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Single Fraction Stereotactic Radiosurgery Compared With Fractionated Stereotactic Radiosurgery in Treating...
Alliance for Clinical Trials in Oncology
Metastatic Malignant Neoplasm in the Brain
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... expand
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 |
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Edwards Lifesciences
Degenerative Mitral Valve Disease
Mitral Regurgitation
Mitral Insufficiency
Functional Mitral Regurgitation
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... expand
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 |
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
ECOG-ACRIN Cancer Research Group
Breast Screening
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... expand
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 |
Heart Transplantation Utilizing NRP DCD
University of Arizona
Heart Transplantation
Perfusion
Transplant Recipients
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... expand
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 |
Impact of Steroid, Diuretic, and Fluid Use on BPD Outcomes
Mednax Center for Research, Education, Quality and Safety
BPD - Bronchopulmonary Dysplasia
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).
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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 |
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 |
Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness...
KCI USA, Inc.
Wounds and Injuries
Wound Healing
Granulation Tissue
Evaluation of wound bed surface area containing clean, healthy viable tissue in
full-thickness wounds.
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Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds. Type: Interventional Start Date: Dec 2018 |
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 |
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
Boston Scientific Corporation
Aortic Stenosis
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.
expand
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 |
A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary...
Bellerophon Pulse Technologies
Pulmonary Fibrosis
Pulmonary Hypertension
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... expand
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 |
Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or...
National Cancer Institute (NCI)
Lung Adenocarcinoma
Lung Large Cell Carcinoma
Resectable Lung Non-Small Cell Carcinoma
Stage IB Lung Non-Small Cell Carcinoma AJCC v7
Stage IB Lung Squamous Cell Carcinoma AJCC v7
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... expand
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 |
Ureteral Jets and Patient Positioning Study
University of Arizona
Ureteral Injury
Surgery--Complications
The objective of the study is to identify the relationship between patient position during
surgery and time to confirmation of ureteral patency on cystoscopy.
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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 |
Pain Management Study
University of Arizona
Pain, Postoperative
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... expand
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 |
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 the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants...
Hoffmann-La Roche
Idiopathic Pulmonary Fibrosis
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).
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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 |
ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement
Northwestern University
Cirrhosis, Liver
Transjugular Intrahepatic Portosystemic Shunt (TIPS)
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... expand
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 |
A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions...
Target PharmaSolutions, Inc.
Nonalcoholic Fatty Liver
Nonalcoholic Steatohepatitis
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... expand
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 |
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 |
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 |