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NCT ID: NCT03868943 Suspended - Glioblastoma Clinical Trials

Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma

JAZZ
Start date: January 27, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects of solriamfetol in improving sleep in patients with grade II-IV glioma. Solriamfetol is a wakefulness-promoting drug. Giving solriamfetol may improve sleep, memory, fatigue, mood, or quality of life in patients with brain tumors (gliomas).

NCT ID: NCT03867500 Suspended - Obesity Clinical Trials

Effects of Niacin on Intramyocellular Fatty Acid Trafficking in Upper Body Obesity and Type 2 Diabetes Mellitus

Start date: November 1, 2018
Phase: Early Phase 1
Study type: Interventional

Muscle insulin resistance is a hallmark of upper body obesity (UBO) and Type 2 diabetes (T2DM). It is unknown whether muscle free fatty acid (FFA) availability or intramyocellular fatty acid trafficking is responsible for the abnormal response to insulin. Likewise, the investigators do not understand to what extent the incorporation of FFA into ceramides or diacylglycerols (DG) affect insulin signaling and muscle glucose uptake. The investigators will measure muscle FFA storage into intramyocellular triglyceride, intramyocellular fatty acid trafficking, activation of the insulin signaling pathway and glucose disposal rates under both saline control (high overnight FFA) and after an overnight infusion of intravenous niacin (lower/normal FFA) to provide the first integrated examination of the interaction between FFA and muscle insulin action from the whole body to the cellular/molecular level. By identifying which steps in the insulin signaling pathway are most affected, the investigators will determine the site-specific effect of ceramides and/or DG on different degrees of insulin resistance. Hypothesis 1: Greater trafficking of plasma FFA into intramyocellular DG will impair proximal insulin signaling and reduce muscle glucose uptake. Hypothesis 2: Lowering FFA in UBO and T2DM by using an intravenous infusion of niacin will alter trafficking of plasma FFA into intramyocellular ceramides in a way that will improve insulin signaling and increase muscle glucose uptake. Hypothesis 3: Lowering FFA in UBO and T2DM by using an intravenous infusion of niacin will alter trafficking of plasma FFA into intramyocellular DG in a way that will improve insulin signaling and increase muscle glucose uptake.

NCT ID: NCT03866668 Suspended - Clinical trials for Autism Spectrum Disorder

A Study of Esomeprazole in Children With Autism

Start date: May 29, 2019
Phase: Phase 2
Study type: Interventional

Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive/stereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of age to participate.

NCT ID: NCT03859752 Suspended - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

TR1801-ADC in Patients With Tumors That Express c-Met

Start date: August 14, 2019
Phase: Phase 1
Study type: Interventional

First-in-human, Phase 1 study to assess safety, tolerability, and pharmacokinetics of TR1801-ADC in patients with select solid tumors that express c-Met.

NCT ID: NCT03855683 Suspended - Anxiety Disorders Clinical Trials

Stress, Anxiety, and Mood Group Therapy

Start date: March 6, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to identify cognitive mechanisms that might facilitate treatment response for individuals experiencing depression and/or anxiety. The Stress, Anxiety, and Mood group helps individuals experiencing symptoms of stress, anxiety, and mood by providing concrete coping skills to regulate emotions, to let go of negative thoughts, and build courage to talk to others about tough topics. Groups meet for 8 weeks, with sessions lasting 90 minutes each. In addition to group therapy, you will be asked to complete some computerized and paper and pencil-based tasks. If you are interested in learning more, please contact us at 650-417-2000 ext. 3642 or paloalto.study@gmail.com. All inquiries will be kept strictly confidential.

NCT ID: NCT03854370 Suspended - Clinical trials for Surgical Site Infection

Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery

Start date: June 21, 2019
Phase: N/A
Study type: Interventional

This is a randomized trial comparing the effectiveness of 4 vaginal prep solutions (betadine, baby shampoo, TechniCare and Peridex) on reducing bacterial colony counts during surgery preparation. Women undergoing a vaginal surgery will be enrolled into the trial prior to surgery. Target sample size per group is 15 patients. During standard surgical prep, a vaginal swab will be taken to assess the initial colony counts for aerobic and anaerobic bacteria. After the initial swab, the incision point will be prepared using one of the prep 4 solutions (betadine, baby shampoo, TechniCare or Peridex). After a predefined 10 minutes, the area will be re-swabbed to determine pre-incision colony counts. A third swab will be collected after incision closure. Laboratory analyses for raw colony counts, sensitivities, identification (using MALDI-TOF) will be performed. The results are expected to show that there will be reduced colony counts at the pre-incision point with baby shampoo having the least reduction, followed by betadine and TechniCare, then Peridex. Patient reported outcomes for vaginal itching and burning as well as patient report of any treatment for vaginal infection will be collected by telephone at 2 days, 2 weeks and 1 month post-surgery.

NCT ID: NCT03845907 Suspended - Breast Cancer Clinical Trials

Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications

Start date: December 19, 2018
Phase: N/A
Study type: Interventional

Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects

NCT ID: NCT03836482 Suspended - Clinical trials for Cardiorenal Syndrome

Selective Cytopheretic Device (SCD) Trial

Start date: November 11, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the selective cytopheretic device on the immune dysregulated state of congestive heart failure(CHF) with CRS and to assess the benefit of the device to improve cardiovascular and renal function. The study will enroll eligible patients in the ICU with acute on chronic systolic heart failure and worsening renal function due to cardiorenal syndrome while awaiting LVAD implantation. In this study patients who are eligible and agree to participate will receive treatment with the SCD. The treatment will be for 6 hours a day up to 6 days. Additionally, participants will have additional study procedures and be evaluated to determine if their kidney function improves enough to undergo LVAD implantation.

NCT ID: NCT03824327 Suspended - Clinical trials for Lung Non-Small Cell Carcinoma

Papaverine and Stereotactic Body Radiotherapy (SBRT) for Non Small Cell Lung Cancer (NSCLC) or Lung Metastases

Start date: February 7, 2019
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and how well papaverine hydrochloride and stereotactic radiation therapy body (SBRT) work in treating patients with non-small cell lung cancer. Papaverine hydrochloride may help radiation therapy work better by making tumor cells more sensitive to the radiation therapy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving papaverine hydrochloride with SBRT may work in treating patients with non-small cell lung cancer.

NCT ID: NCT03804606 Suspended - Heart Failure Clinical Trials

Risk and Benefit Informed MTM Pharmacist Intervention in Heart Failure

Start date: February 28, 2019
Phase: N/A
Study type: Interventional

Out-of-hospital care of complex diseases, such as heart failure, is transitioning from an individual patient-doctor relationship to population health management strategies. As an example, at our institution, medication therapy management (MTM) pharmacists are being deployed to patients with heart failure with the intent of improving patient outcomes (through proper medication management and adherence) while reducing cost (e.g., keeping these patients out of the hospital). The success of such strategies will be dependent on the ability to effectively direct scarce resources to deliver appropriate/needed care to patients. In this prospective, pragmatic randomized and matched controlled study, the investigators hypothesize that the combination of accurate, data-driven benefit models and MTM pharmacist intervention in patients with heart failure will result in reduced 1-year mortality and hospital admissions. Using our extensive historical electronic health record data, the investigators have developed a machine learning model that, for individual patients with heart failure, predicts risk and benefit (that is, reduction in risk) associated with closing specific "care gaps". These care gaps represent standard evidence-based treatments that may be missing for an individual patient, such as beta blockers or flu shots. The investigators will use this model to define three cohorts to be studied: 1) a high risk/high benefit group to be referred for MTM pharmacist intervention, 2) a high risk/high benefit group to continue with existing standard of care (not necessarily involving MTM pharmacy), and 3) a high risk/low benefit group to be referred for MTM pharmacist intervention. Comparison of groups 1 and 2 (for which assignment is randomized) will evaluate the effectiveness of the MTM pharmacy intervention, while comparison of groups 1 and 3 will evaluate the accuracy of the benefit model prediction and importance of appropriate patient selection for treatment. The primary study outcomes will be mortality and number of hospital admissions during 1-year follow-up following study enrollment.