Education and Training

  • Simulation-Based Training for Ultrasound-Guided Perineural Catheter Insertion

    This study will determine the efficacy of a teaching program incorporating hybrid simulation in training practicing anesthesiologists on ultrasound (US)-guided continuous peripheral nerve block (CPNB).

    This study will also examine the extent of practice change following participation in a regional anesthesia teaching program incorporating hybrid simulation. In addition, this study will assess remaining obstacles to incorporating the use of US-guided perineural catheters through identifying potential future interventions and "tool-kits" for setting up perineural catheter programs.

    Now accepting new patients View Details
  • Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Adults Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease

    The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of idelalisib in adults receiving ruxolitinib as therapy for intermediate to high-risk primary myelofibrosis (PMF), post-polycythemia vera, or post-essential thrombocythemia myelofibrosis (post-PV MF or post-ET MF) with progressive or relapsed disease.

    This is a dose-escalation study. There will be 4 cohorts (A, B, C, D). Participants will receive an escalating dose or dose frequency of idelalisib based on the safety data of available cohort(s).

    Not accepting patients at this time View Details
  • Study of the Safety and Tolerability of PCI-32765 in Patients With Recurrent B Cell Lymphoma

    The purpose of this study is to establish the safety and optimal dose of orally administered PCI-32765 in patients with recurrent B cell lymphoma.

    Not accepting patients at this time View Details
  • Treating Tobacco Dependence in Adolescents With Co-occurring Psychiatric Disorders

    This research aims to identify efficacious strategies for treating tobacco dependence among adolescent smokers with co-occurring psychiatric disorders. Adolescent smoking remains a significant public health issue with 23% of high school students reporting smoking a cigarette in the past month1. Smoking rates are two to four times higher among adolescents with psychiatric disorders such as attention deficit disorders, conduct disorder, depression, anxiety disorders, and alcohol and illicit drug dependencies2-4.

    Empirical investigations of adolescent tobacco treatment interventions number less than 50 with many of the studies criticized for methodological problems (i.e., follow up < 6 months, poor retention, lack of control or comparison groups)2,5, 6. There have been no unequivocal successes; however, promising interventions include stage-based, cognitive behavioral (CBT), and multicomponent treatments2, 7. Additionally, the nicotine patch is well tolerated and safe among adolescents8 and rarely abused9. Less than a third of adolescent tobacco users report intention to quit in the near future2, 10, 11; thus, it seems critical that cessation interventions for this complex group be designed to assist smokers at all stages of readiness through the quitting process. A stepped care approach has the potential of matching more intensive services to those ready for and in need of greater treatment. Interventions delivered in health care settings have the appeal of broad reach.

    The primary specific aims of this research are to evaluate, in a randomized clinical trial (N=160), the efficacy of a stepped care intervention for treating smoking among adolescents recruited from outpatient psychiatry settings. To our knowledge, this would be the first study to examine outpatient psychiatry settings for treating tobacco dependence in adolescents. The stepped care intervention combines expert-system contacts, individual CBT sessions, and 12-weeks of nicotine replacement therapy (NRT).

    Investigator

    Not accepting patients at this time View Details
  • Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-modifying Antirheumatic Drug(s) (bDMARDs) Treatment

    The primary objective of the study is to evaluate the effect of GS-5718 versus placebo for the treatment of rheumatoid arthritis (RA) as measured by change from baseline in Disease Activity Score (DAS) based on 28 joints using C-reactive protein (CRP) (DAS28[CRP]) at Week 12.

    Not accepting patients at this time View Details
  • Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia

    Time-to-Progression (TTP)

    Not accepting patients at this time View Details
  • Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

    The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and the need for peripheral retinal ablation.

    Not accepting patients at this time View Details
  • SARS-COV-2 Screening in Dialysis Facilities

    Patients receiving dialysis are one of the highest risk groups for serious illness with SARS-CoV-2 infection. In addition to the inherent risks of travel to and dialysis within indoor facilities, patients receiving dialysis are more likely to be older, non-white, from disadvantaged backgrounds, and have impaired immune responses to viral infections and vaccinations. Universal testing offered at hemodialysis facilities could shield this vulnerable population from exposure, enable early identification and treatment for those affected, and reduce transmission to other patients and family members. In this pragmatic cluster randomized controlled trial as part of NIH RADx-UP Consortium, we will randomize 62 US Renal Care facilities with an estimated 2480 patients to static versus dynamic universal screening testing strategies. Static universal screening will involve offering patients SARS-CoV-2 screening tests every two weeks; the dynamic universal screening strategy will vary the frequency of testing from once every week to once every four weeks, depending on community COVID-19 case rates. We hypothesize that patients dialyzing at facilities randomized to a dynamic testing frequency responsive to community case rates will have higher test acceptability (primary outcome), experience lower rates of COVID-19 death and hospitalization, and report better experience-of-care metrics.

    Not accepting patients at this time View Details
  • Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer

    This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.

    Not accepting patients at this time View Details
  • Technology-Based Distractions During Minor Procedures

    The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.

    Not accepting patients at this time View Details
  • Temperature Study in Cesarean Section

    During surgery body temperature can decrease which can adversely affect how people recover from surgery. This is a common problem. We aim to reduce the incidence of this drop in body temperature during surgery by testing the effectiveness of warm intravenous fluids that the patients will receive as they are being infused, and of warm air blown into a blanket covering the body. The control group will not have any active warming methods.

    Study group 1 will have the intravenous fluid warmer in the pre- and intraoperative period. Study group 2 will have a forced-air warmer in the intra-operative period as well as the fluid warmer in the pre- and intraoperative period. We will also observe the neonates' vital signs following delivery.

    Not accepting patients at this time View Details
  • The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients

    Patients who tear their ACL are at high risk for developing arthritis (post-traumatic osteoarthritis-PTOA) just 10 years later. Joint bleeding and inflammation contribute to deterioration of joint health. This study will determine whether treatment with Tranexamic Acid (TXA), an FDA approved medication that reduces bleeding right after ACL injury and reconstructive surgery reduces inflammation and improves joint health as a new strategy to prevent or delay the onset of PTOA.

    Investigator

    Now accepting new patients View Details
  • Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

    The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).

    Investigator

    Not accepting patients at this time View Details
  • The Insulin-Only Bionic Pancreas Pivotal Trial

    This multi-center randomized control trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas (BP) System versus Usual Care (UC) during a 13-week study period. Participants may be enrolled initially into a screening protocol and then transfer into the RCT protocol, or they may enter directly into the RCT protocol. The RCT will be followed by an Extension Phase in which the RCT Usual Care (UC) Group will use the insulin-only configuration of the iLet Bionic Pancreas (BP) System for 3 months. At the completion of use of the BP system in the RCT only, participants will enter a 2-4 day Transition Phase and be randomly assigned to either transition back to their usual mode of therapy (MDI or pump therapy) based on therapeutic guidance from the iLet BP System or transition back to their usual mode of therapy based on what their own insulin regimens were prior to enrolling in the RCT.

    There is an optional ancillary study to assess the safety of utilizing self-monitored blood glucose (SMBG) measurements instead of continuous glucose monitor (CGM) measurements as input into the iLet for ~48-60 hours. The Study is intended to mirror a real-world situation where CGM may not be available for an extended period of time (eg, user runs out of sensors and is awaiting new shipment).

    Not accepting patients at this time View Details
  • Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone (BMT CTN 1705)

    Study CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD

    Investigator

    Not accepting patients at this time View Details
  • Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

    This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with IPF.

    Investigator

    Not accepting patients at this time View Details
  • Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

    The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.

    The objective of this study was to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.

    Following one year of treatment patients could proceed into the study extension.

    Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.

    Not accepting patients at this time View Details
  • Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia

    The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy regimens using different dosages of cytarabine to eliminate all detectable leukemia.

    Investigator

    Not accepting patients at this time View Details
  • Study of XL647 Administered Orally Daily to Patients With Solid Tumors

    The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.

    Not accepting patients at this time View Details
  • Stereotactic Body Radiation Therapy and T-Cell Infusion in Treating Patients With Metastatic Kidney Cancer

    This pilot phase I trial studies the side effects and best way to give stereotactic body radiation therapy and T-cell infusion in treating patients with metastatic kidney cancer. Giving total body irradiation before a T-cell infusion stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. Chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the radiation therapy.

    Investigator

    Not accepting patients at this time View Details