Education and Training

  • A Study of ASA404 or Placebo in Combination With Docetaxel in Second-line Treatment for (Stage IIIb/IV) Non-small Cell Lung Cancer

    The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes the cancer treatment more effective in patients with locally advanced or metastatic non-small cell lung cancer

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  • Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia

    Helping Babies Breathe (HBB) is a program that teaches providers in low- and middle-income countries about neonatal resuscitation. Historically, HBB training was delivered in person. During the COVID-19 pandemic, many subject matter experts were unable to travel to conduct HBB courses. Innovative methods for teaching HBB are needed to promote the acquisition and retention of resuscitation skills and knowledge.

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  • Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)

    This study is designed to compare long-term outcomes among patients randomized on the BMT CTN 0702 protocol (NCT01109004), "A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma". It is hypothesized that use of novel anti-myeloma agents will improve long-term progression-free survival (PFS) after high-dose melphalan followed by autologous hematopoietic cell transplantation (HCT) as compared to a second autologous transplantation.

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  • CTL019 Out of Specification MAP for ALL or DLBCL Patients

    Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

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  • Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

    A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

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  • A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy

    This Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4602522 in participants with moderate severity Alzheimer's disease. Participants who are taking background therapy of acetylcholinesterase inhibitors (AChEI) alone or in combination with memantine for at least 4 months before screening will be randomized to receive either one of two doses of RO4602522 or placebo for 12 months.

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  • Diagnostic Performance of Coronary CT Angiography With CT FFR in Kidney Transplantation Candidates

    Patients with chronic kidney disease (CKD) before kidney transplantation require that obstructive coronary artery disease (CAD) is excluded, as cardiovascular complications are the leading cause of mortality in kidney transplant patients. However, in this patient population, the optimal method for the detection of obstructive CAD has not been identified. Noninvasive stress tests such as Dobutamine stress echocardiography or nuclear perfusion study have low diagnostic accuracy. CT fractional flow reserve measurement (CT FFR) is a novel non-invasive (FDA approved) imaging test to identify obstructive CAD. The goal of this project is to evaluate the diagnostic accuracy of CT FFR in the detection of obstructive coronary artery disease in patients with chronic kidney disease before kidney transplantation.

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  • Bariatric Atrial Restoration of Sinus Rhythm

    The objective of this study is to determine whether bariatric surgery followed by Atrial Fibrillation (AF) catheter ablation is superior to AF catheter ablation alone in the management of atrial fibrillation in patients with morbid obesity.

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  • A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)

    A Phase 1b/2, Multicenter, Open-Label Study of ACP-196 in Subjects with Recurrent Glioblastoma Multiforme (GBM)

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  • B-cell Immunity to Influenza (SLVP017)- Year 5, 2013

    In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different vaccines given to identical twins and vaccine-naive young adults.

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  • Brain Training in Preterm Children at Risk for Inattention, Hyperactivity, and Executive Function Impairment

    The purpose of this study is to determine if different forms of child-friendly, computer-based puzzles and games ("brain training") targeting executive function (EF) skills (i.e., thinking, problem-solving) result in improvements in EF in preschool children at risk for EF problems due to premature birth. The investigators hypothesize that children receiving active "brain training" will show greater improvements in EF and related skills immediately after treatment than children receiving passive "brain training." The investigators are also interested in whether any improvements in EF and related skills occur or are maintained at 3 and 6 months after completion of brain training.

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  • A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208)

    This trial will study tisotumab vedotin to find out what its side effects are and to see if it works for platinum-resistant ovarian cancer (PROC). It will test different doses of tisotumab vedotin that are given at different times. It will also compare the side effects and ability to treat tumors of these different doses and schedules. In this study, there will be a safety run-in group of approximately 12 patients that will look at a dose-dense treatment schedule. In a dose-dense schedule, smaller doses are given more frequently. In addition to the safety run-in patients, there will be three groups in the study. One group will get tisotumab vedotin once every 3 weeks (21-day cycles). The two other groups will get tisotumab vedotin once a week for 3 weeks followed by 1 week off (28-day cycles).

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  • Digital Behavioral Pain Medicine for Orthopedic Trauma Surgery Patients

    The primary purpose of this study is to determine the feasibility and preliminary efficacy of a perioperative digital behavioral pain medicine intervention delivered to orthopedic trauma surgery patients (compared to an active control group that receives digital health education).

    Aim 1: Determine feasibility of and satisfaction, and perceived utility of "My Surgical Success"

    Hypothesis 1: For My Surgical Success, the investigators anticipate 50% engagement in the study (feasibility). Of those who complete My Surgical Success, the investigators expect 80% satisfaction ratings, and 80% perceived utility of the information learned.

    Aim 2: Determine group differences in time to post-surgical pain and opioid cessation.

    Hypothesis 2: "My Surgical Success" participants will evidence quicker time to post-surgical pain and opioid cessation compared to the HE Control Group.

    Aim 3: Determine group differences in within-subject pain catastrophizing scores (baseline to post-surgery).

    Hypothesis 3: "My Surgical Success" participants evidence greater reduction in pain catastrophizing (measured with the Pain Catastrophizing Scale; PCS) compared to the HE Control group.

    Aim 4: Determine group differences in post-surgical psychological correlates (PROMIS Depression, Anxiety, Function, Pain Interference, Sleep Disturbance, Social Isolation, Fatigue, and Pain Intensity).

    Hypothesis 4: "My Surgical Success" participants will evidence greater post-surgical function and lower pain related interference compared to the HE Control Group.

    The goal of this research is to advance our understanding regarding the feasibility and effectiveness of "My Surgical Success" (a digital, perioperative behavioral pain medicine treatment) and its impact on post-surgical outcomes.

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  • Clinical Trial for Ovarian Cancer (OvaRex®)

    This study will compare the time to disease relapse between OvaRex® MAb-B43.13-treated patients and placebo-treated patients. This study will also compare assessments of survival, quality of life, immune response and safety between active and placebo groups.

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  • Blood Loss Measurement During Cesarean Delivery

    The aim of this study is to assess the ability of the Triton Device to measure blood loss among women undergoing elective and non-elective cesarean delivery. This patient population often experiences significant blood loss during surgery, and measurements of surgical blood loss are often inaccurate.

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  • Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)

    The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.

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  • Digital Knee Osteoarthritis Mindset Intervention

    The aim of our clinical trial is to test if an online mindset intervention improves mindsets and physical activity levels more than an education intervention in individuals with knee osteoarthritis.

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  • A Study of FORE8394 as a Single Agent in Patients With Advanced Unresectable Solid Tumors

    The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of FORE8394.

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  • Assessment of Pain in Newborns and Older Infants (Infant Pain Assessment Study =

    Pain assessments in non-verbal, critically ill infants represent an important clinical challenge. Older children or adults can easily express their pain, but infants lack that capability. They frequently experience repetitive acute pain during routine ICU care, but their analgesic management flounders on the horns of a dilemma: (a) failure to treat infant pain leads to immediate clinical instability and potentially long-term physical, behavioral, and cognitive sequelae, vs. (b) strong analgesics may increase risks for medical complications and/or impaired brain growth. Bedside nurses currently assess pain using pain scores, before taking action to ameliorate pain. Pain scores increase nursing workload and provide subjective assessments, rather than objective data for evaluating infant pain. Consequently, infants exposed to skin-breaking procedures, surgery, or other painful conditions often receive variable and inconsistent pain management in the ICU. The investigators aim to develop a multimodal pain assessment system, using sensor fusion and novel machine learning algorithms to provide an objective measure of pain that is context-dependent and rater-independent. This will enhance the quality of pain management in ICUs and allow continuous pain monitoring in real-time.

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  • Blood Stem Cell Transplant With Low Dose Chemotherapy for Relapsed Follicular Non-Hodgkin's Lymphoma (BMT CTN 0701)

    Blood stem cell transplants are one treatment option for people with lymphoma or other types of blood cancers. For this type of treatment, family members or unrelated donors with a similar tissue type usually donate their blood stem cells to the transplant patients. This study will evaluate the effectiveness of a type of blood stem cell transplant that uses lower doses of chemotherapy in people with relapsed follicular non-Hodgkin's lymphoma (NHL).

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