Education and Training

  • Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis

    The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This will offer patients the benefits of cryoneurolysis of the intercostal nerves, thereby providing short and long term pain control while their ribs heal.

    The Iovera Smart Tip 190 is FDA approved for cryoneurolysis.

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  • Stanford Letter or Traditional Advance Directive in Advance Care Planning in Patients Undergoing Bone Marrow Transplant

    The purpose of the proposed research study is to evaluate whether bone marrow transplant patients prefer the Stanford letter advance care planning tool to the standard Advance directive.

    Completion of advance care planning prior to BMT is very important, but not often done. The investigators believe that the Stanford Letter will be preferred by patients and will allow them to feel more comfortable and share more of their wishes with family members and the medical team.

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  • 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.

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  • Simplified IUD Insertion Technique

    This is a randomized controlled trial that compares traditional IUD insertion with that of a no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD placement is safe and effective without pre-procedural assessment of uterine size, direction, or depth.

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  • Safety, Tolerability, Pharmacokinetics, and Immunoregulatory Study of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Solid Tumors and Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

    The purpose of the study is to assess the safety, tolerability, pharmacokinetics and immunoregulatory activity of urelumab (BMS-663513) in cancer subjects with advanced and/or metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma

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  • Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)

    This is an open-label, multicenter, biomarker study designed to be hypothesis-generating in order to better understand the mechanism of action of ocrelizumab and B-cell biology in RMS or PPMS. The study will be conducted in two cohorts i.e. RMS cohort (4 arm group) and PPMS cohort (one arm group). RMS cohort: Ocrelizumab will be administered as two intravenous (IV) infusions of 300 milligrams (mg) on Days 1 and 15. Subsequent doses will be given as single 600-mg infusions at Weeks 24 and 48. Participants will be randomized in 1:1:1 ratio to receive lumbar puncture (LP) post-treatment at Week 12, 24, or 52 following the first dose of ocrelizumab in three arm groups. A fourth RMS arm with delayed treatment start (Arm 4 [control group]) will not be a part of the randomization and will be recruited separately, wherein treatment with ocrelizumab will be delayed for 12 weeks from pre-treatment baseline. PPMS cohort: Ocrelizumab 600 mg will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks. Participants will receive a LP at the start of the study before dosing with ocrelizumab and second LP at Week 52 following the first dose of ocrelizumab. A long-term extension will be conducted for participants that complete the study and continue to receive ocrelizumab. Treatment with ocrelizumab in the entire study will continue for approximately 4.5 years after the first infusion.

    Investigator

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  • Quantra vs TEG for Congenital Cardiac Surgery - a Pilot Validation Study

    Congenital heart surgery on cardio-pulmonary bypass (CPB) is associated with impacted coagulation quality and increased bleeding after separation of CPB.

    The current testing device used at our institution is the "TEG 5000" (Haemonetics Corporation). The novel coagulation testing device "Quantra System" (Hemosonics) has favorable properties (result within 20 minutes) allowing for a quicker identification of the coagulation problem and hence faster administration of the correct coagulation products, potentially leading to better coagulation quality and possibly reducing the need of additional blood products. The aim of this prospective observational (non-interventional, investigational only) quality improvement study is to investigate if the Quantra is reliable and valid in predicting the coagulation status when compared with our standard-of-care device TEG 5000.

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  • Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

    A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2.

    Investigator

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  • Study of Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy in Patients With Stage III Non-small Cell Lung Cancer

    This randomized phase II trial studies how well positron emission tomography (PET)/computed tomography (CT)-guided radiation therapy works compared to standard radiation therapy in treating patients with stage III non-small cell lung cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Using imaging procedures, such as PET and CT scans, to guide the radiation therapy, may help doctors deliver higher doses directly to the tumor and cause less damage to healthy tissue.

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  • Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

    The incidence of low blood sugar and hypoglycemic seizures at diabetes camp has been reduced thanks to overnight blood glucose level testing. The timing of the overnight blood test is often arbitrary and it is unclear when the highest frequency of nocturnal hypoglycemic events at camp are occurring. It is also unclear what the most appropriate treatment for nocturnal hypoglycemia is: simple carbohydrates, or mini-glucagon.

    In this study, we will use Continuous Glucose Monitors (CGMs) that will send subject data securely to a remote computer located in the medical cottage at camp throughout the night. Study staff will monitor the computer and will intervene on low blood sugar as it occurs in real time. On half of the nights, campers will receive mini-glucagon for low blood sugar, and on the rest, they will receive standard carbohydrate treatment.

    Investigator

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  • The Body Project: Comparing the Effectiveness of an In-person and Virtually Delivered Intervention.

    This present study will compare the efficacy of in-person versus virtually-delivered Body Project groups. It will also evaluate whether this body acceptance class produces greater reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body dissatisfaction, dieting, dietary restraint, negative affect, eating disorder symptoms, and the future onset of eating disorders over a 3-month follow-up in this population. It will also evaluate the effectiveness of this body acceptance class's ability to impact social appearance anxiety, body compassion, and self-stigma surrounding attaining help.

    Investigator

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  • Stanford Regulating Circuits of the Brain Study - MDMA

    This study is a biomarker study designed to characterize how MDMA impacts the reward circuits of the human brain.

    Investigator

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  • Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer

    Bone metastases and associated pain are a major cause of morbidity and mortality in castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated by lack of resolution of lesions on bone scan with these agents) or the pain associated with these metastases.

    This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC.

    Investigator

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  • Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC

    This is a Phase 2, Multi-Cohort, Open-Label, Multi-Center Study. Cohort 1 will be a single-arm study of intratumoral tavokinogene telseplasmid (TAVO) plus electroporation (EP) in combination with pembrolizumab therapy. Cohort 2 will be a single-arm study of intratumoral TAVO-EP plus pembrolizumab along with treatment of an approved chemotherapy per standard of care (either nab-paclitaxel (Abraxane®) or gemcitabine (Gemzar®) plus carboplatin (Paraplatin®)) in participants with TNBC and no prior systemic therapy in the advanced or metastatic setting will be enrolled in this study.

    Investigator

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  • Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)

    The primary objective of the study is to assess the clinical efficacy of repeat subcutaneous (SC) doses of dupilumab, compared with placebo, to relieve symptoms in adult participants with active, moderate to severe Eosinophilic Esophagitis (EoE).

    The secondary objectives of the study are:

    - To assess the safety, tolerability, and immunogenicity of SC doses of dupilumab in adult participants with active, moderate to severe EoE

    - To assess the effect of dupilumab on esophageal eosinophilic infiltration

    - To evaluate the pharmacokinetics (PK) of dupilumab in adult participants with EoE

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  • Stress, Diurnal Cortisol, and Breast Cancer Survival

    The purpose of this study is to learn about the effects of stress on hormones, the relationship between these hormones and cancer progression.

    Investigator

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  • Study of Cobimetinib in Participants With Solid Tumors

    This non-randomized, open-label, study will determine the highest safe dose of cobimetinib, how often it should be taken, how well participants with cancer tolerate cobimetinib and will assess the pharmacokinetic effect of midazolam and dextromethorphan on the study drug.

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  • Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

    The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

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  • Safety and Efficacy of T Cell Genetic Immunotherapy for HIV

    This study uses autologous (one's own) CD4 T cells modified with a viral vector expressing a genetic antisense targeting HIV, this vector is called VRX496. Study treatment is by intravenous infusion of vector modified cells and infusions will be provided every other week for a total of 4 or 8 doses. These modified cells, once infused, may provide immune support and are not destroyed by HIV, and thus may delay or reverse HIV disease progression. The study will enroll up to 40 male and female HIV-positive subjects in up to 8 centers. Subjects will be 18 years of age and over who have failed or are intolerant to at least one triple combination of antiretroviral drugs. Subjects must have a viral load between 5,000 and 200,000 copies/ml and a CD4+ count of ≥150, be in good health and have no evidence of active opportunistic infection, heart disease, or bleeding disorders. Subjects must not be on corticosteroids, immunomodulating agents or hydroxyurea. Subjects must not have received an AIDS vaccine or any investigational gene therapy product at any time. Females must not be pregnant or breastfeeding.

    Investigator

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  • The Myelin Disorders Biorepository Project

    The Myelin Disorders Biorepository Project (MDBP) seeks to collect and analyze clinical data and biological samples from leukodystrophy patients worldwide to support ongoing and future research projects. The MDBP is one of the world's largest leukodystrophy biorepositories, having enrolled nearly 2,000 affected individuals since it was launched over a decade ago.

    Researchers working in the biorepository hope to use these materials to uncover new genetic etiologies for various leukodystrophies, develop biomarkers for use in future clinical trials, and better understand the natural history of these disorders. The knowledge gained from these efforts may help improve the diagnostic tools and treatment options available to patients in the future.

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