University of Arizona College of Medicine - Phoenix

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Type: Interventional

Start Date: Nov 2018

open study

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

Type: Interventional

Start Date: Dec 2014

open study

This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.

Type: Interventional

Start Date: Oct 2019

open study

This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

Type: Interventional

Start Date: Jul 2017

open study

This is a prospective, observational, pilot trial to evaluate the feasibility of heart transplantation using normothermic regional perfusion (NRP) donation after donor circulatory death (DCD). Adults who meet standard criteria for heart transplantation listing and study-specific eligibility criteria will enroll in the study. the investigators anticipate evaluating an initial cohort of approximately 100 DCD donors for a final yield of 40 hearts. The investigators will accept donors between the ages of 18 and 65 who are determined to have heart function/quality appropriate for donation for transplantation based on available donor data and testing. If feasible, donors might be relocated to BUMCP to maintain uniformity of process, minimize cold ischemic time, and allow for more rapid and improved communication during the initial pilot phase. Recipients will be selected based on blood group, crossmatch, size match, and clinical stability per standard allocation practices. Recipients will be followed post-transplantation per BUMCP Heart Transplant standard protocol.

Type: Observational [Patient Registry]

Start Date: Feb 2022

open study

Assess the impact of steroid, diuretic, and fluid practices on BPD outcomes in extreme premature infants in the Banner - University Medical Center Phoenix (BUMCP) neonatal intensive care unit (NICU).

Type: Observational

Start Date: Sep 2021

open study

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

open study

Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.

Type: Interventional

Start Date: Dec 2018

open study

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

open study

To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.

Type: Interventional

Start Date: Jun 2019

open study

A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD

Type: Interventional

Start Date: Dec 2020

open study

TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual clinical practice. TARGET-HCC will create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.

Type: Observational [Patient Registry]

Start Date: Dec 2016

open study

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Type: Interventional

Start Date: Aug 2014

open study

The objective of the study is to identify the relationship between patient position during surgery and time to confirmation of ureteral patency on cystoscopy.

Type: Interventional

Start Date: Feb 2021

open study

This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).

Type: Interventional

Start Date: Mar 2021

open study

This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

Type: Interventional

Start Date: Aug 2014

open study

This study aims to better understand the role that narcotic vs. non-narcotic multimodal pain management play in patients' pain following bariatric surgery (Laproscopic Surgery and Robotic Assisted Surgery). Participation in this study will last approximately 90 days following surgery. During that 90 day period, participants will be asked to report pain and nausea every 4 hours to a study coordinator or nurse while they are recovering in the hospital. Following discharge from the hospital patients will be asked to report pain, nausea, and any medical changes 7 days, 30 days, and 90 days from surgical date. The procedures and medications used in this study are FDA approved medical therapies and are part of Standard of Care for this population. This study aims to therapeutically investigate efficacy of the proposed pain management regimens. The procedures and individual medications are not the subject of research as they are considered routine well established and documented interventions for obesity and the treatment of post operative pain.

Type: Interventional

Start Date: Feb 2022

open study

ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions.

Type: Observational [Patient Registry]

Start Date: Jun 2019

open study

The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.

Type: Interventional

Start Date: Jul 2020

open study

Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.

Type: Interventional

Start Date: Jul 2021

open study

TARGET-NASH is a longitudinal observational cohort study of patients being managed for NASH and related conditions across the entire spectrum NAFLD in usual clinical practice. TARGET-NASH is a research registry of patients with NAFL or NASH within academic and community real-world practices maintained in order to assess the safety and effectiveness of current and future therapies.

Type: Observational [Patient Registry]

Start Date: Jul 2016

open study

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

open study