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Current Clinical Trials

Clinicians at Eisenhower Medical Center continue to take part in groundbreaking research, including: interventional cardiology, orthopedics, novel biotherapies in oncology, targeted therapies base on molecular profile of cancer, early detection of cancer via specialized imaging, drugs aimed at improving survival of HIV patients, and use of integrative therapies to reduce side effects related to cancer treatment..

ApprovedPrincipal InvestigatorDescriptionStatus

Cancer

06/27/08Popescu, IlianaA Double Blind Phase III Trial of Doxorubicin and Cyclophosphomide followed by Pacilitaxel with Bevacizumab or PlaceboOpen
 A Double Blind Phase III Trial of Doxorubicin and Cyclophosphomide followed by Pacilitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer 
06/24/11Tsai, HenryA Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-risk Melanoma Open
02/25/11Dreisbach, LukeA Randomized Phase III Trial of Adjuvant Therapy comparing Chemotherapy Alaone (Six Cycles of TC and Four Cycles of AC Followed by four Cycles of Weekly Paclitaxel to Chemotherapy Plus Trastuzumab in Women with node-Positive or high-risk Node Negative HEROpen
09/05/08Gupta, VarunE5202: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovrin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively Prognostic Value of Molecular Open
01/25/08Vafai, DavoodFlight Attendants medical Research Institute (FAMRI) International Early Lung Cancer Action Program (IELCAP)Open
01/25/08Dreisbach, LukeIBCSG-24-02 A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer (SOFT)Open
03/28/03Vafai, DavoodInternational Early Lung Cancer Program (I-ELCAP) EisenhowerOpen
03/28/03Vafai, DavoodInternational Early Lung Cancer Program (I-ELCAP) EisenhowerOpen
02/24/06Vafai, DavoodMolecular Epidemiology Case-Series of Non-Small Cell Lung Cancer in Smoking & Non-Smoking Women & MenOpen
06/27/08Popescu, IlianaNSABP B-42 A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxoifen Followed by an AI in Prolonging Disease-FreeOpen
01/27/06Popescu, IlianaNSABP-B-38 Phase III Randomized Study of three Different Adjuvant Chemotherapy Regimens Comprising Docetaxel, Doxorubicin, and Cyclophosphamide Versus Dose-Dense Doxorubicin, Cyclophosphamide, and Paclitaxel Versus Dose-Dense Doxorubicin, CyclophosphamideOpen
10/28/11Dreisbach, LukeNSABP-P-5: Phase III Randomized Study of Adjuvant Rosuvastatin in Patients with Resected Stage I or II Colon Cancer.Open
06/23/16Dreisbach, LukePhase II placebo-controlled trial of lisinopril and Coreg CROpen
 Phase II placebo-controlled trial of lisinopril and Coreg CR to reduce cardiotoxicity in patients with breast cancer receiving (neo)adjuvant chemotherapy with trastuzumab (Herceptin) The primary objective of this study is to determine if administration of lisinopril or Coreg CR(r), compared to placebo, will reduce the incidence of trastuzumab-induced cardiotoxicity, as measured by LVEF, in patients receiving adjuvant, or neoadjuvant, therapy for HER2 positive breast cancer. 
11/12/04Vafai, DavoodPhase III Chemoprevention Trial Selenium Supplementation in Persons with Resected Stage 1 Non-Small Cell Lung Cancer Open
01/09/15Dasanu, ConstantinProspective Observational Study of Patients with Polycythemia Vera in US clinical Practices (REVEAL)Open
06/12/15TBDRandomized Control Trial Evaluating the Effects of Inhaled Aromatherapy on Nausea and Vomiting in Patients with Cancer Receiving Treatment in an Outpatient Cancer CenterOpen
06/12/15Dreisbach, LukeS0820 A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and second Primary Colorectal Cancers in Patients with Stage 0-lll Colon Cancer, Phase lll-Preventing Adenomas of the Colon with EflorniOpen
11/18/11Tsai, HenryS0931 EVEREST: EVErolimus for Renal Cancer Ensuring Surgical Therapy, A Phase III StudyOpen
06/12/15Vafai, DavoodS1403 A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naïve Patients with Advanced, EGFR Mutation Positive Non-small Cell Lung Cancer (NSCLC)Open
07/11/14Law, AmySWOG S1207 – Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/NEU Negative Breast Cancer, E³ Breast Cancer StOpen
11/14/14Dreisbach, LukeSWOG S1320, “A Randomized, Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma”Open
09/12/14Dasanu, ConstantinSWOG S1400 – Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer –Version Date 5/20/14Open
01/13/17Tsai, HenryUCSD PREDICT - Profile Related Evidence Determining Individualized Cancer Therapy aka Study of Personalized Cancer Therapy to Determine Response and Toxicity Open
 The purpose of this study is to learn more about personalized cancer therapy including response to treatment and side effects. Information about the tests and treatments a person received, or will receive, for their cancer will be collected from medical records to help the researchers determine whether or not patients respond better when their physicians choose to treat them according to the genetic makeup of their tumor. Optional research tests may be performed on tissue, body cavity fluid, blood or urine provided, discarded biological samples taken during routine care that would normally be disposed of and not saved, or on blood samples collected for this study. These research tests will be used to create a "profile" of the collected specimens which will describe unique characteristics about the genes involved in a person's cancer. The tests will also help researchers look for biomarkers that may help predict how people respond to treatment. 

Cardiac

10/14/16Feldman, LeonA Clinical Evaluation of the Diagnostic Utility of MRI Scans in Patients Implanted with St. Jude Medical Pacemakers, Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy DevicesOpen
 Study of subjects implanted with a SJM pacemaker, ICD or CRT device who are clinically indicated for a non-thoracic MRI scan. 
05/25/12Rubin, AndrewAccent MRI™ Pacemaker and Tendril MRI™ Lead IDE StudyOpen
 IDE study to evaluate safety and efficacy of implanted Accent MRI system (Tendril MRI lead and Accent MRI DR pacemaker in & out of the MRI environment. 
08/14/15Feldman, LeonCardioMEMS™ HF System Post Approval StudyOpen
 Purpose of the CardioMEMs HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMs HF System in patients with NYHA class III heart failure in a commercial setting. 
05/15/09Feldman, LeonCELESTIAL - Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, BipolarOpen
 Observational study to confirm the long-term safety and reliability of the Corox OTW BP left ventricular pacing lead. Per FDA. 
10/26/12Rubin, AndrewINGEVITY Active Fixation and Passive/Fixation Pace/Sense Lead Clinical StudyOpen
 Gather data to establish the safety, performance and effectiveness of the INGEVITY pace/sense leads. 
10/06/11Rubin, AndrewMedtronic Product Surveillance RegistryOpen
 Observational study collecting data on safety and effectiveness of market released products 
12/13/13Patel, PhilipOutcomes Registry for Better Informed Treatment of Atrial Fibrillation II. Open
 Registry to evaluate the utilization of target-specific antithrombotic agents, such as FXa 9factor Xa) inhibitors and direct thrombin inhibitors and associated outcomes.Post-approval observational data collected for evaluating the outcomes associated with these new agents. 
10/09/15Feldman, LeonQP-ExCELS – Sentus QP-Extended CRT Evaluation with Quadripolar Left Ventricular LeadsOpen
 To confirm safety & efficacy of the BIOTRONIK Sentus OTW QP left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in the US. Long-term safety of the lead will be confirmed during a post approval phase. 
03/13/15Rubin, AndrewWRAP-IT: World-wide Randomized Antibiotic Envelope Infection Prevention TrialOpen
 Medtronic sponsored study to evaluate the ability of the TYRX envelope to reduce major infections thru 12 month post cardiac device implant.. 

Emergency Medicine

11/14/14Kontaxis, EuthymExtremity Exsanguination Device™ for Systolic Blood Pressure < 80 mmHg Open

HIV

04/08/16Lichtenstein, KennethA Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) or ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects who are VirologicaOpen
 This study will evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of GS-9883/emtricitabine/tenofovir alafenamide (GS-9883/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed HIV-1 infected adults.  
01/13/17Lichtenstein, KennethAntiretroviral Therapy as Long Acting Suppression (ATLAS)-Evaluating the Efficacy, Safety, & Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1+ AdultsOpen
 The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult participants who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible participants will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, participants who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those participants would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56. 
11/13/15Lichtenstein, KennethREPRIEVE (A5332) Final Version 2.0 dated 12/19/14Open

Infectious Disease

10/14/16Dezfuli, MassoudTelavancin Observational Use Registry (TOUR)Open
 This is a retrospective medical chart review, multicenter, observational study to examine telavancin efficacy and safety in a real-word setting and to characterize the pattern of use of telavancin in hospital-based inpatients and in outpatient infusion centers. All treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol.  

Neurology

06/10/16Young, SeymourImaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study: A Coverage with Evidence Development Longitudinal Cohort StudyOpen
 The Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study will establish an open-label, longitudinal cohort study to assess the impact of amyloid PET on patient outcomes. The study will be performed in accordance with the Center for Medicare & Medicaid Services (CMS) policy of Coverage with Evidence Development (CED) in Medicare beneficiaries who meet the Appropriate Use Criteria (AUC) for amyloid PET (Johnson et al. 2013). Our hypothesis is that amyloid PET will decrease uncertainty and increase confidence in the underlying cause of cognitive impairment, that this will translate into earlier counseling and interventions in these domains, and that these interventions will lead to improved outcomes 
01/31/03Herman, BrianNEUROFORM® Microdelivery Stent: HUDOpen
08/08/14TBDPilot Study of the Effects of Smartphone Technology on Interprofessional Patient Care CommunicationOpen
12/17/10Labib, BishoyPOINT (Platelet-Oriented Inhibition in New TIA or Minor Stroke)Open
05/08/15TBDThe Impact of Smartphone Technology for Interprofessional Patient Care Communication in the Emergency Department and the Critical Care UnitsOpen
06/12/15Labib, BishoyUsability Study for Electronic Wrist Splint for Treatment of Carpal Tunnel DiseaseOpen

Nursing

10/14/16TBDCancer patients' expectations and recommendations concerning suspension of the do-not-resuscitate (DNR) order during the perioperative period if patients were to have surgeryOpen
 The purpose of this non-experimental qualitative study is to explore the meaning of the Do-Not-Resuscitate (DNR) order to patients with cancer and their expectations and recommendations for the timing of discussion about changes in their DNR status during the perioperative period surrounding a required surgery. The study has two research questions, 1) What does the DRN order mean to hospitalized patients with cancer 2) What are the patients' expectations and recommendations concerning discussion of changes in their DNR status for the perioperative period of a surgical procedure. 

Orthopedic

01/08/16Tahernia, AmirA Prospective, Multicenter Study of Instrumented Posterolatral Lumbar Fusion (PLF) with OsteoAMP to Evaluate Long-Term safety and Efficacy in Patients Requiring 1-2 Level Instrumented PLFOpen
11/19/10St. Pierre, PatrickA Randomized, Prospective, Comparative Study of Acupuncture and Post-Operative Pain Management with Shoulder ArthroplastyOpen
05/30/03O'Connell, StephenAscension® PIP (Proximal Interphalangeal) Finger Joint;HUDOpen
11/23/15TBDCorrelation Between Anterior Cruciate Ligament Reconstruction Surgery and Early Onset Total Knee ReplacementOpen
01/13/17St. Pierre, PatrickPost-Approval Observational Data Collection Study on the Conventus Cage(TM) PH for use in Proximal Humerus Fracture Fixation Open
 The purpose of this study is to collect device and procedure experience in everyday clinical practice. 
01/13/17Tahernia, AmirPost-Market 10 year follow up of Mobi-C Cervical Disc for one and two level treatment of cervical disc diseaseOpen
 The purpose of this study is to obtain long term (10 year) clinical and patients outcomes data on patients who participated in the Mobi-C IDE clinical trial and were implanted with Mobi-C.  
04/10/15St. Pierre, PatrickRetrospective Review of Functional Results of Reverse Total Shoulder ArthroplastyOpen
01/25/08Tahernia, AmirThe Investigational Plan for the Evaluation of the ACADIA Facet Replacement System (Pivotal IDE Trial)Open
12/14/14Scherger, JosephUse of Foot Muscle Strengthening to Treat Plantar FasciitisOpen

Other

09/09/16TBDCaring for the Caregivers: A Lifestyle Intervention for Those Caring for Patients with DementiaOpen
 Compared to caregivers of people without dementia, caregivers of people with dementia are twice likely experiencing financial, emotional and physical difficulties. The study will do a 3 month multimodal intervention, designed specifically for family caregivers of dementia patients at the Eisenhower Memory Care Center. The aim is to help them establish good coping techniques for their emotional well-being and establish healthy lifestyles for their physical health overall. The intervention program will focus on 1)breathing techniques; 2)meditation; 3)physical activity; 4)sleep; 5)diet and nutrition. This intervention program may provide a new approach to improve community health. 
06/30/06Herman, BrianThe WINGSPAN™ Stent System and Gateway PTA Baloon Catheter HUDOpen