Clinical Research Trials Available

The following Clinical Research Trials are available through Mercy Health.   Additional information can be found at www.clinicaltrials.gov.

Infectious Disease 419-251-4919


 Clostridium difficille infection (C-Diff)

Protocol

 Clincaltrials.gov link

  A multi-center, randomized, double-blind study to compare the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile associated diarrhea  http://www.clinicaltrials.gov/ct2/show/NCT01983683?term=NCT+01983683&rank=1
 Sepsis

 Protocol

 Clincaltrials.gov link

 

 A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects with Severe Sepsis and Coagulopathy

Treatment of Septic Shock by Inhibiting Autodigestion and Preserving Gut Integrity with Enteric LB1148 (SSAIL Study)

 http://www.clinicaltrials.gov/ct2/show/NCT01598831?term=NCT+01598831&rank=1

https://www.clinicaltrials.gov/ct2/show/NCT02317549?term=LBS-SS201&rank=1

 Bacterial Skin Infections  Protocol  Clincaltrials.gov link
   A Phase I-II Study of the Safety and Efficacy of a True Human Antibody, 514G3, in Subjects Hospitalized with Bacteremia Due to Staphylococcus Aureus  

 PULMONARY 419-251-4919


 
COPD  Protocol  Clincaltrials.gov link
   A Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV study to evaluate the effect of Aclidinium Bromide on long-term Cardiovascular safety and COPD exacerbations in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD). Phase 4-Tudorza      http://www.clinicaltrials.gov/ct2/show/NCT01966107?term=NCT+01966107&rank=1
   A randomized, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD. [DYNAGITO I]   https://clinicaltrials.gov/ct2/show/NCT02296138?term=1237.19&rank=1

SLEEP 419-251-4919

 
 Narcolepsy  Protocol  Clincaltrials.gov link
 Adult  A Twelve-week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy.  https://www.clinicaltrials.gov/ct2/show/NCT02348593?term=NCT02348593&rank=1
 OSA  Protocol  Clincaltrials.gov link
   A Twelve-week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Subjects with Obstructive Sleep Apnea (OSA).  https://www.clinicaltrials.gov/ct2/show/NCT02348606?term=NCT02348606&rank=1
 Narcolepsy or OSA  Protocol  Clincaltrials.gov link
 By invitation only  A Long-Term, Open-Label Safety and Maintenance of Efficacy Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea (OSA).  https://www.clinicaltrials.gov/ct2/show/NCT02348632?term=NCT02348632&rank=1 

CARDIAC 419-251-4919

 
 Atrial Fibrilation  Protocol  Clincaltrials.gov link
   GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients with Atrial Fibrillation (Phase II/III)  http://www.clinicaltrials.gov/ct2/show/NCT01468701?term=NCT01468701&rank=1 
 Cardiac Intervention  Protocol  Clincaltrials.gov link
 Leads  Product Surveillance Registry  http://www.clinicaltrials.gov/ct2/show/NCT01524276?term=NCT01524276&rank=1
 STENT  BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - Bioflow-V  https://clinicaltrials.gov/ct2/show/NCT02389946?term=biotronik+bioflow&rank=3
   Randomized Controlled Trial Clinical Evaluation of the ABSORB™ Bioresorbable Vascular Scaffold (BVS) in the Treatment of Subjects with de novo Native Coronary Artery Lesions  http://www.clinicaltrials.gov/ct2/show/NCT01751906?term=NCT+01751906&rank=1
 Post-intervention   A prospective Randomised, open label, blinded endpoint (PROBE) study to Evaluate DUAL antithrombotic therapy with dabigatran etexilate (110mg and 150mg b.i.d.) plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin (INR 2.0 – 3.0) plus clopidogrel or ticagrelor and aspirin in patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting (RE-DUAL PCI)  https://clinicaltrials.gov/ct2/show/NCT02164864?term=dabigatran+etexilate+plus+clopidogrel&rank=1

 Neurology 419-251-4919

 
 Intervention  Protocol  Clincaltrials.gov link
   Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System  https://clinicaltrials.gov/ct2/show/NCT02340585?term=stryker+atlas&rank=1
   Analysis of Revascularization in Ischemic Stroke With EmboTrap (ARISE II)  https://clinicaltrials.gov/ct2/show/NCT02488915?term=Neuravi+Arise+II&rank=1

 Oncology 419-251-4919

 Brain  Title  lincaltrials.gov NCT #
 Glioblastoma  A Phase II/III Randomized trial of Veliparib or Placebo in combination with adjuvent Temozolomide in newly diagnosed Glioblastoma with MGMT promoter Hypermethylation  NCT02152982
 Glioma  A Phase III Randomized Double Blind Placebo Controlled Study of Armodafinil (Nuvigil) to Reduce Cancer Related Fatigue in Patients with High Grade Glioma  NCT01781468
 Breast    
 Adjuvant  A Randomized, Double Blind, Parrellel Group, Placebo Controlled Multi Center Phase III Study to assess the efficacy and safety of Loaparib versus Placebo as Adjuvant Treatment in patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy  NCT02032823
 Adjuvant  A Randomized Phase III Tiral of Adjuvant Therapy Comparing Doxorubicin plus Cyclophosphamide followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High Risk Node Negative Triple Negative Invasive Breast Cancer  NCT02488967
 Cancer Control  A Randomized Phase III trial of endocrine therapy plus entinostat/placebo in postmenopausal patients with hormone receptor positive advanced breast cancer  NCT02115282
 Colon    
 Colorectal  Randomized phase II study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF mutant Metastatic Colorectal Cancer.  NCT02164916
 GI    
 Pancreas  A Phase II-R and A Phase III Trial Evaulating Both Erlotinib (PH II-R) and Chemoradiation (PH III) as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma  NCT01013649
 Pancreas  A Randomized phase II study of perioperative mFOLFIRINOX versus Gemcitabine/Nab-Paclitaxel as therapy for resectable pancreatic adenocarcinoma  NCT02562716
 GU    
 Renal  Phase III Study: Everolimus for Renal Cancer Ensuing Surgical Therapy  NCT01120249
 Prostate  Androgen Deprivation thereapy and high dose Radiotherapy with or without whole pelvic radiothereapy in unfavorable intermediate or favorable high risk prostate cancer: A Phase III Randomized Trial  NCT01368588
 Prostate  A Phase III trial of enzalutamide (NSC # 766085) versus enzalutamide, abiraterone and prednisone for castration resistant metastatic prostate cancer  NCT01949337
 Prostate  A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients with Intermediate Risk Prostate Cancer  NCT00936390
 Prostate  Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer  NCT01809691
 Genitourinary    
 Bladder  A Radnomized Phase II Study of co Expression Extrapolation (Coxen) with Neoadjuvant Chemotherapy for localized, muscle invasive bladder cancer  NCT02177695
 Head and Neck     
 Advanced Resected  A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally Advanced Resected Head and Neck Cancer  NCT00956007
 Hematology    
 CLL  A Randomized Phase III Study of Ibrutinib (PCI-32765) based Therapy vs. Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)  NCT02048813
 Hodgkin Lymphoma  Phase II Trial of Response-Adapted therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL)   NCT01118026
 Multiple Myeloma  Surveillance, Contact, and Research for MGUS, Myeloma, and Amyloidosis  NCT01408225
 PCV  Prospective Non International Study of Disease Progression and Treatment of Patients with Polycythemia Vera in United States Academic or Community Clinical Practices  NCT 02252159
 Lung    
 Adjuvant  Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)  NCT02194738
 NSCLC  A Phase III Double blind trial for surgically resected early stage non small cell lung cancer: Crizotinib versus Placebo for patients with tumors harboring the anaplastic lymphoma kinase (ALK) fusion protein  
 NSCLC  Randomized double blind placebo controlled study of Erlotinib or Placebo in patients with completely resected epidermal growth factor receptor (EGFR) mutant Non Small Cell Lung Cancer (NSCLC)  NCT02193282
 NSNSCLC  A Phase III open label randomized study of Atezolizumab (MPDL3280A Anti-PD-L1 Antibody) in combination with carboplatin + paclitaxel with or without bevacizumab compared with carboplatin + paclitaxel + bevacizumab in chemotherapy naïve patients with stage IV non squamous non-small cell lung cancer  NCT02366143
 NSCLC  A Phase III, Open label, Multicenter, randomized study evaluating the efficacy and safety of Atezolizumab (MPDL3280A Anti-PD-L1 Antibody) in combination with caroplatin +paclitaxel or Atexolizumab in combination with Carboplatin + Nab Paclitaxel versus carboplatin + Nab Paclitaxel in chemotherapy naive patients with Stage IV Squamous non small cell lung cancer  NCT02367794
 Melanoma/Sarcoma    
 Patient Satisfaction  Assessment of Patient Satisfaction with Participation in Phase II/III NCCTG Clinical Trials  
 Cancer Control Prevention  A Cohort Study to Evaluate Genetic Predictors for Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)  NCT01824836