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Prospective Comparison of Breast MRI vs Contrast Mammography Prior to Surgery in Breast Cancer Patients
University of Arizona
Breast Cancer
In current clinical practice, women with biopsy proven breast cancer can be sent for breast
magnetic resonance imaging (MRI) or contrast enhanced mammography (CEM) prior to surgery in
order to delineate the extent of a known cancer and / or assess for the presence of occult... expand
In current clinical practice, women with biopsy proven breast cancer can be sent for breast magnetic resonance imaging (MRI) or contrast enhanced mammography (CEM) prior to surgery in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers. This study seeks to compare the global costs (based on actual reimbursement rates) of CEM/breast MRI, downstream imaging testing, and diagnostic procedures in women randomized to breast MRI versus CEM. Secondary goals are to compare patient preferences for CEM vs MRI and clinically relevant outcomes (e.g. conversion from lumpectormy to mastecomy). Type: Interventional Start Date: Jan 2021 |
TRILUMINATE Pivotal Trial
Abbott Medical Devices
Tricuspid Regurgitation
The primary objective of this trial is to demonstrate the safety and effectiveness of the
TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid
regurgitation (TR), who are at intermediate or greater estimated risk for mortality or
morbidity... expand
The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy). Type: Interventional Start Date: Aug 2019 |
Hemodynamic-GUIDEd Management of Heart Failure
Abbott Medical Devices
Heart Failure
Heart Failure, Systolic
Heart Failure, Diastolic
Heart Failure NYHA Class II
Heart Failure NYHA Class III
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the
CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients
outside of the present indication, but at risk for future HF events or mortality.
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The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality. Type: Interventional Start Date: Mar 2018 |
Virtual Reality for Postoperative Pain After Laparoscopic Hysterectomy
University of Arizona
Pain Management
Patients will be randomized to either receive virtual reality headsets in the post anesthesia
recovery unit (PACU) as an adjunct therapy or undergo routine postoperative management. Pain
scores will be recorded at standardized intervals in the PACU. The patient will be asked to... expand
Patients will be randomized to either receive virtual reality headsets in the post anesthesia recovery unit (PACU) as an adjunct therapy or undergo routine postoperative management. Pain scores will be recorded at standardized intervals in the PACU. The patient will be asked to complete a survey at their two week post op visit assessing their satisfaction with their post op recovery. The purpose of this study is to determine whether a virtual reality relaxation program used in the immediate postoperative period after laparoscopic hysterectomy will decrease pain scores and reduce both oral and intravenous opioid consumption. Type: Interventional Start Date: Sep 2020 |
Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
Banner Health
Arrhythmias, Cardiac
The primary objective of the study is to determine the safety of MRI in patients with non-MRI
conditional pacemakers. The secondary objective is to determine if there are clinically
relevant parameter changes in the devices.
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The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices. Type: Observational Start Date: Sep 2016 |
Immune Modulators for Treating COVID-19
Daniel Benjamin
Covid19
ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the
treatment of moderately or severely ill patients infected with severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with... expand
ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on other research findings. Comparisons of the agents among themselves is not a research objective. The study population corresponds to moderately and severely ill patients infected with the coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already hospitalized for treatment of COVID-19 infection as well as patients being treated for COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital. Patients both in and out of the ICU are included in the study population. Type: Interventional Start Date: Oct 2020 |
Fycompa Titration Intervals and Effects on Retention Rate
University of Arizona
Epilepsy
This study will aim to improve retention and tolerability by slowing the initial titration
rate of perampanel from a standard up-titration rate of 2 week intervals to a slower
up-titration rate consisting of 3 week intervals. Subjects will be randomized to either
perampanel,... expand
This study will aim to improve retention and tolerability by slowing the initial titration rate of perampanel from a standard up-titration rate of 2 week intervals to a slower up-titration rate consisting of 3 week intervals. Subjects will be randomized to either perampanel, standard titration interval rate (Group A) or perampanel, slower titration interval rate (Group B). Type: Interventional Start Date: Apr 2018 |
Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure...
Cardiovascular Research Foundation, New York
Aortic Valve Stenosis
The objective of this study is to determine the safety and efficacy of transcatheter aortic
valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as
compared with OHFT.
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The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT. Type: Interventional Start Date: Sep 2016 |
Electromyography in Labor and Parturition
University of Arizona
Labor
This study will examine how the uterus, abdominal wall, pelvic floor and brain interact
during labor and parturition. It will uses electromyography (EMG) to compare the
characteristics of the uterus, abdominal wall and perineum in subjects with and without
various pregnancy... expand
This study will examine how the uterus, abdominal wall, pelvic floor and brain interact during labor and parturition. It will uses electromyography (EMG) to compare the characteristics of the uterus, abdominal wall and perineum in subjects with and without various pregnancy characteristics. EMG will help established burst frequency and characteristics of the uterus compared to other parts of the body during labor and delivery. Other parts of the body may include abdominal surfaces (for uterine, abdominal, maternal EMG and fetal heart rate monitoring), perineal surface (for perineal muscles monitoring) and the maternal scalp (brain monitoring). EEG measures the electrical activity of the brain. The activity is recorded using wire electrodes attached to the scalp or mounted on a cap placed on the head. E MG measures electrical activity from muscles. It uses wire electrodes placed on the skin over the muscles. Pregnant adult volunteers and patients who present to the investigator's institution may be eligible for this study. Participants will lay or sit in a semi-reclining chair with sticker electrodes placed on the body surface area of interest. Muscle and/or brain activity will be measured with EEG and EMG recordings. Type: Observational [Patient Registry] Start Date: Apr 2019 |
Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19)
University of Arizona
Coronavirus
This multi-center, open-label, 2 arm parallel-group, randomized, interventional prospective
exploratory study in 40 patients aimed to evaluate safety and explore putative clinical
benefits of Silmitasertib 1000 mg BID dose in patients with severe illness caused be
SARS-COV-2.... expand
This multi-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 40 patients aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in patients with severe illness caused be SARS-COV-2. This will be a two-arm trial comparing the SOC/best supportive care alone to the SOC/best supportive care with addition of Silmitasertib (allocation ratio 1:1). Type: Interventional Start Date: Jan 2021 |
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Xenon Pharmaceuticals Inc.
Focal Epilepsy
The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study
that will evaluate the clinical efficacy, safety and tolerability of increasing doses of
XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy,... expand
The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE). Type: Interventional Start Date: Jan 2019 |
SynCardia 70cc TAH-t for Destination Therapy (DT)
SynCardia Systems. LLC
Life-threatening
Biventricular Heart Failure
Ineligible for Cardiac Transplant
The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and
Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent
(about to happen) death from irreversible biventricular heart failure.
The purpose of... expand
The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent (about to happen) death from irreversible biventricular heart failure. The purpose of this research study is to evaluate whether the TAH-t can support patients with life-threatening irreversible biventricular heart failure who are not eligible for transplantation. The TAH-t, when used for patients who are not eligible for transplant, is considered to be an investigational (not approved by FDA) use. This use is called destination therapy (DT). Nineteen (19) patients with life-threatening, biventricular failure who are not eligible for cardiac transplant will be enrolled in the Primary Arm of the study and followed for up to six months post-TAH-t implant. Safety will be evaluated by reviewing the adverse events that are experienced by the enrolled subjects and comparing them to previous experience of TAH-t patients who were waiting for a heart transplant. Since approximately 74% of patients with this condition would not be expected to live beyond six months, the benefit of the TAH-t for DT will be confirmed based on survival to six months without experiencing permanent disabling stroke-related deficits. After the six month follow-up visit, patients will continue to be followed under the study for up to five (5) years postTAH-t implant [every six months for up to two years while supported with the TAH-t implant and then annually for another three years]. Up to an additional 19 patients may be enrolled in the Secondary Arm of the study to further characterize the use of the TAH-t for DT in a broader patient population. Follow-up would be the same for patients enrolled in both arms of the study. Type: Interventional Start Date: Feb 2016 |
Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy
University of Arizona
Hysterectomy
Pneumoperitoneum
With the limited evidence that lower pneumoperitoneum pressures improve postoperative pain in
laparoscopic or robotic hysterectomy for benign indications, we would like to determine if we
can both further validate this idea but also show that it has minimal effect on physician... expand
With the limited evidence that lower pneumoperitoneum pressures improve postoperative pain in laparoscopic or robotic hysterectomy for benign indications, we would like to determine if we can both further validate this idea but also show that it has minimal effect on physician satisfaction performing the surgery. Type: Interventional Start Date: Mar 2020 |
Peri-device Leakage Closure After LAAO
Cardiovascular Center Frankfurt
Atrial Fibrillation
Stroke
Bleeding
Leakage of Cardiac Device
The investigators thought to evaluate the safety and feasibility of peri-device leakage
closure after left atrial appendage occlusion (LAAO, either surgical or interventional) with
different devices.
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The investigators thought to evaluate the safety and feasibility of peri-device leakage closure after left atrial appendage occlusion (LAAO, either surgical or interventional) with different devices. Type: Observational Start Date: Sep 2020 |