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


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

thumb of John Ambrose, MDDr. John Ambrose
Division of Cardiology
UCSF Fresno

 


 

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

\thumb of Richard Kiel, MDDr. Richard Kiel
Division of Cardiology
UCSF Fresno

 


 

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

thumb of Dr. PalanlswamyDr. Chandrasekar Palaniswamy
Division of Cardiology
UCSF Fresno 

 


 

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

Thumb of Dr. DeedwaniaDr. Prakash Deedwania
Division of Cardiology
UCSF Fresno 

 


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

Thumb of Dr. DeedwaniaDr. Prakash Deedwania
Division of Cardiology
UCSF Fresno 

 


 

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

Thumb of Dr. DeedwaniaDr. Prakash Deedwania
Division of Cardiology
UCSF Fresno 

 


 

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=2

Thumb of Dr. DeedwaniaDr. Prakash Deedwania
Division of Cardiology
UCSF Fresno 

 

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

thumb of Dr. Almasri

Dr. Eyad Almasri
Division of Pulmonary and Critical Care Medicine
UCSF Fresno

 

 


 

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

thumb of Dr. Almasri

Dr. Eyad Almasri
Division of Pulmonary and Critical Care Medicine
UCSF Fresno

 

thumb of Dr. Patil ArmenianDr. Patil Armenian
Department of Emergency Medicine
UCSF Fresno

 


 

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

thumb of Dr. Almasri

Dr. Eyad Almasri
Division of Pulmonary and Critical Care Medicine
UCSF Fresno

 

thumb of Dr. Patil ArmenianDr. Patil Armenian
Department of Emergency Medicine
UCSF Fresno

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

thumb of Dr. Almasri

Dr. Eyad Almasri
Division of Pulmonary and Critical Care Medicine
UCSF Fresno

 


 

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

thumb of Dr. Almasri

Dr. Eyad Almasri
Division of Pulmonary and Critical Care Medicine
UCSF Fresno

 


 

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

thumb of Dr. Almasri

Dr. Eyad Almasri
Division of Pulmonary and Critical Care Medicine
UCSF Fresno

 

 


 

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

thumb of Dr. Soe NaingDr. Soe Naing
Division of Endocrinology
UCSF Fresno

 


 

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

Thumb of Dr. ToytmanDr. Marina Roytman
Department of Medicine
UCSF Fresno

 


 

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

Thumb of Dr. ToytmanDr. Marina Roytman
Department of Medicine
UCSF Fresno

 

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

Thumb of Dr. ToytmanDr. Marina Roytman
Department of Medicine
UCSF Fresno

 

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

Thumb of Dr. AbdulhaqDr. Haifaa Abdulhaq
Division of Hematology/Oncology
UCSF Fresno

 


 

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

Thumb of Dr. AbdulhaqDr. Haifaa Abdulhaq
Division of Hematology/Oncology
UCSF Fresno

 

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

Thumb of Dr. AbdulhaqDr. Haifaa Abdulhaq
Division of Hematology/Oncology
UCSF Fresno

 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

 


 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

 


 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

 

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

thumb of Dr. ChaudhuryDr. Uzair Chaudhary
Division of Hematology/Oncology
UCSF Fresno

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

thumb of Dr. Steve Stoltz

Dr. Steven Stoltz
Department of Internal Medicine
UCSF Fresno

 

 


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

Thumb of Dr. Stockamp

Dr. Nathan Stockamp
Division of Infectious Disease
UCSF Fresno 

 


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

thumb of Dr. Simon Paul

Dr. Simon Paul
Division of Infectious Disease
UCSF Fresno

 


 

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

thumb of Dr. Afshinnik

Dr. Arash Afshinnik
Division of Neuro Critical Care
UCSF Fresno

 


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.

thumb of Dr. Afshinnik

Dr. Arash Afshinnik
Division of Neuro Critical Care
UCSF Fresno

 


 

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.

Thumb of Dr. Kuo

Dr. Yu-Hung Kuo
Division of Neuro Critical Care
UCSF Fresno

 


 

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

thumb of Dr. Haggard

Dr. Derek Taggard
Division of Neuro Critical Care
UCSF Fresno

 


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

Thumb of Dr. Khan

Dr. Amir Khan
Department of Neurosurgery
UCSF Fresno

 


 

 

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

Thumb of Dr. Khan

Dr. Amir Khan
Department of Neurosurgery
UCSF Fresno


 

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

Thumb of Dr. Khan

Dr. Amir Khan
Department of Neurosurgery
UCSF Fresno


 

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

thumb of Dr. Likosky

Dr. William Likosky
Department of Neurology
UCSF Fresno

 


 

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

thumb of Dr. Kremer

Dr. Mallory Kremer
Department of OB/GYN
UCSF Fresno

 


 

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.

thumb of Dr. Ladella

Dr. Subhashini Ladella
Department of OB/GYN
UCSF Fresno

 


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.

http://chaps.berkeley.edu/

thumb of Dr. Vemipally

Dr. Jose Vempilly
Department of Medicine
UCSF Fresno

 


 

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

thumb of Dr. Goddard

Dr. Andrew Goddard
Department of Psychiatry
UCSF Fresno

 


 

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

thumb of Dr. Goddard

Dr. Andrew Goddard
Department of Psychiatry
UCSF Fresno


 

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

Thumb of Dr. Lee

Dr. David Lee
Division of Pulmonary and Critical Care Medicine
UCSF Fresno

 


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.

Thumb of Dr. Lee

Dr. David Lee
Division of Pulmonary and Critical Care Medicine
UCSF Fresno

 


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

Thumb of Dr. Evans

Dr. Tim Evans
Division of Pulmonary and Critical Care Medicine
UCSF Fresno

 


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

Thumb of Dr. Balasubramanian

Dr. Vijay Balasubramanian
Division of Pulmonary and Critical Care Medicine
UCSF Fresno

 


 

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

Thumb of Dr. Balasubramanian

Dr. Vijay Balasubramanian
Division of Pulmonary and Critical Care Medicine
UCSF Fresno


 

 

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

Thumb of Dr. Balasubramanian

Dr. Vijay Balasubramanian
Division of Pulmonary and Critical Care Medicine
UCSF Fresno


 

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

Thumb of Dr. Balasubramanian

Dr. Vijay Balasubramanian
Division of Pulmonary and Critical Care Medicine
UCSF Fresno


 

 

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

thumb of Dr. Davis

Dr. James Davis
Department of Surgery
UCSF Fresno