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Current Clinical Research Trials

Cardiovascular Trials

Management of Antiplatelet Regimen During Surgical Procedures (MARS REGISTRY)

https://clinicaltrials.gov/ct2/show/NCT03981835?term=MARS&draw=2&rank

Sponsor: University of Texas Southwestern Medical Center, Dallas, Texas.

Grant support by: Chiesi Inc.

Principal Investigator: Jeffery Pelton, MD

The purpose of this registry is to evaluate DAPT management for patients that had PCI within the past 2 years and are undergoing surgery and the outcomes of their procedures. Data will be collected between 2 weeks prior and up to 37 days post-surgery.

READY 1: A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the Use of CUSA-081 For Dysfunctional Central Venous Access Devices (CVAD’s)

https://clinicaltrials.gov/ct2/show/NCT03594175?term=READY+1&draw=2&rank=1

Sponsor: Chiesi Farmaceutici S.p.A

Principal Investigator: Gustavo Elias, MD

Sub Investigator: Sam Hijaz, MD

The purpose of this study is to demonstrate that CUSA-081 compared to placebo (normal saline) is better at restoring function to dysfunctional central venous access devices (CVADs) that have been blocked, compare CUSA-081 to alteplase (the current standard of care for occluded CVAD's), to study how often the CVADs gets blocked within 30 days and safety of the study drug.

Cancer Trials

Mtg-022 Translational Medicine: Discovery and Evaluation of Biomarkers/Pharmacogenomics for the Diagnosis and Personalized Management of Patients. Under the Mtg-022 Master Protocol Are the Following Sop Studies: Mt1410-A, mt9920, mt1822-a and Mt1822-B.

Sponsor: The MT Group

Principal Investigator: Jeffery Pelton, MD

MT1410-A-Cancer Cohort: This study is designed to evaluate molecular characteristics in the blood samples of patients with Bladder, Brain, Colorectal, Esophageal, Gastric, Kidney, Liver, Ovarian, Pancreas, and Prostate Cancer. These samples will be used immediately or stored in a “Biobank”. Researchers will use these samples to try to develop new drugs or treatments or tests, as well as to study how individual differences may affect how drugs work.

MT9920 SOP: This study is designed to evaluate biomarkers in samples of patients with cancer. In many cases, the investigation is to identify novel markers to create new anti-cancer therapies and companion diagnostics. The biomarkers could be present in plasma, serum, or the tumor tissue itself. In addition, some tumors will be used in a culture environment to determine the efficacy of novel anti-cancer drugs and some tissues will be mined to isolate, purify, and culture tumor infiltrating lymphocytes, to evaluate immune reactivity in patients.

MT1822-A Lung Cancer: This study is designed to collect blood samples from patients that are diagnosed with lung cancer. Researchers will use the blood samples to try to develop new drugs, treatments or tests, and study how individual differences may affect how drugs work.

Principal Investigator: J. Timothy Sherwood, MD

Click here for more information on the Lung Cancer study.

MT 1822-B LDCT: This study is designed to evaluate biomarker/molecular characteristics in plasma and buffy coat collected from patients scheduled to undergo a low dose CT scan (LDCT) procedure.

Principal Investigator: J. Timothy Sherwood, MD

Click here for more information on the Low Dose CT scan study.

Integrated Care Repository for Cancer Research (iCaRe2)

Sponsor: University of Nebraska Medical Center

Principal Investigator for Breast Registry: Darlene K. Blanchard, MD

Principal Investigator for Thoracic Registry: J. Timothy Sherwood, MD

Purpose of this registry: The data registry, Integrated Care Repository for Cancer Research (iCaRe2), will provide core support services for multi-disciplinary research for cancer. It is the hope that future research using information from this registry will lead to improved diagnosis, prevention, and treatment of cancer.

Click here for more information on the Breast Registry.

Click here for more information on the Thoracic Registry.

Infectious Disease Trials

Observational Cohort Study of Cabenuva Utilization, Outcomes and Patient Experience in the United States (Beyond)

Sponsor: ViiV Healthcare

Principal Investigator: Norman Bernstein, MD

The BEYOND study is a prospective, observational, multisite cohort study of adult participants initiating treatment with Cabenuva (cabotegravir long-acting plus rilpivirine long-acting) in the US. The purpose of the BEYOND study is to better understand reasons why participants and clinicians have chosen to initiate Cabenuva, participants' reasons for switching to Cabenuva, their experience and satisfaction with Cabenuva, their medical history, and their quality of life.

Physician Initiated Studies

Meldb_ Development of a Prospective Database for Surgically Resectable Melanoma Patients With Gene Expression Profile Testing.

Principal Investigator: Jeffrey Pelton, MD

This study will develop a prospective digital database regarding information on all patients with Stage I-III cutaneous melanoma (henceforth referred to as “Melanoma Database”). The database will include clinical details, pathology details, and Gene Expression Profile (GEP) results. The information in the database would be collected prospectively and would be used in future retrospective studies in correlating GEP results, and other clinical and pathologic details, with patient overall survival, recurrence rates and recurrence-free survival. Retrospective review of the database could also be used to examine what types of treatments patients received and patient outcomes after those treatments, especially correlated to GEP results.

Retrospective Investigation of Sinonasal Disease and Clinical Outcomes in Patients Diagnosed With COVID-19.

Principal Investigator: Nariman Dash, MD

This retrospective study is being conducted to further understand the impact of COVID-19 on the paranasal sinuses and determine if nasal symptoms including olfactory changes can be linked to early diagnosis and patient outcomes.

The Impact of Postmortem CT on the Injury Severity Score (ISS) For Deceased Trauma Patients.

Principal Investigator: Jakob Schutz, MD

This is a retrospective physician-initiated study that utilized the trauma registry database of all trauma patients who arrived at MWH deceased or death occurred within the first 24 hours of their hospital stay and received a postmortem CT. The study evaluates what extent of the Injury Severity Score (ISS) is altered in a deceased trauma patient after a postmortem CT, which thereby provides a more accurate retrospective assessment of their likelihood of survival. The study’s hypothesis is a postmortem CT will result in a significant increase the patients' ISS.

Previous Clinical Trials

XIENCE 28 USA - ABT-CIP

https://clinicaltrials.gov/ct2/show/NCT03815175?term=xience+28&cntry=US&draw=2&rank=1

Sponsor: Abbott

Principal Investigator: Harish Chandra, MD

Sub Investigator's Thomas Martyak, MD, Prithvi Rai, MD

Xience 90: A Safety Evaluation of 3-Month Dapt After Xience Implantation for High Bleeding Risk (Hbr) Patients.

https://www.clinicaltrials.gov/ct2/show/NCT03218787?term=xience+90&rank=1

Sponsor: Abbott

Principal Investigator: Harish Chandra, MD

Sub Investigator's: Thomas Martyak, MD, Zeshan Rana, MD

OPTISURE: Optisure Lead Study

https://www.clinicaltrials.gov/ct2/show/record/NCT02235545?term=optisure&rank=1

Sponsor: Abbott

Principal Investigator: Ashok Talreja, MD

Sub Investigator: Henry Clemo, MD

Oncocyte Lung: A Study to Evaluate a Panel of Blood Biomarkers for use in Patients undergoing Evaluation for Lung Cancer, ONC-LN-04

http://www.oncocyte.com/

Sponsor: OncoCyte Corporation
Principal Investigator: J. Timothy Sherwood, MD

BMS-001: A Multicenter Registry Study of Breast Microseed Treatment for Early-Stage Breast Cancer; Breast Microseed Registry

http://www.breastmicroseed.com/

https://www.clinicaltrials.gov/ct2/show/NCT02701244?term=concure&rank=1

Sponsor: Breast Microseed, Inc.

Principal Investigator: John Chinault, MD

Emperial Trial 1245-0167: A Phase III Randomised, Double-Blind Trial to Evaluate the Effect of 12 Weeks Treatment of Once Daily Empagliflozin 10 MG Compared With Placebo on Exercise Ability and Heart Failure Symptoms, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (Hfref) (Emperial-Reduced)

https://www.clinicaltrials.gov/ct2/show/NCT03448419?term=Emperial+trial&rank=1

Emperial Trial 1245-0168: A Phase III Randomised, Double-Blind Trial to Evaluate the Effect of 12 Weeks Treatment of Once Daily Empagliflozin 10 MG Compared With Placebo on Exercise Ability and Heart Failure Symptoms, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (Hfref) (Emperial-Reduced)

https://www.clinicaltrials.gov/ct2/show/NCT03448406?term=Emperial+trial&rank=2

Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc.,

Principal Investigator: Anita Banerjee, MD
Sub Investigator: Anh Vu, MD

GLORIA - AF: Global Registry on Long-Term Oral Anti-Thrombotic TReatment In PAtients with Atrial Fibrillation (Phase II/III)

https://clinicaltrials.gov/ct2/show/NCT01468701?term=GLORIA&recrs=e&draw=2&rank=3

Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc.,

Principal Investigator: Robert Vranian, MD

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