9 matching studies

Sponsor Condition of Interest
Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19 (CYNK-001-COVID-19)
Celularity Incorporated Coronavirus Coronavirus Infection Severe Acute Respiratory Syndrome Coronavirus 2 Pneumonia Pneumonia, Viral
This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease. expand

This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.

Type: Interventional

Start Date: May 2020

open study

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, followed... 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

open study

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 this... 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

open study

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. expand

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

open study

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

open study

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. expand

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

open study

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

open study

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 characteristics.... 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

open study

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. expand

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

open study