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NCT ID: NCT02818946 Terminated - Breast Neoplasms Clinical Trials

Diagnostic Utility of MRI in Female Patients With Nipple Discharge: A Prospective Trial

Start date: July 2016
Phase: N/A
Study type: Interventional

The purpose of the proposed prospective study is to determine the diagnostic value of MRI for the evaluation of patients with pathologic nipple discharge. Breast surgeons will identify clinic patients with pathologic nipple discharge (unilateral and bloody or unilateral and clear) and refer them for breast MRI. When the clinical team notifies the study team that an MRI has been ordered for that purpose, the study team will consent patients to document the results and follow-up. The study team will not be obtaining MRI's on patients for research purposes only. The following data will be collected and analyzed: patient age, characteristics of the discharge (laterality, spontaneous versus expressed, duration of time, color, presence of blood), imaging workup and findings, BI-RADS final assessment categories, pathology results from core biopsy and/or surgical excision, and clinical and radiologic follow-up data during the two years after presentation. Participation in this study poses minimal risk to patients. Risks to the subjects include loss of confidentiality and unnecessary breast biopsy. The risks associated with MRI are minimal; however, since a gadolinium-based contrast agent will be administered for the MRI, patients with compromised renal function and patients who are pregnant will be excluded from the study.

NCT ID: NCT02818894 Terminated - Clinical trials for Total Hip Arthroplasty

Spinal Anesthesia in Total Hip Arthroplasty

Start date: September 27, 2016
Phase: Phase 4
Study type: Interventional

Spinal anesthesia is commonly used in patients undergoing total hip replacements. The purpose of this study is to compare lidocaine to bupivacaine spinal anesthesia in patients having a total hip arthroplasty (THA). The objective of this study is to compare the two spinal anesthesia treatments in regards to transient neurological symptoms (TNS).

NCT ID: NCT02818764 Terminated - Delirium Clinical Trials

Delirium, Intraoperative Cerebral Perfusion and EEG Abnormalities After Total Hip Arthroplasty

Start date: June 2016
Phase:
Study type: Observational

The overall objective of this study is to test for perturbations in intraoperative electroencephalogram (EEG) , cerebral blood flow (CBF), cerebral metabolic rate of oxygen consumption (CMRO2), oxygen extraction fraction (OEF), and serum and cerebral spinal fluid biomarkers associated with delirium in high risk population having elective hip arthroplasty at Penn Presbyterian Medical Center (PPMC).

NCT ID: NCT02818283 Terminated - Clinical trials for Hypercholesterolemia

Soy Modulation of Immune Activation, LDL- Levels, and Lowering Inflammation by Pretzel Isoflavone Dietary Intervention

SMALLLIPIDS
Start date: June 2016
Phase: N/A
Study type: Interventional

Combination antiretroviral therapy (ART, HIV medications) dramatically increases the expected lifespan of HIV (Human Immunodeficiency Virus)infected patients; yet, the risks for cardiovascular disease (CVD), such as heart attacks and stroke, are increased in this population. This increased risk may be linked to persistent inflammation and activation of the immune system. Although the relationship between cardiovascular disease and HIV-infected individuals who are taking HIV medications is not well understood, the team of researchers involved in this study observed that a diet rich in soy, at levels recommended by the FDA (Federal Drug Administration), improved cholesterol levels and inflammation in individuals not infected with HIV. From this study, the researchers hope to gain understanding on how dietary soy will impact HIV-infected individuals who are taking HIV medications. Two pretzels with and without soy developed at OSU (Ohio State University) in the Department of Food Science and Technology and used in previous clinical trials will be used to investigate how the pretzel snacks will affect your cardiovascular disease risk, immunity, and how your body breaks down naturally occurring chemicals from soy.

NCT ID: NCT02818023 Terminated - Melanoma Clinical Trials

Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma

Start date: July 13, 2016
Phase: Phase 1
Study type: Interventional

The study plans to treat patients with pembrolizumab and thus blocking the PD-1/PD-L1 axis would render tumor-infiltrating lymphocytes (TILs) in the tumor parenchyma more functional as a consequence of BRAF inhibition, such that T cell activation by BRAFi would not be dampened by the PD-1/PD-L1 interaction. This combination would reverse dysfunction among T cells in the tumor parenchyma, maximizing T cell mediated immune anti-tumor efficacy. Progression free survival (PFS) with pembrolizumab in KEYNOTE-001 was 57% at 6 months, and 46.4% in the more recently reported phase III trial. PFS with vemurafenib treatment in BRIM-3 was ~50% at 6 months. Combined treatment with pembrolizumab, cobimetinib and vemurafenib for BRAF mutant melanoma is hypothesized to be safe and to improve the PFS compared to these recent historical controls. Because this combination has not yet been tested, and because the primary objective is to assess safety, the investigators are staging accrual in the first phase of the trial. The study aims to accrue up to 30 patients to the mTPI design of this study with the expectation that there will be at least 30 patients treated at RP2D. In case there are less than 30 patients on the RP2D, additional patients will be accrued. Patients will continue to receive treatment with pembrolizumab, vemurafenib and cobimetinib until disease progression or dose limiting toxicity. Patients with treatment response and no dose limiting toxicity may receive treatment with pembrolizumab for up to 24 months.

NCT ID: NCT02817906 Terminated - Clinical trials for Agitation in Dementia, Including Alzheimer's Disease

ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease

Start date: August 29, 2016
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including Alzheimer's disease.

NCT ID: NCT02817516 Terminated - Healthy Volunteers Clinical Trials

A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of TAK-828 Escalating Multiple-Doses in Healthy Participants

Start date: June 30, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of multiple oral doses of TAK-828 in healthy participants.

NCT ID: NCT02817412 Terminated - Binge Eating Clinical Trials

Food Response Training for Binge Eating

Start date: June 2016
Phase: N/A
Study type: Interventional

This study will examine the effectiveness of food response training interventions in reducing binge eating among adults engaged in binge eating.

NCT ID: NCT02816255 Terminated - Clinical trials for Obstructive Sleep Apnea (OSA)

The Efficacy of a New Mathematical Formula to Predict Continuous Positive Air Pressure With an Oronasal Mask Interface.

Start date: January 2017
Phase: N/A
Study type: Interventional

Subjects will all have a two week baseline period in which they will use a nasal mask using an air view CPAP machine (which records all data). After the two week period all will switch to a full face mask with half using the same CPAP pressure and half with a new a CPAP pressure derived from our formula for the final two weeks.

NCT ID: NCT02815540 Terminated - Dravet Syndrome Clinical Trials

The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy

CBD1
Start date: February 16, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The investigators propose to study the effects of cannabidiol (CBD) on cardiac electrical function and the autonomic nervous system in children with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), when the CBD is administered as an artisanal oil obtained through state dispensaries or other sources. The intent is to begin to assess potential risks and benefits of this therapy in a vulnerable patient population by characterizing the effects of CBD on EKG findings, heart rate variability and the occurrence of seizures.