Education and Training

  • EDRN Prostate MRI Biomarker Study

    The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the use of MRI imaging for prostate cancer. How best to use MRI in the initial prostate biopsy setting given the availability of validated prostate cancer early detection markers is uncertain.This study will allow investigators to determine if prostate MRI is superior to validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in the initial biopsy setting.

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  • Gastroschisis Outcomes of Delivery (GOOD) Study

    The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days.

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  • Identifying Risk Factors That Predict Onset of Anorexia Nervosa and Bulimia Nervosa

    Across the United States, thousands of children and adolescents suffer from eating disorders. Among young women alone, an estimated 2 to 4 percent are dealing with anorexia nervosa. Anorexia nervosa also has the highest mortality rate of any psychiatric disorder and produces a six-fold increased risk for death. Unfortunately, study shows that current treatments are only successful with 25 percent of patients and no eating disorder prevention program has been found to reduce future onset of anorexia nervosa. The goal of this study is to conduct a highly innovative pilot study that will identify risk factors that predict future onset of anorexia nervosa and investigate how the risk processes for anorexia nervosa are different from the risk processes for bulimia nervosa. The proposed pilot study will:

    - Compare 30 healthy adolescent girls at high risk for anorexia nervosa to 30 healthy adolescent girls at high risk for bulimia nervosa, and 30 healthy adolescent girls at low risk for eating disorder in an effort to document risk processes that are present in early adolescence before anorexia nervosa typically emerges.

    - Test whether elevations in the hypothesized risk factors predict future onset of anorexia nervosa over a four-year follow-up.

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  • Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes

    Randomized trial of youth aged 7-<18 years with newly diagnosed stage 3 type 1 diabetes (T1D) to assess the effect of both (1) near-normalization of glucose concentrations achieved through use of a hybrid closed loop (HCL) system and (2) verapamil on preservation of β-cell function 12 months after diagnosis. Participants with body weight ≥30 kg (Cohort A) will be randomly assigned in a factorial design to (1) HCL plus intensive diabetes management or usual care with no HCL and (2) verapamil or placebo. Participants with body weight <30 kg (Cohort B) will be randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes management or to usual care with no HCL.

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  • Coaches Activating Reaching and Engaging Patients

    The purpose of the Team Based Advance Care Planning CAREPLAN program is to understand if a trained lay navigator who engages with patients with advanced stages of cancer can help patients in advance care planning, improve patient activation, satisfaction, quality of life, and the quality of end of life cancer care while also ensuring goal concordant cancer care at the end of life.

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  • Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa

    This study will compare the effectiveness of family-based therapy versus individual psychotherapy for the treatment of adolescent anorexia nervosa.

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  • CBT Texts for PTSD & Hazardous Drinking (Project Better)

    The research study seeks to refine and test a brief, self-directed, intervention for individuals from the general public with PTSD and co-occurring HD that can be delivered via text-messaging. This application seeks to refine the intervention further by testing whether theoretically-driven, evidence-based strategies from basic cognitive psychology (message framing) and social psychology (facilitating growth mindsets) result in better outcomes for PTSD symptoms and HD by addressing pilot participant feedback related to avoidance and motivation.

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  • ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

    The objective of this prospective, randomized, double-blind (to subjects, local site's blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor (ET).

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  • Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma

    This phase II trial studies how well dinutuximab works when given with sargramostim in treating patients with osteosarcoma that has come back after treatment (recurrent). Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them. Sargramostim may help the body increase the amount of white blood cells it produces, which help the body fight off infections. Giving dinutuximab with sargramostim may work better and kill more cancer cells.

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  • Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)

    The purpose of this study is to understand nitrous oxide effects in post traumatic stress disorder (PTSD)

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  • Cutaneous Administration of Local Anesthetic for Spine Injection Procedures

    Interventional spine procedures are an increasingly popular means of diagnosis and treatment of spine disease. By convention, local anesthetics are used at the beginning of these procedures with the goal of minimizing pain. However, the infiltration of the local anesthetic is painful. This initial painful stimulus can heighten pain awareness and cause anxiety or excessive movement during the procedure.

    The purpose of this study is to determine patient discomfort with administration of cutaneous local anesthetic prior to interventional spine procedures compared to no anesthetic administration for different gauge procedural needles. Another purpose is to determine patient discomfort with administration of local anesthetic by traditional technique compared to an alternative technique and to develop a standardized technique and criteria for local anesthetic administration during spine injection procedures that minimizes patient pain, and may help reduce the overall risk of these procedures.

    We plan to enroll a total of 200-300 subjects coming to Stanford for symmetric bilateral single injections.

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  • CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL

    This study is designed to test whether CT-2103/carboplatin provides improved overall survival compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels >30 pg/ml.

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  • GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease

    This is a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease (AD) dementia.

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  • FNA Tumor Sampling for CD137 Modulation: A Pilot Study

    The purpose of this study is to better understand the biology of the body's immune response to monoclonal antibody therapy for cancer. Your health information will be used to identify your tissues. The tissue we obtain may be useful for research or education, resulting in new drugs, therapies or diagnostic procedures.

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  • Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

    This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. 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 hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.

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  • Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder Cancer

    This phase II/III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine and cisplatin, 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 chemotherapy before surgery may make the tumor smaller; therefore, may reduce the extent of surgery. Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue. Giving chemotherapy after surgery may kill any remaining tumor cells. This study will determine whether giving chemotherapy before surgery increases the length of time before the cancer may return and whether it will increase a patient's life span compared to the usual approach.

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  • Electronic Application of a Severe Sepsis Screening Tool and Management Bundle

    Thousands of children die from Sepsis following routine infections. Many of these deaths can be prevented with earlier recognition and focused management. No tools are currently available to recognize the signs of early sepsis in children. The investigators have developed a electronic health record-based tool that will recognize children with sepsis early and trigger an alert to their hospital caregivers. The caregivers will be prompted to launch a focused management bundle that can stabilize these children, prevent further deterioration and reduce their chances of sepsis related complications and death. The proposed study will test the validity and effectiveness of this electronic tool in reducing sepsis mortality rates.

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  • Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    The purpose of this study is to evaluate progression-free survival among subjects with KRAS mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib (ARQ 197) compared to single agent chemotherapy.

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  • Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record Review

    Patients who have Alagille Syndrome (AGS) also frequently have blockages (or "stenoses") of their pulmonary arteries. Little is known about the degree or variability of these stenoses, or the effect of this disease on the right ventricle (the chamber of the heart which pumps blood to the lungs). This study will first quantify and describe pulmonary artery stenosis in patients with Alagille Syndrome. The study will also assess the effect of these stenoses on the right ventricle. The investigators hope to learn the degree and characteristics of pulmonary artery stenosis in Alagille Syndrome. The investigators also hope to learn the effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille Syndrome. This information is critical in the management of patients with Alagille syndrome, as there is currently no data to guide clinicians on the management of pulmonary artery stenosis. Furthermore, the information from this study may help physicians manage pulmonary artery stenosis in other patients as well.

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  • COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Camostat Sub-Protocol

    The overall objective of this study is to efficiently evaluate the clinical efficacy and safety of different investigational therapeutics among adults who have COVID-19 but are not yet sick enough to require hospitalization. The overall hypothesis is that through an adaptive trial design, potential effective therapies (single and combination) may be identified for this group of patients.

    COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding (Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the platform, every investigational product will collect data for both Domain primary endpoints. Individual treatments to be evaluated in the platform will be described in separate sub-protocols.

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