Clinical Trials Currently Open At Genesis Health System

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1 A Multicenter, Randonmized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SUN13837 Injection in Adult Subjects with Acute Spinal Cord Injury. A21102 Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias Abbott CANOPY Adaptation of the Environment: Use of the LUCAS2 device in Cardiopulmonary Resuscitation Automated TPHA screen assay (Treponema pallidum hemagglutination) C30801: A RANDOMIZED PHASE III DOUBLE BLIND TRIAL EVALUATING SELECTIVE COX-2 INHIBITION IN COX-2 EXPRESSING ADVANCED NON-SMALL CELL LUNG CANCER CALGB An Intergroup Phase II Clinical Trial For Adolescents And Young Adults With Untreated Acute Lymphocytic Leukemia. CALGB Molecular Markers of Chronic Lymphocytic Leukemia. CALGB A Randomized Phase III Double Blind Trial Evaluating Selective Cox-2 Inhibition In Cox-2 Expresssing Advanced Non-Small Cell Lung. CALGB Phase III randomized study of sorafenib (IND 69896, NSC ) plus doxorubicin versus sorafenib in patients with advanced hepatocellular carcinoma (HCC). CALGB 8461 Cytogenetic Studies in Acute Leukemia. CALGB Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate. CALGB A RANDOMIZED DOUBLE-BLINDED PHASE III STUDY COMPARING GEMCITABINE, CISPLATIN, AND BEVACIZUMAB (IND #7921, NSC #704865) TO GEMCITABINE, CISLPATIN, AND PLACEBO IN PATIENTS WITH ADVANCED TRANSITIONAL CELL CARCINOMA. CALGB 90802: Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus Everolimus Plus Bevacizumab For Advanced Renal Cell Carcinoma Progressing After Treatment With Tyrosine Kinase Inhibitors CALGB 9665 The CALGB Leukemia Tissue Bank. CALGB/SWOG 80702: A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOS plus Celecoxib or Placebo for Patients with Resected Stage III Colon

2 CALGB/SWOG 80702: A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Collaborative Care for Older Patients with Back Pain (COCOA) Clinical Trial: Provider Exit Interviews CTSU C90203: Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate CTSU E1505: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) -IIIA Non-Small Cell Lung (NSCLC) CTSU E3A06: Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma CTSU E5508: Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC Dissertation: Impaired Patient Awareness of Dysphagia Donor screening for infection with GBV-C: sample sourcing at MVRBC and donor enrollment in future studies at University of Iowa. E1305 A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab In Patients with Recurrent Or Metastatic Head and Neck. E1411 Intergroup Randomized Phase 2 Four Arm Study in Patients >/= 60 with Previously Untreated Mantle Cell Lymphoma of Therapy with: Arm A = Rituximab+Bendamustine Followed by Rituximab Consolidation (RB -->R); Arm B = Rituximab+Bendamustine+Bortezomib Followed By Rituximab Consolidation (RBV--> R), Arm C = Rituximab+Bendamustine Followed by Lenalidomide+Rituximab Consolidation (RB --> LR) or Arm D = Rituximab+Bendamustine+Bortezomib Followed by Lenalidomide+Rituximab Consolidation (RBV --> LR) E1505 A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) -IIIA Non-Small Cell Lung (NSCLC).

3 E3A06 Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma E3A06 Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma EXCITE Implementation of a Treatment Based Classification System for Neck Pain. Implementing Safe Practices for Prevention of Perioperative Hypothermia Left Main Disease Database Research Outcomes Registry Long-term Adherence to Change Behaviors in Outpatient Rehabilitation Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients (MultiSENSE) NSABP B-39: A Randomized Phase III Study Of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast NSABP B-43 A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy. NSABP P-5 Statin Polyp Prevention Trial in Patients with Resected Colon. NSABP PROTOCOL B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy NSABP Protocol B-47: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node- Negative HER2-Low Invasive Breast NSABP PROTOCOL B-49: A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Student

4 NSABP Protocol P-5: Statin Polyp Prevention Trial in Patients with Resected Colon OPEN PacTAP Perceptions of the NCLEX-RN: Exploring the effectiveness of nursing program preparation strategies. ADN vs. BSN Perioperative Temperature Management: The Relationship between a Quality Performance Measure and Positive Patient Outcomes Radial Styloidectomy Registry and Assessment pf Screening of Patients for High Risk of Sleep Apnea S0931, EVEREST: EVErolimus for Renal Ensuing Surgical Therapy, A Phase III Study. S0931, EVEREST: EVErolimus for Renal Ensuing Surgical Therapy, A Phase III Study. Sapphire Study of Carpometacarpal Arthroscopic Surgery (CMC) SuperNova: Stenting of the Superficial Femoral and Proximal Popliteal Arteries with the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System SWOG S0702: A Prospective Observational Multicenter Cohort Study To Assess the Incidence of Osteonecrosis of the Jaw (ONJ) In Patients With Bone Metastases Starting Zoledronic Acid Treatment SWOG S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor- Positive and HER-2 Negative Breast with Recurrence Score (RS) of 25 or Less SWOG S1014: Abiraterone Acetate Treatment for Prostate Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II SWOG S1105:Randomized Trial of Text-Messaging Intervention to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women with Early Stage Breast The Chocolate Balloon Angioplasty Registry (The Chocolate BAR) The lived experience of health care providers who want to be culturally competent in the care of Lesbian, Gay, Bisexual and Transgender (LGBT) Patient The SOAPP 1.0 & COMM Instruments as Tools in Chronic Pain

5 TIGRIS TSU E 5508: Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed FollowingCarboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC. Venous Cannualization with the Use of a Vein Visualization Device Will Simulation Assist Pediatric Nurses to Maintain Resuscitation Competency Proficiency Summary Total "Active-Open To Enrollment" Projects: 65