannabidiol. Between 96 and 168 young people who want to quit cannabis and meet criteria for moderate cannabis use disorder (DSM-5) will be recruited from the community. Stage one aims to identify the Most Effective Dose (MEDmg) of oral cannabidiol for reducing cannabis use over four treatment weeks. Stage two will determine whether the MED identified in stage 1 can offer an effective treatment for cannabis dependence.

NCT ID: NCT02044627 Completed - Hyperlipidemia Clinical Trials

Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002

Start date: December 2013
Phase: Phase 1
Study type: Interventional

This Phase 1 study will assess the mass balance recover of carbon-14 (14C) labelled ETC-1002 and the routes and rates of excretion of [14C]-ETC-1002

NCT ID: NCT02044419 Completed - Healthy Clinical Trials

A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled

Start date: October 30, 2013
Phase: Phase 1
Study type: Interventional

To compare the relative bioavailability of lomitapide when administered by sprinkling the contents of a 20 mg capsule of lomitapide in applesauce or in mashed banana to a single oral intact capsule dose of 20 mg lomitapide in healthy subjects.

NCT ID: NCT02044198 Completed - Clinical trials for Plasmodium Falciparum Malaria

A Phase I/IIa Study of the Safety, Immunogenicity and Efficacy of FMP2.1/AS01B, an Asexual Blood-Stage Vaccine for Plasmodium Falciparum Malaria

Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate an experimental malaria vaccine for its ability to prevent malaria infection or disease in a blood-stage challenge model (when volunteers are infected with malaria parasites using malaria-infected red blood cells). The vaccine being testing is a protein called FMP2.1, which is given with an adjuvant (a substance to improve the body's response to a vaccination) called AS01B. The aim is to use this protein and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will enable assessment of: 1. The ability of the vaccine to prevent malaria infection. 2. The safety of the vaccine in healthy participants. 3. The response of the human immune system to the vaccine. This will be done by giving participants three vaccinations and then exposing them to malaria infection by transfusing a small number of red blood cells infected with malaria under carefully regulated conditions. Participants will be followed closely to observe if and when they develop malaria. If the vaccine provides some protection against malaria, participants will take longer to develop malaria than usual or will not develop malaria at all. The study will enrol 15 participants to be vaccinated and then challenged with malaria in addition to recruit 15 individuals to be control subjects.

NCT ID: NCT02044120 Completed - Ewing Sarcoma Clinical Trials

ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and/or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma

Start date: May 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to define the dose-limiting toxicities and maximum tolerated dose of the poly ADP-ribose polymerase inhibitor niraparib and escalating doses of temozolomide and/or irinotecan in patients with pre-treated incurable Ewing sarcoma.

NCT ID: NCT02043899 Completed - Clinical trials for Metastatic Neuroblastoma

A Phase I/II Study of [124I]mIBG PET/CT in Neuroblastoma

Start date: February 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to show that 3-dimensional PET/CT imaging with a new novel PET tracer (called [124I]mIBG) can detect as many or more sites of neuroblastoma (a type of childhood cancer) compared to the recommended 1-dimensional routine scans (called [123I]mIBG planar scintigraphy).