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NCT ID: NCT01866904 Terminated - Clinical trials for Stable Coronary Artery Disease (CAD), Myocardial Infarction

Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable CAD in Post MI Patients

TIGRIS
Start date: June 19, 2013
Phase:
Study type: Observational

THis study is intended to provide contemporary data on the burden of disease in patients 1 to 3 years post-MI, including a description of patient characteristics, current treatment patterns, rate of major CV events, and healthcare resource utilization in a 'real world' patient population at high atherothrombotic risk.

NCT ID: NCT01865253 Terminated - Hypertension Clinical Trials

Renal Denervation for Complicated Hypertension

RDNP-2012-03
Start date: May 2012
Phase: Phase 4
Study type: Interventional

This is an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to: - intolerance to antihypertensive medication - inability to take antihypertensive medication due to planned pregnancy - renal artery stenosis - chronic kidney disease - non-compliance to antihypertensive medication A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study. The duration of this study is 36 months.

NCT ID: NCT01865240 Terminated - Hypertension Clinical Trials

Renal Denervation for Resistant Hypertension

RDNP-2012-01
Start date: February 2012
Phase: Phase 4
Study type: Interventional

This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.

NCT ID: NCT01864798 Terminated - Breast Neoplasms Clinical Trials

A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer

D-Beyond
Start date: July 2013
Phase: Phase 2
Study type: Interventional

This is a prospective, single arm phase IIa trial in which patients with early breast cancer will receive pre-operatively two doses of denosumab 120mg subcutaneously one week apart (maximum 12 days) followed by surgery. Tumor, normal breast tissue and blood samples will be collected at baseline and at surgery. Post-operative treatment will be at the discretion of the investigator. Primary objective: to determine if a short course of RANKL inhibition with denosumab can induce a decrease in tumor proliferation rates as determined by Ki67 immunohistochemistry (IHC) in newly diagnosed, early stage breast cancer in pre-menopausal women. Secondary objectives: - To determine the number of absolute Ki67 responders after a short course of denosumab (defined as <2.7% IHC staining in the post treatment tumor biopsy). - To determine the effects of a short course of denosumab on serum C-terminal telopeptide levels (CTX). - To determine the effects of a short course of denosumab on RANK/RANKL gene expression and signaling as assessed by immunohistochemistry (IHC) and RNA sequencing in the tumor. - To determine the effect of a short course of denosumab on tumor apoptosis rates using IHC - To determine the effect of a short course of denosumab on modulating the immature mammary epithelial cell populations in the tumor. - To determine the effect of a short course of denosumab on estrogen signaling pathways in the tumor. - To determine the effect of a short course of denosumab on various immune - To determine effect of safety profile of denosumab

NCT ID: NCT01863225 Terminated - Clinical trials for Coronary Artery Disease

Characterization of Multi-dose RVX000222 in Combination With Statin Treatment in Dyslipidemia

Start date: May 2013
Phase: Phase 2
Study type: Interventional

This study is designed to characterize the pharmacokinetics of multi-dose RVX000222 and atorvastatin and rosuvastatin when either statin is administered in combination with RVX000222 in subjects with dyslipidemia.

NCT ID: NCT01853982 Terminated - Clinical trials for Ventilator-Associated Pneumonia (VAP)

Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia

Start date: June 14, 2013
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult participants .

NCT ID: NCT01852292 Terminated - Clinical trials for Head and Neck Squamous Cell Carcinoma

Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy

Start date: October 1, 2013
Phase: Phase 2
Study type: Interventional

Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.

NCT ID: NCT01849874 Terminated - Clinical trials for Low-grade Serous Ovarian Cancer

A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer

Start date: June 27, 2013
Phase: Phase 3
Study type: Interventional

The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician's choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study.

NCT ID: NCT01838200 Terminated - Metastatic Melanoma Clinical Trials

Phase I Study of Intralesional Bacillus Calmette-Guerin (BCG) Followed by Ipilimumab in Advanced Metastatic Melanoma

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

This was a Phase 1, open-label, dose-escalation, single-center study in patients with histologically confirmed Stage III or IV melanoma and at least 3 metastatic cutaneous or subcutaneous lesions that were suitable and accessible for intralesional (IL) injection (1 lesion), biopsy (1 lesion), and response evaluation (1 lesion). The primary objective was to determine the safety of IL administration of bacillus Calmette-Guerin (BCG) followed by oral dosing with an antibiotic (isoniazid) and intravenous (IV) infusions of ipilimumab. Secondary objectives were to evaluate the clinical efficacy (induction of tumor response) and immunogenicity (induction of immune response against the tumors) of the combination regimen.

NCT ID: NCT01810016 Terminated - Clinical trials for Unresectable or Metastatic Melanoma

NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma

Start date: January 24, 2014
Phase: Phase 1
Study type: Interventional

This was a Phase 1, open-label, non-randomized study of the combination of NY-ESO-1 plus ipilimumab in patients with unresectable or metastatic melanoma for whom treatment with ipilimumab was indicated. Patients must have had evidence of NY-ESO-1 or LAGE-1 tumor positivity and radiologically measurable disease by the immune-related Response Criteria (irRC). Primary study objectives were to determine the safety and tolerability of the combination and to evaluate humoral and cellular immune response. Secondary objectives were to evaluate tumor response and immunological changes in the tumor microenvironment.