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NCT ID: NCT03865706 Active, not recruiting - Sepsis Clinical Trials

Inulin for Infections in the Intensive Care Unit

Start date: October 14, 2019
Phase: Phase 2
Study type: Interventional

Normal gut bacteria prevent colonization and subsequent infection with MDR organisms (MDROs) through competition for resources and other mechanisms. During critical illness, this function of the microbiome is lost and there are no current treatments to restore it. Preliminary data indicates that the prebiotic fiber inulin is safe and may alter the gastrointestinal microbiome to improve gut barrier function, decrease colonization with MDROs, and reduce downstream risk for intensive care unit (ICU)-acquired MDR infections. However, the impact of inulin during critical illness is unknown. This double-blind, randomized clinical trial will test inulin for the prevention of antibiotic resistant infections in the ICU. The trial's specific aims are to determine (1) the feasibility, tolerability, and safety of inulin in the intensive care unit; (2) the impact of inulin on gut colonization with antibiotic-resistant pathogens; and (2A/exploratory) the impact of inulin on ICU-acquired antibiotic-resistant infections.

NCT ID: NCT03865576 Active, not recruiting - Clinical trials for Intracranial Hypertension

Validation of Non-Invasive Intracranial Pressure (ICP) Monitoring Device

Start date: March 1, 2019
Phase:
Study type: Observational

For purposes of validation, this study compares intracranial pressure measurements obtained with a novel self-calibrating, non-invasive, intracranial pressure measuring (ICP) device, with the values obtained from (a) patients in an intensive care unit (ICU) whose meet standard clinical indications for ICP measurement and whose ICP is measured using gold-standard implanted intracranial instrumentation and in (b) ambulatory subjects who meet clinical indications for lumbar puncture.

NCT ID: NCT03865550 Active, not recruiting - Clinical trials for Osteo Arthritis Knee

Post-op Ketamine Study

Start date: March 28, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to establish the effect of sub-anesthetic dosing of ketamine with spinal anesthesia during total knee arthroplasty on post-operative pain and narcotic consumption. We hypothesize that sub-anesthetic ketamine will decrease post-operative pain and narcotic consumption and may secondarily lead to shorter lengths of stay, faster rehabilitation, improved postoperative outcomes and patient satisfaction.

NCT ID: NCT03865537 Active, not recruiting - Colonoscopy Clinical Trials

Cold Snare Endoscopic Mucosal Resection Trial

LPS-II
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

This study compares different approaches to endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (≥20mm) in a 2 x 2 randomized design. The first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare EMR) and half of patient to polyp resection without electrocautery ("cold" snare EMR). The second randomization will assign half of patients to polyp removal using Eleview as the submucosal injection agent, and the other half using placebo (normal saline with methylene blue) as the submucosal injection agent.

NCT ID: NCT03865498 Active, not recruiting - Loneliness Clinical Trials

Twitter Based Social Support for Hispanic and Black Dementia Caregivers

Tweet-S2
Start date: January 12, 2022
Phase: N/A
Study type: Interventional

The prevalence of dementia is higher in Hispanics and African Americans than non-Hispanic Whites. Moreover, dementia caregivers often experience loneliness as well decreased health status. The expansion of social media use among Hispanics and African Americans, particularly Twitter - a short message service - offers great promise for improving social support. This study aims to evaluate changes of discussion topics, sentiment and networking styles (i.e., number of followers) among anonymous followers of our two Twitter networks; the African American/Black dementia caregiver group and the Hispanic dementia caregiver group.

NCT ID: NCT03865212 Active, not recruiting - Metastatic Melanoma Clinical Trials

Modified Virus VSV-IFNbetaTYRP1 in Treating Patients With Stage III-IV Melanoma

Start date: June 12, 2019
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of a modified virus called VSV-IFNbetaTYRP1 in treating patients with stage III-IV melanoma. The vesicular stomatitis virus (VSV) has been altered to include two extra genes: human interferon beta (hIFNbeta), which may protect normal healthy cells from becoming infected with the virus, and TYRP1, which is expressed mainly in melanocytes (specialized skin cell that produces the protective skin-darkening pigment melanin) and melanoma tumor cells, and may trigger a strong immune response to kill the melanoma tumor cells.

NCT ID: NCT03865082 Active, not recruiting - Solid Tumor Clinical Trials

Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors (ILLUMINATE-206)

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

A Phase 2 study intended to see efficacy of tilsotolimod in combination with immunotherapy drugs ipilimumab and nivolumab in different solid tumors.

NCT ID: NCT03864042 Active, not recruiting - Clinical trials for Advanced Solid Tumors

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

Start date: January 2, 2018
Phase: Phase 1
Study type: Interventional

This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme probe substrates using a probe cocktail, on an organic anion-transporting polypeptide/breast cancer resistance protein (OATP/BCRP) substrate using rosuvastatin and on a CYP2B6 substrate using bupropion. The effect of multiple oral doses of the moderate cytochrome P450 (CYP) inhibitor modafinil on encorafenib in combination with binimetinib will also be assessed. The study will have 2 treatment phases, a drug-drug interaction (DDI) phase followed by a post-DDI phase.

NCT ID: NCT03863704 Active, not recruiting - Ulcerative Colitis Clinical Trials

Transcutaneous VNS to Treat Pediatric IBD

STIMIBD
Start date: February 14, 2019
Phase: N/A
Study type: Interventional

The current available therapies for inflammatory bowel disease (IBD), including immunomodulator and biologic medications may have toxicities limiting use or inadequate effect. We propose a novel approach to the treatment of IBD by using transcutaneous vagal nerve stimulation (VNS). Research has previously identified that VNS using a surgically implanted stimulator can improve symptoms and decrease inflammation in people with inflammatory diseases. This study will evaluate the use of non-invasive nerve stimulation through the skin (rather than through an implanted device) as a potential therapy in pediatric patients with Crohn Disease or ulcerative colitis. We will be evaluating how this nerve stimulation affects symptoms, markers of inflammation found in the blood and stool including cytokine levels, and heart rate variability. The primary hypothesis of the study is the use of transcutaneous VNS will decrease inflammation in people with IBD leading to improved signs and symptoms of disease. The primary endpoint of the study is to evaluate the change in fecal calprotectin after 16 weeks of nerve stimulation. Secondary endpoints include changes in symptom scores, blood cytokine levels, and heart rate variability.

NCT ID: NCT03863184 Active, not recruiting - Clinical trials for Mantle Cell Lymphoma

Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL

Start date: October 11, 2019
Phase: Phase 2
Study type: Interventional

This is a single-arm phase 2 study to evaluate the preliminary evidence of efficacy and safety of the combination of acalabrutinib, lenalidomide and rituximab (ALR) in previously untreated mantle cell lymphoma. The study includes an induction phase consisting of 12 cycles of ALR. Responding subjects will be eligible to enter a maintenance phase. Subjects will continue maintenance ALR until disease progression, development of unacceptable toxicity, or voluntary withdrawal. Subjects will be followed after completing study intervention every 6 months for alternate anti-cancer therapy and survival.