Education and Training

  • Neonatal Seizure Registry - Developmental Functional EValuation

    The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants that aims to evaluate childhood outcomes after acute symptomatic neonatal seizures, as well as examine risk factors for developmental disabilities and whether these are modified by parent well-being.

    Investigator

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  • Management of Insomnia in Breast Cancer Patients

    To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified).

    Participants will be randomized into 4 groups:

    - Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day.

    - Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day.

    - Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention.

    - Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.

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  • Donor After Circulatory Death Heart CAP Trial

    The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)

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  • Evaluation of the Integrated Radio Frequency Denervation System to Improve Glycemic Control in Type 2 Diabetic Subjects

    The objective of this early feasibility study is to evaluate the safety and performance of intravascular hepatic denervation using the Metavention Integrated Radio Frequency Denervation System (iRF System) to improve glycemic control in type 2 diabetes subjects.

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  • Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes

    The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).

    Participants will be asked to:

    1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods

    2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour

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  • Gait Retraining to Reduce Knee Osteoarthritis Pain

    The purpose of this study is to determine how well people can be trained to produce new and different movements through the use of haptic feedback. One particular application is retraining individuals to walk differently in order to reduce knee joint loads to prevent or treat knee osteoarthritis as an alternative to surgical treatments.

    Investigator

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  • Exercise to Prevent Muscle Mass and Functional Loss in Elderly Dialysis Patients

    The majority of individuals with advanced ESRD have reduced exercise capacity in part due to decreased muscle mass. This leads to a reduced ability to perform daily activities, a greater incidence of falls, and a reduced quality of life. The mechanisms responsible for the loss of muscle mass in ESRD are not understood very well. This study is designed to determine the effectiveness of an exercise program on improving muscle mass, exercise capacity and quality of life in persons with ESRD. In addition, the study will attempt to better understand why muscle loss occurs in people with ESRD, the influence exercise has on these mechanisms, and whether the response to exercise can be enhanced with nutrient supplementation.

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  • ITIL-168 in Advanced Melanoma

    DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).

    Investigator

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  • Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

    The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored interventional studies.

    Investigator

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  • Effects of a Peripheral Nerve Block on Biomarkers of Pain and Inflammation

    The purpose of this study is to determine the effect of a local anesthetic nerve block on markers of inflammation and pain after a sunburn. This is important because it may provide information regarding the way that nerve blocks help with the treatment of pain and in particular provide preemptive analgesia.

    Investigator

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  • High Dose Chemotherapy and Allogeneic Hematopoietic Cell Transplant for Non-Hodgkin's Lymphoma

    To evaluate the role of allogeneic hematopoietic cell transplantation in the treatment of NHL.

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  • COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay

    Primary Objectives:

    Cohort A:

    • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR

    Cohort A and Cohort A1:

    • To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo

    Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing COVID-19 symptoms (broad-term)

    Cohort B and Cohort B1

    • To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration compared to placebo

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  • Listening to Mom 2: Neural, Clinical and Language Outcomes

    The purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm.

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  • Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy

    This is a pilot outpatient study conducted at Stanford to obtain preliminary data on how Fiasp® works in a closed-loop system and to determine if any changes need to be made to the 670G pump to optimize the use of Fiasp®.

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  • Clinical Outcome Study for Dysferlinopathy

    The "Clinical Outcome Study for Dysferlinopathy" is being performed in centres in Europe (UK- Newcastle; Spain- Barcelona, Sevilla; San Sebastian;Denmark, Copenhagen, Italy- Padova; France- Paris,), USA (Charlotte, NC; Columbus, OH; St.Louis, MO, Stanford CA, Irvine CA and Columbia NY), Chile (Santiago) Japan (Tokyo) and South Korea (Pusan). Oversight is provided by Newcastle upon Tyne Hospitals Trust. Funding for this study is being provided by the Jain Foundation, a non-profit foundation dedicated to finding therapies for dysferlinopathies(LGMD2b/Miyoshi). The aim of this "Clinical Outcome Study" is to determine the clinical outcome measures required for future clinical trials, characterize the disease progression of dysferlinopathy and collect biological samples for the identification of disease markers that are needed to non-invasively monitor the disease during clinical trials. Without this information, effective clinical trials cannot be performed.

    This study is recruiting a large number of genetically confirmed dysferlinopathy patients aged 10 years or older, who are ambulant or non-ambulant. The study has reopened for a further two years (COS2). Participants will be assessed at 4 further visits over 2 years via medical, physiotherapy, and MRI/MRS assessments, as well as standard blood tests. Optionally, the participants can donate blood samples and a skin sample for use in the identification of disease markers and other approved research. There is a sub-study running in MRI at selected sites.

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  • Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

    This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.

    Investigator

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  • Immunogenicity of Co-administered Oral Polio Vaccine and Oral Cholera Vaccine

    Concomitant administration of multiple vaccines, including live attenuated immunizations, is safe and effective. Some restrictions apply for live vaccines; administering a live-virus vaccine within 4 weeks after administration of another live-virus vaccine can decrease immunogenicity to the second administered vaccine. Thus, it is recommended that live-virus vaccines should be administered the same day or ≥4 weeks apart. Data on co-administration of the currently available whole-cell killed Oral Cholera Vaccine (OCVs) with other oral vaccines, specifically, oral polio vaccines (OPV) is lacking. Although the risk of immunological interference due to co-administration of live vaccines with non-live vaccines is considered small if at all, a theoretical concern of interference has been raised. Given the substantial geographic correlation between polio- and cholera-affected and at-risk areas, which include some of the world's most impoverished and hard-to-reach populations, a strategy of co-administration of OCV with OPV to children targeted to receive OPVs has the potential to optimize the use of limited resources and improve coverage for both vaccines. The manufacturer recommendation for a two-week interval between administration of OPV and OCV precludes an integrated campaign or routine use in which OCV could be co-administered with OPV.

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  • Early Intervention in Cystic Fibrosis Exacerbation

    Individuals with cystic fibrosis (CF) develop chronic lung infections and suffer intermittent acute exacerbations of their lung disease. Most exacerbations are not treated until they cause increased symptoms, and patients seek medical attention. This proposal details a study of home lung function and symptom monitoring. Subjects will be randomly assigned to one of two groups: 1) home monitoring, in which spirometry and symptoms are recorded; or 2) standard care. The home monitoring data will be transmitted electronically to the study center. If spirometry or symptoms have deteriorated substantially, treatment for a CF pulmonary exacerbation will be initiated. It is anticipated that use of home monitoring will lead to earlier, more reliable recognition and treatment of exacerbations, which will translate into better lung health.

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  • Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus

    Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. There is evidence suggesting that repeated oral administration of an autoantigen (the same protein that the immune system is reacting to) may introduce a protective immunity and cause the immune system to stop its attack. An earlier, large scale study was done to see if oral insulin could delay or prevent the development of Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes. However, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies which are directed against insulin itself ( called mIAA).

    The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.

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  • Case-Control Study of the Glycotest™ HCC Panel vs AFP for the Detection of Early-stage Hepatocellular Carcinoma

    Clinical guidelines (AASLD) recommend the use of abdominal ultrasound (US) for surveillance testing for the early detection of Hepatocellular Carcinoma (HCC). The serum protein biomarker alpha-fetoprotein (AFP) is commonly used to augment US but its use alone is not recommended by clinical guidelines. Despite evidence that HCC surveillance improves early detection and reduces mortality from HCC, current HCC surveillance tests lack sensitivity, leaving a significant proportion of patients to present with late-stage disease. The Glycotest HCC Panel has shown better sensitivity than AFP, which is ineffective for the detection of early-stage HCC. This clinical study seeks to validate the Glycotest HCC Panel using a large multicenter cohort of cases and controls that includes patients diagnosed with early-stage HCC against a background of cirrhosis and cirrhotic patients without HCC (at risk) undergoing an established surveillance protocol.

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