Clinical Trials

Open Clinical Trials

Department	Disease	Investigator	Study Sponsor	Title (click for details)
CARDIOLOGY	CORONARY ARTERY DISEASE	John Ambrose MD	National Institutes of Health	CIRT
CARDIOLOGY	HEART FAILURE	Richard Kiel MD	CVRx	BEAT-HF
CARDIOLOGY	HEART FAILURE	Chandrasekar Palaniswamy MD	Abbott	ENSITE
CARDIOLOGY	ISCHEMIC HEART DISEASE	Prakash Deedwania MD	National Institutes of Health	ISCHEMIA
CARDIOLOGY	ISCHEMIC HEART DISEASE	Prakash Deedwania MD	Novartis International AG	PARADISE
CARDIOLOGY	HEART FAILURE	Prakash Deedwania MD	Novartis International AG	PIONEER
CARDIOLOGY	HEART FAILURE	Prakash Deedwania MD	Boehringer Ingelheim	EMPEROR
CRITIAL CARE	ACUTE RESPIRATORY DISTRESS SYNDROME	Eyad Almasri MD	National Institutes of Health (PETAL)	ROSE
CRITICAL CARE/ED	ACUTE RESPIRATORY DISTRESS SYNDROME	Eyad Almasri MD      Patil Armenian MD	National Institutes of Health (PETAL)	VIOLET
CRITICAL CARE/ED	SEPSIS	Eyad Almasri MD      Patil Armenian MD	National Institutes of Health (PETAL)	CLOVERS
CRITIAL CARE	VENTILATED NOSOCOMIAL PNEUMONIA	Eyad Almasri MD	Cubist (Merck)	ASPECT-NP
CRITIAL CARE	HOSPITAL ACQUIRED PNEUMONIA	Eyad Almasri MD	Merck	RESTORE-IMI 2
CRITICAL CARE	STAPH AUREUS BACTEREMIA	Eyad Almasri MD	Theravance Biopharma	0112
ENDOCRINOLOGY	DIABETES	Soe Naing MD	Central California Faculty Medical Group	STEP-DOWN
HEPATOLOGY	NONALCOHOLIC STEATOHEPATITIS	Marina Roytman MD	Genfit SA	RESOLVE-IT
HEPATOLOGY	NONALCOHOLIC STEATOHEPATITIS	Marina Roytman MD	Intercept Pharmaceuticals	REVERSE
HEPATOLOGY	NONALCOHOLIC STEATOHEPATITIS	Marina Roytman MD	Conatus Pharmaceuticals	IDN-6556-17
HEM/ONC	MULTIPLE MYELOMA	Haifaa Abdulhaq MD	Oncopeptides AB	HORIZON
HEM/ONC	B CELL LYMPHOMA	Haifaa Abdulhaq MD	Morphosys	B-MIND
HEM/ONC	HODGEKIN’S LYMPHOMA	Haifaa Abdulhaq MD	Millenium Pharmaceuticals	HL
HEM/ONC	UROTHELIAL CARCINOMA	Uzair Chaudhary MD	Bristol-MyerS Squibb	CHECKMATE 274
HEM/ONC	BREAST CANCER	Uzair Chaudhary MD	NRG (NCI)	NSABP-B51
HEM/ONC	BREAST CANCER	Uzair Chaudhary MD	Alliance (NCI)	A011202
HEM/ONC	NON-SMALL CELL LUNG CANCER	Uzair Chaudhary MD	Alliance (NCI)	A081105
HEM/ONC	NON-SMALL CELL LUNG CANCER	Uzair Chaudhary MD	Alliance (NCI)	A151216
HEM/ONC	GLIOMA	Uzair Chaudhary MD	Alliance (NCI)	A221101
HEM/ONC	BREAST CANCER	Uzair Chaudhary MD	Alliance (NCI)	A011106
HEM/ONC	BREAST CANCER	Uzair Chaudhary MD	Alliance (NCI)	A011502
HEM/ONC	LYMPHOBLASTIC LEUKEMIA	Uzair Chaudhary MD	Alliance (NCI)	A041501
HEM/ONC	BONE PLASMACYTOMA	Uzair Chaudhary MD	Alliance (NCI)	A061402
HEM/ONC	GLIOBLASTOMA	Uzair Chaudhary MD	Alliance (NCI)	A071102
HEM/ONC	GLIOMA	Uzair Chaudhary MD	Alliance (NCI)	N0577
HEM/ONC	LYMPHOBLATIC LEUKEMIA	Uzair Chaudhary MD	ECOG (NCI)	E1910
HEM/ONC	NON-SMALL CELL LUNG CANCER	Uzair Chaudhary MD	ECOG (NCI)	E4512
HEM/ONC	NON-SMALL CELL LUNG CANCER	Uzair Chaudhary MD	ECOG (NCI)	EA5142
HOSPITALIST	RESPIRATORY SYNCYNTIAL VIRUS	Steven Stoltz MD	Janssen (Johnson & Johnson)	JNJ-RSV
INFECTIOUS DISEASE	VALLEY FEVER	Simon Paul MD	Central California Faculty Medical Group	COCCI
INFECTIOUS DISEASE	VALLEY FEVER	Nathan Stockamp MD	National Institutes of Health (DMID)	FLEET-VF
NEURO CRITICAL CARE	NEURO ICU INTUBATED PATIENTS	Arash Afshinnik MD	Hollister Inc	ANCHORFAST
NEURO CRITICAL CARE	TRAUMATIC BRAIN INJURY, STROKE, SUBARACHNOID HEMORRHAGE	Arash Afshinnik MD	California Institute to Advance Precision Medicine	CIAPM
NEUROSURGERY	SPINAL CORD INJURY	Yu-Hung Kuo MD	Department of Defense	TRACK-SCI
NEUROSURGERY	ACUTE CERVICAL SPINAL CORD INJURY	Derek Taggard MD	Vertex Pharmaceuticals	SPRING
NEUROSURGERY	CEREBRAL ANEURYSM	Amir Khan MD	Stryker	FEAT
NEUROSURGERY	CAROTID ATHEROSCLEROSIS	Amir Khan MD	National Institutes of Health (StokeNet)	CREST-2
NEUROLOGY	ISCHEMIC STROKE	Amir  Khan MD	Boehringer Ingelheim	RESPECT ESUS
NEUROLOGY	ISCHEMICA STROKE	William Likosky MD	National Institutes of Health (StokeNet)	ARCADIA
OB/GYN	PLACENTA ACCRETA	Mallory Kremer MD	Central California Faculty Medical Group	TAPAS
OB/GYN	ENVIRONMENTAL REPRODUCTIVE HEALTH	Subhashini Ladella MD	California Office of Environmental Health Hazard Assessment	OEHHA
PSYCHIATRY	RESISTANT MAJOR DEPRESSION	Andrew Goddard MD	National Institutes of Health (NNDC)	BIO-K
PSYCHIATRY	PANIC DISORDER	Andrew Goddard MD	Central California Faculty Medical Group	ORX-A
PULMONARY	ALLERGY & ASTHMA	Jose Vempilly MD	National Institutes of Health (NIEHS)	CHAPS P01
PULMONARY	CYSTIC FIBROSIS	David Lee MD	Vertex Pharmaceuticals	VX16-661-114
PULMONARY	CYSTIC FIBROSIS	David Lee MD	Central California Faculty Medical Group	BRONCHIECTASIS
PULMONARY	MYCOBACTERIUM AVIUM COMPLEX	Tim Evans MD	Insmed Inc	CONVERT (EXTENSION)
PULMONARY	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Vipul Jain MD	Department of Defense	BLOCK-COPD
PULMONARY	INTERSTITIAL LUNG DISEASE	Vijay Balasubramanian MD	United Therapeutics	INCREASE (201/202)
PULMONARY	PULMONARY ARTERIAL HYPERTENSION	Vijay Balasubramanian MD	United Therapeutics	FREEDOM-EV (310)
PULMONARY	PULMONARY ARTERIAL HYPERTENSION	Vijay Balasubramanian MD	United Therapeutics	FREEDOM-EV EXTENSION (311)
PULMONARY	PULMONARY ARTERIAL HYPERTENSION	Vijay Balasubramanian MD	United Therapeutics	ADAPT
SURGERY	ACUTE RESPIRATORY DISTRESS SYNDROME	James Davis MD	Department of Defense	SIVENT

Recently Completed Clinical Trials

Department	Disease	Investigator	Study Sponsor	Title
CARDIOLOGY	CONGESTIVE HEART FAILURE	Shradha Rathi MD	Amgen	COSMIC-HF
CARDIOLOGY	HEART FAILURE	Richard Kiel MD	AMGen	GALACTIC-HF
CRITICAL CARE	VENOUS THROMBOEMBOLISM	Eyad Almasri MD	Portola Pharmaceuticals	APEX
CRITICAL CARE	SEPTIC SHOCK	David Lee MD	Leading BioSciences	SSAIL
GASTROENTEROLOGY	NONALCOHOLIC STEATOHEPATITIS	Muhammad Sheikh MD	Genfit SA	GFT505
GASTROENTEROLOGY	DECOMPENSATED LIVER CIRRHOSIS	Muhammad Sheikh MD	Salix Pharmaceuticals	RNLC2131
GASTROENTEROLOGY	HEPATIC ENCEPHALOPATHY	Muhammad Sheikh MD	Salix Pharmaceuticals	RFHE4044
GASTROENTEROLOGY	INFLAMMATORY BOWEL DISEASE	David Limsui MD	Salix Pharmaceuticals	BUCF3001
GASTROENTEROLOGY	INFLAMMATORY BOWEL DISEASE	David Limsui MD	Salix Pharmaceuticals	BFPS3073
HEM/ONC	B CELL LYMPHOMA	Haifaa Abdulhaq MD	Curis Inc	CUDC-907
HEM/ONC	ACUTE MYELOID LEUKEMIA	Haifaa Abdulhaq MD	Celgene	QUAZAR
HEM/ONC	MULTIPLE MYELOMA	Haifaa Abdulhaq MD	Celgene	OPTIMISMM
HEM/ONC	NON-SMALL CELL LUNG CANCER	Viola Zhu MD	AVEO Pharmaceuticals	OP103
HOSPITALIST	ORAL COMMUNITY ACQUIRED PNEUMONIA	Steven Stoltz MD	Nabriva Therapeutics	LEAP-2
HOSPITALIST	INFLUENZA A	Steven Stoltz MD	Janssen (Johnson & Johnson)	OPAL
NEURO CRITICAL CARE	ANEURYSMAL SUBARACHNOID HEMORRHAGE	Arash Afshinnik MD	Edge Therapeutics	NEWTON-2
NEUROSURGERY	CEREBRAL ANEURYSM	Amir  Khan MD	Penumbra Inc	SMART
NEUROLOGY	MYASTHENIA GRAVIS	Jeffery Rosenfeld MD	Alexion Pharmaceuticals	ECU-MG-301
NEUROLOGY	AMYOTROPHIC LATERAL SCLEROSIS	Jeffery Rosenfeld MD	Hill-Rom	RSM2012
NEUROLOGY	HEMORRHAGIC STROKE	Tanya Warwick MD	National Institutes of Health	ERICH
NEURO CRITICAL CARE	ISCHEMIC STROKE	Arash Afshinnik MD	National Institutes of Health (StokeNet)	DEFUSE-3
NEURO CRITICAL CARE	STATUS EPILEPTICUS	Arash Afshinnik MD	Sage Therapeutics	STATUS
NEUROSURGERY	INTRACEREBRAL HEMORRHAGE	Amir Khan MD	National Institutes of Health	ATTACH-2
NEUROSURGERY	INTRACEREBRAL HEMORRHAGE	Amir Khan MD	Penumbra Inc	CARE
PULMONARY	MYCOBACTERIUM AVIUM COMPLEX	Tim Evans MD	Insmed Inc	CONVERT
PULMONARY	IDIOPATHIC PULMONARY FIBROSIS	Tim Evans MD	Intermume/Roche	PIPF-012
PULMONARY	IDIOPATHIC PULMONARY FIBROSIS	Tim Evans MD	Intermume/Roche	PIPF-031
PULMONARY	PULMONARY ARTERIAL HYPERTENSION	Vijay Balasubramanian MD	Lung Biotechnology	BEAT
PULMONARY	PULMONARY ARTERIAL HYPERTENSION	Vijay Balasubramanian MD	Actelion Pharmaceuticals	SYMPHONY
PULMONARY	PULMONARY ARTERIAL HYPERTENSION	Vijay Balasubramanian MD	Ikaria Therapeutics	IK-7001
PULMONARY	ASTHMA	Vipul Jain MD	Central California Faculty Medical Group	CPAP
PULMONARY	ASTHMA	Jose Vempilly MD	Central California Faculty Medical Group	LUVA
PULMONARY	ALLERGY & ASTHMA	Michael Peterson MD	National Institutes of Health	CHAPS R01

Enrolling Clinical Trials

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Cardiovascular Inflammation Reduction Trial (CIRT)

The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack or multiple coronary blockages. This trial is funded by the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH).

https://clinicaltrials.gov/ct2/show/NCT01594333?term=cirt&rank=3

 

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Barostim Therapy for Heart Failure (BeAT-HF)

The Barostim Neo – Baroreflex Activation Therapy for Heart Failure is a prospective, randomized trial in subjects with reduced ejection fraction heart failure.
https://clinicaltrials.gov/ct2/show/NCT02627196?term=CVRX+BAROSTIM&rank=5

 

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A Clinical Evaluation using EnSite Precision Cardiac Mapping System (ENSITE)

The objectives of this study are To quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System modules, To characterize the mapping duration and point usage when using multipolar catheters with the EnSite™ AutoMap module, and to characterize the relationship of the system usage to patient outcomes in a variety of electrophysiological (EP) procedures and clinical settings.

https://clinicaltrials.gov/ct2/show/NCT03260244?term=abbott+ensite&rank=1

 

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International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA)

The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~8000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT.

THIS STUDY IS NO LONGER ENROLLING NEW PATIENTS

https://clinicaltrials.gov/ct2/show/NCT01471522?term=comparative+health+effectiveness&rank=1

 

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Prospective ARNI versus ACE inhibitor trial to Determine Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE)

A multi-center, randomized, double-blind, active-controlled, parallel-group Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to Ramipril on morbidity and mortality in high risk patients following an acute myocardial infarction.

https://clinicaltrials.gov/ct2/show/NCT02924727?term=NOVARTIS+PARADISE&rank=1

 

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Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode (PIONEER-HF)

A Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled 8-week Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Enalapril on Changes in NT-proBNP and Safety and Tolerability of In-hospital Initiation of LCZ696 Compared to Enalapril in HFrEF Patients Who Have Been Stabilized Following Hospitalization for Acute Decompensated Heart Failure (ADHF).

https://clinicaltrials.gov/ct2/show/NCT02554890?term=NOVARTIS+PIONEER&rank=1

 

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EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure (EMPEROR)

A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF).

https://clinicaltrials.gov/ct2/show/NCT03057951?term=emperor&rank=

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Reevaluation of Systemic Early Neuromuscular Blockade (ROSE)

This study evaluates whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival. Half of the patients will receive a neuromuscular blocker for two days and in the other half the use of neuromuscular blockers will be discouraged.

https://clinicaltrials.gov/ct2/show/NCT02509078?term=petal+rose&rank=1

 

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Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET)

This study aims to evaluate the effect of early administration of high-dose vitamin D3 in reducing all-cause, all-location mortality in vitamin D deficient patients at high risk for ARDS. Patients will be screened for vitamin D deficiency (<20 ng/mL). Only patients screened as vitamin D deficient will be randomized. Half of the vitamin-D deficient patients will be given a high-dose of vitamin D3 and the other half will be given a placebo.

https://clinicaltrials.gov/ct2/show/NCT03096314?term=VIOLET&cond=ARDS&cntry1=NA%3AUS&rank=1

 

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Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS)

This study aims to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension.

https://clinicaltrials.gov/ct2/show/NCT03434028?cond=sepsis+crystalloid+vasopressors&rank=1

 

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Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (ASPECT-NP)

This is a phase 3, multicenter, prospective, randomized study of intravenous (IV) ceftolozane/tazobactam vs. IV meropenem in the treatment of adult participants with either ventilator-associated bacterial pneumonia (VABP) or ventilated hospital-acquired bacterial pneumonia (HABP).

https://clinicaltrials.gov/ct2/show/NCT02070757?term=cubist+aspect&rank=1

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Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014) (RESTORE-IMI 2)

This study aims to compare treatment with imipenem/relebactam/cilastatin (IMI/REL) as a fixed-dose combination (FDC) with piperacillin/tazobactam (PIP/TAZ) FDC in participants with hospital-acquired and ventilator-associated bacterial pneumonia. The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ in the incidence rate of all-cause mortality.

https://clinicaltrials.gov/ct2/show/NCT02493764?term=MERCK&cond=Hospital+Acquired+Pneumonia&rank=4

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Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial (0112)

This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S. aureus) bacteremia and SA right-sided infective endocarditis (RIE).

https://clinicaltrials.gov/ct2/show/NCT02208063?term=THERAVANCE+BACTEREMIA&rank=1

THIS STUDY IS NO LONGER ENROLLING NEW PATIENTS

 

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Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy? (STEP-DOWN)

In the traditional step-up approach, patients with poorly-controlled type 2 diabetes are instructed to take up to 4 insulin injections daily or multiple daily injections (MDI) as the most advanced therapy. However, a significant number of these patients continue to have poor diabetes control. The most common reason is due to noncompliance with MDI and the patient’s reluctance to accept insulin-induced weight gain. More recently, the algorithm in diabetes management has significantly changed to accommodate the newer generation of medications. Addition of diabetes medications that can induce weight loss, such as oral Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors and once-weekly glucagon-like peptide (GLP)-1 receptor agonists (GLP1 RA) injection, to basal insulin is now recommended before a patient is advanced to MDI. Under this approach, the patient no longer requires an insulin injection before each meal. This study will compare these two treatment plans in patients with poorly-controlled type 2 diabetes.

https://clinicaltrials.gov/ct2/show/NCT02846233?term=soe+naing&rank=1

 

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Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients with Nonalcoholic Steatohepatitis (NASH) (RESOLVE-IT)

The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

https://clinicaltrials.gov/ct2/show/NCT02704403?term=genfit+nash&rank=2

 

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Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE)

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

https://clinicaltrials.gov/ct2/show/NCT03439254?cond=nash+obeticholic+acid&rank=3

 

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Randomized Trial of an Oral Caspase Inhibitor in Patients with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis (IDN-6556-17)

The primary objectives of this study are to compare the effect of emricasan on improving event-free survival relative to placebo based on a composite clinical endpoint (where all-cause mortality, new decompensation events, and Model for End-Stage Liver Disease (MELD) [1] score progression [≥4 points] are events), in subjects with decompensated NASH cirrhosis. 

https://clinicaltrials.gov/ct2/show/NCT02686762?cond=nash+emricasan&rank=1

 

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A Trial to Evaluate the Efficacy and Safety of MOR208 With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (B-MIND)

This is a randomised, two-arm, multicentre, open-label phase II/III efficacy and safety study of MOR208 in combination with BEN versus RTX in combination with BEN given to adult patients who have relapsed after or are refractory to at least one but no more than three prior systemic therapies and have failed, or are not candidates for HDC and ASCT, and have thus exhausted their therapeutic options of demonstrated clinical benefit. At least one prior therapy line must have included a CD20-targeted therapy.

https://clinicaltrials.gov/ct2/show/NCT02763319?term=B-MIND&rank=1

 

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A Study of Melflufen in Combination With Dexamethasone in Relapsed Refractory Multiple Myeloma Patients (HORIZON)

A Randomized, Controlled, Open-Label, Phase 3 Study of Melflufen/Dexamethasone Compared with Pomalidomide/ Dexamethasone for Patients with Relapsed Refractory Multiple Myeloma who are Refractory to Lenalidomide.

https://clinicaltrials.gov/ct2/show/NCT02963493?term=melflufen+myeloma&rank=1

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Phase 3 Frontline Therapy Trial in Patients with Advanced Classical Hodgkin Lymphoma (HL)

This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL).

THIS STUDY IS NO LONGER ENROLLING NEW PATIENTS

https://clinicaltrials.gov/ct2/show/NCT01712490?term=millenium+hodgkins+lymphoma&rank=1

 

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Study of Nivolumab, Compared to Placebo, in Patients with Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer (CHECKMATE 274)

A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects with High RiskInvasive Urothelial Carcinoma 

https://clinicaltrials.gov/ct2/show/NCT02632409?term=bristol+myers+squibb+nivolumab+urothelial&rank=1

 

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Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery (NSABP-B51)

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer.

https://clinicaltrials.gov/ct2/show/NCT01872975?term=NSABP-B51&rank=1

 

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Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy (A011202)

This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

https://clinicaltrials.gov/ct2/show/NCT01901094?term=A011202&rank=1

 

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Genetic Testing in Screening Patients With Stage IB-IIIA Non-Small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (A081105)

This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient’s tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

https://clinicaltrials.gov/ct2/show/NCT02194738?term=A081105&rank=1

 

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Genetic Testing in Screening Patients With Stage IB-IIIA Non-Small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (A151216)

This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient’s tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

https://clinicaltrials.gov/ct2/show/NCT02194738?term=A151216&rank=1

 

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Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma (A221101)

This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.

https://clinicaltrials.gov/ct2/show/NCT01781468?term=A221101&rank=1

 

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Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery (A011106)

The study is being conducted to determine whether neoadjuvant endocrine therapy with fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole when given before surgery to shrink the cancer and stop it from growing. Anastrozole inhibits tumor growth by reducing the levels of estrogen and has been approved by the Food and Drug Administration (FDA) of the United States for use after surgery for postmenopausal women with estrogen receptor positive breast cancer. It is also considered a standard of care to give anastrozole for a few months before surgery to shrink the tumor. Fulvestrant inhibits tumor cell growth by reducing the levels of estrogen receptor in the tumor cell. It is not approved by the FDA for use in women with early stage breast cancer before or after surgery, but is approved by the FDA for patients with advanced (Stage 4) estrogen receptor positive breast cancer that has spread to other parts of the body.

https://clinicaltrials.gov/ct2/show/NCT01953588?term=A011106&rank=1

 

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Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy (A011502)

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

https://clinicaltrials.gov/ct2/show/NCT02927249?term=A011502&rank=1

 

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Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia (A041501)

This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

https://clinicaltrials.gov/ct2/show/NCT03150693?term=A041501&rank=1

 

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Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone (A061402)

This randomized phase III trial compares ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid with zoledronic acid alone to see how well they work when given after radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic acid may prevent bone fractures and reduce bone pain, and may also improve survival. Standard treatment for this cancer is radiation therapy alone. It is not yet known whether ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid or zoledronic acid alone is more effective, and whether adding these treatments after radiation therapy is more effective than radiation therapy alone in treating patients with solitary plasmacytoma of bone.

https://clinicaltrials.gov/ct2/show/NCT02516423?term=A061402&rank=1

 

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Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (A071102)

This randomized phase II/III trial studies how well temozolomide and veliparib work compared to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.

https://clinicaltrials.gov/ct2/show/NCT02152982?term=A071102&rank=1

 

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Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma (N0577)

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

https://clinicaltrials.gov/ct2/show/NCT00887146?term=N0577&rank=1

 

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Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia (E1910)

This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as blinatumomab, may block cancer growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia. https://clinicaltrials.gov/ct2/show/NCT02003222?term=E1910&rank=1

 

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Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion MutationsGlioma (E4512)

This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

https://clinicaltrials.gov/ct2/show/NCT02201992?term=E4512&rank=1

 

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Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (EA5142)

This randomized phase III trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies, such as nivolumab, may stimulate the immune system in different ways and kill tumor cells remaining after surgery and standard of care chemotherapy.

https://clinicaltrials.gov/ct2/show/NCT02595944?term=EA5142&rank=1

 

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Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection (JNJ-RSV)

The purpose of this study is to evaluate pharmacokinetics, safety, tolerability, antiviral activity, and impact on the clinical course of Respiratory Syncytial Virus (RSV) infection after multiple oral doses of JNJ-53718678 at different doses and/or dosing regimens in infants (greater than [>] 1 month to less than or equal to [<=] 24 months of age) who are hospitalized with RSV infection.

https://clinicaltrials.gov/ct2/show/NCT02593851?term=JANSSEN+RSV&rank=1

 

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Early Fluconazole Treatment for Coccidiodomycosis Pneumonia (FLEET-VF)

This is a Phase IV randomized, double-blinded, placebo-controlled study in 1000 individuals aged 18 years or older, with community acquired pneumonia (CAP) who meet all eligibility criteria in endemic regions. This study is designed to provide data on the effectiveness of early antifungal treatment (Fluconazole, 400 mg/day) for coccidioidomycosis pneumonia (also referred to as Valley Fever (VF) Pneumonia or acute onset valley fever) vs. placebo in subjects with coccidioidomycosis pneumonia.

https://clinicaltrials.gov/ct2/show/NCT02663674?cond=valley+fever&cntry1=NA%3AUS&draw=1&rank=9

 

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Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis (COCCI)

This is a phase II randomized trial to evaluate the effect of sertraline when added to standard therapy for meningeal or disseminated coccidioidomycosis, with the hypothesis that adjunctive sertraline will be well tolerated and will not affect drug levels of the standard of care treatment fluconazole.

https://clinicaltrials.gov/ct2/show/NCT02908334?term=COCCIDIOIDOMYCOSIS+SERTRALINE&rank=1

 

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Assessment of an Oral Endotracheal SubglotticTube Holder (ANCHORFAST)

This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.

https://clinicaltrials.gov/ct2/show/NCT03328182?term=hollister&recrs=a&rank=2

 

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Inter-observer Variability in Computerized Tomography and Magnetic Resonance Imaging of the Brain in Traumatic Brain Injury, Stroke, and Subarachnoid Hemorrhage (CIAMP)

To determine the interrater reliability (Jaccard index or Dice index) of neuroradiologists, research assistants, and computer-aided detection algorithms for abnormal findings on head computed tomography and brain MRI and to utilize the radiological findings by the computer-aided detection algorithms to advance clinical research analysis methodologies that are effective for precision medicine.

 

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Transforming Research and Clinical Knowledge in Spinal Cord Injury (TRACK SCI)

The purpose of this study is to establish a quality high-density SCI repository with demographic, clinical, imaging, biomarker and outcome data suitable for data mining and research in the characterization, evaluation and prognostication of SCI.

 

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Study to Assess the Efficacy and Safety of VX-210 in Subjects with Acute Traumatic Cervical Spinal Cord Injury (SPRING)

The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific evaluation of the effects of VX-210 on neurological recovery and daily function after spinal cord injury.

https://clinicaltrials.gov/ct2/show/NCT02669849?term=Vertex&cond=Spinal+Cord+Injuries&cntry1=NA%3AUS&rank=2

 

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Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)

This trial is being conducted in order to compare angiographic outcomes in patients receiving 0.014-0.0155″ platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014″ (with a standard diameter).

https://clinicaltrials.gov/ct2/show/NCT01655784?term=stryker+feat&rank=1

 

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Dabigatran Etexilate for Secondary Stroke Prevention in Patients with Embolic Stroke of Undetermined Source (RESPECT ESUS)

This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicylic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory.

THIS STUDY IS NO LONGER ENROLLING NEW PATIENTS

https://clinicaltrials.gov/ct2/show/NCT02239120?term=boehringer+dabigatran+stroke&rank=1

 

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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

https://clinicaltrials.gov/ct2/show/NCT02089217?term=crest-2&rank=2

 

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AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (ARCADIA)

Randomized phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause.

https://clinicaltrials.gov/ct2/show/NCT03192215?term=ARCADIA&recrs=a&rank=1

 

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Perioperative administration of Tranexamic Acid for Placenta Accreta Study (TAPAS)

The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is effective for reducing blood loss during high risk surgical procedures related to placenta previa and placenta accreta. TXA is currently used in other types of surgery for patients who are expected to have a large blood loss, such as orthopedic or open heart surgery.

https://clinicaltrials.gov/ct2/show/NCT02806024?term=TAPAS&rank=14

 

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Screening of Environmental Chemicals in Central California Pregnant Women (OEHHA)

The purpose of this pilot study is to determine the feasibility of collecting data to measure cumulative exposures to environmental pollutants in Fresno during vulnerable periods of development, in particular pregnancy.

 

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The Children’s Health and Air Pollution Study (CHAPS P01)

CHAPS investigates air pollution exposure during pregnancy and throughout childhood to assess the effects of exposures on birth outcomes, development, immune health and metabolism. CHAPS also assesses how the built environment in Fresno impacts the transportation behaviors and air pollution exposures of pregnant women.

https://www.chapssjv.org/

 

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Efficacy of Repeated Ketamine Infusions for Treatment-resistant Depression (BIO-K)

About one-third of depressed patients will not get better after multiple antidepressant treatments. Difficult-to-treat depression might be even worse among Veterans given that the frequency of depressive symptoms is 2 to 5 times higher than among the general US population. A breakthrough discovery happened in recent years when investigators found that one infusion from an old anesthetic named ketamine showed high efficacy and rapid antidepressant effect (sometimes within hours) but lasted only up to a week. The investigators propose to study if multiple infusions of ketamine can provide greater and longer antidepressant effects than one infusion.

https://clinicaltrials.gov/ct2/show/NCT02360280?term=ketamine%2C+mayo&cond=Depression&cntry1=NA%3AUS&rank=5

 

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The Role of Orexin in Human Panic Disorder (ORX-A)

The purpose of this study is to provide some information (pilot data) about whether the study drug, suvorexant, (1) affects levels of orexin in people with panic disorder, and (2) is associated with decreased panic symptoms in response to a carbon dioxide (CO2) challenge.

https://clinicaltrials.gov/ct2/show/NCT02593682?term=ANDREW+GODDARD&rank=1

 

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A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (VX16-661-114)

Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the CFTR gene and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment. This study is designed to evaluate the safety and efficacy of TEZ/IVA.

THIS STUDY IS NO LONGER ENROLLING NEW PATIENTS

https://clinicaltrials.gov/ct2/show/NCT03150719?term=VERTEX&cond=Cystic+Fibrosis&cntry1=NA%3AUS&draw=1&rank=8

 

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Correlation Between Lung Clearance Index and FEV1 in Chronic Bronchiectasis Patients

 (BRONCHIECTASIS)

A Prospective Observational Pilot Study of Chronic Bronchiectasis Patients Assessing the Correlation of Lung Clearance Index Measured by Nitrogen Washout and Forced Expiratory Volume in 1st Second with Functional Capacity Using Six-Minute Walk Testing.

 

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Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung DiseaseComplex (CONVERT-EXTENSION)

This study is an international, multi-center, open-label study designed to provide Liposomal Amikacin for Inhalation (LAI) to eligible subjects with Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Avium Complex (MAC) who have completed the CONVERT study.

THIS STUDY IS NO LONGER ENROLLING NEW PATIENTS

https://clinicaltrials.gov/ct2/show/NCT03038178?term=LIPOSOMAL+AMIKACIN+MYCOBACTERIUM&rank=1

 

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Safety and Efficacy of Inhaled Treprostinil in Adult PH with ILD Including CPFE (INCREASE-201)

This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 75 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).

https://clinicaltrials.gov/ct2/show/NCT02630316?term=UNITED+THERAPEUTICS+ILD&rank=1

 

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A Patient Registry of the Real-world Use of Orenitram® (ADAPT)

This is a prospective, observational, multicenter, patient registry to observe and assess the real-world use and tolerability of Orenitram (treprostinil). Patients who are newly initiated on Orenitram for the treatment of pulmonary arterial hypertension (PAH) or who transition from another prostacyclin therapy will be evaluated for 52 weeks to observe dosing regimens, titration schedules, prostacyclin-related adverse events (AEs), and clinical outcomes of interest.

https://clinicaltrials.gov/ct2/show/NCT03045029?term=UNITED+THERAPEUTICS+tde-ph-401&rank=1

 

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Trial of the Early Combination of Oral Treprostinil with Background Oral Monotherapy in Subjects with Pulmonary Arterial Hypertension (FREEDOM-Ev-310)

This study is an international, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving background oral monotherapy for at least 30 days at randomization for their PAH. Study visits will occur in four week intervals for the first 12 weeks, then every 12 weeks thereafter with key measures of efficacy being time to first clinical worsening event and the 6-minute walk test at Week 24. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Patients who complete all required assessments will also be eligible to enter a long-term, open-label, extension study (TDE-PH-311).

https://clinicaltrials.gov/ct2/show/NCT01560624?term=united+therapeutics+310&rank=2

 

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Open-Label, Long-Term Study of Oral Treprostinil in Subjects with Pulmonary Arterial Hypertension (FREEDOM-Ev EXTENSION-311)

This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.

https://clinicaltrials.gov/ct2/show/NCT01560637?term=united+therapeutics+310&rank=1

 

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Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome (SIVENT)

A randomized, concurrent controlled trial to assess if adding sigh breaths to usual invasive mechanical ventilation of victims of trauma who are at risk of developing ARDS will decrease the number of days they require invasive mechanical ventilation.

https://clinicaltrials.gov/ct2/show/NCT02582957?term=sivent&rank=1