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NCT ID: NCT02004873 Completed - Clinical trials for Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines

Micra Transcatheter Pacing Study

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.

NCT ID: NCT02004691 Completed - Clinical trials for Sphingomyelin Lipidosis

Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency

ASCEND
Start date: December 18, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objective: The primary objective of this phase 2/3 study is to evaluate the efficacy of olipudase alfa (recombinant human acid sphingomyelinase) administered intravenously once every 2 weeks for 52 weeks in adult participants with acid sphingomyelinase deficiency (ASMD) by assessing changes in: 1) spleen volume as measured by abdominal magnetic resonance imaging (MRI) (and, for the United States [US] only, in association with participant perception related to spleen volume as measured by splenomegaly-related score [SRS]); and 2) infiltrative lung disease as measured by the pulmonary function test, diffusing capacity of the lung for carbon monoxide (DLCO). Secondary Objectives: - To confirm the safety of olipudase alfa administered intravenously once every 2 weeks for 52 weeks. - To characterize the effect of olipudase alfa on the participant perception related to spleen volume as measured by the SRS after 52 weeks of study drug administration. (For the US, the effect of olipudase alfa on the SRS is part of the primary objective). - To characterize the effect of olipudase alfa after 52 weeks of study drug administration on the following outcome measures assessed sequentially: - The effect of olipudase alfa on liver volume; - The effect of olipudase alfa on platelet count; - The effect of olipudase alfa on fatigue; - The effect of olipudase alfa on pain; - The effect of olipudase alfa on dyspnea.

NCT ID: NCT02004392 Terminated - Dementia Clinical Trials

Study of the Safety and Clinical Effects of 2 Doses of EVP-6124 in Subjects With Alzheimer's Disease Who Complete Study EVP-6124-024 or EVP-6124-025

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

This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive EVP-6124 for an additional 26 weeks.

NCT ID: NCT02004353 Terminated - Hearing Loss Clinical Trials

Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear

IROS
Start date: July 2011
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to collect patient related benefit data following treatment for permanent hearing loss with a hearing implant from the company Cochlear over a period of 2 years post treatment. Assessment of benefits is based on standard questionnaires of hearing ability and quality of life in general.

NCT ID: NCT02004106 Completed - Neoplasms Clinical Trials

A Study to Evaluate Safety, Pharmacokinetics, and Efficacy of RO6895882 in Participants With Advanced and/or Metastatic Solid Tumors

Start date: December 31, 2013
Phase: Phase 1
Study type: Interventional

This open-label, multi-center, dose-escalation study will evaluate the safety, pharmacokinetics, and therapeutic activity of RO6895882 in participants with Carcinoembryonic Antigen (CEA)-positive solid tumors who have progressed on the standard of care therapy. The study will be conducted in 3 parts. Part 1 will be a single ascending dose study in single participant cohort at low RO6895882 dose (less than or equal to [</=] 6 milligrams [mg]). Part 2 will be a dose-escalation study of RO6895882 monotherapy given every week (qw), every 2 weeks (q2w), and possibly every 3 weeks (q3w). Part 3 will be an expansion phase of the qw, q2w, and possibly q3w at maximum tolerated dose (MTD) (as determined in Part 2). Part 3 will only be conducted if the risk/benefit assessment, as evaluated by the Sponsor and the investigators, is in favor of the participants. Participants will be treated until disease progression, unacceptable toxicity or withdrawal from treatment for other reasons or death for a maximum duration of 24 months.

NCT ID: NCT02004093 Completed - Ovarian Cancer Clinical Trials

A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer

Start date: December 2005
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.

NCT ID: NCT02003924 Active, not recruiting - Prostate Cancer Clinical Trials

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

PROSPER
Start date: October 31, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

NCT ID: NCT02002637 Terminated - Osteoarthritis Clinical Trials

Feasibility of the Latella Implant System for Medial Osteoarthritis (OA)

Start date: November 2013
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and technical feasibility of implanting the Latella Implant System in the treatment of patients with medial osteoarthritis of the knee.

NCT ID: NCT02002312 Completed - Clinical trials for Metastatic Clear Cell Renal Cell Carcinoma

Phase II Study of Lutetium-177 Labeled Girentuximab in Patients With Advanced Renal Cancer

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

To determine the efficacy of multiple doses Lutetium-177-DOTA-girentuximab in patients with advanced clear cell renal cell carcinoma using RECIST criteria.

NCT ID: NCT02000453 Terminated - Colitis, Ulcerative Clinical Trials

Safety and Tolerability Study of GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.

Start date: December 20, 2013
Phase: Phase 1
Study type: Interventional

This is an open label exploratory study to investigate the safety of 400 milligram (mg ) twice a day (b.i.d.) GSK2586184 in patients with moderate to severe, active ulcerative colitis (UC). Study medication will be administered orally (as tablets), twice daily, for up to 8 weeks (56 days). Study medication will be taken with food. Each subject will have 6 out-patient visits: Screening (Day -30 to -1); Baseline and Start of treatment (Day 1); Week 2 (Day 14); Week 4 (Day 28); Week 8 (Day 56); and Follow-up (Week 12; Day 84). Visit windows for weeks 2, 4 and 8 will be + 2 days. The primary objective of this study is to assess the safety and tolerability of GSK2586184. The primary endpoints to measure safety are laboratory tests (including haematology, clinical chemistry and serum creatinine), vital signs, 12-lead electrocardiogram (ECG), physical examination, and adverse event reporting. These are standard measurements to evaluate safety.